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Prenavit

Prenavit

Manufacturer:

Sunward

Distributor:

Antah Pharma
Full Prescribing Info
Contents
Vitamin A, vitamin D, thiamine mononitrate, vitamin B2, pyridoxine hydrochloride, vitamin B12, vitamin C, nicotinamide, folic acid, ferrous sulphate monohydrate, calcium carbonate.
Description
(See table.)

Click on icon to see table/diagram/image
Indications/Uses
As a supplement in pregnancy and nursing mothers.
Dosage/Direction for Use
Oral administration.
One tablet daily. After food or with food.
Overdosage
Overdosage of Calcium Carbonate may result in hypercalcemia. Symptoms of hypercalcemia are mentioned under 'Adverse reactions'.
Treatment of hypercalcemia and overdosage: The treatment consists of immediate discontinuation of the vitamin. Serum calcium measurements should be performed regularly until normocalcemia ensues. Hypercalcemia normally resolves in two to four weeks.
Treatment of accidental/acute overdosage: The treatment of acute accidental overdosage should consist of general supportive measures. If drug ingestion is discovered within a relatively short time, induction of emesis or gastric lavage may be of benefit in preventing further absorption. If the drug has passed through the stomach, the administration of mineral oil may promote faecal elimination. Serial serum calcium determination, rate of urinary calcium excretion and an assessment of electrocardiographic abnormalities due to hypercalcemia should be obtained.
Discontinuation of supplemental calcium diet and low calcium diet are also indicated in accidental overdosage. Should persistent and marked hypercalcemia occur, the use of drugs such as phosphate and corticosteroids as well as measures to induce and appropriate forced diuresis may be considered. The use of peritoneal dialysis against a calcium free dialysate may also be considered.
Contraindications
It is contraindicated in patients who are sensitive to its components and in patients with a history of renal calculi.
Special Precautions
Certain dietary substances interfere with the absorption of calcium. These include oxalic acid (found in large quantities in spinach), phytic acid (bran and whole cereals) and phosphorus (milk and other dairy products).
Administration of corticosteroids may interfere with calcium absorption.
Calcium enhances the effects of digitalis on the heart and may precipitate digitalis intoxication. Calcium salts reduce the absorption of tetracyclines.
When calcium is administered in large amounts for long periods hypercalcemia and hypercalciuria may result. This is most likely to occur in patients with hypoparathyroidism who are receiving high doses of Vitamin D.
Calcium salts should be given cautiously to patients with impaired renal function or a history of renal stone formation.
It is also not intended for treatment of severe specific deficiency.
Care should be taken when given to patients with iron shortage or iron absorption diseases, haemoglobinopathies or existing gastro-intestinal disease.
The absorption of iron is inhibited or decreased in the presence of antacids containing carbonates, magnesium trisilicate or when taken with tea. Iron salts appear to reduce the effects of penicillamine.
The absorption of iron salts and tetracyclines is diminished when they are taken concomitantly by mouth.
This product is not intended for treatment of pernicious anaemia or other megaloblastic anaemias where Vitamin B12 is deficient. Neurologic involvement may develop or progress, despite temporary remission of anaemia, in patients with Vitamin B12 deficiency who receive supplemental folic acid and who are inadequately treated with Vitamin B12.
This product is not intended for treatment of severe specific deficiency.
Pyridoxine may decrease the efficacy of levodopa in the treatment of parkinsonism.
Therefore it should be used with caution for patients undergoing such therapy.
Adverse Reactions
When given by mouth, calcium salts may cause constipation. The other adverse effects are due to hypercalcemia. The early and late signs and symptoms of hypercalcemia include: Early: weakness, headache, somnolence, nausea, vomiting, dry mouth, constipation, muscle pain, bone pain and metallic taste.
Late: polyuria, polydipsia, anorexia, irritability, weight loss, nocturia, conjunctivitis, pancreatitis, photophobia, rhinorrhea, pruritus, hyperthermia, decreased libido, albuminuria, hypercholesteroleamia, ectopic calcification, hypertension, cardiac arrhythmias and rarely overt psychosis.
Drug Interactions
Women receiving oral contraceptives have shown a significant increase in plasma vitamin A level. Excessive dosage of vitamin D induces hypercalcaemia and in some instances hypercalciuria. Hypercalcaemia in patients receiving digitalis may precipitate cardiac arrhythmias.
Cholestyramine has been reported to reduce absorption of fat soluble vitamins: as such it may impair intestinal absorption of vitamin A and vitamin D.
The administration of anti-convulsants has been shown to affect the vitamin D requirements in some patients.
Pyridoxine may decrease the efficacy of levodopa in the treatment of parkinsonism. It should be used with caution for patients undergoing levodopa therapy.
Ascorbic acid taken concomitantly with fluphenazine may necessitate an increase in dosage of fluphenazine.
The absorption of both iron salts and tetracyclines is diminished when they are taken concomitantly by mouth. If treatment with both drugs is required, a time interval of about 2 to 3 hours should be allowed between each administration. The absorption of iron salts may also be decreased by some antacids. The response to iron may be delayed in patients receiving concomitant chloramphenicol therapy. Iron salts have been reported to decrease absorption and thus reduce the bioavailability and clinical effect of levodopa with carbidopa, methyldopa and penicillamine; decreased absorption and bioavailability has also been reported for the fluoroquinolones ciprofloxacin and ofloxacin when administrated with iron salts.
Administration of corticosteroids may intefere with calcium absorption.
Calcium enhances the effects of digitalis on the heart and may precipitate digitalis intoxication. Calcium salts reduce the absorption of tetracyclines.
Storage
Store at temperature 25°C. Keep in dry place.
Protect from light and moisture.
Shelf-Life: 2 years.
MIMS Class
Vitamins & Minerals (Pre & Post Natal) / Antianemics
ATC Classification
A11AB - Multivitamins, other combinations ; Used as dietary supplements.
Presentation/Packing
Form
Prenavit sugar-coated tab
Packing/Price
180's;6 × 30's
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