Levocarnitine 4gm/20ml Inj, 20ml
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
Carnitine replacement
Pregnancy Category
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 fat into energy. This medicine is given when your body doesn't make enough of it or loses too much, which can cause problems like muscle weakness or heart issues. It helps restore your body's energy production.
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 infusion into a vein over a period of time or as a shot into a vein.
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.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion into a vein over a period of time or as a shot into a vein.
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.
Lifestyle & Tips
- Follow your doctor's instructions regarding diet and exercise.
- Report any unusual body odor to your doctor, as this can be a side effect.
- If you are on dialysis, ensure you receive your dose after each session as instructed.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Initial dose of 50 mg/kg IV administered as a slow 2-3 minute bolus or by infusion over 15-30 minutes, given daily. Subsequent doses adjusted based on patient response and plasma carnitine levels.
Dose Range:
50 - 100 mg
Condition-Specific Dosing:
primaryCarnitineDeficiency:
50 mg/kg/day IV, adjusted based on response, up to 100 mg/kg/day.
secondaryCarnitineDeficiencyESRD:
10-20 mg/kg IV after each hemodialysis session, up to 3 times per week.
Pediatric Dosing
Neonatal:
50 mg/kg/day IV, adjusted based on response and plasma carnitine levels.
Infant:
50 mg/kg/day IV, adjusted based on response and plasma carnitine levels.
Child:
50 mg/kg/day IV, adjusted based on response and plasma carnitine levels.
Adolescent:
50 mg/kg/day IV, adjusted based on response and plasma carnitine levels.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
Used in patients with end-stage renal disease (ESRD) on hemodialysis. Dosing is typically post-dialysis to account for drug removal.
Dialysis:
Administer after hemodialysis sessions (e.g., 10-20 mg/kg IV post-dialysis) as levocarnitine is dialyzable.
Hepatic Impairment:
Mild:
No specific adjustment.
Moderate:
No specific adjustment.
Severe:
No specific adjustment.
Pharmacology
Mechanism of Action
Levocarnitine (L-carnitine) is a naturally occurring substance essential for energy metabolism. It facilitates the transport of long-chain fatty acids into the mitochondrial matrix, where they undergo beta-oxidation to produce energy. It also facilitates the efflux of short- and medium-chain fatty acids from the mitochondria, preventing their accumulation. In carnitine deficiency, this process is impaired, leading to accumulation of toxic acyl-CoA compounds and reduced energy production.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV)
Tmax:
Not applicable (IV bolus/infusion)
FoodEffect:
Not applicable (IV)
Distribution:
Vd:
0.2-0.3 L/kg
ProteinBinding:
<5%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 17.4 hours (oral), similar for IV but depends on renal function.
Clearance:
Primarily renal clearance.
ExcretionRoute:
Renal (unchanged drug and acylcarnitines)
Unchanged:
Approximately 80% of an IV dose is excreted in urine as unchanged drug and its esters within 24 hours.
Pharmacodynamics
OnsetOfAction:
Rapid (IV), but clinical improvement in deficiency states may take days to weeks.
PeakEffect:
Not directly applicable for clinical effect, but plasma levels peak shortly after IV administration.
DurationOfAction:
Plasma levels remain elevated for several hours; clinical effects are sustained with regular dosing.
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 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
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 near-fainting
+ 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or persist, contact your doctor:
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. 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 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
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 near-fainting
+ 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. Many people experience no side effects or only mild ones. If you notice any of the following side effects, or if they bother you or persist, contact your doctor:
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. 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 nausea or vomiting
- Persistent or severe abdominal pain
- Diarrhea that does not resolve
- Unusual or strong body odor (fishy smell)
- Any signs of bleeding or bruising (if also taking warfarin)
- Worsening of muscle weakness or fatigue
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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose 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 as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This information will help your doctor and pharmacist identify potential interactions between this medication and other substances.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Never start, stop, or change the dose of any medication without first consulting your doctor.
Precautions & Cautions
It is essential to inform all of 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 you have 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:
- Increased gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps)
- Stronger body odor
What to Do:
Contact a poison control center or emergency medical services immediately. In the US, call 1-800-222-1222. Treatment is generally supportive; hemodialysis can remove levocarnitine.
Drug Interactions
Moderate Interactions
- Warfarin: May potentiate the anticoagulant effect of warfarin, leading to increased INR. Monitor INR closely.
- Valproic acid: Chronic use of valproic acid can induce carnitine deficiency; levocarnitine may be used to treat or prevent this deficiency.
Monitoring
Baseline Monitoring
Plasma free and total carnitine levels
Rationale: To confirm diagnosis of carnitine deficiency and establish baseline for treatment efficacy.
Timing: Prior to initiation of therapy.
Renal function (BUN, creatinine)
Rationale: To assess baseline kidney function, especially in patients with ESRD.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline liver function.
Timing: Prior to initiation of therapy.
INR/PT (if on warfarin)
Rationale: To establish baseline and monitor for potential potentiation of anticoagulant effect.
Timing: Prior to initiation of therapy and frequently during co-administration.
Routine Monitoring
Plasma free and total carnitine levels
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Normal physiological range (e.g., free carnitine 35-60 µmol/L, total carnitine 40-70 µmol/L), or as per clinical guidelines for specific conditions.
Action Threshold: Adjust dose if levels are not within target range or if clinical response is inadequate.
Clinical symptoms (e.g., muscle weakness, fatigue, cardiomyopathy)
Frequency: Regularly during follow-up visits
Target: Improvement or resolution of symptoms
Action Threshold: Re-evaluate treatment plan if symptoms persist or worsen.
INR/PT (if on warfarin)
Frequency: More frequently (e.g., daily to weekly) when initiating or adjusting levocarnitine, then as per standard warfarin monitoring.
Target: Therapeutic INR range for the patient's indication
Action Threshold: Adjust warfarin dose or discontinue levocarnitine if INR is unstable or excessively high.
Symptom Monitoring
- Nausea
- Vomiting
- Abdominal cramps
- Diarrhea
- Body odor (fishy odor)
- Muscle weakness
- Fatigue
- Signs of bleeding (if on warfarin)
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:
No known specific risks identified.
Second Trimester:
No known specific risks identified.
Third Trimester:
No known specific risks identified.
Lactation
Levocarnitine is excreted in human milk. While the amount is small and generally considered safe, caution should be exercised when administered to a nursing mother. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Low risk; no adverse effects reported in breastfed infants, but long-term effects are unknown.
Pediatric Use
Levocarnitine injection is approved for use in pediatric patients with primary and secondary carnitine deficiency. Dosing is weight-based (mg/kg).
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, elderly patients may have reduced renal function, which could affect drug elimination, though levocarnitine is often used in ESRD patients.
Clinical Information
Clinical Pearls
- Administer IV bolus doses slowly over 2-3 minutes or by infusion over 15-30 minutes to minimize gastrointestinal side effects.
- For patients on hemodialysis, administer levocarnitine after the dialysis session to compensate for drug removal during dialysis.
- Monitor plasma carnitine levels (free and total) to guide dose adjustments and ensure therapeutic efficacy.
- A transient, mild increase in body odor (fishy smell) may occur due to the excretion of trimethylamine, a metabolite of carnitine. This can be managed by reducing the dose or temporarily discontinuing the drug.
- Levocarnitine is compatible with most common IV solutions (e.g., Normal Saline, D5W).
Alternative Therapies
- Oral levocarnitine (e.g., tablets, oral solution) for long-term maintenance or less severe deficiencies.
- Dietary modifications (e.g., high-fat, low-carbohydrate diets for certain metabolic disorders, though not a direct replacement for carnitine itself).
Cost & Coverage
Average Cost:
Varies widely per 20ml vial
Generic Available:
Yes
Insurance Coverage:
Often covered by insurance for approved indications, may require 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 guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have 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, 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 detailed information about the overdose, including the type and amount of medication taken, as well as the time it occurred. This information is critical for receiving appropriate treatment.
Proper disposal of unused or expired medications is crucial. Do not dispose of them by flushing down the toilet or pouring down the drain unless specifically instructed to do so. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have 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, 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 detailed information about the overdose, including the type and amount of medication taken, as well as the time it occurred. This information is critical for receiving appropriate treatment.