Instructions Clotrimazole cream 1% tube 20 g
Composition
active ingredient: clotrimazole;
1 g of cream contains 10 mg of clotrimazole;
excipients: cetostearyl alcohol, octyldodecanol, polysorbate 60, sorbitan stearate, cetyl wax esters, benzyl alcohol, purified water.
Dosage form
Cream.
Main physicochemical properties: white cream of uniform consistency.
Pharmacotherapeutic group
Antifungals for topical use. Imidazole and triazole derivatives. Clotrimazole. ATX code D01A C01.
Pharmacological properties
Pharmacodynamics
The mechanism of antimycotic action of clotrimazole is associated with inhibition of ergosterol synthesis, which leads to structural and functional damage to the cytoplasmic membrane.
Clotrimazole has a broad spectrum of antifungal activity in vitro and in vivo and is active against dermatophytes, yeasts, molds and dimorphic fungi.
Under appropriate test conditions, the minimum inhibitory concentrations for these types of fungi are approximately 0.062–8.0 μg/mL substrate.
The mechanism of action of clotrimazole is associated with primary fungistatic or fungicidal activity, depending on the concentration of clotrimazole at the site of infection.
In vitro activity is limited to proliferating fungal elements; fungal spores have only minor sensitivity.
In addition to its antifungal activity, clotrimazole also acts on gram-positive microorganisms (streptococci, staphylococci, Gardnerella vaginalis) and gram-negative microorganisms (Bacteroids).
In vitro, clotrimazole inhibits the growth of Corynebacteria and Gram-positive cocci (except Enterococci) at concentrations of 0.5–10 μg/ml of substrate.
Primary resistant strains of susceptible fungal species are rare. Development of secondary resistance during treatment in susceptible fungi has been observed very rarely to date.
Preclinical studies conducted in volunteers using single and repeated toxic doses did not reveal any harmful toxic, genotoxic or reproductive effects.
Pharmacokinetics
When applied topically to the skin, clotrimazole is absorbed by the epidermis. The highest concentration of clotrimazole is found in the stratum corneum and reticuloderm. The cream enters the systemic circulation in very small amounts (< 2 and 3–10% of the applied dose with a peak plasma concentration of the active substance < 10 ng/ml). Thus, the occurrence of side effects or systemic effects is unlikely.
Indication
Fungal infections of the skin and mucous membranes caused by dermatophytes, yeasts and molds and other pathogens sensitive to clotrimazole.
Skin infections caused by Malassezia furfur (tinker mite) and Corynebacterium minutissimum (erythrasma).
Candidal vulvitis and candidal balanitis.
Contraindication
Hypersensitivity to the active ingredient and to other components of the drug.
Do not use the cream to treat nail or scalp infections.
Interaction with other medicinal products and other types of interactions
When using the cream with latex products (e.g. condoms and diaphragms), the functional ability of the latter may be reduced due to the excipients contained in the cream (especially stearates), which, as a result, may affect the effectiveness of these products. This effect is temporary and is observed only during the use of the drug. Patients are advised to use alternative methods of contraception for at least 5 days after using this drug.
Application features
It is not recommended to apply the cream to areas of skin near the eyes. Avoid contact with eyes. Do not swallow. It is recommended to treat all affected areas of skin at the same time.
Due to the presence of cetostearyl alcohol in the composition of the drug, a local skin reaction (for example, contact dermatitis) may occur during use.
This medicine contains benzyl alcohol and should not be used in premature babies and newborns.
During the use of this drug, sexual contact should be avoided, as the infection may be transmitted to the partner. When using Clotrimazole, cream, simultaneously with latex products (for example, condoms and diaphragms), the functional ability of the latter may be reduced due to excipients contained in Clotrimazole, cream (especially stearates), which, as a result, may affect the effectiveness of these products. This effect is temporary and is observed only during the period of use of the drug.
The patient is advised to consult a doctor: if hypersensitivity to any antifungal agents or imidazole derivatives is detected; if there is a history of venereal diseases in the patient or his sexual partner; if the patient has a high body temperature (38 °C or higher), pain in the lower abdomen, dysuria, back pain, purulent vaginal discharge with an unpleasant odor, vulvar and vaginal ulcers, redness, diarrhea, nausea, vomiting, vaginal bleeding accompanied by shoulder pain.
Do not use tampons, intravaginal irrigations, spermicides, or other vaginal medications while using this medication.
Ability to influence reaction speed when driving vehicles or other mechanisms
No effect.
Use during pregnancy or breastfeeding
Clinical studies on the effect of clotrimazole on fertility in women have not been conducted, however, animal studies have not shown an effect of clotrimazole on fertility.
Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity. The number of studies with the use of clotrimazole during pregnancy is limited, therefore it is recommended to avoid the use of the drug during the first trimester of pregnancy.
Breastfeeding should be discontinued during treatment with the drug. The cream should not be applied to the mammary glands during breastfeeding.
Method of administration and doses
The drug is intended for topical use.
The cream is applied in a thin layer to the affected area of the skin 2–3 times a day and rubbed in lightly.
For candidal vulvitis and candidal balanitis in adults, a strip of cream is applied in a thin layer to the affected areas and rubbed in. Therapy of these diseases requires simultaneous treatment of both partners.
The total duration of treatment is:
dermatomycoses – 3–4 weeks; erythrasma – 2–4 weeks; lichen planus – 1–3 weeks; candidal vulvitis and candidal balanitis – 1–2 weeks.
In order to prevent recurrence of infection, it is important to continue treatment for 2 weeks after the disappearance of subjective symptoms of infection.
If there is no improvement in the condition after 4 weeks of using the drug, the patient should consult a doctor.
Children
There is no experience of use.
Overdose
There is no risk of acute intoxication, as overdose is unlikely to occur after cutaneous application (application to large areas of skin under conditions conducive to increased absorption) or after accidental oral ingestion. There is no specific antidote. In the event of accidental oral ingestion, gastric lavage may rarely be necessary if a life-threatening dose has been taken within the previous hour or if there are visible symptoms of overdose (e.g. dizziness, nausea, vomiting). Gastric lavage should only be performed if appropriate conditions exist for the procedure.
Adverse reactions
Immune system disorders: allergic reactions, including urticaria, dyspnea, hypotension, syncope.
Skin and subcutaneous tissue disorders: itching, rash, blisters, skin exfoliation, discomfort/pain, swelling, redness (erythema), burning sensation, feeling of heat, irritation.
In case of hypersensitivity to cetostearyl alcohol, allergic reactions on the skin or mucous membranes may occur.
Expiration date
3 years.
Storage conditions
Keep out of reach of children. Store below 25°C. Do not freeze.
Packaging
20 g of cream in an aluminum tube, 1 tube in a cardboard box.
Vacation category
Without a prescription.
Producer
GlaxoSmithKline Pharmaceuticals S.A., Poland.
Location of the manufacturer and its business address
GlaxoSmithKline Pharmaceuticals S.A., 189, Grunwaldska Street, 60-322 Poznań, Poland.
