MINOCYCLINE HYDROCHLORIDE capsule

Quốc gia: Hoa Kỳ

Ngôn ngữ: Tiếng Anh

Nguồn: NLM (National Library of Medicine)

Thành phần hoạt chất:

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

Sẵn có từ:

KAISER FOUNDATION HOSPITALS

INN (Tên quốc tế):

MINOCYCLINE HYDROCHLORIDE

Thành phần:

MINOCYCLINE 100 mg

Loại thuốc theo toa:

PRESCRIPTION DRUG

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
KAISER FOUNDATION HOSPITALS
----------
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 100
mg of minocycline. In addition each capsule contains the following
inactive ingredients: corn starch and
magnesium stearate.
The 100 mg capsule shells contain: gelatin and titanium dioxide.
The 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, the
minocycline serum half-lif