COMPOSITIONS :
Ranitidine HCl Film coated tablet 150 mg, each film coated tablet contains : Ranitidine HCl equivalent to Ranitidine 150 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 :
Ranitidine HCl Film coated tablet :
- Duodenal ulcer and benign gastric ulcer, including that associated with non-steroidal anti inflammatory drug (including Acetosal) associated duodenal ulcers, especially in patients with a history of peptic ulcer disease.
- The treatment of pathological hypersecretory conditions (e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
- Treatment of reflux oesophagitis.
- Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers.
- The treatment of chronic episodic dyspepsia, characteristized by pain (epigastric or retrosternal) which is related to meals or disturbs sleep but not associated with the above conditions.
- Post-operative ulcers.
- Prophylaxis of stress ulceration in seriously ill.
- Prophylaxis of recurrent haemorrhage from peptic ulcer.
- Prophylaxis of Mendelson’s syndrome.
DOSAGE AND ADMINISTRATIONS :
Ranitidine HCl Film coated tablet :
Adults :
- Duodenal ulcers or gastric ulcers and reflux oesophagitis : The standard dosage regimen is 150 mg twice daily or a single bedtime dose of 300 mg. It is not necessary to time the dose in relation to meals. In most cases of duodenal ulcer, benign gastric ulcer and postoperative ulcer, healing occurs in 4 weeks. Healing usually occurs after a further 4 weeks of treatment in those patients whose ulcers have not fully healed after the initial course of therapy. In ulcers following non-steroidal anti inflammatory drug therapy or associated with continued non-steroidal anti inflammatory drug, 8 – 12 weeks treatment with Ranitidine may be necessary.
- Prevention of non-steroidal anti-inflammatory drug associated duodenal ulcers : 150 mg twice daily may be given concomitantly with non-steroidal anti inflammatory drug therapy.
- Duodenal ulcer : 300 mg twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with Ranitidine 150 mg twice daily or 300 mg nocte.
The increased dose has not been associated with an increased incidence of unwanted effects. Maintenance treatment at a reduced dosage of 150 mg at bedtime is recommended for patients who have responded to short-term therapy, particularly those with a history of recurrent ulcer.
- Postoperative ulcer : 150 mg twice daily.
- Management of reflux oesophagitis : The recommended course of treatment is either 150 mg twice daily or 300 mg at bedtime for up to 8 weeks. In patients with moderate to severe oesophagitis, the dosage of Ranitidine may be increased to 150 mg 4 times daily for up to 12 weeks.
- Zollinger-Ellison syndrome : The starting dose is 150 mg 3 times daily and this may be increased as necessary. Patients with this syndrome have been given increasing doses up to 6 g a day and these doses have been well tolerated.
- Chronic episodic dyspepsia : The recommended course of treatment is one 150 mg tablet twice daily for up to 6 weeks. Anyone not responding or relapsing shortly afterwards should be investigated.
- Prophylaxis of haemorrhage : In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration, treatment with Ranitidine tablet 150 mg twice daily may be given once oral feeding commences in patients considered to be still at risk from these conditions.
- Risk of mendelson’s syndrome : 150 mg oral dose can be given 2 hours before induction of general anaesthesia and preferably also 150 mg tablet the previous evening. Alternatively, the injection is also available.
- Obstetric patients at commencement of labour : 150 mg oral dose may be given followed by 150 mg at 6 hourly intervals. It is recommended that since gastric emptying and drug absorption are delayed during labour, any patient requiring emergency general anaesthesia should be given, in addition, a non particulate antacid (e.g., Sodium citrate) prior to induction of anaesthesia. The usual precautions to avoid acid aspiration should also be taken.
Children :
The recommended oral dose for the treatment of peptic ulcer is 2 – 4 mg/kg twice daily to a maximum of 300 mg Ranitidine a day.
Renal impairment :
Accumulation of Ranitidine with resulting elevated plasma concentrations will occur in patients with severe renal impairment (creatinine clearance less than 50 ml/minute). It is recommended that the daily dose of Ranitidine in such patients should be 150 mg. In patients undergoing chronic ambulatory peritoneal dialysis or chronic haemodialysis, Ranitidine (150 mg) should be taken immediately after dialysis.
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 Film coated tablet 150 mg Box, 10 strips @ 10 film coated tablets
Reg. No. GKL0302334117A1
STORAGE :
STORE BELOW 25ºC AND DRY PLACE, PROTECT FROM LIGHT
ON MEDICAL PRESCRIPTION ONLY
Manufactured by :
BERNOFARM
Sidoarjo – Indonesia
