Levocarnitine 1gm/5ml Inj, 5ml
It is used to treat carnitine deficiencies.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Metabolic agent
Pharmacologic Class
Amino acid derivative; Carnitine replacement
Pregnancy Category
B
FDA Approved
Dec 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levocarnitine is a natural substance in your body that helps turn fats into energy. People who have certain medical conditions, especially kidney disease or genetic problems, might not have enough of it. This injection helps replace the missing levocarnitine to improve energy and muscle function.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous infusion over a period of time or as an intravenous injection. It's essential to follow the dosage and administration instructions carefully.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action. They will advise you on what to do next.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an intravenous infusion over a period of time or as an intravenous injection. It's essential to follow the dosage and administration instructions carefully.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action. They will advise you on what to do next.
Lifestyle & Tips
- Maintain a balanced diet as advised by your doctor or dietitian.
- Report any unusual body odor to your doctor.
- Adhere to your prescribed dialysis schedule if applicable.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Varies significantly by indication and patient response.
Condition-Specific Dosing:
Primary Systemic Carnitine Deficiency:
50 mg/kg IV bolus over 2-3 minutes, followed by 50 mg/kg/day in divided doses every 3-6 hours by infusion or orally. Max 300 mg/kg/day.
Secondary Carnitine Deficiency (ESRD on Hemodialysis):
10-20 mg/kg IV bolus after each hemodialysis session. Doses up to 200 mg/kg/day have been used in severe cases.
Pediatric Dosing
Neonatal:
Not established for routine use, but used off-label for specific metabolic disorders. Dosing is highly individualized, often 50-100 mg/kg/day IV or oral in divided doses.
Infant:
Not established for routine use, but used off-label for specific metabolic disorders. Dosing is highly individualized, often 50-100 mg/kg/day IV or oral in divided doses.
Child:
Primary Systemic Carnitine Deficiency: 50 mg/kg IV bolus over 2-3 minutes, followed by 50 mg/kg/day in divided doses every 3-6 hours by infusion or orally. Max 300 mg/kg/day.
Adolescent:
Primary Systemic Carnitine Deficiency: 50 mg/kg IV bolus over 2-3 minutes, followed by 50 mg/kg/day in divided doses every 3-6 hours by infusion or orally. Max 300 mg/kg/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for mild impairment, but monitor carnitine levels.
Moderate:
No specific adjustment needed for moderate impairment, but monitor carnitine levels.
Severe:
No specific adjustment needed for severe impairment, but monitor carnitine levels.
Dialysis:
Levocarnitine is dialyzable. Dosing for ESRD patients on hemodialysis is typically administered after dialysis sessions (e.g., 10-20 mg/kg IV post-dialysis).
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Levocarnitine is a naturally occurring substance required in mammalian metabolism for the transport of fatty acids across the inner mitochondrial membrane for beta-oxidation. It acts as a carrier molecule for long-chain fatty acids, facilitating their entry into mitochondria where they are oxidized for energy production. It also facilitates the removal of excess or toxic organic acids from mitochondria, preventing their accumulation.
Pharmacokinetics
Absorption:
Bioavailability:
Oral: 5-18% (highly variable); IV: 100%
Tmax:
Oral: 3.3 hours; IV: End of infusion
FoodEffect:
Food may decrease absorption of oral levocarnitine.
Distribution:
Vd:
0.2-0.3 L/kg
ProteinBinding:
<25%
CnssPenetration:
Limited
Elimination:
HalfLife:
IV: 17.4 hours (terminal); Oral: 2.5-15 hours (variable)
Clearance:
Renal clearance is significant.
ExcretionRoute:
Primarily renal (urine) as unchanged drug and metabolites.
Unchanged:
Approximately 80-90% of an IV dose is excreted unchanged in urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Rapid (IV); effects on carnitine levels are seen within hours.
PeakEffect:
Varies by indication; clinical improvement may take days to weeks.
DurationOfAction:
Dependent on half-life and dosing frequency; maintains carnitine levels with regular administration.
Safety & Warnings
Side Effects
Serious 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 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
Seizures
Muscle pain or weakness
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Chest pain or pressure
Fast or abnormal heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Abnormal sensations, such as burning, numbness, or tingling
Changes in vision
Depression
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, contact your doctor if they bother you or persist:
Diarrhea
Upset stomach or vomiting
Body odor
Dizziness, tiredness, or weakness
Headache
Stomach pain
Irritation at the injection site
Cough
Runny nose
Decreased appetite
Changes in taste
Weight gain or loss
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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.
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 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
Seizures
Muscle pain or weakness
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that won't heal
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Fainting or loss of consciousness
+ Changes in vision
Chest pain or pressure
Fast or abnormal heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling extremely tired or weak
Abnormal sensations, such as burning, numbness, or tingling
Changes in vision
Depression
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, contact your doctor if they bother you or persist:
Diarrhea
Upset stomach or vomiting
Body odor
Dizziness, tiredness, or weakness
Headache
Stomach pain
Irritation at the injection site
Cough
Runny nose
Decreased appetite
Changes in taste
Weight gain or loss
Reporting Side Effects
This list is not exhaustive, and you may experience other side effects not mentioned here. 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 stomach upset (nausea, vomiting, diarrhea, abdominal pain)
- Unusual or strong body odor (fishy smell)
- Muscle weakness or cramps that worsen
- Signs of low blood sugar (dizziness, sweating, confusion, shakiness)
- Any new or worsening symptoms
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
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.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins.
* Any existing health problems, as this medication may interact with other drugs or health conditions.
To ensure your safety, it is crucial to verify that this medication can be taken with all your other medications and health conditions. Always consult your doctor before starting, stopping, or changing the dose of any medication.
Precautions & Cautions
It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests will be necessary, as directed by your doctor, to monitor your condition. Be sure to discuss any concerns or questions with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor immediately. You and your doctor will need to carefully weigh the benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe diarrhea
- Nausea
- Vomiting
- Abdominal cramps
- Unusual body odor
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. Hemodialysis can remove levocarnitine from the blood.
Drug Interactions
Moderate Interactions
- Warfarin
- Thyroid hormones
Minor Interactions
- Valproic acid (may increase carnitine deficiency)
Monitoring
Baseline Monitoring
Plasma total and free carnitine levels
Rationale: To establish baseline deficiency and guide initial dosing.
Timing: Prior to initiation of therapy.
Renal function (BUN, creatinine)
Rationale: To assess kidney health, especially important for patients with ESRD.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess liver health, as some metabolic disorders can affect the liver.
Timing: Prior to initiation of therapy.
Blood glucose
Rationale: To monitor for potential hypoglycemia, especially in patients with metabolic disorders.
Timing: Prior to initiation of therapy.
Routine Monitoring
Plasma total and free carnitine levels
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated) after stabilization.
Target: Free carnitine: 35-60 µmol/L; Total carnitine: 40-70 µmol/L (target ranges may vary by lab and clinical context).
Action Threshold: Levels persistently below target may indicate need for dose adjustment; excessively high levels may indicate over-supplementation.
Renal function (BUN, creatinine)
Frequency: Periodically (e.g., annually or as clinically indicated).
Target: Within normal limits.
Action Threshold: Significant changes may require re-evaluation of overall patient status.
Liver function tests (ALT, AST, bilirubin)
Frequency: Periodically (e.g., annually or as clinically indicated).
Target: Within normal limits.
Action Threshold: Significant elevations may warrant investigation.
INR (for patients on warfarin)
Frequency: More frequently upon initiation or dose adjustment of levocarnitine.
Target: Therapeutic range for warfarin.
Action Threshold: Increased INR may require warfarin dose reduction.
Symptom Monitoring
- Muscle weakness
- Fatigue
- Hypoglycemia (symptoms like sweating, tremor, confusion)
- Cardiomyopathy symptoms (shortness of breath, swelling)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
- Body odor (fishy odor)
- Seizures (in susceptible patients)
Special Patient Groups
Pregnancy
Category B. Animal studies have shown no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified in animal studies.
Second Trimester:
No specific increased risk identified in animal studies.
Third Trimester:
No specific increased risk identified in animal studies.
Lactation
Levocarnitine is naturally present in human milk. While exogenous levocarnitine is excreted into breast milk, the amount is generally considered small and unlikely to cause adverse effects in a breastfed infant. Use with caution.
Infant Risk:
L3 - Moderate risk. Monitor infant for gastrointestinal upset or unusual body odor, though unlikely at therapeutic maternal doses.
Pediatric Use
Dosing is highly individualized based on the specific metabolic disorder and patient weight. Close monitoring of carnitine levels and clinical response is essential. Safety and efficacy for some indications are not fully established in all pediatric age groups.
Geriatric Use
No specific dose adjustments are generally required based on age alone. However, elderly patients may have reduced renal function, which could affect drug elimination. Monitor renal function and carnitine levels as appropriate.
Clinical Information
Clinical Pearls
- Levocarnitine injection is typically administered slowly (e.g., over 2-3 minutes for bolus or as an infusion) to minimize gastrointestinal side effects.
- The 'fishy' body odor is a known side effect, particularly with higher doses, and is due to the accumulation of trimethylamine, a metabolite. This can sometimes be managed by reducing the dose or by co-administering metronidazole.
- Patients on hemodialysis should receive their dose after the dialysis session to ensure maximum retention of the drug.
- Regular monitoring of plasma carnitine levels (free and total) is crucial to ensure therapeutic efficacy and avoid over-supplementation.
- Levocarnitine is not a substitute for dietary restrictions or other specific therapies for metabolic disorders.
Alternative Therapies
- Dietary modifications (e.g., low-fat diet for some metabolic disorders)
- Other specific enzyme replacement therapies or cofactor supplementation depending on the underlying metabolic disorder.
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 5ml vial (1gm)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for specific indications)
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 proper disposal method, consult your pharmacist, as they can provide guidance on disposal procedures and potential 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, it is crucial 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 information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.