ClindaMax (Vaginal)

Clindamycin is used to treat certain vaginal infections. It is part of a group of medicines called macrolide antibiotics. It works by killing bacteria or stopping them from growing. This medicine will not work for vaginal fungus or yeast infections.

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

It 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.

The cream contains mineral oil that may weaken latex or rubber products. Do not use condoms or diaphragms during treatment and for 5 days after using this medicine.

Do not use polyurethane condoms during treatment and for 7 days after using the gel. You may use another form of condom (e.g., 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.

Do not have sex or use vaginal products (e.g., 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.

In deciding to use a medicine, you and your doctor need to think about the risks and benefits. Here are some important points to consider for this medicine:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your health care provider know if you have allergies to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how clindamycin gel affects children younger than 12 years. Its safety and effectiveness have not been established. Clindamycin cream can be used for bacterial vaginosis in teenage girls, but it should not be used before menstruation starts.

Geriatric

So far, studies have not shown any specific problems in older adults that would limit the usefulness of clindamycin cream and gel.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should never be used together, while others may be used together even if there is a risk of interaction. If you are taking this medicine, it is very important for your healthcare provider to know if you are taking any of the following medicines. The interactions listed below are significant, but they may not be all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or schedule for one or both of the medicines.

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

Using this medicine with any of the following medicines may increase the risk of certain side effects, but it may still be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or schedule for one or both of the medicines.

• Atracurium
• Metocurine
• Tubocurarine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be taken while eating food or certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare provider about using this medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect how you can use this medicine. Be sure to tell your doctor about any other medical issues, especially:

• Stomach or bowel disease (e.g., colitis), history of—Use clindamycin gel with caution, as it may worsen this condition.

• Stomach or bowel disease (e.g., colitis, enteritis, C. diff-associated diarrhea), history of—Do not use clindamycin cream in patients with these conditions.

Along with its necessary effects, a medicine may also cause some unwanted effects. Not all of these side effects will occur, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects happen:

More common

• Change in the color, amount, or smell of vaginal discharge
• itching of the vagina or genital area
• pain during sexual intercourse
• thick, white vaginal discharge with no smell or with a mild smell

Less common

• Bladder pain
• bloody or cloudy urine
• diarrhea
• difficulty, burning, or painful urination
• dizziness
• frequent urge to urinate
• headache
• lower back or side pain
• nausea or vomiting
• stomach pain or cramps

Rare

• Burning, itching, rash, redness, swelling, or other signs of skin problems not present before using this medicine
• cramps or pain
• fast heartbeat
• itching, stinging, or redness of the vaginal area
• pelvic pain
• skin itching, rash, or redness
• swelling of the face, throat, or tongue
• trouble breathing
• unusually heavy or unexpected menstrual bleeding
• uterine bleeding between menstrual periods
• vaginal bleeding or spotting
• vaginal burning or pain

Incidence not known

• Agitation
• black, tarry stools
• bleeding gums
• blistering, peeling, or loosening of the skin
• blood in the urine or stools
• chest pain
• chills
• clay-colored stools
• coma
• cough
• dark urine
• decreased urine output
• dizziness
• dry mouth
• fever
• headache
• irritability
• joint or muscle pain
• loss of appetite
• muscle twitching
• pinpoint red spots on the skin
• red irritated eyes
• red skin lesions, often with a purple center
• seizures
• sore throat
• sores, ulcers, or white spots on the lips or in the mouth
• swelling of the face, ankles, or hands
• swollen glands
• thirst
• trouble breathing
• unpleasant breath odor
• unusual bleeding or bruising
• unusual tiredness or weakness
• vomiting blood
• white or brownish vaginal discharge
• yellow eyes or skin

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

More common

• Back pain

Less common

• Constipation

Incidence not known

• Rash with flat lesions or small raised lesions on the skin
• redness of the skin

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

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

In the U.S.

• Cleocin Vaginal
• ClindaMax
• Clindesse
• Xaciato

Available Dosage Forms:

• Suppository
• Cream
• Gel/Jelly

Therapeutic Class: Antibiotic

Chemical Class: Lincosamide

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 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 use the cream:

• Wash your hands with soap and water before and after you use this medicine.
• Peel back the protective foil and remove the pre-filled applicator. Do not remove the tip.
• Do not use the applicator if the tip has been removed or the protective foil is damaged or broken.
• Hold the applicator and pull the ring back to fully extend the plunger. This will activate the plunger.
• Lie on your back with knees bent or in any comfortable position. Gently insert the applicator as far as it will comfortably go.
• Slowly push the plunger until it stops to release all the medicine.
• Remove the empty applicator and throw it in the trash.

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 with a prefilled applicator): Adults and children who have started their monthly period—One pre-filled applicator (5 grams [g]) inserted into the vagina one time at any time of the day. This is a one-day treatment. Children who have not started their monthly period—Use and dose must be determined by your doctor. For vaginal dosage form (gel): Adults and children 12 years of age and older—One pre-filled applicator (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.