Levocarnitine

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Levocarnitine Injection, USP is administered intravenously.
• Metabolic Disorders The recommended dose is 50 mg/kg given as a slow 2 to 3 minute bolus injection or by infusion.
• Often a loading dose is given in patients with severe metabolic crisis, followed by an equivalent dose over the following 24 hours.
• It should be administered every 3 hours or every 4 hours, and never less than every 6 hours either by infusion or by intravenous injection.
• All subsequent daily doses are recommended to be in the range of 50 mg/kg or as therapy may require.
• The highest dose administered has been 300 mg/kg.
• It is recommended that a plasma carnitine concentration be obtained prior to beginning this parenteral therapy.
• Weekly and monthly monitoring is recommended as well.
• This monitoring should include blood chemistries, vital signs, plasma carnitine concentrations (the plasma free carnitine concentration should be between 35 and 60 μmol/L) and overall clinical condition.
• ESRD Patients on Hemodialysis The recommended starting dose is 10 to 20 mg/kg dry body weight as a slow 2 to 3 minute bolus injection into the venous return line after each dialysis session.
• Initiation of therapy may be prompted by trough (pre-dialysis) plasma levocarnitine concentrations that are below normal (40 to 50 µmol/L).
• Dose adjustments should be guided by trough (pre-dialysis) levocarnitine concentrations, and downward dose adjustments (e.g. to 5 mg/kg after dialysis) may be made as early as the third or fourth week of therapy.
• Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

See DOSAGE AND ADMINISTRATION.

Quoted from the official label, section “Pediatric Use”.

Side effects

• Clinical Trials Experience Transient nausea and vomiting have been observed.
• Less frequent adverse reactions are body odor, nausea, and gastritis.
• An incidence for these reactions is difficult to estimate due to the confounding effects of the underlying pathology.
• The table below lists the adverse events that have been reported in two double-blind, placebo-controlled trials in patients on chronic hemodialysis.
• Events occurring at ≥ 5% are reported without regard to causality.
• Adverse Events with a Frequency ≥ 5% Regardless of Causality by Body System Placebo (n=63) Levocarnitine 10 mg (n=34) Levocarnitine 20 mg (n=62) Levocarnitine 40 mg (n=34) Levocarnitine 10, 20 & 40 mg (n=130) Body as Whole Abdominal pain 17 21 5 6 9 Accidental injury 10 12 8 12 10 Allergic reaction 5 6 2 Asthenia 8 9 8 12 9 Back pain 10 9 8 6 8 Chest pain 14 6 15 12 12 Fever 5 6 5 12 7 Flu syndrome 40 15 27 29 25 Headache 16 12 37 3 22 Infection 17 15 10 24 15 Injection site reaction 59 38 27 38 33 Pain 49 21 32 35 30 Cardiovascular Arrhythmia 5 3 3 2 Atrial fibrillation 2 6 2 Cardiovascular disorder 6 3 5 6 5 Electrocardiogram abnormal 3 6 2 Hemorrhage 6 9 2 3 4 Hypertension 14 18 21 21 20 Hypotension 19 15 19 3 14 Palpitations 3 8 5 Tachycardia 5 6 5 9 6 Vascular disorder 2 2 6 2 Digestive Anorexia 3 3 5 6 5 Constipation 6 3 3 3 3 Diarrhea 19 9 10 35 16 Dyspepsia 10 9 6 5 Gastrointestinal disorder 2 3 6 2 Melena 3 6 2 Nausea 10 9 5 12 8 Stomach atony 5 Vomiting 16 9 16 21 15 Endocrine System Parathyroid disorder 2 6 2 6 4 Hemic/Lymphatic Anemia 3 3 5 12 6 Metabolic/Nutritional Hypercalcemia 3 15 8 6 9 Hyperkalemia 6 6 6 6 6 Hypervolemia 17 3 3 12 5 Peripheral edema 3 6 5 3 5 Weight decrease 3 3 8 3 5 Weight increase 2 3 6 2 Musculo-Skeletal Leg cramps 13 8 4 Myalgia 6 Nervous Anxiety 5 2 1 Depression 3 6 5 6 5 Dizziness 11 18 10 15 13 Drug dependence 2 6 2 Hypertonia 5 3 1 Insomnia 6 3 6 4 Paresthesia 3 3 3 12 5 Vertigo 6 2 Respiratory Bronchitis 5 3 3 Cough increase 16 10 18 9 Dyspnea 19 3 11 3 7 Pharyngitis 33 24 27 15 23 Respiratory disorder 5 Rhinitis 10 6 11 6 9 Sinusitis 5 2 3 2 Skin And Appendages Pruritus 13 8 3 5 Rash 3 5 3 3 Special Senses Amblyopia 2 6 3 Eye disorder 3 6 3 3 Taste perversion 2 9 3 Urogenital Urinary tract infect 6 3 3 2 Kidney failure 5 6 6 6 6 Postmarketing Experience The following adverse reactions have been reported:
• Neurologic Reactions:
• Seizures have been reported to occur in patients, with or without pre-existing seizure activity, receiving either oral or intravenous levocarnitine.
• In patients with pre-existing seizure activity, an increase in seizure frequency and/or severity has been reported.
• Hypersensitivity reactions :
• Anaphylaxis, laryngeal edema and bronchospasm (see WARNINGS ).

Quoted from the official label, section “Adverse Reactions”.

What it looks like and how it is packed

• How supplied :
• Levocarnitine Injection, USP is available in 5 mL and 20 mL single-dose vials.
• Each 5 mL vial contains 1 g/5 mL and each 20 mL vial contains 4 g/20 mL (200 mg/mL).
• NDC 0517-1045-05 1 gram/5 mL (200 mg/mL) Single-Dose Vial Packages of 5 NDC 0517-1075-01 4 grams/20 mL (200 mg/mL) Single-Dose Vial Individually boxed
• Store at or below 25°C (77°F) (See USP).
• Do not freeze.
• Store vials in carton until their use to protect from light.
• Discard unused portion of an opened vial, as the formulation does not contain a preservative.

Quoted from the official label, section “How Supplied”.

What is in it

• Levocarnitine is a carrier molecule in the transport of long-chain fatty acids across the inner mitochondrial membrane.
• The chemical name of levocarnitine is 3-carboxy-2( R )-hydroxy-N,N,N-trimethyl-1-propanaminium, inner salt.
• Levocarnitine is a white crystalline, hygroscopic powder.
• It is readily soluble in water, hot alcohol, and insoluble in acetone.
• The specific rotation of levocarnitine is between –29° and –32°.
• Its chemical structure is:
• Levocarnitine injection, USP is a sterile aqueous solution containing 1 g of levocarnitine per 5 mL vial, and 4 g of levocarnitine per 20 mL vial, and water for injection q.s.
• The pH is adjusted to 6 to 6.5 with hydrochloric acid or sodium hydroxide.
• Chemical Structure

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

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Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

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Other strengths and forms

10 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Levocarnitine