Ranitidine Sopharma - instructions for use, doses, side effects, contraindications

Active substance: 150 mg ranitidine (as hydrochloride). Excipients: cellulose microcrystalline (0.110 g), magnesium stearate (0.003 g), silicon dioxide colloid (0.001 g), copovidone (0.018 g)

Sheath:

Opadrai (0.010 g).

Description:

Round biconvex tablets covered with a film coat of white or almost white color. The cross section is almost white.

Pharmacotherapeutic group:An agent that reduces the secretion of the glands of the stomach is the blocker of H2-histamine receptors

ATX: & nbsp

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

A.02.B.A.02 Ranitidine

Pharmacodynamics:

Ranitidine is a selective high-speed blocker H2 - histamine receptors of parietal cells of the gastric mucosa. It reduces basal and stimulated secretion of hydrochloric acid caused by stimulation of the baroreceptors by nutritional load, the action of hormones and biogenic stimulators of gastric juice secretion (gastrin, histamine, / pentagastrin). Ranitadine reduces the volume of gastric juice and the content of hydrochloric acid 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 at therapeutic doses, it does not affect the concentration of prolactin. Inhibits microsomal enzymes of the liver.

Duration of action after a single dose of up to 12 hours.

Pharmacokinetics:

After oral administration ranitidine quickly absorbed regardless of food intake. The bioavailability of ranitidine is approximately 50%. The maximum concentration of ranitidine in the blood plasma is reached in 2-3 hours after its administration. It binds up to 15% with plasma proteins. The volume of distribution is -1.4 l / kg. It is slightly metabolized in the liver. Metabolism occurs with the formation of ranitidine N- oxide (6%), ranitidine S-oxide (2%),

desmethylranitidine (2%) and a furoy acid analogue (1-2%). 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 is 2.5-3 hours, and with creatinine clearance of 20-30 ml / min - 8-9 hours. It is excreted mainly with urine in unchanged form, a small amount - through the intestine. Poorly penetrates the blood-brain barrier.Penetrates through the placental barrier and excreted in breast milk (the concentration of the drug in breast milk in women during lactation is higher than in blood plasma).

With pronounced disturbances of kidney function, the concentration of ranitidine in the plasma increases.

Indications:

treatment and prevention of exacerbations of peptic ulcer of the stomach and duodenum;
gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs);
duodenal ulcers due to infection Helicobacter pylori;
reflux-esophagitis, erosive reflux-esophagitis;
Zollinger-Ellison syndrome;
chronic dyspepsia characterized by heartburn;
treatment and prevention of post-operative "stressful" ulcers of the upper gastrointestinal tract (GIT);
prevention of hemorrhage in patients with peptic ulcers;
prevention of aspiration of gastric juice in operations under general anesthesia (syndrome Mendelssohn).

Contraindications:

Hypersensitivity to ranitidine or any other component of the drug.

Severe renal or hepatic insufficiency.

Pregnancy and lactation;

Children under 12 years.

Carefully:

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

Pregnancy and lactation:

Ranitidine penetrates the placental barrier. During pregnancy and lactation it is recommended to avoid the use of the drug.

Dosing and Administration:

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

Adults and children over 12 years of age.

Treatment and prevention of exacerbations of peptic ulcer of the stomach and duodenum: to treat exacerbations appoint 150 mg twice a day (morning and evening) or 300 mg at night. If necessary, -300 mg 2 times a day. The duration of the course of treatment is 4-8 weeks. To prevent exacerbations appoint 150 mg at night, smoking patients - 300 mg at night.

Gastric and duodenal ulcers associated with the intake of NSAIDs: appoint 150 mg twice a day or 300 mg per night for 8-12 weeks. For prevention of 150 mg 2 times a day during treatment with NSAIDs.

Ulcers of duodenum caused by infection Helicobacter pylori:

the recommended dose is 150 mg twice a day (in the morning andin the evening) or 300 mg once in the evening in combination with amoxicillin (750 mg 3 times a day) and metronidazole (500 mg 3 times a day) for 2 weeks. Ranitidine treatment continues after this course for 2 more weeks.

Reflux-esophagitis, erosive reflux esophagitis: prescribe 150 mg 2 times 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 once a day, if necessary, the dose can be increased: Duration of treatment - as needed .., ", '

Chronic dyspepsia: in patients with dyspepsia with high acidity - 150 mg 2 times a day for 2-4 weeks.

Treatment and prevention of post-operative "stressful" ulcers of the upper gastrointestinal tract: prescribe 150 mg 2 times a day for 4-8 weeks.

Prevention of hemorrhage in patients with peptic ulcers: 150 mg twice a day. Duration of treatment - as needed.

Prevention of the development of aspiration of gastric juice in operations under general anesthesia (Mendelssohn syndrome): appoint a dose of 150 mg 2 hours before the general anesthesia and the night before.If there is a concomitant liver function disorder, a dose reduction may be required. For patients with renal insufficiency with creatinine clearance less than 50 ml / min, the recommended dose is 150 mg per day.

Patients with renal insufficiency

Patients with impaired renal function (creatinine clearance less than 50 ml / min) ranitidine appoint 150 mg per day, and if necessary, the dose can be carefully increased to 300 mg.

Patients with impaired hepatic function

In patients with impaired hepatic function, a dose reduction is necessary.

Side effects:

From the digestive system: nausea, dry mouth, constipation, vomiting, transient and reversible changes in functional hepatic tests, diarrhea, abdominal pain, hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

On the part of the organs of hematopoiesis, leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypo- and aplasia of the bone marrow, immune hemolytic anemia.

From the side of the cardiovascular system: lowering blood pressure, bradycardia, arrhythmia, atrio-ventricular blockade, vasculitis.

From the nervous system: increased fatigue, drowsiness, headache, dizziness, confusion, depression, 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: hyperprolactinaemia, gynecomastia, amenorrhea, decreased libido, reversible impotence, the appearance of swelling or a feeling of discomfort in the mammary glands in men

Allergic reactions: urticaria, skin rash, angioedema '

edema, anaphylactic shock, bronchospasm, arterial hypotension, muliform exudative erythema, fever, chest pain

Other: alopecia, hypercreatininaemia, increased activity of gamma-

glutamyltranspeptidase, acute porphyria.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment is symptomatic. Ranitidine is removed from the body by hemodialysis.

Interaction:

Increases the concentration of metoprolol in the blood serum by 50%, while the half-life of metoprolol increases from 4.4 to 6.5 hours.

Due to the increase in the pH of the contents of the stomach, with simultaneous administration, itraconazole and ketoconazole may be reduced (the drug should be taken 2 hours after the administration of itraconazole or ketoconazole).

Inhibits the metabolism in the liver of phenazone, diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, aminophylline, indirect anticoagulants, glipizide, buformin, metronidazole, blockers of "slow" calcium channels. Drugs that depress the bone marrow increase the risk of neutropenia. With simultaneous use with antacids, sucralfate in high doses, it is possible to slow the absorption of ranitidine, so a break between taking these drugs should be at least 2 hours.

Smoking reduces the effectiveness of ranitidine.

The simultaneous use of ranitidine with alcohol can lead to an increase in the content of ethyl alcohol in the blood.

Special instructions:

Ranitidine treatment can mask symptoms associated with malignant neoplasms of the stomach. Therefore, before the start of therapy, it is necessary to exclude the possibility of such diseases, especially in the presence of malabsorption, as well as in elderly patients with the appearance of dyspeptic symptoms.

If it is necessary to stop treatment, the drug is canceled, gradually reducing the dose, in order to avoid the syndrome of "bounce".

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

There is evidence that ranitidine can cause acute attacks of porphyria.

The drug may increase the activity of gamma-glutamyltranspeptidase and cause a false positive reaction when carrying out a sample for the protein in the urine.

Blockers of Hg-histamine receptors (incl. ranitidine) can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach, therefore, within 24 hours preceding the test, ranitidine Not recommended.

The H2-histamine blocker blockers can suppress the skin reaction to histamine, thus leading to false positive results (before running diagnostic skin tests to detect an allergic skin reaction of immediate type, it is recommended to stop ranitidine).

During treatment should avoid the use of food, beverages and other medicines,which can cause irritation of the gastric mucosa

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

In the period of taking ranitidine, it is necessary to refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions, the drug may cause dizziness and other side effects that may affect these abilities.

Form release / dosage:

Tablets, film-coated 150 mg.

For 10 tablets in a blister of PVC film of orange color and aluminum foil. 1 or 6 blisters with instructions for use in a pack of cardboard

Packaging:For 10 tablets in a blister of PVC film of orange color and aluminum foil. 1 or 6 blisters with instructions for use in a pack of cardboard

Storage conditions:

In dry the dark place at a temperature of no higher than 25 C. Keep out of the reach of children!

Shelf life:

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

Terms of leave from pharmacies:Without recipe

Registration number:П N011543 / 01

Date of registration:15.02.11

The owner of the registration certificate:Sopharma, AOSopharma, AO Bulgaria

Manufacturer: & nbsp

SOPHARMA, AD Bulgaria

Representation: & nbspSOFARMA SA SOFARMA SA Bulgaria

Information update date: & nbsp22.03.2013

Illustrated instructions

Instructions

Ranitidine Sopharma (Ranitidine Sophrama)