Acutrol-400
(Sevelamer 400mg)

Drug Effects

Usage


Pregnancy

Pregnancy Category C: There are no adequate and well-controlled studies in pregnant women. Sevelamer products should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

The effect of sevelamer hydrochloride on the absorption of vitamins and other nutrients has not been studied in pregnant women. Requirements for vitamins and other nutrients are increased in pregnancy. In pregnant rats given doses of sevelamer hydrochloride during organogenesis, reduced or irregular ossification of fetal bones, probably due to a reduced absorption of fat-soluble vitamin D, occurred at a dose approximately equal to the maximum clinical trial dose of 13 g on a body surface area basis. In pregnant rabbits given oral doses of sevelamer hydrochloride by gavage during organogenesis, an increase of early resorptions occurred at dose approximately twice the maximum clinical trial dose on a body surface area basis [see Nonclinical Toxicology (13.2)].

Labor and Delivery

No sevelamer hydrochloride treatment-related effects on labor and delivery were seen in animal studies [see Nonclinical Toxicology (13)]. The effects of sevelamer carbonate on labor and delivery in humans is unknown.

Pediatric Use

The safety and efficacy of Renvela has not been established in pediatric patients.

Geriatric Use

Clinical studies of Renvela did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range.

Adverse Effect


serious side effect such as:

  • black, bloody, or tarry stools;

  • constipation that gets worse or does not clear up;

  • severe constipation with stomach pain; or

  • fever, chills, body aches, flu symptoms.

Less serious side effects of sevelamer may include:

  • nausea, vomiting, stomach pain, loss of appetite;

  • upset stomach, gas, bloating;

  • diarrhea, mild constipation;

  • tired feeling;

  • itching; or

  • joint pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Mechanism Action


Renvela contains sevelamer carbonate, 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 gastrointestinal tract and decreasing absorption, sevelamer carbonate lowers the phosphate concentration in the serum (serum phosphorus).

References


Read more at http://www.drugs.com/sfx/renvela-side-effects.html#svPyMViqxZ3Dyt3P.99