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Side Effects & Adverse Reactions
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.
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
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
There is currently no drug history available for this drug.
The structural formula of doxycycline hyclate is:
with a molecular formula of (C22H24N2O8.HCI)2.C2H6O.H2O and a molecular weight of 1025.89. The chemical designation for doxycycline is 4-(dimethylamino)-1, 4, 4a, 5, 5a, 6, 11, 12a-octahydro-3, 5, 10, 12, 12a-pentahydroxy-6 -methyl-1, 11-dioxo-2-naphthacenecarboxamide monohydrochloride, compound with ethyl alcohol (2:1), monohydrate.
Doxycycline hyclate is a yellow to light-yellow crystalline powder which is soluble in water.
Each tablet for oral administration contains 23mg doxycycline hyclate equivalent to 20 mg of doxycycline. In addition, each tablet contains the following inactive ingredients: anhydrous lactose, carnauba wax, croscarmellose sodium, hypromellose, magnesum stearate, microcrystalline cellulose, poldextrose, polyethylene glycol, titanium dioxide, and triacetin.