Clindesse 100 mg/5g
clindamycin phosphate · CREAM · Padagis Israel Pharmaceuticals Ltd
Clindesse is a vaginal cream containing the antibiotic clindamycin, used to treat bacterial vaginosis in women. It is applied directly into the vagina as a single-dose treatment.
Key Facts
- Brand Name
- Clindesse
- Generic Name
- clindamycin phosphate
- NDC Code (Product)
45802-042- Manufacturer
- Padagis Israel Pharmaceuticals Ltd
- Strength
- 100 mg/5g
- Dosage Form
- CREAM
- Route
- VAGINAL
- Marketing Status
- Application #
- NDA050793
- Marketing Start
- 07/03/2015
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS AND USAGE Clindesse is a lincosamide antibacterial indicated for the treatment of bacterial vaginosis in non-pregnant women ( 1.1 ) 1.1 Treatment of Bacterial Vaginosis Clindesse is indicated for the treatment of bacterial vaginosis (formerly referred to as Haemophilus vaginitis, Gardnerella vaginitis, nonspecific vaginitis, Corynebacterium vaginitis, or anaerobic vaginosis) in non-pregnant women.
Dosage & Administration
2 DOSAGE AND ADMINISTRATION The recommended dose is the complete contents of a single pre-filled applicator containing 5 g of Clindesse cream administered once intravaginally at any time of the day. Not for ophthalmic, dermal, or oral use. • For intravaginal use only • A single applicator of cream administered once intravaginally at any time of the day ( 2 ) • Not for ophthalmic, dermal, or oral use
Contraindications
4 CONTRAINDICATIONS • History of hypersensitivity to clindamycin or other lincosamides ( 4.1 ) • History of regional enteritis, ulcerative colitis, or a history of Clostridioides difficile- associated diarrhea ( 4.2 , 5.1 ) 4.1 Hypersensitivity Clindesse is contraindicated in individuals with a history of hypersensitivity to clindamycin or other lincosamides. Reported reactions to other formulations of clindamycin include rashes, urticaria, erythema multiforme, and anaphylactoid reactions [see Adverse Reactions ( 6.2 )] . 4.2 History of Bowel Disease Clindesse is contraindicated in patients with regional enteritis, ulcerative colitis, or a history of Clostridioides difficile -associated diarrhea.
Drug Interactions
7 DRUG INTERACTIONS No formal drug interaction studies have been conducted for Clindesse. Neuromuscular blocking agents: Enhanced action of neuromuscular blocking agents can occur; use with caution ( 7.1 ) 7.1 Neuromuscular Blocking Agents Orally or intravenously administered clindamycin has 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.
Adverse Reactions
6 ADVERSE REACTIONS Most common adverse reactions reported in ≥2% of patients and at a higher rate in the Clindesse group than in the placebo group are vaginosis fungal (14%), headache (7%), back pain (5%), constipation (2%), and urinary tract infection (2%) ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Padagis ® at 1-866-634-9120 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 in 368 patients. Clindesse 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 wi…
Frequently Asked Questions
What is Clindesse used for?
Clindesse is a vaginal cream containing the antibiotic clindamycin, used to treat bacterial vaginosis in women. It is applied directly into the vagina as a single-dose treatment.
Is Clindesse a controlled substance?
Clindesse is not classified as a controlled substance by the DEA.
What is the generic name for Clindesse?
The generic name for Clindesse is clindamycin phosphate. There are 12 other brand versions of clindamycin phosphate.
What is the NDC code for Clindesse 100 mg/5g?
The NDC (National Drug Code) for Clindesse 100 mg/5g is 45802-042, listed by Padagis Israel Pharmaceuticals Ltd.
Other Clindamycin Brands
See all →- Clindamycin Phosphate and Benzoyl Peroxide25 mg/g72162-2077
- Clindamycin Phoaphate Topical Solution USP, 1%10 mg/mL21922-002
- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE50 mg/g21922-022
- Clindamycin Phosphate10 mg/g21922-027
- CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE25 mg/g21922-074
- Clindamycin phosphate600 mg/50mL43066-993
- Clindamycin Phosphate and Benzoyl Peroxide37.5 mg/g45802-383
- Cleocin Phosphate150 mg/mL0009-0870
- Clindamycin Phosphate10 mg/mL50090-2611
- Cleocin Phosphate150 mg/mL0009-5095
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)