MINOCIN- minocycline hydrochloride capsule, coated pellets

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Bausch Health US, LLC

Designación común internacional (DCI):

MINOCYCLINE HYDROCHLORIDE

Composición:

MINOCYCLINE 50 mg

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

MINOCIN Pellet-Filled Capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: MINOCIN Pellet-Filled Capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: In acute intestinal amebiasis , minocycline may be a useful adjunct to amebicides. In severe acne , minocycline may be useful adjunctive therapy. Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis to eliminate meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment o

Resumen del producto:

MINOCIN® (minocycline hydrochloride) Pellet-Filled Capsules are supplied as capsules containing minocycline hydrochloride equivalent to 50 mg and 100 mg minocycline. 100 mg, two-piece, hard-shell capsule with an opaque light green cap and a transparent green body, printed in white ink with "Onset" over "M0100" on one half and "Onset" over "100 mg" on the other half. Each capsule contains pellets of minocycline hydrochloride equivalent to 100 mg of minocycline, supplied as follows: 50 mg, two-piece, hard-shell capsule with an opaque yellow cap and a transparent green body, printed in black ink with "Onset" over "M050" on one half and "Onset" over "50 mg" on the other half. Each capsule contains pellets of minocycline hydrochloride equivalent to 50 mg of minocycline, supplied as follows: Store at controlled room temperature 20° to 25°C (68° to 77°F). Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP.

Estado de Autorización:

New Drug Application

Información para el usuario

Onset Dermatologics LLC
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PATIENT INFORMATION
MINOCIN® [my-no-sin]
(minocycline hydrochloride)
Pellet-Filled Capsules, 50 mg and 100 mg
Read the Patient Information that comes with MINOCIN® Pellet-Filled
Capsules before you or a family
member starts taking it and each time you get a refill. There may be
new information. This leaflet does
not take the place of talking to your doctor about your medical
condition or treatment.
What is MINOCIN?
MINOCIN® is a tetracycline-class antibiotic medicine. MINOCIN is used
to treat certain infections
caused by bacteria. These include infections of the skin, respiratory
tract, urinary tract, some sexually
transmitted diseases, and others. MINOCIN may be used along with other
treatments for severe acne.
Sometimes other germs, called viruses, cause infections. The common
cold is a virus. MINOCIN, like
other antibiotics, does not treat viruses.
Who should not use MINOCIN?
Do not take MINOCIN if you are allergic to minocycline or other
tetracycline antibiotics.
Ask your doctor or pharmacist for a list of these medications if you
are not sure. See the end of this leaflet
for a complete list of ingredients in MINOCIN.
MINOCIN is not recommended for pregnant women or children up to 8
years old because:
1.
MINOCIN may harm an unborn baby
2.
MINOCIN may permanently turn a baby's or child's teeth
yellow-gray-brown during tooth
development. Tooth development happens in the last half of pregnancy
and birth to age 8 years.
What should I tell my doctor before starting MINOCIN® capsules?
Tell your doctor about all of your medical conditions, including if
you:
•
have liver or kidney problems.
•
are pregnant or planning to become pregnant. MINOCIN may harm your
unborn baby. Stop taking
MINOCIN and call your doctor if you become pregnant while taking it.
•
are breast feeding. MINOCIN passes into your milk and may harm your
baby. You should decide
whether to use MINOCIN or breastfeed, but not both.
Tell your doctor about all the medicines you are taking including
prescription a

Ficha técnica

MINOCIN- MINOCYCLINE HYDROCHLORIDE CAPSULE, COATED PELLETS
ONSET DERMATOLOGICS LLC
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MINOCIN
(MINOCYCLINE HYDROCHLORIDE)
PELLET-FILLED CAPSULES
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of MINOCIN
(minocycline hydrochloride) Pellet-Filled Capsules and other
antibacterial drugs, MINOCIN
(minocycline hydrochloride) Pellet-Filled Capsules should be used only
to treat or prevent infections
that are proven or strongly suspected to be caused by bacteria.
DESCRIPTION
MINOCIN (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. 493.94
MINOCIN Pellet-Filled Capsules for oral administration contain pellets
of minocycline hydrochloride
equivalent to 50 mg or 100 mg of minocycline in microcrystalline
cellulose.
The capsule shells contain the following inactive ingredients: FD&C
Blue #1, Gelatin, Titanium
Dioxide and FD&C Yellow #10. The 50 mg capsule shell also contains
Black and Yellow Iron Oxides.
CLINICAL PHARMACOLOGY
Following a single dose of two MINOCIN 100 mg Pellet-Filled Capsules
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 MINOCIN Pellet-Filled Capsules were given concomitantly with a
high-fat meal, which included
dairy products, the extent of absorption of MINOCIN Pellet-Filled
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. MINOCIN
Pellet-Filled Capsules may be
administered with or without food.
In previous studies with other minocycline dosage forms, the
minocycline serum half-life ran