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

Ranitidine is a histamine H antagonist₂receptors 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 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.

Half-life after ingestion - 2.5 hours, with creatinine clearance of 20-30 ml / min - 8-9 hours. It is excreted mainly with urine in unchanged form, a small amount - with feces. 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; gastric and duodenal ulcers associated with the use of non-steroidal anti-inflammatory drugs (NSAIDs); reflux-esophagitis, erosive esophagitis; Zollinger-Ellison syndrome; treatment and prevention of postoperative, "stressful" ulcers of the upper gastrointestinal tract; prevention of recurrent bleeding from the upper 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. Pregnancy, lactation. Children under 12 years.

Carefully:With caution - renal and / or liver failure, cirrhosis with portosystemic encephalopathy in history, acute porphyria (including in the anamnesis).

Dosing and Administration:

Ranitidine is taken regardless of food intake, without chewing, squeezed with a small amount of liquid.

Adults and children over 12 years of age:

Stomach ulcer and duodenal ulcer. For the treatment of exacerbations appoint 0.15 g 2 times a day (morning and evening) or 0.3 g at night.If necessary - 0.3 g 2 times a day. Duration of treatment - 4-8 weeks. To prevent exacerbations appoint 0.15 g per night.

Ulcers associated with taking NSAIDs. Assign 0.15 g 2 times a day or 0.3 g per night for 8-12 weeks. Prevention of ulceration when taking NSAIDs - 0.15 g 2 times a day.

Postoperative with "stressful" ulcers. Assign 0.15 g 2 times a day for 4-8 weeks.

Reflux-esophagitis, erosive esophagitis. Assign 0.15 g 2 times a day or 0.3 g at night. If necessary, the dose can be increased to 0.15 g 4 times a day. The course of treatment is 8-12 weeks.

Zollinger-Ellison syndrome. The initial dose is 0.15 g 3 times a day, if necessary, the dose can be increased.

Prevention of recurrent bleeding. To 0.15 g 2 times a day. Prevention of the development of Mendelssohn syndrome. Assign a dose of 0.15 g for 2 hours before anesthesia, and also, preferably 0.15 g the evening before.

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

Patients with renal insufficiency with creatinine clearance less than 50ml / min the recommended dose is 0.15 g 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 - hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

From the hematopoiesis: leukopenia, thrombocytopenia,

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

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

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

From the senses: blurred vision, paresis of accommodation.

From the musculoskeletal system: arthralgia, myalgia.

On the part of 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. 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 T1 / 2 metoprolol increased from 4.4 to 6.5 h.

Due to the increase in the pH of the contents of the stomach with simultaneous administration, the absorption of itraquinazole and ketoconazole may decrease.

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

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.

Special instructions:

Ranitidine treatment can mask the symptoms associated with carcinoma of the stomach, so before the start of treatment it is necessary to exclude the presence of cancer-ulcers.

Ranitidine, like all H2-gistaminoblokatory, undesirably 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.

Safety and efficacy of ranitidine in children younger than 12 years of age have not been established.

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

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

Blockers of H2-histamine-receptors should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant decrease in their absorption.

May increase the activity of glutamate transpeptidase.

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, so it is not recommended to use Hg-histamine-receptor blockers within 24 hours prior to the test.

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

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, it is necessary to refrain from engaging in potentially dangerous activities that require a high concentration of attention and speed of psychomotor reactions.

Form release / dosage:

The tablets covered with a cover, on 0,15. On 10 tablets in contour cellular packings. 2 contour mesh packages together with instructions for use in a pack of cardboard.

Packaging: For 10 tablets in contour cell packs. 2 contour mesh packages together with instructions for use in a pack of cardboard.

Storage conditions:List B. In a dry, protected from light and inaccessible to children place.

Shelf life:3 years.Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:P N003425 / 01

Date of registration:05.10.2009

The owner of the registration certificate:NORTH STAR, CJSC NORTH STAR, CJSC Russia

Manufacturer: & nbsp

NORTH STAR, CJSC Russia

Information update date: & nbsp05.10.2009

Illustrated instructions

Instructions

Ranitidine (Ranitidine)