Levocarnitine 10% Oral Solution
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
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 don't have enough of it, or whose bodies can't use it properly, might need to take this medicine to help their bodies work better, especially for muscle function and energy levels.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Take your medication during or after meals to help minimize potential side effects. If you are taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool. You can take your medication alone or mix it with a drink or other liquid food.
To reduce the risk of stomach problems, drink slowly and consider mixing your medication with a larger amount of liquid.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Do not freeze your medication, and protect it from heat sources.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your medication as directed by your doctor or healthcare provider, even if you start to feel better.
Take your medication during or after meals to help minimize potential side effects. If you are taking a liquid dose, measure it carefully using the measuring device that comes with the medication. If no device is provided, ask your pharmacist for a suitable measuring tool. You can take your medication alone or mix it with a drink or other liquid food.
To reduce the risk of stomach problems, drink slowly and consider mixing your medication with a larger amount of liquid.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry place, away from the bathroom. Do not freeze your medication, and protect it from heat sources.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for a missed dose.
Lifestyle & Tips
- Take exactly as prescribed by your doctor. Do not stop taking it without consulting your doctor.
- May be taken with or without food, but consistency is key. If stomach upset occurs, try taking it with food.
- Measure the dose carefully using the provided measuring device (e.g., calibrated spoon or syringe). Do not use household spoons.
- If you miss a dose, take it as soon as you remember. If it's close to your next dose, skip the missed dose and continue your regular schedule. Do not double dose.
- Store at room temperature, away from light and moisture. Do not freeze.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Primary Carnitine Deficiency: 990 mg (10 mL of 10% oral solution) 2 to 3 times daily, or 100 mg/kg/day orally in 2-3 divided doses, up to 3 g/day.
Dose Range:
990 - 3000 mg
Condition-Specific Dosing:
Primary Carnitine Deficiency:
990 mg (10 mL of 10% oral solution) 2 to 3 times daily, or 100 mg/kg/day orally in 2-3 divided doses, up to 3 g/day.
Secondary Carnitine Deficiency (e.g., hemodialysis patients):
10-20 mg/kg/day orally, adjusted based on plasma carnitine levels. Max 3 g/day.
Pediatric Dosing
Neonatal:
Primary Carnitine Deficiency: 50-100 mg/kg/day orally in 2-3 divided doses. Max 3 g/day.
Infant:
Primary Carnitine Deficiency: 50-100 mg/kg/day orally in 2-3 divided doses. Max 3 g/day.
Child:
Primary Carnitine Deficiency: 50-100 mg/kg/day orally in 2-3 divided doses. Max 3 g/day.
Adolescent:
Primary Carnitine Deficiency: 50-100 mg/kg/day orally in 2-3 divided doses. Max 3 g/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
Use with caution. Accumulation of metabolites (e.g., trimethylamine, trimethylamine-N-oxide) may occur, leading to a 'fishy' body odor. Consider lower doses and monitor for symptoms.
Dialysis:
Levocarnitine is dialyzable. Dosing often adjusted to replace losses during dialysis in patients with secondary carnitine deficiency (e.g., 10-20 mg/kg/day orally). Monitor plasma carnitine levels.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Pharmacology
Mechanism of Action
Levocarnitine (L-carnitine) is a naturally occurring substance required in mammalian metabolism for the transport of fatty acids from the cytosol into the mitochondria for beta-oxidation. It acts as a carrier molecule for long-chain fatty acids across the inner mitochondrial membrane, facilitating energy production. It also facilitates the removal of excess acyl groups from the mitochondria, preventing their accumulation and toxicity. In patients with carnitine deficiency, exogenous levocarnitine supplementation restores normal carnitine levels, improving fatty acid oxidation and energy metabolism.
Pharmacokinetics
Absorption:
Bioavailability:
5-18% (oral solution, highly variable)
Tmax:
3.3 hours (oral solution)
FoodEffect:
Food may decrease the rate and extent of absorption.
Distribution:
Vd:
0.24 L/kg
ProteinBinding:
< 25%
CnssPenetration:
Limited
Elimination:
HalfLife:
17.4 hours (oral solution)
Clearance:
Not available (primarily renal excretion)
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
80-90% (of absorbed dose)
Pharmacodynamics
OnsetOfAction:
Days to weeks (for clinical effect)
PeakEffect:
Weeks to months (for stabilization of carnitine levels and clinical improvement)
DurationOfAction:
Dependent on continued administration
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Seizures
- Muscle pain or weakness
Other Possible Side Effects
While not everyone experiences side effects, it's essential to be aware of the potential ones. If you encounter any of the following or any other side effects that bother you or do not go away, contact your doctor for advice:
- Diarrhea
- Upset stomach
- Vomiting
- Body odor
- Stomach cramps
Reporting Side Effects
This list is not exhaustive, and if you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or through their online portal at https://www.fda.gov/medwatch. Your doctor is the best resource for medical advice regarding side effects.
If you experience any of the following symptoms, call your doctor immediately or seek emergency medical attention, as they may be signs of a severe and potentially life-threatening reaction:
- 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, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat
- Seizures
- Muscle pain or weakness
Other Possible Side Effects
While not everyone experiences side effects, it's essential to be aware of the potential ones. If you encounter any of the following or any other side effects that bother you or do not go away, contact your doctor for advice:
- Diarrhea
- Upset stomach
- Vomiting
- Body odor
- Stomach cramps
Reporting Side Effects
This list is not exhaustive, and if you have questions or concerns about side effects, don't hesitate to reach out to your doctor. You can also report side effects to the FDA at 1-800-332-1088 or through their online portal at https://www.fda.gov/medwatch. Your doctor is the best resource for medical advice regarding side effects.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent nausea, vomiting, or diarrhea
- Unusual body odor (fishy smell)
- Increased muscle weakness or cramps
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
- 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
- Fishy body odor
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive, focusing on managing gastrointestinal symptoms.
Drug Interactions
Moderate Interactions
- Warfarin
- Valproic acid
- Divalproex sodium
Monitoring
Baseline Monitoring
Plasma free and acylcarnitine 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 important for patients with severe renal impairment due to potential metabolite accumulation.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess baseline liver function.
Timing: Prior to initiation of therapy.
Routine Monitoring
Plasma free and acylcarnitine levels
Frequency: Every 3-6 months, or as clinically indicated, especially after dose adjustments.
Target: Free carnitine: 35-60 µmol/L; Acyl/free carnitine ratio: < 0.4
Action Threshold: Adjust dose to maintain levels within target range and improve acyl/free ratio.
Clinical status (e.g., muscle strength, fatigue, growth in children)
Frequency: Regularly, at each clinic visit.
Target: Improvement or stabilization of symptoms related to carnitine deficiency.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or re-evaluation of diagnosis.
INR (if on warfarin)
Frequency: More frequently, especially upon initiation or dose changes of levocarnitine.
Target: Therapeutic range for warfarin indication.
Action Threshold: Elevated INR may require warfarin dose reduction.
Symptom Monitoring
- Muscle weakness
- Fatigue
- Hypoglycemia
- Cardiomyopathy symptoms (e.g., shortness of breath, edema)
- Gastrointestinal upset (nausea, vomiting, abdominal cramps, diarrhea)
- Body odor (fishy odor, especially in renal impairment)
- Seizures (in patients with seizure disorders)
Special Patient Groups
Pregnancy
Levocarnitine is a natural component of human metabolism. Animal reproduction studies have shown no evidence of impaired fertility or harm to the fetus. Limited human data suggest no increased risk of major birth defects or miscarriage. Generally considered safe and often continued during pregnancy if indicated for maternal carnitine deficiency, as deficiency can pose risks to both mother and fetus.
Trimester-Specific Risks:
First Trimester:
No increased risk observed.
Second Trimester:
No increased risk observed.
Third Trimester:
No increased risk observed.
Lactation
Levocarnitine is naturally present in human milk. Exogenous levocarnitine is excreted into breast milk. While data are limited, the amount transferred to the infant is generally considered low and unlikely to cause adverse effects, especially given its natural presence and role in infant metabolism. Monitor breastfed infant for any unusual symptoms (e.g., GI upset, fishy odor).
Infant Risk:
Low risk. Considered compatible with breastfeeding, especially if maternal deficiency is being treated.
Pediatric Use
Levocarnitine is widely used and well-established for the treatment of primary and secondary carnitine deficiencies in pediatric patients, including neonates. Dosing is weight-based. Safety and efficacy have been demonstrated.
Geriatric Use
No specific dose adjustments are generally required based on age alone. However, elderly patients may have age-related decline in renal function, which should be considered, especially if severe renal impairment is present, due to potential accumulation of metabolites.
Clinical Information
Clinical Pearls
- Levocarnitine oral solution has a distinctive odor and taste; mixing with beverages (e.g., juice, milk) or food may improve palatability.
- A transient, mild 'fishy' body odor may occur, especially with higher doses or in patients with renal impairment, due to the accumulation of trimethylamine (TMA). This can sometimes be managed by reducing the dose or by using oral charcoal or copper chlorophyllin.
- Patients with primary carnitine deficiency require lifelong treatment.
- Monitor plasma carnitine levels (free and acyl) to guide dosing and assess treatment efficacy, aiming for normalization of levels and acyl/free ratio.
- Ensure adequate hydration to minimize gastrointestinal side effects.
Alternative Therapies
- No direct therapeutic alternatives for carnitine deficiency; levocarnitine is the standard of care. Other supportive therapies may be used depending on the underlying cause of deficiency (e.g., dietary modifications for metabolic disorders).
Cost & Coverage
Average Cost:
Varies widely, typically $100-$500+ per 473 mL bottle (10% oral solution)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (often requires prior authorization for brand, sometimes for generic)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to help healthcare professionals provide the best possible care.