Mfd. By
P.O. Box : 4265 Sana’a /Yemen.
Council of Arab Health Ministers
Union of Arab Pharmacists
- Medicament is a product which affects your health, and its consumption contrary to instructions is dangerous for you.
- Follow strictly the doctor’s prescription, the method of use and the instructions of the pharmacist who sold the medicament.
- The doctor and the pharmacist are experts in medicine, its benefits and risks.
- Do not by yourself interrupt the period of treatment prescribed for you.
- Do not repeat the same prescription without consulting your doctor.
Keep medicament out of reach of children
012-06-110 6/16
INSTRUCTIONS TO THE PATIENT
COMPOSITION :
Each f/c tablet contains : Ranitidine HCl equivalent to ranitidine 150 mg.
DESCRIPTION :
Ranisan (Ranitidine) is a specific rapidly acting histamine H2 - antagonist . It inhibits stimulated secretion of gastric acid, reducing both the
volume and the acid content of the secretion and pepsin after eating or during sleeping . After oral administration of 150 mg ranitidine ,
maximum plasma concentration reaches to 300 - 550 ng/ ml occur after 1 - 3 hours . The absolute bioavailability of ranitidine is 50 - 60 %
and is bound (15%) to plasma proteins. The major route of elimination is renal and half - life of 2 -3 hours.
INDICATIONS :
- Duodenal ulcer, benign gastric ulcer and post - operative ulcer.
- Prophylaxis of non steroidal anti-inflammatory drug associated duodenal ulcer.
- Treatment of duodenal ulcer associated with Helicobacter pylori infection.
- Gastro-oesophageal reflux disease .
- Zollinger - Ellison syndrome .
- Prophylaxis of gastrointestinal haemorrhage from stress ulceration and prophylaxis of recurrent haemorrhage in patient with bleeding
ulcers.
- Prophylaxis of acid aspiration during surgery (Mendlson’s syndrome).
- Chronic dyspepsia , characterised by epigastric pain which is related to meals .
DOSAGE & ADMINISTRATION :
- Duodenal ulcer and benign, gastric ulcer : 150 mg twice daily or 300 mg at night for 6 weeks.
- Prevention of NSAID associated duodenal ulcer : 150 mg twice daily may be given concomitantly with NSAID .
- Duodenal ulcers associated with Helicobacter pylori infection : 300 mg at bed time or 150mg twice daily may be given with oral
amoxicillin 750 mg three times daily and metronidazole 500 mg three times daily for two weeks.
- Gastro - oesophageal reflux disease : 150 mg twice daily for 6 - 8 weeks .
- Zollinger - Ellison syndrome : The starting dose is 150 mg three times daily can be increased up to 6 gm daily.
- Prophylaxis of haemorrhage : 150 mg twice daily.
- Prophylaxis of acid aspiration : 150 mg oral dose can be given 2 hours before anaesthesia.
- Chronic dyspepsia : 150 mg twice daily for up to 6 weeks.
- Renal impairment (creatinine clearance < 50 ml / min.) : The recommended daily dose is 150 mg at night for 4 - 8 weeks.
- Peptic ulcer in children : 2mg /kg - 4mg /kg twice daily up to maximum 300mg daily.
RESTRICTIONS ON USE :
Contraindications
Hypersensitivity to any component of the product.
Precautions
- Gastric malignancy must be excluded before treatment with ranitidine in patients with grastric ulcer because Ranitidine
may mask symptoms of gastric carcinoma.
- Caution should be taken in elderly patients, patients with chronic lung diseases, diabetes or the immunocompromised, because there may
be an increased risk of developing community acquired pneumonia.
Use in pregnancy and lactation
Ranisan should only be used during pregnancy and nursing if necessary.
DRUG INTERACTIONS :
- At usual therapeutic doses of Ranitidine don’t inhibit cytochrome P450 which inactivate drugs such as diazepam , lidocaine , phenytoin ,
propanolol and theophylline.
- Concurrent administration of ranitidine with coumarine anticoagulants ( e.g. warafarin ) altered prothrombin time.
- Administration of high doses of ranitidine increases plasma level of procainamide .
- Administration of ranitidine with midazolam , glipizide and triazolam lead to increase in absorption of these drugs wherease decrease
absorption of ketoconazole and atazanavir.
ADVERSE EFFECTS :
Uncommon adverse effects : Abdominal pain , constipation , nausea.
Rare and very rare adverse effects : reversible leucopenia and thrombocytopenia , urticaria , fever , bronchospasm , hypotension ,
anaphylactic shock , reversible mental confusion, depression and hallucination , headache , dizziness and reversible involuntary movement
disorders , reversible blurred vision , bradycardia, acute pancreatitis, diarrhea , reversible changes in liver function test , hepatitis , skin rash ,
erythema multiforme , alopecia , arthralgia , myalgia ,elevation of plasma creatinine.
OVERDOSAGE :
The patient should be given symptomatic and supportive treatment.
STORAGE INSTRUCTIONS :
Store below 30°C, in a dry place, protect from light.
PRESENTATIONS :
Ranisan Strip 150 : Pack of 10 x 10 tablets and hospital packs of different sizes .