Envitor Tablet 330 mg
Envitor Tablet 330 mg Uses, Dosage, Side Effects, Food Interaction and all others data.
Envitor Tablet 330 mg 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 substrate for oxidation and subsequent energy production in the form of Adenosine Tri phosphate or ATP. Fatty acids are utilized as an energy substrate in all tissues except the brain. In skeletal and cardiac muscle, fatty acids are the main substrate for energy production.
Envitor Tablet 330 mg is a carrier molecule in the transport of long chain fatty acids across the inner mitochondrial membrane. It also exports acyl groups from subcellular organelles and from cells to urine before they accumulate to toxic concentrations. Lack of carnitine can lead to liver, heart, and muscle problems. Carnitine deficiency is defined biochemically as abnormally low plasma concentrations of free carnitine, less than 20 µmol/L at one week post term and may be associated with low tissue and/or urine concentrations. Further, this condition may be associated with a plasma concentration ratio of acylcarnitine/levocarnitine greater than 0.4 or abnormally elevated concentrations of acylcarnitine in the urine. Only the L isomer of carnitine (sometimes called vitamin BT) affects lipid metabolism. The "vitamin BT" form actually contains D,L-carnitine, which competitively inhibits levocarnitine and can cause deficiency. Envitor Tablet 330 mg can be used therapeutically to stimulate gastric and pancreatic secretions and in the treatment of hyperlipoproteinemias.
| Trade Name | Envitor Tablet 330 mg |
| Availability | Prescription only |
| Generic | Levocarnitine |
| Levocarnitine Other Names | (R)-Carnitine, Carnitina, Carnitine, L-Carnitine, Levocarnitin, Levocarnitina, Lévocarnitine, Levocarnitine, Levocarnitinum, Vitamin BT |
| Related Drugs | L-Carnitine, Carnitor |
| Weight | 330 mg |
| Type | Tablet |
| Formula | C7H15NO3 |
| Weight | Average: 161.1989 Monoisotopic: 161.105193351 |
| Protein binding | None |
| Groups | Approved, Investigational |
| Therapeutic Class | Drugs for muscular energy metabolism |
| Manufacturer | Opsonin Pharma Ltd. |
| Available Country | Bangladesh |
| Last Updated: | October 19, 2023 at 6:27 am |
Uses
The supplemental Envitor Tablet 330 mg use is widely established in the management of cardiac ischemia and peripheral arterial disease. It is generally used for cardio protection. It lowers triglyceride levels and increases levels of HDL cholesterol. It is used with benefits in those with primary and secondary carnitine deficiency syndromes. There is also evidence of its use in liver, kidney and immune disorders or in diabetes and Alzheimer's disease. There is little evidence that supplemental Envitor Tablet 330 mg boosts energy, increases athletic performance or inhibits obesity. The indications of Envitor Tablet 330 mg may be summarized as follows:
- Heart Diseases
- Congestive Heart Failure
- Kidney Disease
- Chronic Fatigue Syndrome
- High Cholesterol
- Intermittent Claudication
- Dementia and memory impairment
- Down Syndrome
- Male infertility
- Hyperthyroidism
Envitor Tablet 330 mg is also used to associated treatment for these conditions: Carnitine Deficiency, Congenital carnitine deficiency, Secondary Carnitine deficiency
How Envitor Tablet 330 mg works
Envitor Tablet 330 mg can be synthesised within the body from the amino acids lysine or methionine. Vitamin C (ascorbic acid) is essential to the synthesis of carnitine. Envitor Tablet 330 mg is a carrier molecule in the transport of long chain fatty acids across the inner mitochondrial membrane. It also exports acyl groups from subcellular organelles and from cells to urine before they accumulate to toxic concentrations. Only the L isomer of carnitine (sometimes called vitamin BT) affects lipid metabolism. Envitor Tablet 330 mg is handled by several proteins in different pathways including carnitine transporters, carnitine translocases, carnitine acetyltransferases and carnitine palmitoyltransferases.
Dosage
Envitor Tablet 330 mg dosage
Tablet-
- 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.Syrup-
- Adults: 10 to 30 ml/day. Dosage should start at 10 ml/day in divided doses, and be increased slowly while assessing tolerance and therapeutic response.
- Infants and children: 50 to 100 mg/kg/day which is equivalent to 0.5 ml/kg/day. 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. 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.
Side Effects
Generally Envitor Tablet 330 mg is well tolerated. However, few side effects including transient nausea and vomiting, abdominal cramps, and diarrhoea may occur
Toxicity
LD50 > 8g/kg (mouse, oral). Adverse effects include hypertension, fever, tachycardia and seizures.
Precaution
The safety and efficacy of oral Envitor Tablet 330 mg has not been evaluated in patients with renal insufficiency. Chronic administration of high doses of oral Envitor Tablet 330 mg in patients with severely compromised renal function or in ESRD patients on dialysis may result in accumulation of the potentially toxic metabolites, trimethylamine (TMA) and trimethylamine-N-oxide (TMAO), since these metabolites are normally excreted in the urine
Interaction
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 or after dose adjustments.
Food Interaction
- Take with food. Taking levocarnitine oral solution with meals may reduce gastrointestinal upset such as nausea, vomiting, and cramping.
Volume of Distribution
The steady state volume of distribution (Vss) of an intravenously administered dose, above endogenous baseline levels, was calculated to be 29.0 +/- 7.1L. However this value is predicted to be an underestimate of the true Vss.
Elimination Route
Absolute bioavailability is 15% (tablets or solution). Time to maximum plasma concentration was found to be 3.3 hours.
Half Life
17.4 hours (elimination) following a single intravenous dose.
Clearance
Total body clearance was found to be a mean of 4L/h.
Elimination Route
Following a single intravenous dose, 73.1 +/- 16% of the dose was excreted in the urine during the 0-24 hour interval. Post administration of oral carnitine supplements, in addition to a high carnitine diet, 58-65% of the administered radioactive dose was recovered from urine and feces in 5-11 days.
Pregnancy & Breastfeeding use
Envitor Tablet 330 mg is categorized by the USFDA as Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. Supplemental Envitor Tablet 330 mg should be used by pregnant women only if clearly indicated and only under medical supervision. It is not known whether Envitor Tablet 330 mg is excreted in human milk. Supplemental Envitor Tablet 330 mg is not advised for nursing mothers. Those with seizure disorders should only use Envitor Tablet 330 mg under medical advisement and supervision.
Contraindication
There is no known disease or syndrome in which Envitor Tablet 330 mg administration is contraindicated. It is contraindicated in patients with hypersensitivity to any of its components.
Acute Overdose
There have been no reports of toxicity from levocarnitine overdosage. Envitor Tablet 330 mg is easily removed from plasma by dialysis. The intravenous LD50 of levocarnitine in rats is 5.4 g/kg and the oral LD50 of levocarnitine in mice is 19.2 g/kg. Large doses of levocarnitine may cause diarrhea.
Storage Condition
Tablet: Store in a cool & dry place, protected from light & moisture.
Solution: Store in a cool & dry place, protected from light.
Innovators Monograph
You find simplified version here Envitor Tablet 330 mg
Envitor Tablet 330 mg contains Levocarnitine see full prescribing information from innovator Envitor Tablet 330 mg Monograph, Envitor Tablet 330 mg MSDS, Envitor Tablet 330 mg FDA label
FAQ
What is Envitor Tablet 330 mg used for?
Envitor Tablet 330 mg 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.
How safe is Envitor Tablet 330 mg?
In one review of Envitor Tablet 330 mg safety, doses of approximately 2 grams per day appeared to be safe for long-term use.
How does Envitor Tablet 330 mg work?
Envitor Tablet 330 mg is a naturally occurring substance that the cells of mammals need to produce energy. It is used to treat carnitine deficiency. Envitor Tablet 330 mg is a small protein that binds to and helps transport fatty acids into the mitochondria, the site of energy production within cells.
What are the common side effects of Envitor Tablet 330 mg?
The common side effects of Envitor Tablet 330 mg are upset stomach, nausea, vomiting, diarrhea, headache, muscle pain/weakness, swelling of hands/lower legs/feet, tingling skin, or body odor ("fishy" smell) may occur. If any of these effects persist or worsen, contact your doctor or pharmacist promptly.
Is Envitor Tablet 330 mg safe during pregnancy?
Use is not recommended unless clearly needed. Stopping treatment in a pregnant woman with primary systemic carnitine deficiency may carry serious consequences; the risk of stopping treatment may outweigh the theoretical risks to the fetus of continuing.
Is Envitor Tablet 330 mg safe during breastfeeding?
Taking Envitor Tablet 330 mg is possibly safe in breast-feeding women when taken by mouth in the amounts recommended. Small amounts of Envitor Tablet 330 mg have been given to infants in breast milk and formula with no reported side effects.
Can I drink alcohol with Envitor Tablet 330 mg?
You had better stay away from alcohol in any form while you are on this Envitor Tablet 330 mg and for three days afterward. Read labels carefully and avoid even small amounts of alcohol, as found, for instance, in cough syrups.
When should I take Envitor Tablet 330 mg?
Take Envitor Tablet 330 mg with or just after meals.
How often should I take Envitor Tablet 330 mg?
Envitor Tablet 330 mg should be taken at evenly spaced intervals every 3 or 4 hours.
How long does Envitor Tablet 330 mg take to work?
Envitor Tablet 330 mg levels increase rapidly after i.v. administration (500 mg) to healthy volunteers declining to baseline after 12 h; Envitor Tablet 330 mg levels increase more slowly, reach a peak in 30–60 min, and decline to baseline within 24 h.
Should I take Envitor Tablet 330 mg on an empty stomach?
Envitor Tablet 330 mg supplements are therefore likely to be much better absorbed on an empty stomach.
What is the half life of Envitor Tablet 330 mg?
Using plasma concentrations uncorrected for endogenous Envitor Tablet 330 mg, the mean distribution half life was 0.585 hours and the mean apparent terminal elimination half life was 17.4 hours.
How long can I take Envitor Tablet 330 mg?
Envitor Tablet 330 mg is likely safe when taken for up to 12 months.
Is it safe to take Envitor Tablet 330 mg everyday?
Doses of 2 grams or less per day seem to be well tolerated and safe for most people. Tentative evidence suggests Envitor Tablet 330 mg supplements might increase your risk of atherosclerosis.
Who should not take Envitor Tablet 330 mg?
Do not take Envitor Tablet 330 mg if you are allergic to it. Seek immediate medical attention if you notice any symptoms such as skin rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, breathing difficulty, etc.
What happens if I miss a dose?
Oral forms: If you missed a dose of Envitor Tablet 330 mg, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take two doses together to make up for a missed dose.
Injection: Since Envitor Tablet 330 mg is given in the hospital setting by a qualified healthcare professional, the likelihood of missing a dose is very low.
What happens if I overdose on Envitor Tablet 330 mg?
Oral forms: Never take more than the prescribed dose of Envitor Tablet 330 mg. If you suspect that you might have taken an overdose of this medicine, seek immediate medical help.
Injection: Since Envitor Tablet 330 mg is administered by a healthcare professional, the chances of overdose are very less. However, your doctor will take measures if an overdose is suspected
Can Envitor Tablet 330 mg affect my kidneys?
Envitor Tablet 330 mg is excreted from the kidneys. If you have kidney problems this medicine may accumulate in your kidneys and leads to serious side effects. Your doctor may adjust the dose of this medicine based on your clinical condition. Envitor Tablet 330 mg is not recommended for use if you have severe kidney problems.
Does Envitor Tablet 330 mg cause fatty liver?
Firstly, reduced levels of Envitor Tablet 330 mg may lower fatty acid oxidation and be a contributing factor in the accumulation of liver fat.
Does Envitor Tablet 330 mg cause heart disease?
Envitor Tablet 330 mg can absolutely cause heart disease - but only if you have the gut microbes needed to break it down.
Can Envitor Tablet 330 mg raise blood pressure?
Envitor Tablet 330 mg shown strong correlations between insulin resistance and increased blood pressure.
