BETNOVATE Betamethasone Valerate 1mg / mL Solution for Scalp Application 30mL
RXDRUG-DR-9199
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Treatment of steroid-responsive dermatoses of the scalp eg, psoriasis, seborrhea capitis and inflammation associated with severe dandruff.
Dosage/Direction for Use
Adults, Children (>1 year) and Elderly: A small quantity should be applied to the scalp at night and in the morning until improvement is noticeable. It may then be possible to sustain improvement by applying once a day or less frequently.
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.
Administration: Due to the flammable nature of Betnovate, patients should avoid smoking or being near to an open flame during application and immediately after use.
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.
Administration: Due to the flammable nature of Betnovate, patients should avoid smoking or being near to an open flame during application and immediately after use.
Overdosage
Symptoms: Topically applied Betnovate 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).
Treatment: In the event of overdosage, Betnovate 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 or as recommended by the national poisons center, where available.
Treatment: In the event of overdosage, Betnovate 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 or as recommended by the national poisons center, where available.
Contraindications
Infections of the scalp.
Use in children: Betnovate is contraindicated in children <1 year.
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 Betnovate to ensure the amount applied is the minimum that provides therapeutic benefit.
Betnovate is contraindicated in dermatoses in children <1 year, including dermatitis.
Use in children: Betnovate is contraindicated in children <1 year.
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 Betnovate to ensure the amount applied is the minimum that provides therapeutic benefit.
Betnovate is contraindicated in dermatoses in children <1 year, including dermatitis.
Special Precautions
Hypersensitivity to betamethasone valerate, corticosteroids or to any of the excipients of Betnovate. 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, use on occluded areas of skin [eg, on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing)], increasing hydration of the stratum corneum; use on thin skin areas eg, the face; 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 conditions 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 corticosteroids 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.
Impairment of Fertility: There are no data in humans to evaluate the effect of topical corticosteroids on fertility.
Effects on the Ability to Drive or Operate Machinery: There have been no studies to investigate the effect of Betnovate 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 Betnovate.
Use in pregnancy: There are limited data from the use of Betnovate in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. (See Pharmacology: Toxicology under Actions.)
The relevance of this finding to humans has not been established; however, administration of Betnovate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the fetus. The minimum quantity should be used for the minimum duration.
Use in lactation: 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 Betnovate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation Betnovate should not be applied to the breasts to avoid accidental ingestion by the infant.
Use in children: In infants and children <12 years, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
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, use on occluded areas of skin [eg, on intertriginous areas or under occlusive dressings (in infants the nappy may act as an occlusive dressing)], increasing hydration of the stratum corneum; use on thin skin areas eg, the face; 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 conditions 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 corticosteroids 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.
Impairment of Fertility: There are no data in humans to evaluate the effect of topical corticosteroids on fertility.
Effects on the Ability to Drive or Operate Machinery: There have been no studies to investigate the effect of Betnovate 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 Betnovate.
Use in pregnancy: There are limited data from the use of Betnovate in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. (See Pharmacology: Toxicology under Actions.)
The relevance of this finding to humans has not been established; however, administration of Betnovate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the fetus. The minimum quantity should be used for the minimum duration.
Use in lactation: 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 Betnovate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation Betnovate should not be applied to the breasts to avoid accidental ingestion by the infant.
Use in children: In infants and children <12 years, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur.
Use In Pregnancy & Lactation
Use in pregnancy: There are limited data from the use of Betnovate in pregnant women.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. (See Pharmacology: Toxicology under Actions.)
The relevance of this finding to humans has not been established; however, administration of Betnovate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the fetus. The minimum quantity should be used for the minimum duration.
Use in lactation: 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 Betnovate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation Betnovate should not be applied to the breasts to avoid accidental ingestion by the infant.
Topical administration of corticosteroids to pregnant animals can cause abnormalities of fetal development. (See Pharmacology: Toxicology under Actions.)
The relevance of this finding to humans has not been established; however, administration of Betnovate during pregnancy should only be considered if the expected benefit to the mother outweighs the risk to the fetus. The minimum quantity should be used for the minimum duration.
Use in lactation: 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 Betnovate during lactation should only be considered if the expected benefit to the mother outweighs the risk to the infant.
If used during lactation Betnovate should not be applied to the breasts to avoid accidental ingestion by the infant.
Adverse Reactions
Adverse drug reactions (ADRs) are listed as follows 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.
Post-Marketing Data: Infections and Infestations: Very Rare: Opportunistic infection.
Immune System Disorders: Very Rare: Local hypersensitivity.
Endocrine Disorders: Very Rare: Hypothalamic-pituitary adrenal (HPA) axis suppression; cushingoid features (eg, moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycemia/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.
Post-Marketing Data: Infections and Infestations: Very Rare: Opportunistic infection.
Immune System Disorders: Very Rare: Local hypersensitivity.
Endocrine Disorders: Very Rare: Hypothalamic-pituitary adrenal (HPA) axis suppression; cushingoid features (eg, moon face, central obesity), delayed weight gain/growth retardation in children, osteoporosis, glaucoma, hyperglycemia/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 (eg, 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.
Storage
Store below 25°C. Contents are flammable. Keep away from fire, flame or heat. Protect from light or direct sunlight.
Action
Pharmacology: Pharmacodynamics: 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.
Pharmacodynamic Effects: Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.
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.
Distribution: The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary because circulating levels are well below the level of detection.
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.
Toxicology: Nonclinical Information: Carcinogenicity: Long-term animal studies have not been performed to evaluate the carcinogenic potential of Betnovate.
Genotoxicity: No specific studies have been conducted to investigate the genotoxic potential of Betnovate.
Impairment of Fertility: The effect on fertility of Betnovate has not been evaluated in animals.
Pregnancy: Subcutaneous administration of Betnovate to mice or rats at doses ≥0.1 mg/kg/day or rabbits at doses ≥12 mcg/kg/day during pregnancy produced fetal abnormalities including cleft palate.
Pharmacodynamic Effects: Topical corticosteroids have anti-inflammatory, antipruritic and vasoconstrictive properties.
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.
Distribution: The use of pharmacodynamic endpoints for assessing the systemic exposure of topical corticosteroids is necessary because circulating levels are well below the level of detection.
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.
Toxicology: Nonclinical Information: Carcinogenicity: Long-term animal studies have not been performed to evaluate the carcinogenic potential of Betnovate.
Genotoxicity: No specific studies have been conducted to investigate the genotoxic potential of Betnovate.
Impairment of Fertility: The effect on fertility of Betnovate has not been evaluated in animals.
Pregnancy: Subcutaneous administration of Betnovate to mice or rats at doses ≥0.1 mg/kg/day or rabbits at doses ≥12 mcg/kg/day during pregnancy produced fetal abnormalities including cleft palate.
MedsGo Class
Topical Corticosteroids
Features
Brand
Betnovate
Full Details
Dosage Strength
(0.1%) 1mg /ml
Drug Ingredients
- Betamethasone
Drug Packaging
Solution for Scalp Application 30ml
Generic Name
Betamethasone Valerate
Dosage Form
Solution For Scalp Application
Registration Number
DR-9199
Drug Classification
Prescription Drug (RX)
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