DOXYCYCLINE HYCLATE tablet, film coated DOXYCYCLINE HYCLATE capsule DOXYCYCLINE powder, for suspension

Country: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

DOXYCYCLINE HYCLATE (UNII: 19XTS3T51U) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

থেকে পাওয়া:

Chartwell RX LLC

INN (International Name):

Doxycycline Hyclate

রচনা:

Doxycycline Anhydrous 100 mg

প্রশাসন রুট:

ORAL

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline and other antibacterial drugs, doxycycline should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy. Doxycycline is indicated for the treatment of the following infections - 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) caused by 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 . - Uncomplicated urethral, endocervical, or rectal infections in adults caused by Chlamydia trachomatis . - Nongonococcal urethritis caused by Ureaplasma urealyticum . - Relapsing fever due to Borrelia recurrentis . Doxycycline is also indicated for the treatment of infections caused by the following gram-negative microorganisms: - Chancroid caused by Haemophilus ducreyi . - Plague due to Yersinia pestis . - Tularemia due to Francisella tularensis . - Cholera caused by Vibrio cholerae . - Campylobacter fetus infections caused by Campylobacter fetus. - Brucellosis due to Brucella species (in conjunction with streptomycin). - Bartonellosis due to Bartonella bacilliformis . - Granuloma inguinale caused by Klebsiella granulomatis. Because many strains of the following groups of microorganisms have been shown to be resistant to doxycycline, culture and susceptibility testing are recommended. Doxycycline is indicated for treatment of infections caused by the following gram-negative bacteria when bacteriologic testing indicates appropriate susceptibility to the drug: - Escherichia coli. - Enterobacter aerogenes. - Shigella species. - Acinetobacter species. - Respiratory tract infections caused by Haemophilus influenzae . - Respiratory tract and urinary tract infections caused by Klebsiella species. Doxycycline is indicated for treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug: - Upper respiratory infections caused by Streptococcus pneumoniae. - Anthrax due to Bacillus anthracis, including inhalational anthrax (post-exposure): to reduce the incidence or progression of disease following exposure to aerosolized Bacillus anthracis . When penicillin is contraindicated, doxycycline is an alternative drug in the treatment of the following infections: - Uncomplicated gonorrhea caused by Neisseria gonorrhoeae . - Syphilis caused by Treponema pallidum . - Yaws caused by Treponema pallidum subspecies pertenue . - Listeriosis due to Listeria monocytogenes . - Vincent's infection caused by Fusobacterium fusiforme . - Actinomycosis caused by Actinomyces israelii . - Infections caused by Clostridium species. In acute intestinal amebiasis, doxycycline may be a useful adjunct to amebicides. In severe acne, doxycycline may be useful adjunctive therapy. Doxycycline is indicated for the prophylaxis of malaria due to Plasmodium falciparum in short-term travelers (<4 months) to areas with chloroquine and/or pyrimethamine-sulfadoxine resistant strains. (See DOSAGE AND ADMINISTRATIONsection and Information for Patientssubsection of the PRECAUTIONSsection.) This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

পণ্য সারাংশ:

Doxycycline Hyclate Capsules, USP 50 mg are available as a blue and white capsule filled with yellow powder, imprinted with "2984", containing doxycycline hyclate, equivalent to 50 mg doxycycline; 100 mg are available as a light blue capsule filled with yellow powder imprinted with "2985"containing doxycycline hyclate, equivalent to 100 mg of doxycycline. Doxycycline Hyclate Tablets, USP equivalent to 100 mg doxycycline: Round, orange film-coated tablet engraved with "3626" on one side, and plain on the other side. Doxycycline Hyclate Tablets, USP equivalent to 50 mg doxycycline: Round, orange, film-coated tablet de-bossed with "CE over 30" on one side, and plain on the other side. NDC 62135-625-60                                                    Bottles of 60 tablets Doxycycline for Oral Suspension USP is available as a raspberry-flavored, pink dry powder for oral suspension. When reconstituted, each teaspoonful (5 mL) contains doxycycline monohydrate equivalent to 25 mg of doxycycline in a 2 oz (60 mL) bottle. NDC 62135-417-46 NDC 62135-877-46 Dispense in a tight, light-resistant container as defined in the USP. Use child-resistant closure (as required). Store at 20° to 25° C (68° to 77° F) (see USP controlled room temperature)

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE TABLET, FILM COATED
DOXYCYCLINE HYCLATE- DOXYCYCLINE HYCLATE CAPSULE
DOXYCYCLINE- DOXYCYCLINE POWDER, FOR SUSPENSION
CHARTWELL RX LLC
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DOXYCYCLINE HYCLATE CAPSULES, USP
DOXYCYCLINE FOR ORAL SUSPENSION, USP
DOXYCYCLINE HYCLATE TABLETS, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
Doxycycline and other antibacterial drugs, doxycycline should be used
only to treat or
prevent infections that are proven or strongly suspected to be caused
by bacteria.
DESCRIPTION
Doxycycline is an antibacterial drug synthetically derived from
oxytetracycline, and is
available as Doxycycline Hyclate Tablets and Capsules and Doxycycline
for Oral
Suspension; for oral administration.
The structural formula of doxycycline monohydrate is
with a molecular formula of C
H
N
O
∙H
O and a molecular weight of 462.46. The
chemical designation for doxycycline is
4-(Dimethylamino)-1,4,4a,5,5a,6,11,12a-
octahydro-3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-2-
naphthacenecarboxamide monohydrate. The molecular formula for
doxycycline
hydrochloride hemiethanolate hemihydrate is (C
H
N
O
∙HCl)
∙C
H
O∙H
O and
the molecular weight is 1025.89. Doxycycline is a light-yellow
crystalline powder.
Doxycycline hyclate is soluble in water, while doxycycline monohydrate
is very slightly
soluble in water.
Doxycycline has a high degree of lipoid solubility and a low affinity
for calcium binding. It
is highly stable in normal human serum. Doxycycline will not degrade
into an epianhydro
form.
Inactive ingredients in the capsule formulations are: colloidal
silicon dioxide, lactose
anhydrous, magnesium stearate, methylcellulose, microcrystalline
cellulose, polyethylene
glycol, sodium starch glycolate, and stearic acid. 50 mg gelatin
capsule shell contains:
FD&C Blue #1, D&C Yellow #10, titanium dioxide and gelatin. 100 mg
gelatin capsule
shell contains: FD&C Blue #1, titanium dioxide and gelatin. Black ink
contains shellac
glaze in SD-45, black iron oxide, propylene