Minocycline Hydrochloride TABLET, EXTENDED RELEASE

Get an overview of MINOCYCLINE HYDROCHLORIDE (tablet, extended release), 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, EXTENDED RELEASE

Data Current As Of: 2019-12-16

indications & usage

Minocycline hydrochloride extended-release tablets is tetracycline-class drug indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. (1)

indication

Minocycline hydrochloride extended-release tablets  are indicated to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older.

limitations of use

Minocycline hydrochloride extended-release tablets  did not demonstrate any effect on non-inflammatory acne lesions. Safety of minocycline hydrochloride extended-release tablets has not been established beyond 12 weeks of use. This formulation of minocycline has not been evaluated in the treatment of infections [see CLINICAL STUDIES (14)].

To reduce the development of drug-resistant bacteria as well as to maintain the effectiveness of other antibacterial drugs, minocycline hydrochloride extended-release tablets  should be used only as indicated [see WARNINGS AND PRECAUTIONS (5.11)].

patient counseling information

[See FDA-approved patient labeling (Patient Information)]

Patients taking minocycline hydrochloride extended-release tablets  should receive the following information and instructions:

  • Minocycline hydrochloride extended-release tablets  should not be used by pregnant women or women attempting to conceive a child [see USE IN SPECIFIC POPULATIONS (8.1), NONCLINICAL TOXICOLOGY (13.1.)].
  • It is recommended that minocycline hydrochloride extended-release tablets  not be used by men who are attempting to father a child [see NONCLINICAL TOXICOLOGY (13.1)].
  • Patients should be advised that pseudomembranous colitis can occur with minocycline therapy. If patients develop watery or bloody stools, they should seek medical attention.
  • Patients should be counseled about the possibility of hepatotoxicity. Patients should seek medical advice if they experience symptoms which can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness.
  • Patients who experience central nervous system symptoms [see WARNINGS AND PRECAUTIONS (5.5 )]  should be cautioned about driving vehicles or using hazardous machinery while on minocycline therapy. Patients should seek medical help for persistent headaches or blurred vision.
  • Concurrent use of tetracycline may render oral contraceptives less effective [see DRUG INTERACTIONS (7.5)].
  • Autoimmune syndromes, including drug-induced lupus-like syndrome, autoimmune hepatitis, vasculitis and serum sickness have been observed with tetracycline-class drugs, including minocycline. Symptoms may be manifested by arthralgia, fever, rash and malaise. Patients who experience such symptoms should be cautioned to stop the drug immediately and seek medical help.
  • Patients should be counseled about discoloration of skin, scars, teeth or gums that can arise from minocycline therapy.
  • Photosensitivity manifested by an exaggerated sunburn reaction has been observed in some individuals taking tetracyclines, including minocycline. Patients should minimize or avoid exposure to natural or artificial sunlight (tanning beds or UVA/B treatment) while using minocycline. If patients need to be outdoors while using minocycline, they should wear loose-fitting clothes that protect skin from sun exposure and discuss other sun protection measures with their physician. Treatment should be discontinued at the first evidence of skin erythema.
  • Minocycline hydrochloride extended-release tablets  should be taken exactly as directed. Skipping doses or not completing the full course of therapy may decrease the effectiveness of the current treatment course and increase the likelihood that bacteria will develop resistance and will not be treatable by other antibacterial drugs in the future.
  • Patients should be advised to swallow minocycline hydrochloride extended-release tablets  whole and not to chew, crush, or split the tablets.

patient information

Minocycline Hydrochloride Extended-Release Tablets

Rx only

Read this patient information leaflet that comes with minocycline hydrochloride extended-release tablets before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition or treatment.

What are minocycline hydrochloride extended-release tablets?

Minocycline hydrochloride is tetracycline-class drug. Minocycline hydrochloride extended-release tablets are prescription medicine used to treat pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne vulgaris in people 12 years and older. Minocycline hydrochloride extended-release tablets are not effective for acne that is not red-looking (this means acne that is not inflammatory).

It is not known if minocycline hydrochloride extended-release tablets are:

  • safe for use longer than 12 weeks.
  • safe and effective for the treatment of infections.
  • safe and effective in children under the age of 12 years.

Who should not take minocycline hydrochloride extended-release tablets?

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

What should I tell my doctor before taking minocycline hydrochloride extended-release tablets?

Before you take minocycline hydrochloride extended-release tablets, tell your doctor if you:

  • have kidney problems. Your doctor may prescribe a lower dose of medicine for you.
  • have liver problems.
  • have diarrhea or watery stools.
  • have vision problems.
  • plan to have surgery with general anesthesia.
  • have any other medical conditions.
  • are a male, and you and your female partner are trying to conceive a baby. You should not take minocycline hydrochloride extended-release tablets
  • are pregnant or plan to become pregnant. Minocycline hydrochloride extended-release tablets may harm your unborn baby. Taking minocycline hydrochloride extended-release tablets while you are pregnant may cause serious side effects on the growth of bone and teeth of your baby. Talk to your doctor before taking minocycline hydrochloride extended-release tablets if you plan to become pregnant, or if you are already taking minocycline hydrochloride extended-release tablets and plan to become pregnant. Stop taking minocycline hydrochloride extended-release tablets and call your doctor right away if you become pregnant while taking minocycline hydrochloride extended-release tablets.
  • are breastfeeding or plan to breastfeed. Minocycline hydrochloride passes into your milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride extended-release tablets or breastfeed. You should not do both.

Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Minocycline hydrochloride extended-release tablets may affect the way other medicines work, and other medicines may affect how minocycline hydrochloride extended-release tablets works.

Especially tell your doctor if you take:

  • birth control pills. Minocycline hydrochloride extended-release tablets may make your birth control pills less effective. You could become pregnant. You should use a second form of birth control while taking minocycline hydrochloride extended-release tablets.
  • a blood thinner medicine.
  • a penicillin antibiotic medicine. Minocycline hydrochloride extended-release tablets and penicillins should not be used together.
  • antacids that contain aluminum, calcium, or magnesium or iron-containing products.
  • an acne medicine that contains isotretinoin. (Amnesteem, Claravis, Sotret). Minocycline hydrochloride extended-release tablets and isotretinoin should not be used together.

Ask your doctor or pharmacist if you are not sure if your medicine is one that is listed above.

Know the medicines you take. Keep a list of them to show your doctor and pharmacist.

How should I take minocycline hydrochloride extended-release tablets?

  • Take minocycline hydrochloride extended-release tablets exactly as your doctor tells you.
  • Skipping doses or not taking all doses of minocycline hydrochloride extended-release tablets may:
    • make the treatment not work as well.
    • increase the chance that the bacteria will become resistant to minocycline hydrochloride extended-release tablets
  • Minocycline hydrochloride extended-release tablets can be taken with or without food. Taking minocycline hydrochloride extended-release tablets with food may lower your chances of getting irritation or ulcers in your esophagus. Your esophagus is the tube that connects your mouth to your stomach.
  • Swallow minocycline hydrochloride extended-release tablets whole. Do not chew, crush, or split the tablets.

If you take too much minocycline hydrochloride extended-release tablets, call your doctor or poison control center right away. Your doctor may do blood tests to check you for side effects during treatment with minocycline hydrochloride extended-release tablets

What should I avoid while taking minocycline hydrochloride extended-release tablets?

  • Avoid sunlight, sunlamps, and tanning beds. Minocycline hydrochloride extended-release tablets 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 minocycline hydrochloride extended-release tablets affect you. Minocycline hydrochloride extended-release tablets may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).

What are possible side effects of minocycline hydrochloride extended-release tablets?

Minocycline hydrochloride extended-release tablets may cause serious side effects, including:

  • Harm to an unborn baby. See “What should I tell my doctor before taking minocycline hydrochloride extended-release tablets?”
  • Permanent teeth discoloration. Minocycline hydrochloride extended-release tablets may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Minocycline hydrochloride extended-release tablets should not be used during tooth development. Tooth development happens in the last half of pregnancy, and from birth to 8 years of age. See “What should I tell my doctor before taking minocycline hydrochloride extended-release tablets?”
  • Intestine infection (pseudomembranous colitis). Pseudomembranous colitis can happen with most antibiotics, including minocycline hydrochloride extended-release tablets. 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 hydrochloride extended-release tablets 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. See “What should I avoid while taking minocycline hydrochloride extended-release tablets?” Central nervous system effects such as light headedness, dizziness, and a spinning feeling (vertigo) may go away during your treatment with minocycline hydrochloride extended-release tablets 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets 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 hydrochloride extended-release tablets 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
    • blood in your urine
    • fever, yellowing of the skin or the whites of your eyes, dark colored urine
    • pain on the right side of the stomach area (abdominal pain)
    • chest pain or abnormal heartbeats
    • swelling in your legs, ankles and feet
    • darkening of your nails, skin, eyes, scars, teeth, and gums.

The most common side effects of minocycline hydrochloride extended-release tablets include:

  • headache
  • tiredness
  • dizziness or spinning feeling
  • itching

Call your doctor if you have a side effect that bothers you or that does not go away. Your doctor may do tests to check you for side effects during treatment with minocycline hydrochloride extended-release tablets.

These are not all the side effects with minocycline hydrochloride extended-release tablets. Ask your doctor or pharmacist for more information.

Call your doctor for medical advice about side effects. You may report side effects to Sandoz Inc. at 1-800-525-8747 or FDA at 1-800-FDA-1088.

How should I store minocycline hydrochloride extended-release tablets?

  • Store minocycline hydrochloride extended-release tablets at 20º to 25ºC (68º to 77ºF) [see USP Controlled Room Temperature].
  • Keep minocycline hydrochloride extended-release tablets in the container that it comes in and keep container tightly closed.
  • Keep minocycline hydrochloride extended-release tablets dry.

Keep minocycline hydrochloride extended-release tablets and all medicines out of the reach of children.

General Information about minocycline hydrochloride extended-release tablets

Medicines are sometimes prescribed for purposes other than those listed in the Patient Information Leaflet. Do not use minocycline hydrochloride extended-release tablets for a condition for which it was not prescribed. Do not give minocycline hydrochloride extended-release 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 extended-release tablets. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about minocycline hydrochloride extended-release tablets that is written for health professionals.

For more information, call Sandoz Inc. at 1-800-525-8747

What are the ingredients in minocycline hydrochloride extended-release tablets?

Active Ingredient: Minocycline Hydrochloride, USP

Inactive Ingredients: colloidal silicon dioxide, hypromellose, lactose monohydrate, and magnesium stearate.

The 45 mg extended-release tablets also contain opadry grey, which contains: titanium dioxide, triacetin, iron oxide black, and iron oxide yellow.

The 90 mg extended-release tablets also contain opadry orange, which contains: titanium dioxide, triacetin, iron oxide yellow, FD&C yellow #6, and iron oxide red.

The 135 mg extended-release tablets also contain opadry yellow, which contains: titanium dioxide, triacetin and iron oxide yellow.

Manufactured by:

USV Private Limited,

OIDC, Mahatma Gandhi Udyog Nagar, Dabhel, Daman 396210, India

for Sandoz Inc., Princeton, NJ 08540

Rev. February 2017

principal display panel

Minocycline Hydrochloride ER Tablets

45 mg

30 Tablets

package / label display panel

Minocycline Hydrochloride ER Tablets0 mg

30 Tablets

package / label display panel

Minocycline Hydrochloride ER Tablets

135 mg

30 Tablets

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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