CYTRA-2
-
trisodium citrate dihydrate and
citric acid monohydrate liquid
Pegasus Laboratories
----------
CYTRA-2 Oral Solution A Sugar-Free Systemic Alkalizer
INDICATIONS AND USAGE:Sodium Citrate and Citric Acid Oral Solution USP is a stable systemic alkalizer in a palatable sugar-free base. It is useful in the management of metabolic acidosis especially when the administration of potassium salts is undesirable or contraindicated. This product is also useful for buffering and neutralizing gastric hydrochloric acid quickly and effectively.
CYTRA-2 is concentrated, and when administered after meals and before bedtime, allows one to maintain an alkaline urinary pH around the clock, usually without the necessity of a 2 A.M dose. This product alkalinizes the urine without producing systemic alkalosis in the recommended dosage. This product is highly palatable, pleasant tasting, and tolerable, even when administered for long periods.
DOSAGE AND ADMINISTRATION:
Sodium Citrate and Citric Acid Oral Solution USP should be taken diluted in water followed by additional water, if desired. SHAKE WELL BEFORE USING.
Usual Adult Dosage:2 to 6 teaspoonfuls (10 to 30 mL) DILUTED in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician.
Usual Pediatric Dosage:1 to 3 teaspoonfuls (5 to 15 mL) DILUTED in 1 to 3 ounces of water, after meals and at bedtime, or as directed by a physician. For children under two years of age, use is based on consultation with a physician.
As a neutralizing buffer: 3 teaspoonfuls (15 mL) diluted with 15 mL water, taken as a single dose, or as directed by a physician.
STORAGE:Keep tightly closed. Store at controlled room temperature, 20° - 25°C (68°-77°F). Protect from freezing.
Dispense in a tight, light-resistant container with a child-resistant closure.
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
CONTRAINDICATIONS: Patients with sodium restricted diets or with severe renal failure.
PRECAUTIONS:CYTRA-2 should be used with caution by patients with low urinary output unless under the supervision of a physician. This product should not be administered concurrently with aluminum based antacids. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, impaired renal function peripheral and pulmonary edema and toxemia of pregnancy. Periodic examinations and determinations of serum electrolytes, particularly serum bicarbonate level should be carried out in those patients with renal disease in order to avoid these complications.
ADVERSE REACTIONS:CYTRA-2 is generally well tolerated, without any unpleasant side effects, when given in recommended doses to patients with normal renal function and urinary output. However, as with any alkalizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of alkalosis, especially in the presence hypoglycemia.
OVERDOSAGE:Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia and convulsions.
HOW SUPPLIED
CYTRA-2 (colorless, grape flavor) is supplied in the following oral dosage form: NDC 60258-001-16 (16 fl oz bottles).
| CYTRA-2
sodiun citrate and citric acid liquid |
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
|
||||||||||||||||||
| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 05/05/2006 | 12/30/2010 | |
| Labeler - Pegasus Laboratories (007124357) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pegasus Laboratories Inc | 007124357 | manufacture, analysis | |