Clindamycin Topical Solution Prescribing Information

It may take between 2-6 weeks to notice an improvement in your condition, and up to 12 weeks to see the full benefit.

Clindamycin Phosphate Gel – Uses, Side Effects, and More

This medication is used to treat acne. It helps to decrease the number of acne lesions. Clindamycin is an antibiotic which works by stopping the growth of bacteria.

How to use Clindamycin Phosphate Gel

Use this medication only on the skin. Clean and dry the affected area first. Follow all directions on the product package, or use as directed by your doctor.

If you are using the lotion, shake the bottle well before using. Apply a thin layer of medication usually twice a day or as directed by your doctor.

If you are using the medicated pad or swab, apply to the the affected area gently with it, then discard. Depending on the size of the area to be treated, more than one pad or swab may be necessary.

If you are using the foam, apply it once daily to the affected areas. Use enough to cover the entire affected area. Do not spray the foam directly onto your hands or face, because the foam will begin to melt on contact with warm skin. Instead spray the amount needed directly into the cap or onto a cool surface such as a counter top. If the can seems warm or the foam seems runny, run the can under cold water. Please read the patient information leaflet available from your pharmacist for specific instructions on how to use the foam, and ask about any information that is unclear.

Avoid contact with your eyes, nose, mouth or any areas of broken skin. If you accidentally get medication in these areas, rinse well with plenty of cool water.

It may take between 2-6 weeks to notice an improvement in your condition, and up to 12 weeks to see the full benefit.

Inform your doctor if your condition does not improve or worsens.

Side Effects

Burning, itching, dryness, redness, oily skin or skin peeling may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may be absorbed into your bloodstream and very rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop: diarrhea that doesn’t stop, abdominal or stomach pain/cramping, blood/mucus in your stool.

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US – Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada – Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

Before using clindamycin, tell your doctor or pharmacist if you are allergic to it; or to lincomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: chronic asthma or hay fever (atopic conditions), intestinal diseases (such as ulcerative colitis, enteritis, C. difficile-associated diarrhea).

Tell your doctor if you are pregnant before using this medication.

It is not known if the medication in this product passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor’s approval.

Clindamycin Topical Solution Prescribing Information

Medically reviewed by Drugs.com. Last updated on Oct 1, 2022.

On This Page

• Description
• Clinical Pharmacology
• Indications and Usage
• Contraindications
• Warnings
• Precautions
• Adverse Reactions/Side Effects
• Overdosage
• Dosage and Administration
• How Supplied/Storage and Handling

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 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).

Clindamycin phosphate topical solution USP, 1% contains isopropyl alcohol, 50% v/v; propylene glycol and purified water. Sodium hydroxide or hydrochloric acid may be added to adjust pH between 4.0 to 7.0.

Related/similar drugs

Clindamycin Topical Solution – Clinical Pharmacology

Mechanism of Action

The mechanism of action of clindamycin in treating acne vulgaris is unknown.

Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0 to 3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.

Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic.

Clindamycin is active in vitro against most isolates of Propionibacterium acnes ; however, the clinical significance is unknown.

Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA. Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolideinducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.

Indications and Usage for Clindamycin Topical Solution

Clindamycin phosphate topical solution USP, 1% is 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).

Contraindications

Clindamycin phosphate topical solution is 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.

Warnings

Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis. Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically.

When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile . The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days. Cholestyramine or colestipol resins bind vancomycin in vitro . If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug.

Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

Precautions

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

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.

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.

It is not known whether clindamycin is excreted in breast milk following use of clindamycin phosphate topical solution. However, orally and parenterally administered clindamycin has been reported to appear in breast milk. Clindamycin has the potential to cause adverse effects on the breast-fed infant’s gastrointestinal flora. Monitor the breast-fed infant for possible adverse effects on the gastrointestinal flora, such as diarrhea, candidiasis (thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for clindamycin and any potential adverse effects on the breast-fed child from clindamycin or from the underlying maternal condition.

If used during lactation and clindamycin phosphate topical solution is applied to the chest, care should be taken to avoid accidental ingestion by the infant.

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

Clinical studies for Clindamycin Phosphate 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.

Adverse Reactions

In 18 clinical studies of various formulations of Clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below].

* of 126 subjects

Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.

Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS).

Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

Overdosage

Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS).

Clindamycin Topical Solution Dosage and Administration

Apply a thin film of Clindamycin phosphate topical solution, twice daily to affected area.

Keep all liquid dosage forms in containers tightly closed.

How is Clindamycin Topical Solution Supplied

Clindamycin phosphate topical solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter are clear solution with characteristics odor free from particulate matter. Filled in white HDPE bottle fitted with white PP cap and is available in the following sizes:

Clindamycin phosphate topical solution USP, 1% is

NDC 72578-084-02 in applicator bottle of 30 mL

NDC 72578-084-03 in applicator bottle of 60 mL

Store at 20°C to 25°C (68°F to 77°F) [See USP Controlled Room Temperature].

Protect from freezing.

Call your doctor for medical advice about side effects. You may report side effects to Viona Pharmaceuticals Inc. at 1-888-304-5011 or FDA at 1-800-FDA-1088.

Zydus Lifesciences Ltd.

Changodar, Ahmedabad, India.

Viona Pharmaceuticals Inc.

Cranford, NJ 07016

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clindamycin phosphate topical solution USP, 1%

Product Information
Product Type	HUMAN PRESCRIPTION DRUG LABEL	Item Code (Source)	NDC:72578-084
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CLINDAMYCIN PHOSPHATE (CLINDAMYCIN)	CLINDAMYCIN PHOSPHATE	10 mg in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL ALCOHOL
PROPYLENE GLYCOL
WATER

Packaging
#	Item Code	Package Description
1	NDC:72578-084-02	1 BOTTLE, WITH APPLICATOR in 1 CARTON
1	30 mL in 1 BOTTLE, WITH APPLICATOR
2	NDC:72578-084-03	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	ANDA208767	06/15/2020

Labeler – Viona Pharmaceuticals Inc (081468959)

Registrant – Zydus Lifesciences Limited (650199482)

Establishment
Name	Address	ID/FEI	Operations
Zydus Lifesciences Limited	650650802	ANALYSIS(72578-084), MANUFACTURE(72578-084)

Viona Pharmaceuticals Inc

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