Minocycline Hydrochloride (10 brand names, 8 dosage forms, 4 routes)
Available dosage forms: TABLET, EXTENDED RELEASE, INJECTABLE, CAPSULE, TABLET, SUSPENSION, CAPSULE, EXTENDED RELEASE, AEROSOL, FOAM, POWDER, EXTENDED RELEASE.
Routes of administration: ORAL, INJECTION, TOPICAL, DENTAL.
Brand Names
- AMZEEQ
- ARESTIN
- DYNACIN
- EMROSI
- MINOCIN
- MINOCYCLINE HYDROCHLORIDE
- MINOLIRA
- SOLODYN
- XIMINO
- ZILXI
Indications and Usage
Minocycline hydrochloride capsules, USP are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae. Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence. Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticumor Chlamydia trachomatis. Relapsing fever due to Borrelia recurrentis. Chancroid caused by Haemophilus ducreyi. Plague due to Yersinia pestis. Tularemia due to Francisella tularensis. Cholera caused by Vibrio cholerae. Campylobacter fetus infections caused by Campylobacter fetus. Brucellosis due to Brucellaspecies (in conjunction with streptomycin). Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Escherichia coli. Klebsiella aerogenes Shigellaspecies. Acinetobacterspecies. Respiratory tract infections caused by Haemophilus influenzae . Respiratory tract and urinary tract infections caused by Klebsiellaspecies. Minocycline hydrochloride capsules, USP are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: Upper respiratory tract infections caused by Streptococcus pneumoniae . Skin and skin structure infections caused by Staphylococcus aureus .(NOTE: Minocycline is not the
Dosage and Administration
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFER FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride capsules may be taken with or without food (see CLINICAL PHARMACOLOGY ). Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The capsules should be swallowed whole. For Pediatric Patients above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose.
Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines or to any of the components of the product formulation.
Adverse Reactions
Due to oral minocycline’s virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines: Body as a whole:Fever and discoloration of secretions. Gastrointestinal: Anorexia, nausea, vomiting, diarrhea, dyspepsia, stomatitis, glossitis, dysphagia, enamel hypoplasia, enterocolitis, pseudomembranous colitis, pancreatitis, inflammatory lesions (with monilial overgrowth) in the oral and anogenital regions. Instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION ). Genitourinary:Vulvovaginitis. Hepatic toxicity :Hyperbilirubinemia, hepatic cholestasis, increases in liver enzymes, fatal hepatic failure, and jaundice. Hepatitis, including autoimmune hepatitis, and liver failure have been reported (see PRECAUTIONS ). Skin:Alopecia, erythema nodosum, hyperpigmentation of nails, pruritus, toxic epidermal necrolysis, vasculitis, maculopapular rash and erythematous rash. Exfoliative dermatitis has been reported. Fixed drug eruptions have been reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS-Photosensitivity ). Pigmentation of the skin and mucous membranes has been reported. Respiratory:Cough, dyspnea, bronchospasm, exacerbation of asthma, and pneumonitis. Renal toxicity:Interstitial nephritis. Elevations in BUN have been reported and are apparently dose related (see WARNINGS ). Reversible acute renal failure has been reported. Musculoskeletal:Arthralgia, arthritis, bone discoloration, myalgia, joint stiffness, and joint swelling. Hypersensitivity reactions:Urticaria, angioneurotic edema, polyarthralgia, anaphylax
Drug Interactions
Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage. Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin. Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations. Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see WARNINGS ). Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.
Overdosage
The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting. No specific antidote for minocycline is known. In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.