MINOCYCLINE tablet

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE - UNII:FYY3R43WGO)

Disponível em:

AvKARE

DCI (Denominação Comum Internacional):

MINOCYCLINE HYDROCHLORIDE

Composição:

MINOCYCLINE 50 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

Minocycline hydrochloride tablets 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 Chlamydia 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 Calymmatobacterium granulomatis . Minocycline is indicated for 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 Klebsiella species. Minocycline hydrochloride tablets 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 the 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 and other antibacterial drugs, minocycline hydrochloride tablets 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. 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.

Resumo do produto:

Minocycline hydrochloride tablets are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline. The 50 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed “Par” on one side and “511" on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows: NDC  42291-589-90   Bottles of 90 The 75 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed “Par" on one side and “512" on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline. The 100 mg tablets are white, unscored, modified capsule shaped, coated tablet debossed “Par" on one side and “513" on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: NDC 42291-591-60  Bottle of 60 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container as defined in the USP.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

MINOCYCLINE- MINOCYCLINE TABLET
AVKARE
----------
MINOCYCLINE HYDROCHLORIDE TABLETS, USP
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF MINOCYCLINE HYDROCHLORIDE TABLETS AND OTHER
ANTIBACTERIAL
DRUGS, MINOCYCLINE HYDROCHLORIDE TABLETS SHOULD BE USED ONLY TO TREAT
OR
PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY SUSPECTED TO BE CAUSED
BY
BACTERIA.
DESCRIPTION
Minocycline hydrochloride, 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:
Minocycline hydrochloride tablets for oral administration contain
minocycline HCl
equivalent to 50 mg, 75 mg or 100 mg of minocycline. In addition, 50
mg, 75 mg and
100 mg tablets contain the following inactive ingredients:
Microcrystalline Cellulose NF,
Lactose Anhydrous NF, Povidone USP, Colloidal Silicon Dioxide NF,
Magnesium Stearate
NF, and Sodium Starch Glycolate NF. The 50 mg, 75 mg and 100 mg
tablets also contain
Opadry White which contains: Titanium Dioxide USP, Hypromellose Type
2910 USP,
Polyethylene Glycol 400 NF, and Polysorbate 80 NF.
CLINICAL PHARMACOLOGY
Following a single dose of one 100 mg tablet of minocycline
hydrochloride administered
to 28 normal fasting adult volunteers, maximum serum concentrations
were attained in
1 to 3 hours (average 1.71 hours) and ranged from 491.71 to 1292.70
ng/mL (average
758.29 ng/mL). The serum half-life in the normal volunteers ranged
from 11.38 to 24.31
hours (average 17.03 hours).
When minocycline hydrochloride tablets were given concomitantly with a
meal, which
included dairy products, the extent of absorption of minocycline
hydrochloride tablets
was slightly decreased (6%). The peak plasma concentrations were
slightly decreased
(12%) and delayed by 1.09 hours when administered with food, compared
to dosing
under fasting conditions. Minocycline HCl may be administered with or
without food.
In previous studies with other mino