PRESENTATION: Box of 6 blisters, 10 blisters x 30 tablets.
COMPOSITIONS: Each tablet contains:
Vitamin PP...................................................................50 mg
Excipients (Lactose, Starch, Avicel 101, Talc, Magnesium stearate)..........................................................q.s.
- For prevention Nicotinamide deficiency.
- Treatment of pellagra with symptoms such as:
+ Symmetrical dermatitis in leg and areas exposed to sunlight, skin lesions is initially red and then become scab.
+ Glossitis, canker, esophagithis, gastroenteritis, excessive salivation, diarrhea.
+ Insomnia, headache, depression, confusion, memory disorders, intellectual decline (hallucinations, delusion).
DOSAGE AND ADMINISTRATIONS:
* The usual oral dosage of Nicotinamide is following:
Alduts: 1 tablet daily, in one dose.
* Treatment of pellagra:
- Alduts: the usual oral dosage is 6 - 10 tablets/day, in 3 to 4 divided doses (maximum dose is 30 tablets/day).
- Children: the usual oral dosage is 2 - 6 tablets/day, in 3 to 4 divided doses.
Small doses of Nicotinamide are usually nontoxic, however following larger doses of Nicotinamide, some following adverse reactions may occur and most of these effects subside on withdrawal of the drug.
* Common, ADR > 1/100
- Gastrointestinal: nausea
- Other: flushing of the face and neck, pruritus, sentation of burning, stinging or tingling of skin.
* Less common, 1/1000 < ADR < 1/100
- Gastrointestinal: activating of peptic ulcer, vomiting, anorexia, hunger pains, flatulence, diarrhea.
- Dermal: dry skin, hyperpigmentation, jaundice.
- Metabolism: impairment of liver function, decrease of Glucose tolerance, increase of sebaceous gland activity, precipitating gout.
- Other: hyperglycaemia, hyperruricemia, vasovagal attacks, headache and blurred vision, hypotension, dizziness, tachycardia, syncope.
* Rare, ADR < 1/1000
Nervousness, panic, glucosuria, abnormal liver function test results (including increased serum concentrations of Bilirubin, AST (GOT), ALT (GPT) and LDH), abnormal prothrombin time and hypoalbuminemia, anaphylatic reaction.
Inform your physician of any unusual reactions while using the drug.
- Hypersensitivity to any ingredients of this drug.
- In patients with severe liver disease.
- Active peptic ulcer.
- Arterial haemorrhage.
- Severe hypotension.
When used with large doses of Nicotinamide in patients with history of peptic ulcer; gallbladder disease or a history of jaundice or liver disease; gout, gouty arthritis, and diabetes mellitus.
DRUG - DRUG INTERACTIONS:
- Concurrent use of Nicotinamide with HMG-CoA reductase inhibitors may increase the risk of rhabdomyolysis.
- Concurrent Nicotinamide therapy with a - adrenergic blocking antihypertensives may result in hypotension.
- Diet and/or dosage of oral hypoglycemic drugs or Insulin may require adjustment with concurrent Nicotinamide use.
- Concurrent Nicotinamide use with hepatotoxic drugs may have hepatotoxic additive effects.
- Should not use concomitantly Nicotiamide with Carbamazepine because may make increase in plasma Carbamazepine concentrations, with increase in toxicity.
PREGNANCY AND LACTATION:
- Use with dietary supplements doses of Nicotinamide during pregnancy has not been associated with any adverse effects to the mother or fetus.
- Use with dietary supplements dose of Nicotinamide during lactation has not been associated with any adverse effects to the mother or nursing infant. Dietary supplementary doses of Nicotinamide during lactation are needed when dietary is poor of Nicotinamide.
OVERDOSE AND TREATMENT:
When overdose occurs, there is no specific method for intoxication, the usual measures are gastric emptying by causing vomit or gastric lavage, and symptomatic or supportive treatment.
STORAGE: In a dry place, temperature below 30 0C, protect from light.
SHELF-LIFE: 36 months from manufacturing date.