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