Daptomycin 500mg Inj, 1 Vial
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Lipopeptide Antibiotic
Pregnancy Category
Category B
FDA Approved
Sep 2003
DEA Schedule
Not Controlled
Overview
What is this medicine?
Daptomycin is an antibiotic used to treat serious bacterial infections, especially those caused by resistant bacteria like MRSA. It works by damaging the outer layer of the bacteria, causing them to die. It is given as an injection into a vein.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Adhere to the instructions carefully. This medication is administered intravenously 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 the appropriate course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Adhere to the instructions carefully. This medication is administered intravenously 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 the appropriate course of action.
Lifestyle & Tips
- Report any new or worsening muscle pain, tenderness, or weakness immediately to your doctor.
- Inform your doctor about all medications you are taking, especially cholesterol-lowering drugs (statins), as they may increase the risk of muscle problems.
- Stay well-hydrated unless otherwise instructed by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Complicated Skin and Skin Structure Infections (cSSSI): 4 mg/kg IV once every 24 hours. Staphylococcus aureus Bloodstream Infections (Bacteremia), including Right-Sided Infective Endocarditis: 6 mg/kg IV once every 24 hours.
Dose Range:
4 - 10 mg
Condition-Specific Dosing:
cSSSI:
4 mg/kg IV once every 24 hours for 7-14 days or until infection resolves.
S.aureus Bacteremia/Endocarditis:
6 mg/kg IV once every 24 hours for 2-6 weeks depending on infection site and resolution.
Pediatric Dosing
Neonatal:
Not established (limited data, generally not recommended)
Infant:
Not established (limited data, generally not recommended)
Child:
1 to <7 years: 9-12 mg/kg IV once every 24 hours. 7 to 17 years: 7-9 mg/kg IV once every 24 hours. Dosing varies by indication and weight.
Adolescent:
Same as adult dosing for cSSSI (4 mg/kg) and S. aureus bacteremia/endocarditis (6 mg/kg).
Dose Adjustments
Renal Impairment:
Mild:
No adjustment needed (CrCl > 50 mL/min)
Moderate:
No adjustment needed (CrCl 30-50 mL/min)
Severe:
CrCl < 30 mL/min: Administer once every 48 hours.
Dialysis:
Hemodialysis (HD) or Peritoneal Dialysis (PD): Administer once every 48 hours. If possible, administer after completion of HD session.
Hepatic Impairment:
Mild:
No adjustment needed
Moderate:
No adjustment needed
Severe:
No adjustment needed (pharmacokinetics not significantly altered)
Pharmacology
Mechanism of Action
Daptomycin is a cyclic lipopeptide antibiotic. It binds to bacterial cell membranes in a calcium-dependent manner, causing rapid depolarization of the membrane potential. This leads to inhibition of protein, DNA, and RNA synthesis, resulting in bacterial cell death. It exhibits rapid, concentration-dependent bactericidal activity against Gram-positive bacteria.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV administration, peak concentration at end of infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
0.09-0.11 L/kg
ProteinBinding:
90-92% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
8-10 hours (normal renal function)
Clearance:
7-9 mL/min/kg
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
78% (in urine)
Pharmacodynamics
OnsetOfAction:
Rapid (within minutes of infusion)
PeakEffect:
At end of infusion
DurationOfAction:
24 hours (due to once-daily dosing regimen and post-antibiotic effect)
Confidence:
High
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Feeling extremely tired or weak
Abnormal burning, numbness, or tingling sensations
Fever
Cough
Shortness of breath
Chest pain or pressure
Swelling
Muscle aches or weakness (in rare cases, a severe muscle problem with or without kidney problems may occur)
Diarrhea (especially if it is severe, bloody, or accompanied by stomach pain or cramps)
If you experience any of the following, contact your doctor right away:
Muscle pain or weakness
Dark urine
Trouble passing urine
Stomach pain, cramps, or very loose, watery, or bloody stools (which may be a sign of a severe form of diarrhea called C. diff-associated diarrhea, or CDAD)
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects and they bother you or do not go away, contact your doctor:
Headache
Stomach pain or diarrhea
Trouble sleeping
Excessive sweating
Sore throat
Vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Signs of high blood pressure, including:
+ Severe headache
+ Dizziness
+ Passing out
+ Changes in eyesight
Signs of kidney problems, such as:
+ Inability to pass urine
+ Changes in urine output
+ Blood in the urine
+ Sudden weight gain
Feeling extremely tired or weak
Abnormal burning, numbness, or tingling sensations
Fever
Cough
Shortness of breath
Chest pain or pressure
Swelling
Muscle aches or weakness (in rare cases, a severe muscle problem with or without kidney problems may occur)
Diarrhea (especially if it is severe, bloody, or accompanied by stomach pain or cramps)
If you experience any of the following, contact your doctor right away:
Muscle pain or weakness
Dark urine
Trouble passing urine
Stomach pain, cramps, or very loose, watery, or bloody stools (which may be a sign of a severe form of diarrhea called C. diff-associated diarrhea, or CDAD)
Other Possible Side Effects
Most people do not experience significant side effects, but some may occur. If you notice any of the following side effects and they bother you or do not go away, contact your doctor:
Headache
Stomach pain or diarrhea
Trouble sleeping
Excessive sweating
Sore throat
Vomiting
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe muscle pain or weakness
- Dark urine
- Numbness or tingling in hands or feet
- Persistent cough or shortness of breath
- Fever or chills that do not improve
- Rash or itching
- Signs of kidney problems (e.g., swelling in legs/feet, decreased urination)
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 conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Kidney disease, as this may affect how your body processes the medication.
Inability to break down fructose, a condition that may be exacerbated by certain ingredients in this medication, such as sorbitol. If you have this condition, taking a product with sorbitol can lead to severe and potentially life-threatening health issues.
Current use of any of the following medications: atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin, as these may interact with this medication.
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking.
Discuss any health problems you have, as these may affect the safety and efficacy of this medication.
Verify with your doctor that it is safe to take this medication in combination with your other medications and health conditions.
Never start, stop, or adjust the dose of any medication without first consulting your doctor.
It is essential to inform your doctor about the following conditions to ensure safe treatment:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the allergic reaction you experienced.
Kidney disease, as this may affect how your body processes the medication.
Inability to break down fructose, a condition that may be exacerbated by certain ingredients in this medication, such as sorbitol. If you have this condition, taking a product with sorbitol can lead to severe and potentially life-threatening health issues.
Current use of any of the following medications: atorvastatin, fluvastatin, lovastatin, pitavastatin, pravastatin, rosuvastatin, or simvastatin, as these may interact with this medication.
Please note that this is not an exhaustive list of potential interactions. To ensure your safety, it is crucial to:
Inform your doctor and pharmacist about all prescription and over-the-counter medications, natural products, and vitamins you are taking.
Discuss any health problems you have, as these may affect the safety and efficacy of this medication.
Verify with your doctor that it is safe to take this medication in combination with your other medications and health conditions.
Never start, stop, or adjust the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. This drug may interfere with certain laboratory tests, so be sure to notify your healthcare providers and lab personnel that you are taking it.
Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Discuss any concerns or questions you have with your doctor. Do not take this medication for a longer period than prescribed, as this may increase the risk of a second infection.
A severe and potentially life-threatening reaction, known as a hypersensitivity reaction, has been reported in some cases. This reaction may be characterized by symptoms such as fever, rash, or swollen glands, accompanied by problems in various organs, including the liver, kidney, blood, heart, muscles and joints, or lungs. If you have any questions or concerns, consult your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not recommended for children under 12 months of age, as it may increase the risk of muscle and nerve problems. However, your child's doctor may determine that the benefits of taking this medication outweigh the risks. If your child has been prescribed this medication, ask their doctor to discuss the potential benefits and risks. If you have any questions or concerns, consult your child's doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication to both you and your baby.
Regular blood tests will be necessary to monitor your condition, as directed by your doctor. Discuss any concerns or questions you have with your doctor. Do not take this medication for a longer period than prescribed, as this may increase the risk of a second infection.
A severe and potentially life-threatening reaction, known as a hypersensitivity reaction, has been reported in some cases. This reaction may be characterized by symptoms such as fever, rash, or swollen glands, accompanied by problems in various organs, including the liver, kidney, blood, heart, muscles and joints, or lungs. If you have any questions or concerns, consult your doctor.
If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.
This medication is not recommended for children under 12 months of age, as it may increase the risk of muscle and nerve problems. However, your child's doctor may determine that the benefits of taking this medication outweigh the risks. If your child has been prescribed this medication, ask their doctor to discuss the potential benefits and risks. If you have any questions or concerns, consult your child's doctor.
If you are pregnant, planning to become pregnant, or breastfeeding, inform your doctor. You will need to discuss the potential benefits and risks of taking this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Increased CPK levels
- Muscle pain or weakness
- Peripheral neuropathy
What to Do:
There is no specific antidote. Treatment is supportive. Hemodialysis removes approximately 15% of the dose in 4 hours. Contact a poison control center (1-800-222-1222) or seek emergency medical attention.
Drug Interactions
Major Interactions
- HMG-CoA Reductase Inhibitors (Statins): Increased risk of myopathy and rhabdomyolysis. Consider temporary discontinuation of statins during daptomycin therapy.
- Warfarin: Potential for altered INR. Monitor INR closely if co-administered.
Moderate Interactions
- Tobramycin: Potential for increased daptomycin levels and/or nephrotoxicity (though clinical significance is unclear, monitor renal function).
- Other nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, amphotericin B): Increased risk of renal toxicity. Monitor renal function.
Monitoring
Baseline Monitoring
Creatine Phosphokinase (CPK)
Rationale: To establish baseline muscle enzyme levels before initiating therapy, as daptomycin can cause myopathy.
Timing: Prior to first dose
Renal Function (Serum Creatinine, BUN, CrCl)
Rationale: Daptomycin is primarily renally eliminated; baseline assessment is crucial for appropriate dosing and to monitor for potential nephrotoxicity.
Timing: Prior to first dose
Liver Function Tests (ALT, AST, Bilirubin)
Rationale: Although not significantly metabolized by the liver, baseline assessment is good practice.
Timing: Prior to first dose
Routine Monitoring
Creatine Phosphokinase (CPK)
Frequency: At least weekly (more frequently if symptoms of myopathy occur or if CPK is elevated at baseline)
Target: Within normal limits (typically < 200 U/L or < 5x ULN)
Action Threshold: Discontinue daptomycin if CPK âĨ 5x ULN with muscle symptoms or âĨ 10x ULN without muscle symptoms.
Renal Function (Serum Creatinine, BUN)
Frequency: At least weekly (more frequently in patients with pre-existing renal impairment or on concomitant nephrotoxic drugs)
Target: Within patient's baseline range
Action Threshold: Adjust dose for CrCl < 30 mL/min; consider discontinuation if significant acute kidney injury develops.
Signs and Symptoms of Myopathy
Frequency: Daily patient assessment
Target: Absence of muscle pain, tenderness, weakness
Action Threshold: Investigate new or worsening muscle symptoms; check CPK immediately.
Symptom Monitoring
- Muscle pain
- Muscle tenderness
- Muscle weakness
- Numbness or tingling (peripheral neuropathy)
- Fever
- Rash
- Shortness of breath or cough (eosinophilic pneumonia)
- Signs of kidney problems (e.g., decreased urine output, swelling)
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but human data limited.
Second Trimester:
Low risk based on animal data, but human data limited.
Third Trimester:
Low risk based on animal data, but human data limited.
Lactation
L3 (Moderately Safe). Daptomycin is excreted in human milk in low concentrations. The amount ingested by a breastfed infant is small. Monitor infant for gastrointestinal disturbances (e.g., diarrhea, candidiasis) and potential effects on gut flora.
Infant Risk:
Low risk of adverse effects, but potential for altered gut flora or allergic sensitization.
Pediatric Use
Approved for pediatric patients 1 to 17 years of age for cSSSI and S. aureus bacteremia/endocarditis. Dosing is weight-based and varies by age group. Safety and efficacy in neonates and infants <1 year have not been established.
Geriatric Use
No overall differences in safety or effectiveness were observed between elderly and younger subjects, but greater sensitivity of some older individuals cannot be ruled out. Dose adjustment based on renal function is important in this population.
Clinical Information
Clinical Pearls
- Daptomycin is inactivated by pulmonary surfactant, therefore it is NOT indicated for the treatment of pneumonia.
- Always monitor CPK levels weekly (or more frequently if indicated) due to the risk of myopathy and rhabdomyolysis.
- Consider holding statins during daptomycin therapy to minimize the risk of muscle toxicity.
- Ensure appropriate renal dose adjustments are made for patients with CrCl < 30 mL/min.
- Administer as an IV infusion over 30 minutes (or 2 minutes for IV push, though infusion is preferred).
- It is highly effective against resistant Gram-positive organisms, including MRSA and VRE.
Alternative Therapies
- Vancomycin (for MRSA, VRE)
- Linezolid (for MRSA, VRE)
- Tedizolid (for MRSA)
- Ceftaroline (for MRSA)
- Tigecycline (for cSSSI, not bacteremia)
- Dalbavancin (for cSSSI)
- Oritavancin (for cSSSI)
Cost & Coverage
Average Cost:
Varies widely, typically $500-$1000+ per 500mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 3 or 4 (Specialty Drug) - Requires prior authorization and/or step therapy for most insurance plans.
General Drug Facts
If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. 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. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or drain. If you are unsure about the proper disposal method, consult your pharmacist for guidance. Many communities offer drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. 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 was taken to ensure prompt and effective treatment.