Protopa Tablet
Pantoprazole Sodium Sesquihydrate
20mg
Apollo Pharmaceutical Laboratories Ltd.
| Pack size | 30's pack |
|---|---|
| Unite Price | 4.00 BDT |
Indications
Protopa 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
Risk Summary
Pantoprazole has been detected in breast milk of a nursing mother after a single 40 mg oral dose of pantoprazole. There were no effects on the breastfed infant. There are no data on pantoprazole effects on milk production.
The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for PROTONIX and any potential adverse effects on the breastfed child from pantoprazole or from the underlying maternal condition.
Pregnancy-Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women; advise pregnant women of the potential risk of fetal harm; drug should be used during pregnancy only if potential benefit justifies potential risk to fetus
Lactation
Pantoprazole and metabolites are excreted in milk of rats. Pantoprazole excretion in human milk has been detected in a study of a single nursing mother after a single 40 mg oral dose of pantoprazole sodium; clinical relevance of this finding not known; many drugs excreted in human milk have potential for serious adverse reactions in nursing infants; based on potential for tumorigenicity shown for pantoprazole sodium in rodent carcinogenicity studies, a decision should be made whether to discontinue nursing or to discontinue drug, taking into account benefit of drug to mother
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.
Side 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
Mode 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
Protopa 20mg Tablet generic name is Pantoprazole Sodium Sesquihydrate. Protopa 20mg Tablet is manufactured by Apollo Pharmaceutical Laboratories Ltd.Protopa is availble in all over Bangladesh.
Mes BD drug index information on Protopa Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.