Clindesse is a single-dose therapy used to treat vaginal infections (bacterial vaginosis) caused by certain bacteria in non-pregnant women.

Clindesse Cream is a topical lincomycin antibiotic. It works by slowing the growth of certain bacteria. The recommended dose is a single applicatorful at any time of the day.

Clindesse may also be used for purposes other than those listed in this medication guide.

Do NOT use Clindesse if:

• you are allergic to any ingredient in Clindesse Cream or to lincomycin
• you have Crohn disease, antibiotic-associated colitis, or ulcerative colitis

Contact your doctor or health care provider right away if any of these apply to you.

• Avoid contact with the eyes. Burning and irritation can occur. If contact does occur, rinse the eye with large amounts of cool tap water.
• Do not have sexual intercourse or use other vaginal products, such as tampons or douches, while using Clindesse.
• Use a sanitary napkin rather than a tampon to prevent staining of clothes and bed linens.
• This cream contains mineral oil that may weaken latex products such as condoms and diaphragms. Therefore, do not use these products within 5 days of using this product. They may not provide adequate birth control and you may become pregnant.
• Contact your doctor right away if stomach pain or cramps, severe diarrhea, or bloody stools occur. Do not treat diarrhea without first checking with your doctor. This could be a symptom of a serious side effect requiring immediate medical attention.
• Be sure to use Clindesse for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The bacteria could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.
• Long-term or repeated use of Clindesse may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using this medication while you are pregnant. It is not known if Clindesse is found in breast milk. If you are or will be breast-feeding while you use this medication, check with your doctor. Discuss any possible risks to your baby.

Use Clindesse as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Clindesse Cream is for vaginal use only.
• Wash your hands before and after using this medication.
• Clindesse comes with one prefilled applicator. Do not remove the tip from the applicator before using. Do not use the applicator if the tip has been removed. Do not warm the applicator before using.
• To use Clindesse, hold the applicator firmly and pull the ring back to fully extend the plunger. Gently insert the applicator into the vagina as far as it will comfortably go. Push the plunger to release the cream. Remove the applicator from the vagina and throw it away.
• Only one dose of Clindesse is required. If you forget to use this medication, use it as soon as you remember.

Ask your health care provider any questions you may have about how to use Clindesse.

Some medical conditions may interact with Clindesse. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a gastrointestinal (bowel) disease or diarrhea

Some MEDICINES MAY INTERACT with Clindesse. Because little, if any, clindamycin is absorbed into the blood, the risk of it interacting with another medicine is low.

This may not be a complete list of all interactions that may occur. Ask your health care provider if this medication may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Clindesse may be harmful if swallowed.

Store Clindesse Cream at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store in a tightly-closed container away from heat and light. Protect from freezing. Keep Clindesse out of the reach of children and away from pets.

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Fungal infection; genital itching or burning; inflammation or pain; vaginal discharge.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood/mucus in stool; diarrhea; new or worsening vaginal or vulvar itching; painful sex; stomach cramps/pain; white vaginal discharge.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.