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.
Ranitidine Ranitab (analogous to Zantac) 150 mg tab. No. 60 - Instructions
Release form and composition
The drug is available in the form of tablets with a dosage of 150 mg.
1 tablet contains 150 mg of ranitidine in the form of hydrochloride as an active substance.
Excipients:
- microcrystalline cellulose,
- povidone,
- magnesium stearate,
- macrogol,
- titanium dioxide,
- propylene glycol,
- ethylcellulose,
- sodium lauryl sulfate.
Pharmacodynamics
The drug affects histamine H2 receptors located in the parietal cells of the gastric mucosa. Thanks to these receptors, the stomach determines whether it is full of food and whether it needs to be digested. When these receptors are blocked, there is a decrease in the total volume of gastric juice, a decrease in pepsin activity, and an increase in pH levels, which means a decrease in the acidity of the stomach contents. This effect is manifested in relation to both the main (basal) and food load.
Ranitidine also reduces the secretion of gastric juice caused by gastrin and acetylcholine, although to a lesser extent than histamine. Reducing the secretion of gastric juice leads to the activation of reparative processes in the gastric mucosa and its healing.
Pharmacokinetics
Ranitidine has a long-lasting effect, lasting approximately 12 hours after administration. The drug reaches its highest concentration 2 hours after administration. The biological availability of the active substance is 50%. The half-life of ranitidine is 2.5 hours. The drug is mainly excreted from the body by the kidneys, both in the form of metabolites and unchanged, and partially through the intestines with feces. With insufficient renal function (reduced creatinine clearance), the half-life of ranitidine increases. Penetrates the placental barrier, does not penetrate the blood-brain barrier. Ranitidine is on the list of essential drugs.
Indications for use
Ranitidine is used as part of complex therapy for gastric and duodenal ulcers, Zollinger-Ellison syndrome, reflux esophagitis, erosive esophagitis, chronic dyspepsia, accompanied by pain in the chest area. Ranitidine can also be used to prevent:
- ulcers caused by stress;
- ulcerations in peptic ulcers;
- bleeding from the upper gastrointestinal tract;
- secretion of gastric juice caused by surgical operations under general anesthesia.
The drug can also be used to treat ulcers caused by the use of non-steroidal anti-inflammatory drugs.
Directions for use and doses
The absorption of the drug into the blood does not depend on food intake. Thus, it can be taken both before and after meals, and the effectiveness of the drug will not decrease. The tablets should be swallowed without chewing and with sufficient liquid. The dosage of Ranitidine and the duration of treatment depend on the disease, but in the vast majority of cases we are talking about a daily dosage of 300 mg. For peptic ulcers, a 150 mg tablet 2 times a day or a 300 mg tablet once a day is usually prescribed. If the patient adheres to a two-dose regimen, it is better to take the first Ranitidine tablet in the morning before meals, and the second in the evening before bed. And if it’s a one-dose regimen, then it’s best to take the pill in the evening before bed.
If necessary, the dose of Ranitidine can be doubled - 300 mg 2 times a day. The duration of treatment is 1.5-2 months.
The doctor may also prescribe maintenance therapy lasting 2-3 months. The dose of Ranitidine is 150 mg once a day. The tablet is also best taken before bed. For smoking patients, the dose is usually doubled in this case - up to 300 mg at night.
When treating ulcers associated with taking anti-inflammatory drugs, a 150 mg tablet is prescribed 2 times a day, the course of treatment is 2-3 months. When preventing this phenomenon, the dosage is the same.
For reflux esophagitis, the treatment regimen for Ranitidine is as follows: 2 tablets of 150 mg per day, morning and evening. If necessary, the dose can be increased to 150 mg 4 times a day. The course of treatment is 2 months.
For Zollinger-Ellison syndrome, it is recommended to take a 150 mg tablet three times a day. If necessary, the daily dose can be increased to 600 or even 900 mg. It should also be taken in three doses.
For chronic attacks of dyspepsia, take a 150 mg tablet 2 times a day for 1.5 months. According to the instructions for use, Ranitidine, when preventing stress or ulcerative bleeding in the gastrointestinal tract, should also be taken 150 mg tablet 2 times a day. To prevent aspiration of gastric juice during surgery, it is recommended to give the patient 150 mg 2-4 hours before surgery, as well as 150 mg in the evening before surgery.
For creatinine clearance less than 50 ml/min, the recommended dose is 150 mg per day, divided into two doses.
Contraindications
The drug has no serious contraindications, which means that it can be used by patients who have not only problems with the gastrointestinal tract, but also concomitant diseases.
First of all, the drug is not approved if you are intolerant to ranitidine and the excipients contained in the tablets. Also, the drug is not recommended for use by children under 12 years of age, since there is no data yet on how safe it is for them. Since the drug easily penetrates the placental barrier and into breast milk, it is also better for pregnant and lactating women to avoid it, although there is currently no direct evidence that it can harm the baby. The drug is prescribed with caution in case of renal and liver failure, or with a history of acute porphyria. With reduced creatinine clearance, the dose of Ranitidine should be reduced.
Side effects
Side effects when taking Ranitidine are rare. These may be phenomena associated with the cardiovascular and nervous systems, and the digestive tract.
Adverse reactions related to the cardiovascular system:
- bradycardia;
- decreased blood pressure;
- atrioventricular block, mainly with parenteral administration;
- arrhythmias.
Adverse reactions related to the nervous system:
- dizziness,
- headache,
- increased fatigue,
- drowsiness,
- noise in ears,
- decreased clarity of vision.
In seriously ill patients, confusion and hallucinations are possible.
Adverse reactions associated with the gastrointestinal tract:
- nausea,
- vomit,
- constipation,
- diarrhea,
- abdominal pain.
Allergic reactions of the following type are also possible:
- hives,
- rash,
- angioedema.
Possible changes in blood composition (thrombocytopenia, leukopenia, agranulocytosis), hepatitis, decreased potency or libido, gynecomastia, dry mouth, arthralgia and myalgia, bronchospasm, hair loss.
During the course of taking the drug, it is best to avoid driving due to possible side effects associated with the nervous system. Ranitidine metabolites may give a false-positive test for amphetamine.
Overdose
Main symptoms of overdose:
- skin rashes,
- confusion,
- headache,
- dizziness.
Treatment of overdose is symptomatic. Cleansing of the gastrointestinal tract using enterosorbents is indicated.
Interaction with other substances and other instructions for use
Antacids make it difficult to absorb the drug. Therefore, when taking antacids and Ranitidine simultaneously, an interval of 2 hours should be maintained between the use of these drugs. The same applies to the simultaneous use of Itroconazole and Ketoconazole together with the drug.
Inhibits the metabolism of certain drugs in the liver, including diazepam, metronidazole, indirect anticoagulants, lidocaine.
Ranitidine increases the bioavailability of furosemide. Concomitant use with anticholinergic drugs may contribute to memory and attention impairment in elderly patients.
Smoking is a factor that reduces the effectiveness of the drug.
Ranitidine can mask the symptoms that occur with gastric carcinoma, therefore, before prescribing the drug, the doctor must make sure that the patient does not have cancer. Also, do not suddenly stop taking Ranitidine, as this may lead to relapses of the disease. Practice has shown that the most effective regimen is one that involves taking the drug for 45 days in the autumn and spring.
Rapid intravenous administration of ranitidine can provoke an attack of bradycardia. The drug is prescribed with caution to persons with a history of porphyria, as an acute attack of porphyria may occur.
Ranitidine may cause false positive results in urine protein tests. The drug may also interfere with the normal skin reaction to allergens (due to its effect on histamine receptors). Therefore, before such tests, the drug should be stopped.
During the course of treatment with Ranitidine, you should follow a diet consisting of avoiding foods that can cause irritation of the gastric mucosa.
Terms and conditions of storage
Ranitidine tablets can be stored at +15-30°C for 2 years.
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 injection. 25 mg/ml in amp. 2 ml in pack No. 10 in the pharmacy
Price for Ranitidine solution for intravenous and intramuscular administration, 25 mg/ml in amp. 2 ml in pack No. 10
Instructions for use for Ranitidine solution for intravenous and intramuscular administration, 25 mg/ml in amp. 2 ml in pack No. 10
