mesalamine

ROUTE	ONSET	PEAK	DURATION
PO	unknown	unknown	6–8 hr
ER	2 hr	9–12 hr	24 hr
Rectal	3–21 days	unknown	24 hr

One 800-mg tablet is NOT bioequivalent to two Delzicol 400-mg capsules.

Treatment of Ulcerative Colitis

PO (Adults ): 1.6 g (two 800-mg tablets) 3 times daily for 6 wk; Delzicol: 800 mg (two 400-mg capsules) 3 times daily for 6 wk; Lialda: 2.4–4.8 g (two to four 1.2-g tablets) once daily for up to 8 wk; Pentasa: 1 g (four 250-mg capsules or two 500-mg capsules) 4 times daily for up to 8 wk.
(Adults ): Rowasa: 4-g enema (60 mL) at bedtime, retained for 8 hr for 3–6 wk.
PO (Children ≥12 yr and 54–90 kg): Delzicol: 27–44 mg/kg/day in 2 divided doses (max dose = 2.4 g/day) for 6 wk.
PO (Children ≥12 yr and 33–53 kg): Delzicol: 37–61 mg/kg/day in 2 divided doses (max dose = 2 g/day) for 6 wk.
PO (Children ≥12 yr and 17–32 kg): Delzicol: 36–71 mg/kg/day in 2 divided doses (max dose = 1.2 g/day) for 6 wk.
PO (Children >50 kg): Lialda: 4.8 g (four 1.2-g tablets) once daily for 8 wk, then 2.4 g (two 1.2-g tablets) once daily.
PO (Children 36–50 kg): Lialda: 3.6 g (three 1.2-g tablets) once daily for 8 wk, then 2.4 g (two 1.2-g tablets) once daily.
PO (Children 24–35 kg): Lialda: 2.4 g (two 1.2-g tablets) once daily for 8 wk, then 1.2 g once daily.

Maintenance of Remission of Ulcerative Colitis

PO (Adults ): Apriso: 1.5 g (four 375-mg capsules) once daily in the morning; Delzicol: 800 mg (two 400-mg capsules) 2 times daily; Lialda: 2.4 g (two 1.2-g tablets) once daily; Pentasa: 1 g (four 250-mg capsules or two 500-mg capsules) 4 times daily.

Treatment of Ulcerative Proctosigmoiditis

(Adults ): Rowasa: 4-g enema (60 mL) at bedtime, retained for 8 hr (treatment duration = 3–6 wk).

Treatment of Ulcerative Proctitis

(Adults ): Rowasa: 4-g enema (60 mL) at bedtime, retained for 8 hr (treatment duration = 3–6 wk); Canasa: Insert a 1-g suppository at bedtime, retain for at least 1–3 hr (treatment duration = 3–6 wk).

Availability ⬆ ⬇

(Generic available)

Delayed-release tablets: 400 mg; 500 mg; 800 mg; 1 g; 1.2 g (Lialda); 1.6 g
Delayed-release capsules (Delzicol): 400 mg
Extended-release capsules (Apriso) (contain phenylalanine): 375 mg
Extended-release capsules (Pentasa): 250 mg; 500 mg
Rectal enema (Rowasa): 1 g/100 mL; 2 g/60 mL; 4 g/60 mL; 4 g/100 mL
Rectal foam: 1 g/actuation
Rectal suppository (Canasa): 500 mg; 1 g

Assessment ⬆ ⬇

Assess abdominal pain and frequency, quantity, and consistency of stools at the beginning of and during therapy.
Assess for allergy to sulfonamides and salicylates. Patients allergic to sulfasalazine may take mesalamine or olsalazine without difficulty, but therapy should be discontinued if rash or fever occurs.
Monitor intake and output ratios. Fluid intake should be sufficient to maintain a urine output of ≥1200–1500 mL daily to prevent crystalluria and stone formation.
Monitor for signs of hypersensitivity reactions including rash.If hypersensitivity or severe cutaneous reactions occur,discontinue mesalamine and provide appropriate medical care.
Monitor for signs and symptoms of acute intolerance syndrome (cramping, acute abdominal pain and bloody diarrhea, sometimes fever, headache, rash) during therapy; may be difficult to distinguish from an exacerbation of ulcerative colitis. If syndrome occurs, promptly discontinue therapy.

Lab Test Considerations:

Monitor urinalysis, BUN, and serum creatinine prior to and periodically during therapy. Mesalamine may cause renal toxicity. Discontinue mesalamine if renal functions declines.
- Mesalamine may cause ↑ AST, ALT, alkaline phosphatase, GGT, LDH, amylase, and lipase.

Implementation ⬆ ⬇

PO: Administer with a full glass of water. DNC: Swallow tablets whole; do not break the outer coating, which is designed to remain intact. Take Lialda tablets with a meal. Take Apriso capsules in the morning without regard to meals. Do not coadminister with antacids; may affect dissolution of the coating of the granules in Apriso capsules. Intact or partially intact tablets may occasionally be found in the stool. If this occurs repeatedly, advise patient to notify health care professional. DNC: Swallow Delzicol capsules whole; do not break, crush, or chew. Administer without regard to meals. If needed, may open capsule and swallow inner tablets. Intact or partially intact tablets may occasionally be found in the stool. If this occurs repeatedly, advise patient to notify health care professional. Two Delzicol 400-mg capsules are not equal to one Asacol HD (mesalamine) delayed-release 800-mg tablet. Pentasa capsules may be swallowed whole or opened and sprinkled onto applesauce or yogurt. Consume entire contents immediately.
Patient should empty bowel prior to administration of rectal dose forms.
- Avoid excessive handling of suppository. Remove foil wrapper and insert pointed end first into rectum with gentle pressure. Do not cut or break suppository. Retain suppository for 1–3 hr or more for maximum benefit.
- Administer 60-mL retention enema once daily at bedtime. Solution should be retained for approximately 8 hr. Prior to administration of rectal suspension, shake bottle well and remove the protective cap. Have patient lie on left side with the lower leg extended and the upper leg flexed for support or place the patient in knee-chest position. Gently insert the applicator tip into the rectum, pointing toward the umbilicus. Squeeze the bottle steadily to discharge most of the preparation.

Patient/Family Teaching ⬆ ⬇

Instruct patient on the correct method of administration. Advise patient to take medication as directed, even if feeling better. Take missed doses as soon as remembered unless almost time for next dose. Advise patient to read Patient Information before starting therapy and with each Rx refill in case of changes.
Advise patient not to change brands of mesalamine without consulting health care professional.
Encourage patient to drink an adequate amount of fluids to minimize risk of kidney stones. Notify health care professional if severe side or back pain or blood in urine occur.
Inform patient of possible reddish-brown urine discoloration when in contact with surfaces or water treated with hypochlorite-containing bleach.
May cause dizziness. Caution patient to avoid driving or other activities that require alertness until response to medication is known.
Advise patient to notify health care professional if skin rash, sore throat, fever, mouth sores, unusual bleeding or bruising, wheezing, fever, or hives occur.
Advise patient to avoid sun exposure, wear protective clothing, and use a broad-spectrum sunscreen when outdoors to ↓ risk of photosensitivity.
Instruct patient to notify health care professional if symptoms do not improve after 1–2 mo of therapy.
Instruct patient to notify health care professional if symptoms worsen. If symptoms of acute intolerance (cramping, acute abdominal pain, bloody diarrhea, fever, headache, rash) occur, discontinue therapy and notify health care professional immediately.
Inform patient that proctoscopy and sigmoidoscopy may be required periodically during treatment to determine response.
Rep: Advise females of reproductive potential to notify health care professional if pregnancy is planned or suspected or if breastfeeding. Monitor breastfed infants for diarrhea.
Instruct patient to use rectal suspension at bedtime and retain suspension all night for best results.

Evaluation/Desired Outcomes ⬆ ⬇

Decrease in diarrhea and abdominal pain.
Return to normal bowel pattern in patients with inflammatory bowel disease. Effects may be seen within 3–21 days. The usual course of therapy is 3–6 wk.
Maintenance of remission in patients with inflammatory bowel disease.

US Brand Names ⬆ ⬇

Apriso, ~~Asacol,~~ ~~Asacol HD,~~ Canasa, Delzicol, Lialda, Pentasa, Rowasa

Canadian Brand Names ⬆ ⬇

Mezavant, Mezera, Octasa, Salofalk, Teva 5-ASA

Code ⬆

NDC Code

0023- Allergan, Inc.
- 0023-5853- Delzicol
  - 0023-5853-18- 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0023-5853-18)

0023- Allergan, Inc.
- 0023-5901- Asacol HD
  - 0023-5901-18- 180 TABLET, DELAYED RELEASE in 1 BOTTLE (0023-5901-18)

0037- Meda Pharmaceuticals
- 0037-0022- sfRowasa Sulfite-Free Formulation
  - 0037-0022-07- 7 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-07) > 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

0037- Meda Pharmaceuticals
- 0037-0022- sfRowasa Sulfite-Free Formulation
  - 0037-0022-14- 14 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-14) > 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

0037- Meda Pharmaceuticals
- 0037-0022- sfRowasa Sulfite-Free Formulation
  - 0037-0022-28- 28 BOTTLE, WITH APPLICATOR in 1 CARTON (0037-0022-28) > 60 mL in 1 BOTTLE, WITH APPLICATOR (0037-0022-60)

0037- Meda Pharmaceuticals
- 0037-0066- Rowasa
  - 0037-0066-03- 28 BOTTLE, DISPENSING in 1 CARTON (0037-0066-03) > 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)

0037- Meda Pharmaceuticals
- 0037-0066- Rowasa
  - 0037-0066-05- 7 BOTTLE, DISPENSING in 1 CARTON (0037-0066-05) > 60 mL in 1 BOTTLE, DISPENSING (0037-0066-06)

0093- Teva Pharmaceuticals USA, Inc.
- 0093-5907- Mesalamine
  - 0093-5907-86- 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (0093-5907-86)

0378- Mylan Pharmaceuticals Inc.
- 0378-1375- Mesalamine
  - 0378-1375-78- 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (0378-1375-78)

0378- Mylan Pharmaceuticals Inc.
- 0378-9230- Mesalamine
  - 0378-9230-93- 5 PACKAGE in 1 CARTON (0378-9230-93) > 6 SUPPOSITORY in 1 PACKAGE

0591- Actavis Pharma, Inc.
- 0591-2245- Mesalamine
  - 0591-2245-22- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (0591-2245-22)

0781- Sandoz Inc
- 0781-7088- Mesalamine
  - 0781-7088-33- 30 SUPPOSITORY in 1 BOX (0781-7088-33)

16714- Northstar Rx LLC.
- 16714-830- mesalamine
  - 16714-830-01- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (16714-830-01)

42291- AvKARE, Inc
- 42291-563- Mesalamine
  - 42291-563-18- 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (42291-563-18)

42291- AvKARE, Inc
- 42291-564- Mesalamine
  - 42291-564-12- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (42291-564-12)

43353- Aphena Pharma Solutions - Tennessee, LLC
- 43353-884- APRISO
  - 43353-884-79- 2160 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (43353-884-79)

45802- Perrigo New York Inc
- 45802-098- Mesalamine
  - 45802-098-28- 28 BOTTLE in 1 CARTON (45802-098-28) > 60 mL in 1 BOTTLE

45802- Perrigo New York Inc
- 45802-098- Mesalamine
  - 45802-098-46- 60 mL in 1 BOTTLE (45802-098-46)

45802- Perrigo New York Inc
- 45802-098- Mesalamine
  - 45802-098-51- 7 BOTTLE in 1 CARTON (45802-098-51) > 60 mL in 1 BOTTLE

45802- Perrigo New York Inc
- 45802-923- Mesalamine
  - 45802-923-41- 1 KIT in 1 CARTON (45802-923-41) * 1 SWAB in 1 PACKET * 60 mL in 1 BOTTLE (45802-098-46)

45802- Perrigo New York Inc
- 45802-923- Mesalamine
  - 45802-923-49- 1 KIT in 1 CARTON (45802-923-49) * 7 BOTTLE in 1 CARTON (45802-098-51) > 60 mL in 1 BOTTLE * 1 SWAB in 1 PACKET

45802- Perrigo New York Inc
- 45802-929- Mesalamine
  - 45802-929-49- 4 CARTON in 1 KIT (45802-929-49) > 1 KIT in 1 CARTON * 60 mL in 1 BOTTLE (45802-098-46) * 1 SWAB in 1 PACKET

50090- A-S Medication Solutions
- 50090-3002- Delzicol
  - 50090-3002-0- 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (50090-3002-0)

50090- A-S Medication Solutions
- 50090-3497- mesalamine
  - 50090-3497-0- 180 TABLET, DELAYED RELEASE in 1 BOTTLE (50090-3497-0)

53808- State of Florida DOH Central Pharmacy
- 53808-0823- ASACOL
  - 53808-0823-1- 30 TABLET, DELAYED RELEASE in 1 BLISTER PACK (53808-0823-1)

54092- Shire US Manufacturing Inc.
- 54092-100- Mesalamine
  - 54092-100-01- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-100-01)

54092- Shire US Manufacturing Inc.
- 54092-189- Pentasa
  - 54092-189-81- 240 CAPSULE in 1 BOTTLE (54092-189-81)

54092- Shire US Manufacturing Inc.
- 54092-191- Pentasa
  - 54092-191-08- 1 BLISTER PACK in 1 CARTON (54092-191-08) > 8 CAPSULE in 1 BLISTER PACK

54092- Shire US Manufacturing Inc.
- 54092-191- Pentasa
  - 54092-191-12- 120 CAPSULE in 1 BOTTLE (54092-191-12)

54092- Shire US Manufacturing Inc.
- 54092-476- Lialda
  - 54092-476-01- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)

54092- Shire US Manufacturing Inc.
- 54092-476- Lialda
  - 54092-476-02- 12 BOTTLE in 1 CARTON (54092-476-02) > 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-01)

54092- Shire US Manufacturing Inc.
- 54092-476- Lialda
  - 54092-476-08- 3 CARTON in 1 CARTON (54092-476-08) > 8 BLISTER PACK in 1 CARTON > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK

54092- Shire US Manufacturing Inc.
- 54092-476- Lialda
  - 54092-476-12- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (54092-476-12)

58914- Allergan
- 58914-501- Canasa
  - 58914-501-33- 3 SUPPOSITORY in 1 BOX (58914-501-33)

58914- Allergan
- 58914-501- Canasa
  - 58914-501-42- 42 SUPPOSITORY in 1 BOX (58914-501-42)

58914- Allergan
- 58914-501- Canasa
  - 58914-501-56- 30 SUPPOSITORY in 1 BOX (58914-501-56)

59762- Greenstone LLC
- 59762-0117- MESALAMINE
  - 59762-0117-1- 180 CAPSULE, DELAYED RELEASE in 1 BOTTLE (59762-0117-1)

59762- Greenstone LLC
- 59762-0118- Mesalamine
  - 59762-0118-3- 30 SUPPOSITORY in 1 BOX (59762-0118-3)

60687- American Health Packaging
- 60687-347- mesalamine
  - 60687-347-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-347-25) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-347-95)

60687- American Health Packaging
- 60687-397- Mesalamine
  - 60687-397-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-397-25) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-397-95)

60687- American Health Packaging
- 60687-408- Mesalamine
  - 60687-408-25- 30 BLISTER PACK in 1 BOX, UNIT-DOSE (60687-408-25) > 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (60687-408-95)

62559- ANI Pharmaceuticals, Inc.
- 62559-420- Mesalamine
  - 62559-420-07- 7 BOTTLE in 1 BOX (62559-420-07) > 60 mL in 1 BOTTLE (62559-420-11)

63304- Sun Pharmaceutical Industries, Inc.
- 63304-175- Mesalamine
  - 63304-175-13- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (63304-175-13)

64980- Rising Pharmaceuticals, Inc.
- 64980-282- Mesalamine
  - 64980-282-03- 5 PACKAGE in 1 CARTON (64980-282-03) > 6 SUPPOSITORY in 1 PACKAGE

65649- Salix Pharmaceuticals, Inc.
- 65649-103- APRISO
  - 65649-103-01- 1 BOTTLE in 1 CARTON (65649-103-01) > 4 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

65649- Salix Pharmaceuticals, Inc.
- 65649-103- APRISO
  - 65649-103-02- 1 BOTTLE in 1 CARTON (65649-103-02) > 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-435- mesalamine
  - 68382-435-28- 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-435-28)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-435- mesalamine
  - 68382-435-77- 10 BLISTER PACK in 1 CARTON (68382-435-77) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (68382-435-30)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-649- mesalamine
  - 68382-649-28- 180 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-649-28)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-711- mesalamine
  - 68382-711-19- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-19)

68382- Zydus Pharmaceuticals (USA) Inc.
- 68382-711- mesalamine
  - 68382-711-64- 34 TABLET, DELAYED RELEASE in 1 BOTTLE (68382-711-64)

68682- Oceanside Pharmaceuticals
- 68682-113- mesalamine
  - 68682-113-20- 1 BOTTLE in 1 CARTON (68682-113-20) > 120 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

69918- Amring Pharmaceuticals Inc.
- 69918-560- Mesalamine Rectal
  - 69918-560-30- 30 SUPPOSITORY in 1 BOX (69918-560-30)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1543- ZALDYON
  - 70710-1543-4- 10 BLISTER PACK in 1 CARTON (70710-1543-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70710-1543-2)

70710- Zydus Pharmaceuticals (USA) Inc.
- 70710-1543- ZALDYON
  - 70710-1543-8- 180 TABLET, DELAYED RELEASE in 1 BOTTLE (70710-1543-8)

70771- Cadila Healthcare Limited
- 70771-1071- mesalamine
  - 70771-1071-1- 120 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1071-1)

70771- Cadila Healthcare Limited
- 70771-1071- mesalamine
  - 70771-1071-2- 34 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1071-2)

70771- Cadila Healthcare Limited
- 70771-1110- mesalamine
  - 70771-1110-4- 10 BLISTER PACK in 1 CARTON (70771-1110-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70771-1110-2)

70771- Cadila Healthcare Limited
- 70771-1110- mesalamine
  - 70771-1110-8- 180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1110-8)

70771- Cadila Healthcare Limited
- 70771-1353- ZALDYON
  - 70771-1353-4- 10 BLISTER PACK in 1 CARTON (70771-1353-4) > 10 TABLET, DELAYED RELEASE in 1 BLISTER PACK (70771-1353-2)

70771- Cadila Healthcare Limited
- 70771-1353- ZALDYON
  - 70771-1353-8- 180 TABLET, DELAYED RELEASE in 1 BOTTLE (70771-1353-8)

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Pronunciation ⬇

Classifications ⬆ ⬇

Indications ⬆ ⬇

Action ⬆ ⬇

Pharmacokinetics ⬆ ⬇

Time/Action Profile ⬆ ⬇

Contraind./Precautions ⬆ ⬇

Adv. Reactions/Side Effects ⬆ ⬇

Interactions ⬆ ⬇

Route/Dosage ⬆ ⬇