- Approval Id
- 19d11ae00f454b0f
- Drug Approval Emc Name
- Betamethasone valerate/Neomycin sulphate 1 mg/5 mg/g Cream
- Drug Name
- Betamethasone valerate/Neomycin sulphate 1 mg/5 mg/g Cream
- Company Name
- Chemidex Pharma Ltd
- Company Address
- 7 Egham Business Village, Crabtree Road, Egham, Surrey, TW20 8 RB, UK
- Company Website
- http://www.chemidex.co.uk
- Company Telephone
- +44 (0)1784 477 167
- Company Medical Info Direct Line
- +44 (0)1784 477167
- Company Medical Info Email
- info@chemidex.co.uk
- Atc Code
- D07CC01
- Legal Category
- Prescription only medicine
- Authorisation Holder
- Chemidex Pharma Limited,
Trading as Essential Generics,
Chemidex House,
8a Crabtree Road,
Egham, Surrey TW20 8RN,
United Kingdom
- Authorisation Number
- PL 17736/0098
- Authorisation Date
- 07/11/1997
- Instruction Authorisation Holder
- Chemidex Pharma Limited,
Trading as Essential Generics,
Chemidex House,
8a Crabtree Road,
Egham, Surrey TW20 8RN,
United Kingdom
- Instruction Authorisation Number
- PL 17736/0098
- Instruction Authorisation Date
- 07/11/1997
- Instruction Composition
- Each gram of cream contains 1.22 mg betamethasone valerate and 5 mg neomycin sulfate.
Excipients with known effect:
Each gram of cream contains 1 mg of chlorocresol and 72 mg cetostearyl alcohol
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Aqueous Cream
A smooth white to off-white cream
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Betamethasone/neomycin skin preparations are indicated for the treatment of the following conditions where secondary bacterial infection is present, suspected, or likely to occur: eczema in adults and children (aged 2 years and over), including atopic and discoid eczemas; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses including lichen simplex and lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; insect bite reactions; and anal and genital intertrigo.4.2 Posology and method of administration
Posology
The cream is especially appropriate for moist or weeping surfaces, and the ointment for dry lichenified or scaly lesions, but this is not invariably so.
\*Adults\*
In adults, in the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effects of this medicinal product 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 7 days without medical supervision.
\*Adults and children aged 2 years and over:\*
A small quantity should be applied to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day or even less often.
Betamethasone/neomycin skin preparations are suitable for use in children (2 years and over) at the same dose as adults. When used in children, courses should be limited to 5 days, if possible.
A possibility of increased absorption exists in very young, children; thus this medicinal product is not recommended for use in neonates and infants younger than 2 years of age (see section 4.3 and section 4.4).
\*Dosage in renal impairment:\*
Dosage should be reduced in patients with reduced renal function (see section 4.4).
\*Elderly:\*
Betamethasone/neomycin skin preparations are suitable for use in the elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur (see section 4.4).
Method of administration
For topical administration.4.3 Contraindications
- Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
- Rosacea.
- Acne vulgaris.
- Perioral dermatitis.
- Pruritus without inflammation
- Perianal and genital pruritus.
- Primary cutaneous viral infections (e.g. herpes simplex, chickenpox).
- Use is not indicated in the treatment of primary infected skin lesions caused by infection with fungi or bacteria; primary or secondary infections due to yeast; or secondary infections due to \*Pseudomonas\* or \*Proteus\* species.
- Dermatoses in children under 2 years of age, including dermatitis and napkin eruptions. A possibility of increased absorption exists in very young children, thus this medicinal product is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be enhanced, and renal function may be immature.
- Preparations containing neomycin should not be used for the treatment of otitis externa when the ear drum is perforated, because of the risk of ototoxicity.
- Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Betamethasone/Neomycin skin preparations in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.4.4 Special warnings and precautions for use
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency (see section 4.8 and section 4.9).
Infection
If infection persists, systemic chemotherapy is required.
Withdraw topical corticosteroid if there is a spread of infection.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.
Application to the Face
Avoid prolonged application to the face. The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.
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. If Betamethasone/Neomycin Cream does enter the eye, the affected eye should be bathed in copious amounts of water.
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.
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.
Paediatric population
In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects.
If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.
Use in Psoriasis
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 important.
Long term continuous or inappropriate 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 advise is recommended in these cases or other treatment options should be considered.
Extended or recurrent application may increase the risk of contact sensitisation.
Extension of infection may occur due to the masking effect of the steroid.
Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; and neomycin has nephrotoxic potential.
Renal impairment
In renal impairment the plasma clearance of neomycin is reduced (see Dosage in renal impairment, section 4.2).
Dilution
Products which contain antimicrobial agents should not be diluted.
Fire hazard in contact with dressings, clothing and bedding
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Excipients
This medicine contains chlorocresol, which may cause allergic reactions
This medicinal product contains cetostearyl alcohol. This may cause local skin reactions, such as contact dermatitis.4.5 Interaction with other medicinal products and other forms of interaction
Following significant systemic absorption, neomycin sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.
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.4.6 Fertility, pregnancy and lactation
There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus use of this medicinal product is not recommended in pregnancy or lactation.4.7 Effects on ability to drive and use machines
Betamethasone/neomycin skin preparations has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
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) very rare (<1/10,000), including isolated reports and not known (cannot be estimated from available data).
\*\*Post-marketing data\*\*
| | |
| --- | --- |
| Infections and infestation | |
| 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 |
| Not known | 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) |
| 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.\*
| | |
| --- | --- |
| 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 the 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 Cushing's syndrome may appear and, in this situation, topical steroids should be discontinued gradually under medical supervision (see Section 4.4 Special Warnings and Precautions for use).
Also, consideration should be given to significant systemic absorption of neomycin sulfate (see 4.4 Special Warnings and Precautions for Use). 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 sulfate should also be determined. Haemodialysis may reduce the serum level of neomycin sulfate.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, potent combinations with antibiotics, ATC code: D07CC01
Betamethasone valerate is an active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy and is often effective in the less responsive conditions such as psoriasis.
Neomycin sulfate is a broad-spectrum bactericidal antibiotic effective against the majority of bacteria commonly associated with skin infections.5.2 Pharmacokinetic properties
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the kidneys.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Chlorocresol
Cetomacrogol 1000
Cetostearyl alcohol
White soft paraffin
Liquid paraffin
Sodium acid phosphate
phosphoric acid
Sodium hydroxide
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years.6.4 Special precautions for storage
Store below 25ºC.6.5 Nature and contents of container
Collapsible aluminium tubes internally coated with an epoxy resin based lacquer, and closed with a wadless polypropylene cap.
Pack size: 15 g, 30 g and 100 g.
Not all pack sizes may be marketed6.6 Special precautions for disposal and other handling
Do not dilute
- Instruction Content
- ## Composition
Each gram of cream contains 1.22 mg betamethasone valerate and 5 mg neomycin sulfate.
Excipients with known effect:
Each gram of cream contains 1 mg of chlorocresol and 72 mg cetostearyl alcohol
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Aqueous Cream
A smooth white to off-white cream
## Clinical Particulars
4.1 Therapeutic indications
Betamethasone/neomycin skin preparations are indicated for the treatment of the following conditions where secondary bacterial infection is present, suspected, or likely to occur: eczema in adults and children (aged 2 years and over), including atopic and discoid eczemas; prurigo nodularis; psoriasis (excluding widespread plaque psoriasis); neurodermatoses including lichen simplex and lichen planus; seborrhoeic dermatitis; contact sensitivity reactions; insect bite reactions; and anal and genital intertrigo.4.2 Posology and method of administration
Posology
The cream is especially appropriate for moist or weeping surfaces, and the ointment for dry lichenified or scaly lesions, but this is not invariably so.
\*Adults\*
In adults, in the more resistant lesions, such as the thickened plaques of psoriasis on elbows and knees, the effects of this medicinal product 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 7 days without medical supervision.
\*Adults and children aged 2 years and over:\*
A small quantity should be applied to the affected area two or three times daily until improvement occurs. It may then be possible to maintain improvement by applying once a day or even less often.
Betamethasone/neomycin skin preparations are suitable for use in children (2 years and over) at the same dose as adults. When used in children, courses should be limited to 5 days, if possible.
A possibility of increased absorption exists in very young, children; thus this medicinal product is not recommended for use in neonates and infants younger than 2 years of age (see section 4.3 and section 4.4).
\*Dosage in renal impairment:\*
Dosage should be reduced in patients with reduced renal function (see section 4.4).
\*Elderly:\*
Betamethasone/neomycin skin preparations are suitable for use in the elderly. Caution should be exercised in cases where a decrease in renal function exists and significant systemic absorption of neomycin sulfate may occur (see section 4.4).
Method of administration
For topical administration.4.3 Contraindications
- Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
- Rosacea.
- Acne vulgaris.
- Perioral dermatitis.
- Pruritus without inflammation
- Perianal and genital pruritus.
- Primary cutaneous viral infections (e.g. herpes simplex, chickenpox).
- Use is not indicated in the treatment of primary infected skin lesions caused by infection with fungi or bacteria; primary or secondary infections due to yeast; or secondary infections due to \*Pseudomonas\* or \*Proteus\* species.
- Dermatoses in children under 2 years of age, including dermatitis and napkin eruptions. A possibility of increased absorption exists in very young children, thus this medicinal product is not recommended for use in neonates and infants (up to 2 years). In neonates and infants, absorption by immature skin may be enhanced, and renal function may be immature.
- Preparations containing neomycin should not be used for the treatment of otitis externa when the ear drum is perforated, because of the risk of ototoxicity.
- Due to the known ototoxic and nephrotoxic potential of neomycin sulfate, the use of Betamethasone/Neomycin skin preparations in large quantities or on large areas for prolonged periods of time is not recommended in circumstances where significant systemic absorption may occur.4.4 Special warnings and precautions for use
Reversible hypothalamic-pituitary-adrenal (HPA) axis suppression
Manifestations of hypercortisolism (Cushing's syndrome) and reversible hypothalamic-pituitary-adrenal (HPA) axis suppression can occur in some individuals as a result of increased systemic absorption of topical corticosteroids. In this situation, topical steroids should be discontinued gradually under medical supervision because of the risk of adrenal insufficiency (see section 4.8 and section 4.9).
Infection
If infection persists, systemic chemotherapy is required.
Withdraw topical corticosteroid if there is a spread of infection.
Bacterial infection is encouraged by the warm, moist conditions induced by occlusive dressings, and the skin should be cleansed before a fresh dressing is applied.
Application to the Face
Avoid prolonged application to the face. The face, more than other areas of the body, may exhibit atrophic changes after prolonged treatment with potent topical corticosteroids. This must be borne in mind when treating such conditions as psoriasis, discoid lupus erythematosus and severe eczema.
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. If Betamethasone/Neomycin Cream does enter the eye, the affected eye should be bathed in copious amounts of water.
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.
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.
Paediatric population
In comparison with adults, children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects.
If used in childhood, or on the face, courses should be limited to five days and occlusion should not be used.
Use in Psoriasis
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 important.
Long term continuous or inappropriate 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 advise is recommended in these cases or other treatment options should be considered.
Extended or recurrent application may increase the risk of contact sensitisation.
Extension of infection may occur due to the masking effect of the steroid.
Following significant systemic absorption, aminoglycosides such as neomycin can cause irreversible ototoxicity; and neomycin has nephrotoxic potential.
Renal impairment
In renal impairment the plasma clearance of neomycin is reduced (see Dosage in renal impairment, section 4.2).
Dilution
Products which contain antimicrobial agents should not be diluted.
Fire hazard in contact with dressings, clothing and bedding
Instruct patients not to smoke or go near naked flames - risk of severe burns. Fabric (clothing, bedding, dressings etc) that has been in contact with this product burns more easily and is a serious fire hazard. Washing clothing and bedding may reduce product build-up but not totally remove it.
Excipients
This medicine contains chlorocresol, which may cause allergic reactions
This medicinal product contains cetostearyl alcohol. This may cause local skin reactions, such as contact dermatitis.4.5 Interaction with other medicinal products and other forms of interaction
Following significant systemic absorption, neomycin sulfate can intensify and prolong the respiratory depressant effects of neuromuscular blocking agents.
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.4.6 Fertility, pregnancy and lactation
There is little information to demonstrate the possible effect of topically applied neomycin in pregnancy and lactation. However, neomycin present in maternal blood can cross the placenta and may give rise to a theoretical risk of foetal toxicity, thus use of this medicinal product is not recommended in pregnancy or lactation.4.7 Effects on ability to drive and use machines
Betamethasone/neomycin skin preparations has no or negligible influence on the ability to drive and use machines.4.8 Undesirable effects
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) very rare (<1/10,000), including isolated reports and not known (cannot be estimated from available data).
\*\*Post-marketing data\*\*
| | |
| --- | --- |
| Infections and infestation | |
| 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 |
| Not known | 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) |
| 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.\*
| | |
| --- | --- |
| 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 the 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 Cushing's syndrome may appear and, in this situation, topical steroids should be discontinued gradually under medical supervision (see Section 4.4 Special Warnings and Precautions for use).
Also, consideration should be given to significant systemic absorption of neomycin sulfate (see 4.4 Special Warnings and Precautions for Use). 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 sulfate should also be determined. Haemodialysis may reduce the serum level of neomycin sulfate.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, potent combinations with antibiotics, ATC code: D07CC01
Betamethasone valerate is an active topical corticosteroid which produces a rapid response in those inflammatory dermatoses that are normally responsive to topical corticosteroid therapy and is often effective in the less responsive conditions such as psoriasis.
Neomycin sulfate is a broad-spectrum bactericidal antibiotic effective against the majority of bacteria commonly associated with skin infections.5.2 Pharmacokinetic properties
The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.
Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids.
Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systematically administered corticosteroids.
Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolised primarily by the liver and are then excreted by the kidneys.5.3 Preclinical safety data
There are no preclinical data of relevance to the prescriber which are additional to that in other sections of the SmPC.
## Pharmaceutical Particulars
6.1 List of excipients
Chlorocresol
Cetomacrogol 1000
Cetostearyl alcohol
White soft paraffin
Liquid paraffin
Sodium acid phosphate
phosphoric acid
Sodium hydroxide
Purified water6.2 Incompatibilities
Not applicable.6.3 Shelf life
3 years.6.4 Special precautions for storage
Store below 25ºC.6.5 Nature and contents of container
Collapsible aluminium tubes internally coated with an epoxy resin based lacquer, and closed with a wadless polypropylene cap.
Pack size: 15 g, 30 g and 100 g.
Not all pack sizes may be marketed6.6 Special precautions for disposal and other handling
Do not dilute
