Usage
This combination medication is primarily prescribed for treating nutritional deficiencies, particularly those involving folic acid (vitamin B9), levocarnitine, and methylcobalamin (vitamin B12). It’s used to address conditions such as:
- Folate deficiency anemia: Characterized by insufficient red blood cells due to low folate levels.
- Vitamin B12 deficiency anemia (pernicious anemia): Another type of anemia stemming from inadequate vitamin B12.
- Peripheral neuropathy: Nerve damage causing pain, numbness, and tingling, often in the hands and feet. Methylcobalamin can help prevent and treat this condition.
- Hyperhomocysteinemia: Elevated homocysteine levels, a risk factor for heart disease. Folic acid and methylcobalamin help lower homocysteine.
- Primary systemic carnitine deficiency: A rare genetic disorder where the body cannot utilize certain fats for energy.
- Other conditions: It may also be used to treat cardiomyopathy (weak heart muscles), skeletal myopathy (muscle weakness), and in patients on long-term hemodialysis or receiving valproic acid or zidovudine. It has also been used for male infertility (oligospermia).
This combination falls under the pharmacological classification of nutritional supplements.
Alternate Names
While “Folic Acid + Levo-carnitine + Methylcobalamin” is the generic name, some alternate names include:
- Levocarnitine + Mecobalamin + Folic Acid
- L-Carnitine + Methylcobalamin + Folic Acid
- Methylcobalamin + L-Carnitine + Folic Acid
Brand names for this combination vary widely. Some examples from India include:
- Carnimac Plus
- Carnitor Plus
- Levocarnil Plus
- HappyNerve LC
- Carnik-LC
- Carnisure Plus
- Nurolong-Lc
- Homo-16 LC
- Carnilix-LC 500/1500/1.5
- Reznew LC
- Meaxon-LC
- Nurozox-LC
- Carnidue
- Meconta-LC
- Vitasave-LC
- Hybrin LC
- Nuvit-LC
- Folcarvit
- Nervesmile-LC
- Myliday-LC
- Nurokind LC
- Trinerve LC
- Neurotab LC
How It Works
Pharmacodynamics:
- Folic acid is converted to tetrahydrofolic acid, essential for DNA synthesis, red blood cell production, and homocysteine metabolism.
- Levocarnitine facilitates fatty acid transport into mitochondria for energy production (beta-oxidation) and removes cellular toxins.
- Methylcobalamin, the active form of vitamin B12, is a cofactor for methionine synthase, crucial for DNA synthesis, red blood cell formation, and homocysteine metabolism. It’s also vital for nerve cell function and myelin sheath maintenance.
Pharmacokinetics:
- Absorption: All three components are absorbed orally. Levocarnitine absorption is dose-dependent and enhanced by food. Folic acid is primarily absorbed in the small intestine. Methylcobalamin requires intrinsic factor for absorption in the terminal ileum.
- Metabolism: Folic acid is metabolized in the liver to tetrahydrofolic acid. Levocarnitine is minimally metabolized. Methylcobalamin is converted to other active forms of Vitamin B12 like adenosylcobalamin.
- Elimination: Folic acid metabolites are excreted primarily renally. Levocarnitine is mostly excreted unchanged in urine. Methylcobalamin and its metabolites are eliminated mainly renally, with some biliary excretion.
Dosage
Dosage is individualized and should be determined by a healthcare professional based on the patient’s specific needs and the condition being treated.
Standard Dosage
Adults:
A typical dosage might involve one tablet containing 500mg Levocarnitine, 1500 mcg Methylcobalamin, and 1.5mg Folic Acid, once daily. However, different formulations exist with varied strengths, requiring appropriate dosage adjustment.
Children:
Safety and efficacy in children have not been fully established. The use in children requires careful evaluation and monitoring by a physician. Dosing should be based on the child’s age, weight, and clinical condition.
Special Cases:
- Elderly Patients: Dosage adjustments may be needed based on renal function.
- Patients with Renal Impairment: Dosage adjustments are necessary as levocarnitine and methylcobalamin are primarily eliminated renally. Accumulation of toxic metabolites of levocarnitine can occur in patients with significantly impaired renal function or end-stage renal disease.
- Patients with Hepatic Dysfunction: Levocarnitine and Folic Acid are metabolized in the liver, and dosage adjustment is needed for these individuals.
- Patients with Comorbid Conditions: Conditions like diabetes, cardiovascular disease, or other chronic illnesses may require careful dosage adjustments.
Clinical Use Cases
The use of this combination in specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations is generally not indicated. Its primary role lies in addressing nutritional deficiencies.
Dosage Adjustments
Dose modifications are based on patient-specific factors like renal and hepatic function, age, and other concurrent medical conditions. Genetic polymorphisms affecting drug metabolism should also be considered when available.
Side Effects
Common Side Effects:
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain or cramps
- Bloating
- Flatulence
Rare but Serious Side Effects:
- Allergic reactions (e.g., skin rash, itching, anaphylaxis)
- Blood clots (rare)
- Seizures (worsening in those with pre-existing seizure disorder)
Long-Term Effects:
Limited data are available on long-term effects.
Adverse Drug Reactions (ADR):
Severe allergic reactions require immediate medical intervention.
Contraindications
- Hypersensitivity to any of the components.
- Untreated vitamin B12 deficiency anemia.
- Leber’s hereditary optic neuropathy.
Drug Interactions
- Chloramphenicol: Reduces Vitamin B12 absorption.
- Methotrexate, Fluorouracil: Antagonize the effects of folic acid.
- Warfarin: Folic acid can interfere with warfarin’s anticoagulant effect.
- Colchicine: May interact with Levocarnitine.
- Antacids (Cimetidine, Omeprazole, Lansoprazole, Ranitidine): Reduce vitamin B12 absorption.
- Metformin: Possible interaction with Levocarnitine.
- Sulfasalazine: Interferes with folate absorption.
- Cholestyramine: May reduce absorption of fat-soluble vitamins, potentially affecting Levocarnitine’s action.
- Antiepileptic drugs (Phenytoin, Fosphenytoin, Valproic acid): May interact with Folic acid and Vitamin B12.
It is crucial to consider interactions with other prescribed medications, OTC drugs, supplements, and lifestyle factors (alcohol, smoking). Alcohol may interfere with the absorption and efficacy of this medication.
Pregnancy and Breastfeeding
Folic acid is crucial during pregnancy to prevent neural tube defects and is often recommended. However, the safety of levocarnitine and methylcobalamin in high doses during pregnancy has not been fully established. Consult a physician before using this combination during pregnancy or breastfeeding.
Drug Profile Summary
- Mechanism of Action: See “How It Works” section.
- Side Effects: Nausea, vomiting, diarrhea, allergic reactions (rarely severe).
- Contraindications: Hypersensitivity, untreated vitamin B12 deficiency, Leber’s disease.
- Drug Interactions: Multiple drug interactions possible; see “Drug Interactions” section.
- Pregnancy & Breastfeeding: Folic acid is essential; caution advised with the combination. Consult a doctor.
- Dosage: Individualized based on clinical need; typically one tablet daily for adults.
- Monitoring Parameters: Complete blood count (CBC), vitamin B12 levels, homocysteine levels, renal function tests, liver function tests as needed.
Popular Combinations
This combination itself is a popular combination, and often no further drugs are added. However, other B vitamins may be included in some formulations.
Precautions
- Pre-existing liver or kidney disease.
- History of seizures.
FAQs (Frequently Asked Questions)
Q1: What is the recommended dosage for Folic Acid + Levo-carnitine + Methylcobalamin?
A: Dosage is individualized. A common dosage is one tablet (500mg Levocarnitine, 1500 mcg Methylcobalamin, 1.5mg Folic Acid) daily, but consult a physician for appropriate dosing.
Q2: Can this combination be used during pregnancy?
A: Folic acid is recommended during pregnancy, but consult a doctor regarding the combination as the safety of high-dose levocarnitine and methylcobalamin has not been definitively established.
Q3: What are the common side effects?
A: Nausea, vomiting, and diarrhea are the most common side effects.
Q4: Are there any serious side effects?
A: Rarely, allergic reactions can occur and require immediate medical attention.
Q5: Does this drug interact with other medications?
A: Yes, numerous drug interactions are possible. See the “Drug Interactions” section and inform your physician about all other medications you are taking.
Q6: Can this combination be crushed or chewed?
A: It’s generally recommended to swallow the tablet whole with water. Crushing or chewing may cause mouth irritation.
Q7: Should this combination be taken with food?
A: It can be taken with or without food. Taking with food may reduce gastrointestinal upset in some individuals.
Q8: How long does it take for the medication to work?
A: The onset of effects varies depending on the individual and the condition being treated. It may take several weeks to notice improvements in some cases.
Q9: Is this medication safe for long-term use?
A: Consult a physician regarding long-term use. While generally safe, individual patient factors should be considered.
Q10: What should I do if I miss a dose?
A: Take the missed dose as soon as you remember, unless it’s close to the time for the next dose. Do not double the dose.