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Blocker of histamine H2-receptors. Reduces basal and baroreceptor stimulated irritation, food load, the action of histamine, gastrin and other biogenic stimulants secretion of hydrochloric (hydrochloric) acid.
Reduces both the volume of the secretion and its content of hydrochloric (hydrochloric) acid and pepsin. Helps to increase the pH of the gastric contents, which leads to a decrease in pepsin activity. The duration of action of ranitidine after a single dose is 12 hours.
Helicobacter pylori is determined in approximately 95% of patients with duodenal ulcers and in 80% of patients with gastric ulcers. When combining ranitidine with amoxicillin and metronidazole, eradication of Helicobacter pylori is observed in about 90% of cases. Such combination of drugs significantly reduces the frequency of duodenal ulcer exacerbations.
When administered orally, the bioavailability of ranitidine is approximately 50%. After oral administration with a dose of 150 mg Cmax is reached after 2-3 hours and is 300-550 ng/ml.
After intravenous administration Cmax is reached within 15 min after administration and is 300-500 ng/ml.
Binding to plasma proteins does not exceed 15%. Ranitidine penetrates the placental barrier. It is excreted with breast milk (concentration in breast milk is higher than in plasma). It passes poorly through the BBB.
It is not extensively metabolized. Ranitidine metabolism is the same in parenteral and oral administration, with formation of small amounts of N-oxide (6%), S-oxide (2%), desmethylranitidine (2%) and furoic acid analogue (1-2%).
T1/2 is 2-3 h.
After 3H-ranitidine usage with a dose of 150 mg, 60-70% of the drug is excreted with the urine and 26% with the feces; moreover, 35% of the administered dose is excreted unchanged with the urine.
After intravenous administration of 3H-ranitidine in a dose of 150 mg, 93% of the drug is excreted with urine and 5% - in the feces; during the first 24 hours, 70% of the administered dose is excreted unchanged in the urine.
Pharmacokinetics in special clinical cases
Plasma concentration of ranitidine is increased in marked renal dysfunction.
Contraindications to use
- Acute porphyria (including anamnesis);
- Lactation period (breastfeeding);
- Children under 12 years of age;
- Hypersensitivity to ranitidine and other components of the drug.
Caution should be exercised when the drug is prescribed in renal and hepatic insufficiency, in cirrhosis with portosystemic encephalopathy in the anamnesis.
Administration during pregnancy and lactation
Ranitidine crosses the placenta and is excreted with the breast milk (the concentration in breast milk is higher than in plasma).
Administration of the drug during pregnancy is possible only when the expected benefits to the mother exceed the potential risk to the fetus.
If it is necessary to prescribe the drug during lactation, it is necessary to decide on stopping of breast feeding.
Administration in liver dysfunction
Caution should be exercised when using the drug in case of hepatic insufficiency, liver cirrhosis with portosystemic encephalopathy in anamnesis.
Administration in renal impairment
In patients with severe renal insufficiency (CKR less than 50 ml/min) there is cumulation and increased plasma concentration of ranitidine. The recommended dose is 150 mg once daily.
Patients on prolonged ambulatory peritoneal dialysis or on prolonged hemodialysis should take a dose of 150 mg immediately after the end of the dialysis session.
Administration in children
It is contraindicated in children younger than 12 years of age.
Administration in elderly patients
Elderly patients taking ranitidine in combination with NSAIDs should be monitored regularly.
Indications for the drug Zantac
- Duodenal ulcers and benign peptic ulcers, including those associated with NSAID use;
- Prevention of duodenal ulcers caused by NSAIDs (including acetylsalicylic acid), especially in patients with a history of peptic ulcer disease;
- duodenal ulcers associated with infection with Nelicobacter pylori;
- postoperative ulcers;
- gastroesophageal reflux disease;
- reflux esophagitis;
- Management of pain syndrome in gastroesophageal reflux disease;
- Zollinger-Ellison syndrome;
- Chronic episodic dyspepsia, characterized by epigastric or retrosternal pain associated with food intake or disturbed sleep, but not related to the above conditions;
- Prevention of stress ulcers of the stomach in critically ill patients;
- Prevention of recurrent bleeding from peptic ulcers;
- prevention of Mendelsohn syndrome (aspiration of acidic stomach contents during anesthesia).
Tablets and effervescent tablets
Oral administration in adults with acute duodenal ulcer and benign peptic ulcer is prescribed for 150 mg 2 times a day or 300 mg at night. In most cases duodenal ulcers and benign gastric ulcers heal within 4 weeks. Patients with ulcers which have not healed during this period usually heal with continuation of treatment for next 4 weeks. In treatment of duodenal ulcer the drug administration in dose of 300 mg 2 times per day is more effective than the doses of 150 mg 2 times per day or 300 mg 1 time at night. Increasing the dose does not increase the incidence of side effects.
In long-term prevention of recurrence of duodenal and gastric ulcers, 150 mg 1 time/day (at night) is prescribed. For smoking patients it is more preferable to increase the dose to 300 mg at night (because smoking is associated with a higher incidence of ulcer recurrence).
For treatment of NSAID-associated ulcers, 150 mg 2 times per day or 300 mg at night for 8-12 weeks, for prophylaxis - 150 mg 2 times per day during NSAID treatment.
For treatment of duodenal ulcers associated with Helicobacter pylori, it is prescribed 150 mg 2 times per day (morning and evening) or 300 mg 1 time per day (at night) in combination with amoxicillin in dose 750 mg 3 times per day and metronidazole 500 mg 3 times per day for 2 weeks. Treatment with Zantac should be continued for an additional 2 weeks. This regimen significantly reduces the frequency of recurrence of duodenal ulcers.
In postoperative ulcers it is prescribed 150 mg 2 times per day for 4 weeks. In patients with ulcers which have not healed during this period the healing usually occurs against the background of continuing treatment for the next 4 weeks.
In gastroesophageal reflux disease for treatment of acute reflux esophagitis 150 mg 2 times per day or 300 mg at night during 8 weeks; if necessary treatment course can be prolonged to 12 weeks. In moderate and severe course of reflux esophagitis the dose may be increased to 150 mg 4 times per day and the duration of treatment up to 12 weeks. In prophylactic therapy for reflux esophagitis, the recommended dose is 150 mg 2 times per day.
For pain syndrome relief in gastroesophageal reflux disease it is prescribed 150 mg 2 times per day for 2 weeks. In case of insufficient effectiveness, treatment may be continued in the same dose for the next 2 weeks.
In Zollinger-Ellison syndrome the initial dose is 150 mg 3 times/day, if necessary, the dose may be increased. Doses up to 6 g/day were well tolerated.
In chronic episodes of dyspepsia Zantac is prescribed 150 mg 2 times/day for 6 weeks. In case of absence of positive effect of treatment, as well as in case of deterioration of the condition against the background of treatment, a thorough examination should be carried out.
For prevention of bleeding from stress ulcers in severely ill patients, as well as for prevention of recurrent bleeding from peptic ulcers after the patient is able to eat by mouth, parenteral use of Zantac can be replaced by oral administration of the drug at a dose of 150 mg 2 times / day.
To prevent the development of Mendelsohn syndrome, Zantac is administered in a dose of 150 mg 2 hours before anesthesia, and preferably 150 mg the night before. Parenteral administration of Zantac is possible.
To prevent Mendelsohn syndrome, women in labor are prescribed 150 mg every 6 hours, but if general anesthesia is required, water-soluble antacids (such as sodium citrate) should be used simultaneously with Zantac before it.
In children for treatment of peptic ulcer, a dose of 2-4 mg/kg 2 times/day is recommended; the maximum daily dose is 300 mg.
In patients with severe renal impairment (CKR less than 50 ml/min) there is cumulation and increased plasma concentration of ranitidine. The recommended dose is 150 mg once daily.
Patients on prolonged ambulatory peritoneal dialysis or on prolonged hemodialysis are prescribed the drug in a dose of 150 mg immediately after the end of the dialysis session.