INDICATIONS     CONTRA-INDICATIONS     DOSAGE     SIDE-EFFECTS     PREGNANCY     OVERDOSE     IDENTIFICATION     PATIENT INFORMATION

Logo GULF RANITIDINE 150
GULF RANITIDINE 300

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

GULF RANITIDINE 150
GULF RANITIDINE 300

COMPOSITION:
GULF RANITIDINE 150:
Each film-coated tablet contains: Ranitidine hydrochloride equivalent to
Ranitidine 150 mg
GULF RANITIDINE 300: Each film-coated tablet contains: Ranitidine hydrochloride equivalent to Ranitidine 300 mg

PHARMACOLOGICAL CLASSIFICATION:
A.11.4.3. Medicines acting on Gastro-intestinal tract. Antacids - Other

PHARMACOLOGICAL ACTION:
Ranitidine is a selective and competitive histamine-2 (H
2) receptor antagonist. It inhibits basal and nocturnal gastric acid production. Both the volume and concentration of gastric acid and pepsin are reduced by ranitidine, but not the gastric mucous secretion. Ranitidine also inhibits gastric acid secretion stimulated by food, betazole, pentagastrin, caffeine, insulin and physiological vagal reflex.
Pharmacokinetics:
The bioavailability after oral administration is 50%. Food or antacids do not significantly affect the absorption of ranitidine. Peak concentrations are reached 2 to 3 hours after oral administration. Approximately 15% of ranitidine is bound to plasma proteins. Only small amounts of ranitidine are metabolized in the liver. Ranitidine is excreted via the kidneys in the free and metabolized form. Between 30 to 35% of the oral dose is excreted unchanged in the urine within 24 hours. The elimination plasma half life of ranitidine is 2 to 3 hours.

INDICATIONS:
Gulf Ranitidine
is indicated:
For the treatment of duodenal ulcers
To reduce the risk of duodenal ulceration associated with non-steroidal anti-inflammatory medicines
Reflux oesophagitis
Treatment benign gastric ulcer
Zollinger-Ellison Syndrome
For the treatment of duodenal ulcers associated with Helicobacter pylori infection in combination with appropriate antibiotics
As premedication prior to anaesthesia to reduce the risk of acid aspiration syndrome.

CONTRA-INDICATIONS:
Hypersensitivity to Ranitidine or to any ingredients of the preparation.
Porphyria

WARNINGS:
Treatment with Gulf Ranitidine may mask symptoms associated with carcinoma of the stomach and may, therefore, delay diagnosis of the condition. Accordingly where gastric ulcer is diagnosed the possibility of malignancy should be excluded before therapy with Gulf Ranitidine is instituted.

INTERACTIONS:
Concurrent use of antacids may decrease the absorption of Gulf Ranitidine. It is recommended that the doses of Gulf Ranitidine and an antacid be separated by 1 to 2 hours. Concurrent use with sucralfate may decrease the absorption of any Gulf Ranitidine. Patients should be advised to take Gulf Ranitidine 2 hours before sucralfate.

PREGNANCY AND LACTATION:
Safety and efficacy in pregnancy and lactation has not been established.

DOSAGE AND DIRECTIONS FOR USE:
Gulf Ranitidine
may be taken with or without food.
Gulf Ranitidine is excreted via the kidneys and so plasma levels of the drug are increased and prolonged in patients with severe renal impairment. Accordingly it is recommended that the dose be reduced to 150 mg daily.
Peptic ulceration:
Adults: 150 mg twice daily, taken in the morning and before bedtime or 300 mg taken as a single dose at bedtime.
The duration of treatment for duodenal and benign gastric ulcer is usually 4 weeks. Ulcers, which do not heal within 4 weeks, may require a further course of treatment. For reducing the risk of ulcers developing due to use of non-steroidal anti-inflammatory medicines, 8 to 12 weeks treatment course may be required.
Maintenance treatment:
Adults
: 150 mg at bedtime
Patients with peptic ulceration who have responded to short term therapy, particularly those with a history of recurrent ulcers may require extended maintenance treatment.
Smoking is associated with a higher rate of ulcer relapse. Patients should be advised to stop smoking. In patients unable to stop smoking, a dose of 300 mg at night may provide additional therapeutic benefit over the 150 mg dosage regimen.
Prevention of duodenal ulceration associated with non-steroidal anti-inflammatory medicines
Adults: 150 mg twice daily given concomitantly with the non-steroidal anti-inflammatory medicine.
Reflux oesophagitis:
Adults: 150 mg twice daily or 300 mg at bedtime for up to 8 to 12 weeks. The dose may be increased to 150 mg four times daily for up to 12 weeks in patients with moderate to severe reflux oesophagitis. For the long term management of reflux oesophagitis, the recommended adult oral dose is 150 mg twice daily.
Zollinger-Ellison Syndrome:
Adults: 150 mg three times daily, increased as necessary to 600 mg to 900 mg per day.
Premedication prior to anaesthesia:
Adults: 300 mg given at least 2 hours before induction of anaesthesia. Alternatively a dose of 150 mg given 12 hours before, followed by a further 150 mg given 2 hours before anaesthesia.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Side effects:
Haematological
:
• Leucopenia, thrombocytopenia, agranulocytosis, pancytopenia (occasionally with bone marrow hypoplasia or aplasia)
Cardiovascular:
• Less frequent - bradycardia, AV block
Neurological:
• Headache (sometimes severe), dizziness, mental confusion. Depression, hallucinations (in the elderly and severely ill), involuntary motor disturbances
Endocrine/Metabolic:
• Less frequent - breast symptoms and gynaecomastia in men
Gastro-intestinal:
• Diarrhoea, nausea, vomiting, constipation
Renal/Genitourinary:
• Less frequent - impotence
Hepatic:
• Reversible and transient changes in liver function tests, hepatitis (hepatocellular, hepatocanalicular or both), with or without jaundice, acute pancreatitis
Musculoskeletal:
• Less frequent - arthralgia, myalgia
Skin:
• Skin rash, vasculitis, erythema multiforme, alopecia
Other:
• Anaphylactoid reactions: with anaphylaxis, angioedema, bronchospasm, urticaria, fever and hypotension. These reactions have occasionally occurred after a single dose.

Special Precautions:
Care should be taken to carry out periodic examinations of patients on prolonged maintenance treatment with the medicine as a safeguard against the occurrence of unforeseeable consequences of treatment with this medicine. Regular supervision of patients who are taking non-steroidal anti-inflammatory agents concomitantly with Gulf Ranitidine is recommended especially if elderly.
Current evidence shows that ranitidine protects against NSAID - associated ulceration in the duodenum and not in the stomach.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
Symptoms of overdose:
Symptoms of overdoes are usually reversible, non specific and without adverse sequelae.
Treatment of overdose:
Treatment is symptomatic and supportive. Elimination may be enhanced by haemodialysis.

IDENTIFICATION:
Gulf Ranitidine 150 tablets - White, round, biconvex, film coated tablets (diameter = +9 mm)
Gulf Ranitidine 300 Tablets - White, round, biconvex, film-coated tablets (diameter = +11 mm) :

PRESENTATION:
Gulf Ranitidine 150 Tablets: Unit carton containing 60 tablets in Aluminium foil strips of 10 tablets each
Gulf Ranitidine 300 Tablets: Unit carton containing 30 tablets in Aluminium foil strips of 10 tablets each

STORAGE INSTRUCTIONS:
Store below 25ºC, protected from moisture and light.
Do not remove tablets from blisters until required for use.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
Gulf Ranitidine 150 - A40/11.4.3/0663
Gulf Ranitidine 300 - A40/11.4.3/0415

NAME AND BUSINESS ADDRESS OF THE HOLDER OF THE CERTIFICATE OF REGISTRATION:
Gulf Drug Company (Pty) Ltd
22 Burnside Drive
Old Mill Industrial Park
Mount Edgecombe, 4300

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
05 October 2007

New addition to this site: July 2010
Source: Pharmaceutical Industry

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