Panum - instructions for use, doses, side effects, contraindications

Proton pump inhibitor. Inhibiting the H + / K + -ATPase of parietal cells in the stomach, disrupts the transfer of hydrogen ions from the parietal cell to the lumen of the stomach and blocks the final stage of hydrophilic secretion of hydrochloric acid. Prolonged suppression of basal and stimulated secretion of hydrochloric acid, regardless of the nature of the stimulus (histamine, gastrin, acetylcholine). The maximum effect is manifested only in a highly acidic medium (pH <3), at higher pH values it remains practically inactive.

With duodenal ulcer associated with Helicobacter pylori, decrease in gastric secretion increases sensitivity of microorganisms to antibiotics. Does not affect the motility of the gastrointestinal tract. Secretory activity is normalized 3-4 days after the end of the drug intake.

Compared with other proton pump inhibitors, pantoprazole has a lower interaction potential with the liver oxidase system, which depends on cytochrome P450. Therefore, the drug does not interact with many other drugs.

Pharmacokinetics:

The volume of distribution is 0.15 l / kg, the clearance is 0.1 l / h / kg.

The half-life of the drug is 1 hour. Pharmacokinetics of pantoprazole is the same as after a single, and after repeated use of the drug. In the dose range of 10 to 80 mg, the kinetic curve of the concentration of pantoprazole in blood plasma has a linear relationship both after oral and after intravenous administration.

Pantoprazole is highly associated (98%) with plasma proteins. Metabolised in the liver. 80% of the drug is excreted through the kidneys in the form of metabolites, a small amount is excreted with feces. The main metabolite in blood plasma and urine is desmethylpentoprazole, conjugating with sulfate; the half-life of the main metabolite is about 1.5 hours.

In patients with impaired liver function (including in patients on hemodialysis), dose reduction is not required.

Although the half-life of the main metabolite in these patients increases to 2-3 hours, the excretion of the drug occurs rather quickly and cumulation does not occur. In patients with hepatic insufficiency, the half-life of pantoprazole increases to 7-9 hours, the time to reach the maximum concentration in the plasma increases by 1.5 times in comparison with healthy patients.

Indications:

- peptic ulcer of the stomach and duodenum (in the phase of exacerbation), erosive gastritis, including associated with the use of non-steroidal anti-inflammatory drugs.

- gastroesophageal reflux disease; erosive reflux-esophagitis (treatment), symptomatic treatment of gastroesophageal reflux disease, (ie, non-erosive reflux disease);

- Zollinger-Ellison syndrome;

- eradication Helicobacter pylori in combination with antibacterial agents;

- treatment and prevention of stress ulcers, as well as their complications (bleeding, perforation, penetration).

Contraindications:

Hypersensitivity to the drug components, dyspepsia neurotic, genesis, malignant diseases of the gastrointestinal tract,intestinal tract, severe hepatic insufficiency, children's age, lactation period.

Carefully:Pregnancy; liver failure.

Pregnancy and lactation:The use of the drug in pregnancy is possible only in those cases, the when the use of his application for the mother exceeds the potential risk to the fruits.

Dosing and Administration:

Intravenous administration of the drug is recommended in cases where oral administration is not possible.

The recommended daily dose is 40 mg.

When Long-term treatment of Zollinger-Ellison syndrome and other pathological hypersecretory conditions, the daily dose at the beginning of treatment is 80 mg, which should be divided and administered twice a day. Perhaps a temporary increase in the daily dose to 160 mg.

In the treatment and prevention of stress ulcers, as well as if available complications of peptic ulcer (bleeding, perforation, penetration), the drug is prescribed in a daily dose of 80 mg, which should be divided and is administered twice a day. Perhaps a temporary increase in daily doses up to 160 mg.

To prepare a ready-to-use injection solution add 10 ml of physiological sodium chloride solution to the vial containing the lyophilizate.

This solution can be administered directly or it can be is applied after mixing with a physiological solution of chloride sodium or 5% glucose solution. The prepared solution is introduced intravenously for 2-15 minutes and is used immediately after its preparation. Do not mix the prepared solution with other medicinal preparations.

Side effects:

When prescribed at recommended doses, side effects occur extremely rare, but there may be such side effects as:

a) typical side effects: pain in the upper abdomen, diarrhea, constipation, flatulence, headache.

b) rare side effects (with a frequency of no more than 1 in 10 000 cases): dry mouth, arthralgia, depression, hallucinations, disorientation and confusion.

c) very rare side effects (less than 1 per 10 000 cases): leukopenia, thrombocytopenia, thrombophlebitis at the site of injection, peripheral edema, hepatocellular insufficiency (with jaundice or without the development of hepatic insufficiency), anaphylactic reactions, (including anaphylactic shock), increased hepatic activity enzymes, increased triglycerides, increased body temperature; urticaria, angioedema, Stephen-Johnson syndrome, polymorphic erythema, photosensitivity, Lyell's syndrome; myalgia, interstitial nephritis.

Overdose:

When administered in recommended doses, there was no evidence of drug overdose. There is no specific antidote.

Hemodialysis is ineffective.In the presence of clinical manifestations (possibly increased side effects), symptomatic and supportive therapy is performed.

Interaction:

Simultaneous application of Panuma® can reduce the absorption of drugs whose bioavailability depends on the pH of the stomach (nFor example: salts iron, ketokonasol, atazanavir and ritonavir).

The drug can be prescribed without risk drug interactions the following groups of patients:

- patients with diseases withcardiovascular system, taking cardiac glycosides (digoxin), slow / calcium channel blockers (nifedipine), beta-adrenoblockers (metoprozole);

- patients with diseases of the gastrointestinal tract, taking antacids, antibiotics (amoxicillin, clarithromycin);

patients receiving oral contraceptives;

- patients taking non-steroidal anti-inflammatory drugs drugs (diclofenac, phenazone, naproxen, piroxicam);

- patients with diseases of the endocrine system who receive glybesenclamamide, levothyroxine sodium;

- patients with anxiety and sleep disorders, host diazepam;

- patients with epilepsy receiving carbamazepine and phenytoin;

- patients, receiving indirect anticoagulants, such as warfarin and fenprokumone;

- patients who underwent transplantation taking cyclosporine tacrolimus.

There was no drug interaction with theophylline, caffeine and ethanol.

Special instructions:Intravenous use is recommended only if oral administration of the drug is not possible.

The use of pantoprazole is not indicated for the treatment of mild gastrointestinal disorders, such as dyspepsia of a neurogenic genesis. Before the beginning of treatment, malignant diseases of the esophagus and stomach should be excluded, since symptomatic improvement can delay correct diagnosis and mask the symptoms. The diagnosis of gastroesophageal reflux disease should be endoscopically confirmed. In elderly patients and with renal dysfunction, it is not recommended to exceed the dose of 40 mg per day. In severe hepatic insufficiency, the daily dose of the drug should be reduced to 20 mg, while a continuous control of liver enzymes is required (if exceeded, treatment with pantoprazole should be discontinued).

Effect on the ability to drive transp. cf. and fur:Does not affect the ability to drive and work moving machinery.

Form release / dosage:

Lyophilizate for the preparation of a solution for intravenous administration, 40 mg.

Packaging:

For 40 mg of pantoprazole in a glass vial (type 1 USP), with a capacity of 10 ml, closed with a bromobutyl stopper and crimped with an aluminum breakout cap with a control plastic cover. One bottle is placed in a cardboard box together with instructions for use.

Storage conditions:

At a temperature of no higher than 25 ° C in a dry, dark place. Keep out of the reach of children.

Shelf life:

2 years.

Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-000638

Date of registration:28.09.2011

The owner of the registration certificate:Unik Pharmaceutical Laboratories Unik Pharmaceutical Laboratories India

Manufacturer: & nbsp

UNIQUE PHARMACEUTICAL Laboratories India

Representation: & nbsp"UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")""UNIC PHARMACEUTICAL LABORATORY (branch of the company" JB Chemicals and Pharmaceuticals Ltd. ")"India

Information update date: & nbsp29.08.2015

Illustrated instructions

Instructions

Panum® (Panum®)