Valid Ghana · FDA Ghana

VITAPLEX 2500 INJECTION

METHYLCOBALAMIN USP

FDA/SD.255-030354 blood and blood forming organs

What it does

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

Commonly used for: Vitamin B12 deficiency, Peripheral neuropathy (nerve damage), Anemia

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

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Registration & product details

Registration no.
FDA/SD.255-030354
Registration date
2025-03-03
Expiry date
2030-04-01
Status
Valid
Active ingredient
METHYLCOBALAMIN USP
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
ATC class (WHO)
B03BA - Vitamin B12 (cyanocobalamin and analogues)
Drug group
BLOOD AND BLOOD FORMING ORGANS
RxNorm RxCUI
29421
Manufacturer / MAH
Vega Biotec
Applicant / LTR
RICHBEN PHARMACY TLD
Country of origin
-
Manufacturer location
Unnamed Road, Madhav Nagar, Akota, Vadodara, Gujarat 390007, India

Source: Food and Drugs Authority · fetched 2026-04-18 08:42:14 · updated 2026-09-29 04:00:05

Disclaimer: This information is sourced from Food and Drugs Authority (Ghana). Always consult a qualified healthcare professional before using any medication.

About this medicine

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.

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
PubChem / pathway

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.

This drug in other countries

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

Kenya 25 products
View all 25 in Kenya →
Rwanda 6 products
Malawi 4 products
Tanzania 2 products