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:

Actavis Pharma, Inc.

INN (Tên quốc tế):

MINOCYCLINE HYDROCHLORIDE

Thành phần:

MINOCYCLINE 50 mg

Tuyến hành chính:

ORAL

Loại thuốc theo toa:

PRESCRIPTION DRUG

Chỉ dẫn điều trị:

Minocycline hydrochloride capsules 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 Campylobac

Tóm tắt sản phẩm:

Minocycline Hydrochloride Capsules, USP equivalent to 50 mg minocycline are opaque yellow capsules imprinted “MINOCYCLINE 50 ” and “DAN 5694 ” supplied in bottles of 60 (NDC 0591-5694-60) and 100 (NDC 0591-5694-01). Minocycline Hydrochloride Capsules, USP equivalent to 75 mg minocycline are opaque white and opaque yellow capsules imprinted “MINOCYCLINE 75 ” and “WPI ” supplied in bottles of 100 (NDC 0591-3153-01). Minocycline Hydrochloride Capsules, USP equivalent to 100 mg minocycline are opaque dark gray and opaque yellow capsules imprinted “MINOCYCLINE 100 ” and “DAN 5695 ” supplied in bottles of 50 (NDC 0591-5695-50). 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 with child-resistant closure.

Tình trạng ủy quyền:

Abbreviated New Drug Application

Đặc tính sản phẩm

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
ACTAVIS PHARMA, 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:
C
H N O •HCl M.W. 493.94
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: magnesium stearate and starch (corn).
The 50 mg, 75 mg, and 100 mg capsule shells contain: D&C Red No. 28,
D&C Yellow No. 10, gelatin,
silicon dioxide, sodium lauryl sulfate and titanium dioxide.
The 100 mg capsule shell also contains black iron oxide.
CLINICAL PHARMACOLOGY
Following a single dose of two 100 mg capsules of minocycline HCl
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
minocy