Cyprodiol Tablet

Calcium 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 )

• The recommended initial dose of calcium 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 3-4 capsules with each meal
• Starting dose is 2 capsules with each meal
• Titrate the dose every 2-3 weeks until acceptable serum phosphorus level is reached
• Most patients require 3-4 capsules with each meal

Capsule: 667 mg calcium acetate per capsule. Capsule: 667 mg calcium acetate capsules. ( 3 )

• Safety and effectiveness
• In pediatric patients have not been established

Clinical studies of calcium 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. …

• Inform patients to take calcium acetate with meals, adhere to their prescribed diets, and avoid the use of calcium supplements including nonprescription antacids
• Inform the patients about the symptoms of hypercalcemia [see Warnings and Precautions and Adverse Reactions ]
• 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 calcium acetate
• Manufactured by: Avema Pharma Solutions 10400 NW 29th Terrace, Doral, FL 33172 Manufactured for: Cipla USA, Inc. …

• Patients with hypercalcemia
• Hypercalcemia

The drug interaction of calcium acetate is characterized by the potential of calcium to bind to drugs with anionic functions (e.g., carboxyl, and hydroxyl groups). Calcium acetate may decrease the bioavailability of tetracyclines or fluoroquinolones via this mechanism. There are no empirical data on avoiding drug interactions between calcium acetate and most concomitant drugs. When administering an oral medication with calcium 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 calcium acetate. …

Treat mild hypercalcemia by reducing or interrupting calcium acetate capsules and Vitamin D. Severe hypercalcemia may require hemodialysis and discontinuation of calcium acetate capsules. ( 5.1 ) Hypercalcemia may aggravate digitalis toxicity. ( 5.2 ) 5.1 Hypercalcemia Patients with end stage renal disease may develop hypercalcemia when treated with calcium, including calcium acetate. Avoid the use of calcium supplements, including calcium based nonprescription antacids, concurrently with calcium acetate. An overdose of calcium acetate may lead to progressive hypercalcemia, which may require emergency measures. …

Hypercalcemia is discussed elsewhere [see Warnings and Precautions (5.1) ]. The most common (>10%) adverse reactions are hypercalcemia, nausea and vomiting. ( 6.1 ) In clinical studies, patients have occasionally experienced nausea during calcium acetate therapy. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Cipla Ltd. at 1-866-604-3268 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. …

8.1 Pregnancy Pregnancy Category C Calcium acetate capsules contain calcium acetate. Animal reproduction studies have not been conducted with calcium acetate, and there are no adequate and well controlled studies of calcium acetate use in pregnant women. Patients with end stage renal disease may develop hypercalcemia with calcium acetate treatment [see Warnings and Precautions (5.1) ] . …

Administration of calcium acetate in excess of the appropriate daily dosage may result in hypercalcemia [see Warnings and Precautions (5.1) ].

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.