Betamethasone valerate is a potent topical corticosteroid indicated for the relief of the
inflammatory and pruritic manifestations of steroid responsive dermatoses. Neomycin sulphate is
an aminoglycoside broad spectrum antibiotic. Topical preparations combining betamethasone
valerate and neomycin sulphate are indicated for the treatment of the following conditions where
secondary bacterial infection is present, suspected, or likely to occur:
- Atopic dermatitis
- Nummular dermatitis (discoid eczema)
- Prurigo nodularis
- Psoriasis ( excluding widespread plaque psoriasis)
- Lichen simplex chronicus (neurodermatitis) and lichen planus
- Seborrhoeic dermatitis
- Irritant or allergic contact dermatitis
- Insect bite reactions
- Miliaria (prickly heat)
- Anal and genital intertrigo
- Otitis extema

Recommended Dose for Adults:
Betamed-N-N cream is especially appropriate for moist or weeping surfaces.
Adults and adolescents
Apply thinly and gently rub in using enough to cover the entire affected area once or twice daily
for up to seven days, then change to another corticosteroid preparation not containing neomycin
sulphate if further treatment is required. Allow adequate time for absorption after each application
before applying an emollient. In the more resistant lesions, such as the thickened plaques of
psoriasis on elbows and knees, the effect of Betamed-N can be enhanced, if necessary, by
occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to
bring about a satisfactory response in such lesions, thereafter improvement can usually be
maintained by regular application without occlusion. Treatment should not be continued for more
than seven days without medical supervision. If the condition worsens or does not improve within
seven days, treatment and diagnosis should be re-evaluated.
Children aged 2 years and over
Betamed-N is suitable for use in children (2 years and over) at the same dose as adults. A
possibility of increased absorption exists in very young children, thus Betamed-N is
contraindicated in neonates and infants (less than 2 years) (see Contraindications). Children are
more likely to develop local and systemic side effects of topical corticosteroids and, in general,
require shorter courses and less potent agents than adults. Care should be taken when using
Betamed-N to ensure the amount applied is the minimum that provides therapeutic benefit.

Elderly
Betamed-N is suitable for use in the elderly. Clinical studies have not identified difference in
responses between the elderly and younger patients. The greater frequency of decreased hepatic
and renal function in the elderly may delay elimination if systemic absorption occurs. Therefore
the minimum quantity should be used for the shortest duration to achieve the desired clinical
benefit.

Renal Impairment
Dosage should be reduced in patients with reduced renal function.

Betamed-N is contraindicated in children under 2 years of age. Due to the known ototoxic and nephrotoxic potential of neomycin sulphate, the use ofBetamed-N in large quantities or on large areas for prolonged periods of time is contraindicated in circumstances where significant systemic absorption may occur. The following conditions should not be treated with Betamed-N: - Rosacea - Acne vulgaris - Perioral dermatitis - Pruritus without inflammation - Perianal and genital pruritus - Primary cutaneous viral infections - Primary infected skin lesions caused by infection with fungi, or bacteria - Primary or secondary infections due to yeasts - Secondary infections due to Pseudomonas or Proteus species - Otitis extema when the ear drum is perforated, because of the risk of ototoxicity

Hypersensitivity
BET AMED-N should be used with caution in patients with a history oflocal hypersensitivity to
betamethasone, neomycin or to any of the excipients in the preparation. Local hypersensitivity
reactions (see Adverse Reactions) may resemble symptoms of the condition under treatment.
Pseudomembranous colitis
Pseudomembranous colitis has been reported with the use of antibiotics and may range in severity
from mild to life-threatening. Therefore, it is important to consider its diagnosis in patients who
develop diarrhoea during or after antibiotic use. Although this is less likely to occur with topically
applied BETAMED-N. If prolonged or significant diarrhoea occurs or the patient experiences

abdominal cramps, treatment should be discontinued immediately and the patient investigated
further.
Reversible hypothalamic-pituitary-adrenal (HP A) axis suppression
Manifestations of hypercortisolism (Cushing' s syndrome) and reversible hypothalamicpituitaryadrenal
(HP A) axis suppression can occur in some individuals as a result of increased systemic
absorption of topical corticosteroids. If either of the above are observed, withdraw the drug
gradually by reducing the frequency of application, or by substituting a less potent corticosteroid.
Abrupt withdrawal of treatment may result in glucocorticosteroid insufficiency (see Adverse
Reactions).
Risk factors for increased corticosteroidal systemic effects are:
• Potency and formulation of topical corticosteroid
• Duration of exposure
• Application to a large surface area
• Use on occluded areas of skin ( e.g. on intertriginous areas or under occlusive
dressings (napkins may act as an occlusive dressing)
• Increasing hydration of the stratum corneum
• Use on thin skin areas such as the face
• Use on broken skin or other conditions where the skin barrier may be impaired.

Use in children
In comparison with adults, children and infants may absorb proportionally larger amounts of topical
corticosteroids and thus be more susceptible to systemic adverse effects. This is because children
have an immature skin barrier and a greater surface area to body weight ratio compared with adults.
In children under 12 years of age, long-term continuous topical corticosteroid therapy
should be avoided where possible, as adrenal suppression can occur.
Use in psoriasis
Dilution
Products which contain antimicrobial agents should not be diluted.

Contact sensitization
Extended or recurrent application of BET AMED-N may increase the risk of contact sensitisation.
Ototoxicity and nephrotoxicity
Following significant systemic absorption, aminoglycosides such as neomycin can cause
irreversible ototoxicity. Neomycin has nephrotoxic potential.
Renal impairment
In renal impairment the plasma clearance of neomycin is reduced (see Dosage and Administration).
Application to the face
Prolonged application to the face is undesirable as this area is more susceptible to atrophic changes.
Application to the eyelids
If applied to the eyelids, care is needed to ensure that the preparation does not enter the eye, as
cataract and glaucoma might result from repeated exposure.
Infection
Extension of infection may occur due to the masking effect of the steroid. Any spread of infection
requires withdrawal of topical corticosteroid therapy and administration of appropriate systemic
antimicrobial therapy.

Infection risk with occlusion
Bacterial infection is encouraged by the warm, moist conditions within skin folds or induced by
occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh
dressing is applied.
Chronic leg ulcers
Topical corticosteroids are sometimes used to treat the dermatitis around chronic leg ulcers.
However, this use may be associated with a higher occurrence of local hypersensitivity reactions
and an increased risk of local infection.

Co-administered drugs that can inhibit CYP3A4 ( e.g. ritonavir, itraconazole) have been shown to
inhibit the metabolism of corticosteroids and the potency of the CYP3A4 inhibitor. The extent to
which this interaction is clinically relevant depends on the dose and route of administration of the corticosteroids and the potency of the CYP3A4 inhibitor.
Following significant systemic absorption, neomycin sulphate can intensify and prolong the
respiratory depressant effects of neuromuscular blocking agents. Possibility of cumulative toxicity
should be considered when neomycin sulphate is applied topically in combination with systemic
aminoglycoside therapy.

Fertility
There are no data in humans to evaluate the effect of BETAMED-N fertility.
Pregnancy
There are limited data from the use ofBETAMED-N in pregnant women. Topical administration
of corticosteroids to pregnant animals can cause abnormalities of foetal development (see Nonclinical
information). The relevance of this finding to humans has not been established. However,
neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of
foetal toxicity (see Non-clinical informnation). Thus use ofBETAMED-N is not recommended in
pregnancy.
Lactation
The safe use of BETAMED-N during lactation has not been established. It is not known whether
topical administration of corticosteroids could result in sufficient systemic absorption to produce
detectable amounts in breast milk. Thus use ofBETAMED-N is not recommended in lactation

There have been no studies to investigate the effect ofBETAMED-N on driving performance or the
ability to operate machinery. A detrimental effect on such activities would not be anticipated from
the adverse reaction profile of topical BETAMED-N.

Clinical Trial and Post-marketing Data
Adverse drug reactions (ADRs) are listed.
Frequencies are defined as: very common (􀬛1/10), common (􀬛1/100 and Infections and Infestations
Very rare Opportunistic infection
Immune System Disorders
Very rare Local hypersensitivity
Endocrine Disorders
Very rare : Hypothalamic-pituitary adrenal (HP A) axis suppression: (see also Skin and
Subcutaneous Tissue Disorders) Cushingoid features ( e.g. moon face, central obesity), delayed
weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycaemia/glucosuria,
cataract, hypertension, increased weight/obesity, decreased endogenous cortisol levels.
Skin and Subcutaneous Tissue Disorders
Common : Pruritus, local skin burning/pain of skin
Very rare : Allergic contact dermatitis/dermatitis, erythema, rash, urticaria, pustular psoriasis, skin
thinning* I skin atrophy* skin wrinkling*, skin dryness*, striae*, telangiectasias*, pigmentation
changes*, hypertrichosis, exacerbation of underlying symptoms, alopecia*, trichorrhexis*
General Disorders and Administration Site Conditions
Very rare Application site irritation/pain
*Skin features of hypothalamic-pituitary-adrenal (HPA) axis suppression.

Symptoms and Signs
Topically applied BET AMED-N may be absorbed in sufficient amounts to produce systemic
effects. Acute overdosage is very unlikely to occur, however, in the case of chronic overdosage or
misuse the features ofhypercortisolism may occur (see Adverse Reactions).

In the event of chronic overdose or misuse, topical corticosteroids should be withdrawn gradually
by reducing the frequency of application, or by substituting a less potent steroid because of the risk
of adrenal insufficiency.
Consideration should also be given to significant systemic absorption of neomycin sulphate (see
Warnings and Precautions). If this is suspected, use of the product should be stopped and the
patient's general status, hearing acuity, renal and neuromuscular functions should be monitored.

Blood levels of neomycin sulphate should also be determined. Haemodialysis may reduce the serum
level of neomycin sulphate. Further management should be as clinically indicated or as
recommended by the National Poisons Centre, where available.

Pharmacotherapeutic group: corticosteroid with antibiotics, ATC code: D07CC01

Mechanism of action
Topical corticosteroids act as anti-inflammatory agents via multiple mechanisms to inhibit late
phase allergic reactions including decreasing the density of mast cells, decreasing chemotaxis and
activation of eosinophils, decreasing cytokine production by lymphocytes, monocytes, mast cells
and eosinophils, and inhibiting the metabolism of arachidonic acid. Neomycin interferes with
bacterial protein synthesis by binding to 30S ribosomal subunits.

Pharmacodynamic effects
Topical corticosteroids have anti-inflammatory, antipruritic, and vasoconstrictive properties.
Neomycin has a bactericidal action against many Gram-negative bacteria but it lacks activity
against Pseudomonas aeruginosa. It has partial activity against Gram-positive bacteria. It is used
topically in the treatment of infections of the skin, ear, and eye due to susceptible staphylococci and
other organisms.

Pharmacokinetics
Absorption
Topical corticosteroids can be systemically absorbed from intact healthy skin. The extent of
percutaneous absorption of topical corticosteroids is determined by many factors, including the
vehicle and the integrity of the epidermal barrier. Occlusion, inflammation and/or other disease
processes in the skin may also increase percutaneous absorption
The use of pharmacodynamic endpoints for assessing the systemic exposure of topical
corticosteroids is necessary due to the fact that circulating levels are well below the level of
detection. Absorption of neomycin has been reported to occur from wounds and inflamed skin. It is
poorly absorbed from the gastrointestinal tract when administered orally.

Distribution
Absorbed neomycin distributes to tissues and concentrates in the renal cortex.
Metabolism
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic
pathways similar to systemically administered corticosteroids. They are metabolized, primarily in
the liver.
Elimination
Topical corticosteroids are excreted by the kidneys. In addition, some corticosteroids and their
metabolites are also excreted in the bile. Absorbed neomycin is rapidly excreted by the kidneys as
parent compound. It has been reported to have a half-life of 2 to 3 hours.

Non-clinical studies have not been conducted with BETAMED-N.
Betamethasone valerate and neomycin sulphate individually have been evaluated in animal toxicity
tests, and the following statements reflect the information available on the individual components.

Methyl Paraben
Propyl Paraben
Cetostearyl Alcohol
Cetomacrogol 1000
Liquid Paraffin
Monobasic Sodium Phosphate Dihydrate
White Petrolatum
Purified Water

None known

36 Months

Store below 25°C.

30 gm packed in annealed aluminum tubes coated internally with an epoxide resin lacquer which is packed
inside a box along with leaflet.

For Topical use only