General
ATRIDOX (doxycycline hyclate) ® has not been clinically tested in pregnant women.
ATRIDOX (doxycycline hyclate) ® has not been clinically evaluated in patients with conditions involving
extremely severe periodontal defects with very little remaining periodontium.
ATRIDOX (doxycycline hyclate) ® has not been clinically tested for use in the regeneration of alveolar
bone, either in preparation for or in conjunction with the placement of endosseous
(dental) implants or in the treatment of failing implants.
ATRIDOX (doxycycline hyclate) ® has not been clinically tested in immunocompromised patients (such
as patients immunocompromised by diabetes, chemotherapy, radiation therapy,
or infection with HIV).
As with other antibiotic preparations, ATRIDOX (doxycycline hyclate) ® therapy may result in overgrowth
of nonsusceptible organisms, including fungi.1 The effects of prolonged
treatment, greater than 6 months, have not been studied.
ATRIDOX (doxycycline hyclate) ® should be used with caution in patients with a history of or predisposition
to oral candidiasis. The safety and effectiveness of ATRIDOX (doxycycline hyclate) ® have not been
established for the treatment of periodontitis in patients with coexistent oral
candidiasis.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Long-term studies in animals to evaluate carcinogenic potential of doxycycline
have not been conducted. However, there has been evidence of oncogenic activity
in rats in studies with the related antibiotics, oxytetracycline (adrenal and
pituitary tumors), and minocycline (thyroid tumors). Likewise, although mutagenicity
studies of doxycycline have not been conducted, positive results in in vitro
mammalian cell assays have been reported for related antibiotics (tetracycline,
oxytetracycline). Doxycycline administered orally at dosage levels as high as
250 mg/kg/day had no apparent effect on the fertility of female rats. Effect
on male fertility has not been studied.
Pregnancy Category D. See WARNINGS section
Nursing Mothers
Tetracyclines appear in breast milk following oral administration. It is not
known whether doxycycline is excreted in human milk following use of ATRIDOX (doxycycline hyclate) ® .
Because of the potential for serious adverse reactions in nursing infants from
doxycycline, a decision should be made whether to discontinue nursing or to
discontinue the drug, taking into account the importance of the drug to the
mother. (See WARNINGS section)
Pediatrics
The safety and effectiveness of ATRIDOX (doxycycline hyclate) ® in pediatric patients have not
been established. Oral doses of doxycycline in children up to 8 years of age
have caused permanent discoloration of teeth.
Last reviewed on RxList: 4/11/2011
This monograph has been modified to include the generic and brand name in many instances.