Formulated Dosage Forms

PANCLON

(Pantoprazole Sodium IP & Domperidone IP Capsules) Pantoprazole with Domperidone is used to reduce the amount of acid produced by the stomach, to treat or prevent conditions such as heartburn, Gastritis, ulcers and GERD. For best results, it should be taken just before a meal. It can help with the greater amount of stomach acid that is always produced. The capsules are generally offered in the composition of Pantoprazole 40mg & Domperidone 30 mg sustained release.

DRUG COMPOSITION
Each Serving Size: 1 Tablet film coated tablet contains
Calcium L-5- Methyltetrahydrofolate 2mg
PRODUCT INFORMATION

LEVFOLATE is the body’s preferred and active form of folate, which need not to be activated by the variants of folate dependents enzymes. Directly absorbed as L-Methylfolate and directly involved in lowering the Homocysteine blood levels. Only form of folate able to cross the blood brain barrier with 100% bioavailability. . Safe as demonstrated by extensive toxicological studies. On the contrary the Racemic DL Form and D Form of 5-Methyltetrahydrofolate are not absorbed the blood. The D Form reduces the absorption of Calcium L-5-Methyltetrahydrofolate.

DRUG COMPOSITION Each hard gelatin capsule contains:
• Pantoprazole Sodium IP Eq. to Pantoprazole 40mg (as enteric coated pellets).
• Domperidone IP 30mg (as sustained release pellets).

ADVANTAGES OF PANTOPRAZOLE AND DOMPERIDONE
• No bio availability interference from any food or antacid.
• Rapid action & acid pain relief.
• Better oral bio availability.

MECHANISM OF ACTION
PANCLON is a combination of pantoprazole and domperidone. Pantoprazole inhibits the H + /K + – AT Pase enzyme, which is responsible for gastric acid secretion in the parietal cells of the stomach and irreversibly black the final step of acid secretion. It increases motility of GI tract by inhibiting the action of dopamine and fastens gastric emptying.

PHARMACOKINETICS
Pantoprazole is unstable in acid and is administered orally in the form of an 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 2 ½ 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 ng/ml after a single 10mg tablet, and 70 to 100 ng/ml after oral doses of 60 mg. After oral administration of 40 g 4-domperidone to healthy volunteers, 31st, of the radioactivity is excreted in the urine and 66 % in the faeces over a period of 4 days.

INDICATION
Antacids, Antireflux Agents & Antiulcerants / GIT Regulators, Antiflatulents & Anti-Inflammatories.

DOSAGE
Once or Twice capsule once daily or as directed by the physician.

COMMON SIDE EFFECTS
Nausea, drowsiness, flatulence and dry mouth.

WARNINGS / PRECAUTIONS
Lactation, Pantoprazole: Not recommended in children < 12yrs. Longterm therapy may lead to bacterial overgrowth in GIT. Domeperidone: Increases serum prolactin levels resulting to galactorrhoea in females and gynaecomastia in males.

CONTRA – INDICATIONS
Pantoprazole is contraindicated in heptic impairment; hypersensitivity. Domperidone is contraindicated in the history of hypersensitivity to dimenhydrinate or related compounds.

PRESENTATION & PACKING
10 capsules in Aluminium strip Packing.

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