Ketoconazole
- Ketoconazole
- No Brand Name
- Topical Semi-Solid and Suppository
- 2%
- Bottle
- 20 mL
Each 100 mL Contains:
Ketoconazole 2 g
Ketoconazole 2 g
• Seborrheic Dermatitis
• Tinea infections
• Cutaneous Candidiasis
• Tinea infections
• Cutaneous Candidiasis
Mechanism of Action
Fungistatic in action, but may be fungicidal at high concentrations after prolonged incubation or against very susceptible organisms
Alters cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition
Pharmacokinetics
-
Contraindications
• Hypersensitivity
• Scalp that is broken or inflamed
Adverse Reactions
Rritation (severe), Pruritus, Stinging
Major Drug Interactions
-
Warnings
• -
Recommendations for Patient
• Discontinue if irritation occurs
• Avoid contact with eyes and other mucous membranes, not for oral, intravaginal or ophthalmic use, discontinue use and contact health care professional if condition worsens or does not improve
Pregnancy Considerations
Category: C
Breastfeeding Considerations
There is no information available on presence of ketoconazole in human milk, or effects on breastfed child, or effects on milk production after topical application to women who are breastfeeding, in animal studies ketoconazole was found in milk following oral administration, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition. However, topical use on the breast or nipples should be avoided in nursing mothers because of possible oral ingestion by the infant and the availability of safer alternatives. Only water-miscible products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Fungistatic in action, but may be fungicidal at high concentrations after prolonged incubation or against very susceptible organisms
Alters cellular membranes, resulting in increased membrane permeability, secondary metabolic effects, and growth inhibition
Pharmacokinetics
-
Contraindications
• Hypersensitivity
• Scalp that is broken or inflamed
Adverse Reactions
Rritation (severe), Pruritus, Stinging
Major Drug Interactions
-
Warnings
• -
Recommendations for Patient
• Discontinue if irritation occurs
• Avoid contact with eyes and other mucous membranes, not for oral, intravaginal or ophthalmic use, discontinue use and contact health care professional if condition worsens or does not improve
Pregnancy Considerations
Category: C
Breastfeeding Considerations
There is no information available on presence of ketoconazole in human milk, or effects on breastfed child, or effects on milk production after topical application to women who are breastfeeding, in animal studies ketoconazole was found in milk following oral administration, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on breastfed infant from treatment or from underlying maternal condition. However, topical use on the breast or nipples should be avoided in nursing mothers because of possible oral ingestion by the infant and the availability of safer alternatives. Only water-miscible products should be applied to the breast because ointments may expose the infant to high levels of mineral paraffins via licking.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
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