Acyloc (Aciloc)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Dosage form: & nbsp
coated tablets
solution for intravenous and intramuscular administration
Composition:

Each tablet contains:

Active substance: ranitidine hydrochloride in terms of ranitidine 150 mg or 300 mg.

Excipients: microcrystalline cellulose, calcium hydrogenated phosphate granulate, calcium stearate, sodium hydrophosphate, croscarmellose sodium, silicon dioxide colloid (aerosil), sodium carboxymethyl starch.

Shell: Opadri green (quinoline yellow WS, brilliant blue FCF, titanium dioxide, iron oxide yellow).

1 ml of solution for intravenous and intramuscular administration contains:

Active substance: ranitidine hydrochloride in terms of ranitidine 25.0 mg.

Excipients: phenol, potassium dihydrogen phosphate, sodium hydrogen phosphate dihydrate, water for injection.

Description:

Tablets of 150 mg: round, biconvex tablets, film-coated Green colour.

Tablets 300 mg: capsular form, biconvex tablets, covered with a film coat of green color.

Intramuscular and intravenous solution: transparent from a colorless to pale yellow solution.

Pharmacotherapeutic group:Antiulcer means - H2-histamine receptor blocker
Pharmacodynamics:

Ranitidine blocks histamine H2receptors of parietal cells of the gastric mucosa, reduces basal and stimulated secretion of hydrochloric acid caused by stimulation of baroreceptors, food load, the action of hormones and biogenic stimulants (gastrin, histamine, pentagastrin). Ranitidine reduces the volume of gastric juice and the concentration 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 concentration of prolactin. Inhibits microsomal enzymes.

Duration of action after a single dose - 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. The connection with 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 (60-70%, unchanged - 35%), a small amount - with feces.

With intravenous administration, 93% of the dose is excreted in the urine, with 70 % Ranitidine is excreted unchanged.

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:

Pills

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).

Solution for intravenous and intramuscular injection

Prevention of bleeding during "stress ulcers" and recurrent bleeding in patients with peptic ulcer of the stomach and duodenum; prevention of Mendelssohn syndrome.

Contraindications:

Hypersensitivity to ranitidine or other components of the drug. Pregnancy, 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).

Dosing and Administration:

Pills

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

Adults and children over 12 years of age:

Stomach ulcer and duodenal ulcer. For treatment of exacerbations appoint 150 mg twice a day (morning and evening) or 300 mg at night. If necessary, 300 mg twice 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.

Ulcers associated with taking NSAIDs. Assign 150 mg twice a day or 300 mg per night for 8-12 weeks. Prevention of ulceration when taking NSAIDs - 150 mg 2 times a day.

Postoperative and "stressful" ulcers. Assign 150 mg twice a day for 4-8 weeks.

Erosive reflux esophagitis. Assign 150 mg twice 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 -150 mg 2 times a day.

Zollinger-Ellison syndrome. The initial dose is 150 mg 3 times a day, if necessary, the dose can be increased. Duration of treatment - as needed.

Prevention of recurrent bleeding. 150 mg twice a day. Duration of treatment - as needed.

Prevention of the development of Mendelssohn syndrome. Assign a dose of 150 mg for 2 hours before anesthesia, as well as 150 mg 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.

Solution for intravenous and intramuscular injection

Prevention of bleeding with "stress ulcers" and recurrent bleeding in patients with peptic ulcer of the stomach and duodenum.

Intramuscular injection: 50 mg (2 ml) every 6-8 hours.

Intravenous injection: 50 mg (2 ml) every 6-8 hours. The content of the ampoule (50 mg) is diluted with 0.9% sodium chloride solution or dextrose for injection until a total volume of 20 ml is obtained and slow is introduced within 5 minutes. The drug is administered parenterally until oral intake is possible.

Prevention of the development of Mendelssohn syndrome. 50 mg intramuscularly or intravenously 45-60 minutes before general anesthesia.

For patients with renal insufficiency with creatinine clearance less than 50 ml / min, the recommended single dose is 25 mg.

Side effects:

From the digestive system: nausea, dry mouth, constipation, vomiting, diarrhea, abdominal pain, increased activity of "hepatic" transaminases, 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 of arterial pressure, bradycardia, arrhythmia, atrio-ventricular block; asystole (with parenteral administration).

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

From the sense organs: blurred vision, paresis of accommodation.

From the side of the musculoskeletal system: arthralgia, myalgia.

From the endocrine system: hyperprolactinemia, gynecomastia, amenorrhea, decreased libido, impotence.

Allergic reactions: urticaria, skin rash, angioedema, anaphylactic shock, bronchospasm, multiforme exudative erythema.

Other: alopecia, hypercreatininaemia, increased activity of glutamate transpeptidase, acute porphyria.

Overdose:

Symptoms: convulsions, bradycardia, ventricular arrhythmias.

Treatment: symptomatic. With the development of seizures - diazepam intravenously, with bradycardia or ventricular arrhythmias - atropine, lidocaine. Hemodialysis is effective.

Interaction:

Smoking of tobacco reduces the effectiveness of ranitidine.

Increases the concentration of metoprolol in the 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 intake may reduce the absorption of itraconazole and ketoconazole.

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 developing 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:

Treatment with ranitidine may mask the symptoms associated with carcinoma of the stomach, so before starting treatment it is necessary to exclude the presence of cancer-ulcers.

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

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 H2-gistaminoreceptors should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction in their absorption. The use of ranitidine may cause a false positive response to a sample of protein in the urine.

Blockers H2-gistaminoreceptors can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach, therefore, within 24 hours preceding the test, use blockers H2-gistaminoreceptors is not recommended. Blockers H2-gistaminoreceptors can suppress the skin reaction to histamine, thus leading to false positive results (before conducting diagnostic skin tests to detect an allergic skin reaction of immediate type, the use of blockers H2-gistaminoreceptors it is recommended to stop).

Effect on the ability to drive transp. cf. and fur:During the treatment period it is necessary to refrain from engaging in potentially hazardous activities,requiring increased concentration of attention and speed of psychomotor reactions.
Form release / dosage:

The coated tablets are 150 mg and 300 mg.

Solution for intravenous and vnutrimyshechnogo 25 mg / ml.

Packaging:

For 10 tablets in strips of aluminum foil. 2 or 10 strips together with instructions for use in a cardboard bundle.

A solution for intravenous and intramuscular injection of 25 mg / ml in ampoules of 2 ml. 5 or 10 ampoules placed in a blister, together with instructions for use in a pack of cardboard.

Storage conditions:

Acyl coated tablets

In the dark place at a temperature of no higher than 25 ° C. Keep away from children.

Acyl solution for intravenous and intramuscular injection

In the dark place at a temperature of no higher than 25 ° C. Do not freeze. Keep away from children.

Shelf life:

Tablets - 3 years. The solution is 2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription
Registration number:П N011363 / 02
Date of registration:25.05.2010 / 09.07.2010
Expiration Date:Unlimited
The owner of the registration certificate:Cadil Pharmaceuticals Co., Ltd.Cadil Pharmaceuticals Co., Ltd. India
Manufacturer: & nbsp
Information update date: & nbsp22.09.2017
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