clash Cifrazol Dosage Form: capsule Side Effects Dosage Professional Interactions Reviews More Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here. Cifrazol Description Cifrazol is an orally administered prescription Vitamin for the dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D supplementation due to Vitamin D deficiency and other nutritional supplementation. Cifrazol should be administered under the supervision of a licensed medical practitioner. Vitamin D3 (cholecalciferol) is a white, crystalline powder, very soluble in water, with the following structural formula: Each capsule contains: Folic Acid: 1mg, Vitamin D3 (Cholecalciferol): 3775IU Each capsule contains the following inactive ingredients: Gelatin,Water, Soybean Oil, Yellow Wax, Lecithin,Glycerin, FD&C Red #40, FD&C Yellow #5, Titanium Dioxide. Slideshow ADHD and Your Child: Signs and Treatment Options Indications and Usage for Cifrazol Cifrazol is indicated for dietary management of patients with unique nutritional needs requiring increased folate levels, Vitamin D deficiency or are in need of Vitamin D supplementation and other nutritional supplementation. Cifrazol - Clinical Pharmacology The in vivo synthesis of the major biologically active metabolites of vitamin D occurs in two steps. The first hydroxylation of ergocalciferol takes place in the liver (to 25-hydroxyvitamin D) and the second in the kidneys (to 1,25-dihydroxyvitamin D). Vitamin D metabolites promote the active absorption of calcium and phosphorus by the small intestine, thus elevating serum calcium and phosphate levels sufficiently to permit bone mineralization. Vitamin D metabolites also mobilize calcium and phosphate from bone and probably increase the reabsorption of calcium and perhaps also of phosphate by the renal tubules. There is a time lag of 10 to 24 hours between the administration of vitamin D and the initiation of its action in the body due to the necessity of synthesis of the active metabolites in the liver and kidneys. Parathyroid hormone is responsible for the regulation of this metabolism in the kidneys. Contraindications This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Cifrazol is contraindicated in patients with hypercalcemia, malabsorption syndrome, abnormal sensitivity to the toxic effects of vitamin D, and hypervitaminosis D. Warnings and Precautions Tell your doctor if you have: kidney problems, thyroid disease. This medication should be used as directed during pregnancy or while breast-feeding. Consult your doctor about the risks and benefits. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. Adverse Reactions This medication is generally well tolerated. Notify your doctor if you experience: nausea, loss of appetite, vomiting, stomach cramps, dry mouth, increased thirst, increased urination, muscle or bone pain,headache, weakness, weight loss, dizziness. If you notice other effects not listed above, contact your doctor or pharmacist. Cifrazol Dosage and Administration Take one capsule daily or as directed by a physician. How is Cifrazol Supplied Cifrazol capsules are supplied as orange capsules printed with 300 dispensed in HDPE plastic bottles of 30ct. NDC 69336-310-30 STORAGE AND HANDLING SECTION Store at controlled room temperature 15 -30 C (59 F-86 F). Keep in cool dry place. Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088 . KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. OTHER SAFETY INFORMATION Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician s supervision. There are no implied or explicit claims on therapeutic equivalence. PACKAGE LABEL. PRINCIPAL DISPLAY PANEL Rx Only Reserved for Professional Recommendation All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. This product may be administered only under a physician s supervision. There are no implied or explicit claims on therapeutic equivalence. Manufactured for: Sterling Knight Pharmaceuticals, LLC Ripley, MS 38663 Rev. 1114-1 Cifrazol Cifrazol capsule Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:69336-310 Route of Administration Oral DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 3775 [iU] FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg Inactive Ingredients Ingredient Name Strength WATER SOYBEAN OIL YELLOW WAX LECITHIN, SOYBEAN FD&C RED NO. 40 FD&C YELLOW NO. 5 GLYCERIN TITANIUM DIOXIDE GELATIN Product Characteristics Color orange Score no score Shape capsule Size 22mm Flavor Imprint Code 300 Contains Packaging # Item Code Package Description 1 NDC:69336-310-30 30 capsule in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/10/2017 Labeler - Sterling Knight Pharmaceuticals,LLC (079556942) Revised: 01/2017 Sterling Knight Pharmaceuticals,LLC Next Interactions Print this page Add to My Med List More about Cifrazol (cholecalciferol / folic acid) Side Effects Dosage Information Drug Interactions 0 Reviews Add your own review/rating Drug class: vitamins Consumer resources Professional resources Other brands: Ciferex , Zavara , Durachol , Zolate , Revesta FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only N/A CSA Schedule Not a controlled drug Drug Class Vitamins Related Drugs vitamins cholecalciferol , cyanocobalamin , folic acid , ergocalciferol , Vitamin D3 , biotin Cifrazol Rating No Reviews - Be the first! 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