Pantex
Pantoprazole
Description
Pantex® is a preparation of Pantoprazole. It is a substituted benzimidazole derivative that
suppresses the proton pump, final step of gastric acid secretion, by forming a covalent bond
to two sites of H+-K+ ATPase enzyme. This leads to inhibition of both basal and stimulated
gastric acid secretion irrespective to the stimulus. The binding of Pantex® to the H+-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
treatment with NSAIDs.
GI bleeding form stress or acid peptic diseases: Usual adult oral dosage, if required
the dosage may be increased.
Eradication of Helicobacter pylori : Triple therapy of Pantex® 40mg tablet twice daily in
combination 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 acid
secretion has been achieved, the dose should be gradually reduced to the lowest effective
dose that maintains acid control.
Prophylaxis of acid aspiration syndrome during induction of anaesthesia: one to
two Pantex® 40mg tablet should be given in the evening before surgery and repeated again
the in morning of surgery.
Maintenance therapy :
Maintenance treatment should be involved the lowest dose of the drug. Both 20 and 40mg
dose of Pantex® are safe and effective in maintaining patients with healed reflux
esophagitis and PUD in remission.
Use in Pregnancy and Lactation
No data are available on administration of Pantoprazole to pregnant women. However, this
drug can be used during pregnancy only if clearly needed. There is no data on the
excretion of Pantoprazole into the breast milk.
Warning
Patients should be cautioned that Pantex® enteric coated tablet should not split, chewed or
crushed.
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, epigastric
discomfort, flatulence, skin rash, pruritis have been reported.
Contraindications
Pantoprazole is contraindicated to those patients who have known hypersensitivity to any
component of the formulation.
Drug Interactions
Pantoprazole is metabolized through the Cytochrome P450 system, and subsequently
undergoes phase II conjugation. Based on studies evaluating possible interactions of
Pantoprazole with other drugs metabolized by the cytochrome P-450 system, no dosage
adjustment is needed with concomitant use of the following drugs; theophylline,
antipyrine, caffeine, carbamazepine, diazepam, diclofenac, digoxin, ethanol, glyburide, oral
contraceptive (levonorgestrel or ethynyl estradiol), metoprolol, nifedipine, phenytoin, or
warfarin. 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 release
tablet contains Pantoprazole 20 mg as Sodium Sesquihydrate INN.
Pantex® 40 : Green colored, round, enteric coated tablet. Each delayed release tablet
contains 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.
® Registered Trade Mark
ACI Limited
Brand: ACI Limited.
