Mesalamine

What it is used for

ROWASA is indicated for the treatment of active mild to moderate distal ulcerative colitis, proctosigmoiditis or proctitis in adults.

Side effects, and when to stop

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hypersensitivity reactions
• Renal impairment
• Mesalamine-induced acute intolerance syndrome
• Hepatic failure
• Severe cutaneous adverse reactions
• Photosensitivity
• Nephrolithiasis
• Intracranial Hypertension

Who should not take it

ROWASA is contraindicated in patients with known or suspected hypersensitivity to salicylates, aminosalicylates, sulfites or any other component of this medication.

2 dosage and administration

Evaluate renal function before initiating therapy with ROWASA.

Recommended Dosage

The recommended dosage is one rectal instillation (4 grams) once a day, preferably at bedtime, and retained for approximately eight hours for 3 to 6 weeks depending on symptoms and sigmoidoscopic findings.

Administration Instructions

• Shake the bottle to ensure the suspension is homogeneous.
• Remove the protective sheath from the applicator tip.
• Assume the correct body position:
  • o Lie on the left side with the lower leg extended and the upper right leg flexed forward for balance.
  • o Alternatively, sit in the knee to chest position.
• Gently insert the applicator tip in the rectum pointing toward the umbilicus.
• Steadily squeeze the bottle to discharge the medication.
• Remain in the position for at least 30 minutes. Administer at bedtime with the objective of retaining it all night.
• Drink an adequate amount of fluids during treatment.