Drug Catalog - Product Detail
DOXYCYCLINE CP 40MG 30
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 66993-0815-30 | PRASCO LABORATORIES | 30 | 40MG | CAPSULE |
PACKAGE FILES
Generic Name
DOXYCYCLINE
Substance Name
DOXYCYCLINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
ORAL
Application Number
NDA050805
Description
11 DESCRIPTION Doxycycline, USP Capsules 40 mg are hard gelatin capsule shells filled with two types of doxycycline beads (30 mg immediate release and 10 mg delayed release) that together provide a dose of 40 mg of anhydrous doxycycline (C 22 H 24 N 2 O 8 ). The structural formula of doxycycline, USP is: with an empirical formula of C 22 H 24 N 2 O 8 •H 2 O and a molecular weight of 462.46. The chemical designation for doxycycline is 2-Naphthacenecarboxamide,4-(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro- 3,5,10,12,12a-pentahydroxy-6-methyl-1,11-dioxo-, [4S-(4α, 4aα, 5α, 5aα, 6α,12aα)]-, monohydrate. It is very slightly soluble in water. Inert ingredients in the formulation are: hypromellose, iron oxide red, iron oxide yellow, methacrylic acid copolymer, polyethylene glycol, Polysorbate 80, sugar spheres, talc, titanium dioxide, and triethyl citrate. chem-struct
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING 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.
Indications & Usage
1 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 ) 1.1 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. 1.2 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. 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.
Dosage and Administration
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 ) 2.1 General Dosing Information 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. Administration of adequate amounts of fluid along with the capsules is recommended to wash down the capsule to reduce the risk of esophageal irritation and ulceration [ see Adverse Reactions (6) ]. 2.2 Important Considerations for Dosing Regimen 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 organisms.