To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Sterile Solution is for Intramuscular and Intravenous Use

CLEOCIN PHOSPHATE in the ADD-Vantage® Vial is For Intravenous Use Only

CLEOCIN PHOSPHATE Sterile Solution in vials contains clindamycin phosphate, a water soluble ester of clindamycin and phosphoric acid. Each mL contains the equivalent of 150 mg clindamycin, 0.5 mg disodium edetate and 9.45 mg benzyl alcohol added as preservative in each mL. Clindamycin is a semisynthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin.

The chemical name of clindamycin phosphate is L-threo-α-D-galacto-Octopyranoside, methyl-7-chloro-6,7,8-trideoxy-6-[[(1-methyl-4-propyl-2-pyrrolidinyl)carbonyl] amino]-1-thio-, 2-(dihydrogen phosphate), (2S-trans)-.

The molecular formula is C18H34ClN2O8PS and the molecular weight is 504.96.

The structural formula is represented below:

CLEOCIN PHOSPHATE in the ADD-Vantage Vial is intended for intravenous use only after further dilution with appropriate volume of ADD-Vantage diluent base solution (see Directions for Use).

CLEOCIN PHOSPHATE IV Solution in the GALAXY plastic container for intravenous use is composed of clindamycin phosphate equivalent to 300, 600 and 900 mg of clindamycin premixed with 5% dextrose as a sterile solution. Disodium edetate has been added at a concentration of 0.04 mg/mL. The pH has been adjusted with sodium hydroxide and/or hydrochloric acid.

The plastic container is fabricated from a specially designed multilayer plastic, PL 2501. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period. The suitability of the plastic has been confirmed in tests in animals according to the USP biological tests for plastic containers, as well as by tissue culture toxicity studies.

CLEOCIN PHOSPHATE products are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria.

CLEOCIN PHOSPHATE products are also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate. Because of the risk of antibiotic-associated pseudomembranous colitis, as described in the BOXED WARNING, before selecting clindamycin the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin).

Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin.

Indicated surgical procedures should be performed in conjunction with antibiotic therapy.

CLEOCIN PHOSPHATE is indicated in the treatment of serious infections caused by susceptible strains of the designated organisms in the conditions listed below:

Lower respiratory tract infections including pneumonia, empyema, and lung abscess caused by anaerobes, Streptococcus pneumoniae, other streptococci (except E. faecalis), and Staphylococcus aureus.

Skin and skin structure infections caused by Streptococcus pyogenes, Staphylococcus aureus, and anaerobes.

Gynecological infections including endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection caused by susceptible anaerobes.

Intra-abdominal infections including peritonitis and intra-abdominal abscess caused by susceptible anaerobic organisms.

Septicemia caused by Staphylococcus aureus, streptococci (except Enterococcus faecalis), and susceptible anaerobes.

Bone and joint infections including acute hematogenous osteomyelitis caused by Staphylococcus aureus and as adjunctive therapy in the surgical treatment of chronic bone and joint infections due to susceptible organisms.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of CLEOCIN PHOSPHATE and other antibacterial drugs, CLEOCIN PHOSPHATE should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy. In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.

This drug is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

See BOXED WARNING.

The following reactions have been reported with the use of clindamycin.

Infections and Infestations: Clostridioides difficile colitis

Gastrointestinal: Antibiotic-associated colitis (see WARNINGS), pseudomembranous colitis, abdominal pain, nausea, and vomiting. The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS). An unpleasant or metallic taste has been reported after intravenous administration of the higher doses of clindamycin phosphate.

Hypersensitivity Reactions: Maculopapular rash and urticaria have been observed during drug therapy. Generalized mild to moderate morbilliform-like skin rashes are the most frequently reported of all adverse reactions.

Severe skin reactions such as Toxic Epidermal Necrolysis, some with fatal outcome, have been reported (see WARNINGS). Cases of Acute Generalized Exanthematous Pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. Anaphylactic shock, anaphylactic reaction and hypersensitivity have also been reported (see WARNINGS).

Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported (see Hypersensitivity Reactions).

Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.

Renal: Acute kidney injury (See WARNINGS).

Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.

Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported.

Local Reactions: Injection site irritation, pain, induration and sterile abscess have been reported after intramuscular injection and thrombophlebitis after intravenous infusion. Reactions can be minimized or avoided by giving deep intramuscular injections and avoiding prolonged use of indwelling intravenous catheters.

Musculoskeletal: Polyarthritis cases have been reported.

Cardiovascular: Cardiopulmonary arrest and hypotension have been reported following too rapid intravenous administration (see DOSAGE AND ADMINISTRATION).

Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed.

Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.

If diarrhea occurs during therapy, this antibiotic should be discontinued (see WARNING box).

Clindamycin phosphate IM administration should be used undiluted.

Clindamycin phosphate IV administration should be diluted (see Dilution for IV use and IV infusion rates below).

Each mL of CLEOCIN PHOSPHATE Sterile Solution contains clindamycin phosphate equivalent to 150 mg clindamycin, 0.5 mg disodium edetate, 9.45 mg benzyl alcohol added as preservative. When necessary, pH is adjusted with sodium hydroxide and/or hydrochloric acid. CLEOCIN PHOSPHATE is available in the following packages:

CLEOCIN PHOSPHATE is supplied in ADD-Vantage vials as follows:

1.

Smith RB, Phillips JP: Evaluation of CLEOCIN HCl and CLEOCIN Phosphate in an Aged Population. Upjohn TR 8147-82-9122-021, December 1982.

ADD-Vantage® is a registered trademark of Hospira Inc.

CLEOCIN PHOSPHATE IV Solution in GALAXY plastic containers is manufactured for Pfizer Inc by Baxter Healthcare Corporation, Deerfield, IL 60015.

Galaxy and Mini-Bag are registered trademarks of Baxter International Inc.

This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

LAB-0044-28.0

Revised: 5/2022

For Intravenous Use Only

NOT FOR INTRAMUSCULAR USE

INSTRUCTIONS FOR USE FOR ADD-VANTAGE SYSTEM—FOR IV USE ONLY

To Open Diluent Container:

Peel overwrap from the corner and remove container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually.

To Assemble Vial and Flexible Diluent Container:

(Use Aseptic Technique)

1.

Remove the protective covers from the top of the vial and the vial port on the diluent container as follows:

1.

To remove the breakaway vial cap, swing the pull ring over the top of the vial and pull down far enough to start the opening (SEE FIGURE 1.), then pull straight up to remove the cap. (SEE FIGURE 2.) NOTE: Once the breakaway cap has been removed, DO NOT ACCESS VIAL WITH SYRINGE.

2.

To remove the vial port cover, grasp the tab on the pull ring, pull up to break the three tie strings, then pull back to remove the cover. (SEE FIGURE 3.)

2.

Screw the vial into the vial port until it will go no farther. THE VIAL MUST BE SCREWED IN TIGHTLY TO ASSURE A SEAL. This occurs approximately 1/2 turn (180°) after the first audible click. (SEE FIGURE 4.) The clicking sound does not assure a seal; the vial must be turned as far as it will go. NOTE: Once the vial is seated, do not attempt to remove it. (SEE FIGURE 4.)

3.

Recheck the vial to assure that it is tight by trying to turn it further in the direction of assembly.

4.

Label appropriately.

To Prepare Admixture:

1.

Squeeze the bottom of the diluent container gently to inflate the portion of the container surrounding the end of the drug vial.

2.

With the other hand, push the drug vial down into the container telescoping the walls of the container. Grasp the inner cap of the vial through the walls of the container. (SEE FIGURE 5.)

3.

Pull the inner cap from the drug vial. (SEE FIGURE 6.) Verify that the rubber stopper has been pulled out, allowing the drug and diluent to mix.

4.

Mix container contents thoroughly and use within the specified time.

Preparation for Administration: (Use Aseptic Technique)

1.

Confirm the activation and admixture of vial contents.

2.

Check for leaks by squeezing container firmly. If leaks are found, discard unit as sterility may be impaired.

3.

Close flow control clamp of administration set.

4.

Remove cover from outlet port at bottom of container.

5.

Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated. NOTE: See full directions on administration set carton.

6.

Lift the free end of the hanger loop on the bottom of the vial, breaking the two tie strings. Bend the loop outward to lock it in the upright position, then suspend container from hanger.

7.

Squeeze and release drip chamber to establish proper fluid level in chamber.

8.

Open flow control clamp and clear air from set. Close clamp.

9.

Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

10.

Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

ADD-Vantage® is a registered trademark of Hospira Inc.

LAB-0050-5.0

Revised October 2021

2 mL Vial

NDC 0009-0870-21

Cleocin

Phosphate®

clindamycin injection, USP

300 mg/2 mL*

(150 mg/mL)

For intramuscular or intravenous use

Rx only

NDC 0009-0870-26

Contains 25 of NDC 0009-0870-21

25—2 mL Single Dose Vials

Cleocin Phosphate®

clindamycin injection, USP

300 mg/2 mL*

(150 mg/mL)

For intramuscular or intravenous use

Pfizer

Rx only

4 mL Vial

NDC 0009-0775-20

Cleocin Phosphate®

clindamycin injection, USP

600 mg/4 mL*

(150 mg/mL)

For intramuscular or intravenous use

Rx only

NDC 0009-0775-26

Contains 25 of NDC 0009-0775-20

25—4 mL Single Dose Vials

Cleocin Phosphate®

clindamycin injection, USP

600 mg/4 mL*

(150 mg/mL)

For intramuscular or intravenous use

Pfizer

Rx only

6 mL Vial

NDC 0009-0902-11

Cleocin Phosphate®

clindamycin injection, USP

900 mg/6 mL*

(150 mg/mL)

For intramuscular or intravenous use

Rx only

NDC 0009-0902-18

Contains 25 of NDC 0009-0902-11

25—6 mL Single Dose Vials

Cleocin Phosphate®

clindamycin injection, USP

900 mg/6 mL*

(150 mg/mL)

For intramuscular or intravenous use

Pfizer

Rx only

NDC 0009-0728-05

60 mL Pharmacy

Bulk Package

Cleocin

Phosphate®

clindamycin injection, USP

9,000 mg/60 mL*

(150 mg/mL)

For intramuscular or intravenous use

Not for direct infusion

Pfizer

Rx only

Distributed by Pharmacia & Upjohn Company LLC

A subsidiary of Pfizer Inc, New York, NY 10017

NDC 0009-0728-09

Contains 5 of NDC 0009-0728-05

5—60 mL Pharmacy Bulk Packages

Cleocin Phosphate®

clindamycin injection, USP

9,000 mg/60 mL*

(150 mg/mL)

For intramuscular or intravenous use

Not for direct infusion

Pfizer

Rx only

NDC 0009-3124-01

Single Dose

4 mL ADD-Vantage™ Vial

Cleocin Phosphate®

clindamycin injection, USP

600 mg/4 mL*

(150 mg/mL)

For intravenous use only

Use only with the ADD-Vantage diluent container.

Pfizer Injectables

Rx only

25—4 mL Single Dose

ADD-Vantage® Vials

NDC 0009-3124-03

Contains 25 of NDC 0009-3124-01

Cleocin Phosphate®

clindamycin injection, USP

600 mg/4 mL*

(150 mg/mL)

For intravenous use only

Pfizer Injectables

Rx only

NDC 0009-3447-01

Single Dose

6 mL ADD-Vantage™ Vial

Cleocin Phosphate®

clindamycin injection, USP

900 mg/6 mL*

(150 mg/mL)

For intravenous use only

Use only with the ADD-Vantage diluent container.

Pfizer Injectables

Rx only

25—6 mL Single Dose

ADD-Vantage® Vials

NDC 0009-3447-03

Contains 25 of NDC 0009-3447-01

Cleocin Phosphate®

clindamycin injection, USP

900 mg/6 mL*

(150 mg/mL)

For intravenous use only

Pfizer Injectables

Rx only

NDC 0009-3381-01

Cleocin Phosphate® IV Solution

clindamycin injection

300 mg/ 50 mL*

in 5% DEXTROSE

Rx only

For Intravenous Use

Code 2G3414

Sterile, Nonpyrogenic

GALAXY Single Dose Container

Recommended storage: Room temperature (25°C). Avoid temperatures above 30°C.

DOSAGE AND USE: See accompanying prescribing information.

Not for rapid injection or IV push.

Cautions: Do not add supplementary medication. Must not be used in series

connections. Check for minute leaks and solution clarity.

* Each 50 mL contains clindamycin phosphate equivalent to 300 mg clindamycin

and 2.5 g dextrose hydrous, USP with 2 mg edetate disodium dihydrate,

USP added. pH adjusted with sodium hydroxide and/or hydrochloric acid.

CLEOCIN PHOSPHATE is a registered trademark of

Pharmacia & Upjohn Company.

GALAXY is a registered trademark of Baxter International Inc.

Manufactured for Pfizer Inc by Baxter Healthcare

Corporation, Deerfield, IL 60015

Pfizer Injectables

Distributed by

Pharmacia & Upjohn Co

Division of Pfizer Inc

New York, NY 10017

PL 2501 Plastic

11152901

07-34-72-423

2 x 12 x 50 mL Single Dose Containers

Contains 2 boxes of 12 of NDC 0009-3381-01

Cleocin Phosphate® IV Solution

clindamycin injection

Pfizer Injectables

300 mg/ 50 mL*

in 5% Dextrose

Rx only

NDC 0009-3381-02

Contains 24 of NDC 0009-3381-01

Code 2G3414

NDC 0009-3375-01

Cleocin Phosphate® IV Solution

clindamycin injection

600 mg/ 50 mL*

in 5% DEXTROSE

Rx only

For Intravenous Use

Code 2G3415

Sterile, Nonpyrogenic

GALAXY Single Dose Container

Recommended storage: Room temperature (25°C). Avoid temperatures above 30°C.

DOSAGE AND USE: See accompanying prescribing information.

Not for rapid injection or IV push.

Cautions: Do not add supplementary medication. Must not be used in series

connections. Check for minute leaks and solution clarity.

* Each 50 mL contains clindamycin phosphate equivalent to 600 mg clindamycin

and 2.5 g dextrose hydrous, USP with 2 mg edetate disodium dihydrate,

USP added. pH adjusted with sodium hydroxide and/or hydrochloric acid.

CLEOCIN PHOSPHATE is a registered trademark of

Pharmacia & Upjohn Company.

GALAXY is a registered trademark of Baxter International Inc.

Manufactured for Pfizer Inc by Baxter Healthcare Corporation,

Deerfield, IL 60015

Pfizer Injectables

Distributed by

Pharmacia & Upjohn Co

Division of Pfizer Inc

New York, NY 10017

PL 2501 Plastic

11153201

07-34-72-424

2 x 12 x 50 mL Single Dose Containers

Contains 2 boxes of 12 of NDC 0009-3375-01

Cleocin Phosphate® IV Solution

clindamycin injection

Pfizer Injectables

600 mg/ 50 mL*

in 5% Dextrose

Rx only

NDC 0009-3375-02

Contains 24 of NDC 0009-3375-01

Code 2G3415

NDC 0009-3382-01

Cleocin Phosphate® IV Solution

clindamycin injection

900 mg/ 50 mL*

in 5% DEXTROSE

Rx only

For Intravenous Use

Code 2G3416

Sterile, Nonpyrogenic

GALAXY Single Dose Container

Recommended storage: Room temperature (25°C). Avoid temperatures above 30°C.

DOSAGE AND USE: See accompanying prescribing information.

Not for rapid injection or IV push.

Cautions: Do not add supplementary medication. Must not be used in series

connections. Check for minute leaks and solution clarity.

* Each 50 mL contains clindamycin phosphate equivalent to 900 mg clindamycin

and 2.5 g dextrose hydrous, USP with 2 mg edetate disodium dihydrate,

USP added. pH adjusted with sodium hydroxide and/or hydrochloric acid.

CLEOCIN PHOSPHATE is a registered trademark of

Pharmacia & Upjohn Company.

GALAXY is a registered trademark of Baxter International Inc.

Manufactured for Pfizer Inc by Baxter Healthcare Corporation,

Deerfield, IL 60015

Pfizer Injectables

Distributed by

Pharmacia & Upjohn Co

Division of Pfizer Inc

New York, NY 10017

PL 2501 Plastic

11153501

07-34-72-425

2 x 12 x 50 mL Single Dose Containers

Contains 2 boxes of 12 of NDC 0009-3382-01

Cleocin Phosphate® IV Solution

clindamycin injection

Pfizer Injectables

900 mg/ 50 mL*

in 5% Dextrose

Rx only

NDC 0009-3382-02

Contains 24 of NDC 0009-3382-01

Code 2G3416

NDC 0009-6582-02

Single Dose

2 mL ADD-Vantage® Vial

Cleocin Phosphate®

clindamycin injection, USP

300 mg/2 mL*

(150 mg/mL)

For intravenous use only

Use only with the ADD-Vantage diluent container.

Pfizer Injectables

Rx only

25—2 mL Single Dose

ADD-Vantage® Vials

NDC 0009-6582-01

Contains 25 of NDC 0009-6582-02

Cleocin Phosphate®

clindamycin injection, USP

300 mg/2 mL*

(150 mg/mL)

For intravenous use only

Pfizer Injectables

Rx only