Ranitidine-AKOS - instructions for use, dose, side effects, contraindications

Corn starch, lactose monohydrate (milk sugar), microcrystalline cellulose, low molecular weight povidone (low molecular weight polyvinylpyrrolidone 12600 ± 2700), calcium stearate, crospovidone (kollidone CL).

The shell Dand promromethosis (hydroxypropylmethylcellulose), macrogol-4000 (polyethylene glycol 4000), tropeolin 0, titanium dioxide, propylene glycol, talc.

Description:

The tablets covered with a film membrane, yellow color, round, biconcave.

Pharmacotherapeutic group:a drug that reduces the secretion of the glands of the stomach, - H2-histamine receptor blocker.

ATX: & nbsp

A.02.B.A Blockers of histamine H2-receptors

A.02.B.A.02 Ranitidine

Pharmacodynamics:

The blocker of H2-histamine receptors of the second generation.The mechanism of action is associated with blockade of H2-histamine receptors in membranes of parietal cells of the gastric mucosa. Day and night suppresses secretion of HC1, and basal and stimulated, reduces the volume of gastric juice induced by gastric distension food load, the action of hormones and biogenic stimulators (gastrin, histamine, atsetilho- ling, pentagastrin, caffeine). Reduces the amount of HC1 in gastric juice, virtually not suppressing "hepatic'¹ enzymes associated with cytochrome P450, does not affect the concentration of gastrin in the plasma, the production of mucus. Reduces the activity of pepsin.

Does not affect the concentration of Ca²⁺ in the blood serum. Following oral administration at therapeutic doses do not influence the concentration of prolactin (possibly extending a slight increase in the prolactin concentration in blood serum after intravenous administration at a dose ranitidiia 100 mg and more).

Has no effect on the release of pituitary hormones: gonadotropin, thyroid-stimulating hormone and growth hormone. It does not affect the concentration of cortisol, aldosterone, androgen or estrogen, sperm motility, sperm quantity and composition, as well as does not have anti-androgenic action.

May attenuate the release of vasopressin. It enhances gastric mucosal defense mechanisms and promotes healing of her damage associated with exposure to HC1 (including cessation of gastrointestinal bleeding and scarring stress ulcers) by increasing the formation of gastric mucus glycoprotein content therein, stimulation of secretion of gastric mucosa hydrogencarbonate, endogenous synthesis in it Pg and the regeneration rate. In a dose of 150 mg inhibits the secretion of gastric juice for 8-12 hours. Inhibits microsomal enzymes (weaker than cimetidine).

Pharmacokinetics:

Quickly absorbed, eating does not affect the degree of absorption. Bioavailability - 50%. The maximum concentration is 150 mg ranitidine; the time required to reach a maximum concentration of 2-3 hours. The connection with plasma proteins is 15%. Poorly penetrates the blood-brain barrier; penetrates through the placental barrier and into breast milk (concentration in breast milk in women during lactation is higher than in plasma). It is slightly metabolized in the liver with the formation of desmethylranitidine and S- oxide ranitidine. Has the effect of "first pass" through the liver.The speed and degree of elimination depend little on the condition of the liver. The half-life at normal clearance of creatinine (CC) is 2.5 hours, at a CC of 20-30 ml / min - 8-9 hours. It is excreted by the kidneys - 60-70% (mainly in unchanged form 35%) and through the intestine.

Indications:

Treatment and prevention - peptic ulcer and 12 duodenal ulcer, NSAIDs-gastropathy, heartburn (associated with hyperchlorhydria), hypersecretion of gastric juice, symptomatic ulcers, stress ulcers of the gastrointestinal tract, erosive esophagitis, reflux esophagitis, Zollinger-Ellison syndrome, systemic mastocytosis, polyendocrine adenomatosis; dyspepsia characterized by epigastric or chest pain associated with eating or disturbing sleep, but not due to the above conditions; treatment of bleeding from the upper divisions of the gastrointestinal tract, prevention of recurrences of gastric bleeding in the postoperative period; prevention of aspiration of gastric juice in patients undergoing general anesthetic surgery (Mendelssohn syndrome), aspiration pneumonitis (prophylaxis), rheumatoid arthritis (as adjuvant therapy).

Contraindications:

Hypersensitivity, lactation.

Carefully:

Renal and / or hepatic insufficiency, cirrhosis of the liver with encephalopathy (in the anamnesis), acute porphyria (including in the anamnesis), suppression of immunity, children's age (up to 12 years), pregnancy.

The action category for fetus-B (study of reproduction on animals did not reveal the risk of adverse effects on the fetus, and adequate and strictly controlled studies in pregnant women were not conducted).

Dosing and Administration:

Inside. Peptic ulcer of stomach and duodenum (in the phase of exacerbation), postoperative ulcers - 150 mg twice a day or 300 mg at night for 4-8 weeks. In patients with nevrubtsevshimisya for this period of ulcers - continued treatment for the next 4 weeks.

Prevention of relapse - 150 mg at night; for smoking patients - 300 mg at night. NSAIDs-gastropathy - 150 mg 2 times a day or 300 mg per night for 8-12 weeks; prophylaxis - 150 mg twice a day.

Erosive reflux esophagitis - 150 mg 2 times a day or 300 mg per night for 8 weeks; If necessary, the course of treatment is extended to 12 weeks. At the Fifth Mig. The severity of the reflux esophagitis dose is increased to 600 mg / day in 4 divided doses for 12 weeks. Prolonged preventive therapy is 150 mg twice a day.

Zollinger-Ellison syndrome - initial dose of 150 mg 3 times a day; if necessary, up to 6 g / day.

In chronic episodes of dyspepsia - 150 mg twice a day for 6 weeks.

Children for treatment of peptic ulcer - 2-4 mg / kg 2 times a day; with reflux-esophagitis - 2-8 mg / kg 3 times a day; the maximum daily dose is 300 mg.

Patients with impaired renal function require a correction of the dosing regimen. At CC less than 50 ml / min - 150 mg / day. If there is a concomitant liver function disorder, a further dose reduction may be required.

Patients who are on hemodialysis, the next dose is prescribed immediately after the end of hemodialysis.

Side effects:

From the digestive system: nausea, dry mouth, constipation, vomiting, diarrhea, abdominal pain, jaundice, increased activity of "hepatic" trapsaminases, rarely - hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

From the hematopoiesis: leukopenia, thrombocytopenia; agranulocytosis, pancytopenia, neutropenia, immune hemolytic and aplastic anemia.

From the cardiovascular system: lowering blood pressure; bradycardia, tachycardia, vasculitis, arrhythmia, atrioventricular (AV) blockade.

From the side of the system: headache, dizziness, hyperthermia, increased fatigue, drowsiness; insomnia, emotional lability, agitation, anxiety, depression, nervousness, rarely - confusion, tinnitus, irritability, hallucinations (mainly in the elderly and seriously ill), involuntary movements.

From the sense organs: blurred vision, paresis of accommodation.

From the musculoskeletal system: arthralgia, myalgia.

From the endocrine system: hyperprolactinemia, gynecomastia, amenorrhea, decreased potency and / or libido.

Allergic reactions: hives, skin rash, pruritus, angioneurotic edema, anaphylactic shock, bronchoconstriction, erythema multiforme, including Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis.

Other: alopecia.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment: symptomatic. When taken orally, induce vomiting or / and gastric lavage. With the development of seizures - diazepam in / in, with bradycardia - atropine, ventricular arrhythmias - lidocaine. Hemodialysis is effective.

Interaction:

Increases the area under the concentration-time curve (AUC) and the concentration of metoprolol in the serum (respectively, 80 and 50%), while the half-life of metoprolol increases from 4.4 to 6.5 hours.

Reduces the absorption of itraconazole and ketoconazole.

Inhibits metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, metoprolol, nifedipine, warfarin, diazepam, lidocaine, phenytoin, theophylline, aminophylline, indirect anticoagulants, glipizide, buformin, metronidazole, slow calcium blockers channels (BCC).

Increases the concentration of procainamide.

Antacids, sucralfate slow the absorption of ranitidine (with the simultaneous use of a gap between the intake of antacids and ranitidine should be at least 1-2 hours). Drugs that depress the bone marrow increase the risk of neutropenia. Smoking reduces the effectiveness of ranitidine.

Special instructions:

The symptoms of a peptic ulcer 12 - duodenum may disappear within 1-2 weeks, therapy should be continued for as long as the scarring is not confirmed by endoscopy or X-ray examination.

May mask symptoms associated with carcinoma of the stomach, so before starting treatment, you must exclude the presence of malignant neoplasm.

Ranitidine, it is undesirable to abruptly cancel (syndrome "bounce").

With long-term treatment of weakened patients under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection.

Blockers of H2-histamine receptors should be taken 2 hours after the administration of itraconazole or ketoconazole in order to avoid a significant reduction in their absorption. May be the cause of a false positive reaction when carrying out a sample for protein in the urine.

Increases the level of creatinine, gamma-glutamintransferase (GGT) and transaminase in the serum.

Counteracting influences the influence of pentagastrin and histamine on the acid-forming function of the stomach, therefore it is not recommended to use it for 24 hours preceding the test.

Suppress the skin reaction to histamine, thus resulting in. to false-negative results (before using diagnostic skin tests to detect an allergic skin reaction of immediate type, it is recommended to stop the use of the drug). The effectiveness of the drug in Inghibernatedand night secretion of acid in the stomach can decrease as a result of smoking.

During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa. If there is no improvement, consult a doctor.

Effect on the ability to drive transp. cf. and fur:

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

Form release / dosage:

tablets, film-coated 150 mg, 300 mg.

10 tablets per contour cell pack. 1 or 2 contour squares, together with instructions for use, will be placed in a pack of cardboard.

Packaging:10 tablets per contour cell pack. 1 or 2 contour squares, together with instructions for use, will be placed in a pack of cardboard.

Storage conditions:

List B. In a dry, the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N002761 / 01

Date of registration:24.11.2008

The owner of the registration certificate:SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products SYNTHESIS, JSC Joint-stock Kurgan Society of Medical Preparations and Products Russia

Manufacturer: & nbsp

SYNTHESIS, OJSC Russia

Information update date: & nbsp06.04.2015

Illustrated instructions

Instructions

Ranitidine-ACOS (Ranitidine-AKOS)