Carnitor 1gm/5ml Inj, 5ml
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 1992
DEA Schedule
Not Controlled
Overview
What is this medicine?
Levocarnitine is a natural substance that helps your body turn fat into energy. It's used when your body doesn't make enough of it, or when certain medical conditions (like kidney disease requiring dialysis) cause your body to lose too much of it. This injection helps restore your body's carnitine levels.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion into a vein over a period of time or as an injection into a vein.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is administered as an infusion into a vein over a period of time or as an injection into a vein.
Storing and Disposing of Your Medication
If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.
Missing a Dose
If you miss a dose, contact your doctor to determine the best course of action.
Lifestyle & Tips
- Maintain a balanced diet as recommended by your healthcare provider.
- Adhere to your dialysis schedule if applicable.
- Report any unusual body odor to your doctor.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
For secondary carnitine deficiency in ESRD patients on hemodialysis: 10-20 mg/kg IV slow bolus over 2-3 minutes after each dialysis session. For primary carnitine deficiency: 50 mg/kg/day IV in divided doses, increasing up to 100 mg/kg/day (max 3g/day).
Dose Range:
10 - 100 mg
Condition-Specific Dosing:
ESRD on Hemodialysis:
10-20 mg/kg IV after each dialysis session
Primary Carnitine Deficiency:
50-100 mg/kg/day IV in divided doses
Pediatric Dosing
Neonatal:
Not established for all indications, but used off-label for primary carnitine deficiency (50-100 mg/kg/day IV in divided doses).
Infant:
For primary carnitine deficiency: 50-100 mg/kg/day IV in divided doses. For secondary carnitine deficiency in ESRD on hemodialysis: 10-20 mg/kg IV after each dialysis session.
Child:
For primary carnitine deficiency: 50-100 mg/kg/day IV in divided doses. For secondary carnitine deficiency in ESRD on hemodialysis: 10-20 mg/kg IV after each dialysis session.
Adolescent:
For primary carnitine deficiency: 50-100 mg/kg/day IV in divided doses. For secondary carnitine deficiency in ESRD on hemodialysis: 10-20 mg/kg IV after each dialysis session.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed for ESRD patients on dialysis as dosing is post-dialysis. For other indications, monitor for accumulation of metabolites (e.g., trimethylamine, trimethylamine-N-oxide) which can cause a fishy odor.
Moderate:
No specific adjustment needed for ESRD patients on dialysis. Monitor for metabolite accumulation.
Severe:
No specific adjustment needed for ESRD patients on dialysis. Monitor for metabolite accumulation.
Dialysis:
Administer after each hemodialysis session as the drug is dialyzable. Dosing is typically 10-20 mg/kg IV post-dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended.
Severe:
No specific adjustment recommended. Monitor for fishy body odor, which may indicate metabolite accumulation.
Pharmacology
Mechanism of Action
Levocarnitine is a naturally occurring substance that is essential for energy metabolism. It facilitates 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 short- and medium-chain acyl groups that accumulate during metabolism, which can be toxic.
Pharmacokinetics
Absorption:
Bioavailability:
100% (IV administration)
Tmax:
Not applicable (IV bolus, immediate peak)
FoodEffect:
Not applicable (IV administration)
Distribution:
Vd:
Approximately 0.2-0.3 L/kg
ProteinBinding:
<25%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 17 hours (terminal half-life)
Clearance:
Renal clearance is significant; also cleared by hemodialysis.
ExcretionRoute:
Renal excretion (primarily as unchanged drug and metabolites)
Unchanged:
Approximately 80% of an IV dose is excreted unchanged in urine within 24 hours.
Pharmacodynamics
OnsetOfAction:
Rapid (minutes) after IV administration
PeakEffect:
Correlates with peak plasma concentrations, immediate after IV bolus
DurationOfAction:
Dependent on half-life and underlying carnitine deficiency state; effects persist as long as adequate carnitine levels are maintained.
Safety & Warnings
Side Effects
Serious Side Effects: Seek Medical Help Right Away
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in vision
Chest pain or pressure
Fast or abnormal heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Abnormal sensations, such as burning, numbness, or tingling
Changes in vision
Depression
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Diarrhea
Upset stomach or vomiting
Body odor
Dizziness, tiredness, or weakness
Headache
Stomach pain
Irritation at the injection site
Cough
Runny nose
Decreased appetite
Changes in taste
Weight gain or loss
Reporting Side Effects
These are not all the possible side effects of this medication. 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.
Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you experience any of the following symptoms, contact your doctor or seek medical attention immediately:
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
Signs of high calcium levels, including:
+ Weakness
+ Confusion
+ Feeling tired
+ Headache
+ Upset stomach and vomiting
+ Constipation
+ Bone pain
Signs of infection, such as:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Pain while urinating
+ Mouth sores
+ Wounds that will not heal
Signs of high or low blood pressure, including:
+ Severe headache or dizziness
+ Passing out
+ Changes in vision
Chest pain or pressure
Fast or abnormal heartbeat
Fever, chills, or sore throat
Unexplained bruising or bleeding
Feeling very tired or weak
Abnormal sensations, such as burning, numbness, or tingling
Changes in vision
Depression
Other Possible Side Effects
Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you experience any of the following side effects, or if they bother you or do not go away, contact your doctor:
Diarrhea
Upset stomach or vomiting
Body odor
Dizziness, tiredness, or weakness
Headache
Stomach pain
Irritation at the injection site
Cough
Runny nose
Decreased appetite
Changes in taste
Weight gain or loss
Reporting Side Effects
These are not all the possible side effects of this medication. 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:
- Unusual or strong fishy body odor
- Severe or persistent nausea, vomiting, or diarrhea
- Increased muscle weakness or cramps
- Signs of low blood sugar (e.g., dizziness, sweating, confusion) if you have a history of hypoglycemia
- Signs of heart problems (e.g., chest pain, shortness of breath, swelling in legs/ankles)
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 identify potential interactions between this medication and other substances.
* 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. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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 identify potential interactions between this medication and other substances.
* 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. Always consult your doctor before starting, stopping, or changing the dose of any medication, including this one.
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:
- Diarrhea
- Nausea
- Vomiting
- Abdominal cramps
- Fishy body odor
What to Do:
If you suspect an overdose, seek immediate medical attention or call a poison control center (e.g., 1-800-222-1222 in the US). Treatment is generally supportive, focusing on managing symptoms and discontinuing the drug if appropriate.
Drug Interactions
Moderate Interactions
- Warfarin
- Thyroid hormone
Monitoring
Baseline Monitoring
Plasma free and acyl carnitine levels
Rationale: To confirm carnitine deficiency and establish baseline for monitoring treatment efficacy.
Timing: Prior to initiation of therapy
Renal function (BUN, creatinine)
Rationale: To assess kidney function, especially in patients not on dialysis, as metabolites are renally excreted.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST, bilirubin)
Rationale: To assess liver health, though hepatic impairment does not typically require dose adjustment.
Timing: Prior to initiation of therapy
Routine Monitoring
Plasma free and acyl carnitine levels
Frequency: Periodically (e.g., every 3 months for ESRD patients, or as clinically indicated for primary deficiency)
Target: Maintain free carnitine levels within the normal range and acyl/free carnitine ratio below 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: Ongoing assessment at each visit
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 (if on warfarin)
Frequency: More frequently after initiation or dose changes of levocarnitine
Target: Therapeutic range for warfarin
Action Threshold: Elevated INR may require warfarin dose adjustment.
Symptom Monitoring
- Unusual or fishy body odor (due to accumulation of trimethylamine metabolites)
- Gastrointestinal upset (nausea, vomiting, diarrhea, abdominal cramps)
- Muscle weakness or cramps (if deficiency is not adequately treated)
- Signs of hypoglycemia (in patients with primary carnitine deficiency)
- Signs of cardiomyopathy (e.g., shortness of breath, edema, chest pain)
Special Patient Groups
Pregnancy
Levocarnitine is classified as 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. It should be used 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 are limited.
Second Trimester:
Low risk based on animal data, but human data are limited.
Third Trimester:
Low risk based on animal data, but human data are limited.
Lactation
Levocarnitine is excreted in human milk. While the amount transferred is generally small and no adverse effects have been reported in breastfed infants, caution should be exercised. The benefits of breastfeeding should be weighed against the potential risks.
Infant Risk:
Low risk (L3 - Moderately safe; no adverse effects reported in infants, but data are limited).
Pediatric Use
Levocarnitine injection is used in pediatric patients for primary carnitine deficiency and secondary carnitine deficiency in ESRD on hemodialysis. Dosing is weight-based. Close monitoring of carnitine levels and clinical response is essential. Safety and efficacy in neonates for all indications are not fully established, but it is used off-label in this population.
Geriatric Use
No specific dose adjustments are generally required for geriatric patients. However, as with all medications in the elderly, monitor for adverse effects and consider potential comorbidities and polypharmacy.
Clinical Information
Clinical Pearls
- Administer levocarnitine injection as a slow IV bolus over 2-3 minutes to minimize potential adverse effects like nausea or abdominal discomfort.
- For patients on hemodialysis, administer the dose immediately after each dialysis session to replenish carnitine lost during dialysis.
- Monitor for a 'fishy' body odor, which can indicate accumulation of trimethylamine metabolites, especially with higher doses or in patients with impaired renal function not on dialysis. Dose reduction may be necessary.
- Regular monitoring of plasma free and acyl carnitine levels is crucial to ensure therapeutic efficacy and prevent over-supplementation.
- Levocarnitine is not a substitute for dietary restrictions in patients with inborn errors of metabolism where specific dietary management is required.
Alternative Therapies
- Oral levocarnitine (tablets, oral solution)
- Dietary management (for certain metabolic disorders)
- Other nutritional supplements (depending on the specific deficiency)
Cost & Coverage
Average Cost:
Highly variable, typically several hundred to over a thousand USD per vial/course depending on dose and quantity. per 1gm/5ml vial
Generic Available:
Yes
Insurance Coverage:
Often covered by most prescription drug plans for approved indications (e.g., ESRD, primary carnitine deficiency), typically as a Tier 2 or Tier 3 drug, or under medical benefit for injectables.
General Drug Facts
If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.
To ensure safe use, do not share your prescription medications with others, and never take medication that has been prescribed to someone else.
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Unused or expired medications should be disposed of properly. Unless specifically instructed to do so by a healthcare professional or pharmacist, do not flush medications down the toilet or pour them down the drain. Instead, consult with your pharmacist to determine the best disposal method, as some communities may have designated drug take-back programs.
Some medications may come with an additional patient information leaflet; if you have questions, consult with your pharmacist. If you have any concerns or questions about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.
To ensure safe use, do not share your prescription medications with others, and never take medication that has been prescribed to someone else.
All medications should be stored in a secure location, out of the reach of children and pets, to prevent accidental ingestion.
Unused or expired medications should be disposed of properly. Unless specifically instructed to do so by a healthcare professional or pharmacist, do not flush medications down the toilet or pour them down the drain. Instead, consult with your pharmacist to determine the best disposal method, as some communities may have designated drug take-back programs.
Some medications may come with an additional patient information leaflet; if you have questions, consult with your pharmacist. If you have any concerns or questions about your medication, it is crucial to discuss them with your doctor, nurse, pharmacist, or other healthcare provider.
In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken, as this will aid in providing appropriate treatment.