Carnitor 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
Carnitine supplement; 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 fat into energy. People who have certain medical conditions or are on dialysis 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
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 better.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
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. 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 better.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry place, avoiding the bathroom. Keep all medications in a safe location, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
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. Avoid taking two doses at the same time or taking extra doses.
Lifestyle & Tips
- Take exactly as prescribed by your doctor.
- Tablets can be taken with or without food, but taking with food may help reduce stomach upset.
- Report any unusual body odor (often described as 'fishy') to your doctor, as this may indicate too high a dose.
- Maintain a balanced diet as advised by your healthcare provider.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
Oral: 990 mg (3 x 330mg tablets) 2 to 3 times daily, or 1 to 3 grams per day in divided doses. IV: 50 mg/kg over 2-3 minutes, then 50 mg/kg/day in divided doses every 3-4 hours.
Dose Range:
990 - 3000 mg
Condition-Specific Dosing:
Primary Carnitine Deficiency:
Oral: 1-3 g/day in divided doses. IV: 50 mg/kg over 2-3 min, then 50 mg/kg/day in divided doses every 3-4 hours.
Secondary Carnitine Deficiency (e.g., ESRD on hemodialysis):
Oral: 1-3 g/day in divided doses. IV: 10-20 mg/kg after each dialysis session.
Pediatric Dosing
Neonatal:
Not established for routine use, but used off-label in specific metabolic disorders. Consult specialist.
Infant:
Oral: 50-100 mg/kg/day in divided doses, max 3 g/day. IV: 50 mg/kg over 2-3 min, then 50 mg/kg/day in divided doses every 3-4 hours.
Child:
Oral: 50-100 mg/kg/day in divided doses, max 3 g/day. IV: 50 mg/kg over 2-3 min, then 50 mg/kg/day in divided doses every 3-4 hours.
Adolescent:
Oral: 50-100 mg/kg/day in divided doses, max 3 g/day. IV: 50 mg/kg over 2-3 min, then 50 mg/kg/day in divided doses every 3-4 hours.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed for oral administration, but caution is advised in patients with severe renal impairment or end-stage renal disease (ESRD) due to accumulation of potentially toxic metabolites (trimethylamine, trimethylamine-N-oxide) which are normally excreted renally. IV formulation contains excipients that may accumulate.
Dialysis:
Levocarnitine is dialyzable. For ESRD patients on hemodialysis, IV dosing is typically 10-20 mg/kg after each dialysis session. Oral dosing may be adjusted based on carnitine levels and clinical response.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Levocarnitine is a naturally occurring substance required for energy metabolism. It facilitates the transport of long-chain fatty acids into the mitochondrial matrix for beta-oxidation, a key process for energy production. It also facilitates the removal of short- and medium-chain acyl groups that accumulate during metabolism, which can be toxic. It acts as a cofactor for various enzymes involved in fatty acid metabolism.
Pharmacokinetics
Absorption:
Bioavailability:
10-18% (oral)
Tmax:
3.3 hours (oral)
FoodEffect:
Food may decrease the rate and extent of absorption.
Distribution:
Vd:
29 L
ProteinBinding:
<5%
CnssPenetration:
Limited
Elimination:
HalfLife:
17.4 hours (terminal elimination half-life)
Clearance:
Not available (highly variable, primarily renal)
ExcretionRoute:
Renal (primarily unchanged drug and metabolites)
Unchanged:
80-90% of absorbed dose excreted unchanged in urine
Pharmacodynamics
OnsetOfAction:
Not acutely defined; therapeutic effects are observed with chronic supplementation.
PeakEffect:
Not acutely defined; therapeutic effects are observed with chronic supplementation.
DurationOfAction:
Not acutely defined; therapeutic effects are observed with chronic supplementation.
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. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- 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. You can also 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. Contact your doctor if you experience any of the following side effects or if they persist or bother you:
- 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. 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)
- New or worsening muscle weakness or cramps
- Signs of bleeding or bruising (if also taking blood thinners like warfarin)
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.
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 identify potential interactions.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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.
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 identify potential interactions.
* Any existing health problems, as this medication may interact with certain conditions.
To ensure your safety, it is crucial to verify that this medication can be taken 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 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, 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:
- Severe diarrhea
- Nausea
- Vomiting
- Abdominal cramps
- Strong body odor
What to Do:
Seek immediate medical attention or call a Poison Control Center. In the US, call 1-800-222-1222. Treatment is generally supportive and symptomatic. Hemodialysis can remove levocarnitine.
Drug Interactions
Moderate Interactions
Monitoring
Baseline Monitoring
Plasma carnitine levels (free and acylcarnitine)
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 important in patients with ESRD or those receiving IV formulation due to excipient accumulation.
Timing: Prior to initiation of therapy.
Lipid profile
Rationale: Carnitine plays a role in lipid metabolism; may be relevant in some deficiency states.
Timing: Prior to initiation of therapy.
Routine Monitoring
Plasma carnitine levels (free and acylcarnitine)
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated) to ensure therapeutic levels and guide dose adjustments.
Target: Normalization of free carnitine and acylcarnitine levels, or improvement in acylcarnitine/free carnitine ratio.
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: Ongoing assessment.
Target: Improvement or resolution of symptoms related to carnitine deficiency.
Action Threshold: Lack of improvement or worsening symptoms may indicate inadequate dosing or alternative diagnosis.
INR (International Normalized Ratio)
Frequency: More frequently if patient is concurrently on warfarin, especially upon initiation or dose changes of levocarnitine.
Target: Therapeutic range for warfarin.
Action Threshold: Elevated INR may require warfarin dose reduction.
Symptom Monitoring
- Unusual body odor (fishy odor)
- Gastrointestinal upset (nausea, vomiting, abdominal cramps, diarrhea)
- Muscle weakness or cramps (if new or worsening)
- Signs of bleeding (if on warfarin)
Special Patient Groups
Pregnancy
Category B. Animal studies have shown no evidence of impaired fertility or harm to the fetus. There are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefits outweigh the potential risks.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data, but human data lacking.
Second Trimester:
Low risk based on animal data, but human data lacking.
Third Trimester:
Low risk based on animal data, but human data lacking.
Lactation
Levocarnitine is present in human milk. The amount of levocarnitine in breast milk is higher than in plasma. The effects on the breastfed infant are unknown. Weigh the developmental and health benefits of breastfeeding against the mother's clinical need for levocarnitine and any potential adverse effects on the breastfed infant from levocarnitine or from the underlying maternal condition.
Infant Risk:
L3 (Moderately safe; potential for minor adverse effects or no data available; monitor infant for gastrointestinal upset or unusual odor).
Pediatric Use
Levocarnitine is indicated for the treatment of primary and secondary carnitine deficiency in pediatric patients. Dosing is weight-based. Safety and efficacy have been established in pediatric populations for these indications.
Geriatric Use
No specific dose adjustments are generally required based solely on age. However, elderly patients may have reduced renal function, which should be considered, especially with the IV formulation due to excipient accumulation. Monitor renal function and adjust dose if necessary.
Clinical Information
Clinical Pearls
- The most common side effect is a characteristic 'fishy' body odor, which is due to the accumulation of trimethylamine (TMA) and can be managed by reducing the dose or changing the formulation (e.g., from oral solution to tablet, or vice versa, if available).
- Oral levocarnitine has low and variable bioavailability; IV administration is often preferred for acute or severe deficiency.
- Patients with end-stage renal disease (ESRD) on hemodialysis often develop secondary carnitine deficiency and may benefit from supplementation.
- Monitor INR closely if the patient is also on warfarin, as levocarnitine may potentiate its anticoagulant effect, though this is rare.
- Ensure patients understand the importance of consistent dosing for chronic conditions.
Alternative Therapies
- No direct therapeutic alternatives for primary carnitine deficiency. Treatment is primarily carnitine replacement.
- For secondary carnitine deficiencies, addressing the underlying cause (e.g., dietary changes, treatment of metabolic disorders, discontinuation of offending drugs like valproic acid) is key, in addition to carnitine supplementation.
Cost & Coverage
Average Cost:
Varies widely, typically $50-$200+ per 30 tablets (330mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or Tier 2 (generic), Tier 3 or Non-Formulary (brand)
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 occurred.