Betnovate Scalp Application裨乃膚

Betnovate Scalp Application





Agencia Lei Va Hong
Full Prescribing Info
Betamethasone valerate.
Each 1g contains 1.22mg of betamethasone valerate (0.122% w/w).
Excipients/Inactive Ingredients: Carbomer, isopropyl alcohol, sodium hydroxide, purified water.
Steroid responsive dermatoses of the scalp, such as psoriasis, seborrhoea capitis, inflammation associated with severe dandruff.
Dosage/Direction for Use
A small quantity of BETNOVATE Scalp Application should be applied to the scalp night and morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day, or less frequently.
For topical application.
This product is flammable. Keep the liquid away from open fire and flames and all sources of ignition including smoking during application and immediately after use.
Paediatric population: Betamethasone valerate is contraindicated in children under one year of age.
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; therefore, courses should be limited to five days and occlusion should not be used.
Care should be taken when using betamethasone valerate to ensure the amount applied is the minimum that provides therapeutic benefit.
Elderly: Clinical studies have not identified differences in responses between the elderly and younger patients. The greater frequency of decreased hepatic or 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/Hepatic Impairment: In case of systemic absorption (when application is over a large surface area for a prolonged period) metabolism and elimination may be delayed therefore increasing the risk of systemic toxicity. Therefore the minimum quantity should be used for the shortest duration to achieve the desired clinical benefit.
Topically applied betamethasone valerate 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 of hypercortisolism may occur (see Adverse Reactions).
In the event of overdose, betamethasone valerate should be withdrawn gradually by reducing the frequency of application, or by substituting a less potent corticosteroid because of the risk of glucocorticosteroid insufficiency.
Further management should be as clinically indicated.
Hypersensitivity to the active substance or any of the excipients listed.
Infections of the scalp. Dermatoses in children under one year of age, including dermatitis.
Special Precautions
BETNOVATE should be used with caution in patients with a history of local hypersensitivity to other corticosteroids. Local hypersensitivity reactions (see Adverse Reactions) may resemble symptoms of the condition under treatment.
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, leading to glucocorticosteroid insufficiency, can occur in some individuals as a result of increased systemic absorption of topical steroids. 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 systemic effects are: Potency and formulation of topical steroid; duration of exposure; application to a large surface area; increasing hydration of the stratum corneum; use on occluded areas of the skin; use on thin skin areas; use on broken skin or other conditions where the skin barrier may be impaired.
In comparison with adults, children 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.
Infection risk with occlusion: Bacterial infection is encouraged by the warm, moist condition within skin folds or caused by occlusive dressings. When using occlusive dressings, the skin should be cleansed before a fresh dressing is applied.
Use in Psoriasis: Topical administration should be used with caution in psoriasis as rebound relapses, development of tolerances, risk of generalised pustular psoriasis and development of local or systemic toxicity due to impaired barrier function of the skin have been reported in some cases. If used in psoriasis careful patient supervision is important.
Patients should be advised to avoid: Keep the preparation away from the eyes; avoid smoking whilst applying BETNOVATE scalp application; avoid fire, flame and heat including use of hair dryer after application.
Use in Children: In infants and children under 12 years of age, treatment courses should be limited to five days and occlusion should not be used; long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Use In Pregnancy & Lactation
There are no data in humans to evaluate the effect of topical corticosteroids on fertility.
There are limited data from the use of betamethasone valerate in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development.
The relevance of this finding to humans has not been established; however, administration of betamethasone valerate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the foetus. The minimum quantity should be used for the minimum duration.
The safe use of topical corticosteroids 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. Administration of betamethasone valerate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation betamethasone valerate should not be applied to the breasts to avoid accidental ingestion by the infant.
Adverse Reactions
Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: very common (≥1/10), common (≥1/100 and <1/10), uncommon (≥1/1,000 and <1/100), rare (≥1/10,000 and <1/1,000) and very rare (<1/10,000), including isolated reports.
Infections and Infestations: Very rare: Opportunistic infection.
Immune System Disorders: Very rare: Hypersensitivity, generalised rash.
Endocrine Disorders: Very rare: Hypothalamic-pituitary adrenal (HPA) axis suppression.
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, alopecia, trichorrhexis.
Skin and Subcutaneous Tissue Disorders: Common: Pruritus, local skin burning /skin pain.
Very rare: Allergic contact dermatitis /dermatitis, erythema, rash, urticaria, pustular psoriasis, skin thinning* / skin atrophy*, skin wrinkling*, skin dryness*, striae*, telangiectasias*, pigmentation changes*, hypertrichosis, exacerbation of underlying symptoms.
General Disorders and Administration Site Conditions: Very rare: Application site irritation/pain.
*Skin features secondary to local and/or systemic effects of hypothalamic-pituitary adrenal (HPA) axis suppression.
Drug Interactions
Co-administered drugs that can inhibit CYP3A4 (e.g. ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure. 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.
Caution For Usage
BETNOVATE Scalp Application is flammable. Stay away from heat, fire or flame and do not smoke while you are applying BETNOVATE and just after you have applied it.
Keep all medicines out of the reach of children.
Patient Counseling Information
This preparation has been specially produced for application directly on to the scalp from the squeeze bottle.
Directions for use: Remove the cap, then introduce the nozzle through the hair and on to the affected area of scalp.
Squeeze the bottle gently allowing the liquid to spread until the affected area is completely covered. You will experience a cooling sensation as the liquid evaporates leaving the active medicament on the scalp. If necessary, BETNOVATE Scalp Application may be massaged into the scalp using the tips of the fingers.
Apply twice daily to the affected area of scalp or as directed by your doctor.
If you wash or shampoo your hair, it should be dried before applying the liquid.
Application to parts of body other than the scalp should be made only on the advice of your doctor.
ATC Classification
D07AC01 - betamethasone ; Belongs to the class of potent (group III) corticosteroids. Used in the treatment of dermatological diseases.
Scalp application 0.1% x 30 mL.
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