ORACIT- citric acid and sodium citrate solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL), TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K) (ANHYDROUS CITRIC ACID - UNII:XF417D3PSL)

Available from:

CMP Pharma, Inc.

INN (International Name):

CITRIC ACID MONOHYDRATE

Composition:

ANHYDROUS CITRIC ACID 640 mg in 5 mL

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic 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. 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.

Product summary:

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). 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].

Authorization status:

unapproved drug other

Summary of Product characteristics

ORACIT- CITRIC ACID AND SODIUM CITRATE SOLUTION
CMP PHARMA, INC.
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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ORACIT
ORAL CITRATE (SHOHL'S) SOLUTION
CMP PHARMA, INC.
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.
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ADVERSE REACTIONS
Citrate solution is generally well tolerated when given in recommended
doses when the
patient has normal r