Presentation and Status in Health Basket
Presentation | Basket | Yarpa | Pharmasoft |
---|---|---|---|
Cream 15 g |
7968 | 8243 |
Dosage
Posology: Hydroagisten cream should be thinly and evenly applied to the
affected area twice daily and rubbed in gently. Treatment should be for a
maximum of 7 days.
A total daily dose of 10 mg cream per kg body weight should not be exceeded. For an adult weighing 50 kg the maximum daily dose is 500 mg cream which equals approximately 2 cm of cream to be divided into 2 applications per day.
There is no separate dosage schedule for the elderly or the young. However, long-term therapy to extensive areas of skin should be avoided particularly in infants and children.
Treatment duration: If the acute symptoms have subsided after about 7 days but treatment is still required, this may be carried out with the corticoid-free preparation intended for this purpose.
Indications
Skin inflammation involving fungal infection.
Contra-Indications
– Hypersensitivity to the active substances or to any of the excipients.
– Use on broken skin.
– Diseases affecting the skin (e.g. acne, rosacea, perioral dermatitis, lues, tuberculosis, etc.).
– Any untreated bacterial skin diseases.
– Viral skin diseases (e.g. herpes simplex, chicken pox, shingles etc.).
– Dermal vaccination reactions.
Special Precautions
Because of its corticosteroid content, hydroagisten cream should not be
applied:
• To large areas (more than 5 – 10% of the body surface).
• In long term continuous therapy.
• Under occlusive dressings (such as nappies and bandages).
These restrictions apply particularly in:
• Infants, where the nappy can act as an occlusive dressing and increase
systemic absorption.
• Infants and children, where increased systemic absorption may occur
Resulting in adrenocortical suppression.
• This product contains cetostearyl alcohol, which may cause local skin
reactions (e.g. contact dermatitis).
Side Effects
As the listed undesirable effects are based on spontaneous reports, assigning
accurate frequency of occurrence for each is not possible.
Immune system disorders: allergic reaction (syncope, hypotension, dyspnea, urticaria).
Signs of an allergic reaction may also include: rash, swallowing or breathing problems, swelling of your lips, face, throat or tongue, weakness, feeling dizzy or faint, nausea.
Skin and subcutaneous tissue disorders: blisters, discomfort/pain, oedema, erythema, irritation, peeling/exfoliation, pruritus, rash, stinging/burning.
After use on large areas (more than 10% of the body surface) and/or after long-term use (longer than 2-4 weeks) or use under occlusive dressings, local skin alterations such as skin atrophy, teleangiectasias, hypertrichosis, striations, hypopigmentation, secondary infection and acneiform symptoms may occur.
Drug interactions
Laboratory tests have suggested that, when used together, this product
may cause damage to latex contraceptives. Consequently, the effectiveness of such contraceptives may be reduced. To date this has not been reflected in clinical practice.
Pregnancy and Lactation
Pregnancy: There is a limited amount of data from the use of clotrimazole or
hydrocortisone in pregnant women. Animal studies with clotrimazole and
corticosteroids have shown reproductive toxicity. At the low systemic exposures of clotrimazole and hydrocortisone following topical treatment, harmful effects with respect to reproductive toxicity are not predicted.
Hydroagisten cream can be used during pregnancy, but only under the supervision of a physician. As a precautionary measure it is preferable to refrain from applying the cream for long periods during pregnancy.
Lactation: Available pharmacodynamic/toxicological data in animals have shown excretion of clotrimazole/metabolites in milk after intravenous administration.
No data on hydrocortisone is available, but topically applied hydrocortisone is unlikely to cause systematic effects due to the low percutaneous penetration.
However, cutaneous absorption may be increased under certain circumstances, such as with use of occlusive dressing, the degree of skin damage, and the size of the treated area.
A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue. Hydrocortisone therapy taking into account the benefit of breast feeding for the child and the benefit of therapy for the woman.
Overdose
No reports are available on cases of intoxication with Hydroagisten cream.
No risk of acute intoxication is seen as it is unlikely to occur following a single dermal application of an overdose (application over a large area under conditions favorable to absorption) or inadvertent oral ingestion. There is no specific antidote.
However, in the event of accidental oral ingestion, gastric lavage is rarely required and should be considered only if a life-threatening amount of Clotrimazole has been ingested within the preceding hour or if clinical symptoms of overdose become apparent (e.g. dizziness, nausea or vomiting).
Gastric lavage should be carried out only if the airway can be protected adequately.