Garnak Pharmaceuticals Urgently Require ASM and MR for Guwahati, Shillong, Aizwal, a

VITONAK-L SYRUP

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VITAMIN A

Vitamin A- Retinol (vitamin A) is a fat-soluble substance stored in body organs, principally the liver. Periodic high dose supplementation is intended to protect against vitamin A deficiency which is associated with ocular defects particularly xerophthalmia (including night blindness which may progress to severe eye lesions and blindness), and an increased susceptibility to infections, particularly measles and diarrhoea. 

 Functions: Growth & development, maintenance of epithelial tissue Deficiency: Night blindness, dry eyes, susceptibility to infections, follicular hyperkeratosis.

Contraindications

Hypersensitivity IV use Hypervitaminosis A Malabasorption syndrome (oral therapy) Pregnancy (dose >RDA) 

Cautions

Use caution if dose >25,000 units/day (monitor closely) Evaluate additional vitamin deficiencies if diagnosis of vitamin deficiency occurs (single vitamin A deficiency rare) Caution in renal impairment (toxicity reported) Monitor prolonged administration over 25,000 units/day; take into account vitamin intake from other dietary and supplement sources Efficacy of large systemic doses of 100,000 to 300,000 units/day vitamin A for the treatment of acne not established 

Pregnancy & Lactation

Pregnancy Category: A (oral); C (doses exceeding RDA); X (>6,000 units/day administered parenterally) Lactation: Distributed into milk; safe at RDA levels

Toxicity: Hypervitaminosis A

Acute: Nausea, fatigue, dizziness, dry skin, cerebral edema, increased ICP, skin loss, liver failure Chronic: Osteoporosis, hair loss, high cholesterol, coma, swelling of the optic eye, rash, mouth sores, liver failure Teratogenicity: fetal toxicity, birth defects (>10,000 units/day)   

Pharmacology

Mechanism of Action

Vitamin A supplementation plays a role in embryonic development, visual adaptation to darkness, immune function, and maintenance of epithelial cells 

Pharmacokinetics

Serum concentration: 300-700 ng/mL (adults); 200-500 ng/mL (infants) Peak plasma time: 4-5 hr (oil solution); 304 hr (water-miscible) Protein Bound: Retinol binding protein Distribution: Mainly stored in liver as retinyl palmitate Metabolism: hepatic glucuronidation, decarboxylation Metabolites: retinoic acid, retinal Excretion: Urine and feces (via bil)


Interactions-

1. acitretin 2. alitretinoin 3. alitretinoin 4. beta carotene 5. beta carotene 6. bexarotene 7. bexarotene 8. busulfan 9. busulfan 10. capecitabine 11. capecitabine 12. carboplatin 13. carboplatin 14. carmustine 15. carmustine 16. chitosan 17. chitosan 18. chlorambucil 19. chlorambucil 20. cholestyramine 21. cholestyramine 22. cisplatin 23. cisplatin 24. cladribine 25. cladribine 26. colestipol 27. colestipol 28. cytarabine 29. cytarabine 30. dacarbazine 31. dacarbazine 32. decitabine 33. decitabine 34. dichlorphenamide 35. dichlorphenamide 36. docetaxel 37. docetaxel 38. etretinate 39. etretinate 40. floxuridine 41. floxuridine 42. fludarabine 43. fludarabine 44. fluorouracil 45. fluorouracil 46. gemcitabine 47. gemcitabine 48. ifosfamide 49. ifosfamide 50. irinotecan liposomal 51. irinotecan liposomal 52. irinotecan 53. irinotecan 54. isotretinoin 55. isotretinoin 56. lomustine 57. lomustine 58. mechlorethamine 59. mechlorethamine 60. melphalan 61. melphalan 62. mercaptopurine 63. mercaptopurine 64. mineral oil 65. mineral oil 66. minocycline 67. minocycline 68. mipomersen 69. mipomersen 70. nelarabine 71. nelarabine 72. neomycin po 73. neomycin po 74. orlistat 75. orlistat 76. oxaliplatin 77. oxaliplatin 78. paclitaxel protein bound 79. paclitaxel protein bound 80. paclitaxel 81. paclitaxel 82. pentostatin 83. pentostatin 84. pralatrexate 85. pralatrexate 86. streptozocin 87. streptozocin 88. thioguanine 89. thioguanine 90. thiotepa 91. thiotepa 92. topotecan 93. topotecan 94. treosulfan 95. treosulfan 96. vinblastine 97. vinblastine 98. vincristine liposomal 99. vincristine liposomal 100. vincristine 101. vincristine 102. vinorelbine 103. vinorelbine 

Adverse Effects

Frequency Not Defined

Anaphylaxsis & death after IV use Facial dermatitis Stratum corneum fragility Conjunctivities Sticky skin Granuloma-like lesions in acne Dry mucus Paranochia Corneal opacities Palmoplanar peeling Cheilitis Alopecia.


VITAMIN C

VITAMIN C-(ASCORBIC ACID) is used to prevent or treat low levels of vitamin C in people who do not get enough of the vitamin from their diets. Most people who eat a normal diet do not need extra ascorbic acid. Low levels of vitamin C can result in a condition called scurvy. Scurvy may cause symptoms such as rash, muscle weakness, joint pain, tiredness, or tooth loss. Vitamin C plays an important role in the body. It is needed to maintain the health of skin, cartilage, teeth, bone, and blood vessels. It is also used to protect your body's cells from damage. It is known as an antioxidant. 

Function: Required for collagen biosythesis Deficiency: Scurvy; fatigue, depression, easy bruising & bleeding, weakened cartilage, coiled hairs, difficulty wound healing, thickened skin, abnormal bone growth in infants  

Contraindications

Hypersensitivity 

Cautions

Renal impairment, G6PD deficiency (high doses) Use of parenteral preparation in nursing women Patients with history of renal calculi should avoid taking excessive doses for extended periods of time Solutions exposed to air rapidly oxidized Patients with diabetes mellitus should not take excessive doses for extended periods of times Destroyed by sunlight 

Pregnancy & Lactation

Pregnancy Category: A (dose within RDA); C (dose exceeding RDA recommendation) Lactation: Enters breast milk/compatible 

  

Pharmacology

Mechanism of Action

Necessary for collagen formation and tissue repair; plays a role in oxidation/reduction reactions as well as other metabolic pathways including synthesis of catecholamines, carnitine, and steroids; also plays a role in conversion of folic acid to folinic acid 

Pharmacokinetics

Distribution: Large Metabolism: Liver Absorption: Rapidly absorbed Excretion: Urine 

Administration

When oral administration is not feasible or when malabsorption is suspected IM preferred to IV 

IV Preparation

Dilute with large volume of compatible fluid to minimize adverse reactions Compatible w/ most common diluents (dextrose solns, NS, LR, Ringer's, ½NS, dextrose-saline, dextrose-LR etc) 

IV Administration

Avoid rapid infusion 


Toxicity: Potential for kidney stones, withdrawal from high doses can lead to scurvy, even with "normal" intake 

INTERACTIONS 

1. aluminum hydroxide 2. aspirin rectal 3. aspirin/citric acid/sodium bicarbonate 4. aspirin 5. balsalazide 6. bazedoxifene/conjugated estrogens 7. butabarbital 8. butalbital 9. choline magnesium trisalicylate 10. conjugated estrogens, vaginal 11. conjugated estrogens 12. copper 13. deferasirox 14. deferoxamine 15. diflunisal 16. lornoxicam 17. metolazone 18. oxytetracycline 19. phenobarbital 20. rose hips 21. warfarin 22. wheat germ extract 23. willow bark  

Adverse Effects

Frequency Not Defined

Flushing Flank pain Faintness, headache Diarrhea, dyspepsia, nausea, vomiting Hyperoxaluria (large doses)  

VITAMIN D

 The term vitamin D covers a range of compounds including ergocalciferol (vitamin D2) and cholecalciferol (vitamin D3). These two compounds are equipotent and either can be used to prevent and treat rickets. Simple deficiency of vitamin D occurs in those who have an inadequate dietary intake or who fail to produce enough cholecalciferol (vitamin D3) in their skin from the precursor 7-dehydrocholesterol in response to ultraviolet light.  

Nutritional Supplementation Recommended daily allowance (RDA) 19-70 years: 600 IU (15 mcg)/day Pregnant or lactating women: 600 IU (15 mcg)/day Osteoporosis Prophylaxis and treatment >50 years: 800-1000 IU (20-25 mcg) PO once daily with calcium supplements Hypoparathyroidism 50,000-200,000 IU (0.625-5 mg) PO once daily with calcium supplements Vitamin D-Resistant Rickets 12,000-500,000 IU (0.3-12.5 mg) PO once daily Familial Hypophosphatemia 10,000-60,000 IU (0.25-1.5 mg) PO once daily with phosphate supplements   

Contraindications

Hypercalcemia Hypervitaminosis D Ergocalciferol (oral): Gastrointestinal (GI), liver, or biliary disease associated with malabsorption of vitamin D analogues Documented hypersensitivity with drugs that could have allergenic crossreactivity with ergocalceferol 

Cautions

Ergocalciferol: Use with caution in renal impairment (strong caution), heart disease, kidney stones, arteriosclerosis Obtain serum calcium twice weekly during titration Discontinue if patient becomes hypercalcemic Presence of tartrazine in some products may cause allergic reactions Vitamin D toxicity may last ≥2 months after therapy is discontinued Restrict intake in infants with idiopathic hypercalcemia Concurrent use of cardiac glycosides Adequate clinical response to vitamin D therapy is dependent on adequate dietary calcium Maintain normal serum phosphorous concentrations in patients treated for hyperphosphatemia to prevent metastatic calcification When treating hypoparathyroidism, concomitant treatment with intravenous calcium, parathyroid hormone, and/or dihydrotachysterol may also be required Adults with a body mass index (BMI) greater than 30 kg/m² are at high risk for vitamin D deficiency due to storage of vitamin D in adipose tissue; doses higher than recommended daily allowance may be required, but must be carefully monitored to avoid toxicity Metabolism of vitamin D may be altered in patients with chronic kidney disease In renal impairment, supplementation with ergocalciferol may be necessary; monitor closely In patients with rickets, the range between therapeutic and toxic doses is narrow in vitamin D–resistant patients; adjust dose based on clinical response to avoid toxicity 

Pregnancy & Lactation

Pregnancy category: C (ergocalciferol) Lactation: Drug is distributed into breast milk; use with caution 

Pharmacology

Mechanism of Action

Stimulates calcium and phosphate absorption from small intestine; stimulates phosphate resorption at renal tubule; stimulates secretion of calcium into blood from bone 

Absorption

Peak effect: 1 month with daily dosing 

Metabolism

Metabolized in liver 

Elimination

Excretion: Urine   

Adverse Effects

Frequency Not Defined

Arrhythmias Confusion Constipation Dry mouth Headache Hypercalcemia Lethargy Metallic taste Muscle or bone pain Nausea Sluggishness Vomiting   Interactions-   1. aluminum hydroxide 2. calcium acetate 3. calcium carbonate 4. calcium chloride 5. calcium citrate 6. calcium gluconate 7. chlorothiazide 8. chlorthalidone 9. cholestyramine 10. colesevelam 11. colestipol 12. digoxin 13. fosphenytoin 14. hydrochlorothiazide 15. indapamide 16. magnesium citrate 17. magnesium hydroxide 18. methyclothiazide 19. metolazone 20. mineral oil 21. orlistat 22. phenobarbital 23. phenytoin 24. primidone 25. sucralfate  

VITAMIN E

VITAMIN E is an antioxidant, which is a nutrient that helps fight damage to the cells in the body.  

Functions: Lipid antioxidant, protects membrane phospholipids, intracellular antioxidant, inhibits platelet aggregation Deficiency: Rare; occurs in premature infants & those who cannot absorb fat; sterility; muscle weakness, visceral impairment; infants: anemia, nerve, eye & balance problems that may be permanent Toxicity: Extremely rare   RDA 15 mg PO qDay; not to exceed 1000 mg/day Pregnant Females · <18 years: 15 mg PO qDay; not to exceed 800 mg/day · >18 years: 15 mg PO qDay; not to exceed 1000 mg/day Lactating Females · <18 years: 19 mg PO qDay; not to exceed 800 mg/day · >18 years: 19 mg/day PO qDay; not to exceed 1000 mg/day Vitamin E Deficiency 60-75 units PO qDay Postherpetic Neuralgia (Off-label) 400 units PO twice or four times daily Administration Swallow capsules whole, do not crush or chew 

Pregnancy & Lactation

Pregnancy Category: A (RDA levels) Lactation: Excreted in breast milk; safe 

Warnings

Contraindications

Hypersensitivity to vitamin E or formulation components 

Cautions

Vitamin E, at RDA levels, does not increase bleeding time or affect warfarin except at megadoses (~10x RDA or higher) - adjustment of warfarin may be necessary for such doses Discontinue high dose Vitamin E supplementation 1 month before surgery, may resume after recovery Use with caution in Vitamin K deficiency, bleeding propensity or lesions (bleeding peptic ulcers, hemophilia etc) Vitamin E increases efficacy & decreases toxicity of antineoplastic drugs 

Pharmacology

Mechanism of Action

Plays a role in protecting red blood cells against hemolysis; has protective effects against free radicals on polyunsaturated fatty acids found in cell membranes; plays a role in preventing oxidation of vitamin A and C 

Pharmacokinetics

Absorption: Reduced in patients with history of malabsorption; water preparations better absorbed than oil preparations Distribution: All body tissues especially adipose tissues where it is stored Metabolism: Liver Excretion: Feces   

Adverse Effects

Frequency Not Defined

Fatigue Headache Flatulence Diarrhea Blurred vision Necrotizing enterocolitis (infants) Increased serum creatinine Increased risk of hemorrhagic stroke Recent evidence suggests that Vitamin E may suppress action of other antioxidants Very modest but statistically significant increase in all-cause mortality with supplemental intake of vitamin E =400 IU/day   


INTERACTIONS- 1. alfalfa 2. antithrombin alfa 3. antithrombin iii 4. argatroban 5. bemiparin 6. betrixaban 7. bivalirudin 8. busulfan 9. capecitabine 10. carbonyl iron 11. carboplatin 12. carmustine 13. chitosan 14. chlorambucil 15. cisplatin 16. cladribine 17. cytarabine 18. dacarbazine 19. dalteparin 20. decitabine 21. docetaxel 22. enoxaparin 23. ethanol 24. ferrous fumarate 25. ferrous gluconate 26. ferrous sulfate 27. floxuridine 28. fludarabine 29. fluorouracil 30. fondaparinux 31. gemcitabine 32. heparin 33. ifosfamide 34. irinotecan liposomal 35. irinotecan 36. iron dextran complex 37. iron sucrose 38. lepirudin 39. lomustine 40. mechlorethamine 41. melphalan 42. mercaptopurine 43. mineral oil 44. nelarabine 45. orlistat 46. oxaliplatin 47. paclitaxel protein bound 48. paclitaxel 49. pentostatin 50. phenindione 51. polysaccharide iron 52. pralatrexate 53. protamine 54. rose hips 55. streptozocin 56. thioguanine 57. thiotepa 58. tinzaparin 59. topotecan 60. treosulfan 61. vinblastine 62. vincristine liposomal 63. vincristine 64. vinorelbine 65. vortioxetine 66. warfarin 

VITAMIN K

Vitamin K, Mephyton, AquaMephyton plays a key role in helping the blood clot, preventing excessive bleeding. Unlike many other vitamins, vitamin K is not typically used as a dietary supplement. Vitamin K is actually a group of compounds. The most important of these compounds appears to be vitamin K1 and vitamin K2. Vitamin K1 is obtained from leafy greens and some other vegetables. Vitamin K2 is a group of compounds largely obtained from meats, cheeses, and eggs, and synthesized by bacteria. Low levels of vitamin K can raise the risk of uncontrolled bleeding. While vitamin K deficiencies are rare in adults, they are very common in newborn infants. A single injection of vitamin K for newborns is standard. Vitamin K is also used to counteract an overdose of the blood thinner Coumadin. 

Nutritional Supplementation 

RDA 0-6 months: 2 mcg/day 6-12 months: 2.5 mcg/day 1-3 years: 30 mcg/day 4-8 years: 55 mcg/day 9-13 years: 60 mcg/day 14-18 years: 75 mcg/day Hemorrhagic Disease of the Newborn Prophylaxis: 0.5-1 mg IM within 1 hr of birth Treatment: 1 mg/dose/day SC; my require higher doses if mother has been receiving oral anticoagulants   

Warnings

Black Box Warnings

Severe reactions, including fatalities, have occurred during and immediately after IV administration, even when precautions have been taken with proper dilution and avoidance of rapid infusion Severe reactions also reported after IM administration; typically, these severe reactions involve hypersensitivity or anaphylaxis and include shock and cardiac or respiratory arrest IV/IM reactions may occur with first dose (no prior exposure to phytonadione) Restrict use of IV/IM routes to situations where SC administration is not feasible and serious risk involved is considered justified 

Pharmacology

Mechanism of Action

Promotes hepatic synthesis of clotting factors II, VII, IX, X (exact mechanism is unknown) 

Pharmacokinetics

Onset: 6-10 hr (PO); 1-2 hr (IV) Peak effect: 24-48 hr (PO); 12-14 hr (IV) 

Metabolism

Metabolized in liver 

Elimination

Excretion: Urine, feces 

Contraindications

Hypersensitivity 

Cautions

Rapid IV administration may cause potentially fatal anaphylaxis Protect from light; agent is rapidly degraded Avoid IM route if patients is bleeding or in 3rd trimester of pregnancy Administer phtonadione to quickly lower INR into safe range in patients receiving vitamin K antagonists Other forms of vitamin K (eg, menadione) are not effective in these settings; only vitamin K1 (ie, phytonadione) should be used Time of onset depends on rate of synthesis of clotting factors Potential for overcorrection Inefective in hereditary hypoprothrombinemia Longer treatment durations (up to months) and much higher doses required in patients exposed to long-acting anticoagulant rodenticide Hemolysis, hyperbilirubinemia, and jaundice reported in newborns treated with larger than recommended doses; use caution 

Pregnancy & Lactation

Pregnancy category: C Lactation: Excreted in breast milk; use caution 

Administration

IV Administration

Dilute in preservative-free NS, D5W, or D5NS and infuse slowly; infusion rate not to exceed 1 mg/min IV route should be used only if administration by another route is not feasible 

Storage

Protect injection emulsion from light at all times May be autoclaved     

Adverse Effects

Frequency Not Defined

Anaphylaxis with too-rapid IV administration (has resulted in death) Dyspnea Cyanosis Erythematous skin eruptions Pruritus Scleroderma-like lesions Flushing Hyperbilirubinemia (in premature neonates) Hypotension Injection site reactions Taste alterations     Interactions-   1. aspirin rectal 2. aspirin/citric acid/sodium bicarbonate 3. chlorhexidine oral 4. cholestyramine 5. choline magnesium trisalicylate 6. ciprofloxacin 7. colesevelam 8. colestipol 9. erythromycin base 10. erythromycin ethylsuccinate 11. erythromycin lactobionate 12. erythromycin stearate 13. fennel 14. feverfew 15. flurbiprofen 16. forskolin 17. garlic 18. ginger 19. ginkgo biloba 20. horse chestnut seed 21. ibuprofen 22. indomethacin 23. ketoprofen 24. ketorolac intranasal 25. ketorolac 26. mefenamic acid 27. meloxicam 28. mineral oil 29. mistletoe 30. nabumetone 31. naproxen 32. nettle 33. orlistat 34. oxaprozin 35. panax ginseng 36. pau d'arco 37. phytoestrogens 38. piroxicam 39. reishi 40. salicylates (non-asa) 41. salsalate 42. siberian ginseng 43. sulfasalazine 44. sulindac 45. tolmetin 46. warfarin  

VITAMIN B COMPLEX

VITAMIN B1(Thiamine)

Vitamin B1 is used orally for deficiency due to to inadequate dietary intake. Severe deficiency may result in ‘beri-beri’. Chronic dry ‘beri-beri’ is characterized by peripheral neuropathy, muscle wasting and weakness, and paralysis; wet ‘beriberi’ is characterized by cardiac failure and oedema. Wernicke-Korsakoff syndrome (demyelination of the CNS) may develop in severe deficiency.  

Function: cofactor in glucose metabolism Deficiency: (common in alcoholics, Asians, dialysis patients, those on high carbohydrate diet) Beriberi; causes nerve damage, dementia, heart failure; sometimes irreversible 

Reduced/Destroyed by

Heat-labile thiaminases contained in milled rice, raw shellfish & freshwater fishes Heat-stable anti-thiamine factor in coffee/tea Sulfite-containing foods Alcohol High temp 

Toxicity Symptoms

Toxicity: rare; intake of >400 mg/d; lethargy, balance problems, intestinal problems   RDA Males: 1.2 mg/day Females: 1.1 mg/day Pregnancy/Lactation: 1.4 mg/day Beriberi IM: 5-30 mg three times daily (if critically ill); then 5-30 mg three times daily for 1 month Duration dependent on persistence of symptoms Wernicke Encephalopathy 100 mg IV; then 50-100 mg/day IM or IV until consuming regular balanced diet Thiamin Deficiency 1 tablet or capsule/day Need for thiamin increases when carbohydrate content of diet is high   

Warnings

Contraindications

Hypersensitivity 

Cautions

In pregnancy (doses >RDA) Acute thiamine deficiency reported with dextrose administration; use caution when thiamine status uncertain Hypersensitivity reactions reported following repeated parenteral doses Parenteral products may contain aluminum; use caution in patients with impaired renal function Evaluate for additional vitamin deficiencies if patient diagnosed with thiamin deficiency; single vitamin deficiencies are rare 

Pregnancy & Lactation

Pregnancy Category: A (injectable); C (if >RDA) Lactation: Safe   

Pharmacology

Mechanism of Action

Forms thiamine pyrophosphate by combining with adenosine triphosphate; essential coenzyme in carbohydrate metabolism 

Pharmacokinetics

Distribution: Distributes mainly to heart, brain, kidney, and liver Excretion: Urine Absorption: Adequate (PO); rapid and complete (IM)   

Administration

When oral administration is not feasible When malabsorption is suspected In patients with Wernicke's encephalopathy or high-output heart failure secondary to beriberi IV administration preferred for high-output heart failure Compatible with most common diluents (dextrose solutions; LR, Ringer's; dextrose-saline solutions; dextrose/LR; NS; ½NS; fat emulsion 10%; Na-lactate 1M/6   

Adverse Effects

Frequency Not Defined

Warmth Anaphylaxis Cyanosis Diaphoresis Restlessness Angioneurotic edema Pruritus Urticaria Pulmonary edema Weakness Tightness of the throat Nausea     Interactions:    1. abobotulinumtoxina 2. amikacin 3. atracurium 4. azithromycin 5. aztreonam 6. bumetanide 7. caffeine 8. cefadroxil 9. cefamandole 10. cefpirome 11. ceftibuten 12. ceftizoxime 13. cephalexin 14. chlorhexidine oral 15. ciprofloxacin 16. cisatracurium 17. clarithromycin 18. clindamycin 19. dapsone 20. demeclocycline 21. doripenem 22. doxycycline 23. ertapenem 24. erythromycin base 25. erythromycin ethylsuccinate 26. erythromycin lactobionate 27. erythromycin stearate 28. ethacrynic acid 29. ethanol 30. fleroxacin 31. flucloxacillin 32. fosfomycin 33. furosemide 34. gemifloxacin 35. gentamicin 36. imipenem/cilastatin 37. kanamycin 38. levofloxacin 39. linezolid 40. lymecycline 41. meropenem 42. metronidazole 43. minocycline 44. moxifloxacin 45. nafcillin 46. neomycin po 47. netilmicin 48. nitrofurantoin 49. norfloxacin 50. ofloxacin 51. onabotulinumtoxina 52. oxytetracycline 53. pancuronium 54. paromomycin 55. pivmecillinam 56. quinupristin/dalfopristin 57. rapacuronium 58. rocuronium 59. roxithromycin 60. streptomycin 61. succinylcholine 62. sulfadiazine 63. sulfamethoxazole 64. sulfisoxazole 65. teicoplanin 66. telithromycin 67. temocillin 68. tetracycline 69. ticarcillin 70. tigecycline 71. tobramycin 72. torsemide 73. trimethoprim 74. tubocurarine 75. vancomycin 76. vecuronium  


VITAMIN B2(Riboflavin)-

 

Vitamin B2 is used to prevent or treat low levels of vitamin B2 in people who do not get enough of the vitamin from their diet. Most people who eat a normal diet do not need extra vitamin B2. However, some conditions (such as stomach/intestinal problems, prolonged infection, liver disease, alcoholism, cancer) can cause low levels of vitamin B2. Vitamin B2 plays an important role in the body. It is needed to keep your skin, eyes, nerves, and red blood cells healthy. 

Function: participates in physiologic processes Deficiency: (very rare): swelling of lining of mouth and nose, mouth and lip sores, inflammation of tongue, dermatitis, anemia Reduced by: sunlight, alcohol Toxicity: none known   RDA Males: 1.3 mg/day Females: 1.1 mg/day Pregnant: 1.4 mg/day Nursing: 1.6 mg/day Riboflavin Deficiency Supplementation is indicated for adults with riboflavin deficiency syndromes 6-30 mg/day PO in divided doses   

Warnings

Contraindications

Hypersensitivity 

Cautions

Pregnancy (doses >RDA) Discuss use of drug and side effects with patients as it relates to treatment 

Pregnancy & Lactation

Pregnancy Category: A (within RDA); C (>RDA) Lactation: Safe 

Pharmacology

Mechanism of Action

Component of flavoprotein enzymes, that are necessaryfor normal tissue respiration; plays a role in activation of pyridoxine and conversion of tryptophan to niacin 

Pharmacokinetics

Absorption: Via GI tract; increases with food Metabolism: Liver 


VITAMIN B3(Niacin)


Nutritional Supplementation Recommended daily allowance (RDA) Males: ≥19 years: 16 mg/day Females: ≥19 years: 14 mg/day Pregnant women: 18 mg/day Breastfeeding: 17 mg/day Dietary supplement (OTC) 50 mg PO q12hr or 100 mg PO qDay; many formulations exist Hyperlipidemia Immediate-release: 250 mg PO once daily; dose or frequency adjusted every 4-7 days on basis of effect and tolerance to first-level therapeutic dose of 1.5-2 g PO divided q6-8hr, then adjusted every 2-4 weeks; not to exceed 6 g/day Extended-release: 500 mg/day PO at bedtime initially; dose adjusted every 4 weeks on basis of effect and tolerance to therapeutic dose of 1-2 g once daily; not to exceed 1-2 g/day   Indications · Reduce elevated TC, LDL-C, Apo B and TG levels, and to increase HDL-C in patients with primary hyperlipidemia and mixed dyslipidemia · Indicated to reduce the risk of recurrent nonfatal myocardial infarction in patients with history of MI and hyperlipidemia · Indicated in combination with a bile acid binding resin to slow progression or promote regression of atherosclerotic disease in patients with history of CAD and hyperlipidemia, and also to reduce elevated TC and LDL-C levels in adults with primary hyperlipidemia · Indicated as adjunctive therapy for treatment of adult patients with severe hypertriglyceridemia who present a risk of pancreatitis and who do not respond adequately to a determined dietary effort to control them · Extended release niacin did not reduce cardiovascular morbidity or mortality among patients treated with simvastatin in a large rantomized trial 

Warnings

Contraindications

Hypersensitivity Hepatic disease, active peptic ulcer, severe hypotension, arterial bleeding Persistent, unexplained elevation of serum aminotransferase 

Cautions

Flushing or pruritus may occur Hepatotoxicity reported Use with caution in patients with history of liver disease, gout or gouty diathesis, diabetes mellitus, gallbladder disease, cardiovascular disease, or renal or hepatic impairment Use with caution if patients are taking anticoagulants or HMG-CoA reductase inhibitors or if symptoms of myopathy occur (monitor creatine phosphokinase) Immediate release and extended release dosage forms are not interchangeable 

Pregnancy & Lactation

Pregnancy category: A; C (for doses exceeding RDA) Lactation: Unknown if excreted in milk (consider risk vs benefit)   

Pharmacology

Mechanism of Action

Component of two coenzymes necessary for lipid metabolism, tissue respiration, glycogenolysis, inhibition of very low-density lipoprotein (VLDL) synthesis May increaase chylomicron triglyceride removal from plasma 

Absorption

Rapidly absorbed (60-76%) Peak plasma time: Immediate release, 30-60 min; extended release, 4-5 hr 

Metabolism

Metabolized in liver 

Pharmacokinetics

Half-life: 20-45 min Excretion: Urine (60-88% as unchanged drug)   

Adverse Effects

Frequency Not Defined

Reversible increase in serum aminotransferase Flushing (lower incidence with extended-release products) Pruritus, rash Diarrhea Headache Arrhythmias Hepatic necrosis, hepatotoxicity (higher incidence with extended-release products) Postural hypotension Rhabdomyolysis Abdominal pain Dyspepsia Nausea Vomiting 

Postmarketing Reports

Burning sensation of skin Depression Dermatomyositis Peripheral nerve palsy Progression of cataracts   


INTERACTIONS- 1. atorvastatin 2. carbamazepine 3. cefamandole 4. cefpirome 5. cholestyramine 6. colestipol 7. demeclocycline 8. doxycycline 9. erythromycin base 10. erythromycin ethylsuccinate 11. erythromycin lactobionate 12. erythromycin stearate 13. flucloxacillin 14. fluvastatin 15. insulin degludec/insulin aspart 16. insulin degludec 17. insulin inhaled 18. isoniazid 19. ivacaftor 20. lovastatin 21. lymecycline 22. mecamylamine 23. metformin 24. minocycline 25. mipomersen 26. netilmicin 27. nicotine inhaled 28. nicotine intranasal 29. oxytetracycline 30. pitavastatin 31. pivmecillinam 32. pravastatin 33. rosuvastatin 34. roxithromycin 35. simvastatin 36. sulfisoxazole 37. teicoplanin 38. temocillin 39. tetracycline


VITAMIN B5-