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Declomycin Warnings, Precautions, Pregnancy, Nursing, Abuse - Demeclocycline HCl
WARNINGS
WARNINGS
about use during tooth development: 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 that 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 UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE CONTRAINDICATED.
If renal impairment exists, even usual oral or parenteral doses may lead to excessive systemic accumulation of the drug and possible liver toxicity. Under such conditions, lower than usual total doses are indicated and, if therapy is prolonged. Serum level determinations of the drug may be advisable.
Phototoxic reactions can occur in individuals taking demeclocycline and are characterized by severe burns of exposed surfaces resulting from direct exposure of patients to sunlight during therapy with moderate or large doses of demeclocycline. Patients apt to be exposed to direct sunlight or ultraviolet light should be advised that this reaction can occur, and treatment should be discontinued at the first evidence of skin erythema.
The anti-anabolic action of the tetracyclines may cause an increase in BUN. While this is not a problem in those with normal renal function, in patients with significantly impaired function, higher serum levels of tetracycline may lead to azotemia, hyperphosphatemia. and acidosis.
Administration of DECLOMYCIN has resulted in appearance of the diabetes insipidus syndrome (polyuria, polydipsia and weakness) in some patients on long-term therapy. The syndrome has been shown to be nephrogenic, dose-dependent and reversible on discontinuance of therapy.
Usage in pregnancy ( See above: WARNINGS
about
use during tooth development): 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.
Usage in newborns, infants, and children (See above:
WARNINGS
about use during tooth development)
All tetracyclines form a stable calcium complex in any bone forming tissue. A decrease in the fibula growth rate has been observed in prematures given oral tetracycline in doses of 25 mg/kg every six hours. This reaction was shown to be reversible when the drug was discontinued.
Tetracyclines are present in the milk of lactating women who are taking a drug in this class.
PRECAUTIONS
General
Pseudotumor cerebri (benign intracranial hypertension) in adults has been associated with the use of tetracyclines. The usual clinical manifestations are headache and blurred vision. Bulging fontanels have been associated with the use of tetracyclines in infants. While both of these conditions and related symptoms usually resolve soon after discontinuation of the tetracycline, the possibility for permanent sequelae exists.
As with other antibiotic preparations, use of this drug may result in overgrowth of nonsusceptible organisms, including fungi. If superinfection occurs, the antibiotic should be discontinued and appropriate therapy should be instituted.
In venereal diseases when coexistent syphilis is suspected, darkfield examination should be done before treatment is started and the blood serology repeated monthly for at least 4 months.
In long-term therapy, periodic laboratory evaluation of organ systems, including hematopoietic, renal and hepatic studies should be performed.
All infections due to Group A beta-hemolytic streptococci should be treated for at least ten days.
Interpretation of Bacteriologic Studies. Following a course of therapy, persistence for several days in both urine and blood of bacterio-suppressive levels of demeclocycline may interfere with culture studies. These levels should not be considered therapeutic.
Drug Interactions
Because the tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.
Since bacteriostatic drugs, such as the tetracycline class of antibiotics, may interfere with the bactericidal action of penicillins, it is not advisable to administer these drugs concomitantly.
Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective. Breakthrough bleeding has been reported
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