Potassium Citrate, Sodium Citrate, And Citric Acid
Potassium Citrate, Sodium Citrate, And Citric Acid Monohydrate
Westminster Pharmaceuticals, Llc
Human Prescription Drug
NDC 69367-322Potassium Citrate, Sodium Citrate, And Citric Acid also known as Potassium Citrate, Sodium Citrate, And Citric Acid Monohydrate is a human prescription drug labeled by 'Westminster Pharmaceuticals, Llc'. National Drug Code (NDC) number for Potassium Citrate, Sodium Citrate, And Citric Acid is 69367-322. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Potassium Citrate, Sodium Citrate, And Citric Acid drug includes Citric Acid Monohydrate - 334 mg/5mL Potassium Citrate - 550 mg/5mL Sodium Citrate, Unspecified Form - 500 mg/5mL . The currest status of Potassium Citrate, Sodium Citrate, And Citric Acid drug is Active.
Drug Information:
| Drug NDC: | 69367-322 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Potassium Citrate, Sodium Citrate, And Citric Acid |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Potassium Citrate, Sodium Citrate, And Citric Acid Monohydrate |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Westminster Pharmaceuticals, Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | CITRIC ACID MONOHYDRATE - 334 mg/5mL
POTASSIUM CITRATE - 550 mg/5mL
SODIUM CITRATE, UNSPECIFIED FORM - 500 mg/5mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | ORAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 21 Jul, 2021 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Westminster Pharmaceuticals, LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 309317
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 2968PHW8QP
EE90ONI6FF
1Q73Q2JULR
|
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
| Pharmacologic Class: | Acidifying Activity [MoA]
Anti-coagulant [EPC]
Calcium Chelating Activity [MoA]
Calculi Dissolution Agent [EPC]
Decreased Coagulation Factor Activity [PE]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69367-322-16 | 473 mL in 1 BOTTLE (69367-322-16) | 21 Jul, 2021 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Potassium citrate, sodium citrate, and citric acid potassium citrate, sodium citrate, and citric acid monohydrate potassium citrate anhydrous citric acid sodium citrate, unspecified form anhydrous citric acid citric acid monohydrate anhydrous citric acid water sodium benzoate saccharin sodium sorbitol fd&c yellow no. 6
Indications and Usage:
Indications and usage potassium citrate, sodium citrate and citric acid 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 and when administered after meals and before bedtime, allows one to maintain an alkaline urine 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 dosages. 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 dist
Read more...urb digestion.
Warnings:
Warnings and precautions there have been several reports, published and unpublished, concerning nonspecific small-bowel lesions consisting of stenosis, with or without ulceration, associated with the administration of enteric-coated thiazides with potassium salts. these lesions may occur with enteric-coated potassium tablets alone or when they are used with nonenteric-coated thiazides, or certain other oral diuretics. these small-bowel lesions have caused obstruction, hemorrhage, and perforation. surgery was frequently required and deaths have occurred. based on a large survey of physicians and hospitals, both united states and foreign, the incidence of these lesions is low, and a casual relationship in man has not been definitely established. available information tends to implicate enteric-coated potassium salts, although lesions of this type also occur spontaneously. therefore, coated potassium-containing formulations should be administered only when indicated, and should be discont
Read more...inued immediately if abdominal pain, distention, nausea, vomiting, or gastrointestinal bleeding occur. do not exceed recommended dosage. discontinue use if adverse reactions occur. 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 perparations and to avoid saline laxative effect. sodium salts should be used cautiously in patients with cardiac failure, hypertension, peripheral and pulmonary edema, and toxemia of pregnancy. concurrent administration of potassium-containing medication, potassium-sparing 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.
Dosage and Administration:
Dosage and administration potassium citrate, sodium citrate and citric acid oral solution should be administered by diluting with 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 with water, for times a day, after meals and at bedtime, or as directed by a physician. usual pediatric dosage 1 to 3 teaspoonfuls (5 to 15 ml), diluted with 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 6.5-7.4. 3 to 4 teaspoonfuls (15 to 20 ml), diluted with water taken four times a day, will usually maintain a urinary ph of 7.0-7.6 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. shake well before using
Read more... Contraindications:
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 may be preferable.
Adverse Reactions:
Adverse reactions potassium citrate, sodium citrate and citric acid 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 or alkalosis, especially in the presence of hypocalcemia. potassium intoxication causes listlessness, weakness, mental confusion, and tingling of extremities.
Overdosage:
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.
Description:
Description potassium citrate, sodium citrate and citric acid 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. potassium citrate, sodium citrate, and citric acid oral solution contains in each teaspoonful (5 ml): 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 sodium ion and is equivalent to 2 meq bicarbonate (hco 3 ). inactive ingredients fd&c yellow #6, purified water, raspberry flavor, sodium benzoate, sodium saccharin, sorbital solution. potassium citrate monohydrate has the chemical name: 1,2,3-propanetricarboxylic acid, 2-hydroxy-, tripotassium salt, monohydrate. its chemical structure is as follows c 6 h 5 k 3 o 7 + h 2 o m.w. 324.41 sodium citrate dihydrate has the chemical name: 1,2,3-propanetricarboxylic acid, 2-hydroxy-, trisodium salt, dihydrate. its chemical structure is as follows. c 6 h 5 na 3 o 7 + 2h 2 o m.w. 294.10 citric acid monohydrate has the chemical name: 1,2,3-propanetricarboxylic acid, 2-hydroxy-,monohydrate. its chemical structure is as follows. c 6 h 8 o 7 + h 2 o m.w. 210.14 chemical structure chemical structure chemical structure
Clinical Pharmacology:
Clinical pharmacology potassium citrate and sodium citrate are absorbed and metabolized to potassium bicarbonate and sodium bicarbonate, thus acting as systemic alkalizers. the effects are essentially those of chlorides before absorption and those of bicarbonates subsequently. oxidation is virtually complete so that less than 5% of the citrates are excreted in the urine unchanged.
How Supplied:
How supplied potassium citrate, sodium citrate and citric acid oral solution (orange colored, raspberry flavored) is supplied in the following form: ndc 69367-322-16 (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. tamper evident by foil seal under cap. do not use if foil seal is broken or missing. dispense in a tight, light-resistant container as defined in the usp/nf with a child-resistant closure. keep this and all medications out of the reach of children. in case of accidental overdosage, seek professional assistance or contact a poison control center immediately.
Package Label Principal Display Panel:
Principal display panel - 473 ml bottle label ndc: 69367-322-16 rx only potassium citrate, sodium citrate and citric acid oral solution 550 mg/500 mg/ 334mg per 5 ml a sugar-free systemic alkalizer each teaspoonful (5 ml) contains: 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 sodium ion, and is equivalent to 2 meq bicarbonate (hco 3 ). may not meet usp monograph. 16 fl oz (473 ml) westminster pharmaceuticals principal display panel - 473 ml bottle label