MINOCYCLINE HYDROCHLORIDE capsule

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

Dispensing Solution, Inc.

INN (Διεθνής Όνομα):

MINOCYCLINE HYDROCHLORIDE

Σύνθεση:

MINOCYCLINE 100 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

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 eliminated, as judged by immun

Περίληψη προϊόντος:

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.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
DISPENSING SOLUTION, INC.
----------
MINOCYCLINE
HYDROCHLORIDE
CAPSULES USP
REVISED: JUNE 2009
RX ONLY
190791
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 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, 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 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
23
27
3