| |
|

| MULTIVITAMIN-HAKIM |
| :: Vitamin :: |
|
Oral Drop |
|
|
|
|
|
|
|
Pharmacologic category
Vitamin; Nutritional supplement (including vitamin A , vitamin E , vitamin D , vitamin B1 , vitamin B2, vitamin B6 , vitamin C, nicotinamide , vitamin B12)
Mechanism of action
Vitamin A is necessary for bone development , growth , visual adaptation to darkness , testicular and ovarian function , and as a cofactor in many biochemical processes.
Vitamin E , as an antioxidant , prevents oxidation of vitamin A and C, protect polyunsaturated fatty acids in membranes from attack by free radicals and protects red blood cells against hemolysis .
Vitamin D promotes absorption of calcium in the intestines and retention at the kidneys , thereby increasing calcium levels in the serum ; decreases excessive serum phosphatase levels , parathyroid hormone levels , and decreases bone resorption ; increases renal tubule phosphate resorption.
Vitamin B1 (thiamine) is an essential coenzyme in carbohydrate metabolism by combining with ATP to form thiamine pyrophosphate .
Vitamin B2 (riboflavin) is a component of flavoprotein enzymes that work together , which are necessary for normal tissue respiration ; also needed for activation of pyridoxine and conversion of tryptophan to niacin .
Vitamin B6 (pyridoxine) is precursor to pyridoxal , which function in the metabolism of proteins , carbohydrates, and fats ; pyridoxal also aids in the release of liver and muscle – stored glycogen and in the synthesis of GABA (within CNS) and heme.
Vitamin B12 (cyanocobalamin) is a coenzyme for various metabolic functions , including fat and carbohydrate metabolism and protein synthesis , used in cell replication and hematopoiesis.
Vitamin C is necessary for collagen formation and tissue repair ; involved in some oxidation – reduction reactions as well as other metabolic pathways , such as synthesis of carnitine , steroids , and catecholamines and conversion of folic acid to folinic acid.
Nicotinamide (niacinamide) is used by the body as a source of niacin ; is a component of two coenzymes (NAD and NADP) which is necessary for tissue respiration , lipid metabolism , and glycogenolysis ; inhibits the synthesis of very low density lipoproteins ; dose not have hypolipidemia or vasodilating effects.
Indications
Multivitamin drop is used for prevention/treatment of vitamin deficiencies and as a dietary supplement for infants and children under 4 years of age.
Side/Adverse effects
Vitamin A: Irritability ; Vertigo ; Lethargy ; Malaise ; Fever ; Headache ; Drying or cracking of skin ; Hypercalcemia ; Weight loss; Visual changes ; Hypervitaminosis A
Vitamin E: Blurred vision ; Gonadal dysfunction
Vitamin D: Hypercalcemia ; Cardiac arrhythmia ; Hyper – /hypotension ; headache ;Irritability ; Seizure ; Somnolence ; Psychosis ; Pruritus ; Erythema multiforme ; Hypermagnesemia ; Hyperphosphatemia ; Polydipsia ; Anorexia ; Constipation ; Metallic taste ; Nausea ; Pancreatitis ; Vomiting ; Xerostomia ; Elevated liver enzymes ; Bone pain ; Myalgia ; Dystrophy ; Soft tissue calcification ; Conjunctivitis ; Photophobia ; Polyuria.
Vitamin B1: Cardiovascular collapse ; Paresthesia
Vitamin B2: Discoloration of urine (yellow – orange )
Vitamin B6: Headache ; Sensory neuropathy ; Decreased serum folic acid ; Nausea ; Increased AST ; Paresthesia ; Allergic reactions.
Vitamin B12: Headache ; Anxiety ; Dizziness ; Pain ; Nervousness ; Hypoesthesia ; Itching ; Sore throat ; Nausea and vomiting ; Dyspepsia ; Diarrhea ; Weakness ; Back pain ; Arthritis ; Myalgia ; Paresthesia ; Abnormal gait ; Dyspnea ; Rhinitis.
Vitamin C: Hyperoxaluria ; Dizziness ; Faintness ; Fatigue ; Flank pain ; Headache.
Nicotinamide: Tachycardia ; Increased sebaceous gland activity ; Rash ; Bloating ; Flatulence ; Nausea ; Paresthesia ; Blurred vision ; Wheezing .
Contraindications
Vitamin A: Hypersensitivity to vitamin A ; hypervitaminosis A ; Pregnancy (dose exceeding RDA)
Vitamin D: Hypercalcemia ; Vitamin D toxicity ; Abnormal sensitivity to the effects of vitamin D ; Pregnancy (dose exceeding RDA)
Vitamin B12: Hypersensitivity to cyanocobalamin or cobalt ; Hereditary optic nerve atrophy , Leber’s disease
Nicotinamide: Hypersensitivity to niacin , niacinamide ; Liver disease ; Active peptic ulcer ; Severe hypotension ; Arterial hemorrhage .
Other components: Hypersensitivity to vitamin E , vitamin B1 , vitamin B2 , vitamin B6 , vitamin C or any component of the formulation .
Warnings / Precautions
Vitamin A: Evaluate other sources of vitamin A while receiving this product ; patients receiving > 25000 units/day should be closely monitored for toxicity .
Vitamin E: May induce vitamin K deficiency .
Vitamin D: Adequate dietary (supplemental ) calcium is necessary for clinical response to vitamin D . Avoid hypercalcemia. Calcium – phosphate product must not exceed 70.
Vitamin B6: Dependence and withdrawal may occur with doses > 200 mg/day.
Vitamin C: Diabetics and patients prone to recurrent renal calculi should not take excessive doses for extended periods of time .
Nicotinamide: Use caution in heavy ethanol users , unstable angina or CAD , diabetes , renal disease , active gallbladder disease , gout .
Pregnancy
FDA pregnancy category A (dose not exceeding RDA)
Breast–Feeding
The components are distributed into breast milk. Problem in humans have not been documented with intake of normal daily doses.
Drug Interactions
Vitamin A: Cholestyramine , neomycin and mineral oil decrease absorption of vitamin A. Retinoids my have additive adverse effects.
Vitamin E: Cholestyramine , colestipol and orlistat may reduce absorption of vitamin E . Vitamin E may impair the hematologic response to iron in children with iron –deficiency anemia . Vitamin E may alter the effect of vitamin K action on clotting factors resulting in an increase hypoprothrombinemic response to warfarin .
Vitamin D: Cholestyramine and colestipol may decrease absorption/effect of vitamin D. Corticosteroids may decrease hypercalcemic effect of vitamin D. Risk of digitalis toxicity may be increased due to hypercalcemia from vitamin D. Avoid concurrent use of magnesium –containing antacids because toxicity may be increased by vitamin D. Thiazide diuretics may increase risk of hypercalcemia.
Vitamin B1: Neuromuscular blocking agent , high carbohydrate or IV dextrose increase thiamine requirement .
Vitamin B2: Probenecid decreases absorption of vitamin B2.
Vitamin B6: It decreases serum levels of levodopa , phenobarbital and phenytoin.
Vitamin B12: Neomycin , colchicine , anticonvulsants may decrease absorption . Chloramphenicol may decrease vitamin B12 effects.
Vitamin C: Aspirin decreases vitamin C levels . Vitamin C decreases fluphenazine levels . The effect of warfarin is decreased by vitamin C. Absorption of iron is enhanced . The effect of oral contraceptives is increased by vitamin C.
Nicotinamide: The effect of oral hypoglycemic may be decreased by niacin . Niacin may inhibit uricosuric effects of sulfinpyrazone and probenecid . Aspirin decreases adverse effect of flushing . The risk of toxicity (myopathy) of lovastatin is increased . Concurrent use of adrenergic blocking agents with nicotinamide has additive vasodilating effect and postural hypotension .
Dietary Considerations
Multivitamin drop may be taken with food to decrease stomach upset.
Administration and dosage
- Usual pediatric dose: One ml daily , or as directed by physician.
How Supplied
Each ml contains : Vitamin A 1500 IU ; Vitamin E 5 IU ; Vitamin D 400 IU ;Vitamin B1 0.5 mg ; Vitamin B2 0.6 mg ; Vitamin B6 0.4 mg ; Vitamin B12 1.5 mg ; Vitamin C 35 mg ; Nicotinamide 8 mg .Oral drops contains sodium saccharin as sweetener. Bottles of 15 ml , with dropper.
Storage
Store below 30°C. Protect from light and freezing.
References
- USP DI, 2004
- Up To Date, Vol. 13.1 (2005)
- Martindale, The Complete Drug Reference, 33 rd edition 2002
|