Prazole Forte/Prazole IV

Prazole Forte: Each enteric-coated tablet contains: Pantoprazole Sodium equivalent to Pantoprazole 40mg.
Prazole IV: Each vial of powder for injection contains pantoprazole sodium equivalent to pantoprazole 40 mg.
Pantoprazole is sodium 5-(difluoromethoxy)-2-[[(3,4-dimethoxy-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole sesquihydrate.
Domperidone is 5-chloro-1-[1-[3-(2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)propyl]piperidin-4-yl]-1,3-dihydro-2H-benzimidazol-2-one.

Pharmacology: Mechanism of Action: Pantoprazole is a proton-pump inhibitor (PPI) that suppresses the final step in gastric acid production by covalently binding to the H⁺/K⁺-ATPase results in a duration of antisecretory effect that persists longer than 24 hrs of all doses tested.
Pharmacokinetics: Prazole Forte: Peak plasma of Pantoprazole concentrations are achieved about 2 to 2.5 hours after a dose by mouth. The oral bioavailability is about 77% with the enteric-coated tablet formulation, and does not vary after single or multiple doses. Pantoprazole is 98% bound to plasma proteins. It is extensively metabolized in the liver, primarily by cytochrome P450 isoenzyme CYP2C19, to desmethylpantoprazole; small amounts are also metabolized by CYP3A4, CYP2D6, and CYP2C9. Metabolites are excreted principally about 80% in the urine, with the remainder being excreted in bile. The terminal elimination half-life is about 1 hour, and is prolonged in hepatic impairment; the half-life in patients with cirrhosis was 3 to 6 hours.
Prazole IV: Pantoprazole does not accumulate and its pharmacokinetics are unaltered with multiple daily dosing. Following the administration of pantoprazole sodium for injection, the serum concentration of pantoprazole declines bioexponentially with a terminal elimination t_½ of approximately 1 hr. In extensive metabolizers with normal liver function receiving a dose of Prazole IV 40 mg for injection by constant rate over 15 min, the peak concentration (C_max) is 5.52 mcg/mL and the total area under the plasma concentration versus time curve (AUC) is 5.4 mcg hr/mL. The total clearance is 7.6-14 L/hr and apparent volume of distribution is 11-23.6 mL.
The serum protein-binding of pantoprazole is about 98% primarily to albumin. Pantoprazole is extensively metabolized in the liver through the cytochrome P450 (CYP450) system.
After administration of a single IV dose of pantoprazole to healthy, normal stabilizer subjects, approximately 71% of the dose was excreted in the urine with 18% excreted in the feces through biliary excretion. There was no renal excretion of unchanged pantoprazole.

Prazole Forte: It is used in gastro-oesophageal reflux disease, peptic ulcer disease, duodenal ulceration, benign gastric ulceration, eradication of Helicobacter pylori, Prophylaxis for NSAID-associated ulceration and Zollinger-Ellison syndrome.
Prazole IV: Treatment of gastric ulcer, duodenal ulcer, moderate and severe reflux esophagitis.

Prazole Forte: Gastro-oesophageal reflux disease: 20 to 40 mg once daily for 4-8 weeks.
For maintenance therapy: 20-40 mg daily.
Peptic ulcer disease: 40 mg once daily.
Duodenal ulceration: 40 mg once daily for 2 to 4 weeks.
Benign gastric ulceration: 40 mg once daily for 4 to 8 weeks.
For the eradication of Helicobacter pylori: Pantoprazole may be combined with two antibacterials in a 1-week triple therapy regimen.
Effective regimens include Pantoprazole 40 mg daily twice daily combined with Clarithromycin 500 mg twice daily and either Amoxicillin 1g twice daily or Metronidazole 400 mg twice daily.
Prophylaxis for NSAID-associated ulceration: 20 mg daily.
Zollinger-Ellison syndrome: 80 mg daily, given in 2 divided doses.
Or as directed by the physician.
Prazole IV: Recommended Dose: 40 mg IV once daily for 7 days.
Duodenal Ulcer: Duodenal ulcers generally heal within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.
Gastric Ulcer and Gastroesophageal Reflux: A 4-week period is usually required for the treatment of gastric ulcers and gastroesophageal reflux. If this is not sufficient, healing will usually be achieved in within a further 4 weeks.
Administration: For IV administration only. Prazole IV is recommended only in cases where the oral administration is not indicated. The content of the vial needs to be reconstituted with 0.9% sodium chloride injection w/v 10 mL before injection. This freshly prepared solution should be administered IV over 2-15 min, either as a slow injection or it may be further diluted with 0.9% sodium chloride injection w/v 100 mL or 5% glucose injection and administered as a short-term infusion. The duration of administration should be 2-15 min. The reconstituted solution must be used within 12 hrs of preparation.

Prazole IV: There is no known symptoms of overdosage in humans. Doses of up to 240 IV were administered without adverse effects. Apart from symptomatic and supportive treatment, no specific therapeutic recommendations can be made.

Prazole Forte: Pantoprazole should generally not be used in cases of known hypersensitivity to pantoprazole.
Prazole IV: Known hypersensitivity to pantoprazole or any of the excipients of Prazole IV.

Prazole Forte: Before giving Pantoprazole or other proton pump inhibitors to patients with gastric ulcers the possibility of malignancy should be considered since these drugs may mask symptoms and delay diagnosis. Pantoprazole and other proton pump inhibitors should be used with caution in hepatic impairment.
Prazole IV: Prior to the treatment of gastric ulcer, the possibility of malignancy should be excluded before treatment with pantoprazole sodium is instituted, as treatment may alleviate symptoms and delay diagnosis. Anaphylaxis has been reported with the use of pantoprazole IV. This may require emergency medical treatment. The diagnosis of an inflammation of the esophagus should be endoscopically confirmed.
Effects on the Ability to Drive or Operate Machinery: Pantoprazole IV does not affect the ability to drive and use machines.
Use in pregnancy: During pregnancy, pantoprazole IV should not be used unless the benefit exceeds the potential risk.
Use in lactation: There is no information about the safety of pantoprazole IV during breastfeeding in humans. During breastfeeding, pantoprazole IV should not be used unless the benefit exceeds the potential risk.

Prazole IV: Use in pregnancy: During pregnancy, pantoprazole IV should not be used unless the benefit exceeds the potential risk.
Use in lactation: There is no information about the safety of pantoprazole IV during breastfeeding in humans. During breastfeeding, pantoprazole IV should not be used unless the benefit exceeds the potential risk.

Prazole Forte: Headache, diarrhea, and skin rashes: Other adverse or undesirable effects include pruritus, dizziness, fatigue, constipation, nausea and vomiting, flatulence, abdominal pain, arthralgia and myalgia, urticaria, and dry mouth. Isolated cases of photosensitivity, bullous eruption, erythema multiforme, angioedema, and anaphylaxis have been reported. Effects on the CNS include occasional insomnia, somnolence, and vertigo; reversible confusional states, agitation, depression, and hallucination have occurred in severely ill patients raised liver enzymes, and isolated cases of hepatitis, jaundice, and hepatic encephalopathy, have been reported. Other adverse effects reported rarely or in isolated cases include paraesthesia, blurred vision, alopecia, stomatitis, sweating, taste disturbances, peripheral oedema, malaise, hyponatraemia, blood disorder (including agranulocytosis, leucopenia, and thrombocytopenia), and interstitial nephritis.
Proton pump inhibitors may increase the risk of gastrointestinal infections because of their acid suppressive effects.
Prazole IV: Treatments with pantoprazole IV can occasionally lead to headache or diarrhea. Rarely, nausea, vomiting, abdominal pain, flatulence, constipation, allergic reactions eg, skin rash and pruritus may occur. Individual cases of edema, blurred vision, fever, dizziness, thrombophlebitis, depression or myalgia subsiding after termination of therapy have been reported.

No clinically significant interactions were observed with carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, phenytoin, warfarin and concomitantly administered antacids. As with other antacid secretion inhibitors, changes in absorption may be observed with drugs whose absorption is pH dependent eg, ketoconazole are taken concomitantly.

Store at temperatures not exceeding 30°C.

Antacids, Antireflux Agents & Antiulcerants

A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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