Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED ORACIT ® is supplied in 500 mL bottles (NDC 46287-014-01), 30 mL unit dose bottles, 10 bottles per carton (NDC 46287-014-30), and 15 mL unit dose bottles, 10 bottles per carton (NDC 46287-014-15). PHARMACIST Dispense in well-closed containers. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].; PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label NDC 46287-014-01 500 mL Oracit ® ORAL CITRATE (SHOHL'S) SOLUTION CONTAINS: Hydrous Sodium Citrate USP 490 mg/5 mL; Citric Acid USP 640 mg/5 mL; Methylparaben NF; Propylparaben NF; Alcohol USP 0.25%. USUAL DOSAGE: See package insert. Dispense in a well-closed container. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. GTIN: 00346287014010 Rx Only cmp PHARMA Farmville, NC 27828 3050 R1017 PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
- HOW SUPPLIED ORACIT ® is supplied in 500 mL bottles (NDC 46287-014-01), 30 mL unit dose bottles, 10 bottles per carton (NDC 46287-014-30), and 15 mL unit dose bottles, 10 bottles per carton (NDC 46287-014-15). PHARMACIST Dispense in well-closed containers. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
- PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label NDC 46287-014-01 500 mL Oracit ® ORAL CITRATE (SHOHL'S) SOLUTION CONTAINS: Hydrous Sodium Citrate USP 490 mg/5 mL; Citric Acid USP 640 mg/5 mL; Methylparaben NF; Propylparaben NF; Alcohol USP 0.25%. USUAL DOSAGE: See package insert. Dispense in a well-closed container. Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature]. GTIN: 00346287014010 Rx Only cmp PHARMA Farmville, NC 27828 3050 R1017 PRINCIPAL DISPLAY PANEL - 500 mL Bottle Label
Overview
The product is a clear, colorless solution containing Citric Acid USP 640 mg/5 mL, and Hydrous Sodium Citrate USP 490 mg/5 mL. It also contains Methylparaben NF and Propylparaben NF as preservatives. These concentrations yield 1 mEq of sodium, equivalent to 1 mEq of bicarbonate per mL of solution.
Indications & Usage
INDICATIONS ORACIT ® is indicated for the treatment of metabolic acidosis. This solution is also useful in conditions where long term maintenance of alkaline urine is needed (e.g. uric acid and cystine calculi of the urinary tract). ORACIT ® is also effective in treatment for acidosis of certain renal tubular disorders.
Dosage & Administration
The dose of ORACIT ® is 10 to 30 mL, diluted with water, after meals and at bedtime. The dose should be titrated to achieve desired effects.
Warnings & Precautions
No warnings available yet.
Contraindications
ORACIT ® is contraindicated in patients with severe renal impairment, oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramp, anuria, severe myocardial damage, and hyperkalemia.
Adverse Reactions
Citrate solution is generally well tolerated when given in recommended doses when the patient has normal renal functions. To report suspected adverse reactions, contact CMP Pharma, Inc., toll free at 1-844-321-1443 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Storage & Handling
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
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