Indoxil - Instructions For Using The Gel, Price, Reviews, Analogues

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Indoxil

Indoxil: instructions for use and reviews

1. 1. Release form and composition
2. 2. Pharmacological properties
3. 3. Indications for use
4. 4. Contraindications
5. 5. Method of application and dosage
6. 6. Side effects
7. 7. Overdose
8. 8. Special instructions
9. 9. Application during pregnancy and lactation
10. 10. Use in childhood
11. 11. Drug interactions
12. 12. Analogs
13. 13. Terms and conditions of storage
14. 14. Terms of dispensing from pharmacies
15. 15. Reviews
16. 16. Price in pharmacies

Latin name: Indoxyl

ATX code: D10AF51

Active ingredient: clindamycin (Clindamycin) + benzoyl peroxide (Benzoyl peroxide)

Producer: Glaxo Operations UK Ltd. (Great Britain)

Description and photo update: 28.11.2018

Prices in pharmacies: from 519 rubles.

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Indoxil is a combined external drug for the treatment of acne.

Release form and composition

Dosage form - gel for external use: uniform consistency, from yellowish to white (in a cardboard box 1 aluminum tube of 15 or 25 g and instructions for the use of Indoxil).

The 1000 mg gel contains:

• active substances: anhydrous benzoyl peroxide - 50 mg (benzoyl peroxide - 66.7 mg); clindamycin - 10 mg (clindamycin phosphate - 12, 8 mg);
• additional components: disodium sulfosuccinate laureth - 0.4 mg; edetate disodium - 1 mg; hydrated colloidal silicon dioxide - 2.5 mg; glycerol - 40 mg; sodium hydroxide - 3.1 mg; carbomer - 20 mg; poloxamer 182 - 2 mg; dimethicone - 1 mg; purified water - up to 1000 mg.

Pharmacological properties

Pharmacodynamics

The mechanism of action of Indoxil is based on the properties of its active ingredients:

• clindamycin: antibiotic of the lincosamide group with bacteriostatic action against gram-positive aerobic microorganisms and a wide range of anaerobic bacteria. Clindamycin (lincosamide) binds to the 50S ribosome subunit of susceptible bacteria. It interferes with the transport of peptidyl, thereby preventing peptide chain elongation. The action of the substance is predominantly bacteriostatic, however, when used in high concentrations, it is possible to provide a slow bactericidal effect in relation to sensitive strains. Although clindamycin phosphate is inactive, rapid hydrolysis converts this compound to active clindamycin;
• benzoyl peroxide is a highly lipophilic oxidizing agent with a bactericidal and weak keratolytic effect. The substance forms reactive oxygen species that prevent the emergence of microorganisms that are resistant to clindamycin, which is provided by a nonspecific bactericidal mechanism of action.

Clindamycin is active against propionobacteria (Propionibacterium acnes or P. acnes), which cause acne. There is information about the likelihood of P. acnes resistance to clindamycin. The substance inhibits P. acnes (the minimum inhibitory concentration is 0.4 μg / ml). After application to the skin surface, there is a significant reduction in the free fatty acid content from about 14% to 2%. Clindamycin helps to reduce inflammation by inhibiting leukocyte chemotaxis.

The effectiveness of benzoyl peroxide in the treatment of acne is mainly due to its bactericidal activity, especially against P. acnes. The bactericidal activity of a substance is associated with the release of free or active oxygen radicals that are capable of oxidizing bacterial proteins. Benzoyl peroxide is effective in treating acne due to some keratolytic and anti-inflammatory effects.

Treatment of acne in the form of monotherapy with antibiotics such as erythromycin and clindamycin (topical and oral) is associated with the emergence of antimicrobial resistance in P. acnes, as well as in saprophytic flora (Streptococcus pyogenes, Staphylococcus aureus). With prolonged use of clindamycin, these microorganisms may develop resistance to therapy.

Benzoyl peroxide is bactericidal and does not induce resistance in P. acnes. The inclusion of the substance in the composition of a combined agent containing 1% clindamycin and 5% benzoyl peroxide reduces the number of P. acnes organisms resistant to clindamycin.

For specific organisms, the level of acquired resistance may vary over time and geographic location.

Whenever possible, local knowledge of the resistance of propionobacteria should be taken into account when prescribing Indoxil, especially when treating serious infections.

Cross-resistance exists between lincomycin and clindamycin.

Pharmacokinetics

Clindamycin

Clindamycin phosphate is converted to clindamycin, undergoing rapid hydrolysis by skin phosphatases. Clindamycin is further metabolized to clindamycin sulfoxide. In patients using topically clindamycin phosphate for 14 days, significant concentrations of clindamycin are found in acne elements.

There is no data confirming the systemic accumulation of the substance, as well as its accumulation in the skin after repeated use.

Clindamycin metabolism occurs in the liver with the formation of active and inactive metabolites.

Excretion of clindamycin is carried out mainly in the urine in the form of a starting substance. The half-life is approximately 9 hours. After repeated topical application of the gel containing the substance, up to 0.06% of the dose is excreted in the urine.

Benzoyl peroxide

The substance is absorbed by the skin and metabolized to benzoic acid. When applied topically, less than 5% of the dose enters the systemic circulation in the form of benzoic acid.

The presence of benzoyl peroxide has no effect on the percutaneous absorption of clindamycin.

Excretion is carried out in the form of benzoic acid in the urine.

Indications for use

Indoxil gel is prescribed for the treatment of mild to moderate acne (acne vulgaris), especially in cases where inflammatory skin lesions predominate.

Contraindications

Absolute:

• ulcerative colitis, Crohn's disease, pseudomembranous colitis, including a burdened history;
• age up to 12 years;
• lactation period;
• individual intolerance to clindamycin, lincomycin, benzoyl peroxide and / or any of the components of the drug.

Relative (Indoxil gel is prescribed under medical supervision):

• combined therapy with other topical drugs for the treatment of acne (associated with the likelihood of developing cumulative skin irritation, which in some cases can be severe, especially when treated with agents with an abrasive or exfoliating effect);
• combined therapy with muscle relaxants of peripheral action;
• pregnancy.

Indoxil, instructions for use: method and dosage

Indoxil is used topically. The gel is applied to the entire affected area with a thin layer 1 time per day. Before this, you need to thoroughly prepare the skin with a mild cleanser, and then dry it completely.

When an excessive amount of gel is applied to the skin, it is poorly absorbed. Wash your hands after using the product.

After the gel has been absorbed, a moisturizer can be applied if necessary.

If there is dry skin or peeling, it is necessary to reduce the frequency of use of Indoxil or temporarily suspend therapy. The effectiveness of the drug with a frequency of use less than 1 time per day has not been studied.

With an increase in the frequency of use, the effectiveness of the treatment does not increase, but the risk of developing skin irritation increases.

The average course duration is 2–5 weeks, the maximum is 12 weeks. In the case of Indoxil use for a longer time, it is necessary to assess the expected benefits and possible harm, since the safety profile of such therapy has not been studied.

Side effects

Possible adverse reactions based on the results of clinical studies and post-registration observations [> 10% - very often; (> 1% and 0.1% and 0.01% and <0.1%) - rarely; <0.01% - very rare]:

• immune system: rarely - allergic reactions, including anaphylactic reactions and hypersensitivity;
• digestive system: rarely - colitis (including pseudomembranous colitis), diarrhea, hemorrhagic diarrhea, abdominal pain;
• nervous system: infrequently - paresthesia at the site of application of the gel;
• skin and subcutaneous fat: very often - erythema, burning sensation, flaking, dry skin at the site of application of the gel (usually mild); often - photosensitization at the site of application of the gel; infrequently - dermatitis, erythematous rash, itching, aggravation of acne at the site of application of the gel; rarely - urticaria at the site of application of the gel;
• others: rarely - other reactions at the site of application of the gel, including hair discoloration.

Also, when conducting studies during the topical application of clindamycin as a monopreparation, the development of disorders such as pain at the site of application and headache was often observed.

Severe local reactions were not observed with Indoxil. During the period of therapy, in comparison with the time before it began, the following changes occurred (of weak and moderate severity, respectively):

• peeling: from 6% to 17%; from <1 to 2%;
• erythema: from 28% to 26%; from 3% to 5%;
• dryness: from 6% to 15%; from <1% to 1%;
• burning: from 3% to 5%; <1% (no change).

Overdose

The main symptom of an overdose due to the application of an excessive amount of Indoxil is severe irritation, in which the drug is canceled until this disorder disappears.

When applied topically, benzoyl peroxide is absorbed mainly in an amount that is insufficient for systemic effects to occur. The concentration of absorbed clindamycin can lead to systemic effects. In case of accidental ingestion of active substances inside, there may be the development of undesirable reactions from the gastrointestinal tract, similar to the disorders that occur when clindamycin is used parenterally.

Therapy: symptomatic, aimed at reducing the severity of skin irritation associated with the application of an excessive amount of Indoxil. In case of accidental ingestion of the gel, the appointment of therapeutic measures is based on the clinical situation or, if any, on the recommendations of the local National Poison Center.

special instructions

Avoid contact with the eyes, mouth, lips, other mucous membranes, and irritated damaged skin areas. If the gel accidentally gets on the indicated areas, they should be rinsed well with water.

In most patients, during the first week of therapy, there is an increase in flaking and redness of the skin. Depending on the severity of these disorders, you can use cosmetics with a moisturizing effect, temporarily reduce the frequency of use of Indoxil, or temporarily interrupt therapy. Cancellation of the drug is required in cases of intense skin irritation (in the form of severe erythema, severe dry skin, itching, tingling / burning).

When using benzoyl peroxide, hypersensitivity to sunlight may develop, therefore, prolonged exposure to sunlight should be avoided during the treatment period, and tanning beds should also be avoided. If it is impossible to avoid exposure to the sun, it is recommended to use sunscreen cosmetics for the skin and wear protective clothing from the sun.

If the patient has sunburn, it is contraindicated to use Indoxil until they are cured.

The gel can discolor colored fabric and hair. Therefore, contact with hair, carpets, furniture and fabrics should be avoided.

With the use of almost all antibacterial agents, including clindamycin, cases of pseudomembranous colitis have been reported. The severity of the disorder varies widely, from mild to life-threatening. It should also be taken into account that pseudomembranous colitis may develop several weeks after the end of Indoxil therapy.

When a combination of clindamycin and benzoyl peroxide is used topically, pseudomembranous colitis is unlikely to occur, but if the patient has prolonged or severe diarrhea or abdominal cramps, discontinue treatment immediately and consult a doctor, as these signs may indicate the presence of antibiotic-associated colitis …

Benzoyl peroxide reduces the risk of microorganisms developing resistance to clindamycin. However, in patients who have recently used parenteral / topical erythromycin or clindamycin, the presence of propionobacteria and saprophytic flora with previously acquired antimicrobial resistance is more likely.

Cross-resistance exists between clindamycin and lincomycin; often clindamycin resistance is associated with erythromycin resistance.

Application during pregnancy and lactation

• pregnancy: Indoxil can be prescribed only after assessing the ratio of the expected benefit with the possible risk;
• lactation period: therapy is contraindicated.

Controlled studies of the use of Indoxil with the participation of pregnant women have not been conducted. Information on the use of topical preparations containing the active ingredients of Indoxil is limited. Preclinical studies of direct / indirect adverse effects that can be attributed to reproductive toxicity have not been confirmed.

The safety profile of Indoxil therapy in lactating women has not been studied. The active ingredients of the drug have poor percutaneous absorption, but there is no information about their excretion into breast milk as a result of topical application of the gel. With parenteral and oral administration, clindamycin is excreted into breast milk. Indoxil can only be used in cases where the expected benefit outweighs the potential harm. To avoid accidental ingestion of the gel into the child's body, it should not be applied to the chest area.

Pediatric use

Indoxil is not prescribed for patients under 12 years of age.

Drug interactions

• preparations containing erythromycin: the combination is contraindicated, since clindamycin is antagonistic to erythromycin;
• muscle relaxants of peripheral action: increasing their effectiveness, since clindamycin disrupts neuromuscular transmission;
• tretinoin, isotretinoin, tazarotene: reducing their action and increasing skin irritation (due to benzoyl peroxide); if it is necessary to carry out a combination therapy, drugs should be used at different times of the day;
• topical preparations containing sulfonamide: temporary discoloration of hair and skin at the site of application, in particular orange or yellow discoloration (due to benzoyl peroxide).

Analogs

Indoxil's analogues are: Zenerite, Zerkalin, Klindatop, Klindovit, Benzamycin, Dalatsin, etc.

Terms and conditions of storage

Store at 2–8 ° C, do not freeze. Keep out of the reach of children.

Shelf life is 2 years.

After opening the package, the gel can be used for 2 months at a storage temperature of up to 25 ° C.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Indoxil

Reviews about Indoxil are few. Most often it is indicated that he did not have the expected therapeutic effect. The frequency and severity of side effects have wide individual variability.

Price for Indoxil in pharmacies

The approximate price for Indoxil gel for external use for 1 tube weighing 25 g is 678-920 rubles.

Indoxil: prices in online pharmacies

Drug name Price Pharmacy

Indoxil 50 mg + 10 mg / g gel for external use 25 g 1 pc. RUB 519 Buy

Indoxil gel for outside approx. 50mg + 10mg / 1g tube 25g 768 RUB Buy

Anna Kozlova Medical journalist About the author

Education: Rostov State Medical University, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!