MINOCYCLINE HYDROCHLORIDE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

NuCare Pharmaceuticals,Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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 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 Klebsiella species. 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 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 capsules, USP and other antibacterial drugs, minocycline hydrochloride capsules, 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. 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.

Rezumat produs:

Minocycline Hydrochloride Capsules USP, 100 mg are Maroon/Pink size 2 hard gelatin capsule filled with yellow granular powder and imprinted with C on Maroon cap and 78 on Pink body with black ink. NDC 68071-2225-8 BOTTLES OF 28 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
minocycline hydrochloride capsules and other antibacterial drugs,
minocycline
hydrochloride capsules should be used only to treat or prevent
infections that are
proven or strongly suspected to be caused by bacteria.
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:
Minocycline hydrochloride capsules, USP for oral administration
contain minocycline
hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of
minocycline. The capsule
also contains the following inactive ingredients: corn starch and
magnesium stearate.
The empty hard gelatin capsule shells contain titanium dioxide, sodium
lauryl sulfate, and
gelatin. In addition, the 50 mg capsule shells contain FD&C Red #3,
D&C Red #33, and
FD&C Yellow #6; the 75 mg capsule shells contain black iron oxide; and
the 100 mg
capsule shells contain FD&C Blue #1, D&C Red #28, FD&C Red #40, and
red iron oxide.
The capsules are printed with edible ink containing shellac,
dehydrated alcohol, isopropyl
alcohol, butyl alcohol, propylene glycol, strong ammonia solution,
black iron oxide, and
potassium hydroxide.
CLINICAL PHARMACOLOGY
Following a single dose of two minocycline hydrochloride capsules, 100
mg administered
to 18 normal fasting adult volunteers, maximum serum concentrations
were attained in
1 to 4 hours (average 2.1 hours) and ranged from 2.1 to 5.1 mcg/mL
(average 3.5
mcg/mL). The serum half-life in the normal volunteers ranged from 11.1
to 22.1 hours
(average 15.5 hours).
When minocycline hydrochloride capsules were given concomitantly with
a high-fat meal,
which included dairy products, the extent of absorption of minocycline
hydroch