ClindaReach

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.

ClindaReach is part of the drug classes:

• Gynecological Antibiotics

• Antiinfectives for treatment of acne

• Lincosamides

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.

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of clindamycin, there are no specific foods that you must exclude from your diet when receiving this medication.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Clindamycin falls into category B. There are no well-done studies that have been done in humans with clindamycin. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Take clindamycin exactly as prescribed.

Oral:

This medication is available as an oral capsule, an oral liquid, and granules for oral solution.

Take oral forms of clindamycin with a full glass of water so that the medicine will not irritate your throat.

Topical:

This medication is available as a topical cream, topical gel, topical solution, topical foam, topical swab (pledget), vaginal cream, and vaginal suppository. The topical products are used for treating acne and are applied 1 to 2 times a day. The vaginal products are usually used once a day.

Injectable:

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

If you miss a dose, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of clindamycin at the same time.

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).

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.

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

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