The information provided below corresponds to the official product information from Patient Information Leaflet provided by the manufacturer.
The text does not contain any of medical advices, mode of administration and prescription plans.
Before beginning any treatment, we kindly advise you to consult your healthcare provider.
Active ingredient: Ranitidine
Ranitidine is a second generation H2-histamine receptor blocker with a potent specific affinity to parietal cells of the stomach and possesses gastroselective action. The medication affects the main cause of heartburn and indigestion, normalizing the process of stomach acid production. Ranitidine is considered to be the gold standard in the treatment of gastric and duodenal ulcers (including stress ulcer, NSAID-gastropathy, Zollinger-Ellison syndrome). Ranitidine hcl comes in the form of oral tablets 150mg and 300mg made by Torrent Pharmaceuticals under the name Ranitin.
Ranitidine hcl is highly active histamine H2-receptor of second generation. It possesses a strong and specific affinity for parietal cells exerting gastroprotective action. The main therapeutic effect of ranitidine is based on reducing the overproduction of hydrochloric acid by the stomach. Ranitidine hcl oral inhibits both basal and stimulated by histamine, gastrin, pentagastrin and acetylcholine secretion of hydrochloric acid, decreases the volume of gastric juice and concentration of hydrogen ions. It also reduces the activity of pepsin. In addition, ranitidine hcl oral inhibits degranulation of mast cells, reduces the content of histamine in periacinar zone, and stimulates the process of ulcer healing by increasing the amount of DNA-synthesizing epithelial cells.
Ranitidine stimulates the tonicity of the lower esophageal sphincter. This can help prevent the reflux of acid and peptic stomach contents into the esophagus.
In patients with peptic ulcer, Ranitidine hcl significantly reduces excessive amount of stomach acidity and, especially, night acid secretion, thereby relieves pain and promoting rapid healing of ulcers.
Ranitidine does not affect the concentration of gastrin in serum, the secretion of intrinsic factor, pancreatic function and motility of the duodenum.
Ranitidine is 3-5 times more active than cimetidine and possesses prolonged action. After oral administration of ranitidine 150mg tabs therapeutic effect occurs after 30 minutes and lasts nearly 12 hours. Single evening dose of ranitidine 300 mg is sufficient to inhibit gastric acid secretion during the night and the next day.
Ranitidine is well absorbed into the blood circulation from the gastrointestinal tract. The bioavailability of ranitidine is 40-80%. The maximum plasma concentration is achieved in 1-3 hours after administration. Ranitidine binds to proteins by 15%. The half-life period of ranitidine ranges from 2 to 2.5 hours.
Ranitidine is metabolized in the liver and is excreted mainly with urine in unchanged form, and about 8% - in the form of metabolites. The remainder is excreted in feces. Ranitidine hcl oral may pass through the placenta and is excreted in breast milk.
Ranitidine 150mg, 300mg tablets are used to treat conditions associated with hyperproduction of stomach acid:
- Prevention and treatment of gastric and duodenal ulcers
- Symptomatic ulcers (stress ulcers, NSAID-gastropathy)
- Prevention of stress ulcers, postoperative ulceration, bleeding from the upper gastrointestinal tract
- Elimination of Helicobacter pylori in combination with proton pump inhibitors, antibiotic (amoxicillin, clarithromycin)
- Prior to general anesthesia to prevent aspiration of gastric contents into the lungs (Mendelson syndrome)
- Erosive and reflux esophagitis
- Functional (non-ulcer) dyspepsia
- Exacerbation of chronic gastritis with increased or normal acidity
Ranitidine comes in the form of tablets 150mg and ranitidine 300mg. Ranitidine dosage depends on patient's age, particular medical condition treated concomitant diseases. Ranitidine tablets are taken by mouth once till four times daily with or without food. Patients with decreased kidney function require decreasing the indicated dose.
Ranitidine 150mg tabs are contraindicated in the following conditions:
- History of allergic reactions to Ranitidine or other components of the medication or other H2-histamine receptor blockers
- Pregnancy (Ranitidine is a pregnancy category B)
- Severe liver diseases such as liver failure, cirrhosis
- Severe kidney diseases including renal failure
- Children under 14 years of age
- Acute porphyria
Ranitidine 150mg is characterized by high safety profile. Ranitidine is well tolerated and the frequency of side effects is low and comparable with the placebo.
- Cardiovascular system: arrhythmia (tachycardia, bradycardia, AV block, extrasystoles).
- Digestive system: rarely - diarrhea, constipation, nausea, vomiting, flatulence, dry mouth, and in rare cases - Hepatitis.
- CNS: headache, dizziness, fatigue, drowsiness, blurred vision confusion, hallucinations. Confusion and depression that may occur while taking cimetidine, especially in elderly patients, are extremely rare in the therapy with ranitidine.
- Hematopoietic system: rarely - thrombocytopenia, leukopenia.
- Metabolism: rarely - increased creatinine levels
- Endocrine system: increased prolactin blood levels, gynecomastia, amenorrhea, impotence, decreased libido.
- Musculoskeletal system: arthralgia, myalgia.
- Allergic reactions: skin rash, urticaria, angioedema, anaphylactic shock, bronchospasm, and hypotension.
- Other: recurrent parotitis, and in rare cases - loss of hair. If any of these Ranitidine side effects occur during the treatment, contact your health care provided.
Antacids and sucralfate may reduce the absorption of ranitidine 150mg. Ranitidine hcl oral minimally inhibits hepatic metabolism of coumarin derivatives, theophylline, diazepam, propranolol, glipizide, glyburide, metoprolol, midazolam, nifedipine. Ranitidine hcl oral may increase the effects of indirect anticoagulants.
Ranitidine may increase the concentration of phenytoin in the blood and increases the risk of ataxia.
Ranitidine hcl inhibits the metabolism of paracetamol (acetaminophen). Ranitidine increases the concentration of procainamide in plasma by decreasing its excretion by kidneys.
Smoking reduces the effectiveness of ranitidine. Ranitidine should not be combined with itraconazole, ketoconazole, atazanavir.
Ranitidine 150mg tablets should be stored at room temperature out of reach of children.
This info corresponds to official PIL provided by legal manufacturer and reviewed by: Dr. Rohit Bansali N.