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

Logo HISTAK 150 Tablets
HISTAK 300 Tablets

SCHEDULING STATUS:
S3

PROPRIETARY NAME
(and dosage form):

HISTAK 150 Tablets
HISTAK 300 Tablets

COMPOSITION:
HISTAK 150 Tablets
Each film-coated tablet contains:
Ranitidine hydrochloride equivalent to
Ranitidine 150 mg
HISTAK 300 Tablets
Each film-coated tablet contains:
Ranitidine hydrochloride equivalent to Ranitidine 300 mg

PHARMACOLOGICAL CLASSIFICATION:
A.11.4.3. Antacids - Other.

PHARMACOLOGICAL ACTION:
Histak inhibits competitively the interaction of histamine at the histamine H2-receptors of the parietal cells.
Histak is rapidly and well absorbed from the gastro-intestinal tract with peak concentrations in plasma occurring within 1 or 2 hours after oral administration. The bioavailability of ranitidine is about 50% due to first pass metabolism. About 15% is bound to plasma proteins. The elimination half-life is about 2 to 3 hours. Ranitidine is excreted via the kidneys in the free and metabolised forms. Its major metabolite is the N-oxide, S-oxide and desmethyl ranitidine. Ranitidine generally does not bind to microsomal cytochrome P450.

INDICATIONS:
Histak is indicated in the treatment of the following conditions:
–        Duodenal ulcer
–        Benign gastric ulcer
–        Zollinger-Ellison Syndrome
–        Prevention of duodenal ulceration associated with the use of non-steroidal anti-inflammatory agents
–        Reflux oesophagitis
–        Pre-anaesthetic medication to reduce the volume and acid content of gastric secretion, thereby minimising the consequence of the acid aspiration syndrome.

CONTRA-INDICATIONS:
Hypersensitivity to any of the ingredients.
Ranitidine is contraindicated in patients known to be hypersensitive to any of the histamine H2-receptor antagonists. Should be avoided in patients with a history of acute porphyria. Safety in pregnancy and lactation has not been established. The safety and efficacy in children have not been established.

DOSAGE AND DIRECTIONS FOR USE:
Duodenal/Gastric ulcer
–        300 mg at bed-time or 150 mg twice daily orally for at least four weeks.
Maintenance dose of 150 mg daily at bed-time.
Prophylaxis against duodenal ulceration
–        150 mg twice daily orally during therapy with NSAIDs.Gastro-esophageal reflux
–        150 mg twice daily orally or 300 mg at bed-time for up to eight weeks or if necessary 12 weeks. The dosage may be increased to 150 mg four times daily for up to 12 weeks.Zollinger-Ellison Syndrome
–        Initial oral dose 150 mg twice or three times daily. Maximum dose six grams dailyIn Anaesthesia: For premedication prior to anaesthesia in order to reduce the volume and acid content of gastric secretion, a dose of 150 mg given at least 2 hours before induction and preferably also 150 mg the previous evening is indicated to minimise the consequences of the acid aspiration syndrome. Alternatively, a dose of 150 mg given 12 hours prior, followed by a further 150 mg 2 hours prior to anaesthesia, is effective in suppressing gastric secretion.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS:
Cardiovascular system Less frequently bradycardia, atrio-ventricular block and cardiac arrest
Central nervous system Confusion, loss of colour vision, aggressiveness, hallucinations, severe headache, dizziness and tiredness.
Gastro-intestinal symptoms Diarrhoea, recurrent parotitis, hepatotoxicity.
Eye Increased intraocular pressure.
Dermatological Vasculitic rash, hypersensitivity.
Other Fever, arthralgia, myalgia, agranulocytosis, neutropenia, thrombocytopenia, leucopenia, interstitial nephritis, transient and reversible changes in liver function tests can occur.
Precautions:
General
In severe cases of cirrhosis and renal function impairment, risk-benefit should be considered. Dosage reduction of ranitidine are recommended in patients with renal and hepatic function impairment.
Geriatrics:
No geriatric-specific problems have been documented to date. However, confusion is more likely to occur in elderly patients with impaired hepatic or renal function.
Treatment with 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 ranitidine is instituted.
Interactions
Antacids:
–        Concomitant administration decreases the absorption of ranitidine. Alcohol, Glipizide Glyburide, Metopolol, Phenytoin, Midazolam, Nifedipine, Theophylline or Warfarin.
–        Ranitidine is a weak inhibitor of hepatic drug metabolism. However, isolated cases of interactions have been reported between ranitidine and any one of these medicines.
Phenytoin
–        Concurrent use with ranitidine increases level of phenytoin in blood and may increase the risk of ataxia.
Procainamide
–        Due to competition between ranitidine and procainamide, there are increased blood levels of procainamide.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects. Symptomatic and supportive therapy should be given as appropriate. If need be, the medicine may be removed from the plasma by haemodialysis.

IDENTIFICATION:
Histak 150 Tablets:
Creamish-yellow, biconvex, film-coated tablets imprinted with ‘RAN 150’in black edible ink on one side.
Histak 300 Tablets:
Creamish-yellow, biconvex, film-coated, capsule shaped tablets imprinted with ‘RAN 300’in black edible ink on one side.

PRESENTATION:
Histak 150 Tablets:         Carton containing 60 tablets in blister strips of 10 tablets each.
Histak 300 Tablets:         Carton containing 30 tablets in blister strips of 10 tablets each.

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

REGISTRATION NUMBER:
Histak 150 Tablets:         32/11.4.3/1042
Histak 300 Tablets:         32/11.4.3/1043

NAME AND BUSINESS ADDRESS OF THE APPLICANT:
RANBAXY (SA) (PTY) LTD.
Lincoln House
Epsom Downs Office Park,
13 Sloane Street
Epsom Downs
BRYANSTON

DATE OF PUBLICATION OF THIS PACKAGE INSERT:
May 1998

63012 pmB        2       

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