Medicinal Products

AZANTAC 300 mg

Generic drug of the therapeutic class: Gastro-Entero-Hepatology
Active ingredients: Ranitidine
laboratory: Glaxosmithkline

Effervescent tablet
Box of 1 Tube of 14
All forms

Indication

adults

· In combination with antibiotic therapy, eradication of Helicobacter pylori in peptic ulcer disease (after endoscopic evidence of lesion and infection).

· Evolutionary gastric or duodenal ulcer.

· Esophagitis by gastro-oesophageal reflux.

· Zollinger-Ellison syndrome.

Children (3 to 18 years old)

· Short-term treatment of gastric or duodenal ulcers,

· Treatment of gastroesophageal reflux, including reflux oesophagitis and relief of gastroesophageal reflux symptoms.

Dosage AZANTAC 300 mg Effervescent tablet Box of 1 tube of 14

Because absorption is not influenced by diet, tablets can be taken during or after meals.

Adults and adolescents from 12 years

Evolutionary duodenal ulcer

1 tablet ranitidine 300 mg in the evening for 4 weeks.

Evolutionary gastric ulcer

1 tablet ranitidine 300 mg in the evening for 4 to 6 weeks.

esophagitis

1 tablet of ranitidine 300 mg in the evening, for 4 weeks with a possible second period of 4 weeks at the same dosage depending on the endoscopic results.

adults

Eradication of Helicobacter pylori in case of peptic ulcer disease:

The following dosing regimens are recommended:

300 mg ranitidine morning and evening associated for 14 days to:

· 1 g amoxicillin morning and evening and 500 mg clarithromycin morning and evening;

· Either 500 mg of clarithromycin morning and evening associated with either 500 mg of metronidazole or tinidazole morning and evening, or 1000 mg of tetracycline morning and evening;

· Or, as an alternative to the previous diagrams, 1 g of amoxicillin morning and evening and 500 mg of metronidazole or tinidazole morning and evening.

This triple therapy will be followed by 300 mg ranitidine daily for 2 additional weeks in case of active duodenal ulcer or 2 to 4 additional weeks in case of progressive gastric ulcer.

Zollinger-Ellison Syndrome

The recommended starting dose is 600 mg daily. The dose should be adjusted individually, if necessary up to 1200 mg / day, and treatment continued as long as clinically necessary.

In case of renal insufficiency, reduce the dosage * according to the serum creatinine, according to the following diagram:

· Creatinine from 25 to 60 mg / l (220 to 530 μmol / l): 150 mg every 24 hours;

· Creatinine greater than 60 mg / l (530 μmol / l): 150 mg every 48 hours or 75 mg every 24 hours.

* For reduced dosages, preferably use 150 mg tablets.

Children from 3 to 11 years old and those over 30 kg

See section 5.2. Pharmacokinetic properties Pharmacokinetic properties-Special patient populations.

Depending on the dosage and indication applied to the treatment, the use of other 75 mg and 150 mg dosages may be necessary.

Treatment of acute gastric or duodenal ulcer

The recommended oral dosage for the treatment of gastric and duodenal ulcers in children is 4 mg / kg / day to 8 mg / kg / day administered in two separate doses, with a maximum dose of 300 mg / day ranitidine for 4 weeks.

For patients with incomplete healing, an additional 4 weeks of treatment are indicated, since healing usually occurs after 8 weeks of treatment.

Gastroesophageal reflux

The recommended oral dosing regimen for gastroesophageal reflux disease in pediatric patients is 5 mg / kg / day to 10 mg / kg / day administered in two separate doses, with a maximum dose of 600 mg daily (maximum dose). likely to apply to high weight children and adolescents with severe symptoms).

Safety and effectiveness in neonates have not been established.

Against indications

· Hypersensitivity to ranitidine.

· Phenylketonuria, due to the presence of aspartame.

Azantac side effects

Adverse effects are classified by frequency, using the following classification:

very common (> 1/10); frequent (> 1/100, 1/1000, 1/10000, <1/1000) and very rare (<1/10000).

The frequencies of adverse events were estimated from spontaneous post-marketing reports.

Blood and lymphatic system disorders

Very rare: changes in blood count (leukopenia and thrombocytopenia) usually reversible; agranulocytosis or pancytopenia, sometimes with hypoplasia or bone marrow suppression.

Immune system disorders

Rare: hypersensitivity reactions (urticaria, angioneurotic edema (angioedema), fever, bronchospasm, hypotension, and chest pain).

Very rare: anaphylactic shock.

These effects have been reported after administration of a single dose of ranitidine.

Psychiatric disorders

Very rare: reversible mental confusion, depression and hallucinations reported mainly in very ill and elderly subjects or with renal insufficiency.

Nervous system disorders

Very rare: headaches (sometimes severe), vertigo and reversible involuntary movements (tremors, myoclonus or involuntary eye movements).

Eye disorders

Very rare: reversible blurred vision, suggesting in some cases a modification of the accommodation.

Heart conditions

Very rare: sinus bradycardia and atrioventricular block with sinus pause.

Vascular disorders

Very rare: vasculitis.

Gastrointestinal disorders

Very rare: acute pancreatitis, diarrhea.

Nausea and constipation.

Hepatobiliary disorders

Rare: transient and reversible changes in liver function tests.

Very rare: hepatitis (cytolytic, cholestatic or mixed) with or without jaundice usually reversible.

Skin and subcutaneous tissue disorders

Rare: rash.

Very rare: erythema multiforme, alopecia.

Musculoskeletal and systemic disorders

Very rare: musculoskeletal symptoms such as myalgia, arthralgia.

Kidney and urinary disorders

Very rare: acute interstitial nephritis.

Disorders of reproductive organs and breast

Very rare: reversible impotence, gynecomastia, galactorrhea.

Endocrine disorders

Very rare: hyperprolactinemia.

General disorders and administration site conditions

Asthenia.

Pediatric population

The safety of ranitidine has been evaluated in children aged 0-16 with acid-related disorders. Ranitidine has a side effect profile similar to that of adults. There is little long-term security data available, especially on growth and development.

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