Solodyn (minocycline) is a tetracycline antibiotic supplied as an extended release tablet.

Solodyn is a 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.

Solodyn is not effective for acne that is not red-looking (this means acne that is not inflammatory).

Do not use Solodyn if you are pregnant. It could harm the unborn baby or cause permanent tooth discoloration later in life.

Solodyn 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 Solodyn.

Minocycline passes into breast milk and may affect bone and tooth development in a nursing baby. Do not take Solodyn without telling your doctor if you are breast-feeding a baby. Children should not take this medication. Minocycline can cause permanent yellowing or graying of the teeth in children younger than 8 years old.

Avoid exposure to sunlight or tanning beds. Solodyn can make you sunburn more easily. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Do not take iron supplements, multivitamins, calcium supplements, antacids, or laxatives within 2 hours before or after taking Solodyn. These products can make this medicine less effective.

Throw away any unused medicine after the expiration date on the label has passed. Using expired minocycline can cause damage to your kidneys.

Take Solodyn extended release tablets exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water.

You may take Solodyn with or without food.

Do not crush, chew, or break an extended-release tablet. Swallow the tablet whole.

Use this medicine for the full prescribed length of time.

If you use this medicine long-term, you may need frequent medical tests. You may also need to stop taking Solodyn for a short time if you need surgery.

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Solodyn.

Store at room temperature away from moisture, heat, and light.

Throw away any Solodyn not used before the expiration date on the medicine label. Using expired minocycline can cause damage to your kidneys.

Usual Adult Dose of Solodyn for Acne:

Extended-release formulations:
45 to 49 kg: 45 mg orally once a day
50 to 59 kg: 55 mg orally once a day
60 to 71 kg: 65 mg orally once a day
72 to 84 kg: 80 mg orally once a day
85 to 96 kg: 90 mg orally once a day
97 to 110 kg: 105 mg orally once a day
111 to 125 kg: 115 mg orally once a day
126 to 136 kg: 135 mg orally once a day

Duration of therapy: 12 weeks

Comments:
-Recommended dose is about 1 mg/kg once a day.
-This drug did not show any effect on non-inflammatory acne lesions.
-Safety not established beyond 12 weeks.

Use: To treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris.

Usual Pediatric Dose for Acne:

12 years or older:
Extended-release formulations:
45 to 49 kg: 45 mg orally once a day
50 to 59 kg: 55 mg orally once a day
60 to 71 kg: 65 mg orally once a day
72 to 84 kg: 80 mg orally once a day
85 to 96 kg: 90 mg orally once a day
97 to 110 kg: 105 mg orally once a day
111 to 125 kg: 115 mg orally once a day
126 to 136 kg: 135 mg orally once a day

Duration of therapy: 12 weeks

Comments:
-Recommended dose is about 1 mg/kg once a day.
-This drug did not show any effect on non-inflammatory acne lesions.
-Safety not established beyond 12 weeks.

Use: To treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris.

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

To make sure Solodyn is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease; or

• asthma or sulfite allergy.

You should not use Solodyn if you are pregnant. Minocycline could harm the unborn baby or cause permanent tooth discoloration later in life. Use effective birth control to prevent pregnancy while you are using this medicine, whether you are a man or a woman.

Tell your doctor right away if a pregnancy occurs while either the mother or the father is taking Solodyn. The use of this medicine by either parent may cause tooth discoloration later in the baby's life.

Minocycline can make birth control pills less effective. Ask your doctor about using a non-hormonal birth control (condom, diaphragm with spermicide) to prevent pregnancy.

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 Solodyn.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include dizziness, nausea, or vomiting.

For 2 hours before or after you take Solodyn: Avoid taking antacids, laxatives, multivitamins, or supplements that contain calcium, magnesium, or iron. These other medicines can make it harder for your body to absorb minocycline.

Avoid driving or hazardous activity until you know how minocycline will affect you. Your reactions could be impaired.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Solodyn could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Get emergency medical help if you have signs of an allergic reaction to Solodyn (hives, difficult breathing, fever, swollen glands, joint pain, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Call your doctor at once if you have:

• bronchospasm (wheezing, chest tightness, trouble breathing);

• a seizure;

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath;

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;

• increased pressure inside the skull - severe headaches, ringing in your ears, dizziness, vision problems, pain behind your eyes; or

• signs of liver or pancreas problems - loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, loss of appetite, easy bruising or bleeding, dark urine, jaundice (yellowing of the skin or eyes).

Common Solodyn side effects may include:

• numbness, tingling, burning pain;

• hair loss;

• discoloration of you skin or nails.

• dizziness, spinning sensation;

• muscle or joint pain;

• nausea, diarrhea, loss of appetite;

• swollen tongue, cough, trouble swallowing;

• rash, itching; or

• headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Tell your doctor about all your other medicines, especially:

• isotretinoin;

• a penicillin antibiotic - amoxicillin, ampicillin, dicloxacillin, oxacillin, penicillin, ticarcillin, Amoxil, Moxatag, Augmentin, Principen, and others;

• a blood thinner - warfarin, Coumadin, Jantoven; or

• ergot medicine - dihydroergotamine, ergotamine, ergonovine, methylergonovine.

This list is not complete. Other drugs may interact with minocycline, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.