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Indications for use
- acne (acne vulgaris) of mild and moderate severity, especially with a predominance of inflammatory skin lesions.
- hypersensitivity to clindamycin, lincomycin, benzoyl peroxide and / or to any of the components of the drug;
- children's age up to 12 years;
- lactation period;
- Crohn's disease, ulcerative colitis, pseudomembranous colitis, including a history.
During pregnancy, the combination of clindamycin and benzoyl peroxide is prescribed only if the expected benefit to the mother outweighs the potential risk to the fetus.
The simultaneous use of Indoxyl with other local acne treatments should be prescribed with caution because of the possible occurrence of cumulative skin irritation, which can sometimes be severe, especially when using products with peeling or abrasive action.
Indoxyl gel should be used with caution if necessary, simultaneous reception with muscle relaxants of peripheral action.
How to apply: dosage and treatment
The product is intended for topical use only. The gel is applied with a thin layer to the entire affected area 1 time per day after thorough cleansing of the skin with a gentle cleanser and complete drying of the skin.
The gel is poorly absorbed when applied to the skin of an excessive amount of the drug. Wash your hands after applying the gel.
If necessary, after soaking the gel, you can use a moisturizer. If dry skin or flaking occurs, reduce the frequency of application of the gel or temporarily suspend treatment. The effectiveness of Indoxyl with a frequency of use less than 1 time per day has not been studied.
More frequent than the recommended instructions, the application of the gel does not increase the effectiveness of treatment, but may increase the risk of skin irritation. The duration of treatment required to achieve a therapeutic effect ranges from 2 to 5 weeks, but not more than 12 weeks.
The safety and efficacy of the combination of clindamycin and benzoyl peroxide for the treatment of acne lasting more than 12 weeks have not been studied. The expected benefit for the patient should be carefully evaluated when prescribing a treatment lasting more than 12 weeks of continuous use.
The safety and efficacy of Indoxyl have not been studied for children under the age of 12, therefore, in this age group, the use of Indoxyl gel is not recommended.
Special recommendations for elderly patients are not available.
The need for dose adjustment in patients with renal / hepatic insufficiency is absent. Since the absorption of clindamycin and benzoyl peroxide through the skin when applied topically is weak, the effect of renal / hepatic insufficiency on the occurrence of clinically significant systemic effects is unlikely.
The composition of Indoxyl includes two active ingredients - clindamycin and benzoyl peroxide.
Clindamycin is an antibiotic from the group of lincosamides; it has a bacteriostatic action against gram-positive aerobic microorganisms and a wide range of anaerobic bacteria. Clindamycin acts mainly mainly bacteriostatic, but high concentrations can have a slow bactericidal effect on sensitive strains. Clindamycin is active in vitro against propionobacteria (Propionibacterium acnes), which cause acne.
Benzoyl peroxide is a highly lipophilic oxidizing agent with a bactericidal and weak keratolytic effect; has a non-specific bactericidal mechanism of action, forming reactive oxygen species that prevent the appearance of clindamycin-resistant microorganisms. The effectiveness of benzoyl peroxide in the treatment of acne is mainly due to its bactericidal activity, especially against P. acnes.
Treatment of acne with antibiotics such as clindamycin and erythromycin for local and oral use in the form of monotherapy was associated with the development of antimicrobial resistance in P. acnes, as well as in saprophytic flora (for example, Staphylococcus aureus. Streptococcus pyogenes). Prolonged use of clindamycin may cause the development of resistance in these microorganisms.
Benzoyl peroxide did not cause resistance in P. acnes. The inclusion of benzoyl peroxide in the combination preparation containing 1% clindamycin and 5% benzoyl peroxide reduced the number of clindamycin-resistant organisms of P. acnes.
The level of acquired resistance for specific organisms may vary depending on geographic location and time. If possible, local resistance data should be considered, especially when treating serious infections.
Cross-resistance between clindamycin and lincomycin has been established.
The adverse events presented below are listed in accordance with the damage of organs and organ systems and the frequency of occurrence. The frequency of occurrence is determined as follows: very often (≥ 1/10), often (≥ 1/100 and <1/10), infrequently (≥ 1/1000 and <1/100), rarely (≥ 1/10 000 and < 1/1 000), very rarely (<1/10 000, including individual cases). Frequency categories were formed on the basis of clinical trials of the drug and post-registration observation.
Immune system disorders: seldom: allergic reactions, including hypersensitivity and anaphylactic reactions.
Nervous system disorders: infrequent: paresthesia in the application area.
Gastrointestinal disorders: seldom: colitis (including pseudomembranous colitis), hemorrhagic diarrhea, diarrhea, abdominal pain.
Violations of the skin and subcutaneous tissues: very often: burning sensation, erythema, desquamation, dryness of the skin in the area of application of gel Indoxyl (these phenomena are mostly mild); often: photosensitization in the application area; infrequently: itching, erythematous rash, dermatitis, aggravation of acne in the area of application of the drug; rarely: urticaria in the area of application of the drug.
General disorders and disorders in the area of application: rarely: other reactions in the area of application, including bleaching of hair.
In studies with clindamycin topical use as monotherapy, headache and pain were also often noted in the application area.
The application of excessive amounts of Indoxyl may cause severe irritation. In such cases, stop using the drug until the disappearance of signs of skin irritation.
When applied topically, benzoyl peroxide is mainly absorbed in an amount insufficient to cause systemic effects.
When topically applied with an excessive amount of clindamycin, it can be absorbed in an amount that can cause systemic effects.
If Indoxyl is ingested accidentally, adverse reactions from the gastrointestinal tract may occur, similar to those occurring during parenteral use of clindamycin.
Apply appropriate symptomatic treatment to alleviate irritation caused by applying an excessive amount of Indoxyl gel. Treatment in case of accidental ingestion of the drug should be carried out on the basis of the clinical situation, or in accordance with the recommendations of the local National Toxicological Center, if any.
Gel Indoxyl should be avoided in the mouth, eyes, on the surface of the lips and other mucous membranes, as well as on irritated damaged areas of the skin. If the gel gets accidentally on the indicated areas, rinse them well with water.
During the first week of treatment, peeling and redness of the skin increases in most patients. Depending on the severity of these side effects, patients can use moisturizers, temporarily reduce the frequency of use of the drug or temporarily stop using.
The efficacy of Indoxyl gel when used with a frequency of less than once a day has not been studied.
If severe irritation of the skin occurs (for example, severe erythema, severe dryness of the skin and itching, strong tingling / burning sensation), use of the drug should be discontinued.
Since benzoyl peroxide may cause increased sensitivity to sunlight, prolonged exposure to sunlight should be avoided, and you should not visit the tanning bed during the period of Indoxyl use. In the event that sun exposure cannot be avoided, sunscreen cosmetics for the skin and clothing that protects from the sun should be used. If the patient has sunburn, discontinue use of the drug to cure the burns.
The drug is able to discolor hair and colored fabric. Avoid contact with the hair, cloth, furniture or carpet.
Cases of pseudomembranous colitis have been reported with virtually all antibacterial agents, including clindamycin. The degree of their severity varies in severity from mild to life-threatening. Pseudomembranous colitis may occur several weeks after cessation of therapy. Although pseudomembranous colitis is unlikely to occur when Indoxyl is topically applied, if you experience prolonged or severe diarrhea or if the patient has abdominal cramps, treatment should be stopped immediately and consult a doctor because the symptoms may indicate the presence of antibiotic-induced colitis.
Benzoyl peroxide reduces the likelihood of the emergence of clindamycin-resistant microorganisms. However, in patients who have recently used clindamycin or erythromycin for parenteral or topical use, the presence of propionobacteria and saprophytic flora with previously acquired antimicrobial resistance is more likely.
The presence of cross-resistance between clindamycin and lincomycin has been established.
Clindamycin resistance is often associated with erythromycin resistance.
The negative impact of the drug on the ability to drive vehicles or mechanisms is unlikely.
Since clindamycin shows antagonism with erythromycin, Indoxyl should not be used in combination with drugs containing erythromycin.
Clindamycin has been found to impair neuromuscular transmission and, therefore, may enhance the effect of muscle relaxants of the peripheral action.
It is necessary to avoid the combined use of Indoxyl with tretinoin, isotretinoin and tazaroten, because benzoyl peroxide can reduce their effectiveness and increase skin irritation. If necessary, the combined treatment of drugs should be used at different times of the day (for example, one drug in the morning and another drug in the evening).
The use of topical preparations containing benzoyl peroxide, along with topical preparations containing sulfonamide, may cause a temporary change in the color of the skin and hair at the site of application of the preparation (staining in yellow or orange).
Terms of sell
You don't need a prescription to buy Indoxyl.