Carnitor 1gm/10ml Sol (sugar Free)
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
Pregnancy Category
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. It's used when your body doesn't make enough of it or can't use it properly, which can lead to problems with energy and muscle function.
How to Use This Medicine
Taking Your Medication Correctly
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your 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. If you are taking a liquid dose, measure it 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 your medication alone 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 place, away from the bathroom. Do not freeze your 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 is 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 dose.
To get the most benefit from your medication, follow your doctor's instructions carefully. Read all the information provided with your prescription and follow the instructions closely. Continue taking your 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. If you are taking a liquid dose, measure it 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 your medication alone 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 place, away from the bathroom. Do not freeze your 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 is 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 dose.
Lifestyle & Tips
- Take exactly as prescribed by your doctor.
- May be taken with or without food. Taking with food may help reduce stomach upset, but absorption may be slightly reduced.
- Do not stop taking this medication without consulting your doctor.
- Report any unusual body odor (fishy smell) to your doctor, as this may indicate a need for dose adjustment.
Available Forms & Alternatives
Dosing & Administration
Adult Dosing
Standard Dose:
Oral: 990 mg (10 mL) 2 to 3 times daily, or 50 mg/kg/day in 2 to 3 divided doses. Max 3 g/day.
Dose Range:
990 - 3000 mg
Condition-Specific Dosing:
Primary Carnitine Deficiency:
50 mg/kg/day orally in 2-3 divided doses, increasing as tolerated to 100 mg/kg/day (max 3 g/day).
Secondary Carnitine Deficiency (e.g., valproic acid-induced):
50-100 mg/kg/day orally in 2-3 divided doses.
Pediatric Dosing
Neonatal:
Oral: 50-100 mg/kg/day in 2-3 divided doses. Max 3 g/day.
Infant:
Oral: 50-100 mg/kg/day in 2-3 divided doses. Max 3 g/day.
Child:
Oral: 50-100 mg/kg/day in 2-3 divided doses. Max 3 g/day.
Adolescent:
Oral: 50-100 mg/kg/day in 2-3 divided doses. Max 3 g/day.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed, but accumulation of inactive metabolites (trimethylamine, trimethylamine-N-oxide) may occur in patients with end-stage renal disease (ESRD). Monitor for symptoms of uremic syndrome.
Dialysis:
Levocarnitine is dialyzable. Accumulation of metabolites occurs in ESRD. Monitor for symptoms of uremic syndrome. Supplementation may be needed post-dialysis.
Hepatic Impairment:
Mild:
No specific adjustment needed.
Moderate:
No specific adjustment needed.
Severe:
No specific adjustment needed.
Pharmacology
Mechanism of Action
Levocarnitine (L-carnitine) is a naturally occurring substance essential for energy metabolism. It facilitates the transport of long-chain fatty acids across the inner mitochondrial membrane into the mitochondria, 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.
Pharmacokinetics
Absorption:
Bioavailability:
15-16%
Tmax:
3.3 hours
FoodEffect:
Food can decrease absorption, but taking with food may reduce gastrointestinal upset.
Distribution:
Vd:
0.2-0.3 L/kg
ProteinBinding:
<25%
CnssPenetration:
Limited
Elimination:
HalfLife:
Approximately 17 hours (oral)
Clearance:
Not available
ExcretionRoute:
Primarily renal (unchanged drug and metabolites)
Unchanged:
5-15%
Pharmacodynamics
OnsetOfAction:
Not acutely defined for chronic replacement therapy; clinical effects may take weeks to months.
PeakEffect:
Not acutely defined for chronic replacement therapy.
DurationOfAction:
Not acutely defined for chronic replacement therapy.
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 about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or through their website 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 about side effects, you can also contact your doctor. Additionally, you can report side effects to the FDA at 1-800-332-1088 or through their website at https://www.fda.gov/medwatch.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent nausea, vomiting, abdominal pain, or diarrhea
- Unusual or strong body odor (fishy smell)
- Muscle weakness or cramps that worsen
- 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 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:
- Diarrhea
- Unusual body odor (fishy smell)
What to Do:
In case of suspected overdose, contact a poison control center immediately (e.g., 1-800-222-1222 in the US) or seek emergency medical attention. Management is supportive.
Drug Interactions
Moderate Interactions
Monitoring
Baseline Monitoring
Plasma free and acylcarnitine levels
Rationale: To establish baseline deficiency and guide initial dosing.
Timing: Prior to initiation of therapy
Renal function (BUN, creatinine)
Rationale: To assess kidney function, especially in patients with ESRD where metabolites can accumulate.
Timing: Prior to initiation of therapy
Liver function tests (ALT, AST)
Rationale: To assess baseline liver health.
Timing: Prior to initiation of therapy
Routine Monitoring
Plasma free and acylcarnitine levels
Frequency: Periodically (e.g., every 3-6 months or as clinically indicated)
Target: To normalize levels (e.g., free carnitine >35 µmol/L, acylcarnitine/free carnitine ratio <0.4)
Action Threshold: Persistent abnormal levels may require dose adjustment.
Clinical symptoms (e.g., muscle weakness, fatigue, GI symptoms)
Frequency: Ongoing
Target: Improvement or resolution of symptoms
Action Threshold: Worsening or new symptoms may indicate inadequate dosing or adverse effects.
INR (if on warfarin)
Frequency: Regularly as per warfarin monitoring guidelines
Target: Therapeutic range for warfarin
Action Threshold: Elevated INR may require warfarin dose adjustment or levocarnitine dose adjustment.
Symptom Monitoring
- Nausea
- Vomiting
- Abdominal cramps
- Diarrhea
- Body odor (fishy odor)
- Muscle weakness
- Fatigue
Special Patient Groups
Pregnancy
Category B. Animal studies have not shown harm to the fetus, but there are no adequate and well-controlled studies in pregnant women. Use only if clearly needed.
Trimester-Specific Risks:
First Trimester:
Low risk based on animal data; human data limited.
Second Trimester:
Low risk based on animal data; human data limited.
Third Trimester:
Low risk based on animal data; human data limited.
Lactation
Levocarnitine is excreted in human milk. However, it is an endogenous substance, and levels in milk are generally low. The benefits of breastfeeding should be weighed against the potential risks. Generally considered compatible with breastfeeding, especially when used for maternal deficiency.
Infant Risk:
Low risk; carnitine is naturally present in breast milk and is essential for infant metabolism.
Pediatric Use
Dosing is weight-based. Safety and efficacy have been established in pediatric patients for approved indications. Close monitoring of carnitine levels and clinical response is important.
Geriatric Use
No specific dose adjustments are generally required based on age alone. However, elderly patients may have reduced renal function, which should be considered due to potential accumulation of metabolites in ESRD. Monitor renal function.
Clinical Information
Clinical Pearls
- Carnitor 1gm/10ml Sol (sugar Free) is particularly useful for diabetic patients or those who need to avoid sugar.
- The 'fishy' body odor is a common, dose-related side effect due to the accumulation of trimethylamine (TMA) and can be managed by dose reduction or temporary discontinuation.
- Oral levocarnitine is typically taken in divided doses to optimize absorption and minimize GI side effects.
- Patients with end-stage renal disease (ESRD) on hemodialysis may require levocarnitine supplementation due to loss during dialysis and impaired endogenous synthesis.
Alternative Therapies
- Levocarnitine IV injection (for acute or severe deficiency)
- Dietary management (e.g., high-fat, low-carbohydrate diets for certain metabolic disorders, though not a direct replacement for carnitine deficiency)
Cost & Coverage
Average Cost:
Varies widely per 10 mL bottle
Generic Available:
Yes
Insurance Coverage:
Tier 2 or 3 (Specialty drug, may require prior authorization)
General Drug Facts
If your symptoms or health issues persist or worsen, it is 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 it's a good idea 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 overdose, including the medication taken, the amount, and the time it occurred.