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sevelamer carbonate 800 mg tab generic renvela

In stock Manufacturer AMNEAL PHARMACE 65162005827
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Uses

Hyperphosphatemia

Sevelamer carbonate and sevelamer hydrochloride are used to reduce serum phosphorus in patients with chronic kidney disease (CKD) who are undergoing dialysis. Safety and efficacy of sevelamer in patients with CKD who are not undergoing dialysis have not been studied. The risk of developing hypercalcemia appears to be less with sevelamer hydrochloride than with calcium (e.g., calcium acetate) salts.

Therapeutic measures to control hyperphosphatemia in patients with chronic renal failure usually include reduction in dietary intake of phosphates, inhibition of intestinal phosphate absorption, and removal via dialysis. Reductions in serum phosphate through dietary restrictions and dialysis generally are insufficient, and inhibition of intestinal phosphate absorption usually is necessary. For further information on the management of hyperphosphatemia in patients with chronic renal failure, .

Efficacy of sevelamer carbonate and sevelamer hydrochloride for the management of hyperphosphatemia in patients with CKD undergoing dialysis has been established in several studies of 2-52 weeks'; duration. In one placebo-controlled study, patients older than 18 years of age with CKD undergoing hemodialysis (3 times weekly) who were receiving calcium-containing phosphate binders (with or without vitamin D analogs) were randomized to receive sevelamer hydrochloride or placebo for 2 weeks (2 weeks after discontinuance of calcium-containing phosphate binders). Daily dosage of sevelamer hydrochloride (mean dosage of about 4 g daily) was based on the total daily dosage of calcium (rounded to the nearest 500 mg). At the end of the 2-week treatment period, serum phosphorus concentrations decreased by a mean 1.2 mg/dL in patients receiving sevelamer hydrochloride while serum phosphate concentrations increased by a mean 0.2 mg/dL in those receiving placebo.

Results of an open-label, randomized, 16-week crossover study in 84 patients with CKD undergoing hemodialysis who had hyperphosphatemia (serum phosphorus concentrations exceeding 6 mg/dL) indicate that efficacy of sevelamer hydrochloride (average daily dosage of 4.9 g at the end of the study) in reducing serum phosphorus concentrations is similar to that of calcium acetate (average daily dosage of 5 g at the end of the study). Dosage of sevelamer hydrochloride or calcium acetate was adjusted according to the patient's serum phosphorus concentrations; each drug decreased serum phosphorus concentrations by about 2 mg/dL. In addition, mean total and LDL-cholesterol reductions of 15 and 24% were observed in patients receiving sevelamer hydrochloride while no such reductions were reported with calcium acetate. Some clinicians have suggested that since atherosclerosis is accelerated in patients undergoing dialysis, sevelamer-associated reductions in cholesterol may play a role in the attenuation of disease progression; however, further studies are needed to determine the potential usefulness of the drug's lipid-lowering effects in these patients. Hypercalcemia (serum calcium concentrations of 11 mg/dL or more) was reported in 5 or 22% of patients receiving sevelamer hydrochloride or calcium acetate, respectively. Intact parathyroid hormone (PTH) concentrations were reduced more substantially with calcium acetate than with sevelamer hydrochloride and therefore, calcium salts, calcitriol, or another vitamin D analog usually is administered concomitantly with sevelamer hydrochloride to reduce elevated PTH concentrations that may occur in patients with CKD undergoing hemodialysis. (See Description.)

In an open-label, 52-week comparative study, 200 patients with CKD undergoing hemodialysis who had hyperphosphatemia (serum phosphorus concentrations exceeding 5.5 mg/dL) were randomized to receive sevelamer hydrochloride (average daily dosage of 6.5 g at the end of the study) or active control. At the end of the 52-week treatment period, serum phosphorus concentrations decreased by a mean 2.1 or 1.8 mg/dL in patients receiving sevelamer hydrochloride or active control, respectively.

In a double-blind, 16-week crossover study, 79 patients with Stage 5 CKD undergoing hemodialysis who had hyperphosphatemia received a 5-week run-in period of treatment with sevelamer hydrochloride and then were randomized to receive sevelamer carbonate (at a dosage equal [on a gram per gram basis] to the sevelamer hydrochloride dosage during the run-in period) or sevelamer hydrochloride for 8 weeks each, with no intervening washout period. Average daily dosage was 6 g for both treatments, and both treatments resulted in similar reductions in phosphorus concentrations.

In an open-label, 12-week comparative study, 143 patients, undergoing peritoneal dialysis who had hyperphosphatemia (serum phosphorus concentrations exceeding 5.5 mg/dL) were randomized to receive sevelamer hydrochloride (average daily dosage of 5.9 g at the end of the study) or active control. At the end of the treatment period, serum phosphorus concentrations decreased by a mean of 1.6 mg/dL in patients receiving sevelamer hydrochloride; this was similar to the reduction observed in patients receiving active control treatment.

Dosage and Administration

General

Because of the rapid disintegration of sevelamer carbonate tablets and their rapid reaction with hydrochloric acid in the stomach, the dosage of sevelamer carbonate tablets is anticipated to be similar to that of the sevelamer hydrochloride tablets.

Sevelamer carbonate and sevelamer hydrochloride tablets are administered orally 3 times daily with meals.

Patients Not Currently Receiving Therapy with a Phosphate Binder

The recommended initial dosage of sevelamer carbonate or sevelamer hydrochloride for the treatment of hyperphosphatemia is dependent on the patient's serum phosphorus concentrations. Patients with serum phosphorus concentrations of more than 5.5 to less than 7.5 mg/dL should receive an initial sevelamer carbonate dosage of 800 mg (administered as one 800-mg tablet) 3 times daily with meals or, alternatively, an initial sevelamer hydrochloride dosage of 800 mg (administered as one 800-mg tablet or two 400-mg tablets) 3 times daily with meals. Patients with serum phosphorus concentrations of 7.5 to less than 9 mg/dL should receive an initial sevelamer carbonate dosage of 1.6 g (administered as two 800-mg tablets) 3 times daily or, alternatively, an initial sevelamer hydrochloride dosage of 1.2 g (administered as three 400-mg tablets) 3 times daily or 1.6 g (administered as two 800-mg tablets) 3 times daily. Patients with serum phosphorus concentrations of 9 mg/dL or more should receive an initial sevelamer carbonate dosage of 1.6 g (administered as two 800-mg tablets) 3 times daily or, alternatively, an initial sevelamer hydrochloride dosage of 1.6 g (administered as two 800-mg tablets or four 400-mg tablets) 3 times daily.

Patients Transferred from Sevelamer Hydrochloride Therapy to Sevelamer Carbonate Therapy

For the treatment of hyperphosphatemia in patients currently receiving sevelamer hydrochloride therapy, the recommended initial dosage of sevelamer carbonate is equivalent to the patient's current sevelamer hydrochloride dosage on a gram per gram basis.

Patients Transferred from Calcium Acetate Therapy

The recommended initial dosage of sevelamer carbonate or sevelamer hydrochloride for the treatment of hyperphosphatemia in patients currently receiving calcium acetate therapy is based on the patient's current calcium acetate dosage. In patients who have been receiving a calcium acetate dosage of 667 mg (administered as one 667-mg tablet) 3 times daily, the initial recommended sevelamer carbonate dosage is 800 mg (administered as one 800-mg tablet) 3 times daily or, alternatively, the initial recommended sevelamer hydrochloride dosage is 800 mg (administered as one 800-mg tablet or two 400-mg tablets) 3 times daily. In patients who have been receiving a calcium acetate dosage of 1.334 g (two 667-mg tablets) 3 times daily, the initial recommended sevelamer carbonate dosage is 1.6 g (administered as two 800-mg tablets) 3 times daily, or, alternatvely, the initial recommended sevelamer hydrochloride dosage is 1.2 g (administered as three 400-mg tablets) 3 times daily or 1.6 g (administered as two 800-mg tablets) 3 times daily. In patients who have been receiving a calcium acetate dosage of 2 g (three 667-mg tablets) 3 times daily, the initial recommended sevelamer carbonate dosage is 2.4 g (administered as three 800-mg tablets) 3 times daily, or, alternatively, the initial recommended sevelamer hydrochloride dosage is 2 g (administered as five 400-mg tablets) 3 times daily or 2.4 g (administered as three 800-mg tablets) 3 times daily.

Dose Titration for All Patients

Dosage of sevelamer carbonate should be adjusted according to the patient's serum phosphorus concentrations with the goal of achieving serum phosphorus concentrations within the target range of 3.5-5.5 mg/dL. Dosage of sevelamer carbonate may be increased or decreased by one 800-mg tablet per meal at 2-week intervals as needed.

In a clinical trial, the average daily dosage of sevelamer carbonate was 6 g; the maximum dosage of the drug studied was 14 g daily.

Dosage of sevelamer hydrochloride should be adjusted according to the patient's serum phosphorus concentrations with the goal of reducing serum phosphorus concentrations to 5.5 mg/dL or less. Dosage of sevelamer hydrochloride may be increased or decreased by 1 tablet per meal at 2-week intervals as needed. If serum phosphorus concentrations exceed 5.5 mg/dL, sevelamer hydrochloride dosage should be increased by 1 tablet per meal at 2-week intervals. Patients with serum phosphorus concentrations 3.5-5.5 mg/dL should maintain their current dosage of sevelamer hydrochloride. If serum phosphorus concentrations are less than 3.5 mg/dL, sevelamer hydrochloride dosage should be decreased by 1 tablet per meal at 2-week intervals.

In one clinical study, the average daily dosage of sevelamer hydrochloride was 2.4 g (given as three 800-mg tablets) 3 times daily, and the maximum average dosage of the drug studied was 13 g daily.

Cautions

Contraindications

Hypophosphatemia or bowel obstruction.

Warnings/Precautions

General Precautions

GI Disease or Surgery

Safety of sevelamer carbonate or sevelamer hydrochloride has not been established in patients with swallowing or severe GI motility disorders (including severe constipation), dysphagia, or major GI tract surgery; the drugs should be used with caution in patients with such disorders. Fecal impaction and rare cases of ileus, intestinal obstruction, and intestinal perforation have been reported; patients who develop constipation or experience worsening of existing constipation should be treated appropriately to avoid the development of severe complications.

Patients undergoing peritoneal dialysis should be monitored closely to ensure proper use of aseptic technique and to monitor for signs and symptoms of peritonitis, which should be recognized promptly and managed appropriately.

Effects on Vitamins

In general in humans, in short-term clinical trials, there was no evidence that vitamin A, D, E, K, or folic acid serum concentrations were decreased in patients receiving sevelamer hydrochloride. However, in a 1-year study, administration of sevelamer hydrochloride was associated with a reduction of 25-hydroxyvitamin D concentrations from a mean 39 to 34 mcg/mL. In addition, reductions in concentrations of vitamins D, E, and K and folic acid were observed in animals. Most patients (75%) in clinical studies of sevelamer hydrochloride have received vitamin supplements. Monitor for reduced serum concentrations of vitamin D, E, K (clotting factors) and folic acid is recommended.

Adequate Patient Monitoring

Serum concentrations of chloride and bicarbonate should be monitored.

Specific Populations

Pregnancy

Category C.

It should be considered that vitamin and other nutrient requirements are increased during pregnancy and the effect of sevelamer hydrochloride on absorption of vitamins and other nutrients has not been studied in pregnant women.

Lactation

Caution is advised if the drug is administered in nursing women.

Pediatric Use

Safety and efficacy not established in children younger than 18 years of age.

Geriatric Use

Experience in those 65 years of age and older is insufficient to determine whether they respond differently from younger adults. Dosage generally should be selected cautiously, usually initiating therapy at the low end of the dosage range.

Common Adverse Effects

There are limited data on safety of sevelamer carbonate. The manufacturer states that since the active ingredient (sevelamer) is the same for sevelamer carbonate and sevelamer hydrochloride, the adverse event profiles of the 2 salts should be similar.

Adverse effects occurring in 5% or more of patients receiving sevelamer hydrochloride include abdominal pain, diarrhea, constipation, dyspepsia, flatulence, nausea, peritonitis (in patients on peritoneal dialysis), and vomiting.

Drug Interactions

No drug interaction studies have been performed with sevelamer carbonate. Drug interactions studies have been performed with sevelamer hydrochloride in humans.

Digoxin, Warfarin, Enalapril, Metoprolol, and Iron

Pharmacokinetic interactions unlikely.

Ciprofloxacin

Pharmacokinetic interaction (decrease in ciprofloxacin bioavailability of about 50%) may occur when sevelamer hydrochloride is used concomitantly with ciprofloxacin.

Levothyroxine

Increased thyroid stimulating hormone (TSH) concentrations have been reported rarely in patients receiving sevelamer hydrochloride concomitantly with levothyroxine; TSH concentrations should be monitored closely in patients receiving both drugs.

Other Drugs

Possible decreased bioavailability of other drugs administered concurrently. If reduced bioavailability would have a clinically important effect on safety or efficacy, such drugs should be administered at least 1 hour before or 3 hours after sevelamer; alternatively, monitoring blood concentrations of such agents should be considered. Sevelamer should be used with caution in patients receiving antiarrhythmic or anticonvulsant agents.

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