Levocarnitine 1g/10ml(sugar Free)sl
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 make energy and function better.
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 to feel better. 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 the bathroom. Do not freeze the medication, and protect it from heat sources.
Missing 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. Do not take two doses at the same time or take extra doses to make up for the missed one.
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 to feel better. 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 the bathroom. Do not freeze the medication, and protect it from heat sources.
Missing 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. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take exactly as prescribed by your doctor.
- Measure the dose carefully using the provided measuring device.
- This oral solution is sugar-free and can be mixed with beverages or food.
- Do not stop taking this medication without consulting your doctor.
- Report any unusual body odor to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Oral solution: 1 to 3 g/day in 2 to 3 divided doses, or as directed by physician based on carnitine levels.
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
primary_carnitine_deficiency:
1 to 3 g/day orally in 2 to 3 divided doses. Doses up to 6 g/day have been used.
secondary_carnitine_deficiency_hemodialysis:
Oral solution: 1 to 3 g/day in 2 to 3 divided doses, or as directed by physician based on carnitine levels.
Pediatric Dosing
Neonatal:
Oral solution: 50 to 100 mg/kg/day in 2 to 3 divided doses. Max 300 mg/kg/day (not to exceed 3 g/day).
Infant:
Oral solution: 50 to 100 mg/kg/day in 2 to 3 divided doses. Max 300 mg/kg/day (not to exceed 3 g/day).
Child:
Oral solution: 50 to 100 mg/kg/day in 2 to 3 divided doses. Max 300 mg/kg/day (not to exceed 3 g/day).
Adolescent:
Oral solution: 50 to 100 mg/kg/day in 2 to 3 divided doses. Max 300 mg/kg/day (not to exceed 3 g/day), or adult dose if weight allows.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended. Monitor for accumulation of metabolites (e.g., trimethylamine, trimethylamine-N-oxide) which can cause a fishy body odor.
Dialysis:
Patients on chronic hemodialysis may require supplementation due to carnitine loss during dialysis. Dosing as per adult standard for secondary carnitine deficiency.
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 long-chain fatty acids into the mitochondrial matrix for beta-oxidation. It also facilitates the removal of excess acyl groups from the mitochondria, which can accumulate and become toxic. It is essential for energy production and plays a role in glucose metabolism and branched-chain amino acid catabolism.
Pharmacokinetics
Absorption:
Bioavailability:
15-16% (oral solution)
Tmax:
3.3 hours (oral solution)
FoodEffect:
Food may slightly delay absorption but does not significantly alter the extent of absorption.
Distribution:
Vd:
0.44 L/kg
ProteinBinding:
<5%
CnssPenetration:
Limited (higher concentrations in brain with higher doses)
Elimination:
HalfLife:
17.4 hours (oral solution)
Clearance:
Not readily available for oral route, primarily renal excretion.
ExcretionRoute:
Renal (primarily unchanged)
Unchanged:
80-90% of absorbed dose
Pharmacodynamics
OnsetOfAction:
Variable, clinical effects may take weeks to months to become apparent.
PeakEffect:
Not acutely defined; relates to restoration of carnitine levels and metabolic function.
DurationOfAction:
Dependent on continued administration and maintenance of carnitine levels.
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
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 or 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.
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
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 or 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 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust the dosage 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.
Potential interactions with other medications or health conditions. This medication may interact with other drugs or exacerbate certain health problems.
To ensure safe use, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Any natural products or vitamins you are using
* Existing health problems
Carefully review your medications and health conditions to confirm that it is safe to take this medication in conjunction with them. Never start, stop, or adjust 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. As directed by your doctor, regular blood tests will be necessary to monitor your condition, and you should discuss the results with your doctor. If you are pregnant, planning to become pregnant, or are breastfeeding, you must notify your doctor. This will allow you to have a thorough discussion about the potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Increased gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
- Increased body odor
What to Do:
Contact a poison control center immediately (call 1-800-222-1222 in the US) or seek emergency medical attention. Treatment is generally supportive.
Drug Interactions
Moderate Interactions
- valproic acid
- warfarin
Monitoring
Baseline Monitoring
Plasma free carnitine 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: Levocarnitine is renally excreted; monitor for patients with renal impairment.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST, bilirubin)
Rationale: General baseline assessment.
Timing: Prior to initiation of therapy.
Routine Monitoring
Plasma free carnitine and acylcarnitine levels
Frequency: Every 3 months initially, then every 6-12 months or as clinically indicated.
Target: Free carnitine: 35-60 µmol/L; Acylcarnitine: <10 µmol/L; Acyl/free carnitine ratio: <0.4
Action Threshold: Adjust dose if levels are not within target range or if clinical symptoms persist/worsen.
Clinical status (e.g., muscle strength, fatigue, growth in children)
Frequency: Regularly during follow-up visits.
Target: Improvement or stabilization of symptoms.
Action Threshold: Lack of improvement or worsening symptoms may indicate need for dose adjustment or re-evaluation of diagnosis.
Renal function (BUN, creatinine)
Frequency: Periodically, especially in patients with renal impairment.
Target: Within normal limits or stable for patient's condition.
Action Threshold: Significant changes may require dose adjustment or further investigation.
INR (if on warfarin)
Frequency: More frequently upon initiation or dose changes of levocarnitine.
Target: Therapeutic range for warfarin.
Action Threshold: Elevated INR may require warfarin dose adjustment.
Symptom Monitoring
- Muscle weakness or fatigue
- Hypoglycemia
- Cardiomyopathy symptoms (e.g., shortness of breath, edema)
- Development of a fishy body odor (due to TMA/TMAO accumulation)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
Special Patient Groups
Pregnancy
Levocarnitine is classified as Pregnancy Category B. Animal studies have not shown harm to the fetus, and human data are limited but do not suggest adverse effects. It is considered safe for use during pregnancy when clinically indicated, especially in women with documented carnitine deficiency.
Trimester-Specific Risks:
First Trimester:
Low risk based on available data.
Second Trimester:
Low risk based on available data.
Third Trimester:
Low risk based on available data.
Lactation
Levocarnitine is naturally present in human milk. Exogenous levocarnitine is excreted into breast milk. The amount transferred to the infant is generally considered small and unlikely to cause adverse effects, especially given its natural presence and essential role. L2 (Safer).
Infant Risk:
Low risk; unlikely to cause adverse effects in a breastfed infant. Monitor for any unusual symptoms in the infant.
Pediatric Use
Levocarnitine is widely used and often essential in pediatric patients with primary or secondary carnitine deficiencies. Dosing is weight-based. Close monitoring of carnitine levels and clinical response is crucial.
Geriatric Use
No specific dose adjustments are generally required for elderly patients. However, age-related decline in renal function should be considered, and monitoring for metabolite accumulation (fishy odor) may be prudent, especially in those with impaired renal function.
Clinical Information
Clinical Pearls
- Levocarnitine is an essential cofactor for fatty acid metabolism; deficiency can lead to serious metabolic and cardiac issues.
- The oral solution is often preferred for pediatric patients or those with swallowing difficulties.
- A common side effect is a fishy body odor, which is due to the accumulation of trimethylamine (TMA) and trimethylamine-N-oxide (TMAO) from gut bacterial metabolism of unabsorbed carnitine. This can be managed by reducing the dose or by using metronidazole to alter gut flora.
- Patients on valproic acid therapy should be monitored for carnitine deficiency, and levocarnitine supplementation may be necessary.
- Ensure patients understand the importance of consistent dosing and long-term therapy for chronic conditions.
Alternative Therapies
- No direct therapeutic alternatives for primary carnitine deficiency; levocarnitine is the specific replacement therapy.
- For secondary carnitine deficiencies, addressing the underlying cause (e.g., dietary changes, treatment of metabolic disorders) is crucial, but levocarnitine supplementation often remains a key component.
Cost & Coverage
Average Cost:
Varies widely, e.g., $100-$500+ per 100 mL bottle (1g/10mL)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (may require 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 this 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 overdose, including the medication taken, the amount, and the time it occurred.