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TEVA-SULINDAC is a brand name for Sulindac, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: TEVA-SULINDAC (sulindac tablets) is indicated for: The relief of signs and symptoms related to osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis. Throughout this document, the term NSAIDs refers to both…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations Use of TEVA-SULINDAC should be limited to the lowest effective dose for the shortest possible duration of treatment. 2 Recommended Dose and Dosage Adjustment In osteoarthritis, rheumatoid arthritis and ankylosing spondylitis the recommended starting dosage is 150 mg twice a day.
The dosage may be lowered or raised dependi ng on the response. In acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis, the recommended dosage is 200 mg twice a day. After a satisfactory response has been achieved, the dosage may be reduced according to the response.
In acute painful shoulder, therapy for 7 to 14 days is usually adequate. In acute gouty arthritis, therapy for 7 days is usually adequate. The maximum recommended dose is 400 mg per day.
Pediatrics (< 12 years of age):
Health Canada has not authorized an indication for pediatric use.
See 2 CONTRAINDICATIONS Geriatrics (>65 years of age):
In the elderly, frail and debilitated, the dosage should be reduced to the lowest level providing control of symptoms, and adjusted when necessary. 4 Geriatrics Renal impairment: TEVA-SULINDAC and its metabolites are eliminated primarily by the kidneys.
A lower dose should be considered in patients with mild and moderate renal imp airment. 5 mL/sec) or deteriorating renal disease (individuals with lesser degrees of renal impairment are at risk of deterioration of their renal function when prescribed NSAIDs and must be monitored).
See 2 CONTRAINDICATIONS Hepatic impairment:
Circulating levels of the sulfide and sulfone metabolites may be delayed, elevated and prolonged in patients with poor liver function. A lower dose should be considered in patients with mild and moderate hepatic impairment. TEVA-SULINDAC is contraindicated in severe liver impairment or active liver disease.
4 Administration TEVA-SULINDAC should be administered orally twice a day with food. 5 Missed Dose If a dose is missed, the patient should take it as soon as it is recognized. If it is almost time for the next dose, skip the missed dose and continue with the next schedul ed dose.
). Immune In common with other anti-inflammatory drugs, TEVA-SULINDAC may mask the usual signs of infection.
Aseptic Meningitis:
Rarely, with some NSAIDs, the symptoms of aseptic meningitis (stiff neck, severe headaches, nausea and vomiting, fever or clouding of consciousness) have been observed. ) seem to be pre-disposed. Therefore, in such patients, the health care provider must be vigilant to the development of this complication.
Monitoring and Laboratory Tests Cardiovascular:
Patients on long-term treatment with TEVA-SULINDAC should have their blood pressure monitored regularly.
Hematology:
Hemoglobin, hematocrit, red blood cells (RBCs), white blood cells (WBCs), and platelets should be checked in patients on long-term treatment with TEVA-SULINDAC. Additionally, concurrent therapy with warfarin requires close monitoring of the international normalized ratio (INR).
Hepatic:
During long-term therapy, liver function tests should be monitored periodically. If this drug is to be used in the presence of impaired liver function, it must be done under strict observation.
TEVA- SULINDAC (sulindac) Page 13 of 40 Ophtalmologic:
Ophthalmic examination should be carried out at periodic intervals in any patient receiving this drug for an extended period of time.
Renal:
Serum creatinine, creatine clearance and serum urea should be checked in patient during TEVA-SULINDAC therapy. Electrolytes including serum potassium should be monitored periodically.
1 Pregnant Women 08/2022 TABLE OF CONTENTS Sections or subsections that are not applicable at the time of authorization are not listed. 2 TABLE OF CONTENTS………………………………………………………………………………………………………………2 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 ................................................................. 6 4 DOSAGE AND ADMINISTRATION ..................................................................................... 1 Dosing Considerations ...............................................................................................
2 Recommended Dose and Dosage Adjustment ............................................................ 4 Administration .......................................................................................................... 5 Missed Dose..............................................................................................................
7 5 OVERDOSAGE .................................................................................................................. 8 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING...................................... 8 7 WARNINGS AND PRECAUTIONS.......................................................................................
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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The patient should be instructed not take 2 doses at the same time. TEVA- SULINDAC (sulindac) Page 8 of 40
Pregnancy:
If TEVA-SULINDAC is administered in the middle (approximately 20 weeks) to the end of the second trimester, it is recommended that pregnant women on TEVA-SULINDAC be closely monitored for amniotic fluid volume since TEVA-SULINDAC may result in reduction of amniotic fluid volume and even oligohydramnios.
1 Pregnant Women TEVA-SULINDAC is contraindicated for use in the third trimester of pregnancy. Neurologic Some patients may experience drowsiness, dizziness, blurred vision, vertigo, tinnitus, hearing loss, insomnia or depression with the use of NSAIDs, such as TEVA-SULINDAC.
If patients experience such adverse reaction(s), they should exercise caution in carrying out activities that require alertness. Ophthalmologic Blurred and/or diminished vision has been reported with the use of sulindac and other nonsteroidal anti-inflammatory drugs.
If such symptoms develop this drug should be discontinued and an ophthalmologic examination performed: ophthalmic examination should be carried out at periodic intervals in any patient receiving this drug for an extended period of time.
Peri-Operative Considerations See 2 CONTRAINDICATIONS - Coronary Artery Bypass Graft Surgery. Psychiatric See 7 WARNINGS AND PRECAUTIONS – Neurologic. Renal Long term administration of NSAIDs to animals has resulted in renal papillary necrosis and other abnormal renal pathology.
In humans, there have been reports of acute interstitial nephritis, hematuria, low grade proteinuria and occasionally nephrotic syndrome. Renal insufficiency due to NSAID use is seen in patients with pre -renal conditions leading to reduction in renal blood flow or blood volume.
Under these circumstances, renal prostaglandins help maintain renal perfusion and glomerular filtration rate (GFR). In these patients, administration of a NSAID may cause a reduction in prostaglandin synthesis leading to impaired renal function.
Patients at greatest risk of this reaction are those with pre -existing renal insufficiency (GFR < 60 mL/min or 1 mL/s), dehydrated patients, patients on salt restricted diets, those with congestive heart failure, cirrhosis, liver dysfunction, taking angiotensin -converting enzyme inhibitors, angiotensin-II receptor blockers, cyclosporin, diuretics, and those who are TEVA- SULINDAC (sulindac) Page 14 of 40 elderly.
Serious or life-threatening renal failure has been reported in patients with normal or impaired renal function after short term therapy with NSAIDs. g. dehydration due to gastroenteritis). Discontinuation of NSAIDs is usually followed by recovery to the pre-treatment state.
Caution should be used when initiating treatment with NSAIDs, such as TEVA -SULINDAC, in patients with considerable dehydration. Such patients should be rehydrated prior to initiation of therapy. Caution is also recommended in patients with pre -existing kidney disease.
Advanced renal disease: (See 2 CONTRAINDICATIONS) Fluid and Electrolyte Balance:
Use of NSAIDs, such as TEVA-SULINDAC, can promote sodium retention in a dose-dependent manner, which can lead to fluid retention and edema, and consequences of increased blood pressure and exacerbation of congestive h eart failure.
Thus, caution should be exercised in prescribing TEVA-SULINDAC in patients with a history of congestive heart failure, compromised cardiac function, hypertension, increased age or other conditions predisposing to fluid retention (See 7 WARNINGS AND PRECAUTIONS - Cardiovascular).
Use of NSAIDs, such as TEVA-SULINDAC, can increase the risk of hyperkalemia, especially in patients with diabetes mellitus, renal failure, increased age, or those receiving concom itant therapy with adrenergic blockers, angiotensin-converting enzyme inhibitors, angiotensin-II receptor antagonists, cyclosporin, or some diuretics.
Electrolytes should be monitored periodically (see 2 CONTRAINDICATIONS).
Reproductive Health:
Female and Male Potential Fertility The use of TEVA-SULINDAC, as with any drug known to inhibit cyclooxygenase/prostaglandin synthesis, may impair fertility and is not recommended in women attempting to conceive. Therefore, in women who have difficulties conceiving, or who are undergoing investigation of infertility, withdrawal of TEVA-SULINDAC should be considered.
Respiratory […]
1 Special Populations ............................................................................................... 1 Pregnant Women..................................................................................................
2 Breast-feeding ...................................................................................................... 3 Pediatrics..............................................................................................................
4 Geriatrics .............................................................................................................. 17 8 ADVERSE REACTIONS.....................................................................................................
1 Adverse Reaction Overview ................................................................................... 17 9 DRUG INTERACTIONS ....................................................................................................
4 Drug-Drug Interactions ......................................................................................... 5 Drug-Food Interactions ......................................................................................... 6 Drug-Herb Interactions..........................................................................................
7 Drug-Laboratory Test Interactions ......................................................................... 23 10 CLINICAL PHARMACOLOGY............................................................................................ 1 Mechanism of Action ............................................................................................
3 Pharmacokinetics.................................................................................................. 23 11 STORAGE, STABILITY AND DISPOSAL..............................................................................
24 12 SPECIAL HANDLING INSTRUCTIONS ............................................................................... 25 PART II: SCIENTIFIC INFORMATION.........................................................................................
26 13 PHARMACEUTICAL INFORMATION .................................................................................... 26 14 CLINICAL TRIALS ............................................................................................................
3 Comparative Bioavailability Studies ......................................................................... 26 15 MICROBIOLOGY.............................................................................................................
27 16 NON-CLINICAL TOXICOLOGY .......................................................................................... 27 PATIENT MEDICATION INFORMATION....................................................................................
32 TEVA- SULINDAC (sulindac) Page 4 of 40 PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS TEVA-SULINDAC (sulindac tablets) is indicated for: The relief of signs and symptoms related to osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, acute painful shoulder (acute subacromial bursitis/supraspinatus tendinitis) and acute gouty arthritis.
Throughout this document, the term NSAIDs refers to both non-selective NSAIDs and selective COX-2 inhibitor NSAIDs, unless otherwise indicated. For patients with an increased risk of developing CV and/or GI adverse events, other management strategies that do NOT include the use of NSAIDs should be considered first.
See 2 […]