COMPOSITIONS :
Ranitidine HCl Injection 50 mg/2 ml, each ml contains : Ranitidine HCl equivalent to Ranitidine 25 mg.
DESCRIPTIONS :
Ranitidine HCl contains Ranitidine HCl (equivalent to Ranitidine) as active ingredient available in film coated tablet 150 mg and injection 50 mg/2 ml.
INDICATIONS :
For hospitalized patients with pathological hypersecretory conditions or intractable duodenal ulcers, or as an alternative to the oral dosage form for short-term use in patients who are unable to take Ranitidine oral.
DOSAGE AND ADMINISTRATIONS :
Ranitidine HCl Injection :
IM injection : 50 mg (undilution) every 6 – 8 hours.
IV injection : Intermittent.
- Intermittent bolus : 50 mg (2 ml) every 6 – 8 hours. Diluted 50 mg injection in NaCl 0.9% solution or other compatible IV injection solution until getting a concentration not more than 2.5 mg/ml (20 ml). The rate of injection is not more than 4 ml/minute (5 minutes).
- Intermittent infusion : 50 mg (2 ml) every 6 – 8 hours. Diluted 50 mg injection in Dextrose 5% injection solution or other compatible IV injection solution until getting a concentration not more than 0.5 mg/ml (100 ml). The rate of infusion not more than 5 – 7 ml/minute (15 to 20 minutes).
- Continuous IV infusion : Diluted 150 mg Ranitidine in 250 ml Dextrose 5% or other compatible IV solution and infusion with rate 6.25 mg/hour in 24 hours. For patients with Zollinger-Ellison syndrome or other hypersecretory, Ranitidine injection should be diluted with Dextrose 5% solution or other compatible IV solution until getting concentration not more than 2.5 mg/ml. The rate of infusion starting at 1.0 mg/kg body weight/hour and should be appropriated with patient conditions.
OVERDOSAGE :
Overdose symptoms have been reported, including : Acute gastrointestinal disorders, hypotension, abnormal gait.
Overdose treatments :
- Emesis induction or gastric lavage.
- For attack : By administering Diazepam IV injection.
- For bradycardia : By administering Atropine.
- For arrhythmias : By administering Lidocaine.
CONTRAINDICATION :
Patients known to have hypersensitivity to the drug.
WARNINGS AND PRECAUTIONS :
- Malignancy : The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer (and if indications include dyspepsia : Patients of middle age and over with new or recently changed dyspeptic symptoms) as treatment with Ranitidine may mask symptoms of gastric carcinoma.
- Renal disease : Ranitidine is excreted via the kidney and so plasma levels of the drug are increased in patients with severe renal impairment. Accordingly, it is recommended that the therapeutic regimen for Ranitidine in such patients be 150 mg at night for 4 to 8 weeks. The same dose should be used for maintenance treatment should this be deemed necessary. If an ulcer has not healed after treatment the standard dosage regimen of 150 mg twice daily should be instituted, followed, if need be, by maintenance treatment at 150 mg at night.
- Renal impairment : Regular supervision of patients who are taking non steroidal anti inflammatory drugs concomitantly with Ranitidine is recommended, especially in the elderly and in those with a history of peptic ulcer.
- Pregnancy and nursing : Ranitidine crosses the placenta but therapeutic dose administered to obstetric patients in labour on undergoing caesarean section have been without any adverse effect on labour, delivery or subsequent neonatal progress. Ranitidine is also excreted in human breast milk. Like other drugs, Ranitidine should only be used during pregnancy and nursing if considered essential.
- Clinical reports suggest that Ranitidine may precipitate acute porphyric attacks. Ranitidine should therefore be avoided in patients with a history of acute porphyria.
- Children : Not recommended for children under 8 years of age.
- Pediatric use : Safety and effectiveness in children have not been established.
DRUG INTERACTIONS :
- Ranitidine, at blood levels produced by standard recommended doses, does not inhibit the hepatic cytochrome P450-linked mixed function oxygenase system. Accordingly, Ranitidine in usual therapeutic doses does not potentiate the action of drugs which are inactivated by this enzyme; these include Diazepam, Lignocaine, Phenytoin, Propanolol, Theophylline and Warfarin.
- Concomitant administration with Warfarin may increase or decrease prothrombin time.
ADVERSE REACTIONS :
- Headache.
- Central nervous system, rarely occur : Malaise, dizziness, somnolence, insomnia, vertigo, agitation, depression, hallucinations.
- Cardiovascular, rarely reported : Arrhythmias such as tachycardia, bradycardia, atrioventricular block, premature ventricular beats.
- Gastrointestinal : Constipation, diarrhea, nausea, vomiting, abdominal pain, rarely reported : Pancreatitis.
- Musculoskeletal, rarely reported : Arthralgia and myalgia.
- Hematologic : Leucopenia, granulocytopenia, thrombocytopenia (in some patients). Rarely occur cases such as agranulocytopenia, pancytopenia, thrombocytopenia, aplastic anemia have been reported.
- Endocrine : Gynecomastia, impotence and lost of libido have been reported in male patients.
- Skin, rarely reported : Rash, erythema multiforme, alopecia.
- Others, rare cases of hypersensitivity (e.g., bronchospasm, fever, eosinophilia), anaphylaxis, edema angioneurotic, a slight increase in serum creatinine levels.
PRESENTATIONS :
Ranitidine HCl Injection 50 mg/2 ml Box, 100 ampoules @ 2 ml
Reg. No. GKL0602339143A1
STORAGE :
STORE BELOW 25ºC AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
