Pantomex

Pantomex

pantoprazole

Manufacturer:

Simex
Full Prescribing Info
Contents
Pantoprazole.
Description
Each vial contains: Pantoprazole sodium sesquihydrate equivalent to 40 mg of pantoprazole.
Action
Pharmacology: Mechanism of action: Pantoprazole is a substituted benzimidazole which inhibits the secretion of hydrochloric acid in the stomach by specific action on the proton pumps of the parietal cells. Pantoprazole is converted to its active form in the acidic environment in the parietal cells, where it inhibits the H+, K+, ATPase enzyme, i.e. the final stage in the production of hydrochloric acid in the stomach. The inhibition is dose-dependent and affects both receptor inhibitors, treatment with pantoprazole causes a reduced acidity in the stomach and thereby an increase in gastrin in proportion to the reduction in acidity. The increase in gastrin is reversible. Since pantoprazole binds to the enzyme distal to the cell receptor level, the substance can affect hydrochloric acid secretion independently of the stimulation by other substances (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.
Indications/Uses
Duodenal ulcer.
Gastric ulcer.
Moderate and severe cases of inflammation of the esophagus (reflux esophagitis).
For the treatment of pathological hypersecretory conditions associated with Zollinger - Ellison - Syndrome or other neoplastic conditions.
Dosage/Direction for Use
The intravenous administration of PANTOMEX i.v. is recommended only if oral application is not appropriate.
Recommended dosage: Duodenal ulcer, gastric ulcer, moderate and severe reflux esophagitis: The recommended intravenous dosage is one vial (40 mg pantoprazole) PANTOMEX i.v. per day.
Long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions: Patients should start their treatment with a daily dose of 80 mg PANTOMEX i.v. Thereafter, the dosage can be titrated up or down as needed using measurements of gastric acid secretion to guide. With doses above 80 mg daily, the dose should be divided and given twice daily.
A temporary increase of the dosage above 160 mg pantoprazole is possible but should not be applied longer than required for adequate acid control.
In case a rapid acid control is required, a starting dose of 2 x 80 mg PANTOMEX i.v. is sufficient to manage a decrease of acid output into the target range (< 10 mEq/h) within one hour in the majority of patients. Transition from oral to i.v. and from i.v. to oral formulations of gastric acid inhibitors should be performed in such manner to ensure continuity of effect of suppression of acid secretion.
Overdosage
There are no known symptoms of overdosage in man.
Doses up to 240 mg i.v. were administered over two minutes and were well tolerated. In the case of overdosage with clinical signs of intoxication, the usual rules of intoxication therapy apply.
Contraindications
PANTOMEX i.v. should generally not be used in cases of known hypersensitivity to the constituent.
Special Precautions
The intravenous administration of PANTOMEX i.v. is recommended only if oral application is not appropriate.
Pantoprazole is not indicated for mild gastrointestinal complaints such as nervous dyspepsia. Prior to treatment the possibility of malignancy of gastric ulcer or a malignant disease of the esophagus should be excluded as the treatment with pantoprazole may alleviate the symptoms of malignant ulcer and can thus delay diagnosis.
Diagnosis of reflux esophagitis should be confirmed by endoscopy.
The daily dose of 40 mg pantoprazole should not be exceeded in elderly patients or in those with impaired renal function. In patients with severe liver impairment the daily dose has to be reduced to 20 mg pantoprazole. Furthermore, in these patients the liver enzymes should be monitored during PANTOMEX i.v. therapy. In case of increase of the liver enzymes Pantoprazole i.v. should be discontinued.
To date there has been no experience with treatment in children.
Effect on the ability to drive and to use machines: There are no known effects on the ability to drive and use machines.
Use in Pregnancy & lactation: Clinical experience in pregnant women is limited. In animal reproduction studies, signs of slight fetotoxicity were observed at doses above 5 mg/kg. There is no information on the excretion of pantoprazole into human breast milk. Pantoprazole should only be used when the benefit to the mother is considered greater than the potential risk to the fetus/baby.
Use In Pregnancy & Lactation
Clinical experience in pregnant women is limited. In animal reproduction studies, signs of slight fetotoxicity were observed at doses above 5 mg/kg. There is no information on the excretion of pantoprazole into human breast milk. Pantoprazole should only be used when the benefit to the mother is considered greater than the potential risk to the fetus/baby.
Adverse Reactions
Blood and lymphatic system: leucopenia, thrombocytopenia.
Gastrointestinal disorders: upper abdominal pain, diarrhea, constipation, flatulence, nausea/vomiting, dry mouth.
General disorders and administration site conditions: injection site thrombophlebitis, peripheral edema.
Hepatobiliary disorders: severe hepatocellular damage leading to jaundice with or without hepatic failure.
Immune system disorders: anaphylactic reactions including anaphylactic shock.
Investigations: increased liver enzymes (transaminase, γ-GT), elevated triglycerides, increased body temperature.
Musculoskeletal, connective tissue disorders: arthralgia, myalgia.
Nervous system disorders: headache, dizziness, disturbances in vision (blurred vision).
Psychiatric disorders: mental depression.
Renal and urinary disorders: interstitial nephritis.
Skin and subcutaneous tissue disorders: allergic reactions such as pruritus and skin rash, urticaria, angioedema, severe skin reaction such as Stevens-Johnson syndrome, erythema multiforme, Lyell syndrome, photosensitivity.
Drug Interactions
Changes in absorption should be observed when drugs whose absorption is pH-dependent, e.g. ketoconazole, are taken concomitantly.
The active ingredient of PANTOMEX i.v. is metabolized in the liver via the cytochrome P450 enzyme system. An interaction of pantoprazole with other drugs or compounds which are metabolized using the same enzyme system cannot be excluded. No clinically significant interaction were, however, observed in specific tests with a number of such drugs or compounds, namely carbamazepine, caffeine, diazepam, diclofenac, digoxin, ethanol, glibenclamide, metoprolol, naproxen, nifedipine, phenytoin, piroxicam, theophylline, warfarin and an oral contraceptive. Therefore, in patients being treated with coumarin anticoagulants, monitoring of prothrombin time / INR is recommended after initiation, termination or during irregular use of pantoprazole. There were also no interactions with concomitantly administered antacids.
Caution For Usage
Instruction for use/handling: A ready-to-use solution is prepared by injecting 10 ml of physiological sodium chloride solution into the vial containing the dry substance. This solution may be administered directly or may be administered after mixing with 100 ml physiological sodium chloride solution (0.9% NaCl) or 5% Glucose. It would be better if the solution is used immediately.
After reconstitution as directed with 10 ml 0.9% NaCl or after mixing with a compatible infusion solution (100 ml 0.9% NaCl/5% Glucose), PANTOMEX i.v. may be stored within 12 hours in refrigerator.
PANTOMEX i.v. should not be manufactured or mixed with solvents other than those stated.
As soon as oral therapy is possible, treatment with PANTOMEX i.v. should be discontinued and 40 mg pantoprazole p.o. should be administered instead.
The drug should be administered intravenously over 2 minutes after reconstitution with 10 ml 0.9% NaCl and over 15 minutes after diluted with intravenous infusion.
Any product that has remained in the container or the visual appearance of which has changed (e.g. if cloudiness, discolored or precipitation is observed) has to be discarded.
The contents of the vial is for single use only.
Storage
Store in dry place, below 25°C, protect 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
Powd for inj (vial) 40 mg x 1's.
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