Minocycline Hydrochloride TABLET, FILM COATED

Get an overview of MINOCYCLINE HYDROCHLORIDE (tablet, film coated), including its generic name, formulation (i.e. pill, oral solution, injection, inhaled medicine) and why it’s used. The medication in Minocycline Hydrochloride can be sold under different names.

Refer to the “Also Known As” section to reference different products that include the same medication as Minocycline Hydrochloride.

Drug Basics

Brand Name: Minocycline Hydrochloride

Generic Name: MINOCYCLINE HYDROCHLORIDE

Drug Type: HUMAN PRESCRIPTION DRUG

Route: ORAL

Dosage Form: TABLET, FILM COATED

Data Current As Of: 2019-01-21

Rx Only

To reduce the development of drug-resistant bacteria and maintain the effectiveness of minocycline hydrochloride tablets and other antibacterial drugs, minocycline hydrochloride tablets should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

indications & usage

Minocycline hydrochloride tablets 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 immunoflourescence.
  • 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 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 tablets 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 S treptococcus 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 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 meningitides to eliminate the meningococci from the nasopharynx. In order to preserve the usefulness of minocycline in the treatment of asymptomatic meningococcal carrier, 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 tablets and other antibacterial drugs, minocycline hydrochloride tablets 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 antimicrobial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

contraindications

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.

PATIENT INFORMATION

Minocycline Hydrochloride Tablets, USP 50 mg, 75 mg, and 100 mg 

Read the Patient Information that comes with Minocyline Hydrochloride Tablets 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 Minocycline Hydrochloride?

Minocycline Hydrochloride is a tetracycline-class antibiotic medicine. Minocycline Hydrochloride 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. Minocycline Hydrochloride may be used along with other treatments for severe acne.  

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

Who should not use Minocycline Hydrochloride?

Do not take Minocycline Hydrochloride 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 Minocycline Hydrochloride.  

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

1. Minocycline Hydrochloride may harm an unborn baby.

2. Minocycline Hydrochloride 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 Minocycline Hydrochloride Tablets?

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

  • have liver or kidney problems.
  • are pregnant or planning to become pregnant. Minocycline Hydrochloride may harm your unborn baby. Stop taking Minocycline Hydrochloride and call your doctor if you become pregnant while taking it
  • are breast feeding. Minocycline Hydrochloride passes into your milk and may harm your baby. You should decide whether to use Minocycline Hydrochloride 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. Minocycline Hydrochloride and other medicines may interact. Especially tell your doctor if you take:

  • birth control pills. Minocycline Hydrochloride 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. Minocycline Hydrochloride 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 Minocycline Hydrochloride Tablets?

  • Take Minocycline Hydrochloride Tablets exactly as your doctor tells you to take them. Skipping doses or not taking all your Minocycline Hydrochloride may:

  • Decrease the effectiveness of the treatment.

  • Increase the chance that bacteria will develop resistance to Minocycline Hydrochloride.

  • Take Minocycline Hydrochloride with a full glass of liquid. Taking Minocycline Hydrochloride 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.
  • Minocycline Hydrochloride Tablets may be taken with or without food. If you forget to take Minocycline Hydrochloride, take it as soon as you remember.
  • If you take too much Minocycline Hydrochloride, call you doctor or poison control center right away.  

What are the possible side effects of Minocycline Hydrochloride?

Minocycline Hydrochloridemay cause serious side effects. Stop Minocycline Hydrochlorideand call your doctor if you have:

 Minocycline Hydrochloride 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 Minocycline Hydrochloride. Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in the sunlight. Stop Minocycline Hydrochloride and call your doctor if your skin turns red.

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

How should I store Minocycline Hydrochloride Tablets?

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

General advice about Minocycline Hydrochloride Tablets Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Minocycline Hydrochloride Tablets for a condition for which it was not prescribed. Do not give Minocycline Hydrochloride Tablets 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 Minocycline Hydrochloride. If you would like more information, talk with your doctor.  

Your doctor or pharmacist can give you information about Minocycline Hydrochloride that is written for health care professionals. For more information, you can also call Dr. Reddy’s Laboratories Inc. at 1-888-375-3784. 

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

What are the ingredients in Minocycline Hydrochloride Tablets?

Active ingredient: minocycline hydrochloride USP

Inactive ingredients: Lactose Monohydrate, Magnesium Stearate, Microcrystalline Cellulose, Povidone and Sodium Starch Glycolate. The 50 mg tablets also contain Opadry Yellow which contains: FD&C Blue No. 2, FD&C Yellow No. 5, Titanium Dioxide, Hypromellose, Polyethylene Glycol. The 75 mg and 100 mg tablets contain Opadry Gray, which contains: Titanium Dioxide, Hypromellose, Polyethylene Glycol, Polysorbate 80 and Iron Oxide Black. Minocycline Hydrochloride Tablets, 50 mg contains FD&C Yellow No. 5 (Tartrazine) as color additive.  

To reorder additional Patient Information Sheets, contact Dr. Reddy’s Customer Service at 1-866-733-3952.   

All other trademarks are the property of their respective owners. 

Manufactured for:

Dr. Reddy’s Laboratories Inc.,

Princeton, NJ 08540 USA 

Manufactured by:

USV LIMITED

H-17/H-18, OIDC,

Mahatma Gandhi Udyog Nagar,

Dabhel, Daman 396 210, India   

Revised: 1114

.

also known as

This drug label information is as submitted to the Food and Drug Administration (FDA) and is intended for informational purposes only. If you think you may have a medical emergency, immediately call your doctor or dial 911. 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.
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