Deriva with ms

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT DERIVA C MS (DERIVA C MS)

Composition:

Active substances: adapalene (micronized), clindamycin;

1 g of gel contains 1 mg of micronized adapalene and 10 mg of clindamycin (as clindamycin phosphate);

Excipients: disodium edetate, carbomer 940, propylene glycol, methylparahydroxybenzoate (E 218), poloxamer 407, phenoxyethanol, sodium hydroxide, purified water.

Pharmaceutical form. Gel.

Main physicochemical characteristics: homogeneous gel, white to yellow in color.

Pharmacotherapeutic group.

Topical anti-acne preparations. Topical retinoids for acne treatment. Adapalene combinations. ATC code D10AD53.

Pharmacological properties.

Pharmacodynamics.

Adapalene is a naphthoic acid derivative and a retinoid-like substance that modulates cellular differentiation and keratinization processes, as well as skin inflammatory processes, which constitute the main pathogenetic mechanisms in the development of acne. Adapalene binds to nuclear retinoid receptors and thereby promotes normal differentiation of follicular epithelial cells, resulting in reduced formation of microcomedones and prevention of acne development, helping to maintain intact skin.

In Deriva C MS formulation, adapalene is incorporated into microspheres. Microspheres are spherical microscopic particles made of synthetic polymers. The use of microsphere technology reduces the likelihood of adverse effects and enhances stability, increases bioavailability and therapeutic efficacy of the drug. Microspheres with a diameter of 12 μm possess sponge-like properties, containing the active ingredient and ensuring its controlled release over time after application of Deriva C MS gel to the skin, along with reduced irritation, improved photostability, and enhanced drug penetration into the skin.

Clindamycin phosphate is a semisynthetic antibiotic that acts as an inhibitor of bacterial protein synthesis by binding to the 50S ribosomal subunit and inhibiting the initiation process of peptide chain formation. Clindamycin inhibits all tested strains of Propionibacterium acnes with a minimum inhibitory concentration of 0.4 μg/mL. Cross-resistance between clindamycin and erythromycin has been observed.

Pharmacokinetics.

Not studied.

Clinical characteristics.

Indications.

Local treatment of common acne (acne vulgaris).

Contraindications.

Hypersensitivity to adapalene, clindamycin, or any other components of the drug, as well as to lincomycin. Enteritis, ulcerative colitis, antibiotic-associated colitis (in medical history).

Interaction with other medicinal products and other types of interactions.

Since the drug may cause local irritation in some patients, concomitant use of other potentially irritating topical agents increases the risk of adverse skin effects.

The gel should be used cautiously with medicinal products containing sulfur, resorcinol, or salicylic acid.

If it is necessary to use the drug together with other medicinal products, the gel should be applied once daily at night, and other products should be applied in the morning.

Clindamycin may inhibit neuromuscular transmission; therefore, it should be used with caution in patients receiving other neuromuscular blocking agents due to the possibility of enhanced effects.

Cross-resistance between clindamycin and lincomycin has been demonstrated. Antagonism between clindamycin and erythromycin has been observed.

Special precautions for use.

The product is intended for topical use only.

Contact of the gel with the eyes, lips, nasal alae, eye area, and mucous membranes should be avoided. In case of accidental contact with these areas, they should be thoroughly rinsed with lukewarm water.

Do not apply the gel to areas of skin affected by eczema, sunburn, cuts, or other skin lesions.

Avoid contact with the oral cavity. Hands must be thoroughly washed before applying the gel.

During treatment, excessive exposure to sunlight and ultraviolet light, including tanning lamps, should be avoided due to increased skin sensitivity and a higher risk of developing sunburn erythema.

Concurrent use of the product with cosmetic products that dry the skin (abrasive or medicinal soaps, skin cleansers, products containing excessive amounts of alcohol, astringents, creams or lotions for or after shaving, cleansing agents) may lead to irritation.

If an allergic reaction to any component of the product occurs, treatment should be discontinued and appropriate measures taken.

Clindamycin, when applied topically, is absorbed from the skin surface and in some cases may cause diarrhea, melena, and colitis (including pseudomembranous colitis) in sensitive patients. If these symptoms occur, the product should be discontinued immediately. Symptoms may also appear several weeks after discontinuation of therapy.

Colitis typically presents with severe diarrhea and abdominal cramps. Endoscopic examination may reveal pseudomembranous colitis. For diagnostic purposes, a stool culture for C. difficile or a test for C. difficile toxins should be performed.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition.

For treatment of severe antibiotic-associated colitis, vancomycin may be effective. The usual dose is 125–500 mg orally every 6 hours for 7–10 days. Additional supportive medical measures should be taken if necessary.

Cholestyramine or anion-exchange resins bind vancomycin in vitro. When resins and vancomycin are prescribed concomitantly, it is advisable to separate the administration times of each drug.

Due to the possibility of developing diarrhea, bloody diarrhea, and pseudomembranous colitis, the physician should consider the potential use of alternative, more suitable medicinal products for treatment (see sections "Contraindications", "Side effects").

Oral and parenteral clindamycin have 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 methylparahydroxybenzoate (E 218) present in the formulation may cause allergic reactions (possibly delayed).

The safety and efficacy of the medicinal product 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 systemically acting clindamycin products. Therefore, monitoring of renal function should be considered in patients receiving prolonged therapy who already have impaired renal function or are taking concomitant nephrotoxic drugs (see section "Side effects").

Use during pregnancy or breastfeeding.

Due to limited available data and the potential for very minimal penetration of 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.

Use of the product during breastfeeding is contraindicated due to the possibility of serious adverse reactions in newborns.

Ability to influence reaction speed when driving or operating machinery.

Adapalene does not affect the ability to drive or operate machinery. The effect of clindamycin on the ability to drive or operate machinery has not been evaluated. However, it is unlikely that the fixed combination of adapalene and clindamycin will have a significant effect on reaction speed when driving or operating machinery.

Method of Administration and Dosage

For use in adults and children aged 12 years and older.

Apply a thin layer of gel once daily to clean, dry skin at the sites of eruptions, preferably at night.

During the first weeks of treatment, an initial worsening of acne may occur due to the active ingredient's effect on previously invisible lesions. In such cases, treatment should not be discontinued. The duration of treatment is determined by the physician.

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 topical use only. Overapplication of the gel may cause redness and peeling of the skin.

Excessive topical application of clindamycin may lead to systemic effects.

In case of accidental ingestion, symptoms such as abdominal pain, nausea, vomiting, and diarrhea may occur.

Treatment is symptomatic.

Side effects

In isolated cases, when applying the gel in excessive amounts, reactions typical of irritant dermatitis have been observed. In such cases, the use of a moisturizer is recommended.

Redness, peeling, dryness, itching, and burning of the skin at the application site immediately after application, which subsequently resolve. Allergic reactions, photosensitivity reactions, acne, stinging sensation, gram-negative folliculitis, gastrointestinal disorders, abdominal pain, urticaria, increased skin oiliness, contact dermatitis, skin pain, skin swelling, eyelid erythema, eyelid itching, eyelid swelling, sensation of discomfort.

Although only a small amount of clindamycin is absorbed through the skin, there have been very rare reports of pseudomembranous colitis associated with the use of topical clindamycin preparations. Therefore, there is a theoretical risk of developing pseudomembranous colitis due to clindamycin use.

The following adverse reactions have been reported with oral or parenteral administration of clindamycin:

Infections and infestations: Clostridium difficile–associated colitis.

Hypersensitivity reactions: maculopapular rashes and urticaria. Generalized skin rashes of mild to moderate severity have been most frequently reported. Cases of acute generalized exanthematous pustulosis, erythema multiforme, some resembling Stevens–Johnson syndrome, associated with clindamycin use have been reported. There have also been several reports of anaphylactoid reactions. If a hypersensitivity reaction occurs, the drug should be discontinued immediately.

Musculoskeletal disorders: polyarthritis.

Renal and urinary disorders: acute kidney injury.

Immune system disorders: drug reaction with eosinophilia and systemic symptoms (DRESS syndrome).

Shelf life

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.

Supply category

Over-the-counter (without prescription).

Manufacturer

Glenmark Pharmaceuticals Ltd.

Manufacturer's address

Plot No E-37/39, M.I.D.C., Industrial Estate, Satpur, Nasik – 422 007, India.