Clindamycin Topical Solution

Name: Clindamycin Topical Solution

Clindamycin Topical Solution Description

Clindamycin Phosphate Topical Solution USP, 1% contains clindamycin phosphate USP at a concentration equivalent to 10 mg clindamycin per milliliter.

Clindamycin phosphate is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin.

The solution contains isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 - 7.0).

The structural formula is represented below:

The chemical name for clindamycin phosphate is Methyl 7-chloro-6,7,8-trideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L-threo- α-D-galacto-octopyranoside 2-(dihydrogen phosphate).

Precautions

General -

Clindamycin Phosphate Topical Solution USP, 1% contains an alcohol base which will cause burning and irritation of the eye. In the event of accidental contact with sensitive surfaces (eye, abraded skin, mucous membranes), bathe with copious amounts of cool tap water. The solution has an unpleasant taste and caution should be exercised when applying medication around the mouth.

Clindamycin phosphate topical products should be prescribed with caution in atopic individuals.

Drug Interactions -

Clindamycin has been shown to have neuromuscular blocking properties that may enhance the action of other neuromuscular blocking agents. Therefore it should be used with caution in patients receiving such agents.

Pregnancy:

Teratogenic Effects:

Pregnancy Category B -

In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters has not been associated with an increased frequency of congenital abnormalities. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.

Nursing Mothers -

It is not known whether clindamycin is excreted in human milk following use of Clindamycin Phosphate Topical Solution USP, 1%. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use -

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Geriatric Use -

Clinical studies for clindamycin phosphate topical solution USP, 1% did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

Clindamycin Topical Solution Dosage and Administration

Apply a thin film of Clindamycin Phosphate Topical Solution USP, 1% to the affected area twice daily. Keep container tightly closed.

Package/label principal display panel - carton

Rx Only

Clindamycin Phosphate Topical Solution USP, 1%

For Topical Use Only

60 mL

CLINDAMYCIN PHOSPHATE 
clindamycin phosphate solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45802-562
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN) CLINDAMYCIN 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ISOPROPYL ALCOHOL  
PROPYLENE GLYCOL  
WATER  
SODIUM HYDROXIDE  
Packaging
# Item Code Package Description
1 NDC:45802-562-01 1 BOTTLE, WITH APPLICATOR in 1 CARTON
1 30 mL in 1 BOTTLE, WITH APPLICATOR
2 NDC:45802-562-02 1 BOTTLE, WITH APPLICATOR in 1 CARTON
2 60 mL in 1 BOTTLE, WITH APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA064050 09/17/2013
Labeler - Perrigo New York Inc (078846912)
Revised: 03/2017   Perrigo New York Inc

Highlights for clindamycin

Clindamycin is used to treat acne.

This drug is available in many forms. It comes as an oral capsule, oral solution, topical foam, topical gel, topical lotion, topical swab, topical solution, vaginal suppository, and vaginal cream. It’s also available as an intravenous (IV) drug, which is only given by a healthcare provider. Some of these forms treat other infections.

Clindamycin topical solution is available as the brand-name drugs Cleocin T and Clinda-Derm. It’s also available as a generic drug.

IMPORTANT INFORMATION
  • Diarrhea See Details

  • Contains alcohol See Details

What is clindamycin?

Clindamycin is a prescription drug. It’s available as an oral capsule, oral solution, topical foam, topical gel, topical lotion, topical swab, topical solution, vaginal suppository, and vaginal cream. It’s also available as an intravenous (IV) drug, which is only given by a healthcare provider. 

The topical solution is available as the brand-name drugs Cleocin T and Clinda-Derm. It’s also available as a generic drug. Generic drugs usually cost less. In some cases, they may not be available in every strength or form as the brand-name version.

Why it's used

Clindamycin is used to treat certain infections caused by bacteria. These infections include acne and bacterial vaginosis.

How it works

Clindamycin belongs to a class of drugs called antibiotics.

More Details

Clindamycin Side Effects

More Common Side Effects

Some of the more common side effects that can occur with use of clindamycin include:

  • burning

  • itching

  • dryness

  • redness

  • oily skin

  • peeling

These effects occur on the treated skin. If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.

Serious Side Effects

Call your doctor right away if you have serious side effects. Call 9-1-1 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:

  • Antibiotic-associated diarrhea. Symptoms can include:

    • severe diarrhea
    • bloody diarrhea
    • stomach cramping and pain
    • fever
    • dehydration
    • loss of appetite
    • weight loss
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
(web3)