DESCRIPTION

ClindaReach® (Clindamycin Phosphate Topical Solution USP 1%) Pledgets contain clindamycin phosphate, USP at a concentration equivalent to 10 mg clindamycin per milliliter. Each ClindaReach® pledget applicator contains approximately 1 mL of topical solution.

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).

CLINICAL PHARMACOLOGY

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

Cross resistance has been demonstrated between clindamycin and lincomycin. Antagonism has been demonstrated between clindamycin and erythromycin.

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 (0–3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin.

Clindamycin activity has been demonstrated in comedones from acne patients. The mean concentration of antibiotic activity in extracted comedones after application of clindamycin phosphate topical solution for 4 weeks was 597 mcg/g of comedonal material (range 0–1490). Clindamycin in vitro inhibits all Propionibacterium acnes cultures tested (MICs 0.4 mcg/mL). Free fatty acids on the skin surface have been decreased from approximately 14% to 2% following application of clindamycin.

INDICATIONS AND USAGE

ClindaReach® 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, WARNINGSand ADVERSE REACTIONS).

CONTRAINDICATIONS

ClindaReach® 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

General - ClindaReach® 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. ClindaReach® 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 - Reproduction studies have been performed in rats and mice using subcutaneous and oral doses of clindamycin ranging from 100 to 600 mg/kg/day and have revealed no evidence of impaired fertility or harm to the fetus due to clindamycin. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers - It is not known whether clindamycin is excreted in human milk following use of ClindaReach®. 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.

ADVERSE REACTIONS

In 18 clinical studies of various formulations of topical 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].

Number of Patients Reporting Events

Treatment Emergent Adverse Event	Solution n=553 (%)	Gel n=148 (%)	Lotion n=160 (%)
Burning	62    (11)	15    (10)	17    (11)
Itching	36    (7)	15    (10)	17    (11)
Burning/Itching	60    (11)	#      ( – )	#      ( – )
Dryness	105  (19)	34    (23)	29    (18)
Erythema	86    (16)	10    (7)	22    (14)
Oiliness/Oily Skin	8      (1)	26    (18)	12*   (10)
Peeling	61    (11)	#      ( – )	11     (7)
# not recorded * 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 and gastrointestinal disturbances as well as gram-negative folliculitis have also been reported in association with the use of topical formulations of clindamycin.

OVERDOSAGE

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

DOSAGE AND ADMINISTRATION

Do not use if the seal on jar is broken. Remove pledget from jar just before use. Use a pledget to apply a thin film of ClindaReach® to the affected area twice daily. More than one pledget may be used. Each pledget should be used only once and then discarded. Keep jar tightly closed when not in use.

HOW SUPPLIED

ClindaReach® is available as:

A jar containing 60 single-use pledget applicators (NDC 65880-503-60)
A kit containing 120 single use pledgets, packaged as two jars of 60 single use pledgets each (NDC 65880-503-02)

STORAGE

Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Manufactured for: DUSA Pharmaceuticals, Inc., Wilmington, MA 01887
Manufactured by: PERRIGO, Bronx, NY 10457

Covered by U.S. Pat. No. D552,792. Additional patents pending

Rev. 03/10

DUSA                     LAB-1381 Rev. C
OT900 R3 J3

INFORMATION FOR PATIENTS

ClindaReach®
(Clindamycin Phosphate Topical Solution USP, 1%) Pledgets
*Equivalent to 1% (10 mg/mL) Clindamycin

Patient Guide

With the Integrated EasyReach® Accessory Applicator System†

Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.

† Covered by U.S. Pat. No. D552,792. Additional patents pending.

ClindaReach® is easy to use.

Your treatment system contains ClindaReach® medicated pledgets, the EasyReach® ergonomic Applicator arm, and EasyCling Appliqués. Follow these simple directions to get started.

1. Clean and dry skin areas to be treated (see EasyCleanse note below).

2. Assemble EasyReach® Applicator.

3. Retrieve a single EasyCling Appliqué from its box and secure it to the applicator circular head.

4. Dip applicator with appliqué into the ClindaReach® Pledget jar.

5. As you dip the applicator arm into the jar, gently twist it back and forth over the top of the pledgets to affix a single pledget to the appliqué.

6. Remove the applicator from the jar. There should be a single pledget affixed to the appliqué. You can press the medicated pledget lightly with your fingertips to help secure it more firmly to the appliqué and the applicator arm.

7. Close pledget jar cap tightly immediately after each use to prevent pledgets from drying out.

8. Apply a thin layer of medication to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water.

9. Remove medicated pad and discard after use. ClindaReach® medicated pledgets should be discarded after each use. EasyCling Appliqués are also disposable but can be used more than once. However, they should be discarded along with the medicated pledget or pad at the end of the treatment day. Simply pull the appliqué tab to remove it from the EasyReach® Applicator arm and discard.

To use EasyCleanse Unmedicated Pads, simply follow the instructions above, attaching an EasyCleanse Unmedicated Pad to the appliqué. EasyCleanse Unmedicated Pads should be discarded after each use.

For additional information or questions please call Customer Service at 1-877-533-3872.

ClindaReach®
(Clindamycin Phosphate Topical Solution USP, 1%*) Pledgets
*Equivalent to 1% (10 mg/mL) Clindamycin

The ClindaReach® Treatment Package contains:

• 120 ClindaReach® (Clindamycin Phosphate Topical Solution USP, 1%) Pledgets

• The Integrated EasyReach® Accessory Applicator System,† which includes an ergonomic, collapsible applicator arm and 64 disposable EasyCling Appliqués designed to work together to help you apply the medication

• 64 EasyCleanse Unmedicated Pads

† Covered by U.S. Pat. No. D552,792. Additional patents pending.

NDC #65880-503-02

For topical use only
Rx only

Manufactured for: DUSA Pharmaceuticals, Inc.®,
Wilmington, MA 01887
LAB-1386 Rev. C

DUSA®

PACKAGE LABEL

NDC# 65880-503-02

ClindaReach®
(Clindamycin Phosphate Topical Solution USP, 1%*) Pledgets

120 Pledgets
*Equivalent to 1% (10 mg/mL) Clindamycin

Each package contains:
Medicated Pledgets (120 count)
EasyReach® Applicator†
EasyCling Appliqués (64 count)
EasyCleanse Unmedicated Pads (64 count)

† Covered by U.S. Pat. No. D552,792.
Additional patents pending.

With the Intergrated EasyReach® Accessory Applicator System†

For Topical Use Only
Rx Only

DUSA

The ClindaReach® Treatment Package contains:

• 120 ClindaReach® (Clindamycin Phosphate Topical Solution USP, 1%) Medicated Pledgets
• The Integrated EasyReach® Accessory Applicator System, which includes an ergonomic, collapsible applicator arm and disposable appliqués designed to work together to enable you to easily reach all areas affected by acne

See enclosed package insert for complete prescribing information.

For external use only. Avoid contact with eyes.
Store at controlled room temperature 15° to 30°C (59° to 86°F) (See USP)
Protect from freezing. Flash point 75°F.

Clindamycin phosphate plegets contain clindamycin phosphate topical solution. The solution contains clindamycin phosphate equivalent to 10 mg/mL, isopropyl alcohol 50% v/v, propylene glycol, sodium hydroxide (to adjust the pH to between 4.0 and 7.0), and purified water.

Lot No. and Exp Date. See outer box or enclosed ClindaReach® label, bottom of container or box.

Manufactured for: DUSA Pharmaceuticals, Inc.®, Wilmington, MA 01887

LAB-1385 Rev. D

DUSA®

NDC 65880-503-60

ClindaReach®
(Clindamycin Phosphate Topical Solution USP, 1%*) Pledgets

*Equivalent to 1% (10 mg/mL) clindamycin

For Topical Use Only

Rx Only

60 Pledgets

DUSA®

USUAL DOSAGE: See package insert for complete product information.

Store at 20-° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing.

Instructions for use:

1. Do not use if seal under cap is broken.
2. Clean and dry skin areas to be treated.
3. Apply a thin film of medicatoin to the affected area. Use sparingly, avoiding eyes and mouth. If medication accidentally enters eyes, rinse thoroughly with tap water.
4. Discard pledget after single use.
5. Close tightly after each use.

Each Clindamycin Phosphate Pledget contains Clindamycin Phosphate Topical Solution USP, 1%. The solution contains clindamycin phosphate equivalent to 10 mg/mL, isopropyl alcohol 50% v/v, propylene glycol, purified water, and sodium hydroxide (to adjust the pH to between 4.0 and 7.0).

Lot No. and Exp. Date: See label, bottom of container or see box.

Manufactured for: DUSA Pharmaceuticals, Inc., Wilmington, MA 01887
Manufactured by: PERRIGO, Bronx, NY 10457

Rev. 02/10

DUSA®

LAB-1382 Rev. C