(Ranitidine Hydrochloride Tablets)
HISTAC 150 mg : Each film-coated tablet contains :
Ranitidine Hydrochloride BP equivalent to Ranitidine 150 mg
HISTAC 300 mg : Each film-coated tablet contains :
Ranitidine Hydrochloride BP equivalent to Ranitidine 300 mg
HISTAC 150 mg : Creamish-yellow, round biconvex film-coated tablets embossed
with "HISTAC 150" on one side, and "RANBAXY" on the other side.
HISTAC 300 mg Creamish-yellow, capsule shaped biconvex film-coated tablets
embossed with "HISTAC 300" on one side, and stomach sign on other side.
HISTAC contains Ranitidine Hydrochloride which is a histamine H2 antagonist.
Chemically, it is
N-[2-[[[5-[(Dimethylamino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-N1-methyl-2-nitroethene-1,1-diamine hydrochloride. Its empirical formula is
C13H22,N4,O3,S, HCI and its molecular weight is 350.9. The chemical structure
of Ranitidine HCI is as follows:
PHARMACOLOGY (SUMMARY OF PHARMACODYNAMICS AND PHARMACOKINETICS)
Ranitidine is a specific, rapidly acting histamine H2-antagonist. It
inhibits basal and stimulated secretion of gastric acid, reducing both the
volume, the acid and pepsin content of the secretion. Ranitidine has a
relatively long duration of action and so a single 150 mg dose effectively
suppresses gastric secretion for twelve hours.
The bioavailability of Ranitidine is consistently about 50%. Absorption of
Ranitidine after oral administration is rapid and peak plasma concentrations
are usually achieved in 2-3 hours after administration. Absorption is not
significantly impaired by food or antacids. Ranitidine is not extensively
Elimination of the drug is primarily by tubular secretion. The elimination
half-life of Ranitidine is 2-3 hours. After an oral administration of 150 mg
Ranitidine, 60-70% is excreted in urine and 26% in faeces. About 35% of the
oral dose is eliminated unchanged and 6% of the dose is excreted as the
N-oxide, 2% as the S-oxide, 2% as desmethyl Ranitidine and 1-2% as furoic
Ranitidine tablets BP are indicated for the treatment of duodenal ulcer and
benign gastric ulcer, including that associated with non-steroidal
anti-inflammatory agents. In addition, Ranitidine tablets are indicated for
the prevention of NSAID associated duodenal ulcers.
Ranitidine tablets are also indicated for the treatment of post-operative
ulcer, Zollinger-Ellison syndrome and oesophageal reflux disease including
the long term management of healed oesophagitis. Other patients with chronic
episodic dyspepsia, characterized by pain (epigastric or retrosternal) which
is related to meals or disturbs sleep but not associated with the preceding
conditions may benefits from Ranitidine treatment. Ranitidine tablets are
indicated for the following conditions where reduction of gastric secretion
and acid output is desirable : prophylaxis of gastrointestinal haemorrhage
from stress ulceration in seriously ill patients, prophylaxis of recurrent
haemorrhage in patients with bleeding peptic ulcers and before general
anaesthesia in patients considered to be at risk of acid aspiration (Mandelson's
syndrome), particularly obstetric patients during labour.
Ranitidine is contraindicated for patients known to have hypersensitivity to
SIDE EFFECTS /ADVERSE EFFECTS
Transient and reversible changes in liver function tests can occur. There
have been occasional reports of hepatitis (hepatocellular, hepatocanalicular
or mixed) with or without jaundice. These were usually reversible. Acute
pancreatitis has been reported rarely.
Leucopenia, thrombocytopenia, agranulocytosis or pancytopenia, sometimes
with marrow hypoplasia, or aplasia have been reported.
Hypersensitivity reactions (urticaria, angioneurotic oedema, fever,
bronchospasm, hypotension, anaphylactic shock) have been seen rarely
following an oral administration of Ranitidine. These reactions have
occasionally occurred after a single dose.
As with other H2-receptor antogonists, there have been rare reports of
bradycardia and A-V block.
Headache, sometimes severe, and dizziness have been reported in a very small
proportion of patients. Rare cases of reversible mental confusion,
depression and hallucinations have been reported, predominantly in severely
ill and elderly patients.
Skin rash and musculoskeletal symptoms such as arthralgia and myalgia have
been reported rarely.
No clinically significant interference with endocrine or gonadal function
has been reported. There have been a few reports of breast symptoms
(swelling and / or discomfort) in men taking Ranitidine; some cases have
resolved on continued Ranitidine treatment. Discontinuation of therapy may
be necessary in order to establish the underlying cause.
WARNINGS / PRECAUTIONS / DRUG INTERACTIONS
Treatment with a histamine H2 antagonist may mask symptoms associated with
carcinoma of the stomach and may therefore delay diagnosis of the condition.
Accordingly, where gastric ulcer has been diagnosed or in patients of middle
age and over with new or recently changed dyspeptic symptoms, the
possibility of malignancy should be excluded before therapy with Ranitidine
Ranitidine is excreted via the kidney and so plasma levels of the drug are
increased in patients with severe renal impairment. It is recommended that
the dose of Ranitidine in such patients be 150 mg at night for 4 to 8 weeks.
The same dose should be used for maintenance. If an ulcer has not healed
after treatment the standard dosage
regimen of 150 mg twice daily should be instituted, followed by maintenance
treatment of 150 mg at night.
Regular supervision of patients who are taking non-steroidal
anti-inflammatory drugs concomitantly with Ranitidine is recommended,
especially in the elderly.
Ranitidine crosses the placenta but therapeutic doses administered to
obstetric patients in labour or undergoing caesarean section have been
without any adverse effect on labour, delivery of subsequent neonatal
progress. Ranitidine is also excreted in human breast milk.
Like other drugs, Ranitidine should only be used during pregnancy and
nursing if considered essential.
Ranitidine should be avoided in patients with a history of Acute
Use in elderly patients.
There is no evidence suggesting limitation of usefulness in elderly.