Lincomycin 300mg/ml Inj, 2ml

Manufacturer X-GEN PHARMACEUTICALS, INC Active Ingredient Lincomycin(lin koe MYE sin) Pronunciation lin koe MYE sin
WARNING: Diarrhea is common with antibiotics. Rarely, a severe form called C diff?associated diarrhea (CDAD) may happen. Sometimes, this has led to a deadly bowel problem. CDAD may happen during or a few months after taking antibiotics. Call your doctor right away if you have stomach pain, cramps, or very loose, watery, or bloody stools. Check with your doctor before treating diarrhea.This drug must only be used for very bad bacterial infections, and when other drugs cannot be used. Talk with the doctor to be sure that the benefits of this drug are more than the risks. @ COMMON USES: It is used to treat bacterial infections.
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Drug Class
Antibiotic
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Pharmacologic Class
Lincosamide antibiotic; Protein synthesis inhibitor
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Pregnancy Category
Category C
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FDA Approved
Dec 1964
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Lincomycin is an antibiotic medicine given by injection to treat serious bacterial infections. It works by stopping the growth of bacteria.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully. This medication is administered either as an injection into a muscle or as an infusion into a vein over a specified period.

Storing and Disposing of Your Medication

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.

Missing a Dose

If you miss a dose, contact your doctor to receive guidance on what to do next.
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Lifestyle & Tips

  • Complete the full course of treatment as prescribed, even if you start feeling better, to prevent the infection from returning and to reduce the risk of antibiotic resistance.
  • Report any severe or persistent diarrhea, especially if it's watery or bloody, as this could be a sign of a serious bowel infection (C. difficile).
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Available Forms & Alternatives

Dosing & Administration

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Adult Dosing

Standard Dose: IM: 600 mg every 12-24 hours; IV: 600 mg every 8-12 hours
Dose Range: 600 - 1000 mg

Condition-Specific Dosing:

severeInfections: IM: 600 mg every 8 hours; IV: 1 g every 8-12 hours (up to 8 g/day)
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Pediatric Dosing

Neonatal: Not established (contraindicated in neonates due to benzyl alcohol preservative)
Infant: IM: 10 mg/kg every 12-24 hours; IV: 10-20 mg/kg/day in 2-3 divided doses (for infants >1 month)
Child: IM: 10 mg/kg every 12-24 hours; IV: 10-20 mg/kg/day in 2-3 divided doses (for children >1 month)
Adolescent: IM: 10 mg/kg every 12-24 hours; IV: 10-20 mg/kg/day in 2-3 divided doses (for adolescents >1 month)
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for mild impairment.
Moderate: Consider dose reduction (e.g., 25-30% of normal dose) or increased dosing interval.
Severe: Reduce dose to 25-30% of normal dose or extend dosing interval (e.g., every 12-24 hours).
Dialysis: Hemodialysis removes lincomycin to some extent; administer dose after dialysis.

Hepatic Impairment:

Mild: No specific adjustment needed for mild impairment.
Moderate: Consider dose reduction (e.g., 25-30% of normal dose) or increased dosing interval.
Severe: Reduce dose to 25-30% of normal dose or extend dosing interval (e.g., every 12-24 hours).

Pharmacology

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Mechanism of Action

Lincomycin binds to the 50S ribosomal subunit of susceptible bacteria, primarily at the A and P sites, thereby inhibiting bacterial protein synthesis. This action is primarily bacteriostatic, but may be bactericidal at higher concentrations against highly susceptible organisms.
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Pharmacokinetics

Absorption:

Bioavailability: 90-100% (IM)
Tmax: 0.5-1 hour (IM)
FoodEffect: Not applicable for injectable formulation

Distribution:

Vd: 0.3-0.4 L/kg
ProteinBinding: 72%
CnssPenetration: Limited (increases with meningeal inflammation)

Elimination:

HalfLife: 4.4-6.4 hours (normal renal function)
Clearance: Not available
ExcretionRoute: Renal (10-20% unchanged), Biliary/Fecal (40-50%)
Unchanged: 10-20%
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Pharmacodynamics

OnsetOfAction: Rapid (IV), within 30 minutes (IM)
PeakEffect: Within 30 minutes (IV), 30-60 minutes (IM)
DurationOfAction: 6-8 hours (based on dosing interval)
Confidence: Medium

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek immediate medical attention:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin (with or without fever)
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Urination problems, such as inability to pass urine or changes in urine output
Yellowing of the skin or eyes (jaundice)
Mouth irritation or mouth sores
Ringing in the ears (tinnitus)
Pale skin
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Vaginal itching or discharge
Chest pain or pressure
Severe dizziness or fainting
Severe skin reactions, including:
+ Stevens-Johnson syndrome (SJS)
+ Toxic epidermal necrolysis (TEN)
+ Other severe skin reactions, characterized by:
- Red, swollen, blistered, or peeling skin (with or without fever)
- Skin irritation
- Red or irritated eyes
- Sores in the mouth, throat, nose, or eyes

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects, or if they persist or bother you, contact your doctor:

Diarrhea
Upset stomach or vomiting
Stomach pain
Dizziness or drowsiness
Headache
* Irritation at the injection site

This is not an exhaustive list of potential side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe, watery, or bloody diarrhea
  • Abdominal pain or cramping
  • Fever
  • Skin rash, itching, or hives
  • Swelling of the face, lips, tongue, or throat
  • Difficulty breathing or swallowing
  • Unusual tiredness or weakness
  • Yellowing of the skin or eyes (jaundice)
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, any of its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you are currently using any products that contain erythromycin.

This list is not exhaustive, and it is crucial to discuss all your medications, health conditions, and potential interactions with your doctor. Please provide your doctor and pharmacist with a comprehensive list of:

All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Your existing health problems

Before starting, stopping, or changing the dose of any medication, including this one, consult with your doctor to ensure your safety. It is vital to verify that it is safe to take this medication in combination with your other medications and health conditions.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. If you are taking this drug for an extended period, your doctor may recommend regular blood tests to monitor your condition.

Do not exceed the prescribed duration of treatment, as this may increase the risk of a second infection. Older adults, particularly those 65 years or older, should use this medication with caution, as they may be more susceptible to side effects.

This medication contains benzyl alcohol, which can be harmful to newborns and infants. If possible, avoid using products containing benzyl alcohol in these age groups, as high doses or combination with other benzyl alcohol-containing products can lead to serious side effects. If you have concerns, consult your doctor.

If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. They will discuss the potential benefits and risks of this medication to you and your baby, helping you make an informed decision.
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Overdose Information

Overdose Symptoms:

  • Gastrointestinal upset (nausea, vomiting, diarrhea)
  • Hypotension (low blood pressure)
  • Respiratory depression (especially if co-administered with neuromuscular blockers)

What to Do:

Seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222). Treatment is supportive and symptomatic. Hemodialysis and peritoneal dialysis are not effective in removing lincomycin from the blood.

Drug Interactions

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Major Interactions

  • Neuromuscular blocking agents (e.g., succinylcholine, rocuronium): Lincomycin may enhance the neuromuscular blocking effects, leading to respiratory depression or paralysis.
  • Erythromycin: Antagonistic effect; should not be administered concurrently.
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Moderate Interactions

  • Kaolin-pectin (if oral lincomycin were used): Decreases absorption of lincomycin.
  • Typhoid vaccine (live): Antibiotics may reduce the therapeutic effect of live bacterial vaccines.

Monitoring

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Baseline Monitoring

Renal function (BUN, creatinine)

Rationale: To establish baseline and guide dose adjustments in renal impairment.

Timing: Prior to initiation of therapy

Hepatic function (ALT, AST, bilirubin)

Rationale: To establish baseline and guide dose adjustments in hepatic impairment.

Timing: Prior to initiation of therapy

Complete Blood Count (CBC) with differential

Rationale: To establish baseline and monitor for potential hematologic abnormalities (e.g., leukopenia, neutropenia, thrombocytopenia) with prolonged therapy.

Timing: Prior to initiation of therapy

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Routine Monitoring

Renal function (BUN, creatinine)

Frequency: Periodically, especially with prolonged therapy or in patients with pre-existing renal impairment.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant increase in creatinine or BUN may warrant dose adjustment.

Hepatic function (ALT, AST)

Frequency: Periodically, especially with prolonged therapy or in patients with pre-existing hepatic impairment.

Target: Within normal limits or stable from baseline.

Action Threshold: Significant elevation may warrant dose adjustment or discontinuation.

Complete Blood Count (CBC) with differential

Frequency: Weekly or bi-weekly for prolonged therapy (e.g., >2 weeks).

Target: Within normal limits.

Action Threshold: Significant decrease in WBC, neutrophils, or platelets may require discontinuation.

Bowel movements/Stool consistency

Frequency: Daily

Target: Normal bowel habits.

Action Threshold: Development of severe, persistent diarrhea, abdominal pain, or fever should prompt evaluation for Clostridioides difficile-associated diarrhea (CDAD).

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Symptom Monitoring

  • Severe or persistent diarrhea
  • Abdominal pain or cramping
  • Fever
  • Rash or hives
  • Difficulty breathing or swallowing (signs of allergic reaction)
  • Muscle weakness (if co-administered with neuromuscular blockers)

Special Patient Groups

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Pregnancy

Lincomycin is classified as Pregnancy Category C. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown some adverse effects, but there are no adequate and well-controlled studies in pregnant women.

Trimester-Specific Risks:

First Trimester: Potential for fetal harm, use only if clearly indicated.
Second Trimester: Potential for fetal harm, use only if clearly indicated.
Third Trimester: Potential for fetal harm, use only if clearly indicated.
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Lactation

Lincomycin is excreted in breast milk. Caution should be exercised when lincomycin is administered to a nursing woman. Monitor breastfed infants for potential adverse effects such as diarrhea, candidiasis (thrush), or allergic reactions.

Infant Risk: L3 (Moderately safe - there have been no controlled studies in breastfeeding women, but the risk of adverse effects to the infant is possible. Use should be weighed against the benefits.)
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Pediatric Use

Lincomycin injection contains benzyl alcohol as a preservative, which has been associated with a fatal 'gasping syndrome' in premature infants and neonates. Therefore, it is contraindicated in neonates. For infants >1 month and children, dosing is weight-based, and caution is advised due to potential for adverse effects.

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Geriatric Use

No specific dose adjustment is required based solely on age. However, elderly patients are more likely to have decreased renal or hepatic function, which may necessitate dose adjustments as outlined in the renal and hepatic impairment sections. Elderly patients may also be more susceptible to the development of CDAD.

Clinical Information

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Clinical Pearls

  • Lincomycin is a lincosamide antibiotic, similar to clindamycin, but generally less potent and less commonly used as a first-line agent.
  • It is effective against many Gram-positive bacteria, including staphylococci, streptococci, and pneumococci, and some anaerobes.
  • Often considered for patients with penicillin allergies, particularly for bone and joint infections, or certain skin and soft tissue infections.
  • Administer IV infusions slowly (over at least 1 hour per gram) to avoid hypotension and cardiopulmonary arrest.
  • Always be vigilant for signs and symptoms of Clostridioides difficile-associated diarrhea (CDAD), which can range from mild diarrhea to fatal colitis.
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Alternative Therapies

  • Clindamycin (another lincosamide, more commonly used)
  • Vancomycin (for MRSA or severe Gram-positive infections)
  • Linezolid (for resistant Gram-positive infections)
  • Daptomycin (for resistant Gram-positive infections)
  • Beta-lactam antibiotics (e.g., penicillins, cephalosporins) if patient is not allergic and susceptible.
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Cost & Coverage

Average Cost: Relatively inexpensive per vial
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others or take someone else's medication. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly; do not flush them down the toilet or pour them down the drain unless instructed to do so by a healthcare professional or pharmacist. If you are unsure about the correct disposal method, consult your pharmacist, as they can provide guidance on available drug take-back programs in your area. Additionally, some medications may come with a separate patient information leaflet, which can be obtained from your pharmacist. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it occurred, as this will aid in providing appropriate treatment.