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Lincomycin 300 mg/mL Injection, Solution — NDC 25021-0193-02 package photo

Lincomycin 300 mg/mL Injection, Solution

by Sagent Pharmaceuticals · 10 VIAL in 1 CARTON (25021-193-02) / 2 mL in 1 VIAL
NDC 25021-0193-02
🏷️ FDA NDC (as labeled) 25021-193-02 billing pads the product segment with a zero
This package
Contains2 mL in 1 vial Pack sizes2 compare ↓
Also comes in: 10 vials 25021-0193-10
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) 25021-193-02
Product NDC 25021-193
11-digit billing NDC 25021019302
NCPDP billing unit ML — per mL (volume)
RxCUI 239212
UNII M6T05Z2B68
Application # ANDA215657
SPL Set ID 75e149cc-b668-427e-bae7-a0d215e4fb7a
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2023-04-15
Route INTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL
Dosage form INJECTION, SOLUTION
Substance LINCOMYCIN HYDROCHLORIDE
GPI-14 16220010102005
GCN Seq No 009338
GCN 40810
HICL code 004043
Ingredient (HICL) Lincomycin Hcl
HIC1 code W
Therapeutic class — broad (HIC1) Anti-Infecting Agents
HIC2 code W1
Therapeutic class — intermediate (HIC2) Antibiotics
HIC3 code W1K
Therapeutic class — specific (HIC3) Lincosamide Antibiotics
AHFS code 08:12.28.20
AHFS class Lincomycin Antibiotics
FDB label name LINCOMYCIN HCL 600 MG/2 ML VL
FDB brand name Lincomycin Hcl
Legend status F — Federal legend — prescription drug or device
TE code (Orange Book) AP · RLD · RS
Why two NDCs? The FDA registers this code as 25021-193-02 — a 5-3-2 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 product segment → 25021-0193-02. 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 Lincosamides class.

Drug family (ATC) 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

LabelerSagent Pharmaceuticals
Application holderGLAND PHARMA LTD
FDA applicationANDA215657 (ANDA)
Labeler code25021
First marketedApr 2023
Product typeHuman Prescription Drug
Portfolio209 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 LINCOMYCIN HCL 600 MG/2 ML VL Ingredient Lincomycin Hcl

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
7
Nutrient depletion considerations

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

🧪 Full Lincomycin HCl 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 LKG8494WBH
    Benzyl alcohol is a clear liquid used as a preservative and solvent in medicines. It helps prevent bacterial and fungal growth and dissolves other ingredients to create uniform liquid formulations.
  • 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.

2 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 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 · quarterly No Part D plan price is available for this NDC in our data.
Medicare Part B allowsASP · J2010 $4.234 / J2010 unit —
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.

🧾 Billing & reimbursement

FDA NDC (as labeled)25021-193-02
11-digit billing NDC25021-0193-02
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ2010
DescriptorINJECTION, LINCOMYCIN HCL, UP TO 300 MG
Billing units / pkg1 units
Crosswalk sourcePDAC NDC-HCPCS crosswalk (DME MAC / DMEPOS)
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Lincocin 300 mg/mL 00009-0104-04 Pharmacia 1 vial — AP FDA listed —
Lincocin 300 mg/mL 00009-0107-04 Pharmacia 1 vial — AP FDA listed —
Lincomycin 3000 mg/10mL 00121-1035-55 PAI 10 vials — AP FDA listed —
Lincomycin 300 mg/mL 00404-9901-10 Henry 1 vial — AP FDA listed —
Lincomycin 300 mg/mLthis 25021-0193-02 Sagent 10 vials — AP FDA listed —
Lincomycin 300 mg/mL 39822-0350-02 XGen 10 vials — AP FDA listed —
Lincomycin 300 mg/mL 39822-0353-06 XGen 10 ml — AP FDA listed —
Lincomycin 300 mg/mL 42571-0374-75 Micro 1 vial — AP FDA listed —
lincomycin hydrochloride 300 mg/mL 68083-0478-01 Gland 1 vial — AP FDA listed —
Lincomycin hydrochloride 300 mg/mL 68083-0479-01 Gland 1 vial — AP FDA listed —
lincomycin 300 mg/mL 70436-0034-82 Slate 10 vials — — FDA listed —
lincomycin 300 mg/mL 70436-0035-80 Slate 1 vial — — FDA listed —
Lincomycin 600 mg/2mL 72485-0114-01 Armas 1 vial — AP FDA listed —
Lincomycin 3000 mg/10mL 72485-0115-10 Armas 10 vials — AP 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

🏛️
2023
On the market since
Apr 2023
📍
2026
Currently FDA-listed
3 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.

🔬 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 Lincomycin (this brand).

Top reported reactions

Drug Hypersensitivity24
Diarrhoea14
Cellulitis11
Pyrexia10
Stevens-johnson Syndrome10
Liver Injury9
Rash9

Age at onset

Child1
Adult6
Elderly7

Reporter sex

158 reports
Male · 46%
Female · 52%
Unknown · 2%

Serious outcomes

Hospitalization66
Life-threatening24
Death19
Disabling3
Reports over time (by year) — tap or hover for the count & year
2024 2025 2026 16 4
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 Marketing startStatus
25021-0193-02 You're viewing this 10 VIAL in 1 CARTON (25021-193-02) / 2 mL in 1 VIAL 2023-04-15 Active
25021-0193-10 10 VIAL in 1 CARTON (25021-193-10) / 10 mL in 1 VIAL 2023-04-15 Active

Pack size FAQ

What quantity is in NDC 25021-0193-02?
NDC 25021-0193-02 is listed by the FDA — 10 vial in 1 carton / 2 ml in 1 vial.
What NDC number is used to bill for this package of Lincomycin 300 mg/mL Injection, Solution?
Bill NDC 25021-0193-02 — the 11-digit billing format is 25021019302. 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 ✓ 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 ✓ Available
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 25021-193-02, 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: 25021-0193-02, written without dashes as 25021019302. 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 25021-0193-02, the first segment (25021) is the labeler code FDA assigned to Sagent Pharmaceuticals; the middle segment (0193) 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 Sagent Pharmaceuticals. 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 1 other package presentation of this same product, including 10 vials (25021-0193-10). 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?
Sagent Pharmaceuticals 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J2010 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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 🔄 Drug Interactions 🤰 Pregnancy 🧒 Pediatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients
🚨 Boxed Warning 213 words ▾

WARNING Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including lincomycin injection 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 lincomycin 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. diffficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy.

CDAD must be considered in all patients who present with diarrhea following antibacterial use. Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued.

Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

🎯 Indications and Usage 191 words ▾

INDICATIONS AND USAGE Lincomycin injection is 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 CDAD, as described in the BOXED WARNING , before selecting lincomycin the physician should consider the nature of the infection and the suitability of other alternatives.

Indicated surgical procedures should be performed in conjunction with antibacterial therapy. Lincomycin injection may be administered concomitantly with other antimicrobial agents when indicated. Lincomycin injection is not indicated in the treatment of minor bacterial infections or viral infections.

To reduce the development of drug-resistant bacteria and maintain the effectiveness of lincomycin injection and other antibacterial drugs, lincomycin injection 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 ~2 min read ▾

DOSAGE AND ADMINISTRATION If significant diarrhea occurs during therapy, lincomycin injection should be discontinued. (see BOXED WARNING ) INTRAMUSCULAR— Adults: Serious infections —600 mg (2 mL) intramuscularly every 24 hours. More severe infections —600 mg (2 mL) intramuscularly every 12 hours or more often.

Pediatric patients over 1 month of age: Serious infections —one intramuscular injection of 10 mg/kg (5 mg/lb) every 24 hours. More severe infections —one intramuscular injection of 10 mg/kg (5 mg/lb) every 12 hours or more often. INTRAVENOUS— Adults: The intravenous dose will be determined by the severity of the infection.

For serious infections doses of 600 mg of lincomycin (2 mL of lincomycin injection) to 1 gram are given every 8 to 12 hours. For more severe infections these doses may have to be increased. In life-threatening situations daily intravenous doses of as much as 8 grams have been given.

Intravenous doses are given on the basis of 1 gram of lincomycin diluted in not less than 100 mL of appropriate solution (see PHYSICAL COMPATIBILITIES ) and infused over a period of not less than one hour. Dose Vol. Diluent Time 600 mg 100 mL 1 hr 1 gram 100 mL 1 hr 2 grams 200 mL 2 hr 3 grams 300 mL 3 hr 4 grams 400 mL 4 hr These doses may be repeated as often as required to the limit of the maximum recommended daily dose of 8 grams of lincomycin.

Pediatric patients over 1 month of age: 10 to 20 mg/kg/day (5 to 10 mg/lb/day) depending on the severity of the infection may be infused in divided doses as described above for adults. NOTE: Severe cardiopulmonary reactions have occurred when lincomycin injection has been given at greater than the recommended concentration and rate (see PRECAUTIONS ). SUBCONJUNCTIVAL INJECTION— 0.25 mL (75 mg) injected subconjunctivally will result in ocular fluid concentrations of antibacterial (lasting for at least 5 hours) sufficient for most susceptible pathogens.

Patients with Renal Impairment When therapy with lincomycin injection is required in individuals with severe renal impairment, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys (see PRECAUTIONS ). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

⛔ Contraindications 16 words ▾

CONTRAINDICATIONS Lincomycin injection is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

⚠️ Warnings ~2 min read ▾

WARNINGS (See BOXED WARNING ). Clostridioides difficile associated diarrhea Clostridioides difficile associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including Lincomycin, and may range in severity from mild diarrhea to fatal colitis. Treatment with antibacterial agents alters the normal flora of the colon leading to overgrowth of C. difficile .

C. difficile produces toxins A and B which contribute to the development of CDAD. Hypertoxin producing strains of C. difficile cause increased morbidity and mortality, as these infections can be refractory to antimicrobial therapy and may require colectomy. CDAD must be considered in all patients who present with diarrhea following antibacterial use.

Careful medical history is necessary since CDAD has been reported to occur over two months after the administration of antibacterial agents. If CDAD is suspected or confirmed, ongoing antibacterial use not directed against C. difficile may need to be discontinued. Appropriate fluid and electrolyte management, protein supplementation, antibacterial treatment of C. difficile , and surgical evaluation should be instituted as clinically indicated.

Hypersensitivity Severe hypersensitivity reactions, including anaphylactic reactions and severe cutaneous adverse reactions (SCAR) such as Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), acute generalized exanthematous pustulosis (AGEP), and erythema multiforme (EM) have been reported in patients receiving lincomycin injection therapy. If an anaphylactic reaction or severe skin reaction occurs, lincomycin injection should be discontinued and appropriate therapy should be initiated (see ADVERSE REACTIONS ).

Benzyl Alcohol Toxicity in Pediatric Patients (Gasping Syndrome) Lincomycin injection contains benzyl alcohol as a preservative. The preservative benzyl alcohol has been associated with serious adverse events, including the “gasping syndrome”, and death in pediatric patients. Although normal therapeutic doses of this product ordinarily deliver amounts of benzyl alcohol that are substantially lower than those reported in association with the “gasping syndrome”, the minimum amount of benzyl alcohol at which toxicity may occur is not known.

The risk of benzyl alcohol toxicity depends on the quantity administered and the liver and kidneys' capacity to detoxify the chemical. Premature and low-birth weight infants may be more likely to develop toxicity. Inadequate for Use in Meningitis Although lincomycin appears to diffuse into cerebrospinal fluid, concentrations of lincomycin in the CSF may be inadequate for the treatment of meningitis.

🤒 Adverse Reactions 198 words ▾

ADVERSE REACTIONS The following adverse reactions have been reported with the use of lincomycin. Gastrointestinal disorders Diarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort † , anal pruritus Skin and subcutaneous tissue disorders Toxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, dermatitis bullous, dermatitis exfoliative, erythema multiforme (see WARNINGS ) , rash, urticaria, pruritus Infections and infestations Vaginal infection, pseudomembranous colitis, Clostridioides difficile colitis (see WARNINGS ) Blood and lymphatic system disorders Pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura Immune system disorders Anaphylactic reaction (see WARNINGS ), angioedema, serum sickness Hepatobiliary disorders Jaundice, liver function test abnormal, transaminases increased Renal and urinary disorders Renal impairment, oliguria, proteinuria, azotemia Cardiac disorders Cardio-respiratory arrest (see DOSAGE AND ADMINISTRATION ) Vascular disorders Hypotension (see DOSAGE AND ADMINISTRATION ), thrombophlebitis † Ear and labyrinth disorders Vertigo, tinnitus Neurologic disorders Headache, dizziness, somnolence General disorders and administration site conditions Injection site abscess sterile ‡ , injection site induration ‡ , injection site pain ‡ , injection site irritation ‡ † Event has been reported with intravenous injection. ‡ Reported with intramuscular injection.

To report SUSPECTED ADVERSE REACTIONS, contact Sagent Pharmaceuticals, Inc. at 1-866-625-1618 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

🔄 Drug Interactions 33 words ▾

Drug Interactions Lincomycin 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 191 words ▾

Pregnancy There are no adequate and well-controlled studies in pregnant women. Lincomycin injection Sterile Solution contains benzyl alcohol as a preservative. Benzyl alcohol can cross the placenta (see WARNINGS ) .

Lincomycin injection should be used during pregnancy only if clearly needed. Teratogenic Effects: In a study with 60 pregnant women, cord serum concentrations were approximately 25% of the maternal serum concentrations, indicating that lincomycin crosses the placenta, and no substantial accumulation occurred in the amniotic fluid. Experience with 345 obstetrical patients receiving lincomycin injection revealed no ill effects related to pregnancy.

There was no evidence of teratogenicity when lincomycin was administered in diet to pregnant Sprague Dawley rats during the period of major organogenesis at doses up to 5000 mg/kg (approximately 6 times the maximum recommended human dose [MRHD], respectively, based on body surface area comparison). Nonteratogenic Effects: Reproduction studies performed in rats administered oral lincomycin in diet for 2 weeks prior to mating, throughout pregnancy and lactation, revealed no adverse effects on survival of offspring from birth to weaning at doses up to 1000 mg/kg (1.2 times the MRHD based on body surface area comparison) up to 2 generations.

🧒 Pediatric Use 48 words ▾

Pediatric Use Lincomycin injection contains benzyl alcohol as a preservative. Benzyl alcohol has been associated with a fatal “Gasping Syndrome” in premature infants (see WARNINGS ) . Safety and effectiveness in pediatric patients below the age of one month have not been established (see DOSAGE AND ADMINISTRATION ).

🆘 Overdosage 14 words ▾

OVERDOSAGE Serum concentrations of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.

🧬 Clinical Pharmacology 201 words ▾

CLINICAL PHARMACOLOGY Intramuscular administration of a single dose of 600 mg of lincomycin produces average peak serum concentrations of 11.6 mcg/mL at 60 minutes and maintains therapeutic concentrations for 17 to 20 hours for most susceptible gram-positive organisms. Urinary excretion after this dose ranges from 1.8 to 24.8 percent (mean: 17.3 percent). A two hour intravenous infusion of 600 mg of lincomycin achieves average peak serum concentrations of 15.9 mcg/mL and maintains therapeutic concentrations for 14 hours for most susceptible gram-positive organisms.

Urinary excretion ranges from 4.9 to 30.3 percent (mean: 13.8 percent). The biological half-life after intramuscular or intravenous administration is 5.4 ± 1.0 hours. The serum half-life of lincomycin may be prolonged in patients with severe renal impairment compared to patients with normal renal function.

In patients with hepatic impairment, serum half-life may be twofold longer than in patients with normal hepatic function. Hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the serum. Tissue distribution studies indicate that bile is an important route of excretion.

Significant concentrations have been demonstrated in most body tissues. Although lincomycin appears to diffuse into cerebrospinal fluid (CSF), concentrations of lincomycin in the CSF appear inadequate for the treatment of meningitis.

🧬 Mechanism of Action 29 words ▾

Mechanism of Action Lincomycin inhibits bacterial protein synthesis by binding to the 23S RNA of the 50S subunit of the bacterial ribosome. Lincomycin is predominantly bacteriostatic in vitro .

📦 How Supplied / Storage and Handling 107 words ▾

HOW SUPPLIED Lincomycin Injection, USP is available as a sterile, clear, and colorless solution in the following strength and package sizes: NDC Lincomycin Injection, USP (300 mg per mL) Package Factor 25021-193-02 600 mg per 2 mL Multi-Dose Vial 10 vials per carton 25021-193-10 3,000 mg per 10 mL Multi-Dose Vial 10 vials per carton Each mL of Lincomycin Injection, USP contains 300 mg lincomycin (equivalent to 340 mg lincomycin hydrochloride, USP); also benzyl alcohol, 9.45 mg added as preservative. Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic.

The container closure is not made with natural rubber latex.

📦 Storage and Handling 27 words ▾

Storage Conditions Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Sterile, Nonpyrogenic. The container closure is not made with natural rubber latex.

📋 Description 190 words ▾

DESCRIPTION Lincomycin Injection, USP is a sterile solution containing lincomycin hydrochloride which is the monohydrated salt of lincomycin, a lincosamide antibacterial produced by the growth of a member of the lincolnensis group of Streptomyces lincolnensis (Fam. Streptomycetaceae ). The chemical name for lincomycin hydrochloride is Methyl 6,8-dideoxy-6-(1-methyl-trans-4-propyl-L-2-pyrolidinecarboxamido)-1-thio-D-erythro-α-D-galacto-octopyranoside monohydrochloride monohydrate.

The molecular formula of lincomycin hydrochloride is C 18 H 34 N 2 O 6 S.HCl.H 2 O and the molecular weight is 461.01. The structural formula is represented below: Lincomycin hydrochloride is a white or practically white, crystalline powder and is odorless or has a faint odor. Its solutions are acid and are dextrorotatory.

Lincomycin hydrochloride is freely soluble in water; soluble in dimethylformamide and very slightly soluble in acetone. Lincomycin Injection, USP contains lincomycin hydrochloride in a sterile, clear, colorless solution with benzyl alcohol used as a preservative 9.45 mg per mL, and water for injection. Lincomycin Injection, USP is a sterile solution for intramuscular and intravenous use.

Lincomycin Injection, USP is supplied in 2 mL and 10 mL multiple-dose vials containing 300 mg per mL of lincomycin (equivalent to 340 mg per mL of lincomycin hydrochloride, USP). Figure

💬 Information for Patients 176 words ▾

Information for Patients Patients should be counseled that antibacterial drugs including lincomycin injection should only be used to treat bacterial infections. They do not treat viral infections (e.g., the common cold). When lincomycin injection 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 lincomycin injection or other antibacterial drugs in the future. Diarrhea is a common problem caused by antibacterial which usually ends when the antibacterial is discontinued. Sometimes after starting treatment with an antibacterial, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after taking the last dose of the antibacterial.

If this occurs, patients should contact their physician as soon as possible.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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