Oracit Package Insert

Prescribing information (package insert) - Oracit

Rx Only

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.

Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].

CMP Pharma, Inc.

Post Office Box 147

Farmville, North Carolina 27828

Revised December 2022

3082 R1222

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: December 2022

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Drug information for Oracit

Rx or OTC

Prescription (Rx)?

This drug is available only with a prescription from a licensed healthcare provider.
Rx

Drug class

Anti-coagulant, Calculi Dissolution Agent

Active ingredients

Citric acid monohydrate 640 mg/5 mL, Trisodium citrate dihydrate 490 mg/5 mL

Dosage form

Solution

Route

Oral

Marketing status

listed in the FDA NDC Directory

Company (applicant)

CMP Pharma, Inc.

FDA approval

UNAPPROVED DRUG OTHERUnapproved drug

Manufacturers

1 labelers list this drug on DailyMed

Packages (NDC)

Package
640 mg/5 mL, 490 mg/5 mL – 500 ml in 1 bottle NDC 46287-014-01
640 mg/5 mL, 490 mg/5 mL – 30 ml in 1 bottle, unit-dose / 10 in 1 carton NDC 46287-014-30
640 mg/5 mL, 490 mg/5 mL – 15 ml in 1 bottle, unit-dose / 10 in 1 carton NDC 46287-014-15

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.