MINOCYCLINE HYDROCHLORIDE capsule

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 100 mg

Via de administração:

ORAL

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 pest

Resumo do produto:

Minocycline hydrochloride 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: Minocycline hydrochloride capsules, USP equivalent to 75 mg minocycline are gray opaque capsules imprinted " RX 695 " on cap and body in black ink and supplied as follows: Minocycline hydrochloride tablets, 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 42291-620-05 Bottles of 50 NDC 42291-620-50 Bottles of 500 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 as defined in the USP.

Status de autorização:

Abbreviated New Drug Application

Características técnicas

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
AVKARE
----------
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
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 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:
C
H
N
O
•HCL M.W. 493.95
Each Minocycline hydrochloride capsule, USP for oral administration,
contains
minocycline hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of
minocycline. In
addition, each capsule contains the following inactive ingredients:
corn starch and
magnesium sterate.
The 50mg, 75 mg or 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
23
27
3
7
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
tablets 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