Indications of Denitine 150 mg
Denitine 150 mg is indicated in:
Treatment of active duodenal ulcer
Benign gastric ulcer
Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
Post operative stress ulcer.
Gastroesophageal reflux disease (GERD).
Gastro-intestinal haemorrhage from stress ulcer in seriously ill patient.
Recurrent haemorrhage in patients with bleeding peptic ulcer.
Before general anesthesia in patient considered to be at risk of acid aspiration particulary obstetric patients.
H2 receptor antagonist
Denitine 150 mg competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion. It does not affect pepsin secretion, pentagastrin-stimulated intrinsic factor secretion or serum gastrin.
Dosage & Administration of Denitine 150 mg
Denitine 150 mg Tablet & Syrup:
Duodenal and gastric ulcer: The usual dosage is 150 mg twice daily taken in the morning and evening or 300 mg as a single daily dose at night for 4 to 8 weeks.Reflux oesophagitis: 150 mg twice daily or 300 mg at bed time for up to 8 weeks.Zollinger Ellison syndrome: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses. Dosage should be continued as long as clinically indicated.Episodic dyspepsia: 150 mg twice daily or 300 mg at bed time for up to 6 weeks.Maintenance: 150 mg at night for preventing recurrences.Child (peptic ulcer): 2-4 mg/kg twice daily, maximum 300 mg daily.
Denitine 150 mg IV injection & IV Infusion:
Denitine 150 mg injection may be given either as a slow (over a period of at least two minutes) intravenous injection of 50 mg, after dilution to a volume of 20 ml per 50 mg dose, which may be repeated every six to eight hours; or as an intermittent intravenous infusion at a rate of 25 mg per hour for two hours; the infusion may be repeated at six to eight hour intervals; or as an intramuscular injection of 50 mg (2 ml) every six to eight hours. In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, parenteral administration may be continued until oral feeding commences.In the prophylaxis of upper gastrointestinal haemorrhage from stress ulceration in seriously ill patient sapriming dose of 50 mg as low as intravenous injection followed by a continuous intravenous infusion of 0.125-0.250 mg/kg/hour may be preferred. In patients considered to be at risk of developing aspiration syndrome Denitine 150 mg injection 50 mg may be given intramuscularly or by slow intravenous injection 45 to 60 minutes before induction of general anaesthesia.Children: The recommended oral dose for the treatment of peptic ulcer in children is 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg Denitine 150 mg per day. Safety and effectiveness of Denitine 150 mg injection have not been established in case of children.
Interaction of Denitine 150 mg
Delayed absorption and increased peak serum concentration with propantheline bromide. Denitine 150 mg minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol. May alter absorption of pH-dependent drugs (e.g. ketoconazole, midazolam, glipizide). May reduce bioavailability with antacids.
Patients hypersensitive to Denitine 150 mg
Side Effects of Denitine 150 mg
Denitine 150 mg is well tolerated and side effects are usually uncommon. Altered bowel habit, dizziness, rash, tiredness, reversible confusional states, headache, decreased blood counts, muscle or joint pain have rarely been reported.
Pregnancy & Lactation
Pregnancy: Denitine 150 mg crosses the placenta. But there is no evidence of impaired fertility or harm to the foetus due to Denitine 150 mg. Like other drugs, Denitine 150 mg should only be used during pregnancy if considered essential.Lactation: Denitine 150 mg is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Precautions & Warnings
Denitine 150 mg should be given in reduced dosage to patients with impaired renal and hepatic function.
Overdose Effects of Denitine 150 mg
Denitine 150 mg is very specific in action and accordingly no particular problems are expected following overdosage with the drug. Symptomatic and supportive therapy should be given as appropriate. If required, the drug may be removed from the plasma by haemodiaiysis.
Store in a cool and dry place. protect from light.
Use In Special Populations
Use in elderly patients: In clinical trial the ulcer healing rates have been found similar in patients age 65 and over with those in younger patients. Additionally, there was no difference in the incidence of adverse effects.
Slow IV inj: Denitine 150 mg 50 mg diluted to a concentration ≤2.5 mg/mL (e.g. total of 20 mL) with NaCl 0.9% inj or dextrose 5% or 10%, lactated Ringer's, Na bicarbonate 5% soln. Intermittent slow IV infusion: Denitine 150 mg 50 mg diluted to a concentration ≤0.5 mg/mL (e.g. total of 100 mL) of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln. Continuous IV infusion: Denitine 150 mg 150 mg diluted in 250 mL of dextrose 5% inj or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln. Patients with Zollinger-Ellison syndrome or other hypersecretory conditions: Denitine 150 mg should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.