P-GUT Tablet
Pantoprazole Sodium Sesquihydrate
40mg
THE MADRAS PHARMACEUTICALS
| Pack size | 100's |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 8.00 NPR |
Indications
P-GUT Tablet is used for:
Peptic ulcer disease, H. pylori infection, Gastro-oesophageal reflux disease, Zollinger-Ellison syndrome, Oesophagitis, Acid-related dyspepsia, NSAID-associated ulceration, ulcer resistant to H2 receptor antagonists, Gastrointestinal (GI) bleeding from stress, Prophylaxis for acid aspiration syndrome during induction of anaesthesia
Adult Dose
Erosive Esophagitis Associated With GERD
Treatment: 40 mg PO qDay for 8-16 weeks
Maintenance of healing: 40 mg PO qDay
Alternatively, 40 mg IV qDay for 7-10 days
Short-term Treatment of GERD
Oral therapy inappropriate or not possible: 40 mg IV infusion over 15 minutes qDay for 7-10 days; switch to PO once patient able to swallow
Zollinger-Ellison Syndrome
40 mg PO qDay; up to 240 mg/day administered in some patients
80 mg IV infusion q8-12hr up to 7 days; switch to PO once patient able to swallow
Peptic Ulcer Disease
Duodenal ulcer: 40 mg PO qDay for 2-4 weeks
Gastric ulcer: 40 mg PO qDay for 4-8 weeks
Elderly: No dosage adjustment needed.
Hepatic impairment: Max: 20 mg/day or 40 mg on alternate days.
Child Dose
Erosive Esophagitis Associated With GERD
<5 years: Safety and efficacy not established
>5 years
15 kg to <40 kg: 20 mg PO qDay for up to 8 weeks
40 kg or greater: 40 mg PO qDay for up to 8 weeks
Renal Dose
Renal impairment: No dosage adjustment needed.
Administration
Controlled-release: Should be taken on an empty stomach. Take 1 hr before meals. Swallow whole, do not chew/crush.
Normal release: May be taken with or without food.
IV Preparation
GERD with a history of erosive esophagitis
15-min infusion: Reconstitute with 10 mL NS, THEN further dilute with 100 mL D5W, NS, or LR to final concentration of 0.4 mg/mL
Zollinger-Ellison syndrome
15-min infusion: Reconstitute each vial with 10 mL NS, THEN
Combine 2 vials and further dilute with 80 mL D5W, NS, or LR to total volume of 100 mL (concentration 0.8 mg/mL)
2-min injection: Reconstitute with 10 mL NS to final concentration of 4 mg/mL
IV Administration
Infuse over 15 min no more than 3 mg/min (7 mL/min) for GERD and 6 mg/min (7 mL/min) for pathologic hypersecretory conditions
Contra Indications
Concomitant use w/ rilpivirine, atazanavir and nelfinavir. Lactation.
Precautions
Gastric malignancy should be ruled out. Consider Zn++ supplementation during IV therapy in patients who are prone to Zn++ deficiency. Pregnancy. Monitoring Parameters Monitor Mg levels prior to initiation and periodically during prolonged use.
Lactation: Not known whether pantoprazole is distributed into breast milk; not recommended
Pregnancy-Lactation
Interactions
Increased risk of digoxin-induced cardiotoxic effects. Increased risk of hypomagnesaemia w/ diuretics. May increase INR and prothrombin time of warfarin. May increase serum concentration of methotrexate and saquinavir. Delayed absorption and decreased bioavailability w/ sucralfate. Decreased absorption of ketoconazole, itraconazole.
Potentially Fatal: May decrease serum levels and pharmacological effects of rilpivirine, atazanavir and nelfinavir.
Adverse Effects
Side effects of Pantoprazole Sodium Sesquihydrate :
1-10%
Headache (>4%),Abdominal pain (4%),Facial edema (<4%),Generalized edema (<2%),Chest pain (4%),Diarrhea (4%),Constipation (<4%),Pruritus (4%),Rash (4%),Flatulence (<4%),Hyperglycemia (1%),Nausea (1%),Vomiting (>4%),Photosensitivity (<2%)
Frequency Not Defined
Angioedema,Atrophic gastritis,Anterior ischemic optic neuropathy,Hepatocellular damage leading to hepatic failure,Interstitial nephritis,Pancreatitis,Pancytopenia,Rhabdomyolysis,Risk of anaphylaxis,Stevens-Johnson syndrome,Fatal toxic epidermal necrolysis,Erythema multiforme
Mechanism of Action
Pantoprazole is a substituted benzimidazole, and also known as PPI due to its property to block the final step of acid secretion by inhibiting H+/K+ ATPase enzyme system in gastric parietal cell. Both basal and stimulated acid are inhibited.
Note
P-GUT 40mg Tablet manufactured by THE MADRAS PHARMACEUTICALS. Its generic name is Pantoprazole Sodium Sesquihydrate. P-GUT is availble in Nepal.
Farmaco Nepal drug index information on P-GUT Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.