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TEVA-5 ASA is a brand name for Mesalamine (also known as Mesalazine), supplied as a tablet (enteric-coated). The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TEVA-5 ASA (5-aminosalicylic acid) is indicated for: the treatment of mild to moderate active ulcerative colitis the maintenance of remission of mild to moderate ulcerative colitis. TEVA-5 ASA at the dosage tested of 1.6 g/day may not be effective for the maintenance of remission when the underlying disease is…
Verbatim from this product's HC label. Tap a section to expand.
1 Recommended Dose and Dosage Adjustment For the treatment of mildly to moderately active ulcerative colitis: Usual daily adult dose is 2 to 8 TEVA-5 ASA 400 mg tablets, taken orally in divided doses. In patients with severe active disease, the dose may be increased to 12 tablets daily.
For the maintenance of remission of ulcerative colitis:
The recommended dosage in adults is 4 tablets, taken orally in divided doses. The treatment duration in a well-controlled clinical trial was 6 months. Abrupt discontinuation is not recommended. Ulcerative colitis rarely remits completely.
Thus, it is important for patients to closely comply with the maintenance dosage prescribed by their doctors. By doing so, the risk of relapse can be substantially reduced. Health Canada has not authorized an indication for pediatric use.
4 Administration TEVA-5 ASA Page 6 of 28 Tablets should be swallowed whole, taking care not to break the outer coating. The outer coating is designed to remain intact, to protect the active ingredient until it reaches the terminal ileum, where the tablet coating dissolves and the contents of the tablet are released into the terminal ileum and colon.
Patients should be advised to take TEVA-5 ASA tablets only as prescribed. The number or frequency of tablets ingested should not be changed without first consulting their physician. Intact or partially intact tablets may infrequently appear in the stool.
If this occurs repeatedly, the patient should be advised to consult their physician. 5 Missed Dose If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular dosing schedule.
Do not take double the dose.
TEVA-5 ASA
1 Adverse Drug Reaction Overview 5-aminosalicylic acid is generally well tolerated. The most commonly reported adverse reactions were nausea, diarrhea, abdominal pain and headache. Other common adverse reactions seen in clinical trials with 5-aminosalicylic acid were acute exacerbation of ulcerative colitis symptoms, abnormal hepatic functions tests and rash.
Adverse events seen in clinical trials with 5-aminosalicylic acid tablets have generally been mild and reversible, and have seldom resulted in discontinuation of treatment. 2 Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. 2%) of the placebo patients. Adverse reactions leading to withdrawal from 5-aminosalicylic acid tablets included (each in one patient): diarrhea and colitis flare; dizziness, nausea, joint pain, and headache; rash, lethargy and constipation; dry mouth, malaise, lower back discomfort, mild disorientation, mild indigestion and cramping; headache, nausea, malaise, aching, vomiting, muscle cramps, a stuffy head, plugged ears, and fever.
Adverse events occurring at a frequency of greater than 2% in these clinical trials are listed below. Overall, the incidence of adverse events seen with 5-aminosalicylic acid tablets was similar to placebo. Headache, abdominal pain, eructation, pain, nausea, pharyngitis, dizziness, asthenia, diarrhea, back pain, fever, rash, dyspepsia, rhinitis, arthralgia, vomiting, constipation, hypertonia, flatulence, flu syndrome, chills, colitis exacerbation, chest pain, peripheral edema, myalgia, pruritus, sweating, dysmenorrhea.
2 Breast- Feeding 11/2021 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. RECENT MAJOR LABEL CHANGES.........................................................................................
2 TABLE OF CONTENTS…………………………………………………………………………2 PART I: HEALTH PROFESSIONAL INFORMATION ............................................................. 4 1 INDICATIONS ...............................................................................................................................
1 Pediatrics ................................................................................................................................... 2 Geriatrics ...................................................................................................................................
4 2 CONTRAINDICATIONS .............................................................................................................. 4 3 SERIOUS WARNINGS AND PRECAUTIONS BOX ................................................................
5 4 DOSAGE AND ADMINISTRATION .......................................................................................... 1 Recommended Dose and Dosage Adjustment...........................................................................
4 Administration ........................................................................................................................... 5 Missed Dose ..............................................................................................................................
6 5 OVERDOSAGE .............................................................................................................................. 6 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING............................. 6 7 WARNINGS AND PRECAUTIONS ............................................................................................
TEVA-5-ASA is contraindicated in patients who are hypersensitive to this drug or to any ingredient in the formulation, including any non-medicinal ingredient, or component of the container. For a complete listing, see DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING.
73m2) and/or severe hepatic impairment (see WARNINGS & PRECAUTIONS – Renal and Hepatic/Biliary/Pancreatic) Patients with existing gastric or duodenal ulcer Patients with urinary tract obstruction Patients unable to swallow the intact tablets TEVA-5 ASA Page 5 of 28
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Mesalamine in Canada.
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Of these adverse events, only rash showed a consistently higher frequency with increasing 5-aminosalicylic acid dose in these studies. The following adverse reactions were seen in 2% of the patients in the controlled studies: malaise, arthritis, insomnia, increased cough, acne, and conjunctivitis.
6%) of the placebo patients. Adverse reactions leading to withdrawal from 5-aminosalicylic acid tablets included (each in one patient): anxiety; headache; pruritus, decreased libido; rheumatoid arthritis; and stomatitis and asthenia.
In the 6 month placebo-controlled maintenance trial, the incidence of adverse events seen with 5-aminosalicylic acid tablets was similar to that seen with placebo. 6 g/day group at a frequency of 2% or greater are listed in Table 1 below.
6 g/day in the maintenance study: migraine, ear disorder, rash, vasodilation, allergic reaction, dyspnea, chills, pneumonia, urine abnormality, peripheral edema, palpitations, anorexia, depression, urinary tract infection, leg cramps, alopecia and sweating.
In uncontrolled clinical studies, the following adverse events occurred at a frequency of 5% or greater and appeared to increase in frequency with increasing dose: Asthenia, flu syndrome, back pain, arthralgia, and rhinitis. 4 Abnormal Hematologic and Clinical Chemistry and Other Quantitative data Elevated AST (SGOT) or ALT (SGPT), elevated alkaline phosphatase, elevated serum creatinine and BUN.
5 Post-Market Adverse Drug Reactions TEVA-5 ASA Page 13 of 28 In addition to the […]
1 Special Populations.................................................................................................................... 1 Pregnant Women ....................................................................................................................
2 Breast-feeding ......................................................................................................................... 3 Pediatrics ................................................................................................................................
4 Geriatrics ................................................................................................................................ 9 8 ADVERSE REACTIONS ..............................................................................................................
1 Adverse Drug Reaction Overview ........................................................................................... 2 Clinical Trial Adverse Drug Reactions ...................................................................................
3 Less Common Clinical Trial Adverse Reactions .................................................................... 4 Abnormal Hematologic and Clinical Chemistry and Other Quantitative data ........................ 5 Post-Market Adverse Drug Reactions .....................................................................................
12 9 DRUG INTERACTIONS............................................................................................................. 2 Overview .................................................................................................................................
4 Drug-Drug Interactions............................................................................................................ 5 Drug-Food Interactions............................................................................................................
6 Drug-Herb Interactions ............................................................................................................ 7 Drug-Laboratory Interactions ..................................................................................................
14 10 ACTION AND CLINICAL PHARMACOLOGY ................................................................... 1 Mechanism of Action ............................................................................................................
3 Pharmacokinetics ................................................................................................................... 15 11 STABILITY AND STORAGE RECOMMENDATIONS ......................................................
16 PART II: SCIENTIFIC INFORMATION .................................................................................... 17 13 PHARMACEUTICAL INFORMATION ................................................................................
17 14 CLINICAL TRIALS .................................................................................................................. 1 Trial Design and Study Demographics ..................................................................................
18 16 NON-CLINICAL TOXICOLOGY ........................................................................................... 19 17 SUPPORTING PRODUCT MONOGRAPH ...........................................................................
21 PATIENT MEDICATION INFORMATION ............................................................................... 22 TEVA-5 ASA Page 4 of 28 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TEVA-5 ASA (5-aminosalicylic acid) is indicated for: the treatment of mild to moderate active ulcerative colitis the maintenance of remission of mild to moderate ulcerative colitis.
TEVA-5 […]