DOXYCYCLINE- doxycycline capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Owen Laboratories, Inc.

INN (International Name):

DOXYCYCLINE

Composition:

DOXYCYCLINE ANHYDROUS 40 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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. Doxycycline 40 mg should not be used 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. Efficacy of Doxycycline 40 mg beyond 16 weeks and safety beyond 9 months have not been established. 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 of the

Product summary:

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 69007-822-30). Storage: All products are to be stored at controlled room temperatures of 15°C - 30°C (59°F - 86°F) and dispensed in tight, light-resistant containers (USP). Keep out of reach of children.

Authorization status:

New Drug Application Authorized Generic

Summary of Product characteristics

DOXYCYCLINE- DOXYCYCLINE CAPSULE
OWEN LABORATORIES, INC.
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOXYCYCLINE SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR DOXYCYCLINE.
DOXYCYCLINE, 40 MG CAPSULES FOR ORAL USEINITIAL U.S. APPROVAL: 1967
INDICATIONS AND USAGE
Doxycycline, USP, Capsules 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 40 mg has not been evaluated in the
treatment or prevention of infections. (1.2)
Efficacy of Doxycycline 40 mg beyond 16 weeks and safety beyond 9
months have not been established. (1.2)
DOSAGE AND ADMINISTRATION
One Doxycycline Capsule 40 mg should be taken once daily in the
morning on an empty stomach, preferably at least one
hour prior to or two hours after meals. (2.1)
The dosage of Doxycycline 40 mg differs from that of doxycycline used
to treat infections. Exceeding the recommended
dosage may result in an increased incidence of side effects including
the development of resistant microorganisms. (2.2,
5.5)
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 (last half of
pregnancy, infancy and childhood up to the age of 8
years) may cause permanent discoloration of the teeth
(yellow-gray-brown). (5.1)
If pseudomembranous colitis occurs, discontinue Doxycycline 40 mg.
(5.2)
If renal impairment exists, Doxycycline 40 mg doses may need to be
adjusted to avoid excessive systemic accumulations
of the drug and possible liver injury. (5.3)
Photosensitivity can occur with Doxycycline 40 mg; Patients should
minimize or avoid exposure to natural or artificial
sunlight. (5.4)
Tetracyclines have been associated with the development of autoimmun