Pronunciation:

klin-da-MYE-sin

Brand Names:

• Cleocin Vaginal
• ClindaMax
• Clindesse
• Xaciato

Dosage Forms:

• Suppository
• Cream
• Gel/Jelly

Classifications:

Therapeutic—

Antibiotic

Chemical—

Lincosamide

Uses of This Medicine:

Clindamycin is used to treat certain vaginal infections. It belongs to the class of medicines known as macrolide antibiotics. It works by killing bacteria or preventing their growth. This medicine will not work for vaginal fungus or yeast infections.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of clindamycin gel in children younger than 12 years of age. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of clindamycin gel in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Cholera Vaccine, Live
• Erythromycin
• Fedratinib
• Mavacamten
• Omaveloxolone
• Phenobarbital
• Primidone

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Atracurium
• Metocurine
• Tubocurarine

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Stomach or bowel disease (eg, colitis), history of—Use with caution. May make this condition worse.

Proper Use of This Medicine:

It is very important that you use this medicine exactly as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may cause unwanted side effects.

This medicine is to be used only in the vagina. Do not get any of it in your eyes, nose, mouth, or on your skin. If this medicine does get into your eyes, rinse them immediately with large amounts of cool tap water. If your eyes still burn or are painful, check with your doctor.

This medicine comes with a disposable applicator or in a prefilled applicator that delivers the medicine when inserted into your vagina. Use each applicator only once, and then throw it away.

To use the cream or gel:

• Wash your hands with soap and water before and after you use this medicine.
• Remove cap from the tube and puncture the seal on the tube using the pointed tip on the cap.
• Do not use the tube if it has been opened before or if the seal is damaged or broken.
• Hold the applicator by the grip, screw the tip of the applicator into the tube. Leave the plunger inside the applicator.
• Squeeze the tube from the bottom to push the medicine into the applicator.
• Remove the filled applicator from the tube.
• Lie on your back with knees bent or in any comfortable position. Hold the filled applicator and slowly insert the tip into your vagina as far as it will go.
• Slowly push the plunger until it stops to release all the medicine.

To help clear up your infection completely, it is very important that you keep using this medicine for the full time of treatment , even if your symptoms begin to clear up after a few days. If you stop using this medicine too soon, your symptoms may return. Do not miss any doses. Also, continue using this medicine even if your menstrual period starts during the time of treatment.

Dosing—

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For bacterial vaginosis:
  • For vaginal dosage form (cream):
    • Adults and children 13 years of age and older who are not pregnant—One applicatorful (100 milligrams [mg]) inserted into the vagina once a day for 3 or 7 days, usually at bedtime.
    • Adults and children 13 years of age and older who are pregnant—One applicatorful (100 milligrams [mg]) inserted into the vagina once a day for 7 days, usually at bedtime,.
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
  • For vaginal dosage form (cream with a prefilled applicator):
    • Adults and children 13 years of age and older—One applicatorful (100 milligrams [mg]) inserted into the vagina one time at any time of the day. This is a one-day treatment.
    • Children younger than 13 years of age—Use and dose must be determined by your doctor.
  • For vaginal dosage form (gel):
    • Adults and children 12 years of age and older—One applicatorful (5 grams [g]) inserted into the vagina one time at any time of the day. This is a one-day treatment.
    • Children younger than 12 years of age—Use and dose must be determined by your doctor.

Missed dose—

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage—

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using This Medicine:

IIt is very important that your doctor check your progress at regular visits to make sure this medicine is working properly and does not cause unwanted effects.

This medicine may cause diarrhea, and in some cases it can be severe. It may occur 2 months or more after you or your child stop using this medicine. Do not take any medicine to treat diarrhea without first checking with your doctor. If you have any questions or if mild diarrhea continues or gets worse, check with your doctor.

This medicine may cause some people to become dizzy. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy.

Do not use polyurethane condoms during treatment and for 7 days after using the gel. You may use another form of condom (eg, latex or polyisoprene) for added protection against pregnancy or HIV.

This medicine may cause vaginal yeast infections (candidiasis). Check with your doctor right away if you have itching of the vagina or outside genitals, pain during sexual intercourse, or thick, white curd-like vaginal discharge without odor or with mild odor.

Vaginal medicines usually leak out of the vagina during treatment. To keep the medicine from getting on your clothing, wear a minipad or sanitary napkin. Do not use tampons since they may soak up the medicine.

To help clear up your infection completely and make sure it does not return, good health habits are also required.

• Wear cotton panties (or panties or pantyhose with cotton crotches) instead of synthetic (eg, nylon or rayon) panties.
• Wear only freshly washed panties daily.

Do not have sex or use vaginal products (eg, tampons or douches) during treatment and for 3 days after using the gel. Do not have sexual intercourse while you are using the cream. Having sexual intercourse may reduce the strength of the medicine. This may cause the medicine to not work as well.

Do not use latex (rubber) contraceptive products such as condoms, diaphragms, or cervical caps for 72 hours after stopping treatment with vaginal clindamycin cream. The cream contains oils that weaken or harm the latex products, causing them to not work properly to prevent pregnancy. If you have any questions about this, check with your health care professional.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

Itching of the vagina or genital area

pain during sexual intercourse

thick, white vaginal discharge with no odor or with mild odor

Less common

Diarrhea

dizziness

headache

nausea or vomiting

stomach pain or cramps

Rare

Burning, itching, rash, redness, swelling or other signs of skin problems not present before use of this medicine

Incidence not known

Agitation

black, tarry stools

chest pain

chills

clay-colored stools

coma

cough

dark urine

decreased urine output

dizziness

fever

headache

irritability

loss of appetite

muscle twitching

painful or difficult urination

seizures

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the face, ankles, or hands

swollen glands

trouble breathing

unpleasant breath odor

unusual bleeding or bruising

unusual tiredness or weakness

vomiting of blood

yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

Blistering, peeling, or loosening of the skin

hives, itching, skin rash

joint or muscle pain

rash with flat lesions or small raised lesions on the skin

red irritated eyes

red skin lesions, often with a purple center

redness of the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.