Zantak - Instructions For Use, Price, Analogs, Ampoules, Reviews

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Zantac

Zantak: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. In case of impaired renal function
12. 12. For violations of liver function
13. 13. Use in the elderly
14. 14. Drug interactions
15. 15. Analogs
16. 16. Terms and conditions of storage
17. 17. Terms of dispensing from pharmacies
18. 18. Reviews
19. 19. Price in pharmacies

Latin name: Zantac

ATX code: A02BA02

Active ingredient: ranitidine (ranitidine)

Producer: GlaxoSmithKline Manufacturing (Italy), Glaxo Wellcome Production (France), Losan Pharma GmbH (Germany), GlaxoSmithKline (Tianjin) Co. Ltd (China), Glaxo Wellcome (Spain)

Description and photo update: 2019-09-09

Zantac is an antiulcer agent, a blocker of histamine H ₂ receptors.

Release form and composition

Dosage forms:

• Coated tablets: biconvex, white, engraved on one side: on round - “GX EC2”, on oval - “GX EC3” (10 pcs. In blisters, in a cardboard box 1 blister);
• Effervescent tablets: from almost white to light yellow, flat, round, with beveled edges (6 or 10 pcs. In aluminum blisters, in a cardboard box 1 or 2 blisters; 15 pcs. In polypropylene tubes, in a cardboard box 1 tuba);
• Solution for injection: clear liquid, light yellow or colorless (2 ml in ampoules, in a cardboard box 5 ampoules).

Each pack also contains instructions for using Zantak.

The active ingredient is ranitidine (in the form of hydrochloride):

• 1 coated tablet - 150 mg, 300 mg;
• 1 effervescent tablet - 150 mg, 300 mg;
• 1 ml of solution - 25 mg.

Auxiliary components:

• Film-coated tablets: magnesium stearate, microcrystalline cellulose, methyl hydroxypropyl cellulose, triacetin, titanium dioxide; in addition, in oval tablets - sodium croscarmellose;
• Effervescent tablets: sodium bicarbonate, sodium monocitrate anhydrous, aspartame, sodium benzoate, povidone K30, grapefruit flavor, orange flavor (sodium content in 1 tablet is 328 mg or 479 mg, respectively);
• Solution for injection: potassium dihydrogen phosphate, sodium chloride, nitrogen, sodium hydrogen phosphate disubstituted anhydrous, water for injection.

Pharmacological properties

Pharmacodynamics

Ranitidine, the active substance of Zantac, is a blocker of histamine H ₂ receptors. It helps to reduce the basal and stimulated food load, irritation of baroreceptors, the action of gastrin, histamine and other biogenic stimulants of the secretion of hydrochloric (hydrochloric) acid.

Against the background of the use of the drug, both the volume of secretion and the amount of pepsin and hydrochloric acid in it decrease. Ranitidine increases the pH of gastric contents, resulting in decreased pepsin activity. The duration of the effect after a single dose of Zantac is 12 hours.

Helicobacter pylori is determined in about 80% of patients with gastric ulcers and in 95% with duodenal ulcers. When ranitidine is combined with metronidazole and amoxicillin, Helicobacter pylori eradication is noted in approximately 90% of cases. With this combination of funds, a significant decrease in the frequency of exacerbations of duodenal ulcer is observed.

Pharmacokinetics

The bioavailability of ranitidine after oral administration is about 50%. C _max (maximum concentration of the substance) after oral administration of 150 mg of the substance is 300-550 ng / ml, the time to reach it is from 2 to 3 hours. C _max after intramuscular injection is reached in about 15 minutes and is 300-500 ng / ml.

The binding of ranitidine to plasma proteins is no more than 15%. The substance crosses the placental barrier. Poorly penetrates the blood-brain barrier. Excreted in breast milk (in breast milk, the concentration is higher than in plasma).

Ranitidine does not undergo intensive metabolism. The metabolism of the substance when administered parenterally and when taken orally does not differ. As a result of metabolism, the following forms are formed: S-oxide - 2%, N-oxide - 6%, analog of furoic acid - 1–2%, desmethylranitidine - 2%.

T _1/2 (half-life) ranges from 2 to 3 hours. After taking 150 mg of ³ H-ranitidine, 60-70% of the dose is excreted in the urine (35% of the dose is excreted unchanged), 26% - in the feces.

After intravenous administration of 150 mg of ³ H-ranitidine, 93% of the dose is excreted in the urine (70% of the dose taken in the first 24 hours is excreted unchanged), 5% - in the feces.

In patients with severe renal impairment, the plasma concentration of ranitidine increases.

Indications for use

• Duodenal ulcer associated with Helicobacter pylori infection;
• Duodenal ulcer and benign stomach ulcers, including those that appeared while taking non-steroidal anti-inflammatory drugs (NSAIDs);
• Gastroesophageal reflux disease, including pain relief;
• Postoperative ulcers;
• Reflux esophagitis;
• Chronic episodic dyspepsia, occurring with retrosternal or epigastric pain (not related to the above conditions), which disrupt sleep or are associated with food intake;
• Zollinger-Ellison syndrome;
• Prevention of stress stomach ulcers in patients with severe illnesses;
• Prevention of duodenal ulcers with the use of NSAIDs (including acetylsalicylic acid), especially with a history of peptic ulcer disease;
• Prevention of recurrent bleeding from peptic ulcers;
• Prevention of aspiration of acidic stomach contents during general anesthesia (Mendelssohn's syndrome).

Contraindications

• Acute porphyria (including history);
• The period of pregnancy and breastfeeding;
• Age under 12;
• Hypersensitivity to drug components.

Care should be taken to prescribe Zantac to patients with hepatic and renal failure, liver cirrhosis with a history of portosystemic encephalopathy.

Zantak, instructions for use: method and dosage

Film-coated tablets and effervescent tablets

The tablets are taken orally.

Recommended dosage of Zantac for adult patients:

• Exacerbation of benign gastric and duodenal ulcers: 150 mg 2 times a day (morning and evening) or 300 mg 1 time a day (at night) for 4 weeks. In the absence of complete scarring of the ulcer, treatment should be extended for another 4 weeks. For the treatment of duodenal ulcers, a dose of 300 mg 2 times a day is more effective (increasing the dose does not affect the incidence of undesirable effects);
• Long-term prevention of recurrence of gastric and duodenal ulcers: 150 mg 1 time per day (at night), for smoking patients, the dose is increased to 300 mg 1 time per day;
• Ulcers associated with taking NSAIDs: 150 mg 2 times a day or 300 mg 1 time a day (at night). The course of treatment is 8-12 weeks;
• Prevention of ulcers when using NSAIDs: 150 mg 2 times a day during the entire period of NSAID intake;
• Duodenal ulcer associated with Helicobacter pylori: 150 mg 2 times a day or 300 mg 1 time a day in combination with 750 mg of amoxicillin 3 times a day and 500 mg of metronidazole 3 times a day. The course of treatment is 2 weeks, during the next 2 weeks - monotherapy with Zantac;
• Postoperative ulcers: 150 mg 2 times a day, the duration of therapy is 4 weeks. In the absence of a clinical effect, the treatment is extended for another 4 weeks;
• Gastroesophageal reflux disease: 150 mg: in acute form - 2 times a day (or 1 time a day (at night) at a dose of 300 mg), the course of treatment is 8-12 weeks; with severe and moderate reflux esophagitis - 4 times a day with a duration of therapy for 12 weeks; for relief of pain syndrome - 2 times a day for 2-4 weeks; for prevention - 2 times a day;
• Zollinger-Ellison syndrome: initial dose - 150 mg 3 times a day, if necessary, it is possible to increase the daily dose to 6000 mg;
• Chronic episodic dyspepsia: 150 mg 2 times a day, the course of treatment is 6 weeks. If there is no clinical effect or worsening of the condition, additional examination is necessary;
• Prevention of recurrent bleeding from peptic ulcers and bleeding of stress ulcers in critically ill patients: after transferring the patient to an oral meal, parenteral therapy is replaced by taking Zantak inside - 150 mg 2 times a day;
• Prevention of Mendelssohn's syndrome: 150 mg the day before (in the evening) and 2 hours before general anesthesia, parenteral administration is possible; during labor - 150 mg every 6 hours (if general anesthesia is necessary, the simultaneous use of Zantac and water-soluble antacids (sodium citrate) is indicated).

In case of peptic ulcer in children, Zantac is prescribed taking into account the weight of the child in a dose of 2-4 mg per 1 kg 2 times a day, but not more than 300 mg per day.

In severe renal failure (creatinine clearance (CC) less than 50 ml / min), the plasma concentration of ranitidine increases, so the dose should be 150 mg once a day.

When the patient is on long-term hemodialysis or outpatient peritoneal dialysis, Zantac is prescribed immediately after the end of the session at a dose of 150 mg.

Injection

Solution in ampoules Zantak is intended for intermittent intravenous infusion, intramuscular (intramuscular) or slow (more than 2 minutes) intravenous (intravenous) injection.

A slow intravenous injection is prescribed in a dose of 50 mg, which is brought to a volume of 20 ml and administered every 6-8 hours, an intramuscular injection is administered at a dose of 50 mg every 6-8 hours.

Intermittent intravenous infusion should be performed at a rate of 25 mg per hour for 2 hours with a repeat of the procedure after 6-8 hours.

Recommended dosage of Zantac:

• Prevention of Mendelssohn's syndrome: slowly intravenously or intramuscularly - at a dose of 50 mg 45-60 minutes before anesthesia;
• Prevention of recurrence of bleeding from peptic or stress ulcers in seriously ill patients: start with a slow intravenous injection at a dose of 50 mg, followed by a long intravenous infusion at a rate of 0.125-0.250 mg per 1 kg of body weight per hour. Parenteral treatment lasts until the patient takes food independently, then oral administration of Zantac is possible;
• Treatment of patients with renal insufficiency (CC less than 50 ml / min): 25 mg.

Side effects

• Cardiovascular system: arrhythmia, decreased blood pressure (BP), bradycardia, atrioventricular (AV) block; rarely - vasculitis;
• Digestive system: dry mouth, nausea, vomiting, abdominal pain, constipation, reversible transient changes in liver function tests; in some cases - the development, usually reversible, cholestatic, hepatocellular or mixed hepatitis, with or without jaundice; rarely - acute pancreatitis, diarrhea;
• Hematopoietic system: thrombocytopenia, leukopenia; rarely - pancytopenia, agranulocytosis; sometimes - immune hemolytic anemia, aplasia and hypoplasia of the bone marrow;
• Musculoskeletal system: rarely - myalgia, arthralgia;
• Nervous system: increased fatigue, headache (sometimes severe), drowsiness, dizziness; rarely - tinnitus, irritability, blurred vision, involuntary movements, reversible movement disorders of an involuntary nature; more often in elderly and seriously ill patients - hallucinations, confusion, depression;
• Dermatological reactions: alopecia;
• Endocrine system: gynecomastia, hyperprolactinemia, decreased libido, amenorrhea; rarely - swelling or discomfort in the mammary glands in men, reversible impotence;
• Allergic reactions: urticaria, skin rash, bronchospasm, erythema multiforme, angioedema, anaphylactic shock, fever, arterial hypotension, chest pain.

Overdose

The main symptoms: bradycardia, convulsions, ventricular arrhythmias.

Therapy: symptomatic treatment; with convulsions, intravenous diazepam is indicated, with ventricular arrhythmias and bradycardia, lidocaine, atropine are prescribed. Hemodialysis is effective in removing ranitidine from plasma.

special instructions

The use of Zantac can hide the symptoms of gastric carcinoma, therefore, patients with stomach ulcers or new signs of dyspepsia in old and middle age are advised to exclude the possibility of malignancy before starting treatment.

Because of the risk of ricochet syndrome, Zantac should be discontinued with a gradual dose reduction.

Long-term therapy of debilitated patients under stress conditions can cause bacterial damage to the stomach, followed by intoxication of the body.

Simultaneous administration of ranitidine with NSAIDs must be accompanied by regular monitoring of patients, especially in old age and with a history of peptic ulcer disease.

Effervescent tablets should be used with caution in sodium-restricted patients with phenylketonuria.

It is not recommended to use Zantac before diagnosing skin tests to identify an immediate allergic skin reaction.

Patients with severe renal impairment require dosage adjustments.

An increase in the level of hepatic transaminases can be observed with parenteral administration of high doses of the drug for more than 5 days.

The use of Zantac can increase the activity of glutamate transpeptidase or cause a false positive reaction when testing for the presence of protein in the urine.

In tobacco-dependent patients, the effectiveness of Zantac therapy is reduced.

During the period of treatment, the patient should not eat foods, drinks and medicines that cause irritation of the gastric mucosa.

It is necessary to strictly observe the recommended rate of administration of the solution.

Unused Zantac solution must be destroyed within 24 hours.

Influence on the ability to drive vehicles and complex mechanisms

During the use of Zantac, the patient should not engage in potentially hazardous activities that require concentration of attention and high speed of psychomotor reactions.

Application during pregnancy and lactation

Ranitidine crosses the placenta and is excreted in breast milk.

Pregnancy is a contraindication to taking the drug. Zantac can only be prescribed if the doctor evaluates the expected benefit to the mother above the possible harm to the fetus.

Zantac is contraindicated during lactation.

Pediatric use

Zantak is not prescribed for patients under 12 years of age.

With impaired renal function

In renal failure, Zantac is prescribed with caution.

For violations of liver function

In liver failure and in patients with cirrhosis of the liver with a history of portosystemic encephalopathy, caution is required during therapy.

Use in the elderly

Elderly patients with the combined use of Zantac with NSAIDs require regular monitoring.

Drug interactions

Antacids, high doses of sucralfate can interfere with the absorption of ranitidine, therefore, with simultaneous administration, the interval between taking them and taking Zantac should be at least 2 hours.

When combined with drugs that depress the bone marrow, the risk of neutropenia increases.

Zantac does not affect the action of lidocaine, diazepam, phenytoin, theophylline, propranolol, warfarin and other drugs metabolized with the participation of isoenzymes of the cytochrome P450 system.

Zantac inhibits the metabolism of hexobarbital, aminophenazone, calcium antagonists, phenazone, indirect anticoagulants, buformin, glipizide.

To prevent a decrease in the absorption of ketoconazole or itraconazole, the use of Zantac is indicated only 2 hours after their intake.

With simultaneous use with metoprolol, ranitidine causes an increase in its concentration in the blood serum and an increase in AUC.

Solution for injection in ampoules Zantac can be mixed with 0.9% or 0.18% sodium chloride solution, 5% or 4% dextrose solution, 4.2% sodium bicarbonate solution, Hartmann's solution.

Analogs

Zantak analogs are: Acidex, Gertocalm, Atsilok, Gistak, Zoran, Zantin, Raniberl 150, Ranisan, Ranigast, Ranital, Ranitidin, Ranitin, Ranitidin-Acri, Ranitidin-Ferein, Ranitidin-Lect, Rantak, Ranitidin- Sopharma, Ulit AKOS, Ulran.

Terms and conditions of storage

Keep out of the reach of children.

Store at temperature: tablets - up to 30 ° C, solution for injection - up to 25 ° C.

Shelf life: tablets with an engraving "GX EC2" - 5 years, "GX EC3" - 3 years, effervescent - 2 years; injection solution - 3 years.

Effervescent tablets in tubes should be stored with a tightly closed lid.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Zantaka

Reviews of Zantaka characterize the drug as effective and safe, regardless of indications for use, subject to the recommended dosage regimen. The cost is most often considered high.

Price for Zantak in pharmacies

The approximate price for Zantak is: effervescent tablets (15 pcs. 150 mg each) - 208 rubles, injection solution 25 mg / ml (5 ampoules of 2 ml each) - 158 rubles.

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!