|Manufacturer:||Triax Pharmaceuticals, LLC|
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and 3:00 p.m.Eastern Time, Monday through Friday.Manufactured for Triax Pharmaceuticals, LLC20 Commerce Drive, Cranford, NJ 07016By Wyeth Pharmaceuticals Inc., Philadelphia, PA 19101250F100Rev 3/06
MINOCIN® Pellet-Filled Capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms:Rocky Mountain spotted fever, typhus fever and the typhus group, Q fever, rickettsialpox and tick fevers caused by rickettsiae.Respiratory tract infections caused by Mycoplasma pneumoniae.Lymphogranuloma venereum caused by Chlamydia trachomatis.Psittacosis (Ornithosis) due to Chlamydia psittaci.Trachoma caused by Chlamydia trachomatis, although the infectious agent is not always eliminated, as judged by immunofluorescence.Inclusion conjunctivitis caused by Chlamydia trachomatis.Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum or Chlamydia trachomatis.Relapsing fever due to Borrelia recurrentis.Chancroid caused by Haemophilus ducreyi.Plague due to Yersinia pestis.Tularemia due to Francisella tularensis.Cholera caused by Vibrio cholerae.Campylobacter fetus infections caused by Campylobacter fetus.Brucellosis due to Brucella species (in conjunction with streptomycin).Bartonellosis due to Bartonella bacilliformis.Granuloma inguinale caused by Calymmatobacterium granulomatis.Minocycline is indicated for the treatment of infections caused by the following gram-negative microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Escherichia coli.Enterobacter aerogenes.Shigella species.Acinetobacter species.Respiratory tract infections caused by Haemophilus influenzae.Respiratory tract and urinary tract infections caused by Klebsiella species.MINOCIN® Pellet-Filled Capsules are indicated for the treatment of infections caused by the following gram-positive microorganisms when bacteriologic testing indicates appropriate susceptibility to the drug:Upper respiratory tract infections caused by Streptococcus pneumoniae.Skin and skin structure infections caused by Staphylococcus aureus.
(Note: Minocycline is not the drug of choice in the treatment of any type of staphylococcal infection.)When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections:Uncomplicated urethritis in men due to Neisseria gonorrhoeae and for the treatment of other gonococcal infections.Infections in women caused by Neisseria gonorrhoeae.Syphilis caused by Treponema pallidum subspecies pallidum.Yaws caused by Treponema pallidum subspecies pertenue.Listeriosis due to Listeria monocytogenes.Anthrax due to Bacillus anthracis.Vincent's infection caused by Fusobacterium fusiforme.Actinomycosis caused by Actinomyces israelii.Infections caused by Clostridium species.In acute intestinal amebiasis, minocycline may be a useful adjunct to amebicides.In severe acne, minocycline may be useful adjunctive therapy.Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseriameningitidis to eliminate meningococci from the nasopharynx.
In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carriers, diagnostic laboratory procedures, including serotyping and susceptibility testing, should be performed to establish the carrier state and the correct treatment.
It is recommended that the prophylactic use of minocycline be reserved for situations in which the risk of meningococcal meningitis is high.Oral minocycline is not indicated for the treatment of meningococcal infection.Although no controlled clinical efficacy studies have been conducted, limited clinical data show that oral minocycline hydrochloride has been used successfully in the treatment of infections caused by Mycobacterium marinum.To reduce the development of drug-resistant bacteria and maintain the effectiveness of Minocin (minocycline hydrochloride) Pellet-Filled Capsules and other antibacterial drugs, Minocin (minocycline hydrochloride) Pellet-Filled Capsules 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.
MINOCIN®, 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 the fibula growth rate has been observed in premature human infants given oral tetracycline in doses of 25 mg/kg every six 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 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.
Under such conditions, monitoring of creatinine and BUN is recommended, and the total daily dosage should not exceed 200 mg in 24 hours.
(See DOSAGE AND ADMINISTRATION.) If renal impairment exists, even usual oral or parenteral doses may lead to systemic accumulation of the drug and possible liver toxicity.Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines.
This has been reported 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.Pseudomembranous colitis has been reported with nearly all antibacterial agents and may range in severity from mild to life-threatening.
Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of any antibacterial agent.Treatment with antibacterial agents alters the flora of the colon and may permit overgrowth of clostridia.
Studies indicate that a toxin produced by Clostridium difficile is the primary cause of "antibiotic-associated colitis." After diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated.
Mild cases of pseudomembranous colitis usually respond to drug discontinuation alone.
In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against C.difficile colitis.