Potassium Citrate And Citric Acid
Potassium Citrate And Citric Acid Monohydrate
Westminster Pharmaceuticals, Llc
Human Prescription Drug
NDC 69367-321Potassium Citrate And Citric Acid also known as Potassium Citrate And Citric Acid Monohydrate is a human prescription drug labeled by 'Westminster Pharmaceuticals, Llc'. National Drug Code (NDC) number for Potassium Citrate And Citric Acid is 69367-321. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Potassium Citrate And Citric Acid drug includes Citric Acid Monohydrate - 334 mg/5mL Potassium Citrate - 1100 mg/5mL . The currest status of Potassium Citrate And Citric Acid drug is Active.
Drug Information:
| Drug NDC: | 69367-321 |
| 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 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 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 - 1100 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: | 16 Jan, 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: | 309318
|
| 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
|
| 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 |
|---|
| 69367-321-16 | 473 mL in 1 BOTTLE (69367-321-16) | 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 and citric acid potassium citrate and citric acid monohydrate potassium citrate anhydrous citric acid citric acid monohydrate anhydrous citric acid water sodium benzoate saccharin sodium sorbitol fd&c red no. 40
Indications and Usage:
Indications and usage potassium citrate and citric acid oral solution usp 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. this product 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. this product alkalinizes the urine without producing a systemic alkalosis in recommended dosage. it is highly palatable, pleasant tasti
Read more...ng and tolerable, even when administered for long periods. potassium citrate does not neutralize the gastric juice or disturb digestion.
Warnings:
Warnings 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 causal 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 discontinued immediatel
Read more...y if abdominal pain, distention, nausea, vomiting, or gastrointestinal bleeding occur. 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. do not exceed recommended dosage. discontinue use if adverse reaction occurs.
Dosage and Administration:
Dosage and administration potassium citrate and citric acid oral solution usp should be taken diluted in water according to directions, followed by additional water, if desired. palatability is enhanced if chilled before taking. proper dilution may help prevent gastrointestinal injury associated with the oral ingestion of concentrated potassium salt preparations. usual adult dose: 3 to 6 teaspoonfuls (15 to 30 ml), diluted with 1 glass of water, after meals and at bedtime, or as directed by a physician. usual pediatric dose: 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 15 ml), diluted with a glassful of water, taken four times 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
Read more...urinary ph, hydrion paper (ph 6.0-8.0) or nitrazine paper (ph 4.5-7.5) are available and easy to use.
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 ingredient.
Adverse Reactions:
Adverse reactions potassium citrate and citric acid oral solution usp 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 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. 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 does not neutralize the gastric juice or disturb digestion. intoxication causes restlessness, weakness, mental confusion, tingling of extremities, and other symptoms associated with a high concentrat
Read more...ion 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.
Overdosage:
Overdosage the administration of oral potassium salts to persons with normal excretory mechanisms for potassium rarely causes serious hyperkalemia. however, if excretory mechanisms are impaired, 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/20 gm dextrose. (3) the use of exchange resins, 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 the plasma potassium concentration can produce digitalis toxicity.
Description:
Description potassium citrate and citric acid oral solution usp is a stable and pleasant-tasting oral systemic alkalizer containing potassium citrate and citric acid in a sugar-free, non alcoholic base. potassium citrate and citric acid oral solution usp contains in each teaspoonful (5 ml): potassium citrate monohydrate 1100 mg citric acid monohydrate 334 mg each ml contains 2 meq potassium ion and is equivalent to 2 meq bicarbonate (hco 3 ). inactive ingredients cherry flavor, fd&c red #40, purified water, sodium benzoate, sodium saccharin, sorbitol solution. actions potassium citrate is absorbed and metabolized to potassium bicarbonate, thus acting as a systemic alkalizer. 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 potassium citrate is excreted in the urine unchanged.
How Supplied:
How supplied potassium citrate and citric acid oral solution usp is a (red colored; cherry flavored) oral solution and is supplied in the following oral dosage form: ndc 69367-321-16 (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 childresistant 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. call your doctor for medical advice about side effects. you may report side effects to westminster pharmaceuticals, llc at 1-844-221-7294.
Package Label Principal Display Panel:
Principal display panel - 473 ml bottle label ndc: 69367-321-16 rx only potassium citrate and citric acid oral solution usp 1100 mg/334 mg per 5 ml a sugar-free systemic alkalizer each teaspoonful (5ml) contains: potassium citrate monohydrate 1100 mg citric acid monohydrate 334 mg each ml contains 2 meq potassium ion, and is equivalent to 2 meq bicarbonate (hco 3 ). shake well before use 16 fl oz (473 ml) westminster pharmaceuticals principal display panel - 473 ml bottle label