Clindamycin

Pregnancy

In clinical trials with pregnant women, systemic administration of clindamycin during the second and third trimesters, has not been associated with increased frequency of congenital abnormalities

Clindamycin should be used during first trimester of pregnancy only if clearly needed; there are no adequate and well-controlled studies in pregnant women during first trimester of pregnancy. Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed

Lactation

Clindamycin has been reported to appear in breast milk in range of 0.7 to 3.8 mcg/mL; clindamycin has potential to cause adverse effects on breastfed infant's gastrointestinal flora; if oral or intravenous clindamycin is required by nursing mother, it is not a reason to discontinue breastfeeding, but alternate drug may be preferred; monitor infant for possible adverse effects on gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in stool indicating possible antibiotic-associated colitis

The developmental and health benefits of breastfeeding should be considered along with mother's clinical need for clindamycin and any potential adverse effects on breastfed child from clindamycin or from underlying maternal condition

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

The following reactions have been reported with the use of clindamycin.

Infections and Infestations: Clostridium difficile colitis

Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea (see BOXED WARNING). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). Esophageal ulcer has been reported. An unpleasant or metallic taste has been reported after oral administration.

Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (See WARNINGS). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported.

Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported. (See Hypersensitivity Reactions.)

Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed.

Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.

Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Musculoskeletal: Cases of polyarthritis have been reported.

Clindamycin is a prescription medication used to treat bacterial infections of the lungs, skin, blood, bones, joints, female reproductive system, and internal organs. Clindamycin is also used to treat acne.

Clindamycin belongs to a group of drugs called lincomycin antibiotics. These work by stopping the growth of bacteria.

This medication is available as a topical cream, topical gel, topical solution, topical foam, topical swab (pledget), vaginal cream, vaginal suppository, oral capsule, oral liquid, and granules for oral solution.

This medication is also available in injectable forms to be given directly into a vein (IV) or a muscle (IM) by a healthcare professional.

Common side effects of clindmaycin include nausea, vomiting, joint pain, heartburn, pain when swallowing, and white patches in the mouth.

Clindamycin is part of the drug class:

• Gynecological Antibiotics

Serious side effects have been reported with clindamycin. See the “Clindamycin Precautions” section.

Oral:

Common side effects of oral clindamycin include the following:

• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Rash
• Hives

Topical:

Common side effects of topical clindamycin include the following:

• Burning, itching, dryness, or redness at site of application

Injectable:

Common side effects of oral clindamycin include the following:

• Abdominal pain
• Nausea
• Vomiting
• Diarrhea
• Rash
• Hives

This is not a complete list of clindamycin side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

Especially tell your doctor if you take erythromycin (E.E.S., E-Mycin, Erythrocin). Clindamycin can make erythromycin less effective and usually these medications should not be combined, especially when treating serious infections.

This is not a complete list of clindamycin drug interactions. Ask your doctor or pharmacist for more information.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age

Oral:

The recommended dose of oral clindamycin for the treatment of bacterial infections is 150 to 450 mg every 6 hours.

Topical:

The recommended dose of topical clindamycin for the treatment of acne is application to the affected skin 1 to 2 times daily. The recommended dose of clindamycin vaginal preparations is application once daily at bedtime.

Injectable:

The recommended dose of clindamycin injection for the treatment of bacterial infections is 600 to 2700 mg per day in 2, 3, or 4 doses.

• Store clindamycin at room temperature
• Do not expose clindamycin to excess heat or moisture
• Keep this and all medicines out of the reach of children 

Take clindamycin exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

Take the capsule with a full glass (8 ounces) of water. This is to prevent irritation of the esophagus (tube between the throat and stomach).

Measure the oral liquid correctly using the marked measuring spoon that comes with the package. The average household teaspoon may not hold the right amount of liquid.

To help clear up your infection completely, keep using clindamycin for the full time of treatment, even if you begin to feel better after a few days. If you have a "strep'' infection, you should keep using clindamycin for at least 10 days. This is especially important in "strep" infections. Serious heart problems could develop later if your infection is not cleared up completely. Also, if you stop taking clindamycin too soon, your symptoms may return.

clindamycin works best when there is a constant amount in the blood. To help keep the amount constant, do not miss any doses. Also, it is best to take each dose at evenly spaced times day and night. If you need help in planning the best times to take your medicine, check with your doctor.

Dosing

The dose of clindamycin 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 clindamycin. 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 oral dosage forms (capsules and solution):
  • For treatment of bacterial infections:
    • Adults—150 to 300 milligrams (mg) every 6 hours. For more severe infections, 300 to 450 mg every 6 hours.
    • Children weighing 10 kilograms (kg) or more—Dose is based on body weight and must be determined by your doctor. The dose is usually 8 to 16 milligrams (mg) per kilogram (kg) of body weight per day, divided into 3 or 4 equal doses. For more severe infections, the dose is usually 16 to 25 mg per kg of body weight per day, divided into 3 or 4 equal doses.
    • Children weighing 10 kg or less—Dose is based on body weight and must be determined by your doctor. The dose is usually 37.5 milligrams (mg) or 1/2 teaspoonful 3 times a day.

Missed Dose

If you miss a dose of clindamycin, 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.