Sevelamer Carbonate Zentiva
Sevelamer Carbonate Zentiva Uses, Dosage, Side Effects, Food Interaction and all others data.
Sevelamer Carbonate Zentiva Hydrochloride is a new treatment for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Elevated serum phosphorus levels or uncontrolled hyperphosphatemia leads to development of secondary hyperparathyroidism, renal bone disease, calcification of vascular and nonvascular tissues, and cardiovascular disease. It is a calcium-free and aluminium-free nonabsorbed polymer phosphate binder, it does not cause calcium and aluminium toxicity. When taken with meals it inhibits intestinal absorption of ingested phosphate.
Patients with end-stage renal disease (ESRD) retain phosphorus and can develop hyperphosphatemia. High serum phosphorus can precipitate serum calcium resulting in ectopic calcification. When the product of serum calcium and phosphorus concentrations (Ca x P) exceeds 55 mg2/dL2, there is an increased risk that ectopic calcification will occur. Hyperphosphatemia plays a role in the development of secondary hyperparathyroidism in renal insufficiency. An increase in parathyroid hormone (PTH) levels is characteristic of patients with chronic renal failure. Increased levels of PTH can lead to osteitis fibrosa, a bone disease. A decrease in serum phosphorus may decrease serum PTH levels. Treatment of hyperphosphatemia includes reduction in dietary intake of phosphate, inhibition of intestinal phosphate absorption with phosphate binders, and removal of phosphate with dialysis. Sevelamer Carbonate Zentiva taken with meals has been shown to decrease serum phosphorus concentrations in patients with ESRD who are on hemodialysis. In vitro studies have shown that the capsule and tablet formulations bind phosphate to a similar extent. Sevelamer Carbonate Zentiva treatment also results in a lowering of low-density lipoprotein (LDL) and total serum cholesterol levels.
| Trade Name | Sevelamer Carbonate Zentiva |
| Availability | Prescription only |
| Generic | Sevelamer |
| Sevelamer Other Names | Sevelamer, Sévélamer, Sevelamero, Sevelamerum |
| Related Drugs | sucralfate, Carafate, Renvela, Auryxia, Velphoro, Renagel |
| Type | |
| Formula | C6H12ClNO |
| Weight | Average: 149.619 Monoisotopic: 149.060741718 |
| Groups | Approved |
| Therapeutic Class | Drugs for reduction of serum phosphorus in patients with ESRD |
| Manufacturer | |
| Available Country | Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, United Kingdom |
| Last Updated: | September 19, 2023 at 7:00 am |
Uses
Sevelamer Carbonate Zentiva Hydrochloride is used for the reduction of serum phosphorus in patients with end-stage renal disease (ESRD).
Sevelamer Carbonate Zentiva is also used to associated treatment for these conditions: Hyperphosphataemia
How Sevelamer Carbonate Zentiva works
Sevelamer Carbonate Zentiva prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels.
Dosage
Sevelamer Carbonate Zentiva dosage
Patients not taking a Phosphate Binder: The recommended starting dose of Sevelamer Carbonate Zentiva is 800 to 1600 mg, which can be administered as two to four 400 mg Sevelamer Carbonate Zentiva tablets, with meals based on serum phosphorus level. Renophos 400 Recommendation for the patients with hyperphosphatemia is given below-
Starting dose of Renophos for dialysis patients not taking any phosphate binder:
- Serum Phosphorus >5.5 and <7.5 mg/dL: 800 mg (2 tablets) three times daily with meals
- Serum Phosphorus ≥7.5 and <9.0 mg/dL: 1200 mg (3 tablets) three times daily with meals
- Serum Phosphorus ≥9.0 mg/dL: 1600 mg (4 tablets) three times daily with meals
Starting dose for dialysis patients switching from calcium acetate to Sevelamer Carbonate Zentiva:
- Calcium Acetate 667 mg (1 tablet): Sevelamer Carbonate Zentiva 800 mg (2 tablets)
- Calcium Acetate 1334 mg (2 tablets): Sevelamer Carbonate Zentiva 1200 mg (3 tablets)
- Calcium Acetate 2001 mg (3 tablets): Sevelamer Carbonate Zentiva 2000 mg (5 tablets)
Dose titration guideline:
- Serum Phosphorus >5.5 mg/dL: Increase 400 mg (1 tablet) per meal at 2 week intervals
- Serum Phosphorus 3.5-5.5 mg/dL: Maintain current dose
- Serum Phosphorus <3.5 mg/dL: Decrease 400 mg (1 tablet) per meal
Dose titration for all patients taking Sevelamer Carbonate Zentiva: Dosage should be adjusted based on the serum phosphorus concentration with a goal of lowering serum phosphorus to 5.5 mg/dl or less. The dose may be increased or decreased by one tablet per meal at two week intervals as necessary.
Side Effects
Sevelamer Carbonate Zentiva may cause dyspepsia, peritonitis, diarrhea, nausea, constipation, pruritus, abdominal distension, vomiting, fatigue, anorexia, arthralgia and less commonly ileus, bowel obstruction and bowel perforation.
Toxicity
Sevelamer Carbonate Zentiva has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. Sevelamer Carbonate Zentiva has been given in average doses up to 13 grams per day to hemodialysis patients. There are no reported overdosages of sevelamer in patients. Since sevelamer is not absorbed, the risk of systemic toxicity is low.
Precaution
The safety and efficacy of Sevelamer Carbonate Zentiva in patients with dysphagia, swallowing disorders, severe GI motility disorders including severe constipation, or major GI tract surgery have not been established. Caution should be exercised when Sevelamer Carbonate Zentiva is used in patients with these GI disorders.
Interaction
Sevelamer Carbonate Zentiva has been studied in human drug-drug interaction studies with ciprofloxacin, digoxin, warfarin, enalapril, metoprolol and iron.
Food Interaction
- Take with food.
[Moderate] ADJUST DOSING INTERVAL: Sevelamer Carbonate Zentiva may decrease the oral bioavailability of concomitantly administered drugs. While clinical data are lacking for most drugs, the intestinal absorption of some may be impaired due to sevelamer's binding capabilities.
MANAGEMENT: As a precaution, drugs that can be adversely affected by alterations in blood levels should be administered 1 hour before or 3 hours after sevelamer.
Sevelamer Carbonate Zentiva multivitamins interaction
[Moderate] ADJUST DOSING INTERVAL: Bile acid sequestrants and the phosphate binder, sevelamer, can decrease the absorption of fat-soluble vitamins A, D, E, and K.
In non-clinical safety studies, rats administered colesevelam at doses greater than 30-fold the projected human clinical dose developed hemorrhage in association with vitamin K deficiency.
In a crossover study involving healthy subjects, coadministration of sevelamer with calcitriol resulted in a significant reduction in bioavailability for calcitriol (calcitriol with sevelamer vs calcitriol alone: AUC 137 pg*h
Oral vitamin supplements should be administered at least 4 hours before colesevelam and either 1 hour before or 4 to 6 hours after other bile acid sequestrants and sevelamer.
Sevelamer Carbonate Zentiva Drug Interaction
Moderate: multivitamin with iron, multivitamin, levothyroxine, cholecalciferolUnknown: aspirin, aspirin, docusate, apixaban, epoetin alfa, omega-3 polyunsaturated fatty acids, insulin glargine, insulin glargine, furosemide, metoprolol, metoprolol, polyethylene glycol 3350, insulin aspart, cinacalcet, acetaminophen, ondansetron
Sevelamer Carbonate Zentiva Disease Interaction
Major: gastrointestinal diseaseModerate: dysphagia, renal disease
Elimination Route
Not absorbed following oral administration, however no absorption studies have been performed in patients with renal disease. Sevelamer Carbonate Zentiva may bind to dietary phosphates and prevent its gastrointestinal absorption when sevelamer is administered in combination with food.
Pregnancy & Breastfeeding use
Pregnancy Category C. No adequate and controlled studies have been conducted using Sevelamer Carbonate Zentiva in nursing mothers. Sevelamer Carbonate Zentiva should be used during breastfeeding only if the potential benefit justifies the potential risks.
Contraindication
Sevelamer Carbonate Zentiva is contraindicated in patients with hypophosphatemia or bowel obstruction and in patients with known hypersensitivity to Sevelamer Carbonate Zentiva hydrochloride or any of its constituents.
Acute Overdose
Over dosages of Sevelamer Carbonate Zentiva in patients was never reported. Since Sevelamer Carbonate Zentiva is not absorbed, the risk of systemic toxicity is low.
Innovators Monograph
You find simplified version here Sevelamer Carbonate Zentiva
FAQ
What is Sevelamer Carbonate Zentiva used for?
Sevelamer Carbonate Zentiva is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis .
How does a Sevelamer Carbonate Zentiva work?
Sevelamer Carbonate Zentiva works by lowers your blood phosphorus levels to help protect your kidneys and bones.
What are the common side effects of Sevelamer Carbonate Zentiva?
Sevelamer Carbonate Zentiva may cause common side effects are include:
- diarrhea.
- vomiting.
- nausea.
- stomach pain.
- gas.
- heartburn.
- new or worsening constipation.
Is Sevelamer Carbonate Zentiva safe during pregnancy?
Sevelamer Carbonate Zentiva products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of Sevelamer Carbonate Zentiva hydrochloride on the absorption of vitamins and other nutrients has not been studied in pregnant women.
Is Sevelamer Carbonate Zentiva safe during breastfeeding?
Sevelamer Carbonate Zentiva is not absorbed into the bloodstream, it is not expected to be harmful to a nursing baby.The non-absorbed nature of this drug makes its excretion in human breast milk unlikely. No adequate and controlled studies have been conducted in nursing mothers.
When should Sevelamer Carbonate Zentiva be given?
It is usually taken three times a day with meals. Follow the directions on your prescription label carefully.
Can Sevelamer Carbonate Zentiva tablets be crushed?
Sevelamer Carbonate Zentiva tablets may be crushed and administered via enteral feeding tubes, provided clear instruction on tablet preparation is included.
Can I overdose on Sevelamer Carbonate Zentiva?
If Sevelamer Carbonate Zentiva is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.
How to use Sevelamer Carbonate Zentiva?
Take this medication by mouth as directed by your doctor, usually 3 times daily with meals. Swallow the tablet whole. Do not crush, chew, or split the tablet. The dosage is based on your medical condition, any other medications you take to lower your phosphate levels, and your response to treatment. In children, the dosage is also based on body size.
Can I chew Sevelamer Carbonate Zentiva?
Swallow the tablet whole.Do not crush, chew, or split the tablet.
Does Sevelamer Carbonate Zentiva effect my kidney?
Sevelamer Carbonate Zentiva lowers phosphorus levels in people with kidney disease on dialysis. Take with meals.
What happens if I stop taking Sevelamer Carbonate Zentiva?
If you stop taking Sevelamer Carbonate Zentiva, your phosphate levels may rise again. It is important to keep taking your medicines even if you feel well. Do not stop taking Sevelamer Carbonate Zentiva.
What is the reason for taking Sevelamer Carbonate Zentiva with food?
Sevelamer Carbonate Zentiva should be taken three times a day with meals to help control phosphorus levels in your body. Sevelamer Carbonate Zentiva binds to (or holds on to) phosphorus in the foods you eat so your body doesn't absorb as much.
Does Sevelamer Carbonate Zentiva increase calcium?
Sevelamer Carbonate Zentiva does not contain calcium or metal and is not absorbed, so it does not build up in your body.
How many times a day can I take Sevelamer Carbonate Zentiva?
Sevelamer Carbonate Zentiva takes 3 times per day with meals. As directed by your doctor.
What happens if I miss a dose of Sevelamer Carbonate Zentiva?
Take the missed dose as soon as you remember. Be sure to take the missed dose with food. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
