MINOCYCLINE HYDROCHLORIDE capsule

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

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

Tilgængelig fra:

Aurobindo Pharma Limited

INN (International Name):

MINOCYCLINE HYDROCHLORIDE

Sammensætning:

MINOCYCLINE 50 mg

Indgivelsesvej:

ORAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

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

Produkt oversigt:

Minocycline hydrochloride capsules USP contains minocycline hydrochloride USP equivalent to minocycline 50 mg, 75 mg and 100 mg. Minocycline Hydrochloride Capsules USP, 50 mg are Pink/Pink size ‘3’ hard gelatin capsule filled with yellow granular powder and imprinted with ‘C’ on Pink cap and ‘76’ on Pink body with black ink.                Bottles of 100               NDC 65862-209-01                Bottles of 500               NDC 65862-209-05                Bottles of 1,000            NDC 65862-209-99 Minocycline Hydrochloride Capsules USP, 75 mg are White/Grey size ‘3’ hard gelatin capsule filled with yellow granular powder and imprinted with ‘C’ on White cap and ‘77’ on Grey body with black ink.                Bottles of 100                NDC 65862-210-01                Bottles of 500                NDC 65862-210-05                Bottles of 1,000             NDC 65862-210-99 Minocycline Hydrochloride Capsules USP, 100 mg are Maroon/Pink size ‘2’ hard gelatin capsule filled with yellow granular powder and imprinted with ‘C’ on Maroon cap and ‘78’ on Pink body with black ink.                Bottles of 50                  NDC 65862-211-50                Bottles of 500                NDC 65862-211-05                Bottles of 1,000             NDC 65862-211-99 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°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.

Autorisation status:

Abbreviated New Drug Application

Produktets egenskaber

MINOCYCLINE HYDROCHLORIDE - MINOCYCLINE HYDROCHLORIDE CAPSULE
AUROBINDO PHARMA LIMITED
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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:
Minocycline hydrochloride capsules, USP for oral administration
contain minocycline
hydrochloride, USP equivalent to 50 mg, 75 mg or 100 mg of
minocycline. The capsule
also contains the following inactive ingredients: corn starch and
magnesium stearate.
The empty hard gelatin capsule shells contain titanium dioxide, sodium
lauryl sulfate, and
gelatin. In addition, the 50 mg capsule shells contain FD&C Red #3,
D&C Red #33, and
FD&C Yellow #6; the 75 mg capsule shells contain black iron oxide; and
the 100 mg
capsule shells contain FD&C Blue #1, D&C Red #28, FD&C Red #40, and
red iron oxide.
The capsules are printed with edible ink containing shellac,
dehydrated alcohol, isopropyl
alcohol, butyl alcohol, propylene glycol, strong ammonia solution,
black iron oxide, and
potassium hydroxide.
CLINICAL PHARMACOLOGY
Following a single dose of two minocycline hydrochloride capsules, 100
mg 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
hydrochlo