Minocin minocycline hydrochloride

Brand Name: Minocin

Generic Name: MINOCYCLINE HYDROCHLORIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: CAPSULE, COATED PELLETS

Data Current As Of: 2019-04-01

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 Chlamydophila 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 Klebsiella 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 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 MINOCIN Pellet-Filled Capsules and other antibacterial drugs, MINOCIN 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.

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 instituted.

Hepatotoxicity has been reported with minocycline; therefore, minocycline should be used with caution in patients with hepatic dysfunction and in conjunction with other hepatotoxic drugs.

Incision and drainage or other surgical procedures should be performed in conjunction with antibiotic therapy when indicated.

Prescribing MINOCIN Pellet-Filled Capsules in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic. If this occurs, patients should contact their physician as soon as possible.

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 with use of minocycline.

Patients who experience central nervous system symptoms should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy (see WARNINGS).

Concurrent use of tetracycline with oral contraceptives may render oral contraceptives less effective (see PRECAUTIONS - Drug Interactions).

Patients should be counseled that antibacterial drugs including MINOCIN Pellet-Filled Capsules should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When MINOCIN Pellet-Filled Capsules are prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed. Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by MINOCIN Pellet-Filled Capsules or other antibacterial drugs in the future.

Unused supplies of tetracycline antibiotics should be discarded by the expiration date.

Because tetracyclines have been shown to depress plasma prothrombin activity, patients who are on anticoagulant therapy may require downward adjustment of their anticoagulant dosage.

Since bacteriostatic drugs may interfere with the bactericidal action of penicillin, it is advisable to avoid giving tetracycline-class drugs in conjunction with penicillin.

Absorption of tetracyclines is impaired by antacids containing aluminum, calcium, or magnesium, and iron-containing preparations.

The concurrent use of tetracycline and methoxyflurane has been reported to result in fatal renal toxicity.

Concurrent use of tetracyclines with oral contraceptives may render oral contraceptives less effective.

Administration of isotretinoin should be avoided shortly before, during, and shortly after minocycline therapy. Each drug alone has been associated with pseudotumor cerebri (see WARNINGS).

Increased risk of ergotism when ergot alkaloids or their derivatives are given with tetracyclines.

False elevations of urinary catecholamine levels may occur due to interference with the fluorescence test.

MINOCIN^® [my-no-sin]
(minocycline hydrochloride)
Pellet-Filled Capsules, 50 mg and 100 mg

Read the Patient Information that comes with MINOCIN^® Pellet-Filled Capsules before you or a family member starts taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking to your doctor about your medical condition or treatment.

What is MINOCIN?

MINOCIN^® is a tetracycline-class antibiotic medicine. MINOCIN is used to treat certain infections caused by bacteria. These include infections of the skin, respiratory tract, urinary tract, some sexually transmitted diseases, and others. MINOCIN may be used along with other treatments for severe acne.

Sometimes other germs, called viruses, cause infections. The common cold is a virus. MINOCIN, like other antibiotics, does not treat viruses.

Who should not use MINOCIN?

Do not take MINOCIN if you are allergic to minocycline or other tetracycline antibiotics.

Ask your doctor or pharmacist for a list of these medications if you are not sure. See the end of this leaflet for a complete list of ingredients in MINOCIN.

MINOCIN is not recommended for pregnant women or children up to 8 years old because:

• 1. MINOCIN may harm an unborn baby
• 2. MINOCIN may permanently turn a baby's or child's teeth yellow-gray-brown during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years.

What should I tell my doctor before starting MINOCIN^® capsules?

Tell your doctor about all of your medical conditions, including if you:

• have liver or kidney problems.
• are pregnant or planning to become pregnant. MINOCIN may harm your unborn baby. Stop taking MINOCIN and call your doctor if you become pregnant while taking it.
• are breast feeding. MINOCIN passes into your milk and may harm your baby. You should decide whether to use MINOCIN or breastfeed, but not both.

Tell your doctor about all the medicines you are taking including prescription and non-prescription medications, vitamins, and herbal supplements. MINOCIN and other medicines may interact. Especially tell your doctor if you take:

• birth control pills. MINOCIN may make your birth control pills less effective.
• a blood thinner medicine. The dose of your blood thinner may have to be lowered.
• a penicillin antibiotic medicine. MINOCIN and penicillins should not be used together.
• migraine medicines called ergot alkaloids.
• an acne medicine called isotretinoin (Accutane, Amnesteem, Claravis, Sotret).
• 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 MINOCIN capsules?

•   Take MINOCIN capsules exactly as your doctor tells you to take them. Skipping doses may:
  • oDecrease the effectiveness of the treatment
  • oIncrease the chance that bacteria will develop resistance to MINOCIN
• Take MINOCIN with a full glass of liquid. Taking MINOCIN with enough liquid may lower your chance of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
• MINOCIN capsules may be taken with or without food. If you forget to take MINOCIN, take it as soon as you remember.
• If you take too much MINOCIN, call your doctor or poison control center right away.

What are the possible side effects of MINOCIN?

MINOCIN may cause serious side effects. Stop MINOCIN and call your doctor if you have:

• watery diarrhea
• bloody stools
• stomach cramps
• unusual headaches
• blurred vision
• fever
• rash
• joint pain
• feeling very tired
• swollen lymph nodes

MINOCIN may also cause:

• central nervous system effects. Symptoms include light-headedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate machines if you have these symptoms.
• sun sensitivity (photosensitivity). You may get a worse sunburn with MINOCIN. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop MINOCIN and call your doctor if your skin turns red.

These are not all the side effects with MINOCIN. Ask your doctor or pharmacist for more information.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store MINOCIN^® capsules?

• Store MINOCIN capsules at room temperature and away from excess heat and moisture.
• Throw away any MINOCIN that is outdated or no longer needed.
• Keep MINOCIN capsules and all medicines out of the reach of children.

General advice about MINOCIN capsules

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use MINOCIN capsules for a condition for which it was not prescribed. Do not give MINOCIN^® capsules to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about MINOCIN.

If you would like more information, talk with your doctor.

Your doctor or pharmacist can give you information about MINOCIN that is written for healthcare professionals. For more information, you can also call Valeant Pharmaceuticals North America LLC at 1-800-321-4576.

What are the ingredients in MINOCIN capsules?

Active ingredient: minocycline hydrochloride, 50 mg and 100 mg

Inactive ingredients: FD&C Blue #1, gelatin, titanium dioxide and FD&C Yellow #10. The 50 mg capsule shell also contains black and yellow iron oxides.

Manufactured for:

Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807 USA

Manufactured by:

Patheon Pharmaceuticals Inc.
Cincinnati, OH 45237 USA

MINOCIN is a trademark of Valeant Pharmaceuticals International, Inc. or its affiliates.

All other product/brand names are trademarks of their respective owners.

© 2019 Valeant Pharmaceuticals North America LLC

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  Rev. 01/2019
  9438603