Pantokem/Pantokem IV

Pantokem/Pantokem IV

pantoprazole

Manufacturer:

Alkem Lab

Distributor:

Getz Bros
Full Prescribing Info
Contents
Pantoprazole (tab: sodium sesquihydrate; IV: sodium).
Description
Pantokem: Each enteric-coated tablet contains pantoprazole sodium sesquihydrate USP equivalent to 40 mg Pantoprazole.
Pantokem IV: Each vial contains: Pantoprazole Sodium Eq. to Pantoprazole 40 mg.
Action
Pharmacology: Pharmacokinetics: Metabolism: Pantoprazole is almost exclusively metabolized in the liver through the cytochrome P450 system. The main metabolite is Desmethylpantoprazole which is conjugated with Sulphate. The metabolites of Pantoprazole are inactive.
Elimination: Renal elimination represents the most important route of excretion (approximately 80%) for the metabolites of Pantoprazole. The balance is excreted with the faeces. The half-life of the main metabolite is approximately 11/4 hours which is slightly longer than that of Pantoprazole.
Absorption and distribution: Pantokem: Pantoprazole is unstable in acid and is administered orally in the form of an enteric-coated tablet. Absorption takes place in the small intestine. The absolute systemic bioavailability of Pantoprazole from single and multiple oral doses of Pantoprazole is approximately 77%. The plasma kinetics for Pantoprazole after both oral and intravenous administration is linear over the dose range 10-80mg.
Pharmacokinetic profile in patients: The subpopulations of subjects suffering from mild to moderately severe liver cirrhosis, the half-life increases from 1 hour to between 7 to 9 hours. The AUC values are increased by a factor of 6 to 8, while the maximum serum concentration increases by a factor of only 1½ in comparison with healthy subjects.
In patients with renal impairment the half-life of the main metabolites is moderately increased but there is no accumulation at therapeutic doses. The half-life of Pantoprazole in healthy subjects is short. Pantoprazole is poorly dialysable. A slight increase in AUC and Cmax occurs in elderly compared with younger people.
Pantokem IV: Following intravenous administration of pantoprazole, serum/plasma concentrations decline biexponentially. The terminal half-life is about 1 hour. The total serum clearance is approximately 0, 1/11/h/kg and the volume of distribution is about 0, 15 L/kg.
The plasma kinetics for pantoprazole after both oral and intravenous is linear over the dose range 10 to 80 mg.
Indications/Uses
Pantokem: Pantoprazole is used in the treatment of gastro-oesophageal reflux disease, peptic ulcer disease, NSAID-associated ulceration and Zollinger-Ellison syndrome, for the eradication of Helicobacter pylori, pantoprazole may be combined with two antibacterials.
Pantokem IV: It used in conditions where inhibition of gastric acid secretion may be beneficial, including aspiration syndromes, dyspepsia, gastro-oesophageal reflux disease, peptic ulcer disease, and the Zollinger-Ellison syndrome.
Dosage/Direction for Use
Pantokem: In the treatment of gastro-oesophageal reflux disease, the usual oral dose is 20 to 40 mg once daily for 4 weeks, increased to 8 weeks if necessary, up to 16 weeks of therapy is permitted for healing of erosive oesophagitis. For maintenance therapy, treatment can be continued with 20 to 40 mg 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 4 to 8 weeks for benign gastric ulceration. 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 twice daily combined with clarithromycin 250 mg twice daily and 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 the 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.
Administration in hepatic impairment: Dosage of Pantoprazole may need to be reduced in severe hepatic impairment, or doses given only on alternate days. A maximum dose of 20 mg daily orally or 40 mg orally on alternate days.
Administration in renal impairment: Generally does not recommend dosage adjustment in this group.
Pantokem IV: The recommended dosage is one vial per day administered over 2 to 15 minutes. Pantoprazole should be reconstituted with 10 mL of physiological sodium chloride solution into the vial containing the dry substance. The solution may be administered directly.
Direction for Use: Dissolve the contents of the vial with given sterile Sodium Chloride Injection USP and use immediately. Use the ampoule only once and discard the ampoule.
Contraindications
Pantokem: Hypersensitivity to Pantoprazole.
Safety in pregnancy and during lactation has not been established.
Safety and efficacy in children have not been established.
Severely impaired liver function.
Pantokem IV: Pantoprazole should generally not be used in cases of known hypersensitivity of pantoprazole.
Special Precautions
Pantokem: Pantoprazole is not indicated for mild gastro-intestinal complaints such as nervous dyspepsia. Prior to treatment, the possibility of a malignant disease of the oesophagus should be excluded, as the treatment with Pantoprazole may alleviate the symptoms of malignant ulcers and can thus delay diagnosis.
Diagnosis of reflux oesophagitis should be confirmed by endoscopy.
Pantoprazole and other proton pump inhibitors should be used with caution in hepatic impairment.
Pantokem IV: 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.
Adverse Reactions
Pantokem: Headache and gastro-intestinal complaints such as upper abdominal pain, diarrhea, constipation or flatulence have been reported. With continued treatment complaints usually diminish. There have been reports of allergic reaction such as skin rash, pruritus and in isolated cases also urticaria, angioedema or anaphylactic shock. There have been less frequent reports of nausea, dizziness or disturbances in vision (blurred vision).
Peripheral edema, depression, fever or myalgia have been reported in individual cases.
Pantokem IV: Headache, diarrhea, and skin rashes: 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 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.
Storage
Store at temperatures not exceeding 30°C.
Pantokem: Store in a dry place and protected from light.
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
Pantokem: EC tab 40 mg x 10's, 50's.
Pantokem IV: Lyophilized powd for inj 40 mg [10 mL (vial) + 10 mL (amp) diluent] x 1's.
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