DOXYCYCLINE capsule

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

DOXYCYCLINE (UNII: N12000U13O) (DOXYCYCLINE ANHYDROUS - UNII:334895S862)

Disponibil de la:

AvPAK

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

To reduce the development of drug-resistant bacteria and maintain effectiveness of doxycycline capsules, USP and other antibacterial drugs, doxycycline capsules, USP 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 capsules, USP are 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 capsules, USP are 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 capsules, USP are indicated for treatment of infections caused by the following gram-negative microorganisms, 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 capsules, USP are 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. This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

Rezumat produs:

Doxycycline Capsules USP, 50 mg are light yellow to yellow powder filled in hard gelatin capsule shell having an opaque yellow cap and an opaque white body printed with 782 on cap with black ink and are supplied as follows: NDC 50268-280-15 (10 capsules per card, 5 cards per carton). Doxycycline Capsules USP, 75 mg are light yellow to yellow powder filled in hard gelatin capsule shells having an opaque orange cap and an opaque white body printed with 706 on cap in black ink. Doxycycline Capsules USP, 100 mg are light yellow to yellow powder filled in hard gelatin capsule shells having an opaque yellow cap and an opaque orange body printed with 707 on cap in black ink and are supplied as follows: NDC 50268-281-15 (10 capsules per card, 5 cards per carton). For Institution Use Only. Dispensed in Unit Dose Package. Storage Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP. ANIMAL PHARMACOLOGY AND ANIMAL TOXICOLOGY Hyperpigmentation of the thyroid has been produced by members of the tetracycline class in the following species: in rats by oxytetracycline, doxycycline, tetracycline PO 4 , and methacycline; in minipigs by doxycycline, minocycline, tetracycline PO 4 , and methacycline; in dogs by doxycycline and minocycline; in monkeys by minocycline. Minocycline, tetracycline PO4, methacycline, doxycycline, tetracycline base, oxytetracycline HCl and tetracycline HCl were goitrogenic in rats fed a low iodine diet. This goitrogenic effect was accompanied by high radioactive iodine uptake. Administration of minocycline also produced a large goiter with high radioiodine uptake in rats fed a relatively high iodine diet. Treatment of various animal species with this class of drugs has also resulted in the induction of thyroid hyperplasia in the following: in rats and dogs (minocycline), in chickens (chlortetracycline) and in rats and mice (oxytetracycline). Adrenal gland hyperplasia has been observed in goats and rats treated with oxytetracycline.

Statutul autorizaţiei:

Abbreviated New Drug Application

Caracteristicilor produsului

DOXYCYCLINE- DOXYCYCLINE CAPSULE
AVPAK
----------
DOXYCYCLINE CAPSULES, USP
To reduce the development of drug-resistant bacteria and maintain the
effectiveness of
doxycycline capsules and other antibacterial drugs, doxycycline
capsules should be
used only to treat or prevent infections that are proven or strongly
suspected to be
caused by bacteria.
DESCRIPTION
Doxycycline is a broad-spectrum antibacterial synthetically derived
from oxytetracycline.
Doxycycline capsules 100 mg, 75 mg, and 50 mg capsules contain
doxycycline
monohydrate, USP equivalent to 100 mg, 75 mg, or 50 mg of doxycycline
for oral
administration. The chemical designation of the light-yellow to pale
yellow powder is
alpha-6-deoxy-5-oxytetracycline.
Structural formula:
C
H
N
O
• H
O M.W. = 462.45
Doxycycline has a high degree of lipid solubility and a low affinity
for calcium binding. It is
highly stable in normal human serum. Doxycycline will not degrade into
an epianhydro
form.
Each doxycycline capsule, USP intended for oral administration
contains 50 mg or 75
mg or 100 mg of doxycycline. In addition, each capsule contains the
following inactive
ingredients: colloidal silicon dioxide, gelatin, magnesium stearate,
microcrystalline
cellulose, sodium lauryl sulfate, sodium starch glycolate and titanium
dioxide.
Additionally, each 50 and 100 mg capsule shell contains iron oxide
yellow, each 75 mg
22
24
2
8
2
and 100 mg capsule shell contains: D & C yellow # 10, FD & C blue # 1,
FD & C red # 3
and FD & C yellow # 6 and each 100 mg capsule shell contains iron
oxide red. The
capsule is printed with black pharmaceutical ink which contains
following ingredients:
black iron oxide, potassium hydroxide, propylene glycol, shellac and
strong ammonia
solution.
The Product meets USP Dissolution Test 2.
CLINICAL PHARMACOLOGY
Tetracyclines are readily absorbed and are bound to plasma proteins in
varying degrees.
They are concentrated by the liver in the bile and excreted in the
urine and feces at high
concentrations in a biologically active form. Doxycycline i