Dosing & Uses
Dosage Forms & Strengths
tablets
- 250mg
- 330mg
capsule
- 250mg
oral solution
- 1g/10mL
injectable solution
- 200mg/mL
Carnitine Deficiency
Tablet: 990 mg PO q8-12hr, up to 3 g/day
Oral solution: 1000 mg/day PO initially divided
50 mg/kg IV bolus, THEN 50 mg/kg over next 24 hr (divided q3-6hr)
End-Stage Renal Disease
Indicated for ESRD in patients on hemodialysis
Initial dose: 10-20 mg/kg IV bolus infused over 2-3 minutes; administer into venous return line after dialysis session
Adjust doses by predialysis levocarnitine concentrations
Downward dose titration may begin as within 3-4 weeks after initiating
Valproic Acid Overdose (Orphan)
For the prevention or treatment of secondary carnitine deficiency in valproic acid toxicity
100 mg/kg IV (not to exceed 6 g/dose) once
May give additional doses of 15 mg/kg IV q4hr infused over 30 min
Recommendations vary; some sources advocate limiting total dose to 3 g/day
Orphan indication sponsor
- Sigma-Tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd, Suite 500; Gaithersburg, MD 20878
Myopathy (Orphan)
Treatment of zidovudine-induced mitochondrial myopathy
Orphan indication sponsor
- Sigma-Tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd, Suite 500; Gaithersburg, MD 20878
Rett Syndrome (Orphan)
Acetyl-L-carniticine designated orphan indication for treatment Rett syndrome
Orphan indication sponsor
- Sigma-Tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd, Suite 500; Gaithersburg, MD 20878
Administration
Consume oral solution slowly, may be mixed with drinks and space doses evenly throughout the day (q3-4hr) preferably during or after meals (may decrease GI distress)
Administer IV bolus slowly over at least 2-3 min
Also sold as a non-pharmacologic health supplement (L-carnitine)
Dosage Forms & Strengths
tablets
- 250mg
- 330mg
capsule
- 250mg
oral solution
- 1g/10mL
injectable solution
- 200mg/mL
Carnitine Deficiency
50 mg/kg/day PO divided q8-12hr initially
May increase to 100 mg/kg/day PO divided q8-12hr; not to exceed 3 g/day
IV: 50 mg/kg IV bolus; may repeat 50 mg/kg IV daily if indicated; not to exceed 300 mg/kg
End-Stage Renal Disease
Indicated for ESRD in patients on hemodialysis
Initial dose: 10-20 mg/kg IV bolus infused over 2-3 minutes; administer into venous return line after dialysis session
Adjust doses by predialysis levocarnitine concentrations
Downward dose titration may begin as within 3-4 weeks after initiating
Valproic Acid Overdose (Orphan)
For the prevention or treatment of secondary carnitine deficiency in valproic acid toxicity
Overdose or hyperammonemia: 150-500 mg/kg/day IV; not to exceed 3 g/day or until clinical improvement observed
100 mg/kg/day PO; not to exceed 2 g/day in divided doses
Orphan indication sponsor
- Sigma-Tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd, Suite 500; Gaithersburg, MD 20878
Rett Syndrome (Orphan)
Acetyl-L-carnitine designated orphan indication for treatment Rett syndrome
Orphan indication sponsor
- sigma-tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd; Gaithersburg, MD 20878
Cardiomyopathy (Orphan)
Treatment of pediatric cardiomyopathy
Orphan indication sponsor
- Sigma-Tau Pharmaceuticals, Inc; 9841 Washingtonian Blvd, Suite 500; Gaithersburg, MD 20878
Administration
Consume oral solution slowly, may be mixed with drinks and space doses evenly throughout the day (q3-4hr) preferably during or after meals (may decrease GI distress)
Administer IV bolus slowly over at least 2-3 min
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (1)
- zavegepant intranasal
levocarnitine will increase the level or effect of zavegepant intranasal by Other (see comment). Avoid or Use Alternate Drug. NTCP inhibitors may result in a significant increase in systemic exposure of zavegepant (a NTCP substrate).
Monitor Closely (1)
- warfarin
levocarnitine increases effects of warfarin by unspecified interaction mechanism. Use Caution/Monitor.
Minor (24)
- acetazolamide
acetazolamide decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- carbamazepine
carbamazepine decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- clonazepam
clonazepam decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- eslicarbazepine acetate
eslicarbazepine acetate decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- ethosuximide
ethosuximide decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- felbamate
felbamate decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- fosphenytoin
fosphenytoin decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- gabapentin
gabapentin decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- gabapentin enacarbil
gabapentin enacarbil decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- lacosamide
lacosamide decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- lamotrigine
lamotrigine decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- levetiracetam
levetiracetam decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- lorazepam
lorazepam decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- methsuximide
methsuximide decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- oxcarbazepine
oxcarbazepine decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- phenobarbital
phenobarbital decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- phenytoin
phenytoin decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- primidone
primidone decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- rose hips
rose hips decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- rufinamide
rufinamide decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- tiagabine
tiagabine decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- topiramate
topiramate decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- valproic acid
valproic acid decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
- zonisamide
zonisamide decreases levels of levocarnitine by unspecified interaction mechanism. Minor/Significance Unknown.
Adverse Effects
Frequency Not Defined
GI distress
Mild myasthenia in patients with uremia
Hypertension
Headache
Dizziness
Fever
Vomiting
Hypercalcemia
Anemia
Paresthesia
Cough
Tachycardia
Palpitation
Peripheral edema
Vertigo
Rash
Bronchitis
Gastritis
Postmarketing Reports
Gastrointestinal reactions: Nausea and vomiting, abdominal cramps, and diarrhea
Musculoskeletal reactions: Mild myasthenia (only in uremic patients)
Neurologic reactions: Seizures
Hypersensitivity reactions: Rash, urticaria, and facial edema
Warnings
Contraindications
None listed by the manufacturer
Cautions
Monitor blood chemistries, plasma carnitine concentration, vital signs
INR may increase in patients receiving warfarin therapy; monitor INR levels following initiation of levocarnitine therapy and after dose adjustments
GI reactions may occur from too rapid consumption of carnitine
Carcinogenic potential unknown
Serious hypersensitivity reactions, including rash, urticarial, and facial edema reported; serious reactions, including anaphylaxis, laryngeal edema, and bronchospasm reported following intravenous administration, mostly in patients with end-stage renal disease undergoing dialysis; discontinue use and instruct patients to seek medical attention if they experience symptoms suggestive of a hypersensitivity reaction;
Oral administration
- Gastrointestinal reactions may result from a too rapid consumption of carnitine; oral Solution and sugar-free; oral solution may be consumed alone, or dissolved in drinks or other liquid foods to reduce taste fatigue; they should be consumed slowly and doses should be spaced evenly throughout the day to maximize tolerance
- The safety and efficacy of oral levocarnitine has not been evaluated in patients with renal insufficiency chronic administration of high doses of oral levocarnitine in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are normally excreted in the urine
Pregnancy & Lactation
Pregnancy
There are no adequate and well controlled studies in pregnant women.
Animal data
- Reproductive studies have been performed in rats and rabbits at doses up to 3.8 times the human dose on basis of surface area and have revealed no evidence of impaired fertility or harm to the fetus; because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed
Lactation
Supplementation in nursing mothers has not been specifically studied; studies in dairy cows indicate that the concentration of levocarnitine in milk is increased following exogenous administration of levocarnitine
In nursing mothers receiving levocarnitine, any risks to the child of excess carnitine intake need to be weighed against benefits of drug supplementation to the mother; consideration may be given to discontinuation of nursing or of levocarnitine treatment.
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Quaternary ammonium compound found in all mammalian tissue (particularly striated muscle)
Important for lipid catabolism; essential for FFA transport from cytosol to mitochondria where they are oxidized
Pharmacokinetics
Bioavailability: 10-20%
Distribution half-life: 0.585 hr
Half-life elimination : 17.4 hr
Peak plasma time: (PO) 3.3 hr
Peak plasma concentration: (PO) 80 umol/L
Protein Bound: None
Total Body Clearance: 4 L/hr
Metabolism: Metabolized to trimethylamine-N-oxide and gamma-butyrobetaine
Excretion: Urine (76%); feces (<1%)
Images
| BRAND | FORM. | UNIT PRICE | PILL IMAGE |
|---|---|---|---|
| levocarnitine oral - | 100 mg/mL solution |  | |
| levocarnitine oral - | 1 gram/10 mL solution |  | |
| levocarnitine oral - | 330 mg tablet |  | |
| Carnitor oral - | 330 mg tablet |  | |
| L-Carnitine oral - | 500 mg tablet |  |
Copyright © 2010 First DataBank, Inc.
Patient Handout
levocarnitine oral
LEVOCARNITINE - ORAL
(lee-voh-KAR-nih-teen)
COMMON BRAND NAME(S): Carnitor
USES: This medication is a diet supplement used to prevent and treat low blood levels of carnitine. Carnitine is a substance made in the body from meat and dairy products. It helps the body use certain chemicals (long-chain fatty acids) for energy and to keep you in good health. Low blood levels of carnitine may occur in people whose bodies cannot properly use carnitine from their diets, people on dialysis due to serious kidney disease, and people being treated with certain drugs (such as valproic acid, zidovudine). Carnitine levels that are too low can cause liver, heart, and muscle problems.Carnitine comes in 2 forms, this medication (levocarnitine) and D-carnitine. An over-the-counter product called vitamin Bt contains a mixture of levocarnitine and D-carnitine. Vitamin Bt should not be used to treat serious carnitine deficiency since it can interfere with the body's use of levocarnitine. Do not use levocarnitine to treat serious carnitine deficiency unless prescribed by your doctor.The form of levocarnitine taken by mouth is not recommended for treating people on dialysis due to serious kidney disease. The injectable form should be used for this treatment. Consult your doctor for details.Some supplement products have been found to contain possibly harmful impurities/additives. Check with your pharmacist for more details about the brand you use.The FDA has not reviewed this product for safety or effectiveness. Consult your doctor or pharmacist for more details.
HOW TO USE: If you are taking the over-the-counter product, read all directions on the product package before taking this medication. If you have any questions, consult your pharmacist. If your doctor has prescribed this medication, take it as directed.This medication is best taken with or just after meals to lessen stomach upset. If you are taking more than 1 dose a day, take the doses at evenly spaced times throughout the day (usually at least 3 to 4 hours apart).If you are taking the liquid form, use a medication-measuring device to carefully measure the prescribed dose. Do not use a household spoon. The liquid form may be taken alone or mixed in a drink or other liquid food. To prevent stomach upset, drink your dose slowly or mix the liquid form with more fluids or liquid food.Chewable forms of this medication should be chewed thoroughly before swallowing.The dosage is based on your medical condition and response to therapy. Do not increase your dose or take this medication more often than recommended by your doctor or the package instructions without your doctor's approval. Take this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time(s) each day.If your condition lasts or gets worse, or if you think you may have a serious medical problem, get medical help right away.
SIDE EFFECTS: Upset stomach, nausea, vomiting, diarrhea, headache, muscle pain/weakness, swelling of hands/lower legs/feet, tingling skin, or body odor ("fishy" smell) may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.If your doctor has prescribed this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Get medical help right away if you have any very serious side effects, including: seizure.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before taking levocarnitine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as peanut/soy), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, seizures.Liquid preparations of this product may contain sugar and/or alcohol. Caution is advised if you have diabetes, alcohol dependence, or liver disease. Ask your doctor or pharmacist about using this product safely.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.
DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
NOTES: If your doctor has prescribed this medication, do not share it with others.Do not change brands or dosage forms of levocarnitine without first checking with your doctor or pharmacist. Different products may not work in the same way.Lab and/or medical tests (such as blood chemistries, vital signs, serum carnitine levels) may be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.
MISSED DOSE: If you are taking this medication on a regular schedule and miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Information last revised December 2022. Copyright(c) 2023 First Databank, Inc.
IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.
Formulary
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