Medicinal Products

AZANTAC 50 mg / 2 mL

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

Injectable solution
Box of 5 ampoules of 2 ml
All forms

Indication

adults

· Evolutionary gastric or duodenal ulcer.

· Zollinger-Ellison syndrome.

· Haemorrhage from peptic ulcer disease.

· Gastroduodenal lesions related to stress.

Children and infants (6 months to 18 months)

· Short-term treatment of gastric or duodenal ulcers,

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

Dosage AZANTAC 50 mg / 2 mL Solution for injection Box of 5 ampoules of 2 ml

adults

In IM injection : 1 to 4 50 mg ampoules distributed on the nycthemeron.

In slow IV injection (at least 2 minutes), after dilution of a 50 mg ampoule in 20 ml of solution for injection: 1 to 4 50 mg ampoules distributed on the nycthemeron.

In IV infusion : 0.125 to 0.250 mg / kg / hour.

If necessary, the relay will be taken by the tablets as soon as possible.

Doses can be increased in hypersecretory states (Zollinger-Ellison syndrome).

The dosage should be reduced by one-third to one-half in renally impaired patients and in severe hepato-cellular insufficiency.

Teenagers (12 to 18 years old)

In slow IV injection (at least 2 minutes), after dilution of a 50 mg ampoule in 20 ml of solution for injection: 1 to 4 50 mg ampoules distributed on the nycthemeron.

Children and infants (6 months to 11 years)

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

AZANTAC Injection can be given as a slow IV injection (at least 2 minutes) with a maximum of 50 mg every 6 to 8 hours.

Short-term treatment of gastric or duodenal ulcers and treatment of gastroesophageal reflux disease

Intravenous treatment in children with ulcerative disease is indicated only when oral therapy is not possible.

For the short-term treatment of gastric or duodenal ulcers and the treatment of gastroesophageal reflux disease in children, AZANTAC Injection can be administered in doses that have been shown to be effective in adults in the treatment of these conditions and effective in the decrease of acid secretion in the severely affected child. The initial dose (2.0 mg / kg or 2.5 mg / kg with a maximum of 50 mg) can be administered by slow intravenous injection over 10 minutes, using an electric syringe followed by rinsing. with 3 ml of physiological saline for 5 minutes, or after dilution in 20 ml of physiological saline. Maintaining pH> 4 can be achieved by intermittent infusion of 1.5 mg / kg every 6 to 8 hours. The treatment can also be administered continuously, using a loading dose of 0.45 mg / kg followed by a continuous infusion of 0.15 mg / kg / hour.

Prophylaxis of stress ulcer in severely ill patients

The recommended dose for stress ulcer prophylaxis is 1 mg / kg (with a maximum of 50 mg) every 6 to 8 hours. The treatment can also be administered continuously, using a continuous infusion of 125 to 250 mg / kg / hour.

Newborns (less than a month old)

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

Against indications

Hypersensitivity to ranitidine.

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, atrioventricular block with sinus pause and asystole.

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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