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Logo HISTAK 75 Tablets
SCHEDULING STATUS:
S2

PROPRIETARY NAME
(and dosage form):

HISTAK 75 Tablets

COMPOSITION:
Each film coated tablet contains
Ranitidine hydrochloride
equivalent to Ranitidine         75 mg

PHARMACOLOGICAL CLASSIFICATION:
A11.4.3 Antacids-other

PHARMACOLOGICAL ACTION:
Ranitidine inhibits the basal and noctural gastric acid by competitive inhibition of the interaction of histamine at the histamine H2-receptors of the parietal cells. Ranitidine reduces both the volume of gastric juices and its H+ concentration.
Ranitidine is rapidly and well absorbed from the gastro-intestinal tract with peak concentrations in plasma occuring within 1 or 2 hours after oral administration. The bioavailability of ranitidine is about 50%. The absorption is not significantly impaired by the coadministration of food or antacids. About 15% of ranitidine 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:
Ranitidine 75 tablets are indicated for the prevention and symptomatic relief of heartburn and hyperacidity.

CONTRA-INDICATIONS:
Ranitidine is contraindicated in patients hypersensitive to ranitidine or any of the histamine H2-receptor antagonists.
The safety in pregnancy and lactation has not been established. Histak 75 is not recommended for children under 16 years of age. Histak 75 should be avoided in patients with a history of acute porphyria.

DOSAGE AND DIRECTIONS FOR USE:
Prevention:
The usual dose of Ranitidine for adults and adolescents of 16 years of age and older, is one tablet 30 minutes to one hour before eating a meal, that is expected to cause symptoms. Not more than 4 tablets per day should be taken.
Relief:
One tablet when the symptoms appear, day or night. Up to 4 tablets may be taken in a 24 hour period. Do not use Histak 75 for longer than 2 weeks.

For patients with impaired renal functions (Creatinine clearance of less than 50 mL per minute) dosage adjustment is required; not more than 150 mg/day (2 tablets of Histak 75 per day) should be given to such patients.

SIDE-EFFECTS AND SPECIAL PRECAUTIONS :
Side-effects:
Cardiovascular system - Less frequently bradycardia, atrioventricular block and cardiac arrest.
Central nervous system - Confusion, loss of colour vision, aggressiveness, hallucinations and severe headache.
Gastrointestinal System - Recurrent parotitis, hepatotoxicity.
Eye - Increased intraocular pressure.
Dermatological - Vasculitic rash, hypersensitivity.
Blood disorders - Agranulocytosis, neutropenia, thrombocytopenia,
Others - Interstitial nephritis, fever, arthalgia, myalgia.
There has been a few reports of breast enlargement symptoms in men taking ranitidine.
Precautions:
General
Risk benefit should be assessed before prescribing Histak 75 to patients with following diseases/conditions. The patient must consult the treating doctor before taking Histak 75 when these exists.
(i) Patients with hepatic or renal function impairment
(ii) Pregnant or breast feeding women (See Contraindications).
(iii) Elderly patients

Interactions
Antacids – Concurrent administration decreases the absorption of ranitidine.
Alcohol, Glipizide, Glyburide, Metoprolol, Phenytoin, Midazolam, Nifedipine, Theophylline, or Warfarin – Rantidine is a weak inhibitor of hepatic medicine metabolism. However, isolated cases of medicines 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 – Ranitidine can inhibit tubular secretion of procainamide, thereby increase the plasma concentration of procainamide.

Laboratory value alterations
Serum Creatinine, Serum Gamma-glutamyl transpeptidase and transaminase – Levels may be increased when ranitidine is given.
Urinary protein – False-positive reaction may be produced during ranitidine therapy.
Gastric acid Secretion test – Ranitidine is not recommended during 24 hours preceding the test as it may antagonise the effect of pentagastrin and histamine in the evaluation of gastric acid secretory function.
Skin tests using allergen extracts – H2 receptor antagonists may inhibit the cutaneous histamine response, thus producing false negative results.

KNOWN SYMPTOMS OF OVERDOSAGE AND PARTICULARS OF ITS TREATMENT:
See side-effects and special precautions. Treatment is symptomatic and supportive.

IDENTIFICATION:
Light pink, round, biconvex, film-coated tablets imprinted with '75' in black edible ink on one side.

PRESENTATION:
Carton containing one or two or five blister strips of 6 tablets each.

STORAGE INSTRUCTIONS:
Store below 25°C, protected from moisture and light.
KEEP OUT OF REACH OF CHILDREN.

REGISTRATION NUMBER:
32/11.4.3/0604

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

DATE OF PUBLICATION OF PUBLICATION OF THIS PACKAGE INSERT:
June 2000

Updated on this site: February 2001

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