CYTRA-K
-
potassium citrate and
citric acid monohydrate liquid
Cypress Pharmaceutical Inc
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CYTRA-K Oral Solution A Sugar-Free Systemic AlkalizerDESCRIPTION
CYTRA-K Oral Solution USP is a stable and pleasant tasting oral systemic alkalizer contain potassium citrate and citric acid in a sugar-free, non-alcoholic base.
CYTRA-K Oral Solution USP contains in each teaspoonful (5mL):
POTASSIUM CITRATE
Monohydrate . . . . 1100 mg
CITRIC ACID
Monohydrate . . . . 334 mg
Each mL contains 2 mEq of potassium ion and is equivalent to 2 mEq of bicarbonate (HCO3).
Inactive Ingredients: FD and C Red No. 40, flavoring, polyethylene glycol, propylene glycol, purified water, sodium benzoate and sorbitol solution.
INDICATIONS AND USAGE:CYTRA-K is an effective alkalizing 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, especially when the administration of sodium salts is undesirable or contraindicated. 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 where the administration of potassium citrate may be preferable. This product is highly concentrated, and when administered after meals and before bedtime, allows one to maintain alkaline urinary pH around the clock, usually without the necessity of a 2 A.M. dose. This product alkalinizes without producing a systemic alkalosis in recommended dosage. It is highly palatable, pleasant tasting, and tolerable, even when administered for long periods. Potassium citrate does not neutralize the gastric juice or disturb digestion.
CONTRAINDICATIONS
Severe renal impairment with oliguria or azotemia, untreated Addison's disease, adynamia episodica hereditaria, acute dehydration, heat cramps, anuria, severe myocardial damage, and hyperkalemia from any cause.
WARNINGS
Large doses may cause hyperkalemia and alkalosis, especially in the presence of renal disease. Concurrent administration of potassium-containing medication, potassium-sparing diuretics, angiotensin-converting enzyme (ACE) inhibitors, or cardiac glycosides may lead to toxicity.
PRECAUTIONS
Should be used with caution by patients with low urinary output unless under the supervision of a physician. As with all liquids containing a high concentration of potassium, patients should be directed to diluted adequately with water to minimize the possibility of gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations; and preferably, to take each dose after meals to avoid saline laxative effect.
ADVERSE REACTIONS
CYTRA-K 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 or alkalosis. Potassium intoxication causes restlessness, weakness, mental confusion, tingling of extremities, and other symptoms, associated with a high concentration of potassium in the serum. Periodic determination of serum electrolytes should be carried out in those patients with renal disease in order to avoid these complications. Hyperkalemia may exhibit the following electrocardiograph abnormalities: Disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves, etc.
OVERDOSAGE
The administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely cause serious hyperkalemia. However, is excretory mechanisms are imparied, hyperkalemia can result (See Contraindications and Warnings). Hyperkalemia, when detected, must be treated immediately because lethal levels can be reached in a few hours.
TREATMENT OF HYPERKALEMIA
Should Hyperkalemia occur, treatment measures include the following (1) Elimination of foods or medications containing potassium. (2) The intravenous administration of 300 to 500 mL/hr of dextrose solution (10 to 25%), containing 10 units of insulin/20gm dextrose. (3) The use of exchange resin, hemodialysis, or peritoneal dialysis. In treating Hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, too rapid a lowering of of the plasma potassium concentration can produce digitalis toxicity.
DOSAGE AND ADMINISTRATION
CYTRA-K should be taken diluted in water according to direction followed by additional water, if desired. Palatability is enhanced when chilled.
Usual Adult Dosage: 3 to 6 teaspoonfuls (15 to 30 mL), diluted with 1 glass of water, after meals and at bedtime.
Usual Pediatric Dosage: 1 to 3 teaspoonfuls (5 to 15 mL), diluted with 1/2 glass of water, after meals and at bedtime, or as directed by a physician.
Usual Dosage Range: 2 to 3 teaspoonfuls (10 to 15mlL), diluted with a glassful of water, taken four time a day. Potassium Citrate and Citric Acid Oral Solution USP, diluted with a glassful of water, taken four times a day will usually maintain a urinary pH of 7.0-7.6 throughout most of the 24 hours without unpleasant side effects. To check urinary pH, HYDRION Paper (pH 6.0-8.0) or NITRAZINE Paper (pH 4.5-7.5) are available and easy to use.
HOW SUPPLIED
Potassium Citrate and Citric Acid Oral Solution USP (red colored; berry-citrus flavored) is supplied in the following oral dosage form: NDC 60258-003-16 (16 fl oz bottles).
STORAGE
Keep tightly closed. Store at Controlled Room Temperature, 20°-25°C (68°-77°F). Protect from excessive heating and freezing.
| CYTRA-K
potassium citrate and citric acid liquid |
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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 | 10/31/2009 | |
| Labeler - Cypress Pharmaceutical Inc (790248942) |
| Registrant - Pegasus Laboratories Inc (007124357) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Pegasus Laboratories Inc | 007124357 | manufacture, analysis | |