Tonovit

Constituent of striated muscle and liver. It is used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias.

Tonovit® (Tonovit) 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, hypoketotic hypoglycemia, and/or cardiomyopathy. Associated symptoms included hypotonia, muscle weakness and failure to thrive. A diagnosis of primary carnitine deficiency requires that serum, red cell and/or tissue carnitine levels be low and that the patient does not have a primary defect in fatty acid or organic acid oxidation. In some patients, particularly those presenting with cardiomyopathy, carnitine supplementation rapidly alleviated signs and symptoms. Treatment should include, in addition to carnitine, supportive and other therapy as indicated by the condition of the patient.

Tonovit® (Tonovit) is also indicated for acute and chronic treatment of patients with an inborn error of metabolism which results in a secondary carnitine deficiency.

Tonovit 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 Tonovit for you.

Carnitine comes in two forms. Tonovit should not be confused with the D,Tonovit 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 Tonovit.

Certain Tonovit 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, Tonovit is used in certain patients with the following medical condition:

• Carnitine deficiency that results from treatment with valproic acid

Tonovit® (Tonovit) 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 oral dosage for infants and children is between 50 and 100 mg/kg/day in divided doses, with a maximum of 3 g/day. Dosage should begin at 50 mg/kg/day. The exact dosage will depend on clinical response.

Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations and overall clinical condition.

Tonovit® (Tonovit)

Oral Solution and Tonovit® SF (Tonovit) Sugar-Free

Oral Solution

For oral use only. Not for parenteral use.

Adults: The recommended dosage of Tonovit is 1 to 3 g/day for a 50 kg subject, which is equivalent to 10 to 30 mL/day of Tonovit® (Tonovit)

Oral Solution or Tonovit® SF (Tonovit) Sugar-Free

Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 1 g/day, (10 mL/day), and be increased slowly while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

Infants and children: The recommended dosage of Tonovit is 50 to 100 mg/kg/day which is equivalent to 0.5 mL/kg/day Tonovit® (Tonovit)

Oral Solution or Tonovit® SF (Tonovit) Sugar-Free

Oral Solution. Higher doses should be administered only with caution and only where clinical and biochemical considerations make it seem likely that higher doses will be of benefit. Dosage should start at 50 mg/kg/day, and be increased slowly to a maximum of 3 g/day (30 mL/day) while assessing tolerance and therapeutic response. Monitoring should include periodic blood chemistries, vital signs, plasma carnitine concentrations, and overall clinical condition.

Tonovit® (Tonovit)

Oral Solution or Tonovit® SF (Tonovit) Sugar-Free

Oral Solution may be consumed alone or dissolved in drink or other liquid food. Doses should be spaced evenly throughout the day (every three or four hours) preferably during or following meals and should be consumed slowly in order to maximize tolerance.

How supplied

Tonovit® (Tonovit) Tablets are supplied as 330 mg tablets embossed with “Tonovit ST” in individual blisters, packaged in boxes of 90 (NDC 54482-144-07). Store at controlled room temperature (25°C). See USP. Tonovit® (Tonovit) Tablets are manufactured for Sigma-Tau Pharmaceuticals, Inc. by Sigma-Tau S.p. A., 00040 Pomezia (Rome), Italy.

Tonovit® (Tonovit)

Oral Solution

Oral Solution is manufactured for Sigma-Tau Pharmaceuticals, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.

Tonovit® SF (Tonovit) Sugar-Free

Oral Solution

Oral Solution is manufactured for Sigma-Tau Pharmaceuticals, Inc. by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701.

Sigma-tau Pharmaceuticals, Inc., Gaithersburg, MD 20878. Revised: April 2015.

See also:
What is the most important information I should know about Tonovit?

This medicine is contraindicated in patients with anuria, inborn errors of amino acid metabolism, especially those involving branched chain amino acid metabolism such as Maple Syrup Urine Disease and Isovaleric Acidemia, or hypersensitivity to one or more amino acids present in the solution.

Use Tonovit solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Tonovit solution by mouth during or after meals unless otherwise directed by your doctor.
• Tonovit solution may be poured into drinks or liquid foods to help prevent taste changes. Finish all of the liquid.
• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure how to measure your dose.
• Take each dose of Tonovit solution slowly and space your doses evenly throughout the day.
• If you miss a dose of Tonovit solution, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Tonovit solution.

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 Tonovit intravenous

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.

See also:
What other drugs will affect Tonovit?

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 Tonovit or after dose adjustments.

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What are the possible side effects of Tonovit?

Applies to Tonovit: capsule, powder, solution, tablet, wafer

In addition to its needed effects, some unwanted effects may be caused by Tonovit (the active ingredient contained in Tonovit). In the event that any of these side effects do occur, they may require medical attention.

Severity: Moderate

If any of the following side effects occur while taking Tonovit, check with your doctor or nurse as soon as possible:

More common:

• High blood pressure

• Fast heartbeat
• fever

• Seizures

Minor Side Effects

Some of the side effects that can occur with Tonovit may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

• Abdominal or stomach cramps
• diarrhea
• headache
• nausea or vomiting

• Abdominal discomfort
• body odor
• depression
• dizziness
• impaired vision
• loss of appetite or weight
• swelling in hands, lower legs, and feet
• tingling sensation
• weakness