Important Safety Information

Indications and Usage

What is XIMINO?

XIMINO (minocycline hydrochloride) 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.

XIMINO is not effective for acne that is not red-looking (this means acne that is not inflammatory). It is not known whether XIMINO is: safe for use longer than 12 weeks, safe and effective for the treatment of infections, or safe and effective in children under the age of 12 years.

Important Risk Information

Who should not take XIMINO?

Do not take XIMINO 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 XIMINO?

Before you take XIMINO, tell your doctor if you have kidney or liver problems, diarrhea or watery stools, vision problems, plan to have surgery with general anesthesia, or have any other medical conditions.

You should not take XIMINO if you are a male, and you and your female partner are trying to conceive a baby.

You should not take XIMINO if you are pregnant or plan to become pregnant. XIMINO may harm your unborn baby. Taking XIMINO 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 XIMINO if you plan to become pregnant or if you are already taking XIMINO and plan to become pregnant. Stop taking XIMINO and call your doctor right away if you become pregnant while taking XIMINO.

You should not take XIMINO if you are breastfeeding or plan to breastfeed. XIMINO passes into your milk and may harm your baby. You and your doctor should decide if you will take XIMINO 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. XIMINO may affect the way other medicines work, and other medicines may affect how XIMINO works. Especially tell your doctor if you take birth control pills, blood thinner medicine, penicillin antibiotic medicine, antacids that contain aluminum, calcium, or magnesium, iron-containing products, or an acne medication that contains isotretinoin. XIMINO and penicillins should not be used together. XIMINO should not be taken with an acne medication that contains isotretinoin. XIMINO 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.

What are possible side effects of XIMINO?

XIMINO may cause serious side effects, including:

• Harm to an unborn baby.
• Permanent teeth discoloration. XIMINO may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. XIMINO 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 XIMINO. 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 XIMINO 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 XIMINO 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 XIMINO 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 XIMINO 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. XIMINO 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 XIMINO 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 XIMINO?

• Avoid sunlight, sunlamps, and tanning beds. XIMINO 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 XIMINO affects you. XIMINO may cause you to feel dizzy or lightheaded, or have a spinning feeling (vertigo).

The most common side effects of XIMINO 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 XIMINO.

These are not all the side effects with XIMINO. Ask your doctor or pharmacist for more information. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.