Universal reference book for medicines
Name of the drug: RANITIDINE (RANITIDINE)

Active ingredient: ranitidine

Type: The blocker of histamine H 2 -receptors.
Antiulcer drug
Manufacturer: SHREYA LIFE SCIENCES (India) manufactured by SERENA PHARMA (India)
Composition, form of production and packaging
The tablets covered with a film cover of
light orange color, round, biconcave.

1 tab.

ranitidine (in the form of hydrochloride) 150 mg

[PRING] cellulose microcrystalline, corn starch, kollidon VA-64, silicon dioxide colloid, magnesium stearate, hypromellose, ethyl cellulose, polyethylene glycol 6000, propylene glycol, sodium lauryl sulfate, titanium dioxide, dye sunset yellow.

10 pieces.
- blisters (2) - cardboard boxes.
The tablets covered with a film cover of light orange color, round, biconcave.

1 tab.

ranitidine (in the form of hydrochloride) 300 mg

[PRING] cellulose microcrystalline, corn starch, kollidon VA-64, silicon dioxide colloid, magnesium stearate, hypromellose, ethyl cellulose, polyethylene glycol 6000, propylene glycol, sodium lauryl sulfate, titanium dioxide, dye sunset yellow.

10 pieces.
- blisters (2) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Ranitidine blocks histamine H2-receptors of parietal cells of the gastric mucosa, reduces basal and stimulated hydrochloric acid secretion, caused by stimulation of baroreceptors, nutritional 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%. C max in plasma is achieved 2-3 h after administration.
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 the first passage
through the liver. The speed and degree of elimination depend little on the condition of the liver.
T 1/2 after oral administration - 2.5 hours, with QC
20-30 ml / min - 8-9 h. It is excreted mainly with urine (60-70%, unchanged - 35%), insignificant 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;

- ulcers of the stomach and duodenum associated with the intake of NSAIDs;

- reflux-esophagitis, erosive esophagitis;

- Zollinger-Ellleson 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).

DOSING MODE

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 treatment of exacerbations appoint 150 mg 2 times / 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, for smokers - 300 mg at night.
Ulcers associated with taking NSAIDs.
Assign 150 mg 2 times / day or 300 mg per night for 8-12 weeks. Prevention of ulceration when taking NSAIDs - 150 mg 2 times / day.
Postoperative and "stressful" ulcers.
Assign 150 mg 2 times / day for 4-8 weeks.
Erosive reflux esophagitis.
Assign 150 mg 2 times / day or 300 mg at night. If necessary, the dose may be increased to 150 mg 4 times / day. The course of treatment is 8-12 weeks. Prolonged preventive therapy - 150 mg 2 times / day.
Zollinger-Ellison syndrome.
The initial dose is 150 mg 3 times / day, if necessary, the dose can be increased.
Prevention of recurrent bleeding.
For 150 mg 2 times / day.
Prevention of the development of Mendelssohn syndrome.
Assign a dose of 150 mg for 2 hours before anesthesia, and preferably 150 mg the night before.
If there is a concomitant liver function disorder , a dose reduction may be required.

Patients with renal insufficiency with CC less than 50 ml / min the recommended dose is 150 mg / day.

SIDE EFFECT

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: hyperprolactinaemia, gynecomastia, amenorrhea, decreased libido, impotence.

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

Other: alopecia, hypercreatininaemia.

CONTRAINDICATIONS

- Pregnancy;

- lactation;

- children's age till 12 years;

- Hypersensitivity to ranitidine or other components of the drug.

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

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with renal insufficiency with CC less than 50 ml / min the recommended dose is 150 mg / day.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

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

APPLICATION FOR CHILDREN

Contraindication: children under 12 years.

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, like all H 2 -gistaminoblockers, it is undesirable to abruptly abolish ("ricochet" syndrome).

With long-term treatment of weakened patients under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection.

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

H 2 -gistamine receptor blockers should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction 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.

H 2 -gistaminic receptor blockers can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach, so it is not recommended to use H2-histamine-receptor blockers within 24 hours preceding the test.

H 2 -gistaminic receptor blockers can suppress the skin reaction to histamine, thus leading to false positive results (it is recommended that H 2 -histamine receptor blockers be discontinued before performing 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.

Use in Pediatrics

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

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, it is necessary to 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: symptomatic.
With the development of seizures - diazepam IV, with bradycardia or ventricular arrhythmias - atropine, lidocaine. Hemodialysis is effective.
DRUG INTERACTION

Smoking reduces the effectiveness of ranitidine.

Increases the concentration of metoprolol in the blood serum (by 80% and 50%, respectively), while the half-life of metoprolol increases from 4.4 to 6.5 h.

Due to the increase in the pH of the contents of the stomach with simultaneous intake may decrease 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 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.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Store in a dry place inaccessible to children at a temperature of 15 ° C to 30 ° C.
Shelf life - 3 years. Composition, form of production and packaging
The tablets covered with a film cover of
light orange color, round, biconcave.

1 tab.

ranitidine (in the form of hydrochloride) 150 mg

[PRING] cellulose microcrystalline, corn starch, kollidon VA-64, silicon dioxide colloid, magnesium stearate, hypromellose, ethyl cellulose, polyethylene glycol 6000, propylene glycol, sodium lauryl sulfate, titanium dioxide, dye sunset yellow.

10 pieces.
- blisters (2) - cardboard boxes.
The tablets covered with a film cover of light orange color, round, biconcave.

1 tab.

ranitidine (in the form of hydrochloride) 300 mg

[PRING] cellulose microcrystalline, corn starch, kollidon VA-64, silicon dioxide colloid, magnesium stearate, hypromellose, ethyl cellulose, polyethylene glycol 6000, propylene glycol, sodium lauryl sulfate, titanium dioxide, dye sunset yellow.

10 pieces.
- blisters (2) - cardboard boxes.
INSTRUCTION FOR THE SPECIALIST.

The product description was approved by the manufacturer for the 2009 print edition.

PHARMACHOLOGIC EFFECT

Ranitidine blocks histamine H2-receptors of parietal cells of the gastric mucosa, reduces basal and stimulated hydrochloric acid secretion, caused by stimulation of baroreceptors, nutritional 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%. C max in plasma is achieved 2-3 h after administration.
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 the first passage
through the liver. The speed and degree of elimination depend little on the condition of the liver.
T 1/2 after oral administration - 2.5 hours, with QC
20-30 ml / min - 8-9 h. It is excreted mainly with urine (60-70%, unchanged - 35%), insignificant 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;

- ulcers of the stomach and duodenum associated with the intake of NSAIDs;

- reflux-esophagitis, erosive esophagitis;

- Zollinger-Ellleson 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).

DOSING MODE

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 treatment of exacerbations appoint 150 mg 2 times / 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, for smokers - 300 mg at night.
Ulcers associated with taking NSAIDs.
Assign 150 mg 2 times / day or 300 mg per night for 8-12 weeks. Prevention of ulceration when taking NSAIDs - 150 mg 2 times / day.
Postoperative and "stressful" ulcers.
Assign 150 mg 2 times / day for 4-8 weeks.
Erosive reflux esophagitis.
Assign 150 mg 2 times / day or 300 mg at night. If necessary, the dose may be increased to 150 mg 4 times / day. The course of treatment is 8-12 weeks. Prolonged preventive therapy - 150 mg 2 times / day.
Zollinger-Ellison syndrome.
The initial dose is 150 mg 3 times / day, if necessary, the dose can be increased.
Prevention of recurrent bleeding.
For 150 mg 2 times / day.
Prevention of the development of Mendelssohn syndrome.
Assign a dose of 150 mg for 2 hours before anesthesia, and preferably 150 mg the night before.
If there is a concomitant liver function disorder , a dose reduction may be required.

Patients with renal insufficiency with CC less than 50 ml / min the recommended dose is 150 mg / day.

SIDE EFFECT

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: hyperprolactinaemia, gynecomastia, amenorrhea, decreased libido, impotence.

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

Other: alopecia, hypercreatininaemia.

CONTRAINDICATIONS

- Pregnancy;

- lactation;

- children's age till 12 years;

- Hypersensitivity to ranitidine or other components of the drug.

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

APPLICATION FOR FUNCTIONS OF THE LIVER

Patients with renal insufficiency with CC less than 50 ml / min the recommended dose is 150 mg / day.

APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

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

APPLICATION FOR CHILDREN

Contraindication: children under 12 years.

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, like all H 2 -gistaminoblockers, it is undesirable to abruptly abolish ("ricochet" syndrome).

With long-term treatment of weakened patients under stress, bacterial lesions of the stomach are possible with the subsequent spread of infection.

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

H 2 -gistamine receptor blockers should be taken 2 hours after taking itraconazole or ketoconazole in order to avoid a significant reduction 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.

H 2 -gistaminic receptor blockers can counteract the effects of pentagastrin and histamine on the acid-forming function of the stomach, so it is not recommended to use H2-histamine-receptor blockers within 24 hours preceding the test.

H 2 -gistaminic receptor blockers can suppress the skin reaction to histamine, thus leading to false positive results (it is recommended that H 2 -histamine receptor blockers be discontinued before performing 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.

Use in Pediatrics

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

Impact on the ability to drive vehicles and manage mechanisms

During the treatment period, it is necessary to 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: symptomatic.
With the development of seizures - diazepam IV, with bradycardia or ventricular arrhythmias - atropine, lidocaine. Hemodialysis is effective.
DRUG INTERACTION

Smoking reduces the effectiveness of ranitidine.

Increases the concentration of metoprolol in the blood serum (by 80% and 50%, respectively), while the half-life of metoprolol increases from 4.4 to 6.5 h.

Due to the increase in the pH of the contents of the stomach with simultaneous intake may decrease 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 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.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

List B. Store in a dry place inaccessible to children at a temperature of 15 ° C to 30 ° C.
Shelf life - 3 years.
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