C-1000 plus Zinc and Potassium

Potassium (Potassium Aspartate):

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) reviews

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

The C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride containing 1500 mg of microencapsulated C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride, USP equivalent to 20 mEq of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) in a tablet.

These formulations are intended to slow the release of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) so that the likelihood of a high localized concentration of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride within the gastrointestinal tract is reduced.

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride, and the structural formula is KCl. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride.

Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose.

CLINICAL PHARMACOLOGY

The C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) ion is the principal intracellular cation of most body tissues. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.

The intracellular concentration of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) is a normal dietary constituent and under steady-state conditions the amount of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) is 50 to 100 mEq per day.

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion will occur whenever the rate of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion may produce weakness, fatigue, disturbances or cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

If C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, eg, where the patient requires long-term diuretic therapy, supplemental C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) in the form of high C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) food or C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride may be able to restore normal C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) levels.

In rare circumstances (eg, patients with renal tubular acidosis) C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) replacement should be accomplished with C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salts other than the chloride, such as C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) bicarbonate, C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) citrate, C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) acetate, or C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) gluconate.

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.

2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias.

The use of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) 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, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salts may be indicated.

CONTRAINDICATIONS

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) supplements are contraindicated in patients with hyperkalemia since a further increase in serum C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis, such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

Controlled-release formulations of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).

All solid oral dosage forms of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride are contraindicated in any patient in whom there is structural, pathological (eg, diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

WARNINGS

Hyperkalemia (see OVERDOSAGE )

In patients with impaired mechanisms for excreting C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)), the administration of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) by the intravenous route but may also occur in patients given C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salts in patients with chronic renal disease, or any other condition which impairs C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) excretion, requires particularly careful monitoring of the serum C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salts and a potassium-sparing diuretic (eg, spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin-Converting Enzyme Inhibitors

Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril, enalapril) will produce some C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) retention by inhibiting aldosterone production. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to sustained release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride and thus to minimize the possibility of a high local concentration of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) near the gastrointestinal wall.

Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (ie, 96 mEq per day in divided doses of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing). The relevance of these findings to the usual conditions (ie, non-fasting, no anticholinergic agent, smaller doses) under which controlled-release C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq should be discontinued immediately and the possibility of ulceration, obstruction, or perforation should be considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs.

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salt such as C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) bicarbonate, C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) citrate, C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) acetate, or C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) gluconate.

PRECAUTIONS

General

The diagnosis of C-1000 plus Zinc and Potassium ) depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion. In interpreting the serum C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) while acute acidosis per se can increase the serum C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) concentration into the normal range even in the presence of a reduced total body C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)). The treatment of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

Information for Patients

Physicians should consider reminding the patient of the following: To take each dose with meals and with a full glass of water or other liquid. To take each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration:

• Break the tablet in half, and take each half separately with a glass of water.
• Prepare an aqueous (water) suspension as follows:
  

  1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
  

  2. Allow approximately 2 minutes for the tablet(s) to disintegrate.
  

  3. Stir for about half a minute after the tablet(s) has disintegrated.
  

  4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
  

  5. Add another 1 fluid ounce of water, swirl, and consume immediately.
  

  6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.

To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Laboratory Tests

When blood is drawn for analysis of plasma C-1000 plus Zinc and Potassium ) it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Drug Interactions

Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS ).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. C-1000 plus Zinc and Potassium ) is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal C-1000 plus Zinc and Potassium ) ion content of human milk is about 13 mEq per liter. Since oral C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) becomes part of the body C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) pool, so long as body C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) is not excessive, the contribution of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection; and it may be useful to monitor renal function.

ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS , and OVERDOSAGE ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ). The most common adverse reactions to oral C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salts are nausea, vomiting, flatulence, abdominal pain/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 amount taken at one time.

OVERDOSAGE

The administration of oral C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) salts to persons with normal excretory mechanisms for C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS ). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Treatment measures for hyperkalemia include the following:

• Patients should be closely monitored for arrhythmias and electrolyte changes.
• Elimination of foods and medications containing C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
• Intravenous calcium gluconate if the patient is at no risk of developing digitalis toxicity.
• Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
• Correction of acidosis, if present, with intravenous sodium bicarbonate.
• 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 serum C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) concentration can produce digitalis toxicity.

The extended release feature means that absorption and toxic effects may be delayed for hours.

Consider standard measures to remove any unabsorbed drug.

DOSAGE AND ADMINISTRATION

The usual dietary intake of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) by the average adult is 50 to 100 mEq per day. C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) from the total body store.

Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

Each C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride.

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS ).

Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:

• Break the tablet in half, and take each half separately with a glass of water.
• Prepare an aqueous (water) suspension as follows:
  • Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
  • Allow approximately 2 minutes for the tablet(s) to disintegrate.
  • Stir for about half a minute after the tablet(s) has disintegrated.
  • Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
  • Add another 1 fluid ounce of water, swirl, and consume immediately.
  • Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

HOW SUPPLIED

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.

Storage Conditions

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by:

Eurand, Inc.

Vandalia, OH 45377 USA

Distributed by:

Watson Pharma, Inc.

Rev. Date (01/09) 173714

C-1000 plus Zinc and Potassium (Potassium (Potassium Aspartate)) chloride 20 Meq

Potassium (Potassium Citrate):

• Description
• Clinical pharmacology
• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Overdosage
• Dosage and administration
• How supplied
• C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) reviews

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K

Rx Only

DESCRIPTION

The C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride containing 1500 mg of microencapsulated C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride, USP equivalent to 20 mEq of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) in a tablet.

These formulations are intended to slow the release of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) so that the likelihood of a high localized concentration of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride within the gastrointestinal tract is reduced.

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride, and the structural formula is KCl. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride, USP occurs as a white, granular powder or as colorless crystals. It is odorless and has a saline taste. Its solutions are neutral to litmus. It is freely soluble in water and insoluble in alcohol.

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq begin disintegrating into microencapsulated crystals within seconds and completely disintegrates within 1 minute. The microencapsulated crystals are formulated to provide an extended release of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride.

Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose.

CLINICAL PHARMACOLOGY

The C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) ion is the principal intracellular cation of most body tissues. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) ions participate in a number of essential physiological processes including the maintenance of intracellular tonicity; the transmission of nerve impulses; the contraction of cardiac, skeletal, and smooth muscle; and the maintenance of normal renal function.

The intracellular concentration of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) is approximately 150 to 160 mEq per liter. The normal adult plasma concentration is 3.5 to 5 mEq per liter. An active ion transport system maintains this gradient across the plasma membrane.

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) is a normal dietary constituent and under steady-state conditions the amount of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) is 50 to 100 mEq per day.

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion will occur whenever the rate of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion may produce weakness, fatigue, disturbances or cardiac rhythm (primarily ectopic beats), prominent U-waves in the electrocardiogram, and in advanced cases, flaccid paralysis and/or impaired ability to concentrate urine.

If C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion associated with metabolic alkalosis cannot be managed by correcting the fundamental cause of the deficiency, eg, where the patient requires long-term diuretic therapy, supplemental C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) in the form of high C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) food or C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride may be able to restore normal C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) levels.

In rare circumstances (eg, patients with renal tubular acidosis) C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) replacement should be accomplished with C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salts other than the chloride, such as C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) bicarbonate, C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) citrate, C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) acetate, or C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) gluconate.

INDICATIONS AND USAGE

BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) PREPARATIONS OR FOR PATIENTS IN WHOM THERE IS A PROBLEM OF COMPLIANCE WITH THESE PREPARATIONS.

1. For the treatment of patients with hypokalemia with or without metabolic alkalosis, in digitalis intoxication, and in patients with hypokalemic familial periodic paralysis. If hypokalemia is the result of diuretic therapy, consideration should be given to the use of a lower dose of diuretic, which may be sufficient without leading to hypokalemia.

2. For the prevention of hypokalemia in patients who would be at particular risk if hypokalemia were to develop, eg, digitalized patients or patients with significant cardiac arrhythmias.

The use of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salts in patients receiving diuretics for uncomplicated essential hypertension is often unnecessary when such patients have a normal dietary pattern and when low doses of the diuretic are used. Serum C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) 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, and if dose adjustment of the diuretic is ineffective or unwarranted, supplementation with C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salts may be indicated.

CONTRAINDICATIONS

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) supplements are contraindicated in patients with hyperkalemia since a further increase in serum C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) concentration in such patients can produce cardiac arrest. Hyperkalemia may complicate any of the following conditions: chronic renal failure, systemic acidosis, such as diabetic acidosis, acute dehydration, extensive tissue breakdown as in severe burns, adrenal insufficiency, or the administration of a potassium-sparing diuretic (eg, spironolactone, triamterene, amiloride) (see OVERDOSAGE ).

Controlled-release formulations of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).

All solid oral dosage forms of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride are contraindicated in any patient in whom there is structural, pathological (eg, diabetic gastroparesis), or pharmacologic (use of anticholinergic agents or other agents with anticholinergic properties at sufficient doses to exert anticholinergic effects) cause for arrest or delay in tablet passage through the gastrointestinal tract.

WARNINGS

Hyperkalemia (see OVERDOSAGE )

In patients with impaired mechanisms for excreting C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)), the administration of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) by the intravenous route but may also occur in patients given C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salts in patients with chronic renal disease, or any other condition which impairs C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) excretion, requires particularly careful monitoring of the serum C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) concentration and appropriate dosage adjustment.

Interaction with Potassium-Sparing Diuretics

Hypokalemia should not be treated by the concomitant administration of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salts and a potassium-sparing diuretic (eg, spironolactone, triamterene, or amiloride) since the simultaneous administration of these agents can produce severe hyperkalemia.

Interaction with Angiotensin-Converting Enzyme Inhibitors

Angiotensin-converting enzyme (ACE) inhibitors (eg, captopril, enalapril) will produce some C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) retention by inhibiting aldosterone production. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) supplements should be given to patients receiving ACE inhibitors only with close monitoring.

Gastrointestinal Lesions

Solid oral dosage forms of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride are associated with an increased frequency of small bowel lesions (40-50 per 100,000 patient years) compared to sustained release wax matrix formulations (less than one per 100,000 patient years). Because of the lack of extensive marketing experience with microencapsulated products, a comparison between such products and wax matrix or enteric-coated products is not available. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride and thus to minimize the possibility of a high local concentration of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) near the gastrointestinal wall.

Prospective trials have been conducted in normal human volunteers in which the upper gastrointestinal tract was evaluated by endoscopic inspection before and after 1 week of solid oral C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride therapy. The ability of this model to predict events occurring in usual clinical practice is unknown. Trials which approximated usual clinical practice did not reveal any clear differences between the wax matrix and microencapsulated dosage forms. In contrast, there was a higher incidence of gastric and duodenal lesions in subjects receiving a high dose of a wax matrix controlled-release formulation under conditions which did not resemble usual or recommended clinical practice (ie, 96 mEq per day in divided doses of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride administered to fasted patients, in the presence of an anticholinergic drug to delay gastric emptying). The upper gastrointestinal lesions observed by endoscopy were asymptomatic and were not accompanied by evidence of bleeding (Hemoccult testing). The relevance of these findings to the usual conditions (ie, non-fasting, no anticholinergic agent, smaller doses) under which controlled-release C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride products are used is uncertain; epidemiologic studies have not identified an elevated risk, compared to microencapsulated products, for upper gastrointestinal lesions in patients receiving wax matrix formulations. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq should be discontinued immediately and the possibility of ulceration, obstruction, or perforation should be considered if severe vomiting, abdominal pain, distention, or gastrointestinal bleeding occurs.

Metabolic Acidosis

Hypokalemia in patients with metabolic acidosis should be treated with an alkalinizing C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salt such as C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) bicarbonate, C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) citrate, C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) acetate, or C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) gluconate.

PRECAUTIONS

General

The diagnosis of C-1000 plus Zinc and Potassium ) depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion. In interpreting the serum C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) while acute acidosis per se can increase the serum C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) concentration into the normal range even in the presence of a reduced total body C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)). The treatment of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion, particularly in the presence of cardiac disease, renal disease, or acidosis requires careful attention to acid-base balance and appropriate monitoring of serum electrolytes, the electrocardiogram, and the clinical status of the patient.

Information for Patients

Physicians should consider reminding the patient of the following: To take each dose with meals and with a full glass of water or other liquid. To take each dose without crushing, chewing, or sucking the tablets. If those patients are having difficulty swallowing whole tablets, they may try one of the following alternate methods of administration:

• Break the tablet in half, and take each half separately with a glass of water.
• Prepare an aqueous (water) suspension as follows:
  

  1. Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
  

  2. Allow approximately 2 minutes for the tablet(s) to disintegrate.
  

  3. Stir for about half a minute after the tablet(s) has disintegrated.
  

  4. Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
  

  5. Add another 1 fluid ounce of water, swirl, and consume immediately.
  

  6. Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

To take this medicine following the frequency and amount prescribed by the physician. This is especially important if the patient is also taking diuretics and/or digitalis preparations.

To check with the physician at once if tarry stools or other evidence of gastrointestinal bleeding is noticed.

Laboratory Tests

When blood is drawn for analysis of plasma C-1000 plus Zinc and Potassium ) it is important to recognize that artifactual elevations can occur after improper venipuncture technique or as a result of in vitro hemolysis of the sample.

Drug Interactions

Potassium-sparing diuretics, angiotensin-converting enzyme inhibitors (see WARNINGS ).

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity, mutagenicity, and fertility studies in animals have not been performed. C-1000 plus Zinc and Potassium ) is a normal dietary constituent.

Pregnancy Category C

Animal reproduction studies have not been conducted with C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.

Nursing Mothers

The normal C-1000 plus Zinc and Potassium ) ion content of human milk is about 13 mEq per liter. Since oral C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) becomes part of the body C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) pool, so long as body C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) is not excessive, the contribution of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride supplementation should have little or no effect on the level in human milk.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy.

This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection; and it may be useful to monitor renal function.

ADVERSE REACTIONS

One of the most severe adverse effects is hyperkalemia (see CONTRAINDICATIONS , WARNINGS , and OVERDOSAGE ). There have also been reports of upper and lower gastrointestinal conditions including obstruction, bleeding, ulceration, and perforation (see CONTRAINDICATIONS and WARNINGS ). The most common adverse reactions to oral C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salts are nausea, vomiting, flatulence, abdominal pain/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 amount taken at one time.

OVERDOSAGE

The administration of oral C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) salts to persons with normal excretory mechanisms for C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) is administered too rapidly intravenously, potentially fatal hyperkalemia can result (see CONTRAINDICATIONS and WARNINGS ). It is important to recognize that hyperkalemia is usually asymptomatic and may be manifested only by an increased serum C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) concentration (6.5-8.0 mEq/L) and characteristic electrocardiographic changes (peaking of T-waves, loss of P-waves, depression of S-T segment, and prolongation of the QT-interval). Late manifestations include muscle paralysis and cardiovascular collapse from cardiac arrest (9-12 mEq/L).

Treatment measures for hyperkalemia include the following:

• Patients should be closely monitored for arrhythmias and electrolyte changes.
• Elimination of foods and medications containing C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) and of any agents with potassium-sparing properties such as potassium-sparing diuretics, ARBS, ACE inhibitors, NSAIDS, certain nutritional supplements and many others.
• Intravenous calcium gluconate if the patient is at no risk of developing digitalis toxicity.
• Intravenous administration of 300 to 500 mL/hr of 10% dextrose solution containing 10-20 units of crystalline insulin per 1,000 mL.
• Correction of acidosis, if present, with intravenous sodium bicarbonate.
• 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 serum C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) concentration can produce digitalis toxicity.

The extended release feature means that absorption and toxic effects may be delayed for hours.

Consider standard measures to remove any unabsorbed drug.

DOSAGE AND ADMINISTRATION

The usual dietary intake of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) by the average adult is 50 to 100 mEq per day. C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) from the total body store.

Dosage must be adjusted to the individual needs of each patient. The dose for the prevention of hypokalemia is typically in the range of 20 mEq per day. Doses of 40-100 mEq per day or more are used for the treatment of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) depletion. Dosage should be divided if more than 20 mEq per day is given such that no more than 20 mEq is given in a single dose.

Each C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride.

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq should be taken with meals and with a glass of water or other liquid. This product should not be taken on an empty stomach because of its potential for gastric irritation (see WARNINGS ).

Patients having difficulty swallowing whole tablets may try one of the following alternate methods of administration:

• Break the tablet in half, and take each half separately with a glass of water.
• Prepare an aqueous (water) suspension as follows:
  • Place the whole tablet(s) in approximately 1/2 glass of water (4 fluid ounces).
  • Allow approximately 2 minutes for the tablet(s) to disintegrate.
  • Stir for about half a minute after the tablet(s) has disintegrated.
  • Swirl the suspension and consume the entire contents of the glass immediately by drinking or by the use of a straw.
  • Add another 1 fluid ounce of water, swirl, and consume immediately.
  • Then, add an additional 1 fluid ounce of water, swirl, and consume immediately.

Aqueous suspension of C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq is not recommended.

HOW SUPPLIED

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) Chloride Extended Release Tablets USP, 20 mEq are available in bottles of 100 (NDC 62037-999-01), bottles of 500 (NDC 62037-999-05), and bottles of 1000 (NDC 62037-999-10). Potassium Chloride Extended Release Tablets USP, 20 mEq are capsule shaped, white to off-white tablets, with “ABRS-123” imprinted on one side and scored on the other side for flexibility of dosing.

Storage Conditions

Keep tightly closed. Store at controlled room temperature, 20°-25°C (68°-77°F).

Manufactured by:

Eurand, Inc.

Vandalia, OH 45377 USA

Distributed by:

Watson Pharma, Inc.

Rev. Date (01/09) 173714

C-1000 plus Zinc and Potassium (Potassium (Potassium Citrate)) chloride 20 Meq

Vitamin C (Calcium Ascorbate):

• Pharmacological action
• Pharmacokinetics
• Why is C-1000 plus Zinc and Potassium ) prescribed?
• Dosage and administration
• C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) side effects, adverse reactions
• C-1000 plus Zinc and Potassium ) contraindications
• Using during pregnancy and breastfeeding
• Special instructions
• C-1000 plus Zinc and Potassium ) drug interactions
• C-1000 plus Zinc and Potassium ) in case of emergency / overdose
• C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) reviews

Pharmacological action

Ascorbic acid is essential for the formation of intracellular collagen, is required to strengthen the structure of teeth, bones, and the capillary walls. C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) participates in redox reactions, the metabolism of tyrosine, converting folic acid into folinic acid, metabolism of carbohydrates, the synthesis of lipids and proteins, iron metabolism, processes of cellular respiration. Reduces the need for vitamins B1, B2, A, E, folic acid, pantothenic acid, enhances the body's resistance to infections; enhances iron absorption, contributing to its sequestration in reduced form. C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) has antioxidant properties.

With intravaginal application of ascorbic acid lowers the vaginal pH, inhibiting the growth of bacteria and helps to restore and maintain normal pH and vaginal flora (Lactobacillus acidophilus, Lactobacillus gasseri).

Pharmacokinetics

After oral administration ascorbic acid is completely absorbed from the gastrointestinal tract. Widely distributed in body tissues.

The concentration of ascorbic acid in blood plasma in normal amounts to approximately 10-20 mg / ml.

The concentration of ascorbic acid in white blood cells and platelets is higher than in erythrocytes and plasma. When deficient state of concentration in leucocytes is reduced later and more slowly and is regarded as the best criterion for evaluating the deficit than the concentration in plasma.

Plasma protein binding is about 25%.

Ascorbic acid is reversibly oxidized to form dehydroascorbic acid, is metabolized with the formation of ascorbate-2-sulphate which is inactive and oxalic acid which is excreted in the urine.

Ascorbic acid taken in excessive quantities is rapidly excreted unchanged in urine, it usually happens when exceeding a daily dose is 200 mg.

Why is C-1000 plus Zinc and Potassium ) prescribed?

For systemic use of C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) Kimia Farma: prevention and treatment of hypo- and avitaminosis of C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)); providing increased need for C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) during growth, pregnancy, lactation, with heavy loads, fatigue and during recovery after prolonged severe illness; in winter with an increased risk of infectious diseases.

For intravaginal use: chronic or recurrent vaginitis (bacterial vaginosis, nonspecific vaginitis) caused by the anaerobic flora (due to changes in pH of the vagina) in order to normalize disturbed vaginal microflora.

Dosage and administration

This medication administered orally, IM, IV, intravaginally.

For the prevention of deficiency conditions C-1000 plus Zinc and Potassium ) dose is 25-75 mg / day, for the treatment - 250 mg / day or more in divided doses.

For intravaginal used ascorbic acid drugs in appropriate dosage forms.

C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) side effects, adverse reactions

CNS: headache, fatigue, insomnia.

Digestive system: stomach cramps, nausea and vomiting.

Allergic reaction: describes a few cases of skin reactions and manifestations of the respiratory system.

Urinary system: when used in high doses - hyperoxaluria and the formation of kidney stones of calcium oxalate.

Local reactions: with intravaginal application - a burning or itching in the vagina, increased mucous discharge, redness, swelling of the vulva. Other: sensation of heat.

C-1000 plus Zinc and Potassium ) contraindications

Increased sensitivity to ascorbic acid.

Using during pregnancy and breastfeeding

The minimum daily requirement of ascorbic acid in the II and III trimester of pregnancy is about 60 mg.

Ascorbic acid crosses the placental barrier. It should be borne in mind that the fetus can adapt to high doses of ascorbic acid, which takes a pregnant woman, and then a newborn baby may develop the ascorbic disease as the reaction of cancel. Therefore, during pregnancy should not to take ascorbic acid in high doses, except in cases where the expected benefit outweighs the potential risk.

The minimum daily requirement during lactation is 80 mg. Ascorbic acid is excreted in breast milk. A mother's diet that contains adequate amounts of ascorbic acid, is sufficient to prevent deficiency in an infant. It is unknown whether dangerous to the child's mother use of ascorbic acid in high doses. Theoretically it is possible. Therefore, it is recommended not to exceed the maximum daily nursing mother needs to ascorbic acid, except when the expected benefit outweighs the potential risk.

Special instructions

C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) is used with caution in patients with hyperoxaluria, renal impairment, a history of instructions on urolithiasis. Because ascorbic acid increases iron absorption, its use in high doses can be dangerous in patients with hemochromatosis, thalassemia, polycythemia, leukemia, and sideroblastic anemia.

Patients with high content body iron should apply ascorbic acid in minimal doses.

C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) is used with caution in patients with deficiency of glucose-6-phosphate dehydrogenase.

The use of ascorbic acid in high doses can cause exacerbation of sickle cell anemia.

Data on the diabetogenic action of ascorbic acid are contradictory. However, prolonged use of ascorbic acid should periodically monitor your blood glucose levels.

It is believed that the use of ascorbic acid in patients with rapidly proliferating and widely disseminated tumors may worsen during the process. It should therefore be used with caution in ascorbic acid in patients with advanced cancer.

Absorption of ascorbic acid decreased while use of fresh fruit or vegetable juices, alkaline drinking.

C-1000 plus Zinc and Potassium ) drug interactions

In an application with barbiturates, primidone increases the excretion of ascorbic acid in the urine.

With the simultaneous use of oral contraceptives reduces the concentration of ascorbic acid in blood plasma.

In an application of C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) with iron preparations ascorbic acid, due to its regenerative properties, transforms ferric iron in the bivalent, which improves its absorption.

Ascorbic acid in high doses can decrease urine pH that while the application reduces the tubular reabsorption of amphetamine and tricyclic antidepressants.

With the simultaneous use of aspirin reduces the absorption of ascorbic acid by about a third.

C-1000 plus Zinc and Potassium (Vitamin C (Calcium Ascorbate)) in an application with warfarin may decrease effects of warfarin.

With the simultaneous application of ascorbic acid increases the excretion of iron in patients receiving deferoxamine. In the application of ascorbic acid at a dose of 500 mg / day possibly left ventricular dysfunction.

In an application with tetracycline is increased excretion of ascorbic acid in the urine.

There is a described case of reducing the concentration of fluphenazine in plasma in patients treated with ascorbic acid 500 mg 2 times / day.

May increase the concentration of ethinyl estradiol in the blood plasma in its simultaneous application in the oral contraceptives.

C-1000 plus Zinc and Potassium ) in case of emergency / overdose

Symptoms: long-term use of large doses (more than 1 g) - headache, increased CNS excitability, insomnia, nausea, vomiting, diarrhea, gastritis giperatsidnyh, ultseratsiya gastrointestinal mucosa, inhibition of the function insular apparatus of the pancreas (hyperglycemia, glycosuria), hyperoxaluria, nephrolithiasis (calcium oxalate), damage to the glomerular apparatus of the kidneys, moderate thamuria (when receiving a dose of 600 mg / day).

Decrease capillary permeability (possibly deteriorating trophic tissues, increased blood pressure, hypercoagulability, the development of microangiopathy).

When IV administration in high doses - the threat of termination of pregnancy (due to estrogenemia), hemolysis of red blood cells.

Zinc (Zinc Ascorbate):

• Indications and usage
• Contraindications
• Warnings
• Precautions
• Adverse reactions
• Drug abuse and dependence
• Overdosage
• Dosage and administration
• How supplied
• C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) reviews

INDICATIONS AND USAGE

C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) 1 mg/mL (Zinc Chloride Injection, USP) is indicated for use as a supplement to intravenous solutions given for TPN. Administration helps to maintain C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) serum levels and to prevent depletion of endogenous stores, and subsequent deficiency symptoms.

CONTRAINDICATIONS

None known.

WARNINGS

Direct intramuscular or intravenous injection of C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) 1 mg/mL (Zinc Chloride Injection, USP) is contraindicated as the acidic pH of the solution (2) may cause considerable tissue irritation.

Severe kidney disease may make it necessary to reduce or omit chromium and C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) doses because these elements are primarily eliminated in the urine.

WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum.

Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 mcg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration.

PRECAUTIONS

General

Do not use unless the solution is clear and the seal is intact.

Zinc 1 mg/mL should only be used in conjunction with a pharmacy directed admixture program using aseptic technique in a laminar flow environment; it should be used promptly and in a single operation without any repeated penetrations. Solution contains no preservatives; discard unused portion immediately after admixture procedure is completed.

Zinc should not be given undiluted by direct injection into a peripheral vein because of the likelihood of infusion phlebitis and the potential for increased excretory loss of C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) from a bolus injection. Administration of C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) in the absence of copper may cause a decrease in serum copper levels.

Laboratory Tests

Periodic determinations of serum copper as well as C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) are suggested as a guideline for subsequent C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) administration.

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies to evaluate the carcinogenic potential of C-1000 plus Zinc and Potassium ) 1 mg/mL (Zinc Chloride Injection, USP) have not been performed, nor have studies been done to assess mutagenesis or impairment of fertility.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) 1 mg/mL (Zinc Chloride Injection, USP) is administered to a nursing woman.

Pediatric Use

Pregnancy Category C. Animal reproduction studies have not been conducted with C-1000 plus Zinc and Potassium ) chloride. It is also not known whether C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) chloride can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) chloride should be given to a pregnant woman only if clearly needed.

Geriatric Use

An evaluation of current literature revealed no clinical experience identifying differences in response between elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

ADVERSE REACTIONS

None known.

DRUG ABUSE AND DEPENDENCE

None known.

OVERDOSAGE

Single intravenous doses of 1 to 2 mg zinc/kg body weight have been given to adult leukemic patients without toxic manifestations. However, acute toxicity was reported in an adult when 10 mg C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) was infused over a period of one hour on each of four consecutive days. Profuse sweating, decreased level of consciousness, blurred vision, tachycardia (140/min), and marked hypothermia (94.2° F) on the fourth day were accompanied by a serum C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) concentration of 207 mcg/dl. Symptoms abated within three hours.

Hyperamylasemia may be a sign of impending C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) overdosage; patients receiving an inadvertent overdose (25 mg zinc/liter of TPN solution, equivalent to 50 to 70 mg zinc/day) developed hyperamylasemia (557 to 1850 Klein units; normal: 130 to 310).

Death resulted from an overdosage in which 1683 mg C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) was delivered intravenously over the course of 60 hours to a 72 year old patient.

Symptoms of C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) toxicity included hypotension (80/40 mm Hg), pulmonary edema, diarrhea, vomiting, jaundice, and oliguria, with a serum C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) level of 4184 mcg/dl.

Calcium supplements may confer a protective effect against C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) toxicity.

DOSAGE AND ADMINISTRATION

C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) 1 mg/mL (Zinc Chloride Injection, USP) contains 1 mg zinc/mL and is administered intravenously only after dilution. The additive should be diluted prior to administration in a volume of fluid not less than 100 mL. For the metabolically stable adult receiving TPN, the suggested intravenous dosage is 2.5 to 4 mg zinc/day (2.5 to 4 mL/day). An additional 2 mg zinc/day (2 mL/day) is suggested for acute catabolic states. For the stable adult with fluid loss from the small bowel, an additional 12.2 mg zinc/liter of small bowel fluid lost (12.2 mL/liter of small bowel fluid lost), or an additional 17.1 mg zinc/kg of stool or ileostomy output (17.1 mL/kg of stool or ileostomy output) is recommended. Frequent monitoring of C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) blood levels is suggested for patients receiving more than the usual maintenance dosage level of C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)).

For full term infants and children up to 5 years of age, 100 mcg zinc/kg/day (0.1 mL/kg/day) is recommended. For premature infants (birth weight less than 1500 g) up to 3 kg in body weight, 300 mcg zinc/kg/day (0.3 mL/kg/day) is suggested.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See PRECAUTIONS.

HOW SUPPLIED

C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) 1 mg/mL (Zinc Chloride Injection, USP) is supplied in 10 mL Plastic Vials (List No. 4090).

Store at 20 to 25°C (68 to 77°F).

Revised: October, 2004

© Hospira 2004 EN-0488 Printed in USA

HOSPIRA, INC., LAKE FOREST, IL 60045 USA

10 mL Vial

C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate))

1 mg/mL

C-1000 plus Zinc and Potassium (Zinc (Zinc Ascorbate)) Chloride Inj., USP

Rx only

FOR I.V. USE ONLY AFTER DILUTION.

HOSPIRA, INC., LAKE FOREST, IL 60045 USA