Periostat

Periostat

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-GRAYBROWN). 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

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

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

Periostat® (doxycycline hyclate) should be used with caution in patients with a history or predisposition to oral candidiasis. The safety and effectiveness of Periostat® (doxycycline hyclate) has not been establishedfor the treatment of periodontitis in patients with coexistant oral candidiasis.

If superinfection is suspected, appropriate measures should be taken.

Laboratory Tests

In long term therapy, periodic laboratory evaluations of organ systems, including hematopoietic, renal, and hepatic studies should be performed.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Doxycycline hyclate was assessed for potential to induce carcinogenesis in a study in which the compound was administered to Sprague-Dawley rats by gavage at dosages of 20, 75, and 200 mg/kg/day for two years. An increased incidence of uterine polyps was observed in female rats that received 200 mg/kg/day, a dosage that resulted in a systemic exposure to doxycycline approximately nine times that observed in female humans that used Periostat (doxycycline hyclate) (exposure comparison based upon AUC values). No impact upon tumor incidence was observed in male rats at 200 mg/kg/day, or in either gender at the other dosages studied. Evidence of oncogenic activity was obtained in studies with related compounds, i.e., oxytetracycline (adrenal and pituitary tumors), and minocycline (thyroid tumors).

Doxycycline hyclate demonstrated no potential to cause genetic toxicity in an in vitro point mutation study with mammalian cells (CHO/HGPRT forward mutation assay) or in an in vivo micronucleus assay conducted in CD-1 mice. However, data from an in vitro assay with CHO cells for potential to cause chromosomal aberrations suggest that doxycycline hyclate is a weak clastogen.

Oral administration of doxycycline hyclate to male and female Sprague-Dawley rats adversely affected fertility and reproductive performance, as evidenced by increased time for mating to occur, reduced sperm motility, velocity, and concentration, abnormal sperm morphology, and increased pre-and post-implantation losses. Doxycycline hyclate induced reproductive toxicity at all dosages that were examined in this study, as even the lowest dosage tested (50 mg/kg/day) induced a statistically significant reduction in sperm velocity. Note that 50 mg/kg/day is approximately 10 times the amount of doxycycline hyclate contained in the recommended daily dose of Periostat® (doxycycline hyclate) for a 60 kg human when compared on the basis of body surface area estimates (mg/m²). Although doxycycline impairs the fertility of rats when administered at sufficient dosage, the effect of Periostat® (doxycycline hyclate) on human fertility is unknown.

Pregnancy

Teratogenic Effects

Pregnancy Category D. (See WARNINGS Section). Results from animal studies indicate that doxycycline crosses the placenta and is found in fetal tissues.

Nonteratogenic effects

(See WARNINGS Section).

Labor and Delivery

The effect of tetracyclines on labor and delivery is unknown.

Nursing Mothers

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from doxycycline, the use of Periostat® (doxycycline hyclate) in nursing mothers is contraindicated. (See WARNINGS Section).

Pediatric Use

The use of Periostat® (doxycycline hyclate) in infancy and childhood is contraindicated. (See WARNINGS section.)

Last reviewed on RxList: 10/29/2008
This monograph has been modified to include the generic and brand name in many instances.

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