Ivermectin

Drug overview for IVERMECTIN (ivermectin):

Generic name: IVERMECTIN (EYE-ver-MEK-tin)
Drug class: Acne Antibiotics
Therapeutic class: Dermatological

Ivermectin, a semisynthetic, avermectin-derivative, is used topically as a pediculicide.

No enhanced Uses information available for this drug.

DRUG IMAGES

IVERMECTIN 1% CREAM

The following indications for IVERMECTIN (ivermectin) have been approved by the FDA:

Indications:
Acne rosacea

Professional Synonyms:
Acne erythematosa
Rosacea

Dosing information for IVERMECTIN
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
IVERMECTIN 1% CREAM	Maintenance	Adults apply a pea-sized amount by topical route once daily to cover areas of face with thin layer avoiding the eyes and lips

Generic dosing information for IVERMECTIN
DRUG LABEL	DOSING TYPE	DOSING INSTRUCTIONS
IVERMECTIN 1% CREAM	Maintenance	Adults apply a pea-sized amount by topical route once daily to cover areas of face with thin layer avoiding the eyes and lips

The following adverse reaction information is available for IVERMECTIN (ivermectin):

Overview
Severe
Less Severe

Adverse reaction overview.

Conjunctivitis, ocular hyperemia, eye irritation, dandruff, dry skin, and burning skin sensation were reported in less than 1% of patients 6 months of age or older after a single 10-minute topical application of ivermectin 0.5% lotion.

There are 4 severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Allergic dermatitis Dyspnea Ocular irritation Skin rash

There are 8 less severe adverse reactions.

More Frequent	Less Frequent
None.	None.

Rare/Very Rare
Conjunctival hyperemia Contact dermatitis Dandruff Dry skin Ocular redness Skin irritation Stinging of skin Treatment site sequelae

The following precautions are available for IVERMECTIN (ivermectin):

Pediatric
Pregnant
Lactation
Geriatric

Safety and efficacy of ivermectin 0.5% lotion have not been established in children younger than 6 months of age. Because these young children have a greater skin surface area to body mass ratio and potentially immature skin barrier, systemic absorption may be increased and children younger than 6 months of age may be at increased risk of ivermectin toxicity.

Ivermectin 0.5% lotion should not be used in children younger than 6 months of age. The lotion should be kept out of the reach of children and should be used only under the direct supervision of an adult.

Contraindicated

None

Severe Precaution

None

Management or Monitoring Precaution

None

Category C. (See Users Guide)

Orally administered ivermectin is distributed into milk in low concentrations. Since it is not known if ivermectin is distributed into milk following topical administration, the 0.5% lotion should be used with caution in nursing women.

Clinical studies of ivermectin 0.5% lotion did not include sufficient numbers of patients 65 years of age or older to determine whether geriatric patients respond differently than younger adults; other clinical experience has not identified differences in response between geriatric and younger patients.

Acne rosacea
L71.0	Perioral dermatitis
L71.9	Rosacea, unspecified