India Product

Nuroace Tablets

Nuroace Tablets

Why you have been prescribed this medicine?

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?

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

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:
The 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?

No case of overdose has been reported.
If in case happens symptoms would be that of side effects in severe form.
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?

Tell your doctor immediately if you become pregnant while taking this medication.
For safety of any drug during pregnancy or breastfeeding – please consult your doctor.

Storage Conditions:

Store at the temperature not more than 30°С in dry place. Protect from direct sunlight.
Keep out of reach of children.

Drug Description

Active substance:
Methylcobalamin;
Each film coated tablet contains:
Methylcobalamin 500 mcg
Excipients:
Microcrystalline cellulose (Avicel PH 101), Pregelatinised starch, Microcrystalline cellulose (Avicel PH 102), Poly vinyl Pyrollidone(Povidone K-30), Isopropyl alcohol, Colloidal Silicon Dioxide (Aerosil-200), Talcum powder, Stearic acid, Ethyl cellulose, Titanium dioxide, Polyethylene glycol, Dichloromethane, Opadry Brown 03F565012 .

Indications and dosage.


INDICATIONS:
Methylcobalamintablets are indicated for peripheral neuropathies and megaloblastic anemia caused by vitamin B12 deficiency.

DOSAGE:
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.

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:
The 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


No case of overdose has been reported. If in case happens symptoms would be that of side effects in severe form. 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.

PHARMACOLOGICAL PROPERTIES:
Pharmacodynamic properties
Pharmacotherapeutic Group:
Antianemic

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.

PHARMACEUTICAL CHARACTERISTICS:
General physic-chemical properties:
Mottled, red coloured standard biconvex round shaped tablet.

Shelf-life:
Shelf-life is 2 years.

Storage:
Store at the temperature not more than 30°С in the original package. Keep out of reach of children.

Package:
10 tablets are in alualu blister, 1 blister are in a carton box.

Conditions of supply:
On prescription.

CERTIFICATES

KEEP IN TOUCH

Kusum Healthcare Pvt Ltd

Regd. Office: D-158A, Okhla Industrial Area

Phase-1, New Delhi-110020, India

Tel: 011-41005147, 40514919

Fax: +91-11-40527575

Email: kusumhealth@kusumhealthcare.com

CIN: U65929DL1997PTC085780