SOLODYN®
(SO-lo-dIn)
(minocycline HCl, USP) Extended Release Tablets

Read all patient information that comes with SOLODYN® (minocycline hydrochloride) 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 speaking with your doctor about your condition or treatment.

What is SOLODYN® (minocycline hydrochloride) ?

SOLODYN® (minocycline hydrochloride) is a tetracycline-class drug that contains minocycline. SOLODYN® (minocycline hydrochloride) is only for the treatment of pimples and red bumps (non-nodular inflammatory lesions) that happen with moderate to severe acne in patients 12 years and older. SOLODYN® (minocycline hydrochloride) did not show any effect on acne spots that were not red-looking.

SOLODYN® (minocycline hydrochloride) has not been studied for use longer than 12 weeks.

SOLODYN® (minocycline hydrochloride) has not been studied for the treatment of infections.

Who should not take SOLODYN® (minocycline hydrochloride) ?

Do not take SOLODYN® (minocycline hydrochloride) if you are allergic to minocycline or any other tetracycline antibiotics. Ask your doctor or pharmacist for a list of these medicines if you are not sure. See the end of this leaflet for a complete list of ingredients in SOLODYN® (minocycline hydrochloride) .

SOLODYN® (minocycline hydrochloride) should not be used by pregnant women, women attempting to have a child, or children up to 8 years old because:

1. SOLODYN® (minocycline hydrochloride) may harm an unborn baby
2. SOLODYN® (minocycline hydrochloride) may permanently turn a baby or child's teeth yellow-grey-brown during tooth development. SOLODYN® (minocycline hydrochloride) should not be used during tooth development. Tooth development happens in the last half of pregnancy and birth to age 8 years.

It is recommended that SOLODYN® (minocycline hydrochloride) not be used by men who are attempting to father a child.

What should I tell my doctor before taking SOLODYN® (minocycline hydrochloride) ?

Tell your doctor about all of your medical conditions including if you:

• have kidney problems. Your doctor may prescribe a lower dose of medicine for you.
• have any vision problems such as blurred vision.
• are pregnant or attempting to conceive a child. SOLODYN® (minocycline hydrochloride) may harm your unborn baby. Stop taking SOLODYN® (minocycline hydrochloride) and call your doctor if you become pregnant while taking it.
• are breastfeeding. SOLODYN® (minocycline hydrochloride) passes into your milk and may harm your baby. You should decide whether to use SOLODYN® (minocycline hydrochloride) or breastfeed, but not both.

Tell your doctor about all the other medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. SOLODYN® (minocycline hydrochloride) and other medicines may interact. Especially tell your doctor if you take:

• birth control pills. SOLODYN® (minocycline hydrochloride) may make your birth control pills less effective. You should use a second form of birth control while taking SOLODYN® (minocycline hydrochloride)
• a blood thinner medicine. The dose of your blood thinner may be lowered.
• a penicillin antibiotic medicine. SOLODYN® (minocycline hydrochloride) and penicillins should not be used together.
• antacids that contain aluminum, calcium, or magnesium or iron-containing products. These can affect how much SOLODYN® (minocycline hydrochloride) passes into your body.
• An acne medication that contains isotretinoin. SOLODYN® (minocycline hydrochloride) and isotretinoin should not be used together.

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

How should I take SOLODYN® (minocycline hydrochloride) ?

• SOLODYN® (minocycline hydrochloride) comes in 5 strengths. Your doctor will prescribe the strength that is best for your body weight. The usual dose of SOLODYN® (minocycline hydrochloride) is 1 tablet each day for 12 weeks.
• Take SOLODYN® (minocycline hydrochloride) at the same time each day, with or without food. Taking SOLODYN® (minocycline hydrochloride) 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 SOLODYN® (minocycline hydrochloride) Tablets whole. Do not chew, crush, or split the tablets.
• If you forget to take SOLODYN® (minocycline hydrochloride) , take it as soon as you remember. Do not take more than one tablet of SOLODYN® (minocycline hydrochloride) in one day.
• If you take too much SOLODYN® (minocycline hydrochloride) at a time, call your doctor.
• If you do not notice an improvement in your acne after 12 weeks of treatment with SOLODYN® (minocycline hydrochloride) , call your doctor.

What are possible side effects of SOLODYN® (minocycline hydrochloride) ?

SOLODYN® (minocycline hydrochloride) may cause serious side effects. Stop SOLODYN® (minocycline hydrochloride) and call your doctor if you have:

• watery diarrhea
• bloody stools
• stomach cramps
• unusual headaches
• blurred vision
• fever
• rash
• joint pain
• feeling very tired

SOLODYN® (minocycline hydrochloride) may also cause:

• serious effects on the liver. Symptoms can include loss of appetite, tiredness, diarrhea, skin turning yellow, bleeding easily, confusion, and sleepiness. If you have these symptoms, stop SOLODYN® (minocycline hydrochloride) and call your doctor.
• central nervous system effects. Symptoms include lightheadedness, dizziness, and a spinning feeling (vertigo). You should not drive or operate dangerous machines if you have these symptoms.
• sun sensitivity (photosensitivity). You may get a worse sunburn with SOLODYN® (minocycline hydrochloride) Avoid sun exposure and the use of sunlamps or tanning beds. Protect your skin while out in sunlight. Stop SOLODYN® (minocycline hydrochloride) and call your doctor at the first sign of redness or sunburn.
• darkening of skin, scars, teeth, and gums.

The most common side effects with SOLODYN® (minocycline hydrochloride) 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.

These are not all the side effects with SOLODYN® (minocycline hydrochloride) Ask your doctor or pharmacist for more information.

You may report side effects to FDA at 1-800-FDA-1088 or to Medicis at 1-800-900-6389.

How should I store SOLODYN® (minocycline hydrochloride) ?

• Store SOLODYN® (minocycline hydrochloride) at room temperature. Keep SOLODYN® (minocycline hydrochloride) Tablets in the bottle you received from the pharmacy and store away from moisture and light.
• Keep SOLODYN® (minocycline hydrochloride) and all medicines out of the reach of children.

General Information about SOLODYN® (minocycline hydrochloride)

Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use SOLODYN® (minocycline hydrochloride) for a condition for which it was not prescribed. Do not give SOLODYN® (minocycline hydrochloride) to other people, even if they have the same symptoms you have. It may harm them.

This leaflet summarizes the most important information about SOLODYN® (minocycline hydrochloride) . If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about SOLODYN® (minocycline hydrochloride) that is written for health professionals.

What are the Ingredients in SOLODYN®?

Active Ingredient: minocycline HCl USP equivalent to 45 mg, 65 mg, 90 mg, 115 mg or 135 mg of minocycline.

Inactive Ingredients: lactose monohydrate NF, hypromellose type 2910 USP, magnesium stearate NF, colloidal silicon dioxide NF, and carnauba wax NF. The 45 mg tablets also contain Opadry II Gray which contains: lactose monohydrate NF, hypromellose type 2910 USP, titanium dioxide USP, triacetin USP, and iron oxide black JPE. The 65 mg tablets also contain Opadry II Blue which contains: hypromellose type 2910 USP, lactose monohydrate NF, FD&C Blue #1, polyethylene glycol 3350 NF, FD&C Blue #2, titanium dioxide USP, triacetin USP, and D&C Yellow #10. The 90 mg tablets also contain Opadry II Yellow which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, iron oxide yellow NF, polyethylene glycol 3350 NF, and triacetin USP. The 115 mg tablets also contain Opadry II Green which contains: hypromellose type 2910 USP, lactose monohydrate NF, D&C Yellow #10, triacetin USP, FD&C Blue #1, titanium dioxide USP, FD&C Blue #2. The 135 mg tablets also contain Opadry II Pink which contains: hypromellose type 2910 USP, lactose monohydrate NF, titanium dioxide USP, polyethylene glycol 3350 NF, iron oxide red NF, and triacetin USP.

Last reviewed on RxList: 1/27/2010
This monograph has been modified to include the generic and brand name in many instances.