Generic drug of the Therapeutic class: Dermatology
active ingredients: salicylic acid, betamethasone , dipropionate
what is Diprosalic ?
- Corticosteroid-sensitive dermatoses (skin diseases) with a keratotic component (with thickening of the skin or scaly skin.
- Dermatoses located more particularly on the scalp, in the hairy regions and the folds.
what is diprosalic ointment used for and indication?
Corticosteroid-sensitive dermatoses with a keratotic or squamous component:
- Preferred indications where local corticosteroid therapy is considered the best treatment:
- Lichenification.
- Indications where corticosteroid therapy is one of the usual treatments:
- ·psoriasis,
- ·lichen,
- Seborrheic dermatitis except the face.
PRESENTATION (S) AVAILABLE FOR DIPROSALIC
3 presentations are available for this drug:
- 1 polyethylene bottle (s) of 15 g
- 1 polyethylene bottle (s) of 30 g
- 1 polyethylene bottle (s) of 100 g
| FEATURE | DESCRIPTION |
| Pharmaceutical class | corticosteroids, dermatological preparations |
| Active substance (s) | per 100 g: salicylic acid (2 g), betamethasone dipropionate (0.064 g) |
| General medicine | no |
| Pharmaceutical form | lotion |
| Route (s) of administration | cutaneous |
| Social security reimbursement rate | 15% |
| Laboratory (s) | MSD FRANCE |
| Conditions of issue | available by simple prescription |
Diprosalic Dosage
- Applications will be limited to 2 per day for one to two weeks; in maintenance treatment, a single daily application may be sufficient. An increase in the number of applications could worsen the side effects without improving the therapeutic effects.
- The treatment of large surfaces requires special monitoring (number of tubes used).
- The treatment will be stopped gradually by spacing out the applications or by using a less strong or less dosed corticosteroid or alternating with a base without a dermocorticoid.
Diprosalic Contraindications
Never use DIPROSALIC, lotion in the following cases:
- allergy (hypersensitivity) to the active substance or to any of the ingredients of DIPROSALIC lotion,
- ulcerated lesions,
- acne,
- rosacea (rosacea),
- infectious skin diseases of viral (herpes, shingles, chickenpox), bacterial (example: impetigo, etc.), mycotic (due to microscopic fungi) or parasitic origin,
- in infants,
- DIPROSALIC is not intended for ophthalmic use.
IF IN DOUBT, YOU MUST ASK FOR THE ADVICE OF YOUR DOCTOR OR YOUR PHARMACIST.
How To use Diprosalic ?
- Dermal.
- It is advisable to apply the medicine in spaced areas, then to spread it with a plastic glove. In scalp conditions, the lotion will be applied line by line, well beyond the surface to be treated. In case of manual use, wash hands after application.
Duration of treatment
- Usually the treatment will be short. The treatment will be stopped gradually by spacing out the applications and / or by the use of a less strong or less dosed corticosteroid.
- Prolonged use, use on the face or in children should be subject to strict medical supervision.
how does Diprosalic work?
- Pharmacotherapeutic group: Corticosteroids with strong activity, other combinations, ATC code: D07XC01
- DIPROSALIC is a strong potency dermocorticosteroid (class II) combined with salicylic acid.
- The topical corticosteroid is active on the inflammatory process and the pruritic effect associated with it.
- It has vasoconstrictive (anti-perspirant) properties and inhibits cell multiplication and synthesis processes in the dermis and epidermis.
- Keratolytic action of salicylic acid.
How To Store Diprosalic ?
Ointment
The duration of the conversation :
- 36 months.
Lotion
The duration of the conversation :
- 18 months.
Store at a temperature not exceeding 25 ° C.
After first opening:
- 6 weeks.
Diprosalic Side Effects
Like all medicines, DIPROSALIC, lotion can cause side effects, although not everybody gets them.
- appearance or worsening of rosacea (see “Never use DIPROSALIC, lotion in the following cases”),
- delayed healing of wounds, bedsores (rubbing lesions of the skin), leg ulcers (black scab surrounded by a red inflammatory area),
- possible effects due to the passage of part of the active ingredients in the blood (see “Special warnings”)
- cases of hypertrichosis (abnormal development of the hair system), depigmentation, secondary infections, in particular in the event of treatment under an occlusive dressing or in the folds, have been reported.
In case of prolonged use, on large surfaces, there is a risk of thinning and fragility of the skin, dilation of small blood vessels, stretch marks, acne breakout, redness and irritation around the mouth.
If you notice any side effects not listed in this leaflet, or if any side effects get serious, please tell your doctor or pharmacist.
Keep out of the reach and sight of children.
Diprosalic Interactions
Use of other drugs:
- Based on local use of this product: At recommended doses, betamethasone for topical use is not likely to cause medically significant drug interactions.
- If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.
Effects on ability to Drive and use machines
- Not applicable.
- Not applicable.
- Not applicable.
- Not applicable.
Warnings and Precautions
Take special care with DIPROSALIC, lotion:
Special warnings
- Do not apply on mucous membranes or in the eyes.
- It is necessary to avoid the applications on large surfaces, under a dressing, under a diaper or in the folds, in particular in the children, because of possible passage of part of the active principles in the blood.
Precautions for use
This medication should be used in accordance with the doctor’s advice:
- exact location of applications,
- treatment in children under 12 must be subject to strict medical supervision,
- do not apply to the face, except when prescribed by your doctor.
The following recommendations should be followed:
- avoid prolonged application on the face, in the folds,
- any local irritation or infection should be reported to your doctor,
- if an intolerance reaction appears, the treatment should be stopped,
- if use under occlusion is necessary, it should be monitored due to the risk of superinfection.
IF IN DOUBT, DO NOT HESITATE TO ASK FOR THE OPINION OF YOUR DOCTOR OR YOUR PHARMACIST.
PREGNANCY & BREAST-FEEDING & FERTILITY
Pregnancy
- Clinical data from a large number of pregnancies exposed by the systemic route to corticosteroids have not shown an increase in the overall rate of malformations, although studies in animals by the systemic route have shown a teratogenic effect.
- In humans, no particular malformative effects have been reported with salicylic acid. Fetal toxicity reported with NSAIDs is not expected with Diprosalic given the very low systemic concentrations under normal conditions of use.
- The use of Diprosalic during pregnancy can be envisaged in strict compliance with the conditions of use: application to a skin surface <10% of the body surface, treatment duration limited to 4 weeks.
- The mother may experience a prolonged bleeding time as well as the newborn if treated until delivery.
Feeding with milk
- Corticosteroids and salicylic acid pass into the milk. Due to topical use, Diprosalic can be administered during breast-feeding.
- Do not apply on the breasts.
What happens if I overdose from Diprosalic ?
Symptoms
- Excessive or prolonged use of topical corticosteroids may lead to inhibition of the hypothalamic-pituitary axis resulting in secondary adrenal insufficiency and be the cause of manifestations of hypercorticism, including Cushing’s disease.
- Excessive or prolonged use of topical preparations containing salicylic acid may cause symptoms of salicylic intoxication.
Treatment
- Appropriate symptomatic treatment is indicated. Symptoms of acute hypercorticism are usually reversible. Correct electrolyte disturbances if necessary.
- In the event of chronic toxicity, a gradual stopping of corticosteroids is advised. Treatment of salicylate poisoning is symptomatic.
- Salicylic acid must be eliminated quickly. Orally administer sodium bicarbonate solution to alkalinize the urine and increase diuresis.
What should I do if I miss a dose?
Do not apply a double dose to make up for the dose you forgot to take.
What happens if you stop taking Diprosalic ?
- Not applicable.
- Not applicable.
- Not applicable.
- Not applicable.
If you have further questions on the use of this medicine, ask your doctor or pharmacist for more information.
What is Forms and Composition ?
SHAPES and PRESENTATIONS |
- Ointment: Tube of 30 g.
- Lotion: Bottle of 30 g.
COMPOSITION
| Ointment: | p tube | ||
| Betamethasone | 15 mg | ||
| (as micronized betamethasone dipropionate: 19.2 mg / tube) | |||
| Salicylic acid | 900 mg | ||
- Excipients: thick petrolatum oil, white petrolatum.
| Lotion: | p bottle |
| Betamethasone | 15 mg |
| (as betamethasone dipropionate: 19.2 mg / tube) | |
| Salicylic acid | 600 mg |
- Excipients: hydroxypropylmethylcellulose, sodium hydroxide, sodium edetate, isopropyl alcohol, purified water.
NOT’s
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general information:
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Additional information:
- General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.
Special warnings:
- For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.
Side effects:
- It treats possible side effects and drug interactions that require attention and its effect on continuous use.
- The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.
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