Alpha Lipoic Acid + L-Methyl Folate Calcium + Methylcobalamin + Pregabalin + Pyridoxal-5-phosphate

Usage

This combination medication is primarily prescribed for the management of neuropathic pain, particularly in conditions like diabetic peripheral neuropathy. It aims to protect nerve fibers, repair damaged nerves, and alleviate pain sensations. This combination is considered a metabolic support agent and a medical food for the clinical dietary management of endothelial dysfunction in diabetic peripheral neuropathy.

• Pharmacological Classification: This combination includes agents with various classifications. Alpha-lipoic acid is an antioxidant. L-methylfolate, methylcobalamin, and pyridoxal-5-phosphate are vitamins involved in nerve function and metabolic processes. Pregabalin is an anticonvulsant and analgesic used for neuropathic pain.

• Mechanism of Action: This combination works through multiple pathways. Alpha-lipoic acid acts as an antioxidant, protecting nerves from oxidative stress. The B vitamins (L-methylfolate, methylcobalamin, and pyridoxal-5-phosphate) support nerve function and myelination. Pregabalin binds to voltage-gated calcium channels in the central nervous system, reducing the release of neurotransmitters involved in pain signaling.

Alternate Names

There are no officially recognized alternate names for this specific combination as it is not an FDA-approved drug. The individual components may be referred to by their chemical names or other synonyms.

• Brand Names: Due to the nature of this combination as a compounded medication, brand names can vary. It is not marketed under a single, universally recognized brand name.

How It Works

• Pharmacodynamics: Pregabalin reduces neuronal excitability by modulating calcium influx at nerve terminals. Alpha-lipoic acid exerts antioxidant effects and improves nerve conduction velocity. B vitamins are crucial for nerve metabolism and repair.

• Pharmacokinetics: The individual components have distinct pharmacokinetic profiles. Pregabalin is rapidly absorbed and reaches peak plasma concentrations within an hour. Alpha-lipoic acid is also well-absorbed orally. B vitamins are generally well-absorbed in the gut. The exact pharmacokinetics of this combination have not been specifically studied.

• Mode of Action: Pregabalin binds to the alpha-2-delta subunit of voltage-gated calcium channels, inhibiting calcium influx and neurotransmitter release. Alpha-lipoic acid scavenges free radicals and regenerates other antioxidants. B vitamins act as coenzymes in various metabolic pathways crucial for nerve function.

• Elimination Pathways: Pregabalin is primarily excreted unchanged in the urine. Alpha-lipoic acid undergoes metabolism, and its metabolites are excreted renally. B vitamins are also primarily eliminated via renal excretion.

Dosage

As this is not an FDA-approved combined product, there is no standard dosage. Dosing is determined by the prescribing physician based on the individual patient’s condition and the specific components’ dosages.

Standard Dosage

Adults: Dosing varies based on the specific formulation and the individual’s needs. One suggested regimen is 1 capsule twice daily, or 2 capsules once daily. The prescribing physician should determine the optimal dose and treatment duration.

Children: Safety and efficacy have not been established in pediatric patients.

Special Cases: Dosages may need adjustments based on individual factors such as renal or hepatic impairment, comorbid conditions, and concomitant medications. It is best to consult with a healthcare professional to determine the appropriate dosage in these cases.

Clinical Use Cases

There are no established dosage recommendations for specific clinical settings like intubation, surgical procedures, mechanical ventilation, ICU use, or emergency situations for this specific combination.

Dosage Adjustments

Dose adjustments may be necessary based on individual patient factors, including renal/hepatic function, comorbidities, and other medications. A healthcare professional should make these adjustments.

Side Effects

Common Side Effects

Common side effects may include tiredness, uncoordinated body movements (ataxia), dizziness, and sleepiness.

Rare but Serious Side Effects

Serious side effects are rare but may include angioedema, anaphylaxis, and suicidal ideation.

Long-Term Effects

Potential long-term effects are not well-established for this specific combination.

Adverse Drug Reactions (ADR)

ADRs may include peripheral edema, weight gain, changes in mood or behavior, and hypersensitivity reactions.

Contraindications

Contraindications may include hypersensitivity to any component of the formulation and severe central nervous system depression.

Drug Interactions

Potential drug interactions can occur with alcohol, CNS depressants, and other medications metabolized by CYP450 enzymes.

Pregnancy and Breastfeeding

The safety of this combination during pregnancy and breastfeeding has not been established. It’s best to consult with a healthcare professional.

Drug Profile Summary

See sections above for detailed information.

Popular Combinations

As this is not a standardized pharmaceutical product, there are no established “popular combinations.”

Precautions

General precautions include pre-screening for allergies, metabolic disorders, and organ dysfunction. Specific precautions are advised for pregnant/breastfeeding women, children, elderly patients, and individuals with certain medical conditions.

FAQs (Frequently Asked Questions)

Q1: What is the recommended dosage for Alpha Lipoic Acid + L-Methyl Folate Calcium + Methylcobalamin + Pregabalin + Pyridoxal-5-phosphate?

A: There’s no standard dosage for this combination. Dosages are individualized and determined by the prescribing physician.

Q2: What are the primary uses of this combination?

A: It is primarily used to manage neuropathic pain, especially in conditions like diabetic neuropathy.

Q3: What are the common side effects?

A: Common side effects can include tiredness, dizziness, ataxia, and sleepiness.

Q4: Are there any serious side effects?

A: While rare, serious side effects such as angioedema, anaphylaxis, and suicidal ideation can occur.

Q5: Can this combination be used during pregnancy or breastfeeding?

A: Safety during pregnancy and breastfeeding has not been established. Consult with a healthcare provider.

Q6: How does this combination interact with other medications?

A: Potential interactions may occur with alcohol, CNS depressants, and drugs metabolized by CYP450 enzymes. Consult a physician before combining it with other medications.

Q7: Are there any contraindications to using this combination?

A: Contraindications include hypersensitivity to any of the components and severe CNS depression.

Q8: What precautions should be taken when prescribing this combination?

A: Precautions include assessing for allergies, metabolic disorders, organ dysfunction, and any potential drug interactions. Specific precautions are needed for pregnant/breastfeeding women, children, and the elderly.

Q9: What is the mechanism of action of each component in this combination?

A: Pregabalin inhibits neurotransmitter release. Alpha-lipoic acid acts as an antioxidant. B vitamins are essential for nerve function and metabolism.