cleocin hydrochloride
Pharmaranks rates Cleocin Hydrochloride 3.2/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Cleocin Hydrochloride (Clindamycin Hydrochloride) is a lincosamide antibacterial used to treat Acne Vulgaris, Actinomycetales Infections, Bacteroides Infections, Pneumocystis Pneumonia.
Clindamycin Hydrochloride · by Pfizer
Available as a generic: Clindamycin Hydrochloride
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 Hydrochloride
- Drug class
- Lincosamide Antibacterial
- Form
- Capsule
- Strength
- Clindamycin Hydrochloride EQ 150MG Base · Clindamycin Hydrochloride EQ 300MG Base · Clindamycin Hydrochloride EQ 75MG 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
- NDA050162
- FDA boxed warning
- Yes — see the boxed warning
What is Cleocin Hydrochloride?
From the FDA label:Clindamycin hydrochloride is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibacterial drug produced by a 7(S)-chloro-substitution of the 7(R)-hydroxyl group of the parent compound lincomycin. Clindamycin hydrochloride capsules, USP contain clindamycin hydrochloride equivalent to 150 mg or 300 mg of clindamycin. Inactive ingredients: 150 mg – corn starch, FD & C blue no. 1, FD & C yellow no. 5, gelatin, lactose, magnesium stearate, talc and titanium dioxide; 300 mg – corn starch, FD & C blue no. 1, gelatin, lactose, magnesium stearate, talc, and titanium dioxide. The structural formula is represented below: The chemical name for clindamycin hydrochloride 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 monohydrochloride. Chemical Structure
How to use
If significant diarrhea occurs during therapy, this antibacterial drug should be discontinued (see BOXED WARNING ). Administer clindamycin hydrochloride capsules with a full glass of water (6 to 8 ounces, approximately 200 to 250 mL) and at least 30 minutes before lying down to reduce the potential for esophageal irritation (see ADVERSE REACTIONS ). Adults: Serious infections - 150 to 300 mg every 6 hours. More severe infections - 300 to 450 mg every 6 hours. Pediatric Patients (who are able to swallow capsules) : Serious infections - 8 to 16 mg/kg/day (4 to 8 mg/lb/day) divided into three or four equal doses. More severe infections - 16 to 20 mg/kg/day (8 to 10 mg/lb/day) divided into three or four equal doses. Clindamycin should be dosed based on total body weight regardless of obesity. Clindamycin hydrochloride capsules are not suitable for pediatric patients who are unable to swallow them whole. The capsules do not provide exact mg/kg doses therefore it may be necessary to use the clindamycin palmitate oral solution in some cases. Serious infections due to anaerobic bacteria are usually treated with CLEOCIN PHOSPHATE ® Sterile Solution. However, in clinically appropriate circumstances, the physician may elect to initiate treatment or continue treatment with clindamycin hydrochloride capsules, USP. In cases of β-hemolytic streptococcal infections, treatment should continue…
Side effects
The following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, nausea, vomiting, and diarrhea (see BOXED WARNING ). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ). Esophagitis and esophageal ulcer have been reported, particularly when taken in a lying position or with a small amount of water. An unpleasant or metallic taste has been reported after oral administration. Hypersensitivity Reactions: Generalized mild to moderate morbilliform-like (maculopapular) skin rashes are the most frequently reported adverse reactions. Vesiculobullous rashes, as well as urticaria, have been observed during drug therapy. Severe skin reactions such as toxic epidermal necrolysis, some with fatal outcome, have been reported (see WARNINGS ). Cases of acute generalized exanthematous pustulosis (AGEP), erythema multiforme, some resembling Stevens-Johnson syndrome, anaphylactic shock, anaphylactic reaction, acute myocardial ischemia with or without myocardial infarction occurring as part of an allergic reaction, cutaneous vasculitis, symmetrical drug-related intertriginous and flexural exanthema, and hypersensitivity have also been reported. Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and…
FDA Boxed Warning (the FDA’s most serious warning)
Boxed (black-box) warning — from the FDA label
Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin HCl 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 . Because clindamycin HCl therapy has been associated with severe colitis which may end fatally, it should be reserved for serious infections where less toxic antimicrobial agents are inappropriate, as described in the INDICATIONS AND USAGE section. It should not be used in patients with nonbacterial infections such as most upper respiratory tract infections. 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 antibacterial drug 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 antibacterial drug use not directed against C . difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.
Warnings
Important safety information
See BOXED WARNING Clostridioides difficile- Associated Diarrhea Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin HCl, 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 antibacterial drug 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 antibacterial drug use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial drug treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated. Anaphylactic and Severe Hypersensitivity Reactions Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS ). Severe hypersensitivity reactions, including acute myocardial ischemia with or without myocardial infarction, and severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), Stevens-Johnson syndrome (SJS), some with fatal outcome, have been reported (see ADVERSE REACTIONS ). In case of such an anaphylactic or severe hypersensitivity reaction, discontinue treatment permanently and institute appropriate therapy. A careful inquiry should be made concerning previous sensitivities to drugs and other allergens. Nephrotoxicity Clindamycin is potentially nephrotoxic and cases with acute kidney injury have been reported. Consider monitoring of renal function particularly in patients with pre-existing renal dysfunction or those taking concomitant nephrotoxic drugs. In case of acute kidney injury, discontinue clindamycin HCl when no other etiology is identified. Usage in Meningitis Since clindamycin does not diffuse adequately into the cerebrospinal fluid, the drug should not be used in the treatment of meningitis.
Who should not take Cleocin Hydrochloride
Clindamycin hydrochloride is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
Overdose — what happens if you take too much
Significant mortality was observed in mice at an intravenous dose of 855 mg/kg and in rats at an oral or subcutaneous dose of approximately 2618 mg/kg. In the mice, convulsions and depression were observed. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum.
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
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. Clindamycin is metabolized predominantly by CYP3A4, and to a lesser extent by CYP3A5, to the major metabolite clindamycin sulfoxide and minor metabolite N-desmethylclindamycin. Therefore, inhibitors of CYP3A4 and CYP3A5 may increase plasma concentrations of clindamycin and inducers of these isoenzymes may reduce plasma concentrations of clindamycin. In the presence of strong CYP3A4 inhibitors, monitor for adverse reactions. In the presence of strong CYP3A4 inducers such as rifampicin, monitor for loss of effectiveness. In vitro studies indicate that clindamycin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2E1 or CYP2D6 and only moderately inhibits CYP3A4.
How long does Clindamycin Hydrochloride stay in your body?
The elimination half-life of clindamycin hydrochloride 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 Hydrochloride ranks — best-rated lincosamide antibacterial for:
Dosage forms
Capsule
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
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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.
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Frequently asked questions
- What does Cleocin Hydrochloride treat?
- Cleocin Hydrochloride (Clindamycin Hydrochloride) 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 Hydrochloride work?
- Cleocin Hydrochloride 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 Hydrochloride rated?
- pharmaranks gives Cleocin Hydrochloride 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 Hydrochloride 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 Hydrochloride?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Cleocin Hydrochloride. 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 Hydrochloride?
- Cleocin Hydrochloride is marketed by Pfizer. You can see Pfizer's full profile, rating, and other products on pharmaranks.
- Is Cleocin Hydrochloride a brand-name or generic drug?
- Cleocin Hydrochloride is a brand-name product with the active ingredient Clindamycin Hydrochloride. Lower-cost generic equivalents containing Clindamycin Hydrochloride are available — ask your pharmacist.
- Is Cleocin Hydrochloride available over the counter?
- No. Cleocin Hydrochloride 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 Hydrochloride come in?
- Cleocin Hydrochloride is currently marketed as capsule, per the FDA's National Drug Code Directory.
- What class of drug is Cleocin Hydrochloride?
- Cleocin Hydrochloride is classified as lincosamide antibacterial, per the FDA's Established Pharmacologic Class.
- Is Cleocin Hydrochloride FDA-registered?
- Cleocin Hydrochloride is on record with the U.S. FDA under application number NDA050162. You can verify this on its official FDA label.
- Has Cleocin Hydrochloride been recalled by the FDA?
- Cleocin Hydrochloride 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 Hydrochloride safe?
- There's no single safe-or-not verdict. pharmaranks gives Cleocin Hydrochloride 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 Hydrochloride?
- Cleocin Hydrochloride's side effects are taken directly from its FDA label. From the label: The following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, nausea, vomiting, and diarrhea (see BOXED WARNING ).… 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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