Clotrimazole (Tablets, Solution, Ointment, Cream, Gel, Suppositories) Instructions for Use
ATC Code
G01AF02 (Clotrimazole)
Active Substance
Clotrimazole (Rec.INN registered by WHO)
Clinical-Pharmacological Group
A drug with antifungal action for topical use in gynecology
Pharmacotherapeutic Group
Antifungal agent
Pharmacological Action
Clotrimazole suppresses the growth and division of microorganisms and, depending on the concentration, can have a fungistatic or fungicidal effect.
The mechanism of action of clotrimazole is associated with a change in the permeability of cell membranes due to the effect on the synthesis of ergosterol and binding with phospholipids of the fungal cell wall.
Clotrimazole suppresses the synthesis of proteins, fats, DNA, polysaccharides, damages nucleic acids in fungal cells and accelerates the excretion of potassium.
It can also suppress the activity of oxidant and peroxidant enzymes and the biosynthesis of triglycerides and phospholipids in fungal cells.
At higher concentrations, Clotrimazole causes damage to cell membranes by mechanisms independent of sterol synthesis.
Clotrimazole prevents the transformation of blastospores of Candida albicans into invasive forms of mycelium.
The change in the activity of the cell membrane leads to cell death, and this process depends on the contact of the drug with microbes.
Clotrimazole is characterized by a broad spectrum of antifungal and antibacterial activity.
It is active against: dermatophytes (Epidermophyton floccosum, Microsporum canis, Trichophyton mentagrophytes, Trichophyton rubrum), yeasts (Candida spp., Cryptococcus neoformans), dimorphic fungi (Coccidioides immitis, Histoplasma capsulatum, Paracoccidioides brasiliensis), protozoa (Trichomonas vaginalis).
Also Clotrimazole is active against some gram-positive bacteria.
In vitro Clotrimazole is characterized by a broad spectrum of fungistatic and fungicidal activity.
It affects the mycelium of dermatophytes (Trichophyton, Microsporum, Epidermophyton) similarly to griseofulvin, its effect on budding yeast-like fungi (Candida) is similar to the action of polyenes (amphotericin B and nystatin).
At concentrations of less than 1 µg/ml, Clotrimazole inhibits the development of most strains of pathogenic fungi belonging to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum, Microsporum canis.
At a concentration of 3 µg/ml, Clotrimazole inhibits the development of most other bacteria: Pityrosporum orbiculare, Aspergillus fumigatus, Candida species, including Candida albicans, some strains of Staphylococcus aureus, Streptococcus pyogenes, as well as some strains of Proteus vulgaris and Salmonella.
Clotrimazole is active against Sporothrix, Cryptococcus, Cephalosporium, Fusarium.
At concentrations above 100 µg/ml it is effective against Trichomonas vaginalis.
Fungi resistant to clotrimazole are extremely rare; there is data only on individual strains of Candida guilliermondii.
No development of resistance in clotrimazole-sensitive fungi after passage of Candida albicans and Trichophyton mentagrophytes has been reported.
No cases of development of resistance to clotrimazole in strains of Candida albicans resistant to polyene antibiotics due to chemical mutation have been described.
Pharmacokinetics
Absorption and Distribution
Pharmacokinetic studies of clotrimazole with intravaginal use have shown that absorption is 3-10% of the administered dose.
In the liver, Clotrimazole is metabolized to pharmacologically inactive metabolites, therefore its concentration in blood plasma with intravaginal administration at a dose of 500 mg is less than 10 ng/ml, confirming the fact that Clotrimazole with intravaginal administration does not lead to significant systemic effects or side effects.
Metabolism
Clotrimazole is mainly metabolized in the liver to metabolites excreted through the kidneys and intestines.
Indications
- Vaginitis caused by fungi of the genus Candida;
- Genital infections caused by fungi of the genus Candida, including infections caused by strains resistant to nystatin;
- Superinfections of the genital organs caused by other pathogens sensitive to clotrimazole;
- Sanitation of the birth canal before childbirth.
ICD codes
| ICD-10 code | Indication |
| B37.3 | Candidiasis of vulva and vagina |
| N76 | Other inflammatory diseases of vagina and vulva |
| ICD-11 code | Indication |
| 1F23.10 | Candidiasis of vulva and vagina |
| GA00 | Vulvitis |
| GA02.Z | Unspecified vaginitis |
| GA0Z | Inflammatory diseases of female genital tract, unspecified |
Dosage Regimen
| The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen. |
Cream
For external use. The cream should be applied to the affected areas of the skin 2-3 times/day.
For prevention of relapses, treatment should be continued for at least two weeks after the disappearance of all symptoms of infection.
The cream should be applied to clean, dry areas of the affected skin (washed with soap with a neutral pH), on the feet the cream should be applied between the toes.
The duration of treatment depends on the severity of the disease, its location, and the effectiveness of treatment.
Duration of treatment: dermatomycoses – 3-4 weeks; erythrasma – 2-4 weeks; pityriasis versicolor – 1-3 weeks; candidal vulvitis and balanitis – 1-2 weeks.
The duration of treatment may vary according to individual characteristics, but a duration of treatment of less than 3 weeks is not recommended. To prevent relapse of infection, the use of the drug should be continued for 1-2 weeks after the disappearance of all symptoms of the disease. If after 7 days of treatment there is no improvement in symptoms, it is necessary to consult a doctor.
Tablets
For intravaginal use. Prescribe 1 tab. 2 times/day for 3 days or 1 tab. 1 time/day for 6-7 days, preferably at bedtime.
If there is no effect within 3 days, the diagnosis should be confirmed.
If symptoms persist for more than 7 days, medical supervision is necessary.
Treatment can be repeated if necessary, however, recurrent infections may indicate an underlying pathology, including diabetes mellitus or HIV infection.
If symptoms recur within 2 months, the patient should consult a doctor.
In case of simultaneous infection of the vulva and adjacent areas, external treatment using a cream is necessary.
For complete dissolution of vaginal tablets, normal moisture of the vaginal mucosa is required. In women with dryness of the vaginal mucosa, undissolved parts of the tablet may be released outwards. To prevent this, it is necessary to insert the tablet as deeply as possible into the vagina before going to bed.
Treatment during menstruation is not recommended due to the risk of washing out the tablet; it must be completed before menstruation.
For sanitation of the birth canal, a single dose of 1 tablet immediately before childbirth.
For children over 12 years old, the method of use is the same as for adults.
The drug Clotrimazole vaginal tablets is not recommended for use in children under 12 years of age.
A repeated course of therapy is possible according to medical indications.
Solution, Gel
The dose, method and regimen of application are determined individually, depending on the indications, the patient’s age and the dosage form used.
With external use, the duration of treatment depends on the severity of the disease, the location of pathological changes and the effectiveness of therapy.
Strict adherence to the correspondence of indications and the dosage form used must be observed.
Ointment
Externally. The ointment is applied in a thin layer 2-3 times/day to previously cleansed (using soap with a neutral pH) and dry affected areas of the skin and gently rubbed in.
The duration of treatment depends on the severity of the disease, the location of pathological changes and the effectiveness of therapy.
Treatment of dermatomycoses is carried out for at least 4 weeks, pityriasis versicolor – for 1-3 weeks. Upon completion of the course of therapy (when clinical manifestations disappear), it is advisable to continue treatment for another 14 days, for fungal skin lesions of the legs for 2-3 weeks.
Suppositories
Topically.
For intravaginal use only. For women and adolescent girls (after the onset of sexual activity), vaginal suppositories are inserted in the evening into the vagina, as deeply as possible, in a supine position with slightly bent legs, daily for 6 days, 1 vaginal suppository of 100 mg. A repeated course of treatment is possible after consultation with a doctor.
Adverse Reactions
The adverse events presented below are listed according to the affected organs and organ systems and frequency of occurrence. Frequency is defined as follows: very common (≥1/10), common (≥1/100 and < 1/10), uncommon (≥1/1000 and < 1/100), rare (≥1/10,000 and < 1/1,000), very rare (< 1/10,000, including isolated cases), unknown (frequency cannot be estimated from the available data to date). Frequency categories were formed based on post-registration surveillance.
From the immune system unknown – allergic reactions (urticaria, fainting, arterial hypotension, shortness of breath).
From the gastrointestinal tract unknown – abdominal pain.
From the genital organs and mammary gland: unknown – discomfort in the vulva and vagina, hyperemia and swelling of the vaginal mucosa, vaginal discharge, burning, peeling, irritation, itching, pelvic pain, burning sensation in the penis of the sexual partner, pain during sexual intercourse, rash. If these symptoms appear, clotrimazole therapy should be discontinued.
From the nervous system: unknown – headache.
From the kidneys and urinary tract: unknown – frequent urination, intercurrent cystitis.
Contraindications
- Hypersensitivity to clotrimazole or other components of the drug;
- Age under 12 years;
- Menstrual period.
With caution
In the first case of candidal vaginitis, it is necessary to consult a doctor.
If any of the factors listed below are identified, a doctor should be consulted before prescribing Clotrimazole vaginal tablets
- More than two episodes of candidal vaginitis in the previous 6 months;
- History of sexually transmitted diseases or contact with a partner with a sexually transmitted disease;
- Proven or suspected pregnancy;
- Age over 60 years;
- History of hypersensitivity to imidazoles or other antifungal drugs for vaginal use.
Use in Pregnancy and Lactation
The use of Clotrimazole during pregnancy is allowed only if the intended benefit to the mother outweighs the potential risk to the fetus.
In conducted epidemiological studies, including retrospective analysis, when using clotrimazole during pregnancy (even in the first trimester), no adverse effects on the body of the pregnant woman, as well as congenital defects and adverse effects on the fetus, were identified.
The use of clotrimazole in women during breastfeeding is allowed only if the intended benefit to the mother outweighs the potential risk to the child.
Fertility
No data available.
Special Precautions
Avoid contact with eyes and swallowing.
It is recommended to carry out simultaneous treatment of all affected areas of the body. Clotrimazole vaginal tablets should not be used in the presence of any of the symptoms listed below, unless otherwise recommended by a doctor
- Irregular vaginal bleeding;
- Pathological vaginal bleeding, uterine hemorrhages or bloody discharge from the vagina;
- Ulcers, blisters or open wounds of the vulva or vagina;
- Pain in the lower abdomen or dysuria;
- Any adverse events, such as redness, irritation, swelling, associated with treatment;
- Fever (temperature 38°C (100.4°F) or higher) or chills;
- Nausea or vomiting;
- Diarrhea;
- Vaginal discharge with an unpleasant odor;
- Back pain;
- Shoulder pain.
To prevent reinfection, simultaneous treatment of sexual partners is necessary.
Effect on ability to drive vehicles and mechanisms
Not studied.
Overdose
Symptoms dizziness, nausea, vomiting.
Treatment: in case of accidental ingestion, symptomatic treatment should be carried out.
Drug Interactions
Laboratory data indicate that the use of contraceptives containing latex may cause their damage when used concomitantly with the drug Clotrimazole. Consequently, the effectiveness of such contraceptives may decrease. Patients should be advised to use alternative methods of contraception for at least five days after using the drug Clotrimazole.
Concomitant use of clotrimazole vaginally and tacrolimus (FK-506; immunosuppressant) orally may lead to an increase in the concentration of tacrolimus in plasma. Patients should be carefully monitored for symptoms of tacrolimus overdose with measurement of the drug concentration if necessary.
Amphotericin B, nystatin, natamycin reduce the effectiveness of clotrimazole when used simultaneously.
Storage Conditions
The drug should be stored in a place inaccessible to children at a temperature not exceeding 25°C (77°F).
Shelf Life
Shelf life – 3 years.
Dispensing Status
The drug is approved for use as an over-the-counter product.
Important Safety Information
This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.
Medical DisclaimerBrand (or Active Substance), Marketing Authorisation Holder, Dosage Form
Vaginal cream 2%: 20 g tube with applicators included
Marketing Authorization Holder
Esparma, GmbH (Germany)
Manufactured By
Pharma Wernigerode, GmbH (Germany)
Dosage Form
 |
Clotrimazole | Vaginal cream 2%: 20 g tube with applicators included |
Dosage Form, Packaging, and Composition
Vaginal cream white, homogeneous, odorless.
| 100 g | |
| Clotrimazole | 2 g |
Excipients : sorbitan stearate – 2 g, cetyl palmitate – 3 g, cetearyl alcohol [cetyl alcohol 60% and stearyl alcohol 40%] – 10 g, polysorbate 60 – 1.5 g, octyldodecanol – 13.5 g, benzyl alcohol – 1 g, purified water – 67 g.
20 g – aluminum tubes (1) in a set with disposable applicators (3 pcs.) – cardboard packs.
Cream for external use 1%: tube 20 g
Marketing Authorization Holder
Hyperion, S.A. (Romania)
Dosage Form
|
Clotrimazole | Cream for external use 1%: tube 20 g |
Dosage Form, Packaging, and Composition
Cream for external use 1% in the form of a homogeneous mass from white to whitish-yellowish in color.
| 1 g | |
| Clotrimazole | 10 mg |
Excipients : cetyl alcohol, petrolatum, glycerol, tween-80, nipagin, distilled water.
20 g – aluminum tubes (1) – cardboard packs.
Vaginal tablets 100 mg: 6 pcs.
Marketing Authorization Holder
Magistra C&C (Romania)
Dosage Form
|
Clotrimazole | Vaginal tablets 100 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal tablets white or almost white, or almost white with a yellowish tint, in the shape of a parallelepiped, biconvex, with rounded edges, with a uniform surface and homogeneous structure.
| 1 tab. | |
| Clotrimazole | 100 mg |
Excipients : lactose monohydrate, corn starch, colloidal silicon dioxide, sodium bicarbonate, tartaric acid, magnesium stearate.
6 pcs. – blisters (1) – cardboard boxes.
Vaginal tablets 100 mg: 6 pcs.
Marketing Authorization Holder
Sedate Health Care (P), Ltd. (India)
Dosage Form
|
Clotrimazole | Vaginal tablets 100 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal tablets white, oblong, biconvex, one end of the tablet is flat, the other is oval.
| 1 tab. | |
| Clotrimazole | 100 mg |
Excipients: lactose – 679 mg, corn starch – 692 mg, methylparaben – 2.45 mg, propylparaben – 0.78 mg, povidone – 51.16 mg, titanium dioxide – 2.56 mg, colloidal silicon dioxide – 12.82 mg, magnesium stearate – 19.23 mg.
6 pcs. – strips made of aluminum foil (1) complete with an applicator – cardboard packs.
Cream 1%: 20 g tube
Marketing Authorization Holder
Shreya Life Sciences, Pvt.Ltd. (India)
Dosage Form
|
Clotrimazole | Cream 1%: 20 g tube |
Dosage Form, Packaging, and Composition
Cream 1% is homogeneous, of soft consistency, emulsion type, white to almost white in color.
| 1 g | |
| Clotrimazole | 10 mg |
Excipients: liquid paraffin, cetostearyl alcohol, white soft paraffin, cetomacrogol 1000, purified water, chlorocresol, disodium edetate, citric acid, dibasic sodium phosphate (anhydrous), propylene glycol, sodium metabisulfite.
20 g – tubes (1) – cardboard packs.
Vaginal tablets 100 mg: 6 pcs.
Vaginal tablets 200 mg: 6 pcs.
Vaginal tablets 500 mg: 6 pcs.
Marketing Authorization Holder
Shreya Life Sciences, Pvt.Ltd. (India)
Dosage Forms
|
Clotrimazole | Vaginal tablets 100 mg: 6 pcs. |
| Vaginal tablets 200 mg: 6 pcs. | ||
| Vaginal tablets 500 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal tablets are white, capsule-shaped, one end of the tablet is oval, the other is rectangular.
| 1 tab. | |
| Clotrimazole | 100 mg |
Excipients: lactose, microcrystalline cellulose, PVP-K30, colloidal silicon dioxide, magnesium stearate, purified water.
6 pcs. – strips (1) complete with an applicator – cardboard packs.
Vaginal tablets are white, capsule-shaped, one end of the tablet is oval, the other is rectangular.
| 1 tab. | |
| Clotrimazole | 200 mg |
Excipients: lactose, microcrystalline cellulose, povidone K30, colloidal silicon dioxide, magnesium stearate, purified water.
6 pcs. – strips (1) complete with an applicator – cardboard packs.
Vaginal tablets are white, capsule-shaped, one end of the tablet is oval, the other is rectangular.
| 1 tab. | |
| Clotrimazole | 500 mg |
Excipients: lactose, microcrystalline cellulose, povidone K30, colloidal silicon dioxide, magnesium stearate, purified water.
6 pcs. – strips (1) complete with an applicator – cardboard packs.
Cream for external use 1%: tube 20 g
Marketing Authorization Holder
SK Meditech, Private Limited (India)
Manufactured By
Lok-Beta Pharmaceuticals (India), Private Limited (India)
Dosage Form
|
Clotrimazole | Cream for external use 1%: tube 20 g |
Dosage Form, Packaging, and Composition
Cream for external use in the form of a homogeneous soft mass of white color.
| 1 g | |
| Clotrimazole | 10 mg |
Excipients: cetomacrogol 1000, cetostearyl alcohol, white soft paraffin, liquid paraffin, propylene glycol, chlorocresol, sodium dihydrogen phosphate, purified water.
20 g – tubes (1) – cardboard packs.
Vaginal tablets 100 mg: 6 pcs.
Marketing Authorization Holder
SK Meditech, Private Limited (India)
Manufactured By
Lok-Beta Pharmaceuticals (India), Private Limited (India)
Dosage Form
|
Clotrimazole | Vaginal tablets 100 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal tablets from white to almost white, oblong, biconvex, capsule-shaped, smooth on both sides.
| 1 tab. | |
| Clotrimazole | 100 mg |
Excipients: lactose monohydrate – 926 mg, corn starch – 420 mg, povidone (K-30) – 20 mg, sodium starch glycolate – 74 mg, colloidal silicon dioxide (anhydrous) – 5 mg, purified talc – 8 mg, magnesium stearate – 7 mg.
6 pcs. – strips made of aluminum foil (1) – cardboard packs.
Cream for external use 1%: 20 g, 30 g, or 50 g tubes
Marketing Authorization Holder
Atoll LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Clotrimazole | Cream for external use 1%: 20 g, 30 g, or 50 g tubes |
Dosage Form, Packaging, and Composition
Cream for external use is homogeneous, white in color.
| 100 g | |
| Clotrimazole | 1 g |
Excipients: propylene glycol – 29.45 g, macrogol 1500 – 20 g, poloxamer 338 – 5 g, macrogol 4000 – 5 g, purified water – 4.5 g, cetostearyl alcohol – 2.5 g, macrogol cetostearyl ether 20 – 2.5 g, disodium edetate dihydrate – 0.75 g, macrogol 400 – up to 100 g.
20 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
50 g – aluminum tubes (1) – cardboard packs.
Cream for external use 1%: tube 20 g
Marketing Authorization Holder
GlaxoSmithKline Trading, JSC (Russia)
Manufactured By
GlaxoSmithKline Pharmaceuticals, S.A. (Poland)
Dosage Form
|
Clotrimazole | Cream for external use 1%: tube 20 g |
Dosage Form, Packaging, and Composition
Cream for external use 1% in the form of a homogeneous white mass.
| 100 g | |
| Clotrimazole | 1 g |
Excipients: benzyl alcohol – 1 g, cetostearyl alcohol – 11.5 g, octyldodecanol – 10 g, polysorbate 60 – 1.5 g, sorbitan stearate – 2 g, synthetic spermaceti – 3 g, water – 71 g.
20 g – aluminum tubes (1) – cardboard packs.
Vaginal tablets 100 mg: 6 pcs.
Marketing Authorization Holder
GlaxoSmithKline Trading, JSC (Russia)
Manufactured By
GlaxoSmithKline Pharmaceuticals, S.A. (Poland)
Dosage Form
|
Clotrimazole | Vaginal tablets 100 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal tablets are white, oblong, biconvex, with a smooth surface, rounded at one end and flat at the other.
| 1 tab. | |
| Clotrimazole | 100 mg |
Excipients: lactose monohydrate – 1122.2 mg, potato starch – 180 mg, adipic acid – 140 mg, sodium bicarbonate – 110 mg, magnesium stearate – 31.3 mg, colloidal silicon dioxide – 12.3 mg, sodium lauryl sulfate – 4.2 mg.
6 pcs. – blisters (1) – cardboard packs.
Gel for external use 1%: tubes 20 g or 40 g
Marketing Authorization Holder
Zelenaya Dubrava, CJSC (Russia)
Dosage Form
|
Clotrimazole | Gel for external use 1%: tubes 20 g or 40 g |
Dosage Form, Packaging, and Composition
Gel for external use is white or white with a yellowish tint, homogeneous, with a faint characteristic odor.
| 100 g | |
| Clotrimazole | 1 g |
Excipients: castor oil – 10 g, polyacrylate lightly cross-linked – 1.2 mg, sodium hydroxide – 0.15 g, polysorbate 80 (tween 80) – 1 g, purified water – up to 100 g.
20 g – varnished aluminum tubes (1) – cardboard packs.
40 g – varnished aluminum tubes (1) – cardboard packs.
Vaginal tablets 100 mg: 10 pcs.
Marketing Authorization Holder
ZiO-Health CJSC (Russia)
Dosage Form
|
Clotrimazole | Vaginal tablets 100 mg: 10 pcs. |
Dosage Form, Packaging, and Composition
| Vaginal tablets | 1 tab. |
| Clotrimazole | 100 mg |
10 pcs. – contour cell packs (1) – cardboard packs.
Solution for external use 1%: bottle or dropper bottle 15 ml, 25 ml, 30 ml, 40 ml, 50 ml or 100 ml.
Marketing Authorization Holder
Ivanovo Pharmaceutical Factory PJSC (Russia)
Dosage Form
|
Clotrimazole | Solution for external use 1%: bottle or dropper bottle 15 ml, 25 ml, 30 ml, 40 ml, 50 ml or 100 ml. |
Dosage Form, Packaging, and Composition
Solution for external use: a transparent, from colorless to almost colorless, with a yellowish or brownish tint, viscous liquid. A faint specific odor is allowed.
| 1 g of solution | |
| Clotrimazole | 10 mg |
Excipients: propylene glycol – 990 mg.
15 ml – bottle (1) – cardboard packs.
15 ml – bottle (1) (for hospitals).
15 ml – dropper bottle (1) – cardboard packs.
15 ml – dropper bottle (1) (for hospitals).
25 ml – bottle (1) – cardboard packs.
25 ml – bottle (1) (for hospitals).
25 ml – dropper bottle (1) – cardboard packs.
25 ml – dropper bottle (1) (for hospitals).
30 ml – bottle (1) – cardboard packs.
30 ml – bottle (1) (for hospitals).
30 ml – dropper bottle (1) – cardboard packs.
30 ml – dropper bottle (1) (for hospitals).
40 ml – bottle (1) – cardboard packs.
40 ml – bottle (1) (for hospitals).
40 ml – dropper bottle (1) – cardboard packs.
40 ml – dropper bottle (1) (for hospitals).
50 ml – bottle (1) – cardboard packs.
50 ml – bottle (1) (for hospitals).
50 ml – dropper bottle (1) – cardboard packs.
50 ml – dropper bottle (1) (for hospitals).
100 ml – bottle (1) – cardboard packs.
100 ml – bottle (1) (for hospitals).
100 ml – dropper bottle (1) – cardboard packs.
100 ml – dropper bottle (1) (for hospitals).
Ointment for external use 1%: jars or tubes 25 g, 30 g, 40 g, 50 g, or 100 g
Marketing Authorization Holder
Ivanovo Pharmaceutical Factory PJSC (Russia)
Dosage Form
|
Clotrimazole | Ointment for external use 1%: jars or tubes 25 g, 30 g, 40 g, 50 g, or 100 g |
Dosage Form, Packaging, and Composition
Ointment for external use is white or almost white in color.
| 100 g | |
| Clotrimazole | 1 g |
Excipients: macrogol 400 (polyethylene glycol 400), macrogol 1500 (polyethylene glycol 1500), propylene glycol, methylparaben.
25 g – dark glass jars (1) – cardboard packs.
30 g – dark glass jars (1) – cardboard packs.
40 g – dark glass jars (1) – cardboard packs.
50 g – dark glass jars (1) – cardboard packs.
100 g – dark glass jars (1) – cardboard packs.
25 g – dark glass jars (9-300 pcs.) – cardboard boxes.
30 g – dark glass jars (9-300 pcs.) – cardboard boxes.
40 g – dark glass jars (9-300 pcs.) – cardboard boxes.
50 g – dark glass jars (9-300 pcs.) – cardboard boxes.
100 g – dark glass jars (9-300 pcs.) – cardboard boxes.
25 g – aluminum tube (1) – cardboard packs.
30 g – aluminum tube (1) – cardboard packs.
40 g – aluminum tube (1) – cardboard packs.
50 g – aluminum tube (1) – cardboard packs.
100 g – aluminum tube (1) – cardboard packs.
25 g – aluminum tube (9-300 pcs.) – cardboard boxes.
30 g – aluminum tube (9-300 pcs.) – cardboard boxes.
40 g – aluminum tube (9-300 pcs.) – cardboard boxes.
50 g – aluminum tube (9-300 pcs.) – cardboard boxes.
100 g – aluminum tube (9-300 pcs.) – cardboard boxes.
Solution for external use 1%: fl. 15 ml, 20 ml or 25 ml
Marketing Authorization Holder
Kirov Pharmaceutical Factory, JSC (Russia)
Dosage Form
|
Clotrimazole | Solution for external use 1%: fl. 15 ml, 20 ml or 25 ml |
Dosage Form, Packaging, and Composition
Solution for external use in the form of a transparent, from colorless to almost colorless, with a yellowish or brownish tint, viscous liquid; a faint specific odor is allowed.
| 1 g | |
| Clotrimazole | 10 mg |
Excipients: propylene glycol – 990 mg.
15 ml – bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.
Bottles (10) – cardboard boxes (for hospitals).
Bottles (20) – cardboard boxes (for hospitals).
Bottles (50) – cardboard boxes (for hospitals).
Ointment for external use 1%: tube 15 or 30 g
Marketing Authorization Holder
Murom Instrument-Making Plant, FSUE (Russia)
Dosage Form
|
Clotrimazole | Ointment for external use 1%: tube 15 or 30 g |
Dosage Form, Packaging, and Composition
Ointment for external use from white to white with a yellowish tint with a slight specific odor.
| 100 g | |
| Clotrimazole | 1 g |
Excipients: emulsifying wax 4 g, cetearyl alcohol (cetyl alcohol 60%, stearyl alcohol 40%) 2 g, monoglycerides 4 g, polysorbate 80 2 g, propylene glycol 2 g, glycerol 5 g, castor oil 7 g, methylparaben 0.15 g, propylparaben 0.05 g, purified water up to 100 g.
15 g – aluminum tubes (1) – cardboard packs.
30 g – aluminum tubes (1) – cardboard packs.
Cream for external use 1%: tube 20 g or 30 g
Marketing Authorization Holder
Elfa SPC, JSC (Russia)
Manufactured By
Lok-Beta Pharmaceuticals (India), Private Limited (India)
Dosage Form
|
Clotrimazole | Cream for external use 1%: tube 20 g or 30 g |
Dosage Form, Packaging, and Composition
Cream for external use as a homogeneous white mass.
| 1 g | |
| Clotrimazole | 10 mg |
Excipients: chlorocresol – 1 mg, cetomacrogol 1000 – 18.1 mg, cetearyl alcohol – 73.3 mg, white soft paraffin – 75 mg, liquid paraffin – 60 mg, sodium dihydrogen phosphate dihydrate – 3.4 mg, propylene glycol – 70 mg, purified water – up to 1 g.
20 g – tube (1) – cardboard pack.
30 g – tube (1) – cardboard pack.
Vaginal tablets 100 mg: 3, 6, 9, 12, 15, 18, 24 or 30 pcs.
Marketing Authorization Holder
Ozon, LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Or
Ozon Pharm, LLC (Russia)
Dosage Form
|
Clotrimazole | Vaginal tablets 100 mg: 3, 6, 9, 12, 15, 18, 24 or 30 pcs. |
Dosage Form, Packaging, and Composition
Vaginal tablets white, biconvex, oval-shaped on one side, and rectangular with beveled edges on the other side.
| 1 tab. | |
| Clotrimazole | 100 mg |
Excipients: lactose monohydrate 200 M (milk sugar) – 350 mg, corn starch – 255 mg, microcrystalline cellulose – 205 mg, gelatin – 40 mg, colloidal silicon dioxide – 30 mg, sodium benzoate – 10 mg, magnesium stearate – 10 mg.
3 pcs. – contour cell blisters (1) – cardboard packs.
3 pcs. – contour cell blisters (2) – cardboard packs.
3 pcs. – contour cell blisters (3) – cardboard packs.
3 pcs. – contour cell blisters (4) – cardboard packs.
3 pcs. – contour cell blisters (5) – cardboard packs.
6 pcs. – contour cell blisters (1) – cardboard packs.
6 pcs. – contour cell blisters (2) – cardboard packs.
6 pcs. – contour cell blisters (3) – cardboard packs.
6 pcs. – contour cell blisters (4) – cardboard packs.
6 pcs. – contour cell blisters (5) – cardboard packs.
Cream for external use 1%: tube 20 g
Marketing Authorization Holder
Remedia, LLC (Russia)
Dosage Form
|
Clotrimazole | Cream for external use 1%: tube 20 g |
Dosage Form, Packaging, and Composition
| Cream for external use 1% | 1 g |
| Clotrimazole | 10 mg |
20 g – aluminum tubes (1) – cardboard packs.
Solution for external use 1%: fl. 15 ml, 20 ml or 25 ml
Marketing Authorization Holder
Rif LLC (Russia)
Manufactured By
Ozon, LLC (Russia)
Dosage Form
|
Clotrimazole | Solution for external use 1%: fl. 15 ml, 20 ml or 25 ml |
Dosage Form, Packaging, and Composition
Solution for external use transparent, colorless or almost colorless, with a yellowish or brownish tint, viscous, with a slight characteristic odor.
| 1 ml | |
| Clotrimazole | 10 mg |
Excipients: propylene glycol.
15 ml – bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.
Ointment for external use 1%: tube 30 g
Marketing Authorization Holder
Sintez PJSC (Russia)
Dosage Form
|
Clotrimazole | Ointment for external use 1%: tube 30 g |
Dosage Form, Packaging, and Composition
Ointment for external use 1% white or almost white, homogeneous.
| 1 g | |
| Clotrimazole | 10 mg |
Excipients: propylene glycol, polyethylene oxide 1500, polyethylene oxide 400, nipagin (methylparaben) or methylparaben.
30 g – aluminum tubes (1) – cardboard packs.
Solution for external use 1%: fl. 5 ml,10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 65 ml, 70 ml, 75 ml, 80 ml, 85 ml, 90 ml, 95 ml and 100 ml
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Clotrimazole | Solution for external use 1%: fl. 5 ml,10 ml, 15 ml, 20 ml, 25 ml, 30 ml, 35 ml, 40 ml, 45 ml, 50 ml, 55 ml, 60 ml, 65 ml, 70 ml, 75 ml, 80 ml, 85 ml, 90 ml, 95 ml and 100 ml |
Dosage Form, Packaging, and Composition
Solution for external use transparent, colorless or with a yellowish tint, viscous.
| 1 ml | |
| Clotrimazole | 10 mg |
Excipients: glycerol – 125.2 mg, propylene glycol – 925 mg.
5 ml – bottles (1) – cardboard packs.
10 ml – bottles (1) – cardboard packs.
15 ml – bottles (1) – cardboard packs.
20 ml – bottles (1) – cardboard packs.
25 ml – bottles (1) – cardboard packs.
30 ml – bottles (1) – cardboard packs.
35 ml – bottles (1) – cardboard packs.
40 ml – bottles (1) – cardboard packs.
45 ml – bottles (1) – cardboard packs.
50 ml – bottles (1) – cardboard packs.
55 ml – bottles (1) – cardboard packs.
60 ml – bottles (1) – cardboard packs.
65 ml – bottles (1) – cardboard packs.
70 ml – bottles (1) – cardboard packs.
75 ml – bottles (1) – cardboard packs.
80 ml – bottles (1) – cardboard packs.
85 ml – bottles (1) – cardboard packs.
90 ml – bottles (1) – cardboard packs.
95 ml – bottles (1) – cardboard packs.
100 ml – bottles (1) – cardboard packs.
Cream for external use 1%: 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 110 g, 120 g, 130 g, 140 g, 150 g, 160 g, 170 g, 180 g, 190 g, or 200 g tubes
Marketing Authorization Holder
Tula Pharmaceutical Factory, LLC (Russia)
Dosage Form
|
Clotrimazole | Cream for external use 1%: 10 g, 15 g, 20 g, 25 g, 30 g, 35 g, 40 g, 45 g, 50 g, 55 g, 60 g, 65 g, 70 g, 75 g, 80 g, 85 g, 90 g, 95 g, 100 g, 110 g, 120 g, 130 g, 140 g, 150 g, 160 g, 170 g, 180 g, 190 g, or 200 g tubes |
Dosage Form, Packaging, and Composition
Cream for external use white, homogeneous.
| 100 g | |
| Clotrimazole | 1 g |
Excipients: benzyl alcohol – 2 g, sorbitan stearate – 2 g, polysorbate-60 – 1.5 g, cetyl palmitate – 3 g, cetearyl alcohol [cetyl alcohol 60%, stearyl alcohol 40%] – 10 g, octyldodecanol – 13.5 g, purified water – 67 g.
10 g – tubes (1) – cardboard packs.
15 g – tubes (1) – cardboard packs.
20 g – tubes (1) – cardboard packs.
25 g – tubes (1) – cardboard packs.
30 g – tubes (1) – cardboard packs.
35 g – tubes (1) – cardboard packs.
40 g – tubes (1) – cardboard packs.
45 g – tubes (1) – cardboard packs.
50 g – tubes (1) – cardboard packs.
55 g – tubes (1) – cardboard packs.
60 g – tubes (1) – cardboard packs.
65 g – tubes (1) – cardboard packs.
70 g – tubes (1) – cardboard packs.
75 g – tubes (1) – cardboard packs.
80 g – tubes (1) – cardboard packs.
85 g – tubes (1) – cardboard packs.
90 g – tubes (1) – cardboard packs.
95 g – tubes (1) – cardboard packs.
100 g – tubes (1) – cardboard packs.
110 g – tubes (1) – cardboard packs.
120 g – tubes (1) – cardboard packs.
130 g – tubes (1) – cardboard packs.
140 g – tubes (1) – cardboard packs.
150 g – tubes (1) – cardboard packs.
160 g – tubes (1) – cardboard packs.
170 g – tubes (1) – cardboard packs.
180 g – tubes (1) – cardboard packs.
190 g – tubes (1) – cardboard packs.
200 g – tubes (1) – cardboard packs.
Cream for external use 1%: tube 15 g
Marketing Authorization Holder
Pharmaprim, LLC (Republic of Moldova)
Dosage Form
|
Clotrimazole | Cream for external use 1%: tube 15 g |
Dosage Form, Packaging, and Composition
Cream for external use as a homogeneous mass from white to almost white.
| 1 g | |
| Clotrimazole | 10 mg |
Excipients: cetearyl alcohol, octyldodecanol, polysorbate 60, sorbitan stearate, cetyl palmitate, benzyl alcohol, purified water.
15 g – tube (1) – cardboard packs.
Vaginal suppositories 100 mg: 6 pcs.
Marketing Authorization Holder
Pharmaprim, LLC (Republic of Moldova)
Dosage Form
|
Clotrimazole | Vaginal suppositories 100 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal suppositories cylindroconical in shape, from white to white with a yellowish tint; an air core or funnel-shaped depression may be present on the cut.
| 1 supp. | |
| Clotrimazole | 100 mg |
Excipients: semi-synthetic glycerides (sufficient quantity to obtain a suppository weighing 2 g).
6 pcs. – contour cell blisters (1) – cardboard packs.
Vaginal tablets 100 mg: 6 pcs.
Marketing Authorization Holder
Pharmconcept, LLC (Russia)
Dosage Form
|
Clotrimazole | Vaginal tablets 100 mg: 6 pcs. |
Dosage Form, Packaging, and Composition
Vaginal tablets white or white with a yellowish tint, oblong, biconvex, teardrop-shaped.
| 1 tab. | |
| Clotrimazole | 100 mg |
Excipients: lactose monohydrate – 926 mg, corn starch – 420 mg, povidone (K-30) – 20 mg, sodium carboxymethyl starch – 74 mg, colloidal silicon dioxide (anhydrous) – 5 mg, purified talc – 8 mg, magnesium stearate – 7 mg.
6 pcs. – strips made of aluminum foil (1) – cardboard packs.
Solution for external use 10 mg/1 ml: bottle 15 ml or 20 ml
Marketing Authorization Holder
Pharmstandard-Lexredstva OJSC (Russia)
Dosage Form
|
Clotrimazole | Solution for external use 10 mg/1 ml: bottle 15 ml or 20 ml |
Dosage Form, Packaging, and Composition
Solution for external use as a transparent, from colorless to almost colorless, with a yellowish or brownish tint viscous liquid; a specific odor may be present.
| 1 g | |
| Clotrimazole | 10 mg |
Excipients: propylene glycol.
15 ml – dark glass bottles with a dropper cap (1) with first opening control – cardboard packs.
20 ml – dark glass bottles with a dropper cap (1) with first opening control – cardboard packs.
![Clotrimazole [Tablets, Solution, Ointment, Cream, Gel, Suppositories] 1](https://www.medixlife.com/wp-content/uploads/Medixlife_favi_512.png "Clotrimazole [Tablets, Solution, Ointment, Cream, Gel, Suppositories] 2")