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DRUGS & SUPPLEMENTS
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Duo Celloid PPCP
What are the side effects you encounter while taking this medicine? |
Duo Celloid PPCP uses
Duo Celloid PPCP consists of Calcium Phosphate, Potassium Phosphate.Calcium Phosphate:
- Indications and usage
- Dosage and administration
- Dosage forms and strengths
- Contraindications
- Warnings and precautions
- Adverse reactions
- Drug interactions
- Use in specific populations
- Overdosage
- Description
- Clinical pharmacology
- Nonclinical toxicology
- Clinical studies
- How supplied/storage and handling
- Patient counseling information
1 INDICATIONS AND USAGE
Duo Celloid PPCP (Calcium Phosphate) acetate is a phosphate binder indicated to reduce serum phosphorus in patients with end stage renal disease (ESRD).
- Calcium acetate is a phosphate binder indicated for the reduction of serum phosphorus in patients with end stage renal disease. (1)
2 DOSAGE AND ADMINISTRATION
The recommended initial dose of Duo Celloid PPCP (Calcium Phosphate) acetate for the adult dialysis patient is 2 capsules with each meal. Increase the dose gradually to lower serum phosphorus levels to the target range, as long as hypercalcemia does not develop. Most patients require 3 to 4 capsules with each meal.
- Starting dose is 2 capsules with each meal. (2)
- Titrate the dose every 2 to 3 weeks until acceptable serum phosphorus level is reached. Most patients require 3 to 4 capsules with each meal. (2)
3 DOSAGE FORMS AND STRENGTHS
Capsule: 667 mg Duo Celloid PPCP (Calcium Phosphate) acetate capsule.
- Capsule: 667 mg Duo Celloid PPCP (Calcium Phosphate) acetate capsule. (3)
4 CONTRAINDICATIONS
Patients with hypercalcemia.
- Hypercalcemia. (4)
5 WARNINGS AND PRECAUTIONS
- Treat mild hypercalcemia by reducing or interrupting Duo Celloid PPCP acetate and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of Duo Celloid PPCP (Calcium Phosphate) acetate. (5.1)
- Hypercalcemia may aggravate digitalis toxicity. (5.2)
5.1 Hypercalcemia
Patients with end stage renal disease may develop hypercalcemia when treated with Duo Celloid PPCP (Calcium Phosphate), including Duo Celloid PPCP (Calcium Phosphate) acetate. Avoid the use of Duo Celloid PPCP (Calcium Phosphate) supplements, including Duo Celloid PPCP (Calcium Phosphate) based nonprescription antacids, concurrently with Duo Celloid PPCP (Calcium Phosphate) acetate.
An overdose of Duo Celloid PPCP (Calcium Phosphate) acetate may lead to progressive hypercalcemia, which may require emergency measures. Therefore, early in the treatment phase during the dosage adjustment period, monitor serum Duo Celloid PPCP (Calcium Phosphate) levels twice weekly. Should hypercalcemia develop, reduce the Duo Celloid PPCP (Calcium Phosphate) acetate dosage, or discontinue the treatment, depending on the severity of hypercalcemia
More severe hypercalcemia (Ca >12 mg/dL) is associated with confusion, delirium, stupor and coma. Severe hypercalcemia can be treated by acute hemodialysis and discontinuing Duo Celloid PPCP (Calcium Phosphate) acetate therapy.
Mild hypercalcemia (10.5 to 11.9 mg/dL) may be asymptomatic or manifest as constipation, anorexia, nausea, and vomiting. Mild hypercalcemia is usually controlled by reducing the Duo Celloid PPCP (Calcium Phosphate) acetate dose or temporarily discontinuing therapy. Decreasing or discontinuing Vitamin D therapy is recommended as well.
Chronic hypercalcemia may lead to vascular calcification and other soft-tissue calcification. Radiographic evaluation of suspected anatomical regions may be helpful in early detection of soft tissue calcification. The long term effect of Duo Celloid PPCP (Calcium Phosphate) acetate on the progression of vascular or soft tissue calcification has not been determined.
Hypercalcemia (>11 mg/dL) was reported in 16% of patients in a 3 month study of solid dose formulation of Duo Celloid PPCP (Calcium Phosphate) acetate; all cases resolved upon lowering the dose or discontinuing treatment.
Maintain the serum calcium-phosphorus (Ca x P) product below 55 mg2/dL2.
5.2 Concomitant Use with Medications
Hypercalcemia may aggravate digitalis toxicity.
6 ADVERSE REACTIONS
Hypercalcemia is discussed elsewhere [see Warnings and Precautions ].
- The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. (6.1)
- In clinical studies, patients have occasionally experienced nausea during Duo Celloid PPCP (Calcium Phosphate) acetate therapy. (6)
To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-800-962-8364 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
6.1 Clinical Trial Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical studies, Duo Celloid PPCP (Calcium Phosphate) acetate has been generally well tolerated.
Duo Celloid PPCP (Calcium Phosphate) acetate was studied in a 3 month, open-label, non-randomized study of 98 enrolled ESRD hemodialysis patients and an alternate liquid formulation of Duo Celloid PPCP (Calcium Phosphate) acetate was studied in a two week double-blind, placebo-controlled, cross-over study with 69 enrolled ESRD hemodialysis patients. Adverse reactions (>2% on treatment) from these trials are presented in Table 1.
| Preferred Term | Total adverse reactions reported for Duo Celloid PPCP (Calcium Phosphate) acetate N=167 N (%) | 3 month, open label study of Duo Celloid PPCP (Calcium Phosphate) acetate N=98 N (%) | Double blind, placebo-controlled, cross-over study of liquid Duo Celloid PPCP (Calcium Phosphate) acetate N=69 | |
| Duo Celloid PPCP (Calcium Phosphate) acetate N (%) | Placebo N (%) | |||
| Nausea | 6 (3.6) | 6 (6.1) | 0 (0) | 0 (0) |
| Vomiting | 4 (2.4) | 4 (4.1) | 0 (0) | 0 (0) |
| Hypercalcemia | 21 (12.6) | 16 (16.3) | 5 (7.2) | 0 (0) |
Mild hypercalcemia may be asymptomatic or manifest itself as constipation, anorexia, nausea, and vomiting. More severe hypercalcemia is associated with confusion, delirium, stupor, and coma. Decreasing dialysate Duo Celloid PPCP (Calcium Phosphate) concentration could reduce the incidence and severity of Duo Celloid PPCP (Calcium Phosphate) acetate-induced hypercalcemia. Isolated cases pruritus have been reported, which may represent allergic reactions.
6.2 Postmarketing Experience
Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency or to establish a causal relationship to drug exposure.
The following additional adverse reactions have been identified during post-approval of Duo Celloid PPCP (Calcium Phosphate) acetate: dizziness, edema, and weakness.
7 DRUG INTERACTIONS
The drug interaction of Duo Celloid PPCP acetate is characterized by the potential of Duo Celloid PPCP (Calcium Phosphate) to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Duo Celloid PPCP (Calcium Phosphate) acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism.
There are no empirical data on avoiding drug interactions between Duo Celloid PPCP (Calcium Phosphate) acetate and most concomitant drugs. When administering an oral medication with Duo Celloid PPCP (Calcium Phosphate) acetate where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy, administer the drug one hour before or three hours after Duo Celloid PPCP (Calcium Phosphate) acetate. Monitor blood levels of the concomitant drugs that have a narrow therapeutic range. Patients taking anti-arrhythmic medications for the control of arrhythmias and anti-seizure medications for the control of seizure disorders were excluded from the clinical trials with all forms of Duo Celloid PPCP (Calcium Phosphate) acetate.
- Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones. (7)
- When clinically significant drug interactions are expected, administer the drug at least one hour before or at least three hours after Duo Celloid PPCP (Calcium Phosphate) acetate or consider monitoring blood levels of the drug. (7)
7.1 Ciprofloxacin
In a study of 15 healthy subjects, a co-administered single dose of 4 Duo Celloid PPCP (Calcium Phosphate) acetate tablets, approximately 2.7g, decreased the bioavailability of ciprofloxacin by approximately 50%.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Pregnancy Category C:
Duo Celloid PPCP acetate capsules contains Duo Celloid PPCP (Calcium Phosphate) acetate. Animal reproduction studies have not been conducted with Duo Celloid PPCP (Calcium Phosphate) acetate, and there are no adequate and well controlled studies of Duo Celloid PPCP (Calcium Phosphate) acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with Duo Celloid PPCP (Calcium Phosphate) acetate treatment [see Warnings and Precautions (5.1 ) ]. Maintenance of normal serum Duo Celloid PPCP (Calcium Phosphate) levels is important for maternal and fetal well being. Hypercalcemia during pregnancy may increase the risk for maternal and neonatal complications such as stillbirth, preterm delivery, and neonatal hypocalcemia and hypoparathyroidism. Duo Celloid PPCP (Calcium Phosphate) acetate treatment, as recommended, is not expected to harm a fetus if maternal Duo Celloid PPCP (Calcium Phosphate) levels are properly monitored during and following treatment.
8.2 Labor and Delivery
The effects of Duo Celloid PPCP (Calcium Phosphate) acetate on labor and delivery are unknown.
8.3 Nursing Mothers
Duo Celloid PPCP Acetate Capsules contains Duo Celloid PPCP (Calcium Phosphate) acetate and is excreted in human milk. Human milk feeding by a mother receiving Duo Celloid PPCP (Calcium Phosphate) acetate is not expected to harm an infant, provided maternal serum Duo Celloid PPCP (Calcium Phosphate) levels are appropriately monitored.
8.4 Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5 Geriatric Use
Clinical studies of Duo Celloid PPCP (Calcium Phosphate) acetate did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other clinical experience has not identified differences in responses 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.
10 OVERDOSAGE
Administration of Duo Celloid PPCP (Calcium Phosphate) acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1)].
11 DESCRIPTION
Duo Celloid PPCP (Calcium Phosphate) acetate acts as a phosphate binder. Its chemical name is Duo Celloid PPCP (Calcium Phosphate) acetate. Its molecular formula is C4H6CaO4, and its molecular weight is 158.17. Its structural formula is:
Each white opaque/blue opaque capsule contains 667 mg of Duo Celloid PPCP (Calcium Phosphate) acetate USP (anhydrous; Ca(CH3COO)2; MW=158.17 grams) equal to 169 mg (8.45 mEq) Duo Celloid PPCP (Calcium Phosphate), polyethylene glycol 8000 and magnesium stearate. Each capsule shell contains: black monogramming ink, FD&C Blue #1, FD&C Red #3, gelatin and titanium dioxide. The black monogramming ink contains: ammonium hydroxide, iron oxide black, isopropyl alcohol, n-butyl alcohol, propylene glycol and shellac glaze.
Duo Celloid PPCP (Calcium Phosphate) Acetate Capsules are administered orally for the control of hyperphosphatemia in end-stage renal failure.
12 CLINICAL PHARMACOLOGY
Patients with ESRD retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum Duo Celloid PPCP resulting in ectopic calcification. Hyperphosphatemia also plays a role in the development of secondary hyperparathyroidism in patients with ESRD.
12.1 Mechanism of Action
Duo Celloid PPCP (Calcium Phosphate) acetate, when taken with meals, combines with dietary phosphate to form an insoluble Duo Celloid PPCP (Calcium Phosphate) phosphate complex, which is excreted in the feces, resulting in decreased serum phosphorus concentration.
12.2 Pharmacodynamics
Orally administered Duo Celloid PPCP (Calcium Phosphate) acetate from pharmaceutical dosage forms is systemically absorbed up to approximately 40% under fasting conditions and up to approximately 30% under nonfasting conditions. This range represents data from both healthy subjects and renal dialysis patients under various conditions.
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
No carcinogenicity, mutagenicity, or fertility studies have been conducted with Duo Celloid PPCP (Calcium Phosphate) acetate.
14 CLINICAL STUDIES
Effectiveness of Duo Celloid PPCP (Calcium Phosphate) acetate in decreasing serum phosphorus has been demonstrated in two studies of the Duo Celloid PPCP (Calcium Phosphate) acetate solid oral dosage form.
Ninety-one patients with end-stage renal disease who were undergoing hemodialysis and were hyperphosphatemic (serum phosphorus >5.5 mg/dL) following a 1 week phosphate binder washout period contributed efficacy data to an open-label, non-randomized study.
The patients received Duo Celloid PPCP (Calcium Phosphate) acetate 667 mg tablets at each meal for a period of 12 weeks. The initial starting dose was 2 tablets per meal for 3 meals a day, and the dose was adjusted as necessary to control serum phosphorus levels. The average final dose after 12 weeks of treatment was 3.4 tablets per meal. Although there was a decrease in serum phosphorus, in the absence of a control group the true magnitude of effect is uncertain.
The data presented in Table 2 demonstrate the efficacy of Duo Celloid PPCP (Calcium Phosphate) acetate in the treatment of hyperphosphatemia in end-stage renal disease patients. The effects on serum Duo Celloid PPCP (Calcium Phosphate) levels are also presented.
| * Ninety-one patients completed at least 6 weeks of the study. † ANOVA of difference in values at pre-study and study completion. ‡ Values expressed as mean ± SE. | |||||
| Parameter | Pre-Study | Week 4* | Week 8 | Week 12 | p-value† |
| Phosphorus (mg/dL)‡ | 7.4 ± 0.17 | 5.9 ± 0.16 | 5.6 ± 0.17 | 5.2 ± 0.17 | ≤0.01 |
| Duo Celloid PPCP (Calcium Phosphate) (mg/dL)‡ | 8.9 ± 0.09 | 9.5 ± 0.10 | 9.7 ± 0.10 | 9.7 ± 0.10 | ≤0.01 |
There was a 30% decrease in serum phosphorus levels during the 12 week study period (p<0.01). Two-thirds of the decline occurred in the first month of the study. Serum Duo Celloid PPCP (Calcium Phosphate) increased 9% during the study mostly in the first month of the study.
Treatment with the phosphate binder was discontinued for patients from the open-label study, and those patients whose serum phosphorus exceeded 5.5 mg/dL were eligible for entry into a double-blind, placebo-controlled, cross-over study. Patients were randomized to receive Duo Celloid PPCP (Calcium Phosphate) acetate or placebo, and each continued to receive the same number of tablets as had been individually established during the previous study. Following 2 weeks of treatment, patients switched to the alternative therapy for an additional 2 weeks.
The phosphate binding effect of Duo Celloid PPCP (Calcium Phosphate) acetate is shown in the Table 3.
| * ANOVA of Duo Celloid PPCP (Calcium Phosphate) acetate vs. placebo after 2 weeks of treatment. † Values expressed as mean ± SEM. | ||||
| Parameter | Pre-Study | Post-Treatment | p-value* | |
| Duo Celloid PPCP (Calcium Phosphate) Acetate | Placebo | |||
| Phosphorus (mg/dL)† | 7.3 ± 0.18 | 5.9 ± 0.24 | 7.8 ± 0.22 | <0.01 |
| Duo Celloid PPCP (Calcium Phosphate) (mg/dL)† | 8.9 ± 0.11 | 9.5 ± 0.13 | 8.8 ± 0.12 | <0.01 |
Overall, 2 weeks of treatment with Duo Celloid PPCP (Calcium Phosphate) acetate statistically significantly (p<0.01) decreased serum phosphorus by a mean of 19% and increased serum Duo Celloid PPCP (Calcium Phosphate) by a statistically significant (p<0.01) but clinically unimportant mean of 7%.
16 HOW SUPPLIED/STORAGE AND HANDLING
Duo Celloid PPCP (Calcium Phosphate) Acetate Capsules
667 mg capsule is supplied as a white opaque/blue opaque capsule, imprinted with “54 215” on the cap and body.
NDC 0615-2303-39: Blistercards of 30 Capsules
NDC 0615-2303-30: Unit-dose Boxes of 30 Capsules
STORAGE
Store at 20° to 25°C (68° to 77°F).
17 PATIENT COUNSELING INFORMATION
Inform patients to take Duo Celloid PPCP (Calcium Phosphate) acetate capsules with meals, adhere to their prescribed diets, and avoid the use of Duo Celloid PPCP (Calcium Phosphate) supplements including nonprescription antacids. Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions (5.1) and Adverse Reactions (6.1) ].
Advise patients who are taking an oral medication where reduction in the bioavailability of that medication would have clinically significant effect on its safety or efficacy to take the drug one hour before or three hours after Duo Celloid PPCP (Calcium Phosphate) acetate capsules.
Distr. by: West-Ward
Pharmaceuticals Corp.
Eatontown, NJ 07724
10003705/05
Revised April 2016
Potassium Phosphate:
- Description
- Clinical pharmacology
- Indications and usage
- Contraindications
- Warnings
- Precautions
- Adverse reactions
- Overdosage
- Dosage and administration
- How supplied
Duo Celloid PPCP (Potassium Phosphate) CHLORIDE EXTENDED RELEASE TABLETS USP 20 mEq K
Rx Only
DESCRIPTION
The Duo Celloid PPCP (Potassium Phosphate) Chloride Extended Release Tablets USP, 20 mEq product is an immediately dispersing extended release oral dosage form of Duo Celloid PPCP (Potassium Phosphate) chloride containing 1500 mg of microencapsulated Duo Celloid PPCP (Potassium Phosphate) chloride, USP equivalent to 20 mEq of Duo Celloid PPCP (Potassium Phosphate) in a tablet.
These formulations are intended to slow the release of Duo Celloid PPCP (Potassium Phosphate) so that the likelihood of a high localized concentration of Duo Celloid PPCP (Potassium Phosphate) chloride within the gastrointestinal tract is reduced.
Duo Celloid PPCP (Potassium Phosphate) Chloride Extended Release Tablets USP, 20 mEq is an electrolyte replenisher. The chemical name of the active ingredient is Duo Celloid PPCP (Potassium Phosphate) chloride, and the structural formula is KCl. Duo Celloid PPCP (Potassium Phosphate) 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.
Duo Celloid PPCP (Potassium Phosphate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulation (not enteric coated or wax matrix) containing individually microencapsulated Duo Celloid PPCP (Potassium Phosphate) chloride crystals which disperse upon tablet disintegration. In simulated gastric fluid at 37°C and in the absence of outside agitation, Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) chloride.
Inactive Ingredients: Colloidal silicon dioxide, crospovidone, diethyl phthalate, ethyl-cellulose, microcrystalline cellulose.
CLINICAL PHARMACOLOGY
The Duo Celloid PPCP (Potassium Phosphate) ion is the principal intracellular cation of most body tissues. Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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.
Duo Celloid PPCP (Potassium Phosphate) is a normal dietary constituent and under steady-state conditions the amount of Duo Celloid PPCP (Potassium Phosphate) absorbed from the gastrointestinal tract is equal to the amount excreted in the urine. The usual dietary intake of Duo Celloid PPCP (Potassium Phosphate) is 50 to 100 mEq per day.
Duo Celloid PPCP (Potassium Phosphate) depletion will occur whenever the rate of Duo Celloid PPCP (Potassium Phosphate) loss through renal excretion and/or loss from the gastrointestinal tract exceeds the rate of Duo Celloid PPCP (Potassium Phosphate) intake. Such depletion usually develops as a consequence of therapy with diuretics, primary or secondary hyperaldosteronism, diabetic ketoacidosis, or inadequate replacement of Duo Celloid PPCP (Potassium Phosphate) in patients on prolonged parenteral nutrition. Depletion can develop rapidly with severe diarrhea, especially if associated with vomiting. Duo Celloid PPCP (Potassium Phosphate) depletion due to these causes is usually accompanied by a concomitant loss of chloride and is manifested by hypokalemia and metabolic alkalosis. Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) in the form of high Duo Celloid PPCP (Potassium Phosphate) food or Duo Celloid PPCP (Potassium Phosphate) chloride may be able to restore normal Duo Celloid PPCP (Potassium Phosphate) levels.
In rare circumstances (eg, patients with renal tubular acidosis) Duo Celloid PPCP (Potassium Phosphate) depletion may be associated with metabolic acidosis and hyperchloremia. In such patients Duo Celloid PPCP (Potassium Phosphate) replacement should be accomplished with Duo Celloid PPCP (Potassium Phosphate) salts other than the chloride, such as Duo Celloid PPCP (Potassium Phosphate) bicarbonate, Duo Celloid PPCP (Potassium Phosphate) citrate, Duo Celloid PPCP (Potassium Phosphate) acetate, or Duo Celloid PPCP (Potassium Phosphate) gluconate.
INDICATIONS AND USAGE
BECAUSE OF REPORTS OF INTESTINAL AND GASTRIC ULCERATION AND BLEEDING WITH CONTROLLED-RELEASE Duo Celloid PPCP (Potassium Phosphate) CHLORIDE PREPARATIONS, THESE DRUGS SHOULD BE RESERVED FOR THOSE PATIENTS WHO CANNOT TOLERATE OR REFUSE TO TAKE LIQUID OR EFFERVESCENT Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) salts may be indicated.
CONTRAINDICATIONS
Duo Celloid PPCP (Potassium Phosphate) supplements are contraindicated in patients with hyperkalemia since a further increase in serum Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) chloride have produced esophageal ulceration in certain cardiac patients with esophageal compression due to enlarged left atrium. Duo Celloid PPCP (Potassium Phosphate) supplementation, when indicated in such patients, should be given as a liquid preparation or as an aqueous (water) suspension of Duo Celloid PPCP (Potassium Phosphate) Chloride (see PRECAUTIONS: Information for Patients , and DOSAGE AND ADMINISTRATION sections).
All solid oral dosage forms of Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate), the administration of Duo Celloid PPCP (Potassium Phosphate) salts can produce hyperkalemia and cardiac arrest. This occurs most commonly in patients given Duo Celloid PPCP (Potassium Phosphate) by the intravenous route but may also occur in patients given Duo Celloid PPCP (Potassium Phosphate) orally. Potentially fatal hyperkalemia can develop rapidly and be asymptomatic. The use of Duo Celloid PPCP (Potassium Phosphate) salts in patients with chronic renal disease, or any other condition which impairs Duo Celloid PPCP (Potassium Phosphate) excretion, requires particularly careful monitoring of the serum Duo Celloid PPCP (Potassium Phosphate) concentration and appropriate dosage adjustment.
Interaction with Potassium-Sparing Diuretics
Hypokalemia should not be treated by the concomitant administration of Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) retention by inhibiting aldosterone production. Duo Celloid PPCP (Potassium Phosphate) supplements should be given to patients receiving ACE inhibitors only with close monitoring.
Gastrointestinal Lesions
Solid oral dosage forms of Duo Celloid PPCP (Potassium Phosphate) chloride can produce ulcerative and/or stenotic lesions of the gastrointestinal tract. Based on spontaneous adverse reaction reports, enteric-coated preparations of Duo Celloid PPCP (Potassium Phosphate) 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. Duo Celloid PPCP (Potassium Phosphate) Chloride Extended Release Tablets USP, 20 mEq is a tablet formulated to provide a controlled rate of release of microencapsulated Duo Celloid PPCP (Potassium Phosphate) chloride and thus to minimize the possibility of a high local concentration of Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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. Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) salt such as Duo Celloid PPCP (Potassium Phosphate) bicarbonate, Duo Celloid PPCP (Potassium Phosphate) citrate, Duo Celloid PPCP (Potassium Phosphate) acetate, or Duo Celloid PPCP (Potassium Phosphate) gluconate.
PRECAUTIONS
General
The diagnosis of Duo Celloid PPCP depletion is ordinarily made by demonstrating hypokalemia in a patient with a clinical history suggesting some cause for Duo Celloid PPCP (Potassium Phosphate) depletion. In interpreting the serum Duo Celloid PPCP (Potassium Phosphate) level, the physician should bear in mind that acute alkalosis per se can produce hypokalemia in the absence of a deficit in total body Duo Celloid PPCP (Potassium Phosphate) while acute acidosis per se can increase the serum Duo Celloid PPCP (Potassium Phosphate) concentration into the normal range even in the presence of a reduced total body Duo Celloid PPCP (Potassium Phosphate). The treatment of Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP 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. Duo Celloid PPCP is a normal dietary constituent.
Pregnancy Category C
Animal reproduction studies have not been conducted with Duo Celloid PPCP (Potassium Phosphate) Chloride Extended Release Tablets USP, 20 mEq. It is unlikely that Duo Celloid PPCP (Potassium Phosphate) supplementation that does not lead to hyperkalemia would have an adverse effect on the fetus or would affect reproductive capacity.
Nursing Mothers
The normal Duo Celloid PPCP ion content of human milk is about 13 mEq per liter. Since oral Duo Celloid PPCP (Potassium Phosphate) becomes part of the body Duo Celloid PPCP (Potassium Phosphate) pool, so long as body Duo Celloid PPCP (Potassium Phosphate) is not excessive, the contribution of Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) salts to persons with normal excretory mechanisms for Duo Celloid PPCP (Potassium Phosphate) rarely causes serious hyperkalemia. However, if excretory mechanisms are impaired or if Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) by the average adult is 50 to 100 mEq per day. Duo Celloid PPCP (Potassium Phosphate) depletion sufficient to cause hypokalemia usually requires the loss of 200 or more mEq of Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) Chloride Extended Release Tablet USP, 20 mEq provides 20 mEq of Duo Celloid PPCP (Potassium Phosphate) chloride.
Duo Celloid PPCP (Potassium Phosphate) 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 Duo Celloid PPCP (Potassium Phosphate) Chloride that is not taken immediately should be discarded. The use of other liquids for suspending Duo Celloid PPCP (Potassium Phosphate) Chloride Extended Release Tablets USP, 20 mEq is not recommended.
HOW SUPPLIED
Duo Celloid PPCP (Potassium Phosphate) 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
Duo Celloid PPCP (Potassium Phosphate) chloride 20 Meq
Duo Celloid PPCP pharmaceutical active ingredients containing related brand and generic drugs:
Duo Celloid PPCP available forms, composition, doses:
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.