Clindamycin Topical

• The most common side effects of topical clindamycin are:
  • Burning
  • Itching
  • Dryness
  • Skin redness
  • Oily skin
• Some clindamycin topical solutions contain an alcohol base which will cause burning and irritation in the eye.
• Possible serious side effects of clindamycin include:
• Stomach pain and folliculitis (inflammation of the tissue surrounding the base of hairs) may occur during treatment with topical clindamycin.
• Orally administered and injected clindamycin may cause severe colitis. Orally or injected clindamycin have been associated with severe colitis which may result in death. Diarrhea, colitis, and pseudomembranous colitis may begin up to several weeks after stopping oral and parenteral therapy with clindamycin.
• Topical formulations of clindamycin may be absorbed from the skin surface, and diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical clindamycin.

• Clindamycin given orally may act as a neuromuscular blocker. This means it can increase the action of neuromuscular blocking drugs (for example, pancuronium and vecuronium) that block the contraction of muscles. Less clindamycin is absorbed into the blood stream when given topically so the likelihood of this drug interaction is less likely.

Topically applied CLEOCIN T can be absorbed in sufficient amounts to produce systemic effects. (See WARNINGS.)

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking clindamycin topical and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Do not use other medicated skin products unless your doctor has told you to. Avoid using skin products that can cause irritation, such as harsh soaps, shampoos, or skin cleansers, hair coloring or permanent chemicals, hair removers or waxes, or skin products with alcohol, spices, astringents, or lime.

Avoid getting this medication in your eyes, nose, mouth, rectum, or vagina. If this does happen, rinse with water. Do not use clindamycin topical on sunburned, windburned, dry, chapped, irritated, or broken skin.

Do not smoke while using clindamycin topical foam, or immediately after applying it. The contents of the foam canister are flammable.

• Acne (Pimples)

Clindamycin belongs to the family of medicines called antibiotics. Topical clindamycin is used to help control acne. It may be used alone or with one or more other medicines that are used on the skin or taken by mouth for acne. Topical clindamycin may also be used for other problems as determined by your doctor.

Clindamycin is available only with your doctor's prescription.

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:

• Abdominal or stomach cramps, pain, and bloating (severe)
• diarrhea (watery and severe), which may also be bloody
• fever
• increased thirst
• nausea or vomiting
• unusual tiredness or weakness
• weight loss (unusual)—these side effects may also occur up to several weeks after you stop using clindamycin

Check with your doctor as soon as possible if any of the following side effects occur:

• Skin rash, itching, redness, swelling, or other sign of irritation not present before use of clindamycin

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:

• Dryness, scaliness, or peeling of skin (for the topical solution)

• Abdominal pain
• diarrhea (mild)
• headache
• irritation or oiliness of skin
• stinging or burning feeling of 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.

Refer to adult dosing.

There are no dosage adjustments provided in the manufacturer's labeling.

Erythromycin (Systemic): May diminish the therapeutic effect of Clindamycin (Topical). Avoid combination

Erythromycin (Topical): May diminish the therapeutic effect of Clindamycin (Topical). Avoid combination

Neuromuscular-Blocking Agents: Clindamycin (Topical) may enhance the neuromuscular-blocking effect of Neuromuscular-Blocking Agents. Monitor therapy

Clindamycin is an antibiotic that fights bacteria.

Clindamycin topical (for the skin) is used to treat severe acne in adults and children who are at least 12 years old.

Clindamycin topical may also be used for purposes not listed in this medication guide.

Clindamycin phosphate topical solution, clindamycin phosphate topical gel and clindamycin phosphate topical lotion are indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS, WARNINGS and ADVERSE REACTIONS).

Clindamycin phosphate topical solution, clindamycin phosphate topical gel and clindamycin phosphate topical lotion are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

Clindamycin phosphate topical solution containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes:

30 mL applicator bottleNDC 59762-3728-1
60 mL applicator bottleNDC 59762-3728-2
Carton of 60 single-use pledget applicatorsNDC 59762-3728-3

Clindamycin phosphate topical gel containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

30 gram tubeNDC 59762-3743-1
60 gram tubeNDC 59762-3743-2

Clindamycin phosphate topical lotion containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size:

60 mL plastic squeeze bottleNDC 59762-3744-1

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Protect from freezing.

Rx only

This product's label may have been updated. For current full prescribing information, please visit www.greenstonellc.com.

LAB-0048-9.0
July 2017

NDC 59762-3743-2
60 gram

GREENSTONE® BRAND

clindamycin phosphate topical gel

1%*

For topical use only

Rx only