Instructions for Ranitidine-Darnitsa film-coated tablets 150 mg No. 20
Composition
active ingredient: ranitidine;
1 tablet contains: ranitidine hydrochloride equivalent to ranitidine 150 mg
excipients: microcrystalline cellulose, povidone, lactose monohydrate, potato starch, talc, magnesium stearate, Opadry AMV 80 W yellow.
Dosage form
Film-coated tablets.
Main physicochemical properties: round tablets with a biconvex surface, coated, yellow to yellow-orange in color. Two layers are visible on the cross section.
Pharmacotherapeutic group
Drugs for the treatment of ulcers and gastroesophageal reflux disease. H2-histamine receptor antagonists. ATC code A02B A02.
Pharmacological properties
Pharmacodynamics
Ranitidine is an antiulcer agent, an antagonist of H2-histamine receptors. The mechanism of action is due to competitive inhibition of H2-histamine receptors of the membranes of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid, reducing the volume of gastric juice caused by irritation of baroreceptors (stomach distension), food load, the action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin, caffeine). Ranitidine reduces the amount of hydrochloric acid in gastric juice, does not affect the concentration of gastrin in blood plasma, as well as the production of mucus. Ranitidine is characterized by a long-lasting effect.
Ranitidine does not affect the cytochrome P450 enzyme system of the liver.
Pharmacokinetics
After oral administration, ranitidine is rapidly absorbed from the gastrointestinal tract. Bioavailability is about 50%. The maximum concentration in the blood is reached after 2-3 hours and is 478 ng / ml. It is partially metabolized in the liver to N-oxide (the main metabolite, 4% of the dose), S-oxide and demethylated.
The half-life (after oral administration) with normal creatinine clearance is 2-3 hours, with reduced (20-30 ml / min) - 8-9 hours. Excreted by the kidneys within 24 hours, about 30% of the orally taken dose is excreted unchanged. Penetrates through histohematological barriers, including through the placental barrier, but poorly through the blood-brain barrier. Quite significant concentrations are determined in breast milk. The rate and extent of elimination depend little on the state of the liver and are mainly associated with kidney function.
Indication
Gastric and duodenal ulcer not associated with Helicobacter pylori (in the acute phase), including ulcers associated with taking nonsteroidal anti-inflammatory drugs (NSAIDs); functional dyspepsia; chronic gastritis with acid-forming function of the stomach in the acute phase; gastroesophageal reflux disease (to relieve symptoms) or reflux esophagitis.
Contraindication
Increased individual sensitivity to ranitidine and other components of the drug; presence of malignant gastric diseases, cirrhosis of the liver with portosystemic encephalopathy in history, severe renal failure (creatinine clearance <30 ml/min).
Interaction with other medicinal products and other types of interactions
Ranitidine may affect the absorption, metabolism and renal excretion of other drugs.
Ranitidine in therapeutic doses does not change the activity of the cytochrome P450 enzyme system and does not potentiate the effect of drugs that are metabolized by this system (diazepam, lidocaine, phenytoin, propranolol, theophylline).
Ranitidine, by altering gastric acidity, may affect the bioavailability of some drugs. This leads to either increased absorption (triazolam, midazolam, glipizide) or decreased absorption (ketoconazole, itraconazole, atazanavir, gefitinib).
Antacids and sucralfate slow down the absorption of ranitidine, as a result of which the interval between taking these drugs and ranitidine should be at least 1-2 hours.
Concomitant use with metoprolol may lead to increased serum concentrations of metoprolol.
Ranitidine, when used simultaneously with coumarin anticoagulants (warfarin), may alter prothrombin time (monitoring of prothrombin time is recommended).
Large doses of ranitidine can slow the excretion of procainamide and N-acetylprocainamide, leading to an increase in their levels in the blood plasma.
There are no data on the interaction between ranitidine and amoxicillin or metronidazole.
Tobacco smoking reduces the effectiveness of ranitidine.
Application features
If you are allergic to other drugs in the group of histamine H2 receptor blockers, allergic reactions to ranitidine are possible, therefore, if you are hypersensitivity to other drugs in this group, the drug should be used with caution.
Use the drug with caution in acute porphyria (including a history), immunodeficiency.
Ranitidine is excreted by the kidneys, therefore in patients with severe renal insufficiency its plasma level is increased (see Dosage for such patients in the section "Method of administration and dosage").
Treatment with the drug may mask the symptoms of gastric carcinoma, therefore, before starting treatment, the presence of malignant neoplasms in the stomach should be excluded.
Regular monitoring is necessary for patients (especially the elderly and those with a history of gastric and/or duodenal ulcers) taking ranitidine with nonsteroidal anti-inflammatory drugs. Elderly patients, those with chronic lung disease, diabetes mellitus, or those with weakened immune systems have been observed to be more susceptible to developing pneumonia.
Treatment with the drug should be discontinued gradually due to the risk of developing a "rebound" syndrome with abrupt withdrawal.
The drug contains lactose, which should be taken into account in patients with rare hereditary forms of galactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome.
Ability to influence reaction speed when driving vehicles or other mechanisms
Given that sensitive patients may experience adverse reactions (dizziness, hallucinations, accommodation disorders) when using the drug, you should refrain from driving vehicles or working with other mechanisms while taking the drug.
Use during pregnancy or breastfeeding
The drug is contraindicated during pregnancy.
If necessary, use of the drug should stop breastfeeding.
Method of administration and doses
For adults and children over 12 years of age. Take orally, without chewing, with a small amount of water, regardless of meals.
Gastric and duodenal ulcers not associated with Helicobacter pylori (in the acute phase). Prescribe 150 mg (1 tablet) 2 times a day in the morning and evening or 300 mg (2 tablets) once at night for 4 weeks. For ulcers that have not healed, continue treatment for the next 4 weeks.
Prevention of gastric and duodenal ulcers associated with the use of nonsteroidal anti-inflammatory drugs. Prescribe 150 mg (1 tablet) 2 times a day in the morning and evening for the period of NSAID therapy.
Functional dyspepsia. Prescribe 150 mg (1 tablet) 2 times a day in the morning and evening for 2-3 weeks.
Chronic gastritis with increased acid-forming function of the stomach in the acute stage. Prescribe 150 mg (1 tablet) 2 times a day in the morning and evening for 2-4 weeks.
Gastroesophageal reflux disease. To relieve symptoms, prescribe 150 mg (1 tablet) 2 times a day in the morning and evening for 2 weeks, if necessary, continue the course of treatment.
For long-term treatment and in case of exacerbation of GERD, prescribe 150 mg (1 tablet) 2 times a day in the morning and evening or 300 mg (2 tablets) once a day at night for 8 weeks, if necessary, extend the course of treatment to 12 weeks.
Patients with renal insufficiency (creatinine clearance less than 50 ml/min). The daily dose of the drug for this category of patients is 1 tablet (150 mg of ranitidine).
Children
For children from 12 years of age, the drug is indicated for the purpose of reducing the duration of treatment of gastric and duodenal ulcers, for the treatment of GERD, including reflux esophagitis, and for the relief of GERD symptoms.
Overdose
Possible increase in adverse reactions.
Treatment: if necessary, undergo adequate symptomatic and supportive therapy.
Adverse reactions
From the blood system: leukopenia, reversible thrombocytopenia, agranulocytosis or pancytopenia, sometimes with bone marrow hypoplasia or aplasia, neutropenia, immune hemolytic and aplastic anemia (usually reversible).
On the part of the immune system: hypersensitivity reactions, including urticaria, angioedema, anaphylactic shock, bronchospasm, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, hyperthermia.
On the part of the psyche: increased fatigue, reversible confusion, drowsiness, agitation, insomnia, emotional lability, anxiety, restlessness, depression, nervousness, hallucinations, tinnitus, irritability, disorientation, confusion. These manifestations are observed mainly in seriously ill or elderly patients.
Nervous system: headache, dizziness and reversible involuntary movement disorders.
On the part of the organs of vision: blurred visual perception, accommodation disorders.
Cardiovascular system: decreased blood pressure, bradycardia, tachycardia, asystole, atrioventricular block, vasculitis, chest pain, arrhythmia, extrasystole.
Gastrointestinal tract: dry mouth, nausea, vomiting, constipation, diarrhea, abdominal pain, flatulence, acute pancreatitis, decreased appetite.
On the part of the hepatobiliary system: rapidly passing and reversible changes in liver function tests, hepatocellular, cholestatic or mixed hepatitis with or without jaundice (usually reversible).
Skin and subcutaneous tissue disorders: hyperemia, itching, skin rashes, erythema multiforme, alopecia, dry skin.
Musculoskeletal system: arthralgia, myalgia.
From the urinary system: renal dysfunction, interstitial nephritis.
From the reproductive system: hyperprolactinemia, galactorrhea, gynecomastia, amenorrhea, decreased potency (reversible) and/or libido.
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature above 25 ° C.
Keep out of reach of children.
Packaging
10 tablets in a blister; 1 or 2 contour cell packs in a pack.
Vacation category
According to the recipe.
Producer
PrJSC "Pharmaceutical Company "Darnitsa".
Location of the manufacturer and its business address
Ukraine, 02093, Kyiv, Boryspilska Street, 13.
