MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Lake Erie Medical DBA Quality Care Products LLC

INN (International Name):

MINOCYCLINE HYDROCHLORIDE

Composition:

MINOCYCLINE 100 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

INDICATIONS AND USAGE 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. 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. Respiratory tract infections caused by Mycoplasma pneumoniae. - Lymphogranuloma venereum caused by Chlamydia trachomatis. Lymphogranuloma venereum caused by Chlamydia trachomatis. - Psittacosis (Ornithosis) due to Chlamydia psittaci. Psittacosis (Ornithosis) due to Chlamydia psittaci. - Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminat

Product summary:

HOW SUPPLIED Minocycline Hydrochloride Capsules USP, equivalent to 50 mg minocycline are opaque yellow capsules imprinted MINOCYCLINE 50 and DAN 5694 supplied in bottles of 60 and 100. 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. 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. Dispense in a tight, light-resistant container with child-resistant closure. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature.] Protect from light, moisture and excessive heat.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC
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MINOCYCLINE HYDROCHLORIDE 100 MG
DESCRIPTION
Minocycline hydrochloride 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
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 μg/mL (average 3.5 μg/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 meal which included dairy
products, the extent of absorption of minocycline hydrochloride
capsules was not noticeably
influenced. The peak plasma concentrations were slightly decreased
(11.2%) and delayed by one hour
when administered with food, compared to dosing under fasting
conditions.
In previous studies with other minocycline dosage forms, the
minocycline serum half-life ranged from
11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to
69 hours in 5 patients with renal
dysfunction. The urinary and fecal recovery of minocycline when
administered to 12 normal volunteers
was one-half to one-third that of other tetracyclines.
Microbiology
The tetracyclines are primarily bacteriostatic and are thought to
exert their antimicrobial effect by the
inhibition of protein synthesis. The tetracyclines, including
minocycline, have a similar antimicrobial
spectrum of activity against a wide range of gram-positive and
gram-negative organisms. Cross-
resistance of these organisms to tetracycline is common.
Minocycline has been shown to be active against most strains of the
following microorganisms, both in
vitro and in clinical infections as described in the INDICATIONS AND
USAGE section.
AEROBIC GRAM-POSIT