Brawn Labs


D & G Pharma
Full Prescribing Info
Pantoprazole sodium.
Each vial contains: Pantoprazole Sodium (Eq. to Pantoprazole) 40 mg.
Pharmacokinetics: Absorption and Distribution: 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.
Metabolism: Pantoprazole is almost exclusively metabolised in the liver. The main metabolite is desmethylpantoprazole, which is conjugated with sulfate.
Elimination: Renal elimination represents the most important route of excretion (approximately 80%) for the metabolite of Pantoprazole. The balance is excreted with faeces. The half-life of the main metabolite is approximately 1 and half hours which is slightly longer than that of Pantoprazole.
It used in conditions where inhibition of gastric acid secretion may be beneficial, including aspiration syndromes, dyspepsia, gastroesophageal reflux disease, peptic ulcer disease, and the Zollinger-Ellison syndrome.
Dosage/Direction for Use
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.
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.
Pantoprazole should generally not be used in cases of known hypersensitivity of Pantoprazole.
Special Precautions
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
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 confusion 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, leukopenia, and thrombocytopenia), and interstitial nephritis.
Proton pump inhibitors may increase the risk of gastrointestinal infections because of their acid suppressive effects.
Store at temperatures not exceeding 30°C.
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).
Lyophilized powd for inj (vial) 40 mg (+ 10 mL diluent in amp) x 1's.
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