- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
Topical formulations containing minoxidil.
Scalp and hair should be thoroughly dry before application.
Licensed in patients aged 18 to 49 years only. It is not recommended for patients over the age of 49 to use the foam preparation as safety and efficacy have not been established.
A dose of 1g (equivalent to half a capful) should be applied topically to the total affected areas of the scalp twice daily. The total daily dose should not exceed 2g.
Users of the foam formulation should discontinue treatment if there is no improvement after 16 weeks.
It may take twice daily applications for up to 8 weeks or more before evidence of hair regrowth can be expected. If hair regrowth occurs, twice daily applications are necessary for continued hair growth.
Licensed in patients aged 18 to 65 years only.
A dose of 1g (equivalent to half a capful) should be applied topically to the total affected areas of the scalp once daily. The total daily dose should not exceed 1g.
Users of the foam formulation should discontinue treatment if there is no improvement after 24 weeks.
Solution (2% or 5%)
Licensed in patients aged 18 to 65 years only.
The 5% solution is licensed in men only.
A dose of 1ml should be applied topically to the total affected areas of the scalp twice daily. The total daily dose should not exceed 2ml.
Users of the solution should discontinue treatment if there is no improvement after one year.
It may take twice daily applications for up to 4 months or more, depending on the strength of the product used, before evidence of hair regrowth can be expected. If hair regrowth occurs, twice daily applications are necessary for continued hair growth. Re-grown hair may disappear 3 to 4 months after treatment is discontinued.
Children under 18 years
Patients over 65 years
Scalp abnormality (including psoriasis, severe excoriations and sunburn)
Precautions and Warnings
Advise patient ability to drive or operate machinery may be impaired
Not all available brands are licensed for all age groups
Not all preparations are licensed for use in women
Some formulations contain butylated hydroxy toluene (E321)
Some formulations contain cetostearyl alcohol
Some formulations contain propylene glycol
Advise patient to wash hands after use
Avoid contact with diseased or inflamed skin
Avoid contact with eyes
Avoid contact with mucous membranes
Avoid occlusive dressings
Avoid other topical preparations which may cause increased absorption
If accidental contact with the eyes occurs, rinse thoroughly with water
Not to be used on shaved skin
Product is highly flammable - administer away from naked flame
Advise patient to seek medical advice if signs of hypotension occur
An increase in shedding may be seen in the first 2 to 6 weeks of treatment
Discontinue if shedding persists for longer than 2 weeks
Discontinue if hypotension occurs for any reason
Discontinue if persistent redness or irritation occurs
Discontinue if sudden pain in the chest occurs
Avoid inhalation of the product
May be 2 to 4 months before effect is seen
The foam formulation contains butylated hydroxytoluene and cetyl and stearyl alcohol which may cause skin reactions and/or irritation to the eyes or mucous membranes.
Use with caution in patients with acute porphyria. Topical minoxidil can be absorbed, with absorption quoted by the manufacturer in the range of 1 to 2%. Other sources describe up to 4.5% dose absorption.
Pregnancy and Lactation
Topical minoxidil is contraindicated in pregnancy.
Animal studies have revealed reproductive toxicity at exposure levels that were very high compared to those intended for human exposure. There are limited case reports following exposure in humans. Reports following oral use for hypertension (usually as part of combination therapy) and topical use for alopecia (sometimes with co-morbidities), reveal several cases of multiple congenital abnormalities and heart defects.
Minoxidil is poorly absorbed after topical application from normal intact skin. Systemic absorption of topical minoxidil ranges from 0.3% to 4.5% of the total applied dose. It is not known if minoxidil crosses the placenta, however foetal exposure should be expected due to low molecular weight (about 209) and moderately long elimination half-life (4.2 hours). In addition, there have been cases of hypertrichosis in infants, following in utero exposure, which suggests that minoxidil crosses the placenta (Briggs, 2015).
Schaefer (2015) suggests inadvertent intake of minoxidil does not justify either interruption of pregnancy or invasive diagnostic procedures.
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 ).
Use topical minoxidil with caution in breastfeeding.
The manufacturer contraindicates the use of minoxidil during breastfeeding.
Minoxidil is excreted into breast milk. Only one case report has been located (minoxidil given orally). This reported no observable effect on the infant.
Hale (2014) suggests it is unlikely that the amount absorbed via topical application would produce clinically relevant concentrations in breast milk.
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
Changes in hair colour
Changes in hair texture
Exacerbation of hair loss
Increased facial hair
Increased heart rate
Inflamed and dry skin
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 ).
Last Full Review Date: July 2018
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.
Medications and Mothers' Milk, Sixteenth Edition (2014) Hale, T and Rowe, H, Hale Publishing, Plano, Texas.
Summary of Product Characteristics: Regaine For Men Extra Strength. McNeil Products Ltd. Revised May 2018.
Summary of Product Characteristics: Regaine For Men Extra Strength Scalp Foam 5% w/w Cutaneous Foam. McNeil Products Ltd. Revised May 2018.
Summary of Product Characteristics: Regaine For Women Once a Day Scalp Foam 5% w/w Cutaneous Foam. McNeil Products Ltd. Revised May 2018.
Summary of Product Characteristics: Regaine For Women Regular Strength. McNeil Products Ltd. Revised May 2018.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 03 July 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
Minoxidil. Last revised: 09 January 2018
Last accessed: 03 July 2018
The Norwegian Porphyria Centre (NAPOS).
Available at: https://www.drugs-porphyria.org
Last revised: 16 April 2010
Last accessed: 03 July 2018
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
FDB Disclaimer : FDB Multilex is intended for the use of healthcare professionals and is provided on the basis that the healthcare professionals will retain FULL and SOLE responsibility for deciding what treatment to prescribe or dispense for any particular patient or circumstance.