lincomycin hydrochloride 300 mg/mL
lincomycin hydrochloride · INJECTION, SOLUTION · Gland Pharma Limited
lincomycin hydrochloride is a injection, solution containing lincomycin hydrochloride at 300 mg/mL, taken intramuscular. Manufactured by Gland Pharma Limited.
Key Facts
- Brand Name
- lincomycin hydrochloride
- Generic Name
- lincomycin hydrochloride
- NDC Code (Product)
68083-478- Manufacturer
- Gland Pharma Limited
- Strength
- 300 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAMUSCULAR, INTRAVENOUS, SUBCONJUNCTIVAL
- Marketing Status
- Application #
- ANDA215657
- Marketing Start
- 09/26/2022
Recall History
No Recall HistorySide 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 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 selec…
Dosage & Administration
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…
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 Neurol…
Frequently Asked Questions
What is lincomycin hydrochloride used for?
lincomycin hydrochloride contains lincomycin hydrochloride. It is a injection, solution taken intramuscular. Consult your doctor for specific uses.
Is lincomycin hydrochloride a controlled substance?
lincomycin hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for lincomycin hydrochloride?
The generic name for lincomycin hydrochloride is lincomycin hydrochloride. There are 8 other brand versions of lincomycin hydrochloride.
What is the NDC code for lincomycin hydrochloride 300 mg/mL?
The NDC (National Drug Code) for lincomycin hydrochloride 300 mg/mL is 68083-478, listed by Gland Pharma Limited.