Nocid

Nocid

omeprazole

pantoprazole

Manufacturer:

Nutramedica

Distributor:

Nutramedica
Full Prescribing Info
Contents
Pantoprazole.
Description
Each capsule contains: Pantoprazole (as Pantoprazole Sodium) 40 mg.
Pantoprazole is a proton pump inhibitor. It inhibits secretion of gastric acid by irreversibly blocking the enzyme system of hydrogen/potassium adenosine triphosphates (H+/K+ ATPase), the 'proton pump' of the gastric parietal cell.
Action
Pharmacology: Pharmacokinetics: Peak plasma-pantoprazole concentrations are achieved about 2 to 2.5 hours after an oral dose.
The oral bioavailability is about 77% with the enteric-coated formulation, and dose does not vary after single or multiple doses. Pantoprazole is 98% bound to plasma proteins. It is extensively metabolized in the liver, primarily by the cytochrome P450 isoenzyme CYP2C19, to desmethylpantoprazole; small amounts are also metabolized by CYP3A4, CYP2D6, and CYP2C9.
Metabolites are excreted mainly (about 80%) in the urine, with the remainder being excreted in the 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.
Indications/Uses
Pantoprazole is used in conditions where inhibition of gastric secretion may be beneficial, including gastro-oesophageal reflux disease, peptic ulcer disease, and the Zollinger-Ellison syndrome.
Dosage/Direction for Use
In the treatment of gastro-oesophageal reflux disease, the usual dose by mouth is 20 to 40 mg once daily for 4 weeks, increased to 8 weeks if necessary; sometimes up to 16 weeks for healing of erosive oesophagitis. For maintenance therapy, treatment can be continued with 20 to 40 mg once daily. Alternatively, for recurring symptoms, an on-demand regimen of 20 mg daily may be given.
The usual dose for the treatment of peptic ulcer disease is 40 mg once daily. Treatment is usually given for 2 to 4 weeks for duodenal ulceration, or for 4 to 8 weeks for benign gastric ulceration.
For the eradication of Helicobacter pylori in peptic ulceration pantoprazole may be combined with two antibacterials in a one-week therapy regimen. Effective regimens include pantoprazole 40 mg twice daily combined with clarithromycin 500 mg twice daily and either amoxicillin 1 g twice daily or metronidazole 400 mg twice daily.
Patients who require prophylaxis for NSAID-associated ulceration may take 20 mg daily.
In the treatment of pathological hypersecretory states such as Zollinger-Ellison syndrome, the initial dose is 80 mg daily, adjusted as required.
Doses of up to 240 mg daily have been used. Daily doses greater than 80 mg should be given in 2 divided doses. Doses of pantoprazole may need to be reduced in patients with hepatic impairment.
Or as prescribed by the physician.
Overdosage
Very few instances have been reported showing drowsiness, headache (possibly due to a metabolite), and tachycardia, but recovered uneventfully without specific treatment.
Pantoprazole is not removed by hemodialysis. In case of overdosage, treatment should be symptomatic and supportive.
Contraindications
Pantoprazole is contraindicated to those who are allergic to the active or any component of the formulation.
Special Precautions
Before giving pantoprazole to patients with gastric ulcers the possibility of malignancy should be considered since the drug may mask symptoms and delay diagnosis. Pantoprazole should be used with caution in hepatic impairment because an increase in pantoprazole bioavailability and elimination half-life has been reported.
Adverse Reactions
Adverse effects most frequently reported with pantoprazole includes headache, diarrhea, and skin rashes: and they have sometimes been severe enough to require stopping treatment.
Other 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 hallucinations have occurred in severely ill patients. Raised liver enzymes, and isolated cases of the 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 disorders (including agranulocytosis, leucopenia, and thrombocytopenia), and interstitial nephritis.
Proton pump inhibitors may increase the risk of gastrointestinal infections because of their acid suppressive effects.
Drug Interactions
Pantoprazole and other proton pump inhibitors are metabolized by the cytochrome P450 system, primarily by isoenzyme CYP2C19, and may alter the metabolism of some drugs metabolize by these enzymes. Pantoprazole may prolong the elimination of diazepam, phenytoin, tolbutamide, and warfarin. Pantoprazole and other proton pump inhibitors can reduce the absorption of drugs such as ketoconazole, and possibly itraconazole, whose absorption is dependent on an acid gastric pH.
With voriconazole, the plasma concentration of both drugs may be increased and a reduced dose of pantoprazole is recommended.
Storage
Store at temperatures not exceeding 30°C.
MIMS Class
Antacids, Antireflux Agents & Antiulcerants
ATC Classification
A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).
Presentation/Packing
Form
Nocid cap 40 mg
Packing/Price
100's
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