MINOCYCLINE HYDROCHLORIDE capsule

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

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

Beschikbaar vanaf:

Zydus Lifesciences Limited

Toedieningsweg:

ORAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

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 Chlamydophila 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 caused by Vibrio cholerae . Campylobacter fetus infections caused

Product samenvatting:

Minocycline hydrochloride capsules, USP are supplied as capsules containing minocycline hydrochloride, USP equivalent to 50 mg, 75 mg, and 100 mg minocycline: Capsules containing minocycline hydrochloride, USP equivalent to 50 mg minocycline. The 50 mg capsule is supplied with a pink body and cap and is imprinted "═" on the cap and "316" on the body, in bottles of 100 (NDC 70771-1426-1). Capsules containing minocycline hydrochloride, USP equivalent to 75 mg minocycline. The 75 mg capsule is supplied with a light gray opaque body and white opaque cap and is imprinted "═" on the cap and "317" on the body, in bottles of 100 (NDC 70771-1427-1). Capsules containing minocycline hydrochloride, USP equivalent to 100 mg minocycline. The 100 mg capsule is supplied with a pink body and maroon cap and is imprinted "═" on the cap and "318" on the body, in bottles of 50 (NDC 70771-1428-7). Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from light, moisture, and excessive heat. Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required). KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Autorisatie-status:

Abbreviated New Drug Application

Bijsluiter

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE CAPSULE
Cadila Healthcare Limited
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PATIENT INFORMATION
MINOCYCLINE (mye-no-SYE-kleen) HYDROCHLORIDE CAPSULES USP
Rx only
Read the Patient Information that comes with minocycline hydrochloride
capsules 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?
Minocycline hydrochloride capsules are a tetracycline-class antibiotic
medicine. Minocycline hydrochloride
capsules 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 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, like other antibiotics, do not treat viruses.
Who should not use minocycline hydrochloride capsules?
Do not take minocycline hydrochloride capsules 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.
Minocycline hydrochloride capsules are not recommended for pregnant
women or children up to 8 years old
because:
1.
Minocycline hydrochloride capsules may harm an unborn baby
2.
Minocycline hydrochloride capsules 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?
Tell your doctor about all of your medical conditions, including if
you:
•
have liver or kidney problems
•
are pregnant or planning to become

Productkenmerken

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE CAPSULE
ZYDUS LIFESCIENCES LIMITED
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MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1426-1
Minocycline Hydrochloride Capsules USP, 50 mg
100 Capsules
Rx only
NDC 70771-1427-1
Minocycline Hydrochloride Capsules USP, 75 mg
100 Capsules
Rx only
NDC 70771-1428-7
Minocycline Hydrochloride Capsules USP, 100 mg
50 Capsules
Rx only
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1426
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF
STRENGTH
STRENGTH
MINOCYCLINE HYDROCHLORIDE (UNII: 0020414E5U) (MINOCYCLINE -
UNII:FYY3R43WGO)
MINOCYCLINE
50 mg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRENGTH
STARCH, CORN (UNII: O8232NY3SJ)
MAGNESIUM STEARATE (UNII: 70097M6I30)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SHELLAC (UNII: 46N107B71O)
AMMONIA (UNII: 5138Q19F1X)
ALUMINUM OXIDE (UNII: LMI26O6933)
PRODUCT CHARACTERISTICS
COLOR
PINK (pink body and cap)
SCORE
no score
SHAPE
CAPSULE (CAPSULE)
SIZE
16mm
FLAVOR
IMPRINT CODE
316
CONTAINS
PACKAGING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:70771-
1426-1
100 in 1 BOTTLE; Type 0: Not a Combination
Product
04/03/2017
MARKETING INFORMATION
MARKETING
CATEGORY
APPLICATION NUMBER OR MONOGRAPH
CITATION
MARKETING START
DATE
MARKETING END
DATE
ANDA
ANDA063011
04/03/2017
MINOCYCLINE HYDROCHLORIDE
minocycline hydrochloride capsule
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN PRESCRIPTION DRUG
ITEM CODE (SOURCE)
NDC:70771-1427
ROUTE OF ADMINISTRATION
ORAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
B