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Basic Drug Info
Drug Name:Doxycycline hyclate
Manufacturer:Mutual Pharmaceutical Company, Inc.
Other Info:Manufactured By:MUTUAL PHARMACEUTICAL COMPANY, INC.Philadelphia, PA 19124 USARev: June 2006Ch



Clinical Trials:


Indications and Usage

To reduce the development of drug-resistant bacteria and maintain the effectiveness of Doxycycline Hyclate Tablets and other antibacterial drugs, Doxycycline Hyclate Tablets 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 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.
Infection -- Invasion of the host organism by microorganisms that can cause pathological conditions or diseases.

Chronic Periodontitis -- Chronic inflammation and loss of PERIODONTIUM that is associated with the amount of DENTAL PLAQUE or DENTAL CALCULUS present. Chronic periodontitis occurs mostly in adults and was called adult periodontitis, but this disease can appear in young people.

Contraindications
This drug is contraindicated in persons who have shown hypersensitivity to doxycycline or any of the other tetracyclines.
Hypersensitivity -- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.

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 RISKSAll 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.
Branded Drugs
The following US Branded drugs contain Doxycycline hyclate


DORYX -- MAYNE PHARMA INTERNATIONAL FAULDING PHARM

DORYX -- WARNER CHILCOTT BERMUDA LTD

DOXY-LEMMON -- TEVA PHARMACEUTICALS USA INC

PERIOSTAT -- COLLAGENEX INC

VIBRAMYCIN -- PFIZER LABORATORIES DIV PFIZER INC

DOXY 100 -- ABRAXIS PHARMACEUTICAL PRODUCTS

DOXY 200 -- ABRAXIS PHARMACEUTICAL PRODUCTS

DOXYCHEL HYCLATE -- RACHELLE LABORATORIES INC

DOXYCYCLINE -- BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE

DOXYCYCLINE -- BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC

ATRIDOX -- TOLMAR INC

PERIOSTAT -- GALDERMA LABORATORIES LP

VIBRA-TABS -- PFIZER LABORATORIES DIV PFIZER INC


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