- Approval Id
- 97def89f376f63e9
- Drug Approval Emc Name
- Hydrocortisone 1 %w/w cream - PL 13606/0185
- Drug Name
- Hydrocortisone 1 %w/w cream - PL 13606/0185
- Company Name
- Strides Pharma UK Ltd
- Company Address
- Unit 4, Metro Centre, Tolpits Lane, Watford, Hertfordshire, UK
- Company Website
- //www.stridespharma.co.uk
- Company Telephone
- +44 1923 255580
- Company Medical Info Direct Line
- +44 8000 988 048
- Company Medical Info Email
- drugsafety@strides.com
- Atc Code
- D07AA02
- Legal Category
- Pharmacy
- Authorisation Holder
- Strides Pharma UK Ltd
Unit 4, Metro Centre
Tolpits Lane
Watford
Hertfordshire
WD18 9SS
- Authorisation Number
- PL 13606 / 0185
- Authorisation Date
- 20/11/2014
- Instruction Authorisation Holder
- Strides Pharma UK Ltd
Unit 4, Metro Centre
Tolpits Lane
Watford
Hertfordshire
WD18 9SS
- Instruction Authorisation Number
- PL 13606 / 0185
- Instruction Authorisation Date
- 20/11/2014
- Instruction Composition
- Ointment containing 1% micronised hydrocortisone
Excipient(s) with known effect
Wool fat
For the full list of excipients, see section 6.1.
- Instruction Dosage Form
- Ointment
Smooth off white translucent ointment
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Insect bite and sting reactions only.4.2 Posology and method of administration
Posology
\*Adults and elderly:\* Apply sparingly to a small area once or twice daily for a maximum period of 2-3 days. If the condition does not improve consult your doctor. The same dose is used for adults and the elderly, as clinical evidence would indicate that no special dosage regimen is necessary in the elderly.
\*Children aged 10 years and above:\* As for adults and the elderly. Long term therapy should be avoided and where possible limited two to three days.
Do not use for children under 10 years old.
Method of administration
For cutaneous use.4.3 Contraindications
• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
• Use on the eyes, face or ano-genital region.
• Use on untreated bacterial (e.g. impetigo), fungal (e.g. candida or dermatophyte) or viral (e.g. herpes simplex) infections of the skin, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.
• Children under 10 years of age.
• Not to be used for other bites and stings or for other skin conditions.4.4 Special warnings and precautions for use
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.
Remarks on indications
1. There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes.
2. Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
3. Topical corticosteroids are not generally indicated in psoriasis excluding widespread plaque psoriasis provided that warnings are given.
In children long-term treatment should be avoided especially on the face as adrenal suppression can occur.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development tolerance, the risk of generalized pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin; careful patient supervision is important.
Although generally regarded as safe, even for long-term administration in adults, there is potential for adverse effects if overused in infancy. Extreme caution is required in dermatoses of infancy, including napkin eruption. In such patients, courses of treatment should not normally exceed seven days.
Appropriate antimicrobial therapy should be used treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.
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.
In children particularly, care should be taken that the lowest strength of hydrocortisone ointment that is clinically effective is used.
The use of an occlusive dressing can considerably increase the degree of systemic absorption.
As with all corticosteroids, application to the face may damage the skin and should be avoided. Caution should be taken to keep away from the eyes.
Healthcare professionals should be aware that if the product comes into contact with dressing, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.
Do not use in children under 10 years of age.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Fertility, pregnancy and lactation
Pregnancy
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. Therefore there may be a small risk of such events to the human foetus. There is a theoretical risk of such effects on the human foetus.
The product should not be used in pregnancy without medical advice.
Breast-feeding
There is no evidence against use in lactating women. However, caution should be exercised when hydrocortisone ointment is administered to nursing mothers. In this event, the product should not be applied to the chest area. There is theoretical risk of infant adrenal function impairment if maternal systemic absorption occurs.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
Treatment with hydrocortisone ointment is usually well tolerated but treatment should be stopped immediately if symptoms of hypersensitivity occur.
Epidermal thinning, telangiectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption.
Following prolonged topical use systemic absorption from sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin are treated.
Eye disorders:
Frequency Not known: Vision, blurred (see section 4.4).
Skin and Subcutaneous Tissue Disorders
Not known (cannot be estimated from available data) 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).
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; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically. Acute overdosage is very unlikely to occur. In the case of chronic overdosage or misuse the features or hypercorticism may appear and in this situation topical steroids should be discontinued.
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, weak (group I), ATC Code: D07AA02.
Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction of the vascular component of the inflammatory response and reduction of the formation of inflammatory fluid and cellular exudates. The granulation reaction is also decreased due to the inhibition effect of hydrocortisone on connective tissue. Stabilisation of most cell granules and lysomal membranes decreases the mediators involved in inflammatory response and reduces release of enzymes involved in prostaglandin synthesis. The vasoconstrictor action of hydrocortisone may also contribute to its anti-inflammatory activity.5.2 Pharmacokinetic properties
\*\*Absorption:\*\* Topically applied steroids are absorbed to a significant extent only if applied to broken skin, to very large areas or under occlusive dressings.
\*\*Distribution:\*\* Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk.
\*\*Metabolism:\*\* Hydrocortisone is metabolised mainly in the liver, but also the kidney, to various degraded and hydrogenated forms such as tetrahydrocortisone.
\*\*Elimination:\*\* Hydrocortisone is excreted in the urine, mostly conjugated as glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.5.3 Preclinical safety data
Adverse effects of hydrocortisone are due to its effects on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of hydrocortisone has only rarely been associated with systemic side effects.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Wool fat
Liquid paraffin
White soft paraffin6.2 Incompatibilities
None known.6.3 Shelf life
60 Months6.4 Special precautions for storage
Do not Store above 25° C.6.5 Nature and contents of container
A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex endseal band in the crimp seal area and a white plastic cap for re closure after piercing membrane.
10 g pack size only.6.6 Special precautions for disposal and other handling
No special precautions are required.
- Instruction Content
- ## Composition
Ointment containing 1% micronised hydrocortisone
Excipient(s) with known effect
Wool fat
For the full list of excipients, see section 6.1.
## Pharmaceutical Form
Ointment
Smooth off white translucent ointment
## Clinical Particulars
4.1 Therapeutic indications
Insect bite and sting reactions only.4.2 Posology and method of administration
Posology
\*Adults and elderly:\* Apply sparingly to a small area once or twice daily for a maximum period of 2-3 days. If the condition does not improve consult your doctor. The same dose is used for adults and the elderly, as clinical evidence would indicate that no special dosage regimen is necessary in the elderly.
\*Children aged 10 years and above:\* As for adults and the elderly. Long term therapy should be avoided and where possible limited two to three days.
Do not use for children under 10 years old.
Method of administration
For cutaneous use.4.3 Contraindications
• Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1.
• Use on the eyes, face or ano-genital region.
• Use on untreated bacterial (e.g. impetigo), fungal (e.g. candida or dermatophyte) or viral (e.g. herpes simplex) infections of the skin, infected lesions, ulcerative conditions, rosacea, peri-oral dermatitis or acne.
• Children under 10 years of age.
• Not to be used for other bites and stings or for other skin conditions.4.4 Special warnings and precautions for use
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.
Remarks on indications
1. There is no good evidence that topical corticosteroids are efficacious against immediate (Type 1) allergic skin reactions or short-lived weal and flare reactions from other causes.
2. Topical corticosteroids are ineffective in granulomatous conditions and other inflammatory reactions involving the deeper regions of the dermis.
3. Topical corticosteroids are not generally indicated in psoriasis excluding widespread plaque psoriasis provided that warnings are given.
In children long-term treatment should be avoided especially on the face as adrenal suppression can occur.
Topical corticosteroids may be hazardous in psoriasis for a number of reasons including rebound relapses following development tolerance, the risk of generalized pustular psoriasis and local and systemic toxicity due to impaired barrier function of the skin; careful patient supervision is important.
Although generally regarded as safe, even for long-term administration in adults, there is potential for adverse effects if overused in infancy. Extreme caution is required in dermatoses of infancy, including napkin eruption. In such patients, courses of treatment should not normally exceed seven days.
Appropriate antimicrobial therapy should be used treating inflammatory lesions which have become infected. Any spread of infection requires withdrawal of topical corticosteroid therapy, and systemic administration of antimicrobial agents.
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.
In children particularly, care should be taken that the lowest strength of hydrocortisone ointment that is clinically effective is used.
The use of an occlusive dressing can considerably increase the degree of systemic absorption.
As with all corticosteroids, application to the face may damage the skin and should be avoided. Caution should be taken to keep away from the eyes.
Healthcare professionals should be aware that if the product comes into contact with dressing, clothing and bedding, the fabric can be easily ignited with a naked flame. Patients should be warned of this risk and advised to keep away from fire when using this product.
Do not use in children under 10 years of age.4.5 Interaction with other medicinal products and other forms of interaction
None known.4.6 Fertility, pregnancy and lactation
Pregnancy
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. Therefore there may be a small risk of such events to the human foetus. There is a theoretical risk of such effects on the human foetus.
The product should not be used in pregnancy without medical advice.
Breast-feeding
There is no evidence against use in lactating women. However, caution should be exercised when hydrocortisone ointment is administered to nursing mothers. In this event, the product should not be applied to the chest area. There is theoretical risk of infant adrenal function impairment if maternal systemic absorption occurs.4.7 Effects on ability to drive and use machines
None known.4.8 Undesirable effects
Treatment with hydrocortisone ointment is usually well tolerated but treatment should be stopped immediately if symptoms of hypersensitivity occur.
Epidermal thinning, telangiectasia and striae may occur in areas of high absorption such as skin folds, the face and where occlusive dressings are used. Local atrophic changes may occur in intertriginous areas or in nappy areas in young children where moist conditions favour hydrocortisone absorption.
Following prolonged topical use systemic absorption from sites may be sufficient to produce hypercorticism and suppression of the pituitary adrenal axis after prolonged treatment. This effect is more likely to occur in infants and children and if occlusive dressings are used or large areas of skin are treated.
Eye disorders:
Frequency Not known: Vision, blurred (see section 4.4).
Skin and Subcutaneous Tissue Disorders
Not known (cannot be estimated from available data) 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).
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; website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.4.9 Overdose
Excessive use under occlusive dressings may produce adrenal suppression. No special procedures or antidote. Treat any adverse effects symptomatically. Acute overdosage is very unlikely to occur. In the case of chronic overdosage or misuse the features or hypercorticism may appear and in this situation topical steroids should be discontinued.
## Pharmacological Properties
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: Corticosteroids, weak (group I), ATC Code: D07AA02.
Hydrocortisone is an anti-inflammatory steroid. Its anti-inflammatory action is due to reduction of the vascular component of the inflammatory response and reduction of the formation of inflammatory fluid and cellular exudates. The granulation reaction is also decreased due to the inhibition effect of hydrocortisone on connective tissue. Stabilisation of most cell granules and lysomal membranes decreases the mediators involved in inflammatory response and reduces release of enzymes involved in prostaglandin synthesis. The vasoconstrictor action of hydrocortisone may also contribute to its anti-inflammatory activity.5.2 Pharmacokinetic properties
\*\*Absorption:\*\* Topically applied steroids are absorbed to a significant extent only if applied to broken skin, to very large areas or under occlusive dressings.
\*\*Distribution:\*\* Corticosteroids are rapidly distributed to all body tissues. They cross the placenta and may be excreted in small amounts in breast milk.
\*\*Metabolism:\*\* Hydrocortisone is metabolised mainly in the liver, but also the kidney, to various degraded and hydrogenated forms such as tetrahydrocortisone.
\*\*Elimination:\*\* Hydrocortisone is excreted in the urine, mostly conjugated as glucuronides. Only very small amounts of unchanged hydrocortisone are excreted.5.3 Preclinical safety data
Adverse effects of hydrocortisone are due to its effects on electrolyte balance, metabolism and particularly adrenal suppression. Topical use of hydrocortisone has only rarely been associated with systemic side effects.
## Pharmaceutical Particulars
6.1 List of excipients
Wool fat
Liquid paraffin
White soft paraffin6.2 Incompatibilities
None known.6.3 Shelf life
60 Months6.4 Special precautions for storage
Do not Store above 25° C.6.5 Nature and contents of container
A collapsible aluminium tube, with a membrane seal at the nozzle, internal epoxy lacquer, latex endseal band in the crimp seal area and a white plastic cap for re closure after piercing membrane.
10 g pack size only.6.6 Special precautions for disposal and other handling
No special precautions are required.
