{"abuse":["Abuse"],"adverse_reactions":["ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. Paresthesia and somnolence have been reported with pyridoxine (Vitamin B6). Mild transient diarrhea, polycythemia vera, itching transient exanthema and feeling of swelling of entire body has been associated with cyanocobalamin (Vitamin B12). Oral supplementation with L-arginine at doses up to 15 grams daily are generally well tolerated. The most common adverse reactions of higher doses of arginine — from 15 to 30 grams daily — are nausea, abdominal cramps and diarrhea. Some may experience these symptoms at lower doses."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis, Mutagenesis, Impairment of Fertility"],"clinical_pharmacology":["CLINICAL PHARMACOLOGY"],"contraindications":["CONTRAINDICATIONS Known hypersensitivity to any of the components of an L-arginine, folic acid, cyanocobalamin (Vitamin B12), pyridoxine (Vitamin B6), and/or Bioperine® containing preparation. Supplemental L-arginine is contraindicated in those with the rare genetic disorder argininemia."],"controlled_substance":["Controlled Substance"],"dependence":["Dependence"],"description":["DESCRIPTION Each orange, football-shaped coated tablet contains: Bioperine® (Black Pepper Extract) .......................................... 5 mg Folic Acid ................................................................................ 2 mg L-Arginine HCl .................................................................... 500 mg Cyanocobalamin (Vitamin B12) .......................................... 500 mcg Pyridoxine (Vitamin B6) ........................................................ 50 mg Also contains the following inactive ingredients: croscarmellose sodium, dicalcium phosphate, FD&C yellow No. 6 aluminum lake, hydroxypropyl cellulose, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, stearic acid, titanium dioxide, triacetin. Cardiotek®-RX tablets do not contain sugar or lactose The use of supplemental folic acid may be indicated in patients with increased requirements for this vitamin. Folic acid administration may reduce the risk of neural tube defects in the developing fetus. Folate as 5-methyltetrahydrofolate and Vitamin B12 as methylcobalamin participate in the remethylation reaction of homocysteine to methionine. L-Arginine is a basic amino acid with the molecular formula C6H14N4O2 and with a molecular weight of 174.20. It has 3 pKs: pK1=2.18, pK2=9.09 and pK3=13.2. Therefore, it carries a positive charge at physiological pH. The stereoisomer of L-arginine, D-arginine, does not have any biological activity, as far as we know. L-Arginine is also known as 2-amino-5- guanidinovaleric acid and (S)-2-amino-5-[(aminoiminomethyl) amino] pentanoic acid. Its one-letter abbreviation is R. It is also abbreviated as Arg. The terms L-arginine and arginine are frequently used interchangeably. L-Arginine shows promise as a nutritional adjunct in patients undergoing treatment for cardiovascular disease (including atherosclerosis, hypertension, hyperlipidemia and angina pectoris), some forms of male infertility and some kidney disorders and for wound healing in some circumstances. There is preliminary evidence that it could be helpful as a nutritional adjunct in some men undergoing treatment for erectile dysfunction and in some others being treated for migraine, liver disease and primary ciliary dyskinesia. There is conflicting but mostly negative evidence related to claims that it can improve exercise performance and promote lean muscle mass. Cyanocobalamin (Vitamin B12) appears as dark red crystals or crystalline red powder. The chemical name is 5,6- dimethylbenzimidazolyl cyanocobamide. Its empirical formula is C63H88CoN14O14P. Pyridoxine (Vitamin B6) is a colorless or white crystal or a white crystalline powder. It is stable in air and is slowly affected by sunlight. The chemical name is 2-methly-3 hydroxy-4, 5-bis (hydroxymethyl) pyridine. Pyridoxine’s empirical formula is C8H11NO3. A pyridine derivative, C18H11NO3, occurring especially in cereals, yeast, liver, and fish and serving as a coenzyme in amino acid synthesis."],"dosage_and_administration":["DOSAGE AND ADMINISTRATION Adult dosage 1 to 2 tablets daily, or as prescribed by a physician or practitioner. Not recommended for use in pediatrics."],"drug_abuse_and_dependence":["DRUG ABUSE AND DEPENDENCE Controlled Substance Abuse Dependence"],"drug_and_or_laboratory_test_interactions":["Drug/Laboratory Test Interactions"],"drug_interactions":["Interactions Drug Interactions Pyridoxine (Vitamin B6) supplements should not be given to patients receiving levodopa alone, the action of the latter drug is antagonized by pyridoxine (Vitamin B6). However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness. L-Arginine may counteract the antineuritic effect of cyclosporine, or it may increase the absorption of ibuprofen if taken concomitantly. L-Arginine supplements theoretically may potentiate the effects of organic nitrates if taken concomitantly. L-Arginine supplements taken concomitantly with sildenafil citrate, may potentiate the effects of the drug. HERBS: L-Arginine, if used concomitantly, may enhance the effect of yohimbe. Drug/Laboratory Test Interactions","Drug Interactions Pyridoxine (Vitamin B6) supplements should not be given to patients receiving levodopa alone, the action of the latter drug is antagonized by pyridoxine (Vitamin B6). However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness. L-Arginine may counteract the antineuritic effect of cyclosporine, or it may increase the absorption of ibuprofen if taken concomitantly. L-Arginine supplements theoretically may potentiate the effects of organic nitrates if taken concomitantly. L-Arginine supplements taken concomitantly with sildenafil citrate, may potentiate the effects of the drug. HERBS: L-Arginine, if used concomitantly, may enhance the effect of yohimbe."],"effective_time":"20110310","general_precautions":["General"],"geriatric_use":["Geriatric Use"],"how_supplied":["HOW SUPPLIED Cardiotek®-RX Tablets are supplied as orange football shaped coated tablets debossed with CAR/RX on the top and plain on the bottom. Supplied in containers of 30 tablets, NDC 24839-333-30 and unit dose packs of 1 tablet NDC 24839-333-99. Dispense in tight, light-resistant containers as defined in USP/NF with a child-resistant closure. Store at room temperature 15°C to 30°C (59°F-86°F). WARNING: Keep this and all medicine out of the reach of children."],"id":"1b3003cf-478d-415e-b8ec-28001cf54405","indications_and_usage":["INDICATIONS AND USAGE Cardiotek®-RX is indicated for nutritional support and dietary supplementation of folic acid, L-arginine HCI, cyanocobalamin (Vitamin B12) and pyridoxine (Vitamin B6) in patients with cardiovascular disease, cerebrovascular disease, peripheral vascular disease, arteriosclerotic vascular disease, neurological disorders renal disease and/or patients that have need for an increase in L-arginine derived nitric oxide (NO)."],"information_for_patients":["Information for Patients Cardiotek®-RX is a medical food for use only as directed by a licensed physician or practitioner"],"labor_and_delivery":["Labor and Delivery"],"laboratory_tests":["Laboratory Tests"],"nonteratogenic_effects":["Nonteratogenic Effects"],"nursing_mothers":["Nursing Mothers"],"openfda":{},"overdosage":["OVERDOSAGE"],"package_label_principal_display_panel":["PACKAGE/LABEL PRINCIPAL DISPLAY PANEL CONTAINER LABEL 7102 CL"],"pediatric_use":["Pediatric Use The safety and effectiveness of Cardiotek®-RX in pediatric patients have not been established."],"precautions":["PRECAUTIONS Folic acid in doses above 1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. An oral dose of 100-250 mcg/day will maintain adequate serum Vitamin B12 levels in most patients with pernicious anemia, although some patients may require as much as 1,000 mcg/day. Those with renal or hepatic failure should exercise caution in the use of supplemental L-arginine. Proteins of the herpes simplex virus are rich in L-arginine, and there are a few reports (mainly anecdotal) of those taking supplemental L-arginine who have had recurrences of oral herpes lesions. Although it is unlikely that those with a history of herpes simplex virus infection will have recurrences if they use larginine supplements, they should nevertheless be aware of this possibility. General Information for Patients Cardiotek®-RX is a medical food for use only as directed by a licensed physician or practitioner Laboratory Tests Interactions Drug Interactions Pyridoxine (Vitamin B6) supplements should not be given to patients receiving levodopa alone, the action of the latter drug is antagonized by pyridoxine (Vitamin B6). However, this vitamin may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa. Concurrent use of phenytoin and folic acid may result in decreased phenytoin effectiveness. L-Arginine may counteract the antineuritic effect of cyclosporine, or it may increase the absorption of ibuprofen if taken concomitantly. L-Arginine supplements theoretically may potentiate the effects of organic nitrates if taken concomitantly. L-Arginine supplements taken concomitantly with sildenafil citrate, may potentiate the effects of the drug. HERBS: L-Arginine, if used concomitantly, may enhance the effect of yohimbe. Drug/Laboratory Test Interactions Carcinogenesis, Mutagenesis, Impairment of Fertility Pregnancy This product is not indicated for use during pregnancy or nursing. Because of absence of long-term safety studies, and because of the possibility of growth hormone stimulation, pregnant women and nursing mothers should avoid L-arginine supplementation. Teratogenic Effects Nonteratogenic Effects Labor and Delivery Nursing Mothers Pediatric Use The safety and effectiveness of Cardiotek®-RX in pediatric patients have not been established. Geriatric Use"],"pregnancy":["Pregnancy This product is not indicated for use during pregnancy or nursing. Because of absence of long-term safety studies, and because of the possibility of growth hormone stimulation, pregnant women and nursing mothers should avoid L-arginine supplementation. Teratogenic Effects Nonteratogenic Effects"],"set_id":"1b3003cf-478d-415e-b8ec-28001cf54405","spl_product_data_elements":["Cardio Rx WATER SOLUBLE VITAMINS with ARGINENE AND BIPERINE ARGININE HYDROCHLORIDE ARGININE CYANOCOBALAMIN CO-57 CYANOCOBALAMIN CO-57 PYRIDOXINE HYDROCHLORIDE PYRIDOXINE FOLIC ACID FOLIC ACID BIPERIDEN HYDROCHLORIDE BIPERIDEN DIBASIC CALCIUM PHOSPHATE DIHYDRATE HYDROXYPROPYL CELLULOSE CELLULOSE, MICROCRYSTALLINE CROSCARMELLOSE SODIUM STEARIC ACID MAGNESIUM STEARATE CAR;RX"],"teratogenic_effects":["Teratogenic Effects"],"version":"1","warnings":["WARNINGS"]}