Drugs List

Therapeutic Indications

Uses

Cerebrovascular disease
Peripheral vascular disease

Indicated for the treatment of peripheral vascular disorders (intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud's syndrome, diabetic arteriopathy and acrocyanosis).

Indicated for the treatment of cerebral vascular disorders (cerebral insufficiency and cerebral atherosclerosis, particularly where these manifest themselves as mental deterioration and confusion in the elderly).

Contraindications

Children under 18 years
History of nephrolithiasis
Hyperoxaluria
Nephrolithiasis

Precautions and Warnings

Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
Contains arachis (peanut oil), soya or soya derivative
Ensure patient has adequate fluid intake
Discontinue if jaundice or other evidence of hepatic impairment occurs

Ensure patient has adequate fluid intake to maintain adequate diuresis. Administration of naftidrofuryl without liquid before going to bed may cause local oesophagitis.

The administration of naftidrofuryl may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones.

Pregnancy and Lactation

Pregnancy

Use naftidrofuryl oxalate with caution in pregnancy.

There is inadequate evidence of the safety of naftidrofuryl oxalate in human pregnancy, however it has been used widely for many years without any apparent ill effects during pregnancy. Therefore use during pregnancy is only considered acceptable if there is no safer alternative. Also, animal studies have shown no hazard. In cases of doubt, a detailed ultrasound diagnosis can be performed to confirm normal morphological development (Schaefer, 2007).

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 naftidrofuryl oxalate with caution in breastfeeding.

Naftidrofuryl and its primary metabolite appear only in trace amounts in the milk and there are no known toxic effects on the infant. Schaefer (2007) suggests that in cases where a therapeutic effect is, in fact, expected with naftidrofuryl therapy, this drug seems acceptable. The manufacturers recommended that the drug is avoided.

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

Agitation
Diarrhoea
Dizziness
Epigastric pain
Headache
Hepatic failure
Hepatitis
Kidney stones
Nausea
Oesophagitis
Rash
Sleep disturbances
Vomiting

Presentation

Oral formulations of naftidrofuryl

Drugs List

Therapeutic Indications

Uses

Cerebrovascular disease
Peripheral vascular disease

Indicated for the treatment of peripheral vascular disorders (intermittent claudication, night cramps, rest pain, incipient gangrene, trophic ulcers, Raynaud's syndrome, diabetic arteriopathy and acrocyanosis).

Indicated for the treatment of cerebral vascular disorders (cerebral insufficiency and cerebral atherosclerosis, particularly where these manifest themselves as mental deterioration and confusion in the elderly).

Dosage

Adults

Elderly

Patients with Renal Impairment

Contraindications

Children under 18 years
History of nephrolithiasis
Hyperoxaluria
Nephrolithiasis

Precautions and Warnings

Breastfeeding
Hepatic impairment
Pregnancy
Renal impairment

Advise ability to drive/operate machinery may be affected by side effects
Not all available brands are licensed for all indications
Contains arachis (peanut oil), soya or soya derivative
Ensure patient has adequate fluid intake
Discontinue if jaundice or other evidence of hepatic impairment occurs

Ensure patient has adequate fluid intake to maintain adequate diuresis. Administration of naftidrofuryl without liquid before going to bed may cause local oesophagitis.

The administration of naftidrofuryl may modify the composition of the urine, promoting the formation of calcium oxalate kidney stones.

Pregnancy and Lactation

Pregnancy

Use naftidrofuryl oxalate with caution in pregnancy.

There is inadequate evidence of the safety of naftidrofuryl oxalate in human pregnancy, however it has been used widely for many years without any apparent ill effects during pregnancy. Therefore use during pregnancy is only considered acceptable if there is no safer alternative. Also, animal studies have shown no hazard. In cases of doubt, a detailed ultrasound diagnosis can be performed to confirm normal morphological development (Schaefer, 2007).

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 naftidrofuryl oxalate with caution in breastfeeding.

Naftidrofuryl and its primary metabolite appear only in trace amounts in the milk and there are no known toxic effects on the infant. Schaefer (2007) suggests that in cases where a therapeutic effect is, in fact, expected with naftidrofuryl therapy, this drug seems acceptable. The manufacturers recommended that the drug is avoided.

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

Agitation
Diarrhoea
Dizziness
Epigastric pain
Headache
Hepatic failure
Hepatitis
Kidney stones
Nausea
Oesophagitis
Rash
Sleep disturbances
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: May 2014

Reference Sources

Drugs During Pregnancy and Lactation: Treatment Options and Risk Assessment, 2nd edition (2007) ed. Schaefer, C., Peters, P. and Miller, R. Elsevier, London.

Joint Formulary Committee. British National Formulary (online) London: BMJ Group and Pharmaceutical Press https://www.medicinescomplete.com Accessed on May 8, 2014.

Summary of Product Characteristics: Naftidrofuryl capsules 100mg. Actavis UK Ltd. Revised March 2015.

Summary of Product Characteristics: Praxilene capsules. Merck Serono. Revised July 2015.

The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.