Pantex 40mg

Tablet
Pantoprazole
ACI Pharmaceuticals

Other Strength:
- Pantex 20mg

Alternative:
- Pantobex 40mg
- PROTOCID 40mg
- Pregel 40mg
- Nixpan 40mg
- Pantogut 40mg
- Pantodac 40mg
- Prilosec 40mg
- Pantopra 40mg
- Proton-P 40mg
- Pantotop 40mg
- Trupan 40mg
- Protonil 40mg



Pantex
Description
Pantex®is a preparation of Pantoprazole. It is a substituted benzimidazole derivative thatsuppressesthe proton pump, final step of gastric acid secretion, by forming a covalent bondto two sites of H+-K+ ATPase enzyme. This leads to inhibition of both basal and stimulatedgastric acid secretion irrespective to the stimulus. The binding of Pantex®to theH+-K+ATPase results antisecretory effect which persist longer than 24 hours.

Indications
Pantex®is indicated in the following indications:
-Peptic ulcer diseases
-Gastro esophageal reflux diseases
-Treatment of ulcer resistant to H2
-receptor antagonist-Treatment of ulcer induced by NSAIDs
-Gastro intestinal bleeding from stress or acid peptic diseases
-Eradication of Helicobacter pylori (in combination with antibiotics)
-Zollinger-Ellison syndrome
-Prophylaxis for acid aspiration syndrome during induction of anesthesia

Dose and Administration
The usual recommended adult dose of Pantex®enteric coated tablet is 40mg given once daily,Preferably in the morning with or without food. The duration of therapy is ranging from 2-8weeks.

Duodenal ulcer: Pantex®40mg tablet once daily for 2-4 weeks.

Gastric ulcer: Pantex®40mg tablet once daily for 4-8 weeks.

Reflux esophagitis: Pantex®40mg tablet for once daily for 4-8 weeks.

Resistance ulcer: Pantex®40mg tablet once daily for 8 weeks.

NSAIDs induced ulcer: Pantex®40mg tablet once daily, in patients of continuous treatmentwith NSAIDs.

GI bleeding form stress or acid peptic diseases: Usual adult oral dosage, if required thedosage may be increased.

Eradication of Helicobacter pylori : Triple therapy of Pantex®40mg tablet twice daily incombination with appropriate antibiotic for one week to achieve eradication rate of 90-100%

Zollinzer-Ellison syndrome: Four Pantex®40mg tablets per day. Once control of acidsecretion has been achieved, the dose should be gradually reduced to the lowest effectivedose that maintains acid control.

Prophylaxis of acid aspiration syndrome during induction of anaesthesia: one to twoPantex®40mg tablet should be given in the evening before surgery and repeated again the inmorning of surgery.

Maintenance therapy :
Maintenance treatment should be involved the lowest dose of the drug. Both 20 and 40mgdose of Pantex®are safe and effective in maintaining patients with healed refluxesophagitis and PUD in remission.

Use in Pregnancy and Lactation
No data are available on administration of Pantoprazole to pregnant women. However, thisdrug can be used during pregnancy only if clearly needed. There is no data on theexcretion of Pantoprazoleinto the breast milk.

Warning
Patients should be cautioned that Pantex®enteric coated tablet should not split, chewed orcrushed.

Side Effects
No potentially life threatening side-effects or serious adverse reactions has been reported.In some few cases headache, diarrhea, abdominal pain, nausea, dizziness, epigastricdiscomfort, flatulence, skin rash, pruritis have been reported.

Contraindications
Pantoprazole is contraindicated to those patients who have known hypersensitivity to anycomponent of theformulation.

Drug Interactions
Pantoprazole is metabolized through the Cytochrome P450 system, and subsequentlyundergoes phase II conjugation. Based on studies evaluating possible interactions ofPantoprazole with other drugs metabolized by the cytochrome P-450 system, no dosageadjustment is needed with concomitant use of the following drugs; theophylline,antipyrine, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glyburide, oralcontraceptive (levonorgestrel or ethynyl estradiol), metoprolol, nifedipine, phenytoin, orwarfarin. There was also no interaction with concomitantly administered antacids.

Pharmaceutical Precautions
Stored in a cool dry place, protect from light.

Presentation
Pantex®20 :Light yellow colored, round, enteric coated tablet. Each delayed releasetablet contains Pantoprazole 20 mg as Sodium Sesquihydrate INN.Pantex®40 : Green colored, round, enteric coated tablet. Each delayed release tabletcontains Pantoprazole 40 mg as Sodium Sesquihydrate INN.

Packaging Quantities
Pantex®20 : Carton of 50 tablets in Alu-Alu blister.
Pantex®40 : Carton of 30 tablets in Alu-Alu blister.

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