NDC 70625-113 Lincomycin

Lincomycin

NDC Product Code 70625-113

NDC 70625-113-01

Package Description: 1 VIAL in 1 CARTON > 10 mL in 1 VIAL

NDC Product Information

Lincomycin with NDC 70625-113 is a a human prescription drug product labeled by Praxgen Pharmaceuticals Llc. The generic name of Lincomycin is lincomycin. The product's dosage form is injection, solution and is administered via intramuscular; intravenous; subconjunctival form.

Labeler Name: Praxgen Pharmaceuticals Llc

Dosage Form: Injection, Solution - A liquid preparation containing one or more drug substances dissolved in a suitable solvent or mixture of mutually miscible solvents that is suitable for injection.

Product Type: Human Prescription Drug What kind of product is this?
Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

Lincomycin Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • LINCOMYCIN HYDROCHLORIDE 300 mg/mL

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • BENZYL ALCOHOL (UNII: LKG8494WBH)

Administration Route(s)

What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.

  • Intramuscular - Administration within a muscle.
  • Intravenous - Administration within or into a vein or veins.
  • Subconjunctival - Administration beneath the conjunctiva.

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Praxgen Pharmaceuticals Llc
Labeler Code: 70625
FDA Application Number: ANDA212770 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Marketing Category: ANDA - A product marketed under an approved Abbreviated New Drug Application. What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Start Marketing Date: 03-30-2021 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2022 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: N - NO What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Lincomycin Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Other

PETERSON


PHARMACEUTICALS


Athenex


Rx only


To reduce the development of drug-resistant bacteria and maintain the effectiveness of Lincomycin and other antibacterial drugs, Lincomycin should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria.

Warning

Clostridium 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.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.

Description

Lincomycin Injection, USP sterile solution contains lincomycin hydrochloride which is the monohydrated salt of lincomycin, a substance 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
18H
34N
2O
6S●HCl●H
2O 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.Each mL contains lincomycin hydrochloride equivalent to 300 mg lincomycin. Also contains 9.45 mg benzyl alcohol added as a preservative.

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

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.

Resistance

Cross resistance has been demonstrated between clindamycin and lincomycin. Resistance is most often due to methylation of specific nucleotides in the 23S RNA of the 50S ribosomal subunit, which can determine cross resistance to macrolides and streptogramins B (MLS


B phenotype). Macrolide-resistant isolates of these organisms should be tested for inducible resistance to lincomycin/clindamycin using the D-zone test or other appropriate method.

Antimicrobial Activity

  • Lincomycin has been shown to be active against most strains of the following bacteria
  • Both
  • In vitro
  • And in clinical infections (see
  • INDICATIONS AND USAGE):
  • Staphylococcus aureusStreptococcus pneumoniaeThe following
  • In vitro data are available, but their clinical significance is unknown.
  • Lincomycin has been shown to be active
  • In vitro against the following microorganisms; however, the safety and efficacy of lincomycin in treating clinical infections due to these organisms have not been established in adequate and well controlled trials.
  • Gram-positive bacteria:
  • Corynebacterium diphtheriaeStreptococcus pyogenesViridans group streptococci
  • Anaerobic bacteria:
  • Clostridium tetaniClostridium perfringensSusceptibility TestingFor specific information regarding susceptibility test interpretive criteria and associated test methods and quality control standards recognized by FDA for this drug, please see:
  • Https://www.fda.gov/STIC.

Indications And Usage

Lincomycin Injection sterile solution 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.
The drug may be administered concomitantly with other antimicrobial agents when indicated.
Lincomycin 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.

Contraindications

This drug is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.

Warnings

See


BOXED WARNING.

Clostridium Difficile Associated Diarrhea

Clostridium 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)

This product 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.

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.

General

Review of experience to date suggests that a subgroup of older patients with associated severe illness may tolerate diarrhea less well. When lincomycin injection is indicated in these patients, they should be carefully monitored for change in bowel frequency.
Lincomycin injection should be prescribed with caution in individuals with a history of gastrointestinal disease, particularly colitis.
Lincomycin injection should be used with caution in patients with a history of asthma or significant allergies.
Certain infections may require incision and drainage or other indicated surgical procedures in addition to antibacterial therapy.
The use of lincomycin injection may result in overgrowth of nonsusceptible organisms— particularly yeasts. Should superinfections occur, appropriate measures should be taken as indicated by the clinical situation. When patients with pre-existing monilial infections require therapy with lincomycin injection, concomitant antimonilial treatment should be given.
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.
Patients with severe renal impairment and/or hepatic impairment should be dosed with caution and serum lincomycin concentrations monitored during high-dose therapy (see


DOSAGE AND ADMINISTRATION).



Lincomycin should not be injected intravenously undiluted as a bolus, but should be infused over at least 60 minutes as directed in the


DOSAGE AND ADMINISTRATION section.



Prescribing lincomycin injection in the absence of a proven or strongly suspected bacterial infection or a prophylactic indication is unlikely to provide benefit to the patient and increases the risk of the development of drug-resistant bacteria.

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 antibacterial, patients can develop watery and bloody stools (with or without stomach cramps and fever) even as late as two or more months after having taken the last dose of the antibacterial. If this occurs, patients should contact their physician as soon as possible.

Laboratory Tests

During prolonged therapy with lincomycin injection, periodic liver and kidney function tests and blood counts should be performed.

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 in caution in patients receiving such agents.

Carcinogenesis, Mutagenesis, Impairment Of Fertility

The carcinogenic potential of lincomycin has not been evaluated.
Lincomycin was not found to be mutagenic in the Ames


Salmonella reversion assay or the V79 Chinese hamster lung cells at the HGPRT locus. It did not induce DNA strand breaks in V79 Chinese hamster lung cells as measured by alkaline elution or chromosomal abnormalities in cultured human lymphocytes.


In vivo, lincomycin was negative in both the rat and mouse micronucleus assays and it did not induce sex-linked recessive lethal mutations in the offspring of male


Drosophila. However, lincomycin did cause unscheduled DNA syntheses in freshly isolated rat hepatocytes.



Impairment of fertility was not observed in male or female rats given oral 300 mg/kg doses of lincomycin (0.36 times the highest recommended human dose based on mg/m


2).

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 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 revealed no ill effects related to pregnancy.
There was no evidence of teratogenicity when lincomycin was administered in diet or via oral gavage to pregnant Sprague Dawley rats during the period of major organogenesis at doses up to 5,000 mg/kg and 100 mg/kg (approximately 6 times and 0.12 times the maximum recommended human dose [MRHD], respectively, based on body surface area comparison).

Nonteratogenic Effects

However, 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 1,000 mg/kg (1.2 times the MRHD based on body surface area comparison) up to 2 generations.

Nursing Mothers

Lincomycin has been reported to appear in human milk in concentrations of 0.5 to 2.4 mcg/mL. Because of the potential for serious adverse reactions in nursing infants from lincomycin injection, a decision should be made whether to discontinue nursing, or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Lincomycin injection sterile solution 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).

Adverse Reactions

The following adverse reactions have been reported with the use of lincomycin.
Gastrointestinal disordersDiarrhea, nausea, vomiting, glossitis, stomatitis, abdominal pain, abdominal discomfort


†, anal pruritus



Skin and subcutaneous tissue disordersToxic epidermal necrolysis, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, dermatitis bullous, dermatitis exfoliative, erythema multiforme (see


WARNINGS), rash, urticaria, pruritus



Infections and infestationsVaginal infection, pseudomembranous colitis,


Clostridium difficile colitis (see


WARNINGS)



Blood and lymphatic system disordersPancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura
Immune system disordersAnaphylactic reaction (see


WARNINGS), angioedema, serum sickness



Hepatobiliary disordersJaundice, liver function test abnormal, transaminases increased
Renal and urinary disordersRenal impairment, oliguria, proteinuria, azotemia
Cardiac disordersCardio-respiratory arrest (see


DOSAGE AND ADMINISTRATION)



Vascular disordersHypotension (see


DOSAGE AND ADMINISTRATION), thrombophlebitis


†Ear and labyrinth disordersVertigo, tinnitus
Neurologic disordersHeadache, dizziness, somnolence
General disorders and administration site conditionsInjection 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 Athenex Pharmaceutical Division, LLC. at 1-855-273-0154 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

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

Dosage And Administration

If significant diarrhea occurs during therapy, this antibacterial 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.


DoseVol. DiluentTime600 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 this drug has been given at greater than the recommended concentration and rate.

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 diminished renal function:


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.

How Supplied

Lincomycin Injection, USP is supplied as follows:Lincomycin Injection, USPNDC(300 mg per mL)Package Factor70625-113-013,000 mg per 10 mL Single-Dose Vial1 vial per cartonEach mL of Lincomycin Injection, USP contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative.Discard unused portion.

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.

Animal Pharmacology

In vivo experimental animal studies demonstrated the effectiveness of lincomycin injection preparations (lincomycin) in protecting animals infected with
Streptococcus viridans, β-
hemolytic Streptococcus, Staphylococcus aureus, Streptococcus pneumoniae and
Leptospira pomona. It was ineffective in
Klebsiella, Pasteurella, Pseudomonas, Salmonella and
Shigella infections.
PHYSICAL COMPATIBILITIESPhysically compatible for 24 hours at room temperature unless otherwise indicated.Infusion Solutions5% Dextrose Injection10% Dextrose Injection5% Dextrose and 0.9% Sodium Chloride Injection10% Dextrose and 0.9% Sodium Chloride InjectionRinger's Injection1/
6 M Sodium Lactate Injection
Travert 10%-Electrolyte No. 1Dextran in Saline 6% w/vVitamins in Infusion SolutionsB-ComplexB-Complex with Ascorbic AcidAntibacterial in Infusion SolutionsPenicillin G Sodium (Satisfactory for 4 hours)CephalothinTetracycline HClCephaloridineColistimethate (Satisfactory for 4 hours)AmpicillinMethicillinChloramphenicolPolymyxin B SulfatePhysically Incompatible with:NovobiocinKanamycinIT SHOULD BE EMPHASIZED THAT THE COMPATIBLE AND INCOMPATIBLE DETERMINATIONS ARE PHYSICAL OBSERVATIONS ONLY, NOT CHEMICAL DETERMINATIONS. ADEQUATE CLINICAL EVALUATION OF THE SAFETY AND EFFICACY OF THESE COMBINATIONS HAS NOT BEEN PERFORMED.PETERSON PHARMACEUTICALS

Athenex
Mfd. for Peterson Athenex

Schaumburg, IL 60173 (USA)

Made in Taiwan

©2019 Athenex.
September 2019

* Please review the disclaimer below.