doxycycline hyclate

FDA Drug Profile — doxycycline hyclate, DOXYCYCLINE HYCLATE DELAYED RELEASE, Acticlate CAP, DORYX MPC, TARGADOX

doxycycline hyclate is listed in the FDA National Drug Code directory with 29 NDC codes, marketed under brand names including doxycycline hyclate, DOXYCYCLINE HYCLATE DELAYED RELEASE, Acticlate CAP. Available dosage forms: capsule, tablet, delayed release, powder, for solution, tablet.

Drug Details

Generic Name
doxycycline hyclate
Brand Names
doxycycline hyclate, DOXYCYCLINE HYCLATE DELAYED RELEASE, Acticlate CAP, DORYX MPC, TARGADOX
Application Number
ANDA062500
Sponsor
Proficient Rx LP
NDC Codes
29
Dosage Forms
CAPSULE, TABLET, DELAYED RELEASE, POWDER, FOR SOLUTION, TABLET
Routes
ORAL, INTRAVENOUS
Active Ingredients
DOXYCYCLINE HYCLATE, DOXYCYCLINE ANHYDROUS

Indications and Usage

INDICATIONS AND USAGE Doxycycline hyclate is indicated for use as an adjunct to scaling and root planing to promote attachment level gain and to reduce pocket depth in patients with adult periodontitis.

Warnings

WARNINGS THE USE OF DRUGS OF THE TETRACYCLINE CLASS DURING TOOTH DEVELOPMENT (LAST HALF OF PREGNANCY, INFANCY AND CHILDHOOD TO THE AGE OF 8 YEARS) MAY CAUSE PERMANENT DISCOLORATION OF THE TEETH (YELLOW-GRAY-BROWN). This adverse reaction is more common during long-term use of the drugs but has been observed following repeated short-term courses. Enamel hypoplasia has also been reported. TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP AND IN PREGNANT OR NURSING MOTHERS UNLESS THE POTENTIAL BENEFITS MAY BE ACCEPTABLE DESPITE THE POTENTIAL RISKS. All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in fibula growth rate has been observed in premature infants given oral tetracyclines in doses of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was discontinued. Doxycycline can cause fetal harm when administered to a pregnant woman. Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues, and can have toxic effects on the developing fetus (often related to retardation of skeletal development). Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. If any tetracyclines are used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. The catabolic action of the tetracyclines may cause an increase in BUN. Previous studies have not observed an increase in BUN with the use of doxycycline in patients with impaired renal function. Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur with tetracycline drugs, and treatment should be discontinued at the first evidence of skin erythema. Severe skin reactions, such as exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis, and drug reaction with eosinophilia and systemic symptoms (DRESS) have been reported in patients receiving doxycycline. Fixed drug eruptions have occurred with doxycycline and have been associated with worsening severity upon subsequent administrations, including generalized bullous fixed drug eruption (See ADVERSE REACTIONS). If severe skin reactions occur, discontinue doxycycline hyclate immediately and institute appropriate therapy.