Maynmar Product

Methydon Tablets

Methydon Tablets

Why you have been prescribed this medicine?

You have been prescribed this medicine if you have any of the following:

Methydon® tablets are indicated for peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.

When you should consult your doctor?

You should consult your doctor if you experience any of the following:

In some people, vitamin B12 might cause diarrhea, blood clots, itching, serious allergic reactions, and other side effects.
Vitamin B12 also appears to be safe when used on the skin for psoriasis. Mild itching has been reported in one person who used a specific avocado oil plus vitamin B12 cream for psoriasis.

  • Irritability
  • Insomnia
  • Sore muscles
  • Achy joints
  • Acne
  • Rash
  • Severe anxiety
  • Palpitations
  • Nausea
  • Headaches
  • Migraines
  • What to do if you miss a dose? ?

    If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise take it as soon as you remember and then go back to taking it as you would normally.

    Things you MUST NOT DO while on this medicine?

    Chloramphenicol: Limited case reports suggest that chloramphenicol can delay or interrupt the reticulocyte response to supplemental Vitamin B12 in some patients. Monitor blood levels carefully if the combination cannot be avoided.

    Absorption: Following medicines can reduce the absorption of Vitamin B12: aminosalicylic acid, antibiotics, colchicine, cholestyramine, H2 blockers, metformin, neomycin, nitrous oxide, oral contraceptives, phenytoin, phenobarbital, primidone, proton pump inhibitor, zidovudine.

    What to do if you accidentally take too much (overdose) of the medicine?

    Treatment should be symptomatic and supportive.
    In the case of accidental overdose of the product, contact the nearest hospital or poison control centre.

    Is it safe in pregnancy and breast-feeding?

    Vitamin B12 is likely safe for pregnant or breast-feeding women when taken by mouth in the amounts recommended. The recommended amount for pregnant women is 2.6 mcg per day. Breast-feeding women should take no more than 2.8 mcg per day. Don’t take larger amounts. The safety of larger amounts is unknown.

    Storage Conditions:

    Store below 30˚C. Protect from light & moisture.
    Keep all medicines out of reach of children.

    Drug Description

    Drug description
                General physico-chemical properties
    Brown coloured, standard biconvex round shaped film coated tablet plain on both sides.

    Composition
    Each film coated tablet contains:
    Methylcobalamin 500 mcg

    Excipients: Microcrystalline cellulose, pregelatinised starch, povidone (K-30), isopropyl alcohol, colloidal silicon dioxide, purified talc, stearic acid, ethyl cellulose, titanium dioxide, polyethylene glycol,  dichloromethane, opadry brown 03F565012.

    Indications and dosage.

    INDICATIONS
    Methydon® tablets are indicated for peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.

    RECOMMENDED DOSE
    The dosage for clinical effect is 1500-6000 mcg per day. No significant therapeutic advantage appears to occur from dosages exceeding this maximum dose. Methylcobalamin has been administered orally, intramuscularly, and intravenously; however, positive clinical results have been reported irrespective of the method of administration. It is not clear whether any therapeutic advantage is gained from the non-oral methods of administration.

    MODE OF ADMINISTRATION
    For oral use.

    Side effects and drug interactions.

      Adverse reactions:
    In some people, vitamin B12 might cause diarrhea, blood clots, itching, serious allergic reactions, and other side effects.
    Vitamin B12 also appears to be safe when used on the skin for psoriasis. Mild itching has been reported in one person who used a specific avocado oil plus vitamin B12 cream for psoriasis.

    • Irritability
    • Insomnia
    • Sore muscles
    • Achy joints
    • Acne
    • Rash
    • Severe anxiety
    • Palpitations
    • Nausea
    • Headaches
    • Migraines

               Drug interactions
    Chloramphenicol: Limited case reports suggest that chloramphenicol can delay or interrupt the reticulocyte response to supplemental Vitamin B12 in some patients. Monitor blood levels carefully if the combination cannot be avoided.

    Absorption: Following medicines can reduce the absorption of Vitamin B12: aminosalicylic acid, antibiotics, colchicine, cholestyramine, H2 blockers, metformin, neomycin, nitrous oxide, oral contraceptives, phenytoin, phenobarbital, primidone, proton pump inhibitor, zidovudine.

    Warnings and precautions

    Caution should be exercised in patients with history of liver disease, any allergy, during pregnancy and breastfeeding.


    Overdosage and Contraindications

    Overdosage:
    Treatment should be symptomatic and supportive.
    In the case of accidental overdose of the product, contact the nearest hospital or poison control centre. 

    Contraindications
    Hypersensitivity to the active substance or to any of the excipients.

    Clinical pharmacology.

    Pharmacodynamic Properties
    Pharmacotherapeutic Group: Vitamin
    ATC code: B03BA05

    Methylcobalamin is an essential water soluble vitamin B also known as vitamin B12. Vitamin B12 is required for nuclear-protein and myelin synthesis, cell reproduction, normal growth, and normal erythropoiesis. Vitamin B12 is converted to coenzyme B12, which is essential for the conversion of methylmalonate to succinate, and the synthesis of methionine from homocysteine. Vitamin B12 is involved in maintaining sulfhydryl groups in the reduced form required by enzymes involved in fat and carbohydrate metabolism, and protein synthesis. Vitamin B12 is involved in folate synthesis and a deficiency of methylcobalamin results in a functional folate deficiency. Vitamin B12 is required as part of the remethylation of homocysteine to methionine. Elevated levels of homocysteine has been linked to the increase risk of endothelial cell damage, impaired endothelial-dependent vasodilation due to reduced nitric oxide activity, increased oxidation and arterial deposition of low-density lipoproteins (LDL), increased platelet adhesiveness, and activation of the clotting cascade. Vitamin B12 supplements have a small additive effect to folic acid in lowering fasting homocysteine levels, but probably only in people with vitamin B12 deficiency. Elevated homocysteine concentrations are possibly associated with other conditions such as decreased cognitive function, impaired memory, Alzheimer's disease, and vascular dementia. The methylcobalamin form of vitamin B12 might also influence melatonin levels. Methylcobalamin seems to improve alertness and reduce sleep time in humans with normal sleep patterns, possibly due to effects on melatonin.      

    Pharmacokinetic Properties
    Vitamin B12 is absorbed via an active transport mechanism in the terminal ileum. This requires the glycoprotein, intrinsic factor, which is produced by the stomach. At normal gastric pH, vitamin B12 is cleaved from proteins in food. It then binds to intrinsic factor and is absorbed by ileal transport. Absorption may be reduced by increased gastric pH such as atrophic gastritis, use of acid-suppressing drugs, or partial gastrectomy. The half-life of vitamin B12 is 6 hours and is secreted mainly via the bile.

    SHELF LIFE
    24 months

    STORAGE CONDITIONS
    Store below 30˚C. Protect from light & moisture.
    Keep all medicines out of reach of children.

    DOSAGE FORM AND PACKING AVAILABLE
    Opaque red PVC/PVDC-alu blister of 10 tablets, 3 or 10 such blisters are packed in a carton.
    NAME AND ADDRESS OF MANUFACTURER
    Kusum Healthcare Pvt. Ltd.
    SP 289 (A), RIICO, Indl. Area,
    Chopanki, Bhiwadi (Rajasthan), India

    CERTIFICATES

    KEEP IN TOUCH

    Kusum Healthcare
    D-158A, OKHLA,INDUSTRIAL AREA,
    PHASE-I, NEW DELHI,
    Pin 110020
    INDIA
    Tel: 011-41005147, 011-40514919
    Fax: +91-11-40527575