CARNITOR Tablet / Oral solution (2021)

Βιβλιογραφική αναφορά

Συγγραφείς

Leadiant Biosciences, Inc.

Λέξεις κλειδιά

54482-144

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1. Description

CARNITOR (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, ...

2. Clinical Pharmacology

CARNITOR (levocarnitine) is a naturally occurring substance required in mammalian energy metabolism. It has been shown to facilitate long-chain fatty acid entry into cellular mitochondria, thereby delivering ...

3. Indications and Usage

CARNITOR (levocarnitine) is indicated in the treatment of primary systemic carnitine deficiency. In the reported cases, the clinical presentation consisted of recurrent episodes of Reye-like encephalopathy, ...

4. Contraindications

None known.

5. Warnings

Hypersensitivity Reactions Serious hypersensitivity reactions, including rash, urticaria, and facial edema have been reported with oral CARNITOR. Other serious hypersensitivity reactions, including anaphylaxis, ...

6.1. General

CARNITOR (levocarnitine) Oral Solution and CARNITOR SF (levocarnitine) Sugar-Free Oral Solution are for oral/internal use only. Not for parenteral use. Gastrointestinal reactions may result from ...

6.4. Drug Interactions

Reports of INR increase with the use of warfarin have been observed. It is recommended that INR levels be monitored in patients on warfarin therapy after the initiation of treatment with levocarnitine ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Mutagenicity tests performed in Salmonella typhimurium, Saccharomyces cerevisiae, and Schizosaccharomyces pombe indicate that levocarnitine is not mutagenic. No long-term animal studies ...

6.7. Pregnancy

Reproductive studies have been performed in rats and rabbits at doses up to 3.8 times the human dose on the basis of surface area and have revealed no evidence of impaired fertility or harm to the fetus ...

6.9. Nursing Mothers

Levocarnitine 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 ...

6.10. Pediatric Use

See DOSAGE AND ADMINISTRATION.

7. Adverse Reactions

The following adverse reactions associated with the use of oral formulations of levocarnitine were identified in clinical trials or postmarketing reports. Because these reactions were reported voluntarily ...

9. Overdosage

There have been no reports of toxicity from levocarnitine overdosage. Levocarnitine is easily removed from plasma by dialysis. The intravenous LD50 of levocarnitine in rats is 5.4 g/kg and the ...

10. Dosage and Administration

CARNITOR (levocarnitine) Tablets. Adults: The recommended oral dosage for adults is 990 mg two or three times a day using the 330 mg tablets, depending on clinical response. Infants and children: The recommended ...

11. How Supplied

CARNITOR (levocarnitine) Tablets are supplied as 330 mg tablets embossed with CARNITOR ST in individual blisters, packaged in boxes of 90 (NDC 54482-144-07). CARNITOR (levocarnitine) Tablets are distributed ...

12. Storage and Handling

CARNITOR (levocarnitine) Tablets: Store at controlled room temperature (25°C). See USP. CARNITOR (levocarnitine) Oral Solution: Store at controlled room temperature (25°C). See USP. CARNITOR ...

14. References

Bohmer, T., Rydning, A. and Solberg, H.E. 1974. Carnitine levels in human serum in health and disease. Clin. Chim. Acta 57:55-61. Brooks, H., Goldberg, L., Holland, R. et al. 1977. Carnitine-induced ...