Beechams Powders Capsules

1. Name Of The Medicinal Product

Beechams Powders Capsules

2. Qualitative And Quantitative Composition

Active Constituents	mg / Capsule
Paracetamol	300.00
Caffeine	25.00
Phenylephrine Hydrochloride	5.00

3. Pharmaceutical Form

Capsule

4. Clinical Particulars

4.1 Therapeutic Indications

Symptomatic relief of symptoms of influenza, feverishness, chills and colds including feverish colds.

The symptomatic relief of nasal congestion and difficult breathing arising from this, sinusitis and its associated pain, acute nasal catarrh.

4.2 Posology And Method Of Administration

Recommended Dose and Dosage Schedule

Adults (including elderly) and children aged 12 years and over:

2 capsules every 4 to 6 hours as required, but no more than 12 capsules in any 24 hours.

Do not take continuously for more than 7 days without medical advice

Children under 12 years of age

Not to be given under the age of 12

4.3 Contraindications

Concomitant use of other sympathomimetic decongestants

Phaeochromocytoma

Closed angle glaucoma

Known hypersensitivity to paracetamol or any of the other ingredients. Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, and heart disease.

Patients taking tricyclic antidepressants, or beta blocking drugs and those who are taking or who have taken within the last two weeks monoamine oxidase inhibitors (see section 4.5).

4.4 Special Warnings And Precautions For Use

Medical advice should be sought before using this product in patients with these conditions:

An enlargement of the prostate gland

Occlusive vascular disease (e.g. Raynaud's phenomenon)

Cardiovascular disease

This product should not be used by patients taking other sympathomimetics (such as decongestants, appetite suppressants and amphetamine-like psychostimulants) (see interactions).

Excessive intake of caffeine (e.g. coffee, tea and some canned drinks) should be avoided while taking this product.

Keep out of the reach and sight of children

Contains Paracetamol

Do not exceed the stated dose

If symptoms persist consult your doctor

If you are under the care of your doctor or receiving prescribed medicines consult your doctor before taking this product.

Do not take other flu, cold or decongestant medicines or other paracetamol-containing medicines, with this product.

Care is advised in the administration of paracetamol to patients with renal or hepatic impairment. The hazard of overdose is greater in those with non-cirrhotic alcoholic liver disease.

Special Label Warnings

Do not take with any other paracetamol-containing products. Do not take with other flu, cold or decongestant products.

Immediate medical advice should be sought in the event of an overdose, even if you feel well.

Special Leaflet Warnings

Immediate medical advice should be sought in the event of an overdose, even if you feel well, because of the risk of delayed, serious liver damage.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Enzyme-inducing drugs may increase hepatic damage, as does excessive intake of alcohol. The speed of absorption of paracetamol may be increased by metoclopramide or domperidone and absorption reduced by colestyramine. These interactions are considered to be of unlikely clinical significance in acute usage at the dosage regimen proposed.

Medical advice should be sought before taking paracetamol-caffeine phenylephrine in combination with the following drugs:

Monoamine oxidase inhibitors (including moclobemide)	Hypertensive interactions occur between sympathomimetic amines such as phenylephrine and monoamine Oxidase inhibitors (see contraindications).
Sympathomimetic amines	Concomitant use of phenylephrine with other sympathomimetics amines can increase the risk of cardiovascular side effects (see warnings and precautions).
Beta-blockers and other antihypertensives (including debrisoquine, guanethidine, reserpine, methyldopa)	Phenylephrine may reduce the efficacy of beta-blocking drugs and antihypertensive drugs. The risk of hypertension and other cardiovascular side effects may be increased (see contraindications).
Tricyclic antidepressants (eg amitriptyline)	May increase the risk of cardiovascular side effects with phenylephrine (see contraindications).
Digoxin and cardiac glycosides	Concimitant use of phenylephrine with digoxin or cardiac glycosides may increase the ris of irregular heartbeat or heart attack.
Ergot alkaloids	(ergotamine and methylsergide) increased risk of ergotism
Warfarin and other coumarins	The anticoagulant effect of warfarin and other coumarins may be enhanced by prolonged regular daily use of paracetamol with an increased risk of bleeding; occasional doses have no significant effect.

4.6 Pregnancy And Lactation

This product is not recommended for use in pregnancy due to the phenylephrine and caffeine content. There is a potential increased risk of lower birth weight and spontaneous abortion associated with caffeine consumption during pregnancy.

This product should not be used while breast-feeding without medical advice.

Caffeine in breast milk may have a stimulating effect on breast-fed infants.

Phenylephrine may be excreted in breast milk.

4.7 Effects On Ability To Drive And Use Machines

Patients should be advised not to drive or operate machinery if affected by dizziness.

4.8 Undesirable Effects

Adverse events of paracetamol from historical clinical trial data are both infrequent and from small patient exposure. Accordingly, events reported from extensive post-marketing experience at therapeutic/labelled dose and considered attributable are tabulated below by system class. The frequency of these adverse events is not known (cannot be estimated from available data).

Paracetamol

Body System	Undesirable effect
Blood and lymphatic system disorders	Thrombocytopenia Agranulocytosis These are not necessarily causally related to paracetamol.
Immune system disorders	Anaphylaxis Cutaneous hypersensitivity reactions including skin rashes, angiodema and Stevens Johnson syndrome, toxic epidermal necrolysis
Respiratory, thoracic and mediastinal disorders	Bromchospasm*
Hepatobiliary disorders	Hepatic dysfunction

* There have been cases of bronchospasm with paracetamol, but these are more likely in asthmatics sensitive to aspirin or other NSAIDs.

Caffeine

Adverse reactions identified through post-marketing use with caffeine are listed below. The frequency of these reactions is unknown.

Central Nervous system

Nervousness and anxiety Irritability, Restlessness and Excitability Dizziness

When the recommended paracetamol-caffeine dosing regimen is combined with dietary caffeine intake, the resulting higher dose of caffeine may increase the potential for caffeine-related adverse effects such as insomnia, restlessness, anxiety, irritability, headaches, gastrointestinal disturbances and palpitations.

Phenylephrine

The following adverse events have been observed in clinical trials with phenylephrine and may therefore represent the most commonly occurring adverse events.

Body System	Undesirable effect
Psychiatric disorders	Nervousness
Nervous system disorders	Headache, dizziness, insomnia
Cardiac disorders	Increased blood pressure
Gastrointestinal disorders	Nausea, vomiting, diarrhoea

Adverse reactions identified during post-marketing use are listed below. The frequency of these reactions is unknown.

Eye disorders	Mydriasis, acute angle closure glaucoma, most likely to occur in those with closed angle glaucoma
Cardiac disorders	Tachycardia, palpitations
Skin and subcutaneous disorders	Allergic reactions (e.g. rash, urticaria, allergic dermatitis). Hypersensitivity reactions – including that cross-sensitivity may occur with other sympathomimetics
Renal and urinary disorders	Dysuria, urinary retention. This is most likely to occur in those with bladder outlet obstruction, such as prostatic hypertrophy.

4.9 Overdose

Paracetamol

Liver damage is possible in adults who have taken 10g or more of paracetamol. Ingestion of 5g or more of paracetamol may lead to liver damage if the patient has risk factors (see below).

Risk factors:

If the patient

a, Is on long term treatment with carbamazepine, phenobarbitone, phenytoin, primidone, rifampicin, St John's Wort or other drugs that induce liver enzymes.

Or

b, Regularly consumes ethanol in excess of recommended amounts.

Or

c, Is likely to be glutathione deplete e.g. eating disorders, cystic fibrosis, HIV infection, starvation, cachexia.

Symptoms:

Symptoms of paracetamol overdosage in the first 24 hours are pallor, nausea, vomiting, anorexia and abdominal pain. Liver damage may become apparent 12 to 48 hours after ingestion. Abnormalities of glucose metabolism and metabolic acidosis may occur. In severe poisoning, hepatic failure may progress to encephalopathy, haemorrhage, hypoglycaemia, cerebral oedema, and death. Acute renal failure with acute tubular necrosis, strongly suggested by loin pain, haematuria and proteinuria, may develop even in the absence of severe liver damage. Cardiac arrhythmias and pancreatitis have been reported.

Management:

Immediate treatment is essential in the management of paracetamol overdose. Despite a lack of significant early symptoms, patients should be referred to hospital urgently for immediate medical attention. Symptoms may be limited to nausea or vomiting and may not reflect the severity of overdose or the risk of organ damage. Management should be in accordance with established treatment guidelines, see BNF overdose section.

Treatment with activated charcoal should be considered if the overdose has been taken within 1 hour. Plasma paracetamol concentration should be measured at 4 hours or later after ingestion (earlier concentrations are unreliable). Treatment with N-acetylcysteine may be used up to 24 hours after ingestion of paracetamol, however, the maximum protective effect is obtained up to 8 hours post-ingestion. The effectiveness of the antidote declines sharply after this time. If required the patient should be given intravenous N-acetylcysteine, in line with the established dosage schedule. If vomiting is not a problem, oral methionine may be a suitable alternative for remote areas, outside hospital. Management of patients who present with serious hepatic dysfunction beyond 24h from ingestion should be discussed with the NPIS or a liver unit.

Caffeine

Symptoms and signs

Overdose of caffeine may result in epigastric pain, vomiting, diurese, tachycardia or cardiac arrhythmia, CNS stimulation (insomnia, restlessness, excitement, agitation, jitteriness, tremors and convulsions).

It must be noted that for clinically significant symptoms of caffeine overdose to occur with this product, the amount ingested would be associated with serious paracetamol-related liver toxicity.

Treatment

No specific antidote is available, but supportive measures may be used.

Phenylephrine

Symptoms and signs

Phenylephrine overdosage is likely to result in effects similar to those listed under adverse reactions. Additional symptoms may include hypertension, and possibly reflex bradycardia. In severe cases confusion, hallucinations, seizures and arrhythmias may occur. However the amount required to produce serious phenylephrine toxicity would be greater than that required to cause paracetamol-related liver toxicity.

Treatment

Treatment should be as clinically appropriate. Severe hypertension may need to be treated with alpha blocking drugs such as phentolamine.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Paracetamol: An analgesic and antipyretic.

Caffeine: A mild stimulant

Phenylephrine hydrochloride: A sympathomimetic decongestant.

The active ingredients are not known to cause sedation.

5.2 Pharmacokinetic Properties

Paracetamol: is readily absorbed from the gastrointestinal tract. It is metabolised in the liver and excreted in the urine, mainly as glucoronide and sulphate conjugates.

Caffeine: is absorbed readily after oral administration, maximal plasma concentrations are achieved within one hour and the plasma half-life is about 3.5 hours. 65-80% of administered caffeine is excreted in the urine as 1-methyluric acid and 1-methylxanthine.

Phenylephrine Hydrochloride: is irregularly absorbed from the gastrointestinal tract and undergoes first-pass metabolism by monoamine oxidase in the gut and liver; orally administered phenylephrine thus has reduced bioavailability. It is excreted in the urine almost entirely as the sulphate conjugate.

5.3 Preclinical Safety Data

Pre-clinical safety data on these active ingredients in the literature have not revealed any pertinent and conclusive findings which are of relevance to the recommended dosage and use of the product and which have not already been mentioned elsewhere in this Summary.

The toxicity of paracetamol has been extensively studied in numerous animal species. Pre-clinical studies in rats and mice have indicated single dose oral LD₅₀ values of 3.7 g/kg and 338 mg/kg, respectively. Chronic toxicity in these species at large multiples of the human therapeutic dose, occurs as degeneration and necrosis of hepatic, renal and lymphoid tissue, and blood count changes. The metabolites believed responsible for these effects have also been demonstrated in man. Paracetamol should not, therefore, be taken for long periods of time, and in excessive doses. At normal therapeutic doses, paracetamol is not associated with genotoxic or carcinogenic risk. There is no evidence of embryo-or foetus-toxicity from paracetamol in animal studies.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Lactose

Colloidal silica

Dimeticone

Shell capsule (G dye/100g capsule part)

Amaranth (E123)

Erthyrosine (E127)

Sunset yellow (E110)

Titanium dioxide (E171)

Gelatin

Shell body (G dye/100G capsule part)

Gelatin

Titanium dioxide (E171)

6.2 Incompatibilities

None known

6.3 Shelf Life

Five years

6.4 Special Precautions For Storage

None stated

6.5 Nature And Contents Of Container

Opaque blisters of polyvinyl chloride (PVC)/polyvinylidene chloride (PVdC) backed with aluminium foil. Ten or 16 capsules are blistered and packed into boxboard cartons.

6.6 Special Precautions For Disposal And Other Handling

Not applicable

7. Marketing Authorisation Holder

Beecham Group Plc

980 Great West Road

Brentford

Middlesex

TW8 9GS

United Kingdom

Trading as: GlaxoSmithKline Consumer Healthcare, Brentford, TW8 9GS, U.K.

8. Marketing Authorisation Number(S)

PL 00079/0205

9. Date Of First Authorisation/Renewal Of The Authorisation

1.7.82 / 1.7.97

10. Date Of Revision Of The Text

May 2010.

Metvixia topical

Generic Name: methyl aminolevulinate (topical) (METH il a MEE noe LEV ue LIN ate)

Brand Names: Metvixia

What is methyl aminolevulinate?

Methyl aminolevulinate makes your skin more sensitive to light. It works by causing a reaction with light that can destroy certain types of diseased skin cells.

Methyl aminolevulinate topical (for the skin) is used in combination with red light therapy to treat a skin condition called actinic keratosis of the face and scalp.

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

What is the most important information I should know about methyl aminolevulinate?

You should not use this medication if you are allergic to methyl aminolevulinate, porphyrins, peanuts or almonds, or if your skin is especially sensitive to light.

Before you are treated with methyl aminolevulinate, tell your doctor about all of your medical conditions. Also tell your doctor about all other medications you use, especially drugs that can make your skin more sensitive to sunlight, such as certain antibiotics, heart or blood pressure medications, diuretics (water pills), sulfa drugs, oral diabetes medications, or NSAID pain or arthritis medicines.

Methyl aminolevulinate is applied by a healthcare provider in a clinic setting. For at least 48 hours after your treatment, avoid exposing treated skin to sunlight, sunlamps, tanning beds, or other bright lights. Sunscreen is not effective enough to protect treated skin from harm caused by bring light during this time. Wear protective clothing whenever you are outdoors. Call your doctor at once if you have severe stinging, burning, redness, oozing, or swelling of treated skin areas, especially if you have these effects for longer than 3 weeks after treatment.

It may take several weeks before you notice improvement in your skin condition. Your doctor will need to check your treated skin 3 months after the end of your last treatment with methyl aminolevulinate.

Your skin lesions may need to be treated more than once, and they may come back after treatment. Talk to your doctor about the number of treatments needed to treat your condition.

What should I discuss with my health care provider before taking methyl aminolevulinate?

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

• 
  

  an allergy to peanuts or almonds;

  
  


• 
  

  an allergy to porphyrins; or

  
  


• 
  

  if your skin is especially sensitive to light.

  
  

Before you are treated with methyl aminolevulinate, tell your doctor about all of your medical conditions.

FDA pregnancy category C. It is not known whether methyl aminolevulinate is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether methyl aminolevulinate passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How is methyl aminolevulinate used?

Methyl aminolevulinate topical is a cream that is applied to actinic keratosis skin lesions prior to red light treatment. Your doctor, nurse, or other healthcare provider will prepare your skin and apply this medication in a clinic setting.

Prior to application of methyl aminolevulinate, your skin lesions will be gently scraped to remove any scales or crusting. After the medication is applied, your caregiver will cover the treatment area with a bandage. You will need to leave this bandage in place for 3 hours.

During this 3-hour period, avoid exposure to cold temperatures and sunlight or bright indoor lights. Wear a wide-brimmed hat if you must be outdoors during this time.

After your bandaging is removed, any excess medication will be removed with a saline solution. You will then be ready to receive the light treatment.

You will be given eye-wear to protect your eyes during red light treatment.

You may feel a slight stinging or burning during light therapy. Tell your caregivers if you have any type of severe discomfort.

Methyl aminolevulinate and red light therapy is usually given in two sessions one week apart. Your treatment schedule may be different. Follow your doctor's instructions.

It may take several weeks before you notice improvement in your skin condition. Your doctor will need to check your treated skin 3 months after the end of your last treatment with methyl aminolevulinate.

Your skin lesions may need to be treated more than once, and they may come back after treatment. Talk to your doctor about the number of treatments needed to treat your condition.

What happens if I miss a dose?

Since methyl aminolevulinate is applied only when needed prior to red light therapy, you will not be on a dosing schedule.

What happens if I overdose?

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

Symptoms of a methyl aminolevulinate overdose are not known.

What should I avoid while taking methyl aminolevulinate?

Tell your caregivers right away if any of this medication gets into your eyes, mouth, or nose. Avoid touching the treated skin areas after methyl aminolevulinate cream has been applied to them. Special gloves must be worn by the healthcare provider while applying this medication, and you should not allow your own fingers to come into contact with the cream on your skin. For at least 48 hours after your treatment, avoid exposing treated skin to sunlight, sunlamps, tanning beds, or other bright lights. Sunscreen is not effective enough to protect treated skin from harm caused by bring light during this time. Wear protective clothing whenever you are outdoors.

Even if you do not receive the light therapy portion of your treatment, you must still protect your skin from light for 48 hours after the cream was applied.

Methyl aminolevulinate 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 severe stinging, burning, redness, oozing, or swelling of treated skin areas, especially if you have these effects for longer than 3 weeks after treatment.

Less serious side effects may include:

• 
  

  mild skin redness, warmth, burning, or swelling;

  
  


• 
  

  puffy eyes;

  
  


• 
  

  slight pain; or

  
  


• 
  

  itching, peeling, scabs or crusting of treated skin.

  
  

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect.

What other drugs will affect methyl aminolevulinate?

Tell your doctor about all other medications you use, especially drugs that can make your skin more sensitive to sunlight, such as:

• 
  

  amiodarone (Cordarone, Pacerone);

  
  


• 
  

  diabetes medications you take by mouth;

  
  


• 
  

  diltiazem (Tiazac, Cartia, Cardizem);

  
  


• 
  

  furosemide (Lasix);

  
  


• 
  

  porfimer (Photofrin);

  
  


• 
  

  quinidine (Quinaglute, Quinidex, Quin-Release);

  
  


• 
  

  tacrolimus (Prograf);

  
  


• 
  

  verteporfin (Visudyne);

  
  


• 
  

  an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), or trandolapril (Mavik);

  
  


• 
  

  an antibiotic such as ciprofloxacin (Cipro), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), levofloxacin (Levaquin), ofloxacin (Floxin), norfloxacin (Noroxin), tetracycline (Brodspec, Panmycin, Sumycin, Tetracap);

  
  


• 
  

  a diuretic (water pill) such as hydrochlorothiazide (HCTZ), contained in Aldoril, Atacand, Capozide, HydroDiuril, Hyzaar, Lopressor, Lotensin, Moduretic, Monopril, Tekturna, Teveten, Vaseretic, Zestoretic, Ziac, and others;

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Motrin, Advil), naproxen (Aleve, Naprosyn), diclofenac (Cataflam, Voltaren), etodolac (Lodine), indomethacin (Indocin), ketoprofen (Orudis), and others; or

  
  


• 
  

  a sulfa drug (such as Bactrim, Septra, SMX-TMP, and others).

  
  

This list is not complete and there may be other drugs that can interact with methyl aminolevulinate. 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 Metvixia resources

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

Compare Metvixia with other medications

• Actinic Keratosis

Where can I get more information?

• Your doctor or pharmacist can provide more information about methyl aminolevulinate.

See also: Metvixia side effects (in more detail)

Cobalin-H Injection (Amdipharm Plc)

1. Name Of The Medicinal Product

Cobalin-H

2. Qualitative And Quantitative Composition

Anhydrous hydroxocobalamin 1000mcg/ml.

3. Pharmaceutical Form

Injection

4. Clinical Particulars

4.1 Therapeutic Indications

Treatment of Addisonian pernicious anaemia.

Prophylaxis and treatment of other macrocytic anaemias due to vitamin B₁₂ deficiency.

Treatment of tobacco amblyopia.

Treatment of Leber's atrophy.

4.2 Posology And Method Of Administration

The following dosages are suitable for children and adults.

Addisonian pernicious anaemia and other macrocytic anaemias without neurological involvement:

Initially:	250 micrograms to 1000 micrograms intramuscularly on alternate days for one or two weeks then 250 micrograms weekly until blood count is normal.
Maintenance:	1000 micrograms every two or three months.

Addisonian pernicious anaemia and other macrocytic anaemias with neurological involvement:

Initially:	1000 micrograms on alternate days as long as improvement continues.
Maintenance:	1000 micrograms every two months.

Prophylaxis of macrocytic anaemias associated with vitamin B₁₂ deficiency resulting from gastrectomy, ileal resection, certain ma/absorption states and vegetarianism:

1000 micrograms every two or three months.

Tobacco amblyopia and Leber's optic atrophy:

Initially:	1000 micrograms daily by intramuscular injection for two weeks then twice weekly as long as improvement is maintained.
Maintenance:	1000 micrograms every three months or as required.

4.3 Contraindications

Sensitivity to hydroxocobalamin / vitamin B₁₂.

4.4 Special Warnings And Precautions For Use

Cobalin-H should not be given before a megaloblastic marrow has been demonstrated. Regular monitoring of the blood is advisable. Doses of hydroxocobalamin greater than 10 micrograms daily may produce a haematological response in patients with folate deficiency. Indiscriminate use may mask the exact diagnosis. Cardiac arrhythmias secondary to hypokalaemia have been reported during initial therapy and plasma potassium should, therefore, be monitored during this period.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

The serum concentration of hydroxocobalamin may be reduced by concurrent administration of oral contraceptives. Chlorphenicol-treated patients may respond poorly to hydroxocobalamin. Vitamin B₁₂ assays by microbiological techniques are invalidated by antimetabolites and most antibiotics.

4.6 Pregnancy And Lactation

Hydroxocobalamin should not be used to treat megaloblastic anaemia of pregnancy.

4.7 Effects On Ability To Drive And Use Machines

None stated.

4.8 Undesirable Effects

The following effects have been reported and are listed below by body system:

Disorders of the immune system:
Rare:	Allergic hypersensitivity reactions
Very rare:	Anaphylaxis
Gastro intestinal disorders:
Frequency Not Known:	Nausea
General disorders:
Frequency Not Known:	Fever, dizziness, Injection site disorders
Neurological disorders:
Frequency Not Known:	Headache

4.9 Overdose

Treatment is unlikely to be needed in cases of overdosage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Vitamin B₁₂

ATC classification: B03B A03

5.2 Pharmacokinetic Properties

Vitamin B₁₂ is extensively bound to specific plasma proteins called transcobalamins; transcobalamin II appears to be involved in the rapid transport of the cobalamins to tissues. It is stored in the liver, excreted in the bile, and undergoes enterohepatic recycling; part of a dose is excreted in the urine, most of it in the first 8 hours.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the Summary of Product Characteristics.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium dihydrogen orthophosphate

Sodium chloride

Water for Injections

6.2 Incompatibilities

None stated.

6.3 Shelf Life

60 months.

6.4 Special Precautions For Storage

Protect from light. Store below 25°C.

6.5 Nature And Contents Of Container

Cobalin-H is supplied in clear 1ml Type I glass ampoules in cartons of 5 or 10.

6.6 Special Precautions For Disposal And Other Handling

None stated.

7. Marketing Authorisation Holder

AMDIPHARM PLC

REGENCY HOUSE

MILES GRAY ROAD

BASILDON

ESSEX

SS14 3AF

UNITED KINGDOM

8. Marketing Authorisation Number(S)

PL 20072/0217

9. Date Of First Authorisation/Renewal Of The Authorisation

18^th June 1993 / 6^th November 1998

10. Date Of Revision Of The Text

18/05/2011

Mutamycin

Pronunciation: mye-toe-MYE-sin
Generic Name: Mitomycin
Brand Name: Mutamycin

Mutamycin may cause bone marrow suppression, which may cause severe blood problems such as low platelet levels (thrombocytopenia) and low white blood cell levels (leukopenia). These blood problems may increase your risk of developing severe bleeding or a severe and possibly fatal infection. Mutamycin may also increase your risk of developing hemolytic uremic syndrome (HUS), which may cause problems such as hemolytic anemia, low platelet count, and permanent kidney failure. HUS may occur at any time during treatment. Higher doses may increase your risk for developing this side effect. Blood transfusions may make the symptoms of this syndrome worse. Notify your doctor immediately if you develop symptoms of an infection (eg, fever, chills, persistent sore throat), fatigue, unusual bleeding or bruising, or a change in the amount of urine produced.

Mutamycin is used for:

Treating cancer of the stomach or pancreas in combination with other medicines. It may also be used to reduce the severity of these cancers when they have not responded to other treatments. It may also be used for other conditions as determined by your doctor.

Mutamycin is an antibiotic that has been shown to have action against tumors. It works by blocking growth of the cancer cell.

Do NOT use Mutamycin if:

• you are allergic to or have had an unusual reaction to any ingredient in Mutamycin


• you have low blood platelet levels (thrombocytopenia), low white blood cell levels (leukopenia), blood clotting problems, or bleeding problems


• you have active severe bleeding


• you have shingles or chickenpox

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mutamycin:

Some medical conditions may interact with Mutamycin. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have kidney problems, breathing problems, or bone marrow problems

Some MEDICINES MAY INTERACT with Mutamycin. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Vinca alkaloids (eg, vincristine) or other cancer medicines because lung problems, such as severe shortness of breath, may occur


• Tamoxifen because risk of anemia, low blood platelet levels, or hemolytic uremic syndrome may be increased


• Doxorubicin because risk of heart failure may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Mutamycin may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Mutamycin:

Use Mutamycin as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Mutamycin is usually administered as an injection at your doctor's office, hospital, or clinic. If you are using Mutamycin at home, carefully follow the injection procedures taught to you by your health care provider.


• If nausea, vomiting, or loss of appetite occur, ask your doctor or pharmacist for ways to lessen these effects.


• Mutamycin may cause a serious reaction if it comes in contact with your skin. If this happens, wash the area with soap and water for approximately 15 minutes. Contact your doctor as soon as possible. The use of gloves while handling Mutamycin is recommended.


• If Mutamycin contains particles or is discolored, or if the vial is cracked or damaged in any way, do not use it.


• Keep this product, as well as syringes and needles, out of the reach of children and away from pets. Do not reuse needles, syringes, or other materials. Dispose of properly after use. Ask your doctor or pharmacist to explain local regulations for proper disposal.


• If you miss a dose of Mutamycin, contact your doctor immediately.

Ask your health care provider any questions you may have about how to use Mutamycin.

Important safety information:

• Mutamycin may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.


• Mutamycin may lower your body's ability to fight infection. Prevent infection by avoiding contact with people with colds or other infections. Notify your doctor of any signs of infection, including fever, sore throat, rash, or chills. Do not touch your eyes or the inside of your nose unless you have thoroughly washed your hands first.


• Avoid vaccinations with live virus vaccines (eg, measles, mumps, oral polio) while you are taking Mutamycin. Talk to your doctor before having any vaccinations while you are using Mutamycin.


• Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Mutamycin.


• LAB TESTS, including platelet count, complete blood cell count, and kidney function tests, may be performed to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.


• Use Mutamycin with extreme caution in CHILDREN. Safety and effectiveness have not been confirmed.


• PREGNANCY and BREAST-FEEDING: It is unknown if Mutamycin can cause harm to the fetus. If you become pregnant while taking Mutamycin, discuss with your doctor the benefits and risks of using Mutamycin during pregnancy. It is unknown if Mutamycin is excreted in breast milk. Do not breast-feed while taking Mutamycin.

Possible side effects of Mutamycin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Hair loss; loss of appetite; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; decreased urination; dizziness; dry cough; fever, chills, or sore throat; pain, redness, or swelling at the injection site; shortness of breath; sores or swelling of the mouth, lips, hands, or feet; unusual bruising or bleeding; unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Mutamycin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Mutamycin:

Mutamycin is usually handled and stored by a health care provider. If you are using Mutamycin at home, store Mutamycin as directed by your pharmacist or health care provider.

General information:

• If you have any questions about Mutamycin, please talk with your doctor, pharmacist, or other health care provider.


• Mutamycin is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mutamycin. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mutamycin resources

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

• Mutamycin Prescribing Information (FDA)


• Mutamycin Advanced Consumer (Micromedex) - Includes Dosage Information


• Mutamycin Concise Consumer Information (Cerner Multum)


• Mutamycin Monograph (AHFS DI)


• Mitomycin Prescribing Information (FDA)


• Mitomycin Professional Patient Advice (Wolters Kluwer)

Compare Mutamycin with other medications

• Bladder Cancer
• Pancreatic Cancer
• Stomach Cancer

Tersi Foam

Pronunciation: se-LEE-nee-um
Generic Name: Selenium
Brand Name: Tersi Foam

Tersi Foam is used for:

Treating scalp and skin conditions such as seborrhea or tinea versicolor (a fungal infection). It may also be used for other conditions as determined by your doctor.

Tersi Foam is a antiseborrheic and antifungal combination. It decreases skin cell growth associated with flaking and itching. It also kills sensitive fungi.

Do NOT use Tersi Foam if:

• you are allergic to any ingredient in Tersi Foam

Contact your doctor or health care provider right away if any of these apply to you.

Before using Tersi Foam:

Some medical conditions may interact with Tersi Foam. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances


• if you have broken, irritated, inflamed, or oozing skin at the application site

Some MEDICINES MAY INTERACT with Tersi Foam. Because little, if any, of Tersi Foam is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Tersi Foam may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Tersi Foam:

Use Tersi Foam as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Remove jewelry before using Tersi Foam.


• Shake well before each use.


• Turn the container upside down to dispense medicine. Apply enough medicine to cover the affected area as directed by your doctor. Rub the medicine in until it is completely absorbed. Wash your hands immediately after using Tersi Foam.


• If you miss a dose of Tersi Foam, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Tersi Foam.

Important safety information:

• Tersi Foam is for external use only. Do not get Tersi Foam in your eyes, nose, mouth, or in the genital area. If you get it in any of these areas, rinse right away with cool water.


• If your symptoms do not get better or if they get worse, check with your doctor.


• Do not use more often or for longer than prescribed without checking with your doctor. If you use topical products too often, some conditions may become worse.


• Do not use Tersi Foam for another skin condition at a later time.


• Do not use Tersi Foam on broken, blistered, or inflamed skin.


• Tersi Foam may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.


• Tersi Foam should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Tersi Foam while you are pregnant. It is not known if Tersi Foam is found in breast milk after topical use. If you are or will be breast-feeding while you use Tersi Foam, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Tersi Foam:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Temporary mild stinging, burning, itching, or irritation of the skin.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); severe redness, stinging, burning, or irritation.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Tersi side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Tersi Foam may be harmful if swallowed.

Proper storage of Tersi Foam:

Store Tersi Foam at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat and direct sunlight. Do not puncture, break, or burn the canister even if it appears to be empty. Keep Tersi Foam out of the reach of children and away from pets.

General information:

• If you have any questions about Tersi Foam, please talk with your doctor, pharmacist, or other health care provider.


• Tersi Foam is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Tersi Foam. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Tersi resources

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

• Tersi Foam Concise Consumer Information (Cerner Multum)


• Tersi Foam Topical Advanced Consumer (Micromedex) - Includes Dosage Information


• Tersi Foam Prescribing Information (FDA)


• Selsun Concise Consumer Information (Cerner Multum)

Compare Tersi with other medications

• Seborrheic Dermatitis
• Tinea Versicolor

Precose

Generic Name: Acarbose
Class: alpha-Glucosidase Inhibitors
VA Class: HS502
Chemical Name: O - 4,6 - dideoxy - 4 - [[[1S - (1α,4α,5β,6α)] - 4,5,6 - trihydroxy - 3 - (hydroxymethyl) - 2 - cyclohexen - 1 - yl]amino] - α - d -glucopyranosyl-(1→4)-O-α-d-glucopyranosyl-(1→4)-d-glucose
Molecular Formula: C₂₅H₄₃NO₁₈
CAS Number: 56180-94-0

Introduction

Antidiabetic agent; an α-glucosidase inhibitor.^{1 6 30 52}

Uses for Precose

Diabetes Mellitus

Used as monotherapy as an adjunct to diet and exercise for the management of type 2 (noninsulin-dependent) diabetes mellitus (NIDDM) in patients whose hyperglycemia cannot be controlled by diet and exercise alone.^{1 6 14 47}

Also used as adjunct to diet and exercise in combination with metformin, a sulfonylurea, or insulin for management of type 2 diabetes mellitus in patients whose hyperglycemia cannot be controlled with acarbose, metformin, insulin, or sulfonylurea monotherapy, diet, and exercise.^{1 3 6 14 23 26 44 47}

Metformin generally recommended over other antidiabetic agents for initial oral antidiabetic therapy because of absence of weight gain or hypoglycemia, relatively lower expense and greater efficacy, and generally low adverse effect profile.¹¹⁰

ADA and other clinicians prefer addition of an insulin, a sulfonylurea, or a thiazolidinedione over an α-glucosidase inhibitor (e.g., acarbose), pramlintide, exenatide, or a meglitinide (e.g., repaglinide, nateglinide) as second-line therapy in patients inadequately controlled on metformin monotherapy because of relatively lesser efficacy, limited clinical data, frequent GI adverse effects, and/or greater cost with the latter agents.¹¹⁰

Acarbose should not be used as sole antidiabetic therapy in patients whose diabetes is complicated by ketoacidosis with or without coma (e.g., type 1 [insulin-dependent, IDDM] diabetes mellitus); instead, such patients should receive insulin.^{1 57}

Precose Dosage and Administration

General

• 
  

  Individualize treatment and adjust target blood glucose and glycosylated hemoglobin A_1c (HbA_1c) concentrations based on patient’s understanding and adherence to the treatment regimen, the risk of severe hypoglycemia, and other factors that may increase risk or decrease benefit (e.g., very young or old age, comorbid conditions, other diseases that materially shorten life expectancy).^{1 62}

  
  


• 
  

  Goal of therapy is to reduce both postprandial blood (or plasma) glucose and hemoglobin values to normal or near normal using lowest effective dosage of acarbose as monotherapy or combined with a sulfonylurea antidiabetic agent, metformin, or insulin.¹ (Plasma glucose concentrations generally 10–15% higher than those in whole blood and may vary according to method and laboratory used.)⁶³ During therapy initiation and dosage titration, obtain 1-hour postprandial glucose concentration to determine therapeutic response and minimum effective dosage.^{1 14 23 52 62} Monitor HbA_1c values at approximately every 3 months to evaluate long-term glycemic control.^{1 14 23 52 62} Monitor glucose concentrations 1–2 hours after the start of a meal in those who have elevated HbA_1c despite adequate preprandial glucose concentrations.⁶²

  
  

Administration

Oral Administration

Administer orally at the beginning (with the first bite) of each main meal.^{1 23} If a dose is missed, take the next dose at the next meal.¹⁰⁸ Do not take a double dose to make up for the missed dose.¹⁰⁸

Dosage

Adults

Diabetes Mellitus

Oral

Initially, 25 mg 3 times daily at the beginning of each main meal.^{1 23} In patients with adverse GI effects,^{2 12 23 34} initiate at 25 mg once daily and increase dosage gradually as necessary to 25 mg 3 times daily.¹

Once dosage of 25 mg 3 times daily has been reached, increase dosage at intervals of 4–8 weeks as tolerated to achieve the desired 1-hour postprandial glucose concentration (i.e., <180 mg/dL).^{1 23 34 41 52 62} Maintenance dosage ranges from 50–100 mg 3 times daily.^{1 6 47}

Dosages higher than 100 mg 3 times daily are not recommended since such dosages have been associated with an increased risk of elevated serum aminotransferase concentrations.^{1 10 18 19 20 22 23 25 27 30 37 43 52} If no further therapeutic benefit occurs at the maximum recommended dosage, consider lowering the dosage.¹

Prescribing Limits

Adults

Diabetes Mellitus

Oral

Patients ≤60 kg: maximum 50 mg 3 times daily.^{1 23 34 41 52}

Patients >60 kg: maximum 100 mg 3 times daily.¹

Cautions for Precose

Contraindications

• 
  

  Known hypersensitivity to the drug.¹

  
  


• 
  

  Diabetic ketoacidosis.¹

  
  


• 
  

  Cirrhosis.¹

  
  


• 
  

  Inflammatory bowel disease, colonic ulceration, existing partial intestinal obstruction or predisposition to this condition.¹

  
  


• 
  

  Chronic intestinal diseases associated with marked disorders of digestion or absorption.¹

  
  


• 
  

  Co-existing conditions that may deteriorate as a result of increased intestinal gas formation.¹

  
  

Warnings/Precautions

General Precautions

Metabolic Effects

Should not cause hypoglycemia when administered alone in the fasted or postprandial state.¹ However, hypoglycemia (rarely hypoglycemic shock) may occur when used concomitantly with a sulfonylurea antidiabetic agent and/or insulin.¹ If hypoglycemia occurs, adjust dosage of these agents appropriately.¹ Use oral glucose (dextrose) for the treatment of mild to moderate hypoglycemia instead of sucrose (table sugar);¹ the absorption of oral glucose is not inhibited by acarbose.¹ Severe hypoglycemia may require the use of either IV glucose or parenteral glucagon.¹

Insulin may be required for correction of temporary hyperglycemia that is not controlled by dietary regulation or oral antidiabetic agents during periods of severe stress (e.g., acute infection, trauma, surgery, fever).^{1 57 59}

Hepatic Effects

Elevations in serum aminotransferase (i.e., ALT, AST) concentrations and, in rare instances, hyperbilirubinemia may occur, particularly with dosages exceeding 150 mg daily (50 mg 3 times daily).^{1 23} Jaundice and fatal hepatitis reported during postmarketing experience.¹

Determine serum aminotransferase concentrations every 3 months during the first year of therapy and periodically thereafter.¹ If elevations in serum aminotransferase concentrations occur, reduce dosage.¹ May be necessary to withdraw the drug, particularly if elevated serum aminotransferase concentrations persist.¹

Adherence to Prescribed Diet

If prescribed diet not followed closely, adverse GI effects may be intensified.^{1 108} To minimize adverse GI effects, avoid rich foods, sauces, and certain beverages, including beer and carbonated soft drinks.¹⁰⁸ Limit intake of gas-producing foods such as beans, nuts, bran cereals, broccoli, and cabbage.¹⁰⁸ Consume low-fat meals and snacks.¹⁰⁸ Drink plenty of water, especially in the early morning, midmorning, and afternoon.¹⁰⁸ Avoid overeating; food portions should be small to moderate in size.¹⁰⁸ Eat food slowly and chew thoroughly.¹⁰⁸ Keep food diary to identify problem foods.¹⁰⁸

Specific Populations

Pregnancy

Category B.¹

Lactation

Distributed into milk in rats.¹ Not known whether distributed into human milk.¹ Use not recommended in nursing women.¹

Pediatric Use

Safety and efficacy in children <18 years of age not established.^{1 23}

Geriatric Use

Safety and efficacy in those ≥65 years of age similar to that in younger adults.¹ (See Special Populations under Pharmacokinetics: Absorption.)

Hepatic Impairment

Contraindicated in patients with cirrhosis.^{1 23 52} Not studied in other conditions associated with hepatic impairment.^{1 23 52}

Renal Impairment

Not recommended for use in diabetic patients with appreciable renal impairment (S_cr >2 mg/dL).^{1 23}

Common Adverse Effects

Flatulence, diarrhea, abdominal discomfort/pain.¹

Interactions for Precose

Digestive Enzyme Supplements

Possible reduction in the glycemic effects of acarbose.¹ Avoid concomitant use.¹

Intestinal Adsorbents

Possible reduction in the glycemic effects of acarbose.¹ Avoid concomitant use.¹

Specific Drugs

Drug	Interaction	Comments
Amylase (digestive enzyme preparation)	Possible reduction in glycemic effects of acarbose1	Avoid concomitant use1
Calcium-channel blocking agents	Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1 No effect of acarbose on the pharmacokinetic or pharmacodynamics of nifedipine1	Monitor for loss of glycemic control1 When calcium-channel blocking agents are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1
Charcoal (intestinal adsorbent)	Possible reduction in glycemic effects of acarbose1	Avoid concomitant use1
Corticosteroids	Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When corticosteroids are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1
Contraceptives, oral	Potential exacerbation of hyperglycemia/loss of glycemic control1	Monitor for loss of glycemic control1 When oral contraceptives are withdrawn in patients receiving concurrent sulfonylureas or insulin, observe for evidence of hypoglycemia1
Digoxin	Decreased blood concentrations of digoxin1	May require increased digoxin dosage1
Diuretics (e.g., thiazides)	Potential exacerbation of hyperglycemia, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When diuretics are withdrawn in patients receiving concurrent sulfonylureas or insulin, observe for evidence of hypoglycemia1
Estrogens	Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When estrogens are withdrawn in patients receiving concurrent sulfonylureas or insulin, observe for evidence of hypoglycemia1
Glyburide	No effect on absorption or disposition of concomitant glyburide1	Pharmacokinetic interaction with glyburide unlikely1
Insulin	Increased risk of hypoglycemia, rarely hypoglycemic shock, with concomitant insulin1	If hypoglycemia occurs, reduce insulin dosage1
Isoniazid	Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When isoniazid is withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1
Metformin	Possible decreased peak plasma concentration of metformin1	Pharmacokinetic interaction not considered clinically important1
Nicotinic acid	Potential to exacerbate diabetes mellitus, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When nicotinic acid is withdrawn in patients receiving concurrent sulfonylureas or insulin, observe for evidence of hypoglycemia1
Pancreatin (digestive enzyme preparation)	Possible reduction in glycemic effects of acarbose1	Avoid concomitant use1
Phenothiazines	Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When phenothiazines are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1
Phenytoin	Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When phenytoin is withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1
Pramlintide	Delayed gastric emptying caused by α-glucosidase inhibitors may alter effects of pramlintide on GI absorption of nutrients112	Avoid concomitant pramlintide; safety/efficacy of combination therapy not established112
Propranolol	Pharmacokinetic or pharmacodynamic interaction unlikely1
Ranitidine	Pharmacokinetic or pharmacodynamic interaction unlikely1
Rosiglitazone	Reduced extent of absorption and prolonged half-life of rosiglitazone113 Potential for altered glycemic control is uncertain114	Pharmacokinetic interaction not considered clinically important113
Sulfonylureas	Increased risk of hypoglycemia, hypoglycemic shock with sulfonylureas1	If hypoglycemia occurs, reduce sulfonylurea dosage1
Sympathomimetic agents	Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When sympathomimetic agents are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia.1
Thyroid agents	Potential to exacerbate hyperglycemia, resulting in loss of glycemic control1	Monitor for loss of glycemic control1 When thyroid agents are withdrawn in patients receiving concurrent sulfonylureas or insulin, monitor for evidence of hypoglycemia1

Precose Pharmacokinetics

Absorption

Bioavailability

Low systemic bioavailability of parent compound; <2% of dose is absorbed as active drug (parent compound and active metabolite).¹ Peak plasma concentrations of active drug attained at approximately 1 hour.¹ Approximately 34% of dose absorbed as numerous metabolites.¹

Onset

Satisfactory control of blood glucose concentrations achieved within a few days after dosage adjustment; however^{18 23} maximum response may be delayed for up to 2 weeks.^{18 23}

Special Populations

In geriatric patients, mean AUC and peak blood concentrations of the drug were higher compared with younger adults;¹ differences not statistically significant.¹

In individuals with severe renal impairment (CL_cr <25 mL/minute), peak plasma drug concentrations and AUC increased compared with those values in individuals with normal renal function.¹

Distribution

Extent

Distributed into milk in rats.¹

Elimination

Metabolism

Metabolized exclusively in GI tract, principally by intestinal bacteria but also by digestive enzymes to numerous metabolites, one of which is active.¹

Elimination Route

Excreted principally in feces (51% of dose) as unabsorbed drug and in urine as metabolites (34% of dose).¹ No accumulation with recommended dosing frequency.¹

Half-life

Approximately 2 hours.¹

Stability

Storage

Oral

Tablets

≤25°C.¹ Protect from moisture.¹

ActionsActions

• 
  

  Small inhibitory effect on α-glucosidase enzymes (e.g., glucoamylase, sucrase, maltase, isomaltase) that hydrolyze oligosaccharides, trisaccharides, and disaccharides to glucose and other monosaccharides in the intestinal brush-border.^{2 6 14 24 29 30 52} Small inhibitory effect on pancreatic α-amylase, which hydrolyzes starch into maltose, maltotriose, and dextrins in the lumen of the small intestine.^{2 14 30 33} No inhibitory effect on lactase and would not be expected to produce lactose intolerance.¹

  
  


• 
  

  Delays carbohydrate breakdown and glucose absorption and reduces postprandial hyperglycemia in diabetic patients.^{1 2 6 7 10 14 23 24 30}

  
  


• 
  

  Reduces fluctuations in the daily blood glucose concentration-time profile in patients with type 2 diabetes mellitus and in lean or obese nondiabetic individuals.^{1 2 3 6 7 19 20 21 23 24 35 37 39 47} Fasting blood glucose concentrations either not affected or mildly decreased.^{1 2 3 6 7 19 20 21 23 24 35 37 39 47}

  
  


• 
  

  In contrast to sulfonylurea antidiabetic agents, acarbose does not enhance insulin secretion.¹ Does not produce hypoglycemia when given as monotherapy in fasting individuals.¹

  
  


• 
  

  When used in combination with sulfonylurea antidiabetic agents are used in combination, acarbose reduces the insulinotropic and weight-increasing effects of sulfonylureas.¹ No clinically important loss of calories or weight loss occurs in either diabetic or nondiabetic individuals.^{2 6 13 14 18 21 23 28 35 37 39}

  
  

Advice to Patients

• 
  

  Importance of adherence to diet and exercise regimen.^{1 23 54}

  
  


• 
  

  Importance of adherence to dietary precautions designed to minimize adverse GI effects.^{1 108} Importance of consulting a clinician for dosage adjustments if adverse GI effects occur despite adherence to such dietary precautions.¹ (See Adherence to Prescribed Diet under Cautions.)

  
  


• 
  

  Importance of regular monitoring of blood glucose concentrations.^{1 14 23 52 62}

  
  


• 
  

  Importance of avoiding infection.²³

  
  


• 
  

  Provide instruction on the management of hyperglycemia or hypoglycemia.^{23 62} Advise of the risk of hypoglycemia, its symptoms, and conditions that predispose to the development of hypoglycemia.¹ Importance of keeping a readily available source of glucose (dextrose) to treat symptoms of hypoglycemia when used in combination with a sulfonylurea agent or insulin.¹

  
  


• 
  

  Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.¹

  
  


• 
  

  Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Acarbose

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Oral	Tablets	25 mg	Precose	Bayer
		50 mg	Precose	Bayer
		100 mg	Precose	Bayer

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Acarbose 100MG Tablets (WATSON LABS): 100/$89.99 or 300/$239.97

Acarbose 25MG Tablets (WATSON LABS): 100/$81.99 or 300/$223.9

Acarbose 50MG Tablets (WATSON LABS): 100/$87.99 or 300/$235.96

Precose 100MG Tablets (BAYER HEALTHCARE PHARMA): 90/$109.99 or 270/$299.97

Precose 25MG Tablets (BAYER PHARMACEUTICAL): 90/$85.51 or 270/$238.56

Precose 50MG Tablets (BAYER PHARMACEUTICAL): 90/$88.49 or 270/$250.48

Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions November 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Bayer. Precose (acarbose) tablets prescribing information. West Haven, CT; 2004 Nov.

2. Clissold SP, Edwards C. Acarbose: a preliminary review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential. Drugs. 1988; 35:214-43. [IDIS 240384] [PubMed 3286212]

3. Anon. Acarbose–an α-glucosidase inhibitor. Int Pharm J. 1994; 8:11-12.

6. Santeusanio F, Compagnucci P. A risk-benefit appraisal of acarbose in the management of non-insulin-dependent diabetes mellitus. Drug Saf. 1994; 11:432-44. [PubMed 7727053]

7. Jenkins DJA, Taylor RH, Goff DV et al. Scope and specificity of acarbose in slowing carbohydrate absorption in man. Diabetes. 1981; 30:951-4. [IDIS 166882] [PubMed 7028548]

10. Hayakawa T, Kondo T, Okumura N et al. Enteroglucagon release in disaccharide malabsorption induced by intestinal α-glucosidase inhibition. Am J Gastroenterol. 1989; 84:523-6. [IDIS 257433] [PubMed 2655436]

11. Bristol-Myers Squibb, Princeton, NJ: personal communication on metformin.

12. Scheppach W, Fabian C, Ahrens F et al. Effect of starch malabsorption on colonic function and metabolism in humans. Gastroenterology. 1988; 95:1549-55. [IDIS 248963] [PubMed 3053313]

13. Fölsch UR, Ebert R, Creutzfeldt W. Response of serum levels of gastric inhibitory polypeptide and insulin to sucrose ingestion during long-term application of acarbose. Scand J Gastroenterol. 1981; 16:629-32. [IDIS 140169] [PubMed 7034156]

14. Balfour JA, McTavish D. Acarbose: an update of its pharmacology and therapeutic use in diabetes mellitus. Drugs. 1993; 46:1025-54. [PubMed 7510610]

16. Carlisle BA, Kroon LA, Koda-Kimble MA. Diabetes mellitus. In: Koda-Kimble MA, Young LY, eds. Applied therapeutics: the clinical use of drugs. 8th ed. Philadelphia, PA: Lippincott Williams &Wilkins; 2005: 50-1–50-86.

18. Coniff RF, Shapiro JA, Seaton TB. Long-term efficacy and safety of acarbose in the treatment of obese subjects with non-insulin-dependent diabetes mellitus. Arch Intern Med. 1994; 154:2442-8. [IDIS 338784] [PubMed 7979840]

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