Effer-k Unflavored

Potassium Bicarbonate


Nomax Inc.
Human Prescription Drug
NDC 51801-007
Effer-k Unflavored also known as Potassium Bicarbonate is a human prescription drug labeled by 'Nomax Inc.'. National Drug Code (NDC) number for Effer-k Unflavored is 51801-007. This drug is available in dosage form of Tablet, Effervescent. The names of the active, medicinal ingredients in Effer-k Unflavored drug includes Potassium Bicarbonate - 977.5 mg/1 . The currest status of Effer-k Unflavored drug is Active.

Drug Information:

Drug NDC: 51801-007
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: Effer-k Unflavored
Also known as the trade name. It is the name of the product chosen by the labeler.
Proprietary Name Base: Effer-k
The base of the Brand/Proprietary name excluding its suffix.
Proprietary Name Suffix: Unflavored
A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
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 Bicarbonate
Also known as the generic name, this is usually the active ingredient(s) of the product.
Labeler Name: Nomax Inc.
Name of Company corresponding to the labeler code segment of the ProductNDC.
Dosage Form: Tablet, Effervescent
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:POTASSIUM BICARBONATE - 977.5 mg/1
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: 30 Jan, 2013
This is the date that the labeler indicates was the start of its marketing of the drug product.
Marketing End Date: 25 Dec, 2025
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:Nomax Inc.
Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC.
RxCUI:1088772
1088774
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:HM5Z15LEBN
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.

Packaging Information:

Package NDCDescriptionMarketing Start DateMarketing End DateSample Available
51801-007-3030 POUCH in 1 CARTON (51801-007-30) / 1 TABLET, EFFERVESCENT in 1 POUCH30 Jan, 2013N/ANo
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:

Effer-k unflavored potassium bicarbonate potassium bicarbonate bicarbonate ion citric acid monohydrate mineral oil talc cellulose, microcrystalline ek;25 effer-k orange potassium bicarbonate potassium bicarbonate bicarbonate ion citric acid monohydrate mineral oil talc cellulose, microcrystalline ek;25 effer-k lemon citrus potassium bicarbonate potassium bicarbonate bicarbonate ion citric acid monohydrate mineral oil talc cellulose, microcrystalline ek;25 lemon citrus effer-k cherry berry potassium bicarbonate potassium bicarbonate bicarbonate ion citric acid monohydrate mineral oil talc cellulose, microcrystalline ek;25 cherry berry

Drug Interactions:

Drug interactions the simultaneous administration of potassium supplements and a potassium-sparing diuretic can produce severe hyperkalemia (see contraindications ). potassium supplements should be used cautiously in patients who are using salt substitutes, because most of the latter contain substantial amounts of potassium. such concomitant use could result in hyperkalemia. moreover, the following drugs may produce unfavorable interactions when used concomitantly with potassium supplements: angiotension-converting enzyme (ace) inhibitors, nonsteroid anti-inflammatory drugs (nsaids), beta-adrenergic blocking drugs, heparin, low-salt foods, other potassium containing medications, digitalis glycosides and others.

Indications and Usage:

Indications and usage for therapeutic use in patients with hypokalemia with or without metabolic alkalosis; in chronic digitalis intoxication; and in patients with hypokalemic familial periodic paralysis. for prevention of potassium depletion when the dietary intake of potassium ion is inadequate in the following conditions; patients receiving digitalis and diuretics for congestive heart failure; hepatic cirrhosis with ascites; states of aldosterone excess with normal renal function; potassiumlosing nephropathy, and certain diarrheal states; long-term corticosteroid therapy. the use of potassium salts in patients receiving diuretics for uncomplicated essential hypertension or receiving certain antibiotics is often unnecessary when such patients have a normal dietary pattern. serum potassium should be checked periodically, however, and, if hypokalemia occurs, dietary supplementation with potassium-containing foods may be adequate to control milder cases. in more severe cases supplementa
tion with potassium salts may be indicated.

Warnings:

Warnings in patients with hyperkalemia and impaired mechanisms for excreting potassium the administration of potassium salts can produce hyperkalemia and cardiac arrest. this occurs most commonly in patients given potassium by the intravenous route but may also occur in patients given potassium orally. potentially fatal hyperkalemia can develop rapidly and be asymptomatic. the use of potassium salts in patients with chronic renal disease, or any other condition which impairs potassium excretion, requires particularly careful monitoring of the serum potassium concentration and appropriate dosage adjustment. note: there is no conclusive evidence that potassium supplements lower blood pressure in hypertensive patients.

Dosage and Administration:

Dosage and administration dosage and administration: adults- one effer-k ® flavored tablet, (orange, lemon citrus or cherry berry) each containing 25 meq (978 mg) of potassium, completely dissolved in 4 ounces of cold or ice water, 1 to 4 times daily, depending on the requirement of the patient. for effer-k ® unflavored tablets (each containing 25 meq (978 mg) of potassium) we recommend completely dissolving one tablet in 12 to 16 ounces of cold juice of the patient's choice. note: it is suggested that any effervescent potassium tablets be taken with meals and sipped slowly over a 5 to 10 minute period.

Contraindications:

Contraindications potassium supplements are contraindicated in patients with hyperkalemia since a further increase in serum potassium concentration in such patients can produce cardiac arrest. conditions predisposing to hyperkalemia include: chronic renal failure, acute metabolic acidosis, uncontrolled diabetes mellitus, esophageal compression or delayed gastric emptying or intestinal obstruction/stricture or peptic ulcer. potassium supplements should be used with caution and only where medically indicated in patients with familial periodic paralysis, myotonia congenita or severe/complete heart block. important: potassium supplements are contraindicated in patients receiving potassium-sparing diuretics (e.g. spironolactone, triamterene) since such use may produce severe hyperkalemia.

Adverse Reactions:

Adverse reactions one of the most severe adverse effects is hyperkalemia (see contraindications , warnings and overdosage ). the most common adverse reactions to oral potassium salts are nausea, vomiting, abdominal discomfort, and diarrhea. these symptoms are due to irritation of the gastrointestinal tract and are best managed by diluting the preparation further, taking the dose with meals, or reducing the dose. skin rash has been reported rarely.

Drug Interactions:

Drug interactions the simultaneous administration of potassium supplements and a potassium-sparing diuretic can produce severe hyperkalemia (see contraindications ). potassium supplements should be used cautiously in patients who are using salt substitutes, because most of the latter contain substantial amounts of potassium. such concomitant use could result in hyperkalemia. moreover, the following drugs may produce unfavorable interactions when used concomitantly with potassium supplements: angiotension-converting enzyme (ace) inhibitors, nonsteroid anti-inflammatory drugs (nsaids), beta-adrenergic blocking drugs, heparin, low-salt foods, other potassium containing medications, digitalis glycosides and others.

Use in Pregnancy:

Usage in pregnancy pregnancy category c animal reproduction studies have not been conducted with effer-k ® 25meq tablets (potassium bicarbonate effervescent tablets for oral solution, usp). it is also not known whether these products can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. effer-k ® 25meq tablets (potassium bicarbonate effervescent tablets for oral solution, usp) should be given to a pregnant woman only if clearly needed.

Pediatric Use:

Usage in children safety and effectiveness in children have not been established.

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 or if potassium is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see contraindications and warnings ). it is important to recognize that initally hyperkalemia is usually asymptomatic and may be manifested only by an increased serum potassium concentration and characteristic electrocardiographic changes (peaking of t-waves, loss of p-wave, depression of s-t segment, and prolongation of the qt interval). late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest. treatment measures for hyperkalemia include the elimination of foods and medications containing potassium and potassium-sparing diuretics, as well as ace inhibitors, beta blocking agents, nsaids, heparin, and cyclosporine. in cases of life-threatening hyperkalemia, treatment measures may include: (1) intravenous administration of 300 to 500 ml/hr of 10% dextrose solution containing 10-20 units of insulin per 1,000 ml; (2) correction of acidosis, if present, with intravenous sodium bicarbonate; (3) use of exchange resins, hemodialysis, or peritoneal dialysis; (4) administration of a calcium salt to antagonize the cardiotoxic effects in patients whose electrocardiograms show appropriate characteristics, and who are not receiving digitalis glycosides; and (5) maintenance of a high urine output in suitable patients. in treating hyperkalemia, it should be recalled that in patients who have been stabilized on digitalis, rapid lowering of serum potassium can produce digitalis toxicity.

Description:

Description description: effer-k® 25 meq tablets (potassium bicarbonate effervescent tablets for oral solution, usp) are intended for the preparation of an oral solution of potassium. each tablet contains 2.5 g. potassium bicarbonate and 2.1 g. citric acid which in solution provides 25 meq (978 mg) of elemental potassium as potassium citrate. tablets also contain: sd flavors, microcrystalline cellulose, mineral oil, saccharine and talc. the orange tablets contain fd&c yellow no. 6 and fd&c yellow no, 6 lake. the lemon citrus tablets contain d&c yellow no. 10 and yellow no. 10 lake. the cherry berry tablets contain fd&c red no. 40 and fd&c red no. 40 lake. the unflavored tablets do not contain any natural or synthetic dyes, flavors or sweeteners. tablets are one inch in diameter round, flat face on both sides with large bevels. "ek-25" is imprinted on one side of the tablets. each tablet is foil-pouched with the product description on one side of the pouch and the lot number, expiration and barcode on the other.

Clinical Pharmacology:

Clinical pharmacology potassium ion is the principal intracellular cation of most body tissues, whereas sodium ion is relatively low in concentration. in extracellular fluid the opposite exists, sodium ion being principal and potassium ion being low. the situation is maintained by an active membrane-bound enzyme (na + k + atpase). this potassium ion concentration gradient is essential to conduct nerve impulses in such specialized tissues as the brain, heart, and skeletal muscle; and in addition, to maintain normal renal function, acid-base balance, and various cellular metabolic functions. elimination values are 90% renal and 10% fecal. potassium depletion may occur if the rate of potassium ion loss by renal excretion and/or loss from the gastrointestinal tract exceeds the rate of potassium ion intake. such depletion usually develops slowly as a consequence of prolonged therapy with oral diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, severe diarrhea, or inad
equate replacement of potassium in patients on prolonged parenteral nutrition. potassium depletion due to these causes is usually accompanied by a concomitant deficiency of chloride and is manifested by hypokalemia and metabolic alkalosis. potassium depletion may produce weakness, fatigue, mood or mental changes, nausea, vomiting, disturbances of cardiac rhythm (primarily ectopic beats), prominent u-waves in the electrocardiogram, and in advanced cases flaccid paralysis and/or impaired ability to concentrate urine.

Carcinogenesis and Mutagenesis and Impairment of Fertility:

Carcinogenesis, mutagenesis, impairment of fertility potassium is an essential constituent of the human diet. there are no data available on long-term potential for carcinogenicity, mutagenicity, or impairment of fertility in animals or in human beings.

How Supplied:

How supplied effer-k ® 25 meq tablets (potassium bicarbonate effervescent tablets for oral solution, usp). each tablet in solution provides 25 meq of elemental potassium as potassium citrate. store below 40˚c (104˚f) preferably between 15˚ and 30˚c (59˚ and 86˚f), in original hermetic packaging. tablets are one inch diameter round, flat face on both sides with large bevels. "ek 25" is imprinted one side of the tablets. each tablet is pouched with the product description on one side of the pouch and the lot number, expiration date, and barcode on the other. ndc 51801-001-30 orange-flavored, package of 30 tablets. ndc 51801-005-30 lemon citrus-flavored, package of 30 tablets. ndc 51801-001-40 orange-flavored, package of 100 tablets. ndc 51801-006-30 cherry berry-flavored, package of 30 tablets. ndc 51801-007-30 unflavored, package of 30 tablets. nomax, inc. st. louis, mo 63123 - made in usa msn 015-031 rev. 08/10

Information for Patients:

Information for patients to minimize the possibility of gastrointestinal irritation associated with the oral ingestion of concentrated potassium salt preparations, patients should be directed to dissolve each dose completely in the stated amount of water. each dose should be taken immediately after a meal or with food. patients should avoid low-salt foods and salt substitutes, unless approved by physician. the patient should be cautioned to comply strictly with the regimen, particularly when taking diuretics or digitalis, to visit the physician regularly and to report at once any unusual symptoms (e.g. blackish stools, a sign of gastrointestinal bleeding). as with any other medicine, the patient should be counseled on this background information and advised to report to the physician any changes in routine (e.g. starting a fitness program). proper storage and handling of the product is important. tablets should not be removed from foil pouch until shortly before use.

Package Label Principal Display Panel:

Principal display panel - 30 tablet pouch carton - unflavored ndc 51801-007-30 30 tablets effer-k ® 25 meq tablets potassium bicarbonate effervescent tablets for oral solution, usp each tablet contains 25meq (978 mg) of potassium unflavored (dissolve in 12-16 ounces of juice) rx only nomax inc principal display panel - 30 tablet pouch carton - unflavored

Principal display panel - 30 tablet pouch carton - orange ndc 51801-001-30 30 tablets effer-k ® 25 meq tablets potassium bicarbonate effervescent tablets for oral solution, usp each tablet contains 25meq (978 mg) of potassium orange flavored rx only nomax inc principal display panel - 30 tablet pouch carton - orange

Principal display panel - 30 tablet pouch carton - lemon ndc 51801-005-30 30 tablets effer-k ® 25 meq tablets potassium bicarbonate effervescent tablets for oral solution, usp each tablet contains 25meq (978 mg) of potassium lemon citrus flavored rx only nomax inc principal display panel - 30 tablet pouch carton - lemon

Principal display panel - 30 tablet pouch carton - cherry ndc 51801-006-30 30 tablets effer-k ® 25 meq tablets potassium bicarbonate effervescent tablets for oral solution, usp each tablet contains 25meq (978 mg) of potassium cherry berry flavored rx only nomax inc principal display panel - 30 tablet pouch carton - cherry


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