Ranitak 150 mg
(Effervescent granules)
Ranitak Effervescent granulesComposition:
Ranitidine hydrochloride ….167.4 mg
(Equivalent to ranitidine 150 mg )Pharmaceutical form:
Effervescent granules
Pharmacodynamic properties:
Pharmacotherapeutic 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.
Ranitak 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.
This 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 community-acquired pneumonia.

Pharmacokinetic properties:
Absorption: Following 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 300mg
Therapeutic indications:
In the 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 disease.
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 of administration:
Adults (including the elderly) / Adolescents (12 years and over)
The usual 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 smoking.
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 postoperative ulcer:
Healing occurs within 4 weeks.
Healing usually 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 ulcers:
Ranitidine 150 mg twice daily may be given concomitantly with non-steroidal anti-inflammatory drug therapy.
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.
In patients with moderate to severe oesophagitis, the dosage may be increased to 150 mg four times daily, alternatively 300mg twice a day, if necessary.
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.
In 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 conditions.
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.
Children from 3 to 11 years and over 30 kg of weight:
Pharmacokinetic properties special patient populations.
Peptic Ulcer Acute Treatment:
The 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.
For those patients with incomplete healing, another 4 weeks of therapy is indicated, as healing usually occurs after eight weeks of treatment.
Gastro-Esophageal Reflux:
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.

Renal insufficiency:
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.


Contraindications:
Use in patients known to have hypersensitivity to any component of the product.


Special warnings and precautions:
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 acquired pneumonia.
A large 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 2.64).
As Ranitak Effervescent Sachets contain Sorbitol, Patients with rare hereditary problems of Fructose intolerance, should not take this medicine.
As Ranitak 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).
Rare clinical reports suggest that ranitidine may precipitate acute porphyric attacks.Ranitidine should therefore be avoided in patients with a history of acute porphyria.
In keeping with the recommended clinical practice, it is advisable that patients on long-term maintenance therapy receive regular routine assessment by practitioners.


Interaction with other medicinal products and other forms of interaction:
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 treatment.
Interactions occur by several mechanisms including:
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 with ranitidine.
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 route.
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 these drugs.
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, delaviridine, gefitnib).

Pregnancy and lactation:
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


Side effects:
HeadacheRare hypersensitivity reactions BradycardiaDizzinessSkin rashTransient reversible changes in the liver function tests may occur.Reversible leucopenia & thrombocytopenia have been rarely reported.
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 population.


Overdose:
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 hemodialysis.


Storage
Keep at room temperature not exceeding 30ºC & away from moisture.


Presentation:
Carton box containing 10 terta-laminated sachets each of 4 gm of granules with inner leaflet.
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.