MINOCYCLINE HYDROCHLORIDE tablet, film coated

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

Minocycline Hydrochloride (UNII: 0020414E5U) (Minocycline - UNII:FYY3R43WGO)

থেকে পাওয়া:

Dr. Reddy's Laboratories Limited

INN (আন্তর্জাতিক নাম):

Minocycline Hydrochloride

রচনা:

Minocycline 50 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

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

পণ্য সারাংশ:

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 20ºC to 25ºC (68ºfF to 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.

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

MINOCYCLINE HYDROCHLORIDE- MINOCYCLINE HYDROCHLORIDE TABLET, FILM
COATED
DR. REDDY'S LABORATORIES LIMITED
----------
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, USP 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 USP 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 p