Instructions for the medical use of the medicinal product Deriva C MS

active substances:

adapalene (micronized), clindamycin;
1 g of gel contains adapalene (micronized) 1 mg, clindamycin (in the form of clindamycin phosphate) 10 mg;

excipients:

disodium edetate, carbomer 940, propylene glycol, methyl parahydroxybenzoate (E 218), poloxamer 407, phenoxyethanol, sodium hydroxide, purified water.

Medical form:

Gel.

Main physical and chemical properties:

homogeneous gel from white to yellow color.

Pharmacotherapeutic group:

Preparations for local treatment of acne. Retinoids for topical treatment of acne. Adapalene, combinations. PBX code D10А D53.

Pharmacological properties:

Pharmacodynamics

Adapalene is a derivative of naphthoic acid, a retinoid-like substance that modulates the processes of cell differentiation and keratinization, as well as inflammatory processes of the skin, which are the main pathogenetic links in the development of acne. Adapalene binds to the retinoid receptors of the cell nucleus and, thus, contributes to the normal differentiation of the epithelial cells of the follicles, which leads to a decrease in the formation of microcomedones and prevents the development of acne, helps to preserve intact skin.

Adapalene in the Deriva C MS drug is enclosed in microspheres. Microspheres are rounded microscopic particles made of synthetic polymers. The use of microsphere technology reduces the likelihood of side effects and increases the stability, bioavailability and effectiveness of the drug. Microspheres with a diameter of 12 μm have the properties of microsponges containing the active substance and ensure its time-controlled release after applying the Deriva C MS gel to the skin, in combination with reduced irritation, improved photostability and increased penetration of the drug into the skin.

Clindamycin phosphate is a semi-synthetic antibiotic that acts as an inhibitor of bacterial protein synthesis due to binding to the 50S subunit of ribosomes and inhibiting the process of initiation of peptide chain formation. Clindamycin inhibits all tested cultures of P ropionibacterium aspe s with a minimum inhibitory concentration of 0.4 μg/ml. Cross-resistance between clindamycin and erythromycin was detected.

Pharmacokinetics

Not investigated.

Clinical characteristics:

Testimony.

Local treatment of common acne (acne vulgaris).

Contraindications.

Hypersensitivity to adapalene, clindamycin or other components of the drug, as well as lincomycin. Enteritis, ulcerative colitis, colitis associated with antibiotics (in history).
Interaction with other medicinal products and other types of interactions.
Since the drug may have a local irritating effect in some patients, the simultaneous use of other potentially irritating local drugs increases the risk of unwanted effects on the skin.
The gel should be used with caution with drugs containing sulfur, resorcinol, or salicylic acid.

If it is necessary to use the drug together with other drugs, use the gel once a day at night, and use other drugs in the morning.
Clindamycin can block neuromuscular transmission, so it should be used with caution in patients treated with other neuromuscular drugs, due to the possibility of enhancing their effect.
Cross-resistance between clindamycin and lincomycin has been demonstrated.Antagonism is observed between clindamycin and erythromycin.

Peculiarities of application.

The drug is intended for local use only.

You should avoid contact of the gel with the eyes, lips, areas of the wings of the nose and the skin around the eyes, as well as mucous membranes. If the gel accidentally gets on these areas, it is necessary to thoroughly wash them with warm water.
Do not apply the gel to eczematous skin lesions, sunburns, cuts or other skin lesions.
Avoid getting into the mouth. Before applying the gel, you must wash your hands thoroughly.
During treatment, excessive exposure to sunlight and ultraviolet light, including lamps, should be avoided due to increased skin sensitivity and increased risk of solar erythema.

Using the drug together with cosmetic products that dry the skin (abrasive or medicated soaps, skin cleansers, products containing excessive amounts of alcohol, astringents, creams or lotions for or after shaving, detergents) can lead to irritation.
In case of an allergic reaction to any of the components of the drug, the therapy should be stopped and appropriate measures should be taken.

Clindamycin when applied topically is absorbed from the surface of the skin and in some cases can cause diarrhea, melena, and colitis (including pseudomembranous colitis) in sensitive patients. If these phenomena occur, the use of the drug should be stopped immediately. Symptoms may also persist for several weeks after stopping therapy.
Colitis is usually manifested by severe diarrhea and abdominal cramps. Endoscopic examination can reveal pseudomembranous colitis. For diagnostic purposes, stool cultures should be cultured for C. difficile or do an analysis for toxinsC. difficile
Anticonvulsants such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition.

In the treatment of severe colitis associated with antibiotics, the use of vancomycin can be effective. The usual dose is 125 to 500 mg orally every 6 hours for 7 to 10 days. If necessary, additional measures of supportive medical care should be taken.
Cholestyramine or serostapol resins bind vancomycin in vitro. With the simultaneous appointment of resins and vancomycin, it is advisable to separate the time of taking each drug. Given the possibility of diarrhea, bloody diarrhea and pseudomembranous colitis, the doctor should consider the possibility of using other drugs that are more suitable for treatment (see sections “Contraindications”, “Adverse reactions”).
Oral and parenteral clindamycin has been associated with severe colitis, which may be fatal.
Clindamycin for topical use should be used with caution in patients with atopic diseases.
Propylene glycol and methyl parahydroxybenzoate (E 218) present in the medicinal product can cause allergic reactions (perhaps delayed).
The safety and efficacy of the drug in patients aged 65 years and older have not been established.
Use during pregnancy or breastfeeding.
Due to the limited available data and due to the possibility of very weak penetration of active substances through the skin, the drug should not be used during pregnancy. In case of unexpected pregnancy, treatment should be stopped.
Use of the drug during breastfeeding is contraindicated due to the possibility of developing serious adverse reactions in newborns.
The ability to influence the speed of reaction when driving vehicles or other mechanisms.
Adapalene does not affect the ability to drive vehicles or other mechanisms. The effect of clindamycin on the ability to drive vehicles or other mechanisms has not been evaluated. However, it is unlikely that the use of a fixed combination of adapalene and clindamycin will have a significant effect on the speed of reaction when driving a motor vehicle or other mechanisms.

How to use and dosage.

Apply to adults and children over 12 years of age.

Apply the gel in a thin layer on clean, dry skin in places of rashes once a day, at night.
During the first weeks of treatment, exacerbation of the acne process is possible due to the effect of the active substance on lesions that were not visible before. In this case, treatment should not be stopped. The course of treatment is determined by the doctor.

Children.

The safety and efficacy of the drug in children under 12 years of age have not been established, therefore the drug should not be used in children under 12 years of age.

Overdose.

Symptoms.

Adapalene is intended for dermal use only. When applying an excessive amount of gel, redness and peeling of the skin is possible.
With local application of clindamycin in excessive amounts, the development of systemic effects is possible.
Abdominal pain, nausea, vomiting and diarrhea are possible in case of accidental ingestion of the medicinal product.

Treatment is symptomatic.

Side reactions.

In some cases, when applying the gel in excessive amounts, reactions typical of irritant dermatitis were observed. In such cases, it is recommended to use a moisturizer.
Redness, peeling, dryness, itching and burning of the skin at the place of application of the gel immediately after its application, which disappears later. Allergic reactions, photosensitivity reactions, acne, tingling sensation, gram-negative folliculitis, gastrointestinal disorders, abdominal pain, urticaria, increased skin oiliness, contact dermatitis, skin pain, skin swelling, eyelid erythema, eyelid itching, eyelid swelling, a feeling of discomfort.
Although only a small amount of clindamycin is absorbed through the skin, cases of pseudomembranous colitis have been reported very rarely with topical clindamycin preparations. Therefore, there is a theoretical risk of developing pseudomembranous colitis caused by the use of clindamycin.

Expiry date.

2 years.

Storage conditions.

Store at a temperature not higher than 25 °C. Do not freeze.
Keep out of the reach of children.

Packaging.

15 g of gel in a tube, 1 tube in a cardboard box.

Category of release.

Without a prescription.

Producer.

Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.

Location of the manufacturer and its address of the place of activity.

Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422007, India.

Registration.

Registration certificate: UA/14954/01/01;
Order of the Ministry of Health No. 269 dated February 6, 2020;
Validity of the registration certificate: unlimited from 07.11.2018

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