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SUVEXX is a brand name for Sumatriptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: SUVEXX (sumatriptan succinate and naproxen sodium) is indicated for the acute treatment of migraine attacks with or without aura in adults. SUVEXX is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic, basilar, or ophthalmoplegic migraine (see CONTRAINDICATIONS). Safety…
Verbatim from this product's HC label. Tap a section to expand.
1 General SUVEXX should not be used prophylactically. 2 Dosing Considerations Renal Impairment SUVEXX should be avoided in patients with renal failure and those with severe renal impairment (creatinine clearance <30 mL/min; see CONTRAINDICATIONS).
SUVEXX is not recommended in patients with mild (creatinine clearance: 60-89 mL/min) or moderate (creatinine clearance: 30-59 mL/min) renal impairment. If there is a need to use SUVEXX in patients with mild or moderate renal impairment, only one dose should be administ ered within a 24-hour period and renal function should be monitored during treatment (see WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY).
Hepatic Impairment SUVEXX should be avoided in patients with moderate and severe (Child Pugh B and C ) hepatic impairment (see CONTRAINDICATIONS). SUVEXX is not recommended in patients with mild hepatic impairment (Child Pugh A). If there is a need to use SUVEXX in patients with mild hepatic impairment, only one dose should be used within a 24-hour period and patient should be monitored during treatment (see WARNINGS AND PRECAUTIONS and ACTION AND CLINICAL PHARMACOLOGY).
3 Recommended Dose and Dosage Adjustment Dosage in Adults The recommended dosage for adults is 1 tablet of SUVEXX 85/500 mg. SUVEXX 85/500 mg contains a dose of sumatriptan succinate higher than the lowest effective dose of 50 mg. The choice of the dose of sumatriptan succinate, and of the use of a fixed combination such as in SUVEXX 85/500 mg should be made on an individual basis, weighing the possible benefit of a higher dose of sumatriptan succinate with the potential for a greater risk of adverse reactions.
The maximum recommended dosage in a 24-hour period is 2 tablets, taken at least 2 hours apart. Efficacy of the second dose as rescue medication was not systematically evaluated in clinical trials. The effectiveness of a second dose if the initial dose is ineffective is not established.
It is advisable that SUVEXX be taken as early as possible after the onset of a migraine attack. SUVEXX is effective when administered at any stage of the attack. The safety of treating an average of more than 5 migraine headaches in a 30 -day period has not been established.
4 Administration SUVEXX tablets may be administered with or without food. Tablets should not be split, crushed, or chewed. 5 Missed Dose SUVEXX is only taken when needed and does not have a daily dosing schedule. No more than 2 tablets, taken at least 2 hours apart, should be taken within a 24-hour period.
1 Adverse Reaction Overview Since SUVEXX contains both sumatriptan succinate and naproxen sodium, the same pattern of adverse reactions reported for these individual components may occur with the combination product. Serious cardiac events, including some that have been fatal, have occurred fol lowing the use of 5-HT1 agonists, such as sumatriptan succinate, a component of SUVEXX.
These events are very rare and most have been reported in patients with risk factors predictive of coronary artery disease (CAD). Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS - Cardiovascular).
The most common adverse reactions encountered with nonsteroidal anti-inflammatory drugs, SUVEXX® Product Monograph (sumatriptan/naproxen sodium) tablets Page 21 of 45 such as naproxen sodium, a component of SUVEXX, are gastrointestinal, of which peptic ulcer, with or without bleeding, is the most severe.
Fatalities have occurred particularly in the elderly. Most commonly reported adverse reactions in adults with SUVEXX (incidence ≥2%) are: dizziness, somnolence, paresthesia, nausea, dry mouth, dyspepsia, chest discomfort . No new safety findings were identified during SUVEXX treatment compared to the established safety profile for the individual substances.
2 Clinical Trial Adverse 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 reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. The adverse reactions reported below are specific to the clinical trials with SUVEXX. Table 2 lists adverse reactions that occurred in 2 placebo-controlled clinical trials evaluating adult subjects who took 1 dose of study drug.
Please see the Serious Warnings and Precautions Box at the beginning of Part I:
Health Professional Information. General SUVEXX should only be used where a clear diagnosis of migraine has been established.
Cluster Headache:
There is insufficient information on the efficacy and safety of SUVEXX in the treatment of cluster headache, which is present in an older, predominantly male population. The need for prolonged use and the demand for repeated medication in this condition re nders the dosing information inapplicable for cluster headache.
Psychomotor Impairment:
Patients should be cautioned that drowsiness may occur as a result of treatment with SUVEXX. g. driving or operating machinery) if drowsiness occurs or until they have gained sufficient knowledge on SUVEXX to gauge whether or not it affects their mental and/or motor performance adversely .
Medication Overuse Headache:
Overuse of acute headache treatments is associated with the exacerbation of headache (medication overuse headache, MOH). Medication overuse headache may present as migraine-like daily headaches, or as a marked increase in frequency of migraine attacks.
In these cases, discontinuation of medication should be considered.
Concomitant NSAID Use:
SUVEXX contains naproxen sodium, an NSAID. SUVEXX is NOT recommended for use with other NSAIDs, with the exception of low-dose ASA for cardiovascular prophylaxis, because of the absence of any evidence demonstrating synergistic benefits and the potential for additive adverse reactions.
(See DRUG INTERACTIONS – NSAID related Drug-Drug Interactions - Acetylsalicylic acid (ASA) or other NSAIDs) Cardiovascular Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events: Sumatriptan succinate, a component of SUVEXX has been associated with transient chest and/or neck pain, pressure, heaviness and tightness which may resemble angina pectoris.
, anaphylactic reactions, angioedema, and serious skin reactions) to sumatriptan, naproxen sodium, or any component of SUVEXX. Ischemic coronary artery disease (CAD) (angina pectoris, history of myocardial infarction, or documented silent ischemia) or coronary artery vasospasm, including Prinzmetal’s angina.
In the setting of coronary artery bypass graft (CABG) surgery. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders. History of stroke or transient ischemic attack (TIA) or history of hemiplegic, basilar, or ophthalmoplegic migraine because these patients are at a higher risk of stroke.
Peripheral vascular disease. Ischemic bowel disease. Uncontrolled hypertension. , within 24 hours) of ergotamine-containing medication, ergot-type medication (such as dihydroergotamine or methysergide), or another 5 - hydroxytryptamine1 (5-HT1) agonist.
Concurrent administration of a monoamine oxidase (MAO)-A inhibitor or recent (within 2 weeks) use of an MAO-A inhibitor. History of asthma, urticaria, or allergic-type reactions after taking acetylsalicylic acid (ASA) or other NSAIDs.
Severe, sometimes fatal, anaphylactic reactions to NSAIDs SUVEXX® Product Monograph (sumatriptan/naproxen sodium) tablets Page 5 of 45 have been reported in such patients. The potential for cross-reactivity between different NSAIDs must be kept in mind (see WARNINGS AND PRECAUTIONS: Hypersensitivity Reactions: Naproxen Sodium).
During the third trimester of pregnancy, because of risk of premature closure of the ductus arteriosus, and prolonged parturition. Breastfeeding women. 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 WARNINGS AND PRECAUTIONS – Renal) Known hyperkalemia (see WARNINGS AND PRECAUTIONS - Renal - Fluid and Electrolyte Balance) SUVEXX® Product Monograph (sumatriptan/naproxen sodium) tablets Page 6 of 45
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Only reactions that occurred at a frequency of ≥1% and were more frequent than in the placebo group are included in Table 2. 2) 0 1 Total number of subjects w ith at least one adverse reaction (Study 1 = MT400-301, Study 2 = MT400-302) The incidence of adverse reactions in controlled clinical trials was not affected by gender or age.
There were insufficient data to assess the impact of race on the incidence of adverse reactions. Long-Term Safety In a long-term, open-label, multiple attack study, 80 male and 485 female patients treated 24,485 migraine attacks with SUVEXX over a period of up to 12 months.
Each attack could be treated with a single dose of SUVEXX or, if needed, a second dose could b e taken at least two hours after the first dose. A total of 43 patients (8%) withdrew from the study due to adverse events. 4%). 3%). 4 Abnormal Laboratory Findings: Hematologic, Clinical Chemistry and Other Quantitative Data No clinically relevant shifts were noted in any hematological or chemistry values during clinical trials with migraine patients taking SUVEXX.
5 Post-Market Adverse Reactions Reports of serious adverse events temporally associated with the individual components of SUVEXX during post-marketing experience are included below. Because these events are reported voluntarily from a population of uncertain size, it is not always possibl e to reliably estimate their frequency or clearly establish a causal relationship to SUVEXX drug exposure.
Post-marketing reports with SUVEXX use are in accordance with those listed below. No new adverse events have been reported specific to the combinatio n product. The following adverse events have been reported with NSAIDs including NAPROXEN and NAPROXEN SODIUM , a […]
In rare cases, the symptoms have been identified as being the likely result of coronary vasospasm or myocardial ischemia. Rare cases of serious coronary events or arrhythmia have occurred following use of sumatriptan succinate. Sumatriptan succinate should not be given to patients who have documented ischemic or vasospastic coronary artery disease (CAD) (see CONTRAINDICATIONS).
, hypertension, hypercholesterolemia, smoking, obesity, diabetes, strong family history of CAD, female who is surgically or physiologically postmenopausal, or male who is over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significan t underlying cardiovascular disease.
The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is unknown. If, during the SUVEXX® Product Monograph (sumatriptan/naproxen sodium) tablets Page 10 of 45 cardiovascular evaluation, the patient’s medical history or ele ctrocardiographic investigations reveal findings indicative of, or consistent with, coronary artery vasospasm or myocardial ischemia, SUVEXX should not be administered (see CONTRAINDICATIONS).
For patients with risk factors predictive of CAD who are considered to have a satisfactory cardiovascular evaluation, the first dose of SUVEXX should be administered in the setting of a physician’s office or similar medically staffed and equipped facility.
Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining electrocardiograms in patients with risk factors during the interval immediately following SUVEXX administration on the first occasion of use.
However, an absence of drug-induced cardiovascular effects on the occasion of the initial dose does not preclude the possibility of such effects occurring with subsequent administrations. Intermittent long-term users of SUVEXX who have or acquire risk factors predictive of CAD as described above, should receive periodic interval cardiovascular evaluations over the course of treatment.
If symptoms consistent with angina occur after the use of SUVEXX, ECG evaluation should be carried out to look for ischemic changes. The systematic approach described above is intended to reduce the likelihood that patients with unrecognized cardiovascular disease will be inadvertently exposed to SUVEXX.
Because 5-HT1 agonists may cause coronary vasospasm, patients who experience signs or symptoms suggestive of angina following SUVEXX should be evaluated for the presence of CAD or a predisposition to variant angina before receiving additional doses, and should be monitored electrocardiographically if dosing is resumed and similar symptoms recur.
Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud’s syndrome, following SUVEXX should be evaluated for atherosclerosis or predisposition to vasospasm (see CONTRAINDICATIONS and WARNINGS and PRECAUTIONS and ADVERSE DRUG REACTIONS, Clinical Trial Adverse Drug Reactions).
Cardiac Events and Fatalities Associated with 5-HT1 Agonists Sumatriptan succinate, a component of SUVEXX can cause coronary artery vasospasm. Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported within a few hours following the administration of 5-HT1 agonists.
Considering the extent of use of 5-HT1 agonists in patients with migraine, the incidence of these events is extremely low. The fact that some of these events have occurred in patients with no prior cardiac disease history and with documented absence of CAD, and the close proximity of the events to sumatriptan succinate use support the conclusion […]