Minocycline (topical)
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From MedlinePlus, U.S. National Library of Medicine
Dosing in kidney impairment
If renal impairment exists, oral minocycline doses may need to be adjusted to avoid excessive systemic accumulations of the drug and possible liver toxicity. In patients with significantly impaired function, higher serum levels of tetracycline-class drugs may lead to azotemia, hyperphosphatemia, and acidosis. If renal impairment exists, recommended oral or parenteral doses may lead to excessive systemic accumulations of the drug and possible liver toxicity.
Under such conditions, adjust the dose downward, and if therapy is prolonged, serum level determinations of the drug may be advisable. 5.8 Central Nervous System Effects Central nervous system side effects including light-headedness, dizziness or vertigo have been reported with oral minocycline therapy.
Drug interactions
Check minocycline (topical) against a medication listLabel text (4 paragraphs)
7 DRUG INTERACTIONS • Patients on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. ( 7.1 ) • Penicillin: avoid coadministration. ( 7.2 )
7.1 Anticoagulants Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
7.2 Penicillin Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.
7.3 Drug/Laboratory Test Interactions False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.
Supplement interactions
Dietary supplement interactions
2 noted- Magnesium can form insoluble complexes with tetracyclines, such as demeclocycline (Declomycin) and doxycycline (Vibramycin), and with quinolone antibiotics, such as ciprofloxacin (Cipro) and levofloxacin (Levaquin). These antibiotics should be taken at least 2 hours before or 4 to 6 hours after a magnesium-containing supplement.
- Both quinolone antibiotics (such as Cipro) and tetracycline antibiotics (such as Achromycin and Sumycin) might interact with zinc in the gastrointestinal tract, which could inhibit the absorption of both zinc and the antibiotic if they are taken at the same time. Taking the antibiotic at least 2 hours before or 4 to 6 hours after the zinc supplement minimizes this interaction.
Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any other ingredients in ZILXI. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or any of the ingredients in ZILXI. ( 4 )
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
ALikelihood score A: Well known cause of clinically apparent liver injury.
Minocycline is a tetracycline antibiotic with excellent absorption and tissue penetration that is used for several bacterial infections as well as treatment of acne. Minocycline can cause both an acute hepatitis-like syndrome occurring within 1 to 3 months of starting therapy or a more insidious chronic hepatitis with autoimmune features typically after long term treatment.
ABCDEA: well known cause; E: unlikely cause. [HD]: high doses only.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Available data with ZILXI 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 ZILXI in humans is low following once daily topical administration of ZILXI under maximal clinical use conditions [see Clinical Pharmacology ( 12.3 )] . Because of low systemic exposure, it is not expected that maternal use of ZILXI 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 [see Warnings and Precautions 5.2 , 5.3 , 5.4 ) . Animal reproduction studies were not conducted with ZILXI. In animal reproduction studies, oral administration of minocycline to pregnant rats and rabbits during organogenesis induced skeletal malformations in fetuses at systemic exposures of 2,000 and 1,300 times, respectively, the maximum recommended human dose (MRHD based on AUC comparison) of ZILXI ( see Data ). 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. Data Animal Data Results of animal studies with oral administration 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, (2,000 times and 1,300 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 (680 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 (1,700 times the…
Breastfeeding (LactMed)
Many reviews state that tetracyclines are contraindicated during breastfeeding because of possible staining of infants’ dental enamel or bone deposition of tetracyclines. However, available literature indicates that there is not likely to be harm in short-term use of minocycline during lactation because milk levels are low and absorption by the infant is inhibited by the calcium in breastmilk. Although the manufacturer recommends avoiding breastfeeding during administration of minocycline and for 4 days after the last dose, short-term use of minocycline is probably acceptable in nursing mothers. As a theoretical precaution, avoid prolonged or repeat courses during nursing. Monitor the infant for rash and for possible effects on the gastrointestinal flora, such as diarrhea or candidiasis (thrush, diaper rash). Black discoloration of breastmilk has been reported with minocycline.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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