Carnitor 10% 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
Not available
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. It helps improve energy levels, muscle function, and heart health, especially in people with certain genetic conditions or kidney problems.
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 your medication during or after meals to help minimize potential side effects. When taking the liquid form, measure your dose 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 this medication on its own or mix it with a drink or other liquid food.
To reduce the risk of stomach problems, drink slowly and consider mixing the medication with a larger amount of liquid.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms and areas exposed to heat. Do not freeze your medication.
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 a 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 your medication during or after meals to help minimize potential side effects. When taking the liquid form, measure your dose 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 this medication on its own or mix it with a drink or other liquid food.
To reduce the risk of stomach problems, drink slowly and consider mixing the medication with a larger amount of liquid.
Storing and Disposing of Your Medication
Store your medication at room temperature in a dry location, avoiding bathrooms and areas exposed to heat. Do not freeze your medication.
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 a missed one.
Lifestyle & Tips
- Take exactly as prescribed by your doctor.
- Measure the liquid carefully using the provided measuring device, not a household spoon.
- You can mix the oral solution with beverages or soft foods, but consume immediately.
- 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.
- 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
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Oral: 990 mg (1 g) 2 to 3 times daily, or 100 mg/kg/day divided into 2-3 doses (max 3 g/day)
Dose Range:
990 - 3000 mg
Condition-Specific Dosing:
Primary Carnitine Deficiency:
Oral: 990 mg (1 g) 2 to 3 times daily, or 100 mg/kg/day divided into 2-3 doses (max 3 g/day)
Secondary Carnitine Deficiency (e.g., hemodialysis):
Oral: 10-20 mg/kg/day, adjusted based on plasma carnitine levels. Max 3 g/day.
Pediatric Dosing
Neonatal:
Oral: 50-100 mg/kg/day divided into 2-3 doses. Max 300 mg/kg/day (not to exceed 3 g/day).
Infant:
Oral: 50-100 mg/kg/day divided into 2-3 doses. Max 300 mg/kg/day (not to exceed 3 g/day).
Child:
Oral: 50-100 mg/kg/day divided into 2-3 doses. Max 300 mg/kg/day (not to exceed 3 g/day).
Adolescent:
Oral: 50-100 mg/kg/day divided into 2-3 doses. Max 300 mg/kg/day (not to exceed 3 g/day).
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, monitor for accumulation of metabolites.
Moderate:
No specific adjustment recommended, monitor for accumulation of metabolites.
Severe:
Consider dose reduction or extended dosing interval; monitor plasma carnitine levels and for signs of metabolite accumulation (e.g., trimethylamine-related body odor).
Dialysis:
Levocarnitine is dialyzable. Dosing often adjusted to replace losses during dialysis. For patients on hemodialysis, IV administration is often preferred post-dialysis. Oral dosing may be 10-20 mg/kg/day.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended, as levocarnitine is not extensively metabolized by the liver. Monitor clinical response.
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, where they undergo beta-oxidation to produce energy. It also facilitates the removal of excess acyl groups from the mitochondria, which can accumulate and become toxic. In individuals with carnitine deficiency, supplementation restores normal fatty acid oxidation and energy production.
Pharmacokinetics
Absorption:
Bioavailability:
5-18% (oral)
Tmax:
3.3 hours (oral solution)
FoodEffect:
Food can decrease the rate and extent of absorption.
Distribution:
Vd:
0.4 L/kg
ProteinBinding:
<5%
CnssPenetration:
Limited
Elimination:
HalfLife:
17.4 hours (oral solution)
Clearance:
Not readily available for oral route, primarily renal.
ExcretionRoute:
Renal (unchanged drug and metabolites)
Unchanged:
80-90% of absorbed dose excreted renally as unchanged drug or its acyl esters.
Pharmacodynamics
OnsetOfAction:
Days to weeks for clinical effect, depending on severity of deficiency.
PeakEffect:
Weeks to months for full therapeutic effect.
DurationOfAction:
Dependent on dosing frequency and patient's metabolic state.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Attention Immediately
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
- 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. Although many people do not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other 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, 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.
While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
- 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. Although many people do not experience side effects or only have mild ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other 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, 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, vomiting, or diarrhea that doesn't go away
- Unusual or strong body odor (fishy smell)
- Increased muscle weakness or fatigue
- Signs of low blood sugar (e.g., dizziness, sweating, confusion, hunger)
- Swelling in your hands, ankles, or feet
- Shortness of breath
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 assess potential interactions between this medication and other substances you are taking.
* 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 current medications and health conditions. 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.
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 assess potential interactions between this medication and other substances you are taking.
* 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 current medications and health conditions. Never start, stop, or adjust the dosage 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 potential benefits and risks of this medication to both you and your baby.
Overdose Information
Overdose Symptoms:
- Severe gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
- Increased body odor
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic. Hemodialysis can remove levocarnitine.
Drug Interactions
Moderate Interactions
- Valproic acid
- Thyroid hormone
Monitoring
Baseline Monitoring
Plasma free and acyl carnitine 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 baseline kidney function, as levocarnitine is renally eliminated and metabolites can accumulate in renal impairment.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST)
Rationale: To assess baseline liver health, especially in patients with underlying metabolic disorders.
Timing: Prior to initiation of therapy.
Blood glucose
Rationale: To assess baseline glucose levels, as carnitine can affect glucose metabolism.
Timing: Prior to initiation of therapy.
Routine Monitoring
Plasma free and acyl carnitine 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 if levels are outside target range or if clinical symptoms persist/worsen.
Renal function (BUN, creatinine)
Frequency: Annually, or more frequently in patients with renal impairment.
Target: Normal range for age.
Action Threshold: Consider dose adjustment or increased monitoring if renal function declines.
Liver function tests (ALT, AST)
Frequency: Annually, or as clinically indicated.
Target: Normal range.
Action Threshold: Investigate significant elevations.
Blood glucose
Frequency: Periodically, especially in diabetic patients.
Target: Individualized.
Action Threshold: Monitor for hypoglycemia, especially in patients with impaired glucose metabolism.
Symptom Monitoring
- Muscle weakness
- Fatigue
- Cardiomyopathy symptoms (e.g., shortness of breath, edema)
- Hypoglycemia symptoms (e.g., sweating, tremor, confusion)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
- Body odor (fishy odor, due to trimethylamine accumulation, especially in renal impairment)
Special Patient Groups
Pregnancy
Levocarnitine is considered generally safe during pregnancy. While older classifications listed it as Category B, current FDA labeling encourages a risk summary approach. Human data suggest no increased risk of major birth defects or miscarriage. It is often continued in pregnant women with diagnosed carnitine deficiency to prevent maternal metabolic decompensation.
Trimester-Specific Risks:
First Trimester:
No increased risk of major birth defects observed.
Second Trimester:
No adverse effects reported.
Third Trimester:
No adverse effects reported.
Lactation
Levocarnitine is excreted into breast milk, but the amount is small and unlikely to cause adverse effects in a breastfed infant. It is considered compatible with breastfeeding. Monitor the infant for any signs of gastrointestinal upset.
Infant Risk:
Low risk.
Pediatric Use
Levocarnitine is widely used and well-established in pediatric populations for primary and secondary carnitine deficiencies. Dosing is weight-based and adjusted according to clinical response and plasma carnitine levels. Oral solution is often preferred for ease of administration.
Geriatric Use
No specific dose adjustments are generally required based solely on age. However, geriatric patients may have age-related decline in renal function, which should be considered when dosing, as levocarnitine and its metabolites are renally excreted. Monitor for accumulation of metabolites, especially in those with impaired renal function.
Clinical Information
Clinical Pearls
- 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. This can sometimes be managed by reducing the dose or by using activated charcoal.
- Oral solution should be measured accurately with a calibrated device. It can be mixed with water, juice, or food, but should be consumed immediately.
- Patients with primary carnitine deficiency often require lifelong therapy.
- Regular monitoring of plasma carnitine levels (free and acyl) is crucial to ensure therapeutic efficacy and avoid excessive accumulation.
- Levocarnitine can lower blood glucose levels, so diabetic patients should monitor their blood sugar closely.
- Valproic acid therapy can induce secondary carnitine deficiency; co-administration of levocarnitine may be considered in these patients, especially if symptomatic.
Alternative Therapies
- No direct therapeutic alternatives for primary carnitine deficiency; levocarnitine is the standard of care.
- For secondary carnitine deficiencies, addressing the underlying cause (e.g., discontinuing valproic acid, managing renal disease) is key, but levocarnitine supplementation is often still necessary.
Cost & Coverage
Average Cost:
Varies widely by pharmacy and volume (e.g., $100-$300+ for 118 mL bottle) per 118 mL bottle (100 mg/mL)
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3, often requires prior authorization for brand name, generic may be preferred.
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 discuss them with 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.