COMPOSITION :- Each capsule contains:-
Pantoprazole 40 mg
Domperidone 30 mg
- Domperidone belongs to a class of medicines known as anti-emetics. Domperidone acts by helping food move faster through the food pipe, stomach and gut; thus normalising the digestion process.
- Pantoprazole belongs to a class of drugs known as proton pump inhibitors. It acts by reducing the amount of acid produced in the stomach.
Pantoprazole is rapidly absorbed after oral administration, with peak plasma concentrations (C max ) of 1.1 to 3.1. (mean 2.1) mg/L occurring within 2 to 4 (mean 2.7) hours (tmax) after ingestion of an enteric coated 40 mg tablet. The volume of distribution is low (mean 0.16 L/kg at steady state) due to high degree of plasma protein binding (-98%). Plasma Pantoprazole concentrations decline monophasically after oral administration, with a mean plasma terminal half-life (ty,P) of 0.9 to 1.9 hours. However, since inhibition of acid secretion is non-competitive or irreversible, there is no correlation between plasma levels and the duration of action of Pantoprazole. Concomitant intake of food has no influence on the bioavailability of Pantoprazole, and any possible retardant effect of food on the rate of drug absorption is not of clinical relevance, considering the prolonged antisecretory action of Pantoprazole. The enteric coating does not influence the bioavailability of Pantoprazole. Pantoprazole undergoes extensive hepatic metabolism via cytochrome P450 oxidase followed by sulphate conjugation. Elimination of Pantoprazole is predominantly renal, with -80% of an oral dose being excreted as urinary metabolite; the remainder is excreted in the feces and originates primary from biliary secretion.
Domperidone is rapidly and almost completely (93%) absorbed after oral administration. Peak plasma concentrations occur within 30 min. after oral administration. The peak plasma concentration value after a 20mg oral dose is in the range of 15 to 19 ng/ml. The mean elimination half-life ranges from 12 – 16 hours for an oral dose. Oral bioavailability of Domperidone is 13 – 17% because of extensive presystemic metabolism in gut wall and liver. Administration of Domperidone 90 minutes after a meal increases bioavailability whereas Cimetidine or alkali pretreatment reduces bioavailability. Domperidone is strongly bound to plasma proteins (90-93%). Domperidone undergoes extensive biotransformation with <1% excreted unchanged in urine.
INDICATION : Gastro- oesophageal reflux disease
DOSAGE : As directed by the physician.
SIDE EFFECTS : Vertigo, Fracture of the hip, Wrist or spine, Pruritis, Pyrexia, Diarrhea, Blurred vision, Dizzines