Ranitidine hydrochloride ….167.4 mg
(Equivalent to ranitidine 150mg )
group: Alimentary tract and metabolism.
Ranitidine is a specific, rapidly acting
histamine H2-antagonist. It inhibits basal
and stimulated secretion of gastric acid,
reducing both the volume and the acid and
pepsin content of the secretion.
has a relatively long duration of action and
so a single 150mg dose effectively
suppresses gastric acid secretion for twelve
hours. Clinical evidence has shown that
ranitidine combined with amoxycillin and
metronidazole eradicates Helicobacter pylori
in approximately 90% of patients.
combination therapy has been shown to
significantly reduce duodenal ulcer
recurrence. Helicobacter pylori infects
about 95% of patients with duodenal ulcer
and 80% of patients with gastric ulcer.
Although no clear casual link has been
established, a large epidemiological study
showed an increased risk of developing
community acquired pneumonia in current
users of H2 receptor antagonists versus
those who had stopped treatment, with an
observed adjusted relative risk increase of
1.63 (95% CI, 1.07 2.48). Therefore, in
patients with conditions predisposing to the
development of pneumonia, such as chronic
lung disease, diabetes, or the immuno-compromised,
there may be an increased risk of developing
oral administration of 150 mg ranitidine,
maximum plasma concentrations (300 to 550 ng/mL) occurred after 1-3 hours.
Two distinct peaks or a plateau in the
absorption phase result from reabsorption of
drug excreted into the intestine. The
absolute bioavailability of ranitidine is
50-60%, and plasma concentrations increase
proportionally with increasing dose up to
treatment of duodenal ulcer and benign
gastric ulcer including that associated with
non-steroidal anti-inflammatory agents.
Prevention of non-steroidal
anti-inflammatory drug (including aspirin)
associated duodenal ulcers, especially in
patients with a history of peptic ulcer
Ranitak is also indicated for
treatment of post-operative ulcer, reflux
esophagitis, Zollinger-Ellison syndrome and
other conditions where reduction of gastric
acid secretion is likely to be beneficial.
Children (3 to 18 years): Short term
treatment of peptic ulcer. Treatment of
gastro-esophageal reflux, including reflux
esophagitis and symptomatic relief of
gastro-esophageal reflux disease.
Posology and method
(including the elderly) / Adolescents (12
years and over)
initial dosage is 150 mg twice daily or
300mg at night. This may be increased to
ranitidine 300mg twice daily without an
increased incidence of unwanted effects.
Subsequently a maintenance dose of 150 mg at
night may be used.
Smoking is associated
with a higher rate of ulcer relapse, and
such patients should be advised to stop
In those who fail to comply
with such advice, a dose of 300 mg at night
provides additional therapeutic benefit over
the standard dose.
► In most cases
of Duodenal ulcer, benign gastric ulcer and
occurs within 4 weeks.
occurs after a further 4 weeks in those not
fully healed after the initial 4 weeks.
► In ulcers following non-steroidal
anti-inflammatory drug therapy:
8 - 12 weeks treatment may be necessary.
► For the prevention of non-steroidal
anti-inflammatory drug associated duodenal
Ranitidine 150 mg twice
daily may be given concomitantly with
non-steroidal anti-inflammatory drug
In the management of Reflux
oesophagitis, the usual course of treatment
is either 150 mg twice daily or 300 mg at
night administered for up to a period of 8,
or if necessary 12 weeks.
with moderate to severe oesophagitis, the
dosage may be increased to 150 mg four times
daily, alternatively 300mg twice a day, if
► For the long-term
management of reflux oesophagitis:
The recommended adult oral dose is 150 mg
twice daily for the prevention of relapse in
patients with reflux oesophagitis.
Ranitak 150mg effervescent sachets are not
indicated in patients with complications of
reflux oesophagitis e.g. severe oesophegeal
stricture or Barratt's oesophagus.
keeping with the recommended clinical
practice, it is advisable that patients on
long-term maintenance therapy receive
regular routine assessment by practitioners.
► Zollinger-Ellison syndrome:
The starting dose is 150 mg thrice daily,
increased as necessary up to a maximum of 6
grams daily. Prophylaxis of hemorrhage from
stress ulceration in seriously ill patients
or the prophylaxis of recurrent hemorrhage
in patients bleeding from peptic ulceration,
treatment with Ranitidine 150 mg twice daily
may be substituted for ranitidine Injection
once oral feeding commences in patients
considered to be still at risk from these
► Obstetric patients:
An oral dose of 150 mg may be
given at commencement of labor, followed by
150mg at 6 hourly intervals. It is
recommended that in addition, a
non-particulate antacid (e.g. sodium
citrate) should be given prior to induction
of anesthesia in any patient requiring
emergency general anesthesia.
from 3 to 11 years and over 30 kg of weight:
Pharmacokinetic properties special
Ulcer Acute Treatment:
recommended oral dose for the treatment of
peptic ulcer in children is 4 mg/kg/day to 8
mg/kg/day administered as two divided doses
to a maximum of 300 mg ranitidine per day
for duration of 4 weeks.
patients with incomplete healing, another 4
weeks of therapy is indicated, as healing
usually occurs after eight weeks of
The recommended oral
dose for the treatment of gastro-oesophageal
reflux in children is 5 mg/kg/day to 10
mg/kg/day administered as two divided doses
in a maximum dose of 600 mg (the maximum
dose is likely to apply to heavier children
or adolescents with severe symptoms).
Safety and efficacy in new-born patients
has not been established.
Accumulation of ranitidine with
resulting elevated plasma concentrations
will occur in patients with renal impairment
(creatinine clearance less than 50 ml/min).
It is recommended that the daily dose of
ranitidine in such patients should be 150mg.
Use in patients known to have
hypersensitivity to any component of the
Special warnings and
Before initiation of
ranitidine treatment for any gastric
ulceration, malignancy should be excluded by
endoscopy and biopsy if possible.
Treatment may mask the symptoms of
malignancy, delaying diagnosis.
Ranitidine is excreted via the kidney and so
plasma levels of the drug are increased in
patients with severe renal impairment.
Regular supervision of patients who are
taking non-steroidal anti-inflammatory drugs
concomitantly with ranitidine is
recommended, especially in the elderly and
in those with a history of peptic ulcer. In
patients such as the elderly, persons with
chronic lung disease, diabetes or the top of
immuno-compromised, there may be an
increased risk of developing community
epidemiological study showed an increased
risk of developing community acquired
pneumonia in current users of ranitidine
alone versus those who had stopped
treatment, with an observed adjusted
relative risk increase of 1.82 (95% CI 1.26
As Ranitak Effervescent Sachets
contain Sorbitol, Patients with rare
hereditary problems of Fructose intolerance,
should not take this medicine.
Effervescent Sachets contain Aspartame; a
source of phenylalanine, it may be harmful
for patients with phenylketonuria.
Ranitak Effervescent Sachets contains
sodium. Care should therefore be taken in
treating patients in whom sodium restriction
is indicated (e.g. in case of hypertension,
heart failure, liver failure).
clinical reports suggest that ranitidine may
precipitate acute porphyric
attacks.Ranitidine should therefore be
avoided in patients with a history of acute
IIn keeping with the
recommended clinical practice, it is
advisable that patients on long-term
maintenance therapy receive regular routine
assessment by practitioners.
other medicinal products and other forms of
Ranitidine has the
potential to affect the absorption,
metabolism or renal excretion of other
drugs. The altered pharmacokinetics may
necessitate dosage adjustment of the
affected drug or discontinuation of
Interactions occur by several
Inhibition of cytochrome P450-linked mixed
function oxygenase system: Ranitidine at
usual therapeutic doses does not potentiate
the actions of drugs which are inactivated
by this enzyme system such as diazepam,
lidocaine, phenytoin, propranolol and
theophylline. There have been reports of
altered prothrombin time with coumarin
anticoagulants (e.g. warfarin). Due to the
narrow therapeutic index, close monitoring
of increased or decreased prothrombin time
is recommended during concurrent treatment
Competition for renal tubular secretion:
Since ranitidine is partially eliminated by
the cationic system, it may affect the
clearance of other drugs eliminated by this
High doses of ranitidine (e.g.
such as those used in the treatment of
Zollinger-Ellison syndrome) may reduce the
excretion of procainamide and N-acetylprocainamide
resulting in increased plasma levels of
Alteration of gastric pH: The
bioavailability of certain drugs may be
affected. This can result in either an
increase in absorption (e.g. triazolam,
midazolam) or a decrease in absorption (e.g.
ketoconazole, atazanavir, glipizide,
Ranitidine should not
be administered during pregnancy or
lactation unless considered essential by the
physician. Ranitidine crosses the placenta
and has been detected in breast milk.
Effects on ability to drive and use
machines: Not applicable
► Skin rash
reversible changes in the liver function
tests may occur.
leucopenia & thrombocytopenia have been
Unlike Cimetidine, Ranitidine has little or
No anti-androgenic effects & incidence of
gynecomastia & impotence in patients treated
with higher doses has been reported not to
differ from that encountered in the general
Ranitidine is very specific in action and no
particular problems are expected following
over dosage with the drug.
Symptomatic and supportive therapy should be
given as appropriate. If need be, the drug
may be removed from the plasma by
Keep at room
temperature not exceeding 30ºC & away from
Carton box containing 10 terta-laminated
sachets each of 4 gm of granules with inner
Special precautions for
disposal and other handling:
One or two
Ranitak Effervescent Sachets should be
dissolved in half a glass of water (at least
75 ml) and drink immediately.