Betnovate Cream

1. Name Of The Medicinal Product

Betnovate Cream

2. Qualitative And Quantitative Composition

Betamethasone Valerate BP 0.122% ^W/_W

3. Pharmaceutical Form

Aqueous Cream

4. Clinical Particulars

4.1 Therapeutic Indications

Betamethasone valerate is an active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy, and is often effective in the less responsive conditions such as psoriasis.

Betnovate preparations are indicated for the treatment of eczema in children and adults, including atopic and discoid eczemas, prurigo nodularis, psoriasis (excluding widespread plaque psoriasis); neurodermatoses, including lichen simplex, lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; discoid lupus erythematosus and they may be used as an adjunct to systemic steroid therapy in generalised erythroderma.

4.2 Posology And Method Of Administration

A small quantity of Betnovate should be applied gently to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day, or even less often, or by using the appropriate ready-diluted (1 in 4) preparation Betnovate R.D. If no improvement is seen within two to four weeks, reassessment of the diagnosis, or referral, may be necessary.

Betnovate and Betnovate R.D. creams are especially appropriate for dry, lichenified or scaly lesions, but this is not invariably so.

In the more recent resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effect of Betnovate can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response in such lesions; thereafter improvement can usually be maintained by regular application without occlusion.

Children

Courses should be limited to five days. Occlusion should not be used.

For topical administration.

4.3 Contraindications

Hypersensitivity to the active substance or any of the excipients in the product.

The following conditions should not be treated with betamethasone valerate:

• Untreated cutaneous infections

• Rosacea

• Acne vulgaris

• Pruritus without inflammation

• Perianal and genital pruritus

• Perioral dermatitis

Betamethasone valerate is contraindicated in dermatoses in infants under one year of age, including dermatitis

4.4 Special Warnings And Precautions For Use

Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression, with or without clinical features of Cushing's syndrome, can occur even without occlusion. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency (see section 4.8 Undesirable Effects and Section 4.9 Overdose).

The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema. If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as glaucoma might result.

If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis careful patient supervision is important.

Appropriate antimicrobial therapy should be used whenever treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy and systemic administration of antimicrobial agents. Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and so the skin should be cleansed before a fresh dressing is applied.

Further Information

The least potent corticosteroid which will control the disease should be selected. None of these preparations contain lanolin. Betnovate Cream and Ointment and the corresponding RD preparations do not contain parabens. Betnovate Lotion contains parabens.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.

4.7 Effects On Ability To Drive And Use Machines

There have been no studies to investigate the effect of betamethasone valerate on driving performance or the ability to operate machinery. A detrimental effect on such activities would not be anticipated from the adverse reaction profile of topical betamethasone valerate.

4.8 Undesirable Effects

Adverse events are listed below by system organ class and frequency. Frequencies are defined as: very common (

Immune system disorders
Very rare:	Hypersensitivity.
If signs of hypersensitivity appear, application should stop immediately.
Endocrine disorders
Very rare:	Features of Cushing's syndrome

As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce suppression of the HPA axis and the clinical features of Cushing's syndrome (see Section 4.4 Special Warnings and Precautions for use). These effects are more likely to occur in infants and children, and if occlusive dressings are used. In infants the napkin may act as an occlusive dressing.

Skin and subcutaneous tissue disorders
Common:	Local skin burning and pruritus.
Very rare:	Local atrophic changes in the skin such as thinning, striae and dilatation of the superficial blood vessels may be caused by prolonged and intensive treatment with highly active corticosteroid preparations, particularly when occlusive dressings are used or when skin folds are involved. Pigmentation changes, hypertrichosis, allergic contact dermatitis, exacerbation of symptoms, pustular psoriasis (due to treatment of psoriasis with corticosteroids or its withdrawal: see Section 4.4. Special Warnings and Precautions for use)

4.9 Overdose

Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse the features of Cushing's syndrome may appear and in this situation topical steroids should be discontinued gradually under medical supervision (see Section 4.4 Special Warnings and Precautions for use).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Betamethasone valerate is an active corticosteroid with topical anti-inflammatory activity.

5.2 Pharmacokinetic Properties

Absorption

Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of percutaneous absorption of topical corticosteroids is determined by many factors, including the vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease processes in the skin may also increase percutaneous absorption.

Distribution

The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary because circulating levels are well below the level of detection.

Metabolism

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. They are metabolised, primarily in the liver.

Elimination

Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their metabolites are also excreted in the bile.

5.3 Preclinical Safety Data

Reproductive toxicity

Subcutaneous administration of betamethasone valerate to mice or rats at doses

The effect on fertility of betamethasone valerate has not been evaluated in animals.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Chlorocresol	BP
Cetomacrogol 1000	BP
Cetostearyl Alcohol	BP
White Soft Paraffin	BP
Liquid Paraffin	BP
Sodium Acid Phosphate	BP
Phosphoric Acid	BP
Sodium Hydroxide	BP
Purified Water	BP

6.2 Incompatibilities

None known.

6.3 Shelf Life

Tubes	36 Months
500gm pots	18 months

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

15gm, 30gm and 100gm collapsible aluminium tubes internally coated with an epoxy resin based lacquer and closed with a cap.

500mg opaque high density polythene pots with black urea formaldehyde screw caps having a steran faced wad.

Not all pack sizes may be marketed

6.6 Special Precautions For Disposal And Other Handling

No special instructions.

Administrative Data

7. Marketing Authorisation Holder

Glaxo Wellcome UK Ltd.,

T/A GlaxoSmithKline UK

Stockley Park West,

Uxbridge,

Middlesex UB11 1BT

8. Marketing Authorisation Number(S)

PL10949/0014

9. Date Of First Authorisation/Renewal Of The Authorisation

24 October 1997

10. Date Of Revision Of The Text

1 February 2012

phenylephrine

Generic Name: phenylephrine (FEN il EFF rin)

Brand names: Ah-Chew D, Dimetapp Cold Drops, Lusonal, Nasop, Nasop12, PediaCare Children's Decongestant, Phenyl-T, Sudafed PE, Sudafed PE Children's Nasal Decongestant, Sudafed PE Quick Dissolve, Sudogest PE, Triaminic Thin Strips Cold, ...show all 19 brand names.Neo-Synephrine, Despec-SF, Sudafed PE Extra Strength, Triaminic Thin Strips Nasal Congestion, Triaminic Toddler Congestion Thin Strips, Triaminic Thin Strips Infant Decongestant, Dimetapp Children's Cold & Allergy

What is phenylephrine?

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

Phenylephrine is used to treat nasal congestion and sinus pressure caused by allergies, the common cold, or the flu. Phenylephrine may be used to treat congestion of the tubes that drain fluid from your inner ears, called the eustachian (yoo-STAY-shun) tubes.

Phenylephrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about phenylephrine?

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children.

You should not use this medication if you are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have heart disease, heart rhythm disorder, high blood pressure, circulation problems, diabetes, glaucoma, a thyroid disorder, kidney disease, an enlarged prostate or urination problems, anxiety, sleep problems, bipolar disorder or other mental illness.

Phenylephrine may interact with heart or blood pressure medications, antidepressants, diabetes medications, migraine headache medications, and other decongestants.

Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

What should I discuss with my healthcare provider before taking phenylephrine?

You should not use this medication if you are allergic to phenylephrine.

Do not use phenylephrine if you have used linezolid (Zyvox) or procarbazine (Matulane), or if you have taken a monoamine oxidase inhibitor (MAOI) such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) in the last 14 days. Serious, life-threatening side effects can occur if you take phenylephrine before these other drugs have cleared from your body.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before you take phenylephrine, tell your doctor if you are allergic to any decongestants, or if you have:

• 
  

  heart disease, heart rhythm disorder;

  
  


• 
  

  high blood pressure;

  
  


• 
  

  circulation problems (such as Raynaud's syndrome);

  
  


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  a thyroid disorder;

  
  


• kidney disease;


• 
  

  an enlarged prostate or urination problems;

  
  


• 
  

  sleep problems, anxiety; or

  
  


• 
  

  mental illness such as bipolar disorder.

  
  

FDA pregnancy category C. Is not known whether this medication will harm an unborn baby. Before you take phenylephrine, tell doctor if you are pregnant. Phenylephrine may pass into breast milk and could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Older adults may be more likely to have side effects from this medication.

Disintegrating and liquid forms of cold medicine may contain sugar or artificial sweeteners (phenylalanine). This would be important to know if you have diabetes or phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about sugar or phenylalanine.

How should I use phenylephrine?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 4 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. You may take phenylephrine with food if it upsets your stomach. Take the phenylephrine tablet with a full glass of water.

Measure the liquid form of phenylephrine 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 for one.

The chewable phenylephrine tablet must be chewed thoroughly before you swallow it.

To use the phenylephrine disintegrating strip, place one strip on your tongue and allow it to dissolve without chewing.

To use the disintegrating tablet, make sure your hands are dry and peel back the foil from the blister package. Place the tablet on your tongue. It will begin to dissolve right away. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Phenylephrine is usually taken every 4 hours. Follow the directions on the medicine label. Never take more of the medicine than directed on the label or prescribed by your doctor.

Call your doctor if your symptoms do not improve after 7 days of using phenylephrine, or if they get worse and your also have a fever.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Store phenylephrine at room temperature away from moisture and heat. Keep the disintegrating tablets or strips in their package until you are ready to take one.

Throw away any unused phenylephrine after the expiration date on the label has passed. Do not flush this medication down a toilet. Ask your pharmacist about the safest way to dispose of unused medicines.

What happens if I miss a dose?

Cold medicine is usually taken only as needed, so 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.

Overdose symptoms may include feeling restless or nervous, severe dizziness, sweating, vomiting, hallucinations, fast or uneven heart rate, fainting, seizure (convulsions), and weak or shallow breathing.

What should I avoid while using phenylephrine?

Do not use any other over-the-counter cold, allergy, or cough medication without first asking your doctor or pharmacist. Phenylephrine is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much phenylephrine. Read the label of any other medicine you are using to see if it contains phenylephrine or another decongestant.

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.

Avoid smoking. It can add to the effects of phenylephrine in decreasing blood flow, which can lead to uncomfortable symptoms. Avoid drinking alcohol while you are taking phenylephrine.

Phenylephrine 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 phenylephrine and call your doctor at once if you have a serious side effect such as:

• 
  

  severe dizziness, restless feeling, nervousness, or insomnia;

  
  


• 
  

  unusual thoughts or behavior;

  
  


• 
  

  feeling like you might pass out;

  
  


• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  tremors or shaking;

  
  


• 
  

  numbness, tingling, or cold feeling in your hands or feet; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  headache, dizziness;

  
  


• 
  

  feeling excited or restless (especially in children);

  
  


• 
  

  upset stomach; or

  
  


• 
  

  mild sleep problems.

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Phenylephrine Dosing Information

Usual Adult Dose for Hypotension:

IM or subcutaneous: 2 to 5 mg every 1 to 2 hours as needed.

IV bolus: 0.2 mg/dose (range: 0.1 to 0.5 mg/dose) every 10 to 15 minutes as needed (initial dose should not exceed 0.5 mg)

IV infusion: 100 to 180 mcg/min initially. The usual maintenance dose is 40 to 60 mcg/min.
Alternatively, 0.5 mcg/kg/minute; titrate to desired response. Dosing ranges between 0.4 to 9.1 mcg/kg/minute have been reported.

Usual Adult Dose for Shock:

IM or subcutaneous: 2 to 5 mg every 1 to 2 hours as needed.

IV bolus: 0.2 mg/dose (range: 0.1 to 0.5 mg/dose) every 10 to 15 minutes as needed (initial dose should not exceed 0.5 mg)

IV infusion: 100 to 180 mcg/min initially. The usual maintenance dose is 40 to 60 mcg/min.
Alternatively, 0.5 mcg/kg/minute; titrate to desired response. Dosing ranges between 0.4 to 9.1 mcg/kg/minute have been reported.

Usual Adult Dose for Supraventricular Tachycardia:

0.25 to 0.5 mg IV over 30 seconds.

Usual Adult Dose for Nasal Congestion:

Tablets or oral liquid: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine 7.5 mg/5 mL oral liquid:
15 mg orally every 6 hours not to exceed 60 mg daily.

Phenylephrine 10 mg oral tablet:
10 mg orally every 4 to 6 hours not to exceed 4 doses daily.

Phenylephrine 10 mg oral disintegrating strip:
10 mg orally every 4 hours not to exceed 6 doses daily.

Phenylephrine 10 mg/5 mL oral suspension, extended release:
10 to 20 mg orally every 12 hours.

Phenylephrine tannate 10 mg oral tablet, chewable, extended release:
10 to 20 mg orally every 12 hours.

Phenylephrine tannate 7.5 mg/5 mL oral suspension, extended release
7.5 to 15 mg orally every 12 hours.

Usual Pediatric Dose for Hypotension:

IM or subcutaneous: 0.1 mg/kg every 1 to 2 hours as needed. Maximum dose: 5 mg.
IV bolus: 5 to 20 mcg/kg/dose every 10 to 15 minutes as needed.
IV: 0.1 to 0.5 mcg/kg/min titrated to effect.

Usual Pediatric Dose for Shock:

IM or subcutaneous: 0.1 mg/kg every 1 to 2 hours as needed. Maximum dose: 5 mg.
IV bolus: 5 to 20 mcg/kg/dose every 10 to 15 minutes as needed.
IV: 0.1 to 0.5 mcg/kg/min titrated to effect.

Usual Pediatric Dose for Supraventricular Tachycardia:

5 to 10 mcg/kg IV over 30 seconds.

Usual Pediatric Dose for Nasal Congestion:

phenylephrine 1.25 mg/0.8 mL oral liquid:
2 years to 5 years: 1.6 mL orally every 4 hours not to exceed 6 doses daily.

Chewable tablets or oral liquid:
6 years to 11 years: 10 mg orally every 4 hours as needed.
12 years or older: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine 7.5 mg/5 mL oral liquid:
2 years to 5 years: 3.75 mg orally every 6 hours not to exceed 15 mg daily.
6 years to 11 years: 7.5 mg orally every 6 hours not to exceed 30 mg daily.
12 years or older: 15 mg orally every 6 hours not to exceed 60 mg daily.

Phenylephrine 10 mg oral tablet:
12 years or older: 10 mg orally every 4 to 6 hours not to exceed 4 doses daily.

Phenylephrine 10 mg oral tablet, disintegrating:
2 years to 5 years: 5 mg orally every 4 hours as needed.
6 years to 11 years: 10 mg orally every 4 hours as needed.
12 years or older: 10 to 20 mg orally every 4 hours as needed.

Phenylephrine 10 mg/5 mL oral suspension, extended release:
12 years or older: 10 to 20 mg orally every 12 hours.
6 years to 11 years: 5 to 10 mg orally every 12 hours.

Phenylephrine 10 mg oral disintegrating strip:
12 years or older: 10 mg orally every 4 hours not to exceed 6 doses daily.

Phenylephrine tannate 10 mg oral tablet, chewable, extended release:
6 years to 11 years: 5 to 10 mg orally every 12 hours.
12 years or older: 10 to 20 mg orally every 12 hours.

Phenylephrine tannate 7.5 mg/5 mL oral suspension, extended release
2 years to 5 years: 1.25 to 2.5 mL orally every 12 hours.
6 years to 11 years: 2.5 to 5 mL orally every 12 hours.
12 years or older: 5 to 10 mL orally every 12 hours.

phenylephrine 1.25 mg oral disintegrating strip:
2 years to 3 years: 2.5 mg orally every 4 hours, not to exceed 15 mg in 24 hours.

phenylephrine 2.5 mg oral disintegrating strip:
2 years to 5 years: 2.5 mg orally every 4 hours, not to exceed 15 mg in 24 hours.
6 years to 11 years: 5 mg orally every 4 hours, not to exceed 30 mg in 24 hours.

phenylephrine 1.25 mg oral tablet, chewable:
12 years or older: 5 mg orally every 4 hours not to exceed 6 doses daily.

phenylephrine 2.5 mg/5 mL oral liquid:
4 years to 5 years: 5 mL orally every 4 hours, not to exceed 6 doses in 24 hours.
6 years to 11 years: 10 mL orally every 4 hours, not to exceed 6 doses in 24 hours.

What other drugs will affect phenylephrine?

Tell your doctor about all other medications you use, especially:

• 
  

  other decongestants, including nasal sprays;

  
  


• 
  

  digoxin (digitalis, Lanoxin);

  
  


• 
  

  medicine to treat diabetes;

  
  


• 
  

  medicines to treat high blood pressure such as reserpine, methyldopa (Aldomet), and others;

  
  


• 
  

  migraine headache medicine such as ergotamine (Ergomar), naratriptan (Amerge), sumatriptan (Imitrex) or zolmitriptan (Zomig);

  
  


• 
  

  an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others;

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carvedilol (Coreg), metoprolol (Lopressor, Toprol), propranolol (Inderal), sotalol (Betapace), and others; or

  
  


• 
  

  a calcium channel blocker such as amlodipine (Norvasc), diltiazem (Tiazac, Cartia, Cardizem), felodipine (Plendil), nifedipine (Procardia, Adalat), verapamil (Calan, Covera, Isoptin, Verelan), and others.

  
  

This list is not complete and there may be other drugs that can interact with phenylephrine. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

More phenylephrine resources

• Phenylephrine Use in Pregnancy & Breastfeeding
• Drug Images
• Phenylephrine Drug Interactions
• Phenylephrine Support Group
• 3 Reviews for Phenylephrine - Add your own review/rating

• phenylephrine Nasal Advanced Consumer (Micromedex) - Includes Dosage Information


• Phenylephrine MedFacts Consumer Leaflet (Wolters Kluwer)


• AH-Chew D Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Lusonal Liquid MedFacts Consumer Leaflet (Wolters Kluwer)


• Nasop Dissolving Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Phenylephrine Hydrochloride Monograph (AHFS DI)


• Sudafed PE Consumer Overview


• Sudafed PE MedFacts Consumer Leaflet (Wolters Kluwer)

Compare phenylephrine with other medications

• Hypotension
• Nasal Congestion
• Shock
• Supraventricular Tachycardia

Where can I get more information?

• Your pharmacist can provide more information about phenylephrine.

Cardizem CD

Generic Name: diltiazem (dil TYE a zem)

Brand Names: Cardizem, Cardizem CD, Cardizem LA, Cartia XT, Dilacor XR, Dilt-CD, Dilt-XR, Diltia XT, Diltiazem Hydrochloride CD, Diltiazem Hydrochloride SR, Diltiazem Hydrochloride XR, Diltiazem Hydrochloride XT, Diltzac, Taztia XT, Tiazac

What is Cardizem CD (diltiazem)?

Diltiazem is in a group of drugs called calcium channel blockers. It works by relaxing the muscles of your heart and blood vessels.

Diltiazem is used to treat hypertension (high blood pressure), angina (chest pain), and certain heart rhythm disorders.

Diltiazem may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Cardizem CD (diltiazem)?

Do not use this medication if you have certain heart conditions such as "sick sinus syndrome" or "AV block" (unless you have a pacemaker), low blood pressure, or if you have recently had a heart attack.

Before taking diltiazem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure.

Diltiazem may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop taking this medication without first talking to your doctor. If you stop taking diltiazem suddenly, your condition may become worse.

Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms.

What should I discuss with my healthcare provider before taking Cardizem CD (diltiazem)?

You should not use this medication if you are allergic to diltiazem, or if you have:

• 
  

  certain heart conditions, especially "sick sinus syndrome" or "AV block" (unless you have a pacemaker);

  
  


• 
  

  low blood pressure; or

  
  


• 
  

  if you have recently had a heart attack.

  
  

To make sure you can safely take diltiazem, tell your doctor if you have any of these other conditions:

• kidney disease;


• liver disease;


• 
  

  congestive heart failure; or

  
  


• 
  

  if you are also taking clonidine (Catapres).

  
  

FDA pregnancy category C. It is not known whether diltiazem will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. Diltiazem 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.

How should I take Cardizem CD (diltiazem)?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results.

Take diltiazem with a full glass of water. Do not crush, chew, break, or open an extended-release tablet or capsule. Swallow it whole. Breaking or opening the pill may cause too much of the drug to be released at one time.

If you have trouble swallowing a diltiazem capsule whole, ask your doctor or pharmacist if it is safe for you to open the capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow this mixture right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

Use diltiazem regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not stop taking this medication without first talking to your doctor. If you stop taking diltiazem suddenly, your condition may become worse.

If you are being treated for high blood pressure, keep using this medication even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Diltiazem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely.

To be sure this medicine is helping your condition and is not causing harmful effects, your blood pressure will need to be checked often. Your liver and kidney function may also need to be tested. Visit your doctor regularly.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of diltiazem can be fatal.

Overdose symptoms may include slow heartbeat, weakness, chest pain, shortness of breath, feeling light-headed, or fainting.

What should I avoid while taking Cardizem CD (diltiazem)?

Diltiazem may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Avoid drinking alcohol while taking diltiazem.

Grapefruit and grapefruit juice may interact with diltiazem and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Avoid exposure to sunlight or tanning beds. Diltiazem can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Cardizem CD (diltiazem) 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. Call your doctor at once if you have a serious side effect such as:

• 
  

  a red, blistering skin rash;

  
  


• 
  

  swelling in your hands or feet;

  
  


• 
  

  trouble breathing;

  
  


• 
  

  slow heartbeats;

  
  


• 
  

  dizziness, fainting, fast or pounding heartbeat;

  
  


• 
  

  upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

  
  


• 
  

  severe skin reaction -- fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

  
  

Less serious side effects may include:

• 
  

  headache;

  
  


• 
  

  dizziness, weakness, tired feeling;

  
  


• 
  

  upset stomach, nausea;

  
  


• 
  

  sore throat, cough, stuffy nose; or

  
  


• 
  

  flushing (warmth, redness, or tingly feeling).

  
  

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect Cardizem CD (diltiazem)?

Tell your doctor about all other medicines you use, especially:

• 
  

  amiodarone (Cordarone, Pacerone);

  
  


• 
  

  buspirone (BuSpar);

  
  


• 
  

  carbamazepine (Carbatrol, Tegretol);

  
  


• 
  

  cimetidine (Tagamet);

  
  


• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  digoxin (digitalis, Lanoxin, Lanoxicaps);

  
  


• 
  

  quinidine (Quin-G);

  
  


• 
  

  rifampin (Rifadin, Rimactane, Rifater);

  
  


• 
  

  an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), or telithromycin (Ketek);

  
  


• 
  

  antifungal medication such as itraconazole (Sporanox), ketoconazole (Extina, Ketozole, Nizoral, Xolegal), miconazole (Oravig), or voriconazole (Vfend);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Dutoprol, Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others;

  
  


• 
  

  cholesterol medications such as atorvastatin (Lipitor, Caduet), fluvastatin (Lescol), lovastatin (Mevacor, Altoprev, Advicor), pravastatin (Pravachol), rosuvastatin (Crestor), or simvastatin (Zocor, Simcor, Vytorin);

  
  


• 
  

  HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), or ritonavir (Norvir, Kaletra); or

  
  


• 
  

  a sedative such as midazolam (Versed) or triazolam (Halcion).

  
  

This list is not complete and other drugs may interact with diltiazem. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Cardizem CD resources

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

• Cardizem CD Advanced Consumer (Micromedex) - Includes Dosage Information


• Cardizem CD 24-Hour Sustained-Release Beads Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardizem CD Prescribing Information (FDA)


• Diltiazem Prescribing Information (FDA)


• Cardizem Consumer Overview


• Cardizem MedFacts Consumer Leaflet (Wolters Kluwer)


• Cardizem Prescribing Information (FDA)


• Cardizem LA Prescribing Information (FDA)


• Cardizem LA 24-Hour Extended-Release Beads Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Cartia XT Prescribing Information (FDA)


• DILT-CD Prescribing Information (FDA)


• Dilacor XR 24-Hour Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Dilacor XR Prescribing Information (FDA)


• Dilt-XR Prescribing Information (FDA)


• Diltia XT Prescribing Information (FDA)


• Diltiazem Hydrochloride Monograph (AHFS DI)


• Matzim LA Prescribing Information (FDA)


• Taztia XT Prescribing Information (FDA)


• Taztia XT 24-Hour Extended-Release Beads Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Tiazac Prescribing Information (FDA)


• Tiazac Consumer Overview

Compare Cardizem CD with other medications

• Angina Pectoris Prophylaxis
• Atrial Fibrillation
• Atrial Flutter
• Heart Failure
• High Blood Pressure
• Raynaud's Syndrome
• Supraventricular Tachycardia

Where can I get more information?

• Your pharmacist can provide more information about diltiazem.

See also: Cardizem CD side effects (in more detail)

Teveten HCT

Generic Name: eprosartan and hydrochlorothiazide (Oral route)

ep-roe-SAR-tan MES-i-late, hye-droe-klor-oh-THYE-a-zide

Oral route(Tablet)

Drugs that act directly on the renin-angiotensin system can cause injury or death to the developing fetus when used during the second and third trimesters. Stop therapy as soon as possible when pregnancy is detected .

Commonly used brand name(s)

In the U.S.

• Teveten HCT

Available Dosage Forms:

• Tablet

Therapeutic Class: Angiotensin II Receptor Antagonist/Thiazide Combination

Pharmacologic Class: Eprosartan

Chemical Class: Thiazide

Uses For Teveten HCT

Eprosartan and hydrochlorothiazide combination is used alone or with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. High blood pressure may also increase the risk of heart attacks. These problems may be less likely to occur if blood pressure is controlled.

Eprosartan is an angiotensin II receptor blocker. It works by blocking a substance in the body that causes blood vessels to tighten. As a result, eprosartan relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.

Hydrochlorothiazide is a thiazide diuretic (water pill). It reduces the amount of water in the body by increasing the flow of urine, which helps lower the blood pressure.

This medicine is available only with your doctor's prescription.

Before Using Teveten HCT

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 eprosartan and hydrochlorothiazide combination in the pediatric population. 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 eprosartan and hydrochlorothiazide combination in the elderly.

Pregnancy

	Pregnancy Category	Explanation
1st Trimester	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.
2nd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
3rd Trimester	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 this medicine, 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 this medicine 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.

• Dofetilide

Using this medicine 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.

• Acetyldigoxin


• Arsenic Trioxide


• Benazepril


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Droperidol


• Enalapril


• Enalaprilat


• Flecainide


• Ketanserin


• Levomethadyl


• Lisinopril


• Lithium


• Metildigoxin


• Moexipril


• Ouabain


• Perindopril


• Proscillaridin


• Quinapril


• Ramipril


• Sotalol


• Trandolapril

Using this medicine 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.

• Alacepril


• Apazone


• Aspirin


• Benazepril


• Bepridil


• Bromfenac


• Captopril


• Carbamazepine


• Celecoxib


• Chlorpropamide


• Cholestyramine


• Cilazapril


• Cyclophosphamide


• Delapril


• Diclofenac


• Diflunisal


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Fenoprofen


• Flurbiprofen


• Fosinopril


• Ginkgo


• Glipizide


• Gossypol


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indomethacin


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Moexipril


• Nabumetone


• Naproxen


• Nepafenac


• Oxaprozin


• Pentopril


• Perindopril


• Piroxicam


• Quinapril


• Ramipril


• Salicylic Acid


• Salsalate


• Spirapril


• Sulindac


• Temocapril


• Tolmetin


• Topiramate


• Trandolapril


• Zofenopril

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Anuria (not able to form urine) or


• Sulfonamide (antibiotic or stomach medicines, e.g., sulfamethoxazole, sulfasalazine, sulfisoxazole, Azulfidine®, Bactrim®, or Septra®) allergy—Should not be used in patients with these conditions.

• Allergies or


• Asthma, history of—May increase likelihood of having an allergic reaction.

• Diabetes or


• Gout or


• Kidney problems or


• Liver problems or


• Systemic lupus erythematosus (an autoimmune disorder)—Use with caution. May make these conditions worse.

• Electrolyte imbalances (e.g., high calcium or low potassium, magnesium, or sodium in the body) or


• Fluid imbalances (caused by dehydration, vomiting, or diarrhea)—Use with caution. The blood pressure-lowering effects of this medicine may be increased.

Proper Use of Teveten HCT

This medicine should not be the first medicine you use to treat your condition. It is meant to be used only after you have tried other medicines that have not worked or have caused unwanted side effects.

In addition to the use of this medicine, treatment for your high blood pressure may include weight control and a change in the types of foods you eat, especially foods high in sodium (salt). Your doctor will tell you which of these are most important for you. You should check with your doctor before changing your diet.

Many patients who have high blood pressure will not notice any signs of the problem. In fact, many may feel normal. It is very important that you take your medicine exactly as directed and that you keep your appointments with your doctor even if you feel well.

Remember that this medicine will not cure your high blood pressure, but it does help control it. You must continue to take it as directed if you expect to lower your blood pressure and keep it down. You may have to take high blood pressure medicine for the rest of your life. If high blood pressure is not treated, it can cause serious problems such as heart failure, blood vessel disease, stroke, or kidney disease.

You may take this medicine with or without food.

Dosing

The dose of this medicine 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 this medicine. 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 oral dosage form (tablets):
  
  • For high blood pressure:
    
    • Adults—One tablet once a day. Your doctor may increase your dose as needed or administer twice daily. Usually the dose is not more than 800 mg per day.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, 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 Teveten HCT

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using this medicine while you are pregnant (especially in your second or third trimester) can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using this medicine, tell your doctor right away.

Dizziness, lightheadedness, or fainting may occur, especially when you get up from a lying or sitting position suddenly. Getting up slowly may help. These symptoms are more likely to occur when you begin taking this medicine, or when the dose is increased.

Check with your doctor right away if you become sick while taking this medicine, especially with severe or continuing nausea, vomiting, or diarrhea. These conditions may cause you to lose too much water or salt which may cause low blood pressure.

Check with your doctor right away if you experience dizziness, fainting, confusion, muscle pain, weakness, and/or a fast heartbeat. Use extra care if you exercise or if the weather is hot. Heavy sweating can cause dehydration (loss of too much water) or electrolyte imbalances (loss of potassium, magnesium, or sodium in the body).

Stop using this medicine and check with your doctor immediately if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during or after treatment. This could be a sign of a serious eye problem. Your doctor will want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may affect blood sugar levels. If you notice a change in the results of your blood or urine sugar tests, or if you have any questions, check with your doctor.

Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.

Do not use medicines, supplements, or salt substitutes that contain potassium without first checking with your doctor.

Drinking alcohol or taking narcotic pain relievers or sleeping pills with this medicine may intensify feeling lightheaded, dizzy, or faint. Tell your doctor if you are drinking alcohol or using pain relievers or sleeping pills.

Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.

Teveten HCT 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:

Rare

• Abdominal or stomach pain


• ankle, knee, or great toe joint pain


• arm, back, or jaw pain


• bladder pain


• bloating or swelling of the face, arms, hands, lower legs, or feet


• bloody or cloudy urine


• blurred vision


• chest pain or discomfort


• chest tightness or heaviness


• coma


• confusion


• convulsions


• cramps in the legs


• decreased urine output


• difficult with breathing


• difficult, burning, or painful urination


• dizziness


• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position


• dry mouth


• fainting


• fast, pounding, or irregular heartbeat or pulse


• feeling of warmth


• fever


• flushed or dry skin


• frequent urge to urinate


• frequent urination


• fruit-like breath odor


• headache


• increased hunger


• increased thirst


• increased urination


• increased volume of pale, dilute urine


• irregular heartbeat


• itching of the skin


• joint stiffness or swelling


• loss of appetite


• loss of bladder control


• loss of consciousness


• lower back or side pain


• mood changes


• muscle pain or cramps


• nausea or vomiting


• nervousness


• numbness and tingling of the face, fingers, or toes


• pain in the arms legs, or lower back, especially pain in the calves and/or heels upon exertion


• pale skin


• pale, bluish-colored, or cold hands or feet


• pinpoint red or purple spots on the skin


• rapid weight gain


• redness of the face, neck, arms, and occasionally, upper chest


• shortness of breath


• sudden decrease in the amount of urine


• sudden sweating


• sugar in the urine


• sweating


• swelling of the face, ankles, or hands


• swelling of the legs and feet


• swelling or puffiness of the face


• troubled breathing with exertion


• unexplained weight loss


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight gain or loss


• vomiting


• weakness or heaviness of the legs

Incidence not known

• Back, leg, or stomach pains


• black, tarry stools


• bleeding gums blistering, peeling, or loosening of the skin


• bloody or cloudy urine


• chills


• constipation


• cough or hoarseness


• coughing up blood


• darkened urine


• decrease in urine output or decrease in urine-concentrating ability


• decreased frequency or amount of urine


• diarrhea


• difficulty with swallowing


• drowsiness


• fever with or without chills


• general body swelling


• general feeling of discomfort or illness


• general feeling of tiredness or weakness


• greatly decreased frequency of urination or amount of urine


• hives


• indigestion


• irritability


• joint or muscle pain


• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs


• mood changes


• nosebleeds


• pains in the stomach, side, or abdomen, possibly radiating to the back


• pale skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• red skin lesions, often with a purple center


• red, irritated eyes


• skin rash


• sore throat


• sores, ulcers, or white spots on the lips or in the mouth


• swollen or painful glands


• thickening of bronchial secretions


• troubled breathing


• unusual weight loss


• vision changes


• weak pulse


• weight gain


• wheezing


• yellow eyes or 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:

Rare

• Acid or sour stomach


• belching


• body aches or pain


• bone pain


• burning feeling in the chest or stomach


• burning or stinging of the skin


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• burning, dry, or itching eyes


• change in hearing


• cold or flu-like symptoms


• congestion


• continuing ringing or buzzing or other unexplained noise in the ears


• cough producing mucus


• degenerative disease of the joint


• depression


• difficulty with moving


• discharge, excessive tearing


• ear congestion


• ear drainage


• earache


• excess air or gas in the stomach or intestines


• fear or nervousness


• feeling of constant movement of self or surroundings


• feeling unusually cold


• full feeling


• headache, severe and throbbing


• hearing loss


• heartburn


• increased sweating


• irritation in the mouth


• itching ears


• lack or loss of strength


• loose teeth


• loss of voice


• multiple swollen and inflamed skin lesions


• muscle pain or stiffness


• nasal congestion


• pain or burning in the throat


• pain, inflammation, or swelling in the calves, shoulders, or hands


• painful cold sores or blisters on the lips, nose, eyes, or genitals


• passing gas


• persistent breath odor or bad taste in your mouth


• rash with flat lesions or small raised lesions on the skin


• redness and swelling of the gums


• redness or swelling of the ears


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• runny or stuffy nose


• sensation of spinning


• shakiness and unsteady walk


• shakiness in the legs, arms, hands, or feet


• shivering


• skin rash, encrusted, scaly, and oozing


• sleepiness or unusual drowsiness


• sleeplessness


• sneezing


• stomach discomfort or upset


• tender, swollen glands in the neck


• tenderness in the stomach area


• toothache


• trembling or shaking of the hands or feet


• trouble sleeping


• unable to sleep


• unsteadiness, trembling, or other problems with muscle control or coordination


• voice changes


• weight loss

Incidence not known

• Decreased interest in sexual intercourse


• hair loss or thinning of the hair


• hives or welts


• inability to have or keep an erection


• increased sensitivity of the skin to sunlight


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


• muscle spasm


• redness of the skin


• redness or other discoloration of the skin


• severe sunburn


• tenderness of the salivary glands

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: Teveten HCT 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Teveten HCT resources

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

• Teveten HCT Prescribing Information (FDA)


• Teveten HCT Concise Consumer Information (Cerner Multum)


• Teveten HCT MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Teveten HCT with other medications

• High Blood Pressure

erlotinib

er-LOE-ti-nib

Commonly used brand name(s)

In the U.S.

• Tarceva

Available Dosage Forms:

• Tablet

Therapeutic Class: Antineoplastic Agent

Pharmacologic Class: Tyrosine Kinase Inhibitor

Uses For erlotinib

Erlotinib belongs to the group of medicines called antineoplastics. It is used for the treatment and maintenance therapy of advanced or metastatic (cancer that has already spread) non-small cell lung cancer after the failure of other chemotherapy treatment. It is also used together with another medicine called gemcitabine (e.g., Gemzar®) to treat cancer of the pancreas.

erlotinib is available only with your doctor's prescription.

Before Using erlotinib

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 erlotinib, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to erlotinib 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 erlotinib in the pediatric population. 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 erlotinib in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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 erlotinib, 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 erlotinib 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.

• Carbamazepine


• Esomeprazole


• Fosphenytoin


• Lansoprazole


• Omeprazole


• Pantoprazole


• Phenobarbital


• Phenytoin


• Rabeprazole


• Rifabutin


• Rifampin


• Rifapentine


• St John's Wort

Using erlotinib 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.

• Aluminum Carbonate, Basic


• Aluminum Hydroxide


• Aluminum Phosphate


• Calcium Carbonate


• Ciprofloxacin


• Dihydroxyaluminum Aminoacetate


• Dihydroxyaluminum Sodium Carbonate


• Ketoconazole


• Magaldrate


• Magnesium Carbonate


• Magnesium Hydroxide


• Magnesium Oxide


• Magnesium Trisilicate


• Ranitidine


• 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 erlotinib. Make sure you tell your doctor if you have any other medical problems, especially:

• Bleeding problems (e.g., hemolytic anemia, thrombocytopenia) or


• Dehydration or


• Eye or vision problems or


• Heart attack, history of or


• Intestinal or stomach problems (e.g., peptic ulcer), or history of or


• Lung or breathing problems (e.g., interstitial lung disease), history of or


• Stroke, history of—Use with caution. May make these conditions worse.

• Kidney disease or


• Liver disease—Use with caution. The chance of serious side effects is greatly increased.

Proper Use of erlotinib

Medicines used to treat cancer are very strong and can have many side effects. Before receiving erlotinib, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.

It is important that you take erlotinib one hour before or at least two hours after the ingestion of food.

Do not eat grapefruit or drink grapefruit juice while you are using erlotinib.

Avoid smoking cigarettes or using other tobacco products while you are using erlotinib.

Dosing

The dose of erlotinib 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 erlotinib. 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 oral dosage form (tablets):
  
  • For lung cancer, non-small cell:
    
    • Adults—150 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  
  • For cancer of the pancreas:
    
    • Adults—100 milligrams (mg) once a day. Your doctor may adjust your dose as needed.
    
    
    • Children—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of erlotinib, 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 erlotinib

It is very important that your doctor check your progress at regular visits to make sure erlotinib is working properly. Blood and urine tests may be needed to check for unwanted effects.

Using erlotinib while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. You should continue to use birth control at least 14 days after you have stopped taking erlotinib. However, if you think you have become pregnant while using the medicine, tell your doctor right away.

It is important that you talk to your doctor right away if you have severe or continuing diarrhea, nausea, loss of appetite, or vomiting.

Call your doctor right away if you have unexplained shortness of breath, cough, and fever that comes on suddenly.

Check with your doctor right away if you have bloody or black, tarry stools; severe stomach pain; or vomiting of blood or material that looks like coffee grounds. These could be symptoms of a serious stomach or bowel problem.

Liver problems may occur while you are using erlotinib. Stop using erlotinib and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

Serious skin reactions can occur with erlotinib. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using erlotinib.

You may use alcohol-free emollient creams, sunscreen, or sun blocking lotions to prevent dry skin and other serious skin reactions.

Check with your doctor immediately if blurred vision, difficulty in reading, any other change in vision, or eye pain or irritation occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

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 (St. John's wort) or vitamin supplements.

erlotinib 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

• Burning, tingling, numbness or pain in the hands, arms, feet, or legs


• cough or hoarseness


• diarrhea, severe


• difficult or labored breathing


• fever or chills


• lower back or side pain


• painful or difficult urination


• rash, severe


• sensation of pins and needles


• shortness of breath


• stabbing chest pain


• tightness in the chest


• wheezing

Rare

• Bloody or black, tarry stool


• blurred vision


• chest pain or discomfort


• constipation


• convulsions (seizures)


• eye irritation or redness


• inability to speak


• pain or discomfort in the arms, jaw, back, or neck


• severe stomach pain


• slurred speech


• sudden, severe chest pain


• sudden, severe headache


• sudden, severe weakness in the arm or leg on one side of the body


• sweating


• vision changes


• vomiting of blood or material that looks like coffee grounds

Incidence not known

• Agitation


• blistering, peeling, or loosening of the skin


• bloody nose


• burning feeling in the chest or stomach


• burning upper abdominal or stomach pain


• coma


• confusion


• dark-colored urine


• darkening of the skin


• decreased urine output


• general feeling of tiredness or weakness


• headache


• increased thirst


• irregular heartbeat


• lethargy


• light-colored stools


• loss of appetite


• mood changes


• muscle twitching


• nausea or vomiting


• rapid weight gain


• red skin lesions, often with a purple center


• sore throat


• sores, ulcers, or white spots in the mouth or on the lips


• stomach pain, continuing


• stupor


• swelling of the face, ankles, or hands


• tenderness in the stomach area


• trouble breathing


• unusual tiredness or weakness


• yellow eyes or 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:

More common

• Acid or sour stomach


• belching


• blemishes on the skin


• bloated, full feeling


• bone pain


• burning, dry, or itching eyes


• diarrhea, mild


• difficulty with moving


• dizziness


• dry eyes


• dry skin


• excess air or gas in the stomach or intestines


• excessive tearing


• fear


• feeling sad or empty


• feeling unusually cold


• hair loss


• headache


• heartburn


• indigestion


• irritability


• itching skin


• joint pain


• loss of interest or pleasure


• muscle aching or cramping


• muscle pains or stiffness


• nervousness


• passing gas


• pimples


• rash, mild


• redness, pain, or swelling of the eye, eyelid, or inner lining of the eyelid


• shivering


• sleeplessness


• stomach discomfort, upset, or pain


• swelling


• swelling or inflammation of the mouth


• swollen joints


• thinning of the hair


• tiredness


• trouble with concentrating


• trouble or inability to sleep


• weight loss

Less common

• Loosening of the fingernails


• redness or soreness around the fingernails

Incidence not known

• Brittle and loose nails


• discharge, excessive tearing


• increased hair growth, especially on the face

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: erlotinib 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More erlotinib resources

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

• Erlotinib Professional Patient Advice (Wolters Kluwer)


• Erlotinib Monograph (AHFS DI)


• Erlotinib MedFacts Consumer Leaflet (Wolters Kluwer)


• Tarceva Prescribing Information (FDA)


• Tarceva Consumer Overview

Compare erlotinib with other medications

• Non-Small Cell Lung Cancer
• Pancreatic Cancer
• Renal Cell Carcinoma

Zymar

Generic Name: gatifloxacin (Ophthalmic route)

gat-i-FLOX-a-sin

Commonly used brand name(s)

In the U.S.

• Zymar


• Zymaxid

Available Dosage Forms:

• Solution

Therapeutic Class: Antibiotic

Chemical Class: Fluoroquinolone

Uses For Zymar

Gatifloxacin ophthalmic (eye) preparation is used to treat infections of the eye, such as bacterial conjunctivitis. Gatifloxacin belongs to a group of medicines called fluoroquinolone antibiotics. It works by killing bacteria that cause conjunctivitis.

This medicine is available only with your doctor's prescription.

Before Using Zymar

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 this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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 performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of Zymaxid™ in children. However, safety and efficacy have not been established in children younger than 1 year of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of Zymaxid™ in the elderly.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Proper Use of gatifloxacin

This section provides information on the proper use of a number of products that contain gatifloxacin. It may not be specific to Zymar. Please read with care.

Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

• First, wash your hands. Then tilt the head back and pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the infection.


• If you think you did not get the drop of medicine into your eye properly, repeat the directions with another drop.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

To help clear up your eye infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared and even if you feel better after the first few doses. Your infection may not clear up if you stop using the medicine too soon. Do not miss any doses.

Dosing

The dose of this medicine 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 this medicine. 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 ophthalmic dosage form (eye drops):
  
  • For bacterial conjunctivitis:
    
    • Adults and children 1 year of age and older—
      
      • Day 1: Put one drop in the affected eye every two hours while awake, up to 8 times.
      
      
      • Days 2 through 7: Put one drop in the affected eye two to four times a day while awake.
      
      
    
    
    • Infants younger than 1 year of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

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 Zymar

If your eye infection does not improve within a few days, or if it becomes worse, check with your doctor.

Stop using this medicine and check with your doctor right away if you have a rash, itching, or red or swollen skin around the eye or eyelid. These may be symptoms of an allergic reaction.

Do not wear contact lenses while you are using this medicine to avoid further eye irritation.

Zymar 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

• Eye irritation


• eye pain


• eye redness

Less common

• Bloody eye


• decrease in vision


• swelling of the membrane covering the white part of the eye

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:

More common

• Blurred vision


• discharge from the eyes


• itching eyes


• stringy mucus secretions


• swelling of the eye, eyelid, or inner lining of the eyelid


• watering eyes

Less common

• Bad, unusual, or unpleasant (after) taste


• change in taste


• dry eye


• headache

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: Zymar 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.

The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.

More Zymar resources

• Zymar Side Effects (in more detail)
• Zymar Use in Pregnancy & Breastfeeding
• Zymar Support Group
• 6 Reviews for Zymar - Add your own review/rating

• Zymar Prescribing Information (FDA)


• Zymar eent Monograph (AHFS DI)


• Zymar Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Zymaxid Prescribing Information (FDA)


• Zymaxid Consumer Overview

Compare Zymar with other medications

• Conjunctivitis
• Conjunctivitis, Bacterial
• Ophthalmic Surgery