DOXYCYCLINE capsule

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Prasco Laboratories

INN:

DOXYCYCLINE

composition:

DOXYCYCLINE ANHYDROUS 40 mg

administration_route:

ORAL

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Doxycycline 40 mg is indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. No meaningful effect was demonstrated for generalized erythema (redness) of rosacea. This formulation of doxycycline has not been evaluated in the treatment or prevention of infections. Do not use Doxycycline 40 mg for treating bacterial infections, providing antibacterial prophylaxis, or reducing the numbers or eliminating microorganisms associated with any bacterial disease. To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, Doxycycline 40 mg should be used only as indicated. Doxycycline 40 mg has not been evaluated for the treatment of the erythematous, telangiectatic, or ocular components of rosacea. This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any other tetracyclines. Risk Summary Doxycycline may cause reversible inhibition of bone growth and permanent discoloration of deciduous teeth when administered during the second and third trimesters of pregnancy [see Warnings and Precautions (5.1 and 5.2) ]. Available data from published studies have not shown a difference in major birth defect risk with doxycycline exposure in the first trimester of pregnancy compared to unexposed pregnancies. Avoid use of Doxycycline 40 mg during the second and third trimester of pregnancy. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2–4% and 15–20%, respectively. Data Human Data Published studies, including epidemiological and observational studies, with use of doxycycline during the first trimester of pregnancy have not identified drug-related increases in major birth defects. The use of tetracycline during tooth development (second and third trimester of pregnancy) may cause permanent discoloration of deciduous teeth (yellow-gray-brown). This adverse reaction is more common during long-term use of the drug but has been observed following repeated short-term courses. Animal Data Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues. Risk Summary Based on available published data, doxycycline is likely to be present in human breast milk but the specific concentration in breastmilk is not clear. There is no information on the effects of doxycycline on the breastfed infant or the effects on milk production. Because there are other antibacterial drug options available to treat rosacea in lactating women and because of the potential for serious adverse reactions, including tooth discoloration and inhibition of bone growth, advise patients that breastfeeding is not recommended during treatment with Doxycycline 40 mg and for 5 days after the last dose. Doxycycline 40 mg should not be used in infants and children less than 8 years of age [see Warnings and Precautions (5.1) ]. Doxycycline 40 mg has not been studied in children of any age with regard to safety or efficacy, therefore use in children is not recommended. Clinical studies of Doxycycline 40 mg did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and concomitant disease or other drug therapy.

leaflet_short:

Doxycycline 40 mg (beige opaque capsule imprinted with “GLD 40”) containing doxycycline, USP in an amount equivalent to 40 mg of anhydrous doxycycline. Bottle of 30 (NDC 66993-815-30). Storage: All products are to be stored at controlled room temperatures of 59°F - 86°F (15°C - 30°C) and dispensed in tight, light-resistant containers (USP).  Keep out of reach of children.

authorization_status:

New Drug Application Authorized Generic

SPC

DOXYCYCLINE- DOXYCYCLINE CAPSULE
PRASCO LABORATORIES
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXYCYCLINE 40 MG
CAPSULES SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR
DOXYCYCLINE 40 MG
CAPSULES.
DOXYCYCLINE 40 MG CAPSULES FOR ORAL USE
INITIAL U.S. APPROVAL: 1967
INDICATIONS AND USAGE
Doxycycline 40 mg is a tetracycline-class drug indicated for the
treatment of only inflammatory lesions
(papules and pustules) of rosacea in adult patients. (1.1)
Limitations of Use
This formulation of doxycycline has not been evaluated in the
treatment or prevention of infections. Do not
use Doxycycline 40 mg for treating bacterial infections, providing
antibacterial prophylaxis, or reducing the
numbers or eliminating microorganisms associated with any bacterial
disease. (1.2)
Doxycycline 40 mg has not been evaluated for the treatment of the
erythematous, telangiectatic, or
ocular components of rosacea. (1.2)
DOSAGE AND ADMINISTRATION
Take one Doxycycline 40 mg capsule once daily in the morning on an
empty stomach, preferably at least
one hour prior to or two hours after meals. (2.1) Exceeding the
recommended dosage may result in an
increased incidence of side effects including the development of
resistant microorganisms. (2.2, 5.9)
DOSAGE FORMS AND STRENGTHS
40 mg capsule. (3)
CONTRAINDICATIONS
Doxycycline 40 mg is contraindicated in persons who have shown
hypersensitivity to doxycycline or other
tetracyclines. (4)
WARNINGS AND PRECAUTIONS
The use of Doxycycline 40 mg during tooth development (the second and
third trimesters of pregnancy,
infancy and childhood up to the age of 8 years) may cause permanent
discoloration of the teeth
(yellow-gray-brown) and reversible inhibition of bone growth. (5.1,
5.2, 8.1, 8.4)
Treatment with antibacterial agents alters the normal flora of the
colon leading to overgrowth of
_Clostridium difficile_. If _C. difficile_ associated diarrhea occurs,
discontinue Doxycycline 40 mg. (5.3)
If renal impairment exists, D