Composition:

• Pantolam 20 tablet: Each tablet contains Pantoprazole Sodium Sequihydrate BP equivalent to Pantoprazole 20 mg.
• Pantolam 40 tablet: Each tablet contains Pantoprazole Sodium Sequihydrate BP equivalent to Pantoprazole 40 mg.

Pharmacology:
Pantolam is chemically a novel substituted benzimidazole derivative, which suppresses the final step in gastric acid production by forming a covalent bond to two sites of the H+/K+ -ATase enzyme system at the secretory surface of the gastric parietal cell. This leads to inhibition of both basal and stimulated gastric acid secretion irrespective of the stimulus. The binding to the H+/K+ – ATpase results in duration of antisecretory effect that persists longer than 24 hours. Pantoprazole is quantitatively absorbed and bioavailability does not change upon multiple dosing, Pantoprazole is extensively metabolized in the liver. Almost 80% of an oral dose is excreted as metabolites in urine; the remainder is found in feces and originates from biliary secretion.

Indications and Usage:
Pantolam is indicated where suppression of acid secretion is of therapeutic benefit. Pantolam is registered for the following indications:

• Peptic ulcer diseases (PUD)
• Gastro esophageal reflux diseases (GERD)
• Treatment of ulcer resistant to H2 receptor antagonists (H2RAs)
• Treatment of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs)
• Gastrointestinal (GI) bleeding from stress or acid peptic diseases
• Eradication of Helicobacter pylori (in combination with antibiotics)
• Zollinger-Ellison syndrome
• Prophylaxis for acid aspiration syndrome during induction of anesthesia

Dosage and Administration:
The usual recommended adult oral dose is 40 mg given once daily, before breakfast. The duration of therapy is ranging from 2-8 weeks.

• Duodenal Ulcers: Pantolam 40 mg tablet, once daily for 2 to 4 weeks. Duodenal ulcer generally heals within 2 weeks.
• Gastric ulcers: Pantolam 40 mg tablet, once daily for 4 to 8 weeks. Gastric ulcer generally heals within 4 weeks.
• Reflux esophagitis: Pantolam 40 mg tablet, once daily for 4 to 8 weeks. Reflux esophagitis generally heals within 4 weeks of treatment.
• In resistant ulcers: Pantolam 40 mg tablet, once daily for 8 weeks.
• Ulcers induced by NSAIDs: Pantolam 40 mg tablet once daily, in patients receiving continuous treatment with NSAIDs.
• GI bleeding from stress or acid peptic disease: Usual adult oral dosage, if required the dosage may be increased.
• Eradication of Helicobacter pylori: Triple therapy of Pantolam 40 mg twice daily in combination with appropriate antibiotics for one week achieved eradication rates of 90 to 100%.
• Zollinger-Ellison syndrome: Pantolam 40 mg tablets per day. Once control of acid secretion has been achieved, the dose should be gradually reduced to the lowest effective dose that maintains acid control.
• Prophylaxis for acid aspiration syndrome during induction of anesthesia: 1 or 2 Pantolam 40 mg tablets should be given the evening before surgery and repeated again the morning of surgery.
• Maintenance Therapy: Maintenance treatment should involve the lowest dose of the drug. Both 20 and 40 mg doses of Pantoprazole (Pantolam) are safe and effective in maintaining patients with healed reflux esophagitis and PUD in remission.

Contraindication:
Pantolam tablets are contraindicated in patients with known hypersensitivity to any of the formulation.

Precautions:
Patients should be cautioned that Pantolam tablets should not be split, chewed or crushed.

Side effects:

• Potentially life-threatening effects: None has been reported with respect to Pantoprazole.
• Severe or irreversible adverse effects: No serious adverse reactions have been described to date.
• Symptomatic adverse effects: Headache (1.3%) and diarrhea (1.5%) are the two commonest reported adverse events. It doesn’t influence renal, cardiovascular, respiratory, endocrine, cognitive or motor functions, and no consistent change have been found in any biochemical or haematological parameters. Peripheral edema has occasionally been reported in female patients. Other side effects may include abdominal pain, dizziness, nausea, epigastric discomfort, flatulence, skin rash, pruritus, etc.

Pregnancy & Lactation:

• Pregnant women: USFDA pregnancy category B. Studies using animals have not found any risk to the fetus.
• Lactating Mother: There are no data on the excretion of Pantoprazole into the breast milk.
• Neonates & Children: No data are available on administration of Pantoprazole.
• Elder Patient: No problems with Pantoprazole have been encountered in clinical use in this patient group.

Concurrent Disease:
No dosage adjustment of Pantoprazole is required in patients with mild, moderate, or severe renal insufficiency or in elderly patients. No dosage adjustment is necessary in patients undergoing hemodialysis. No dosage adjustment is needed in patients with mild or moderate hepatic impairment. In hepatic cirrhosis, it is recommended that the dosing is reduced to every other day.

Drug Interactions:
Pantoprazole is metabolized through the cytochrome P-450 system, and subsequently undergoes phase II conjugation. Based on studies evaluating possible interactions of Pantoprazole with other drugs metabolized by the cytochrome P-450 system, no dosage adjustment is needed with concomitant use of the following drugs; theophylline, antipyrine, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glyburide, an oral contraceptive (Levonorgestrel/ethinyl estradiol), metoprolol, nifedipine, phenytoin, or warfarin. There was also no interaction with concomitantly administered antacids.

Overdosage:
There are no known symptoms of overdosage in humans. Since Pantoprazole is highly protein-bound, it is not readily dialyzable. Apart from symptomatic and supportive management, no specific therapy is recommended.

Storage:
Do not store above 30° C. Keep away from light and out of the reach of children.

Commercial Pack:

• Pantolam 20 tablet: Each box contains 5 Alu-Alu blister strips of 10 tablets.
• Pantolam 40 tablet: Each box contains 5 Alu-Alu blister strips of 10 tablets.