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

Logo APO-RANITIDINE 150 mg (tablets)
APO-RANITIDINE 300 mg (tablets)

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

APO-RANITIDINE 150 mg (tablets)
APO-RANITIDINE 300 mg (tablets)

COMPOSITION:
APO-RANITIDINE 150 mg: Each tablet contains ranitidine hydrochloride equivalent to 150 mg
ranitidine.
APO-RANITIDINE 300 mg: Each tablet contains ranitidine hydrochloride equivalent to 300 mg ranitidine.

PHARMACOLOGICAL CLASSIFICATION:
A.11.4.3 Medicines acting on the gastro-intestinal tract. Antacids - other

PHARMACOLOGICAL ACTION:
Ranitidine is a competitive H2-receptor antagonist and inhibits basal and stimulated secretions, acid and pepsin content, gastric mucous secretion is not affected. Ranitidine has no anti-serotinergic or antihistamine H1-receptor blocking activities, and it does not affect serum prolactin concentrations. It has no affinity for androgen, oestrogen, progesterone, or mineralocorticoid receptors.

Pharmacokinetics:
Peak plasma concentrations are usually reached within 2-3 hours following oral administration and the absorption is not influenced by food or antacids. With an elimination half-life of approximately 2-3 hours, ranitidine is excreted via kidneys in the free and metabolised forms. N-oxide is the main metabolite and S-oxide and desmethyl ranitidine in smaller quantities. There is normally no interaction between ranitidine and the cytochrome P450-linked drug metabolising enzyme system.
Ranitidine crosses the placental barrier and is excreted into breast milk where concentrations are reported to be higher than in plasma.

INDICATIONS:
Ranitidine is indicated for the treatment of duodenal ulcers, benign gastric ulcer including prevention of duodenal ulceration associated with non-steroidal anti-inflammatory agents, reflux oesophagitis and the Zollinger-Ellison syndrome.
To minimise the consequences of acids-aspiration syndrome during anaesthesia, ranitidine is used as premedication to reduce volume and acid content of gastric secretion.

CONTRA-INDICATIONS:
Any known hypersensitivity to any of the ingredients. Safety during pregnancy and lactation has not been established.
Patients with a known history of porphyria should avoid taking APO-RANITIDINE.

DOSAGE AND DIRECTIONS FOR USE:
Adults:
Peptic ulceration: Usual dosage is 150 mg twice daily, taken in the morning and before retiring, or a single dose of 300 mg taken at bedtime. Dosage does not need to be taken with meals. A four week treatment should be sufficient to treat duodenal and benign gastric ulcers in most cases. Ulcers that do not heal within 4 weeks may require a further course of treatment. An 8-12 week treatment may be necessary for ulcers following non-steroidal anti-inflammatory therapy or associated with continued use of these agents.

For the prevention of non-steroidal anti-inflammatory agent associated duodenal ulcers, APO-RANITIDINE 150 mg twice daily may be given concomitantly with non-steroidal anti-inflammatory agent therapy.

Reflux-oesophagitis: Treatment for 8 up to 12 weeks with APO-RANITIDINE 150 mg twice daily or 300 mg once daily at bedtime. The dosage may be increased to 150 mg four times a day for up to 12 weeks in cases where reflux oesophagitis is moderate to severe.

Zollinger-Ellison Syndrome: Starting with 150 mg three times a day and may be increased up to between 600 and 900 mg per day.

Anaesthesia: 300 mg APO-RANITIDINE given 2 hours before induction, or APO-RANITIDINE 150 mg 12 hours prior and a further 150 mg 2 hours prior to anaesthesia in order to reduce the volume and acid content of gastric secretion, will minimise the consequences of the acid aspiration syndrome.

Maintenance treatment: Patients, particularly those with a history of a recurrent ulcer, should be advised to take 150 mg at bedtime. They should also be advised to give up smoking, because smoking is associated with a higher rate of ulcer relapse. An additional 300 mg taken at night could be given to patients unable to stop smoking.

Children:
Use of ranitidine in children is limited.

SIDE EFFECTS AND SPECIAL PRECAUTIONS:
Side-effects:
- Transient and reversible changes in liver functions.
- Occasional reports of reversible hepatitis without jaundice (hepatocellular, hepatocanicular or mixed).
- Blood count changes (leucopenia, thrombocytopenia)
- Agranulocytosis or pancytopaenia with marrow hypoplasia or aplasia have been reported.
- After a single dose administration orally, anaphylactoid reactions eg. urticaria angioneurotic oedema, fever, bronchospasm, hypotension and anaphylactic shock have been observed.
- Bradycardia, AV-block, headache and dizziness following oral administration
- Mainly in severely ill and elderly patients, incidents of reversible mental confusion, depression and hallucinations have been reported.
- Constipation, diarrhoea, nausea and vomiting.
- Skin rash, including cases of erythema multiforme.
- Acute pancreatitis, arthralgia and myalgia.
- Males treated with ranitidine have complained of discomfort, pain and/or swelling of breasts and gynaecomastia.

Special Precautions
Where a gastric ulcer is present, the possibility of malignancy should be excluded before treating a patient with a H2-antagonist, for it may mask the symptoms of carcinoma in the stomach and therefore delay diagnosis of the condition.
Patients with severe renal impairment will have increased and prolonged plasma levels of ranitidine (ranitidine is excreted via the kidney) therefore it is advised to reduce the dosage to 150 mg daily.
Ongoing monitoring of patients on long term treatment of APO-RANITIDINE is necessary to safeguard against unforeseeable consequences of the medicine. Elderly patients who are taking a combination of APO-RANITIDINE and non-steroidal anti-inflammatory agents, should be well monitored.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See "Side-Effects and Special Precautions".
Treatment is supportive and symptomatic.
Ranitidine can be removed from plasma by haemodialysis.

IDENTIFICATION:
APO-RANITIDINE 150 mg: White, round, biconvex, film-coated tablets, "APO" over "150" on one side, plain on the other.
APO-RANITIDINE 300 mg: White capsule-shaped, biconvex, film coated tablet engraved "APO-300" on one side, plain on the other.

PRESENTATION:
APO-RANITIDINE 150 mg: Tablets are packed in white plastic bottles of 60, 100 and 500.
Also available in blister packs of 60's and 100's
APO-RANITIDINE 300 mg: Tablets are packed in white plastic bottles of 30, 100 and 500.
Also available in blister packs of 30's.

STORAGE INSTRUCTIONS:
Keep tightly closed. Store below 25°C. Protect from moisture and light.
KEEP OUT OF REACH OF CHILDREN

REGISTRATION NUMBER:
150 mg: 31/11.4.3/0673
300 mg: 31/11.4.3/0674

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
APOTEX S.A.
PHARMACEUTICAL INNOVATION
APOTEX S.A. (PTY) LTD
Cnr Fleming and Watt Street
Meadowdale, Ext. 1

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
13/01/98

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