LEVOCARNITINE (Systemic)

Some commonly used brand names are:

In the U.S.?

• Carnitor

In Canada?

• Carnitor

Another commonly used name is L-carnitine.

Category

• Carnitine deficiency prevention and therapy agent

Description

Levocarnitine (lee-voe-KAR-ni-teen) is used to prevent and treat a lack of carnitine. It isused to prevent and treat this condition in patients with kidney disease ondialysis. It is given to people whose body cannot properly use carnitine fromtheir diet. Lack of carnitine can lead to liver, heart, and muscle problems.Your doctor may treat lack of carnitine by prescribing levocarnitine for you.

Carnitine comes in two forms. Levocarnitine (L-carnitine) should not beconfused with the D,L-carnitine form (labeled as ?vitamin B _T?'). Only the L-form of carnitine is used by the body to treatserious carnitine deficiency. The D,L-form does not help the body use fatand can actually interfere with and cause a lack of levocarnitine.

Certain levocarnitine products have been specifically approved by the U.S.Food and Drug Administration for medical use and are available only with yourdoctor's prescription. Other levocarnitine products are sold without a prescriptionas food supplements and should not be used to treat serious levocarnitinedeficiency.

Levocarnitine is available by prescription in the following dosage forms:

Oral
• Solution (U.S. and Canada)
• Tablets (U.S. and Canada)

Parenteral
• Injection (U.S. and Canada)

Before Using This Medicine

In deciding to use a medicine,the risks of taking the medicine must be weighed against the good it willdo. This is a decision you and your doctor will make. For levocarnitine, thefollowing should be considered:

Allergies?Tell your health care professional if you are allergicto any substances, such as foods, preservatives, or dyes.

Pregnancy?Studies have not been done in humans. However, levocarnitinehas not been shown to cause birth defects or other problems in animal studies.

Breast-feeding?It is not known whether levocarnitine passes intothe breast milk. Carnitine normally is present in breast milk, even in womennot taking supplements of it, because it is obtained from the diet.

Children?Although there is no specific information comparinguse of levocarnitine in children with use in other age groups, this dietarysupplement is not expected to cause different side effects or problems inchildren than it does in adults.

Older adults?There is no specific information comparing use oflevocarnitine in the elderly with use in other age groups; however, this medicineis not expected to cause different side effects or problems in older peoplethan it does in younger adults.

Other medicines?Although certain medicines should not be usedtogether at all, in other cases they may be used together even if an interactionmight occur. In these cases, your doctor may want to change the dose, or otherprecautions may be necessary. Tell your health care professional if you aretaking any other prescription or nonprescription (over-the-counter [OTC])medicine.

Other medical problems?The presence of other medicalproblems may affect the use of levocarnitine. Make sure you tell your doctorif you have any other medical problems, especially:

• Seizures?occur more often and are more severe in patients witha history of seizure activity
• Severe renal dysfunction?administration of high doses of orallevocarnitine for long periods of time may build up in the body of patientswith severe kidney disease

Proper Use of This Medicine

Take levocarnitinewith or just after meals. Also, if you are taking it in liquid form, drinkit slowly. It will be less likely to upset your stomach if you take it thisway. The liquid form may be taken alone or dissolved in drink or other liquidfood.

This medicine is also less likely to cause unwanted effects when thereis a constant amount in the blood. If you are taking more than one dose aday, take the doses at evenly spaced times throughout the day. Doses shouldbe spaced at least 3 to 4 hours apart. If you need help in planning the besttimes to take your medicine, check with your health care professional.

Dosing?The dose of levocarnitine will be differentfor different patients. Follow your doctor's orders orthe directions on the label. The following information includes onlythe average doses of levocarnitine. If your dose is different,do not change it unless your doctor tells you to do so.

The number of tablets or of teaspoonfuls of solution that you take or thenumber of injections you receive depends on the strength of the medicine.Also, the number of doses you take each day, the timeallowed between doses, and the length of time you take the medicine dependon the medical problem for which you are taking levocarnitine.

Do NOT change brands or dosage forms of levocarnitinewithout first checking with your doctor. Different products may not work inthe same way. If you refill your medicine and it looks different, check withyour pharmacist.

• For oral dosage form (solution):
  • To prevent or treat carnitine deficiency:
    • Adults and teenagers?At first, 1 gram taken once a day withfood. Your doctor may change the dose if needed.
    • Children?The dose is based on body weight and must be determinedby your doctor. The usual dose at first is 50 mg per kg (22.7 mg per pound)of body weight a day, divided into smaller amounts with meals. Your doctormay change the dose if needed.
• For oral dosage form (tablets):
  • To prevent or treat carnitine deficiency:
    • Adults and teenagers?990 milligrams taken two or three timesa day with meals.
    • Children?The dose is based on body weight and must be determinedby your doctor. The usual dose at first is 50 mg per kg (22.7 mg per pound)of body weight a day, divided into smaller amounts with meals. Your doctormay change the dose if needed.
• For injection dosage form:
  • To treat carnitine deficiency:
    • Adults and children?The dose is based on body weight and mustbe determined by your doctor. The usual dose is 50 mg per kg (22.7 mg perpound) of body weight a day injected into a vein. Your doctor may change thedose if needed.
  • To prevent and treat carnitine deficiency in kidney disease patientson hemodialysis:
    • Adults and children?10 to 20 mg per kg of body weight a day,after dialysis. The dose may be reduced based on laboratory test results,after 3 to 4 weeks of therapy.

Missed dose?If you miss a dose of this medicine, skip the misseddose and go back to your regular dosing schedule. Do not double doses. Takingdoses too close together may increase stomach upset.

Storage?To store this medicine:

• Keep out of the reach of children.
• Store away from heat and direct light.
• Do not store in the bathroom, near the kitchen sink, or in otherdamp places. Heat or moisture may cause the medicine to break down.
• Store at room temperature. Do not refrigerate.
• Do not keep outdated medicines or those no longer needed. Be surethat any discarded medicine is out of the reach of children.

Precautions While Using This Medicine

Do not change brands or dosage forms of levocarnitine withoutfirst checking with your doctor. Different products may not work in the sameway. If you refill your medicine and it looks different, check with your pharmacist.

Side Effects of This Medicine

Along with its needed effects,a medicine may cause some unwanted effects. Although not all of these sideeffects may occur, if they do occur, they may need medical attention.

Check with your doctor as soon as possible if any of the following sideeffects occur:

More common

Less common

Rare

The following sideeffects may go away during treatment as your body adjusts to the medicine.However, check with your doctor if any of these effects continue or are bothersome:

More common

Less common

Other side effects not listed above may also occur insome patients. If you notice any other effects, check with your doctor.

Additional Information

Once a medicine has been approvedfor marketing for a certain use, experience may show that it is also usefulfor other medical problems. Although this use is not included in product labeling,levocarnitine is used in certain patients with the following medical condition:

• Carnitine deficiency that results from treatment with valproic acid

Other than the above information, there is no additional information relatingto proper use, precautions, or side effects for this use.