CONTRAINDICATIONS
This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.
WARNINGS
Oral
MINOCYCLINE HCL TABLETS AND PELLET-FILLED CAPSULES, LIKE OTHER
TETRACYCLINE-CLASS ANTIBIOTICS, CAN CAUSE FETAL HARM WHEN
ADMINISTERED TO A PREGNANT WOMAN. IF ANY TETRACYCLINE IS USED
DURING PREGNANCY, OR IF THE PATIENT BECOMES PREGNANT WHILE TAKING
THESE DRUGS, THE PATIENT SHOULD BE APPRISED OF THE POTENTIAL HAZARD
TO THE FETUS. 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 drug but has been observed
following repeated short-term courses. Enamel hypoplasia has also been reported.
TETRACYCLINE DRUGS, THEREFORE, SHOULD NOT BE USED DURING TOOTH
DEVELOPMENT UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR
ARE CONTRAINDICATED.
All tetracyclines form a stable calcium complex in any bone-forming tissue. A decrease in fibula
growth rate has been observed in young animals (rats and rabbits) given oral tetracycline in doses
of 25 mg/kg every 6 hours. This reaction was shown to be reversible when the drug was
discontinued.
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 been noted in animals treated early in pregnancy.
The antianabolic 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. If renal
impairment exists, even usual oral or parenteral doses may lead to excessive systemic
accumulations 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.
Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some
individuals taking tetracyclines. This has been reported rarely with minocycline.
Central nervous system side effects including light-headedness, dizziness, or vertigo have been
reported with minocycline therapy. Patients who experience these symptoms should be cautioned
about driving vehicles or using hazardous machinery while on minocycline therapy. These symptoms
may disappear during therapy and usually disappear rapidly when the drug is discontinued.
Intravenous Injection
In the presence of renal dysfunction, particularly in pregnancy, intravenous tetracycline therapy in
daily doses exceeding 2 g has been associated with deaths through liver failure.
When the need for intensive treatment outweighs its potential dangers (mostly during pregnancy or
in individuals with known or suspected renal or liver impairment), it is advisable to perform renal and
liver function tests before and during therapy. Also tetracycline serum concentrations should be
followed.
If renal impairment exists, even unusual 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. This hazard is of particular importance in the parenteral administration of tetracyclines to
pregnant or postpartum patients with pyelonephritis. When used under these circumstances, the
blood level should not exceed 15 mg/ml and liver function tests should be made at frequent intervals.
Other potentially hepatotoxic drugs should not be used concomitantly.
THE USE OF TETRACYCLINES 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.
TETRACYCLINES, THEREFORE, SHOULD NOT BE USED IN THIS AGE GROUP
UNLESS OTHER DRUGS ARE NOT LIKELY TO BE EFFECTIVE OR ARE
CONTRAINDICATED.
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. Studies to date indicate that photosensitivity is rarely reported
with minocycline HCl.
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.
CNS side effects including light-headedness, dizziness or vertigo have been reported. Patients who
experience these symptoms may disappear during therapy and usually disappear rapidly when the
drug is discontinued.
Usage in Pregnancy
See 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.
The safety of minocycline HCl for use during pregnancy has not been established.
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 young animals (rats and rabbits) 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
Oral: 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.
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 after discontinuation of the tetracycline, the possibility for
permanent sequelae exists.
Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic
therapy when indicated.
Intravenous Injection: 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 non-susceptible
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 four 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.
Information for the Patient
Oral: 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. This reaction has been reported rarely with use of
minocycline.
Patients who experience central nervous system symptoms (see WARNINGS) should be cautioned
about driving vehicles or using hazardous machinery while on minocycline therapy.
Concurrent use of tetracycline may render oral contraceptives less effective (see DRUG
INTERACTIONS.)
Tablets Only: Patients should be informed that minocycline HCl tablets should be taken at least one
hour before meals or 2 hours after meals (see DOSAGE AND ADMINISTRATION).
Laboratory Tests
Oral: In venereal diseases when coexistent syphilis is suspected, dark-field 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.
Drug/Laboratory Test Interactions
Oral: False elevations of urinary catecholamine levels may occur due to interference with the
fluorescence test.
Carcinogenesis, Mutagenesis, and Impairment of Fertility
Oral: Dietary administration of minocycline in long-term tumorigenicity studies in rats resulted in
evidence of thyroid tumor production. Minocycline has also been found to produce thyroid
hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in
studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Likewise,
although mutagenicity studies of minocycline have not been conducted, positive results in in vitro
mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported
for related antibiotics (tetracycline HCl and oxytetracycline). Segment I (fertility and general
reproduction) studies have provided evidence that minocycline impairs fertility in male rats.
Pregnancy, Teratogenic Effects, Pregnancy Category D
Oral: See WARNINGS.
Labor and Delivery
Oral: The effect of tetracyclines on labor and delivery is unknown.
Nursing Mothers
Oral: Tetracyclines are excreted in human milk. Because of the potential for serious adverse
reactions in nursing infants from tetracyclines, a decision should be made whether to discontinue
nursing or discontinue the drug, taking into account the importance of the drug to the mother (see
WARNINGS).
Pediatric Use
Oral: See WARNINGS.