Composition, form of production and packaging
? The tablets covered with a film cover of light pink color, round, biconcave; on the fracture - the core is almost white or whitish-yellow in color and the shell is light pink in color.
1 tab.
ranitidine hydrochloride 84 mg,
which corresponds to a ranitidine content of 75.26 mg
[PRING] microcrystalline cellulose, corn starch, magnesium stearate, copovidone, povidone 25, titanium dioxide, methylhydroxypropylcellulose, iron oxide red, iron oxide yellow, simethicone emulsion with silicon dioxide, polyethylene glycol 6000.
10 pieces. - blisters (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
The description of the drug was approved by the manufacturer for the 2006 print edition.
PHARMACHOLOGIC EFFECT
The blocker of histamine H 2 -receptors of parietal cells of the gastric mucosa. Reduces basal and stimulated secretion of hydrochloric acid (hydrochloric acid), caused by irritation of baroreceptors, food load, action of hormones and biogenic stimulants (histamine, gastrin, pentagastrin).
Reduces the volume of gastric juice and the content of hydrochloric acid (hydrochloric acid) in it. Promotes an increase in the pH of gastric contents, which leads to a decrease in the activity of pepsin. Inhibits microsomal enzymes.
The duration of action of ranitidine after a single dose is 12 hours.
PHARMACOKINETICS
Suction
After oral administration, it is rapidly absorbed from the digestive tract. The bioavailability of ranitidine is approximately 50%. Eating does not affect the degree of absorption.
After intake of C max is achieved in 2-3 hours.
Distribution
Binding to plasma proteins does not exceed 15%. Ranitidine penetrates the placental barrier. Excreted in breast milk (concentration in breast milk is higher than in plasma). Badly penetrates the BBB.
Metabolism
It is slightly metabolized in the liver with the formation of S-oxide ranitidine and desmethylranitidine. Has the effect of "first pass" through the liver.
Excretion
T 1/2 is 2.5 hours.
After taking 60-70% of the drug is excreted in the urine and 26% - with feces; 35% of the dose taken is excreted unchanged in the urine.
Pharmacokinetics in special clinical cases
With a creatinine clearance of 20-30 ml / min T 1/2 is 8-9 hours.
INDICATIONS
- symptomatic treatment of dyspepsia associated with high acidity of the gastric juice (heartburn, nausea, eructation).
DOSING MODE
Adults and children over the age of 12 years with the appearance of heartburn or other symptoms of dyspepsia are prescribed 1 tab. The maximum daily dose is 2 tablets. Duration of admission - no more than 14 days.
The tablet should be swallowed whole, washed down with a small amount of water.
SIDE EFFECT
On the part of the digestive system: nausea, dry mouth, constipation, vomiting, diarrhea, abdominal pain; rarely - the development of hepatitis (hepatocellular, cholestatic or mixed), acute pancreatitis.
On the part of the hematopoiesis system: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, hypo- and aplasia of the bone marrow, immune hemolytic anemia.
On the part of the cardiovascular system: lowering blood pressure, arrhythmia, bradycardia, AV-blockade.
From the side of the central nervous system: headache, dizziness, fatigue, drowsiness; rarely - irritability, confusion, tinnitus, blurred vision, paresis of accommodation, involuntary movements, hallucinations (mainly in critically ill and elderly patients).
From the musculoskeletal system: arthralgia, myalgia.
On the part of the endocrine system: hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, reversible impotence.
Allergic reactions: skin rash, erythema multiforme, hives, angioedema, anaphylactic shock, bronchospasm.
Other: alopecia, hypercreatininaemia.
CONTRAINDICATIONS
- Pregnancy;
- lactation period (breastfeeding);
- children's age till 12 years;
- Hypersensitivity to ranitidine and other components of the drug.
With caution should prescribe the drug in renal and hepatic insufficiency, with cirrhosis of the liver with portosystemic encephalopathy in history, acute porphyria (including in the anamnesis).
PREGNANCY AND LACTATION
Ranitidine penetrates the placenta and is excreted in breast milk (concentration in breast milk is higher than in plasma).
The use of the drug during pregnancy is contraindicated.
If it is necessary to prescribe the drug during lactation, the question of stopping breastfeeding should be solved.
APPLICATION FOR FUNCTIONS OF THE LIVER
With caution should prescribe the drug for kidney failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
With caution should prescribe the drug for liver failure, with cirrhosis with portosystemic encephalopathy in history, acute porphyria (including in the anamnesis).
APPLICATION FOR CHILDREN
The drug is contraindicated for children under 12 years.
SPECIAL INSTRUCTIONS
With caution should appoint Ranisan in the presence of a history of peptic ulcer, violations of the heart rhythm, failure of the liver and kidneys, porphyria, swallowing disorders, unmotivated weight loss, taking other medications.
Before starting treatment, it is necessary to exclude the possibility of having a malignant disease of the esophagus, stomach or duodenum.
Ranisan should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant decrease in their absorption.
The blockers of histamine H 2 receptors can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach, therefore it is not recommended to use Ranisan within 24 hours preceding the test.
The blockers of histamine H 2 -receptors can suppress the skin reaction to histamine, thus leading to false negative results. Therefore, before carrying out diagnostic skin tests to detect an allergic skin reaction of immediate type, Ranisan should be discarded.
During treatment, avoid eating foods, beverages and other medications that can cause irritation of the gastric mucosa.
Smoking reduces the effectiveness of Ranisan.
Impact on the ability to drive vehicles and manage mechanisms
During the period of taking the drug, Ranisan should refrain from engaging in potentially dangerous activities that require an increased concentration of attention and speed of psychomotor reactions.
OVERDOSE
Symptoms: convulsions, bradycardia, ventricular arrhythmias.
Treatment: conduct symptomatic therapy; with the development of convulsions - diazepam IV, with bradycardia and ventricular arrhythmias, atropine, lidocaine is administered. Ranitidine can be removed from the plasma during hemodialysis.
DRUG INTERACTION
When taken on a background of ranitidine, AUC and the concentration of metoprolol in the blood serum (respectively, 80% and 50%), while T 1/2 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 with ranitidine, the absorption of itraconazole and ketoconazole may decrease.
Ranitidine inhibits the metabolism of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, lidocaine, phenytoin, theophylline, aminophylline, indirect anticoagulants, glipizide, buformin, metronidazole, calcium antagonists.
With the simultaneous administration of ranitidine and drugs that depress the bone marrow, the risk of developing neutropenia increases.
With the simultaneous use of ranitidine with antacids, sucralfate in high doses, it is possible to slow the absorption of ranitidine, therefore, the interval between doses of these drugs should be at least 2 hours.
TERMS OF RELEASE FROM PHARMACY
The drug is approved for use as a means of OTC.
TERMS AND CONDITIONS OF STORAGE
Tablets should be stored in a dry, protected from light and out of reach of children at a temperature of 15-25 В° C. Shelf life - 2 years.
