Zoran - instructions for use, dose, side effects, contraindications

Excipients: cellulose microcrystalline, carboxymethyl starch sodium, magnesium stearate, silicon dioxide colloid, hypromellose, propylene glycol, tyran dioxide, talc purified, dye sunset yellow.

Description:Orange, round, biconvex tablets with a smooth surface, coated. The view of the fracture is a pale yellow mass.

Pharmacotherapeutic group:The iron of the stomach secretion is a lowering agent - 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.Suppresses the day and night secretion of hydrochloric acid, as well as basal and stimulated, reduces the amount of gastric juice caused by the gastric strain of the food load, the action of hormones and biogenic stimulants (gastrin, histamine, acetylcholine, pentagastrin, caffeine). Reduces the amount of hydrochloric acid in gastric juice, virtually not suppressing the "hepatic" 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 calcium ions in the blood serum. After oral administration in therapeutic doses does not affect the concentration of prolactin.

Does not affect the release of pituitary hormones: gonadotropin, thyroidotropic and growth hormone, does not affect the concentration of cortisol, aldosterone, androgens or estrogens, the motility of spermatozoa, the amount and composition of sperm, and has no antiandrogenic effect. protective mechanisms of the gastric mucosa and promotes the healing of its damage associated with the action of hydrochloric acid (including,cessation of gastrointestinal bleeding and scarring stress ulcers) by increasing the formation of gastric mucus glycoprotein content therein, stimulating the secretion of gastric mucosa hydrogencarbonate, endogenous synthesis of prostaglandins in it and regenerating rate.

AT a dose of 150 mg suppresses the secretion of gastric juice for 8-12 hours. Inhibits microsomal enzymes.

Pharmacokinetics:ATSucks and distribution: after taking the drug inside quickly absorbed, eating does not affect the degree of absorption. Bioavailability - 50%. The maximum concentration in plasma (C_max) - 36-94 ng / ml (with oral administration of 150 mg ranitidine). Time to reach the maximum concentration (T_Cmax) after oral administration for 2-3 hours. Connection with plasma proteins - 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).

Metabolism and excretion: It is slightly metabolized in the liver with the formation of desmethylranitidine and S- ranitidine oxide. Has the effect of "first pass" across liver.The speed and degree of elimination depend little on the condition of the liver. Half-life (T_1/2) after ingestion with normal clearance of creatinine - 2.5 hours, with creatinine clearance of 20-30 ml / min - 8-9 hours.

It is excreted by the kidneys when ingested - 60-70% (35% unchanged) and through the intestine.

Indications:

Treatment and prevention of gastric ulcer and duodenal ulcer, NSAID-gastropathy, heartburn (associated with hyperchlorhydria), hypersecretion of gastric juice, symptomatic ulcers, stress ulcers of the gastrointestinal tract (GIT), erosive esophagitis, reflux esophagitis, Zollinger- Ellison, 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 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); prevention of aspiration pneumonitis; as an auxiliary therapy in the treatment of rheumatoid arthritis.

Contraindications:

Hypersensitivity to ranitidine or other components of the drug.

Pregnancy, lactation.

Children under 12 years.

Carefully:

Renal and / or hepatic insufficiency, cirrhosis of the liver with encephalopathy (in the anamnesis), acute porphyria (including, in the anamnesis), suppression of immunity.

Dosing and Administration:

Inside adults and children over 12 years, regardless of food intake, without chewing, squeezed a small amount of liquid.

Stomach ulcer and duodenal ulcer. For treatment of exacerbations appoint 150 mg twice a day (morning and evening) or 300 mg at night. If necessary, 300 mg twice a day. The duration of the course of treatment is 4-8 weeks. To prevent exacerbations appoint 150 mg at night.

NSAIDs are gastropathy. 150 mg twice a day or 300 mg per night for 8-12 weeks. Prevention of ulceration when taking NSAIDs - 150 mg 2 times a day.

. Postoperative ulcers. For 150 mg 2 times asukki for 4-8 weeks.

Gastroesophageal reflux disease. 150 mg twice a day or 300 mg per night. If necessary, the dose can be increased to 150 mg 4 times a day. Course of treatment 8-12 weeks. When P-III Art. The severity of the reflux esophagitis dose is increased to 600 mg / day in 4 divided doses for 12 weeks.Prolonged preventive therapy -150 mg 2 times a day.

Zollinger-Ellison syndrome. The initial dose is 150 mg 3 times a day, if necessary, the dose can be increased to 6 g / day.

Prevention of recurrent bleeding. 150 mg twice a day.

Prevention of the development of Mendelssohn syndrome. Assign a dose of 150 mg for 2 hours before anesthesia, and also, preferably 150 mg the night before.

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

Children for the treatment of peptic ulcer - inside, 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 correction of the dosing regimen is required. When creatinine clearance is less than 50 ml / min, the recommended dose is 150 mg per 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; rarely - hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

Co sides of hemopoiesis: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypo- and aplasia of the bone marrow, immune hemolytic anemia.

Co cardiovascular system: lowering blood pressure, bradycardia, arrhythmia, AV-blockade.

From the nervous system: increased fatigue drowsiness; rarely - confusion, tinnitus, irritability, hallucinations (mainly in elderly patients and severe patients), 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 libido, impotence.

Allergic reactions: urticaria, skin rash, angioedema, anaphylactic shock, bronchospasm, erythema multiforme.

Other: alopecia, hypercreatininaemia.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment: symptomatic. Induction of vomiting or / and gastric lavage are indicated. With the development of seizures - diazepam intravenously, with bradycardia - atropine, ventricular arrhythmias - lidocaine.Hemodialysis is effective.

Interaction:

Increases AUC (the area under the pharmacokinetic curve) and the concentration of metoprolol in the serum (by 80 and 50%, respectively), while T_1/2 metoprolol increased from 4.4 to 6.5 h.

Reduces the absorption of itraconazole and ketoconazole.

Inhibits the 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 channel blockers.

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:

Symptoms of duodenal ulcer can disappear within 1-2 weeks, but therapy should be avoided. continue until the scarring is confirmed by endoscopic or X-ray data

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 "rebound").

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, GGT (gamma-glutamyltransferase) and transaminase in serum.

It counteracts 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 leading 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 inhibiting night secretion of acid in the stomach can be reduced by smoking.

During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa.

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 hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Tablets coated with a film coat of 150 mg and 300 mg.

Packaging:10 tablets in a strip of aluminum foil, laminated with low density polyethylene film. , 2 or 10 strips packed in a pack of cardboard with instructions for use.

Storage conditions:

List B.

In a dry, protected from light, 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 expiry date printed on the package.

Terms of leave from pharmacies:Without recipe

Registration number:П N015021 / 01

Date of registration:28.09.2009 / 28.02.2013

Expiration Date:Unlimited

The owner of the registration certificate:Dr. Reddy's Laboratories Ltd.Dr. Reddy's Laboratories Ltd. India

Manufacturer: & nbsp

DR. REDDY`S LABORATORIES, LTD. India

Information update date: & nbsp17.10.2017

Illustrated instructions

Instructions

Zoran® (Zoran®)