Medicinal Ingredients:
Ranitidine hydrochloride 150mg
Non-Medicinal Ingredients:
Carnauba wax, colloidal silicon dioxide, croscarmellose sodium, hydroxypropyl methylcellulose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, titanium dioxide and vanillin.
Appearance:
Pink, shield shaped, biconvex film coated tablets. Engraved '150' on one side and 'APO' on the other side.
Tablet Size:
Diameter: 0.3300 x 0.3494 shield
Thickness: 0.118" - 0.140"
Packaging:
8's, 24's
Blister: Foil on foil blister.
Carton: Solid bleached stock cardboard 0.16".
Storage:
Store at room temperature (15 to 30°C). Protect from light.
Indications:
Ranitidine relieves and treats the burning and discomfort of heartburn, acid indigestion, upset and sour stomach, associated with excess acid providing fast and effective relief. Ranitidine tablets reduces and controls stomach acid for up to 12 hours, day or night.
Directions:
150 mg: Adults and children 16 years and older: One tablet should be taken when symptoms appear, day or night. If symptoms persist for more than 1 hour or return after 1 hour, a second tablet may be taken. The maximum dosage is 2 tablets (300 mg ranitidine) in a 24 hour period. For prevention of symptoms brought on by consuming food or beverages, 1 tablet should be taken 30 to 60 minutes before eating a meal or consuming beverages expected to cause symptoms.
Cautions:
If you are taking a prescription medicine for stomach ulcer, have difficulty swallowing or persistent abdominal discomfort, have kidney disease, or are pregnant or breast-feeding, consult your doctor before taking this product. Keep out of the reach of children.
Drug Interactions / Contraindications:
Contraindicated in patients known to have hypersensitivity to any of the component of the preparation. Ranitidine may mask symptoms associated with carcinoma of the stomach and, therefore, may delay diagnosis of that condition. Ranitidine may precipitate acute porphyritic attacks, therefore it should be avoided in patients with a history of acute porphyria. Ranitidine is excreted via kidneys and, in the presence of severe renal impairment, plasma levels of ranitidine are increased and elimination prolonged. Concurrent administration of antacids and ranitidine may decrease absorption of ranitidine; therefore, antacids should not be taken within 1/2 - 1 hour of ranitidine ingestion.
Simultaneous administration of ketokonazole and ranitidine may result in reduction of the absorption of ketoconazole. Ranitidine should not be taken for at least for 2 hours after ketoconazole. High doses of sucralfate (2 grams) may reduce absorption of ranitidine. It is recommended to take sucralfate 2 hours after ranitidine administration.
Toxicity/Adverse Reactions:
The most common adverse events include headache, nausea, vomiting and diarrhea. It can also cause dizziness, vertigo, hallucinations (predominantly in severely ill elderly patients), premature ventricular beats, bradycardia, atrioventricular block, transient and reversible changes of liver function tests, hepatitis with or without jaundice. Rare cases of agranulocytosis and pancytopenia, sometimes with marrow hypoplasia or aplasia, rash, small increase in serum creatinine, and acute pancreatitis have been reported. Hypersensitivity reactions can occur including bronchospasm, anaphylaxis, hypotension and angioneurotic edema.
Symptoms and Treatment of Overdose:
There is no experience to date with deliberate overdosage. The usual measures to remove unabsorbed drug from the gastrointestinal tract (including activated charcoal or syrup of ipecac), clinical monitoring and supportive therapy should be employed. Also, if need, the drug can be removed from the plasma by haemodialysis. Up to 6g per day has been administered without untoward effect.