Data from FDA - Curated by EPG Health - Last updated 30 August 2017

Indication(s)

INDICATIONS AND USAGE CYTRA-K CRYSTALS 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, 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. CYTRA-K CRYSTALS is highly 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. CYTRA-K CRYSTALS 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 does not neutralize the gastric juice or disturb digestion.

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Advisory information

contraindications
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. Known hypersensitivity to any ingredients in this product.
Adverse reactions
ADVERSE REACTIONS CYTRA-K CRYSTALS 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 listlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentration of potassium in the serum. Periodic determinations of serum electrolytes should be carried out in those patients with renal disease in order to avoid these complications. Hyperkalemia may exhibit the following electrocardiographic abnormalities: Disappearance of the P wave, widening and slurring of QRS complex, changes of the S-T segment, tall peaked T waves, etc.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION CYTRA-K CRYSTALS should be taken mixed in cool water or juice according to directions, followed by additional water or juice, if desired. Proper dilution may help prevent gastroin-testinal injury associated with the oral ingestion of concentrated potassium salt preparations. Usual Adult Dose CYTRA-K CRYSTALS - Contents of 1 packet reconstituted with at least 6 ounces of cool water or juice, after meals and at bedtime, or as directed by physician. Usual Pediatric Dose CYTRA-K CRYSTALS is not recommended for pediatric use. Usual Dosage Range Contents of 1 packet CYTRA-K CRYSTALS, reconstituted as directed and taken four times a day, will usually maintain a urinary pH of 6.5-7.4. 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.

More information

Category Value
Agency product number EE90ONI6FF
Orphan designation No
Product NDC 60258-005
Date Last Revised 20-09-2016
Type HUMAN PRESCRIPTION DRUG
RXCUI 1652638
List of excipients INACTIVE INGREDIENTS Sodium saccharin, fruit punch flavor, and FD&C Red Dye #3. Potassium Citrate Monohydrate has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-,tripotassium salt, monohydrate. Its chemical structure is as follows: C6H5K3O7 ∙ H2O M.W. 324.41 Citric Acid Monohydrate has the chemical name: 1,2,3-Propanetricarboxylic acid, 2-hydroxy-, monohydrate. Its chemical structure is as follows: C6H8O7 ∙ H2O M.W. 210.14 Chemical Structure Chemical Structure
Storage and handling STORAGE Store at controlled room temperature, 15°-30°C (59°-86°F). Protect from excessive heat or freezing.
Marketing authorisation holder Cypress Pharmaceutical, Inc.