RENPHOS 4OO

 

RENPHOS

Renphos – 400

Sevelamer Carbonate Tablets 400 mg

 

Composition:

Each film coated tablet contains:
Sevelamer Carbonate ……….. 400mg
Excipients ……………………….. q.s.

Colours: Ferric Oxide Yellow USP-NF & Titanium Dioxide BP

 

INDICATIONS and USAGE

RENPHOS (Sevelamer Carbonate) is indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease (CKD) on dialysis.

 

Dosage and Administration

General Dosing Information

Starting dose for adult patients not taking a phosphate binder. The recommended starting dose of Renphos is 0.8 to 1.6 g taken orally with meals based on serum phosphorus level. Table 1 provides recommended starting dose of Renphos for adult patients not taking a phosphate binder.

 

Table 1: Starting Dose for Adult Dialysis Patients Not Taking a Phosphate Binder

Serum Phosphorus	Renphos
> 5.5 and < 7.5 mg/dL	0.8 g three times daily with meals
≥ 7.5 mg/dL	1.6 g three times daily with meals

 

Dose Titration for Adult Patients Taking Renphos.

Titrate the Renphos dose by 0.8 g three times per day with meals at two-week intervals as necessary to achieve target serum phosphorus level. Based on clinical studies, the average prescribed adult daily dose of sevelamer carbonate is approximately 7.2 g per day. The highest daily adult dose of sevelamer carbonate studied was 14 grams in CKD patients on dialysis.

 

Starting Dose for Pediatric Patients Not Taking a Phosphate Binder. 

The recommended starting dose for pediatric patients 6 years of age and older is 0.8 to 1.6 g taken three times per day with meals based on the patients’ body surface area (BSA) category;  see table 2.

 

Table 2: Recommended Starting Dosage and Titration Increment Based on Pediatric Patient’s Body Surface Area (m²)

BSA (m2)	Starting Dose Per Meal/Snack	Titration Increases/Decreases Per Dose
≥ 0.75 to < 1.2	0.8 g	Titrated by 0.4 g
≥ 1.2	1.6 g	Titrated by 0.8 g

 

Dose Titration for Pediatric Patients Taking Renphos. Titrate the Renphos dose as needed to achieve target levels at two week intervals based on BSA category, as shown in Table 2.

 

Switching from Sevelamer Hydrochloride Tablets. For adult patients switching from sevelamer hydrochloride tablets to sevelamer carbonate tablets or powder, use the same dose in grams.

 

Switching between Sevelamer Carbonate Tablets and Powder. Use the same dose in grams.

 

Switching from Calcium Acetate. Table 3 gives recommended starting doses of Renphos based on a patient’s current calcium acetate dose.

 

Table 3: Starting Dose for Dialysis Patients Switching from Calcium Acetate to Renphos

Calcium Acetate 667 mg (Tablets per meal)	Renphos
1 tablet	0.8 g
2 tablets	1.6 g
3 tablets	2.4 g

 

PHARMACOLOGICAL ACTION:

Pharmacodynamics:

Sovelarmer carbonate is a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. It contains multiple amines separated by one carbon from the polymer backbone. These amines exist in a protonated form in the intestine and interact with phosphate molecules through ionic and hydrogen bonding. By binding phosphate in the dietary tract and decreasing absorption, Sevelamercarbonate lowers the phosphate concentration in the serum.

In addition to effects on serum phosphate levels, Sevelamer hydrochloride has been shown to bind bile acids in vitro and in vivo in experimental animal models. Because Sevelamer binds bile acids, it may interfere with normal fat absorption and thus may reduce absorption of fat soluble vitamins such as A, D and K as wellas other substances such as cholesterol.

In vitro equilibrium studies demonstrated that sevelamer hydrochloride tablets and sevelamer carbonate tablets were equivalent in terms of phosphate binding, with and without acid pre-treatment. Kinetic experiments demonstrate that Sevelamer carbonate and Sevelamer hydrochloride tablets bind phosphate in a similarly rapid manner. Therefore, these in vitro studies have shown that Sevelamer carbonate and Sevelamer hydrochloride tablets are equivalent in their phosphate binding properties.

Sevelamer does not contain calcium and decreases the incidence of hypercalcemic episodes as compared to patients using calcium-based phosphate binders alone. The effects of Sevelamer on phosphorus and calcium were proven to be maintained throughout a study with one year follow-up.

 

Pharmacokinetics:

Pharmacokinetic studies have not been carried out with Sevelamer carbonate or Sevelamer hydrochloride as Sevelamer is not absorbed from the GI  tract, as confirmed by an absorption study in healthy volunteers. In this study a mass balance study using l4C-sevelamer hydrochloride in 16 healthy male and female volunteers showed that Sevehmer hydrochloride is not systemically absorbed. No absorption studies have been performed in patients with renal disease.

 

Method of Administration:

For Oral Use

Tablets should be swallowed intact and should not be crashed, chewed or broken into piece (prior to administration).

 

CONTRAINDICATION:

Hypersensitivity to the active substance or to any of the excipients
Hypophosphatemia
Bowel obstruction

 

INTERACTIONS WITH OTHER MEDICINE:

Tell your doctor if you are taking or have recently taken or might take any other medicines.
• RENPHOS 400 should not be taken at the same time as ciprofloxacin (an antibiotic).
• If you are taking medicines for heart rhythm problems or for epilepsy, you should consult your doctor when taking RENPHOS 400.
•The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by RENPHOS 400. Your doctor will advise you if you are taking these medicines.
• Thyroid hormone deficiency may uncommonly be observed in certain people taking levothyroxine (used to treatment low thyroid hormone levels) and RENPHOS 400. Therefore your doctor may monitor the levels of thyroid stimulating hormone in your blood more closely.
•If you are taking medicine to treat heartburn, gastroesophageal reflux disease (GERD) or gastric ulcers, such as omeprazole, pantoprazole, or lansoprazole, you should consult your doctor when taking RENPHOS 400.

Your doctor will check for interactions between RENPHOS 400 and other medicines on a regular basis.
In some cases where RENPHOS 400 should be taken at the same time as another medicine. Your doctor may advise you to take this medicine 1 hour before or 3 hours after RENPHOS 400 intake, or they may consider monitoring the blood levels of that medicine.

 

Children

The safety and efficacy in children (below the age of 18 years) have not been studied. Therefore RENPHOS 400 is not recommended for use in children below the age of 18 years.

 

Pregnancy and breast-feeding

It is unknown whether RENPHOS 400 has any effect on unborn babies.

 

Driving and using machines

RENPHOS 400 is unlikely to affect ability to drive or to use machines.

 

WARNINGS AND PRECAUTIONS:

Swallowing problems
Problems with motility (movement) in your stomach and bowel being sick frequently
Active inflammation of the bowel major surgery on stomach or bowel

 

UNDESIRABLE EFFECTS:

Since constipation may be an early symptom of a blockage in your intestine, please inform your doctor or pharmacist.

The following side effects have been reported in patients taking RENPHOS:
Very common (may affect more than 1 in 10 people): vomiting, constipation, upper abdominal pain, nausea
Common (may affect up to 1 in 10 people): diarrhoea, abdominal pain, indigestion, flatulence
Very rare (may affect up to 1 in 10000 people): hypersensitivity
Not known (frequency cannot be estimated from the available data): cases of itching, rash, slow intestine motility (movement)/blockages in the intestine, and perforation in the intestine wall have been reported

 

STORAGE CONDITION:

Store below 30°C, in a cool dry & dark place. Protect from light and moisture.
Keep the medicines out of reach of children.

 

Packaging:

10 x 10 Tablets in Alu-Alu blister pack.

 

SHELFLIFE:

24 Months from the date of manufacturing.

 

Product of:
Zifam Pinnacle Pty Ltd
Sydney, Australia

 

Manufactured by:
Ravenbhel Healthcare Pvt Ltd.,
16-17, EPIP, SIDCO, Kartholi, Bari Brahmana, Jammu, J& K-181133, INDIA

 

Updated on February 21, 2024.