In the dose range from 10 to 80 mg of pantoprazole pharmacokinetic parameters are linear after intravenous administration. The drug is not cumulated. The values of the pharmacokinetic parameters of pantoprazole in multiple and single injection comparable. Distribution The volume of distribution ly, the drug is distributed in the extracellular fluid.Plasma protein binding is 98%. Metabolism Intensively metabolized in the liver primarily, with the participation of the enzyme cypionate testosteronesystem. The main metabolite in plasma and urine is desmetilpantoprazol conjugated with sulfate. Elimination half-life after intravenous administration is on average 1 hour Most of the drug is excreted by the kidneys in the form of inactive metabolites. In small quantities, is derived through the intestines. In liver failure duration increases half-life to 7 – 9 hours area under the curve values. “Concentration – time” is 5-7 times higher, and the maximum concentration is 1.5 times higher in patients with liver failure compared to volunteers.
Indications for use:
- Peptic ulcer and 12 duodenal ulcer (in the acute phase), erosive gastritis (including related to the use of nonsteroidal anti-inflammatory ..;
- Gastroesophageal reflux disease: erosive reflux esophagitis (healing), symptomatic treatment (ie cypionate testosterone
- Non-erosive reflux disease);
- Zollinger-Ellison syndrome;
- Eradication of Helicobacter pylori in combination with antibacterial agents.Contraindications:
Hypersensitivity, dyspepsia neurotic genesis, cancer of the gastrointestinal tract, lactation, children under 18 years.Precautions:
Pregnancy; liver failure.
Dosing and Administration
This formulation Sanpraza shown only for intravenous administration. The drug is recommended only in those cases where oral administration of pantoprazole is not shown. Once there is a possibility of oral therapy, intravenous injection must be terminated.
The recommended dose is administered by intravenous administration the contents of one vial (40 mg pantoprazole) once per day. These allow for intravenous use for 7-10 days, extension of treatment depends on the clinical need.
- Prolonged treatment of Zollinger-Ellison syndrome , and other pathological hypersecretory conditions recommended dose at the beginning of treatment is 80 mg Sanpraza.Thereafter, the dosage may be increased or decreased. In the case of the preparation in a daily dose of more than 80 mg, the dose should be divided and administered twice daily. Perhaps a temporary increase in the daily dose to 160 mg Sanpraza. When Helicobacter pylori eradication in combination with antibacterial agents recommended daily dose is 80 mg Sanpraza within 7-10 days, the dose should be divided and administered twice daily. Patients with impaired hepatic function: if severe hepatic dysfunction the daily dose should be reduced to 20 mg pantoprazole. In addition, during the treatment with these cypionate testosterone patients requires regular monitoring of liver enzymes. In case of increase of liver enzymes the treatment should be stopped. Elderly patients: there is no need to increase the daily dose of pantoprazole 40 mg, also in patients with impaired renal function (including patients on dialysis). Pregnancy and lactation: experience with the drug in the limited period. In studies of reproductive function in animals were minor embryotoxicity at doses greater than 5 mg / kg. The drug may be used only if the benefits to the mother of the application exceeds the potential risk to the fetus. Data on the allocation of pantoprazole in breast milk does not.
- It should stop breast-feeding during treatment. Children’s age. There is not enough data on the use of the drug in children under 18 years. The contents of the vial prior to injection necessary to restore with 10 mL of 0.9% sodium chloride solution. This solution is injected or produced jet infusion after mixing with 100 ml of 0.9% sodium chloride solution, 5% glucose solution or a 10% glucose solution. The pH of the ready to use solution should be in the range 9-10. The duration of administration should be 2-15 minutes. The prepared solution should be used within 3 hours after preparation.Side effects:
When taken Sanpraza in accordance with the indications and at the recommended doses, side effects are extremely rare.
The appointment of pantoprazole cypionate testosterone can be accompanied by the following adverse reactions: headache, pain in the upper abdomen, diarrhea, constipation, flatulence, rarely – nausea / vomiting. Rare: dry mouth;arthralgia; depression, hallucinations (especially in predisposed patients), disorientation and confusion. Very rare: leukopenia, thrombocytopenia; peripheral edema; hepatocellular insufficiency resulting in jaundice with or without hepatic failure; anaphylactic reactions, including anaphylactic shock; increased activity of liver enzymes (transaminases, glutamyl); increase in triglycerides; interstitial nephritis;urticaria, angioedema, allergic reactions such as itching and skin rash, severe skin reaction (Stevens-Johnson syndrome, erythema multiforme, photosensitivity, Lyell’s syndrome); local reactions (phlebitis, thrombophlebitis). In a few cases reported dizziness or blurred vision, peripheral edema, fever, myalgia.