MINOCYCLINE HYDROCHLORIDE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

NuCare Pharmaceuticals,Inc.

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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. NDC 68071-4163-5 Bottles of 15 NDC 68071-4163-8 Bottles of 28 NDC 68071-4163-3 Bottles of 30 -resistant closure. Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Protect from light, moisture and excessive heat.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS,INC.
----------
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.
23
27
3
7
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 minocycli