CYTRA 3
-
potassium citrate,
sodium citrate and
citric acid monohydrate syrup
Pegasus Laboratories
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DESCRIPTION:
CYTRA-3 Oral Solution is a stable and pleasant-tasting oral systemic alkalizer containing potassium citrate, sodium citrate, and citric acid in a sugar-free, non-alcoholic base.
CYTRA-3 Oral Solution contains in each teaspoonful (5mL) :
POTASSIUM CITRATE
Monohydrate. . . . . 550 mg
SODIUM CITRATE
Dihydrate . . . . . . . 500 mg
CITRIC ACID
Monohydrate . . . . 334 mg
Each mL contains 1 mEq potassium ion and 1 mEq of sodium ion and is equivalent to 2 mEq bicarbonate (HCO3).
Inactive Ingredients:
FD and C Yellow No. 6, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate, and sorbitol solution.
ACTIONS
Potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalizers. The effects of essentially those of chlorides before absorption and those of bicarbonates subsequently. Oxidation is virtually complete so less than 5% of the citrates are excreted in the urine unchanged.
INDICATIONS AND ADVANTAGES
CYTRA-3 Oral Solution is an effective alkalinizing agent useful in those conditions where long-term maintenance of an alkaline urine is desirable, such as in patients with uric acid and cystine calculi of the urinary tract. In addition, it is a valuable adjuvant when administered with uricosuric agents in gout therapy, since urates tend to crystallize out of an acid urine. It is also effective in correcting the acidosis of certain renal tubular disorders. This product is highly concentrated, an 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 a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Potassium citrate and sodium citrate do not neutralize the gastric juice or disturb digestion.
CONTRAINDICATIONS
Severe renal impairment with oliguria or azotemia, untreated Addison's disease or severe myocardial damage. In certain situations, when patients are on a sodium restricted diet, the use of potassium citrate may be preferable; or, when patients are on a potassium restricted diet, the use of sodium citrate my be preferable.
PRECAUTIONS AND WARNINGS:
Should be used with caution by patients with low urinary output or reduced glomerular filtration rates unless under the supervision of a physician. Aluminum-based antacids should be avoided in these patients. Patients should be directed to dilute adequately with water and preferably, to take each dose after meals, to minimize the possibility of gastrointestinal injury associated with oral ingestion of potassium salt preparations and to avoid saline laxative effect. Sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral an pulmonary edema, and toxemia of pregnancy.
Concurrent administration of potassium-containing medication, potassium-sparring diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity. Periodic examination 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-3 Oral Solution 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 alkalinizing agent, caution must be used in certain patients with abnormal renal mechanisms to avoid development of hyperkalemia of alkalosis, especially in the presence of hypocalcemia. Potassium intoxication causes restlessness, weakness, mental confusion, and tingling of extremities.
DOSAGE AND ADMINISTRATION
CYTRA-3 Oral Solution should be taken diluted in water, followed by additional water, if desired. Palatability is enhanced if chilled before taking.
Usual Adult Dosage: 3 to 6 teaspoonfuls (15 to 30 mL), diluted in water four times a day, after meals and before bedtime, or as directed by a physician.
Usual Pediatric Dosage: 1 to 3 teaspoonfuls (5 to 15 mL) diluted in water, four times a day, after meals and at bedtime, or as directed by a physician.
Usual Dosage Range: 2 to 3 teaspoonfuls (10 to 15 mL) diluted with water, taken four times a day, will usually maintain a urinary pH of 6.5 to 7.4. 3 to 4 teaspoonfuls (15 to 20 mL), diluted with water, taken four times a day, will usually maintain a urinary pH of 7.0 to 7.6 throughout most of the 24 hours without unpleasant side effects. To check urine pH, HYDRION paper (pH 6.0-8.0) or NITRAZINE paper (pH 4.5-7.5) are available and easy to use.
OVERDOSAGE
Overdosage with sodium salts may cause diarrhea, nausea and vomiting, hypernoia, and convulsions. Overdosage with potassium salts may cause hyperkalemia and alkalosis, especially in the presence of renal disease.
HOW SUPPLIED
CYTRA-3 Oral Solution (orange colored, raspberry flavored) is supplied in the following oral dosage form: NDC 60258-002-16 (16 fl oz bottles).
STORAGE
Keep tightly closed. Store at controlled room temperature 20°-25°C (68°-77°F). Protect from excessive heat and freezing.
| CYTRA 3
potassium citrate, sodium citrate and citric acid monohydrate syrup |
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| unapproved drug other | 05/05/2006 | 10/17/2009 | |
| Labeler - Pegasus Laboratories (007124357) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pegasus Laboratories | 007124357 | manufacture, analysis | |