so one can Sodium Citrate and Citric Acid Oral Solution Generic Name: sodium citrate and citric acid monohydrate Dosage Form: oral solution Overview Side Effects Professional Interactions Reviews More Support Group Q & A Pricing & Coupons 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. A Sugar-Free Systemic Alkalizer Sodium Citrate and Citric Acid Oral Solution Description Sodium Citrate and Citric Acid Oral Solution USP is a stable and pleasant-tasting systemic alkalizer containing sodium citrate and citric acid in a sugar-free base. It is a nonparticulate neutralizing buffer. Sodium Citrate and Citric Acid Oral Solution USP contains in each teaspoonful (5 mL): SODIUM CITRATE Dihydrate 500 mg (0.34 Molar) CITRIC ACID Monohydrate 334 mg (0.32 Molar) Each mL contains 1 mEq sodium ion and is equivalent to 1 mEq bicarbonate (HCO3). INACTIVE INGREDIENTS: Flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution. Slideshow Understanding Insulin: What You Need To Know Sodium Citrate and Citric Acid Oral Solution - Clinical Pharmacology Sodium citrate is absorbed and metabolized to sodium bicarbonate, thus acting as a systemic alkalizer. The effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so that less than 5% of sodium citrate is excreted in the urine unchanged. Indications and Usage for Sodium Citrate and Citric Acid Oral Solution Sodium Citrate and Citric Acid Oral Solution USP is an effective alkalinizing agent. It is useful in those conditions where long-term maintenance of an alkaline urine is desirable, and is of value in the alleviation of chronic metabolic acidosis, such as results from chronic renal insufficiency or the syndrome of renal tubular acidosis, especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively. Sodium Citrate and Citric Acid Oral Solution USP is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes the urine without producing a systemic alkalosis in the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Contraindications Patients on sodium-restricted diets or with severe renal impairment. Precautions Sodium Citrate and Citric Acid Oral Solution USP should be used with caution by patients with low urinary output unless under the supervision of a physician. This product should not be administered concurrently with aluminum-based antacids. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function, peripheral and pulmonary edema, and toxemia of pregnancy. Periodic examinations and determinations of serum electrolytes, particularly serum bicarbonate level, should be carried out in those patients with renal disease in order to avoid these complications. Adverse Reactions Sodium Citrate and Citric Acid Oral Solution USP is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence of hypocalcemia. Overdosage Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions. Sodium Citrate and Citric Acid Oral Solution Dosage and Administration Sodium Citrate and Citric Acid Oral Solution USP should be taken diluted in water, followed by additional water, if desired. SHAKE WELL BEFORE USING. For Systemic Alkalization Usual Adult Dose 2 to 6 teaspoonfuls (10 to 30 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. Usual Pediatric Dose 1 to 3 teaspoonfuls (5 to 15 mL), diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician. As a neutralizing buffer 3 teaspoonfuls (15 mL), diluted with 15 mL water, taken as a single dose, or as directed by a physician. How is Sodium Citrate and Citric Acid Oral Solution Supplied Sodium Citrate and Citric Acid Oral Solution USP (colorless, grape flavor) is supplied in the following oral dosage forms: NDC 0121-0595-16: 16 fl oz (473 mL) bottle NDC 0121-0595-15: 15 mL unit dose cup NDC 0121-0595-00: Case contains 100 unit dose cups of 15 mL (0121-0595-15) packaged in 10 trays of 10 unit dose cups each. NDC 0121-1190-30: 30 mL unit dose cup NDC 0121-1190-00: Case contains 100 unit dose cups of 30 mL (0121-1190-30) packaged in 10 trays of 10 unit dose cups each. STORAGE: Keep tightly closed. Store at controlled room temperature, 20 -25 C (68 -77 F). Protect from freezing. Rx ONLY Manufactured By: Pharmaceutical Associates, Inc. Greenville, SC 29605 www.paipharma.com R06/16 PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label NDC 0121-0595-16 NSN 6505-01-097-4766 Sodium Citrate and Citric Acid Oral Solution USP 500 mg/334 mg per 5 mL A SUGAR-FREE SYSTEMIC ALKALIZER Each teaspoonful (5 mL) contains: Sodium Citrate Dihydrate..........500 mg Citric Acid Monohydrate............334 mg Each mL provides 1 mEq Sodium Ion and is equivalent to 1 mEq Bicarbonate (HCO3). Rx ONLY 16 fl oz (473 mL) pai Pharmaceutical Associates, Inc. Greenville, SC 29605 DOSAGE AND ADMINISTRATION: Sodium Citrate and Citric Acid Oral Solution USP should be taken diluted in water followed by additional water, if desired. SHAKE WELL BEFORE USING. Usual Adult Dose : 2 to 6 teaspoonfuls (10 to 30 mL) diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. Usual Pediatric Dose : 1 to 3 teaspoonfuls (5 to 15 mL) diluted in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician. STORAGE: Keep tightly closed. Store at controlled room temperature, 20 -25 C (68 -77 F). Protect from freezing. Dispense in a tight, light-resistant container with a child-resistant closure. INDICATIONS AND USAGE : Sodium Citrate and Citric Acid Oral Solution USP is a stable systemic alkalizer in a palatable sugar-free base. It is useful in the management of metabolic acidosis especially when the administration of potassium salts is undesirable or contraindicated. SEE ACCOMPANYING LITERATURE. PRINCIPAL DISPLAY PANEL - 30 mL Unit Dose Cup Label Delivers 30 mL NDC 0121-1190-30 S ODIUM C ITRATE and C ITRIC A CID O RAL S OLUTION USP (Sugar Free) 3 g/2 g per 30 mL SHAKE WELL-DILUTE AS DIRECTED FOR INSTITUTIONAL USE ONLY Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F05953002 PRINCIPAL DISPLAY PANEL - 15 mL Unit Dose Cup Label Delivers 15 mL NDC 0121-0595-15 S ODIUM C ITRATE and C ITRIC A CID O RAL S OLUTION USP (sugar Free) 1.5 g/1 g per 15 mL SHAKE WELL-DILUTE AS DIRECTED FOR INSTITUTIONAL USE ONLY Rx ONLY PHARMACEUTICAL ASSOCIATES, INC. GREENVILLE, SC 29605 SEE INSERT F05951501 SODIUM CITRATE AND CITRIC ACID sodium citrate and citric acid monohydrate solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0121-0595 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CITRATE (ANHYDROUS CITRIC ACID) SODIUM CITRATE 500 mg in 5 mL ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 334 mg in 5 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0121-0595-16 473 mL in 1 BOTTLE 2 NDC:0121-0595-00 10 TRAY in 1 CASE 2 10 CUP, UNIT-DOSE in 1 TRAY 2 NDC:0121-0595-15 15 mL in 1 CUP, UNIT-DOSE 3 NDC:0121-0595-30 10 TRAY in 1 CASE 3 10 CUP, UNIT-DOSE in 1 TRAY 3 30 mL in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/1969 SODIUM CITRATE AND CITRIC ACID sodium citrate and citric acid monohydrate solution Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0121-1190 Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CITRATE (ANHYDROUS CITRIC ACID) SODIUM CITRATE 500 mg in 5 mL ANHYDROUS CITRIC ACID (ANHYDROUS CITRIC ACID) ANHYDROUS CITRIC ACID 334 mg in 5 mL Inactive Ingredients Ingredient Name Strength POLYETHYLENE GLYCOLS PROPYLENE GLYCOL WATER SODIUM BENZOATE SORBITOL Product Characteristics Color Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description 1 NDC:0121-1190-00 10 TRAY in 1 CASE 1 10 CUP, UNIT-DOSE in 1 TRAY 1 NDC:0121-1190-30 30 mL in 1 CUP, UNIT-DOSE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/1969 Labeler - Pharmaceutical Associates, Inc. (044940096) Establishment Name Address ID/FEI Operations Pharmaceutical Associates, Inc. 097630693 manufacture(0121-0595, 0121-1190) Revised: 03/2017 Pharmaceutical Associates, Inc. Next Interactions Print this page Add to My Med List More about citric acid/sodium citrate Side Effects Drug Interactions Support Group Pricing & Coupons En Español 1 Review Add your own review/rating Drug class: minerals and electrolytes Consumer resources Citric acid and sodium citrate Sodium Citrate and Citric Acid Professional resources Sodium Citrate and Citric Acid (Wolters Kluwer) Other brands: Oracit Related treatment guides Urinary Tract Stones Urinary Alkalinization} 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 Pregnancy Category Not classified N/A CSA Schedule Not a controlled drug Drug Class Minerals and electrolytes Related Drugs minerals and electrolytes potassium chloride , calcium carbonate , Caltrate , magnesium oxide , Klor-Con , sodium chloride Urinary Alkalinization sodium bicarbonate , Bicitra , citric acid / potassium citrate , Cytra-2 , Cytra-K , Neut , Virtrate-2 , Cytra-3 , Tricitrates , Polycitra-K , Polycitra , More... Urinary Tract Stones magnesium oxide , Bicitra , citric acid / potassium citrate , Cytra-2 , Cytra-K , Virtrate-2 , Mag-200 , Polycitra-K , More... Citric acid / sodium citrate Rating 1 User Review 1 User Review Not Rated - Be the first!} } occasionally
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