Description and Brand Names

Drug information provided by: Merative, Micromedex®

US Brand Name

  1. Cleocin Vaginal
  2. ClindaMax
  3. Clindesse
  4. Xaciato

Descriptions


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.

This product is available in the following dosage forms:

  • Suppository
  • Cream
  • Gel/Jelly

Before Using

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.

Pediatric

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. Clindamycin cream may be used for bacterial vaginosis in teenage females but should not be used before the start of menstruation. .

Geriatric

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

Breastfeeding

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.

Drug Interactions

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.

  • Asciminib
  • Avacopan
  • Carbamazepine
  • Ceritinib
  • Cholera Vaccine, Live
  • Clarithromycin
  • Crizotinib
  • Daridorexant
  • Enasidenib
  • Enzalutamide
  • Erythromycin
  • Fedratinib
  • Lanreotide
  • Mavacamten
  • Mitotane
  • Mobocertinib
  • Nirogacestat
  • Octreotide
  • Omaveloxolone
  • Palbociclib
  • Phenobarbital
  • Primidone
  • Repotrectinib
  • Ribociclib
  • Selpercatinib
  • Sotorasib
  • Taurursodiol
  • Tocilizumab
  • Tucatinib
  • Vonoprazan

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 clindamycin gel with caution. May make this condition worse.
  • Stomach or bowel disease (eg, colitis, enteritis, C. diff-associated diarrhea), history of—clindamycin cream should not be used in patients with these conditions.

Proper Use

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.

Precautions

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.

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 (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.

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.

Side Effects

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

  1. Change in the color, amount, or odor of vaginal discharge
  2. itching of the vagina or genital area
  3. pain during sexual intercourse
  4. thick, white vaginal discharge with no odor or with mild odor

Less common

  1. Bladder pain
  2. bloody or cloudy urine
  3. diarrhea
  4. difficult, burning, or painful urination
  5. dizziness
  6. frequent urge to urinate
  7. headache
  8. lower back or side pain
  9. nausea or vomiting
  10. stomach pain or cramps

Rare

  1. Burning, itching, rash, redness, swelling or other signs of skin problems not present before use of this medicine
  2. cramps or pain
  3. fast heartbeat
  4. itching, stinging, or redness of the vaginal area
  5. pelvic pain
  6. skin itching, rash, or redness
  7. swelling of the face, throat, or tongue
  8. trouble breathing
  9. unusually heavy or unexpected menstrual bleeding
  10. uterine bleeding between menstrual periods
  11. vaginal bleeding or spotting
  12. vaginal burning or pain

Incidence not known

  1. Agitation
  2. black, tarry stools
  3. bleeding gums
  4. blistering, peeling, or loosening of the skin
  5. blood in the urine or stools
  6. chest pain
  7. chills
  8. clay-colored stools
  9. coma
  10. cough
  11. dark urine
  12. decreased urine output
  13. dizziness
  14. dry mouth
  15. fever
  16. headache
  17. irritability
  18. joint or muscle pain
  19. loss of appetite
  20. muscle twitching
  21. pinpoint red spots on the skin
  22. red irritated eyes
  23. red skin lesions, often with a purple center
  24. seizures
  25. sore throat
  26. sores, ulcers, or white spots on the lips or in the mouth
  27. swelling of the face, ankles, or hands
  28. swollen glands
  29. thirst
  30. trouble breathing
  31. unpleasant breath odor
  32. unusual bleeding or bruising
  33. unusual tiredness or weakness
  34. vomiting of blood
  35. white or brownish vaginal discharge
  36. 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:

More common

  1. Back pain

Less common

  1. Constipation

Incidence not known

  1. Rash with flat lesions or small raised lesions on the skin
  2. 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.