MINOCYCLINE HYDROCHLORIDE capsule

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Department of State Health Services, Pharmacy Branch

INN (mednarodno ime):

MINOCYCLINE HYDROCHLORIDE

Sestava:

MINOCYCLINE 50 mg

Pot uporabe:

ORAL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 immu

Povzetek izdelek:

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° to 25°C (68° to 77°F) [See USP controlled room temperature]. Protect from light, moisture and excessive heat.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
DEPARTMENT OF STATE HEALTH SERVICES, PHARMACY BRANCH
----------
MINOCYCLINE
HYDROCHLORIDE
CAPSULES USP
REVISED: JULY 2014
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 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 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).
23
27
3
7
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 stud