Geno Pharmaceuticals
 
 
 
Vertidom

COMPOSITION:
Each uncoated tablet contains:
Cinnarizine IP                               20mg
Domperidone Maleate IP       
Equivalent to Domperidone          15 mg

PHARMACOLOGICAL CLASSIFICATION:
Anti- emetics and antivertigo preparations.

PHARMACOLOGY:
Cinnarizine is a centrally acting antihistamine and calcium channel antagonist. Cinnarizine inhibits contractions of vascular smooth muscle cells by blocking calcium channels.
Cinnarizine increases erythrocyte deformability and decreases blood viscosity in vitro. Cinnarizine inhibits stimulation of the vestibular system. Cinnarizine blocks H1 receptor pathway from the inner ear to cerebellum and treats nausea and vomiting
The peak plasma levels of Cinnarizine are obtained 1 to 3 hrs after intake. Cinnarizine disappears from plasma with a half-life of 4 hrs. Cinnarizine is completely metabolized. About 1/3 of these metabolites are eliminated in the urine and 2/3 in the faeces.
The plasma protein binding of Cinnarizine is 91%.
Domperidone: Domperidone is a dopamine-receptor blocking agent. Its action on the dopamine-receptors in the chemo-emetic trigger zone produces an anti-emetic effect.
Domperidone does not cross the blood-brain barrier to any appreciable degree and so exerts relatively little effect on cerebral dopaminergic receptors.
Domperidone has been shown to increase the duration of antral and duodenal contractions to increase gastric emptying.
Domperidone does not alter gastric secretions and has no effect on intracranial pressure or on the cardio-vascular system.
Domperidone is rapidly absorbed, with peak plasma concentration at approximately1 hour after oral administration.
The absolute bio-availability of oral Domperidone is low (approximately 15%) due to first – pass hepatic and intestinal metabolism.
Domperidone is 91 to 93% bound to plasma proteins. The plasma half-life after a single oral dose is 7 to 9 hrs in healthy subjects but is prolonged in patients with severe renal insufficiency.
Urinary and faecal excretion amount to 31% and 66% of the oral dose resp. The proportion of drug excreted unchanged is small (approximately 1% of urinary and 10% of faecal excretion)


INDICATIONS:
Vertidom is a wider spectrum Anti-emetic that is indicated in Nausea and Vomiting which have multiple etiologies like Migraine and headache, motion sickness, blurred vision, labyrinth disorders and even drug induced GI irritation.

CONTRAINDICATIONS:
In patients with known hypersensitivity to any of the contents of the tablet. Vartidom should not be used whenever stimulation of gastric motility is to be avoided or could be harmful e.g.: in the presence of gastro-intestinal haemorrhage, obstruction or perforation.
Vertidom is also contraindicated in patients with a prolactin-releasing pituitary tumour (prolactinoma).
The safety of use during pregnancy and lactation has not been established.

WARNINGS:
This medicine may lead to drowsiness and impaired concentration, which may be aggravated by simultaneous intake of alcohol or other central nervous system depressants. Patients should not operate hazardous machinery or drive motor vehicles or perform potentially hazardous tasks where loss of concentration may lead to accidents.

DOSAGE AND DIRECTION FOR USE:
As directed by the Physician.

SIDE-EFFECTS AND SPECIAL PRECAUTION
The most common antihistaminic side-effects of Cinnarizine is sedation which can vary from slight drowsiness to deep sleep, which includes inability to concentrate, lassitude, dizziness and inco-ordination. Sedative effects, when they occur, may diminish after a few days.
Domperidone has been reported to show allergic reactions, such as rash or urticaria abdominal cramps have been reported.
Reversible raised serum prolactin levels have been observed which may lead to galactorrhoea and gynaecomastia.

 
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