Becadexamin

Becadexamin by GSK lists 17 ingredients, 17 with an amount per serving of 0 capsules, such as 5,000 IU of vitamin A, 400 IU (10 mcg) of vitamin D3, 15 mg of vitamin E and 5 mg of vitamin B1. Its current label entered the NIH Dietary Supplement Label Database on December 26, 2020.

What is in Becadexamin?

Each row as the label prints it, per serving of 0 capsules. The capsule beside an amount places it among every product in the NIH database that lists the same ingredient: the bar is the middle half of their amounts, the line in it the median, the whiskers the 10th and 90th percentiles; the green tick is the FDA Daily Value and the red dashed tick the adult upper limit (IOM).

* % Daily Value computed from the printed amount and the FDA Daily Value (21 CFR 101.9); the label prints none for that row.

Is that a lot?

The rows in the top or bottom tenth of the products that list the same ingredient, and any above the adult upper limit at the most servings a day the directions give:

• At 1 serving a day, the most its directions give, the label lists 45 mg of niacin, 1.3 times the adult Tolerable Upper Intake Level.
• Its 1,000 mcg of folic acid (filed by NIH under folate) is higher than 93% of the 7,022 folate products that print an amount; 183 list more.
• 93% of the 6,382 products that print an amount of iodine list more than its 25 mcg of potassium iodide (filed by NIH under iodine) (median 150 mcg).

The NIH database records one serving a day from the label's directions; its % Daily Values are for adults and children 4 or more years of age. The directions as printed are further down this page.

The Tolerable Upper Intake Level is the most of a nutrient per day, from food, water and supplements together, that is likely to pose no risk for almost all adults (Institute of Medicine, 2011). It does not apply under medical supervision. This page compares labels; it is not medical advice.

What does the label say about taking it?

Quoted from the label as DSLD transcribed it: the maker's words, including any claim about what the product does, which the FDA has not evaluated and PlainVitamins does not endorse.

Directions

Posology and method of administration Adults and adolescents Once capsule once daily. In adolescents dosing regimen should be adjusted according to the individual patient's needs. Duration of treatment depends on the improvement of the deficiency states.

Warnings

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

Children Becadexamin is not recommended for paediatric use.

Renal Impairment Caution should be exercised when using Becadexamin in patients with renal disorders (see section Special Warnings and Special Precautions for Use). Hepatic Impairment Caution should be exercised when using Becadexamin in patients with hepatic disorders (see section Special Warnings and Special Precautions for Use). Contraindications Becadexamin is contraindicated in: Hypersensitivity to any of the components, Treatment with retinoids (see section Interaction with Other Medicaments and Other Forms of Interaction). Special Warnings and Special Precautions for Use Concomitant conditions Caution should be used in case of the following concomitant conditions: Hepatitis or hepatic disorders, Kidney disorders, Intestinal stricture inflammation, Active duodenal or gastric ulcer, Diabetes mellitus. Gastrointestinal symptoms Patients with ostomies may have altered intestinal transit times. Cardiac disorders Becadexamin should be used with caution in the presence of cardiac disease, as it contains vitamin D. Vision disorders Cyanocobalamin (vitamin B12) should not be used for Leber's disease or tobacco amblyopia since these optic neuropathies may degenerate further. Hypercalcaemia Becadexamin is not recommended for patients with hypercalcaemia or diseases associated with hypercalcaemia such as sarcoidosis and some malignancies, as it contains calcium and vitamin D. It should be given cautiously to these patients. Effects on the Thyroid Although iodine is required for the production of thyroid hormones, excessive quantities can cause hyperthyroidism, or even paradoxical goitre and hypothyroidism (see section Undesirable Effects). Special populations Patients over the age of 45 years or with nodular goiter are especially susceptible to hyperthyroidism when given iodine supplementation. Reduced doses should therefore be used and supplementation with iodised oil may not be appropriate. High dose of nicotinamide should be used with caution in patients with peptic ulcer disease, gastritis, liver disease, gall bladder disease, diabetes and gout. Investigations As iodine and iodides can affect the thyroid gland, their use may interfere with tests of thyroid function. Large doses of riboflavin (vitamin B2) result in a bright yellow discoloration of the urine that may interfere with certain laboratory tests. Ascorbic acid, a strong reducing agent, interferes with laboratory tests involving oxidation and reduction reactions. Falsely-elevated or false-negative test results may be obtained form plasma, faeces, or urine samples depending on such factors as the dose of ascorbic acid and specified method used. Long-term treatment Caution is necessary if preparations containing iodine or iodides are taken for long periods. Long-term use of large doses of pyridoxine (vitamin B6) is associated with the development of severe peripheral neuropathies; the dose at which these occur is not established. The use of excessive amounts of vitamin A substances over long periods can lead to toxicity (see section Overdose). Risk of overdosage Other medicinal product containing vitamin A should not be used while taking Becadexamin as it may cause overdose symptoms (see sections Interaction with Other Medicaments and Other Forms of Interaction; Overdose). Overdose symptoms may occur as a result of prolonged (several weeks or months) administration of doses starting from 10 000 IU daily, in patients with liver or kidney impairment, low body weight, hypoproteinemia and alcohol abuse (see section Overdose). Other medicinal product containing vitamin E should not be used while taking this product as it may cause overdose symptoms (see section Overdose). Treatment preparation and monitoring Becadexamin should, if possible, not be given to patients with suspected vitamin B12 deficiency without first confirming the diagnosis. Plasma phosphate concentrations should be controlled during vitamin D therapy to reduce the risk of ectopic calcification. Tolerance Tolerance may be induced with prolonged use of large doses of vitamin C, resulting in symptoms of deficiency when intake is reduced to normal.

Interaction with Other Medicaments and Other Forms of Interaction Diuretics As Becadexamin contains calcium and vitamin D, hypercalcaemia may occur when it is given with thiazide diuretics. Thiazide diuretics decrease urinary excretion of calcium. Plasma-calcium concentrations should be monitored in patients receiving the drugs together. Corticosteroids Corticosteroids reduce calcium absorption. Corticosteroids may counteract the effect of vitamin D. Cardiac glycosides Calcium enhances the effects of digitalis glycosides on the heart and may precipitate digitalis intoxication. Antibiotics Tetracycline antibiotics, other than doxycycline also decreases zinc absorption, they should therefore be administered 2 hours before or 3 hours after the administration of Becadexamin, in those cases where concomitant use is necessary. Penicillamine (a chelating agent) may reduce the absorption of zinc. Penicillamine and antituberculous drugs (such as isoniazid) may increase the requirements for folic acid and pyridoxine (vitamin B6). Neomycin used orally may reduce the absorption of vitamin A, vitamin B12 and vitamin E. Rifampicin and isoniazid may reduce the effectiveness of vitamin D. Bisphosphonates As Becadexamin contains calcium and magnesium salts, it reduces the absorption of bisphosphates, therefore doses should be separated by at least 3 hours. Folic acid antagonists Folate deficiency states may be produced by folic acid antagonists such as methotrexate, pyrimethamine, triamterene, trimethoprim and sulfonamides. Amiodarone The effects of iodine and iodides on the thyroid may be altered by other compounds including amiodarone. Cholestyramine, colestipol and mineral oils Cholestyramine, colestipol and mineral oils used orally may reduce the absorption of vitamin A and vitamin E. Retinoids Combined treatment with retinoids (isotretinoin, etretinate, bexarotene) and vitamin A in doses exceeding 4000-5000 IU daily may induce vitamin A overdose symptoms (see sections Special Warnings and Special Precautions for Use; Overdose). Thus, the use of Becadexamin is contraindicated during the treatment with retinoids (see section Contraindications). Oral contraceptives Oral contraceptives may increase vitamin A plasma concentration. Serum concentration of vitamin B6, vitamin B12 and folic acid may be decreased by use of oral contraceptives. Large supplements of vitamin C have been reported to increase serum ethinylestradiol concentrations in women taking oral contraceptives, but a further study showed no effect on either ethinylestradion or levonorgestrel. Levodopa Becedexamin contains vitamin B6 which reduces the effects of levodopa, but this does not occur if a dopa decarboxylase inhibitor is also given. Altretamine Becadexamin contains B6 which reduces the activity of altretamine. Lithium The effects of iodine and iodides on the thyroid may be altered by other compounds including lithium. Antiepileptics Vitamin B6 and folic acid has been reported to decrease serum concentrations of phenobarbital and phenytoin. Some antiepileptics (e.g. carbamazepine, phenobarbital, phenytoin, and primidone) may increase vitamin D requirements. Antiepileptics may produce folate deficiency states. Replacement therapy with folinic acid or folic acid may become necessary during antiepileptic therapy in order to prevent development of megaloblastic anaemia. Concomitant nicotinamide and carbamazepine may decrease carbamazepine clearance. Hydralazine Hydralazine may increase the requirements for pyridoxine. Omeprazole Omeprazole has been reported to impair the bioavailability of vitamin B12 and dietary vitamin C. Anticoagulants As Becadexamin contains vitamin E, caution should be used during concomitant administration of anticoagulants (dicoumarol, warfarin, indanediones) due to the risk of their efficacy reduction, hypoprothrombinaemia and bleeding. During prolonged administration of vitamin E, the prothrombin time should be monitored on a regular basis. Cyclosporine Vitamin E may increase the absorption of cyclosporine.

Calcium, vitamin D There is an increased risk of hypercalcaemia if vitamin D is given with calcium. Vitamin D increases the gastrointestinal absorption of calcium. Plasma-calcium concentrations should be monitored in such situations. Fluoride As Becadexamin contains calcium, it reduces the absorption of fluoride; therefore doses should be separated by at least 3 hours. Phosphates As Becadexamin contains vitamin D, there is an increased risk of hypercalcaemia if it is given with phosphate. Plasma-calcium concentrations should be monitored in such situations. Phosphorus-containing preparations may reduce the absorption of zinc. Iron supplements The absorption of zinc may be reduced by additionally taken iron supplements. Calcium in Becadexamin may reduce iron absorption when administered concomitantly with iron supplements. Oral iron preparations should not therefore be taken within 1 hour before or 2 hours after taking Becadexamin. Zinc supplements Additionally taken zinc supplements reduce the absorption of copper. Vitamin C As Becadexamin contains vitamin C, it may increase the absorption of iron in iron-deficiency states. Alcohol Alcohol enhances the toxic effect of vitamin A and may produce folate deficiency states.

Pregnancy Becadexamin should be used by pregnant women only after consultation with a physician. Lactation Becadexamin should be used by lactating women only after consultation with a physician.

Undesirable effects Multivitamins are generally well tolerated when used within the recommended dose. The following adverse events have been reported with use of ingredients of Becadexamin. The frequency of most of these events cannot be estimated from the available data. Adverse drug reactions (ADRs) are listed below by MedDRA system organ class and by frequency. Frequencies are defined as: Very common greater than or equal to 1/10 Common greater than or equal to 1/100 to less than 1/10 Uncommon greater than or equal to 1/1000 to less than 1/100 Rare greater than or equal to 1/10000 to less than 1/1000 Very rare less than 1/10000 Not known (cannot be estimated from the available data). Immune system disorders Not Known: Hypersensitivity reactions (see Skin and subcutaneous tissue disorders), anaphylactic reaction Gastrointestinal disorders Not Known: Abdominal pain, nausea, vomiting, diarrhea, constipation, gastrointestinal disturbances, black faeces. Psychiatric disorders Not Known: Sleep disturbances. Nervous system disorders Not Known: Headache, dizziness. Skin and subcutaneous tissue disorders Not Known: Rash Metabolic disorders Very Rare: Diabetogenic effects Overdose Overdose of Becadexamin can lead to the following symptoms and signs. Symptoms and signs Symptoms include: gastrointestinal disturbances (abdominal pain, nausea, vomiting, diarrhea, constipation, taste disturbances, thirst), cardiac arrhythmias (tachycardia, bradycardia), hypotension, cardiac arrest, renal impairment, polyuria, nocturia, muscle weakness, headache, drowsiness, dizziness/vertigo, irritability, sweating, lassitude, somnolence, confusion, shock, coma, thirst, elevations in liver tests and liver damage, including jaundice and parenchymal liver cell injury. Treatment The treatment consists of its withdrawal and symptomatic treatment, if necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.

Keep out of reach of children.

Storage

Special Precautions for Storage Store at temperature not exceeding 30 degrees C protected from direct sunlight.

What else is on the label?

Other ingredients: Soy Lecithin, partially hydrogenated Vegetable Oil, yellow Beeswax, Arachis oil, purified Water, Capsule Shell contains.

How many labels does Becadexamin have?

One label is on file, entered on December 26, 2020.

1. Label 239677 (current) Entered December 26, 2020 · on the market · 30 capsules

Who makes it?

The label names Geltec Private Ltd. (manufacturer), Bangalore. All GSK products.

Where next?

• Vitamin A
• Vitamin D3
• Vitamin E
• Vitamin B1
• Vitamin D3 (cholecalciferol)
• GSK
• Check an amount of vitamin A