Lincomycin 300 mg/mL
Lincomycin · INJECTION, SOLUTION · Micro Labs Limited
Lincomycin is a injection, solution containing lincomycin at 300 mg/mL, taken intramuscular. Manufactured by Micro Labs Limited.
Key Facts
- Brand Name
- Lincomycin
- Generic Name
- Lincomycin
- NDC Code (Product)
42571-374- Manufacturer
- Micro Labs Limited
- Strength
- 300 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS
- Marketing Status
- Application #
- ANDA215082
- Marketing Start
- 02/01/2022
Recall History
US Compounding Inc
Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
American Pharmaceutical Ingredients LLC
CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Attix Pharmaceuticals
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Main Street Family Pharmacy, LLC
The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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 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 and other antibacterial drugs, lincomycin 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 antibacteria…
Dosage & Administration
DOSAGE AND ADMINISTRATION If significant diarrhea occurs during therapy, lincomycin 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) 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 30…
Warnings
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. Hypersensiti…
Contraindications
CONTRAINDICATIONS Lincomycin injection is contraindicated in patients previously found to be hypersensitive to lincomycin or clindamycin.
Drug Interactions
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.
Adverse Reactions
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 Neurologi…
Frequently Asked Questions
What is Lincomycin used for?
Lincomycin contains Lincomycin. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is Lincomycin a controlled substance?
Lincomycin is not classified as a controlled substance by the DEA.
What is the generic name for Lincomycin?
The generic name for Lincomycin is Lincomycin. There are 7 other brand versions of Lincomycin.
What is the NDC code for Lincomycin 300 mg/mL?
The NDC (National Drug Code) for Lincomycin 300 mg/mL is 42571-374, listed by Micro Labs Limited.