Cleocin Ovules

Clindamycin is an antibiotic that fights bacteria.

Clindamycin vaginal (for use in the vagina) is used to treat vaginal infections caused by bacteria.

Clindamycin vaginal may also be used for purposes not listed in this medication guide.

Avoid having sexual intercourse or using vaginal products such as tampons, lubricants, or douches while you are using this medication.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop using clindamycin vaginal and call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Applies to clindamycin topical: vaginal cream, vaginal suppository

Other dosage forms:

• topical foam, topical gel/jelly, topical lotion, topical pad, topical solution

Along with its needed effects, clindamycin topical (the active ingredient contained in Cleocin Ovules) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking clindamycin topical:

• Itching of the vagina or genital area
• pain during sexual intercourse
• thick, white vaginal discharge with no odor or with mild odor

• Diarrhea
• dizziness
• headache
• nausea or vomiting
• stomach pain or cramps

• Burning, itching, rash, redness, swelling or other signs of skin problems not present before use of this medicine

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Itching of the vagina or genital area
• pain during sexual intercourse
• thick, white vaginal discharge with no odor or with mild odor

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

Data not available

Administration advice:
-The intravaginal cream formulation is for vulvovaginal use only; not for ophthalmic or oral use.
-Pledgets should be used promptly after opening and should only be used once, then properly discarded.
-Lotion formulations should be thoroughly shaken immediately prior to use.

Storage requirements:
-The manufacturer product information should be consulted.

General:
-Bacterial vaginosis is usually defined by the presence of a homogeneous vaginal discharge with the following: a pH greater than 4.5, 'fishy' amine odor when mixed with 10% KOH solution, and/or the presence of clue cells on microscopic examination.
-Diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out prior to prescribing another course of therapy.
-Healthcare providers should consider the potential risk of pseudomembranous colitis associated with this drug; other agents may be more appropriate for use.
-If the condition does not improve or worsens during treatment, modification and/or alternative therapy should be considered.

Monitoring:
-Signs/symptoms of pseudomembranous colitis/Clostridium difficile associated diarrhea (CDAD)

Patient advice:
-Patients should be instructed to avoid vaginal intercourse or use of other vaginal products (including tampons or douches) during and up to 72 hours after treatment.
-Patients should be told to notify their healthcare provider if signs/symptoms of CDAD occur during or after use (e.g., severe diarrhea, abdominal pain).
-Patients should be advised that decreases in acne may not occur for 2 to 6 weeks, and some patients may require up to 8 weeks of treatment for definitive beneficial effects.