Ranisan - instructions for use, doses, side effects, contraindications


Composition per one tablet
Active substance:
Ranitidine	84.00 mg	168.00 mg
hydrochloride '
(equivalent to
ranitidine	75.26 mg	150.53 mg
Excipients
Core:
cellulose micro-	22.00 mg	44.00 mg
crystalline
starch	14.50 mg	30.00 mg
corn	'
copovidone	2.00 mg	4.00 mg
povidone 25	2.00 mg	4.00 mg
magnesium stearate	1.50 mg	3.00 mg
Massandra	126.00 mg	253.00 mg
Sheath:
simethicone,	0.035 mg	0.020 mg
emulsion
Opadry	06F23882	06F28325
	9.965 mg:	19.980 mg:
hypromellose 5	2,500 mg	5.009 mg
hypromellose 15	2,500 mg	5.009 mg
titanium dioxide	2.364 mg	4,470 mg
macrogol 6000	1.651 mg	3,227 mg
magnesium stearate	0.850 mg	2.265 mg
dibutyl phthalate	-	-
iron dye	0.050 mg	-
oxide red
iron dye	0.050 mg	-
oxide yellow
Shell Weight	10,000mg	20,000 mg
Weight of a tablet	136.00 mg	273,000 mg

Description:

round, biconvex tablets covered with a film coat of light pink color. At the break: the core is almost white or with a yellowish tinge, the shell is light pink in 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:

The blocker of H2-histamine receptors of the second generation. The mechanism of action is associated with blockade of H2-histamine receptors in membranes of parietal cells of the gastric mucosa. Suppresses day and night, as well as basal and stimulated secretion of hydrochloric acid (HCl), reduces the amount of gastric juice caused by stretching the stomach food load, the action of hormones and biogenic stimulants (gastrin, histamine, acetylcholine, pentagastrin, caffeine) 'Reduces the number of HCl in gastric juice, practically ns suppressing "hepatic" enzymes associated with cytochrome P450, does not affect the concentration of gastrin in the plasma, the production of mucus. Reduces the activity of pepsin.

Does not affect the concentration of calcium ions in the blood serum. After oral administration in therapeutic doses does not affect the concentration of prolactin. Has no effect on the release of pituitary hormones: gonadotropin, thyrotropic and somatotropic hormones. Does not affect the concentration of cortisol, aldosterone,androgens or estrogens, the motility of spermatozoa, the amount and composition of sperm, and also has no antiandrogenic effect.

May attenuate the release of vasopressin. Strengthens the protective mechanisms of the gastric mucosa and promotes the healing of its damage associated with the action of hydrochloric acid, by increasing the formation of gastric mucus, her glycoproteins, stimulation of the secretion of bicarbonate by the gastric mucosa, endogenous synthesis in it of prostaglandia (Pg) and the regeneration rate. In a dose of 150 mg inhibits the secretion of gastric juice for 8-12 hours. Inhibits microsomal enzymes (weaker cimetidine). Duration of action after a single dose of up to 12 hours.

Pharmacokinetics:

Quickly absorbed, food intake does not affect the degree of absorption, does not have virtually no effect on the plasma concentration of ranntidine and its pharmacokinetic properties. After a single oral dose of 150 mg ranitidine maximum plasma concentrations reach 403-411 kg / ml. with the repeated administration of the same dose in 12-hour intervals in a steady state, plasma concentrationsreach 653 ng / ml. When administered orally, the bioavailability of ranitidine is approximately 50%. The maximum concentration (Cmax) - 36-94 ng / ml (with oral administration of 150 mg ranitidine), time to reach Cmax in blood plasma is 2-3 hours after administration. Binding to plasma proteins does not exceed 15%. The total clearance is 568-709 ml / min. Ranitidine very well penetrates into tissues and liquids: it passes through the placental barrier (the concentration of ranitidine in breast milk in women is higher in lactation than in plasma), the central nervous system (CNS), where it reaches 15-20% of the plasma concentration. Has the effect of "first pass" through the liver. The speed and degree of elimination depend little on the condition of the liver. Hepatitis clearance of ranitidine reaches 70% after ingestion. Half-life after taking the drug inside with a normal clearance of creatinine (CC) - 2.5 hours, with KK 20-30 ml / min - 8-9 hours. Metabolised in the liver with the formation of desmethylranitidine (1,7-2,4%), oxide ranitidina-N (3-5%), ranitidine oxide-S (1.1-1.7%). All these metabolites are pharmacologically inactive, but the level of their hydrophilia is greater than that of ranitidine, and therefore they are excreted mainly in the urine (60-70%), unchanged ranitidine (35%) is excreted by glomerular filtration and tubular secretion through the kidneys and through the intestine.

Indications:

Symptomatic treatment of dyspeptic disorders associated with high acidity of gastric juice (heartburn, nausea, acidic eructation).

Without the appointment of a doctor, the drug can be taken by adults (over 18 years), children under 12 years old - only on the advice of a doctor.

Contraindications:

Ranisan® should not be used: with increased sensitivity to ranitidine and excipients of the drug; with lactation; before excluding the diagnosis of the malignant nature of the stomach ulcer; children up to 3 years.

Carefully:

Renal and / or hepatic insufficiency, cirrhosis of the liver with portentous encephalopathy in history, suppression of immunity, acute porphyria (including in history), pregnancy.

Pregnancy and lactation:

Ranitidine passes into breast milk and creates a concentration in it above the plasma. After a single oral intake of 150 mg ranitidine, the concentration ratio in breast milk and plasma was 0.6-2.7 (2 hours after administration), 1.1-10.2 (4 hours after administration), and 2.9-17.1 ( 8 hours after administration). With the repeated administration of the drug, these relationships are still increasing.The amount of ranitidine taken by an infant with breast milk can reach 0.4-0.54 mg / kg / day, which corresponds to 11.9% of the dose taken by the mother during breastfeeding. For the above reasons, taking RANISAN® during lactation is contraindicated.

Dosing and Administration:

In case of heartburn or other symptoms of dyspepsia, I take Ranisan ® tablet.

The tablet should be swallowed whole, washed down with a small amount of water. Do not use more than two tablets per day.

Without the appointment of a doctor, the drug should not be used for more than 14 days. .

Side effects:

From the digestive system: nausea, dry mouth, constipation, vomiting, diarrhea, abdominal pain, jaundice, increased activity of "liver" transamnaz; rarely - hepatocellular, cholestatic or mixed hepatitis, acute pancreatitis.

From the hematopoiesis: leukopenia, thrombocytopenia, agranulocytosis, pancytopenia, neutropenia, immune hemolytic and aplastic anemia, hypo- and aplasia.

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

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

Co side of the senses: blurred vision, paresis of accommodation. From the musculoskeletal system: arthralgia, myalgia.

From the endocrine system: hyperprolactinemia, gynecomastia, amenorrhea, decreased potency and / or libido.

Allergic reactions: urticaria, skin rash, itching, angioedema, anaphylactic shock, bronchospasm, multiform exudative erythema, incl. Stevens-Johnson syndrome, exfoliative dermatitis, toxic epidermal pecrolisis.

Other: alopecia, hypercreatinemia.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment: symptomatic. Induction of emesis and / or gastric lavage is indicated. With the development of seizures - diazepam intravenously, with bradycardia - atropine, ventricular arrhythmia - lidocaia.Hemodialysis is effective.

Interaction:

Increases AUC (the area under the concentration-time curve) and the concentration of metoprolol in the serum (respectively, 80% and 50%), while the half-life period (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 intake may reduce the absorption of itraconazole and ketoconazole.

Increases the concentration of procainamide.

Inhibits the metabolism in the liver of phenazone, aminophenazone, diazepam, hexobarbital, propranolol, mstoprolol, nifedipine, warfarin, lidocaine, pheniton, theophylline, amnofnllnna, indirect anticoagulants, glipizide, buformin, metronidazole, slow calcium channel blockers.

Drugs that depress the bone marrow increase the risk of neutropenia. With simultaneous use with antacids, sucralfate, the absorption of ranitidine is slowed, therefore a break between taking these drugs should be at least 2 hours.

The use of ranitidine with theophylline may be the cause of an increase in the concentration of theophylline in the plasma, resulting in tachycardia, a feeling of depression.

Smoking reduces the effectiveness of ranitidine.

Special instructions:

Before taking the drug, you should consult a doctor who has a history of gastric ulcer, cardiac rhythm disorder, liver and kidney function, porphyria, swallowing, unmotivated weight loss, and other medications.

Before starting treatment, you must exclude the possibility of

malignant disease of the esophagus, stomach or duodenum.

Ranitidine is undesirable to 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. Blockers of Hg-histamine receptors should be taken after 2 hrs of administration of itraconazole or ketoconazole to avoid a significant decrease in their absorption.

Increases the level of creatinine, glutamatranspett tsazy and gamma-glutamintransferase in the blood serum.

It counteracts the influence of peptagastrin and histamine on the acid-forming function of the stomach, therefore it is not recommended to apply it within 24 hours preceding the test.

May be the cause of a false positive reaction when carrying out a sample for protein in the urine.

Blockers Hi-gistaminovyh receptors can suppress the skin reaction to histamine, thus leading to false positive results (before using diagnostic skin tests to detect an allergic skin reaction of immediate type, it is recommended to stop the use of the drug). The effectiveness of the drug in inhibiting night secretion of acid in the stomach can be reduced by smoking.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

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, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Form release / dosage:

Film coated tablets 75 mg. 10 tablets per blister of PBX/ aluminum foil. 1 blister together with instructions for use in a cardboard pack.

Packaging:10 tablets per blister of PBX/ aluminum foil. 1 blister together with instructions for use in a cardboard pack.

Storage conditions:

List B. Store in dry the dark place at a temperature of 15 - 25 ° C. Keep out of the reach of children!

Shelf life:

3 years. Do not use after the expiration date!

Terms of leave from pharmacies:Without recipe

Registration number:П N014593 / 01

Date of registration:03.12.2009

The owner of the registration certificate:PRO.MED.CS Prague as.PRO.MED.CS Prague as. Czech Republic

Manufacturer: & nbsp

PRO.MED.CS Praha, a.s. Czech Republic

Information update date: & nbsp03,12.2009

Illustrated instructions

Instructions

Ranisan® (Ranisan® )