Indilan

Indilan may be available in the countries listed below.

Ingredient matches for Indilan

Indinavir

Indinavir sulphate (a derivative of Indinavir) is reported as an ingredient of Indilan in the following countries:

• Mexico

International Drug Name Search

saquinavir

sa-KWIN-a-vir

Commonly used brand name(s)

In the U.S.

• Invirase

Available Dosage Forms:

• Capsule, Liquid Filled


• Tablet


• Capsule

Therapeutic Class: Antiretroviral Agent

Pharmacologic Class: Protease Inhibitor

Uses For saquinavir

Saquinavir is used in combination with ritonavir (Norvir®) and other medicines for the treatment of the infection caused by the human immunodeficiency virus (HIV). HIV is the virus that causes acquired immune deficiency syndrome (AIDS).

Saquinavir will not cure or prevent HIV infection or AIDS. It helps keep HIV from reproducing and appears to slow down the destruction of the immune system. This may help delay the development of problems usually related to AIDS or HIV disease from occurring. Saquinavir will not keep you from spreading HIV to other people. People who receive saquinavir may continue to have other problems usually related to AIDS or HIV disease.

saquinavir is available only with your doctor's prescription.

Before Using saquinavir

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For saquinavir, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to saquinavir or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of saquinavir in children and teenagers younger than 16 years of age. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of saquinavir in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require caution in patients receiving saquinavir.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking saquinavir, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using saquinavir with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Alfuzosin


• Amiodarone


• Astemizole


• Bepridil


• Cisapride


• Colchicine


• Crizotinib


• Dasatinib


• Dihydroergotamine


• Dofetilide


• Dronedarone


• Ergoloid Mesylates


• Ergonovine


• Ergotamine


• Flecainide


• Lapatinib


• Lidocaine


• Lovastatin


• Mesoridazine


• Methylergonovine


• Midazolam


• Nilotinib


• Pimozide


• Posaconazole


• Propafenone


• Quinidine


• Ranolazine


• Rifampin


• Sildenafil


• Silodosin


• Simvastatin


• Sorafenib


• Sparfloxacin


• Telithromycin


• Terfenadine


• Thioridazine


• Tolvaptan


• Trazodone


• Triazolam


• Vandetanib


• Vemurafenib


• Ziprasidone

Using saquinavir with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Abiraterone


• Amitriptyline


• Amoxapine


• Amprenavir


• Apomorphine


• Arsenic Trioxide


• Asenapine


• Atazanavir


• Azithromycin


• Bosentan


• Brentuximab Vedotin


• Cabazitaxel


• Chloroquine


• Chlorpromazine


• Ciprofloxacin


• Citalopram


• Clarithromycin


• Clomipramine


• Clozapine


• Darunavir


• Desipramine


• Digoxin


• Docetaxel


• Dolasetron


• Droperidol


• Eplerenone


• Erythromycin


• Everolimus


• Fluphenazine


• Fluticasone


• Fosamprenavir


• Fusidic Acid


• Garlic


• Gatifloxacin


• Gemifloxacin


• Granisetron


• Halofantrine


• Haloperidol


• Ibutilide


• Iloperidone


• Imipramine


• Ixabepilone


• Levofloxacin


• Loperamide


• Lopinavir


• Lumefantrine


• Mefloquine


• Methadone


• Moxifloxacin


• Norfloxacin


• Nortriptyline


• Octreotide


• Ofloxacin


• Ondansetron


• Oxycodone


• Paliperidone


• Pazopanib


• Pentamidine


• Perflutren Lipid Microsphere


• Perphenazine


• Procainamide


• Prochlorperazine


• Promazine


• Promethazine


• Protriptyline


• Rifabutin


• Rivaroxaban


• Romidepsin


• Ruxolitinib


• Salmeterol


• Sirolimus


• Sodium Phosphate


• Sodium Phosphate, Dibasic


• Sodium Phosphate, Monobasic


• Sotalol


• St John's Wort


• Sunitinib


• Tadalafil


• Tamsulosin


• Telavancin


• Temsirolimus


• Tetrabenazine


• Ticagrelor


• Tipranavir


• Topotecan


• Toremifene


• Trifluoperazine


• Triflupromazine


• Trimipramine


• Vardenafil


• Venlafaxine

Using saquinavir with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alfentanil


• Atorvastatin


• Cerivastatin


• Cimetidine


• Cyclosporine


• Dapsone


• Delavirdine


• Efavirenz


• Fentanyl


• Fluconazole


• Flunarizine


• Fosphenytoin


• Gallopamil


• Indinavir


• Itraconazole


• Ketoconazole


• Lacidipine


• Maraviroc


• Nelfinavir


• Nevirapine


• Nilvadipine


• Nitrendipine


• Omeprazole


• Rifapentine


• Tacrolimus


• Voriconazole


• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Other Medical Problems

The presence of other medical problems may affect the use of saquinavir. Make sure you tell your doctor if you have any other medical problems, especially:

• Alcoholism, history of or


• Liver disease or


• Diabetes or


• Hemophilia (a bleeding problem) or


• Hyperglycemia (high blood sugar) or


• Hyperlipidemia (high cholesterol or fat in the blood) or


• Liver disease (e.g., hepatitis B or C)—Use with caution. May increase your chance for serious side effects.

• Heart block without a pacemaker or


• Heart rhythm problems (e.g., congenital long QT syndrome) or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood) or


• Liver disease, severe—Should not be used in patients with these conditions.

• Heart disease (e.g., cardiomyopathy, ischemia, congestive heart failure), history of or


• Heart rhythm problems (e.g., arrhythmias, prolonged PR or QT interval), history of—Use with caution. May increase risk for more serious side effects.

• Lactose intolerance—Use with caution. Saquinavir capsules contain lactose.

Proper Use of saquinavir

Take saquinavir exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. Also, do not stop taking saquinavir without checking first with your doctor.

It is important that saquinavir be taken with food in order to work properly. Take saquinavir within 2 hours after a meal.

Saquinavir capsules or tablets (Invirase®) should always be taken together, at the same time, with ritonavir (Norvir®). Take all other medicines your doctor has prescribed at the right time of the day. This will make your medicines work better.

Keep taking saquinavir for the full time of treatment, even if you begin to feel better.

saquinavir works best when there is a constant amount in the blood. To help keep blood levels constant, take saquinavir at the same time each day and do not miss any doses. It is best to take the doses at evenly spaced times, day and night. For example, if you are to take three doses a day, the doses should be spaced about 8 hours apart. If you need help in planning the best times to take your medicine, check with your doctor.

Only take medicine that your doctor has prescribed especially for you. Do not share your medicine with others.

Read and carefully follow the Medication Guide and patient information leaflet before starting saquinavir treatment and each time you get a refill. Ask your doctor if you have any questions.

Dosing

The dose of saquinavir will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of saquinavir. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For treatment of HIV infection:
  
  • For oral dosage form (capsules or tablets):
    
    • Taken in combination with ritonavir (Norvir®):
      
      • Adults and teenagers 16 years of age and older—1000 milligrams (mg) (5 capsules or 2 tablets) of saquinavir and 100 mg of ritonavir two times per day.
      
      
      • Children younger than 16 years of age—Use and dose must be determined by your doctor.
      
      
    
    
    • Taken in combination with lopinavir/ritonavir (Kaletra®):
      
      • Adults and teenagers 16 years of age and older—1000 milligrams (mg) (5 capsules or 2 tablets) of saquinavir and 400 mg of lopinavir plus 100 mg of ritonavir two times per day.
      
      
      • Children younger than 16 years of age—Use and dose must be determined by your doctor.
      
      
    
    
  
  

Missed Dose

If you miss a dose of saquinavir, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using saquinavir

It is very important that your doctor check the progress of you or your child at regular visits to make sure saquinavir is working properly. Blood tests may be needed to check for unwanted effects.

You should not take saquinavir if you or your child are also taking medicine for heart rhythm problems (e.g., amiodarone, bepridil, dofetilide, flecainide, lidocaine, propafenone, quinidine, Cordarone®, Pacerone®, Quinora®, Rhythmol®, Tambocor®, Tikosyn®, or Vascor®), ergotamine medicines (e.g., dihydroergotamine, ergonovine, ergotamine, methylergonovine, Cafergot®, D.H.E. 45®, Embolex®, Ergomar®, Ergostate®, Ergotrate®, Methergine®, Migergot®, Migranal®, Wigraine®, or Wigrettes®), medicine to lower cholesterol (e.g., lovastatin, simvastatin, Advicor®, Altoprev®, Mevacor®, Simcor®, Vytorin®, or Zocor®), alfuzosin (Uroxatral®), astemizole (Hismanal®), cisapride (Propulsid®), fluticasone (Flonase®), oral midazolam (Versed®), pimozide (Orap®), rifampin (Rifadin®, Rifamate®, Rifater®, Rimactane®), sildenafil (Revatio®), terfenadine (Seldane®), tipranavir (Aptivus®), trazodone (Desyrel®, Oleptro®), or triazolam (Halcion®). Taking any of these together with saquinavir may increase the chance for serious side effects.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort, garlic capsules) or vitamin supplements.

saquinavir may decrease the effects of some oral contraceptives (birth control pills). To keep from getting pregnant, use an additional form of birth control together with your pills, such as condoms, diaphragms, or contraceptive foams or jellies.

saquinavir can cause changes in heart rhythms, such as a condition called PR or QT interval prolongation. It may change the way your heart beats and cause fainting or serious side effects in some patients. Contact your doctor right away if you or your child have any symptoms of heart rhythm problems, such as fast, pounding, or irregular heartbeats.

saquinavir may increase blood sugar levels. Check with your doctor if you or your child notice a change in the results of your blood or urine sugar tests.

Check with your doctor right away if you or your child have pain or tenderness in the upper stomach; pale stools; dark urine; loss of appetite; nausea; unusual tiredness or weakness; or yellow eyes or skin. These could be symptoms of a serious liver problem.

Saquinavir does not decrease the risk of transmitting the HIV infection to others through sexual contact or by contamination through blood. HIV may be acquired from or spread to others through infected body fluids, including blood, vaginal fluid, or semen. If you are infected, it is best to avoid any sexual activity involving an exchange of body fluids with other people. If you do have sex, always wear (or have your partner wear) a condom (“rubber”). Only use condoms made of latex, and use them every time you have vaginal, anal, or oral sex. The use of a spermicide (such as nonoxynol-9) may also help prevent the spread of HIV if it is not irritating to the vagina, rectum, or mouth. Spermicides have been shown to kill HIV in lab tests. Do not use oil-based jelly, cold cream, baby oil, or shortening as a lubricant—these products can cause the condom to break. Lubricants without oil, such as K-Y Jelly, are recommended. Women may wish to carry their own condoms. Birth control pills and diaphragms will help protect against pregnancy, but they will not prevent someone from giving or getting the AIDS virus. If you inject drugs, get help to stop. Do not share needles or equipment with anyone. In some cities, more than half of the drug users are infected, and sharing even 1 needle or syringe can spread the virus. If you have any questions about this, check with your doctor.

When you start taking HIV medicines, your immune system may get stronger. If you or your child have certain infections, such as pneumonia or tuberculosis, you may notice new symptoms when your body tries to fight them. If this occurs, be sure to tell your doctor right away.

saquinavir may cause you to have excess body fat. Tell your doctor if you or your child notice changes in your body shape, such as an increased amount of fat in the upper back and neck, or around the chest and stomach area; or a loss of fat from the legs, arms, and face.

saquinavir Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Chest pain


• cough


• fever or chills


• increased amount of fat in the upper back and neck, or around the chest and stomach area


• loss of fat from the legs, arms, and face


• shortness of breath


• sneezing


• sore throat


• tightness in the chest


• troubled breathing


• wheezing

Less common

• Blurred vision


• cough-producing mucus


• diarrhea


• difficulty with breathing


• dry mouth


• flushed, dry skin


• fruit-like breath odor


• general feeling of discomfort or illness


• headache


• increased hunger


• increased thirst


• increased urination


• joint pain


• loss of appetite


• loss of consciousness


• muscle aches and pains


• nausea


• runny nose


• shivering


• skin rash


• sore throat


• stomachache


• sweating


• trouble sleeping


• troubled breathing


• unexplained weight loss


• unusual tiredness or weakness


• vomiting

Rare

• Burning or prickling sensation


• confusion


• dehydration


• dry or itchy skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common

• Acid or sour stomach


• back pain


• belching


• bloated or full feeling


• change in taste


• decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• discouragement


• excess air or gas in the stomach or intestines


• fear


• feeling sad or empty


• headache


• heartburn


• inability to have or keep an erection


• indigestion


• irritability


• lack of appetite


• loss in sexual ability, desire, drive, or performance


• loss of interest or pleasure


• mouth ulcers


• nervousness


• pain or tenderness around the eyes and cheekbones


• passing gas


• skin rash, encrusted, scaly, and oozing


• skin warts


• sleeplessness


• stomach upset, discomfort, or pain


• stuffy nose


• tiredness


• trouble concentrating


• unable to sleep


• weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: saquinavir side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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More saquinavir resources

• Saquinavir Side Effects (in more detail)
• Saquinavir Use in Pregnancy & Breastfeeding
• Saquinavir Drug Interactions
• Saquinavir Support Group
• 0 Reviews for Saquinavir - Add your own review/rating

• Saquinavir Monograph (AHFS DI)


• Saquinavir MedFacts Consumer Leaflet (Wolters Kluwer)


• Fortovase Prescribing Information (FDA)


• Invirase Prescribing Information (FDA)


• Invirase MedFacts Consumer Leaflet (Wolters Kluwer)


• Invirase Consumer Overview

Compare saquinavir with other medications

• HIV Infection
• Nonoccupational Exposure

Hypaque-76

Dosage Form: Injection, USP 76%

Sterile Aqueous Injection

For Excretory Urography

Aortography

Angiocardiography (Ventriculography, Pulmonary

Angiography, Selective Coronary Arteriography)

Peripheral Angiography (Peripheral Arteriography

and Peripheral Venography)

Intravenous Digital Arteriography

Contrast Enhancement of Computed

Tomographic Head Imaging

Contrast Enhancement of Computed

Tomographic Body Imaging

Selective Renal Arteriography

Selective Visceral Arteriography

Central Venography

Renal Venography

NOT FOR INTRATHECAL USE

Hypaque-76 Description

Hypaque-76, brand of diatrizoate meglumine and diatrizoate sodium, is a water-soluble, radiopaque diagnostic medium. It is supplied as a 76 percent sterile aqueous solution providing 66 percent (w/v) diatrizoate meglumine and 10 percent (w/v) diatrizoate sodium. It is a triiodinated benzoic acid derivative containing 37 percent (w/v) organically bound iodine. Each mL contains 370 mg iodine and 3.68 mg (0.16 mEq) sodium. It is constituted as a radiopaque iodinated anion, diatrizoate, and the radiolucent cations meglumine and sodium. It is the organically bound iodine of the anion which opacifies internal structures for x-ray visualization and fluoroscopy.

The solution is hypertonic to blood with an osmolality of 2016 mosm/kg (determined by VPO). The viscosity is 9 cp at 37° C. The pH is adjusted between 6.0 and 7.7 using Na2CO3 with HCl or NaOH. The pKa is 3.4 for diatrizoic acid. Edetate calcium disodium 0.01 percent has been added as a sequestering stabilizing agent. The solution is clear, colorless to pale yellow.

Diatrizoate meglumine is 1-deoxy-1-(methylamino)-D-glucitol 3, 5-diacetamido-2,4,6-triiodobenzoate (salt) and has the following structural formula:

Diatrizoate sodium is monosodium, 3, 5-diacetamido-2,4,6-triiodobenzoate and has the following structural formula:

Hypaque-76 - Clinical Pharmacology

Intravascular injection of a radiopaque diagnostic agent opacifies those vessels in the path of the flow of the contrast medium, permitting radiographic visualization of the internal structures of the human body until significant hemodilution occurs.

At physiologic pH, the water-soluble contrast media are completely dissociated into a radiopaque anion and a solubilizing cation. While circulating in tissue fluids, the compound remains ionized. However, it is not metabolized but excreted unchanged in the urine, each diatrizoate molecule remaining "obligated" to its sodium or meglumine moiety.

Following intravenous injection, the radiopaque diagnostic agents are immediately diluted in the circulating plasma. Equilibrium is reached with the extracellular compartment at about 10 minutes. Hence, the plasma concentration at 10 minutes is closely related to the dose corrected to body size.

The pharmacokinetics of the intravenously administered radiopaque contrast media are usually best described by a two compartment model with a rapid alpha phase for drug distribution and a slow beta phase for drug elimination. In patients with normal renal function, the alpha and beta half-lives were respectively 30 minutes and 120 minutes for diatrizoate. But in patients with renal functional impairment, the elimination half-life for the beta phase can be prolonged up to several days.

Injectable radiopaque diagnostic agents are excreted either through the liver or through the kidneys. These two excretory pathways are not mutually exclusive, but the main route of excretion seems to be governed by the affinity of the contrast medium for serum albumin. From 0% to 10% of diatrizoate sodium is bound to serum protein.

Diatrizoate salts are excreted unchanged predominantly through the kidneys by glomerular filtration. The amount excreted by the kidney during any period of time is determined by the filtered load; i.e., the product of plasma contrast media concentration and glomerular filtration rate. The plasma concentration is dependent upon the dose administered and the body size. The glomerular filtration rate varies with the body size, sex, age, circulatory dynamics, diuretic effect of the drug, and renal function. In patients with normal renal function the maximum urinary concentration of diatrizoate meglumine and diatrizoate sodium occurs within 10 minutes with 12 percent of the administered dose being excreted. The mean values of cumulative urinary excretion for diatrizoate meglumine and diatrizoate sodium expressed as percentage of administered dose are 38 percent at 60 minutes, 45 percent at 3 hours, and 94 to 100 percent at 24 hours.

Urinary excretion of contrast media is delayed in infants younger than 1 month and in patients with urinary tract obstruction. The urinary iodine concentration is higher with the sodium salt of diatrizoic acid than with the meglumine salt.

The liver and small intestine provide the major alternate route of excretion for diatrizoate. In patients free of severe renal disease, the fecal recovery is less than 2 percent of the administered dose. In patients with severe renal impairment the excretion of these contrast media through the gallbladder and into the small intestine sharply increases; up to 20 percent of the administered dose has been recovered in the feces in 48 hours.

Saliva is a minor secretory pathway for injectable radiopaque diagnostic agents. In patients with normal renal function, minimal amounts of contrast media are secreted unchanged. However, in uremic patients small amounts of free iodides resulting from deiodination prior to administration or in vivo, have been detected in the saliva.

Diatrizoate salts cross the placental barrier in humans by simple diffusion and appear to enter fetal tissue passively. No apparent harm to the fetus was observed when diatrizoate sodium and diatrizoate meglumine were injected intravenously 24 hours prior to delivery. However, abnormal neonatal opacification of the small intestine and colon were detected 4 to 6 days after delivery. Procedures including radiation involve a certain risk related to the exposure of the fetus. (See PRECAUTIONS—General, Pregnancy Category C.)

Injectable radiopaque diagnostic agents are excreted unchanged in human milk. (See PRECAUTIONS—General, Nursing Mothers.)

Computed Tomography

Hypaque-76 enhances computed tomographic brain scanning through augmentation of radiographic efficiency. The degree of enhancement of visualization of tissue density is directly related to the iodine content in an administered dose; peak iodine blood levels occur immediately following rapid injection of the dose. These levels fall rapidly within five to ten minutes. This can be accounted for by the dilution in the vascular and extracellular fluid compartments which causes an initial sharp fall in plasma concentration. Equilibration with the extracellular compartments is reached in about ten minutes; thereafter, the fall becomes exponential. Maximum contrast enhancement frequently occurs after peak blood iodine levels are reached. The delay in maximum contrast enhancement can range from five to forty minutes, depending on the peak iodine levels achieved and the cell type of the lesion. This lag suggests that radiographic contrast enhancement is at least in part dependent on the accumulation of iodine within the lesion and outside the blood pool, although the mechanism by which this occurs is not clear. The radiographic enhancement of nontumoral lesions, such as arteriovenous malformations and aneurysms, is probably dependent on the iodine content of the circulating blood pool.

In brain scanning, Hypaque-76, brand of diatrizoate meglumine and diatrizoate sodium injection, does not accumulate in normal brain tissue due to the presence of the blood-brain barrier. The increase in x-ray absorption in normal brain is due to the presence of contrast agent within the blood pool. A break in the blood-brain barrier such as occurs in malignant tumors of the brain allows the accumulation of the contrast medium within the interstitial tumor tissue. Adjacent normal brain tissue does not contain the contrast medium.

In nonneural tissues (during computed tomography of the body), diatrizoate diffuses rapidly from the vascular into the extravascular space. Increase in x-ray absorption is related to blood flow, concentration of the contrast medium, and extraction of the contrast medium by interstitial tumor tissue since no barrier exists. Contrast enhancement is thus due to the relative differences in extravascular diffusion between normal and abnormal tissue, quite different from that in the brain.

The pharmacokinetics of diatrizoate in both normal and abnormal tissue have been shown to be variable. Contrast enhancement appears to be greatest soon after administration of the contrast medium, and following intra-arterial rather than intravenous administration. The greatest enhancement can be detected by a series of consecutive two- to three-second scans performed just after injection (within 30 to 90 seconds), i.e., dynamic computed tomographic scanning.

Effects of Steroid Therapy

The anti-inflammatory and antiedema effects in patients receiving steroid therapy have interfered with the expected distribution of CT tissue enhancement on the scan in certain diseases.

Indications and Usage for Hypaque-76

Hypaque-76 is indicated for excretory urography, aortography, angiocardiography (ventriculography, pulmonary angiography, selective coronary arteriography), peripheral angiography (peripheral arteriography and peripheral venography), intravenous digital arteriography, contrast enhancement of computed tomographic head imaging, contrast enhancement of computed tomographic body imaging, selective renal arteriography, selective visceral arteriography, central venography, and renal venography.

In addition to the following generalCONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS, there are additional listings in these categories under the particular procedures.

CONTRAINDICATIONS—General

Hypaque-76 has no absolute contraindications in its recommended uses (see general WARNINGS and PRECAUTIONS).

Do not use Hypaque-76 for myelography or for examination of dorsal cysts or sinuses which might communicate with the subarachnoid space. Even a small amount in the subarachnoid space may produce convulsions and result in fatality. (See also AORTOGRAPHY, Warnings.) Epidural injection is also contraindicated.

Hypaque-76 should not be injected directly into the carotid, vertebral, or spinal arteries.

Hypaque-76 is contraindicated in patients with a hypersensitivity to salts of diatrizoic acid.

Urography is contraindicated in patients with anuria.

Urography and large dose vascular procedures are contraindicated in dehydrated azotemic patients. (See also PRECAUTIONS—General.)

WARNINGS—General

SEVERE ADVERSE EVENTS - INADVERTENT INTRATHECAL ADMINISTRATION

Serious adverse reactions have been reported due to the inadvertent intrathecal administration of iodinated contrast media that are not indicated for intrathecal use. These serious adverse reactions include: death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema. Special attention must be given to insure that this drug product is not administered intrathecally.

Ionic iodinated contrast media inhibit blood coagulation, in vitro, more than nonionic contrast media. Nonetheless, it is prudent to avoid prolonged contact of blood with syringes containing ionic contrast media.

Serious, rarely fatal, thromboembolic events causing myocardial infarction and stroke have been reported during angiographic procedures with both ionic and nonionic contrast media. Therefore, meticulous intravascular administration technique is necessary, particularly during angiographic procedures, to minimize thromboembolic events. Numerous factors, including length of procedure, catheter and syringe material, underlying disease state and concomitant medications may contribute to the development of thromboembolic events. For these reasons, meticulous angiographic techniques are recommended including close attention to guidewire and catheter manipulation, use of manifold systems and/or three-way stopcocks, frequent catheter flushing with heparinized saline solutions and minimizing the length of the procedure. The use of plastic syringes in place of glass syringes has been reported to decrease but not eliminate the likelihood of in vitro clotting.

Excretory urography is potentially hazardous in patients with multiple myeloma. In some of those patients, therapeutically resistant anuria resulting in progressive uremia, renal failure, and eventually death has followed this procedure. Although neither the contrast agent nor dehydration has been proved separately to be the cause of anuria in myelomatous patients, it has been speculated that the combination of both may be causative. The risk of excretory urography in myelomatous patients is not a contraindication to the procedure; however, they require special precautions. Partial dehydration in the preparation of these patients for the examination is not recommended since this may predispose to the precipitation of myeloma protein in the renal tubules. Myeloma, which occurs most commonly in persons over age 40, should be considered before instituting urographic procedures.

Contrast media may promote sickling in individuals who are homozygous for sickle cell disease when the material is injected intravenously or intra-arterially.

Administration of radiopaque materials to patients known or suspected of having pheochromocytoma should be performed with extreme caution. If, in the opinion of the physician, the possible benefits of such procedures outweigh the considered risks, the procedures may be performed; however, the amount of radiopaque medium injected should be kept to an absolute minimum. The blood pressure should be assessed throughout the procedure and measures for treatment of a hypertensive crisis should be available.

Recent reports of thyroid storm occurring following the intravascular use of iodinated radiopaque diagnostic agents in patients with hyperthyroidism or with an autonomously functioning thyroid nodule suggest that this additional risk be evaluated in such patients before use of diatrizoate salts.

Contrast media administered for cardiac catheterization and angiocardiography may cause cellular injury to circulating lymphocytes. Chromosomal damage in humans includes inhibition of mitosis, increases in the number of micronuclei, and chromosome aberrations. The damages appear to be related to the contrast medium itself rather than to the x-ray radiation. It is to be noted that those agents have not been adequately tested in animal or laboratory systems.

Urography should be performed with caution in patients with severely impaired renal function and patients with combined renal and hepatic disease.

Subcutaneous extravasation causes transitory stinging, chiefly because of hypertonic cellulitis. If the volume extravasated is small, ill effects are very unlikely. However, if the extravasation is extensive, especially in poorly vascularized areas (e.g., dorsum of the foot or hand), and especially in the presence of vascular disease, skin slough may occur. Injection of sterile water to dilute or addition of spreading agents to speed absorption have not been successful and may aggravate the condition.

Selective spinal arteriography or arteriography of trunks providing spinal branches can cause mild to severe muscle spasm. However, serious neurologic sequelae, including permanent paralysis, could occur with even small doses of the 76 percent concentration.

In patients with subarachnoid hemorrhage, a rare association between contrast administration and clinical deterioration, including convulsions and death, has been reported. Therefore, administration of intravascular iodinated ionic contrast media in these patients should be undertaken with caution.

PRECAUTIONS—General

Diagnostic procedures which involve the use of radiopaque diagnostic agents should be carried out under the direction of personnel with the prerequisite training and with a thorough knowledge of the particular procedure to be performed. Appropriate facilities should be available for coping with any complication of the procedure, as well as for emergency treatment of severe reactions to the contrast agent itself. After parenteral administration of a radiopaque agent, competent personnel and emergency facilities should be available for at least 30 to 60 minutes since severe delayed reactions have occurred (see ADVERSE REACTIONS—General).

The possibility of a reaction, including serious, life-threatening, fatal, anaphylactic or cardiovascular reactions should always be considered (see ADVERSE REACTIONS). It is of utmost importance that a course of action be carefully planned in advance for immediate treatment of serious reactions, and that adequate and appropriate personnel be readily available in case of any reaction.

The possibility of an idiosyncratic reaction in susceptible patients should always be considered (see ADVERSE REACTIONS—General). The susceptible population includes patients with a history of a previous reaction to a contrast media, patients with a known sensitivity to iodine per se, and patients with a known clinical hypersensitivity: bronchial asthma, hay fever, and food allergies.

The occurrence of severe idiosyncratic reactions has prompted the use of several pretesting methods. However, pretesting cannot be relied upon to predict severe reactions and may itself be hazardous for the patient. It is suggested that a thorough medical history with emphasis on allergy and hypersensitivity, prior to the injection of any contrast media, may be more accurate than pretesting in predicting potential adverse reactions.

A positive history of allergies or hypersensitivity does not arbitrarily contraindicate the use of a contrast agent, where a diagnostic procedure is thought essential, but caution should be exercised (see ADVERSE REACTIONS—General). Premedication with antihistamines or corticosteroids to avoid or minimize possible allergic reactions in such patients should be considered. Recent reports indicate that such pretreatment does not prevent serious life-threatening reactions, but may reduce both their incidence and severity.

Preparatory dehydration for angiography and CT procedures is unnecessary and may be dangerous, contributing to acute renal failure in infants, young children, the elderly, patients with preexisting renal insufficiency, patients with advanced vascular disease, and diabetic patients. Dehydration in these patients seems to be enhanced by the osmotic diuretic action of urographic agents. Overnight fluid restriction for urography may be undesirable and is considered unnecessary when using this relatively high (76%) concentration.

Although azotemia is not a contraindication, the medium should be used with great care in patients with advanced renal destruction associated with severe uremia. (See also EXCRETORY UROGRAPHY, Precautions.)

Acute renal failure has been reported in diabetic patients with diabetic nephropathy and in susceptible nondiabetic patients (often elderly with preexisting renal disease) following excretory urography. Therefore, careful consideration of the potential risks should be given before performing this radiographic procedure in these patients. (See also EXCRETORY UROGRAPHY, Precautions—Preparatory Dehydration.)

Immediately following surgery, excretory urography should be used with caution in renal transplant recipients.

Due to the transitory increase in the circulatory osmotic load, injections of urographic agents should be used with caution in patients with congestive heart failure. Such patients should be observed for several hours following the procedure to detect delayed hemodynamic disturbances.

General anesthesia may be indicated in the performance of some procedures, in young or uncooperative children and in selected adult patients; however, a higher incidence of adverse reactions has been reported in these patients, and may be attributable to the inability of the patient to identify untoward symptoms, or to the hypotensive effect of anesthesia, which can reduce cardiac output and increase the duration of exposure to the contrast agent.

Seizure activity is rare (about 0.01%) on intravenous injection of ionic contrast media. However, in the higher doses used for CT in patients with brain metastases the incidence can be much higher (1% to 10%). In these patients prophylactic use of a small parenteral dose of diazepam is suggested immediately before injection when extra high dose CT regimens are employed.

In addition to the general precautions already described, excretory urography, angiography, and other uses also have hazards associated with the particular techniques employed. (See INDIVIDUAL INDICATIONS AND USAGE section.)

Information for Patients

Patients receiving injectable radiopaque diagnostic agents should be instructed to:

1. Inform the physician if they are pregnant (see CLINICAL PHARMACOLOGY).


2. Inform the physician if they are diabetic or if they have multiple myeloma, pheochromocytoma, homozygous sickle cell disease or known thyroid disorder (see WARNINGS—General).


3. Inform the physician if they are allergic to any drugs, food, or if they have had any reactions to previous injections of dyes used for x-ray procedures (see PRECAUTIONS—General).


4. Inform the physician about any other medications they are currently taking, including nonprescription drugs, before they are administered this drug.

Drug Interactions

Renal toxicity has been reported in a few patients with liver dysfunction who were given oral cholecystographic agents followed by urographic agents. Administration of intravascular urographic agents should therefore be postponed in any patient with a known or suspected hepatic or biliary disorder who has recently received a cholecystographic contrast agent.

Addition of an inotropic agent to contrast agents may produce a paradoxical depressant response which can be deleterious to the ischemic myocardium.

Diphenhydramine hydrochloride may cause precipitation when mixed in the same syringe with Hypaque-76.

Under certain circumstances (pH, temperature, concentrations, time), diatrizoate solutions are incompatible with promethazine hydrochloride, diphenhydramine hydrochloride, brompheniramine maleate, or papavarine hydrochloride solutions.

Do not prefill plastic syringes with Hypaque-76 for prolonged periods (i.e., for several hours or longer) before use.

Drug/Laboratory Test Interactions

If any of these studies, which might be affected by contrast media, are indicated, it is recommended that they be performed prior to administration of the contrast medium or two or more days afterwards.

Diatrizoate salts interfere with several laboratory urine and blood tests.

Blood Tests

Coagulation: Diatrizoate salts significantly inhibit all stages of coagulation. The fibrinogen concentration and Factors V, VII, and VIII are decreased. Prothrombin time and thromboplastin time are increased.

Platelet aggregation: High levels of plasma diatrizoates inhibit platelet aggregation.

Serum calcium: Diatrizoate salts may decrease serum calcium levels. However, this depletion of serum calcium may also be the result of the addition of chelating agents (edetate disodium) in the preparation of certain contrast media.

Red cell counts: Transitory decreases in red cell counts. Technetium-99m—RBC labeling interference.

Leukocyte counts: Decrease.

Urea nitrogen (BUN): Transitory increase (see CLINICAL PHARMACOLOGY).

Serum creatinine: Transitory increase.

Urine Tests

Contrast media which are excreted in the urine may interfere with some laboratory determinations, eg, proteinuria, specific gravity, osmolality, or bacterial cultures.

Thyroid Function Tests

Protein-bound iodine (PBI) and total serum organic iodine: Transient increase of both tests following urography have been noticed. The results of PBI and radioactive iodine uptake studies which depend on iodine estimations will not accurately reflect thyroid function for up to 16 days following administration of iodinated urographic media. However, thyroid function tests not depending on iodine estimations, eg, T3 resin uptake or free thyroxine assays, are not affected.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term studies in animals have not been performed in order to evaluate carcinogenic potential, mutagenesis, or whether Hypaque-76 can affect fertility in males or females.

Pregnancy Category C

Animal reproduction studies have not been conducted with Hypaque-76. It is also not known whether Hypaque-76 can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hypaque-76 should be given to a pregnant woman only if clearly needed.

Labor and Delivery

It is not known whether use of these contrast agents during labor or delivery has immediate or delayed adverse effects on the fetus, prolongs the duration of labor or increases the likelihood that forceps delivery or other obstetrical intervention or resuscitation of the newborn will be necessary.

Nursing Mothers

Diatrizoate salts are excreted unchanged in human milk. Because of the potential adverse reactions, although it has not been established that serious adverse reactions occur in nursing infants, caution should be exercised when these contrast media are administered to a nursing woman.

Pediatric Use

Infants and small children should not have any fluid restriction prior to excretory urography or any other procedures (see PRECAUTIONS—General). Guidelines for pediatric dosages are presented in DOSAGE AND ADMINISTRATION—General.

ADVERSE REACTIONS—General

Approximately 95 percent of adverse reactions accompanying the intravascular use of diatrizoate salts are of mild to moderate severity. However, life-threatening reactions and fatalities, mostly of cardiovascular origin, have occurred.

Adverse reactions to injectable contrast media fall into two categories: chemotoxic reactions and idiosyncratic reactions.

Chemotoxic reactions result from the physicochemical properties of the contrast media, the dose, and the speed of injection. All hemodynamic disturbances and injuries to organs or vessels perfused by the contrast medium are included in this category.

Idiosyncratic reactions include all other reactions. They occur more frequently in patients 20 to 40 years old. Idiosyncratic reactions may or may not be dependent on the amount of dose injected, the speed of injection, the mode of injection, and the radiographic procedure. Idiosyncratic reactions are subdivided into minor, intermediate, and severe. The minor reactions are self-limited and of short duration; the severe reactions are life-threatening and treatment is urgent and mandatory.

The reported incidence of adverse reactions to contrast media in patients with a history of allergy are twice that of the general population. Patients with a history of previous reactions to a contrast medium are three times more susceptible than other patients. However, sensitivity to contrast media does not appear to increase with repeated examinations.

Most adverse reactions to injectable contrast media appear within one to three minutes after the start of injection, but delayed reactions may occur.

Adverse reactions are grouped by organ system and listed below by decreasing order of occurrence and with an approximate incidence of occurrence. Significantly more severe reactions are listed before the other reactions regardless of frequency.

Greater Than 1 in 100 Patients

Body as a Whole: Reported incidences of death range from 6.6 per 1 million (0.00066 percent) to 1 in 10,000 patients (0.01 percent). Most deaths occur during injection or 5 to 10 minutes later, the main feature being cardiac arrest with cardiovascular disease as the main aggravating factor.

Isolated reports of hypotensive collapse and shock following urography are found in the literature. The incidence of shock is estimated to occur in 1 out of 20,000 (0.005 percent) patients.

Cardiovascular System: The most frequent adverse reaction to diatrizoate salts is vasodilation (feeling of warmth). The estimated incidence is 49 percent.

Digestive System: Nausea 6 percent, vomiting 3 percent.

Nervous System: Paresthesia 6 percent, dizziness 5 percent.

Respiratory System: Rhinitis 1 percent, increased cough 2 percent.

Skin and Appendages: Urticaria 1 percent.

Pain at the injection site is estimated to occur in about 12 percent of the patients undergoing urography. Pain is usually due to extravasation.

Painful hot erythematous swelling above the venipuncture site was estimated to occur in more than one percent of the patients undergoing phlebography.

Special Senses: Perversion of taste 11 percent.

Urogenital System: Osmotic nephrosis of the proximal tubular cells is estimated to occur in 23 percent of patients following excretory urography.

Less Than 1 in 100 Patients

Other infrequently reported reactions without accompanying incidence rates are listed below, grouped by organ system.

Body as a Whole: Malaria relapse, uremia, high creatinine and BUN (see PRECAUTIONS—General, Drug/Laboratory Test Interactions), thrombocytopenia, leukopenia, and anemia.

Cardiovascular System: Cerebral hematomas, hemodynamic disturbances, sinus bradycardia, transient electrocardiographic abnormalities, ventricular fibrillation, petechiae, chest pain, and cardiac arrest.

Digestive System: Severe unilateral or bilateral swelling of the parotid and submaxillary glands.

Nervous System: Convulsions, paralysis, and coma. (See PRECAUTIONS—General.)

Respiratory System: Asthma, dyspnea, laryngeal edema, pulmonary edema, and bronchospasm.

Skin and Appendages: Extravasation necrosis, urticaria with or without pruritus, mucocutaneous edema, and angioneurotic edema.

Special Senses: Bilateral ocular irritation, lacrimation, itching, conjunctival chemosis, infection, and conjunctivitis.

Urogenital: Renal failure, pain.

Overdosage

At dosage levels of diatrizoate sodium above a level containing 45 g of iodine, the incidence of unpleasant side effects increases. At total dosage equivalent to 80 gI or 90 gI administered over a short period of time (e.g., 30 minutes), clinical signs of systemic intolerance appear (mostly related to hyperosmolar effects) and are manifest as tremors, irritability, and tachycardia. Above these maximal tolerated dosage levels in otherwise healthy adults, an increasing incidence and severity of dyspnea and pulmonary edema should be expected.

Four cases of overdosage in infants, during urography, are reported. Three of the infants died within 19 hours of the injection. The overdose ranged from slightly above the recommended pediatric dosage to a dose exceeding 19 g/kg. The symptoms of overdosage appeared between 10 minutes to several hours after injection of the contrast medium. Adverse effects were life-threatening, affecting mainly the pulmonary and cardiovascular systems. The symptoms included: cyanosis, bradycardia, acidosis, pulmonary hemorrhage, convulsions, coma, and cardiac arrest. All infants showed a poor visualization of the kidneys and a diffuse opacification of all the tissues and vasculature. Autopsy findings showed acute pulmonary damage and/or edema of subcutaneous tissues. Treatment of an overdose of injectable radiopaque contrast media is directed toward the support of all vital functions, and prompt institution of symptomatic therapy.

The acute intravenous LD50 of diatrizoate salts in mice is equivalent in iodine content of 5.3 gI/kg to 8.0 gI/kg and seems to be directly proportioned to the rate of injection.

Diatrizoate salts are dialyzable.

DOSAGE AND ADMINISTRATION—General

Preparation of the patient will vary with preference of the radiologist and the type of radiological procedure performed. Specific radiographic procedures used will depend on the state of the patient and the diagnostic indications. Individual dose should be tailored according to age, body size, and indication for examination. (See INDIVIDUAL INDICATIONS AND USAGE section for specific Dosage and Administration.)

Solutions of radiopaque diagnostic agents for intravascular use should be at body temperature when injected and may need to be warmed before use. In the event that crystallization occurs, the solution may be clarified by placing the vial in a water bath at 40°C to 50°C and shaking it gently for two to three minutes or until the solids redissolve. If the particles still persist, do not use this vial but discard it. The solution may be autoclaved once.

The solution should be stored at room temperature and protected from strong light and any unused portion remaining in the container should be discarded.

Dilution and withdrawal of the contrast agents should be accomplished under aseptic conditions with sterile syringes.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Avoid contaminating catheters, syringes, needles, and contrast media with glove powder or cotton fibers.

Pediatric Dosage

Pediatric doses of injectable radiopaque diagnostic agents are generally determined on a weight basis and should be calculated for each patient individually. (See INDIVIDUAL INDICATIONS AND USAGE section.)

Drug Incompatibilities

Diatrizoate salts are incompatible in vitro with some antihistamines and many other drugs. It is believed that one of the chief causes of in vitro incompatibility is an alteration of pH. Turbidity of solutions of intravascular contrast medium occurs between pH 2.5 and 4.1. Another cause is chemical interaction; therefore, other pharmaceuticals should not be mixed with contrast agents in the same syringe.

INDIVIDUAL INDICATIONS AND USAGE

THE FOLLOWING SECTIONS FOR INDIVIDUAL INDICATIONS AND USAGE CONTAIN CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, AND DOSAGE AND ADMINISTRATION SECTIONS RELATED TO THE SPECIFIC PROCEDURES. HOWEVER, IT SHOULD BE UNDERSTOOD THAT THE INFORMATION IN THE GENERAL SECTIONS IS ALSO LIKELY TO APPLY TO ALL OF THESE SPECIFIC USES.

Hydration: With the possible exception of urography, patients should be fully hydrated prior to the following procedures.

EXCRETORY UROGRAPHY

Diatrizoate salts are used in small, medium, and large dose urography. Visualization of the urinary tract can be achieved by either direct intravenous bolus injection, intravenous drip infusion, or incidentally following intra-arterial procedures. Visualization of the urinary tract is delayed in infants less than 1 month old, and in patients with urinary tract obstruction (see CLINICAL PHARMACOLOGY).

Nephrotomography and "Adequate" or High Dose Urography

Hypaque-76 solution may be used for excretory urography in selected patients. It may be used when prior urography has failed to provide diagnostic contrast and for preliminary excretory tract study to detect obstruction in azotemic patients or to avoid retrograde instrumentation. It may also be used as a high dosage medium to intensify and prolong the nephrographic effect when the prime purpose is examination of the renal parenchyma, especially with tomography. When combined with the urea "washout" technique, Hypaque-76 provides the necessary increased pyelographic contrast and diuresis required for screening or special examination of patients with suspected renal hypertension.

Contraindication

Urography is contraindicated in patients with anuria.

Precautions

Although azotemia is not considered a contraindication, care is required in patients with advanced renal failure. The usual preparatory dehydration should be omitted, and urinary output should be observed for one to two days in these patients. Adequate visualization may be difficult or impossible to attain in patients with severely impaired renal and/or hepatic function. Use with extreme caution in patients with concomitant hepatorenal disease.

When Hypaque-76 is used with a urea "washout" procedure, the patient should also be observed for a few hours to detect signs of undue dehydration caused by increased diuresis induced by both the medium and the urea. Ingestion of water may be required for rehydration.

In myelomatosis, urography should only be performed with caution. If a weak protein-binding agent such as a diatrizoate is used for the procedure, it is essential to omit preparatory dehydration, administer fluids, and attempt to alkalinize the urine.

Preparatory Dehydration: Preparatory dehydration is dangerous in infants, young children, the elderly, and azotemic patients (especially those with polyuria, oliguria, diabetes, advanced vascular disease, or preexisting dehydration). The undesirable dehydration in these patients may be accentuated by the osmotic diuretic action of the medium.

Dehydration may improve image quality in patients with adequate renal function particularly if a low dose is used. Dehydration, however, will not improve contrast quality in patients with substantial renal insufficiencies and will increase risk of contrast induced renal damage. Dehydration in these patients is therefore contraindicated.

Adverse Reactions

Side effects following this relatively high dose urography are usually mild and transitory and do not appear to occur more frequently or severely than those induced by "standard dose" urography. Nausea, facial flushing, and emesis are not uncommon reactions. (See also ADVERSE REACTIONS—General.)

Dosage and Administration

The usual intravenous dose for adults is 20 mL, with a range of 20 mL to 40 mL. Children require less in proportion to weight: Under 6 months of age—4 mL; 6 to 12 months—6 mL; 1 to 2 years—8 mL; 2 to 5 years—10 mL; 5 to 7 years—12 mL; 8 to 10 years—14 mL; 11 to 15 years—16 mL.

ANGIOGRAPHY—General

Diatrizoate salts are used for radiographic studies throughout the cardiovascular system.

Intravascular radiopaque diagnostic agents of high concentration are not recommended for cerebral or spinal angiography (see CONTRAINDICATIONS—General), and contrast agents with the lowest compatible viscosity and higher concentration of iodine (310 mg/mL to 480 mg/mL of bound iodine) must be used for angiocardiography. Contrast media approaching serum ionic content and osmolality have less potential for deleterious effects on the myocardium (see PRECAUTIONS—General, Drug Interactions).

Addition of chelating agents may contribute to toxicity in coronary angiography, and the sodium content of angiographic agents used in coronary arteriography is of crucial importance.

AORTOGRAPHY

Hypaque-76 solution may be injected by commonly accepted techniques, such as translumbar, retrograde catheter, retrograde pressure injection (by cannula) or antegrade (brachial) catheter, for examination of the aorta and its major branches.

Warnings

During aortography by the translumbar technique, extreme care is advised to avoid inadvertent intrathecal injection since the injection of even small amounts (5 mL to 7 mL) of the contrast medium may cause convulsions, permanent sequelae, or fatality. Should the accident occur, the patient should be placed upright to confine the hyperbaric solution to a low level, anesthesia may be required to control convulsions, and if there is evidence of a large dose having been administered, a careful cerebrospinal fluid exchange-washout should be considered.

Pheochromocytoma: Administration of angiographic media to patients known or suspected to have pheochromocytoma can cause dangerous changes in blood pressure. A minimum dose should be injected. The blood pressure should be carefully monitored and measures for controlling major fluctuations should be available.

Precautions

The presence of a vigorous pulsatile flow should be established before using a catheter or pressure injection technique. A small "pilot" dose (about 2 mL) should be administered to locate the exact site of needle or catheter tip to help prevent injection of the main dose into a branch of the aorta or intramurally. In the translumbar technique, severe pain during injection may indicate intramural placement and abdominal or back pain afterwards may indicate hemorrhage from the injection site. Following catheter procedures, gentle pressure hemostasis for 5 to 10 minutes is advised, followed by observation for 30 to 60 minutes and immobilization of the limb for several hours to prevent hemorrhage from the site of arterial puncture.

Under conditions of slowed aortic circulation there is an increased likelihood of aortography causing muscle spasm. Occasional serious neurologic complications, including paraplegia, have also been reported in patients with aortic-iliac or even femoral artery bed obstruction, abdominal compression, hypotension, hypertension, spinal anesthesia, injection of vasopressors to increase contrast, and low injection sites (L2-3). In these patients the concentration, dose, and number of repeat injections of the medium should be maintained at a minimum with appropriate intervals between injections. The position of the patient and catheter tip should be carefully evaluated.

Adverse Reactions

The only adverse reaction expected is a mild burning or painful sensation on injection. Unusual reactions can occur, as in angiocardiography. An abrupt hypertensive episode can occur following entry of the medium into the renal artery in patients with pheochromocytoma. Mesenteric necrosis, acute pancreatitis, renal shutdown (usually transitory), and neurologic complications have been reported following inadvertent injection of a large part of the aortic dose into a branch of the aorta. Entry of the large aortic dose into the renal artery can cause, even in the absence of symptoms, albuminuria, cylindruria, hematuria, and an elevated BUN. Rapid and complete return of function usually follows.

Additional procedural reactions include injury to the aorta and neighboring organs, pleural puncture, renal damage including infarction and acute tubular necrosis with oliguria and anuria, accidental selective filling of the right renal artery during the translumbar procedure in the presence of preexistent renal disease, and retroperitoneal hemorrhage from the translumbar approach.

Dosage and Administration

Adult: The usual adult dose as a single injection is 15 mL to 40 mL, repeated if indicated, to a total of 160 mL.

Pediatric: The usual single pediatric dose ranges from 0.3 mL/kg to 0.9 mL/kg. The total dose should not exceed 1 mL/kg.

ANGIOCARDIOGRAPHY

Pharmacology-Hemodynamic Changes

Due to its physical characteristics (chiefly tonicity and viscosity) and the volume administered, Hypaque-76 may cause a number of transitory hemodynamic changes. When the medium is ejected from the left ventricle or introduced at the root of the ascending aorta, a brief (three seconds) hypertensive response is usually induced, followed immediately by a decrease in aortic and peripheral blood pressures below normal levels, lasting for at least two minutes. This hypotensive phase may be followed by a 15- to 20-minute period of fluctuating blood pressure.

Clinical doses (up to 1 mL per kg) injected into the vena cava or right heart outflow tract usually cause an irregular rise in right ventricular blood pressure, a slight increase in pulmonary artery blood pressure, and delayed signs of peripheral hypotension.

Other changes reported clinically include an increase in cardiac output and atrial pressure, a decrease in myocardial contractile force, and at the peak of postinjection hypotension, a marked rise in aortic and carotid blood flow, and elevation of central venous pressure. At dosage levels used in angiocardiography, the hematocrit and hemoglobin level may fall about 10 to 15 percent and serum osmolality may rise 10 to 12 percent. Blood carbon dioxide, pH, and BUN levels may fall. These changes commence immediately after injection, reach a maximum in two to five minutes, and return to normal values in 10 to 15 minutes. However, after the initial rise, plasma volume may decrease and continue to fall below control levels, even beyond 30 minutes, probably due to diuresis. If repeat injections are made in rapid succession these changes are likely to be more pronounced. (See also Dosage and Administration.) Hypaque-76 is not metabolized. It is eliminated unchanged, rapidly and completely in the urine by glomerular filtration.

Precautions

During administration of large doses of Hypaque-76 continuous monitoring of vital signs is desirable. Caution is advised in the administration of large doses to patients with incipient heart failure because of the possibility of aggravation of the preexisting condition. Hypotension should be corrected promptly since it may induce serious arrhythmias.

Because of the hemodynamic changes which may occur on injection into the right heart outflow tract, special care, especially regarding dosage, should be observed in patients with right ventricular failure, pulmonary hypertension, or obliterated pulmonary vascular beds.

Precautions in Infants

Apnea, bradycardia and other arrhythmias, cerebral effects (lethargy and depression), and a tendency to acidosis are more likely to occur in cyanotic infants. It is desirable that vital signs be monitored on an intensive care basis afterwards to detect delayed adverse effects (arrhythmia, electrolyte and hemodynamic disturbances). Infants are more likely than adults to respond with convulsions, particularly after repeated injections. Unlike in the adult, the amount of the total dosage in young infants is of particular importance. (See Dosage and Administration.)

Adverse Reactions

See ADVERSE REACTIONS—General.

Dosage and Administration

The individual dose is determined by the size of the structure to be visualized, the anticipated degree of hemodilution, and valvular competence. Weight is a minor consideration in adults. The size of each individual dose is a more important consideration than the total dosage used. When large individual doses are adm

MultiVit with Fluoride Chewable Tablets

Dosage Form: chewable tablets
Multi-Vitamin With Fluoride Chewable Tablets

Rx Only

*Daily Value not established
Supplement Facts
Serving Size: 1 Chewable Tablet
Amount Per Tablet	% Daily Value Adults & children 4 years or more
Vitamin A ................................. 2500 IU	50%
Vitamin C ................................... 60 mg	100%
Vitamin D .................................. 400 IU	100%
Vitamin E .................................... 15 IU	50%
Thiamin (B1) .......................... 1.05 mg	70%
Riboflavin (B2) ......................... 1.2 mg	71%
Niacin ..................................... 13.5 mg	68%
Vitamin (B6) ........................... 1.05 mg	53%
Folate ........................................ 0.3 mg	75%
Vitamin B12 ............................ 4.5 mcg	75%
Fluoride (as sodium fluoride) ... 1.0 mg	*

Active ingredient for Caries Prophylaxis: Fluoride as Sodium Fluoride.

Other ingredients: Artificial grape flavor, ascorbic acid, butylated hydroxyl toluene, cholecalciferol, citric acid, compressible sugar, DL-alpha Tocopherol, D&C Red # 7 calcium lake, FD&C Blue #1 aluminum lake, folic acid, gelatin, magnesium stearate, maltodextrin, mannitol, medium chain triglycerides, methyl cellulose, mono- and di-glycerides, niacinamide, povidone, pyridoxine, riboflavin, silicon dioxide, sodium ascorbate, sodium citrate, starches, sucralose, thiamine, vitamin A acetate, vitamin B12 and vitamin E acetate.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Multi-vitamin with Fluoride Chewable Tablets provide sodium fluoride and ten essential vitamins in a chewable tablet. Because the tablets are chewable, they provide a topical as well as systemic source of fluoride.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:

Ca10(PO4)6(OH)2 + 2F-  —————> Ca10(PO4)6F2 + 2OH-

(Hydroxyapatite)                                   (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

2.  After enamel has been laid down, fluoride deposition continues in the surface enamel.  Diffusion of fluoride from the surface inward is apparently restricted.

3.  After eruption, the surface enamel acquires fluoride from the water, food, supplementary fluoride and smaller amounts from saliva.

INDICATIONS AND USAGE

Supplementation of the diet with ten essential vitamins.

Supplementation of the diet with fluoride for caries prophylaxis.

See Dosage and Administration.

Multi-vitamin with Fluoride Chewable Tablets supply significant amounts of Vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, vitamin B12, and folate to supplement the diet, and to help assure that nutritional deficiencies of these vitamins will not develop. Thus, in a single easy-to-use preparation, children obtain ten essential vitamins and the important mineral, fluoride.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.

Children using Multi-vitamin with fluoride Chewable Tablets regularly should receive semiannual dental examinations. The regular brushing of teeth and attention to good oral hygiene practices are also essential.

WARNINGS

As in the case of all medications, keep out of the reach of children.

Should be chewed. This product, as all chewable tablets, is not recommended for children under age 4 due to risk of choking.

PRECAUTIONS

The suggested dose of Multi-vitamin with Fluoride Chewable Tablets should not be exceeded, since dental fluorosis may result from continued ingestion of large amounts of fluoride.

Before prescribing Multi-vitamin with Fluoride Chewable Tablets, read these Important Considerations When Using Dosage Schedule found in Dosage and Administration.

• If fluoride level is unknown, drinking water should be tested for fluoride content before supplements are prescribed. For testing of fluoride content, contact the local or state health department.


• All sources of fluoride should be evaluated with a thorough fluoride history.


• Patient exposure to multiple water sources can make proper prescribing complex.


• Ingestion of higher than recommended levels of fluoride by children has been associated with an increase in mild dental fluorosis in developing, unerupted teeth.


• Fluoride supplements require long-term compliance on a daily basis.

ADVERSE REACTIONS

Allergic rash and other idiosyncrasies have been rarely reported.

DOSAGE AND ADMINISTRATION

*1.0 ppm = 1 mg / liter
**2.2 mg Sodium Fluoride contains 1mg fluoride ion.
Fluoride Ion Level in Drinking Water (ppm)*
AGE	<0.3 ppm	0.3-0.6 ppm	>0.6 ppm
4-6 years	0.50 mg / day** (1/2 tablet)	0.25 mg / day (1/4 tablet)	None
6-16 years	1.0 mg / day (1 tablet)	0.50 mg / day (1/2 tablet)	None

HOW SUPPLIED

Multi-vitamin 1 mg Sodium Fluoride Tablets: grape flavored, round, purple, debossed “BP 815”, available in 100 ct. bottle, NDC 64376-815-01.

Multi-vitamin 0.5 mg Sodium Fluoride Tablets: cherry flavored, square, red, debossed “BP 814”, available in 100 ct. bottle, NDC 64376-814-01.

Multi-vitamin 0.25 mg Sodium Fluoride Tablets: orange flavored, round, orange, debossed “BP 813”, available in 100 ct. bottle, NDC 64376-813-01.

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C -30°C (59°-86°F) [See USP Controlled Room Temperature].

Manufactured for:

Boca Pharmacal, Inc.

Coral Springs, FL 33065

www.bocapharmacal.com

1-800-354-8460 Iss. 07/11

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

[Rev 13]

MULTI-VITAMIN  vitamin a, vitamin d, thiamine, riboflavin, niacin, pyridoxine, folic acid, fluoride ion, ascorbic acid, alpha-tocopherol-acetate-dl, cyanocobalamin  tablet, chewable

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 64376-815 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength VITAMIN A (VITAMIN A) VITAMIN A 2500 [iU] VITAMIN D (VITAMIN D) VITAMIN D 400 [iU] THIAMINE (THIAMINE) THIAMINE 1.05 mg RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.2 mg NIACIN (NIACIN) NIACIN 13.5 mg PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.05 mg FOLIC ACID (FOLIC ACID) FOLIC ACID 0.3 mg FLUORIDE ION (FLUORIDE ION) FLUORIDE ION 1.0 mg ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL ACETATE, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 15 [iU] CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 4.5 ug

Inactive Ingredients Ingredient Name Strength SODIUM CITRATE   CHOLECALCIFEROL   CYANOCOBALAMIN   FD&C BLUE NO. 1   FOLIC ACID   GELATIN   STARCH, CORN   MAGNESIUM STEARATE   MANNITOL   NIACINAMIDE   POVIDONE   PYRIDOXINE   GRAPE   RIBOFLAVIN   SILICON DIOXIDE   SODIUM ASCORBATE   THIAMINE   VITAMIN A ACETATE   ALPHA-TOCOPHEROL ACETATE   D&C RED NO. 7   ASCORBIC ACID   SUCRALOSE   BUTYLATED HYDROXYTOLUENE   CITRIC ACID MONOHYDRATE   .ALPHA.-TOCOPHEROL, DL-   MALTODEXTRIN   MEDIUM-CHAIN TRIGLYCERIDES   SUCROSE   GLYCERYL MONOSTEARATE   METHYLCELLULOSE (1500 CPS)

Product Characteristics Color PURPLE Score no score Shape ROUND (Biconvex) Size 13mm Flavor GRAPE Imprint Code BP;815 Contains

Packaging # NDC Package Description Multilevel Packaging 1 64376-815-01 100 TABLET In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/06/2011

Labeler - Boca Pharmacal, Inc (170266089)

Registrant - Boca Pharmacal, Inc (170266089)

Establishment
Name	Address	ID/FEI	Operations
Cispharma, Inc		833171445	MANUFACTURE

Revised: 09/2011Boca Pharmacal, Inc

carbinoxamine and pseudoephedrine

Generic Name: carbinoxamine and pseudoephedrine (kar bi NOX a meen and soo doe e FED rin)

Brand names: Andec, Cordron-D NR, Rondamine, ...show all 35 brand names.Carbiset, Rondec Tablet(obsolete), Cydec, Palgic-DC, Mooredec, Biohist-LA, Cardec (obsolete), Cardec-S, Maldec, Palgic-D, Andec-TR, Carbic-D, Dura-Ron, Palgic-DS, Rondec-TR(obsolete), Ex-Dec-TR, Coldec, Coldec-TR, Andehist, Rondec Drops(obsolete), Hydro-Tussin CBX, Carboxine-PSE, Cordron-D, Pediatex-D, Rondec(obsolete), Cordron-12 D, Pseudo Carb, Mintex PSE, Pediatex 12 D, Carboxine-D, Carboxine 12 D, PSE Allergy

What is carbinoxamine and pseudoephedrine?

Carbinoxamine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of carbinoxamine and pseudoephedrine is used to treat sneezing, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Carbinoxamine and pseudoephedrine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about carbinoxamine and pseudoephedrine?

Always ask a doctor before giving a cold or allergy medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children. Do not use carbinoxamine and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine and pseudoephedrine before the MAO inhibitor has cleared from your body. Carbinoxamine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

What should I discuss with my doctor before taking carbinoxamine and pseudoephedrine?

Do not use carbinoxamine and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take carbinoxamine and pseudoephedrine before the MAO inhibitor has cleared from your body.

Before taking this medication, tell your doctor if you are allergic to carbinoxamine or pseudoephedrine, or if you have:

• kidney disease;


• liver disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  thyroid disease;

  
  


• 
  

  emphysema or chronic bronchitis; or

  
  


• 
  

  an enlarged prostate or urination problems.

  
  

If you have any of these conditions, you may not be able to use carbinoxamine and pseudoephedrine, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Carbinoxamine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take carbinoxamine and pseudoephedrine?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label. Cold medicine is usually taken only for a short time until your symptoms clear up.

Always ask a doctor before giving a cold or allergy medicine to a child, even if the medicine label provides dosing instructions for children. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.

The chewable tablet should be chewed before you swallow it.

Measure the liquid form of carbinoxamine and pseudoephedrine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Call your doctor if you have a fever, or if your symptoms get worse or do not improve after taking this medicine for 7 days.

Store carbinoxamine and pseudoephedrine at room temperature away from moisture and heat.

See also: Carbinoxamine and pseudoephedrine dosage (in more detail)

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a carbinoxamine and pseudoephedrine overdose may include confusion, blurred vision, feeling restless or nervous, dry mouth, hallucinations, fainting, and seizure (convulsions).

What should I avoid while taking carbinoxamine and pseudoephedrine?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. Antihistamines and decongestants are contained in many medicines available over the counter. If you take certain products together you may accidentally take too much of one or more types of medicine. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Avoid using other medicines that make you sleepy (such as cold medicine, pain medication, muscle relaxers, and medicine for seizures, depression or anxiety). They can add to sleepiness caused by carbinoxamine and pseudoephedrine.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Carbinoxamine and pseudoephedrine side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  feeling light-headed, fainting;

  
  


• 
  

  urinating less than usual or not at all;

  
  


• 
  

  wheezing, tightness in your chest;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).

  
  

Continue taking this medication and talk to your doctor if you have any of these less serious side effects:

• 
  

  drowsiness, dizziness;

  
  


• 
  

  lack of coordination;

  
  


• 
  

  upset stomach;

  
  


• 
  

  stuffy nose, chest congestion;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  feeling restless or excited (especially in children);

  
  


• 
  

  dry mouth or nose; or

  
  


• 
  

  blurred vision.

  
  

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Carbinoxamine and pseudoephedrine Dosing Information

Usual Adult Dose for Allergic Rhinitis:

Liquid:
10 mL orally 4 times a day as needed.

Suspension, extended release:
10 mL to 20 mL orally every 12 hours as needed.

Tablets: 1 to 2 tablets orally 4 times a day as needed.

Sustained release tablets: 1 tablet every 12 hours as needed.

Maximum dose: 240 mg/day of pseudoephedrine.

Usual Adult Dose for Cold Symptoms:

Liquid:
10 mL orally 4 times a day as needed.

Suspension, extended release:
10 mL to 20 mL orally every 12 hours as needed.

Tablets: 1 to 2 tablets orally 4 times a day as needed.

Sustained release tablets: 1 tablet every 12 hours as needed.

Maximum dose: 240 mg/day of pseudoephedrine.

Usual Pediatric Dose for Allergic Rhinitis:

Drops:
1 to 3 months: 0.25 mL orally 4 times a day as needed. (Maximum dose: 15 mg/day of pseudoephedrine).
3 to 6 months: 0.5 mL orally 4 times a day as needed. (Maximum dose: 30 mg/day of pseudoephedrine).
6 to 9 months: 0.75 mL orally 4 times a day as needed. (Maximum dose: 45 mg/day of pseudoephedrine).
9 to 18 months: 1 mL orally 4 times a day as needed. (Maximum dose: 60 mg/day of pseudoephedrine).

Liquid:
less than 2 years: safety and effectiveness unknown
2 years to 6 years: 5 mL orally 4 times a day. (Maximum dose: 60 mg/day of pseudoephedrine).
7 years: 10 mL orally 4 times a day. (Maximum dose: 120 mg/day of pseudoephedrine).

Syrup:
less than 2 years: safety and effectiveness unknown
2 years to 5 years: 2.5 mL orally 4 times a day as needed. (Maximum dose: 60 mg/day of pseudoephedrine).
6 years or older: 5 mL orally 4 times a day as needed. (Maximum dose: 120 mg/day of pseudoephedrine).

Suspension, extended release::
2 years to 6 years: 2.5 mL to 5 mL orally every 12 hours.
7 years to 11 years: 5 mL to 10 mL orally every 12 hours.
12 years or older: 10 mL to 20 mL orally every 12 hours.

Sustained release tablets:
12 years or older: 1 tablet orally 2 times a day as needed. (Maximum dose: 240 mg/day of pseudoephedrine).

Usual Pediatric Dose for Cold Symptoms:

Drops:
1 to 3 months: 0.25 mL orally 4 times a day as needed. (Maximum dose: 15 mg/day of pseudoephedrine).
3 to 6 months: 0.5 mL orally 4 times a day as needed. (Maximum dose: 30 mg/day of pseudoephedrine).
6 to 9 months: 0.75 mL orally 4 times a day as needed. (Maximum dose: 45 mg/day of pseudoephedrine).
9 to 18 months: 1 mL orally 4 times a day as needed. (Maximum dose: 60 mg/day of pseudoephedrine).

Liquid:
less than 2 years: safety and effectiveness unknown
2 years to 6 years: 5 mL orally 4 times a day. (Maximum dose: 60 mg/day of pseudoephedrine).
7 years: 10 mL orally 4 times a day. (Maximum dose: 120 mg/day of pseudoephedrine).

Syrup:
less than 2 years: safety and effectiveness unknown
2 years to 5 years: 2.5 mL orally 4 times a day as needed. (Maximum dose: 60 mg/day of pseudoephedrine).
6 years or older: 5 mL orally 4 times a day as needed. (Maximum dose: 120 mg/day of pseudoephedrine).

Suspension, extended release::
2 years to 6 years: 2.5 mL to 5 mL orally every 12 hours.
7 years to 11 years: 5 mL to 10 mL orally every 12 hours.
12 years or older: 10 mL to 20 mL orally every 12 hours.

Sustained release tablets:
12 years or older: 1 tablet orally 2 times a day as needed. (Maximum dose: 240 mg/day of pseudoephedrine).

What other drugs will affect carbinoxamine and pseudoephedrine?

Before taking carbinoxamine and pseudoephedrine, tell your doctor if you are using any of the following drugs:

• 
  

  a diuretic (water pill), or blood pressure medicine;

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

If you are using any of these drugs, you may not be able to use carbinoxamine and pseudoephedrine, or you may need dosage adjustments or special tests during treatment.

There may be other drugs that can affect carbinoxamine and pseudoephedrine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More carbinoxamine and pseudoephedrine resources

• Carbinoxamine and pseudoephedrine Side Effects (in more detail)
• Carbinoxamine and pseudoephedrine Dosage
• Carbinoxamine and pseudoephedrine Use in Pregnancy & Breastfeeding
• Carbinoxamine and pseudoephedrine Drug Interactions
• Carbinoxamine and pseudoephedrine Support Group
• 0 Reviews for Carbinoxamine and pseudoephedrine - Add your own review/rating

Compare carbinoxamine and pseudoephedrine with other medications

• Cold Symptoms
• Hay Fever

Where can I get more information?

• Your pharmacist has information about carbinoxamine and pseudoephedrine written for health professionals that you may read.

What does my medication look like?

Carbinoxamine and pseudoephedrine is available with a prescription under many different brand names. Generic formulations may also be available. Ask your pharmacist any questions you have about this medication, especially if it is new to you.

See also: carbinoxamine and pseudoephedrine side effects (in more detail)