
cleocin
Pharmaranks rates Cleocin 3.2/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cleocin (Clindamycin Phosphate) is a lincosamide antibacterial used to treat Acne Vulgaris, Actinomycetales Infections, Bacteroides Infections, Pneumocystis Pneumonia.
Clindamycin Phosphate · by Pfizer
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, Suppository
- Strength
- Clindamycin Phosphate EQ 2% Base
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- Manufacturer
- Pfizer
- 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
- NDA050680
What is Cleocin?
From the FDA label:Clindamycin phosphate 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- α− D-galacto -octopyranoside 2-(dihydrogen phosphate). It has a molecular weight of 504.96, and the molecular formula is C 18 H 34 ClN 2 O 8 PS. The structural formula is represented below: Clindamycin phosphate vaginal cream 2%, is a semi-solid, white cream, which contains 2% clindamycin phosphate, USP, at a concentration equivalent to 20 mg clindamycin per gram. The pH of the cream is between 3.0 and 6.0. The cream also contains benzyl alcohol, cetostearyl alcohol, mixed fatty acid esters, mineral oil, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, and stearic acid. Each applicatorful of 5 grams of vaginal cream contains approximately 100 mg of clindamycin phosphate. Chemical Structure
How to use
Cleocin is sold in more than one form (Topical and Suppository), and each is dosed differently. The instructions below come from the FDA label for application NDA050680 — follow the label that came with the product you were actually prescribed.
The recommended dose is one applicatorful of clindamycin phosphate vaginal cream 2%, (5 grams containing approximately 100 mg of clindamycin phosphate) intravaginally, preferably at bedtime, for 3 or 7 consecutive days in non-pregnant patients and for 7 consecutive days in pregnant patients. (See CLINICAL STUDIES .)
Side effects
Clinical trials Non-pregnant Women In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with clindamycin phosphate vaginal cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events. Medical events judged to be related, probably related, possibly related, or of unknown relationship to vaginally administered clindamycin phosphate vaginal cream 2%, were reported for 20.7% of the patients receiving treatment for 3 days and 21.3% of the patients receiving treatment for 7 days. Events occurring in ≥1% of patients receiving clindamycin phosphate vaginal cream 2% are shown in Table 1. TABLE 1 – Events Occurring in ≥1% of Non-pregnant Patients Receiving Clindamycin Phosphate Vaginal Cream 2% Clindamycin Phosphate Vaginal Cream Event 3 Day n=600 7 Day n=1325 Urogenital Vaginal moniliasis 7.7 10.4 Vulvovaginitis 6.0 4.4 Vulvovaginal disorder 3.2 5.3 Trichomonal vaginitis 0 1.3 Body as a Whole Moniliasis (body) 1.3 0.2 Other events occurring in <1% of the clindamycin vaginal cream 2% groups include: Urogenital system: vaginal discharge, metrorrhagia, urinary tract infection, endometriosis, menstrual disorder, vaginitis/vaginal infection, and vaginal pain. Body as a whole: localized abdominal pain, generalized abdominal pain, abdominal cramps, halitosis, headache, bacterial…
Warnings
Important safety information
Pseudomembranous colitis has been reported with nearly all antibacterial agents, including clindamycin, and may range in severity from mild to life-threatening. Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of orally and parenterally administered clindamycin, as well as with topical (dermal and vaginal) formulations of clindamycin. Therefore, it is important to consider this diagnosis in patients who present with diarrhea subsequent to the administration of clindamycin, even when administered by the vaginal route, because approximately 5% of the clindamycin dose is systemically absorbed from the vagina. Treatment with antibacterial agents alters the normal flora of the colon and may permit overgrowth of clostridia. Studies indicate that a toxin produced by Clostridioides difficile is a primary cause of "antibiotic-associated" colitis. After the diagnosis of pseudomembranous colitis has been established, therapeutic measures should be initiated. Mild cases of pseudomembranous colitis usually respond to discontinuation of the drug alone. In moderate to severe cases, consideration should be given to management with fluids and electrolytes, protein supplementation, and treatment with an antibacterial drug clinically effective against Clostridioides difficile colitis. Onset of pseudomembranous colitis symptoms may occur during or after antimicrobial treatment.
Who should not take Cleocin
Clindamycin phosphate vaginal cream 2%, is contraindicated in individuals with a history of hypersensitivity to clindamycin, lincomycin, or any of the components of this vaginal cream. Clindamycin phosphate vaginal cream 2%, is also contraindicated in individuals with a history of regional enteritis, ulcerative colitis, or a history of "antibiotic-associated" colitis.
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 .)
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
Systemic clindamycin has been shown to have 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 Cleocin ranks — best-rated lincosamide antibacterial for:
Dosage forms
Topical and Suppository
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
A same-class option may cost less. See alternatives →
Frequently asked questions
- What does Cleocin treat?
- Cleocin (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 Cleocin work?
- Cleocin 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 Cleocin rated?
- pharmaranks gives Cleocin a composite score of 3.2 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 Cleocin 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 Cleocin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cleocin. 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 Cleocin?
- Cleocin is marketed by Pfizer. You can see Pfizer's full profile, rating, and other products on pharmaranks.
- Is Cleocin a brand-name or generic drug?
- Cleocin is a brand-name product with the active ingredient Clindamycin Phosphate. Lower-cost generic equivalents containing Clindamycin Phosphate are available — ask your pharmacist.
- Is Cleocin available over the counter?
- No. Cleocin 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 Cleocin come in?
- Cleocin is currently marketed as topical and suppository, per the FDA's National Drug Code Directory.
- What class of drug is Cleocin?
- Cleocin is classified as lincosamide antibacterial, per the FDA's Established Pharmacologic Class.
- Is Cleocin FDA-registered?
- Cleocin is on record with the U.S. FDA under application number NDA050680. You can verify this on its official FDA label.
- Has Cleocin been recalled by the FDA?
- Cleocin 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 Cleocin safe?
- There's no single safe-or-not verdict. pharmaranks gives Cleocin a recall-safety score of 64/100, 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 Cleocin?
- Cleocin's side effects are taken directly from its FDA label. From the label: Clinical trials Non-pregnant Women In clinical trials involving non-pregnant women, 1.8% of 600 patients who received treatment with clindamycin phosphate vaginal cream 2% for 3 days and 2.7% of 1325 patients who received treatment for 7 days discontinued therapy due to drug-related adverse events.… 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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cleocin
64/100