Important Safety Information
Indications and Usage
What is Minocycline Hydrochloride Extended-Release Capsules?
Minocycline hydrochloride extended-release capsules is a tetracycline-class drug 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 capsules is not effective for acne that is not red-looking (this means acne that is not inflammatory). It is not known whether it is safe for use longer than 12 weeks, safe and effective for the treatment of infections and safe and effective in children under the age of 12 years.
Important Risk Information
Who Should Not Take Minocycline Hydrochloride Extended-Release Capsules?
Do not take minocycline hydrochloride extended-release capsules if you are allergic to tetracycline class medicines. 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 Capsules?
Before you take minocycline hydrochloride extended-release capsules, tell your doctor if you have kidney or liver problems, diarrhea or watery stools, vision problems or plan to have surgery with general anesthesia or any other medical conditions.
You should not take minocycline hydrochloride extended-release capsules if you are a male, and you and your female partner are trying to conceive a baby.
You should not take minocycline hydrochloride extended-release capsules if you are pregnant or plan to become pregnant. Minocycline hydrochloride extended-release capsules may harm your unborn baby. Taking minocycline hydrochloride extended-release capsules 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 capsules if you plan to become pregnant or if you are already taking minocycline hydrochloride extended-release capsules and plan to become pregnant. Stop taking minocycline hydrochloride extended-release capsules and call your doctor right away if you become pregnant while taking minocycline hydrochloride extended-release capsules.
You should not take minocycline hydrochloride extended-release capsules if you are breastfeeding or plan to breastfeed. Minocycline hydrochloride extended-release capsules passes into your milk and may harm your baby. You and your doctor should decide if you will take minocycline hydrochloride extended-release capsules or breastfeed. You should not do both.
Tell your doctor about all of the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Minocycline hydrochloride extended-release capsules may affect the way other medicines work, and other medicines may affect how minocycline hydrochloride extended-release capsules works. Especially tell your doctor if you take birth control pills, blood thinner medicine, a penicillin antibiotic medicine. Minocycline hydrochloride extended-release capsules and penicillins should not be used together and antacids that contain aluminum, calcium, or magnesium or iron containing products. Minocycline hydrochloride extended-release capsules should not be taken with an acne medication that contains isotretinoin. Minocycline hydrochloride extended-release capsules and isotretinoin should not be used together.
What Are Possible Side Effects Of Minocycline Hydrochloride Extended-Release Capsules?
Minocycline hydrochloride extended-release capsules may cause side effects, including:
- Harm to an unborn baby.
- Permanent teeth discoloration. Minocycline hydrochloride extended-release capsules may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. Minocycline hydrochloride extended-release capsules 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 hydrochloride extended-release capsules. Call your doctor right away if you get watery diarrhea, diarrhea that does not go away, or bloody stools. You may have stomach cramps and a fever. Pseudomembranous colitis can happen 2 or more months after you have finished your medication.
- Serious liver problems. Stop taking minocycline hydrochloride extended-release capsules 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 hydrochloride extended-release capsules or if treatment is stopped. Call your doctor if you get headaches that do not go away or blurred vision.
- 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 capsules and tell you 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 capsules 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 capsules 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 capsules 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
What Should I Avoid While Taking Minocycline Hydrochloride Extended-Release Capsules?
- Avoid sunlight, sunlamps, and tanning beds. Minocycline hydrochloride extended-release capsules can make your skin sensitive to the sun and the light from sunlamps and tanning beds. You could get severe sunburn.
- Wear loose-fitting clothes that protect your skin from sun exposure. Talk to your doctor about other ways to protect your skin while out in sunlight.
- You should not drive or operate dangerous machinery until you know how minocycline hydrochloride extended-release capsules affects you. Minocycline hydrochloride extended-release capsules may cause you to feel dizzy and lightheaded, or have a spinning feeling (vertigo).
The most common side effects of minocycline hydrochloride extended-release capsules were headache, tiredness, dizziness, or spinning feeling and 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 capsules.
These are not all the side effects with minocycline hydrochloride extended-release capsules. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects.
To report SUSPECTED ADVERSE REACTIONS, contact JG Pharma, Inc. at 1-855-422-9439, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
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