Each hard gelatin capsule contains pantoprazole sodium sesquihydrate BP (as enteric-coated pellets) equivalent to pantoprazole 40 mg and domperidone BP (as sustained release pellets) 30 mg.
Excipients/Inactive Ingredients: Approved colour used in empty capsule shell.
Pharmacology: Pharmacodynamics: Pantoprazole is metabolized in the liver by the cytochrome P450 system. Metabolism mainly consists of demethylation by CYP2C19 followed by sulfation. Another metabolic pathway is oxidation by CYP3A4. Pantoprazole metabolites are not thought to have any pharmacological significance. Pantoprazole is relatively free of drug interactions; however, it may alter the absorption of other medications that depend on the amount of acid in the stomach, such as ketoconazole or digoxin.
Generally inactive at acidic pH of stomach, thus it is usually given with a prokinetic drug. Pantoprazole binds irreversibly to H+K+ATpase (proton pumps) and suppresses the secretion of acid. As it binds irreversibly to the pumps, new pumps have to be made before acid production could be resumed. The drug's plasma half-life is about 2 hours.
Domperidone blocks the action of dopamine. It has strong affinities for the D2 and D3 dopamine receptors, which are found in the chemoreceptor trigger zone, located just outside the blood brain barrier, which among others, and regulates nausea and vomiting (area postrema on the floor of the fourth ventricle and rhomboid fossa).
Pharmacokinetics: Pantoprazole: Pantoprazole is unstable in acid and is administered orally in form of enteric-coated tablet. Absorption takes place in the small intestine. On average, the maximum serum/plasma concentrations are approximately 2 to 3 micrograms/mL about 2½ hrs after administration of 40 mg pantoprazole daily.
Domperidone: In man, peak plasma level of domperidone occurs within 30 minutes after oral (fasted) administration. Peak plasma concentrations are 20 mg/mL after a single 10 mg tablet, and 70 to 100 mg/mL after oral doses of 60 mg. After administration of 40 mg 4-domperidone to healthy volunteers, 31% of the radioactivity is excreted in the urine and 66% in the feces over a period of 4 days.
Pantoprazole + domperidone is indicated in the management of gastroesophageal reflux disease; non-ulcer dyspepsia, gastric or duodenal ulcer, dyspepsia, bloating, fullness, belching, NSAID-induced dyspepsia.
One or two capsules once daily or as directed by the physician.
Administration: Swallow capsule as whole, do not chew the capsule.
In the event of overdosage, gastric lavage should be performed. Symptomatic and supportive measures are recommended.
Pantoprazole is contraindicated in patients with impairment; hypersensitivity. Pantoprazole + domperidone is contraindicated in patients with history of hypersensitivity to dimenhydrinate or related compounds.
Pantoprazole: Not recommended in children <12 yrs. Long term therapy may lead to gastrointestinal bacterial overgrowth.
Domperidone: Increases serum prolactin levels resulting to galactorrhoea in females and gynaecomastia in males.
Effect on Ability to Drive and Use Machine: No known effect on ability to drive and use machines.
Due to lack of controlled studies in pregnant and lactating women, use of pantoprazole + domperidone (Panto Plus) is contraindicated in this group of patients.
Nausea, drowsiness, flatulence, and dry mouth.
Pantoprazole: Pantoprazole is metabolized through the cytochrome P450 system, primarily the CYP2C19 and CYP3A4 isoenzymes, and subsequently undergoes phase II conjugation. Based on studies evaluating possible interactions of pantoprazole with other drugs metabolized by the cytochrome P450 system, no dosage adjustment is needed with concomitant use of the following drugs: Theophylline, cisapride, phenazone, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, oral contraceptives (levonorgestrel/ethinylestradiol), metoprolol, nifedipine, phenytoin or warfarin. Clinically relevant interactions of pantoprazole with other drugs with the same metabolic pathways are not expected. Therefore, when co-administered with pantoprazole, adjustment of the dosage of pantoprazole with such drugs may not be necessary. There was also no interaction with concomitantly administered antacids.
Because of profound and long lasting inhibition of gastric acid secretion, it is theoretically possible that pantoprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g. ketoconazole, ampicillin esters and iron salts).
Domperidone: Anticholinergic drugs may inhibit the anti-dyspeptic effects of domperidone. Domperidone suppresses the peripheral effects (digestive disorders, nausea and vomiting) of dopaminergic agonists. Since domperidone has gastrokinetic effects, it could influence the absorption of concomitant orally administered drugs, particularly those with sustained-release or enteric-coated formulations. As domperidone interferes with serum prolactin levels, it may interfere with other hypoprolactinaemic agents and with some diagnostic tests. Antacids and anti-secretory agents lower the oral bioavailabilty of domperidone. They should be taken after meals and not before meals, i.e. they should not be taken simultaneously with domperidone.
Reduced gastric acidity impairs the absorption of domperidone.
Oral bioavailability is decreased by prior administration of cimetidine or sodium carbonate.
Store at temperatures not exceeding 30°C. Protect from light and moisture.
A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).