RENPHOS 800

Composition:
Each film coated tablet contains:
Sevelamer Carbonate              800mg
Excipients                                  q.s.

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

THERAPEUTIC INDICATIONS:
RENPHOS 800 is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. RENPHOS 800 is also indicated for the control of hyperphosphataemia in adult patients with chronic kidney disease (CKD) not on dialysis with serum phosphorus> 1.78 mmol/l. RENPHOS 800 should be used within the context of a multiple
therapeutic approach, which could include calcium supplement, I 25dihydroxy Vitamin D3 or one of its analogues to control the development of renal bone disease.

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.

DOSAGE & METHOD OF ADMINISTRATION:
Dosing Consideration:

REMHOS 800 (Sevelamer carbonate tablets) should be taken immediately prior to or with meals, since its action is to bind ingested phosphate

When administering any other medication where a reduction in the bioavailability of that medication would have a clinically significant effect on safety or efficacy, the physician should consider monitoring blood levels or dosing that medicine apart from RENPHOS 800 to prevent GI binding (at least one hour before or three hours after RENPHOS 800).

 

Recommended Dosage:
The recommended starting dose of RENPHOS 800 tablets for adults and older people (> 65 years) is one to two tables of 800mg with each meal,3 times a day.
Initially, your doctor will check the levels of phosphorus in your blood every 2-4 weeks and may adjust the dose of RENPHOS 800 when necessary to reach an adequate phosphate level.
Patients taking RENPHOS 800 should adhere to their prescribed diets.
Serum phosphorus should be monitored on a regular basis with the goal of maintaining serum phosphorus levels consistent with current medical standards

 

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 800 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 800.
•The effects of medicines such as ciclosporin, mycophenolate mofetil and tacrolimus (medicines used to suppress the immune system) may be reduced by RENPHOS 800. 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 800. 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 800.

Your doctor will check for interactions between RENPHOS 800 and other medicines on a regular basis.
In some cases where RENPHOS 800 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 800 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 800 is not recommended for use in children below the age of 18 years.

Pregnancy and breast-feeding
It is unknown whether RENPHOS 800 has any effect on unborn babies.

Driving and using machines
RENPHOS 800 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 800:
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.

DOSAGE FORMS AND PACKAGING AVAILABLE:
10 x 10 Tablets in Alu-Alu blister pack in unit carton.

SHELFLIFE:
24 Months from the date of manufacturing.

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

Product of:
Zifam Pinnacle Pty Ltd
Sydney, Australia