FORMULATION:
Each tablet contains:
Ranitidine (as Hydrochloride)............150 mg
Ranitidne (as Hydrochloride).............300 mg
INDICATIONS:
Ranitidine is indicated for:
-Benign gastric ulcer and duodenal ulcer, including the induced by
the use of non-steroidal anti-inflammatory agents.
-Duodenal ulcer associated with Helicobacter pylori infection.
-Prevention and prophylaxis of NSAIDs (including aspirin) induced duodenal
ulcer, especially in patients with a history of peptic ulcer disease.
-Reflux oesophagitis.
-Zollinger-Ellison syndrome.
-Prophylaxis of stress ulceration in seriously ill patients.
-Prophylaxis of acid aspiration in obstetrics (Mendelson’s syndrome).
-Prophylaxis of recurrent haemorrhage from peptic ulcer.
-Post operative ulcer.
-Chronic episodic dyspepsia.
DOSAGE & ADMINISTRATION:
ADULTS:
Benign gastric ulcer and duodenal ulcer.
Acute treatment: The standard dosage regimen is 150 mg twice
daily, or 300 mg at night, for 4 to 8 weeks. Healing usually occurs
after a further 4 weeks in those patients not fully healed after the initial
4 weeks therapy. In duodenal ulcer Ranitidine 300 mg tablet can be
given twice for 4 weeks to achieve a higher healing rate.
Maintenance management: For long-term maintenance of benign gastric
ulcer or duodenal ulcer, the recommended dosage regimen is Ranitidine 150
mg tablet at night.
Duodenal ulceration associated with Helicobacter pylori infection:
Ranitidine 300 mg tablet once at bedtime or Ranitidine 150 mg tablet twice
daily plus amoxicillin 750 mg 3 times daily and metronidazole 500 mg 3
times daily for two weeks. Therapy with Ranitidine only should continue
for a further two weeks. This dose regimen significantly reduces
the frequency of recurrence of duodenal ulcer.
NSAIDs induced duodenal ulcer:
Acute treatment: In NSAIDs induced duodenal ulcer or associated
with continued therapy, Ranitidine 150 mg twice daily or Ranitidine 300
mg at night for 8 weeks may be necessary.
Prophylaxis: For the prevention of NSAIDs associated duodenal
ulcer, Ranitidine 150 mg tablet twice daily may be given concomitantly
with NSAIDs therapy.
Reflux oesophagitis:
Acute reflux oesophagitis: Ranitidine 150 mg twice daily or Ranitidine
300 mg tablet at bed time for up to 8 weeks, or if necessary for 12 weeks.
In patients with moderate to severe oesophagitis, the dosage may be
increased to Ranitidine 150 mg tablet four times daily for up to 12 weeks.
Long-term management of healed oesophagitis: The recommended
adult dose is Ranitidine 150 mg tablet twice daily.
Zollinger-Ellison syndrome:The initial dosage regimen is Ranitidine
150 mg tablet three times daily, but this may be increased as necessary.
Doses up to 6 grams daily in divided doses have been used and well tolerated.
Prophylaxis of stress ulceration in seriously ill patients or prophylaxis
of recurrent haemorrage from peptic ulcer. Ranitidine 150 mg tablet
twice daily may be substituted for the injection when oral feeding is resumed.
Prophylaxis of acid aspiration in obstetrics patients at delivery (Mendelson’s
syndrome): Ranitidine 150 mg tablet at onset of labour, then every
6 hours, if required.
Surgical Prophylaxis:
For surgical prophylaxis, Ranitidine 150 mg tablet 2 hours before induction
of anaesthesia and also preferably Ranitidine 150 mg tablet on the preceding
evening.
Chronic episodic dyspepsia:
The standard regimen in younger patients is Ranitidine 150 mg tablet
twice daily for up to 6 weeks. Patients not responding or relapsing
shortly afterwards should be investigated further. This regimen is
undesirable in older patients as diagnosis of gastric cancer may be delayed
or as directed by the physician.
CHILDREN:
The recommended oral dose for the treatment of peptic ulcer in children
is 2-4 mg/kg twice daily to a maximum of 300 mg Ranitidine per day.
CONTRAINDICATIONS:
Ranitidine Tablet is contraindicated in patients known to have hypersensitivity
to Ranitidine. It should be avoided in patients with a history of
acute prophyria.
PRECAUTIONS:
Before giving ranitidine to patients with gastric ulcers the possibility
of malignancy should be considered since ranitidine may mask symptoms and
delay diagnosis. It should be given in reduced dosage to patients with
impaired renal function.
Intravenous injections of cimetidine should be given slowly and intrvenous infusion is recommended in patients with cardiovascular impairment.
USE IN PREGNANCY AND LACTATION:
Ranitidine crosses the placenta and is also excreted in breast milk.
As with most drugs, Ranitidine tablet should not be given during pregnancy
and lactation unless the physician considers its use essential.
SIDE EFFECTS:
Ranitidine has little or no anti-androgenic effect, although there
have been isolated reports of gynaecomastia and impotence.
DRUG INTERACTIONS:
Ranitidine does not seem to affect cytochrome P450 to any great extent,
and therefore is considered to have little effect on the metabolism of
other drugs. The absorption of ranitidine is reported to be impaired by
the concomitant administration of sucralfate.
AVAILABILITY:
Ranitidine 150 mg Tablets in blister pack of 10’s x 2 (box of 20’s).
Ranitidine 150 mg Tablets in blister pack of 10’s x 1 (box of 10’s).
STORAGE CONDITION
Store below 25oC in a dry place.
CAUTION
Foods, Drugs, Devices and Cosmetics Acts prohibits despensing without
prescription.
MANUFACTURED BY :
globalpharma Co. LLC
P.O. Box 72168
Dubai, U.A.E.
IMPORTED AND EXCLUSIVELY DISTRIBUTED BY:
S.M.H.P. Maketing Consultancy
# 2629 Taft Avenue, Malate, Manila,
Philippines
Ranitidine 300 mg Tablets in blister pack of 10’s x1 lets.
STORAGE CONDITION:
Store below 25°C in a dry place.
CAUTION:
Foods, Drugs, Devices and Cosmetics Acts prohibits dispensing without
prescription.
Manufactured By:
globalpharma Co. LLC
P.O. Box 72168
Dubai, U.A.E.
Imported & Exclusively Distributed By:
S.M.H.P. Marketing Consultancy
#2629 Taft Avenue, Malate, Manila
Philippines