Minocycline Hydrochloride

MINOCYCLINE HYDROCHLORIDE

Manufacturer: Lupin Pharmaceuticals, Inc.

Score: 145.0

Quick Summary

Minocycline Hydrochloride is a tetracycline-class drug indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. The recommended dosage is approximately 1 mg/kg once daily for 12 weeks. The drug has several important safety considerations, including contraindications in persons who have shown hypersensitivity to any of the tetracyclines, and potential adverse reactions such as headache, fatigue, dizziness, and pruritus. Special population considerations include use during pregnancy, nursing mothers, pediatric use, and geriatric use.

Key Clinical Findings and Indications

Minocycline Hydrochloride is indicated for the treatment of inflammatory lesions of non-nodular moderate to severe acne vulgaris
The mechanism of action of Minocycline Hydrochloride extended-release tablets for the treatment of acne is unknown
Minocycline Hydrochloride extended-release tablets are not bioequivalent to non-modified release minocycline products

Important Safety Information

Warning

Minocycline Hydrochloride should not be used during pregnancy due to the potential for serious adverse effects on bone and tooth development in nursing infants

Contraindications

Hypersensitivity to any of the tetracyclines

Adverse Reactions

Headache
Fatigue
Dizziness
Pruritus

Dosing Recommendations

General Guidance

In patients with renal impairment, the total dosage should be decreased by either reducing the recommended individual doses and/or by extending the time intervals between doses

Inflammatory lesions of non-nodular moderate to severe acne vulgaris

Adult Dose

Approximately 1 mg/kg once daily for 12 weeks

Pediatric Dose

Not established for patients under 12 years of age

Special Population Considerations

Pregnancy

Minocycline Hydrochloride should not be used during pregnancy due to the potential for serious adverse effects on bone and tooth development in nursing infants
Pregnancy category D

Nursing Mothers

Tetracycline-class antibiotics are excreted in human milk
A decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

Pediatric Use

Minocycline Hydrochloride is indicated for patients 12 years and older
Safety and effectiveness in pediatric patients below the age of 12 has not been established

Geriatric Use

Clinical studies of Minocycline Hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects
Dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range

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