Dynacin capsules

Minocycline Hydrochloride 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)   Brucellosis due to Bartonella bacilliformis   Granuloma inguinale caused by Calymmatobacterium granulomatis  

Minocycline is indicated for 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

Minocycline hydrochloride 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 Straphylococcus 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 when penicillin is contraindicated.   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 Fusobacteruim 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 Neisseria meningitidis 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 minocycline hydrochloride capsules and other antibacterial drugs, minocycline hydrochloride 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.

This drug is contraindicated in persons who have shown hypersensitivity to any of the tetracyclines.

MINOCYCLINE, 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 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. 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 lightheadedness, 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.

Due to oral minocycline's virtually complete absorption, side effects to the lower bowel, particularly diarrhea, have been infrequent. The following adverse reactions have been observed in patients receiving tetracyclines.

Gastrointestinal

Anorexia, nausea, vomiting, diarrhea, glossitis, dysphagia, enterocolitis, pancreatitus, inflammatory lesions (with monilial overgrowth) in the anogenital region, and increases in liver enzymes have been reported. Rarely, hepatitis and liver failure have been reported. These reactions have been caused by both the oral and the parenteral administration of tetracyclines. Rare instances of esophagitis and esophageal ulcerations have been reported in patients taking the tetracycline-class antibiotics in capsule and tablet form. Most of these patients took the medication immediately before going to bed (see DOSAGE AND ADMINISTRATION).

Skin

Maculopapular and erythematous rashes. Exfoliative dermatitis has been reported but is uncommon. Fixed drug eruptions have been rarely reported. Lesions occurring on the glans penis have caused balanitis. Erythema multiforme and rarely Stevens-Johnson syndrome have been reported. Photosensitivity is discussed above (see WARNINGS). Pigmentation of the skin and mucous membranes has been reported.

Renal toxicity

Elevations in BUN have been reported and are apparently dose related (see WARNINGS). Acute renal failure has been rarely reported and, in most cases, has been reversible.

Hypersensitivity reactions

Urticaria, angioneurotic edema, polyarthralgia, anaphylaxis, anaphylactoid purpura, pericarditis, exacerbation of systemic lupus erythematosus and rarely pulmonary infiltrates with eosinophilia have been reported. A lupus-like syndrome and serum sickness-like reactions also have been reported.

Blood

Hemolytic anemia, thrombocytopenia, neutropenia, and eosinophilia have been reported.

Central Nervous System

Bulging fontanels in infants and benign intracranial hypertension (pseudotumor cerebri) in adults (see PRECAUTIONS-General) have been reported. Headache has also been reported.

Other

When given over prolonged periods, tetracyclines have been reported to produce brown-black microscopic discoloration of the thyroid glands. Very rare cases of abnormal thyroid function have been reported.

Tooth discoloration in pediatric patients less than 8 years of age (see WARNINGS) and also, rarely, in adults has been reported.

Tinnitus and decreased hearing have been rarely reported in patients on minocycline hydrochloride.

Minocycline hydrochloride has been observed to cause a dark discoloration of the thyroid in experimental animals (rats, minipigs, dogs and monkeys). In the rat, chronic treatment with minocycline hydrochloride has resulted in goiter accompanied by elevated radioactive iodine uptake, and evidence of thyroid tumor production. Minocycline hydrochloride has also been found to produce thyroid hyperplasia in rats and dogs.

1. National Committee for Clinical Laboratory Standards, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically – Fourth Edition; Approved Standard. NCCLS Document M7-A4, Vol. 17, No. 2, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA. January 1997.
2. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disks Susceptibility Tests – Sixth Edition; Approved Standard. NCCLS Document M2-A5, Vol. 17, No. 1, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA. January 1997.
3. National Committee for Clinical Laboratory Standards, Performance Standards for Antimicrobial Disk Susceptibility Tests – Eighth Edition; Approved Standard. NCCLS Document M100-S8, Vol. 18, No. 1, NCCLS, 940 West Valley Road, Suite 1400, Wayne, PA. January 1998

Manufactured for:
MEDICIS, The Dermatology Company®
Scottsdale, AZ 85258

IN-5178/S
Prescribing Information as of February 2004

Dynacin  minocycline hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:99207-487 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength minocycline hydrochloride (minocycline) minocycline 50 mg

Inactive Ingredients Ingredient Name Strength magnesium stearate   starch (corn)   gelatin   silicon dioxide   sodium lauryl sulfate   titanium dioxide

Product Characteristics Color WHITE (Opaque white) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 0487;Dynacin;50;mg Contains      Coating false Symbol true

Packaging # Item Code Package Description 1 NDC:99207-487-10 100 CAPSULE (100 CAPSULE) in 1 BOTTLE 2 NDC:99207-487-11 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE

Dynacin  minocycline hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:99207-489 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength minocycline hydrochloride (minocycline) minocycline 75 mg

Inactive Ingredients Ingredient Name Strength magnesium stearate   starch (corn)

Product Characteristics Color GRAY (light, opaque gray) Score no score Shape CAPSULE Size 16mm Flavor Imprint Code 0489;Dynacin;75;mg Contains      Coating false Symbol false

Packaging # Item Code Package Description 1 NDC:99207-489-10 100 CAPSULE (100 CAPSULE) in 1 BOTTLE 2 NDC:99207-489-11 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE

Dynacin  minocycline hydrochloride capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:99207-488 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength minocycline hydrochloride (minocycline) minocycline 100 mg

Inactive Ingredients Ingredient Name Strength magnesium stearate   starch (corn)

Product Characteristics Color GRAY (dark, opaque gray) , WHITE (WHITE) Score no score Shape CAPSULE Size 18mm Flavor Imprint Code 0488;Dynacin;100;mg Contains      Coating false Symbol false

Packaging # Item Code Package Description 1 NDC:99207-488-05 50 CAPSULE (50 CAPSULE) in 1 BOTTLE 2 NDC:99207-488-11 1000 CAPSULE (1000 CAPSULE) in 1 BOTTLE

Labeler - MEDICIS, The Dermatology Company

Revised: 11/2006   MEDICIS, The Dermatology Company