Carnitine

Levocarnitine is used to prevent and treat a lack of carnitine. It is used to prevent and treat this condition in patients with kidney disease on dialysis. It is given to people whose body cannot properly use carnitine from their 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 be confused with the D,L-carnitine form (labeled as “vitamin B T”'). Only the L-form of carnitine is used by the body to treat serious carnitine deficiency. The D,L-form does not help the body use fat and 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 your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for 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

This product is available in the following dosage forms:

• Capsule
• Tablet
• Solution
• Wafer
• Powder

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make.

For this medicine, the following should be considered:

Allergies: Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, tell your healthcare professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric Population: Although there is no specific information comparing the use of levocarnitine in children with use in other age groups, this dietary supplement is not expected to cause different side effects or problems in children than it does in adults.

Geriatric Population: There is no specific information comparing the use of levocarnitine in the elderly with use in other age groups; however, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Pregnancy: All Trimesters: Category B: Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breastfeeding: There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions: Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur.

In these cases, your doctor may want to change the dose or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below.

The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases.

If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acenocoumarol

Other Interactions: Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems: The presence of other medical problems may affect the use of this medicine.

Make sure you tell your doctor if you have any other medical problems, especially:

• Seizures—occur more often and are more severe in patients with a history of seizure activity.
• Severe renal dysfunction—administration of high doses of oral levocarnitine for long periods of time may build up in the body of patients with severe kidney disease.

Take levocarnitine with or just after meals. Also, if you are taking it in liquid form, drink it slowly. It will be less likely to upset your stomach if you take it this way.

The liquid form may be taken alone or dissolved in drink or other liquid food. This medicine is also less likely to cause unwanted effects when there is a constant amount in the blood.

If you are taking more than one dose a day, take the doses at evenly spaced times throughout the day. Doses should be spaced at least 3 to 4 hours apart.

If you need help in planning the best times to take your medicine, check with your health care professional.

Dosing: The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label.

The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Do NOT change brands or dosage forms of levocarnitine without first checking with your doctor. Different products may not work in the same way. If you refill your medicine and it looks different, check with your pharmacist.

For oral dosage form (solution):

To prevent or treat carnitine deficiency:

• Adults and teenagers—At first, 1 gram taken once a day with food. Your doctor may change the dose if needed.
• Children—The dose is based on body weight and must be determined by 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 doctor may 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 times a day with meals.
• Children—The dose is based on body weight and must be determined by 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 doctor may change the dose if needed.

For injection dosage form:

To treat carnitine deficiency: Adults and children—The dose is based on body weight and must be determined by your doctor. The usual dose is 50 mg per kg (22.7 mg per pound) of body weight a day injected into a vein. Your doctor may change the dose if needed.

To prevent and treat carnitine deficiency in kidney disease patients on 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, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses. Taking doses too close together may increase stomach upset.

Storage Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children. Do not keep outdated medicine or medicine no longer needed.

Do not change brands or dosage forms of levocarnitine without first checking with your doctor.

Different products may not work in the same way. If you refill your medicine and it looks different, check with your pharmacist.

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

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

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine.

Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.