For the use of only a Registered Medical Practitioner or a Hospital or a Laboratory

Not to be sold by retail without the prescription of a Registered Medical Practitioner

Mecobalamin, Zinc, Calcium Pantothenate, Vitamin B6, Folic Acid, Niacinamide & Chromium Tablets
BLUVIT® Tablets

Prescribing Information
1. Generic Name
Mecobalamin, Zinc, Calcium Pantothenate, Vitamin B6, Folic Acid, Niacinamide & Chromium Tablets.
(Brand Name: BLUVIT ® Tablets)

2. Qualitative and Quantitative Composition

Each Film Coated Tablet Contains:
Mecobalamin IP………………………………….…. 500 mcg
Zinc Sulphate Monohydrate IP………….……..….. 61.8 mg
(Equivalent to elemental Zinc 22.5 mg)
Calcium Pantothenate IP…………………...….……. 10 mg
Pyridoxine Hydrochloride IP……………………………3 mg
Folic Acid IP………………….…………………..…….1.5 mg
Niacinamide IP………………..………………….……..50 mg
Chromium ………………………….……………..……50 mcg
(As Chromium Picolinate IP)
Excipients…………………………………..……………..q.s.
Colours: Ponceau 4R & Mica based pearlescent pigment

3. Dosage Form and Strength

Dosage Form: Tablet.
Dosage Strength: Mecobalamin 500 mcg, Zinc sulphate 61.8 mg, Calcium Pantothenate 10 mg, Pyridoxine Hydrochloride 3
mg, Folic Acid 1.5 mg, Niacinamide 50 mg and Chromium Picolinate 50 mcg per tablet.

4. Clinical Particulars
4.1 Therapeutic Indication
BLUVIT Tablets are indicated for vitamin and mineral deficiency patients.

4.2 Posology and Method of Administration

For oral administration.
Adults and adolescents: One tablet of BLUVIT to be administered once daily.
The tablet should be swallowed whole with water.
Or, as prescribed by the physician.

4.3 Contraindications
BLUVIT Tablets are contraindicated in the following:
 Patients with known or suspected hypersensitivity to any component of the formulation.
 An existing hypervitaminosis.

4.4 Special Warnings and Precautions for Use

Mecobalamin
Mecobalamin is susceptible to photolysis. Thus, BLUVIT Tablets should not be exposed to light/moisture. The prolonged use
of larger doses of mecobalamin is not recommended for patients whose occupation requires the handling of mercury or
mercury compounds. Those with early Leber’s disease (hereditary optic nerve atrophy) when treated with vitamin B12 can
develop swift, and severe optic atrophy. BLUVIT Tablet must be advocated with caution in such patients.
Zinc
Long-term, excessive alcohol drinking is linked to poor zinc absorption in the body. Large doses of zinc can lower blood sugar
in people with diabetes. People with diabetes should use zinc-containing products cautiously. Avoid taking zinc with foods
that are high in calcium or phosphorus, as it may cause decrease in absorption of zinc.
Pyridoxine
Pyridoxine may decrease the efficiency of levodopa. Pyridoxine should be advocated cautiously with drugs such as oral
hypoglycemics, anticonvulsants, furosemide, isoniazid, penicillamine, hydralazine, and oral contraceptives.
Folic Acid
Taking folic acid might mask anemia caused by vitamin B12 deficiency and delay appropriate treatment. Taking folic acid
supplements might make seizures worse in people with seizure disorders, particularly in high doses.

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Niacinamide
It should be used after consultation from the doctor if patients have existing liver disease, stomach ulcers, gout and liver
disease.
Chromium
Caution should be exercised and doctor should be consulted for patients with impaired liver and kidney function before taking
Bluvit tablets.

4.5 Drug Interactions

Mecobalamin
Oral Contraceptives: Serum concentrations of mecobalamin may be decreased by use of oral contraceptives.
Chloramphenicol: Chloramphenicol should not be used with mecobalamin. Parenteral chloramphenicol may attenuate the
effect of vitamin B12 in anemia.
Other Drugs: Excessive alcohol consumption, anti-acne drugs, anti-retrovirals, anti-gout drugs (colchicine),
antihypertensives, anti-tubercular drugs (aminosalicylic acid), anti-ulcer drugs, biguanides (metformin), H2 antagonists
(cimetidine, ranitidine), proton pump inhibitors, sulfonamides, tetracyclines, aminoglycosides and antiepileptic drugs can
reduce vitamin B12 levels. Thus, caution should be exercised while co-administering vitamin B12 with these drugs.
Drug/Laboratory Test Interactions: Use of antibiotics, methotrexate, and pyrimethamine may invalidate vitamin B12
diagnostic blood assays.
Zinc Sulphate
When taken together, zinc may reduce the absorption of tetracyclines (but not doxycycline), and quinolone antibacterials. In
addition, zinc may also interfere with the absorption of cephalexin or ceftibuten. An interval of at least three hours should be
allowed between administration of zinc and any of these medicines. Drugs which reduce the absorption of zinc such as
pencillamine should not be taken together. An interval of at least three hours should be allowed between administation of
zinc and drugs such as penicillamine.
Calcium Pantothenate
Antibiotics, Tetracycline -- Vitamin B5 interferes with the absorption and effectiveness of the antibiotic tetracycline and
should take B vitamins at different times from tetracycline.
Drugs to treat Alzheimer's disease -- Vitamin B5 may increase the effects of a group of drugs called cholinesterase
inhibitors (Donepezil, Memantine, Rivastigmine), which are used to treat Alzheimer's disease.
Since high doses of vitamin B5 can increase bleeding, caution should be exorcized while taking anti-coagulany medications,
such as warfarin (Coumadin), aspirin, and others.
Pyridoxine
Pyridoxine reduces the effects of levodopa and activity of altretamine. It also decreases serum concentrations of
phenobarbital and phenytoin. Pyridoxine may decrease antibiotic activities of erythromycin, kanamycin, streptomycin,
doxycycline, and lincomycin. Drugs such as hydralazine, isoniazid, penicillamine, and oral contraceptives may increase the
requirements for pyridoxine.
Folic Acid
Phenytoin: Folic acid may increase phenytoin metabolism and lower the serum concentration of phenytoin resulting in
increased seizure activity. Also, phenytoin may decrease serum folic acid concentrations.
Methotrexate: Folic acid may decrease a patient's response to methotrexate therapy.
Barbiturates: Folate reduces serum barbiturate concentrations.
Other Drugs and Alcohol: Folate deficiency states may be produced by drugs such as antiepileptics, oral contraceptives,
anti-tuberculosis drugs, alcohol, and folic acid antagonists such as methotrexate, pyrimethamine, triamterene, trimethoprim,
and sulfonamides.
Drug/Laboratory Test Interactions: Most of the antibiotics, methotrexate and pyrimethamine may invalidate folic acid
diagnostic blood assays.
Niacinamide
Nicotinamide may decrease antibiotic activities of erythromycin, kanamycin, streptomycin, doxycycline, and lincomycin.

Chromium Picolinate
Antidiabetic medications: Chromium picolinate might increase insulin sensitivity. It might lower blood glucose levels
therefore, chromium supplements might have an additive effect with insulin, metformin or other antidiabetes medications and
thus might increase the risk of hypoglycemia.
Levothyroxine: Chromium picolinate decreases the absorption of levothyroxine absorption. To help avoid this interaction,
levothyroxine should be taken 30 minutes before or 3-4 hours after taking chromium.

4.6 Use in Special Populations

Pregnant Women
There are no adequate and well controlled studies of this combination therapy in pregnant women. BLUVIT Tablet should be
used during pregnancy only if the potential benefit justifies the possible risk to the fetus.

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Lactating Women
It is not known whether components of BLUVIT Tablet are excreted in human milk. Caution should be exercised when this
product is administered to a nursing woman. Nursing mothers should not use this preparation unless clearly needed and
recommended by physician.
Paediatric Patients
The safety and efficacy of this formulation has not been established in the paediatric population. BLUVIT Tablet are not
intended for use in children.
Geriatric Patients
Generally, dose adjustment is not required in the geriatric population. Elderly patients with normal renal and hepatic function
may be given the same dose as recommended for adults.
Renal and Hepatic Impairment Patients
This formulation has not been studied in patents with hepatic and renal impairment. Caution should be exercised when
BLUVIT Tablet are administered to these patients and it is recommended to monitor renal and hepatic functions.

4.7 Effect on Ability to Drive and Use Machines

BLUVIT Tablet are unlikely to cause any impact on the ability to drive and use machines.

4.8 Undesirable effect

Bluvit tablets are generally well tolerated when used within the recommended dose.
Common adverse effects may include rash, anorexia, nausea, vomiting, diarrhea and headache.

4.9 Overdose
Mecobalamin
Data regarding overdose with mecobalamin is limited. Mecobalamin has excellent tolerability and no known toxicity.
Zinc Sulphate
High doses of zinc cause emesis. In addition, zinc sulfate is corrosive at high doses, and may cause irritation and corrosion
of the gastrointestinal tract, including ulceration of the stomach and possible perforation. Over dosage with zinc has also
been associated with acute renal tubular necrosis and interstitial nephritis. Prolonged high dose zinc supplementation may
result in copper deficiency.
Calcium Pantothenate
Do not take more than the recommended dose of Calcium Pantothenate. An overdose of this supplement generally does not
cause any severe symptoms except diarrhea.
Pyridoxine
Pyridoxine can cause neurological disorders, such as loss of sensation in legs and lack of balance/coordination, when taken
in high doses (200 mg or more per day) over a long period of time. Pyridoxine/vitamin B6 toxicity can damage sensory nerves,
leading to numbness in the hands and feet as well as difficulty in walking. Symptoms of a pyridoxine overdose may include
poor coordination, staggering, numbness, decreased sensation to touch, temperature, vibration and tiredness for up to 6
months.
Folic Acid
Toxicity from excessive folic acid intake does not normally occur as folic acid is water soluble and regularly excreted by the
body. High levels of folic acid can provoke seizures in patients taking anticonvulsant medications.
Niacinamide
Overdose signs and symptoms include severe skin flushing combined with dizziness, rapid heartbeat, itching, nausea and
vomiting, abdominal pain, and diarrhea.
Chromium Picolinate
Overdose symptoms may include vomiting, diarrhea, blood in your urine or stools, or coughing up blood.
Treatment
BLUVIT tablets contains water soluble B-vitamins, so drinking more water will lead to flushing of these B-vitamins through
urine. In the event of overdose, treatment consists of its withdrawal and symptomatic treatment, if necessary.

5 Pharmacological Properties
5.1 Mechanism of Action
Mecobalamin
Mecobalamin regulates nerve function and reduces plasma homocysteine levels by following mechanisms:
5.2 Mecobalamin promotes myelination (phospholipid synthesis): Mecobalamin promotes the synthesis of lecithin, the
main constituent of medullary sheath lipid and increases myelination of neurons in rat tissue culture more than cobamamide
does.
5.3 Mecobalamin promotes axonal transport and axonal regeneration: Mecobalamin normalizes axonal skeletal protein
transport in sciatic nerve cells from rat models with streptozotocin-induced diabetes mellitus. It exhibits neuropathologically
and electrophysiologically inhibitory effects on nerve degeneration in neuropathies induced by drugs, such as adriamycin,

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acrylamide, and vincristine (in rats and rabbits), models of axonal degeneration in mice and neuropathies in rats with
spontaneous diabetes mellitus.
5.4 Mecobalamin is a kind of endogenous coenzyme B12: Mecobalamin plays an important role in transmethylation as a
coenzyme of methionine synthetase in the synthesis of methionine from homocysteine.
5.5 Mecobalamin is well transported to nerve cell organelles, and promotes nucleic acid and protein synthesis:
Mecobalamin is better transported to nerve cell organelles than cyanocobalamin in rats. Also, mecobalamin promotes nucleic
acid and protein synthesis in rats more than cobamamide does.
Zinc Sulphate
Zinc is an essential trace element. Zinc functions as a cofactor of various enzymes including DNA polymerases, RNA
polymerases, alcohol dehydrogenase, and alkaline phosphatases. Zinc is a coordinator of protein structural folding, such as
folding of ‘Zinc finger’ motif that interacts with a variety of proteins, lipids, and nucleic acids. In addition, zinc is a catalyst of
essential biochemical reactions, including activation of substrates of carbonic anhydrase in erythrocyte. Also, zinc is a
signaling mediator modulating multiple signaling pathways.
Calcium Pantothenate
Pantothenic acid is incorporated into Coenzyme A and protects cells against peroxidative damage by increasing the level of
glutathione.
Pyridoxine
Pyridoxine/vitamin B6 is a water soluble vitamin required for amino acid, carbohydrate, and fat metabolism. Pyridoxine have
role as a coenzyme in a wide variety of enzymes involved in cell growth and cell division.
High homocysteine level in the blood (hyperhomocysteinemia) is a risk factor for cardiovascular disease, blood clotting
abnormalities, myocardial infarction (heart attack), and ischemic stroke. Pyridoxine alone or in combination with folic acid has
been shown to be effective for lowering homocysteine levels.
Folic Acid
Folic acid is reduced in the body to tetrahydofolate, which is a coenzyme for various metabolic processes including the
synthesis of purine and pyrimidine nucleotides, and hence the synthesis of DNA.
Niacinamide
Niacin required for the synthesis of nicotinamide adenine dinucleotide (NAD+) and nicotinamide adenine dinucleotide
phosphate (NADP+) enzymes is present in the cytosol of most cell. The nicotinamide nucleotides play a widespread role as
coenzymes to many dehydrogenase enzymes occurring both in the cytosol and within the mitochondria. They are therefore
key components of many metabolic pathways affecting carbohydrate, lipid, and amino acid metabolism. Generally, NAD+
linked dehydrogenases catalyze oxidoreduction reactions in oxidative pathways, whereas NADP+ linked dehydrogenases or
reductases are often found in pathways concerned with reductive syntheses.
Chromium Picolinate
Chromium might play a role in carbohydrate, lipid, and protein metabolism by potentiating insulin action. Although the precise
mechanism for this activity has not been identified, scientists have proposed that chromium binds to an oligopeptide to form
chromodulin, a low-molecular-weight, chromium-binding substance that binds to and activates the insulin receptor to promote
insulin action. Chromium might also have antioxidant effects

5.6 Pharmacodynamic Properties

Mecobalamin
Mecobalamin is the neurologically active form of vitamin B12. In many cases, liver does not convert cyanocobalamin, the
commonly available form of vitamin B12, into adequate amounts of mecobalamin. Nutritional inadequacies, enzyme defects,
and pathological changes in tissues can all contribute to a reduced ability of the body to accomplish the synthesis of the
active forms of vitamin B12 from cyanocobalamin. BLUVIT tablets provides the readymade (active) form of vitamin B12 i.e.,
mecobalamin. Mecobalamin is useful to regulate various neurological defects such as neuropathies including diabetic
neuropathy. Mecobalamin is also effective in the treatment of megaloblastic anemia caused by vitamin B12 deficiency.
Zinc Sulphate
Zinc is an essential component of a large number (> 300) of enzymes participating in the synthesis and degradation of
carbohydrates, lipids, proteins, and nucleic acids as well as in the metabolism of other micronutrients. Zinc plays a major role
in the immune system. It also acts as an antioxidant. It is important for normal growth, wound healing and sexual maturation,
for crystallization and release of insulin (the pancreas of diabetic individuals contains only half of the normal quantity of zinc).
Calcium Pantothenate
Pantothenic acid is used in the synthesis of coenzyme A (CoA). CoA is thought to act as a carrier molecule, allowing the
entry of acyl groups into cells. This is of critical importance as these acyl groups are used as substrates in the tricarboxylic
acid cycle to generate energy and in the synthesis of fatty acids, cholesterol, and acetylcholine. Additionally, CoA is part of
acyl carrier protein (ACP), which is required in the synthesis of fatty acids in addition to CoAs use as a substrate.Pantothenic
acid in the form of CoA is also required for acylation and acetylation, which, for example, are involved in signal transduction
and enzyme activation and deactivation, respectively.Since pantothenic acid participates in a wide array of key biological
roles, it may have numerous wide-ranging effects.
Pyridoxine Hydrochloride
Pyridoxine is essential for cell growth and cell division. Pyridoxine also involves in carbohydrate, protein, and fat metabolism.
Pyridoxine also reduces homocysteine levels in the blood.

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Folic Acid
Folic acid is used in the treatment and prevention of the folate deficiency state. It is also involved in some amino-acid
conversions, and in the formation and utilization of formate.
Niacinamide
Niacinamide is key components of many metabolic pathways. It is required for carbohydrate, lipid, and amino acid
metabolism.
Chromium Picolinate
Chromium is an essential trace element that potentiates insulin action and thus influences carbohydrate, lipid, and protein
metabolism.

5.7 Pharmacokinetic Properties

Mecobalamin
Vitamin B12 is extensively bound to specific plasma proteins called transcobalamins; transcobalamin II appears to be
involved in the rapid transport of the cobalamins to tissues. Vitamin B12 diffuses across the placenta and also appears in
breast milk. Vitamin B12 is stored in the liver, excreted in the bile, and undergoes extensive enterohepatic recycling. Part of
a dose is 7 excreted in the urine, most of it in the first 8 hours; urinary excretion, however, accounts for only a small fraction
in the reduction of total body stores acquired by dietary means.
Zinc Sulphate
Zinc is incompletely absorbed from the small bowel, with between 10 and 40% of an ingested dose absorbed. Numerous
dietary components can interfere with zinc absorption, particularly phytates and fibre, which bind to zinc, resulting in poorly
absorbed zinc complexes. Approximately 60% of circulating zinc is bound to albumin and roughly 30% is bound to
macroglobulin. The majority of zinc is stored in the liver and kidney, chiefly intracellularly, and bound to metalloproteins. In
adults, it has been estimated that 0.5–1 mg is secreted daily in the biliary tract and excreted in the stool, while 0.5–0.8 mg is
excreted daily in the urine.
Calcium Pantothenate
Pantothenic acid is readily absorbed from the GI tract following oral administration. Normal serum pantothenate
concentrations are 100 ug/mL or greater. Pantothenic acid is widely distributed into body tissues, mainly as coenzyme A.
Highest concentrations are found in the liver, adrenal glands, heart, and kidneys. About 70% of an oral dose of pantothenic
acid is excreted unchanged in urine and about 30% in feces.
Pyridoxine
Pyridoxine hydrochloride is absorbed rapidly from the upper intestine regardless of the size of the dose given. Absorption
may also occur from ileum and to a small extent from the colon. Pyridoxine is rapidly converted in the liver to pyridoxine
phosphate, pyridoxal phosphate and pyridoxamine phosphate via oxidation. This causes the release of pyridoxal and some
pyridoxal phosphate to the general circulation where it reaches other organs chiefly as circulating pyridoxal. Pyridoxine and
its metabolites are stored mainly in the liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites.
Pyridoxal crosses the placenta and is also distributed into breast milk. Pyridoxine is excreted primarily unchanged in the
urine; with a small amount in the form of metabolite, most likely 4-pyridoxic acid. As the dose increases, proportionally greater
amounts are excreted unchanged in the urine.
Niacinamide
Niacinamide and nicotinic acid are widely distributed in the body tissues. Nicotinic acid appears in breast milk. The main
route of metabolism is their conversion to N-methylnicotinamide and the 2-pyridone and 4-pyridone derivatives; nicotinuric
acid is also formed. Small amounts of nicotinic acid and nicotinamide are excreted unchanged in urine after therapeutic
doses; however the amount excreted unchanged is increased with larger doses.
Chromium Picolinate
Most chromium is bound to plasma proteins, particularly transferrin, and only about 5% is unbound. Chromium accumulates
mainly in the liver, spleen, soft tissue, and bone. Chromium is excreted mainly in the urine.

6 Nonclinical Properties
6.1 Animal Toxicology
There are no relevant data available for BLUVIT tablets

7 Description
Pearlescent Red coloured, circular, biconvex, film coated tablets, plain on both sides.

Mecobalamin
Mecobalamin appears as dark red crystals or crystalline powder. It is sparingly soluble in water, slightly soluble in ethanol
and practically insoluble in acetonitrile.
Molecular Weight: 1344.38 g/mol.
Molecular Formula: C63H91CoN13O14P
Chemical Name: Methyl-5, 6-dimethylbenzimidazolylcobalamin.
Structural Formula:

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Zinc Sulphate
Anhydrous zinc sulphate is a colorless crystalline solid which is soluble in water. Zinc sulphate is also obtained as a
hexahydrate and as a heptahydrate.
Molecular Formula: ZnSO4.
Molecular Weight: 161.4 g/mol.
Chemical Name: Zinc(2+);sulphate.
Structural Formula:

Calcium Pantothenate
Calcium Pantothenate is a white to off-white hygroscopic crystals or powder that is soluble in ethanol and water.
Molecular Weight: 238.27 g/mol
Molecular Formula: C₉H₁₆O₅N.1/2Ca
Chemical Name: (R)-(+)-N-(2,4-Dihydroxy-3,3-dimethyl-1-oxobutyl)-β-alanine hemicalcium salt ,D-Pantothenic acid
hemicalcium salt , Calcium D-pantothenate
Structural Formula:

Pyridoxine
Pyridoxine hydrochloride is a white or practically white crystals or crystalline powder, soluble in water and insoluble in ether.
Molecular Weight: 169.18 g/mol.
Molecular Formula: C8H11NO3.
Chemical Name: 4,5-bis(hydroxymethyl)-2-methylpyridin-3-ol.
Structural Formula:

Folic Acid
Folic acid is a yellow, yellow-brownish, or yellowish orange, odourless crystalline powder. Very slightly soluble in water;
insoluble in alcohol, in acetone, in chloroform, and in ether.
Molecular Weight: 441.40 g/mol.
Molecular Formula: C19H19N7O6.

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Chemical Name: (2S)-2-[(4-{[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino} phenyl) formamido] pentanedioic acid.
Structural Formula:

Niacinamide
Niacinamide is a white powder, slightly soluble in ethanol, easily soluble in boiling water, boiling alcohol, soluble in propylene
glycol, chloroform, hydroxide and carbonate solutions, insoluble in ether and lipid solvents.
Molecular Weight: 122.12 g/mol
Molecular Formula: C6H6N2O
Chemical Name: 3 - Pyri di ne - Carboxylami de
Structural Formula:

Chromium Picolinate
Chromium picolinate appears as fine purple crystalline powder with good fluidity. It is chemically stable at room temperature
and is slightly soluble in water but insoluble in ethanol, wherein the chromium is in the trivalent form.
Molecular Weight: 418.3 g/mol
Molecular Formula: C18H12CrN3O6
Chemical Name: chromium(3+);pyridine-2-carboxylate
Structural Formula:

Inactive ingredients (excipients) of BLUVIT Tablet contain Silicified Microcrystalline Cellulose, Colloidal Silicon Dioxide,
Crospovidone, Magnesium Stearate, Instacoat Smart (Polyvinyl Alcohol, Triacetin, Talc, Strawberry Flavour, Mica based
pearlescent Pigment, Lake Ponceau 4R) and Flavour Strawberry.

8 Pharmaceutical Particulars
8.1 Incompatibilities
None known.

8.2 Shelf-life
24 Months.

8.3 Packaging Information

15 tablets per Alu-Alu blister pack.

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8.4 Storage and Handling Instructions
Store protected from light & moisture, at a temperature not exceeding 25°C.
Keep out of reach of children.

9 Patient Counseling Information

Instructions to Patients
 Instruct patients not to change their medication dose or schedule without consulting doctor or pharmacist. Do not
exceed the recommended dose or duration of treatment.
 Pregnant women and nursing mothers can use this medicine only in consultation with their doctor.
 This medicine is not recommended for use in children.
 Instruct patients not to share their medication with others even though it has been prescribed for same
disease/condition. Also, not to use medication prescribed for others.
 BLUVIT Tablet should not be exposed to light/moisture because mecobalamin is susceptible to degradation by
photolysis.

10 Details of Manufacturer
Pure & Cure Healthcare Pvt. Ltd.
(A subsidiary of Akums Drugs & Pharmaceuticals Ltd.)
Plot No. 26A, 27-30, Sector - 8A, I.I.E., SIDCUL,
Ranipur, Haridwar - 249 403, Uttarakhand.

11 Details of Permission or License Number with Date

Mfg. Lic. No. 51/UA/SC/P-2013. Date of Product Permission 29/11/2023.

12 Date of Revision
January 2024

Ver. No. 00 Dt 10/03/2024

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