CARVI 1000 Tablets

Each capsule contains:

  • L-Carnitine L-Tartrate 1000mg
  • Vitamin E - 50 mg

DESCRIPTION

CARVI- 1000 contains L-Carnitine, a naturally occurring metabolite. Its main function is to regulate the free fatty acid metabolism for production of energy, by facilitating the transport of FFA through inner mitochondrial membrane. Thus, it plays a fundamental role as in many fatal disorders like cardiovascular disorders, post- dialysis complication, primary and secondary deficiency of carnitine. L-Carnitine can be synthesized in the body from amino acids like Lysine. Dietary sources such as meat and dairy products also provide carnitine.

HIGHLIGHTS (USPs)

  • It is the natural regulator of fatty acid and glucose metabolism within the cell.
  • Cardiac tissue concentration is 80 to 100 times higher than plasma.
  • Protects the heart from the ischaemic and other cardiomyopathies.
  • Oral L-carnitine is safe and moderately improves the duration of exercise and time to recovery of ST changes in patients with chronic stable angina.
  • Post MI the parameters like QRS score, angina incidence, LV enlargement, and arrhythmias showed significant improvement with carnitine.
  • L-carnitine attenuates progressive left ventricular dilatation after acute anterior MI.
  • Carnitine supplementation increases walking distance in patients of Peripheral Vascular Disease.
  • Dilated cardiomyopathy, which is common form of children CM, is significantly responsive to carnitine.

CLINICAL PHARMACOLOGY

CARVI 1000 is recommended in the diseases related to heart, kidney and it is also recommended for premature infants. Any clinical condition that affects the heart usually results in inefficient functioning of the heart. Causes and reasons can be many, viral infections, heart attacks, alcoholism, stress, severe high blood pressure (hypertension) etc.

CARVI 1000 (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, therefore delivering substrate for oxidation and subsequent energy production. Levocarnitine clears the acyl CoA compound by formation of acyl carnitine, which is quickly excreted. Levocarnitine deficiency is defined biochemically as abnormally low plasma levels of free carnitine, less than 20 M/ Lat age greater than one-week post term and may be associated with low tissue and or urine levels.

Further, this condition may be associated with a ration of plasma ester/ free levocarnitine levels greater than 0.4 or abnormally elevated levels of esterified levocarnitine in the urine. In premature infants and newborns, secondary deficiency is defined as plasma free levocarnitine levels below age related normal levels.

Adequate supplementation of L Carnitine results in varied effects, such as:

  • Preservation of fatty acid metabolism
  • Improved oxidative utilization of glucose
  • Decreased lactate formation and acidosis
  • Removal of toxic long chain fatty acid metabolites
  • Decreases lipid peroxidation

INDICATIONS

It is indicated for the treatment and management of:

Cardiovascular disorders: In acute myocardial infarction, acute/ chronic ischemic heart disease, cardiomyopathies, anthracycline induced cardiotoxicity etc.

Post hemodialysis complications: asthenia, cramps, cardiac dysfunction, anemia and hyperlipidemias.

Primary and secondary carnitine deficiency: Acute and Chronic treatment of inborn errors of metabolism, which results in secondary carnitine deficiency.

Male Infertility: the maturity and motility of sperm has been related to carnitine levels in semen and sperm cell.

DOSAGE AND ADMINISTRATION

Adults: The recommended oral dosage for adults is 2gm - 3gm a day using the 1000 mg tablets, depending on the clinical response.

Infants and Children: The recommended oral dosage for infant and children is between 50 and 100

CONTRAINDICATIONS

No known contraindication except interaction with antiepileptic drugs.

ADVERSE REACTIONS

Generally, CARVI-1000 is well tolerated. Various mild gastrointestinal complaints have been reported during the long-term administration of oral L-Carnitine, these include transient nausea ,vomiting, abdominal cramps and diarrhea.

PRECAUTIONS

General Mutagenecity performed in salmonella typhimurium, saccharomyces cerevisiae and Schizosaccharomyces pombe, do not indicate that CARVI-1000 is mutagenic.

Pregnancy Pregnancy Category B. 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 due to CARVI-1000. There are, however, no adequate and well-controlled studies in pregnant women.

Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing Mothers It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

OVERDOSAGE

There have been no reports of toxicity from levocarnitine overdosage. The oral LD50 of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.

PRESENTATION

CARVI-1000 Tablets available in 30's Container pack

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