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Logo AUTRIN* Capsules

SCHEDULING STATUS:
Unscheduled

PROPRIETARY NAME
(and dosage form):

AUTRIN* Capsules

COMPOSITION:
Each AUTRIN* haematinic capsule contains:
Vitamin B12 (15 micrograms) with Intrinsic Factor Concentrate
1.5 N.F. Units (Oral)
Ferrous Fumarate         350 mg
(Elemental iron 115 mg)
Ascorbic Acid (Vitamin C)        150 mg
Folic Acid         2 mg

PHARMACOLOGICAL CLASSIFICATION:
A 8.3 Erythropoietics (Haematinics)

PHARMACOLOGICAL ACTION:
AUTRIN* is used for the treatment of anaemias as indicated below. It contains the common substances used in the prevention and treatment of anaemic conditions.

INDICATIONS:
Indicated for the treatment and maintenance of common anaemias, including iron-deficient anaemias, megaloblastic anaemias of pregnancy, pellagra and those of nutritional origin. All of the other means that are recognised as suited to the treatment of these anaemias should also be employed. If cases prove resistant to this form of therapy, further exploration of the aetiology and additional therapeutic measures should be instituted.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Symptoms of iron intolerance.

WARNINGS:
See "Side-effects and Special Precautions" below.
Prolonged administration in excess of the recommended dose as prescribed by the physician (one capsule per day) may result in iron overload. Iron overloading and toxicity may occur in patients receiving both oral and parenteral administration of iron.

DOSAGE AND DIRECTIONS FOR USE:
One capsule daily with or after meals will treat and maintain the average uncomplicated case of anaemia.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
Some patients affected with pernicious anaemia may not respond to orally administered Vitamin B12 with Intrinsic Factor Concentrate and there is no known way to predict which patients will respond or which patients may cease to respond. Periodic examinations and laboratory studies of pernicious anaemia patients are essential and recommended.
Folic acid may obscure pernicious anaemia in that the peripheral blood picture may revert to normal while neurological manifestations may remain progressive.
AUTRIN* haematinic capsules should not be relied on to correct the serious folic acid deficiency characterising sprue or the malabsorption syndromes. In these conditions therapeutic amounts of folic acid should be administered.
Excessive doses of iron preparations may lead to toxicity in children.
Adverse effects of iron administered in therapeutic doses may include gastro-intestinal discomfort, diarrhoea, vomiting, constipation. Side-effects may be reduced by taking the medication with or immediately after food. As a result of iron therapy stools may become darkened or black in colour.
Symptoms, which may not appear for several hours, include epigastic pain, diarrhoea, vomiting and haematemesis. Circulatory failure may follow if the diarrhoea and haemorrhage are severe. Hours or days later, after apparent recovery, metabolic acidosis, convulsions and coma may occur. If the patient survives, symptoms of acute liver necrosis may develop and may lead to death due to hepatic coma.
Special Precautions
Iron salts should not be given to patients receiving repeated blood transfusions or to patients with anaemias not produced by iron deficiency unless iron deficiency is also present. Care should be taken when given to patients with iron-storage or iron-absorption diseases, haemoglobinopathies, or existing gastro-intestinal disease.
Interactions
Iron salts and tetracycline absorption is diminished if taken concomitantly by mouth. Iron salts should be administered 3 hours before or 2 hours after the tetracycline.
Concomitant ingestion of antacids and tea will also decrease the absorption of iron salts.
Iron salts may reduce the effects of penicillamine.
Quinolone anti-infective agent absorption is diminished if taken concomitantly by mouth with iron salts. Oral preparations should not be administered within two hours of quinolone agents. (Reference- American Hospital Formulary Service, Drug Information 97, Iron Preparations, Oral, page 1074).

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdosage can be any of those described under "Side-effects and Special Precautions" above.
If any symptoms of intolerance occur, the drug should be temporarily or permanently discontinued.
In acute poisoning desferrioxamine should be administered under the direction of a physician but preferably should not be administered during the 1st trimester of pregnancy. Alternatively, and preferably in the treatment during pregnancy and lactation, empty the stomach by inducing emesis using a 1 to 5% solution of sodium bicarbonate lavage.
Fluid loss should be replaced by the I.V. administration of compound sodium lactate injection or NaCl and dextrose injection.
A dose of as little as 1g of iron should be considered toxic in children. Speed is essential here to block the absorption of iron.

IDENTIFICATION:
Red, two piece, size 0, hard shell capsules, the name "AUTRIN" on the other half.

PRESENTATION:
Packs of 30 and 100 capsules.

STORAGE INSTRUCTIONS:
Store at room temperature up to 25°C.
KEEP OUT OF REACH OF CHILDREN.

REFERENCE NUMBER:
H689 (Act 101/1965)

NAME AND BUSINESS ADDRESS OF THE APPLICANT
Pharmacare Limited
7 Fairclough Road
Korsten
Port Elizabeth

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
August 1998

        D942
Highland Print

Updated on this site: April 2005
Source: Pharmaceutical Industry

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