Becadexamin
Product Overview
Brand: GSK
Net Contents: 30 Capsule(s)
Serving Size (Overview): 1 Capsule(s)
Product Type: Other Combinations [A1325]
Form: Capsule [E0159]
Date Entered: Dec 26, 2020
Market Status: On Market
Suggested Use (Overview): Posology and method of administrationAdults and adolescentsOnce 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.
Product Self-Roles:
- No specific self-roles defined.
Dietary Supplement Facts
| Ingredient | Category | Amount Per Serving | Unit | % Daily Value | Target Group | Serving Size (Fact) |
|---|---|---|---|---|---|---|
| Vitamin A | vitamin | 5000 | IU | N/A | N/A | 0 Capsule(s) |
| Vitamin D3 | vitamin | 400 | IU | N/A | N/A | 0 Capsule(s) |
| Vitamin E | vitamin | 15 | mg | N/A | N/A | 0 Capsule(s) |
| Vitamin B1 | vitamin | 5 | mg | N/A | N/A | 0 Capsule(s) |
| Vitamin B2 | vitamin | 5 | mg | N/A | N/A | 0 Capsule(s) |
| Nicotinamide | vitamin | 45 | mg | N/A | N/A | 0 Capsule(s) |
| D-Panthenol | non-nutrient/non-botanical | 5 | mg | N/A | N/A | 0 Capsule(s) |
| Vitamin B6 | vitamin | 2 | mg | N/A | N/A | 0 Capsule(s) |
| Vitamin C | vitamin | 75 | mg | N/A | N/A | 0 Capsule(s) |
| Folic Acid | vitamin | 1000 | mcg | N/A | N/A | 0 Capsule(s) |
| Vitamin B12 | vitamin | 5 | mcg | N/A | N/A | 0 Capsule(s) |
| Dibasic Calcium Phosphate | mineral | 70 | mg | N/A | N/A | 0 Capsule(s) |
| Copper Sulfate Pentahydrate | mineral | 0.1 | mg | N/A | N/A | 0 Capsule(s) |
| Manganese Sulfate Monohydrate | mineral | 0.01 | mg | N/A | N/A | 0 Capsule(s) |
| Zinc Sulfate Monohydrate | mineral | 28.7 | mg | N/A | N/A | 0 Capsule(s) |
| Potassium Iodide | mineral | 0.025 | mg | N/A | N/A | 0 Capsule(s) |
| light Magnesium Oxide | mineral | 0.15 | mg | N/A | N/A | 0 Capsule(s) |
Other Ingredients
Soy Lecithin; partially hydrogenated Vegetable Oil; yellow Beeswax; Arachis oil; purified Water; Capsule Shell contains (Brilliant Blue FCF; Erythrosine; Ethyl hydroxybenzoate; Ethyl Vanillin; Gelatin; Glycerin; Methyl hydroxybenzoate; Ponceau 4R; Propyl Hydroxybenzoate; purified Water; Sunset Yellow FCF; Titanium Dioxide)
Label Statements
Precautions
- For the use only of Registered Medical Practitioners or a Hospital or a Laboratory ChildrenBecadexamin is not recommended for paediatric use. Renal ImpairmentCaution should be exercised when using Becadexamin in patients with renal disorders (see section Special Warnings and Special Precautions for Use).Hepatic ImpairmentCaution should be exercised when using Becadexamin in patients with hepatic disorders (see section Special Warnings and Special Precautions for Use).ContraindicationsBecadexamin is contraindicated in:Hypersensitivity to any of the componentsTreatment with retinoids (see section Interaction with Other Medicaments and Other Forms of Interaction).Special Warnings and Special Precautions for UseConcomitant conditionsCaution should be used in case of the following concomitant conditions:Hepatitis or hepatic disordersKidney disordersIntestinal stricture inflammationActive duodenal or gastric ulcerDiabetes mellitus.Gastrointestinal symptomsPatients with ostomies may have altered intestinal transit times.Cardiac disordersBecadexamin should be used with caution in the presence of cardiac disease as it contains vitamin D.Vision disordersCyanocobalamin (vitamin B12) should not be used for Leber's disease or tobacco amblyopia since these optic neuropathies may degenerate further.HypercalcaemiaBecadexamin 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 ThyroidAlthough 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 populationsPatients 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.InvestigationsAs 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 treatmentCaution 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 overdosageOther 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 monitoringBecadexamin 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.ToleranceTolerance 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 InteractionDiureticsAs 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.CorticosteroidsCorticosteroids reduce calcium absorption.Corticosteroids may counteract the effect of vitamin D.Cardiac glycosidesCalcium enhances the effects of digitalis glycosides on the heart and may precipitate digitalis intoxication.AntibioticsTetracycline 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.BisphosphonatesAs Becadexamin contains calcium and magnesium salts it reduces the absorption of bisphosphates therefore doses should be separated by at least 3 hours.Folic acid antagonistsFolate deficiency states may be produced by folic acid antagonists such as methotrexate pyrimethamine triamterene trimethoprim and sulfonamides.AmiodaroneThe effects of iodine and iodides on the thyroid may be altered by other compounds including amiodarone.Cholestyramine colestipol and mineral oilsCholestyramine colestipol and mineral oils used orally may reduce the absorption of vitamin A and vitamin E.RetinoidsCombined 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 contraceptivesOral 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.LevodopaBecedexamin contains vitamin B6 which reduces the effects of levodopa but this does not occur if a dopa decarboxylase inhibitor is also given.AltretamineBecadexamin contains B6 which reduces the activity of altretamine.LithiumThe effects of iodine and iodides on the thyroid may be altered by other compounds including lithium.AntiepilepticsVitamin 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.HydralazineHydralazine may increase the requirements for pyridoxine.OmeprazoleOmeprazole has been reported to impair the bioavailability of vitamin B12 and dietary vitamin C.AnticoagulantsAs 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.CyclosporineVitamin E may increase the absorption of cyclosporine. Calcium vitamin DThere 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.FluorideAs Becadexamin contains calcium it reduces the absorption of fluoride; therefore doses should be separated by at least 3 hours.PhosphatesAs 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 supplementsThe 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 supplementsAdditionally taken zinc supplements reduce the absorption of copper.Vitamin CAs Becadexamin contains vitamin C it may increase the absorption of iron in iron-deficiency states.AlcoholAlcohol enhances the toxic effect of vitamin A and may produce folate deficiency states. PregnancyBecadexamin should be used by pregnant women only after consultation with a physician.LactationBecadexamin should be used by lactating women only after consultation with a physician. Undesirable effectsMultivitamins 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 1/10Common greater than or equal to 1/100 to less than 1/10Uncommon greater than or equal to 1/1000 to less than 1/100Rare greater than or equal to 1/10000 to less than 1/1000Very rare less than 1/10000Not known (cannot be estimated from the available data).Immune system disordersNot Known: Hypersensitivity reactions (see Skin and subcutaneous tissue disorders) anaphylactic reactionGastrointestinal disordersNot Known: Abdominal pain nausea vomiting diarrhea constipation gastrointestinal disturbances black faeces.Psychiatric disordersNot Known: Sleep disturbances.Nervous system disordersNot Known: Headache dizziness.Skin and subcutaneous tissue disordersNot Known: RashMetabolic disordersVery Rare: Diabetogenic effectsOverdoseOverdose of Becadexamin can lead to the following symptoms and signs.Symptoms and signsSymptoms 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.TreatmentThe 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.
Formulation
- Multivitamin Multimineral Capsules Clinical particularsTherapeutic IndicationsBecadexamin is indicated for the treatment of vitamins and minerals deficiency states in adults which may be associated with the following conditions:Dietary restrictions: in conditions such as obesity cardiovascular diseases chronic diarrhea or dysentery etc.MalnutritionInfections or recovering from infectionsLong term antibiotic useOld age Pharmacological PropertiesPharmacodynamic PropertiesPharmacotherapeutic group: Multivitamins and other minerals including combinations ATC Code A11AA03.Mechanism of action and Pharmacodynamic EffectsBecadexamin contains active substances with synergistic therapeutic actions necessary for maintenance and/or improvement of functional activities of the body.Vitamins their precursors minerals and trace elements are included to treat deficiencies. Many of those act as co-factors for various metabolic functions.Vitamin ARetinol is an essential nutrient needed in small amounts by humans for the normal functioning of the visual system growth and development and maintenance of epithelial cellular integrity immune function and reproduction.Vitamin D (cholecalciferol)Vitamin D is required to maintain normal blood levels of calcium and phosphate which are in turn needed for the normal mineralization of bone muscle contraction nerve conduction and general cellular function in all cells of the body.Vitamin E (tocopherol acetate)Vitamin E is the major lipid-soluble antioxidant in the cell antioxidant defense system acts and maintains the integrity of the vascular endothelium.Vitamin B1 (thiamine mononitrate)Vitamin B1 is an essential co-enzyme in oxidative metabolism of -ketoacids and increases the activity of acetylcholine in nerve endings.Vitamin B2 (riboflavin)Vitamin B2 is an essential component in function of certain co-enzymes important for energy production taking part in numerous oxidation and reduction reactions. It has also an important role in maintaining a healthy skin.NicotinamideNicotinamide is involved in a large number or processes such as production of energy synthesis of fatty acids cholesterol steroids signal transduction and the maintenance of integrity of genome.D-PanthenolD-Panthenol (Dexpanthenol) is the synthetic alcohol form of pantothenic acid. It is converted to pantothenic acid n the body and therefore can be considered a provitamin form of pantothenic acid. Pantothenic acid is a precursor of co-enzyme A necessary for energy production involved in fatty acid metabolism formation of acetylcholine and improvement of epithelization and wound healing. It is also necessary for folic acid and carbohydrate metabolism.Vitamin B6 (pyridoxine hydrochloride)It takes part in formation of some important co-enzymes involved in protein metabolism and HEM biosynthesis. As a coenzyme it functions in metabolism of amino acids glycogen and sphingoid bases.Vitamin C (ascorbic acid)Vitamin C is an electron donor (reducing agent or antioxidant) for 11 enzymes. It has a role in hydroxylation of certain compounds. It helps in maintenance of intracellular skeleton of cartilages bones and teeth. It is essential in maintenance of capillary wall integrity and regulation of capillary permeability. Vitamin C promotes absorption of soluble non-haem iron.Folic acidIt is essential for erythropoiesis maturation of red blood cells and biosynthesis of the DNA.Vitamin B12 (cyanocobalamin)It is essential for erythropoiesis formation of myelin sheet and synthesis of the DNA.CalciumIt activates certain enzymes. It maintains the normal excitability of the myocardium and nerves and helps in maintenance of capillary wall integrity. It is essential in the structure of bones and teeth for muscular contraction and many metabolic processes.CopperIt is essential for synthesis of hemoglobin formation of bone and myelin for the activity of certain enzymes such as cytochrome oxidases (tissue oxidation).ManganeseIs it a co-factor in many enzyme reactions which involve phosphorylation and synthesis of cholesterol and fatty acids.ZincZinc 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).IodineIt has a role in the synthesis of thyroid hormones.MagnesiumMagnesium functions as a co-factor of many enzymes involved in energy metabolism protein synthesis RNA and DNA synthesis maintenance of the electrical potential of nervous tissues cell membrane stabilizing action and muscle contraction.
Other
- Qualitative and Quantitative Composition(Appropriate overages added)Pharmaceutical formCapsules for oral administration. Shelf LifeThe expiry date is indicated on the label and packaging. Nature and Specification of ContainerCapsules in an amber glass bottle.
Suggested Use
- Posology and method of administrationAdults and adolescentsOnce 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.
Product Specific Information
- Special Precautions for StorageStore at temperature not exceeding 30 degrees C protected from direct sunlight.
Associated Company Information & Roles
Geltec Private Ltd.
At: Survey No. 24 26/3 27/2 Yadavanahalli Attibele Bangalore-Hosur Road,
Bangalore,
562 107
Roles for this Product:
- Manufacturer
GlaxoSmithKline Pharmaceuticals Ltd.
Regd. Office Dr. Annie Besant Road,
Worli,
400 030
Mumbai
Roles for this Product:
- Distributor