Acutrol 400

ACUTROL 400 Tablet

Name

• Brand Name: Acutrol 400
• Common Name: Sevelamer Tablet

Composition

Acutrol 400 Tablet contains Sevelamer (400mg) as its active ingredient. Some formulations may refer to it as Sevelamer Carbonate.

Uses

Acutrol 400 Tablet is primarily prescribed to manage and control high phosphate levels (hyperphosphatemia) in the blood. It is particularly used in:

• Adult patients with chronic kidney disease (CKD) who are undergoing dialysis (hemodialysis or peritoneal dialysis).
• Patients with chronic renal disease who do not require dialysis but have elevated serum phosphorus levels.

By binding to dietary phosphate in the gastrointestinal tract and preventing its absorption, Acutrol 400 helps to:

• Prevent the unsafe buildup of phosphate in the body.
• Support healthy bones and reduce the risk of bone pain, itching, and fractures.
• Decrease the risk of cardiovascular complications, heart disease, and strokes associated with high phosphate levels.

Dosage and Administration

Acutrol 400 Tablet should be taken orally with food, as advised by a healthcare professional.

• Swallow the tablet whole with a glass of water. Do not crush, chew, split, or break the tablet.
• Take the medicine regularly and at a fixed time each day to achieve maximum benefit.
• The specific dosage and duration will be determined by your doctor based on your medical condition and blood phosphate levels.
• Avoid taking any other medications 1 hour before or 3 hours after taking Acutrol 400 Tablet to prevent potential interactions and ensure optimal effectiveness.

Side Effects

Common Side Effects:

• Nausea
• Vomiting
• Abdominal pain
• Constipation
• Diarrhea
• Indigestion (dyspepsia)
• Flatulence (gas)

Serious Side Effects (less common):

• Low levels of calcium (hypocalcemia), folic acid, and vitamins A, D, E, and K in the blood.
• Gastrointestinal obstruction.
• Excessively low levels of phosphate (hypophosphatemia).
• Allergic reactions, including rash, itching, swelling of the face, lips, tongue, or throat, and difficulty breathing.
• Difficulty swallowing.

If you experience any severe or persistent side effects, consult your doctor immediately.

Precautions

• Allergies: Do not take Acutrol 400 if you are allergic to Sevelamer or any of its ingredients.
• Contraindications: Avoid use if you have low phosphate levels in your blood or a blockage in your bowel (intestinal obstruction).
• Gastrointestinal Conditions: Use with caution and inform your doctor if you have swallowing disorders, severe gastrointestinal motility issues, severe constipation, or a history of major stomach or bowel surgery.
• Pregnancy and Breastfeeding: If you are pregnant, planning to become pregnant, or breastfeeding, discuss the risks and benefits with your doctor. Acutrol 400 should only be used if clearly necessary.
• Drug Interactions: Inform your doctor about all other medications, supplements, and over-the-counter drugs you are taking. Sevelamer can interact with certain medications, including some antibiotics (e.g., ciprofloxacin), immunosuppressants (e.g., ciclosporin, tacrolimus, mycophenolate mofetil), levothyroxine, and proton pump inhibitors. Avoid taking antacids containing aluminum, calcium, or magnesium within 1-2 hours before or after taking Sevelamer.
• Monitoring: Regular blood tests are necessary to monitor phosphate, calcium, and vitamin levels. Your doctor may prescribe supplements if needed.
• Diet: Adhere to the diet prescribed by your doctor, especially regarding phosphate intake, to enhance the medication's effectiveness.
• Pediatric Use: Acutrol 400 Tablet is not recommended for use in children and adolescents below 18 years of age as its safety and efficacy have not been established in this age group.
• Alcohol: Avoid alcohol consumption while taking Acutrol 400 Tablet as it might cause unpleasant side effects.

Storage

Store Acutrol 400 Tablet in its original container below 25°C or 30°C, in a cool and dry place, away from direct sunlight and moisture. Keep it out of the sight and reach of children.

What is Acutrol 400 used for?

Acutrol 400, containing Sevelamer, is primarily used to control high phosphate levels in the blood (hyperphosphatemia) in adult patients with chronic kidney disease, particularly those undergoing dialysis (hemodialysis or peritoneal dialysis). It helps prevent the unsafe buildup of phosphate in the body, which can lead to bone disease and decrease the risk of heart disease and strokes.

How does Acutrol 400 work?

Acutrol 400 works as a phosphate binder. It binds to dietary phosphate in the gastrointestinal tract, preventing its absorption into the bloodstream and thereby lowering the phosphate concentration in the body.

What is the usual dosage for Acutrol 400?

Acutrol 400 should be taken with meals, exactly as advised by your doctor. The specific dosage and frequency will depend on your individual condition and blood phosphate levels. You should swallow the tablet whole with a glass of water and not crush, chew, or break it.

What are the possible side effects of Acutrol 400?

Common side effects include vomiting, upper abdominal pain, nausea, diarrhea, stomach ache, indigestion, flatulence, and constipation. In rare cases, more severe side effects like intestinal blockage or allergic reactions (rash, swelling, hives, trouble breathing) may occur. Acutrol 400 may also lead to low levels of calcium, folic acid, and vitamins A, D, E, and K in the blood, for which your doctor may prescribe supplements.

Is Acutrol 400 safe during pregnancy or breastfeeding?

During pregnancy, Acutrol 400 should only be used if your doctor determines it is clearly necessary, as there are limited human studies and animal studies have shown potential harmful effects on the developing baby. For breastfeeding, Acutrol 400 is considered probably safe, as it is not expected to pass into breast milk, but consultation with your doctor is recommended.

Can Acutrol 400 be taken with other medications?

Acutrol 400 can interact with several medications. It is generally advised to avoid taking other medicines 1 hour before or 3 hours after Acutrol 400. Specifically, it can reduce the effect of antibiotics like ciprofloxacin (ciprofloxacin should be taken at least 2 hours before or 6 hours after sevelamer). It can also decrease the absorption of levothyroxine (take levothyroxine at least 4 hours before or after sevelamer), certain heart rhythm medications (e.g., amiodarone, quinidine), epilepsy medications (e.g., phenytoin), immunosuppressants (e.g., ciclosporin, tacrolimus, mycophenolate mofetil), warfarin, and some oral diabetes medications. Always inform your doctor about all medications, supplements, and herbal products you are taking.

What precautions should be taken while using Acutrol 400?

Do not take Acutrol 400 if you are allergic to Sevelamer or its ingredients, or if you have very low phosphate levels in your blood or a bowel obstruction. Exercise caution and inform your doctor if you have difficulty swallowing, have undergone major gastrointestinal surgery, suffer from severe constipation, or have inflammatory bowel disease. It's also advisable to avoid alcohol consumption while on this medication. Regular monitoring of your blood phosphate levels is essential, and your doctor may also check levels of vitamins A, D, E, K, and folic acid. Acutrol 400 is not recommended for children under 18 years of age.

What happens if a dose of Acutrol 400 is missed?

If you miss a dose of Acutrol 400, take it as soon as you remember. However, if it is almost time for your next scheduled dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one.

How should Acutrol 400 be stored?

Acutrol 400 should be stored in a cool and dry place, away from direct sunlight. Keep the medication out of the sight and reach of children. The ideal storage temperature is generally between 10ºC to 25ºC or below 30ºC.