RVP

Drug Catalog - Product Detail

MINOCYCLINE HCL TABS USP 50MG 100CT

NDC Mfr Size Str Form
57664-0854-88 SUN PHARMACEUTICALS 100 50MG NA
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Package Image
Generic Name
MINOCYCLINE HYDROCHLORIDE
Substance Name
MINOCYCLINE HYDROCHLORIDE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
ANDA090217
Description
DESCRIPTION Minocycline hydrochloride, USP is a semisynthetic derivative of tetracycline, 4,7-Bis(dimethylamino)‑1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1, 11-dioxo-2‑naphthacenecarboxamide monohydrochloride. Its structural formula is: C 23 H 27 N 3 O 7 ·HCl M.W. 493.94 Minocycline hydrochloride tablets USP for oral administration contain minocycline hydrochloride equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, each tablet contains the following inactive ingredients: lactose monohydrate, microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide and magnesium stearate. In addition the coaling contains hypromellose, titanium dioxide, polyethylene glycol and iron oxide black. structure
How Supplied
HOW SUPPLIED Minocycline hydrochloride tablets 50 mg are dark grey colored, capsule-shaped, film-coated tablets debossed with ‘854’ on one side and plain on the other side available as follows: Bottles of 50 NDC 57664-854-85 Bottles of 100 NDC 57664-854-88 Bottles of 500 NDC 57664-854-13 Bottles of 1000 NDC 57664-854-18 Minocycline hydrochloride tablets 75 mg are grey colored, capsule-shaped, film-coated tablets debossed with ‘855’ on one side and plain on the other side available as follows: Bottles of 50 NDC 57664-855-85 Bottles of 100 NDC 57664-855-88 Bottles of 500 NDC 57664-855-13 Bottles of 1000 NDC 57664-855-18 Minocycline hydrochloride tablets 100 mg are dark grey colored, capsules-shaped, film-coated tablets debossed with ‘856’ on one side and plain on the other side available as follows: Bottles of 50 NDC 57664-856-85 Bottles of 100 NDC 57664-856-88 Bottles of 500 NDC 57664-856-13 Bottles of 1000 NDC 57664-856-18 Store at 20 to 25ºC (68º to 77ºF) [See USP Controlled Room Temperature]. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container as defined in the USP with child resistant closure.
Indications & Usage
INDICATIONS AND USAGE Minocycline hydrochloride tablets, 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 urealyticum or 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 Brucella species (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. • Enterobacter aerogenes . • Shigella species. • Acinetobacter species. • Respiratory tract infections caused by Haemophilus influenzae. • Respiratory tract and urinary tract infections caused by Kiebsiella species. Minocycline hydrochloride tablets, 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 drug of choice in the treatment of any type of staphylococcal infection). When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: • Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections. • Infections in women caused by Neisseria gonorrhoeae. • Syphilis caused by Treponema pallidum subspecies pallidum . • Yaws caused by Treponema pallidum subspecies pertenue . • Listeriosis due to Listeria monocytogenes . • Anthrax due to Bacillus anthracis . • Vincent’s infection caused by Fusobacterium fusiforme . • Actinomycosis caused by Actinomyces israelii . • Infections caused by Clostridium species. In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment. It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high. Oral minocycline is not indicated for the treatment of meningococcal infection . Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum . To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets, USP and other antibacterial drugs, minocycline hydrochloride tablets, USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
Dosage and Administration
DOSAGE AND ADMINISTRATION THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride tablets, USP 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 tablets 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. Adults The usual dosage of minocycline hydrochloride tablets is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg tablets may be given initially followed by one 50 mg capsule 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days. In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended. In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days. Mycobacterium marinum infections : Although optimal doses have not been established, 100 mg every 12 hours for 6 to 8 weeks have been used successfully in a limited number of cases. Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis or Ureaplasma urealyticum : 100 mg orally, every 12 hours for at least 7 days. 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 pharmacokinetics of minocycline in patients with renal impairment (CLCR <80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored (see WARNINGS ).