MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride capsule

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

NuCare Pharmaceuticals, Inc.

INN (الاسم الدولي):

MINOCYCLINE HYDROCHLORIDE

تركيب:

MINOCYCLINE 100 mg

طريقة التعاطي:

ORAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

Minocycline hydrochloride capsules, USP 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. ·     Respiratory tract infections caused by Mycoplasma pneumoniae . ·     Lymphogranuloma venereum caused by Chlamydia trachomatis . ·   Psittacosis (Ornithosis) due to Chlamydia psittaci. ·   Trachoma caused by Chlamydia trachomatis , although the infectious agent is not always eliminated, as judged by immunofluorescence. ·     Inclusion conjunctivitis caused by Chlamydia trachomatis . ·     Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis . ·     Relapsing fever due to Borrelia recurrentis . ·     Chancroid caused by Haemophilus ducreyi . ·     Plague due to Yersinia pestis . ·   Tularemia due to Francisella tularensis . ·     Cholera cau

ملخص المنتج:

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 14 NDC 68071-3307-4 Bottles of 28 NDC 68071-3307-8 Bottles of 30 NDC 68071-3307-3 Bottles of 60 NDC 68071-3307-9 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].

الوضع إذن:

Abbreviated New Drug Application

نشرة المعلومات

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
NuCare Pharmaceuticals, Inc.
----------
SPL MEDGUIDE
PATIENT INFORMATION
Minocycline Hydrochloride Capsules, USP
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:
·

خصائص المنتج

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
NUCARE PHARMACEUTICALS, INC.
----------
MINOCYCLINE HYDROCHLORIDE CAPULES, 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,6,1 1,1 2a-octahydro-3,1 0,12,1 2a-tetrahydroxy-1,11
-dioxo-2-naphthacenecarboxamide
monohydrochloride.
Its structural formula is:
C
H
N
O
•HCl M.W. 493.94
Each Minocycline hydrochloride capsule USP for oral administration
contains minocycline hydrochlo-
ride USP equivalent to 50 mg, 75 mg or 100 mg 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 contain D&C
Red #33, FD&C Red #3 and
FD&C Yellow #6; 75 mg capsules contains FDA/E172 black iron oxide and
100 mg capsules contains
D&C Red #28, FD&C Blue #1, FD&C Red #40 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
included dairy products, the extent of absorption of minocycline
hydroch