Under exceptional circumstances, if Dioderm is used excessively, particularly in young children, it is theoretically possible that adrenal suppression and skin thinning may occur. The symptoms are normally reversible on cessation of treatment.
24 months.
As with all topical steroids, Dioderm is not to be used where there is bacterial, viral or fungal infection.
Not to be used on open wounds, ulcers or broken skin.
Not to be used in cases of sensitivity to any of the ingredients.
None known.
Citric Acid; Emulsifying Wax; White Soft Paraffin; Liquid Paraffin; Propylene Glycol; Purified Water.
Smooth white aqueous cream.
Reported side effects of corticosteroids include skin thinning and striae. Although rare, these could occur even with hydrocortisone, especially when used under occlusion or in the folds of the skin.
Dioderm is usually well tolerated but in the event of a hypersensitivity reaction (allergic contact dermatitis) treatment should be discontinued.
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.
No special information.
WHAT IS ACTICITY AND WHAT IS IT USED FOR
Acticity belongs to the group of hormonal medicines called
Corticosteroids are systemic and act as powerful anti-inflammatory agents.
Acticity is used to treat:
Corticosteroids are used in pharmacological doses for their anti-inflammatory and immunosuppressive glucocorticoid properties which suppress the clinical manifestations of a wide range of diseases. Although many synthetic derivatives have been developed, hydrocortisone is still used widely in topical formulations for inflammatory dermatoses. It has the advantage over its synthetic derivatives that it is metabolised in the skin and therefore cannot accumulate to form a depot which may result in local side effects.
The cream formulation of Dioderm was developed in order to optimise the release and partition of its active ingredient, hydrocortisone, into the skin. The hydrocortisone is presented as a saturated or near saturated solution in aqueous propylene glycol, which represents the continuous phase of the emulsion system. It has been shown, by the vasoconstrictor assay on normal skin, that, in this environment, a 0.1% concentration of the hydrocortisone is equivalent to the 1.0% concentration of the official cream formulations appearing in the British Pharmacopoeia where the drug substance is in suspension. Clinical studies have confirmed that 0.1% Dioderm is equivalent to 1.0% Hydrocortisone Cream BP whilst the reduced strength of Dioderm increases the margin of safety.
January 2015.
DIODERMâ„¢ 0.1% w/w CREAM
Dermal Laboratories
Tatmore Place, Gosmore
Hitchin, Herts SG4 7QR, UK.
Do not store above 25°C. Replace cap tightly after use.
30 g collapsible tube. This is supplied as an original pack (OP).
00173/0047.
Hydrocortisone 0.1% w/w.
For excipients, see section List of excipients.
POSSIBLE SIDE EFFECTS
Like all medicines, It's a medicine this can lead to adverse consequences, even if not all people suffer from them.
The side effects of glucocorticoids depend on the dose, time of administration and duration of treatment. Adverse reactions can be minimized by using the lowest effective dose for as short a time as possible.
The following adverse reactions of hydrocortisone drugs administered at high doses or for indications other than replacement therapy have been reported in adrenal insufficiency, although the frequency is unknown.
| Bodies/ The system | Adverse event |
| Infections and infestations | Increased risk of infection |
| Diseases of the blood and lymphatic system | Changes in blood cells (An increase in white blood cells and platelets in the blood, a decrease in eosinophils and lymphocytes in the blood, thrombosis) |
| Immune system disorders | Allergic reactions |
| Endocrine disorders | Withdrawal syndrome (headache, nausea, dizziness, decreased appetite, weakness, emotional changes, changes in the level of consciousness and inappropriate reactions to stressful situations) growth retardation in children. Cushing's syndrome is mainly characterized by a change in the location of fat (moon face, central obesity, buffalo hump), a decrease in potassium levels increased cholesterol in the blood increased triglycerides in the blood increased lipoproteins thyroid disorder increased ketone bodies in the blood hyperosmolar hyperglycemic status manifestation of latent hyperparathyroidism tumor lysis syndrome |
| Mental disorders | Euphoria, depression, psychotic disorder caused by corticosteroids, insomnia, mood changes, personality changes, mania |
| Disorders of the nervous system | Epidural lipomatosis (fat deposition around the spinal cord), increased pressure inside the skull in children, more often when taking the drug. Worsening of epilepsy |
| Visual impairment | Cataract, increased eye pressure, glaucoma, papillary edema, posterior subcapsular cataract, corneal constriction, exacerbation of eye infections, central serous chorioretinopathy, blurred vision |
| Heart disorders | Worsening of congestive heart failure, a disorder of the myocardium, arrhythmias |
| Gastrointestinal disorders | Feeling of heaviness after eating, digestive ulcer, inflammation of the pancreas, candida fungal infection |
| Diseases of the skin and subcutaneous tissue | Violations of routine, leave the skin, Sinai, hair increase, Restore, pre, occurs, there are, centuries In the Auberge on the skin area, after 30% of the body surface (played by Nicholas), the response to this API is with and return to its centuries in the skin, especially around the mouth, nose, eyes and other organs (Stephen-Johnson syndrome). Redness and itching |
| Diseases of the musculoskeletal system and connective tissue | Osteoporosis, bone fractures, muscle disorders, bone death, tendon rupture and inflammation |
| Diseases of the kidneys and urination | Need to urinate at night (nocturia), uric stone (stone) hydroelectrolytic changes: fluid and salt retention |
| Metabolic and nutritional disorders | Weight gain, disorders in the management of diabetes, increased appetite |
| Vascular disorders | Thromboembolism, hypertension |
| General disorders and changes in the injection site | After intravenous administration, tingling may appear in some areas of the body, which usually disappears within a few minutes |
| Disorders of the reproductive system | Menstrual irregularities, including the lack of them |
Special caution in patients with renal or heart failure due to possible fluid retention and in patients with hepatic insufficiency due to increased levels of corticosteroids in the blood. These patients should be closely monitored by their doctor.
Symptoms and signs of suppression
Rapid removal of the corticoid after prolonged treatment can lead to "withdrawal symptoms", including fever, joint and muscle pain, nasal congestion, conjunctivitis, lumps on the skin that can be painful and/or cause itching, and weight loss.
The message on the adverse consequences of
If you experience any side effects, contact your doctor, pharmacist, or nurse, even if these are possible side effects that are not listed in this brochure. You can also communicate directly with them through the Spanish pharmacovigilance system of medicines used by humans: www.notificaRAM.es.
None known.
HOW TO TAKE ACTICITY
Your doctor will determine the injection site, the amount of medication, and the number of injections you need to make depending on the disease to be treated and its severity. Your doctor will you will administer the lowest dose for as short a time as possible to relieve the symptoms.
The recommended dose is as follows:
Adults
Generally, we recommend two goals of 100 to 500 mg (1 to 5 ml), could be given in injections for 1-10 minutes (for a dose of 500 mg or higher). This two-can with another bear interval of 2, 4 or 6 hours, depending on the disease, Policy and direct, and patient response. Alternatively, this drug can be administered as an intravenous perfusion. The clinical effect is observed within two to four hours and persists for up to eight hours after intravenous injection. The same dose can be administered by intramuscular injection, but the response is likely to be less rapid, especially in shock They should not exceed 6 g / day.
Use in children
Although two-can be a notepad for people and children, it depends more on the severity of the condition and the patient's reaction than on age or body weight, but it should be at least 25 mg per day.
Elderly patients
Long-term use of corticosteroids in these patients is associated with an increased risk of diabetes, hypertension, congestive heart failure, osteoporosis, and depression.
Careful clinical monitoring is necessary to avoid life-threatening reactions.
Impaired Renal Function
Dose adjustment is not required in patients with renal insufficiency.
Impaired Liver Function
Patients with impaired liver function are more likely to suffer from serious adverse effects as a result of due to decreased protein binding due to hypoalbuminemia and decreased liver hydrocortisone metabolism. Dose adjustments may be required.
The occurrence of undesirable effects can be minimized by using the minimum effective dose for the minimum required period of time. Frequent check-ups of the patient are required to ensure the correct dose intake.
Management form
Rules for correct administration: it is written, will be in Judas, with 5 ml of water for injection and I need a doctor, train slowly, by layer or in Esperanto, but, it is not with Restore but if for.
If you have more Acetocarmine than they should
With long-term treatment, an increase in cortisol levels in the blood may occur, which disappears on some days when drugs are suppressed.
No cases of overdose have been described. In case of overdose or accidental ingestion, consult a doctor and / or hospital.
If you forget to use Acticity
Do not take a double dose to compensate for missed doses.
If you stop treatment with Actocortin
Your doctor will tell you the duration of your treatment with this drug.
Treatment should not be abruptly discontinued. Your doctor will tell you how to do this, as rapid removal of the corticoid after prolonged treatment can lead to serious complications such as acute adrenal insufficiency and hypotension.
"Withdrawal symptoms” may also occur, including fever, myalgia, arthralgia, rhinitis, conjunctivitis, painful / itchy skin nodules, and weight loss.
Not applicable.
9 May 2008.
