Drugs List

Therapeutic Indications

Uses

Prophylaxis of recurrent urinary tract infections
Prophylaxis of urinary infection during instrumental procedures
Pyelitis - treatment
Severe chronic recurrent urinary tract infections
Uncomplicated lower urinary tract infection

Contraindications

Children under 3 months
Acute porphyria
Breastfeeding - where infant is G6PD deficient
G6PD deficiency
Pregnancy at term
Renal impairment - eGFR below 30ml/minute/1.73m sq

Precautions and Warnings

Atopy
Debilitation
Elderly
Predisposition to peripheral neuropathy
Anaemia
Breastfeeding
Diabetes mellitus
Electrolyte imbalance
Folate deficiency
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Neurological disorder
Peripheral neuropathy
Pregnancy
Pulmonary disease
Renal impairment - eGFR 30 to 44 ml/minute/1.73m sq
Vitamin B deficiency

Advise patient ability to drive or operate machinery may be impaired
Exclude G6PD deficiency before commencing treatment
Some formulations contain lactose
Advise patient to take with or after food
Haematological monitoring required in long term use
Monitor for signs of neurological toxicity
Monitor for signs of pulmonary toxicity on long term therapy
Monitor hepatic function on long term therapy
Discontinue treatment if haemolysis occurs
Prolonged use may result in superinfection with non-susceptible organisms
May affect urinary glucose test for reducing substances
Discontinue if haematological abnormalities develop
Discontinue if neurological toxicity occurs
Discontinue if pulmonary toxicity occurs
Discontinue if symptoms of hepatic disease occur
May discolour urine yellow or brown

Pregnancy and Lactation

Pregnancy

Use nitrofurantoin with caution in pregnancy
Nitrofurantoin is contraindicated in pregnancy at term.

Animal studies with nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive clinical use since 1952 and its suitability in human pregnancy has been well documented. However as with all drugs, the maternal side effects may adversely affect the course of pregnancy. The drug should be used at the lowest dose as appropriate for a specific indication, only after careful assessment.
Nitrofurantoin is however contraindicated in pregnant women during labour and delivery because of the possible risk of haemolysis of the infants immature red cells.

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 nitrofurantoin with caution in breastfeeding

Administration of nitrofurantoin directly to infants under 1 month of age and in those with G-6-PD deficiency is contraindicated because of potential haemolysis in these infants. However, the time of greatest risk for haemolysis in full term newborns without G-6-PD deficiency might be as short as 8 days after birth. Nitrofurantoin doses in milk are low and it can be used while breastfeeding older infants, but alternate drugs are preferred in mothers of infants under 8 days of age, or infants with G-6-PD deficiency of any age. Observe infants for possible diarrhoea.
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
Agranulocytosis
Allergic skin reactions
Alopecia (transient)
Anaphylaxis
Angioedema
Anorexia
Aplastic anaemia
Arthralgia
Asthenia
Benign intracranial hypertension
Blood disorders
Chest pain
Chills
Cholestatic jaundice
Collapse
Confusion
Cough
Cyanosis
Depression
Diarrhoea
Discolouration of urine
Dizziness
Drowsiness
Drug fever
Dyspnoea
ECG changes
Eczema
Eosinophilia
Erythema
Erythema multiforme
Euphoria
Exfoliative dermatitis
Fever
G6PD deficiency anaemia
Gastro-intestinal disturbances
Granulocytopenia
Haemolytic anaemia
Headache
Hepatic necrosis
Hepatitis
Hepatotoxicity
Hypersensitivity reactions
Interstitial pneumonitis
Leucopenia
Lupus erythematosus-like syndrome
Maculopapular rash
Malaise
Megaloblastic anaemia
Motor disturbances
Nausea
Nystagmus
Optic neuritis
Pancreatitis
Peripheral neuropathy
Pleural effusion
Pruritus
Psychotic reactions
Pulmonary fibrosis
Pulmonary infiltration
Pulmonary reactions (acute)
Pulmonary reactions (chronic)
Rash
Sensory disturbances
Sialadenitis
Stevens-Johnson syndrome
Superinfections
Thrombocytopenia
Urticaria
Vertigo
Vomiting

Presentation

Modified release capsules containing Nitrofurantoin

Drugs List

Therapeutic Indications

Uses

Prophylaxis of recurrent urinary tract infections
Prophylaxis of urinary infection during instrumental procedures
Pyelitis - treatment
Severe chronic recurrent urinary tract infections
Uncomplicated lower urinary tract infection

Dosage

Adults

Elderly

Children

Patients with Renal Impairment

Contraindications

Children under 3 months
Acute porphyria
Breastfeeding - where infant is G6PD deficient
G6PD deficiency
Pregnancy at term
Renal impairment - eGFR below 30ml/minute/1.73m sq

Precautions and Warnings

Atopy
Debilitation
Elderly
Predisposition to peripheral neuropathy
Anaemia
Breastfeeding
Diabetes mellitus
Electrolyte imbalance
Folate deficiency
Galactosaemia
Glucose-galactose malabsorption syndrome
Hepatic impairment
Lactose intolerance
Neurological disorder
Peripheral neuropathy
Pregnancy
Pulmonary disease
Renal impairment - eGFR 30 to 44 ml/minute/1.73m sq
Vitamin B deficiency

Advise patient ability to drive or operate machinery may be impaired
Exclude G6PD deficiency before commencing treatment
Some formulations contain lactose
Advise patient to take with or after food
Haematological monitoring required in long term use
Monitor for signs of neurological toxicity
Monitor for signs of pulmonary toxicity on long term therapy
Monitor hepatic function on long term therapy
Discontinue treatment if haemolysis occurs
Prolonged use may result in superinfection with non-susceptible organisms
May affect urinary glucose test for reducing substances
Discontinue if haematological abnormalities develop
Discontinue if neurological toxicity occurs
Discontinue if pulmonary toxicity occurs
Discontinue if symptoms of hepatic disease occur
May discolour urine yellow or brown

Pregnancy and Lactation

Pregnancy

Use nitrofurantoin with caution in pregnancy
Nitrofurantoin is contraindicated in pregnancy at term.

Animal studies with nitrofurantoin have shown no teratogenic effects. Nitrofurantoin has been in extensive clinical use since 1952 and its suitability in human pregnancy has been well documented. However as with all drugs, the maternal side effects may adversely affect the course of pregnancy. The drug should be used at the lowest dose as appropriate for a specific indication, only after careful assessment.
Nitrofurantoin is however contraindicated in pregnant women during labour and delivery because of the possible risk of haemolysis of the infants immature red cells.

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 nitrofurantoin with caution in breastfeeding

Administration of nitrofurantoin directly to infants under 1 month of age and in those with G-6-PD deficiency is contraindicated because of potential haemolysis in these infants. However, the time of greatest risk for haemolysis in full term newborns without G-6-PD deficiency might be as short as 8 days after birth. Nitrofurantoin doses in milk are low and it can be used while breastfeeding older infants, but alternate drugs are preferred in mothers of infants under 8 days of age, or infants with G-6-PD deficiency of any age. Observe infants for possible diarrhoea.
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
Agranulocytosis
Allergic skin reactions
Alopecia (transient)
Anaphylaxis
Angioedema
Anorexia
Aplastic anaemia
Arthralgia
Asthenia
Benign intracranial hypertension
Blood disorders
Chest pain
Chills
Cholestatic jaundice
Collapse
Confusion
Cough
Cyanosis
Depression
Diarrhoea
Discolouration of urine
Dizziness
Drowsiness
Drug fever
Dyspnoea
ECG changes
Eczema
Eosinophilia
Erythema
Erythema multiforme
Euphoria
Exfoliative dermatitis
Fever
G6PD deficiency anaemia
Gastro-intestinal disturbances
Granulocytopenia
Haemolytic anaemia
Headache
Hepatic necrosis
Hepatitis
Hepatotoxicity
Hypersensitivity reactions
Interstitial pneumonitis
Leucopenia
Lupus erythematosus-like syndrome
Maculopapular rash
Malaise
Megaloblastic anaemia
Motor disturbances
Nausea
Nystagmus
Optic neuritis
Pancreatitis
Peripheral neuropathy
Pleural effusion
Pruritus
Psychotic reactions
Pulmonary fibrosis
Pulmonary infiltration
Pulmonary reactions (acute)
Pulmonary reactions (chronic)
Rash
Sensory disturbances
Sialadenitis
Stevens-Johnson syndrome
Superinfections
Thrombocytopenia
Urticaria
Vertigo
Vomiting

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 Date: March 2015.

Reference Sources

Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

Joint Formulary Committee. British National Formulary(online) London: BMJ Group and Pharmaceutical Press. Accessed on 09 March 2015.

Martindale: The Complete Drug Reference (online) London: Brayfield A (ed). Pharmaceutical Press [Accessed on DD Month YYYY].

MHRA Drug Safety Update September 2014.
Available at: https://www.mhra.gov.uk
Last accessed: 09 March 2015

Paediatric Formulary Committee. BNF for Children (online) London: BMJ Group, Pharmaceutical Press, and RCPCH Publications. Accessed on 09 arch 2015.

Summary of Product Characteristics: Macrobid capsules 100 mg capsules. Amdipharm Mercury Company Limited. Revised August 2014.

Summary of Product Characteristics: Nitrofurantoin 25 mg/5 ml oral suspension. Amdipharm Mercury Company Limited. Revised September 2014.

Summary of Product Characteristics: Nitrofurantoin 50 mg capsules. Amdipharm Mercury Company Limited. Revised September 2014.

Summary of Product Characteristics: Nitrofurantoin 50 mg tablets. Dr, Reddy's Laboratories (UK) Ltd. Revised August 2014.