Clotrimazolum – when can it be used? What precautions should I take?

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Clotrimazolum is a cream medicine that is available over the counter in pharmacies. The active substance of the drug, i.e. clotrimazole, is a compound that exhibits antifungal activity. This topical drug is practically not absorbed through the skin and is poorly absorbed through the mucous membranes. How does Clotrimazolum cream work and when is it worth reaching for? Are there any contraindications to the use of this cream? How to dose Clotrimazole and what precautions should be taken? How much does the cream cost and can it be replaced with other preparations?

Clotrimazolum is a cream drug intended for topical use. The active substance of the preparation is clotrimazole. This substance is effective against most fungi that cause human infections. Clotrimazole belongs to the imidazole derivatives. Clotrimazolum cream works especially against yeasts and dermatophytes.

Clotrimazolum cream is available at a pharmacy without a prescription. Clotrimazolum is a white cream with a specific smell. The package of the drug contains a tube of cream with a capacity of 20 g, and 1 g of cream contains 10 mg of clotrimazole.

Several pharmaceutical companies are currently responsible for the production and distribution of Clotrimazolum cream. Therefore, the following preparations are currently available on the market:

  1. Clotrimazolum USP – the manufacturer of this cream is USP Zdrowie, a Polish pharmaceutical company that was founded in 1992 in the United States. USP Zdrowie is a leader on the market of over-the-counter (OTC) products and drugs in Poland. Preparations of this company are in almost every home medicine cabinet. The flagship products of USP Zdrowie are: Apap, Ibuprom, Gripex, Stoperan, Xenna, Verdin and Artresan;
  2. Clotrimazolum Hasco – the manufacturer of this cream is Hasco-Lek, a Polish pharmaceutical company based in Wrocław. The company was founded in 1984 by Dr. Stanisław Han. Initially, the company dealt mainly with the production of cosmetics. It was not until 1991 that the first medicinal preparations appeared in the company’s offer. They were syrups composed of natural ingredients. Hasco-Lek is the first company in Poland that in 1999 started the production of gelatin capsules by the method of matrix extrusion. The Hasco-Lek Group also includes the Vratislavia Medica Szpital im. Saint John Paul II;
  3. Clotrimazolum Aflofarm – the manufacturer of this cream is Aflofarm, one of the largest and most recognizable pharmaceutical companies in Poland. The company has been operating in the healthcare sector for thirty years and has introduced over 115 product brands to the market during that time. Currently, Aflofarm is a leader on the pharmaceutical market in the OTC segment, including with brands such as Desmoxan, Neosine and Dafurag;
  4. Clotrimazolum GSK – the manufacturer of this cream is GlaxoSmithKline, a British pharmaceutical company. The GSK concern was established in December 2000 as a result of the merger of Glaxo Wellcome and SmithKline Beecham. In the ranking of the 50 largest pharmaceutical companies for 2012, GSK was placed sixth. In Poland, GSK is a leading pharmaceutical company. The company provides patients with over 300 drugs, vaccines and health care products. Medicines produced by GSK are used to treat respiratory diseases and HIV infection. In 2017 alone, the GSK concern delivered 3,6 million doses of vaccines. The company is the largest investor in the pharmaceutical industry in Poland. Among others, it was bought by Poznańskie Zakłady Farmaceutyczne Polfa SA. 

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Clotrimazolum – composition and action

Clotrimazolum is a cream whose main ingredient and active ingredient is clotrimazole. Clotrimazole is an organic chemical compound, an imidazole derivative, that is used as a broad-spectrum antifungal drug. Clotrimazole is practically insoluble in water, but the compound is soluble in ethanol and ether.

How does clotrimazole work? First of all, this compound inhibits ergosterol biosynthesis. In order to understand this mechanism of action, it is necessary to explain and describe the structure of fungal cells.

The fungal cells are surrounded by a cell wall which is primarily made of chitin. Under the cell wall there is a semi-permeable cell membrane made of two layers of phospholipids and proteins. One of the steroids that make up the cell membrane is ergosterol. The task of this steroid is to stabilize the membrane. It is not found in the membranes of animal cells, so antifungal drugs affecting its transformations are safe for humans.

Clotrimazole, by inhibiting the biosynthesis of ergosterol, leads to disorders of the fungal cell permeability, as well as to the leakage of phosphates and potassium from the cell. This in turn causes damage to the nucleic acids of the cell nucleus and eventually kills the cell.

This drug is fungistatic and fungicidal against dermatophytes, Candida (especially Candida albicans), Cryptococcus neoformans and Malassezia and Aspergillus as well as bimorphic fungi. There is virtually no inherent resistance to clotrimazole except in Candida guilliermondii, C. glabrata and C. krusi.

When applied topically, clotrimazole is poorly absorbed from mucous membranes. It is practically not absorbed through the skin, but it penetrates into the deeper layers of the epidermis.

In addition to the active substance, additional auxiliary ingredients of Clotrimazolum cream are: cetyl alcohol, stearyl alcohol, cetyl palmitate, octyldodecanol, sorbitan stearate, polysorbate 60, benzyl alcohol and purified water.

If you want to know more about clotrimazole read on: Clotrimazole – recommendations, use, contraindications

Clotrimazolum is a cream with antifungal activity, therefore the indications for the use of this preparation are:

  1. fungal skin infections caused by dermatophytes, yeasts, molds and other species of fungi: tinea pedis, tinea pedis, paronychia, tinea pedis, inguinal mycosis, tinea versicolor, tinea capitis, erythematous dandruff;
  1. candidiasis of the skin and mucous membranes external genitalia (Candida vulvitis and balanitis), labia, foreskin and glans;
  2. infections of the oral mucosa caused by yeast-like fungi.

How to recognize and treat vaginal mycosis? Read: Vaginal mycosis – causes, symptoms, treatment, prevention [EXPLAINED]

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Clotrimazolum – contraindications

Despite its effectiveness in fighting fungal infections, Clotrimazolum cream cannot be used by all patients who might need it. Contraindications to the use of Clotrimazolum cream are:

  1. allergic to clotrimazole or any of the other ingredients of this medicine;
  2. vaginal application of the cream;
  3. renal dysfunction;
  4. XNUMXst trimester of pregnancy;
  5. age of the patient – the cream should not be used in children under 11 years of age. Children under 11 years of age and the elderly (over 65 years of age) may only use the medicine on the recommendation of a doctor.

What medications must not be given to children? Check: Warning, these drugs can be dangerous to children

Before and during the use of Clotrimazolum antifungal cream, follow the precautions included in the package leaflet.

Among the precautionary measures, it is indicated that:

  1. Clotrimazolum cream contains cetostearyl alcohol. The drug may cause a local skin reaction, such as contact dermatitis;
  2. some diseases may constitute a contraindication to use or an indication to change the dosage of the preparation. In some situations it may be necessary to carry out certain check-ups;
  3. if the symptoms worsen or do not disappear after several uses of the ointment, consult a doctor;
  4. avoid contact of the drug with the eyes;
  1. the cream should not be applied to wounds and damaged skin;
  2. Clotrimazolum cream should be stored out of the sight and reach of children, in the original packaging, at a temperature below 25 degrees Celsius;
  3. the preparation should not be frozen;
  4. the shelf life after first opening the cream tube is 28 days;
  5. the cream should not be used after the expiry date which is stated on the tube and on the box. The expiry date refers to the last day of that month;
  6. this medicine should not be disposed of via wastewater or household waste. It’s best to ask your pharmacist how to dispose of medicines you no longer use.

In addition, special care should be taken when using Clotrimazolum cream if the patient:

  1. is taking medicines that suppress the immune system (so-called immunosuppressants, used in patients after organ transplants or, for example, in atopic dermatitis);
  2. receives chemotherapy;
  3. has diabetes;
  4. is infected with HIV;
  5. is allergic to itraconazole, fluconazole, ketoconazole or miconazole (medicines used to treat infections caused by fungi).

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Always use Clotrimazolum cream exactly as described in the package leaflet or as directed by your doctor or pharmacist. According to the instructions in the leaflet, the cream should be applied 2-3 times a day. For the treatment to be effective, a thin layer of cream should be applied to the affected areas and the adjacent area. The cream should be applied to all infected areas at the same time.

Clotrimazolum cream is applied topically. Before using the drug, you should thoroughly wash and dry the skin. On average, it is estimated that the duration of treatment with this cream is about 2-4 weeks. Treatment of fungal infections of the mucous membranes of the external genitalia should last from one week to two weeks.

If, after 7 days of using the cream, the fungal symptoms worsen or do not begin to subside, consult a doctor for advice.

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Clotrimazolum – interactions with other drugs

Before using Clotrimazolum cream, tell your doctor or pharmacist about all the drugs you are taking or have recently taken, and about any drugs you plan to use in the near future.

Clotrimazole reduces the effectiveness of amphotericin and other polyene antibiotics (e.g. nystatin, natamycin). On the other hand, simultaneously applied topical preparations containing potent steroids weaken the effect of clotrimazole.

Significant interactions of the cream with other preparations are considered to be:

  1. Clotrimazolum i Warfin – these preparations contain clotrimazole and warfarin. Concomitant use of these drugs may increase the anticoagulant effect of warfarin, increasing the risk of bleeding, bruising and bleeding time from any cuts and open wounds. In the event of unusual bleeding (e.g. from the nose), general malaise, weakness, significantly prolonged blood clotting time, subcutaneous haematomas, tarry stools or other disturbing symptoms, the patient should immediately contact a doctor;
  2. Clotrimazolum i Tyverb – these preparations contain clotrimazole and lapatinib. Concomitant use of these drugs reduces the effect of lapatinib, thus reducing its effectiveness. You should immediately inform your doctor about any disturbing symptoms.

Which drugs should never be combined with each other? Check: Dangerous interactions

Clotrimazolum cream, like any other drug, may cause side effects in patients. It is important to report any suspected adverse reactions after authorization of the medicinal product so that the benefit / risk balance of the medicinal product can be monitored.

The frequency classification of adverse body reactions (ADRs) is based on the following principles: very common (≥1 / 10), common (≥1 / 100 to <1/10), uncommon (≥1 / 1 to <000/1), rare (≥ 100 / 1 to <10 / 000), very rare (<1 / 1), not known (cannot be estimated from the available data).

Wśród działań niepożądanych, które mogą wystąpić na skutek zastosowania kremy Clorimazolum wymienia się:

  1. allergic reaction;
  2. general hypersensitivity reaction – rash, severe swelling of the face, mouth or throat, making it difficult to breathe, speak or swallow, drop in blood pressure, slow or fast heart rate, paleness, restlessness, sweating, dizziness, unconsciousness, stopping breathing and heartbeat;
  3. baking;
  4. itching;
  5. transient irritation at the application site;
  6. disorders of the stomach and intestines;
  7. disorders of the reproductive system and breast;
  8. feeling of discomfort;
  9. pelvic pain;

Very rarely, the following may also occur:

  1. generalized erythema;
  2. rash;
  3. edema;
  4. hives;
  5. exfoliation of the epidermis;
  6. shortness of breath;
  7. fainting.

It is worth noting that the adverse skin changes caused by the use of the drug are transient and usually disappear after discontinuing the use of the cream.

WARNING

The occurrence of side effects after the use of Clotrimazolum cream can also be reported directly to the Department of Monitoring Adverse Effects of Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw.

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Clotrimazolum and pregnancy and breastfeeding

The use of any medications or dietary supplements during pregnancy requires consultation with the attending physician. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, consult your doctor or pharmacist for advice before using Clotrimazolum cream.

According to the information contained in the leaflet, Clotrimazolum cream must not be used in the first trimester of pregnancy. In turn, in the second and third trimesters of pregnancy, the use of Clotrimazolum cream is possible, but only on the express order of the doctor and only when, in his opinion, the use of the drug is necessary. Women who are breastfeeding may only use this antifungal cream on the advice of a doctor.

What is worth knowing about proper supplementation during pregnancy? Check: Conscious choices. Diet and supplementation in pregnancy

Clotrimazolum cream price may differ depending on the town where the antifungal preparation will be purchased or the selected pharmacy. The price of the product also depends on the manufacturer responsible for the distribution of the drug.

It can be estimated that for a package of Clotrimazolum cream containing 20 g of the product, you pay on average:

  1. Clotrimazolum USP – about PLN 2-3;
  2. Clotrimazolum Hasco – about PLN 3-4;
  3. Clotrimazolum Aflofarm – approx. 3 zlotys;
  4. Clotrimazolum GSK – approx. PLN 6.

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Clotrimazolum – substitutes and similar preparations

Products that have the same international name and exist in the same form do not have to be substitutes, because the use of a given drug is determined by the content of the active substance, i.e. the dose of the drug.

It should be remembered that even when the dose of the active substance is similar, the patient may not always use the substitute, because he may be allergic to any of the other excipients of the drug.

Therefore, before using a substitute for Clotrimazolum cream, read the package leaflet or consult your doctor or pharmacist.

Among the ointments and creams that contain ingredients similar to the Clotrimazolum preparation and exhibit similar properties, the following are mentioned:

  1. The canest – it is a medicine in the form of vaginal capsules. It is an antifungal preparation used in infections of the vagina and female external genitals caused by microorganisms such as fungi (usually Candida) that are sensitive to clotrimazole. Canesten can be used in adult women and patients over 16 years of age. 1 soft vaginal capsule contains 500 mg of clotrimazole. There is one vaginal tablet in the pack. The drug costs about PLN 35-40 and is available without a prescription;
  2. Clotidal – it is a medicinal preparation in the form of a vaginal cream with attached applicators with a capacity of 5 ml. The drug is used during fungal inflammation of the mucous membranes of the genital organs. The cream can also be used in men during the infection of the glans (penis crown). The drug is intended for people from 16 years of age. 1 g of vaginal cream contains 10 mg of clotrimazole. For 35 g of cream and 6 applicators you have to pay about PLN 20-30. The cream is available over the counter;
  3. Fungotac – it is a medicine in the form of ear drops with antifungal properties. The medicinal product is intended for use in infections of the outer and middle ear. 1 ml of solution contains 10 mg of clotrimazole. The drug is available over the counter. You have to pay about PLN 20 for 40 ml of this preparation;

It is also worth mentioning complex preparations in which one of the ingredients is clotrimazole:

  1. Lotriderm – a cream containing clotrimazole and betamethasone. The indications for its use are: mycosis of the groin, perineum, feet and hairless skin caused by dermatophytes, i.e. fungi that affect only the skin, nails and hair, as well as candidiasis accompanied by inflammation or allergic changes. 1 g of cream contains 10 mg of clotrimazole, 0,64 mg of betamethasone in the form of betamethasone dipropionate. The drug is available on prescription. You must pay about PLN 15 for a package of Lotriderm, which contains 25 g of the preparation;
  2. Triderm – it is a medicine available in the form of ointments and cream. It contains clotrimazole, betamethasone and gentamicin. 1 g of cream contains 0,64 mg of betamethasone dipropionate (equivalent to 0,5 mg of betamethasone), 10 mg of clotrimazole, 1 mg of gentamicin in the form of gentamicin sulphate. However, 1 g of ointment contains: 0,64 mg of betamethasone dipropionate (corresponding to 0,5 mg of betamethasone), 10 mg of clotrimazole and 1 mg of gentamicin in the form of gentamicin sulphate. Both forms are available on prescription. For 15 g of the preparation in the form of a cream or ointment, you have to pay about 20-25 zlotys.

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