Levocarnitine 1g/10ml U/d Oral Sol
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
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. This medicine is used to treat conditions where your body doesn't have enough carnitine, which can cause problems like muscle weakness or heart issues. It helps your body use fat for energy and remove waste products.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well. Take the medication during or after meals to help minimize potential side effects.
When taking the liquid form of this medication, measure the dose carefully using the measuring device that comes with it. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing. You can take this medication on its own or mix it with a drink or other liquid food.
To reduce the risk of stomach problems, drink the medication slowly. Mixing it with more liquid may also help.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding bathrooms and areas with excessive heat. Do not freeze the medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start feeling well. Take the medication during or after meals to help minimize potential side effects.
When taking the liquid form of this medication, measure the dose carefully using the measuring device that comes with it. If a measuring device is not provided, ask your pharmacist for one to ensure accurate dosing. You can take this medication on its own or mix it with a drink or other liquid food.
To reduce the risk of stomach problems, drink the medication slowly. Mixing it with more liquid may also help.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding bathrooms and areas with excessive heat. Do not freeze the medication.
What to Do If You Miss a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Avoid taking two doses at the same time or taking extra doses.
Lifestyle & Tips
- Take the medicine exactly as prescribed by your doctor.
- You can mix the oral solution with water or juice, or take it directly.
- If you miss a dose, take it as soon as you remember, unless it's almost time for your next dose. Do not double dose.
- Report any unusual body odor (fishy smell) to your doctor, especially if you have kidney problems.
- Maintain regular follow-up appointments and blood tests as advised by your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
1 to 3 g/day orally in 2 to 3 divided doses
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
Primary Carnitine Deficiency:
1 to 3 g/day orally in 2 to 3 divided doses
Secondary Carnitine Deficiency (e.g., ESRD on hemodialysis):
1 to 3 g/day orally in 2 to 3 divided doses
Pediatric Dosing
Neonatal:
50 to 100 mg/kg/day orally in 2 to 3 divided doses; maximum 3 g/day
Infant:
50 to 100 mg/kg/day orally in 2 to 3 divided doses; maximum 3 g/day
Child:
50 to 100 mg/kg/day orally in 2 to 3 divided doses; maximum 3 g/day
Adolescent:
50 to 100 mg/kg/day orally in 2 to 3 divided doses; maximum 3 g/day (or adult dose if weight appropriate)
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required, but accumulation of potentially toxic metabolites (e.g., trimethylamine, trimethylamine-N-oxide) may occur in patients with severe renal impairment or ESRD. Monitor for fishy body odor.
Dialysis:
Levocarnitine is dialyzable. Dosing should be administered after dialysis sessions on dialysis days. Monitor plasma carnitine levels.
Hepatic Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required, but monitor clinical response and adverse effects.
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 subsequent beta-oxidation and energy production. It also facilitates the removal of excess acyl groups from the mitochondria, which can accumulate and become toxic.
Pharmacokinetics
Absorption:
Bioavailability:
15-20% (oral)
Tmax:
3.3 hours (oral solution)
FoodEffect:
Food may decrease the rate and extent of absorption.
Distribution:
Vd:
0.44 L/kg
ProteinBinding:
<25%
CnssPenetration:
Limited
Elimination:
HalfLife:
17.4 hours (terminal elimination half-life)
Clearance:
Not readily quantifiable due to endogenous production and reabsorption.
ExcretionRoute:
Renal excretion (unchanged drug and metabolites)
Unchanged:
5-15% (oral dose)
Pharmacodynamics
OnsetOfAction:
Variable, clinical effects may take weeks to months.
PeakEffect:
Not well-defined for therapeutic effect; plasma levels peak around 3.3 hours.
DurationOfAction:
Dependent on dosing frequency and half-life.
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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Seizures
Muscle pain or weakness
Other Possible Side Effects
Most people taking this medication will not experience serious side effects. However, some may occur. If you experience any of the following side effects, or if they persist or bother you, contact your doctor:
Diarrhea
Upset stomach
Vomiting
Body odor
Stomach cramps
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing 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
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Seizures
Muscle pain or weakness
Other Possible Side Effects
Most people taking this medication will not experience serious side effects. However, some may occur. If you experience any of the following side effects, or if they persist or bother you, contact your doctor:
Diarrhea
Upset stomach
Vomiting
Body odor
Stomach cramps
Reporting Side Effects
This is not an exhaustive list of possible side effects. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch. Your doctor can provide medical advice on managing side effects.
Seek Immediate Medical Attention If You Experience:
- Severe nausea or vomiting
- Persistent abdominal pain or cramps
- Severe diarrhea
- Strong, fishy body odor
- Unusual bleeding or bruising (if on warfarin)
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
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 allergic reaction you experienced, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all 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:
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, including any symptoms that occurred.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.
To ensure your safety, it is vital to verify that it is safe to take this medication with all 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 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:
- 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.
Drug Interactions
Moderate Interactions
- Warfarin (may potentiate anticoagulant effect, monitor INR)
- Valproic acid/Divalproex (may increase risk of carnitine deficiency, consider supplementation)
Monitoring
Baseline Monitoring
Plasma free and acylcarnitine levels
Rationale: To confirm diagnosis of carnitine deficiency and establish baseline for therapeutic monitoring.
Timing: Prior to initiation of therapy.
Renal function (BUN, creatinine)
Rationale: To assess kidney function, especially in patients with pre-existing renal impairment.
Timing: Prior to initiation of therapy.
INR (if on warfarin)
Rationale: To establish baseline for patients on concomitant warfarin therapy.
Timing: Prior to initiation of therapy.
Routine Monitoring
Plasma free and acylcarnitine levels
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: Normalization of free carnitine levels and acylcarnitine/free carnitine ratio.
Action Threshold: Persistent abnormal levels may indicate need for dose adjustment.
Clinical symptoms (e.g., muscle weakness, fatigue, cardiomyopathy)
Frequency: Regularly
Target: Improvement or resolution of symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate inadequate dosing or alternative diagnosis.
INR (if on warfarin)
Frequency: More frequently after initiation or dose changes of levocarnitine, then as per standard warfarin monitoring.
Target: Therapeutic range for indication.
Action Threshold: INR outside target range requires warfarin dose adjustment.
Body odor
Frequency: Regularly
Target: Absence of strong fishy odor.
Action Threshold: Development of strong fishy odor may indicate accumulation of metabolites, especially in renal impairment; consider dose reduction.
Symptom Monitoring
- Nausea
- Vomiting
- Abdominal cramps
- Diarrhea
- Body odor (fishy)
- Muscle weakness
- Fatigue
- Changes in cardiac function
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. Levocarnitine is naturally present in human milk. While exogenous levocarnitine is excreted into breast milk, the amount is generally considered low and unlikely to cause adverse effects in a healthy, full-term infant. Monitor breastfed infant for any adverse effects.
Infant Risk:
Low risk for healthy, full-term infants. Potential for accumulation of metabolites in infants with renal impairment.
Pediatric Use
Safe and effective for the treatment of primary and secondary carnitine deficiency in pediatric patients. Dosing is weight-based. Close monitoring of plasma carnitine levels and clinical response is essential.
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 regarding the accumulation of metabolites.
Clinical Information
Clinical Pearls
- Oral solution can be diluted in water or juice to improve palatability.
- The 'fishy' body odor is a common side effect, especially with higher doses or in patients with renal impairment, due to the accumulation of trimethylamine (TMA). This can be managed by reducing the dose or by using activated charcoal.
- Patients with end-stage renal disease (ESRD) on hemodialysis should take their dose after dialysis sessions.
- Monitor INR closely if co-administered with warfarin due to potential for increased anticoagulant effect.
- Levocarnitine supplementation may be considered in patients on long-term valproic acid therapy, as valproic acid can induce carnitine deficiency.
Alternative Therapies
- No direct therapeutic alternatives for primary carnitine deficiency; levocarnitine is the standard of care.
- For secondary carnitine deficiency, addressing the underlying cause (e.g., dietary changes, managing renal disease) is crucial, but levocarnitine supplementation is often necessary.
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200 per 100 mL bottle (1g/10mL)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 (brand)
General Drug Facts
If your symptoms or health condition do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance. To ensure your safety and the effectiveness of your treatment, never share your medication with others or take someone else's medication. 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 reach out to your doctor, nurse, pharmacist, or other healthcare provider for clarification and guidance. 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 detailed information about the overdose, including the name of the medication taken, the amount, and the time it occurred.