Oracit
Oracit is an FDA drug label for the active ingredient CITRIC ACID AND SODIUM CITRATE manufactured by CMP Pharma, Inc. administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231207.
- Generic name
- CITRIC ACID AND SODIUM CITRATE
- Manufacturer
- CMP Pharma, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- ORAL
- Dosage form
- N/A
- NDC
- 46287-014
- Application
- N/A
- Label effective
- 20231207
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
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.
Warnings
Not available.
Adverse Reactions
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.