RANITIDINE TABLETS 150 mg

RANITIDINE TABLETS 300 mg

(RANITIDINE TABLETS B.P.)

Antiulcerative Tablets for Oral use.

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Composition
Each hard gelatin capsule contains:
Ranitidine Hydrochloride B.P. equv. to Ranitidine: 150 mg
Colour: Lake Sunset Yellow
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INDICATIONS:
Excessive secretion of stomach acid due to a tumour or enlargement of the pancreas (Zollinger Ellison syndrome)
Gastro-oesophageal reflux disease
Peptic ulcers
Prevention of bleeding from stomach or duodenal ulcers caused by stress in seriously ill people
Prophylaxis of peptic ulcers in people taking non-steroidal anti-inflammatory drugs (NSAIDs)
Prophylaxis of recurrent bleeding in people with bleeding peptic ulcers

DOSAGE & ADMINISTRATION:
Acute treatment: 300 mg taken as a single dose at bedtime, or 150 mg taken twice daily, in the morning and at bedtime.

Maintenance treatment - Duodenal ulcer- 150 mg taken at night.

Gastric ulcer: 150 mg taken at night for a period of one year.

Gastrinoma (Zollinger-Ellison syndrome):150 mg taken three times daily initially and increased, as necessary, to 600 to 900 mg/day.

Oesophagitis: 300 mg taken as a single dose at bedtime or 150 mg taken twice daily, in the morning and at bedtime.

It is not necessary to time the dose in relation to meals. In severe reflux oesophagitis the efficacy of 300 mg, taken as a single dose at bedtime, has been established for treatment periods of up to three months.

Or as directed by the Physician.

CONTRAINDICATIONS:
Hypersensitivity to Ranitidine or any of the ingredients.

WARNINGS & PRECAUTIONS:
Do not use:
• If allergic to ranitidine or other acid reducers
• If there is kidney disease, except under the advice and supervision of a doctor
Ask a doctor before use if you have:
• Heartburn over 3 months. This may be a sign of a more serious condition.
• Chest pain with shortness of breath; sweating; pain spreading to arms, neck or shoulders
• Frequent chest pain, frequent wheezing, particularly with heartburn

DRUG - INTERACTIONS:
Antacids:Concomitant administration decreases the absorption of ranitidine.Alcohol , Glipizide,Nifedipine,Theophylline or Warfarin.Ranitidine is a weak inhibitor of hepatic drug metabolism.Isolated cases of interactions have been reported between ranitidine and any of these medicines.

PREGNANCY AND LACTATION:
Ranitidine crosses the placenta but therapeutic doses administered to obstetric patients in labour or undergoing caesarean section have been without any adverse effect on labour, delivery or subsequent neonatal progress. It is excreted in human breast milk.
Like other drugs it should only be used during pregnancy and nursing if considered essential

UNDESIRABLE EFFECTS:
Inflammation of the liver (hepatitis), Hair loss (alopecia), Pain in the muscles and joints have been reported in small proportion of patients.

PHARMACOLOGICAL ACTION:
Ranitidine is a specific rapidly acting histamine H2-antagonist. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of the secretion. Ranitidine has a relatively long duration of action and so a single 150 mg dose effectively suppresses gastric acid secretion for twelve hours.

PHARMACOKINETICS:
Absorption of ranitidine after oral administration is rapid and peak plasma concentrations are usually achieved within two hours of administration. Absorption is not significantly impaired by food or antacids. The elimination half-life of ranitidine is approximately 2 hours. Ranitidine is excreted via the kidneys mainly as the free drug and in minor amounts as metabolites Its major metabolite is an N-oxide and there are smaller quantities of S-oxide and desmethyl ranitidine. The 24 hour urinary recovery of free ranitidine and its metabolites is about 40% with orally administered drug.

STORAGE INSTRUCTIONS:
Store below 25°C, keep in a dry place.

KEEP OUT OF REACH OF CHILDREN.

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Presentation

10 Strips of 10 Tablets each is packed in a Carton along with the insert literature


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