Pantotop 40mg

Tablet
Pantoprazole
BENHAM pharmaceuticals

Other Strength:
- Pantotop 20mg

Alternative:
- Pantobex 40mg
- PROTOCID 40mg
- Pregel 40mg
- Nixpan 40mg
- Pantogut 40mg
- Pantex 40mg
- Pantodac 40mg
- Prilosec 40mg
- Pantopra 40mg
- Proton-P 40mg
- Trupan 40mg
- Protonil 40mg



Pantotop
Presentation:
Pantotop® 20 tablet: Each delayed release tablet contains Pantoprazole Sodium Sequihydrate BP equivalent to Pantoprazole 20 mg. Pantotop® 40 tablet: Each delayed release tablet contains Pantoprazole Sodium Sequihydrate BP equivalent to Pantoprazole 40 mg. Description: Pantoprazole (Pantotop®) 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 secrerory 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 (Pantotop®) is quantitatively absorbed and bioavailability does not change upon multiple dosing, Pantoprazole (Pantotop®) 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: Pantoprazole

(Pantotop®) is indicated where suppression of acid secretion is of therapeutic benefit. Pantoprazole (Pantotop®) is registered for the following indications:-
1. Peptic ulcer diseases (PUD)
2. Gastro esophageal reflux diseases (GERD)
3. Treatment of ulcer resistant to H2 receptor antagonists (H2RAs)
4. Treatment of ulcers induced by non-steroidal anti-inflammatory drugs (NSAIDs)
5. Gastrointestinal (Gl) bleeding from stress or acid peptic diseases
6. Eradication of Helicobacter pylori (in combination with antibiotics)
7.Zollinger-Ellison syndrome
8. Prophylaxis for acid aspiration syndrome during induction of anaesthesia

Dosage and Administration:
Delayed release tablet 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: Pantotop® 40 mg tablet, once daily for 2 to 4 weeks. Duodenal ulcer generally heals within 2 weeks.
Gastric ulcers: Pantotop® 40 mg tablet, once daily for 4 to 8 weeks. Gastric ulcer generally heals within 4 weeks.
Reflux esophagitis. Pantotop® 40 mg tablet, once daily for 4 to 8 weeks. Reflux esophagitis generally heals within 4 weeks of treatment.
In resistant ulcers: Pantotop® 40 mg tablet, once daily for 8 weeks.
ulcers induced by NSAIDs: Pantotop® 40 mg tablet once daily, in patients receiving continuous treatment with NSAIDs.
Gl bleeding from stress or acid peptic disease: Usual adult oral dosage, if required the dosage may be increased.
Eradication of Healicobacter pylori: Triple theapy of Pantotop® 40 mg twice daily in combination with appropriate antibiotic for one week achieved eradication rates of 90 to 100%.
Zollinger-Ellison syndrome: 4 Pantotop® 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 anaesthesia: 1 or 2Pantotop® 40 mg tablet 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 (Pantotop®) are safe and effective in maintaining patients with healed reflux esophagitis and PUD in remission.

Contraindication:
Pantotop® delayed release tablets are contraindicated in patients with known hypersensitivity to any of the formulation.
Precautions: Patients should be cautioned that Pantotop® delayed release tablets should not be split, chewed of crushed.

Side effects:
Potentially life-threatening effects: None has been reported with respect to Pantoprazole.
sever or irreversible adverse effects: No serious adverse reactions have been described to date.
Symptomatic adverse effects: Headache (1.3%) and diarrhoea (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 pregnacy 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 sever renal insufficiency or in elderly patients. No dosage adjustment is necessary in patients undergoing haemodialysis. 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 it conjugation. Based on studies evaluating possible interactions of Pantoprazole with other drugs metabolized by the cytochoreme 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/ethinlyl estradiol), metoprolol, nifedipine, phenytion, 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.



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