Cleocin T

Cleocin T, Clindagel, ClindaDerm, Clindets, and Evoclin are the brand names available for topical clindamycin phosphate in the US.

Yes

Cleocin T 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.

Before taking clindamycin, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to clindamycin or to any of its ingredients
• are allergic to lincomycin (Lincocin)
• have or have had asthma
• have or have had eczema
• have liver problems
• have kidney problems
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Apply the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to apply the medicine and skip the missed dose. Do not use extra medicine to make up the missed dose.

Your pharmacist can provide more information about clindamycin topical.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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You should not use clindamycin topical if you have ulcerative colitis or enteritis (inflammation of your intestines), or if you have ever had severe diarrhea caused by antibiotic medicine.

You should not use this medicine if you are allergic to clindamycin or lincomycin, or if you have:

• inflammation of your intestines (also called enteritis);

• ulcerative colitis; or

• if you have ever had severe diarrhea caused by antibiotic medicine.

Clindamycin topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant.

It is not known whether clindamycin topical passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not use this medication on a child younger than 12 years old without the advice of a doctor.

Applies to clindamycin topical: topical foam, topical gel, topical kit, topical lotion, topical solution, topical swab, vaginal cream, vaginal suppository

Dermatologic

Lotion:
Very common (10% or more): Dryness (Up to 18%), erythema (Up to 14%), itching (Up to 11%), oiliness/oily skin (Up to 10%)
Common (1% to 10%): Seborrhea, skin problems, peeling, skin irritation, urticaria
Frequency not reported: Gram-negative folliculitis/folliculitis, contact dermatitis
Postmarketing reports: Rash, pruritus, blisters, papular pruritic skin rash, hair loss, skin inflammation, scaling, skin discoloration

Topical Gel:
Very common (10% or more): Dryness (Up to 23%), oiliness/oily skin (Up to 18%), itching (Up to 10%)
Common (1% to 10%): Erythema
Frequency not reported: Acne aggravated, erythema, scaly rash, skin disorder, gram-negative folliculitis, contact dermatitis

Topical Solution:
Very common (10% or more): Skin dryness (Up to 19%), erythema (Up to 16%), peeling (Up to 11%)
Common (1% to 10%): Skin oiliness/oily skin, skin problems, itching, irritation, urticaria
Frequency not reported: Gram-negative folliculitis, contact dermatitis

Vaginal Cream:
Frequency not reported: Rash, exanthema, urticaria, skin candida, pruritus (non-application site), rash macular, erythema, maculopapular rash[Ref]

Genitourinary

Lotion:
Common (1% to 10%): Urinary tract infection
Postmarketing reports: Fertility disorders, bladder infection

Topical Solution:
Common (1% to 10%): Vaginitis

Vaginal Cream:
Very common (10% or more): Cervicitis/vaginitis (Up to 14%), vulvovaginal moniliasis/candidiasis (Up to 13.3%)
Common (1% to 10%): Vulvovaginal irritation/disorder/pain, vulvovaginitis trichomonal, Candida infection
Frequency not reported: Urinary tract/vaginal infection, menstrual disorder, metrorrhagia, vaginal discharge, endometriosis, proteinuria, dysuria
Postmarketing reports: Pelvic pain

Vaginal Suppository:
Common (1% to 10%): Vulvovaginal disorder, vaginal pain, vaginal moniliasis
Frequency not reported: Menstrual disorder, dysuria, vaginal discharge, vaginitis/vaginal infection[Ref]

Vulvovaginal candidiasis, fungal infection, dysuria, and proteinuria occurred more frequently in pregnant patients given this drug compared to placebo for 7 days.[Ref]

Local

Lotion:
Very common (10% or more): Application site burning/itching (Up to 11%)

Topical Gel:
Frequency not reported: Application site burning/dryness/erythema

Vaginal Cream:
Frequency not reported: Pruritus (topical application site)[Ref]

Gastrointestinal

Lotion:
Common (1% to 10%): Diarrhea
Uncommon (0.1% to 1%): Vomiting
Frequency not reported: Abdominal pain, gastrointestinal disturbances
Postmarketing reports: Nausea, acute colitis, bloating, constipation, colored tongue, dyspepsia, flatulence, gastrointestinal distress/reflux, heartburn, pseudomembranous colitis, rectal bleeding

Topical Gel:
Frequency not reported: Abdominal pain, gastrointestinal disturbances, diarrhea, bloody diarrhea (including pseudomembranous colitis)

Topical Solution:
Common (1% to 10%): Diarrhea, vomiting, nausea, abdominal cramps/pain
Uncommon (0.1% to 1%): Gastrointestinal disturbances
Frequency not reported: Bloody diarrhea (including pseudomembranous colitis)

Vaginal Cream:
Frequency not reported: Heartburn, nausea, vomiting, diarrhea, constipation, localized/generalized abdominal pain, abdominal cramps, breath odor/halitosis, dyspepsia, flatulence, gastrointestinal disorder
Postmarketing reports: Pseudomembranous colitis, abdominal distension

Vaginal Suppository:
Frequency not reported: Abdominal cramps, localized/general abdominal pain[Ref]

Nervous system

Lotion:
Very common (10% or more): Burning sensation (Up to 11%)
Postmarketing reports: Headache, dizziness, facial numbness, metallic taste, voice loss

Topical Gel:
Very common (10% or more): Burning sensation (up to 10%)

Topical Solution:
Very common (10% or more): Burning sensation (Up to 11%)

Vaginal Cream:
Frequency not reported: Dizziness, headache, vertigo, taste perversion[Ref]

Other

Abnormal labor occurred in 1.1% of pregnant patients (in their second trimester) compared to 0% of patients given placebo for 7 days.

Fungal infections occurred in 1.7% of pregnant patients (in their second trimester) compared to 0% of patients given placebo for 7 days.[Ref]

Lotion:
Common (1% to 10%): Dental procedure
Postmarketing reports: Facial swelling, fungal infection

Topical Gel:
Frequency not reported: Smarting

Topical Solution:
Common (1% to 10%): Dental procedure

Vaginal Cream:
Common (1% to 10%): Abnormal labor, fungal infection
Frequency not reported: Bacterial infection, inflammation, microbiology test abnormal, candida infection/moniliasis (body), inflammatory swelling
Postmarketing reports: Pain

Vaginal Suppository:
Common (1% to 10%): Fungal infection[Ref]

Respiratory

Lotion:
Common (1% to 10%): Sore throat/tonsillitis/laryngitis
Uncommon (0.1% to 1%): Upper respiratory tract infection/cough/tracheitis
Postmarketing reports: Epistaxis

Topical Solution:
Common (1% to 10%): Sinusitis/congestion

Vaginal Cream:
Frequency not reported: Epistaxis, upper respiratory tract infection[Ref]

Musculoskeletal

Lotion:
Uncommon (0.1% to 1%): Fracture

Topical Solution:
Common (1% to 10%): Fracture

Vaginal Cream:
Postmarketing reports: Back pain

Vaginal Suppository:
Frequency not reported: Flank pain[Ref]

Immunologic

Lotion:
Common (1% to 10%): Cold/flu

Vaginal Cream:
Frequency not reported: Hypersensitivity[Ref]

Ocular

Lotion:
Frequency not reported: Stinging of the eye, eye pain
Postmarketing reports: Eye irritation

Topical Gel:
Frequency not reported: Eye pain

Topical Solution:
Frequency not reported: Stinging of the eye, eye pain[Ref]

Cardiovascular

Lotion:
Postmarketing reports: Edema, rapid heartbeat, chest tightness

Topical Solution:
Frequency not reported: Sensation of warmth[Ref]

Renal

Vaginal Cream:
Frequency not reported: Glycosuria

Vaginal Suppository:
Frequency not reported: Pyelonephritis[Ref]

Hypersensitivity

Lotion:
Postmarketing reports: Allergic reaction

Vaginal Cream:
Frequency not reported: Allergic reaction[Ref]

Metabolic

Lotion:
Postmarketing reports: Weight loss

Vaginal Cream:
Frequency not reported: Hyperthyroidism[Ref]

Hematologic

Lotion:
Postmarketing reports: Leukopenia[Ref]

Hepatic

Topical Gel:
Postmarketing reports: Elevated liver enzymes[Ref]

Some side effects of Cleocin T may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.