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AURO-ELETRIPTAN is a brand name for Eletriptan, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 3 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations Auro-Eletriptan (eletriptan hydrobromide) tablets should be taken as early as possible after the onset of a migraine attack, but are also effective if taken at a later stage. Auro-Eletriptan tablets should not be used prophylactically.
Recommended Dose and Dosage Adjustment Adult (18-65 years of age):
In controlled clinical trials, single doses of 20 mg and 40 mg were effective for the acute treatment of migraine in adults. A greater proportion of patients had a response following a 40 mg dose than following a 20 mg dose. Individuals may vary in response to doses of Auro-Eletriptan tablets.
When initiating treatment with Auro-Eletriptan, a starting dose of 20 mg or 40 mg may be considered. Patients who do not obtain satisfactory efficacy after an initial trial of 20 mg may be effectively treated with 40 mg in subsequent migraine attacks.
The choice of dose should therefore be made on an individual basis, according to the clinical status of the patient and weighing the possible risk/benefit of the 40 mg dose. A minimal effective dose should be used. If after an initial dose of 20 mg, headache improves but then returns a repeat dose of 20 mg may be beneficial and should be taken at least 2 hours after the initial dose.
If an initial dose of 40 mg is taken, a second dose is not recommended. If the initial dose is ineffective, controlled clinical trials have not shown a benefit of a second dose to treat the same attack. The maximum daily dose should not exceed 40 mg.
The safety of treating an average of more than 3 headaches in a 30-day period has not been established. Patients Receiving Potent CYP3A4 Inhibitors Auro-Eletriptan tablets are contraindicated within 72 hours of treatment with the following potent CYP3A4 inhibitors, due to potential for significant increases in eletriptan hydrobromide blood levels: ketoconazole, itraconazole, clarithromycin, troleandomycin, ritonavir, nelfinavir and nefazodone.
Auro- Eletriptan is also contraindicated within 72 hours with any other drugs that have demonstrated potent CYP3A4 inhibition and have this potent effect described in the CONTRAINDICATIONS or WARNINGS AND PRECAUTIONS sections of their labeling (see WARNINGS AND PRECAUTIONS, DRUG INTERACTIONS and CONTRAINDICATIONS).
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Patients with Hepatic Impairment No dose adjustment is required in patients with mild or moderate hepatic impairment. As eletriptan hydrobromide has not been studied in patients with severe hepatic impairment, it is contraindicated in these patients (see ACTION AND CLINICAL PHARMACOLOGY and CONTRAINDICATIONS).
Page 17 of 32 Patients with Renal Impairment In some patients with renal impairment, an elevation in blood pressure was observed. A total daily dose of greater than 20 mg should be administered with caution. Auro-Eletriptan is not recommended for patients with severe renal impairment (see ACTION AND CLINICAL PHARMACOLOGY and WARNINGS AND PRECAUTIONS).
Administration Auro-Eletriptan tablets should be swallowed whole with water.
OVERDOSAGE Symptoms:
No significant overdoses in clinical trials have been reported. Twenty-one (21) subjects have received single doses of 120 mg in Phase 1 trials and 427 in Phase 2/3 trials without significant adverse effects. Based on the pharmacology of 5-HT1 agonists, hypertension or other more serious cardiovascular symptoms could occur on overdose.
Treatment:
In case of overdose, standard supportive measures should be adopted. The elimination half-life of eletriptan is about 4 hours (see ACTION AND CLINICAL PHARMACOLOGY), and therefore monitoring of patients after overdose with eletriptan should continue for at least 20 hours, or longer should symptoms or signs persist.
There is no specific antidote to eletriptan. In cases of severe intoxication, intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system.
It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentration of eletriptan. For management of a suspected drug overdose, contact your regional Poison Control Centre immediately. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Eletriptan binds with high affinity to 5-HT1B, 5-HT1D and 5-HT1F receptors, has modest affinity for 5-HT1A, 5-HT1E, 5-HT2B and 5-HT7 receptors, and little or no affinity for 5-HT2A, 5-HT2C, 5- HT3, 5-HT4, 5-HT5A and 5-HT6 receptors.
Eletriptan has no significant affinity or pharmacological activity at adrenergic alpha1, alpha2, or beta; dopaminergic D1 or D2; muscarinic; or opioid receptors. Two theories have been proposed to explain the efficacy of 5-HT receptor agonists in migraine.
One theory suggests that activation of 5-HT1 receptors located on intracranial blood vessels, including those on the arteriovenous anastomoses, leads to vasoconstriction, which is correlated with the relief of migraine headache. The other hypothesis suggests that activation of 5-HT1 Page 18 of 32 receptors on sensory nerve endings in the trigeminal system results in the inhibition of pro- inflammatory neuropeptide release.
In the anesthetized dog, eletriptan has been shown to reduce carotid arterial blood flow, with only a small increase in arterial blood pressure at high doses. While the effect on blood flow was selective for the carotid arterial bed, decreases in coronary artery diameter were observed.
Eletriptan has also been shown to inhibit trigeminal nerve activity in the rat. 5 hours after dosing to healthy subjects. 0 hours. The mean absolute bioavailability of eletriptan is approximately 50%. The oral pharmacokinetics are slightly more than dose proportional over the clinical dose range.
The AUC and Cmax of eletriptan are […]