Zilxi (minocycline HCl)

It isessential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

*For topical use only. Not for oral, ophthalmic or intravaginal use.

*After shaking the can containing the minocycline foam well, a small amount of topical foam (e.g., a cherry-sized amount) should be expressed from the can onto the fingertips of the hand and then gently rubbed into acne-affected parts of the face. This should be repeated as needed until all acne-affected parts of the face are treated.

*If acne is present on other parts of the patient's body (neck, shoulders, arms, back or chest), additional amounts of topical foam should also be applied to these areas.

*The topical foam should be applied once daily at approximately the same time each day at least 1 hour before bedtime.

*The patient should not bathe, shower or swim for at least 1 hour after application of the product.

No dosing information is available for this tab.

No dosing information is available for this tab.

No dosing information is available for this tab.

There is no enhanced messaging for this drug.

There are no contraindication interactions for this drug.

There are no severe interactions for this drug.

There are no moderate interactions for this drug.

Topical use of minocycline foam is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the ingredients within the commercially available formulation.

There are no contraindication contraindications for this drug.

There are no severe contraindications for this drug.

There are no moderate contraindications for this drug.

The most commonly observed adverse reaction is headache.

There are no severe adverse reactions for this drug.

There are no less severe adverse reactions for this drug.

No enhanced messaging available.

The safety and effectiveness of minocycline topical foam have been established in pediatric patients 9 years of age and older for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris. Use of minocycline foam for this indication is supported by three adequate and well controlled 12-week trials in patients 9 years of age and older; two of the trials included a 40-week open-label extension. Additional data were obtained from a 7-day open-label safety and pharmacokinetics study conducted in 20 patients 10 years to less than 17 years of age with acne vulgaris. A total of 686 subjects 9 years of age and older received minocycline topical foam in these clinical trials.

Safety and effectiveness for this indication have not been established in pediatric patients less than 9 years of age. The use of oral tetracycline drugs during tooth development below the age of 8 years may cause permanent discoloration of the teeth (yellow-gray-brown) and inhibition of bone growth.

Risk Summary: Available data with minocycline topical foam use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic absorption of minocycline in humans is low following once-daily topical administration of minocycline foam for 21 days. Because of low systemic exposure, it is not expected that maternal use of minocycline foam will result in significant fetal exposure to the drug.

Tetracycline-class drugs may cause permanent discoloration of teeth and reversible inhibition of bone growth when administered orally during pregnancy.

Animal reproduction studies were not conducted with minocycline topical foam. In animal reproduction studies, oral administration of minocycline administered to pregnant rats and rabbits during the period of organogenesis induced skeletal malformations in fetuses at systemic exposures of 750 and 500 times, respectively, the maximum recommended human dose (MRHD; based on AUC comparison) of minocycline topical foam.

The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively.

Animal Data: Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can cause retardation of skeletal development of the developing fetus.

Minocycline induced skeletal malformations (bent limb bones) in fetuses when orally administered to pregnant rats and rabbits during the period of organogenesis at doses of 30 mg/kg/day and 100 mg/kg/day, respectively (750 and 500 times, respectively, the systemic exposure at the MRHD based on AUC comparison). Reduced mean fetal body weight was observed when minocycline was orally administered to pregnant rats during the period of organogenesis at a dose of 10 mg/kg/day (250 times the systemic exposure at the MRHD based on AUC comparison).

Minocycline was assessed for effects on peri- and post-natal development of rats in a study that involved oral administration to pregnant rats during the period of organogenesis through lactation, at doses of 5, 10, or 50 mg/kg/day. In this study, body weight gain was significantly reduced in pregnant females that received 50 mg/kg/day (650 times the systemic exposure at the MRHD based on AUC comparison). No effects of treatment on the duration of the gestation period or the number of live pups born per litter were observed. Gross external anomalies observed in F1 pups (offspring of animals that received oral minocycline) included reduced body size, improperly rotated forelimbs, and reduced size of extremities. No effects were observed on the physical development, behavior, learning ability, or reproduction of F1 pups, and there was no effect on gross appearance of F2 pups (offspring of F1 animals).

Tetracycline-class drugs, including minocycline, are present in breast milk following oral administration. It is not known whether minocycline is present in human milk after topical administration to the nursing mother. There are no data on the effects of minocycline on milk production. Because of the potential for serious adverse reactions, advise patients that breastfeeding is not recommended during treatment with minocycline topical foam.

Clinical studies of topical minocycline foam did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.