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Cleocin Vaginal Ovules

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Cleocin Vaginal Ovules

Cleocin Vaginal Ovules

Cleocin Vaginal Ovules Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Cleocin Vaginal Ovules (clindamycin phosphate vaginal suppositories) is used to treat vaginal infections caused by bacteria. It is an antibiotic. Common side effects include mild nausea or stomach pain, constipation, gas, vaginal itching, discharge, or pain, changes in your menstrual periods, or mild skin rash or itching.

The recommended dose is one Cleocin Vaginal Ovule (containing clindamycin phosphate equivalent to 100 mg clindamycin per 2.5 g suppository) intravaginally per day, preferably at bedtime, for 3 consecutive days. Other drugs may affect Cleocin Vaginal Ovules. Tell your doctor all medications and supplements you use. Cleocin Vaginal Ovules is not expected to be harmful to a fetus. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Cleocin Vaginal Ovules may contain mineral oil, which can weaken the latex rubber in a condom, causing it to break, and an unintended pregnancy could result. Avoid using a condom as a birth control method while you are using Cleocin vaginal and for at least 72 hours (3 days) after treatment ends. Clindamycin vaginal can pass into breast milk and may harm a nursing baby. Breastfeeding while using this medication is not recommended.

Our Cleocin Vaginal Ovules (clindamycin phosphate vaginal suppositories) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Cleocin Vaginal Ovules in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using clindamycin vaginal and call your doctor at once if you have diarrhea that is watery or bloody.

Keep using clindamycin vaginal and talk to your doctor if you have any of these less serious side effects:

  • mild nausea or stomach pain;
  • constipation, gas;
  • vaginal itching, discharge, or pain; or
  • changes in your menstrual periods; or
  • mild skin rash or itching.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Cleocin Vaginal Ovules (Clindamycin Phosphate Vaginal Suppositories) »

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Cleocin Vaginal Ovules FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials

In clinical trials, 3 (0.5%) of 589 nonpregnant women who received treatment with CLEOCIN Vaginal Ovules discontinued therapy due to drug-related adverse events. Adverse events judged to have a reasonable possibility of having been caused by clindamycin phosphate vaginal suppositories were reported for 10.5% of patients. Events reported by 1% or more of patients receiving CLEOCIN Vaginal Ovules were as follows:

Urogenital system: Vulvovaginal disorder (3.4%), vaginal pain (1.9%), and vaginal moniliasis (1.5%).

Body as a whole: Fungal infection (1.0%).

Other events reported by < 1% of patients included:

Urogenital system: Menstrual disorder, dysuria, pyelonephritis, vaginal discharge, and vaginitis/vaginal infection.

Body as a whole: Abdominal cramps, localized abdominal pain, fever, flank pain, generalized pain, headache, localized edema, and moniliasis.

Digestive system: Diarrhea, nausea, and vomiting.

Skin: Nonapplication-site pruritis, rash, application-site pain, and application-site pruritis.

Other clindamycin formulations

The overall systemic exposure to clindamycin from CLEOCIN Vaginal Ovules is substantially lower than the systemic exposure from therapeutic doses of oral clindamycin hydrochloride (two-fold to 20-fold lower) or parenteral clindamycin phosphate (40-fold to 50-fold lower) (see CLINICAL PHARMACOLOGY). Although these lower levels of exposure are less likely to produce the common reactions seen with oral or parenteral clindamycin, the possibility of these and other reactions cannot be excluded.

The following adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin and may also occur following administration of CLEOCIN Vaginal Ovules:

Gastrointestinal: Abdominal pain, esophagitis, nausea, vomiting, and diarrhea (See WARNINGS).

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

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. Rare instances of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported. If a hypersensitivity reaction occurs, the drug should be discontinued.

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

Musculoskeletal: Rare instances of polyarthritis have been reported.

Renal: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunction as evidenced by azotemia, oliguria, and/or proteinuria has been observed in rare instances.

Read the entire FDA prescribing information for Cleocin Vaginal Ovules (Clindamycin Phosphate Vaginal Suppositories) »

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Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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