MOSEGOR SYRUP 100ML

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Contents
Pizotifen, vitamin B-complex.
Description
Each capsule contains Pizotifen (as hydrogen maleate) 500 mcg, thiamine (Vit. B1) 3 mg (as mononitrate), Riboflavin Phosphate (Vit. B2) 3.2 mg, Pyridoxine hydrochloride (Vit. B6) 2.4 mg and Nicotinamide 19 mg.
Each 5 mL syrup contains Pizotifen (as hydrogen maleate) 250 mcg, Thiamine (Vit. B1) 700 mcg (as hydrochloride), Riboflavin Phosphate (Vit. B2) 1.14 mg, Pyridoxine hydrochloride (Vit. B6) 700 mcg and Nicotinamide 5 mg.
Action
Pharmacology: Pizotifen has an appetite-stimulating action suitable for increasing body weight in underweight anorectic patients. The compound is well tolerated, permitting treatment of anorexia both in children and adults.
Owing to its inhibitory effect on biogenic amines, pizotifen is also used for the prophylactic (interval) treatment of migraine.
The B-complex vitamins B1, B2, B6 and nicotinamide prevent deficiencies of these vitamins often associated with inadequate food intake. Such a need may also arise from antibiotic or other drug therapy with vitamin utilization.
Pharmacokinetics: The absorption of pizotifen is fast (absorption half-life 0.5-0.8 hours) and nearly complete (80%). The substance is metabolized with a half-life of about 1 hour. The main metabolite (N-glucuronide) is eliminated with a half-life approx. 23 hours. The protein binding amounts to 91% and the distribution volume to 485 L. Less than 1% of the administered dose is excreted unchanged in urine, whereas 55% is excreted as metabolites. In patients with kidney insufficiency, dosage adjustment may therefore be necessary.
Indications/Uses
Anorexia of somatic or psychogenic origin in underweight patients, in whom prevention of vitamin-B deficiency secondary to impaired dietary intake or absorption (e.g. as a consequence of antibiotics or other drug therapy interfering with absorption or utilization of B-group vitamins) is indicated. Priority should always be given to identifying and treating the underlying cause of anorexia, such as infectious or parasitic diseases, chronic diarrhea, anorexia nervosa or depressive states in the elderly.
Dosage/Direction for Use
For Syrup: Children: Small initial dose should be gradually increased to an average maintenance dosage of 0.025 mg. Pizotifen per kg. body weight daily e.g., 2-6 years: 10-20 mL daily in 2 or 3 divided doses or as directed by the physician.
Adults: Starting with 10 mL syrup per day, dosage should be progressively increased up to 10 mL syrup three times daily.
Duration of therapy: as directed by the physician.
For Capsules: Adults: Starting with 1 capsule per day, dosage should be progressively increased to 1 capsule thrice daily.
Duration of therapy: as directed by the physician.
Overdosage
Symptoms which may be expected are: drowsiness, nausea, hypotension, dizziness, excitatory states (in children), coma.
Treatment: gastric lavage followed by administration of activated charcoal. If necessary. symptomatic treatment including monitoring of the cardiovascular and respiratory system; for excitatory states or convulsion: benzodiazepines.
Contraindications
Hypersensitivity to the drug.
Pizotifen + Thiamine HCl + Riboflavin phosphate + Pyridoxine HCl + Nicotinamide (Mosegor Vita) should not be given to children below 1 year of age.
Special Precautions
Patients should be warned that, owing to its possible sedative effect, Pizotifen + Thiamine HCl + Riboflavin phosphate + Pyridoxine HCl + Nicotinamide (Mosegor Vita) may slow their reactions when driving vehicles, operating machinery, etc.
In view of the very slight anticholinergic effect of pizotifen, caution is required in patients with narrow-angle glaucoma (except those successfully treated by surgery) or urinary retention (e.g. in prostatic enlargement). Up to now no untoward reactions have been reported in such patients, not even in the elderly, when given the recommended dose. As clinical data with pizotifen in pregnancy are very limited, Pizotifen + Thiamine HCl + Riboflavin phosphate + Pyridoxine HCl + Nicotinamide (Mosegor Vita) would be administered in pregnancy only under compelling circumstances. Although the concentration of pizotifen measured in the milk of treated mothers are not likely to affect the infant, its use in nursing mothers is not recommended.