Clindesse
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Clindesse
Clindesse Side Effects Center
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 Overview?
A concise overview of the drug for the patient or caregiver from First DataBank.
Clindesse Overview - Patient Information: Side Effects
Infrequently, vaginal discomfort/itching/discharge may occur or worsen. These symptoms may be due to a new vaginal infection (e.g., yeast/fungal infection). Contact your doctor if you notice a change in vaginal discharge or other new vaginal symptoms.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
A very small amount of this medication may be absorbed into your blood and may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of resistant bacteria. This condition may occur during treatment or weeks to months after treatment has stopped. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor immediately if you develop: persistent diarrhea, abdominal or stomach pain/cramping, blood/mucus in your stool.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Read the entire patient information overview for Clindesse (Clindamycin Phosphate)»
What is Prescribing information?
The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.
Clindesse FDA Prescribing Information: Side Effects
(Adverse Reactions)
SIDE EFFECTS
Clinical Study Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described below reflect exposure to Clindesse (clindamycin phosphate) in 368 patients. Clindesse (clindamycin phosphate) was studied in three clinical studies: placebo-controlled (n=85), active-controlled (n=263), and single-arm (n=20). The population was female, aged 18 to 78, who were diagnosed with bacterial vaginosis. Patient demographics in the trials were 51% Caucasian, 36% Black, 10% Hispanic, and 3% Asian, other or unknown. All patients received 100 mg clindamycin phosphate cream intravaginally in a single dose.
Of the 368 women treated with a single dose of Clindesse (clindamycin phosphate) , 1.6% of the patients discontinued therapy due to adverse reactions. Adverse reactions occurred in 126 of 368 patients (34%) treated with Clindesse (clindamycin phosphate) and in 32 of 85 patients (38%) treated with placebo.
Adverse reactions occurring in ≥ 1% of patients receiving Clindesse (clindamycin phosphate) in the three clinical studies are shown in Table 1.
Table 1: Adverse Reactions Occurring in ≥ 1% of Clindesse (clindamycin phosphate) -Treated
Patients and at a Higher Rate than Placebo-Treated Patients
| Adverse Event | Clindesse (clindamycin phosphate) N=368 n (%) |
Placebo N=85 n (%) |
| Vaginosis fungal NOS* | 52 (14) | 7 (8) |
| Headache NOS | 10 (3) | 2 (2) |
| Back pain | 6 (2) | 1 (1) |
| Constipation | 4 (1) | 0 (0) |
| Urinary tract infection NOS | 4 (1) | 0 (0) |
| N = number of patients in intent-to-treat
population n (%) = number and percentage of patients with reported adverse reaction NOS = not otherwise specified * The use of clindamycin may result in the overgrowth of non-susceptible fungal organisms in the vagina and may require antifungal treatment |
||
Other reactions reported by < 1% of those women treated with Clindesse (clindamycin phosphate) include:
Dermatologic: Pruritic rash
Gastrointestinal: Diarrhea, vomiting
General: Fatigue
Immune System: Hypersensitivity
Nervous System: Dizziness
Reproductive System: Dysfunctional uterine bleeding, dysmennorrhea, intermenstrual bleeding, pelvic pain, vaginal burning, vaginal irritation, vulvar erythema<, vulvitis, vulvovaginal discomfort, vulvovaginal dryness, vulvovaginitis
Other Clindamycin Formulations
Clindesse (clindamycin phosphate) affords minimal peak serum levels and systemic exposure (AUCs) of clindamycin compared to an oral or intravenous dose of clindamycin [see CLINICAL PHARMACOLOGY]. Data from well-controlled trials directly comparing clindamycin administered orally to clindamycin administered vaginally are not available.
The following additional adverse reactions and altered laboratory tests have been reported with the oral or parenteral use of clindamycin:
Gastrointestinal: Abdominal pain, esophagitis, nausea, Clostridium difficile-associated diarrhea [see WARNINGS AND PRECAUTIONS]
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, vesiculobullous 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. Cases of erythema multiforme, some resembling Stevens-Johnson syndrome, have been associated with clindamycin. A few cases of anaphylactoid reactions have been reported.
Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy.
Musculoskeletal: Cases 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.
Postmarketing Experience
The following adverse reactions have been identified during postapproval use of Clindesse (clindamycin phosphate) . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Dermatologic: Rash
Gastrointestinal: Hematochezia
Reproductive System: Vaginal erythema, vulvovaginal pruritis, vaginal discharge, vaginal swelling, vaginal bleeding, vaginal pain
Read the entire FDA prescribing information for Clindesse (Clindamycin Phosphate) »
Additional Clindesse Information
Clindesse - User Reviews
Clindesse User Reviews
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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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