Sevelamer Hydrochloride 800 mg/1
Sevelamer Hydrochloride · TABLET, FILM COATED · Macleods Pharmaceuticals Limited
Sevelamer Hydrochloride is a tablet, film coated containing sevelamer hydrochloride at 800 mg/1, taken oral. Manufactured by Macleods Pharmaceuticals Limited.
Key Facts
- Brand Name
- Sevelamer Hydrochloride
- Generic Name
- Sevelamer Hydrochloride
- NDC Code (Product)
33342-242- Manufacturer
- Macleods Pharmaceuticals Limited
- Strength
- 800 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA206883
- Marketing Start
- 05/26/2023
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE Sevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The safety and efficacy of sevelamer hydrochloride tablets in CKD patients who are not on dialysis have not been studied. • Sevelamer hydrochloride tablets are a phosphate binder indicated for the control of serum phosphorus in patients with chronic kidney disease on dialysis. ( 1 )
Dosage & Administration
2. DOSAGE AND ADMINISTRATION Patients Not Taking a Phosphate Binder . The recommended starting dose of sevelamer hydrochloride tablets is 800 to 1600 mg, which can be administered as one or two 800 mg sevelamer hydrochloride tablets or two to four 400 mg sevelamer hydrochloride tablets, with meals based on serum phosphorus level. Table 1 provides recommended starting doses of sevelamer hydrochloride tablets for patients not taking a phosphate binder. Table 1: Starting Dose for Dialysis Patients Not Taking a Phosphate Binder Serum Phosphorus Sevelamer Hydrochloride Tablets 800 mg Sevelamer Hydrochloride Tablets 400 mg >5.5 and <7.5 mg/dL 1 tablet three times daily with meals 2 tablets three times daily with meals ≥7.5 and <9 mg/dL 2 tablets three times daily with meals 3 tablets three times daily with meals ≥9 mg/dL 2 tablets three times daily with meals 4 tablets three times daily with meals Patients Switching from Calcium Acetate . In a study in 84 CKD patients on hemodialysis, a similar reduction in serum phosphorus was seen with equivalent doses (approximately mg for mg) of sevelamer hydrochloride tablets and calcium acetate. Table 2 gives recommended starting doses of sevelamer…
Contraindications
4. CONTRAINDICATIONS Sevelamer hydrochloride is contraindicated in patients with bowel obstruction. Sevelamer hydrochloride tablets are contraindicated in patients with known hypersensitivity to sevelamer hydrochloride or to any of the excipients. • Bowel obstruction. ( 4 ) • Known hypersensitivity to sevelamer hydrochloride or to any of the excipients. ( 4 )
Drug Interactions
7. DRUG INTERACTIONS There are no empirical data on avoiding drug interactions between sevelamer hydrochloride and most concomitant oral drugs. For oral medication where a reduction in the bioavailability of that medication would have a clinically significant effect on its safety or efficacy (e.g., cyclosporine, tacrolimus, levothyroxine), consider separation of the timing of the administration of the two drugs [see Clinical Pharmacology ( 12.3 )] . The duration of separation depends upon the absorption characteristics of the medication concomitantly administered, such as the time to reach peak systemic levels and whether the drug is an immediate-release or an extended-release product. Where possible monitor clinical responses or blood levels of concomitant drugs that have a narrow therapeutic range. Table 4: Sevelamer Drug Interactions Oral drugs for which sevelamer did not alter the pharmacokinetics when administered concomitantly Digoxin Enalapril Iron Metoprolol Warfarin Oral drugs that have demonstrated interaction with sevelamer and are to be dosed separately from sevelamer hydrochloride Dosing Recommendations Ciprofloxacin Take at least 2 hours before or 6 hours after sevela…
Adverse Reactions
6. ADVERSE REACTIONS • The most common reasons for discontinuing treatment were gastrointestinal adverse reactions. ( 6.1 ) • In a parallel design study of 12 weeks duration, treatment-emergent adverse reactions to sevelamer hydrochloride tablets in peritoneal dialysis patients included dyspepsia (12%), peritonitis (8%), diarrhea (5%), nausea (5%), constipation (4%), pruritus (4%), abdominal distension (3%), vomiting (3%), fatigue (3%), anorexia (3%), and arthralgia (3%). ( 6.1 ) • Cases of fecal impaction and, less commonly, ileus, bowel obstruction, and bowel perforation have been reported. ( 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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 a parallel design study of sevelamer hydrochloride with treatment duration of 52 weeks, adverse reactions reported for sevelamer hydrochloride…
Frequently Asked Questions
What is Sevelamer Hydrochloride used for?
Sevelamer Hydrochloride contains Sevelamer Hydrochloride. It is a tablet, film coated taken oral. Consult your doctor for specific uses.
Is Sevelamer Hydrochloride a controlled substance?
Sevelamer Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Sevelamer Hydrochloride?
The generic name for Sevelamer Hydrochloride is Sevelamer Hydrochloride. There are 6 other brand versions of Sevelamer Hydrochloride.
What is the NDC code for Sevelamer Hydrochloride 800 mg/1?
The NDC (National Drug Code) for Sevelamer Hydrochloride 800 mg/1 is 33342-242, listed by Macleods Pharmaceuticals Limited.