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Ranitidine

Ranitidine is an antagonist of H2-histamine receptors on parietal cells of the gastric mucosa and is used for various gastrointestinal pathologies, including ulcerative lesions of the gastric mucosa and duodenum. The drug inhibits basal (in the absence of any irritants) and stimulated, caused by exposure to any external factors, secretion of hydrochloric acid. The role of irritating factors that stimulate the release of HCl into the lumen of the stomach can be food intake, irritation of baroreceptors that perceive mechanical stretching of the gastric wall, the action of hormones and other biologically active substances (gastrin, pentagastrin, histamine). Ranitidine reduces the amount of gastric juice produced and the concentration of hydrochloric acid in it, reduces the acidity of the stomach, which entails the inactivation of the main proteolytic enzyme - pepsin, and inhibits the work of microsomal liver enzymes. The therapeutic effect of a single dose of ranitidine lasts for 12 hours.

Ranitidine can be taken at any time without regard to diet. The tablet is swallowed whole and washed down with a sufficient amount of water. In case of exacerbation of gastric ulcer and duodenal ulcer, incl. caused by taking NSAIDs, ranitidine is prescribed 150 mg in the morning and evening (the entire daily dose of the drug can be taken at one time before bedtime).

In severe cases, 300 mg twice a day can be taken. The duration of the therapeutic course is from 4 to 8 weeks. To prevent exacerbation of the disease, ranitidine is taken in an amount of 150 mg 1 time per day (for smokers, the dose is doubled because this human defect reduces the effectiveness of ranitidine).

A feature of ranitidine (as, in fact, other drugs of this pharmacological group) is the occurrence of withdrawal syndrome when the drug is abruptly stopped. This syndrome (also called rebound syndrome) leads to an exacerbation of all those symptoms of the disease that were previously suppressed by the drug. In this regard, the completion of the therapeutic course should be smooth.

The effectiveness of ranitidine can play a cruel joke on the patient in cases where the cause of dyspeptic disorders is much more serious. Therefore, before starting treatment, it is advisable to undergo examination by an oncologist to exclude the possibility of a malignant neoplasm in the stomach. Another important recommendation is a “taboo” while taking the drug on the consumption of food and drinks that can irritate the gastric mucosa.

Ranitidine solution for intravenous and intramuscular administration 25 mg/ml in 2 ml ampoules No. 10

Name

Ranitidine.

Release forms

Solution.

INN

Ranitidine.

FTG

H2-histamine receptor blocker.

Description

Transparent colorless or slightly yellowish liquid.

Compound

Each ampoule (2 ml of solution) contains: active ingredient: ranitidine (in the form of ranitidine hydrochloride) – 50 mg; excipients: sodium chloride, potassium dihydrogen phosphate, disodium phosphate dihydrate, water for injection.

Pharmacotherapeutic group

Drugs used to treat peptic ulcers and gastroesophageal reflux disease. Antagonist of H2-histamine receptors. ATX code - A02BA02.

Pharmacological properties

Pharmacodynamics II generation H2-histamine receptor blocker. The mechanism of action is associated with the blockade of H2-histamine receptors in the membranes of parietal cells of the gastric mucosa. Suppresses daytime and nighttime secretion of hydrochloric acid, as well as basal and stimulated, reduces the volume of gastric juice caused by gastric distension by food load, the action of hormones and biogenic stimulants (gastrin, histamine, acetylcholine, pentagastrin, caffeine). Reduces the amount of hydrochloric acid in gastric juice, practically without suppressing “liver” enzymes associated with cytochrome P450, and does not affect the concentration of gastrin in plasma or mucus production. Reduces pepsin activity. Does not affect the concentration of Ca2+ in the blood serum. A transient slight increase in the concentration of prolactin in the blood serum is possible after intravenous administration of ranitidine at a dose of 100 mg or more. It does not affect the release of pituitary hormones: gonadotropin, thyroid-stimulating hormone (TSH) and somatotropic hormone (STH). Does not affect the concentration of cortisol, aldosterone, androgens or estrogens, sperm motility, sperm quantity and composition, and does not have an antiandrogenic effect. May weaken the release of vasopressin. Strengthens the protective mechanisms of the gastric mucosa and promotes the healing of its damage associated with the effects of hydrochloric acid (including the cessation of gastrointestinal bleeding and scarring of stress ulcers), by increasing the formation of gastric mucus, the content of glycoproteins in it, and stimulating the secretion of bicarbonate by the mucous membrane stomach, endogenous synthesis of Pg in it and the rate of regeneration. Pharmacokinetics: Rapidly absorbed. The maximum concentration of the drug in blood plasma (Cmax) is 300–500 ng/ml (after intramuscular administration); TCmax 15–30 min. Communication with plasma proteins – 15%. Poorly penetrates the blood-brain barrier (BBB); penetrates the placental barrier and into breast milk (the concentration in breast milk of a woman during lactation is higher than in plasma). Slightly metabolized in the liver to form desmethylranitidine, ranitidine S-oxide and ranitidine N-oxide and a furoic acid analogue. Has a “first pass” effect through the liver. The rate and degree of elimination depend little on the condition of the liver. T1/2 after intravenous administration - 1.9 hours. Excreted by the kidneys: with intravenous administration - 93% (mainly unchanged 70%) and through the intestines.

Indications for use

Ranitidine is indicated for the treatment of duodenal ulcers, benign gastric ulcers, postoperative ulcers, reflux esophagitis, Zollinger-Ellison syndrome and the prevention of the following conditions in which it is necessary to reduce gastric secretion and reduce the formation of hydrochloric acid: prevention of gastrointestinal bleeding in stress ulcers in severe patients, prevention of recurrent bleeding in patients with bleeding gastric ulcers, and before general anesthesia in patients at risk of acid aspiration (Mendelssohn syndrome), especially during childbirth. Ranitidine injections are indicated for short-term use in hospitalized patients with pathological hypersecretory conditions who are unable to take oral medications.

Contraindications

- acute porphyria (including history); - pregnancy; - lactation period (breastfeeding); - children under 12 years of age; - hypersensitivity to ranitidine and other components of the drug.

Carefully

The drug should be prescribed with caution in case of renal and liver failure, cirrhosis of the liver with a history of portosystemic encephalopathy.

Directions for use and doses

Parenterally (intravenously, intramuscularly). Intravenously slowly (over 5 minutes) 50 mg, diluted with 0.9% sodium chloride solution or 5% dextrose solution to 20 ml; if necessary, repeat administrations are carried out every 6-8 hours. Intravenous drip, at a rate of 25 mg/hour for 2 hours; if necessary, repeat administration after 6-8 hours. Intramuscularly - 50 mg 3-4 times a day. To prevent bleeding from the upper gastrointestinal tract in patients with stress ulcers, slow intravenous administration is preferable at an initial dose of 50 mg, followed by continuous intravenous infusion at a rate of 0.125-0.25 mg/kg/h. The administration is carried out until the patient is able to eat on his own. To prevent the development of Mendelssohn's syndrome - intramuscularly or slowly intravenously, 50 mg 45-60 minutes before general anesthesia. In patients with renal failure (creatinine clearance less than 50 ml/min), accumulation of ranitidine may occur with increased plasma concentrations. Accordingly, in such patients ranitidine is prescribed at a dose of 25 mg. For patients on hemodialysis, the next dose is prescribed immediately after the end of hemodialysis.

Side effect

Below are the adverse events depending on the frequency of their occurrence in the following groups: very often (≥ 1/10), often (from ≥ 1/100 to

Interaction with other drugs

When taking ranitidine and drugs that depress bone marrow simultaneously, the risk of developing neutropenia increases. When used together with coumarin anticoagulants (for example, warfarin), prothrombin time may change. Due to the narrow therapeutic index, careful monitoring of prothrombin time is necessary. High doses of ranitidine (eg, used in the treatment of Zollinger-Ellison syndrome) may decrease the elimination of procainamide and N-acetylprocainamide, resulting in increased plasma levels of these drugs. Ranitidine inhibits the metabolism of phenazone, aminophenazone, hexobarbital, indirect anticoagulants, glipizide, buformin, and calcium antagonists. Due to an increase in the pH of the gastric contents, when administered concomitantly with ranitidine, the absorption of itraconazole and ketoconazole may be reduced. When taken against the background of ranitidine, the AUC and concentration of metoprolol in the blood serum increases (by 80% and 50%, respectively), while T1/2 of metoprolol increases from 4.4 to 6.5 hours. There is no interaction of ranitidine with metronidazole and amoxicillin.

Pharmaceutical interactions

Ranitidine solution is compatible with the following infusion solutions: 0.9% sodium chloride solution, 5% dextrose solution, 0.18% sodium chloride solution and 4% dextrose solution, 4.2% sodium bicarbonate solution, Hartmann's solution.

Precautionary measures

Evaluation for the presence of malignancy. Before starting treatment, the presence of malignant neoplasms in the stomach and duodenum should be excluded (may mask the symptoms of stomach cancer). Use for renal dysfunction. In patients with severe renal failure (creatinine clearance less than 50 ml/min), accumulation and increased plasma concentrations of ranitidine are observed. The recommended dose is 150 mg 1 time per day. For patients undergoing long-term ambulatory peritoneal dialysis or long-term hemodialysis, the drug is prescribed at a dose of 150 mg immediately after the end of the dialysis session. In patients with heart disease, rapid intravenous administration and use in high doses increases the risk of cardiotoxic effects (bradycardia). The use of ranitidine in doses higher than recommended may lead to increased creatinine concentrations, glutamate transpeptidase activity and hepatic transaminases in the serum. Ranitidine can provoke attacks of acute porphyria, so its use should be avoided in patients with a history of attacks of porphyria. Elderly patients, patients with chronic lung disease, diabetes mellitus, or those who are immunocompromised have an increased risk of developing community-acquired pneumonia (1.82 times (95% CI: 1.26–2.64)) compared with patients who did not receive ranitidine ). In elderly patients and patients with severe health problems, the use of ranitidine may lead to confusion, depression and hallucinations. With long-term treatment of weakened patients under stress, bacterial damage to the stomach is possible with subsequent spread of infection. Ranitidine should not be abruptly discontinued; there is a risk of rebound syndrome. Symptoms of duodenal ulcer may disappear within 1-2 weeks, but therapy should be continued until scarring is confirmed by endoscopic or x-ray examination. Ranitidine should be taken 2 hours after the use of itraconazole or ketoconazole to avoid a significant decrease in their absorption. The use of ranitidine may cause a false-positive reaction when testing for the presence of protein in the urine. It counteracts the effect of pentagastrin and histamine on the acid-forming function of the stomach and mast cells, therefore, it is not recommended to use it within 24 hours preceding the test, as well as before conducting diagnostic skin tests with histamine to detect an immediate allergic skin reaction. Smoking reduces the effectiveness of the drug. During treatment, you should avoid consuming foods, drinks and other medications that may irritate the gastric mucosa.

Use during pregnancy and breastfeeding

Ranitidine crosses the placenta and is excreted in breast milk (concentrations in breast milk are higher than in plasma). The use of a drug during pregnancy is possible only if the expected benefit to the mother outweighs the potential risk to the fetus. If it is necessary to prescribe a drug during lactation, the issue of stopping breastfeeding should be decided.

Use in pediatrics

The safety and effectiveness of ranitidine in children under 12 years of age have not been established.

Use for liver dysfunction

The drug should be prescribed with caution in case of liver failure, cirrhosis of the liver with a history of portosystemic encephalopathy.

Impact on the ability to drive vehicles and operate machinery

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: convulsions, bradycardia, ventricular arrhythmias. Treatment: symptomatic. For the development of seizures, intravenous diazepam; for bradycardia, atropine; and for ventricular arrhythmias, lidocaine. Hemodialysis is effective.

Package

2 ml in glass ampoules. 10 ampoules along with the package insert are placed in a cardboard box (No. 10). 10 ampoules, together with a leaflet, are placed in a cardboard pack with a cardboard insert for fixing the ampoules (No. 10).

Storage conditions

In a place protected from light, at a temperature not exceeding 25°C. Keep out of the reach of children.

Best before date

2 years. The medicine cannot be used after the expiration date.

Conditions for dispensing from pharmacies

On prescription.

Buy Ranitidine solution for IV and IM administration 25 mg/ml in ampoules 2 ml No. 10 in the pharmacy

Price for Ranitidine solution for IV and IM administration 25 mg/ml in 2 ml ampoules No. 10

Instructions for use for Ranitidine solution for IV and IM administration 25 mg/ml in 2 ml ampoules No. 10

Ranitidine

Aluminum phosphate.

Against the background of aluminum phosphate, the absorption of ranitidine is reduced.

Acenocoumarol.

When used in combination, ranitidine can either enhance or weaken the effect of acenocoumarol.

Acetylsalicylic acid + Chlorphenamine + Phenylephrine.

When used simultaneously with acetylsalicylic acid (as part of a combination of acetylsalicylic acid + chlorphenamine + phenylephrine), ranitidine increases its toxicity.

Bisacodyl.

Ranitidine may cause the enteric coating of bisacodyl to dissolve too quickly and irritate the gastric or duodenal mucosa; when administered in combination, the interval between doses should be at least 1 hour.

Warfarin.

Ranitidine changes prothrombin time: it can be lengthened or shortened; When administered together, monitoring of hemocoagulation parameters is necessary.

Gliclazide + Metformin.

Ranitidine, secreted in the tubules, competes for tubular transport systems and, with long-term combination therapy, can increase the maximum concentration of metformin (as part of the combination of gliclazide + metformin) by 60%.

Diazepam.

Against the background of ranitidine, biotransformation slows down and the effect of diazepam may increase.

Dirithromycin.

Against the background of ranitidine, the absorption of dirithromycin increases.

Ibandronic acid.

Ranitidine (when administered intravenously) increases the bioavailability of ibandronic acid by 20%.

Itraconazole, ketoconazole.

It is a weak acid and, against the background of ranitidine, which alkalizes the contents of the stomach, is absorbed with less speed and completeness; when prescribed together, a 2 hour (or more) interval between doses is required.

Metformin.

Ranitidine slows excretion, increases (by more than half) the maximum concentration (secreted by the renal tubules and competes for tubular transport systems), enhances the effect.

Metformin + Saxagliptin.

Ranitidine is excreted by the kidneys by tubular secretion and theoretically can interact with metformin (as part of the combination metformin + saxagliptin), competing for common transport systems of the renal tubules. It is recommended to carefully monitor patients and, if necessary, adjust the dose of the combination of metformin + saxagliptin and/or ranitidine if they are used simultaneously.

Metformin + Sitagliptin

. Careful monitoring of the patient and dose adjustment of the combination of metformin + sitagliptin and/or ranitidine are recommended.

Metformin + [Sibutramine + Microcrystalline cellulose].

Ranitidine, secreted in the renal tubules, competes with metformin (as part of the combination metformin + [sibutramine + MCC]) for tubular transport systems and, when used in combination, can lead to an increase in the maximum concentration of metformin.

Midodrine.

Ranitidine may retard (reciprocally) excretion by competing for the common transport system in the renal tubules.

Morphine.

Ranitidine may alter the enterohepatic circulation; If coadministration is necessary, careful monitoring is necessary.

Naproxen.

Against the background of ranitidine, which alkalizes the contents of the stomach, the absorption of naproxen is reduced; simultaneous use is not recommended.

Procainamide

. Against the background of ranitidine, a decrease in excretion (competition for the excretory systems of the renal tubules) and an increase in the concentration of procainamide in the blood are possible.

Propranolol

. Against the background of ranitidine, the biotransformation of propranolol slows down.

Rilpivirine.

It is suggested that rilpivirine should be used with caution when administered concomitantly with ranitidine as this may result in a significant decrease in rilpivirine plasma levels due to increased gastric pH. Ranitidine should be taken at least 12 hours before or 4 hours after rilpivirine.

Sucralfate.

Against the background of sucralfate, the absorption of ranitidine may be reduced; when administered in combination, the interval between doses should be at least 2 hours.

Theophylline.

Against the background of ranitidine, the biotransformation of theophylline is inhibited.

Phenytoin.

Against the background of ranitidine, the biotransformation of phenytoin slows down.

Cyclosporine.

Ranitidine increases the risk of renal dysfunction.

Ciprofloxacin

. Against the background of ranitidine, the absorption of ciprofloxacin is reduced (should be taken 2 hours before or 4 hours after ranitidine).

Ranitidine 150 mg 30 pcs. film-coated tablets

pharmachologic effect

Histamine H2 receptor blocker. Suppresses basal and stimulated by histamine, gastrin and acetylcholine (to a lesser extent) secretion of hydrochloric acid. Helps increase the pH of gastric contents and reduces pepsin activity. The duration of action of ranitidine with a single dose is 12 hours.

Composition and release form Ranitidine 150 mg 30 pcs. film-coated tablets

Tablets - 1 tablet: ranitidine 150 mg.

10 pieces. — cellular contour packages (3) — cardboard packs.

Description of the dosage form

Film-coated tablets.

Directions for use and doses

Installed individually. Orally for treatment of adults and children over 14 years of age, a daily dose of 300-450 mg is used, if necessary, the daily dose is increased to 600-900 mg; Frequency of administration: 2-3 times/day. To prevent exacerbations of diseases, use 150 mg/day before bedtime. The duration of treatment is determined by the indications for use. Patients with renal failure with a creatinine level of more than 3.3 mg/100 ml - 75 mg 2 times a day.

IV or IM - 50-100 mg every 6-8 hours.

Pharmacokinetics

After oral administration, ranitidine is rapidly absorbed from the gastrointestinal tract. Food intake and antacids have little effect on the degree of absorption. Subject to a first-pass effect through the liver. Cmax in plasma is achieved 2 hours after a single oral dose. After intramuscular administration, it is quickly and almost completely absorbed from the injection site. Cmax is reached after 15 minutes.

Protein binding - 15%. Vd - 1.4 l/kg. Ranitidine is excreted in breast milk.

T1/2 is 2-3 hours. About 30% of the dose taken is excreted unchanged in the urine. The rate of excretion is reduced if liver or kidney function is impaired.

Indications for use Ranitidine 150 mg 30 pcs. film-coated tablets

Peptic ulcer of the stomach and duodenum in the acute phase; prevention of exacerbations of peptic ulcer disease; symptomatic ulcers; erosive and reflux esophagitis; Zollinger-Ellison syndrome; prevention of “stress” gastrointestinal ulcers, postoperative ulcers, recurrent bleeding from the upper gastrointestinal tract; prevention of aspiration of gastric juice during operations under anesthesia.

Contraindications

Pregnancy, lactation (breastfeeding), hypersensitivity to ranitidine.

Application of Ranitidine 150 mg 30 pcs. film-coated tablets during pregnancy and breastfeeding

Adequate and well-controlled studies of the safety of ranitidine during pregnancy have not been conducted, and therefore use during pregnancy is contraindicated.

If it is necessary to use ranitidine during lactation, breastfeeding should be stopped.

Use in children

Clinical data on the safety of ranitidine in pediatrics are limited.

special instructions

Use with caution in patients with impaired renal excretory function.

Before starting treatment, it is necessary to exclude the possibility of a malignant disease of the esophagus, stomach or duodenum.

With long-term treatment in weakened patients under stress, bacterial damage to the stomach is possible with subsequent spread of infection.

It is undesirable to abruptly stop taking ranitidine due to the risk of relapse of peptic ulcer disease. The effectiveness of preventive treatment of peptic ulcer is higher when taking ranitidine in courses of 45 days in the spring-autumn period than when taking it continuously. Rapid intravenous administration of ranitidine has rarely caused bradycardia, usually in patients predisposed to cardiac arrhythmias.

There are isolated reports that ranitidine may precipitate the development of an acute attack of porphyria, and therefore its use should be avoided in patients with a history of acute porphyria.

During the use of ranitidine, distortion of laboratory test data is possible: an increase in the level of creatinine, GGT activity and liver transaminases in the blood plasma.

In cases where ranitidine is used in combination with antacids, the interval between taking antacids and ranitidine should be at least 1-2 hours (antacids may impair the absorption of ranitidine).

Clinical data on the safety of ranitidine in pediatrics are limited.

Side effects Ranitidine 150 mg 30 pcs. film-coated tablets

From the cardiovascular system: in isolated cases (with intravenous administration) - AV blockade.

From the digestive system: rarely - diarrhea, constipation; in isolated cases - hepatitis.

From the side of the central nervous system: rarely - headache, dizziness, feeling of fatigue, blurred vision; in isolated cases (in seriously ill patients) - confusion, hallucinations.

From the hematopoietic system: rarely - thrombocytopenia; with long-term use in high doses - leukopenia.

From the side of metabolism: rarely - a slight increase in serum creatinine at the beginning of treatment.

From the endocrine system: with long-term use in high doses, an increase in prolactin levels, gynecomastia, amenorrhea, impotence, and decreased libido are possible.

From the musculoskeletal system: very rarely - arthralgia, myalgia.

Allergic reactions: rarely - skin rash, urticaria, angioedema, anaphylactic shock, bronchospasm, arterial hypotension.

Other: rarely - recurrent mumps; in isolated cases - hair loss.

Drug interactions

When used simultaneously with antacids, the absorption of ranitidine may be reduced.

When used simultaneously with anticholinergic drugs, memory and attention may be impaired in elderly patients.

It is believed that histamine H2 receptor blockers reduce the ulcerogenic effect of NSAIDs on the gastric mucosa.

When used simultaneously with warfarin, the clearance of warfarin may be reduced. A case of hypoprothrombinemia and bleeding in a patient receiving warfarin is described.

When used simultaneously with bismuth tripotassium dicitrate, an undesirable increase in the absorption of bismuth is possible; with glibenclamide - cases of hypoglycemia have been described; with ketoconazole, itraconazole - the absorption of ketoconazole and itraconazole decreases.

When used simultaneously with metoprolol, it is possible to increase the plasma concentration and increase the AUC and T1/2 of metoprolol.

When used simultaneously with sucralfate in high doses (2 g), the absorption of ranitidine may be impaired.

When used simultaneously with procainamide, it is possible to reduce the excretion of procainamide by the kidneys, which leads to an increase in its concentration in the blood plasma.

There is evidence of increased absorption of triazolam when administered concomitantly, apparently due to changes in the pH of the gastric contents under the influence of ranitidine.

It is believed that when used simultaneously with phenytoin, it is possible to increase the concentration of phenytoin in the blood plasma and increase the risk of toxicity.

When used simultaneously with furosemide, there is a moderate increase in the bioavailability of furosemide.

A case of the development of ventricular arrhythmia (bigeminy) with simultaneous use with quinidine has been described; with cisapride - a case of cardiotoxicity has been described.

A slight increase in the concentration of cyclosporine in the blood plasma cannot be excluded when it is used simultaneously with ranitidine.