Canasa

Name: Canasa

Canasa Overview

Canasa is a prescription medication used to treat ulcerative proctitis. Canasa helps relieve the symptoms of ulcerative proctitis (swelling in the rectum). Canasa belongs to a group of drugs called aminosalicylates. These work by stopping the body from producing a certain substance that may cause pain or inflammation.

Canasa comes in a rectal suppository. It is usually instilled once a day at bedtime.

Common side effects of Canasa include rectal pain and fever. It can also cause dizziness. Do not drive until you know how it affects you. 

Canasa Food Interactions

Medicines can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of mesalamine, there are no specific foods that you must exclude from your diet when receiving this medication.

 

Canasa Usage

Use Canasa exactly as prescribed. Do not change the dose or stop using Canasa without talking to your doctor.

  • Canasa rectal suppositories is instilled once a day at bedtime.
    • For best results, empty your rectum (have a bowel movement) just before using the suppository.
    • Detach one suppository from the strip of suppositories.
    • Hold the suppository upright and carefully peel open the plastic at the pre-cut line to take out the suppository.
    • Insert the suppository with the pointed end first completely into your rectum, using gentle pressure.
    • For best results, keep the suppository in your rectum for 3 hours or longer, if possible.
    • If you have trouble inserting the suppository, you may put a little bit of lubricating gel on the suppository.
    • Do not handle the suppository too much, since it may begin to melt from the heat from your hands and body.

Other Requirements

  • Store Canasa below 25°C (77°F), may be refrigerated. Keep away from direct heat, light or humidity.
  • Rectal suppositories: these can cause stains on things it touches. Therefore keep it away from clothing and other fabrics, flooring, painted surfaces, marble, granite, plastics, andenamel. Be careful since the suppository may stain clothing.
  • Keep this and all medicines out of the reach of children.

Uses of Canasa

  • It is used to treat mild to moderate disease at the far end of the colon.
  • It may be given to you for other reasons. Talk with the doctor.

How is this medicine (Canasa) best taken?

Use this medicine as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • Keep taking Canasa as you have been told by your doctor or other health care provider, even if you feel well.
  • To gain the most benefit, do not miss doses.
  • You could be on both a tablet or capsule and a rectal product at the same time.
  • Use suppository rectally.
  • Use at bedtime.
  • Wash your hands before and after use.
  • If suppository is soft, chill in a refrigerator or run cold water over it.
  • Take foil off the suppository and put in, pointed end first. Do not handle too much. Keep the suppository in for 1 to 3 hours or longer if you can. Do not cut or break the suppository.

What do I do if I miss a dose?

  • Take a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not take 2 doses at the same time or extra doses.

How do I store and/or throw out Canasa?

  • Store at room temperature or in a refrigerator. Do not freeze.
  • Protect from heat.
  • Store in a dry place. Do not store in a bathroom.
  • Protect from light.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Dosage forms and strengths

Canasa Suppository: 1000 mg mesalamine in a bullet shaped, light tan to grey suppository.

Adverse reactions

The most serious adverse reactions seen in Canasa clinical trials or with other products that contain or are metabolized to mesalamine are:

  • Renal Impairment [see Warnings and Precautions (5.1)]
  • Mesalamine-Induced Acute Intolerance Syndrome [see Warnings and Precautions (5.2)]
  • Hypersensitivity Reactions [see Warnings and Precautions (5.3)]
  • Hepatic Failure [see Warnings and Precautions (5.4)]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

The most common adverse reactions in adult patients with mildly to moderately active ulcerative proctitis in double-blind, placebo-controlled trials are summarized in the Table 1 below.

Table 1: Adverse Reactions Occurring In More Than 1% of Mesalamine Suppository Treated Patients (Comparison to Placebo)
Symptom Mesalamine
(n = 177)
Placebo
(n = 84)
N % N %
Dizziness 5 3 2 2.4
Rectal Pain 3 1.8 0 0
Fever 2 1.2 0 0
Rash 2 1.2 0 0
Acne 2 1.2 0 0
Colitis 2 1.2 0 0

In a multicenter, open-label, randomized, parallel group study in 99 patients comparing the Canasa 1000 mg suppository administered nightly to that of the mesalamine 500 mg suppository twice daily. The most common adverse reactions in both groups were headache (14%), flatulence (5%), abdominal pain (5%), diarrhea (3%), and nausea (3%). Three (3) patients discontinued medication because of an adverse reaction; one of these adverse reactions (headache) was deemed possibly related to study medication. The recommended dosage of Canasa is 1000 mg administered rectally once daily at bedtime [see Dosage and Administration (2)].

Postmarketing Experience

In addition to the adverse reactions reported above in clinical trials involving Canasa, the adverse reactions listed below have been identified during post-approval use of Canasa and other mesalamine-containing products. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

  • Body as a Whole: drug fever, fatigue, lupus-like syndrome, medication residue
  • Cardiac Disorders: myocarditis, pericarditis, pericardial effusion [see Warnings and Precautions (5.3)]
  • Endocrine: Nephrogenic diabetes insipidus
  • Eye disorders: eye swelling
  • Gastrointestinal Disorders: abdominal cramps, abdominal distension, anal pruritus, anorectal discomfort, constipation, feces discolored, flatulence, frequent bowel movements, gastrointestinal bleeding, mucus stools, nausea, painful defecation, pancreatitis, proctalgia, rectal discharge, rectal tenesmus, stomach discomfort, vomiting
  • Hepatic Disorders: cholestatic jaundice, hepatitis, jaundice, Kawasaki-like syndrome including changes in liver enzymes, liver necrosis, liver failure
  • Hematologic Disorders: agranulocytosis, aplastic anemia, thrombocytopenia
  • Neurological/Psychiatric Disorders: Guillain-Barre syndrome, peripheral neuropathy, transverse myelitis, intracranial hypertension
  • Renal Disorders: interstitial nephritis, renal failure, minimal change nephropathy [see Warnings and Precautions (5.1)]
  • Respiratory, Thoracic and Mediastinal Disorders: hypersensitivity pneumonitis (including allergic alveolitis, eosinophilic pneumonitis, interstitial pneumonitis)
  • Skin and Subcutaneous Tissue Disorder: alopecia, erythema, erythema nodosum, pruritus, psoriasis, pyoderma gangrenosum, urticaria
  • Urogenital: reversible oligospermia
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