Carnitor 1g/10ml 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
B
FDA Approved
Dec 1985
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levocarnitine is a natural substance that helps your body turn fat into energy. People who don't have enough of this substance, or whose bodies can't use it properly, might need to take it as a medicine. It's often used for certain genetic conditions or kidney problems that cause a shortage of this important substance.
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.
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 continue with 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.
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 continue with 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.
- Can be taken with or without food, but taking with food may reduce stomach upset.
- Do not stop taking this medication without consulting your doctor.
- Report any unusual body odor to your doctor, as this may indicate a need for dose adjustment.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Oral: 1 to 3 grams per day, divided into 2 or 3 doses.
Dose Range:
1000 - 3000 mg
Condition-Specific Dosing:
Primary Carnitine Deficiency:
Oral: 1 to 3 grams per day, divided into 2 or 3 doses. Initial dose often 1 gram/day, titrated based on response and plasma carnitine levels.
Secondary Carnitine Deficiency (e.g., ESRD on hemodialysis):
Oral: 1 to 3 grams per day, divided into 2 or 3 doses. Doses up to 4 grams/day have been used.
Pediatric Dosing
Neonatal:
Not established for routine use, but used off-label for specific metabolic disorders. Dosing highly individualized, often 50-100 mg/kg/day divided.
Infant:
Oral: 50 to 100 mg/kg/day, divided into 2 or 3 doses. Max 3 grams/day. Titrate based on response and plasma carnitine levels.
Child:
Oral: 50 to 100 mg/kg/day, divided into 2 or 3 doses. Max 3 grams/day. Titrate based on response and plasma carnitine levels.
Adolescent:
Oral: 50 to 100 mg/kg/day, divided into 2 or 3 doses. Max 3 grams/day or adult dose of 1-3 grams/day. Titrate based on response and plasma carnitine levels.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required for oral use, but monitor for accumulation of metabolites (e.g., TMAO) in patients with ESRD. Hemodialysis removes levocarnitine.
Dialysis:
Levocarnitine is dialyzable. For patients on hemodialysis, supplementation is often necessary due to loss during dialysis and impaired endogenous synthesis. Dosing for secondary carnitine deficiency in ESRD is typically 1-3 grams/day orally.
Hepatic Impairment:
Mild:
No specific adjustment required.
Moderate:
No specific adjustment required.
Severe:
No specific adjustment required, but monitor clinical status.
Pharmacology
Mechanism of Action
Levocarnitine (L-carnitine) is a naturally occurring substance required in mammalian energy metabolism. It facilitates the transport of long-chain fatty acids across the inner mitochondrial membrane 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, this transport and removal process is impaired, leading to accumulation of fatty acids and metabolic dysfunction.
Pharmacokinetics
Absorption:
Bioavailability:
5-25% (oral solution)
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:
Approximately 17 hours (terminal half-life)
Clearance:
Renal clearance is significant, but varies with dose and plasma concentration.
ExcretionRoute:
Renal (primarily as unchanged drug and its metabolites, including TMA and TMAO)
Unchanged:
Approximately 5-15% of an oral dose is excreted unchanged in urine.
Pharmacodynamics
OnsetOfAction:
Weeks to months for clinical improvement in chronic conditions.
PeakEffect:
Not acutely measurable; related to restoration of carnitine levels and metabolic function.
DurationOfAction:
Sustained with regular dosing; related to half-life and metabolic turnover.
Safety & Warnings
Side Effects
Urgent Side Effects: Seek Medical Help Right Away
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, which may include:
+ 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. 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 is not exhaustive, and you may experience other side effects not mentioned here. 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.
Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience any of the following symptoms, contact your doctor immediately or seek emergency medical attention:
Signs of an allergic reaction, which may include:
+ 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. 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 is not exhaustive, and you may experience other side effects not mentioned here. 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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent nausea, vomiting, or diarrhea
- Unusual or strong body odor (fishy smell)
- Increased muscle weakness or fatigue
- 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 symptoms you experienced as a result of the allergy.
Potential interactions with other medications or health conditions. This medication may affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
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 affect or be affected by other drugs or health problems, so it is crucial to disclose all relevant information.
To ensure safe treatment, provide your doctor and pharmacist with a comprehensive list of:
All prescription and over-the-counter (OTC) medications you are taking
Natural products and vitamins you are using
* Any health problems you have
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; be sure to discuss any concerns or questions you have 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:
- Diarrhea
- Nausea
- Vomiting
- Abdominal cramps
- Unusual body odor
What to Do:
In case of suspected overdose, seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is generally supportive and symptomatic.
Drug Interactions
Moderate Interactions
- Valproic acid
- Thyroid hormone
Monitoring
Baseline Monitoring
Plasma free and acylcarnitine levels
Rationale: To confirm diagnosis of carnitine deficiency and establish baseline for monitoring treatment efficacy.
Timing: Prior to initiation of therapy.
Renal function (BUN, creatinine)
Rationale: To assess baseline kidney function, especially in patients with pre-existing renal impairment.
Timing: Prior to initiation of therapy.
Liver function tests (ALT, AST)
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 during dose titration.
Target: Target free carnitine levels typically >35-40 µmol/L, with a free:acyl carnitine ratio <0.4.
Action Threshold: If levels remain low or symptoms persist, consider dose adjustment. If levels are excessively high, consider dose reduction.
Clinical symptoms (e.g., muscle weakness, fatigue, cardiomyopathy)
Frequency: Regularly, at each follow-up visit.
Target: Improvement or resolution of symptoms.
Action Threshold: Worsening or new symptoms may indicate inadequate dosing or other underlying issues.
Renal function (BUN, creatinine)
Frequency: Annually, or more frequently in patients with renal impairment.
Target: Within normal limits or stable for patient's condition.
Action Threshold: Significant decline may warrant re-evaluation of overall patient management.
Liver function tests (ALT, AST)
Frequency: Annually, or as clinically indicated.
Target: Within normal limits.
Action Threshold: Significant elevation may warrant investigation.
Symptom Monitoring
- Muscle weakness
- Fatigue
- Cardiomyopathy symptoms (e.g., shortness of breath, edema)
- Hypoglycemia (especially in infants/children)
- Encephalopathy
- Abdominal discomfort
- Nausea
- Vomiting
- Diarrhea
- Body odor (fishy odor)
Special Patient Groups
Pregnancy
Levocarnitine is considered Category B. Animal studies have shown no evidence of harm to the fetus. There are no adequate and well-controlled studies in pregnant women. However, carnitine is essential for normal metabolism, and deficiency during pregnancy could be detrimental to both mother and fetus. Use during pregnancy only if clearly needed and potential benefits outweigh potential risks.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified.
Second Trimester:
No specific increased risk identified.
Third Trimester:
No specific increased risk identified.
Lactation
Levocarnitine is naturally present in human milk. While there are no specific studies on the effects of supplemental levocarnitine on breastfed infants, the amount transferred is likely small and unlikely to cause adverse effects. It is considered L3 (moderately safe). Benefits of breastfeeding should be weighed against potential risks.
Infant Risk:
Low risk of adverse effects to the infant. Monitor for any unusual symptoms or changes in feeding patterns.
Pediatric Use
Levocarnitine is commonly used in pediatric patients for primary and secondary carnitine deficiencies. Dosing is weight-based (mg/kg/day) and should be carefully titrated based on clinical response and plasma carnitine levels. Safety and efficacy are established for appropriate indications.
Geriatric Use
No specific dose adjustments are generally required for elderly patients based solely on age. However, geriatric patients may have reduced renal function, which should be considered. Monitor renal function and adjust dose if necessary, as with other adult patients.
Clinical Information
Clinical Pearls
- The 'fishy' body odor is a common and benign side effect, often dose-related. It can be managed by reducing the dose or by temporarily discontinuing the drug.
- Oral solution can be mixed with beverages or food, but avoid mixing with very hot liquids.
- Patients with end-stage renal disease (ESRD) on hemodialysis often require levocarnitine supplementation due to impaired synthesis and loss during dialysis.
- Regular monitoring of plasma carnitine levels (free and acyl) is crucial to ensure therapeutic efficacy and avoid excessive dosing.
- Levocarnitine is not a substitute for dietary restrictions in patients with specific metabolic disorders (e.g., fatty acid oxidation disorders); it is an adjunct therapy.
Alternative Therapies
- Dietary modifications (e.g., medium-chain triglyceride oil for some fatty acid oxidation disorders)
- Other nutritional supplements (depending on the specific metabolic disorder)
Cost & Coverage
Average Cost:
Varies widely by pharmacy and dosage form (oral solution vs. tablets) per 10ml bottle (1g/10ml)
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans, typically Tier 2 or 3, especially for approved indications. Prior authorization may be required.
General Drug Facts
If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective 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's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.