MINOCYCLINE HYDROCHLORIDE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Zydus Pharmaceuticals USA Inc.

INN (International Name):

MINOCYCLINE HYDROCHLORIDE

Composition:

MINOCYCLINE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 summary:

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 68382-316-01). 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 68382-317-01). 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 68382-318-18). 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.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE CAPSULE
Zydus Pharmaceuticals USA Inc.
----------
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

Summary of Product characteristics

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
----------
MINOCYCLINE HYDROCHLORIDE CAPSULES, USP
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, 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.
INACTIVE INGREDIENTS
_Drug Product:_ corn starch and magnesium stearate.
_Capsule Shell:_ Gelatin and titanium dioxide.
In addition, the 100 mg capsule shells contain D&C Red #28, FD&C Blue
#1, FD&C Red
#40, and red iron oxide; the 75 mg capsule shells contain black iron
oxide; and the 50
mg capsule shells contain D&C Red #33, FD&C Red #3, and FD&C Yellow
#6.
_Printing Ink: _black iron oxide, propylene glycol, D&C Yellow #10
Aluminum Lake, FD&C
Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40
Aluminum Lake
and shellac. In addition, the 50 mg and 100 mg ink contains strong
ammonia solution.
CLINICAL PHARMACOLOGY
Following a single dose of two minocycline hydrochloride capsules, 100
mg administered
23
27
3
7
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 minocyc