Instructions for Deriva C MS gel tube 15 g
Composition
active ingredients: adapalene (micronized), clindamycin;
1 g of gel contains adapalene (micronized) 1 mg, clindamycin (as clindamycin phosphate) 10 mg;
Excipients: disodium edetate, carbomer 940, propylene glycol, methyl parahydroxybenzoate (E 218), poloxamer 407, phenoxyethanol, sodium hydroxide, purified water.
Dosage form
Gel.
Main physicochemical properties: homogeneous gel from white to yellow.
Pharmacotherapeutic group
Preparations for topical acne treatment. Retinoids for topical acne treatment. Adapalene, combinations. ATX code D10A D53.
Pharmacological properties
Pharmacodynamics.
Adapalene is a naphthoic acid derivative, a retinoid-like substance that modulates the processes of cellular differentiation and keratinization, as well as skin inflammation, which are the main pathogenetic links in the development of acne. Adapalene binds to retinoid receptors in the cell nucleus and, thus, promotes normal differentiation of follicular epithelial cells, which leads to a decrease in the formation of microcomedones and prevents the development of acne, helps to preserve intact skin.
Adapalene in Deriva C MS 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 stability, increases bioavailability and effectiveness of the drug. Microspheres with a diameter of 12 microns have the properties of microsponges that contain the active substance and provide its time-controlled release after applying Deriva C MS gel to the skin, together with reduced irritation, improved photostability and increased penetration of the drug into the skin.
Clindamycin phosphate is a semisynthetic antibiotic that acts as an inhibitor of bacterial protein synthesis by binding to the 50S subunit of the ribosome and inhibiting the initiation of peptide chain formation. Clindamycin inhibits all cultures of Propionibacterium aspes tested with a minimum inhibitory concentration of 0.4 μg/ml. Cross-resistance between clindamycin and erythromycin has been demonstrated.
Pharmacokinetics.
Not studied.
Indication
Topical treatment of common acne (acne vulgaris).
Contraindication
Hypersensitivity to adapalene, clindamycin or other components of the drug, as well as lincomycin. Enteritis, ulcerative colitis, antibiotic-associated colitis (history).
Interaction with other medicinal products and other types of interactions
Since the drug may have a local irritant effect in some patients, the simultaneous use of other potentially irritating local drugs increases the risk of undesirable effects on the skin.
The gel should be used with caution with preparations containing sulfur, resorcinol, or salicylic acid.
If it is necessary to use the drug together with other medications, apply the gel once a day at night, and apply other medications 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 has been demonstrated between clindamycin and lincomycin. Antagonism has been observed between clindamycin and erythromycin.
Application features
The drug is intended for topical use only.
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 rinse them thoroughly with warm water.
Do not apply the gel to eczematous skin lesions, sunburns, cuts or other skin lesions.
Avoid getting into the mouth. Wash hands thoroughly before applying the gel.
During treatment, excessive exposure to sunlight and ultraviolet light, including lamps, should be avoided due to increased skin sensitivity and an increased risk of solar erythema.
Using the drug together with cosmetics 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) may lead to irritation.
In the event of an allergic reaction to any of the components of the drug, therapy should be discontinued and appropriate measures should be taken.
Clindamycin, when applied topically, is absorbed from the skin surface and in some cases in susceptible patients may cause diarrhea, melena, and colitis (including pseudomembranous colitis). If these phenomena occur, the drug should be discontinued immediately. Symptoms may also occur for several weeks after discontinuation of therapy.
Antiperistaltic agents, such as opiates and diphenoxylate with atropine, may prolong and/or worsen the condition.
Vancomycin may be effective in the treatment of severe antibiotic-associated colitis. The usual dose is 125–500 mg orally every 6 hours for 7–10 days. Additional supportive care should be provided as needed.
Cholestyramine or serostatus resins bind vancomycin in vitro. When resins and vancomycin are administered concomitantly, it is advisable to separate the time of administration of each drug.
Given the possibility of diarrhea, bloody diarrhea, and pseudomembranous colitis, the physician should consider using other medications that are more suitable for treatment (see sections "Contraindications", "Adverse Reactions").
Clindamycin administered orally and parenterally has been associated with severe colitis, which can be fatal.
Use clindamycin topically with caution in patients with atopic diseases.
Propylene glycol and methyl parahydroxybenzoate (E 218) present in the medicinal product may cause allergic reactions (possibly delayed).
The safety and efficacy of the drug in patients aged 65 years and older have not been established.
Acute kidney injury.
Rare cases of acute kidney injury, including acute renal failure, have been reported with systemic clindamycin. Therefore, monitoring of renal function should be considered in patients receiving long-term therapy with pre-existing renal impairment or concomitant nephrotoxic drugs (see Adverse Reactions).
Use during pregnancy or breastfeeding
Due to the limited data available and the possibility of very low penetration of the active substances through the skin, the medicinal product should not be used during pregnancy. In the event of an unexpected pregnancy, treatment should be discontinued.
The use of the drug during breastfeeding is contraindicated due to the possibility of serious adverse reactions in newborns.
Ability to influence reaction speed when driving vehicles or other mechanisms
Adapalene does not affect the ability to drive or use machines. The effect of clindamycin on the ability to drive or use machines 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 or using machines.
Method of administration and doses
Use for adults and children over 12 years of age.
Apply the gel in a thin layer to clean, dry skin in the areas of rashes once a day, at night.
During the first weeks of treatment, the acne process may worsen due to the effect of the active substance on previously invisible lesions. In this case, treatment should not be discontinued. 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 for cutaneous use only. Applying too much gel may cause redness and peeling of the skin.
With topical application of clindamycin in excessive amounts, systemic effects may develop.
In case of accidental ingestion of the medicine, abdominal pain, nausea, vomiting and diarrhea are possible.
Treatment is symptomatic.
Side effects
In some cases, reactions typical of irritant dermatitis have been observed when applying excessive amounts of the gel. In such cases, the use of a moisturizer is recommended.
Redness, peeling, dryness, itching and burning of the skin at the site 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 oiliness of the skin, contact dermatitis, skin pain, skin swelling, eyelid erythema, eyelid itching, eyelid swelling, discomfort.
Although only a small amount of clindamycin is absorbed through the skin, very rare cases of pseudomembranous colitis have been reported with the use of topical clindamycin preparations. Therefore, there is a theoretical risk of pseudomembranous colitis associated with the use of clindamycin.
The following adverse reactions have been reported with oral or parenteral use of clindamycin.
Infections and infestations: Clostridial colitis (caused by Clostridium difficile).
Hypersensitivity reactions: maculopapular rash and urticaria. Generalized skin rashes of mild to moderate severity were most commonly reported. Cases of acute generalized exanthematous pustulosis, erythema multiforme, some resembling Stevens-Johnson syndrome, have been reported in association with clindamycin. A few cases of anaphylactoid reactions have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued.
Renal and urinary disorders: acute kidney injury.
Immune system disorders: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).
Expiration date
2 years.
Storage conditions
Store at a temperature not exceeding 25 ° C. Do not freeze.
Keep out of reach of children.
Packaging
15 g of gel in a tube, 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
Glenmark Pharmaceuticals Ltd. / Glenmark Pharmaceuticals Ltd.
Address
Plot No. E-37/39, MIDC, Industrial Estate, Satpur, Nasik – 422 007, India.
