Pantopump

1 gastro-resistant caplet contains: Pantoprazole sodium sesquihydrate equivalent to 40 mg Pantoprazole.

Pharmacology: 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 basal and stimulated acid secretion. As with other proton pump inhibitors and H₂ 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 simulation by other substance (acetylcholine, histamine, gastrin). The effect is the same whether the product is given orally or intravenously.

EC caplet: In combination with two appropriate antibiotics (see Dosage & Administration) for the eradication of Helicobacter pylori in patients with peptic ulcers with the objective of reducing the recurrence of duodenal and gastric ulcers caused by this microorganism.
Duodenal ulcer.
Gastric ulcer.
Moderate and severe reflux esophagitis.
Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions.
Powd for inj: Duodenal & gastric ulcer, moderate and severe cases of inflammation of the esophagus (reflux esophagitis), Zollinger-Ellison syndrome where oral therapy is impossible.

EC caplet: PANTOPUMP 40 mg caplets should not be chewed or crushed, and should be swallowed whole with water 1 hour before breakfast. In combination therapy for eradication of Helicobacter pylori infection, the second PANTOPUMP 40 mg caplet should be taken before the evening meal. The combination therapy is implemented for 7 days in general and can be prolonged to up to two weeks maximum. If to ensure healing of the ulcers, further treatment with Pantoprazole is indicated, the dosage recommendations for duodenal and gastric ulcers should be considered.
A duodenal ulcers generally heals within 2 weeks. If a 2-week period of treatment is not sufficient, healing will be achieved in almost all cases within a further 2 weeks.
A 4-week period is usually required for the treatment of gastric ulcers and reflux esophagitis. If this is not sufficient, healing will usually be achieved within a further 4 weeks.
Recommended dosage: In Helicobacter pylori positive patients with gastric and duodenal ulcers, eradication of the germ by a combination therapy should be achieved. Depending upon the resistance pattern, the following combinations can be recommended for the eradication of Helicobacter pylori.
a. 2 x 1 PANTOPUMP 40 mg gastro-resistant caplet/day
+ 2 x 1000 mg amoxycillin/day
+ 2 x 500 mg clarithromycin/day.
b. 2 x 1 PANTOPUMP 40 mg gastro-resistant caplet/day
+ 2 x 500 mg metronidazole/day
+ 2 x 500 mg clarithromycin/day.
c. 2 x 1 PANTOPUMP 40 mg gastro-resistant caplet/day
+ 2 x 1000 mg amoxycillin/day
+ 2 x 500 mg metronidazole/day.
If combination therapy is not an option, e.g. if the patient has tested negative for Helicobacter pylori, the following dosage guidelines apply for PANTOPUMP 40 mg monotherapy: For the treatment of gastric and duodenal ulcer and reflux esophagitis: One caplet of PANTOPUMP 40 mg gastro-resistant caplet per day.
In individual cases the dose may be doubled (increase to 2 PANTOPUMP 40 mg gastro-resistant caplets daily) especially when there has been no response to other treatment.
For the long-term management of Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions: Patients should start their treatment with a daily dose of 80 mg (2 caplets of PANTOPUMP 40 mg). 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.
Treatment duration in Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions is not limited and should be adapted according to clinical needs.
In patients with severe liver impairment the dose has to be reduced to 1 caplet (40 mg Pantoprazole) every other day.
Furthermore, in these patients the liver enzymes should be monitored during PANTOPUMP 40 mg therapy. In the case of a rise of the liver enzymes, PANTOPUMP 40 mg should be discontinued.
The daily dose of 40 mg Pantoprazole should not be exceeded in elderly patients or in patients with impaired renal function. An exception is combination therapy for eradication of Helicobacter pylori, where also elderly patients should receive the usual Pantoprazole dose (2 x 40 mg per day) during 1-week treatment.
In the case of a rise of the liver enzymes, PANTOPUMP 40 mg should be discontinued.
Powd for inj: Gastric and duodenal ulcers, reflux esophagitis: 40 mg intravenously daily.
Zollinger-Ellison syndrome and other pathological hypersecretory conditions: Initially 80 mg intravenously. May be titrated up or down as needed. Doses more than 80 mg should be given twice daily.

EC caplet: There are no known symptomps of overdosage in man.
In the case of over dosage with clinical signs of intoxication, the usual rules of intoxication apply. If you taken too little PANTOPUMP 40 mg or have forgotten to take it do not take the dose late, but continue with the next regular dose on your dosing schedule.
Talk to the doctor the patient wants to interrupt or prematurely discontinue treatment with PANTOPUMP 40 mg.

PANTOPUMP 40 mg should generally not be used in cases of known hypersensitivity to one of the constituents of Pantoprazole 40 mg or of the combination partner.
PANTOPUMP 40 mg must not be used in combination treatment for eradication of Helicobacter pylori in patients with moderate to severe hepatic or renal dysfunction since currently no data are available on the efficacy and safety of PANTOPUMP 40 mg in combination treatment of these patients.

Pantoprazole is not indicated for mild gastrointestinal complaints, such as nervous dyspepsia. In the case of combination therapy, the summaries of product characteristics of the respective drugs should be observed. 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 ulcers and can thus delay diagnosis. Diagnosis of reflux esophagitis should be confirmed by endoscopy.
EC caplet: To date there has been no experience with treatment in children.
In patient with Zollinger-Ellison-Syndrome and other pathological hypersecretory conditions requiring long-term treatment, Pantoprazole, as all acid-blocking medicines, may reduce the absorption of vitamin B12 (cyanocobalamin) due to hypo- or achlorhydria. This should be considered if respective clinical symptoms are observed.
Powd for inj: Impaired renal function and severe liver impairment (reduce daily dose to 20 mg). Monitor liver enzymes during therapy.
Effect on the ability to drive and to use machines: There are no known effects on the ability to drive and use of machines.
Use in Pregnancy and 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 caplets should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/baby.

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 caplets should only be used when the benefit to the mother is considered greater than the potential risk to the foetus/baby.

Blood and lymphatic system: Rare: agranulocytosis.
Very rare: leukopenia, thrombocytopenia, pancytopenia.
Gastrointestinal disorders: Uncommon: nausea/vomiting, diarrhoea, constipation, dry mouth, abdominal pain, flatulence.
General disorders and administration site conditions: Rare: body temperature increased, oedema peripheral.
Hepatobiliary disorders: Uncommon: liver enzymes increases (transamines, γ-GT).
Not known: hepatocellular injury, jaundice, hepatocellular failure.
Immune system disorders: Rare: hypersensitivity (including anaphylactic reaction and anaphylactic shock).
Musculoskeletal connective tissue disorders: Rare: arthralgia, myalgia.
Nervous system disorders: Uncommon: headache, dizziness.
Rare: Taste disorder.
Psychiatric disorders: Rare: depression (and all aggravations).
Renal and urinary disorders: Not known: interstitial nephritis.
EC caplet: Skin and subcutaneous tissue disorders: Uncommon: allergic reactions such as pruritus and skin rash.
Rare: urticaria, angioedema.
Not known: Stevens-Johnson syndrome, Lyell syndrome, erythema multiforme, photosensitivity.
Metabolism and nutrition disorders: Rare: elevated triglycerides, hypomagnesaemia.
Unknown: Hypomagnesaemia.
Eye disorders: Rare: distrubances in visions/blurred vision.
Reproductive system and breast disorders: Rare: gynaecomastia.
Powd for inj: Upper abdominal pain, diarrhea, constipation, flatulence, headache.

PANTOPUMP 40 mg may reduce the absorption of drugs whose bioavailability is pH-dependent (e.g. Ketoconazole).
Pantoprazole is metabolized in the liver via the cytochrome P450 enzyme system. An interaction with other drugs or compounds which are metabolized using the same enzyme system cannot be excluded. No clinically significant interactions 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, and an oral contraceptive.
Although no interaction during concomitant administration of Phenprocoumon or Warfarin has been observed in clinical pharmacokinetic studies, a few isolated cases of changes in INR have been reported during concomitant treatment in the post-marketing period. 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.
Human kinetic interaction studies have been performed administering Pantoprazole concomitantly with the respective antibiotics (Chlarithromycin, Metronidazole, Amoxicyllin). No clinically interactions were found.

Store below 30°C.
Protect from light.

Antacids, Antireflux Agents & Antiulcerants

A02BC02 - pantoprazole ; Belongs to the class of proton pump inhibitors. Used in the treatment of peptic ulcer and gastro-oesophageal reflux disease (GERD).

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