Clotrimazole (Dosing, Interaction, Side Effect, Administration, Etc..)

DRUG CLASS:
Antifungal
Imidazole

DOSING:
Adult Dose:
Important Note:
Orphan drug designation:
Treatment of sickle cell disease
Treatment of Huntington disease
Topical treatment in adults and children with pouchitis
(Otic solution): Treatment of fungal otitis externa (otomycosis)

General Dosage Information:

Clotrimazole

1%

cream

and solution has not been found by the US Food and Drug Administration (FDA) to be safe and effective; and the drug product labeling has not been approved by the FDA.

Candidal vulvovaginitis:
(1%

external cream

)
Apply a small amount of cream to itchy; irritated skin outside the vagina twice daily for up to 7 days

(2% external cream)
Apply a small amount of

cream

to itchy; irritated skin outside the vagina twice daily for up to 7 days

(1%

vaginal cream

)
1 Applicatorful (50 mg) intravaginally at bedtime for 7 days (FDA dosage)

(1% vaginal cream)
1 Applicatorful (50 mg) intravaginally at bedtime for 7 to 14 days (guideline dosage)

(2% vaginal cream)
1 Applicatorful (100 mg) intravaginally at bedtime for 3 days

Candidal vulvovaginitis; Recurrent; Prophylaxis:
500 mg vaginal suppository intravaginally once weekly OR 200 mg vaginal

tablet

intravaginally twice weekly for at least 6 months

Candidiasis; Topical:
Apply thin layer of 1% cream twice daily for up to 4 weeks

Oropharyngeal candidiasis:
Slowly dissolve one 10mg lozenge orally 5 times/day for 14 days (FDA dosage)

(Troches)
10 mg orally 5 times daily for 7 to 14 days (guideline dosage)

(HIV infection. troches)
10 mg orally 5 times daily for 7 to 14 days (guideline dosage)

Oropharyngeal candidiasis; Prophylaxis:
(Lozenge)
Slowly dissolve one 10mg lozenge orally 3 times/day for the duration of chemotherapy or until steroids are reduced to maintenance levels

Pityriasis versicolor:
Apply thin layer of 1% cream twice daily for up to 4 weeks

Tinea corporis:
Apply thin layer of 1%

topical cream

or solution over the affected area twice daily for 4 weeks

Tinea cruris:
Apply thin layer of 1% topical cream or solution over the affected area twice daily for 2 weeks

Tinea pedis:
Apply thin layer of 1% topical cream or solution over the affected area twice daily for 4 weeks

Pediatric Dose:
Important Note:
Orphan drug designation:
Treatment of sickle cell disease
Treatment of Huntington disease
Topical treatment in adults and children with pouchitis
(Otic solution): Treatment of fungal otitis externa (otomycosis)

General Dosage Information:

Clotrimazole

1% cream and solution have not been found by the US Food and Drug Administration (FDA) to be safe and effective; and the drug product labeling has not been approved by the FDA.

Candidal vulvovaginitis: for 12 years or older
(1% external cream) (2% external cream)
Apply a small amount of cream to itchy; irritated skin outside the vagina twice daily for up to 7 days

(1% vaginal cream)
1 Applicatorful (50 mg) intravaginally at bedtime for 7 days

(2% vaginal cream)
1 Applicatorful (100 mg) intravaginally at bedtime for 3 days

Candidiasis; Topical:
Apply thin layer of 1% cream twice daily for up to 4 weeks

Oropharyngeal candidiasis:
(3 years and older)
Slowly dissolve one 10mg lozenge orally 5 times/day for 14 days (FDA dosage)

(HIV positive)
Slowly dissolve 1 lozenge orally 4 times/day for 7 to 14 days(Guideline dosage)

Pityriasis versicolor:
Apply thin layer of 1% cream twice daily for up to 4 weeks

Tinea corporis:
(2 years or older)
Apply thin layer of

1% topical cream

or solution over the affected area twice daily for 4 weeks

Tinea cruris:
(2 years or older)
Apply thin layer of 1% topical cream or solution over the affected area twice daily for 2 weeks

Tinea pedis:
(2 years or older)
Apply thin layer of 1% topical cream or solution over the affected area twice daily for 4 weeks

INDICATIONS:
FDA-LABELED INDICATIONS:
Candidal vulvovaginitis
Candidiasis; Topical
Oropharyngeal candidiasis
Oropharyngeal candidiasis; Prophylaxis
Pityriasis versicolor

NON-FDA LABELED INDICATIONS:
Candidal vulvovaginitis; Recurrent; Prophylaxis
Tinea corporis
Tinea cruris
Tinea pedis

MECHANISM OF ACTION:
Oral-Local and Topical:
Fungistatic; may be fungicidal; depending on concentration; inhibits biosynthesis of ergosterol or other sterols; damaging the fungal cell wall membrane and altering its permeability ; as a result; loss of essential intracellular elements may occur ; also inhibits biosynthesis of triglycerides and phospholipids by fungi; in addition; inhibits oxidative and peroxidative enzyme activity; resulting in intracellular buildup of toxic concentrations of hydrogen peroxide; which may contribute to deterioration of subcellular organelles and cellular necrosis. In Candida albicans; inhibits transformation of blastospores into invasive mycelial form.
Also has some antibacterial activity.

ADVERSE EFFECT:
Common:
Gastrointestional:
Nausea
Vomiting

CONTRAINDICATION:
Hypersensitivity to Clotrimazole

DRUG INTERACTION:
Moderate:
Tacrolimus (established)
Trimetrexate (probable)
PHARMACOKINETICS:
Absorption:
Oral local: Poor and erratic
Topical: Minimal

Metabolism:
Oral-Local: Hepatic

Excretion:
Oral-Local: Fecal

PRECAUTION:
Hepatic impairment (troches)
Pregnancy (

vaginal use

)

PREGNANCY CATEGORY:
C (FDA)
A (AUS)

BREAST FEEDING:
Risk cannot be ruled out.

MONITORING:
Symptomatic improvement
Oral candidiasis patients: liver function when treating with oral troches
Signs of local irritation; erythema or inflammation at application site

HOW TO TAKE OR ADMINISTRATION:
Insertion, vaginal:
Do not

use

tampons, douches, spermicides, or other vaginal products during treatment.
Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases during treatment.
Do not have vaginal intercourse during treatment.

Oral:
Slowly dissolve lozenge in the mouth.

Topical:
For

external use

only
Avoid contact with eyes
Wash the affected area and dry thoroughly
For athlete's foot, pay special attention to spaces between toes, wear wellfitting, ventilated shoes, and change shoes and socks at least once daily

Topical application, vaginal:
Do not use tampons, douches, spermicides, or other vaginal products during treatment.
Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases during treatment.
Do not have vaginal intercourse during treatment.
Apply to itchy, irritated skin outside the vagina.

DOSAGE FORM:
Vaginal Cream: 2 %
Topical Cream: 1 %

TOXICOLOGY:
A minimum toxic dose has not been established; and significant toxicity is not expected after an overdose. Ingestion of even large quantities should produce only minor GI symptoms (eg; nausea; vomiting; and diarrhea).

TREATMENTS:
MANAGEMENT OF MILD TO MODERATE TOXICITY:
Treatment is symptomatic and supportive. Toxicity due to these agents is negligible.

MANAGEMENT OF SEVERE TOXICITY:
Treatment is symptomatic and supportive. Significant toxicity is not expected after an overdose. Correct any significant fluid and/or electrolyte abnormalities in patients with severe diarrhea and/or vomiting. In patients with acute allergic reaction; oxygen therapy; bronchodilators; diphenhydramine; corticosteroids; vasopressors and epinephrine may be required.

PATIENT COUNSELING OR CLINICAL TEACHING:
Oral form may cause nausea or vomiting.
Advise patients using the intravaginal formulation to not use tampons during treatment.
Instruct patients using the topical formulation to not use occlusive dressings over the treated area.
Patient should avoid douches or other intravaginal products during drug therapy




Disclaimer:
For the Registered Medical Practitioner Only. We are not recommended for self medication. self medication is may harmful for health. We are only information about medicine.