Clindets

Dosage Forms And Strengths

Box of 60 individual pledgets. Each CLINDETS^® pledget applicator contains approximately 1 mL of 1% w/v clindamycin (as phosphate) topical solution.

Stability And Storage Recommendations

Store between 15°C and 25°C. Do not freeze. Contents are flammable. Keep away from fire, flame or heat. Do not leave CLINDETS^® in direct sunlight. Keep out of the sight and reach of children.

GlaxoSmithKline Inc. 7333 Mississauga Road, Mississauga, Ontario L5N 6L4. Revised: 2014.

CLINDETS^® (clindamycin phosphate pledget) is indicated in the treatment of moderate acne vulgaris.

CLINDETS^® (clindamycin phosphate pledget) should be applied to areas affected by acne twice daily, in the morning and at night. The area to be treated should be washed first with a mild soap or cleanser, rinsed well and patted dry. A thin film of medication should be applied avoiding the eyes and mouth. Each pledget should be removed from the foil immediately before use, used only once and then discarded.

Hands should be washed after application. CLINDETS^® is not for oral, ophthalmic, or intravaginal use. Six to eight weeks of treatment may be required before a therapeutic effect is observed. Treatment should be discontinued if there has been no improvement or if the condition becomes worse.

Due to increased risk of antimicrobial resistance, the benefit of continuing treatment beyond 12 weeks should be evaluated.

Elderly

There are no specific recommendations for use in the elderly.

Renal Impairment

No dosage adjustment is necessary. As percutaneous absorption is low following topical application, renal impairment is not expected to result in systemic exposure of clinical significance.

Hepatic Impairment

No dosage adjustment is necessary. As percutaneous absorption is low following topical application, hepatic impairment is not expected to result in systemic exposure of clinical significance.

CLINDETS^® (clindamycin phosphate pledget) is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, or any other component of the preparation. CLINDETS^® is also contraindicated in patients with or with a history of regional enteritis or ulcerative colitis, or a history of antibioticassociated colitis (including pseudomembranous colitis).

WARNINGS

Skin

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. CLINDETS^® (clindamycin phosphate pledget) is known to be a mild irritant in humans and animals. Avoid contact with eyes, mouth, lips, other mucous membranes, or areas of broken skin. In the event of sensitization or severe local irritation from CLINDETS ^®, usage should be discontinued immediately, the solution carefully washed off, and appropriate therapy initiated.

The solution contains isopropyl alcohol. In the event of accidental contact with sensitive surfaces (eyes, abraded skin, mucous membranes), wash with large amounts of cool tap water.

Gastrointestinal

Clostridium Difficile-Associated Disease (CDAD)

Use of topical formulation of clindamycin results in absorption of clindamycin from the skin surface. Clostridium difficile-associated disease (CDAD), including pseudomembranous colitis has been reported with the use of topical, oral and parenteral administration of clindamycin (see ADVERSE REACTIONS). CDAD may range in severity from mild diarrhea to fatal colitis. It is important to consider this diagnosis in patients who present with diarrhea, or symptoms of colitis, pseudomembranous colitis, toxic mega colon, or perforation of colon subsequent to the administration of any antibacterial agent. CDAD has been reported to occur 2 months after the administration of antibacterial agents.

Treatment with antibacterial agents may alter the normal flora of the colon and may permit overgrowth of Clostridium difficile. Clostridium difficile produces toxins A and B, which contribute to the development of CDAD. CDAD may cause significant morbidity and mortality.

If the diagnosis of CDAD is suspected or confirmed, appropriate therapeutic measures should be initiated. Mild cases of CDAD usually respond to discontinuation of antibacterial agents not directed against Clostridium difficile. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial agent clinically effective against Clostridium difficile. Surgical evaluation should be instituted as clinically indicated, as surgical intervention may be required in certain severe cases.

PRECAUTIONS

General

The use of preparations containing antibiotics such as clindamycin may be associated with overgrowth of antibiotic resistant microorganisms including those initially sensitive to the drug. The treatment of acne with topical antibiotics is associated with the development of antimicrobial resistance in Propionibacterium acnes as well as other bacteria (e.g. Staphylococcus aureus, Streptococcus pyogenes). The use of clindamycin may result in developing inducible resistance in these organisms. If this occurs, therapy should be discontinued and alternative acne therapy should be initiated. Resistance to clindamycin is often associated with resistance to erythromycin. It is therefore advisable to avoid concurrent use of the two agents either by topical or oral treatment.

Concomitant topical acne therapy should be used with caution since a possible cumulative irritancy effect may occur, especially with the use of peeling, desquamating or abrasive agents. If irritancy or dermatitis occurs, clindamycin should be discontinued.

Flammability

Due to the flammable nature of CLINDETS^®, patients should avoid smoking or being near an open flame during application and immediately after use.

Use In Pregnancy

The safety of CLINDETS^® during pregnancy has not been established. No adequate and well-controlled reproduction studies have been conducted with clindamycin in pregnant women. Systemic absorption of clindamycin following topical administration of clindamycin phosphate is less than 5%. Clindamycin readily crosses placental barrier. Animal reproduction studies have not been conducted with CLINDETS^® (clindamycin phosphate pledget) and it is not known whether CLINDETS^® can cause fetal harm when administered to pregnant women or can affect reproduction capacity. CLINDETS^® should not be administered to a pregnant woman unless the potential benefits to the mother clearly outweigh the possible risks to the fetus.

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 (see Toxicology). Conclusions from such animal studies may not always be predictive of the effects on human reproduction.

Use In Nursing Mothers

The safety of CLINDETS^® in nursing women has not been established. No adequate and well-controlled data in nursing women treated with clindamycin 1% (clindamycin as clindamycin phosphate) solution are available. It is not known if topically applied clindamycin is excreted in human milk following the topical use of CLINDETS^®. Orally and parenterally administered clindamycin is excreted 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 CLINDETS^® therapy to the mother. If used during lactation, clindamycin should not be applied to the breast area to avoid accidental ingestion by the infant.

Pediatric Use

Safety and effectiveness in the pediatric population under the age of 13 have not been established.

SIDE EFFECTS

Clinical Trial Adverse Drug Reactions

The safety was assessed in 150 acne vulgaris patients from a placebo-controlled study in which CLINDETS^® or placebo (vehicle) pledgets were applied twice daily over a period of 11 weeks. The number of patients with worsening scores of erythema, peeling and burning is presented in Table 1.

Table 1: Patients with worsening signs or symptoms of acne in a CLINDETS^® Clinical Trial

Number of patients reporting common (≥1%) treatment emergent adverse reactions are provided in Table 2.

Table 2: Most common drug related adverse reactions reported by ≥1% of patients in a CLINDETS^® Clinical Trial

Additional Adverse Drug Reactions Reported In Other Clindamycin Phosphate Clinical Trials

The following additional common adverse drug reactions (≥ 1%) have been reported in clinical trials involving other clindamycin phosphate formulations:

Skin and subcutaneous disorders: pruritus, rash, stinging, dryness, oiliness, small red bumps (including gram negative folliculitis pustules).

Immune system disorders: urticaria, whealing, swollen lips.

Gastrointestinal disorders: abdominal cramping.

Post-Market Adverse Drug Reactions

Immune system disorders: allergic reaction.

Gastrointestinal disorders: bloody diarrhea, colitis (including pseudomembranous colitis) (See WARNINGS, Gastrointestinal, CDAD).

DRUG INTERACTIONS

Clindamycin and erythromycin have been shown to be antagonistic in vitro.

Systemic 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.

Clinical Trial Adverse Drug Reactions

The safety was assessed in 150 acne vulgaris patients from a placebo-controlled study in which CLINDETS^® or placebo (vehicle) pledgets were applied twice daily over a period of 11 weeks. The number of patients with worsening scores of erythema, peeling and burning is presented in Table 1.

Table 1: Patients with worsening signs or symptoms of acne in a CLINDETS^® Clinical Trial

Number of patients reporting common (≥1%) treatment emergent adverse reactions are provided in Table 2.

Table 2: Most common drug related adverse reactions reported by ≥1% of patients in a CLINDETS^® Clinical Trial

Additional Adverse Drug Reactions Reported In Other Clindamycin Phosphate Clinical Trials

The following additional common adverse drug reactions (≥ 1%) have been reported in clinical trials involving other clindamycin phosphate formulations:

Skin and subcutaneous disorders: pruritus, rash, stinging, dryness, oiliness, small red bumps (including gram negative folliculitis pustules).

Immune system disorders: urticaria, whealing, swollen lips.

Gastrointestinal disorders: abdominal cramping.

Post-Market Adverse Drug Reactions

Immune system disorders: allergic reaction.

Gastrointestinal disorders: bloody diarrhea, colitis (including pseudomembranous colitis) (See WARNINGS, Gastrointestinal, CDAD).

For management of a suspected drug overdose, contact your regional Poison Control Centre.

Symptoms

Topically applied clindamycin phosphate from CLINDETS^® can be absorbed in sufficient amounts to produce systemic gastrointestinal side effects including abdominal pain, nausea, vomiting and diarhhea (see WARNINGS). In the case of excessive application or accidental ingestion of CLINDETS^®, the use of the pledgets should be discontinued for several days before resuming therapy (see WARNINGS).

CLINDETS^® contains a significant quantity of isopropyl alcohol (44%). Systemic absorption of isopropyl alcohol should be considered a possibility in the event of accidental ingestion.

Treatment

No specific antidote is available. In the case of excessive application or accidental ingestion of CLINDETS^® the application site should be washed off with lukewarm water and the use of the pledgets should be discontinued for several days before resuming therapy (see WARNINGS).