Drugs List

Therapeutic Indications

Uses

Dermatoses
Infected intertrigo
Insect bites
Psoriasis excluding widespread plaque psoriasis

Treatment of inflammatory dermatoses normally responsive to topical corticosteroids where secondary bacterial and/or fungal infection is present, suspected or likely including:
Eczema
Prurigo nodularis
Psoriasis (excluding widespread plaque psoriasis)
Neurodermatoses
Seborrhoeic dermatitis
Contact sensitivity reactions
Discoid lupus erythematosus

Treatment of secondary infected insect bites
Treatment of anal and genital intertrigo

Contraindications

Children under 2 years
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Pregnancy
Rosacea

Precautions and Warnings

Breastfeeding
Renal impairment

Careful supervision of patients with psoriasis required
May mask symptoms or signs of infections
Reduce dose in patients with renal impairment
Use appropriate antimicrobial therapy in infected lesions
Exclude fungal infection before treatment
Exclude primary bacterial infection before treatment
Exclude viral infection before treatment
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Cleanse skin thoroughly before applying occlusive dressings
Do not use over large areas of the body
If accidental contact with the eyes occurs, rinse thoroughly with water
Perforated tympanic membrane - not for use in external auditory canal
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Extended or recurrent use may increase the risk of contact sensitisation
Potentially ototoxic and nephrotoxic
Prolonged continuous use increases the risk of systemic toxicity
Prolonged use may cause atrophic skin changes
Risk of generalised pustular psoriasis with use of topical corticosteroids
Withdraw gradually after long-term use
Discontinue if hypersensitivity reactions occur
Discontinue if no improvement occurs within 7 days
If infection persists use systemic antibiotics. If it spreads stop steroid
Avoid long-term use particularly in infants and children
Limit use in infants or on face to 5 days and without occlusion
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to take care when applying to the face
Fire hazard: Keep away from naked flames and potential sources of ignition

Facial areas may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids more than other body areas. This should be considered when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is required.

Pregnancy and Lactation

Pregnancy

The use of betamethasone valerate with neomycin preparations are not recommended during pregnancy.

There is little information on the possible effects of administering betamethasone with neomycin preparations during pregnancy. Neomycin can cross the human placenta and may give rise to foetal toxicity.

Betamethasone crosses the placenta to the foetus. The drug is partially metabolised (47%) by the perfused placenta to its inactive derivative.
Although there are insufficient data regarding teratogenic potential of topically applied corticosteroids in pregnant women, the use of corticosteroids has been associated with orofacial clefts.

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 14-17 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

The manufacturer suggests betamethasone valerate with neomycin preparations should not be used during breastfeeding.

There are no reports, at the time of writing, on the use of betamethasone or neomycin during breastfeeding.
The molecular weights of betamethasone (about 435 for the acetate salt and about 517 for the sodium phosphate salt) are low enough that excretion into milk should be expected.
Small amounts of aminoglycosides similar to neomycin are excreted into breast milk and absorbed by the breast fed infant. Limited systemic bioavailability of oral neomycin suggests that the amounts of neomycin in breast milk are clinically insignificant.

Any preparation used on the breast area should be washed off prior to breastfeeding the infant.

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

Allergic contact dermatitis
Burning sensation (local)
Cushing's syndrome
Exacerbation of symptoms
Hypersensitivity reactions
Hypertrichosis
Pruritus
Pustular psoriasis
Skin pigmentation changes
Striae (irreversible)
Superficial vascular dilation
Suppression of the hypothalamic-pituitary-adrenal axis
Thinning of skin

Presentation

Topical formulations containing betamethasone valerate and neomycin sulfate

Drugs List

Therapeutic Indications

Uses

Dermatoses
Infected intertrigo
Insect bites
Psoriasis excluding widespread plaque psoriasis

Treatment of inflammatory dermatoses normally responsive to topical corticosteroids where secondary bacterial and/or fungal infection is present, suspected or likely including:
Eczema
Prurigo nodularis
Psoriasis (excluding widespread plaque psoriasis)
Neurodermatoses
Seborrhoeic dermatitis
Contact sensitivity reactions
Discoid lupus erythematosus

Treatment of secondary infected insect bites
Treatment of anal and genital intertrigo

Dosage

The cream presentation is often appropriate for moist or weeping surfaces. The ointment is often appropriate for dry, lichenified of scaly lesions.

Adults

Elderly

Children

Contraindications

Children under 2 years
Acne vulgaris
Genital pruritus
Perianal pruritus
Perioral dermatitis
Pregnancy
Rosacea

Precautions and Warnings

Breastfeeding
Renal impairment

Careful supervision of patients with psoriasis required
May mask symptoms or signs of infections
Reduce dose in patients with renal impairment
Use appropriate antimicrobial therapy in infected lesions
Exclude fungal infection before treatment
Exclude primary bacterial infection before treatment
Exclude viral infection before treatment
Breastfeeding: Wash product off breasts prior to breastfeeding infant
Cleanse skin thoroughly before applying occlusive dressings
Do not use over large areas of the body
If accidental contact with the eyes occurs, rinse thoroughly with water
Perforated tympanic membrane - not for use in external auditory canal
Risk of glaucoma if preparation enters eye
Adrenal suppression may occur even without occlusion
Extended or recurrent use may increase the risk of contact sensitisation
Potentially ototoxic and nephrotoxic
Prolonged continuous use increases the risk of systemic toxicity
Prolonged use may cause atrophic skin changes
Risk of generalised pustular psoriasis with use of topical corticosteroids
Withdraw gradually after long-term use
Discontinue if hypersensitivity reactions occur
Discontinue if no improvement occurs within 7 days
If infection persists use systemic antibiotics. If it spreads stop steroid
Avoid long-term use particularly in infants and children
Limit use in infants or on face to 5 days and without occlusion
Advise patient residue on clothing/bedding may cause fire hazard
Advise patient to take care when applying to the face
Fire hazard: Keep away from naked flames and potential sources of ignition

Facial areas may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids more than other body areas. This should be considered when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.

Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses, development of tolerance, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin. If used in psoriasis, careful patient supervision is required.

Pregnancy and Lactation

Pregnancy

The use of betamethasone valerate with neomycin preparations are not recommended during pregnancy.

There is little information on the possible effects of administering betamethasone with neomycin preparations during pregnancy. Neomycin can cross the human placenta and may give rise to foetal toxicity.

Betamethasone crosses the placenta to the foetus. The drug is partially metabolised (47%) by the perfused placenta to its inactive derivative.
Although there are insufficient data regarding teratogenic potential of topically applied corticosteroids in pregnant women, the use of corticosteroids has been associated with orofacial clefts.

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 14-17 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

The manufacturer suggests betamethasone valerate with neomycin preparations should not be used during breastfeeding.

There are no reports, at the time of writing, on the use of betamethasone or neomycin during breastfeeding.
The molecular weights of betamethasone (about 435 for the acetate salt and about 517 for the sodium phosphate salt) are low enough that excretion into milk should be expected.
Small amounts of aminoglycosides similar to neomycin are excreted into breast milk and absorbed by the breast fed infant. Limited systemic bioavailability of oral neomycin suggests that the amounts of neomycin in breast milk are clinically insignificant.

Any preparation used on the breast area should be washed off prior to breastfeeding the infant.

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

Allergic contact dermatitis
Burning sensation (local)
Cushing's syndrome
Exacerbation of symptoms
Hypersensitivity reactions
Hypertrichosis
Pruritus
Pustular psoriasis
Skin pigmentation changes
Striae (irreversible)
Superficial vascular dilation
Suppression of the hypothalamic-pituitary-adrenal axis
Thinning of skin

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: January 2013

Reference Sources

British National Formulary, 64th Edition (2012) Pharmaceutical Press, London.

BNF for Children (2012-2013) Pharmaceutical Press, London.

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

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.

Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

Summary of Product Characteristics: Betamethasone valerate and Neomycin sulfate 1mg/5mg/g cream. Essential Generics. Revised March 2012.
Summary of Product Characteristics: Betamethasone valerate and Neomycin sulfate 1mg/5mg/g ointment. Essential Generics. Revised March 2012.

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
Betamethasone. Last revised: August 14, 2012
Last accessed: January 25, 2012

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
Neomycin. Last revised: January 31, 2011
Last accessed: January 25, 2012