MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride tablet, film coated

Χώρα: Ηνωμένες Πολιτείες

Γλώσσα: Αγγλικά

Πηγή: NLM (National Library of Medicine)

Δραστική ουσία:

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

Διαθέσιμο από:

REMEDYREPACK INC.

INN (Διεθνής Όνομα):

MINOCYCLINE HYDROCHLORIDE

Σύνθεση:

MINOCYCLINE 100 mg

Οδός χορήγησης:

ORAL

Τρόπος διάθεσης:

PRESCRIPTION DRUG

Θεραπευτικές ενδείξεις:

Minocycline hydrochloride tablets 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 immunoflourescence. - 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

Περίληψη προϊόντος:

Minocycline hydrochloride tablets USP are supplied as aqueous film coated tablets containing minocycline hydrochloride equivalent to 50 mg, 75 mg and 100 mg minocycline.  The 50 mg tablets are yellow, round, biconvex, film coated tablets debossed “I71" on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 50 mg minocycline, supplied as follows:  (NDC 55111-637-01) Bottle of 100 (NDC 55111-637-10) Bottle of 1000  The 75 mg tablets are grey, round, biconvex, film coated tablets debossed “I72" on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 75 mg minocycline, supplied as follows: (NDC 55111-638-01) Bottle of 100 (NDC 55111-638-10) Bottle of 1000  The 100 mg tablets are dark grey, round, biconvex, film coated tablets debossed “I73" on one side and plain on the other. Each tablet contains minocycline hydrochloride equivalent to 100 mg minocycline, supplied as follows: (NDC 55111-639-50) Bottle of 50 (NDC 55111-639-60) Bottle of 60 (NDC 55111-639-10) Bottle of 1000  Store between 20º-25ºC (68º-77ºF) [See USP Controlled Room Temperature]. Protect from light, moisture and excessive heat. Dispense in a tight, light-resistant container as defined in the USP.

Καθεστώς αδειοδότησης:

Abbreviated New Drug Application

Αρχείο Π.Χ.Π.

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE TABLET, FILM
COATED
REMEDYREPACK INC.
----------
RX ONLY
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of minocycline
hydrochloride tablets and other antibacterial drugs, minocycline
hydrochloride tablets should be used
only to treat or prevent infections that are proven or strongly
suspected to be caused by bacteria.
DESCRIPTION
Minocycline hydrochloride, a semisynthetic derivative of tetracycline,
is 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 tablets for oral administration contain
minocycline HCl equivalent to 50 mg,
75 mg or 100 mg of minocycline. In addition, 50 mg, 75 mg and 100 mg
tablets contain the following
inactive ingredients: Lactose Monohydrate, Magnesium Stearate,
Microcrystalline Cellulose, Povidone
and Sodium Starch Glycolate. The 50 mg tablets also contain Opadry
Yellow which contains: FD&C
Blue No. 2, FD&C Yellow No. 5, Titanium Dioxide, Hypromellose,
Polyethylene Glycol. The 75 mg
and 100 mg tablets contain Opadry Gray, which contains: Titanium
Dioxide, Hypromellose,
Polyethylene Glycol, Polysorbate 80 and Iron Oxide Black.
Minocycline Hydrochloride Tablets, 50 mg contains FD&C Yellow No. 5
(Tartrazine) as color
additive.
CLINICAL PHARMACOLOGY
Following a single dose of one 100 mg tablet of minocycline
hydrochloride administered to 28 normal
fasting adult volunteers, maximum serum concentrations were attained
in 1 to 3 hours (average 1.71
hours) and ranged from 491.71 to 1292.70 ng/mL (average 758.29 ng/mL).
The serum half-life in the
normal volunteers ranged from 11.38 to 24.31 hours (average 17.03
hours).
When minocycline hydrochloride tablets were given concomitantly with a
meal, which included dairy
products, the extent of absorption of minocycline hydrochloride
tablets was slightly decreased (6%).
The peak plasma concentrations we