Daptomycin 350mg For Iv Solution
It is used to treat bacterial infections.
Drug Class
Antibiotic
Pharmacologic Class
Cyclic Lipopeptide Antibacterial
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 affecting the skin or bloodstream, caused by certain types of bacteria. It works by damaging the outer layer of the bacteria, causing them to die.
How to Use This Medicine
To use this medication correctly, follow your doctor's instructions and carefully read all accompanying information. Adhere to the dosage instructions provided by your healthcare team. This medication is administered intravenously over a specified period.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor promptly to receive guidance on the appropriate course of action.
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist to determine the proper storage procedure.
In the event that you miss a dose, contact your doctor promptly 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.
- Stay well-hydrated unless otherwise instructed by your doctor.
- Inform your doctor about all medications you are taking, especially cholesterol-lowering drugs (statins), as they may need to be temporarily stopped.
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 Bacteremia (including Right-Sided Infective Endocarditis): 6 mg/kg IV once every 24 hours.
Dose Range:
4 - 6 mg
Condition-Specific Dosing:
complicated_skin_and_skin_structure_infections:
4 mg/kg IV once every 24 hours for 7-14 days or until infection resolution.
staphylococcus_aureus_bacteremia_including_right_sided_infective_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 avoided due to potential for muscle toxicity in neonates).
Infant:
Not established (limited data, generally avoided due to potential for muscle toxicity in infants < 1 year).
Child:
1 to < 7 years: cSSSI: 10 mg/kg IV once every 24 hours. S. aureus bacteremia: 12 mg/kg IV once every 24 hours. 7 to 11 years: cSSSI: 7 mg/kg IV once every 24 hours. S. aureus bacteremia: 9 mg/kg IV once every 24 hours.
Adolescent:
12 to 17 years: cSSSI: 5 mg/kg IV once every 24 hours. S. aureus bacteremia: 7 mg/kg IV once every 24 hours.
Dose Adjustments
Renal Impairment:
Mild:
No dosage adjustment required (CrCl 50-80 mL/min).
Moderate:
No dosage adjustment required (CrCl 30-49 mL/min).
Severe:
For CrCl < 30 mL/min (including hemodialysis and CAPD patients): Administer 4 mg/kg (for cSSSI) or 6 mg/kg (for S. aureus bacteremia) once every 48 hours.
Dialysis:
Administer dose after dialysis on dialysis days for patients receiving hemodialysis. For CAPD, administer once every 48 hours.
Hepatic Impairment:
Mild:
No dosage adjustment required.
Moderate:
No dosage adjustment required.
Severe:
No dosage adjustment required.
Pharmacology
Mechanism of Action
Daptomycin is a cyclic lipopeptide antibacterial. It inserts into the bacterial cell membrane in a calcium-dependent manner, leading to rapid depolarization of the membrane potential. This disruption of membrane function inhibits protein, DNA, and RNA synthesis, ultimately resulting in bacterial cell death. It is bactericidal.
Pharmacokinetics
Absorption:
Bioavailability:
100% (administered intravenously)
Tmax:
Approximately 0.7 hours (at end of 30-minute infusion)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.1 L/kg
ProteinBinding:
Approximately 92% (primarily to albumin)
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 8-9 hours (in subjects with normal renal function)
Clearance:
Approximately 7-9 mL/hr/kg
ExcretionRoute:
Primarily renal (78% of dose excreted in urine as unchanged drug)
Unchanged:
Approximately 78%
Pharmacodynamics
OnsetOfAction:
Rapid (bactericidal activity observed within hours)
PeakEffect:
Not directly applicable as it's a concentration-dependent killer, but peak concentrations are achieved at the end of infusion.
DurationOfAction:
Sustained bactericidal activity due to post-antibiotic effect and once-daily dosing.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Immediately
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 medical attention right away:
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
+ Fainting
+ Changes in vision
Signs of kidney problems, such as:
+ Inability to urinate
+ 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 (common with antibiotics, but rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem)
If you experience any of the following, contact your doctor immediately:
Muscle pain or weakness
Dark urine
Trouble urinating
Stomach pain, cramps, or very loose, watery, or bloody stools (CDAD may occur during or after taking antibiotics)
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any others that 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, 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.
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 medical attention right away:
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
+ Fainting
+ Changes in vision
Signs of kidney problems, such as:
+ Inability to urinate
+ 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 (common with antibiotics, but rarely, a severe form called C. diff-associated diarrhea (CDAD) may occur, which can lead to a life-threatening bowel problem)
If you experience any of the following, contact your doctor immediately:
Muscle pain or weakness
Dark urine
Trouble urinating
Stomach pain, cramps, or very loose, watery, or bloody stools (CDAD may occur during or after taking antibiotics)
Other Possible Side Effects
Like all medications, this drug may cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any others that 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, 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, tenderness, or weakness
- Dark, reddish, or cola-colored urine
- Fever
- Unusual tiredness or fatigue
- Numbness or tingling sensations
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, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
If you have a condition that prevents you from breaking down fructose, a type of sugar. Some formulations of this medication contain sorbitol, which can cause severe and potentially life-threatening health issues in individuals with this condition.
If you are currently taking any of the following medications:
+ Atorvastatin
+ Fluvastatin
+ Lovastatin
+ Pitavastatin
+ Pravastatin
+ Rosuvastatin
+ Simvastatin
Please note that this is not an exhaustive list of all potential interactions.
To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to assess potential interactions and determine whether it is safe for you to take this medication. Never start, stop, or adjust the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about the following:
Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced.
If you have kidney disease, as this may affect how your body processes the medication.
If you have a condition that prevents you from breaking down fructose, a type of sugar. Some formulations of this medication contain sorbitol, which can cause severe and potentially life-threatening health issues in individuals with this condition.
If you are currently taking any of the following medications:
+ Atorvastatin
+ Fluvastatin
+ Lovastatin
+ Pitavastatin
+ Pravastatin
+ Rosuvastatin
+ Simvastatin
Please note that this is not an exhaustive list of all potential interactions.
To ensure your safety, it is crucial to disclose all of your medications, including prescription and over-the-counter drugs, natural products, and vitamins, as well as any health problems you may have. Your doctor and pharmacist need this information to assess potential interactions and determine whether it is safe for you to take this medication. Never start, stop, or adjust the dosage 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 in this age group. 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 about giving this medication to your child, consult their doctor.
If you are pregnant, plan to become pregnant, or are 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 in this age group. 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 about giving this medication to your child, consult their doctor.
If you are pregnant, plan to become pregnant, or are 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
- Rhabdomyolysis
- Renal impairment
What to Do:
There is no specific antidote for daptomycin overdose. Treatment should be supportive. Hemodialysis may remove daptomycin from the body (approximately 15% of dose removed in 4 hours). Contact a poison control center (e.g., 1-800-222-1222) for specific guidance.
Drug Interactions
Major Interactions
- HMG-CoA Reductase Inhibitors (Statins): Concomitant use may increase the risk of myopathy and rhabdomyolysis. Consider temporary discontinuation of statin therapy during daptomycin treatment.
Moderate Interactions
- Warfarin: Although not a direct pharmacokinetic interaction, post-marketing reports suggest potential for increased INR or bleeding events. Monitor INR closely.
- Tobramycin: Potential for increased nephrotoxicity when co-administered with other nephrotoxic agents. Monitor renal function.
- Other Nephrotoxic Drugs (e.g., NSAIDs, aminoglycosides, cyclosporine): Increased risk of renal impairment. Monitor renal function.
Monitoring
Baseline Monitoring
Creatine Phosphokinase (CPK)
Rationale: To establish baseline levels before initiating therapy, as daptomycin can cause muscle toxicity.
Timing: Prior to first dose
Renal Function (Serum Creatinine, BUN, CrCl)
Rationale: Daptomycin is primarily renally eliminated, and dosage adjustments are required in severe renal impairment.
Timing: Prior to first dose
Routine Monitoring
Creatine Phosphokinase (CPK)
Frequency: At least once weekly, or more frequently if muscle pain/weakness develops.
Target: Normal range (typically < 200 U/L or institution-specific normal)
Action Threshold: Discontinue daptomycin if CPK levels are âĨ 5 times the upper limit of normal (ULN) or if CPK levels are âĨ 1000 U/L in the absence of symptoms, or if CPK levels are âĨ 5 times ULN with muscle symptoms.
Renal Function (Serum Creatinine, BUN)
Frequency: Periodically, especially in patients with pre-existing renal impairment or those receiving concomitant nephrotoxic agents.
Target: Within patient's baseline or normal limits
Action Threshold: Adjust dose if CrCl falls below 30 mL/min; consider discontinuation if acute kidney injury develops.
Symptom Monitoring
- Muscle pain
- Muscle tenderness
- Muscle weakness
- Tingling or numbness (paresthesia)
- Fever
- Dark urine (suggestive of rhabdomyolysis)
Special Patient Groups
Pregnancy
Daptomycin is 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 during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but human data are limited.
Second Trimester:
Low risk based on animal data, but human data are limited.
Third Trimester:
Low risk based on animal data, but human data are limited.
Lactation
Daptomycin is excreted in human milk. Due to the potential for serious adverse reactions in breastfed infants, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
Moderate concern (L3). Potential for gastrointestinal upset, alteration of gut flora, and theoretical risk of muscle toxicity in the infant. Monitor infant for adverse effects.
Pediatric Use
Daptomycin is approved for use in pediatric patients (1 to 17 years of age) for cSSSI and S. aureus bacteremia. Dosing is weight-based and varies by age group and indication. Not recommended for infants younger than 1 year due to potential for muscle toxicity.
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. Dosage adjustment is not required based on age alone, but monitor renal function as elderly patients are more likely to have decreased renal function.
Clinical Information
Clinical Pearls
- Daptomycin is active against Gram-positive bacteria only, including MRSA and VRE. It is NOT active against Gram-negative bacteria.
- Daptomycin is inactivated by pulmonary surfactant and therefore should NOT be used to treat pneumonia.
- Always monitor CPK levels weekly or more frequently if muscle symptoms occur.
- Ensure adequate hydration to minimize the risk of muscle toxicity.
- Administer via intravenous infusion over 30 minutes.
- Compatible with normal saline (0.9% NaCl) and lactated Ringer's solution.
Alternative Therapies
- Vancomycin (for MRSA, VRE)
- Linezolid (for MRSA, VRE)
- Telavancin (for MRSA, cSSSI)
- Oritavancin (for MRSA, cSSSI)
- Dalbavancin (for MRSA, cSSSI)
- Ceftaroline (for MRSA, cSSSI)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per 350mg vial
Generic Available:
Yes
Insurance Coverage:
Tier 3 or Specialty Tier (requires prior authorization)
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure safe use, never share your prescription medications with others, and do not take medications that have been prescribed to someone else.
Store all medications in a secure location, out of the 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 or pharmacist, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to 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 critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.
Store all medications in a secure location, out of the 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 or pharmacist, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper disposal method, consult with your pharmacist, who can provide guidance on safe disposal practices or inform you about potential drug take-back programs in your area.
Some medications may come with an additional patient information leaflet, so it is a good idea to check with your pharmacist for more information. If you have any questions or concerns about your medication, do not hesitate to 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 critical information, including the name of the medication taken, the amount, and the time it was taken, to ensure prompt and effective treatment.