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Ranitidine

Ranitidine

(lat.
ranitidine
) - an antiulcer drug, a blocker of histamine H2 receptors. Historically, it is the second (after cimetidine) antisecretory drug that suppresses acid production in the stomach. It is currently considered relatively old, has more side effects than modern drugs and is less effective than famotidine and proton pump inhibitors. In the fall of 2022, a number of drugs containing ranitidine were banned for use or approval for their use in clinical practice was temporarily suspended by regulators in many countries due to the presence or suspicion of the presence (the latter motivated by unsatisfactory testing of the drug for this ingredient) of potential carcinogen - N-nitrosodimethylamine.

The FDA, in its release dated April 1, 2022, required that all drugs containing ranitidine be removed from use and sale in US pharmacies due to the fact that when stored at temperatures above room temperature, drugs containing ranitidine may increase the amount of N-nitrosodimethylamine in some of them .

Ranitidine is a chemical compound

N-[2-[[5-(Dimethylaminomethyl)furfuryl]thio]ethyl]-N'-methyl-2-nitro-1,1-ethenediamine hydrochloride. Empirical formula: C13H22N4O3S.

Ranitidine is a drug

Ranitidine is the international nonproprietary name (INN) of the drug. According to the pharmacological index, it belongs to the group “II generation H2-histamine receptor blockers”. According to ATC, it belongs to the group “H2-histamine receptor blockers” and has the code A02BA02.

Pharmacodynamics of ranitidine

Ranitidine is a blocker of histamine H2 receptors on parietal cells of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid caused by irritation of baroreceptors, food load, the action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin). Ranitidine reduces the volume of gastric juice and the content of hydrochloric acid in it, reduces the acidity of the stomach, which leads to a decrease in pepsin activity. The duration of action of ranitidine after a single dose is up to 12 hours.

Pharmacokinetics of ranitidine

When taken orally, the bioavailability of ranitidine is 50%. Plasma protein binding does not exceed 15%. Partially metabolized in the liver. Maximum concentrations of ranitidine in plasma are achieved 2 hours after taking film-coated tablets, 1 hour after taking effervescent tablets and range from 36 to 94 ng/ml. The half-life is 2-3 hours. About 30% of the administered dose of ranitidine is excreted unchanged in the urine, and a small amount is excreted in the feces. Penetrates through the placenta. Excreted in breast milk.

Professional medical work covering the treatment of gastrointestinal diseases with ranitidine

Gorbakov V.V., Makarov Yu.S., Golochalova T.V. Comparative characteristics of antisecretory drugs of various groups according to daily pH monitoring // Attending physician. 2001. – No. 5–6.
Yakovenko E.P. Zantac in the treatment of acid-related diseases. RGMU, Federal Gastroenterological Center, Moscow.
Makhakova G.Ch., Dicheva D.T., Odintsova T.A. and others. Comparative characteristics of acid-suppressing drugs by conducting pharmacological tests with intragastric daily pH-metry // Attending physician. – 1999. – No. 6. – P. 24–26.

On the website gastroscan.ru in the literature catalog there is a section “H2-blockers”, containing articles devoted to the treatment of diseases of the gastrointestinal tract using H2-blockers of histamine receptors, including the use of ranitidine.

Indications for use of ranitidine

treatment and prevention of exacerbations of gastric and duodenal ulcers;
stomach and duodenal ulcers associated with taking NSAIDs;
reflux esophagitis, erosive esophagitis;
Zollinger-Ellison syndrome;
treatment and prevention of postoperative, “stress” stomach ulcers;
prevention of recurrent bleeding from the upper gastrointestinal tract;
prevention of aspiration of gastric juice during operations under anesthesia (Mendelssohn syndrome).

Method of administration of ranitidine and dose

Peptic ulcer of the stomach and duodenum. To treat exacerbations, ranitidine is prescribed 150 mg 2 times a day (morning and evening) or 300 mg at night. If necessary, 300 mg 2 times a day. The duration of treatment is 4-8 weeks. To prevent exacerbations, 150 mg is prescribed at night.
Ulcers associated with NSAIDs. Prescribe 150 mg of ranitidine 2 times a day or 300 mg at night for 8-12 weeks. Prevention of ulcer formation when taking NSAIDs - 150 mg 2 times a day.
Postoperative ulcers. Prescribe 150 mg of ranitidine 2 times a day for 4-8 weeks.
Gastroesophageal reflux disease. Prescribe 150 mg 2 times a day or 300 mg at night. If necessary, the dose can be increased to 150 mg 4 times a day. The course of treatment is 8-12 weeks.
Zollinger-Ellison syndrome. The initial dose is 150 mg ranitidine 3 times a day, the dose can be increased if necessary.
Prevention of recurrent bleeding. 150 mg 2 times a day.
Prevention of the development of Mendelssohn's syndrome. Ranitidine is prescribed at a dose of 150 mg 2 hours before anesthesia, and also, preferably 150 mg the night before.

Ranitidine is taken regardless of meals, without chewing, with a small amount of liquid.
Effervescent tablets are dissolved in a glass of water and drunk after complete dissolution.

For patients with renal failure with creatinine clearance less than 50 ml/min, the recommended dose is 150 mg of ranitidine per day.

Experience with the use of ranitidine in the treatment of functional heartburn

The updated American Gastroenterological Association functional heartburn guidelines (2020) present results from treating patients with functional heartburn with ranitidine 150 mg daily. It is noted that ranitidine has an analgesic effect by reducing the sensitivity of esophageal chemoreceptors to acid perfusion (Fass R., Zerbib F., Gyawali CP).

Precautions when using ranitidine

It is undesirable to abruptly stop taking ranitidine due to the risk of relapse of peptic ulcer disease.
Ranitidine should be used with caution in patients with impaired renal and hepatic function.
Before starting treatment with ranitidine, it is necessary to exclude the possibility of a malignant disease of the esophagus, stomach or duodenum.

Contraindications to the use of ranitidine

Hypersensitivity to ranitidine or other components of the drug. Pregnancy, lactation. Children's age up to 14 years.

Side effects of ranitidine

From the nervous system and sensory organs: headache, feeling of fatigue, dizziness, drowsiness, insomnia, vertigo, anxiety, depression; rarely - confusion, hallucinations (especially in elderly and weakened patients), reversible blurred vision, impaired accommodation of the eye.
From the cardiovascular system and blood (hematopoiesis, hemostasis): arrhythmia, tachycardia, bradycardia, AV block, decreased blood pressure; reversible leukopenia, thrombocytopenia, granulocytopenia; rarely - agranulocytosis, pancytopenia, sometimes with bone marrow hypoplasia, aplastic anemia; sometimes - immune hemolytic anemia.
From the gastrointestinal tract: nausea, vomiting, constipation, diarrhea, abdominal discomfort, pain; rarely - pancreatitis. Sometimes - hepatocellular, cholestatic or mixed hepatitis with/without jaundice (in such cases, ranitidine should be stopped immediately). These effects are usually reversible, but in rare cases they can be fatal. Rare cases of liver failure have also been reported. In healthy volunteers, AST concentrations were increased by at least 2-fold relative to pre-treatment levels in 6 of 12 people receiving 100 mg 4 times IV for 7 days and in 4 of 24 people receiving 50 mg 4 times IV for 5 days.
From the musculoskeletal system: rarely - arthralgia, myalgia.
Allergic reactions: skin rash, bronchospasm, fever, eosinophilia; rarely - erythema multiforme, anaphylactic shock, angioedema.

Ranitidine interactions

Antacids, sucralfate in high doses (2 g) slow down the absorption of ranitidine (when used simultaneously, the interval between taking antacids and ranitidine should be at least 1-2 hours).
Smoking reduces the effectiveness of ranitidine. Additional prolongation of PT has been reported when ranitidine was coadministered with warfarin; however, in human pharmacokinetic studies at a ranitidine dose of 400 mg/day, no interaction was observed; ranitidine had no effect on the clearance of warfarin and PT; the possibility of interaction with warfarin at doses above 400 mg per day has not been studied. When administered twice daily with ranitidine and triazolam, plasma concentrations of triazolam were higher than when administered with triazolam alone. Triazolam AUC values in people 18–60 years of age were 10 and 28% higher after administration of ranitidine 75 and 150 mg tablets than after administration of triazolam alone. In patients over 60 years of age, AUC values were approximately 30% higher after taking ranitidine 75 and 150 mg tablets. Ranitidine increases the AUC (by 80%) and concentration (by 50%) of metoprolol in the blood serum, while the half-life of metoprolol increases from 4.4 to 6.5 hours. Reduces the absorption of itraconazole and ketoconazole (ranitidine should be taken 2 hours after taking them). Inhibits the metabolism of phenazone, hexobarbital, glipizide, buformin, BCC. Compatible with 0.9% sodium chloride solution, 5% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 4.2% sodium bicarbonate solution. When taken simultaneously with drugs that depress bone marrow, the risk of developing neutropenia increases. Possible interaction with alcohol. When taken together with loperamide, serious heart problems are possible (FDA Notice dated 6.7.2916).

Ranitidine overdose

Symptoms: convulsions, bradycardia, ventricular arrhythmias.
Treatment: induction of vomiting or gastric lavage, symptomatic therapy. For convulsions - intravenous diazepam, for bradycardia - atropine, for ventricular arrhythmias - lidocaine.

Use of ranitidine during pregnancy and lactation

Ranitidine is contraindicated for use during lactation. FDA category of risk for the fetus when used throughout pregnancy is B (animal studies have not revealed a risk of adverse effects on the fetus; there have been no adequate studies in pregnant women).

general information

By Decree of the Government of the Russian Federation of December 30, 2009 No. 2135-r, ranitidine (solution for intravenous and intramuscular administration; solution for injection; film-coated tablets; film-coated tablets) is included in the List of vital and essential medicines.

Trade names of drugs containing the active ingredient ranitidine

Having or having been registered in Russia: Asitek, Acidex, Atsilok, Vero-Ranitidine, Gistak, Zantac, Zantin, Zoran, Raniberl 150, Ranigast, Ranisan, Ranison, Ranitidine, Ranitidine-LekT, Ranitidine Vramed, Ranitidine SEDICO, Ranitidine-AKOS, Ranitidine-Acri, Ranitidine-BMS, Ranitidine-ratiopharm, Ranitidine-Ferein, Ranitidine hydrochloride, Ranitidine film-coated tablets, Ranitin, Rantag, Rantak, Ranks, Ulkodin, Ulran, Yazitin from the following manufacturers: Akrikhin HFC, Russia;
Bryntsalov-A, Russia; Wave International, India; Vector, Russia; Vector-Farm, Russia; Vertex, Russia; J.R. Sharma Overseas, India; Health UKR, Ukraine; Irbit Chemical and Pharmaceutical Plant, Russia; Kanonpharma production, Russia; Krka, Slovenia; Moskhimfarm-preparations named after. ON THE. Semashko, Russia; Natur Product, France; Natur Product Europe B.V., the Netherlands; Ozon, Russia; Olainfarm, Latvia; Panacea Biotech, India; Northern Star, Russia; Serena Pharma/Shreya Life Sciences, India; HEMOPHARM CONCERN A.D., Yugoslavia. The Zantac brand of ranitidine is registered in the USA: prescription Zantac 150 USP, Zantac 300 USP, Zantac 25 EFFERdose, Zantac Syrup USP and over-the-counter Zantac 75, which has a reduced content of ranitidine - 75 mg and is approved for self-treatment of heartburn.

Instructions from manufacturers

Some instructions for the medical use of drugs with the only active ingredient - ranitidine (pdf):

For Russia:
"Ranitidine-Akri", film-coated tablets, 150 mg, JSC "Akrikhin",

for USA (in English):

"Zantac 150 (ranitidine hydrochloride) Tablets, USP. Zantac 300 (ranitidine hydrochloride) Tablets, USP. Zantac 25 (ranitidine hydrochloride effervescent) EFFERdose Tablets, USP. Zantac (ranitidine hydrochloride) Syrup, USP. Prescribing Information". GlaxoSmithKline, January 2011

Ranitidine has contraindications, side effects and application features; consultation with a specialist is necessary. Back to section