Ranitidine [Discontinued in SA Market]

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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• Duodenal ulcers
• Gastric ulcers
• Reflux oesophagitis
• Zollinger-Ellison syndrome
• Premedication in anaesthesia

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Contraindications

• Hypersensitivity to the active ingredient or any of its excipients

Caution

• Pregnancy
• Breastfeeding
• Moderate to severe renal impairment
• Hepatic impairment
• Elderly  
• Rapid administration (inj)
• Chronic lung disease
• Diabetes
• Immunocompromised patients
• History of peptic ulcer
• Prolonged treatment
• Alcoholism(sol)
• Epilepsy(sol)
• Brain injury or disease(sol)
• Low sodium diet (sol)
• Fructose intolerance (sol)

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Treatment and prevention of gastric and duodenal ulceration

• Oral (tab, eft, syr): Initial: 150mg, 12hrly OR 300mg, dly at night; Maintenance: 150-300mg, dly at night; Treatment duration: 4-12 weeks
• IV: 50mg, 6-8hrly

Reflux oesophagitis - Mild

• Oral (tab, eft, syr): Initial: 150mg, 12hrly OR 300mg, dly at night; Maintenance: 150mg, 12hrly; Treatment duration: 8-12 weeks
• IV: 50mg, 6-8hrly

Reflux oesophagitis - Moderate to severe

• Oral (tab, eft, syr): Initial: 150mg, 6hrly; Maintenance: 150mg, 12hrly; Max treatment duration: 12 weeks
• IV: 50mg, 6-8hrly

Zollinger-Ellison syndrome

• Oral (tab, eft, syr): 150-300mg, 8hrly
• IV: 50mg, 6-8hrly

Premedication in anaesthesia

• Oral (tab, eft, syr): 300mg, at least 2hrs before induction
  OR 
• Oral (tab, eft, syr): 150mg, 12hrs before induction; Repeat dose 2hrs before induction
• IV/IM: 50mg, 45-60min before induction

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See additional prescribing points for administration directions

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Prophylaxis of stress ulceration in seriously ill patients

Younger than 1 month

• Not established for use

Between 1 month-12 years

• IV: 1mg/kg, 6-8hrly; Max: 50mg/dose
  OR
• IV: 125-250μg/kg/hr, as a continuous infusion

Older than 12 years

• See adult dosage

Peptic ulcer - Acute 

Younger than 1 month

• Not established for use

Between 1 month-12 years

• Oral (tab, syr): 4-8mg/kg/day, in 2 divided doses; Max: 300mg/24hrs; Treatment duration: 4-8 weeks
• IV: Initial: 2-2.5mg/kg, as a slow bolus; Maintenance: 1.5mg/kg, 6-8hrly; Max: 50mg/dose
  OR
• IV: Initial: 0.45mg/kg, as a slow bolus; Maintenance: 0.15mg/kg/hr

Older than 12 years

• See adult dosage

Gastro-oesophageal reflux

Younger than 1 month

• Not established for use

Between 1 month -12 years

• Oral (tab, syr): 5-10mg/kg/day, in 2 divided doses; Max: 600mg/24hrs
• IV: Initial: 2-2.5mg/kg, as a slow bolus; Maintenance: 1.5mg/kg, 6-8hrly; Max: 50mg/dose
  OR
• IV: Initial: 0.45mg/kg, as a slow bolus; Maintenance: 0.15mg/kg/hr

Older than 12 years

• See adult dosage

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IV therapy is only indicated when oral therapy is not possible

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For IV administration dilute 50mg of ranitidine with normal saline to a volume of 20ml, given over at least 10min

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Pregnancy

• Caution; no evidence of risk in studies
• 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 or subsequent neonatal progress. Like other drugs, ranitidine should only be used during pregnancy if considered essential

Breastfeeding

• Caution
• Ranitidine is excreted in human breast milk. Like other drugs, ranitidine should only be used during breastfeeding if considered essential

Renal Impairment

• Mild: No dose adjustment recommended
• Moderate to severe: Caution, dose adjustment recommended

Adult Dose:

CrCl (ml/min)	Dose (Oral)	Dose (IV)
> 50	No adjustment necessary	No adjustment necessary
< 50	Oral (tab, eft, syr): 150mg, dly at night	IV: Max: 50mg, 18-24hrly
Haemodialysis	Adjust dosing schedule so that dosing coincides with the end of hemodialysis	Adjust dosing schedule so that dosing coincides with the end of hemodialysis

Paediatric Dosage:

CrCl (ml/min)	Dose (Oral)	Dose (IV)
> 50	No adjustment necessary	No adjustment necessary
30-50	Oral (tab, syr): 2mg/kg, 12hrly	IV: 1mg/kg, 12hrly
10-29	Oral (tab, syr): 1mg/kg, 12hrly	IV: 0.5mg/kg, 12hrly
< 10	Oral (tab, syr): 1mg/kg, dly	IV: 0.5mg/kg, dly
Haemodialysis	Oral (tab, syr): 1mg/kg, dly	IV: 0.5mg/kg, dly

Hepatic Impairment

• Caution; no dose adjustment recommended

Elderly

• Caution; no dose adjustment recommended

Porphyria Information

• Probably not porphyrinogenic (PNP)

Drugs in Sport

• Permitted - No warnings

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Central Nervous System Disorders

• Confusion
• Depression 
• Hallucinations
• Headache 
• Dizziness 
• Involuntary movement disorders

Cardiovascular Disorders

• Bradycardia
• Atrioventricular block
• Tachycardia 
• Vasculitis

Gastrointestinal Disorders

• Abdominal pain
• Constipation
• Nausea 
• Diarrhoea

Hepatobiliary Disorders

• Changes in liver function tests
• Hepatitis
• Jaundice
• Acute pancreatitis

Genitourinary Disorders

• Elevation of plasma creatinine 
• Acute interstitial nephritis
• Reversible impotence
• Gynaecomastia 
• Galactorrhoea

Musculoskeletal Disorders

• Arthralgia
• Myalgia

Skin and Subcutaneous Tissue Disorders

• Skin Rash
• Erythema multiforme
• Alopecia

Immune, Blood and Lymphatic System Disorders

• Leucopenia
• Thrombocytopenia
• Agranulocytosis 
• Pancytopenia
• Marrow hypoplasia 
• Marrow aplasia
• Hypersensitivity reactions
• Anaphylactic shock
• Dyspnoea

Sensory Disorders

• Blurred vision

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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• Warfarin
• Procainamide
• N-acetylprocainamide
• Drugs affected by alteration of gastric pH
• Sucralfate

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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None routine.  Specific cases may require

• Renal function 
• Hepatic function

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Administration directions

Effervescent tablets

• Dissolve in water before swallowing
• Use a minimum of 75ml of water for 150mg tablets and 150ml of water for 300mg tablets

IV injection

• 50mg ranitidine diluted to a volume of 20ml
• Give over at least 2min

IV infusion

• 0.9% sodium chloride, 5% dextrose, 0.18% sodium chloride, 4% dextrose, 4,2% sodium bicarbonate and hartmann's solution are compatible fluids for IV administration
• Intermittent infusion rate: 25mg/hr (for 2 hrs)

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market. The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.

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Ranitidine is a competitive inhibitor of histamine at the parietal cell H2 receptor. It inhibits basal and stimulated secretion of gastric acid, reducing both the volume and the acid and pepsin content of gastric secretions.

Tablet 75mg

• Austac (Austell)
• Histak (Ranbaxy)
• Simayla Ranitidine (Ranbaxy)
• Zantac (GSK) originator

Tablet effervescent 75mg

• Zantac (GSK) originator

Tablet 150mg

• Apex Ranitidine (Camox)
• Austac (Austell)
• Ranitidine 150 Pharma-Q (Pharma-Q)
• Gulf Ranitidine (Gulf Drug)
• Histak (Ranbaxy)
• Ranihexal (Sandoz)
• Ranit (Be-tabs)
• Ranitidine Biotech (Biotech)
• Simayla Ranitidine (Ranbaxy)
• Ultak (Cipla)
• Zantac (GSK) originator

Tablet effervescent 150mg

• Zantac (GSK) originator

Tablet 300mg

• Apex Ranitidine (Camox)
• Austac (Austell)
• Ranitidine 300 Pharma-Q (Pharma-Q)
• Gulf Ranitidine (Gulf Drug)
• Histak (Ranbaxy)
• Ranihexal (Sandoz)
• Ranit (Be-Tabs)
• Ranitidine Biotech (Biotech)
• Simayla Ranitidine (Ranbaxy)
• Ultak (Cipla)
• Zantac (GSK) originator

Tablet effervescent 300mg

• Zantac (GSK) originator

Syrup (per 5ml) 75mg

• Zantac (GSK) originator

Injection (per 2ml) 50mg

• Ranitidine Injection Pharma-Q (Pharma-Q)
• R-Loc (Zydus)
• Zantac (GSK) originator