MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride_capsule

CLINICAL PHARMACOLOGY
Following a single dose of two 100 mg capsules of minocycline hydrochloride administered to 18 normal fasting adult volunteers, maximum serum concentrations were attained in 1 to 4 hours (average 2. 1 hours) and ranged from 2. 1 mcg/mL (average 3. The serum half-life in the normal volunteers ranged from 11. 1 hours (average 15. When minocycline hydrochloride capsules were given concomitantly with a high-fat meal, which included dairy products, the extent of absorption of minocycline hydrochloride capsules was unchanged compared to dosing under fasting conditions. The mean T max In previous studies with other minocycline dosage forms, the minocycline serum half-life ranged from 11 to 16 hours in 7 patients with hepatic dysfunction, and from 18 to 69 hours in 5 patients with renal dysfunction. The urinary and fecal recovery of minocycline when administered to 12 normal volunteers was one-half to one-third that of other tetracyclines. Mechanism of Action Antimicrobial Activity INDICATIONS AND USAGE Gram-positive Bacteria Bacillus anthracis Listeria monocytogenes Staphylococcus aureus Streptococcus pneumoniae Acinetobacter species Bartonella bacilliformis Brucella Campylobacter fetus Escherichia coli Francisella tularensis Haemophilus ducreyi Haemophilus influenzae Klebsiella aerogenes Klebsiella granulomatis Klebsiella Neisseria gonorrhoeae Neisseria meningitidis Shigella Yersinia pestis Vibrio cholerae Actinomyces Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Clostridium Entamoeba Fusobacterium nucleatum fusiforme Mycobacterium marinum Mycoplasma pneumoniae Propionibacterium acnes Treponema pallidum pallidum Treponema pallidum pertenue Ureaplasma urealyticum For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by the FDA for this drug, please see https://www.
Microbiology
Mechanism of Action Antimicrobial Activity INDICATIONS AND USAGE Gram-positive Bacteria Bacillus anthracis Listeria monocytogenes Staphylococcus aureus Streptococcus pneumoniae Acinetobacter species Bartonella bacilliformis Brucella Campylobacter fetus Escherichia coli Francisella tularensis Haemophilus ducreyi Haemophilus influenzae Klebsiella aerogenes Klebsiella granulomatis Klebsiella Neisseria gonorrhoeae Neisseria meningitidis Shigella Yersinia pestis Vibrio cholerae Actinomyces Borrelia recurrentis Chlamydophila psittaci Chlamydia trachomatis Clostridium Entamoeba Fusobacterium nucleatum fusiforme Mycobacterium marinum Mycoplasma pneumoniae Propionibacterium acnes Treponema pallidum pallidum Treponema pallidum pertenue Ureaplasma urealyticum
ANIMAL PHARMACOLOGY AND TOXICOLOGY
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. Watson Pharma Private Limited Teva Pharmaceuticals Rev. B 8/2024

Minocycline hydrochloride capsules are indicated in the treatment of the following infections due to susceptible strains of the designated microorganisms: Respiratory tract infections caused by Mycoplasma pneumoniae. Lymphogranuloma venereum caused by Chlamydia trachomatis. Psittacosis (Ornithosis) due to Chlamydophila psittaci. Trachoma caused by Chlamydia trachomatis, . Inclusion conjunctivitis caused by Chlamydia trachomatis. Nongonococcal urethritis, endocervical, or rectal infections in adults caused by Ureaplasma urealyticum 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 Bartonellosis due to Bartonella bacilliformis. Granuloma inguinale caused by Klebsiella granulomatis. Escherichia coli. Klebsiella aerogenes Shigella Acinetobacter Respiratory tract infections caused by Haemophilus influenzae. Respiratory tract and urinary tract infections caused by Klebsiella 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. Staphylococcus aureus. When penicillin is contraindicated, minocycline is an alternative drug in the treatment of the following infections: Uncomplicated urethritis in men due to Neisseria gonorrhoeae Infections in women caused by Neisseria gonorrhoeae. Syphilis caused by Treponema pallidum pallidum. Yaws caused by Treponema pallidum 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 . In acute intestinal amebiasis, In severe acne Oral minocycline is indicated in the treatment of asymptomatic carriers of Neisseria meningitidis 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.

THE USUAL DOSAGE AND FREQUENCY OF ADMINISTRATION OF MINOCYCLINE DIFFER FROM THAT OF THE OTHER TETRACYCLINES. EXCEEDING THE RECOMMENDED DOSAGE MAY RESULT IN AN INCREASED INCIDENCE OF SIDE EFFECTS. Minocycline hydrochloride capsules may be taken with or without food (see CLINICAL PHARMACOLOGY Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline-class is recommended to reduce the risk of esophageal irritation and ulceration. The capsules should be swallowed whole. For Pediatric Patients above 8 Years of Age Usual pediatric dose: 4 mg/kg initially followed by 2 mg/kg every 12 hours, not to exceed the usual adult dose. Adults The usual dosage of minocycline hydrochloride capsules is 200 mg initially followed by 100 mg every 12 hours. Alternatively, if more frequent doses are preferred, two or four 50 mg capsules may be given initially followed by one 50 mg capsule 4 times daily. Uncomplicated gonococcal infections other than urethritis and anorectal infections in men: 200 mg initially, followed by 100 mg every 12 hours for a minimum of 4 days, with post-therapy cultures within 2 to 3 days. In the treatment of uncomplicated gonococcal urethritis in men, 100 mg every 12 hours for 5 days is recommended. For the treatment of syphilis, the usual dosage of minocycline hydrochloride should be administered over a period of 10 to 15 days. Close follow-up, including laboratory tests, is recommended. In the treatment of meningococcal carrier state, the recommended dosage is 100 mg every 12 hours for 5 days. Mycobacterium marinum Uncomplicated urethral, endocervical, or rectal infection in adults caused by Chlamydia trachomatis Ureaplasma urealyticum: Ingestion of adequate amounts of fluids along with capsule and tablet forms of drugs in the tetracycline class is recommended to reduce the risk of esophageal irritation and ulceration. The pharmacokinetics of minocycline in patients with renal impairment (CL CR WARNINGS-Antianabolic Action

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: Body as a whole: Gastrointestinal: DOSAGE AND ADMINISTRATION Genitourinary: Hepatic toxicity: PRECAUTIONS Skin: WARNINGS-Photosensitivity Respiratory: Renal toxicity: WARNINGS Musculoskeletal: Hypersensitivity reactions: Blood: Central Nervous System: WARNINGS-Intracranial Hypertension Other: Tooth discoloration in children less than 8 years of age (see WARNINGS-Tooth Development Oral cavity discoloration (including tongue, lip, and gum) has been reported. Tinnitus and decreased hearing have been reported in patients on minocycline hydrochloride. The following syndromes have been reported. In some cases, involving these syndromes, death has been reported. As with other serious adverse reactions, if any of these syndromes are recognized, the drug should be discontinued immediately: Hypersensitivity syndrome consisting of cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, and one or more of the following: hepatitis, pneumonitis, nephritis, myocarditis, and pericarditis. Fever and lymphadenopathy may be present. Lupus-like syndrome consisting of positive antinuclear antibody; arthralgia, arthritis, joint stiffness, or joint swelling; and one or more of the following: fever, myalgia, hepatitis, rash, and vasculitis. Serum sickness-like syndrome consisting of fever; urticaria or rash; and arthralgia, arthritis, joint stiffness, or joint swelling and lymphadenopathy. Eosinophilia may be present. Post-Marketing Experience Skin and hypersensitivity reactions To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

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

Susceptibility Testing
For specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by the FDA for this drug, please see https://www.fda.gov/STIC.
WARNINGS
Tooth Development 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. Skeletal Development Use in Pregnancy Dermatologic Reaction Antianabolic Action DOSAGE AND ADMINISTRATION Photosensitivity Central Nervous System Clostridium difficile- Clostridium difficile C. difficile. C. difficile C. difficile C. difficile C. difficile Intracranial Hypertension
OVERDOSAGE
The adverse events more commonly seen in overdose are dizziness, nausea, and vomiting. No specific antidote for minocycline is known. In case of overdosage, discontinue medication, treat symptomatically, and institute supportive measures. Minocycline is not removed in significant quantities by hemodialysis or peritoneal dialysis.
PATIENT INFORMATION
Dispense with Patient Package Insert available at: www.tevausa.com/PatientPI PATIENT INFORMATION Minocycline Hydrochloride (min″ oh sye′ kleen hye″ droe klor′ ide) Capsules Read the Patient Information that comes with minocycline hydrochloride capsules before you or a family member starts taking it and each time you get a refill. There may be new information. This Patient Information leaflet does not take the place of talking to your healthcare provider about your medical condition or treatment. What are minocycline hydrochloride capsules? Who should not take minocycline hydrochloride capsules? Do not take minocycline hydrochloride capsules if you are allergic to minocycline or other tetracycline antibiotics. Minocycline hydrochloride capsules are not recommended for pregnant women or children under 8 years of age because: Minocycline hydrochloride capsules may harm an unborn baby. Minocycline hydrochloride capsules may permanently turn a baby''s or child''s teeth yellow-gray-brown during tooth development. What should I tell my doctor before taking minocycline hydrochloride capsules? Before taking minocycline hydrochloride capsules, tell your doctor about all of your medical conditions, including if you: have liver or kidney problems. are pregnant or plan to become pregnant. Stop taking minocycline hydrochloride capsules and call your doctor if you become pregnant while taking it. are breastfeeding or plan to breastfeed. Tell your doctor about all the medicines you take, Especially tell your doctor if you take: birth control pills. a blood thinner medicine. a penicillin antibiotic medicine. migraine medicines called ergot alkaloids. an acne medicine by mouth called isotretinoin. antacids that contain aluminum, calcium, or magnesium, or iron-containing products. Know the medicines you take, keep a list of them to show your doctor and pharmacist each time you get a new medicine. How should I take minocycline hydrochloride capsules? Take minocycline hydrochloride capsules exactly as your doctor tells you to take them Decrease the effectiveness of the treatment. Increase the chance that bacteria will develop resistance to minocycline hydrochloride capsules. Take minocycline hydrochloride capsules with a full glass of liquid. Minocycline hydrochloride capsules may be taken with or without food. If you take too many minocycline hydrochloride capsules, call your doctor or poison control center right away. What are the possible side effects of minocycline hydrochloride capsules? Minocycline hydrochloride may cause serious side effects. Stop minocycline hydrochloride capsules and call your doctor if you have: watery diarrhea blurred vision feeling very tired bloody stools fever swollen lymph nodes stomach cramps rash unusual headaches joint pain Minocycline hydrochloride may also cause: central nervous system effects. sun sensitivity (photosensitivity). These are not all the possible side effects of minocycline hydrochloride capsules. For more information ask your doctor or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA- 1088. How should I store minocycline hydrochloride capsules? Store minocycline hydrochloride capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep minocycline hydrochloride capsules away from light, moisture, and excess heat. Throw away any minocycline hydrochloride capsules that are outdated or no longer needed. Keep minocycline hydrochloride capsules and all medicines out of the reach of children. General information about the safe and effective use of minocycline hydrochloride capsules. What are the ingredients in minocycline hydrochloride capsules? Active ingredient: Inactive ingredients: Watson Pharma Private Limited Teva Pharmaceuticals This Patient Information has been approved by the U.S. Food and Drug Administration Rev. B 8/2024

Actavis Pharma, Inc.

MINOCYCLINE HYDROCHLORIDE- minocycline hydrochloride_capsule Product manual source documgent