Blackmores Executive B

Uses

Biotin is a B-complex vitamin found in many multivitamin products.

For nutritional supplementation, also for treating dietary shortage or imbalance.

Calcium is a mineral found in over-the-counter supplements or prescription formulations used for the treatment of specific medical conditions related to calcium deficiency.

Calcium plays a vital role in the anatomy, physiology and biochemistry of organisms and of the cell, particularly in signal transduction pathways. It is vital in cell signaling, muscular contractions, bone health, and signalling cascades.

Choline is a nutrient found in a wide variety of vitamins including pre-natal formulations.

For nutritional supplementation, also for treating dietary shortage or imbalance

This preparation is used for Pernicious anemia,Vitamin B12 deficiency due to low intake from food,Thyrotoxicosis, Hemorrhage, Malignancy, Liver or kidney disease,Gastric bypass surgery, Total or partial gastrectomy, Gluten enteropathy or sprue, Folic acid deficiency, Macrocytic anaemia

Prophylaxis of megaloblastic anaemia in pregnancy, Supplement for women of child-bearing potential, Folate-deficient megaloblastic anaemia, Prophylaxis of neural tube defect in pregnancy

Lecithin is fatty substances commonly found in nutritional supplements.

Magnesium is a medication used for many purposes including constipation, indigestion, magnesium deficiency, and pre-eclampsia.

Healthy levels of magnesium can be achieved through a well balanced diet, but if food sources are insufficient, magnesium supplements can be used to prevent and treat magnesium deficiencies.

In medicine, various magnesium salts may be used in laxative and antacid products. For example, magnesium citrate is available over-the-counter and may be used to manage occasional constipation. Magnesium sulfate may be used on its own or with total parenteral nutrition to treat hypomagnesemia. Magnesium sulfate is also indicated to prevent seizures in pregnant women with pre-eclampsia, and to manage seizures associated with eclampsia.

Nicotinamide is an ingredient found in a variety of cosmetic products.

Pyridoxine (vitamin B6) is used to prevent or treat low levels of vitamin B6 in people who do not get enough of the vitamin from their diets. Most people who eat a normal diet do not need extra vitamin B6. However, some conditions (such as alcoholism, liver disease, overactive thyroid, heart failure) or medications (such as isoniazid, cycloserine, hydralazine, penicillamine) can cause low levels of vitamin B6. Vitamin B6 plays an important role in the body. It is needed to maintain the health of nerves, skin, and red blood cells.

Pyridoxine has been used to prevent or treat a certain nerve disorder (peripheral neuropathy) caused by certain medications (such as isoniazid). It has also been used to treat certain hereditary disorders (such as xanthurenic aciduria, hyperoxaluria, homocystinuria).

Preventing and treating riboflavin deficiency and conditions related to riboflavin deficiency.

Cataracts, an eye disorder. People who eat more riboflavin as part of their diet seems to have a lower risk of developing cataracts. Also, taking supplements containing riboflavin plus niacin seems to help prevent cataracts.

High amounts of homocysteine in the blood (hyperhomocysteinemia). Some people are unable to convert the chemical homocysteine into the amino acid methionine. People with this condition, especially those with low riboflavin levels, have high amounts of homocysteine in the blood. Taking riboflavin for 12 weeks seems to reduce homocysteine levels by up to 40% in some people with this condition. Also, certain antiseizure drugs can increase homocysteine in the blood. Taking riboflavin along with folic acid and pyridoxine seems to lower homocysteine levels by 26% in people with high homocysteine levels due to antiseizure drugs.

Migraine headaches. Taking high-dose riboflavin (400 mg/day) seems to significantly reduce the number of migraine headache attacks. However, taking riboflavin does not appear to reduce the amount of pain or the amount of time a migraine headache lasts. Also, taking lower doses of riboflavin (200 mg/day) does not seem to reduce the number of migraine headache attacks.

Thiamine is specifically used in the treatment of the various manifestations of thiamine deficiency such as Beriberi and Wernick's encephalopathy, neuritis associated with pregnancy and pellagra. Supplementary Thiamine may be used prophylactically in conditions where there is low dietary intake or impaired gastro intestinal absorption of thiamine (e.g. alcohol) or where requirements are increased (pregnancy, carbohydrate rich diet).

As a dietary supplement:

• Vitamin E deficiency resulting from impaired absorption.
• Increased requirements due to diet rich in polyunsaturated fats.
• For healthy hair & skin
• As an Antioxidant
• Hemolytic anemia due to Vitamin E deficiency

Therapeutic use

: Heavy metal poisoning, Hepatotoxin poisoning, Hemolytic anemia, Oxygen therapy and replacement therapy in nutritional deficiency states for the betterment of skin and hair.

Blackmores Executive B is also used to associated treatment for these conditions: Vitamin Deficiency, Nutritional supplementationCalcium Deficiency, Deficiency, Vitamin D, Osteodystrophy, Osteomalacia, Osteoporosis, Chronic Hypocalcemia, Chronic Hypocalcemia caused by anticonvulsant medications, Care of the Joint, Mineral supplementation, Nutritional supplementationVitamin C DeficiencyNutritional supplementationAnemia, Anemia, Pernicious, Combined Vitamin B1 and B12 deficiency, Convalescence, Diabetic Neuropathies, Folate deficiency, Iron Deficiency Anemia (IDA), Neuritis, Vitamin B1 deficiency, Vitamin B12 Deficiency, Vitamin B12 concentration, Vitamin B6 Deficiency, Vitamin Deficiency, Nutritional supplementation, Vitamin supplementationAnaemia folate deficiency, Folate deficiency, Iron Deficiency (ID), Iron Deficiency Anemia (IDA), Latent Iron Deficiency, Neural Tube Defects (NTDs), Vitamin Deficiency, Methotrexate toxicity, Nutritional supplementationCalcium Deficiency, Magnesium Deficiency, Zinc DeficiencyGastrointestinal insufficiency, Hepatic Insufficiency, Macrocytic anemia, Secondary anemia, Vitamin Deficiency, Severe debilitation, Dietary and Nutritional Therapies, Nutritional supplementation, Dietary supplementationBackache, Dizziness, Fever, Headache, Hepatic; Functional Disturbance, Hepatitis, Iron Deficiency Anemia (IDA), Ketosis, Macrocytic anemia, Menière's Disease, Menstrual Distress (Dysmenorrhea), Metabolic Acidosis, Motion Sickness, Nausea and vomiting, Neuralgia, Sciatic, Neuritis, Neurological Conditions caused by B Vitamin Deficiency, Secondary anemia, Soreness, Muscle, Toothache, Toxinfectious state, Trigeminal Neuralgia (TN), Vitamin B1 deficiency, Vitamin B12 Deficiency, Vitamin B6 Deficiency, Vitamin Deficiency, Minor aches and pains, Minor pain, Nutritional supplementation, Supplementation, Vitamin supplementation, Wellness of the LiverAriboflavinosis, Beriberi, Constipation, Functional Gastrointestinal Disorders, Joint Pain, Metabolic cardiomyopathy, Migraine, Neuralgia, Peripheral neuritis, Peripheral paralysis, Soreness, Muscle, Vitamin B complex deficiency, Vitamin B1 deficiency, Vitamin Deficiency, Wernicke's encephalopathy, Dietary and Nutritional Therapies, Nutritional supplementation, Vitamin supplementation, Dietary supplementationAnemia, B12 Deficiency Anemia, Beriberi, Cardiovascular Heart Disease caused by Thiamine Deficiency, Folic Acid Deficiency Anemia, Infantile Beriberi, Infection, Iron Deficiency (ID), Liver disorder, Neuritis caused by Pregnancy, Secondary anemia, Thiamine Deficiency, Vitamin Deficiency, Wernicke's encephalopathy, Nutritional supplementation, Vitamin supplementation, Dietary supplementationVitamin Deficiency, Long-chain omega-3 fatty acid supplementation, Dietary supplementation

How Blackmores Executive B works

Biotin is necessary for the proper functioning of enzymes that transport carboxyl units and fix carbon dioxide, and is required for various metabolic functions, including gluconeogenesis, lipogenesis, fatty acid biosynthesis, propionate metabolism, and catabolism of branched-chain amino acids.

Calcium plays a vital role in the anatomy, physiology and biochemistry of organisms and of the cell, particularly in signal transduction pathways. More than 500 human proteins are known to bind or transport calcium. The skeleton acts as a major mineral storage site for the element and releases Ca2+ ions into the bloodstream under controlled conditions. Circulating calcium is either in the free, ionized form or bound to blood proteins such as serum albumin. Parathyroid hormone (secreted from the parathyroid gland) regulates the resorption of Ca2+ from bone. Calcitonin stimulates incorporation of calcium in bone, although this process is largely independent of calcitonin. Although calcium flow to and from the bone is neutral, about 5 mmol is turned over a day. Bone serves as an important storage point for calcium, as it contains 99% of the total body calcium. Low calcium intake may also be a risk factor in the development of osteoporosis. The best-absorbed form of calcium from a pill is a calcium salt like carbonate or phosphate. Calcium gluconate and calcium lactate are absorbed well by pregnant women. Seniors absorb calcium lactate, gluconate and citrate better unless they take their calcium supplement with a full breakfast. The currently recommended calcium intake is 1,500 milligrams per day for women not taking estrogen and 800 milligrams per day for women on estrogen. There is close to 300 milligrams of calcium in one cup of fluid milk. Calcium carbonate is currently the best and least expensive form of calcium supplement available.

Choline is a major part of the polar head group of phosphatidylcholine. Phosphatidylcholine's role in the maintenance of cell membrane integrity is vital to all of the basic biological processes: information flow, intracellular communication and bioenergetics. Inadequate choline intake would negatively affect all these processes. Choline is also a major part of another membrane phospholipid, sphingomyelin, also important for the maintenance of cell structure and function. It is noteworthy and not surprising that choline deficiency in cell culture causes apoptosis or programmed cell death. This appears to be due to abnormalities in cell membrane phosphatidylcholine content and an increase in ceramide, a precursor, as well as a metabolite, of sphingomyelin. Ceramide accumulation, which is caused by choline deficiency, appears to activate Caspase, a type of enzyme that mediates apoptosis. Betaine or trimethylglycine is derived from choline via an oxidation reaction. Betaine is one of the factors that maintains low levels of homocysteine by resynthesizing L-methionine from homocysteine. Elevated homocysteine levels are a significant risk factor for atherosclerosis, as well as other cardiovascular and neurological disorders. Acetylcholine is one of the major neurotransmitters and requires choline for its synthesis. Adequate acetylcholine levels in the brain are believed to be protective against certain types of dementia, including Alzheimer's disease.

Vitamin B12 serves as a cofactor for methionine synthase and L-methylmalonyl-CoA mutase enzymes. Methionine synthase is essential for the synthesis of purines and pyrimidines that form DNA. L-methylmalonyl-CoA mutase converts L-methylmalonyl-CoA to succinyl-CoA in the degradation of propionate , an important reaction required for both fat and protein metabolism. It is a lack of vitamin B12 cofactor in the above reaction and the resulting accumulation of methylmalonyl CoA that is believed to be responsible for the neurological manifestations of B12 deficiency . Succinyl-CoA is also necessary for the synthesis of hemoglobin .

In tissues, vitamin B12 is required for the synthesis of methionine from homocysteine. Methionine is required for the formation of S-adenosylmethionine, a methyl donor for nearly 100 substrates, comprised of DNA, RNA, hormones, proteins, as well as lipids . Without vitamin B12, tetrahydrofolate cannot be regenerated from 5-methyltetrahydrofolate, and this can lead to functional folate deficiency , . This reaction is dependent on methylcobalamin (vitamin B12) as a co-factor and is also dependent on folate, in which the methyl group of methyltetrahydrofolate is transferred to homocysteine to form methionine and tetrahydrofolate. Vitamin B12 incorporates into circulating folic acid into growing red blood cells; retaining the folate in these cells . A deficiency of vitamin B12 and the interruption of this reaction leads to the development of megaloblastic anemia.

Folic acid, as it is biochemically inactive, is converted to tetrahydrofolic acid and methyltetrahydrofolate by dihydrofolate reductase (DHFR). These folic acid congeners are transported across cells by receptor-mediated endocytosis where they are needed to maintain normal erythropoiesis, synthesize purine and thymidylate nucleic acids, interconvert amino acids, methylate tRNA, and generate and use formate. Using vitamin B12 as a cofactor, folic acid can normalize high homocysteine levels by remethylation of homocysteine to methionine via methionine synthetase.

Magnesium is a cofactor for at least 300 enzymes and is important for several functions in the body with some key processes identified below. Enzymes that rely on magnesium to operate help produce energy through oxidative phosphorylation, glycolysis and ATP metabolism. They are also involved in nerve function, muscle contraction, blood glucose control, hormone receptor binding, protein synthesis, cardiac excitability, blood pressure control, gating of calcium channels and transmembrane ion flux.

The mitochondrial intracellular space is rich in magnesium, since it is required to produce the active form of ATP (adenosine triphosphate) from ADP (adenosine diphosphate) and inorganic phosphate, and behaves as a counter ion for the energy rich molecule. Additionally, magnesium is essential for ATP metabolism.

Vitamin B6 is the collective term for a group of three related compounds, pyridoxine (PN), pyridoxal (PL) and pyridoxamine (PM), and their phosphorylated derivatives, pyridoxine 5'-phosphate (PNP), pyridoxal 5'-phosphate (PLP) and pyridoxamine 5'-phosphate (PMP). Although all six of these compounds should technically be referred to as vitamin B6, the term vitamin B6 is commonly used interchangeably with just one of them, pyridoxine. Vitamin B6, principally in its biologically active coenzyme form pyridoxal 5'-phosphate, is involved in a wide range of biochemical reactions, including the metabolism of amino acids and glycogen, the synthesis of nucleic acids, hemogloblin, sphingomyelin and other sphingolipids, and the synthesis of the neurotransmitters serotonin, dopamine, norepinephrine and gamma-aminobutyric acid (GABA).

Binds to riboflavin hydrogenase, riboflavin kinase, and riboflavin synthase. Riboflavin is the precursor of flavin mononucleotide (FMN, riboflavin monophosphate) and flavin adenine dinucleotide (FAD). The antioxidant activity of riboflavin is principally derived from its role as a precursor of FAD and the role of this cofactor in the production of the antioxidant reduced glutathione. Reduced glutathione is the cofactor of the selenium-containing glutathione peroxidases among other things. The glutathione peroxidases are major antioxidant enzymes. Reduced glutathione is generated by the FAD-containing enzyme glutathione reductase.

It is thought that the mechanism of action of thiamine on endothelial cells is related to a reduction in intracellular protein glycation by redirecting the glycolytic flux. Thiamine is mainly the transport form of the vitamin, while the active forms are phosphorylated thiamine derivatives. Natural derivatives of thiamine phosphate, such as thiamine monophosphate (ThMP), thiamine diphosphate (ThDP), also sometimes called thiamine pyrophosphate (TPP), thiamine triphosphate (ThTP), and thiamine triphosphate (AThTP), that act as coenzymes in addition to their each unique biological functions.

The mechanism of action for most of vitamin E's effects are still unknown. Vitamin E is an antioxidant, preventing free radical reactions with cell membranes. Though in some cases vitamin E has been shown to have pro-oxidant activity.

One mechanism of vitamin E's antioxidant effect is in the termination of lipid peroxidation. Vitamin E reacts with unstable lipid radicals, producing stable lipids and a relatively stable vitamin E radical. The vitamin E radical is then reduced back to stable vitamin E by reaction with ascorbate or glutathione.

Dosage

Blackmores Executive B dosage

Usual Adult Dose for Pernicious Anemia

Initial dose: 1000 mcg intramuscularly or deep subcutaneous once a day for 6 to 7 daysIf clinical improvement and reticulocyte response is seen from the above dosing:

• 100 mcg every other day for 7 doses, then
• 100 mcg every 3 to 4 days for 2 to 3 weeks, then
• Maintenance dose: 100 to 1000 mcg monthly

Administer concomitant folic acid if needed. Chronic treatment should be done with an oral preparation in patients with normal intestinal absorption.

Usual Adult Dose for B12 Nutritional Deficiency: 25 to 2000 mcg orally daily

Usual Adult Dose for Schilling Test: 1000 mcg intramuscularly is the flushing dose

Usual Pediatric Dose for B12 Nutritional Deficiency: 0.5 to 3 mcg daily

Supplement for women of child-bearing potential: 0.4 mg daily.

Folate-deficient megaloblastic anaemia: 5 mg daily for 4 mth, up to 15 mg daily in malabsorption states. Continued dosing at 5 mg every 1-7 days may be needed in chronic haemolytic states, depending on the diet and rate of haemolysis.

Prophylaxis of neural tube defect in pregnancy: 4 or 5 mg daily starting before pregnancy and continued through the 1st trimester.

Prophylaxis of megaloblastic anaemia in pregnancy: 0.2-0.5 mg daily.

ADULTS:

BY MOUTH:

• For hereditary sideroblastic anemia: Initially, 200-600 mg of vitamin B6 is used. The dose is decreased to 30-50 mg per day after an adequate response.
• For vitamin B6 deficiency: In most adults, the typical dose is 2.5-25 mg daily for three weeks then 1.5-2.5 mg per day thereafter. In women taking birth control pills, the dose is 25-30 mg per day.
• For abnormally high levels of homocysteine in the blood: For reducing high levels of homocysteine in the blood after childbirth, 50-200 mg of vitamin B6 has been taken alone. Also, 100 mg of vitamin B6 has been taken in combination with 0.5 mg of folic acid.
• For preventing macular degeneration: 50 mg of vitamin B6 in the form of pyridoxine has been used daily in combination with 1000 mcg of vitamin B12 (cyanocobalamin) 1000 mcg and 2500 mcg of folic acid for about 7 years.
• For hardening of the arteries (atherosclerosis): A specific supplement (Kyolic, Total Heart Health, Formula 108, Wakunga) containing 250 mg of aged garlic extract, 100 mcg of vitamin B12, 300 mcg of folic acid, 12.5 mg of vitamin B6, and 100 mg of L-argininedaily for 12 months.
• For kidney stones: 25-500 mg of vitamin B6 has been used daily.
• For nausea during pregnancy: 10-25 mg of vitamin B6 taken three or four times per day has been used. In people who don't respond to vitamin B6 alone, a combination product containing vitamin B6 and the drug doxylamine (Diclectin, Duchesnay Inc.) is used three or four times per day. Also, another product containing 75 mg of vitamin B6, 12 mcg of vitamin B12, 1 mg of folic acid, and 200 mg of calcium (PremesisRx, KV Pharmaceuticals) is used daily.
• For symptoms of premenstrual syndrome (PMS): 50-100 mg of vitamin B6 is used daily, alone or along with 200 mg of magnesium.
• For treating tardive dyskinesia: 100 mg of vitamin B6 per day has been increased weekly up to 400 mg per day, given in two divided doses.

INJECTED INTO THE MUSCLE:

• Hereditary sideroblastic anemia: 250 mg of vitamin B6 daily, reduced to 250 mg of vitamin B6 weekly once adequate response is achieved.

CHILDREN:

BY MOUTH:

• For kidney stones: Up to 20 mg/kg daily in children aged 5 years and up.

INJECTED INTO THE VEIN OR MUSCLE:

• For seizures that respond to vitamin B6 (pyridoxine-dependent seizures): 10-100 mg is recommended.

The daily recommended dietary allowances (RDAs) of vitamin B6 are:

• Infants 0-6 months, 0.1 mg
• Infants 7-12 months, 0.3 mg
• Children 1-3 years, 0.5 mg
• Children 4-8 years, 0.6 mg
• Children 9-13 years, 1 mg
• Males 14-50 years, 1.3 mg
• Males over 50 years, 1.7 mg
• Females 14-18 years, 1.2 mg
• Females 19-50 years, 1.3 mg
• Females over 50 years, 1.5 mg
• Pregnant women, 1.9 mg
• Breast-feeding women, 2 mg
• Some researchers think the RDA for women 19-50 years should be increased to 1.5-1.7 mg per day.

The recommended maximum daily intake is:

• Children 1-3 years, 30 mg
• Children 4-8 years, 40 mg
• Children 9-13 years, 60 mg

Adults, pregnant and breast-feeding women:

• 14-18 years, 80 mg
• over 18 years, 100 mg

For treating low levels of riboflavin (riboflavin deficiency) in adults: 5-30 mg of riboflavin (Vitamin B2) daily in divided doses.

For preventing migraine headaches: 400 mg of riboflavin (Vitamin B2) per day. It may take up to three months to get best results.

For preventing cataracts: a daily dietary intake of approximately 2.6 mg of riboflavin (Vitamin B2) has been used. A combination of 3 mg of riboflavin (Vitamin B2) plus 40 mg of niacin daily has also been used.

The daily recommended dietary allowances (RDAs) of riboflavin (Vitamin B2) are:

• Infants 0-6 months: 0.3 mg
• Infants 7-12 months: 0.4 mg
• Children 1-3 years: 0.5 mg
• Children 4-8 years: 0.6 mg
• Children 9-13 years: 0.9 mg
• Men 14 years or older: 1.3 mg
• Women 14-18 years: 1 mg
• Women over 18 years: 1.1 mg
• Pregnant women: 1.4 mg
• Breastfeeding women: 1.6 mg

Prophylaxis: 3 to 10 mg daily.

Mild chronic deficiency: 10 to 25 mg daily.

Severe deficiency: 200 to 300 mg daily.

Betterment of Cardiovascular health: 400 mg - 800 mg / day

Deficiency syndrome in adults: 200 mg - 400 mg / day

Deficiency syndrome in children: 200 mg / day

Thalassemia: 800 mg / day

Sickle-cell anemia: 400 mg / day

Betterment of Skin & Hair: 200 mg - 400 mg / day (Topical use is also established for beautification)

Chronic cold in adults: 200 mg / day

May be taken with or without food.

Side Effects

Arthralgia (12%), Dizziness (12%), Headache (12%), Nasopharyngitis (12%), Anaphylaxis, Angioedema, Congestive heart failure, Peripheral vascular disease,Pulmonary edema, Diarrhea, Dyspepsia, Polycythemia vera, Sore throat, Nervousness, Rhinitis, Glossitis, Hypoesthesia

GI disturbances, hypersensitivity reactions; bronchospasm.

Pyridoxine usually has no side effects when used in recommended doses.

If your doctor has prescribed this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Pyridoxine can cause side effects when taken in large doses for a long time. Tell your doctor right away if any of these unlikely but serious side effects occur: headache, nausea, drowsiness, numbness/tingling of arms/legs.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Riboflavin may cause your urine to turn a yellow-orange color, but this is usually not a harmful side effect.

Vitamin B1 does not have adverse effects when given orally, but in a few fatal cases anaphylactic reactions have occurred after intravenous administration of large doses (400 mg) in sensitive patients, especially children, and in one case following an intramuscular dose of 125 mg. The risk of such reactions increases with repeated administration of the drug by parenteral route. Transient mild soreness may occur at the site of intramuscular administration

Overdoses (>1g) have been associated with minor side effects, including hypertension, fatigue, diarrhea and myopathy

Toxicity

Prolonged skin contact may cause irritation.

Oral rat LD₅₀: 3400 mg/kg

LD50 Oral (mouse): > 5,000 mg/kg .

General toxicity

Vitamin B12 is generally non-toxic, even at higher doses. Mild, transient diarrhea, polycythemia vera, peripheral vascular thrombosis, itching, transitory exanthema, a feeling of swelling of entire body, pulmonary edema and congestive heart failure in early treatment stages, anaphylactic shock and death have been observed after vitamin B12 administration .

Carcinogenesis and mutagenesis

Long term studies in animals examining the carcinogenic potential of any of the vitamin B12 formulations have not completed to date. There is no evidence from long-term use in patients with pernicious anemia that vitamin B12 has carcinogenic potential. Pernicious anemia is known to be associated with an increased incidence of stomach carcinoma, however, this malignancy has been attributed to the underlying cause of pernicious anemia and has not been found to be related to treatment with vitamin B12 .

Use in pregnancy

No adverse effects have been reported with ingestion of normal daily requirements during pregnancy .

A note on the use of the nasal spray in pregnancy

Although vitamin B12 is an essential vitamin and requirements are increased during pregnancy, it is currently unknown whether the nasal spray form can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. The nasal spray form should be given to a pregnant woman only if clearly needed, as it is considered a pregnancy category C drug in this form. Sufficient well-controlled studies have not been done to this date in pregnant women .

Use in lactation

Vitamin B12 has been found distributed into the milk of nursing women in concentrations similar to the maternal blood vitamin B12 concentrations. No adverse effects have been reported to date with intake of normal required doses during lactation .

IPR-MUS LD₅₀ 85 mg/kg,IVN-GPG LD₅₀ 120 mg/kg, IVN-MUS LD₅₀ 239 mg/kg, IVN-RAT LD₅₀ 500 mg/kg, IVN-RBT LD₅₀ 410 mg/kg

The recommended dietary allowance of magnesium ranges from 30 mg for infants to 420 mg for males between the age of 31 and 50. According to the institute of Medicine (IOM), the majority of adults can tolerate 350 mg of magnesium per day without experiencing adverse effects. Symptoms of magnesium toxicity include diarrhea and other gastrointestinal effects, thirst, muscle weakness, drowsiness, severe back and pelvic pain, hypotension, dizziness, confusion, difficulty breathing, lethargy, and deterioration of kidney function. Other more severe symptoms associated with magnesium overdose include loss of consciousness, respiratory arrest, cardiac arrhythmias and cardiac arrest.

Regular use of laxatives containing magnesium may lead to severe and even fatal hypermagnesemia.

Discontinuation of magnesium products including supplements, laxatives, and antacids is usually sufficient to manage mild cases of magnesium overdose; however, patients should also be screened for renal impairment.

In severe cases of magnesium overdose, patients may require supportive care and interventions including intravenous fluids and furosemide, IV calcium chloride or calcium gluconate, renal dialysis and artificial respiratory support.

Oral Rat LD50 = 4 gm/kg. Toxic effects include convulsions, dyspnea, hypermotility, diarrhea, ataxia and muscle weakness.

Thiamine toxicity is uncommon; as excesses are readily excreted, although long-term supplementation of amounts larger than 3 gram have been known to cause toxicity. Oral mouse LD₅₀ = 8224 mg/kg, oral rat LD₅₀ = 3710 mg/kg.

There is no data available for effects in pregnancy, breast feeding, hepatic impairment, or renal impairment. However, it appears that the process of vitamin E elimination is strict and self regulating enough that vitamin E toxicity is exceedingly rare. Studies showing adverse effects from excess vitamin E generally involve people consuming more than 1000mg/day for weeks to months.

Precaution

Intensive treatment of B12-deficient megaloblastic anemia may cause hypokalemia and sudden death. Use with caution in patients with Leber optic nerve atrophy. Thrombocytosis may occur with treatment of severe vitamin B12 megaloblastic anemia

Treatment resistance may occur in patients with depressed haematopoiesis, alcoholism, deficiencies of other vitamins. Neonates.

Before taking pyridoxine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

During pregnancy, this vitamin has been found to be safe when used in recommended doses.

This vitamin passes into breast milk and is considered to be safe during breast-feeding when used in recommended doses. Consult your doctor for more information.

Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. Caution is advised in premature infants with high dose Vitamin E supplementation, because of reported risk of necrotizing enterocilitis.

Interaction

Absorption reduced by antibiotics, aminosalicylic acid, anticonvulsants, biguanides, cholestyramine, cimetidine, colchicine, K salts, methyldopa.

Antiepileptics, oral contraceptives, anti-TB drugs, alcohol, aminopterin, methotrexate, pyrimethamine, trimethoprim and sulphonamides may result to decrease in serum folate contrations. Decreases serum phenytoin concentrations.

The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.

To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.

Some products that may interact with this vitamin include: altretamine, cisplatin, phenytoin.

This vitamin may interfere with certain laboratory tests (including urine test for urobilinogen), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this vitamin.

Rate and extent of absorption may be affected by propantheline bromide.

No hazardous drug interactions have been reported. Vitamin B1 acts synergistically with other vitamins of the B-complex group and its potential for causing adverse effects is considerably reduced.

Vitamin E may impair the absorption of Vitamin A. Vitamin K functions impairement happens at the level of prothrombin formation and potentiates the effect of Warfarin.

Volume of Distribution

Cobalamin is distributed to tissues and stored mainly in the liver and bone marrow .

Tetrahydrofolic acid derivatives are distributed to all body tissues but are stored primarily in the liver.

According to a pharmacokinetic review, the volume of distribution of magnesium sulphate when used to manage patients with pre-eclampsia and eclampsia ranged from 13.65 to 49.00 L.

Pyridoxine main active metabolite, pyridoxal 5’-phosphate, is released into the circulation (accounting for at least 60% of circulating vitamin B6) and is highly protein bound, primarily to albumin.

0.41L/kg in premature neonates given a 20mg/kg intramuscular injection.

Elimination Route

Systemic - approximately 50%

Vitamin B12 is quickly absorbed from intramuscular (IM) and subcutaneous (SC) sites of injection; with peak plasma concentrations achieved about 1 hour after IM injection .

Orally administered vitamin B12 binds to intrinsic factor (IF) during its transport through the stomach. The separation of Vitamin B12 and IF occurs in the terminal ileum when calcium is present, and vitamin B12 is then absorbed into the gastrointestinal mucosal cells. It is then transported by transcobalamin binding proteins . Passive diffusion through the intestinal wall can occur, however, high doses of vitamin B12 are required in this case (i.e. >1 mg). After the administration of oral doses less than 3 mcg, peak plasma concentrations are not reached for 8 to 12 hours, because the vitamin is temporarily retained in the wall of the lower ileum .

Folic acid is absorbed rapidly from the small intestine, primarily from the proximal portion. Naturally occurring conjugated folates are reduced enzymatically to folic acid in the gastrointestinal tract prior to absorption. Folic acid appears in the plasma approximately 15 to 30 minutes after an oral dose; peak levels are generally reached within 1 hour.

Approximately 24-76% of ingested magnesium is absorbed in the gastrointestinal tract, primarily via passive paracellular absorption in the small intestine.

The B vitamins are readily absorbed from the gastrointestinal tract, except in malabsorption syndromes. Pyridoxine is absorbed mainly in the jejunum. The Cmax of pyridoxine is achieved within 5.5 hours.

Vitamin B2 is readily absorbed from the upper gastrointestinal tract.

Absorbed mainly from duodenum, by both active and passive processes

10-33% of deuterium labelled vitamin E is absorbed in the small intestine. Absorption of Vitamin E is dependant upon absorption of the fat in which it is dissolved. For patients with poor fat absorption, a water soluble form of vitamin E may need to be substituted such as tocopheryl polyethylene glycol-1000 succinate.

In other studies the oral bioavailability of alpha-tocopherol was 36%, gamma-tocotrienol was 9%. The time to maximum concentration was 9.7 hours for alpha-tocopherol and 2.4 hours for gamma-tocotrienol.

Half Life

Approximately 6 days (400 days in the liver) .

Magnesiums biologic half-life is reported to be approximately 1000 hours or 42 days.

The total adult body pool consists of 16 to 25 mg of pyridoxine. Its half-life appears to be 15 to 20 days.

66-84 minutes

44 hours in premature neonates given a 20mg/kg intramuscular injection. 12 minutes in intravenous injection of intestinal lymph.

Clearance

During vitamin loading, the kidney accumulates large amounts of unbound vitamin B12. This drug is cleared partially by the kidney, however, multiligand receptor megalin promotes the reuptake and reabsorption of vitamin B12 into the body , .

6.5mL/hr/kg in premature neonates given a 20mg/kg intramuscular injection.

Elimination Route

The kidney excretes 250 mmol a day in urine, and resorbs 245 mmol, leading to a net loss in the urine of 5 mmol/d.

This drug is partially excreted in the urine . According to a clinical study, approximately 3-8 mcg of vitamin B12 is secreted into the gastrointestinal tract daily via the bile. In patients with adequate levels of intrinsic factor, all except approximately 1 mcg is reabsorbed. When vitamin B12 is administered in higher doses that saturate the binding capacity of plasma proteins and the liver, the unbound vitamin B12 is eliminated rapidly in the urine. The body storage of vitamin B12 is dose-dependent .

After a single oral dose of 100 mcg of folic acid in a limited number of normal adults, only a trace amount of the drug appeared in the urine. An oral dose of 5 mg in 1 study and a dose of 40 mcg/kg of body weight in another study resulted in approximately 50% of the dose appearing in the urine. After a single oral dose of 15 mg, up to 90% of the dose was recovered in the urine. A majority of the metabolic products appeared in the urine after 6 hours; excretion was generally complete within 24 hours. Small amounts of orally administered folic acid have also been recovered in the feces. Folic acid is also excreted in the milk of lactating mothers.

The majority of magnesium is excreted renally.

The major metabolite of pyridoxine, 4-pyridoxic acid, is inactive and is excreted in urine

Alpha tocopherol is excreted in urine as well as bile in the feces mainly as a carboxyethyl-hydrochroman (CEHC) metabolite, but it can be excreted in it's natural form .

Pregnancy & Breastfeeding use

Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Lactation: Drug distributed in milk.

Pregnancy Category A. Adequate and well-controlled human studies have failed to demonstrate a risk to the fetus in the first trimester of pregnancy (and there is no evidence of risk in later trimesters).

Category A: Controlled studies in women fail to demonstrate a risk to the foetus in the 1st trimester (and there is no evidence of a risk in later trimesters), and the possibility of foetal harm remains remote.

Riboflavin is LIKELY SAFE for pregnant or breast-feeding women when taken in the amounts recommended. The recommended amounts are 1.4 mg per day for pregnant women and 1.6 mg per day in breast-feeding women. Riboflavin is POSSIBLY SAFE when taken by mouth in larger doses, short-term. Some research shows that riboflavin is safe when taken at a dose of 15 mg once every 2 weeks for 10 weeks.

The drug may be given safely to neonates, children, pregnant and lactating women and elderly patients.

Use in pregnancy: Vitamin E may be used in pregnancy in the normally recommended dose but the safety of high dose therapy has not been established.

Use in lactation: There appears to be no contraindication to breast feeding by mothers taking the normally recommended dose.

Contraindication

Leber's disease, tobacco amblyopia.

Undiagnosed megaloblastic anaemia; pernicious, aplastic or normocytic anaemias.

There is no absolute contraindication but the risk of anaphylaxis is increased by repeated parenteral administration. Mild allergic phenomena, such as sneezing or mild asthma are warning signs that further may give rise to anaphylactic shock. To avoid this possibility it is advisable to start a second course of injection with a dose considerably lower than that previously used. Because of the above, vitamin B1 injection should not be given intravenously except in the case of comatose patients. Once thiamine deficiency is corrected there is no need for parenteral administration or for the administration of amounts in excess of daily requirement.

No known contraindications found.

Special Warning

Use in Children: Vitamin E is safe for children

Acute Overdose

Large doses of vitamin E (more than 1 gm/day) have been reported to increase bleeding tendency in vitamin K deficient patients such as those taking oral anticoagulants.

Storage Condition

Store at 15-30° C.

Store at 15-30° C.

Thiamine injection should be protected from light and moisture.

Store at a cool and dry place, Protect from light and moisture.

Innovators Monograph

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