levocarnitine (Rx)

Brand and Other Names:Carnitor, carnitine
  • Print

Dosing & Uses

AdultPediatric

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

Next:

Interactions

Interaction Checker

and levocarnitine

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (0)

                Monitor Closely (1)

                • warfarin

                  levocarnitine will increase the level or effect of warfarin by unknown mechanism. Use Caution/Monitor. INR may increase in patients receiving warfarin therapy; monitor INR levels following initiation of levocarnitine therapy and after dose adjustments

                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.

                Previous
                Next:

                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

                Previous
                Next:

                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
                Previous
                Next:

                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.

                Previous
                Next:

                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%)

                Previous
                Next:

                Images

                BRAND FORM. UNIT PRICE PILL IMAGE
                L-Carnitine oral
                -
                500 mg tablet
                Carnitor oral
                -
                330 mg tablet
                levocarnitine oral
                -
                100 mg/mL solution
                levocarnitine oral
                -
                1 gram/10 mL solution
                levocarnitine oral
                -
                330 mg tablet

                Copyright © 2010 First DataBank, Inc.

                Previous
                Next:

                Patient Handout

                Select a drug:
                Patient Education
                levocarnitine intravenous

                LEVOCARNITINE - INJECTION

                (lee-voh-KAR-nih-teen)

                COMMON BRAND NAME(S): Carnitor

                USES: This medication is 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 (e.g., valproic acid, zidovudine). Carnitine levels that are too low can cause liver, heart, and muscle problems.The injectable form of this drug is recommended if you have serious kidney disease (e.g., ESRD/dialysis) because high doses of the form taken by mouth may increase the risk of serious side effects. Consult your doctor or pharmacist for details.

                HOW TO USE: This medication is given into a vein by slow injection or through an IV, as directed by your doctor. The dosage is based on your weight, medical condition, and response to therapy.If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.Inform your doctor if your condition persists or worsens.

                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 persist or worsen, contact your doctor or pharmacist promptly.Remember that this medication has been prescribed because 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 using 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, 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.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: Do not share this medication with others.Laboratory and/or medical tests (e.g., blood chemistries, vital signs, serum carnitine levels) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

                MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

                STORAGE: Store the unmixed vials at room temperature away from light and moisture. Do not store in the bathroom. Do not freeze. Keep all medications away from children and pets.After mixing and dilution, the drug may be stored at room temperature for up to 24 hours. Discard any unused portion of an opened vial.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 August 2021. Copyright(c) 2021 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.

                Previous
                Next:

                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
                Additional Offers
                Email to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Email Forms to Patient

                From:

                To:

                The recipient will receive more details and instructions to access this offer.

                By clicking send, you acknowledge that you have permission to email the recipient with this information.

                Previous
                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.