CLINDAMYCIN HYDROCHLORIDE 300 mg Capsule, 21-count
Other active recalls for Clindamycin Hydrochloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
Where does this data come from?
🏷️ RxNorm drug class
This medicine belongs to the Lincosamide Antibacterial class.
Where does this data come from?
🏭 Manufacturer & labeler
Where does this data come from?
🩺 Clinical
Clindamycin is used to treat certain types of bacterial infections. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria. Antibiotics such as clindamycin will not work for colds, flu, or other viral infections. Using antibiotics when they are not needed increases your risk of getting an infection later that resists antibiotic treatment.
Read the full MedlinePlus article ↗- Clindamycin is used for serious bacterial infections — things like deep skin infections, lung abscesses, pelvic infections, and abdominal infections. It's often chosen when penicil...
- What kinds of infections is clindamycin actually used for?
- You don't have to eat with it — food doesn't meaningfully change how it's absorbed. But the most important thing is to take each capsule with a full, large glass of water, and stay...
- Do I need to take clindamycin with food?
Patient education
Supplement & herbal interactions
Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.
Where does this data come from?
Ask a licensed pharmacist directly — free, answered by our team.
💊 What it looks like
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.
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UNII 3K9958V90M
A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
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UNII 5138Q19F1X
Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
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UNII 8PJ61P6TS3
Butyl alcohol is a clear liquid organic solvent derived from petroleum or natural sources. In medicines, it helps dissolve active ingredients and serves as a solvent in liquid formulations and some topical products.
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UNII H3R47K3TBD
FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
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UNII 2G86QN327L
Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
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UNII ND2M416302
Isopropyl alcohol is a clear liquid solvent derived from petroleum. In medicines, it dissolves active ingredients and other components, helps the product flow smoothly, and aids in sterilization during manufacturing.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
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UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
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UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
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UNII O8232NY3SJ
A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
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UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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UNII 15FIX9V2JP
Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.
14 inactive ingredients listed in the exact product block matched to this NDC.
Where does this data come from?
ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
Why might an inactive ingredient be missing?
Can inactive ingredients matter?
💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.1397 | $2.93 / 21 capsules |
Where does this data come from?
🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Clindamycin Hydrochloride 300 mg 00904-7194-61 | Major | 100 capsules | $0.168 | AB | Availability likely | — |
| Clindamycin Hydrochloride 300 mg 42571-0252-01 | Micro | 100 capsules | $0.168 | AB | Availability likely | — |
| Clindamycin Hydrochloride 300 mg 50268-0185-15 | AvPAK | 50 capsules | $0.168 | AB | Availability likely | — |
| Clindamycin Hydrochloride 300 mg 62135-0766-01 | Chartwell | 100 capsules | $0.168 | AB | Availability likely | — |
| Clindamycin hydrochloride 300 mg 63304-0693-01 | Sun | 100 capsules | $0.168 | AB | Availability likely | — |
| Clindamycin Hydrochloride 300 mg 65862-0186-01 | Aurobindo | 100 capsules | $0.168 | AB | Availability likely | — |
| Clindamycin Hydrochloride 300 mg 68084-0244-01 | American | 100 capsules | $0.168 | AB | Availability likely | — |
| Clindamycin Hydrochloride 300 mg 68462-0144-01 | GLENMARK | 100 capsules | $0.168 | AB | Availability likely | — |
| clindamycin hydrochloride 300 mg 59762-5010-01 | Mylan | 16 capsules | $0.176 | AB | Discontinued | — |
| Cleocin Hydrochloride 300 mg 00009-0395-14 | Pharmacia | 100 capsules | — | AB | FDA listed | — |
| Clindamycin hydrochloride 300 mg 50090-0967-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 50090-3907-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 50090-4575-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 50090-7354-00 | A-S | 30 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 50090-7659-00 | A-S | 28 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 50090-7669-00 | A-S | 28 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 51655-0317-51 | Northwind | 40 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 55700-0761-21 | Quality | 21 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 60760-0827-10 | St. | 10 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 63187-0127-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Clindamycin hydrochloride 300 mg 63187-0141-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 67046-2073-03 | Coupler | 30 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 67296-0940-02 | Redpharm | 28 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 67296-1749-03 | RedPharm | 40 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 67296-2149-01 | Redpharm | 21 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 68071-2346-09 | NuCare | 9 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 68071-3577-01 | NuCare | 14 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 68071-3983-09 | NuCare | 9 capsules | — | AB | FDA listed | — |
| Clindamycin hydrochloride 300 mg 68071-4257-01 | NuCare | 14 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 68071-5174-02 | NuCare | 20 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 68788-8685-01 | Preferred | 14 capsules | — | AB | FDA listed | — |
| clindamycin hydrochloride 300 mg 69238-2121-03 | Amneal | 10 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 70518-2153-00 | REMEDYREPACK | 30 capsules | — | AB | Discontinued | — |
| Clindamycin Hydrochloride 300 mg 70518-3772-00 | REMEDYREPACK | 30 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 71205-0444-20 | Proficient | 20 capsules | — | AB | FDA listed | — |
| Clindamycin hydrochloride 300 mg 71335-0320-00 | Bryant | 16 capsules | — | AB | Discontinued | — |
| Clindamycin Hydrochloride 300 mgthis 71335-1412-04 | Bryant | 21 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 71335-2432-00 | Bryant | 16 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 71335-2677-01 | Bryant | 10 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 72189-0189-30 | DIRECT | 30 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 72789-0167-09 | PD-Rx | 9 capsules | — | AB | FDA listed | — |
| Clindamycin hydrochloride 300 mg 72789-0207-09 | PD-Rx | 9 capsules | — | AB | FDA listed | — |
| Clindamycin hydrochloride 300 mg 76420-0202-12 | Asclemed | 12 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 76420-0614-01 | Asclemed | 100 capsules | — | AB | FDA listed | — |
| Clindamycin HCL 300 mg 80425-0103-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Clindamycin HCL 300 mg 80425-0145-01 | Advanced | 30 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 80425-0416-01 | Advanced | 21 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 82804-0278-21 | Proficient | 21 capsules | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 83939-0019-01 | VERITYRX, | 1 capsule | — | AB | FDA listed | — |
| Clindamycin Hydrochloride 300 mg 85766-0028-01 | Sportpharm | 100 capsules | — | AB | FDA listed | — |
| Clindamycin hydrochloride 300 mg 85534-0088-00 | HAWAII | 8 capsules | — | AB | FDA listed | — |
Where does this data come from?
⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
Where does this data come from?
🔬 Reported adverse events (FAERS)
Top reported reactions
Age at onset
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 71335-1412-00 | 16 CAPSULE in 1 BOTTLE (71335-1412-0) | 2021-08-30 | Active |
| 71335-1412-01 | 30 CAPSULE in 1 BOTTLE (71335-1412-1) | 2019-11-18 | Active |
| 71335-1412-02 | 20 CAPSULE in 1 BOTTLE (71335-1412-2) | 2020-01-14 | Active |
| 71335-1412-03 | 40 CAPSULE in 1 BOTTLE (71335-1412-3) | 2019-12-24 | Active |
| 71335-1412-04 You're viewing this | 21 CAPSULE in 1 BOTTLE (71335-1412-4) | 2019-12-16 | Active |
| 71335-1412-05 | 28 CAPSULE in 1 BOTTLE (71335-1412-5) | 2020-01-23 | Active |
| 71335-1412-06 | 12 CAPSULE in 1 BOTTLE (71335-1412-6) | 2022-06-30 | Active |
| 71335-1412-07 | 120 CAPSULE in 1 BOTTLE (71335-1412-7) | 2019-12-12 | Active |
| 71335-1412-08 | 14 CAPSULE in 1 BOTTLE (71335-1412-8) | 2019-12-19 | Active |
| 71335-1412-09 | 45 CAPSULE in 1 BOTTLE (71335-1412-9) | 2020-03-18 | Active |
You're viewing one of 10 pack sizes for this product.
Pack size FAQ
What quantity is in NDC 71335-1412-04?
What is the difference between NDC 71335-1412-04 and NDC 71335-1412-06?
What NDC number is used to bill for this package of CLINDAMYCIN HYDROCHLORIDE 300 mg Capsule?
🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
Questions about this listing
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📄 Full prescribing information FDA SPL
🚨 Boxed Warning ▾
WARNING Clostridioides difficile- associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride 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 hydrochloride 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 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.
🎯 Indications and Usage ▾
INDICATIONS AND USAGE Clindamycin is indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin is also indicated in the treatment of serious infections due to susceptible strains of streptococci, pneumococci, and staphylococci. Its use should be reserved for penicillin-allergic patients or other patients for whom, in the judgment of the physician, a penicillin is inappropriate.
Because of the risk of colitis, as described in the BOXED WARNING , before selecting clindamycin, the physician should consider the nature of the infection and the suitability of less toxic alternatives (e.g., erythromycin). Anaerobes: Serious respiratory tract infections such as empyema, anaerobic pneumonitis, and lung abscess; serious skin and soft tissue infections; septicemia; intra-abdominal infections such as peritonitis and intra-abdominal abscess (typically resulting from anaerobic organisms resident in the normal gastrointestinal tract); infections of the female pelvis and genital tract such as endometritis, nongonococcal tubo-ovarian abscess, pelvic cellulitis, and postsurgical vaginal cuff infection.
Streptococci: Serious respiratory tract infections; serious skin and soft tissue infections. Staphylococci: Serious respiratory tract infections; serious skin and soft tissue infections. Pneumococci: Serious respiratory tract infections.
Bacteriologic studies should be performed to determine the causative organisms and their susceptibility to clindamycin. To reduce the development of drug-resistant bacteria and maintain the effectiveness of clindamycin hydrochloride capsules USP and other antibacterial drugs, clindamycin hydrochloride capsules USP should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. When culture and susceptibility information are available, they should be considered in selecting or modifying antibacterial therapy.
In the absence of such data, local epidemiology and susceptibility patterns may contribute to the empiric selection of therapy.
⏱️ Dosage and Administration ▾
DOSAGE AND ADMINISTRATION If significant diarrhea occurs during therapy, this antibiotic should be discontinued (see BOXED WARNING ). Adults: Serious infections - 150 to 300 mg every 6 hours. More severe infections - 300 to 450 mg every 6 hours.
Pediatric Patients (for children 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.
To avoid the possibility of esophageal irritation, clindamycin hydrochloride capsules should be taken with a full glass of water. Clindamycin hydrochloride Capsules are not suitable for children 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. In cases of β-hemolytic streptococcal infections, treatment should continue for at least 10 days.
⛔ Contraindications ▾
CONTRAINDICATIONS Clindamycin hydrochloride is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.
⚠️ Warnings ▾
WARNINGS See BOXED WARNING Clostridioides difficile- Associated Diarrhea Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including clindamycin hydrochloride, 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. Anaphylactic and Severe Hypersensitivity Reactions Anaphylactic shock and anaphylactic reactions have been reported (see ADVERSE REACTIONS ).
Severe hypersensitivity reactions, including severe skin reactions such as toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and 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 hydrochloride 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.
🤒 Adverse Reactions ▾
ADVERSE REACTIONS The following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridioides difficile colitis Gastrointestinal: Abdominal pain, pseudomembranous colitis, esophagitis, nausea, vomiting, and diarrhea (see BOXED WARNING ). The onset of pseudomembranous colitis symptoms may occur during or after antibacterial treatment (see WARNINGS ).
Esophageal ulcer has been reported. 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 and hypersensitivity have also been reported.
Skin and Mucous Membranes: Pruritus, vaginitis, angioedema and rare instances of exfoliative dermatitis have been reported. (See Hypersensitivity Reactions.) Liver: Jaundice and abnormalities in liver function tests have been observed during clindamycin therapy. Renal: Acute kidney injury (See WARNINGS ).
Hematopoietic: Transient neutropenia (leukopenia) and eosinophilia have been reported. Reports of agranulocytosis and thrombocytopenia have been made. No direct etiologic relationship to concurrent clindamycin therapy could be made in any of the foregoing.
Immune System: Drug reaction with eosinophilia and systemic symptoms (DRESS) cases have been reported. Musculoskeletal: Cases of polyarthritis have been reported. To report SUSPECTED ADVERSE REACTIONS, contact Micro Labs USA Inc. at 1-855-839-8195 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
🔄 Drug Interactions ▾
Drug 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.
🤰 Pregnancy ▾
Pregnancy Teratogenic effects In clinical trials with pregnant women, the systemic administration of clindamycin during the second and third trimesters, has not been associated with an increased frequency of congenital abnormalities. Clindamycin should be used during the first trimester of pregnancy only if clearly needed. There are no adequate and well-controlled studies in pregnant women during the first trimester of pregnancy.
Because animal reproduction studies are not always predictive of the human response, this drug should be used during pregnancy only if clearly needed. Reproduction studies performed in rats and mice using oral doses of clindamycin up to 600 mg/kg/day (3.2 and 1.6 times the highest recommended adult human dose based on mg/m 2 , respectively) or subcutaneous doses of clindamycin up to 250 mg/kg/day (1.3 and 0.7 times the highest recommended adult human dose based on mg/m 2 , respectively) revealed no evidence of teratogenicity.
🧒 Pediatric Use ▾
Pediatric Use When clindamycin hydrochloride is administered to the pediatric population (birth to 16 years), appropriate monitoring of organ system functions is desirable.
🧓 Geriatric Use ▾
Geriatric Use Clinical studies of clindamycin did not include sufficient numbers of patients age 65 and over to determine whether they respond differently from younger patients. However, other reported clinical experience indicates that antibiotic-associated colitis and diarrhea (due to Clostridioides difficile ) seen in association with most antibiotics occur more frequently in the elderly (>60 years) and may be more severe. These patients should be carefully monitored for the development of diarrhea.
Pharmacokinetic studies with clindamycin have shown no clinically important differences between young and elderly subjects with normal hepatic function and normal (age-adjusted) renal function after oral or intravenous administration.
🆘 Overdosage ▾
OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
CLINICAL PHARMACOLOGY Human Pharmacology Absorption Pharmacokinetic studies with a 150 mg oral dose of clindamycin hydrochloride in 24 normal adult volunteers showed that clindamycin was rapidly absorbed after oral administration. An average peak serum concentration of 2.50 mcg/mL was reached in 45 minutes; serum concentrations averaged 1.51 mcg/mL at 3 hours and 0.70 mcg/mL at 6 hours. Absorption of an oral dose is virtually complete (90%), and the concomitant administration of food does not appreciably modify the serum concentrations; serum concentrations have been uniform and predictable from person to person and dose to dose.
Pharmacokinetic studies following multiple doses of clindamycin hydrochloride for up to 14 days show no evidence of accumulation or altered metabolism of drug. Doses of up to 2 grams of clindamycin per day for 14 days have been well tolerated by healthy volunteers, except that the incidence of gastrointestinal side effects is greater with the higher doses. Distribution Concentrations of clindamycin in the serum increased linearly with increased dose.
Serum concentrations exceed the MIC (minimum inhibitory concentration) for most indicated organisms for at least six hours following administration of the usually recommended doses. Clindamycin is widely distributed in body fluids and tissues (including bones). No significant concentrations of clindamycin are attained in the cerebrospinal fluid, even in the presence of inflamed meninges.
Metabolism In vitro studies in human liver and intestinal microsomes indicated that clindamycin is predominantly metabolized by Cytochrome P450 3A4 (CYP3A4), with minor contribution from CYP3A5, to form clindamycin sulfoxide and a minor metabolite, N-desmethylclindamycin. Excretion The average biological half-life is 2.4 hours. Approximately 10% of the bioactivity is excreted in the urine and 3.6% in the feces; the remainder is excreted as bioinactive metabolites.
Specific Populations Patients with Renal/Hepatic Impairment The elimination half-life of clindamycin is increased slightly in patients with markedly reduced renal or hepatic function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Dosage schedules do not need to be modified in patients with renal disease.
Geriatric Patients Pharmacokinetic studies in elderly volunteers (61 to 79 years) and younger adults (18 to 39 years) indicate that age alone does not alter clindamycin pharmacokinetics (clearance, elimination half-life, volume of distribution, and area under the serum concentration-time curve) after IV administration of clindamycin phosphate. After oral administration of clindamycin hydrochloride, the average elimination half-life is increased to approximately 4 hours (range 3.4 to 5.1 h) in the elderly compared to 3.2 hours (range 2.1 to 4.2 h) in younger adults.
The extent of absorption, however, is not different between age groups and no dosage alteration is necessary for the elderly with normal hepatic function and normal (age-adjusted) renal function 1 . Obese Pediatric Patients Aged 2 to Less than 18 Years and Obese Adults Aged 18 to 20 Years An analysis of pharmacokinetic data in obese pediatric patients aged 2 to less than 18 years and obese adults aged 18 to 20 years demonstrated that clindamycin clearance and volume of distribution, normalized by total body weight, are comparable regardless of obesity.
Microbiology Mechanism of Action Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic. Resistance Resistance to clindamycin is most often caused by modification of specific bases of the 23S ribosomal RNA.
Cross-resistance between clindamycin and lincomycin is complete. Because the binding sites for these antibacterial drugs overlap, cross-resistance is sometimes observed among lincosamides, macrolides and streptogramin B. Macrolide-inducible resistance to clindamycin o…
📦 How Supplied / Storage and Handling ▾
HOW SUPPLIED Clindamycin hydrochloride capsules USP 300 mg-Light blue opaque (body)/ light blue opaque (cap), size 0 hard gelatin capsule printed with “M” on cap and “42” on body filled with white to off white granular powder. NDC: 71335-1412-1: 30 Capsules in a BOTTLE NDC: 71335-1412-2: 20 Capsules in a BOTTLE NDC: 71335-1412-3: 40 Capsules in a BOTTLE NDC: 71335-1412-4: 21 Capsules in a BOTTLE NDC: 71335-1412-5: 28 Capsules in a BOTTLE NDC: 71335-1412-6: 12 Capsules in a BOTTLE NDC: 71335-1412-7: 120 Capsules in a BOTTLE NDC: 71335-1412-8: 14 Capsules in a BOTTLE NDC: 71335-1412-9: 45 Capsules in a BOTTLE NDC: 71335-1412-0: 16 Capsules in a BOTTLE Store at controlled room temperature 20° to 25° C (68° to 77° F) [see USP].
Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504
📋 Description ▾
DESCRIPTION Clindamycin hydrochloride USP is the hydrated hydrochloride salt of clindamycin. Clindamycin is a semisynthetic antibiotic 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 USP equivalent to 75 mg, 150 mg, or 300 mg of clindamycin.
Inactive ingredients: corn starch, lactose monohydrate, magnesium stearate and talc. Composition of empty hard gelatin capsule shells: For 75 mg strength-size ‘3’: FD&C Blue 1, D&C Yellow 10, gelatin and water. For 150 mg Strength-Size ‘2’: titanium dioxide, FD&C Blue 1, D&C Yellow 10, gelatin and water.
For 300 mg Strength-Size ‘0’: FD&C Blue 1, titanium dioxide, gelatin and water. The empty hard gelatin capsules are printed with TekPrint ™ SW-0012 White Ink. Composition of imprinting ink [TekPrint ™ SW-0012 White Ink] utilized for printing on the capsule shell are presented below: Shellac–NF, Dehydrated alcohol–USP, Isopropyl alcohol–USP, Butyl alcohol–NF, Propylene glycol–USP, Strong ammonia solution–NF, Purified water–USP, Potassium hydroxide–NF, Titanium dioxide USP.
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.
💬 Information for Patients ▾
Information for Patients Patients should be counseled that antibacterial drugs, including clindamycin hydrochloride, should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When clindamycin hydrochloride is prescribed to treat a bacterial infection, patients should be told that although it is common to feel better early in the course of therapy, the medication should be taken exactly as directed.
Skipping doses or not completing the full course of therapy may (1) decrease the effectiveness of the immediate treatment and (2) increase the likelihood that bacteria will develop resistance and will not be treatable by clindamycin hydrochloride or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibiotics which usually ends when the antibiotic is discontinued. Sometimes after starting treatment with antibiotics, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibiotic.
If this occurs, patients should contact their physician as soon as possible.