СЕЛАМЕРЕКС
СЕЛАМЕРЕКС Uses, Dosage, Side Effects, Food Interaction and all others data.
СЕЛАМЕРЕКС 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. СЕЛАМЕРЕКС 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. СЕЛАМЕРЕКС treatment also results in a lowering of low-density lipoprotein (LDL) and total serum cholesterol levels.
Trade Name | СЕЛАМЕРЕКС |
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 | Russia |
Last Updated: | September 19, 2023 at 7:00 am |
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Uses
СЕЛАМЕРЕКС Hydrochloride is used for the reduction of serum phosphorus in patients with end-stage renal disease (ESRD).
СЕЛАМЕРЕКС is also used to associated treatment for these conditions: Hyperphosphataemia
How СЕЛАМЕРЕКС works
СЕЛАМЕРЕКС prevents hyperphosphatemia by binding to dietary phosphate in the gut, preventing its absorption and thus decreasing serum parathyroid hormone levels.
Dosage
СЕЛАМЕРЕКС dosage
Patients not taking a Phosphate Binder: The recommended starting dose of СЕЛАМЕРЕКС is 800 to 1600 mg, which can be administered as two to four 400 mg СЕЛАМЕРЕКС 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 СЕЛАМЕРЕКС:
- Calcium Acetate 667 mg (1 tablet): СЕЛАМЕРЕКС 800 mg (2 tablets)
- Calcium Acetate 1334 mg (2 tablets): СЕЛАМЕРЕКС 1200 mg (3 tablets)
- Calcium Acetate 2001 mg (3 tablets): СЕЛАМЕРЕКС 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 СЕЛАМЕРЕКС: 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
СЕЛАМЕРЕКС may cause dyspepsia, peritonitis, diarrhea, nausea, constipation, pruritus, abdominal distension, vomiting, fatigue, anorexia, arthralgia and less commonly ileus, bowel obstruction and bowel perforation.
Toxicity
СЕЛАМЕРЕКС has been given to normal healthy volunteers in doses of up to 14 grams per day for eight days with no adverse effects. СЕЛАМЕРЕКС 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 СЕЛАМЕРЕКС 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 СЕЛАМЕРЕКС is used in patients with these GI disorders.
Interaction
СЕЛАМЕРЕКС 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: СЕЛАМЕРЕКС 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.
СЕЛАМЕРЕКС 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.
СЕЛАМЕРЕКС 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
СЕЛАМЕРЕКС 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. СЕЛАМЕРЕКС 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 СЕЛАМЕРЕКС in nursing mothers. СЕЛАМЕРЕКС should be used during breastfeeding only if the potential benefit justifies the potential risks.
Contraindication
СЕЛАМЕРЕКС is contraindicated in patients with hypophosphatemia or bowel obstruction and in patients with known hypersensitivity to СЕЛАМЕРЕКС hydrochloride or any of its constituents.
Acute Overdose
Over dosages of СЕЛАМЕРЕКС in patients was never reported. Since СЕЛАМЕРЕКС is not absorbed, the risk of systemic toxicity is low.
Innovators Monograph
You find simplified version here СЕЛАМЕРЕКС
FAQ
What is СЕЛАМЕРЕКС used for?
СЕЛАМЕРЕКС is used to control high blood levels of phosphorus in people with chronic kidney disease who are on dialysis .
How does a СЕЛАМЕРЕКС work?
СЕЛАМЕРЕКС works by lowers your blood phosphorus levels to help protect your kidneys and bones.
What are the common side effects of СЕЛАМЕРЕКС?
СЕЛАМЕРЕКС may cause common side effects are include:
- diarrhea.
- vomiting.
- nausea.
- stomach pain.
- gas.
- heartburn.
- new or worsening constipation.
Is СЕЛАМЕРЕКС safe during pregnancy?
СЕЛАМЕРЕКС products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The effect of СЕЛАМЕРЕКС hydrochloride on the absorption of vitamins and other nutrients has not been studied in pregnant women.
Is СЕЛАМЕРЕКС safe during breastfeeding?
СЕЛАМЕРЕКС 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 СЕЛАМЕРЕКС be given?
It is usually taken three times a day with meals. Follow the directions on your prescription label carefully.
Can СЕЛАМЕРЕКС tablets be crushed?
СЕЛАМЕРЕКС tablets may be crushed and administered via enteral feeding tubes, provided clear instruction on tablet preparation is included.
Can I overdose on СЕЛАМЕРЕКС?
If СЕЛАМЕРЕКС 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 СЕЛАМЕРЕКС?
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 СЕЛАМЕРЕКС?
Swallow the tablet whole.Do not crush, chew, or split the tablet.
Does СЕЛАМЕРЕКС effect my kidney?
СЕЛАМЕРЕКС lowers phosphorus levels in people with kidney disease on dialysis. Take with meals.
What happens if I stop taking СЕЛАМЕРЕКС?
If you stop taking СЕЛАМЕРЕКС, your phosphate levels may rise again. It is important to keep taking your medicines even if you feel well. Do not stop taking СЕЛАМЕРЕКС.
What is the reason for taking СЕЛАМЕРЕКС with food?
СЕЛАМЕРЕКС should be taken three times a day with meals to help control phosphorus levels in your body. СЕЛАМЕРЕКС binds to (or holds on to) phosphorus in the foods you eat so your body doesn't absorb as much.
Does СЕЛАМЕРЕКС increase calcium?
СЕЛАМЕРЕКС 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 СЕЛАМЕРЕКС?
СЕЛАМЕРЕКС takes 3 times per day with meals. As directed by your doctor.
What happens if I miss a dose of СЕЛАМЕРЕКС?
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.