International reference: 1 US FDA recall for this ingredient

Subpotent Drug (methyltetrahydrofolate)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in Malawi.

Registered Malawi · PMRA

SABVIT COMBINATION PRODUCT CAPSULES

DOCOSAHEXAENOIC ACID, L-5 METHYLTETRAHYDROFOLATE CALCIUM, PYRIDOXAL-5 PHOSPHATE & METHYLCOBALAMIN

PMPB/PL477/43 CAPSULES blood and blood forming organs

What it does

Docosahexaenoic is an omega-3 fatty acid that is beneficial for heart and brain health.

Commonly used for: high cholesterol (hyperlipidemia), heart disease (cardiovascular disease), inflammatory conditions, cognitive function support

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Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Medicine sourcing is available in Kenya only. We don't sell or dispense medicines - licensed pharmacies do.

Sourcing - Kenya only

Registration & product details

Registration no.
PMPB/PL477/43
Registration date
27/11/2020
Expiry date
31/03/2024
Status
Registered
Active ingredient
DOCOSAHEXAENOIC ACID, L-5 METHYLTETRAHYDROFOLATE CALCIUM, PYRIDOXAL-5 PHOSPHATE & METHYLCOBALAMIN
Dosage form
CAPSULES
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
B03BA - Vitamin B12 (cyanocobalamin and analogues)
RxNorm RxCUI
29421
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:44 · updated 2026-09-29 04:33:06

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About docosahexaenoic

Docosahexaenoic is an omega-3 fatty acid that is beneficial for heart and brain health.

What it treats

  • high cholesterol (hyperlipidemia)
  • heart disease (cardiovascular disease)
  • inflammatory conditions
  • cognitive function support

How it works

It helps reduce inflammation and supports healthy brain and heart function.

Who it's for

It is suitable for adults looking to improve their heart and brain health, especially those with certain health conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About methylcobalamin

Methylcobalamin is a form of vitamin B12 that helps your body produce red blood cells and maintain healthy nerve cells.

What it treats

  • Vitamin B12 deficiency
  • Peripheral neuropathy (nerve damage)
  • Anemia

How it works

It supports the production of red blood cells and helps in the proper functioning of the nervous system.

Who it's for

It is suitable for individuals with low vitamin B12 levels or conditions affecting nerve health.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About methyltetrahydrofolate

Methyltetrahydrofolate is a form of folate (vitamin B9) that helps support various bodily functions, especially in the development of healthy cells.

What it treats

  • folate deficiency
  • support during pregnancy
  • certain types of anemia

How it works

It helps produce and maintain new cells, and is essential for making DNA and RNA.

Who it's for

It is suitable for people who need extra folate, such as pregnant women or those with certain health conditions.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About pyridoxal-5

Pyridoxal-5 is a form of vitamin B6 that helps in various body functions, including the production of neurotransmitters and the metabolism of proteins.

What it treats

  • vitamin B6 deficiency
  • certain types of anemia
  • nervous system support

How it works

It aids in the production of important substances in the body that help to regulate mood and support brain health.

Who it's for

This supplement is for individuals who may not get enough vitamin B6 from their diet or have specific health conditions that require additional vitamin B6.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: docosahexaenoic

Docosahexaenoic acid (DHA) is an omega-3 fatty acid that is crucial for human health, particularly in the development and function of the brain, eyes, and cardiovascular system. It is predominantly found in fish oil and certain algae, and it plays an important role in cellular membrane fluidity and signaling pathways. DHA is often used as a dietary supplement to support cognitive function and cardiovascular health.

Indications

  • Support for cognitive function
  • Cardiovascular health
  • Anti-inflammatory effects
  • Eye health
  • Neuroprotection

Dosage

Children: Refer to specific product guidelines or clinical recommendations for dosage.

Adults: Refer to specific product guidelines or clinical recommendations for dosage.

Mechanism of action

DHA is incorporated into cell membranes, particularly in the brain and retina, where it contributes to membrane fluidity and function. It serves as a precursor for the synthesis of neuroprotective and anti-inflammatory mediators, including resolvins and protectins, which help to modulate inflammatory responses and promote neuronal health.

Pharmacodynamics

DHA influences various physiological processes, including lipid metabolism, inflammation, and neuronal signaling. It has been shown to enhance synaptic plasticity and cognitive functions, and it may exert cardioprotective effects by improving endothelial function and reducing triglyceride levels. DHA also plays a role in the modulation of gene expression related to inflammation and lipid metabolism.

Pharmacokinetics

DHA is absorbed from the gastrointestinal tract and distributed throughout the body, particularly to the brain and retina. Its bioavailability can be influenced by dietary factors and the presence of other fatty acids. Metabolism occurs primarily through beta-oxidation and incorporation into phospholipids, with elimination taking place via the bile and urine. The half-life of DHA varies, but its effects can be prolonged due to incorporation into tissue.

Adverse effects

  • Nausea
  • Diarrhea
  • Gastrointestinal discomfort
  • Increased bleeding tendency
  • Allergic reactions

Interactions

  • Anticoagulants (e.g., warfarin) - may increase the risk of bleeding
  • Antiplatelet drugs - may enhance the effects of these medications

Precautions

  • Use caution in patients with a known allergy to fish or shellfish
  • Monitor bleeding in patients taking anticoagulants or antiplatelet medications
  • Consult healthcare provider before use in patients with liver disease

Pregnancy

DHA is generally considered safe during pregnancy, but high doses should be avoided unless prescribed by a healthcare provider.

Breast-feeding

DHA is beneficial during breastfeeding, as it can support infant brain development, but consult a healthcare provider for dosage.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Softgel capsules
  • Liquid fish oil
  • Fortified foods and beverages

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: methylcobalamin

BNF-referenced

Methylcobalamin is a form of vitamin B12, essential for various biological processes including DNA synthesis, red blood cell formation, and neurological function. It is particularly important in the metabolism of homocysteine, which is a risk factor for cardiovascular diseases. Methylcobalamin is often used in the treatment of vitamin B12 deficiency and associated conditions such as neuropathy and megaloblastic anemia.

Indications

  • Vitamin B12 deficiency
  • Megaloblastic anemia
  • Peripheral neuropathy
  • Neuropathic pain
  • Multiple sclerosis

Dosage

Children: For paediatric patients, refer to the BNF for Children for appropriate dosing guidelines.

Adults: The typical adult dosage for methylcobalamin is 500 micrograms to 1,000 micrograms administered intramuscularly or subcutaneously, usually once daily for the initial treatment, followed by maintenance doses as needed.

Mechanism of action

Methylcobalamin serves as a cofactor for the enzyme methionine synthase, which catalyzes the conversion of homocysteine to methionine. This reaction is crucial in the synthesis of S-adenosylmethionine (SAMe), an important methyl donor in numerous methylation reactions within the body. Methylcobalamin also plays a role in myelin formation and the maintenance of nerve cells.

Pharmacodynamics

Methylcobalamin exhibits neuroprotective effects, promoting nerve regeneration and repair in peripheral neuropathy. It is believed to enhance nerve conduction and improve neurological function. The physiological effects are primarily attributed to its role in methylation processes and the synthesis of neurotransmitters.

Pharmacokinetics

Methylcobalamin is water-soluble and is absorbed in the intestine. The bioavailability can be affected by gastrointestinal health, and intrinsic factor is not required for its absorption. It is distributed throughout the body, with high concentrations in the liver, kidneys, and brain. The elimination half-life of methylcobalamin is approximately 6 hours, and it is excreted primarily in the urine.

Adverse effects

  • Nausea
  • Diarrhea
  • Headache
  • Dizziness
  • Anxiety
  • Rash
  • Pruritus

Precautions

  • Monitor patients with Leber's disease due to potential optic nerve damage.
  • Caution in patients with allergies to cobalt or vitamin B12.
  • Use with caution in patients with renal impairment.

Pregnancy

Methylcobalamin is classified as a category A drug. It is generally considered safe during pregnancy, but consultation with a healthcare provider is recommended.

Breast-feeding

Methylcobalamin is excreted in breast milk. It is generally considered safe during breastfeeding, but consultation with a healthcare provider is recommended.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Tablets
  • Injections
  • Sublingual tablets
  • Oral solutions

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: methyltetrahydrofolate

BNF-referenced

Methyltetrahydrofolate is the active form of folate, a B-vitamin essential for various biological processes, including DNA synthesis and repair, amino acid metabolism, and methylation reactions. It plays a crucial role in the formation of neurotransmitters and is vital for proper cell division and growth.

Indications

  • Folate deficiency
  • Megaloblastic anemia
  • Hyperhomocysteinemia
  • Neurological disorders related to folate deficiency

Dosage

Children: Refer to the BNF for Children for appropriate dosing in paediatric patients.

Adults: Refer to the BNF for specific dosing guidelines as they may vary based on the condition being treated.

Mechanism of action

Methyltetrahydrofolate acts as a cofactor in the conversion of homocysteine to methionine, a process that is critical for maintaining levels of S-adenosylmethionine (SAM), an important methyl donor for numerous biological reactions. It is involved in the one-carbon metabolism pathway, facilitating the transfer of one-carbon units necessary for the synthesis of nucleotides and amino acids.

Pharmacodynamics

Methyltetrahydrofolate is essential for the synthesis of purines and pyrimidines, which are necessary for DNA and RNA synthesis. It also plays a significant role in the methylation of DNA and proteins, influencing gene expression and cellular function. Deficiency in methyltetrahydrofolate can lead to megaloblastic anemia and neurological disorders due to impaired DNA synthesis and repair.

Pharmacokinetics

Methyltetrahydrofolate is absorbed in the intestines and is widely distributed in body tissues. It is primarily metabolized in the liver and excreted in urine. The bioavailability of methyltetrahydrofolate is high when administered orally, and it has a relatively short half-life, requiring regular intake for sustained physiological effects.

Pregnancy

Methyltetrahydrofolate is generally considered safe during pregnancy, as it is a naturally occurring form of folate. However, it is important to consult with a healthcare provider before use.

Breast-feeding

Methyltetrahydrofolate is likely safe during breastfeeding, but as with any medication, a healthcare provider should be consulted for personalized advice.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: pyridoxal5

Pyridoxal 5'-phosphate, the active form of vitamin B6, plays a crucial role in numerous biological processes. It acts as a coenzyme in the metabolism of amino acids, carbohydrates, and lipids. Vitamin B6 is essential for the synthesis of neurotransmitters such as serotonin, dopamine, and gamma-aminobutyric acid (GABA), and is involved in hemoglobin formation and immune function.

Indications

  • Vitamin B6 deficiency
  • Peripheral neuropathy
  • Certain types of anemia
  • Pyridoxine-dependent seizures
  • Supplementation in pregnant women to alleviate nausea

Dosage

Children: Refer to established guidelines for specific dosing, as pyridoxal 5'-phosphate dosages can vary based on indication and patient-specific factors.

Adults: Refer to established guidelines for specific dosing, as pyridoxal 5'-phosphate dosages can vary based on indication and patient-specific factors.

Mechanism of action

Pyridoxal 5'-phosphate functions primarily as a coenzyme in various enzymatic reactions. It is involved in transamination, decarboxylation, and racemization reactions, facilitating the conversion of amino acids and the production of neurotransmitters. It also plays a role in the metabolism of tryptophan to niacin and the synthesis of sphingolipids.

Pharmacodynamics

The pharmacodynamic effects of pyridoxal 5'-phosphate are closely tied to its role as a cofactor in enzymatic reactions. Its deficiency can lead to neurological disorders, impaired immune function, and anemia. Adequate levels are associated with improved mood, cognitive function, and overall metabolic health.

Pharmacokinetics

Pyridoxal 5'-phosphate is absorbed in the intestine and is widely distributed throughout the body, including the brain. It is metabolized primarily in the liver, where it can be converted into other forms of vitamin B6. The elimination half-life is variable and can depend on individual metabolic rates. Excess vitamin B6 is excreted in urine as pyridoxal and pyridoxic acid.

Adverse effects

  • Peripheral neuropathy
  • Photosensitivity
  • Gastrointestinal disturbances
  • Nausea
  • Headache
  • Drowsiness

Interactions

  • May interact with certain antiepileptic drugs, potentially reducing their effectiveness
  • May affect the metabolism of levodopa, reducing its effectiveness
  • Can interact with isoniazid, potentially reducing the effectiveness of pyridoxine therapy

Precautions

  • Use caution in patients with liver disease
  • Monitor for neuropathy with prolonged use
  • Consider vitamin B6 status in patients with malabsorption syndromes

Pregnancy

Pyridoxal 5'-phosphate is generally considered safe during pregnancy when used at recommended doses.

Breast-feeding

Pyridoxal 5'-phosphate is excreted in breast milk, but is considered safe for breastfeeding mothers when used at recommended doses.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

Formulations

  • Tablets
  • Capsules
  • Injectable solutions

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: methylcobalamin

PubChem CID 10898559

Molecular formula: C63H91CoN13O14P

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

Molecular reference: methyltetrahydrofolate

PubChem CID 136126080

Molecular formula: C20H25N7O6

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.