MINOCYCLINE HYDROCHLORIDE capsule

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Proficient Rx LP

Vartojimo būdas:

ORAL

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Minocycline hydrochloride capsules, USP 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: Minocycline hydrochloride capsules, USP 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

Produkto santrauka:

Minocycline hydrochloride Capsules USP, 100 mg are Maroon Opaque/ Flesh Opaque colored hard gelatin capsules, imprinted with ‘853’ on both cap and body in black ink available as follows: Bottles of 30                          NDC 71205-511-30 Bottles of 60                          NDC 71205-511-60 Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).  Protect from light, moisture and excessive heat. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].

Autorizacija statusas:

Abbreviated New Drug Application

Pakuotės lapelis

Proficient Rx LP
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PATIENT INFORMATION
PATIENT INFORMATION
Minocycline Hydrochloride Capsules, USP
(mye-no-SYE-kleen) Hydrochloride Capsules
50 mg, 75 mg, and 100 mg
Rx Only
Read the Patient Information that comes with minocycline hydrochloride
capsules, USP before you or a
family member starts taking them 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 are Minocycline Hydrochloride Capsules, USP?
Minocycline hydrochloride capsules, USP are a tetracycline class
antibiotic medicine. Minocycline
hydrochloride capsules, USP are used to treat certain infections
caused by bacteria. These include
infections of the skin, respiratory tract, urinary tract, some
sexually transmitted diseases, and others.
Minocycline hydrochloride capsules, USP may be used along with other
treatments for severe acne.
Sometimes, other germs, called viruses cause infections. The common
cold is a virus. Minocycline
hydrochloride capsules, USP, like other antibiotics, do not treat
viruses.
Who should not use Minocycline Hydrochloride Capsules, USP? Do not
take minocycline hydrochloride
capsules, USP 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 minocycline hydrochloride
capsules, USP.
Minocycline hydrochloride capsules, USP are not recommended for
pregnant women or children up to 8
years old because:
1. Minocycline hydrochloride capsules, USP may harm an unborn baby.
2. Minocycline hydrochloride capsules, USP 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 Minocycline Hydrochloride
Capsules, USP?
Tell your doctor about all of your medical conditions, including if
you:
o
ha

Prekės savybės

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
PROFICIENT RX LP
----------
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
RX ONLY
TO REDUCE THE DEVELOPMENT OF DRUG-RESISTANT BACTERIA AND MAINTAIN THE
EFFECTIVENESS OF MINOCYCLINE HYDROCHLORIDE CAPSULES, USP AND OTHER
ANTIBACTERIAL DRUGS, MINOCYCLINE HYDROCHLORIDE CAPSULES, USP SHOULD BE
USED
ONLY TO TREAT OR PREVENT INFECTIONS THAT ARE PROVEN OR STRONGLY
SUSPECTED TO
BE CAUSED BY BACTERIA.
DESCRIPTION
Minocycline hydrochloride USP, 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
Minocycline hydrochloride capsules USP for oral administration contain
minocycline
hydrochloride, USP equivalent to 50 mg, 75 mg, or 100 mg of
minocycline and the
following inactive ingredients: lactose monohydrate, microcrystalline
cellulose, povidone,
sodium starch glycolate, colloidal silicon dioxide, magnesium
stearate, titanium dioxide,
gelatin, D&C Yellow #10 aluminum lake, FD&C Blue #1 aluminum lake,
FD&C Blue #2
aluminum lake, FD&C Red #40 aluminum lake, black iron oxide, propylene
glycol and
shellac.
In addition 50 mg capsules contains D&C Red #33 aluminum lake, FD&C
Red #3
aluminum lake and FD&C Yellow #6 aluminum lake; 75 mg capsules
contains FDA/E172
black iron oxide and 100 mg capsules contains D&C Red #28 aluminum
lake, FD&C Blue
#1 aluminum lake, FD&C Red #40 aluminum lake and FDA/E172 red iron
oxide.
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CLINICAL PHARMACOLOGY
Following a single dose of two 100 mg capsules of minocycline
hydrochloride
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 incl