MINOCYCLINE HYDROCHLORIDE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Proficient Rx LP

INN (International Name):

MINOCYCLINE HYDROCHLORIDE

Sammensætning:

MINOCYCLINE 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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 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 C

Produkt oversigt:

Minocycline HCl Capsules, USP equivalent to 50 mg* minocycline are white opaque capsules imprinted “RX 694 ” on cap and body in black ink and supplied as follows: NDC 63187-450-20 Bottles of 20 NDC 63187-450-21 Bottles of 21 NDC 63187-450-30 Bottles of 30 NDC 63187-450-60 Bottles of 60 NDC 63187-450-90 Bottles of 90 Minocycline HCl Capsules, USP equivalent to 100* mg minocycline with a gray opaque cap and white opaque body imprinted “RX 696 ” on cap and body in black ink and supplied as follows: NDC 63187-036-20 Bottles of 20 NDC 63187-036-21 Bottles of 21 NDC 63187-036-30 Bottles of 30 NDC 63187-036-60 Bottles of 60 NDC 63187-036-90 Bottles of 90 Store at 20° - 25° C (68° - 77° F). [See USP Controlled Room Temperature]. Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant containers with child-resistant closure. * The appearance of the product may vary depending on the source of the ingredients filled in the capsule.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
PROFICIENT RX LP
----------
RXONLY
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
bacteria.
DESCRIPTION
Minocycline hydrochloride capsules, 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.
The structural formula is:
C
H N O •HCl M.W. 493.95
Each minocycline hydrochloride capsule, USP for oral administration,
contains the equivalent of 50 mg,
75 mg or 100 mg of minocycline. In addition each capsule contains the
following inactive ingredients:
corn starch and magnesium stearate.
The 50 mg, 75 mg and 100 mg capsule shells contain: gelatin and
titanium dioxide.
The 75 mg and 100 mg capsule shells also contain: black iron oxide.
The imprinting ink contains: black iron oxide, potassium hydroxide,
propylene glycol, and shellac.
CLINICAL PHARMACOLOGY
Following a single dose of two minocycline hydrochloride 100 mg
capsules 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
hydrochloride capsules was unchanged
compared to dosing under fasting conditions. The mean T
was delayed by one hour when
administered with food, compared to dosing under fasting conditions.
Minocycline hydrochloride
capsules may be administered with or without food.
In previous studies with other minocycline dosage forms