Levocarnitine 330mg Tablets
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 have certain medical conditions, especially kidney disease or genetic disorders, might not have enough of it. This medication helps replace the missing carnitine to improve energy and muscle function.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs available in your area.
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 the missed one.
To get the most benefit from your medication, take it exactly as directed by your doctor. Carefully read all the information provided with your prescription, and follow the instructions closely. Continue taking your medication as prescribed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
To maintain the effectiveness and safety of your medication, store it at room temperature in a dry location, avoiding the bathroom. Keep all medications in a secure place, out of the reach of children and pets. When disposing of unused or expired medication, do not flush it down the toilet or pour it down the drain unless specifically instructed to do so. Instead, consult with your pharmacist for guidance on the proper disposal method. You may also want to inquire about drug take-back programs available in your area.
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 the missed one.
Lifestyle & Tips
- Take with or after meals to reduce stomach upset.
- Do not crush or chew tablets; swallow whole.
- Maintain a balanced diet as advised by your doctor or dietitian.
- Report any unusual body odor to your doctor, as this may indicate a need for dose adjustment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Oral: 990 mg (330 mg x 3 tablets) 2 to 3 times daily, or 1 to 3 g daily in divided doses.
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
Primary Carnitine Deficiency:
1 to 3 g/day orally in divided doses, adjusted based on patient response and plasma carnitine levels.
Secondary Carnitine Deficiency (e.g., hemodialysis patients):
1 to 3 g/day orally in divided doses, or 10-20 mg/kg/day orally in divided doses.
Pediatric Dosing
Neonatal:
Not established for tablets; oral solution/IV formulations used. Dosing typically 50-100 mg/kg/day in 2-3 divided doses.
Infant:
Not established for tablets; oral solution/IV formulations used. Dosing typically 50-100 mg/kg/day in 2-3 divided doses.
Child:
50-100 mg/kg/day orally in 2-3 divided doses, up to a maximum of 3 g/day. Tablets may be used if child can swallow.
Adolescent:
50-100 mg/kg/day orally in 2-3 divided doses, up to a maximum of 3 g/day. Adult dosing may apply for older adolescents.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, but accumulation of inactive metabolites may occur with high doses in ESRD. Monitor for symptoms.
Dialysis:
Levocarnitine is dialyzable. Supplementation is often required in hemodialysis patients due to carnitine loss during dialysis. Dosing typically 1-3 g/day orally in divided doses, or 10-20 mg/kg/day.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended.
Confidence:
Medium
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 to produce energy. It also facilitates the removal of excess acyl groups from the mitochondria, which can accumulate and become toxic.
Pharmacokinetics
Absorption:
Bioavailability:
10-16% (oral, highly variable)
Tmax:
3.3 hours (oral solution), 4.5 hours (oral tablet)
FoodEffect:
Food may decrease absorption but is often recommended to minimize GI upset.
Distribution:
Vd:
0.44 L/kg
ProteinBinding:
<5%
CnssPenetration:
Limited (low concentrations in CSF compared to plasma)
Elimination:
HalfLife:
17.4 hours (oral solution), 15 hours (oral tablet)
Clearance:
Not readily available for oral route; primarily renal excretion.
ExcretionRoute:
Renal (unchanged and metabolites)
Unchanged:
80-90% (of absorbed dose)
Pharmacodynamics
OnsetOfAction:
Variable; clinical effects may take weeks to months.
PeakEffect:
Not acutely defined; related to restoration of carnitine levels.
DurationOfAction:
Related to half-life and sustained carnitine levels.
Confidence:
Medium
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Attention Immediately
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, or swelling of the mouth, face, lips, tongue, or throat
- Seizures
- Muscle pain or weakness
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 or any other unusual symptoms 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 does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor or seek medical help 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, or swelling of the mouth, face, lips, tongue, or throat
- Seizures
- Muscle pain or weakness
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 or any other unusual symptoms 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 does not include all possible side effects. If you have questions or concerns about side effects, consult your doctor. For medical advice about side effects, you can also contact your doctor. Additionally, you can 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 or persistent nausea, vomiting, diarrhea, or abdominal pain.
- Unusual or strong body odor (fishy smell).
- Signs of allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing).
- Any new or worsening 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 any allergies you have, including:
Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced due to the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, discontinue, or modify the dosage of any medication without first consulting your doctor.
It is essential to inform your doctor about any allergies you have, including:
Allergies to this medication or any of its components
Allergies to other medications, foods, or substances
The specific symptoms you experienced due to the allergy
Additionally, this medication may interact with other medications or health conditions. To ensure safe use, please disclose the following information to your doctor and pharmacist:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
Any existing health problems or conditions
It is crucial to verify that it is safe to take this medication with all your other medications and health conditions. Do not initiate, discontinue, or modify 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. 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
- Increased body odor
What to Do:
In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive and symptomatic.
Drug Interactions
Moderate Interactions
- Warfarin
- Valproic acid
- Other pivalate-containing compounds (e.g., pivampicillin)
Monitoring
Baseline Monitoring
Plasma free and total carnitine levels
Rationale: To confirm 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 ESRD.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST)
Rationale: To assess baseline liver health.
Timing: Prior to initiation of therapy.
Routine Monitoring
Plasma free and total carnitine levels
Frequency: Every 3 months initially, then every 6-12 months or as clinically indicated.
Target: Free carnitine: 35-60 µmol/L; Total carnitine: 40-70 µmol/L (target ranges may vary by lab and indication).
Action Threshold: Adjust dose if levels remain low or symptoms persist; consider dose reduction if levels are excessively high.
Renal function (BUN, creatinine)
Frequency: Periodically, especially in patients with renal impairment.
Target: Within normal limits.
Action Threshold: Monitor for accumulation of inactive metabolites in severe renal impairment.
INR (for patients on warfarin)
Frequency: More frequently when initiating or adjusting levocarnitine.
Target: Therapeutic range for warfarin.
Action Threshold: Adjust warfarin dose as needed based on INR.
Symptoms (e.g., muscle weakness, fatigue, GI upset, body odor)
Frequency: Ongoing.
Target: Improvement in deficiency symptoms; absence of significant side effects.
Action Threshold: Adjust dose or consider alternative if symptoms worsen or side effects are intolerable.
Symptom Monitoring
- Muscle weakness
- Fatigue
- Cardiomyopathy symptoms (e.g., shortness of breath, edema)
- Hypoglycemia (in primary deficiency)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
- Body odor (fishy odor)
Special Patient Groups
Pregnancy
Levocarnitine is a naturally occurring substance. Animal reproduction studies have shown no evidence of impaired fertility or harm to the fetus. Human data are limited but generally reassuring. Use during pregnancy should be considered if clearly needed, especially in women with confirmed carnitine deficiency.
Trimester-Specific Risks:
First Trimester:
Low risk based on available data; essential for maternal metabolism.
Second Trimester:
Low risk.
Third Trimester:
Low risk.
Lactation
Levocarnitine is naturally present in human milk. Exogenous levocarnitine is excreted into breast milk. While the amount transferred to the infant is likely small and within physiological range, caution is advised. Benefits of breastfeeding should be weighed against potential risks.
Infant Risk:
Low risk; generally considered compatible with breastfeeding, especially if the mother has a confirmed deficiency.
Pediatric Use
Dosing is weight-based. Tablets may not be suitable for very young children who cannot swallow them whole. Oral solution is often preferred for infants and young children. Close monitoring of carnitine levels is crucial.
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 with high doses, due to potential accumulation of inactive metabolites.
Clinical Information
Clinical Pearls
- Levocarnitine is often prescribed for primary carnitine deficiency (genetic) and secondary carnitine deficiency (e.g., in patients on hemodialysis, or those taking valproic acid).
- The most common side effect is gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps), which can often be minimized by taking the medication with or after meals.
- A 'fishy' body odor can occur due to bacterial metabolism of carnitine to trimethylamine; this can be managed by reducing the dose or by adding metronidazole.
- Patients on warfarin should have their INR monitored more closely when initiating or adjusting levocarnitine due to a potential interaction.
- Therapeutic response may not be immediate and can take several weeks or months to become apparent, especially for chronic conditions like cardiomyopathy or muscle weakness.
Alternative Therapies
- No direct therapeutic alternatives for carnitine deficiency; levocarnitine is the specific replacement therapy.
- For specific symptoms (e.g., fatigue), other supportive therapies might be used, but they do not address the underlying carnitine deficiency.
Cost & Coverage
Average Cost:
Varies widely, e.g., $50 - $200+ per 30 tablets
Generic Available:
Yes
Insurance Coverage:
Tier 2 or Tier 3 (often requires prior authorization for specific indications)
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 taken, the amount, and the time it happened.