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

Excipients: microcrystalline cellulose, corn starch, povidone, sodium carboxymethyl starch type A, magnesium stearate, sodium lauryl sulfate. SHELL: hypromellose, 6 cp, iron dye oxide yellow, E172, iron dye oxide red, E172, titanium dioxide, talc, propylene glycol.

Description:

Tablets of 150 mg: round, biconvex tablets, covered with a film coating of light brown color.

Tablets 300 mg: round, biconvex tablets with bevelled edge and risk on one side, covered with a film shell of light brown color.

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:

Ranitidine is a blocker of histamine Hg-receptors of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid, caused by irritation of baroreceptors, food load, action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin). Ranitidine reduces the volume of gastric juice and the content of hydrochloric acid in it, increases the pH of the contents of the stomach, which leads to a decrease in the activity of pepsin. After oral administration in therapeutic doses does not affect the level of prolactin. Inhibits microsomal enzymes. Duration of action after a single dose of up to 12 hours.

Pharmacokinetics:

Quickly absorbed, eating does not affect the degree of absorption. When administered orally, the bioavailability of ranitidine is approximately 50%. Maximum plasma concentrations are achieved 2-3 hours after admission. Binding to plasma proteins does not exceed 15%. It is slightly metabolized in the liver with the formation of dimethyl-mannitidine and S-oxy ranitidine. Has the effect of "first pass" through the liver.The speed and degree of elimination depend little on the condition of the liver. Half-life after ingestion - 2.5 hours, with creatinine clearance of 20-30 ml / min - 8-9 hours. It is excreted mostly with urine (60-70%, unchanged - 35%), a small amount - with bile. Poorly penetrates the blood-brain barrier. Penetrates through the placenta. Excreted in breast milk (concentration in breast milk in women during lactation is higher than in plasma).

Indications:

Treatment and prevention of exacerbations of peptic ulcer of the stomach and duodenum.
Treatment and prevention of symptomatic gastric and duodenal ulcers (NSAIDs-gastropathy, postoperative, "stressful" ulcers of the upper gastrointestinal tract) and bleeding;
Functional dyspepsia associated with increased secretory function of the stomach.
Treatment of gastroesophageal reflux disease (GERD): reflux-esophagitis, erosive esophagitis.
Zollinger-Ellison syndrome.
Treatment and prevention of recurrence of bleeding from the upper sections of the gastrointestinal tract.
Prevention of aspiration of gastric juice in operations under general anesthesia (Mendelssohn syndrome).

Contraindications:

Hypersensitivity to ranitidine or other components of the drug.
Lactation period.
Children under 12 years.

Carefully:

renal and / or hepatic insufficiency, cirrhosis with portosystemic encephalopathy in history, acute porphyria (including in history), arrhythmia, suppression of immunity, pregnancy.

Pregnancy and lactation:

renal and / or hepatic insufficiency, cirrhosis with portosystemic encephalopathy in history, acute porphyria (including in history), arrhythmia, suppression of immunity, pregnancy.

Dosing and Administration:

Inside, regardless of food intake, without chewing, squeezed a small amount of liquid.

Adults and children over 12 years of age:

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, for smokers - 300 mg at night.

NSAIDs are gastropathy. Assign 150 mg twice a day or 300 mg per night for 8-12 weeks; prophylaxis - 150 mg twice a day.

Postoperative and "stressful" ulcers. Assign 150 mg twice a day for 4-8 weeks.

Erosive reflux esophagitis. Assign 150 mg twice a day or 300 mg at night. If necessary, the dose can be increased to 150 mg 4 times a day. The course of treatment is 8-12 weeks. Prolonged preventive therapy is 150 mg twice 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 per 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.

If there is a concomitant liver function disorder, a dose reduction may be required.

Patients with renal insufficiency with creatinine clearance less than 50 ml / min the recommended dose is 150 mg per day.

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 - increased activity of "hepatic" transaminases, hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

On the part of the organs of hematopoiesis: leukopenia, thrombocytopenia, rarely -

agranulocytosis, pancytopenia, neutropenia, hypo- and aplasia of the bone marrow, immune hemolytic anemia.

From the cardiovascular system: lowering blood pressure, bradycardia, tachycardia, arrhythmia, ventricular extrasystole, atrioventricular blockade, vasculitis.

From the nervous system: increased fatigue, drowsiness, insomnia, headache, dizziness, hyperthermia; rarely - confusion, tinnitus, emotional lability, irritability, hallucinations, confusion, anxiety, anxiety, depression (mainly in elderly patients and severe patients), very rarely involuntary movements.

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

On the part of the musculoskeletal system, arthralgia, myalgia.

From the endocrine system: hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, impotence.

Allergic reactions: urticaria, skin rash, angioedema,

anaphylactic shock, itching, bronchospasm, multiforme exudative erythema, incl.Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal necrolysis.

Other: alopecia.

Overdose:

Symptoms: convulsions, vomiting, arterial hypotension, bradycardia, ventricular arrhythmias, dyspnea.

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

Interaction:

Smoking reduces the effectiveness of ranitidine.

Increases AUC and the concentration of metoprolol in the serum (respectively, 80% and 50%), while T 14 metoprolol increased from 4.4 to 6.5 h.

Due to the increase in the pH of the contents of the stomach with simultaneous intake may reduce the absorption of itraconazole and ketoconazole.

Inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, aminophylline, indirect anticoagulants, glipizide, buformin, metronidazole, calcium antagonists. Increases the concentration of procainamide.

Medicines that depress hemopoiesis in the bone marrow increase the risk of neutropenia.

When used simultaneously with antacids, sucralfate in high doses, the absorption of ranitidine may be impaired, so the interval between taking these drugs should be at least 1-2 hours.

Special instructions:

Ranitidine treatment can mask the symptoms associated with carcinoma of the stomach, so before starting treatment it is necessary to exclude the presence of malignant neoplasm.

Ranitidine, like all H2 - gistaminoblokatory, it is undesirable to abruptly cancel (syndrome "bounce").

Safety and efficacy in children under 12 years of age have not been established.

There is evidence that in patients suffering from porphyria, ranitidine can cause acute attacks of porphyria.

Blockers H2-gistaminoreceptors should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption.

Can increase the level of glutamate transpeptidase, creatinine and transaminase serum.

It can be the cause of a false positive response to a sample of protein in the urine.

The H2-histamine-receptor blockers can counteract the effects of pentahister and histamine on the acid-forming function of the stomach, therefore, within 24 hours preceding the test, use H2-histaminoreceptors is not recommended.

The H2-histamine-receptor blockers can inhibit the skin reaction to histamine, thus leading to false positive results (before conducting diagnostic skin tests to detect an immediate allergic skin reaction, use of H2-histamine-receptor blockers it is recommended to stop).

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

during the treatment period, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Film-coated tablets, 150 mg and 300 mg.

Packaging:10 tablets in a blister pack.
Tablets of 150 mg: 2 blisters together with instructions for use in a cardboard bundle.

Tablets 300 mg: 3 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

Store in a dry, 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 expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N015063 / 01

Date of registration:13.02.2008

Date of cancellation:2017-04-28

The owner of the registration certificate:KRKA, dd, Novo mesto, AOKRKA, dd, Novo mesto, AO

Manufacturer: & nbsp

KRKA, dd, Novo mesto, AO Slovenia

Information update date: & nbsp28.04.2017

Illustrated instructions

Instructions

Ullran® (Ulran®)