Drugs List

Therapeutic Indications

Uses

Prevention of heartburn and dyspepsia associated with food and drink
Symptomatic relief of heartburn and dyspepsia

Contraindications

None known

Precautions and Warnings

Children under 16 years
Elderly
Immunosuppression
Acute porphyria
Breastfeeding
Chronic respiratory impairment
Diabetes mellitus
Dysphagia
Hepatic impairment
Pregnancy
Renal impairment - creatinine clearance below 50ml/minute

May mask symptoms of serious disease of the stomach and delay diagnosis
Exclude gastric cancer before commencing treatment
Not all available brands are licensed for all indications
Monitor for signs/symptoms of pneumonia in patients at risk
Advise patients to report new or recently changed dyspeptic symptoms
Advise patient to consult a doctor if symptoms persist despite treatment
Advise patient to seek medical advice if taking NSAIDs

The manufacturer advises to avoid in patients with a history of acute porphyria. Rare clinical reports suggest ranitidine may precipitate acute porphyric attacks. However, the Welsh Medicines Information Centre considers the drug to be safe in acute porphyria. NAPOS website classifies the drug as probably not porphyrinogenic, to be used as a first hand choice with no precautions needed. This is based on uneventful clinical experiences which points to non-porphyrinogenicity. They question the causality of the few case reports which pointed the drug as porphyrinogenic.

There may be an increased risk of development of community acquired pneumonia in elderly or immunocompromised patients, and in patients with chronic lung disease or diabetes.

Pregnancy and Lactation

Pregnancy

Use ranitidine with caution during pregnancy.

The manufacturer advises to avoid unless considered essential. Although there is consensus that ranitidine may be used during pregnancy and that it may be prescribed where antacids have failed.

Animal studies have shown no evidence of teratogenicity or impairment of fertility. Available data on human pregnancies suggests that ranitidine is not a major teratogen. 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.

Current practice guidelines also state that ranitidine is considered safe for use during pregnancy on the basis of several years of use without incidence and supporting evidence from observational studies.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use ranitidine with caution during breastfeeding.

Ranitidine is excreted in breast milk although the amount present in breast milk is lower than the paediatric dose. Since ranitidine has been widely used in paediatrics without significant side effects and exposure levels via breast milk are sub-therapeutic, there is consensus that ranitidine may be used during breastfeeding. Maternal ranitidine would not be expected to cause any adverse effects in breastfed infants. Schaefer concludes that ranitidine may be used during lactation but other drugs of the same class that are excreted into breast milk at lower levels should be preferred.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Side Effects

Abdominal pain
Acute pancreatitis
Agranulocytosis
Alopecia
Altered liver function tests
Anaphylactic shock
Angioneurotic oedema
Arthralgia
Atrioventricular block
Blurred vision
Bone marrow aplasia
Bone marrow hypoplasia
Bradycardia
Breast symptoms in men
Bronchospasm
Chest pain
Confusion
Constipation
Depression
Diarrhoea
Dizziness
Erythema multiforme
Fever
Galactorrhoea
Gynaecomastia
Hallucinations
Headache
Hepatitis
Hypersensitivity reactions
Hypotension
Impotence
Interstitial nephritis
Involuntary movement disorders
Jaundice
Leucopenia
Myalgia
Nausea
Pancytopenia
Rash
Serum creatinine increased
Thrombocytopenia
Urticaria
Vasculitis

Presentation

Tablets containing 75mg ranitidine.

Drugs List

Therapeutic Indications

Uses

Prevention of heartburn and dyspepsia associated with food and drink
Symptomatic relief of heartburn and dyspepsia

Dosage

Adults

Children

Patients with Renal Impairment

Contraindications

None known

Precautions and Warnings

Children under 16 years
Elderly
Immunosuppression
Acute porphyria
Breastfeeding
Chronic respiratory impairment
Diabetes mellitus
Dysphagia
Hepatic impairment
Pregnancy
Renal impairment - creatinine clearance below 50ml/minute

May mask symptoms of serious disease of the stomach and delay diagnosis
Exclude gastric cancer before commencing treatment
Not all available brands are licensed for all indications
Monitor for signs/symptoms of pneumonia in patients at risk
Advise patients to report new or recently changed dyspeptic symptoms
Advise patient to consult a doctor if symptoms persist despite treatment
Advise patient to seek medical advice if taking NSAIDs

The manufacturer advises to avoid in patients with a history of acute porphyria. Rare clinical reports suggest ranitidine may precipitate acute porphyric attacks. However, the Welsh Medicines Information Centre considers the drug to be safe in acute porphyria. NAPOS website classifies the drug as probably not porphyrinogenic, to be used as a first hand choice with no precautions needed. This is based on uneventful clinical experiences which points to non-porphyrinogenicity. They question the causality of the few case reports which pointed the drug as porphyrinogenic.

There may be an increased risk of development of community acquired pneumonia in elderly or immunocompromised patients, and in patients with chronic lung disease or diabetes.

Pregnancy and Lactation

Pregnancy

Use ranitidine with caution during pregnancy.

The manufacturer advises to avoid unless considered essential. Although there is consensus that ranitidine may be used during pregnancy and that it may be prescribed where antacids have failed.

Animal studies have shown no evidence of teratogenicity or impairment of fertility. Available data on human pregnancies suggests that ranitidine is not a major teratogen. 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.

Current practice guidelines also state that ranitidine is considered safe for use during pregnancy on the basis of several years of use without incidence and supporting evidence from observational studies.

The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Lactation

Use ranitidine with caution during breastfeeding.

Ranitidine is excreted in breast milk although the amount present in breast milk is lower than the paediatric dose. Since ranitidine has been widely used in paediatrics without significant side effects and exposure levels via breast milk are sub-therapeutic, there is consensus that ranitidine may be used during breastfeeding. Maternal ranitidine would not be expected to cause any adverse effects in breastfed infants. Schaefer concludes that ranitidine may be used during lactation but other drugs of the same class that are excreted into breast milk at lower levels should be preferred.

Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
Specialist advice is available from the UK Drugs in Lactation Advisory Service at https://www.midlandsmedicines.nhs.uk/content.asp?section=6&subsection=17&pageIdx=1

Counselling

Patients should be advised that they should not be take ranitidine for more than 6 days without the advice of a pharmacist or doctor and that they should not take it continuously for more than 2 weeks.

Side Effects

Abdominal pain
Acute pancreatitis
Agranulocytosis
Alopecia
Altered liver function tests
Anaphylactic shock
Angioneurotic oedema
Arthralgia
Atrioventricular block
Blurred vision
Bone marrow aplasia
Bone marrow hypoplasia
Bradycardia
Breast symptoms in men
Bronchospasm
Chest pain
Confusion
Constipation
Depression
Diarrhoea
Dizziness
Erythema multiforme
Fever
Galactorrhoea
Gynaecomastia
Hallucinations
Headache
Hepatitis
Hypersensitivity reactions
Hypotension
Impotence
Interstitial nephritis
Involuntary movement disorders
Jaundice
Leucopenia
Myalgia
Nausea
Pancytopenia
Rash
Serum creatinine increased
Thrombocytopenia
Urticaria
Vasculitis

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last full review: February 2018.

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 3rd edition (2015) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G., Freeman, R. Wolters Kluwer Health, Philadelphia.

Summary of Product Characteristics: Gavilast 75mg tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised April 2012

Summary of Product Characteristics: Gavilast Heartburn and Indigestion 75mg Film-coated tablets. Reckitt Benckiser Healthcare (UK) Ltd. Revised May 2017.

Summary of Product Characteristics: Zantac 75 tablets. Omega Pharma Ltd. Revised April 2016

Summary of Product Characteristics: Zantac 75 Relief. Omega Pharma Ltd. Revised April 2016

Summary of Product Characteristics: RaniCalm 75mg film-coated tablets. Bristol Laboratories Ltd. Revised April 2016

The Renal Drug Handbook. Fourth Edition (2014) ed. Ashley, C and Dunleavy, A, Radcliffe Publishing Ltd, London.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 20 February 2018.

The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.com/languages/UnitedKingdom/s1.php?l=gbr
Last revised: January 11, 2012
Last accessed: 20 February 2018.

US National Library of Medicine. Toxicology Data Network. Drugs and Lactation Database (LactMed).
Available at: https://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT
Last revised: March 10, 2015
Last accessed: 20 February 2018.

The Welsh Medicines Information Centre (WMIC) - Porphyria Information Service.
Available at: https://www.wmic.wales.nhs.uk/porphyria_info.php
Last revised: May, 2016
Last accessed: 20 February 2018.