Oracit
Citric Acid and Sodium Citrate · Solution · Oral
Uses
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 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.
Contraindications
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.
Side effects
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.
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.
How supplied
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].
Storage
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F). [See USP Controlled Room Temperature].
Label text from the FDA structured product label by CMP Pharma, Inc. (revised Dec 7, 2023). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Citric Acid Monohydrate in 1 product
- Trisodium Citrate Dihydrate in 1 product
Oracit NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 46287-014 | Citric Acid Monohydrate 640 mg/5mL; Trisodium Citrate Dihydrate 490 mg/5mL Solution | CMP Pharma, Inc. | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Oracit used for?
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.
What are the side effects of Oracit?
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. See the full label for the complete list.
Who makes Oracit?
Oracit is listed by 1 labeler in the FDA NDC directory, including CMP Pharma, Inc..