- Approval Id
- 192269fc182c9b64
- Drug Approval Emc Name
- Betacap Scalp Application
- Drug Name
- Betacap Scalp Application
- Company Address
- Tatmore Place, Gosmore, Hitchin, Herts, SG4 7QR
- Company Website
- http://www.dermal.co.uk
- Company Telephone
- +44 (0)1462 458 866
- Atc Code
- D07AC
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place,
Gosmore
Hitchin,
Herts
SG4 7QR
UK
- Authorisation Number
- PL 00173/0149
- Authorisation Date
- 13 January 1994 / 22 June 2004
- Instruction Authorisation Holder
- Diomed Developments Limited
T/A Dermal Laboratories
Tatmore Place,
Gosmore
Hitchin,
Herts
SG4 7QR
UK
- Instruction Authorisation Number
- PL 00173/0149
- Instruction Authorisation Date
- 13 January 1994 / 22 June 2004
- Instruction Composition
- Betamethasone (as valerate) 0.1% w/w
For excipients see section 6.1.
- Instruction Dosage Form
- Cutaneous solution.
Transparent, slightly gelled, emollient, scalp application.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
For the topical treatment of dermatoses of the scalp, such as psoriasis and seborrhoeic dermatitis, which are unresponsive to less potent corticosteroids.4.2 Posology and method of administration
For adults, including the elderly, and children over the age of one year: Betacap Scalp Application should be applied sparingly 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 the treatment of seborrhoeic dermatitis in children, the product should not be used for longer than 5 to 7 days.4.3 Contraindications
Not to be used where there is bacterial, fungal or viral infection of the scalp.
Not to be used in cases of sensitivity to any of the ingredients.
Not to be used in children under the age of one year.4.4 Special warnings and precautions for use
Keep away from the eyes.
Betacap is highly flammable. Do not use near a fire or naked flame. Allow the treated scalp to dry naturally.
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion. Complications sometimes associated with the use of topical corticosteroids in psoriasis include the possibility of 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 important.
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.
The label will state strong steroid.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
For external use only.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
Betamethasone valerate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercorticism and suppression of the HPA axis. These effects are more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment, particularly under occlusion.
Adverse drug reactions 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse reaction\*\* |
| Immune System Disorders | Not known | Hypersensitivity |
| Endocrine Disorders | Not known | Hypothalamic-pituitary adrenal (HPA) axis suppression Hypercorticism |
| Skin and Subcutaneous Tissue Disorders | Not known | Skin atrophy Pustular psoriasis Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4) |
| Eye disorders | Not known | Vision, blurred (see also section 4.4) |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.4.9 Overdose
Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation treatment with Betacap Scalp Application should be discontinued.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*ATC code\*\*
D07AC - Corticosteroids, potent (group III)
Betamethasone (as valerate) is a well-established example of a corticosteroid which is used in dermatological therapy in pharmacological doses for its anti-inflammatory and immuno-suppressive glucocorticoid properties. It suppresses the clinical manifestations of a wide range of inflammatory dermatoses and is frequently used at the concentration of 0.1% (as valerate). Betacap Scalp Application complies with the specification given in the monograph for Betamethasone Valerate Scalp Application BP. Betacap Scalp Application includes a coconut-oil related emollient ingredient to reduce the drying effect that a standard alcoholic vehicle may otherwise have on the scalp. The vehicle also contains isopropyl alcohol, which has antiseptic activity.5.2 Pharmacokinetic properties
For clinical usage, the betamethasone valerate is presented as a slightly thickened evaporative solution which allows drug availability over the affected area, whilst reducing the propensity to spread onto uninvolved skin. In addition, after rapidly drying, the drug substance is thus deposited uniformly in a micronised crystalline form for efficient absorption into the skin. The lipid characteristics of the drug substance ensure that these micro-fine crystals rapidly dissolve in skin lipids to enhance molecular diffusion through the outer epidermal tissue and to encourage permeation into the deeper layers where it reverses the pathological processes responsible for the inflammation.5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in this SPC.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Macrogolglycerol Cocoates (a water dispersible derivative of coconut oil)
Isopropyl Alcohol
Carbomer
Sodium Hydroxide
Purified Water.6.2 Incompatibilities
None known.6.3 Shelf life
3 years6.4 Special precautions for storage
Do not store above 25°C. Protect from light. Return bottle to carton between use.6.5 Nature and contents of container
30 ml and 100 ml polyethylene squeeze bottle with integral nozzle/applicator for convenient direct application to the scalp through the hair, and tamper-evident replaceable cap.6.6 Special precautions for disposal and other handling
Not applicable
- Instruction Content
- ## Composition
Betamethasone (as valerate) 0.1% w/w
For excipients see section 6.1.
## Pharmaceutical Form
Cutaneous solution.
Transparent, slightly gelled, emollient, scalp application.
## Clinical Particulars
4.1 Therapeutic indications
For the topical treatment of dermatoses of the scalp, such as psoriasis and seborrhoeic dermatitis, which are unresponsive to less potent corticosteroids.4.2 Posology and method of administration
For adults, including the elderly, and children over the age of one year: Betacap Scalp Application should be applied sparingly 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 the treatment of seborrhoeic dermatitis in children, the product should not be used for longer than 5 to 7 days.4.3 Contraindications
Not to be used where there is bacterial, fungal or viral infection of the scalp.
Not to be used in cases of sensitivity to any of the ingredients.
Not to be used in children under the age of one year.4.4 Special warnings and precautions for use
Keep away from the eyes.
Betacap is highly flammable. Do not use near a fire or naked flame. Allow the treated scalp to dry naturally.
Long-term continuous topical therapy should be avoided where possible, particularly in infants and children, as adrenal suppression can occur even without occlusion. Complications sometimes associated with the use of topical corticosteroids in psoriasis include the possibility of 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 important.
Topical steroid withdrawal syndrome
Long term use of topical steroids can result in the development of rebound flares after stopping treatment (topical steroid withdrawal syndrome). A severe form of rebound flare can develop which takes the form of a dermatitis with intense redness, stinging and burning that can spread beyond the initial treatment area. It is more likely to occur when delicate skin sites such as the face and flexures are treated. Should there be a reoccurrence of the condition within days to weeks after successful treatment a withdrawal reaction should be suspected. Reapplication should be with caution and specialist advice is recommended in these cases or other treatment options should be considered.
The label will state strong steroid.
Visual disturbance
Visual disturbance may be reported with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR) which have been reported after use of systemic and topical corticosteroids.
For external use only.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Pregnancy and lactation
There is inadequate evidence of safety in human pregnancy. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development including cleft palate and intra-uterine growth retardation. There may therefore be a very small risk of such effects in the human foetus.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
Betamethasone valerate preparations are usually well tolerated, but if signs of hypersensitivity appear, application should be stopped immediately. As with other topical corticosteroids, prolonged use of large amounts or treatment of extensive areas can result in sufficient systemic absorption to produce the features of hypercorticism and suppression of the HPA axis. These effects are more likely to occur in infants and children, and if occlusive dressings are used. Local atrophy may occur after prolonged treatment, particularly under occlusion.
Adverse drug reactions 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), very rare (<1/10,000) and not known (cannot be estimated from the available data).
| | | |
| --- | --- | --- |
| \*\*System Organ Class\*\* | \*\*Frequency\*\* | \*\*Adverse reaction\*\* |
| Immune System Disorders | Not known | Hypersensitivity |
| Endocrine Disorders | Not known | Hypothalamic-pituitary adrenal (HPA) axis suppression Hypercorticism |
| Skin and Subcutaneous Tissue Disorders | Not known | Skin atrophy Pustular psoriasis Withdrawal reactions - redness of the skin which may extend to areas beyond the initial affected area, burning or stinging sensation, itch, skin peeling, oozing pustules. (see section 4.4) |
| Eye disorders | Not known | Vision, blurred (see also section 4.4) |
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in Google Play or Apple App Store.4.9 Overdose
Acute overdosage is very unlikely to occur. However, in the case of chronic overdosage or misuse, the features of hypercorticism may appear and in this situation treatment with Betacap Scalp Application should be discontinued.
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*ATC code\*\*
D07AC - Corticosteroids, potent (group III)
Betamethasone (as valerate) is a well-established example of a corticosteroid which is used in dermatological therapy in pharmacological doses for its anti-inflammatory and immuno-suppressive glucocorticoid properties. It suppresses the clinical manifestations of a wide range of inflammatory dermatoses and is frequently used at the concentration of 0.1% (as valerate). Betacap Scalp Application complies with the specification given in the monograph for Betamethasone Valerate Scalp Application BP. Betacap Scalp Application includes a coconut-oil related emollient ingredient to reduce the drying effect that a standard alcoholic vehicle may otherwise have on the scalp. The vehicle also contains isopropyl alcohol, which has antiseptic activity.5.2 Pharmacokinetic properties
For clinical usage, the betamethasone valerate is presented as a slightly thickened evaporative solution which allows drug availability over the affected area, whilst reducing the propensity to spread onto uninvolved skin. In addition, after rapidly drying, the drug substance is thus deposited uniformly in a micronised crystalline form for efficient absorption into the skin. The lipid characteristics of the drug substance ensure that these micro-fine crystals rapidly dissolve in skin lipids to enhance molecular diffusion through the outer epidermal tissue and to encourage permeation into the deeper layers where it reverses the pathological processes responsible for the inflammation.5.3 Preclinical safety data
No relevant information additional to that contained elsewhere in this SPC.
## Pharmaceutical Particulars
6.1 List of excipients
Macrogolglycerol Cocoates (a water dispersible derivative of coconut oil)
Isopropyl Alcohol
Carbomer
Sodium Hydroxide
Purified Water.6.2 Incompatibilities
None known.6.3 Shelf life
3 years6.4 Special precautions for storage
Do not store above 25°C. Protect from light. Return bottle to carton between use.6.5 Nature and contents of container
30 ml and 100 ml polyethylene squeeze bottle with integral nozzle/applicator for convenient direct application to the scalp through the hair, and tamper-evident replaceable cap.6.6 Special precautions for disposal and other handling
Not applicable
- Company Detail Path
- /organization/dermal-laboratories-limited
