Minocin

Name: Minocin

Overdose

If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Minocin Precautions

Serious side effects can occur including:

  • Harm to an unborn baby. If you are pregnant talk to your doctor about the risks associated with taking minocycline during pregnancy.
  • Permanent teeth discoloration. Minocycline may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Minocycline should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age. 
  • Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including minocycline. Call your doctor right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools.
  • Serious liver problems. Stop taking minocycline and call your doctor right away if you get any of the following symptoms of liver problems:
    • loss of appetite
    • tiredness
    • diarrhea
    • yellowing of your skin or the whites of your eyes
    • unexplained bleeding
    • confusion
    • sleepiness
  • Central nervous system effects. Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with minocycline or if treatment is stopped.
  • Benign intracranial hypertension, also called pseudotumor cerebri. This is a condition where there is high pressure in the fluid around the brain. This swelling may lead to vision changes and permanent vision loss. Stop taking minocycline and tell your doctor right away if you have blurred vision, vision loss, or unusual headaches.
  • Immune system reactions including a lupus-like syndrome, hepatitis, and inflammation of blood or lymph vessels (vasculitis). Using minocycline for a long time to treat acne may cause immune system reactions. Tell your doctor right away if you get a fever, rash, joint pain, or body weakness. Your doctor may do tests to check your blood for immune system reactions.
  • Serious rash and allergic reactions. Minocycline may cause a serious rash and allergic reactions that may affect parts of your body such as your liver, lungs, kidneys and heart. Sometimes these can lead to death. Stop taking minocycline and get medical help right away if you have any of these symptoms:
    • skin rash, hives, sores in your mouth, or your skin blisters and peels
    • swelling of your face, eyes, lips, tongue, or throat
    • trouble swallowing or breathing

Do not take minocycline if you are allergic to tetracycline-class drugs. Ask your doctor or pharmacist for a list of these medicines if you are not sure.

  • Avoid sunlight, sunlamps, and tanning beds. Minocycline can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn.
  • Protect your skin while out in sunlight.
  • You should not drive or operate dangerous machinery until you know how this medication affects you. Minocycline may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).

Other Requirements

  • Store minocycline at room temperature between 59°F to 86°F (15°C to 30°C).
  • Keep minocycline and all medicines out of the reach of children.

What should I discuss with my healthcare provider before taking Minocin (minocycline)?

You should not take this medicine if you are allergic to minocycline or to similar antibiotics such as demeclocycline, doxycycline, or tetracycline.

If you are using minocycline to treat gonorrhea, your doctor may test you to make sure you do not also have syphilis, another sexually transmitted disease.

To make sure minocycline is safe for you, tell your doctor if you have:

  • liver disease;

  • kidney disease; or

  • asthma or sulfite allergy.

You should not use minocycline if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life. Tell your doctor right away if you become pregnant during treatment.

Minocycline can make birth control pills less effective. Ask your doctor about using a non hormone method of birth control (such as a condom, diaphragm, spermicide) to prevent pregnancy while using minocycline.

Minocycline passes into breast milk and may affect bone and tooth development in a nursing baby. You should not breast-feed while you are taking minocycline.

Do not give this medicine to a child without medical advice. Minocycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Commonly used brand name(s)

In the U.S.

  • Cleeravue-M
  • Dynacin
  • Minocin
  • Minolira
  • Myrac
  • Solodyn
  • Ximino

Available Dosage Forms:

  • Capsule, Extended Release
  • Tablet
  • Tablet, Extended Release
  • Capsule
  • Suspension

Therapeutic Class: Antibiotic

Chemical Class: Tetracycline (class)

Uses For Minocin

Minocycline is used to treat pimples and red bumps (non-nodular inflammatory lesions) that occur with moderate to severe acne vulgaris in patients 12 years of age and older.

Minocycline capsules are used to treat bacterial infections in many different parts of the body. It is also used to treat anthrax infection and other infections in patients who cannot receive penicillins.

Minocycline belongs to the class of medicines known as tetracycline antibiotics. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.

This medicine is available only with your doctor's prescription.

Microbiology

Mechanism of Action

The tetracyclines are primarily bacteriostatic and are thought to exert their antimicrobial effect by the inhibition of protein synthesis. The tetracyclines, including minocycline, have a similar antimicrobial spectrum of activity against a wide range of gram-positive and gram-negative organisms. Cross-resistance of these organisms to tetracycline is common.

Antimicrobial Activity

Minocycline has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section:

Gram-positive Bacteria

Bacillus anthracis
Listeria monocytogenes
Staphylococcus aureus
Streptococcus pneumoniae

Gram-negative Bacteria

Bartonella bacilliformis
Brucella species
Klebsiella granulomatis
Campylobacter fetus
Francisella tularensis
Haemophilus ducreyi
Vibrio cholerae
Yersinia pestis
Acinetobacter species
Enterobacter aerogenes
Escherichia coli
Haemophilus influenzae
Klebsiella species
Neisseria gonorrhoeae1
Neisseria meningitidis1
Shigella species

Other Microorganisms

Actinomyces species
Borrelia recurrentis
Chlamydophila psittaci
Chlamydia trachomatis
Clostridium species
Entamoeba species
Fusobacterium nucleatum subspecies fusiforme
Mycobacterium marinum
Mycoplasma pneumoniae
Propionibacterium acnes
Rickettsiae
Treponema pallidum subspecies pallidum
Treponema pallidum subspecies pertenue
Ureaplasma urealyticum

Carcinogenesis, Mutagenesis, Impairment of Fertility

Dietary administration of minocycline in long-term tumorigenicity studies in rats resulted in evidence of thyroid tumor production. Minocycline has also been found to produce thyroid hyperplasia in rats and dogs. In addition, there has been evidence of oncogenic activity in rats in studies with a related antibiotic, oxytetracycline (i.e., adrenal and pituitary tumors). Likewise, although mutagenicity studies of minocycline have not been conducted, positive results in in vitro mammalian cell assays (i.e., mouse lymphoma and Chinese hamster lung cells) have been reported for related antibiotics (tetracycline hydrochloride and oxytetracycline). Segment I (fertility and general reproduction) studies have provided evidence that minocycline impairs fertility in male rats.

Nursing Mothers

Tetracyclines are excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from the tetracyclines, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother (see WARNINGS).

Geriatric Use

Clinical studies of oral minocycline did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy (see WARNINGS and DOSAGE AND ADMINISTRATION).

Minocin Pellet-Filled Capsules (50 mg and 100 mg) do not contain sodium.

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

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 or not taking all your Minocin may: o Decrease the effectiveness of the treatment o Increase 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 Minocinthat 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.

©Valeant Pharmaceuticals North America LLC

 
Rev. 04/2017 9438602

In Summary

More frequent side effects include: vulvovaginal candidiasis, diarrhea, dizziness, dysphagia, epigastric distress, melanoglossia, nausea and vomiting, sore throat, stomatitis, and anorexia. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to minocycline: oral capsule, oral capsule extended release, oral suspension, oral tablet, oral tablet extended release

Other dosage forms:

  • intravenous powder for solution

Along with its needed effects, minocycline (the active ingredient contained in Minocin) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking minocycline:

Incidence not known
  • Black, tarry stools
  • blistering, peeling, or loosening of the skin
  • blood in the urine or stools
  • blurred or double vision
  • bulging soft spot on the head of an infant
  • chest pain, possibly moving to the left arm, neck, or shoulder
  • confusion
  • diarrhea
  • dizziness or lightheadedness
  • eye pain
  • fast heartbeat
  • general feeling of discomfort or illness
  • general tiredness and weakness
  • hives, itching, or skin rash
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • loss of appetite
  • nausea or vomiting
  • red skin lesions, often with a purple center
  • severe headache
  • severe stomach pain
  • sores, ulcers, or white spots on the lips or in the mouth
  • troubled breathing
  • unusual bleeding or bruising
  • upper right abdominal or stomach pain
  • yellow eyes and skin

Some side effects of minocycline may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Less common
  • Continuing ringing or buzzing or other unexplained noise in the ears
  • difficulty with moving
  • hearing loss
  • hives or welts
  • muscle stiffness
  • redness of the skin
  • sleepiness or unusual drowsiness
Incidence not known
  • Bloating
  • discoloration of the tooth
  • increased sensitivity of the skin to sunlight
  • indigestion
  • severe sunburn

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