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Clindamycin Phosphate 10 mg/mL Solution — NDC 51672-4081-04 package photo

Clindamycin Phosphate 10 mg/mL Solution

by Sun Pharmaceutical Industries, Inc. · 1 BOTTLE, WITH APPLICATOR in 1 CARTON (51672-4081-4) / 60 mL in 1 BOTTLE, WITH APPLICATOR
NDC 51672-4081-04
🏷️ FDA NDC (as labeled) 51672-4081-4 billing pads the package segment with a zero
This package
Contains60 mL in 1 bottle, with applicator Cost per mL$0.1487 NADAC Per package$8.92 / 60 ml Pack sizes2 compare ↓
Also priced by: Medicaid pays $0.3430/unit · Part D plans $0.3076/unit — full pricing hub ↓
Also comes in: 30 mL 51672-4081-03
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

🚨
Active recall for this product.
Class III · Nov 26, 2025 — Failed Impurities/Degradation: Out of Specification results for Total Impurities and for Assay. (SUN PHARMACEUTICAL INDUSTRIES INC) · FDA recall D-0257-2026
Check your lot/expiration against the official notice — look up the recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 51672-4081-4
Product NDC 51672-4081
11-digit billing NDC 51672408104
NCPDP billing unit ML — per mL (volume)
RxCUI 309333
UNII EH6D7113I8
UPC 0351672408138
Application # ANDA065184
SPL Set ID 5b8a6767-2d46-401c-9f85-d427dda9eff7
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 2004-03-31
Route TOPICAL
Dosage form SOLUTION
Substance CLINDAMYCIN PHOSPHATE
GPI-14 90051010102005
GPI class Clindamycin Phosphate
GCN Seq No 007727
GCN 31720
HICL code 004045
Ingredient (HICL) Clindamycin Phosphate
HIC1 code Q
Therapeutic class — broad (HIC1) Ear/Eye/Nose/Rectum/Topical/Vagina/Other
HIC2 code Q5
Therapeutic class — intermediate (HIC2) Agents Acting Principally On The Skin
HIC3 code Q5W
Therapeutic class — specific (HIC3) Topical Antibiotics
AHFS code 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name CLINDAMYCIN PH 1% SOLUTION
FDB brand name Clindamycin Phosphate
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AT · RLD · RS
Why two NDCs? The FDA registers this code as 51672-4081-4 — 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 → 51672-4081-04. 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

LabelerSun Pharmaceutical Industries, Inc.
Application holderTARO PHARMACEUTICAL INDUSTRIES LTD
FDA applicationANDA065184 (ANDA)
Labeler code51672
First marketedMar 2004
Product typeHuman Prescription Drug
Portfolio889 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

Label name CLINDAMYCIN PH 1% SOLUTION Ingredient Clindamycin Phosphate
📖 What it is MedlinePlus · NLM

Topical clindamycin is used to treat acne. Clindamycin is in a class of medications called lincomycin antibiotics. It works by slowing or stopping the growth of bacteria that cause acne and by decreasing swelling.

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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • 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.
  • 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.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

3 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — 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?
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 mLPer package
Retail pharmacies payNADAC · weekly $0.149 $8.92 / 60 ml
Medicaid paysCMS SDUD · 12 mo $0.3430 $20.58 / 60 ml
Medicare drug plans payPart D · Q2 2026 $0.3076 $18.46 / 60 ml
NADAC price history (per mL) — tap or hover for the price & month
Dec 2021 Jul 2022 Dec 2025 Aug 2026 $0.223 $0.149
▼ Down 30% over the last 24 months.
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 Phoaphate Topical Solution USP, 1% 10 mg/mL 21922-0002-01 Encube 1 bottle $0.149 AT Availability likely —
Clindamycin Phosphate 10 mg/mLthis 51672-4081-04 Sun 1 bottle $0.149 AT Availability likely —
clindamycin phosphate 10 mg/mL 00168-0201-30 E. 1 bottle $0.184 AT Availability likely +24%
Clindamycin Phosphate 10 mg/mL 45802-0562-01 Padagis 1 bottle $0.184 AT Availability likely +24%
Clindamycin Phosphate 10 mg/mL 72578-0084-02 Viona 1 bottle $0.184 AT Availability likely +24%
Clindamycin Phoaphate Topical Solution USP, 1% 10 mg/mL 72603-0321-01 Northstar 1 bottle $0.184 AT Availability likely +24%
Clindamycin Phosphate 10 mg/mL 45802-0263-37 Padagis 60 applicators $0.284 AT Availability likely +91%
Clindamycin Phosphate 10 mg/mL 16571-0256-60 Rising 60 applicators $0.284 AT Availability likely +91%
Clindacin P 10 mg/mL 43538-0170-69 Eurofarma, 69 applicators — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 50090-2611-00 A-S 1 bottle — AT FDA listed —
Clindamycin Phosphate 11.9 mg/mL 50090-5779-00 A-S 1 bottle — AT FDA listed —
Clindamycin Phoaphate Topical USP, 1% 10 mg/mL 50090-6592-00 A-S 1 bottle — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 50090-6593-00 A-S 1 bottle — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 62135-0478-30 Chartwell 30 ml — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 63629-8633-01 Bryant 1 bottle — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 63629-8634-01 Bryant 1 bottle — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 68788-7990-06 Preferred 1 bottle — AT FDA listed —
Clindamycin phosphate 10 mg/mL 70771-1414-02 Zydus 1 bottle — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 71335-2861-01 Bryant 1 bottle — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 71335-2863-01 Bryant 1 bottle — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 72162-1418-03 Bryant 1 bottle — AT FDA listed —
Clindamycin Phosphate 10 mg/mL 50090-1932-00 A-S 60 applicators — AT 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

🏛️
2004
On the market since
Mar 2004
📍
2026
Currently FDA-listed
22 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 51672-4081-04, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q4 2025 · 4 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
18.9K
Units reimbursed last 4 qtrs
1.2M
Gross reimbursed last 4 qtrs
$399K
Avg / prescription
$21.15
Avg / unit
$0.3430
Latest quarter Q4 2025
6.3KRx
Medicaid pays / mL
$0.3430
gross reimbursed
vs
NADAC / mL
$0.1487
acquisition cost
=
Spread
+$0.1943
+131% vs cost
What Medicaid paid per mL (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
59% FFS 41% MCO
Fee-for-service · 11,042 Rx Managed care · 7,824 Rx
State Medicaid map
Alaska: 2,640 units · 360 per 100k residents AK Maine: no data reported ME Washington: 24,656 units · 316 per 100k residents WA Idaho: 720 units · 36.7 per 100k residents ID Montana: 7,080 units · 625 per 100k residents MT North Dakota: 4,140 units · 529 per 100k residents ND Minnesota: 9,570 units · 167 per 100k residents MN Wisconsin: 5,250 units · 88.8 per 100k residents WI Michigan: 244,880 units · 2,440 per 100k residents MI New York: 402,090 units · 2,055 per 100k residents NY Vermont: 4,020 units · 621 per 100k residents VT New Hampshire: no data reported NH Oregon: 2,280 units · 53.9 per 100k residents OR Nevada: 3,720 units · 116 per 100k residents NV Wyoming: no data reported WY South Dakota: 2,640 units · 287 per 100k residents SD Iowa: 720 units · 22.5 per 100k residents IA Illinois: 3,990 units · 31.8 per 100k residents IL Indiana: 6,120 units · 89.2 per 100k residents IN Ohio: 23,010 units · 195 per 100k residents OH Pennsylvania: 16,560 units · 128 per 100k residents PA New Jersey: 14,520 units · 156 per 100k residents NJ Massachusetts: 2,520 units · 36.0 per 100k residents MA California: 219,289 units · 563 per 100k residents CA Utah: 5,040 units · 147 per 100k residents UT Colorado: 5,760 units · 98.0 per 100k residents CO Nebraska: 4,740 units · 240 per 100k residents NE Missouri: 3,180 units · 51.3 per 100k residents MO Kentucky: 14,640 units · 323 per 100k residents KY West Virginia: 1,080 units · 61.0 per 100k residents WV Virginia: 2,760 units · 31.7 per 100k residents VA Maryland: 6,330 units · 102 per 100k residents MD Connecticut: 6,960 units · 192 per 100k residents CT Rhode Island: no data reported RI Arizona: 1,500 units · 20.2 per 100k residents AZ New Mexico: 8,940 units · 423 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 4,410 units · 61.9 per 100k residents TN North Carolina: 21,900 units · 202 per 100k residents NC South Carolina: 6,300 units · 117 per 100k residents SC Delaware: no data reported DE Oklahoma: 2,460 units · 60.7 per 100k residents OK Louisiana: 3,330 units · 72.8 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: 5,760 units · 52.2 per 100k residents GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 16,440 units · 53.9 per 100k residents TX Florida: 37,698 units · 167 per 100k residents FL
Units reimbursed · per 100k residents
20.22,440
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 Michigan 2,440 /100k
2 New York 2,055 /100k
3 Montana 625 /100k
4 Vermont 621 /100k
5 California 563 /100k
6 North Dakota 529 /100k
7 New Mexico 423 /100k
8 Alaska 360 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
1 bottle this page51672-4081-04 18,866 Rx · $399,007
1 bottle51672-4081-03 3,519 Rx · $54,691
Drug total (last 4 qtrs): 22,385 Rx · 1,291,289 units · $453,699 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Clindamycin Phosphate — the program that covers self-administered drugs. 16 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 Phosphate. 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
$6.9M
Claims incl. refills
181.3K
Beneficiaries
134.5K
Spend / beneficiary
$51.31
Spend / claim
$38.08
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.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Clindamycin Phosphate — the ingredient across all brands.

Top reported reactions

Drug Hypersensitivity2,885
Diarrhoea2,242
Rash2,049
Nausea1,961
Pain1,787
Fatigue1,548
Acute Kidney Injury1,428

Age at onset

Neonate149
Infant54
Child118
Adolescent224
Adult2,915
Elderly1,318

Reporter sex

33,708 reports
Male · 37%
Female · 63%
Unknown · 0%

Serious outcomes

Hospitalization12,220
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 3,867 898
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startStatus
51672-4081-03 1 BOTTLE, WITH APPLICATOR in 1 CARTON (51672-4081-3) / 30 mL in 1 BOTTLE, WITH APPLICATOR $0.1843 / mL $5.53 2004-03-31 Active
51672-4081-04 You're viewing this 1 BOTTLE, WITH APPLICATOR in 1 CARTON (51672-4081-4) / 60 mL in 1 BOTTLE, WITH APPLICATOR $0.1487 / mL $8.92 2004-03-31 Active

This pack has the lowest per-mL cost of the 2 priced pack sizes ($0.1487 NADAC).

In Medicaid, this is the most-dispensed pack of this product — about 84% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 51672-4081-04?
NDC 51672-4081-04 is listed by the FDA — 1 bottle, with applicator in 1 carton / 60 ml in 1 bottle, with applicator.
What NDC number is used to bill for this package of Clindamycin Phosphate 10 mg/mL Solution?
Bill NDC 51672-4081-04 — the 11-digit billing format is 51672408104. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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.
🎯 Indications and Usage ⏱️ Dosage and Administration ⛔ Contraindications ⚠️ Warnings 🤒 Adverse Reactions 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description
🎯 Indications and Usage 45 words ▾

INDICATIONS AND USAGE Clindamycin Phosphate Topical Solution is indicated in the treatment of acne vulgaris. In view of the potential for diarrhea, bloody diarrhea and pseudomembranous colitis, the physician should consider whether other agents are more appropriate (see CONTRAINDICATIONS , WARNINGS and ADVERSE REACTIONS ).

⏱️ Dosage and Administration 42 words ▾

DOSAGE AND ADMINISTRATION Apply a thin film of Clindamycin Phosphate Topical Solution twice daily to affected area. Clindamycin Phosphate Topical Solution USP, 1% is flammable. Keep away from heat, sparks or open flames. Keep all liquid dosage forms in containers tightly closed.

⛔ Contraindications 34 words ▾

CONTRAINDICATIONS Clindamycin Phosphate Topical Solution is contraindicated in individuals with a history of hypersensitivity to preparations containing clindamycin or lincomycin, a history of regional enteritis or ulcerative colitis, or a history of antibiotic-associated colitis.

⚠️ Warnings ~1 min read ▾

WARNINGS Orally and parenterally administered clindamycin has been associated with severe colitis which may result in patient death. Use of the topical formulation of clindamycin results in absorption of the antibiotic from the skin surface. Diarrhea, bloody diarrhea, and colitis (including pseudomembranous colitis) have been reported with the use of topical and systemic clindamycin.

Studies indicate a toxin(s) produced by clostridia is one primary cause of antibiotic-associated colitis. The colitis is usually characterized by severe persistent diarrhea and severe abdominal cramps and may be associated with the passage of blood and mucus. Endoscopic examination may reveal pseudomembranous colitis.

Stool culture for Clostridium difficile and stool assay for C. difficile toxin may be helpful diagnostically. When significant diarrhea occurs, the drug should be discontinued. Large bowel endoscopy should be considered to establish a definitive diagnosis in cases of severe diarrhea.

Antiperistaltic agents such as opiates and diphenoxylate with atropine may prolong and/or worsen the condition. Vancomycin has been found to be effective in the treatment of antibiotic-associated pseudomembranous colitis produced by Clostridium difficile . The usual adult dosage is 500 milligrams to 2 grams of vancomycin orally per day in three to four divided doses administered for 7 to 10 days.

Cholestyramine or colestipol resins bind vancomycin in vitro . If both a resin and vancomycin are to be administered concurrently, it may be advisable to separate the time of administration of each drug. Diarrhea, colitis, and pseudomembranous colitis have been observed to begin up to several weeks following cessation of oral and parenteral therapy with clindamycin.

🤒 Adverse Reactions 178 words ▾

ADVERSE REACTIONS In 18 clinical studies of various formulations of clindamycin phosphate using placebo vehicle and/or active comparator drugs as controls, patients experienced a number of treatment emergent adverse dermatologic events [see table below]. Number of Patients Reporting Events Treatment Emergent Adverse Event Solution n=533 (%) Gel n=148 (%) Lotion n=160 (%) Burning 62 (11) 15 (10) 17 (11) Itching 36 (7) 15 (10) 17 (11) Burning/Itching 60 (11) not recorded (-) (-) Dryness 105 (19) 34 (23) 29 (18) Erythema 86 (16) 10 (7) 22 (14) Oiliness/Oily Skin 8 (1) 26 (18) 12 of 126 subjects (10) Peeling 61 (11) (-) 11 (7) Orally and parenterally administered clindamycin has been associated with severe colitis which may end fatally.

Cases of diarrhea, bloody diarrhea and colitis (including pseudomembranous colitis) have been reported as adverse reactions in patients treated with oral and parenteral formulations of clindamycin and rarely with topical clindamycin (see WARNINGS ). Abdominal pain, gastrointestinal disturbances, gram-negative folliculitis, eye pain and contact dermatitis have also been reported in association with the use of topical formulations of clindamycin.

🔄 Drug Interactions 33 words ▾

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.

🤰 Pregnancy 59 words ▾

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. There are no adequate studies in pregnant women during the first trimester of pregnancy. Clindamycin should be used during the first trimester of pregnancy only if clearly needed.

🧒 Pediatric Use 17 words ▾

Pediatric Use Safety and effectiveness in pediatric patients under the age of 12 have not been established.

🧓 Geriatric Use 45 words ▾

Geriatric Use Clinical studies for Clindamycin Phosphate Topical Solution did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.

🆘 Overdosage 18 words ▾

OVERDOSAGE Topically applied clindamycin phosphate can be absorbed in sufficient amounts to produce systemic effects (see WARNINGS) .

🧬 Clinical Pharmacology 187 words ▾

CLINICAL PHARMACOLOGY Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown. Pharmacokinetics Following multiple topical applications of clindamycin phosphate at a concentration equivalent to 10 mg clindamycin per mL in an isopropyl alcohol and water solution, very low levels of clindamycin are present in the serum (0 to 3 ng/mL) and less than 0.2% of the dose is recovered in urine as clindamycin. Although clindamycin phosphate is inactive in vitro , rapid in vivo hydrolysis converts this compound to the antibacterially active clindamycin.

Microbiology Clindamycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the ribosome. Clindamycin is bacteriostatic. Antimicrobial Activity Clindamycin is active in vitro against most isolates of Propionibacterium acnes ; however, the clinical significance is unknown.

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.

🧬 Mechanism of Action 15 words ▾

Mechanism of Action The mechanism of action of clindamycin in treating acne vulgaris is unknown.

📦 How Supplied / Storage and Handling 87 words ▾

HOW SUPPLIED Clindamycin Phosphate Topical Solution USP, 1% containing clindamycin phosphate equivalent to 10 mg clindamycin per milliliter is available in the following sizes: 1 oz (30 mL) applicator bottle NDC 51672-4081-3 2 oz (60 mL) applicator bottle NDC 51672-4081-4 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Clindamycin Phosphate Topical Solution USP, 1% is flammable.

Keep away from heat, sparks or open flames. This product’s label may have been updated. For current full prescribing information, please visit https://www.sunpharma.com/usa/products.

📦 Storage and Handling 47 words ▾

Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. Clindamycin Phosphate Topical Solution USP, 1% is flammable. Keep away from heat, sparks or open flames. This product’s label may have been updated. For current full prescribing information, please visit https://www.sunpharma.com/usa/products.

📋 Description 87 words ▾

DESCRIPTION Clindamycin Phosphate Topical Solution contains clindamycin phosphate, USP, at a concentration equivalent to 10 mg clindamycin per milliliter. 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 solution contains isopropyl alcohol 50% v/v, propylene glycol, and purified water.

May contain sodium hydroxide for pH balance. The structural formula is represented below: 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). Chemical 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.