Omnadren jelfa – histamine receptors. It inhibits both basal and stimulated gastric secretion, reducing both its volume and the content of hydrochloric acid and pepsin in secret. Ranitidine has a relatively long duration of action, so that a single dose of 150 mg effectively suppresses gastric acid secretion for 12 hours. Elimination of the drug is primarily carried out by tubular secretion. The half-life is 2-3 hours.In patients with renal insufficiency, the half-life of ranitidine is extended by 2-3 times compared with patients with normal renal function. In patients with chronic renal failure receiving ranitidine 150 mg orally.
Indications Adults and adolescents aged 12 years and older:
- Gastric ulcer and duodenal ulcer. including those associated with the use of nonsteroidal anti-inflammatory drugs (NSAIDs).
- Prevention of duodenal ulcers caused by NSAIDs (including acetylsalicylic acid), especially in patients with a history of peptic ulcer disease.
- Duodenal ulcer associated with an infection of Helicobacter pylori.
- Postoperative ulcers (gastric ulcers, duodenal ulcers and anastomosis).
- Reflux esophagitis.
- Relief of symptoms of omnadren jelfa gastroesophageal reflux disease.
- Zollinger-Ellison Syndrome.
- Chronic episodic dyspepsia, characterized by epigastric or retrosternal pain, are associated with a meal break or a dream, but do not belong to the above conditions.
- Prevention of stress ulcers in critically ill patients.
- Prevention of recurrent bleeding from peptic ulcer.
- Prevention Mendelson’s syndrome.Contraindications:
Hypersensitivity to ranitidine or any other component of the formulation.
should be used with caution in patients with renal and hepatic insufficiency, acute porphyria (also in history), inhibition immunity.
Pregnancy and Lactation
Ranitidine crosses the placenta and is excreted in breast milk.
During pregnancy and lactation, ranitidine should be applied only in cases.
Where the potential omnadren jelfa benefit to the mother outweighs any possible risk to the fetus or child.
If used during lactation should stop breastfeeding feeding.
Dosing and Administration Adults and adolescents aged 12 years and older: Gastric ulcer and duodenal ulcer treatment relapse: The usual recommended dose is 150 mg twice daily or 300 mg once a day at night. In most cases of duodenal ulcers and benign gastric ulcer scar for 4 weeks. Unhealed for the ulcer duration usually heal on a background of continuing treatment for a further 4 weeks. In the treatment of duodenal ulcers more efficient reception Zantac 300 mg twice a day for 4 weeks than dosing regimens, 150 mg x 2 times a day, or 300 mg x 1 time per day at night. Prolonged prophylactic treatment: for the prevention of recurrence of duodenal ulcers and stomach standard recommended dose is 150 mg once a day night. Smoking is associated with higher rates of relapse of duodenal ulcers, therefore such patients should be advised to stop smoking. in patients who omnadren jelfa continue to smoke, the appointment of Zantac more effective at a dose of 300 mg once a day at night compared to the dosing schedule of 150 mg x 1 once a day at night. Peptic ulcers associated with nonsteroidal anti-inflammatory drugs (NSAID) treatment in acute: For the treatment of ulcers formed after or while taking NSAIDs. The recommended dose is 150 mg twice daily or 300 mg once a day at night for 8-12 weeks. Prevention of ulcers: recommended to prescribe ranitidine 150 mg twice daily in the treatment of NSAIDs for prevention of the formation of duodenal ulcers. Ulcers duodenal disease associated with infection of Helicobacter pylori recommended dose is 300 mg at night or 150 mg two times a day in combination with amoxicillin 750 mg three times daily and metronidazole 500 mg three times a day for 2 weeks. Zantac Treatment in that the dose should continue for the next two weeks. This regimen significantly reduces the frequency of relapse of duodenal ulcers. Postoperative ulcers (gastric ulcer, duodenal ulcer, anastomotic zone) standard recommended dose of 150 mg twice a day. Scarring usually occurs within 4 weeks. Unhealed for this term, ulcers in most cases heal on a background of continuing treatment for a further 4 weeks. Gastroesophageal Reflux Disease Treatment of acute reflux esophagitis: Recommended dose 150 mg twice daily or 300 mg once a day at bedtime for 8 weeks if necessary, treatment can be extended to 12 weeks. In moderate and severe reflux oesophagitis the dosage may be increased to 150 mg 4 times a day with the duration of treatment to 12 weeks. Preventive therapy for reflux esophagitis: The recommended dose of 150 mg twice daily. Relief of symptoms of gastroesophageal reflux disease: For pain associated with hit acidic stomach contents into the esophagus, the reception Zantac recommended dose of 150 mg twice a day for 2 weeks. In case of insufficient effectiveness of treatment may be resumed at the same dose over the next two weeks. Zollinger-Ellison Syndrome initial dose of 150 mg three times a day. The dose may be increased if necessary. Doses up to 6 g per day were well tolerated. Chronic episodic dyspepsia usual recommended dose of 150 mg twice a day for 6 weeks. If no effect or in the event of renewed dyspeptic symptoms shortly after the treatment necessary to conduct a patient examination. Prevention of bleeding from stress ulceration in seriously ill patients and preventing recurrent bleeding from peptic ulcers After the patient can eat, Zantac injectable dosage form may be replaced Zantac to receive inside a pill in a dose of 150 mg twice daily Prevention Mendelson’s syndrome recommended dose of 150 mg 2 hours before anesthesia; preferably also appoint 150 mg the previous evening. Instead, tablets can be applied in Zantac injectable dosage form. Women giving birth during delivery is recommended to prescribe Zantac 150 mg orally every 6 hours, but if they will require general anesthesia, before it should be simultaneously with Zantac to use water-soluble antacids (eg, sodium citrate) Application for violations of renal function Patients with severe renal impairment (creatine clearance and less than 50 ml / min), there is accumulation and increased plasma concentration Zantac. In such patients, the daily dose should be 150 mg.
These side effects are classified according to frequency of occurrence, which is defined as follows: very common> 1/10. . often> 1/100 and <1/10, sometimes> 1/1000 and <1/100, rare> 1/10000 and <1/1000, very rare <1/10000 Hematopoietic and lymphatic system: very rarely – changes in the blood count (leukopenia, thrombocytopenia). Agranulocytosis or pancytopenia, sometimes with hypoplasia or aplasia of the bone marrow. Acquired autoimmune hemolytic anemia. Since the cardiovascular system: very rarely – bradycardia and atrioventricular block, vasculitis, decreased blood pressure, arrhythmia, tachycardia, early ventricular premature beats. From a sight organ: very rarely – blurred vision, which may be associated with change of accommodation. From the gastrointestinal tract: Very rare – diarrhea, nausea, dry mouth, constipation, vomiting, abdominal pain. on the part of the liver, biliary tract and pancreas: rare transient changes in liver function tests. Very rarely – hepatitis (hepatocellular, cholestatic or mixed) with or without jaundice (usually reversible), in this case, ranitidine should be abolished. Liver failure. Very rare acute pancreatitis. On the part of the musculoskeletal system and connective tissue disorders: Very rare – arthralgia and myalgia. On the part of the central nervous system and psyche: Very rarely – reversible confusion, hallucinations and depression. These phenomena are mainly observed in critically ill patients and the elderly. Very rarely – headache (sometimes severe), dizziness, reversible involuntary movement, fatigue, drowsiness, insomnia, tinnitus, irritability, pyrexia, emotional lability, anxiety. On the part of the immune system: rarely – hypersensitivity reactions (urticaria, angioedema , fever, bronchospasm, reduction in blood pressure, chest pain). Very rarely – anaphylactic shock. On the side of the skin and subcutaneous fat: Rarely – skin rash. Very rarely – exudative erythema multiforme, including Stevens-Johnson syndrome. exfoliative dermatitis, toxic epidermal necrolysis, alopecia. On the part of the kidney and urinary tract: Very rare – acute interstitial nephritis. On the part of the endocrine and reproductive system: Very rare reversible impotence, disorders of the breast (such as gynaecomastia and galactorrhoea), hyperprolactinemia , amenorrhea, decreased libido.
Overdose Symptoms: There may be convulsions, bradycardia, ventricular arrhythmias, lowering blood pressure and gait disturbances. Treatment: Symptomatic therapy.
The interaction with other drugs.
Ranitidine may influence the absorption, metabolism or renal excretion of other drugs. Consequently, as may be necessary dosage adjustment or removal of the drug, which affects the pharmacokinetics of ranitidine. Interactions occur through several omnadren jelfa mechanisms:
1. The inhibitory effect on cytochrome-P 450 -oksigenaznuyu system.
Ranitidine increases the area under the curve, “concentration-time” (AUC) and the concentration of metoprolol in the blood serum (respectively 80 and 50%), the half-life (T1 / 2) metoprolol increased from 4.4 to 6.5 hours. Ranitidine inhibits the metabolism in the liver phenazone, aminophenazone, diazepam, hexobarbital, propranolol, metoprolol, nifedipine, diazepam, lidocaine, phenytoin, theophylline, aminophylline, glipizide, buformina, metronidazole blockers “slow” calcium channel. However, when used in recommended doses, ranitidine does not potentiate the effect of those drugs which are inactivated by the enzyme cytochrome P- 450 cases of changes in prothrombin time have been reported during treatment with coumarin anticoagulants (eg, warfarin). Considering the narrow therapeutic index, amid concurrent treatment with ranitidine is recommended careful monitoring of the prothrombin time.
2. Competitive renal tubular secretion:
Because ranitidine is partially derived cationic system, it may affect the clearance of drugs that are eliminated in the same way. The use of high doses of ranitidine (e.g., in the treatment of Zollinger-Ellison syndrome) may reduce the excretion of procainamide and its active metabolite (N-apetilprokainamida). which leads to increased concentrations of the drug and its metabolite in plasma.
3. Effect on gastric pH:
possible effects on the bioavailability of certain drugs, which may lead either to increased absorption (e.g., midazolam, triazolam glipizide..). or decreased absorption (such as ketoconazole. atazanavir. delavirdine. gefitinib).
Interaction ranitidine and amoxicillin and metronidazole were detected. With simultaneous application of high dosages (2 g) sucralfate with ranitidine absorption of the latter may be reduced. This effect does not occur if sucralfate reception carried out with 2:00 intervals.
Drugs that suppress the bone marrow to increase the risk of neutropenia.
ranitidine treatment can mask the symptoms of stomach cancer, so patients with gastric ulcer, patients of middle and old age with dyspeptic symptoms and changed recently symptomatic, should be before the start of treatment ranitidine exclude the presence of a malignant tumor. Ranitidine is excreted by the kidneys and therefore the concentration of drug in plasma increases with severe renal insufficiency. In this case, the dose should be adjusted according to the recommendations.
With increasing doses of intravenous blockers H 2 histamine receptors and treatment duration of 5 days may be observed increase in liver enzymes.
In rare cases, ranitidine promotes the development of an acute attack of porphyria, why his appointment should be avoided in patients with acute porphyria history. In a large epidemiological study it showed that some groups of patients (elderly patients, patients with chronic lung disease, diabetes, immunocompromised patients) taking blockers H 2 histamine receptors, the risk of community-acquired pneumonia is higher compared to patients Discontinue treatment ranitidine. Ranitidine is undesirable sharply cancel because of the risk of the syndrome of “rebound”. Ranitidine may cause false positive reaction in the test of protein in the urine.
Ranitidine counteracts the influence of pentagastrin and histamine on acid-stomach function, so for 24 hours prior to the study of gastric secretion, its use is not recommended.
Ranitidine suppresses skin reaction to histamine, so in to avoid false negative results prior to diagnostic skin tests to detect immediate allergic skin reaction such as the use of the drug is recommended to stop.
When concomitant NSAIDs and ranitidine is recommended regular medical surveillance, particularly with regard to elderly patients with peptic ulcer history.
Effects on ability to drive and moving mechanisms
In the period of treatment omnadren jelfa must be careful when driving and occupation of other potentially hazardous activities that require high concentration and psychomotor speed reactions.
Tablets, film-coated, 150 or 300 mg. 10 tablets in the A1 / A1 blister.
1 blister (tablets of 300 mg) or 2 blisters (tablets of 150 mg), together with instructions for use in a cardboard box.
Do not use after the expiration date printed on the package.
at temperatures below 30 ° C.
Keep out of reach of children.