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Clindamycin HCL 300 mg Capsule, 21-count

by Advanced Rx Pharmacy of Tennessee, LLC · 21 CAPSULE in 1 BOTTLE (80425-0145-2)
NDC 80425-0145-02
🏷️ FDA NDC (as labeled) 80425-0145-2 billing pads the package segment with a zero
This package
Contains21-count Pack sizes3 compare ↓
Also priced by: Part D plans $0.1397/unit — full pricing hub ↓
Also comes in: 28 capsules 80425-0145-03 30 capsules 80425-0145-01
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

🆔 Identity & classification

FDA NDC (as labeled) 80425-0145-2
Product NDC 80425-0145
11-digit billing NDC 80425014502
NCPDP billing unit EA — each (per item)
RxCUI 284215
UNII T20OQ1YN1W
Application # ANDA065442
SPL Set ID c46cac0a-0c36-02fa-e053-2995a90a772b
Established class (EPC) Lincosamide Antibacterial
Physiologic effect Decreased Sebaceous Gland Activity; Neuromuscular Blockade
Chemical class Lincosamides
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2009-08-26
Route ORAL
Dosage form CAPSULE
Substance CLINDAMYCIN HYDROCHLORIDE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 80425-0145-2 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 80425-0145-02. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Lincosamide Antibacterial class.

Pharmacologic class Lincosamide Antibacterial
Drug family (ATC) Antiinfectives for treatment of acne, Antibiotics, Lincosamides
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerAdvanced Rx Pharmacy of Tennessee, LLC
Application holderAUROBINDO PHARMA LTD
FDA applicationANDA065442 (ANDA)
Labeler code80425
First marketedAug 2009
Product typeHuman Prescription Drug
Portfolio254 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

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 ↗
📗 Our plain-language guide HelloPharmacist
  • 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?
📖 Read our full Clindamycin guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
7
Nutrient depletion considerations

Clindamycin may be associated with lower levels of 7 nutrients — worth a chat with your pharmacist, not a cause for alarm.

🧪 Full Clindamycin nutrient depletion report →
An association is not a deficiency. Educational only — don't start or stop anything without professional guidance.
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

A current SPL was checked, but it does not contain a structured or narrative inactive-ingredient list for this product. This does not mean the product has no inactive ingredients.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 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 systemPer eachPer 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?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Clindamycin Hydrochloride 300 mg 00904-7194-61 Major 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 42571-0252-01 Micro 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 50268-0185-15 AvPAK 50 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 62135-0766-01 Chartwell 100 capsules $0.175 AB Availability likely —
Clindamycin hydrochloride 300 mg 63304-0693-01 Sun 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 65862-0186-01 Aurobindo 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 68084-0244-01 American 100 capsules $0.175 AB Availability likely —
Clindamycin Hydrochloride 300 mg 68462-0144-01 GLENMARK 100 capsules $0.175 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 mg 71335-1412-00 Bryant 16 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 mgthis 80425-0145-02 Advanced 21 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 —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2009
On the market since
Aug 2009
📍
2026
Currently FDA-listed
17 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Clindamycin HCl — the program that covers self-administered drugs. 8 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Clindamycin HCl. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$3.45M
Claims incl. refills
471.3K
Beneficiaries
409.9K
Spend / beneficiary
$8.41
Spend / claim
$7.31
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
80425-0145-01 30 CAPSULE in 1 BOTTLE (80425-0145-1) 2009-08-26 Active
80425-0145-02 You're viewing this 21 CAPSULE in 1 BOTTLE (80425-0145-2) 2023-03-30 Active
80425-0145-03 28 CAPSULE in 1 BOTTLE (80425-0145-3) 2023-09-12 Active

You're viewing the smallest of 3 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 80425-0145-02?
NDC 80425-0145-02 is a 21-count package — 21 capsule in 1 bottle.
What is the difference between NDC 80425-0145-02 and NDC 80425-0145-03?
Both are Clindamycin HCL 300 mg Capsule — the drug itself is identical. NDC 80425-0145-02 is the 21-count package, while NDC 80425-0145-03 is the 28 capsules package.
What NDC number is used to bill for this package of Clindamycin HCL 300 mg Capsule?
Bill NDC 80425-0145-02 — the 11-digit billing format is 80425014502. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

Finished prescription product
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is 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.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 80425-0145-2, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 80425-0145-02, written without dashes as 80425014502. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 80425-0145-02, the first segment (80425) is the labeler code FDA assigned to Advanced Rx Pharmacy of Tennessee, LLC; the middle segment (0145) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (02) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Advanced Rx Pharmacy of Tennessee, LLC. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 2 other package presentations of this same product, including 28 capsules (80425-0145-03), 30 capsules (80425-0145-01). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Advanced Rx Pharmacy of Tennessee, LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📋 Description
🚨 Boxed Warning 215 words ▾

Boxed Warning WARNING Clostridium 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 ~1 min read ▾

Indications and Usage Section INDICATIONS AND USAGE Clindamycin hydrochloride capsules are indicated in the treatment of serious infections caused by susceptible anaerobic bacteria. Clindamycin hydrochloride capsules are 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 and other antibacterial drugs, clindamycin hydrochloride 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 204 words ▾

Dosage and Administration Section 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 clindamycin injection. 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 19 words ▾

Contraindications Clindamycin hydrochloride capsules are contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin.

⚠️ Warnings ~1 min read ▾

Warnings See BOXED WARNING Clostridium difficile Associated Diarrhea Clostridium 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.

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 ~1 min read ▾

Adverse Reactions Section ADVERSE REACTIONS The following reactions have been reported with the use of clindamycin. Infections and Infestations: Clostridium 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: Although no direct relationship of clindamycin to renal damage has been established, renal dysfunc­tion as evidenced by azotemia, oliguria, and/or proteinuria has been observed.

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.

🆘 Overdosage 48 words ▾

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 ~3 min read ▾

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 2.5 mcg/mL was reached in 45 minutes; serum concentrations averaged 1.51 mcg/mL at 3 hours and 0.7 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 Impairment Serum half-life of clindamycin is increased slightly in patients with markedly reduced renal function. Hemodialysis and peritoneal dialysis are not effective in removing clindamycin from the serum. Elderly 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 function1. 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 occurs in some isolates of macrolide-resistant bacteria.

Macrolide-resistant isolates of staphylococci and b…

📦 How Supplied / Storage and Handling 92 words ▾

How Supplied/Storage and Handling Clindamycin Hydrochloride Capsules USP, 300 mg are light blue opaque/light blue opaque size ‘0’ hard gelatin capsule filled with white to off-white powder and imprinted with ‘C’ on light blue opaque cap and ‘40’ on light blue opaque body with black ink. Bottles of 30: NDC 80425-0145-01 Bottles of 21: NDC 80425-0145-02 Bottles of 28: NDC 80425-0145-03 Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Pharmacist: Dispense in a tight container with child-resistant closure.

📋 Description 118 words ▾

Description Clindamycin hydrochloride 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. 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.

The structural formula is represented below: Clindamycin hydrochloride capsules, USP contain clindamycin hydro­chloride USP equivalent to 150 mg or 300 mg of clindamycin. Each capsule also contains the following inactive ingredients: lactose monohydrate, corn starch, talc, and magnesium stearate. The empty hard gelatin capsule shell consists of FD&C Blue #1, titanium dioxide, gelatin, and sodium lauryl sulphate.

In addition 150 mg also contains yellow iron oxide. The capsules are printed with edible ink containing black iron oxide and shellac. Structure

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.