"The U.S. Food and Drug Administration is alerting hospitals, health care professionals, and patients of a voluntary recall of all non-expired drug products produced and distributed for sterile use by Abrams Royal Compounding Pharmacy in Dallas, T"...
MINOCIN® (minocycline inj) Intravenous is indicated in the treatment of the following infections due to susceptible isolates of the designated bacteria:
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.
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 Klebsiella (Calymmatobacterium) granulomatis.
Minocycline is indicated for the treatment of infections caused by the following Gram-negative bacteria when bacteriologic testing indicates appropriate susceptibility to the drug:
Respiratory tract infections caused by Haemophilus influenzae.
Respiratory tract and urinary tract infections caused by Klebsiella species.
MINOCIN® (minocycline inj) Intravenous is indicated for the treatment of infections caused by the following Gram-positive bacteria 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:
Meningitis due to Neisseria meningitidis.
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.
To reduce the development of drug-resistant bacteria and maintain the effectiveness of MINOCIN® (minocycline) Injection and other antibacterial drugs, MINOCIN® (minocycline) Injection 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.
DOSAGE AND ADMINISTRATION
THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFERS FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS.
Note: Rapid administration is to be avoided. Parenteral therapy is indicated only when oral therapy is not adequate or tolerated. Oral therapy should be instituted as soon as possible. If intravenous therapy is given over prolonged periods of time, thrombophlebitis may result.
For Pediatric Patients above 8 years of Age
Usual pediatric dose: Initial dose of 4 mg/kg, then 2 mg/kg every 12 hours, not to exceed the usual adult dose
Usual adult dose: Initial dose of 200 mg, then 100 mg every 12 hours and should not exceed 400 mg in 24 hours. The cryodesiccated powder should be reconstituted with 5 mL Sterile Water for Injection USP and immediately further diluted to 500 mL to 1,000 mL with Sodium Chloride Injection USP, Dextrose Injection USP, Dextrose and Sodium Chloride Injection USP, Ringer's Injection USP, or Lactated Ringer's Injection USP, but not with other solutions containing calcium because a precipitate may form especially in neutral and alkaline solutions. When further diluted in 500 mL to 1,000 mL of compatible solutions (except Lactated Ringer's), the pH usually ranges from 2.5 to 4.0. The pH of MINOCIN® (minocycline inj) IV 100 mg in Lactated Ringer's 500 mL to 1,000 mL usually ranges from 4.5 to 6.0.
Final dilutions (500 mL to 1,000 mL) should be administered immediately but product and diluents are compatible at room temperature for 24 hours without a significant loss of potency. Any unused portions must be discarded after that period.
The pharmacokinetics of minocycline in patients with renal impairment (CLcR < 80 mL/min) have not been fully characterized. Current data are insufficient to determine if a dosage adjustment is warranted. The total daily dosage should not exceed 200 mg in 24 hours in patients with renal impairment. However, due to the anti-anabolic effect of tetracyclines, BUN and creatinine should be monitored (See WARNINGS).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
MINOCIN® (minocycline inj) IV should not be mixed before or during administration with any solutions containing: adrenocorticotropic hormone (ACTH), aminophylline, amobarbital sodium, amphotericin B, bicarbonate infusion mixtures, calcium gluconate or chloride, carbenicillin, cephalothin sodium, cefazolin sodium, chloramphenicol succinate, colistin sulfate, heparin sodium, hydrocortisone sodium succinate, iodine sodium, methicillin sodium, novobiocin, penicillin, pentobarbital, phenytoin sodium, polymyxin, prochlorperazine, sodium ascorbate, sulfadiazine, sulfisoxazole, thiopental sodium, vitamin K (sodium bisulfate or sodium salt), whole blood.
MINOCIN® (minocycline for injection) Intravenous is supplied as 100 mg vials of sterile cryodesiccated powder.
Product No. NDC 14290-545-92
Store at Controlled Room Temperature 20° to 25°C (68° to 77°F).
1. Clinical and Laboratory Standards (CLSI). Methods for Dilution Susceptibility Tests for Bacteria that Grow Aerobically; Approved Standard - 8th ed. CLSI document M07-A8. CLSI, 940 West Valley Rd., Suite 1400, Wayne, PA 19087-1898, 2009
This product's label may have been updated. For current package insert and further product information, please visit www.triaxpharma.com or call our toll-free number: 800 978 5060. Call between 9:00 a.m. and 5:00 p.m. Eastern Time, Monday through Friday. TRIAX PHARMACEUTICALS, LLC Manufactured for Triax Pharmaceuticals, LLC Cranford, NJ 07016By Patheon Italia S.p.A Monza (Milan), Italy Marketed and Distributed by Triax Pharmaceuticals, LLC. Rev: 08/10
Last reviewed on RxList: 10/18/2010
This monograph has been modified to include the generic and brand name in many instances.
Additional Minocin Injection Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
Find out what women really need.