Editin-R 50 mg/2 ml (IM/IV Injection)
Medicine Details
| Category | Details |
|---|---|
| Generic | Ranitidine hydrochloride |
| Company | Edruc limited |
| Also available as |
Indications
- Treatment of active duodenal ulcer
- Benign gastric ulcer
- Treatment & prevention of ulcer associated with non-steroidal anti-inflammatory agent
- Post operative stress ulcer
- Zollinger-Ellison Syndrome
- Gastroesophageal reflux disease (GERD)
Pharmacology
Ranitidine competitively blocks histamine at H2-receptors of the gastric parietal cells which inhibits gastric acid secretion.
Dosage & Administration
- Ranitidine Tablet & Syrup:
- Usual dosage: 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 dosage: 150 mg twice daily or 300 mg at bed time for up to 8 weeks
- Zollinger Ellison syndrome dosage: 150 mg 3 times daily and increased if necessary up to 6 g daily in divided doses
- Episodic dyspepsia dosage: 150 mg twice daily or 300 mg at bed time for up to 6 weeks
- Maintenance dosage: 150 mg at night for preventing recurrences
- Child (peptic ulcer) dosage: 2-4 mg/kg twice daily, maximum 300 mg daily
- Ranitidine IV injection & IV Infusion:
- Different modes of administration and dosages for prophylaxis of haemorrhage from stress ulceration, recurrent haemorrhage, and when patient is at risk of developing aspiration syndrome
- Recommended oral dose for the treatment of peptic ulcer in children: 2 mg/kg to 4 mg/kg twice daily to a maximum of 300 mg ranitidine per day; Safety and effectiveness of Ranitidine injection have not been established in case of children
Interaction
Delayed absorption and increased peak serum concentration with propantheline bromide. Editin-R minimally inhibits hepatic metabolism of coumarin anticoagulants, theophylline, diazepam and propanolol.
Contraindications
Patients hypersensitive to Ranitidine
Side Effects
- Altered bowel habit
- Dizziness
- Rash
- Tiredness
- Reversible confusional states
- Headache
- Decreased blood counts
- Muscle or joint pain
Pregnancy & Lactation
- Pregnancy: Ranitidine crosses the placenta, but there is no evidence of impaired fertility or harm to the fetus due to Ranitidine. Like other drugs, Ranitidine should only be used during pregnancy if considered essential.
- Lactation: Ranitidine is excreted in human breast milk. Caution should be exercised when the drug is administered to a nursing mother.
Precautions & Warnings
Editin-R should be given in reduced dosage to patients with impaired renal and hepatic function.
Use in Special Populations
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.
Overdose Effects
Editin-R 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 haemodialysis.
Therapeutic Class
H2 receptor antagonist
Reconstitution
- Slow IV inj: Different dilutions of Editin-R for slow IV injection and infusion
- Intermittent slow IV infusion: Editin-R 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: Editin-R 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: Editin-R should be diluted to a concentration ≤2.5 mg/mL with dextrose 5% or NaCl 0.9%, lactated Ringer's, Na bicarbonate 5% soln.
Storage Conditions
Store in a cool and dry place. Protect from light.