Brand Names of Ranitidine in Kenya
Aciloc®,Cadila Pharmaceuticals (Ea) Ltd
Labtac®, Lab and Allied Ltd
Neotack®,Square Pharmaceuticals Ltd
Rantag, Julphar Pharmaceutical Industries
Rani Denk®, Denk Pharma GmbH & Co. KG
Ranison, Jayson Pharmaceutical Ltd.
Ranitid, Sakar Healthcare Ltd.
Ranitidine, Kilitch Drugs (India) Ltd
Ultac® , Cosmos Limited
Umetac, Umedica Laboratories Pvt Ltd
Rinatadin, Orange Pharma Ltd
RANITIDINE WAS RECALLED FROM KENYAN MARKET BY PPB
Ranitidine is a competitive, reversible inhibitor of the action of histamine at the histamine H2-receptors, including receptors on the gastric cells. Ranitidine does not lower serum Ca++ in hypercalcemic states. Ranitidine is not an anticholinergic agent.
Ranitidine is indicated in:
Short-term treatment of active duodenal ulcer.
Most patients heal within 4 weeks. Studies available to date have not assessed the safety of ranitidine in uncomplicated duodenal ulcer for periods of more than 8 weeks.
Maintenance therapy for duodenal ulcer patients at reduced dosage after healing of acute ulcers. No placebo-controlled comparative studies have been carried out for periods of longer than 1 year.
The treatment of pathological hypersecretory conditions
(e.g., Zollinger-Ellison syndrome and systemic mastocytosis).
Short-term treatment of active, benign gastric ulcer.
Most patients heal within 6 weeks and the usefulness of further treatment has not been demonstrated. Studies available to date have not assessed the safety of ranitidine in uncomplicated, benign gastric ulcer for periods of more than 6 weeks.
Maintenance therapy for gastric ulcer patients at reduced dosage after healing of acute ulcers. Placebo-controlled studies have been carried out for 1 year.
Treatment of GERD.
Symptomatic relief commonly occurs within 24 hours after starting therapy with ranitidine 150 mg twice daily.
Treatment of endoscopically diagnosed erosive esophagitis.
Symptomatic relief of heartburn commonly occurs within 24 hours of therapy initiation with ranitidine 150 mg 4 times daily.
Maintenance of healing of erosive esophagitis.
Placebo-controlled trials have been carried out for 48 weeks.
Concomitant antacids should be given as needed for pain relief to patients with active duodenal ulcer; active, benign gastric ulcer; hypersecretory states; GERD; and erosive esophagitis
DOSAGE AND ADMINISTRATION
Adults (including the elderly) / Adolescent (12 years and over):
The usual dosage is 150mg twice daily.
Duodenal ulcer, gastric ulcer:
The standard dosage regimen is 150 mg twice daily or 300 mg at night. It is not necessary to time the dose in relation to meals.
In most cases of duodenal ulcer, benign gastric ulcer and post operative ulcer, healing occurs in 4 weeks. Healing usually occurs after a further 4 weeks of treatment in those patients whose ulcers have not fully healed after the initial course of therapy.
Ulcers following NSAID therapy or associated with continued NSAIDs:
8 weeks’ treatment may be necessary.
Prevention of NSAID associated duodenal ulcers:
150 mg twice daily may be given concomitantly with NSAID therapy.
In duodenal ulcer 300mg twice daily for 4 weeks results in healing rates which are higher than those at 4 weeks with ranitidine 150mg twice daily or 300mg at night. The increased dose has not been associated with an increased incidence of unwanted effects.
Duodenal ulcers associated with Helicobacter pylori infection:
For duodenal ulcers associated with Helicobacter pylori infection, ranitidine 300 mg at bedtime or 150 mg twice daily may be given with oral amoxicillin 750 mg three times daily and metronidazole 500 mg three times daily for two weeks. Therapy with ranitidine should continue for a further two weeks. This dose regimen significantly reduces the frequency of duodenal ulcer recurrence.
Maintenance treatment at a reduced dosage of 150 mg at bedtime is recommended for patients who have responded to short term therapy, particularly those with a history of recurrent ulcer.
Gastro-oesophageal reflux disease:
Symptom relief in gastro-oesophageal reflux disease. In patients with gastro-oesophageal reflux disease, a dose regimen of 150 mg twice daily for 2 weeks is recommended and this can be repeated in patients in whom the initial symptomatic response is inadequate.
Oesophageal reflux disease
In the management of oesophageal reflux disease, the recommended course of treatment is either 150 mg twice daily or 300 mg at bedtime for up to 8 weeks or 12 weeks if necessary.
In patients with moderate to severe oesophagitis, the dosage of ranitidine may be increased to 150mg four times daily for up to 12 weeks. The increased dose has not been associated with an increased incidence of unwanted effects.
For long term treatment, the recommended adult oral dose is 150mg twice daily. Long-term treatment is not indicated in the management of patients with unhealed oesophagitis, with or without Barrett’s epithelium.
In patients with Zollinger-Ellison syndrome, the starting dose is 150mg three times daily and this may be increased as necessary. Patients with this syndrome have been given increasing doses up to 6 g daily and these doses have been well tolerated.
Chronic episodic dyspepsia:
For patients with chronic episodic dyspepsia the recommended course of treatment is 150mg twice daily for up to 6 weeks. Anyone not responding or relapsing shortly afterwards should be investigated.
In the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration.
Prophylaxis of acid aspiration (Mendelson’s syndrome):
In patients thought to be at risk of acid aspiration (Mendelson’s) syndrome an oral dose of 150mg can be given 2 hours before induction of general anaesthesia, and preferably also 150mg the previous evening.
In obstetric patients at commencement of labour, an oral dose of 150mg may be given followed by 150mg at 6 hourly intervals. It is recommended that since gastric emptying and drug absorption are delayed during labour, any patient requiring emergency general anaesthesia should be given, in addition, a non-particulate antacid (eg sodium citrate) prior to induction of anaesthesia. The usual precautions to avoid acid aspiration should also be taken.
Children 12 years and over
For children 12 years and over the adult dosage is given.
Children from 3 to 11 years and over 30 kg of weight
See Section 5.2 Pharmacokinetic Properties – Special Patient Populations.
Peptic Ulcer Acute Treatment
The recommended oral dose for the treatment of peptic ulcer in children is 4mg/kg/day to 8mg/kg/day administered as two divided doses to a maximum of 300mg ranitidine per day for a 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.
The recommended oral dose for the treatment of gastro-oesophageal reflux in children is 5mg/kg/day to 10mg/kg/day administered as two divided doses to a maximum dose of 600mg (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.
Adults (including older people) / Adolescents (12 years and over)
Ranitidine Solution for Injection may be given at a dose of 50mg either as slow intravenous injection, intermittent intravenous infusion or intramuscularly.
Slow intravenous injection:
50mg diluted to a volume of 20ml and given over at least a period of 2 minutes which may be repeated every 6 to 8 hours.
Intermittent intravenous infusion:
25mg per hour for 2 hours; may be repeated 6 to 8 hours.
50mg (2ml) every six to eight hours.
Parenteral administration for the prophylaxis of haemorrhage from stress ulceration in seriously ill patients or the prophylaxis of recurrent haemorrhage in patients bleeding from peptic ulceration may be continued until oral feedings commences. Patients considered at risk requiring further treatment may then be transferred to treatment with ranitidine tablets.
For prophylaxis of upper gastro-intestinal haemorrhage from stress ulceration in seriously ill patients it may be preferable to give a priming dose of 50mg by slow intravenous injection followed by a continuous intravenous infusion of 0.125 – 0.25mg/kg/hr.
In patients considered to be at risk of developing acid aspiration syndrome, ranitidine 50mg may be given 45-60 minutes before induction of general anaesthesia either intramuscularly or by slow intravenous injection (over at least 2 minutes).
Normal dosage (as per adults) is recommended except in patients who have moderate to severe renal impairment.
Children/infants (6 months to 11 years):
Ranitidine Injection may be given as a slow (over 2 minutes) i.v. injection up to a maximum of 50mg every 6 to 8 hours.
Neonates (under 1 month)
Peptic Ulcer Acute Treatment and Gastro-Oesophageal Reflux
Intravenous therapy in children with peptic ulcer disease is indicated only when oral therapy is not possible.
For acute treatment of peptic ulcer disease and gastro-oesophageal reflux in paediatric patients, Ranitidine injection may be administered at doses that have been shown to be effective for these diseases in adults and effective for acid suppression in critically ill children. The initial dose (2.0 mg/kg or 2.5 mg/kg, maximum 50 mg) may be administered as a slow intravenous infusion over 10 minutes, either with a syringe pump followed by a 3 mL flush with normal saline over 5 min, or following dilution with normal saline to 20 mL. Maintenance of pH > 4.0 can be achieved by intermittent infusion of 1.5 mg/kg every 6 h to 8 h.
Ranitidine is contraindicated for patients known to have hypersensitivity to the drug or any of the ingredients
Symptomatic response to therapy with ranitidine does not preclude the presence of gastric malignancy.
Since ranitidine is excreted primarily by the kidney, dosage should be adjusted in patients with impaired renal function. Caution should be observed in patients with hepatic dysfunction since ranitidine is metabolized in the liver.
Rare reports suggest that ranitidine may precipitate acute porphyric attacks in patients with acute porphyria. Ranitidine should therefore be avoided in patients with a history of acute porphyria.
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:
1) 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.
2) 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.
3) 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, glipizide) or a decrease in absorption (e.g. ketoconazole, atazanavir, delaviridine, gefitnib).
ADVERSE DRUG REACTIONS:
Blood & Lymphatic System Disorders
Very Rare: Blood count changes (leucopenia, thrombocytopenia). These are usually reversible. Agranulocytosis or pancytopenia, sometimes with marrow hypoplasia or marrow aplasia.
Immune System Disorders
Rare: Hypersensitivity reactions (urticaria, angioneurotic oedema, fever, bronchospasm, hypotension and chest pain).
Very Rare: Anaphylactic shock
These events have been reported after a single dose.
Very Rare: Reversible mental confusion, depression and hallucinations.
These have been reported predominantly in severely ill and elderly patients.
Nervous System Disorders
Very Rare: Headache (sometimes severe), dizziness and reversible involuntary movement disorders.
Very Rare: Reversible blurred vision.
There have been reports of blurred vision, which is suggestive of a change in accommodation.
Very Rare: As with other H2 receptor antagonists bradycardia, A-V block and asystole (injection only).
Very Rare: Vasculitis.
Uncommon: Abdominal pain, constipation, nausea (these symptoms mostly improved during continued treatment).
Very Rare: Acute pancreatitis, diarrhoea
Rare: Transient and reversible changes in liver function tests.
Very Rare: Hepatitis (hepatocellular, hepatocanalicular or mixed) with or without jaundice, these were usually reversible.
Skin and Subcutaneous Tissue Disorders
Rare: Skin rash.
Very Rare: Erythema multiforme, alopecia.
Musculoskeletal and Connective Tissue Disorders
Very Rare: Musculoskeletal symptoms such as arthralgia and myalgia.
Renal and urinary disorders
Rare: Elevation of plasma creatinine (usually slight; normalised during continued treatment).
Very rare: acute interstitial nephritis.
Reproductive System and Breast Disorders
Very Rare: Reversible impotence, breast symptoms and breast conditions (such as gynaecomastia and galactorrhoea)
Reporting of suspected adverse reactions:
The PPB Department of Pharmacovigilance was set up with a vision to develop, implement and continuously upgrade an appropriate system for detecting, reporting, and monitoring adverse drug reactions (ADRs) and other relevant problems with medicines in Kenya. The department strives to ensure the safety and efficacy of pharmaceutical products in Kenya.
Reporting suspected adverse reactions after authorization of the medicinal product are important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals/ Patients are encouraged to report any suspected adverse reactions via Pharmacovigilance Yellow Form, firstname.lastname@example.org or clicking below button:
Ranitidine in Kenya
Ranitidine in Kenya
Ranitidine in Kenya
Ranitidine in Kenya
Ranitidine in Kenya
Ranitidine in Kenya
Price of Ranitidine in Kenya
Ranitidine in Kenya
Clinical | Pharmacokinetic data
Pregnancy Category: B (No risk in non-human studies)
Routes of Administration: By mouth, intravenous (IV) , IM
Bioavailability: 50% (by mouth)
Protein Binding: 15%
Metabolosim: Liver: FMOs, including FMO3; other enzymes
Onset of Action: 55–65 minutes (150 mg dose) | 55–115 minutes (75 mg dose)
Elimination Half life: 2–3 hours
Excretion: 30–70% kidney
Legal Status | Dosage forms & Strengths
Prescription only Medicine (POM) , ℞-only
Narcotic Drugs and Psychotropic Substances (Control ) Act Schedule:
This drug is not a controlled substance under Narcotic Drugs and Psychotropic Substances (Control ) Act
Dosage Forms | Strengths:
|CompTox Dashboard (EPA)|
- PPB Drugs Retention Register
- Roberts, C. J. C. “Clinical pharmacokinetics of ranitidine.” Clinical pharmacokinetics 9.3 (1984): 211-221.
- Vial, Thierry, et al. “Side effects of ranitidine.” Drug safety 6.2 (1991): 94-117.
- Grant, Susan M., Heather D. Langtry, and Rex N. Brogden. “Ranitidine.” Drugs 37.6 (1989): 801-870.