Label: CLINDAMYCIN PHOSPHATE lotion
CLINDAMYCIN PHOSPHATE solution
CLINDAMYCIN PHOSPHATE gel

Rx only

For External Use

Clindamycin Phosphate Topical Solution and Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension USP, 1%) contain clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. Clindamycin Phosphate Gel contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per gram. 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, and purified water.

The gel contains allantoin, carbomer 974P, methylparaben, polyethylene glycol 400, propylene glycol, sodium hydroxide, and purified water.

The lotion contains cetostearyl alcohol (2.5%); glycerin; glyceryl stearate SE (with potassium monostearate); isostearyl alcohol (2.5%); methylparaben (0.3%); sodium lauroyl sarcosinate; stearic acid; and purified water.

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).

Mechanism of Action

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

Pharmacokinetics

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.

Microbiology

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

Antimicrobial Activity

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

Resistance

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. Macrolide-inducible resistance to clindamycin occurs in some isolates of macrolide-resistant bacteria.

Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Lotion are 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).

Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Gel, and Clindamycin Phosphate Lotion are 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.

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.

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].

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

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

Apply a thin film of Clindamycin Phosphate Topical Solution, Clindamycin Phosphate Lotion, or Clindamycin Phosphate Gel twice daily to affected area.

Lotion: Shake well immediately before using.

Keep all liquid dosage forms in containers tightly closed.

Clindamycin Phosphate Topical Solution, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes:

30 mL applicator bottle NDC 0168-0201-30
60 mL applicator bottle NDC 0168-0201-60

Clindamycin Phosphate Gel, USP 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per gram is available in the following sizes:

30 gram tube NDC 0168-0202-30
60 gram tube NDC 0168-0202-60

Clindamycin Phosphate Lotion (Clindamycin Phosphate Topical Suspension, USP 1%) containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following size:

60 mL bottle NDC 0168-0203-60

Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP].

Protect from freezing.

Fougera
PHARMACEUTICALS INC.

E. FOUGERA & CO.
A division of Fougera Pharmaceuticals Inc.
MELVILLE, NEW YORK 11747

46263755A
R01/2020

NDC 0168-0203-60

Fougera ®

CLINDAMYCIN
PHOSPHATE LOTION
(Clindamycin Phosphate
Topical Suspension
USP, 1%)

Equivalent to 1% (10 mg/mL)
clindamycin

FOR TOPICAL USE ONLY.
60 mL

Rx only

E. FOUGERA & CO.
A division of
Fougera Pharmaceuticals Inc.
Melville, New York 11747

NDC 0168-0203-60

Fougera ®

CLINDAMYCIN
PHOSPHATE
LOTION
(Clindamycin
Phosphate Topical
Suspension
USP, 1%)

Equivalent to 1%
(10 mg/mL) clindamycin

FOR TOPICAL USE ONLY.

60 mL

Rx only

E. FOUGERA & CO.
A division of
Fougera Pharmaceuticals Inc.
Melville, New York 11747

NDC 0168-0201-60

Fougera ®

CLINDAMYCIN
PHOSPHATE
Topical Solution USP, 1%
Equivalent to 1%
(10 mg/mL) clindamycin

For Topical Use Only.

Rx only
60 mL

E. FOUGERA & CO.
A division of
Fougera Pharmaceuticals Inc.
Melville, New York 11747

NDC 0168-0201-60

Fougera ®

CLINDAMYCIN
PHOSPHATE
Topical Solution
USP, 1%

Equivalent to 1%
(10 mg/mL) clindamycin

For Topical Use Only.

60 mL

Rx only

E. FOUGERA & CO.
A division of
Fougera Pharmaceuticals Inc.
Melville, New York 11747

NDC 0168-0202-30

Fougera ®

CLINDAMYCIN
PHOSPHATE GEL USP, 1%
equivalent to 1% clindamycin

For Topical Use Only.

Rx only

NET WT 30 grams

NDC 0168-0202-30

Rx only

Fougera ®

CLINDAMYCIN
PHOSPHATE GEL USP, 1%
equivalent to 1% clindamycin
For Topical Use Only.

FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES.
WARNING: Keep out of
reach of children.

NET WT 30 grams