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CMP Pharma, Inc.
Post Office Box 147
Farmville, North Carolina 27828
Revised October 2016
Copyright © CMP Pharma, Inc. 2016
Oracit Solution
FDA Label NDC 46287-014
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cmp Pharma, Inc. for the product Oracit (NDC 46287-014). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, description, action, indications, contraindications, precautions, adverse reactions, dosage and administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Description
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.
Action
Oral citrate solution is used as a systemic and urinary alkalinizer. Less than 5% of the citrate is excreted in the urine unchanged, since citrate oxidation is to a great extent complete.
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.
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.
Precautions
The citrate solution should be used with caution in patients with impaired renal function to avoid hypernatremia or alkalosis in the presence of hypocalcemia. Periodic determinations of serum electrolyte levels (especially bicarbonate levels) should be done in patients with renal disease to avoid cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. The solution should be diluted with water and preferably taken after meals to avoid saline laxative effects.
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.
Dosage And 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.
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.
Storage And Handling
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].
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CMP
PHARMA
Farmville, NC 27828
Principal Display Panel (500 mL Bottle Label)
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