Alodox - Warnings Doxycyline Hyclate

The FDA requires all potential medication risks for ALODOX (doxycyline hyclate tablet) be disclosed to consumers, no matter how rare. Here are the warnings and precautions for Alodox.

Warnings & Precautions

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.

Precautions

General: Prescribing Doxycycline Hyclate Tablets in the absence of a proven or
strongly suspected bacterial infection or a prophylactic indication is unlikely to
provide benefit to the patient and increases the risk of the development of drugresistant
bacteria.

While no overgrowth by opportunistic microorganisms such as yeast were noted
during clinical studies, as with other antimicrobials, doxycycline hyclate therapy
may result in overgrowth of nonsusceptible
microorganisms including fungi.

The use of tetracyclines may increase the incidence of vaginal candidiasis.

Doxycycline hyclate should be used with caution in patients with a history or
predisposition to oral candidiasis. The safety and effectiveness of doxycycline
hyclate has not been established for the treatment of periodontitis in patients with
coexistant oral candidiasis.

If superinfection is suspected, appropriate measures should be taken.

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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