clindesse
Pharmaranks rates Clindesse 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Clindesse (Clindamycin Phosphate) is a lincosamide antibacterial used to treat Acne Vulgaris, Actinomycetales Infections, Bacteroides Infections, Pneumocystis Pneumonia.
Clindamycin Phosphate · by Padagis US
Available as a generic: Clindamycin Phosphate
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Clindamycin Phosphate
- Drug class
- Lincosamide Antibacterial
- Form
- Topical
- Strength
- Clindamycin Phosphate EQ 2% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Padagis US
- Half-life
- about 2.4 hours (how long it stays in your system)
- What the pharmacy pays
- ~$0.18 per gm — not your price
- FDA application
- NDA050793
What is Clindesse?
From the FDA label:Clindamycin phosphate, a lincosamide, is a water soluble ester of the semi-synthetic antibiotic produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent antibiotic lincomycin. The chemical name for clindamycin phosphate is methyl 7-chloro- 6,7,8-trideoxy-6-(1-methyl- trans - 4-propyl-L-2-pyrrolidinecarboxamido)-1-thio-L- threo-(alpha)-D-galacto- octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C 18 H 34 CIN 2 O 8 PS. The structural formula is represented below: Clindesse is a semi-solid, white cream, which contains clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin base per gram. The cream also contains edetate disodium, glycerol monoisostearate, lecithin, methylparaben, microcrystalline wax, mineral oil, polyglyceryl-3-oleate, propylparaben, purified water, silicon dioxide and sorbitol solution. Clindesse does not comply with the pH test of the USP monograph for clindamycin phosphate vaginal cream. Structural Formula
How to use
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
Side effects
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 with a single dose of Clindesse, 1.6% of the patients discontinued therapy due to adverse reactions. Adverse reactions occurred in 126 of 368 patients (34%) treated with Clindesse and in 32 of 85 patients (38%) treated…
Warnings
Important safety information
Clostridioides difficile -Associated Diarrhea: Discontinue and evaluate if diarrhea occurs ( 5.1 ) • Use with Condoms and Vaginal Contraceptive Diaphragms: The use of barrier contraceptives (condoms or vaginal contraceptive diaphragms) is not recommended concurrently or for 5 days following treatment. Condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases during this time period ( 5.2 , 8.3 ) 5.1 Clostridioides difficile -Associated Diarrhea (CDAD) Clostridioides difficile -associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile . C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibiotic use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibiotic treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated [see Adverse Reactions ( 6.2 )] . 5.2 Use with Condoms and Vaginal Contraceptive Diaphragms This cream contains mineral oil that may weaken latex or rubber products such as condoms or vaginal contraceptive diaphragms. Therefore, the use of such barrier contraceptives is not recommended concurrently or for 5 days following treatment with Clindesse. During this time period, condoms may not be reliable for preventing pregnancy or for protecting against transmission of HIV and other sexually transmitted diseases [see Use in Specific Populations ( 8.3 )] .
Who should not take Clindesse
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.
Overdose — what happens if you take too much
Vaginally applied clindamycin phosphate vaginal cream 2% could be absorbed in sufficient amounts to produce systemic effects [see Warnings and Precautions (5.1) and Adverse Reactions ( 6.2 )] .
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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.
How long does Clindamycin Phosphate stay in your body?
The elimination half-life of clindamycin phosphate is about 2.4 hours — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. The label gives an average biological (elimination) half-life of 2.4 hours for oral clindamycin hydrochloride, the active form. It runs slightly longer in older adults (about 4.0 hours, range 3.4–5.1, vs 3.2 hours, range 2.1–4.2, in younger adults) and is increased slightly in people with markedly reduced kidney or liver function. Clindamycin palmitate (oral pediatric solution) and clindamycin phosphate (injection) are inactive prodrugs that are hydrolyzed in the body to this same active clindamycin. Half-life reflects how fast the drug leaves the blood, not how long a drug test can detect it.
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: CLEOCIN HYDROCHLORIDE (clindamycin hydrochloride) capsule — FDA label, DailyMed.
Drug class
How this class works, per Clindamycin - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
- acne vulgaris
- actinomycetales infections
- bacteroides infections
- pneumocystis pneumonia
- staphylococcal infections
- streptococcal infections
See how Clindesse ranks — best-rated lincosamide antibacterial for:
Dosage forms
Topical
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
Compare alternatives
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Frequently asked questions
- What does Clindesse treat?
- Clindesse (Clindamycin Phosphate) may be used to treat acne vulgaris, actinomycetales infections, bacteroides infections, pneumocystis pneumonia, staphylococcal infections, streptococcal infections, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Clindesse work?
- Clindesse is a lincosamide antibacterial. Lincosamides such as clindamycin attach to the bacterial ribosome, the cell's protein-building machine, and stop it from linking amino acids together. Because the bacteria can no longer make the proteins they need, their growth is halted or, depending on the organism and dose, they are killed.
- How is Clindesse rated?
- pharmaranks gives Clindesse a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Clindesse cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $0.18 per gm, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Clindesse?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Clindesse. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Clindesse?
- Clindesse is marketed by Padagis US. You can see Padagis US's full profile, rating, and other products on pharmaranks.
- Is Clindesse a brand-name or generic drug?
- Clindesse is a brand-name product with the active ingredient Clindamycin Phosphate. Lower-cost generic equivalents containing Clindamycin Phosphate are available — ask your pharmacist.
- Is Clindesse available over the counter?
- No. Clindesse is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Clindesse come in?
- Clindesse is currently marketed as topical, per the FDA's National Drug Code Directory.
- What class of drug is Clindesse?
- Clindesse is classified as lincosamide antibacterial, per the FDA's Established Pharmacologic Class.
- Is Clindesse FDA-registered?
- Clindesse is on record with the U.S. FDA under application number NDA050793. You can verify this on its official FDA label.
- Has Clindesse been recalled by the FDA?
- Clindesse has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Clindesse safe?
- There's no single safe-or-not verdict. pharmaranks gives Clindesse a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Clindesse?
- Clindesse's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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clindesse
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