APR RANTOCID 30ml

Ranitidine 50mg Injection

Read all of this information carefully before you start taking this medicine because it contains important information for you.

• Keep this information. You may need to read it again.
• If you have any further questions, ask your doctor, pharmacist or nurse.
• This medicine is prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this information.

1. COMPOSITION:

Each vial contains:
Ranitidine – 50mg
For intravenous/intramuscular use only.

1. DESCRIPTION:

Ranitidine is a drug that reduces stomach acid production. It belongs to a class of drugs known as Histamine H2 receptor antagonist.

1. PHARMACOLOGICAL ACTION:

Ranitidine is a specific rapidly acting histamine H2-antagonist. It inhibits basal & stimulated secretion of gastric acid reducing both the volume & the acid & pepsin content of the secretion. It has a relatively long duration of action & so a single 150mg dose effectively suppresses gastric acid secretion for 12 hours.

1. CLINICAL PHARMACOKINETICS:

Peak plasma conc. is rapid & usually achieved within 15 minutes following IM injection. It is not extensively bound to plasma proteins (15%) but exhibits a large volume of distribution ranging from 96-142 L. It is not extensively metabolised. The fraction of the dose recovered as metabolites is similar after both oral & IV dosing & includes 6% of the dose in urine as the N-oxide, 2% as the S-oxide, 2% as desmethylranitidine & 1-2% as furoic acid analogue. Plasma conc. decline bi-exponentially with a terminal half-life of 2-3 hours. The major route of elimination is renal. After IV administration of 150mg 3H- ranitidine 98% of the dose was recovered including 5% in faeces & 93% in urine of which 70% was unchanged parent drug. Less than 3% is excreted in bile. Renal clearance is approximately 500mL/min which exceeds glomerular filtration indicating net renal tubular secretion.

1. INDICATIONS:

Ranitidine injection is indicated for:

• Benign gastric & duodenal ulceration including reflux oesophagitis
• Post-operative ulcers & other conditions where reduction of gastric acid output is beneficial
• Prophylaxis of GI haemorrhage from stress ulceration in seriously ill patients
• Prophylaxis of recurrent haemorrhage in patients with bleeding peptic ulcers & in patients before general anaesthesia considered to be at risk of acid aspiration (Mendelson’s Syndrome), particularly obstetric patients during labour
• Zollinger – Ellison Syndrome

Paediatric population (6 months to 18 years)
– Short term treatment of peptic ulcer
– Treatment of gastro-oesophageal reflux, including reflux oesophagitis and symptomatic relief of gastro-oesophageal reflux disease.

1. CONTRAINDICATIONS:

Ranitidne tablets are contraindicated in the following cases:

 

1. Hypersensitivity to the active constituent or to any of the excipients in the tablets.

1. WARNINGS AND PRECAUTIONS:

The possibility of malignancy should be excluded before commencement of therapy in patients with gastric ulcer [& if indications include dyspepsia; patients of middle age & over with new/recently changed dyspeptic symptoms must be included] as treatment may mask symptoms of gastric carcinoma.
Is excreted via the kidney & so plasma levels of the drug are increased in patients with renal impairment.

May precipitate acute porphyric attacks. Should therefore be avoided in patients with a history of acute porphyria.

In patients such as the elderly, persons with chronic lung disease, diabetes or the immuno-compromised, there may be an increased risk of developing community acquired pneumonia.

Regular supervision of patients who are taking NSAID’s concomitantly is recommended especially in the elderly & in those with a history of peptic ulcer.

1. ADVERSE EFFECTS:

Common side effects include:

• Abdominal pain, constipation, nausea,
• Hypersensitivity reactions
• Headache, dizziness
• Transient changes in liver function test

1. DRUG INTERACTIONS:

Interactions occur by several mechanisms including:
1) Inhibition of cytochrome P450-linked mixed function oxygenase system:

There have been reports of altered prothrombin time with coumarin anticoagulants (e.g. warfarin). Due to the narrow therapeutic index, close monitoring of increased/decreased prothrombin time is recommended
2) Competition for renal tubular secretion:

May reduce the excretion of procainamide & N-acetylprocainamide resulting in increased plasma levels of these drugs.

3) Alteration of gastric pH:

The bioavailability of certain drugs may be affected. This can result in either an increase in absorption (e.g. triazolam, midazolam, glipizide) or a decrease in absorption (e.g. ketoconazole, atazanavir, delaviridine, gefitnib).

If high doses of sucralfate are co-administered the absorption may be reduced. This effect is not seen if sucralfate is taken after an interval of 2 hours.

1. DOSAGE:

Slow intravenous injection: 50mg diluted to a volume of 20ml & given over at least a period of 2 min which may be repeated every 6-8 hours.

Intermittent intravenous infusion: 25mg/hr for 2 hours; may be repeated 6-8 hours.

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

1. ADMINISTRATION:

For Intravenous or intramuscular injection.

Administration to be done by a registered medical practitioner/nurse in a proper sterile & hospital setting only.

1. PRESENTATION:
2. STORAGE:

Store below 25°C in a cool & dry pace. Protect from direct sunlight. Keep away from the reach of children.

1. MANUFACTURED BY:
2. MARKETED BY:

This information was last revised on May 2019.