Description of the active substance:
This information is a reference and it is not enough that the drug has been prescribed by a doctor ..
PHARMACHOLOGIC EFFECT
The blocker of histamine H 2 -receptors. Suppresses the basal and stimulated by histamine, gastrin and acetylcholine (to a lesser extent) the secretion of hydrochloric acid. It increases the pH of gastric contents and reduces the activity of pepsin. The duration of action ranitidine with a single admission - 12 hours.
PHARMACOKINETICS
Once inside, ranitidine is rapidly absorbed from the digestive tract. Food intake and antacids slightly affect the degree of absorption. Exposed to the effect of "first passage" through the liver. C max in plasma is achieved 2 hours after a single oral intake. After the / m introduction quickly and almost completely absorbed from the injection site. C max is reached after 15 minutes.
Binding to proteins - 15%. V d - 1.4 l / kg. Ranitidine is excreted in breast milk.
T 1/2 is 2-3 hours. About 30% of the dose is excreted unchanged in the urine. The rate of excretion is reduced if the liver or kidney function is impaired.
INDICATIONS
Stomach ulcer and duodenal ulcer in the phase of exacerbation; prevention of exacerbations of peptic ulcer; symptomatic ulcers; erosive and reflux esophagitis;Zollinger-Ellison syndrome; prevention of "stressful" gastrointestinal ulcers, postoperative ulcers, relapses of bleeding from the upper gastrointestinal tract; prevention of aspiration of gastric juice during surgery under anesthesia.
DOSING MODE
Install individually. Inside for the treatment of adults and children over 14 years of age use in a daily dose of 300-450 mg, if necessary, the daily dose is increased to 600-900 mg; the frequency of reception is 2-3 times / day. For the prevention of exacerbations of diseases apply 150 mg / day before bedtime. The duration of treatment is determined by indications for use. Patients with renal insufficiency with a creatinine level of more than 3.3 mg / 100 ml - 75 mg 2 times / day.
In / in or / m - for 50-100 mg every 6-8 hours.
SIDE EFFECT
From the side of the cardiovascular system: in isolated cases (with iv introduction) - AV blockade.
From the digestive system: rarely - diarrhea, constipation; in isolated cases - hepatitis.
From the side of the central nervous system: rarely - headache, dizziness, fatigue, blurred vision; in isolated cases (in seriously ill patients) - confusion, hallucinations.
From the hemopoietic system: rarely - thrombocytopenia; with prolonged use in high doses - leukopenia.
From the side of metabolism: rarely - a slight increase in serum creatinine at the beginning of treatment.
On the part of the endocrine system: with prolonged use in high doses, an increase in prolactin, gynecomastia, amenorrhea, impotence, a decrease in libido is possible.
From the musculoskeletal system: very rarely - arthralgia, myalgia.
Allergic reactions: rarely - skin rash, hives, angioedema, anaphylactic shock, bronchospasm, arterial hypotension.
Other: rarely - recurrent parotitis; in isolated cases - hair loss.
CONTRAINDICATIONS
Pregnancy, lactation (breastfeeding), hypersensitivity to ranitidine.
PREGNANCY AND LACTATION
Adequate and well-controlled studies of the safety of ranitidine in pregnancy have not been conducted, and therefore the use in pregnancy is contraindicated.
If it is necessary to use ranitidine during lactation, breastfeeding should be stopped.
APPLICATION FOR FUNCTIONS OF THE LIVER
Use with caution in patients with impaired renal excretion.
APPLICATION FOR CHILDREN
Clinical data on the safety of ranitidine in pediatrics are limited.
SPECIAL INSTRUCTIONS
Use with caution in patients with impaired renal excretion.
Before starting treatment, it is necessary to exclude the possibility of having a malignant disease of the esophagus, stomach or duodenum.
With long-term treatment in weakened patients under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection.
It is undesirable to abruptly stop taking ranitidine because of the risk of recurrence of peptic ulcer. The effectiveness of preventive treatment of peptic ulcer is higher when taking ranitidine by courses of 45 days in the spring-autumn period than with a constant intake. Rapid intravenous administration of ranitidine in rare cases causes bradycardia, usually in patients predisposed to heart rhythm disturbances.
There have been isolated reports that ranitidine may contribute to the development of an acute attack of porphyria, and therefore it is necessary to avoid its use in patients with acute porphyria in the anamnesis.
Against the background of the use of ranitidine, there may be distortions in laboratory data: an increase in the level of creatinine, GGT activity and liver transaminase in the blood plasma.
In those cases where ranitidine is used in combination with antacids, the interval between taking antacids and ranitidine should be at least 1-2 hours (antacids can cause impaired absorption of ranitidine).
Clinical data on the safety of ranitidine in pediatrics are limited.
DRUG INTERACTION
With simultaneous use with antacids, it is possible to reduce the absorption of ranitidine.
When used simultaneously with anticholinergic drugs, memory and attention may be impaired in elderly patients.
It is believed that the blockers of histamine H 2 -receptors reduce the ulcerogenic effect of NSAIDs on the gastric mucosa.
With simultaneous use with warfarin, a decrease in warfarin clearance is possible. A case of development of hypoprothrombinemia and bleeding in a patient receiving warfarin is described.
With the simultaneous use of dicitrate with bismuth tricalium, an undesirable increase in the absorption of bismuth is possible; with glibenclamide - cases of development of hypoglycemia are described; with ketoconazole, itraconazole - the absorption of ketoconazole, itraconazole decreases.
With simultaneous use with metoprolol, an increase in plasma concentration and an increase in AUC and T 1/2 of metoprolol are possible.
With simultaneous application with sucralfate in high doses (2 g), a violation of the absorption of ranitidine is possible.
With simultaneous use with procainamide, a decrease in the excretion of procainamide by the kidneys is possible, which leads to an increase in its concentration in the blood plasma.
There is evidence of an increase in the absorption of triazolam when it is used concomitantly, apparently due to a change in the pH of the stomach contents under the influence of ranitidine.
It is believed that with simultaneous use with phenytoin, an increase in the concentration of phenytoin in the blood plasma and an increased risk of toxicity development are possible.
With simultaneous application with furosemide moderately expressed increase in bioavailability of furosemide.
A case of development of ventricular arrhythmia (bigemini) is described with simultaneous application with quinidine; with cisapride - the case of the development of cardiotoxicity has been described.
It is impossible to exclude a slight increase in the concentration of cyclosporine in the blood plasma when it is used simultaneously with ranitidine.
