Lincomycin

Lincomycin Hydrochloride


Henry Schein, Inc.
Human Prescription Drug
NDC 0404-9901
Lincomycin also known as Lincomycin Hydrochloride is a human prescription drug labeled by 'Henry Schein, Inc.'. National Drug Code (NDC) number for Lincomycin is 0404-9901. This drug is available in dosage form of Injection, Solution. The names of the active, medicinal ingredients in Lincomycin drug includes Lincomycin Hydrochloride - 300 mg/mL . The currest status of Lincomycin drug is Active.

Drug Information:

Drug NDC: 0404-9901
The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
Proprietary Name: Lincomycin
Also known as the trade name. It is the name of the product chosen by the labeler.
Product Type: Human Prescription Drug
Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing.
Non Proprietary Name: Lincomycin Hydrochloride
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Henry Schein, Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Injection, Solution
The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources.
Status: Active
FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved.
Substance Name:LINCOMYCIN HYDROCHLORIDE - 300 mg/mL
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.
Route Details:INTRAMUSCULAR
INTRAVENOUS
SUBCONJUNCTIVAL
The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Marketing Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Marketing Category: ANDA
Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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.
Marketing Start Date: 12 Jan, 2022
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 21 Dec, 2025
This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached.
Application Number: ANDA201746
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.
Listing Expiration Date: 31 Dec, 2023
This is the date when the listing record will expire if not updated or certified by the firm.

OpenFDA Information:

An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
Manufacturer Name:Henry Schein, Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:239212
The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms.
UNII:M6T05Z2B68
Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
0404-9901-101 VIAL in 1 BAG (0404-9901-10) / 10 mL in 1 VIAL12 Jan, 2022N/ANo
Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together.

Product Elements:

Lincomycin lincomycin hydrochloride lincomycin hydrochloride lincomycin benzyl alcohol

Boxed Warning:

Boxed warninig 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.

Warnings:

Warnings see warning box. 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. appro
priate fluid and electrolyte management, protein supplementation, antibacterial treatment of c. difficile, and surgical evaluation should be instituted as clinically indicated. hypersensitivity serious hypersensitivity reactions, including anaphylaxis and erythema multiforme, have been reported with use of lincomycin injection. if an allergic reaction to lincomycin occurs, discontinue the drug. (see adverse reactions ) benzyl alcohol toxicity in pediatric patients ("gasping syndrome") lincomycin injection sterile solution 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 kidney's 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, levels of lincomycin in the csf may be inadequate for the treatment of meningitis.

Dosage and Administration:

Dosage and adminisration if significant diarrhea occurs during therapy, this antibacterial should be discontinued. (see warning box.) 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. 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 levels of antibacterial (lasting for at least 5 hours) with mics sufficient for most susceptible pathogens. patients with diminished renal function: when therapy with lincomycin is required in individuals with severe impairment of renal function, an appropriate dose is 25 to 30% of that recommended for patients with normally functioning kidneys. image2.jpg

Contraindications:

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

Adverse Reactions:

Adverse reactions the following reactions have been reported with the use of lincomycin and are listed by system organ class. frequencies are defined as: commom (≥1% and<10%) uncommon (≥0.1% and <1%), rare (≥0.01% and <0.1%) and not known (cannot be estimated from the available data). gastrointestinal disorders common: persistent diarrhea (4.3%), nausea (1.8%), vomiting (1.6%) rare: stomatitis (0.04%) not known: glossitis, abdominal discomfort, and pruritus skin and subcutaneous tissue disorders uncommon: rash (0.8%), urticaria (0.1%) rare: pruritus (0.4%) infections and infestations uncommon: vaginal infection (0.12%) not known: pseudomembranous colitis, clostridium difficile colitis (see warnings ) blood and lymphatic system disorders not known: pancytopenia, agranulocytosis, aplastic anemia, leukopenia, neutropenia, thrombocytopenic purpura immune system disorders not known: anaphylactic reaction (see warnings ) angioedema, serum sickness hepatobiliary disorders not k
nown: jaundice, liver function test abnormal, transaminases increased renal and urinary disorders not known: renal impairment, oliguria, proteinuria, azotemia ¹no direct relationship of lincocin to renal damage has been established. cardiac disorders not known: cardio-respiratory arrest (see dosage and administration) vascular disorders not known: hypotension (see dosage and administration ), thrombophlebitis² ²event has been reported with intravenous injection. ear and labyrinth disorders not known: vertigo, tinnitus not known: injection site abscess sterile³, injection site induration³, injection site pain³, injection site irritation³ ³reported with intramuscular injection.

Overdosage:

Overdosage serum levels of lincomycin are not appreciably affected by hemodialysis and peritoneal dialysis.

Description:

Description lincomycin injection is a sterile solution which 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 c18h34n2o6s.hcl.h2o 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. image1.jpg

Clinical Pharmacology:

Clinical pharmacology intramuscular administration of a single dose of 600 mg of lincomycin produces average peak serum concentrations of 11.6 µg/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 µg/ml and yields 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 impairment of renal function compared to patients with normal renal function. in patients with abnormal hepatic function, 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 level concentrations indicate that bile is an important route of excretion. significant concentrations have been demonstrated in the majority of body tissues. although lincomycin appears to diffuse into cerebrospinal fluid (csf), concentrations of lincomycin in the csf appear inadequate for the treatment of meningitis. microbiology: lincomycin has been shown to be active against most strains of the following organisms both in vitro and in clinical infections: (see indications and usage). staphylococcus aureus streptococcus pneumoniae the 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 diphtheriae streptococcus pyogenes viridans group streptococci anaerobic bacteria: clostridium tetani clostridium perfringens 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 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. there are currently no antimicrobial susceptibility testing (ast) interpretive criteria for lincomycin.

Clinical Studies:

Clinical studies experience with 345 obstetrical patients receiving this drug revealed no ill effects related to pregnancy. (see precautions, pregnancy )

How Supplied:

How supplied lincomycin injection, usp is available in the following strength and package sizes: 300 mg/ml 2 ml vials ndc 39822-0350-1 packaged as 10 vials per carton ndc 39822-0350-2 10 ml vials ndc 39822-0353-5 packaged as 10 vials per carton ndc 39822-0353-6 each ml of lincomycin injection, usp contains lincomycin hydrochloride equivalent to lincomycin 300 mg; also benzyl alcohol, 9.45 mg added as preservative. store at controlled room temperature 20° to 25°c (68° to 77°f) [see usp] product repackaged by: henry schein, inc., bastian, va 24314 from original manufacturer/distributor's ndc and unit of sale to henry schein repackaged product ndc and unit of sale total strength/total volume (concentration) per unit ndc 39822-0353-6 10 pack ndc 0404-9901-10 1 10 ml vial in a bag (vial bears ndc 39822-0353-5) 300 mg/ml

Package Label Principal Display Panel:

Sample package label label1.jpg


Comments/ Reviews:

* Data of this site is collected from www.fda.gov. This page is for informational purposes only. Always consult your physician with any questions you may have regarding a medical condition.