RENVELA 800 MG 180 TAB

Indications

Approved Uses

Control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis

Off-Label Uses

No common off-label use; use in CKD not on dialysis is an approved indication (not off-label).

Dosage & Administration

Dosing by Condition

CKD on dialysis: initial 800 mg TID with meals if serum phosphorus 5.5 to <7.5 mg/dL, or 1600 mg TID with meals if ≥7.5 mg/dL; titrate by 800 mg per meal at ~2-week intervals to target phosphorus. CKD not on dialysis: initial 800 mg TID with meals; titrate by 800 mg per meal at ~2-week intervals based on serum phosphorus.

Initial Dose

For adults not taking a phosphate binder, 800 mg to 1600 mg taken three times daily with meals, based on serum phosphorus level.

Maintenance Dose

800-1600 mg three times daily with meals, titrated to achieve target serum phosphorus

Maximum Dose

No formally established maximum dose; doses up to 14 g/day have been studied in adults on dialysis.

Dose Adjustment Notes

Titrate based on serum phosphorus (typically adjust by 800 mg per meal at ~2-week intervals); no renal/hepatic dose adjustment is required; when switching from sevelamer hydrochloride, use the same total daily dose in mg.

How to Take

Take orally WITH meals; swallow tablets whole-do not crush, chew, or break.

Side Effects

Common Side Effects

Vomiting, nausea, diarrhea, dyspepsia, abdominal pain, flatulence, constipation.

Side Effect Frequency

Very common (≥10%): vomiting, nausea, diarrhea, dyspepsia. Common (1-10%): abdominal pain, constipation, flatulence. Uncommon/rare: ileus/subileus, intestinal obstruction, intestinal perforation (serious GI events).

Safety & Warnings

Contraindications

Bowel obstruction; hypersensitivity to sevelamer carbonate or any excipients.

Warnings & Precautions

Use caution in dysphagia/swallowing disorders, severe constipation or GI motility disorders, and history of major GI surgery; monitor for severe constipation/obstruction/perforation; manage drug-binding interactions with dose separation (especially ciprofloxacin) and monitoring for narrow-therapeutic-index drugs; monitor bicarbonate/chloride (acid-base) and consider monitoring fat-soluble vitamins/folate in dialysis patients.

Drug Interactions

Drug Interactions

Reduces absorption of some oral drugs; separate administration-ciprofloxacin should not be co-administered (give at least 2 hours before or 6 hours after), and for levothyroxine, mycophenolate mofetil, cyclosporine, tacrolimus (and other narrow-therapeutic-index oral drugs) separate dosing and monitor clinical response/levels.

Interaction Severity

MAJOR/contraindicated to coadminister: ciprofloxacin (sevelamer markedly reduces exposure-separate or avoid per labeling). MODERATE/clinically significant: levothyroxine (reduced absorption-separate and monitor TSH), mycophenolate mofetil (reduced exposure-separate/monitor), cyclosporine and tacrolimus (possible reduced absorption-monitor levels).

Food Interaction

Must be taken with food (with meals).

Special Populations

Elderly

Standard adult dosing; no specific dose adjustment required, but monitor for gastrointestinal tolerability

Kidney Impairment

No renal dose adjustment; dose is titrated to serum phosphorus (and tolerability) in CKD, including dialysis patients.

Liver Impairment

No hepatic dose adjustment required.

Storage & Patient Advice

Stopping the Medicine

May be discontinued if clinically indicated, but serum phosphate will rise/recur; do not stop without prescriber guidance in CKD patients.

Overdose

Systemic toxicity is unlikely (not absorbed); overdose may cause GI adverse effects (notably constipation/possible obstruction); manage symptomatically/supportively and seek medical evaluation if significant symptoms occur.

Patient Counseling

Take with meals every time; swallow tablets whole (do not crush/chew); follow a low-phosphorus diet; separate other oral medications when advised (notably ciprofloxacin and levothyroxine) and keep a consistent schedule; report severe constipation, abdominal pain, vomiting, or signs of bowel obstruction; attend regular labs for phosphorus and related CKD-MBD parameters.

Monitoring Requirements

Monitor serum phosphorus frequently during titration (e.g., about every 2 weeks) then periodically; also monitor calcium and bicarbonate as clinically indicated; consider monitoring PTH and fat-soluble vitamins/folate with long-term therapy, especially if dietary intake is restricted.

Pharmacology

Mechanism of Action

Non-absorbed anion-exchange polymer that binds dietary phosphate in the GI tract (exchanging carbonate), forming an insoluble complex excreted in feces, thereby lowering serum phosphate.

Onset of Action

Serum phosphorus reduction can be seen within ~1-2 weeks; full titration/steady control often requires several weeks (commonly 2-4 weeks) depending on dose adjustments.

Duration of Effect

Effect persists only with ongoing dosing taken with meals; serum phosphate rises after discontinuation.

Half-Life

Not applicable as the drug is not systemically absorbed.

Bioavailability

Not systemically absorbed (<0.1%)

Metabolism

Not metabolized (not absorbed; acts locally in the gastrointestinal tract).

Excretion

Fecal excretion; sevelamer is not systemically absorbed and is eliminated in feces (as the polymer and bound complexes).

Protein Binding

Not applicable as the drug is not systemically absorbed.

Product Information

Available Dosage Forms

Film-coated tablet; powder for oral suspension

Composition per Dose

Each film-coated tablet: 800 mg sevelamer carbonate

OTC Alternatives

No OTC alternative

Urological Condition

Kidney Disease Complications

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