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TEVA-NARATRIPTAN is a brand name for Naratriptan, 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 .......................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Dosing Considerations TEVA-NARATRIPTAN (naratriptan hydrochloride) tablets are recommended only for the acute treatment of migraine attacks. TEVA-NARATRIPTAN should not be used prophylactically. The safety of treating, on average, more than four headaches in a 30 day period has not been established.
If a patient does not respond to the first dose of TEVA-NARATRIPTAN tablets, a second dose should not be taken for the same attack, as it is unlikely to be of benefit. TEVA-NARATRIPTAN can be taken with or without food.
Recommended Dose and Dosage Adjustment Adults:
The minimal effective single adult dose of TEVA-NARATRIPTAN Tablets is 1 mg. 5 mg, which should not be exceeded (see CLINICAL TRIALS). 5 mg dose. 5 mg dose with the potential for a greater risk of adverse events. Administration TEVA-NARATRIPTAN tablets should be swallowed whole with water.
TEVA- NARATRIPTAN tablets should be taken as early as possible after the onset of a migraine headache, but are effective if taken at a later stage. Redosing If the migraine headache returns, or if a patient has a partial response, the initial dose may be repeated once after 4 hours, for a maximum dose of 5 mg in a 24 hours period.
TEVA-NARATRIPTAN Page 16 of 32 Special Populations Renal Impairment:
Renal disease/functional impairment causes prolongation of the half-life of orally administered TEVA-NARATRIPTAN. Consequently, if treatment is deemed advisable in the presence of renal impairment, a maximum single dose of 1 mg should be administered.
No more than a total of 2 mg should be taken in any 24 hour period. Repeated dosing in renally impaired patients has not been evaluated (see ACTION AND CLINICAL PHARMACOLOGY). Administration of TEVA-NARATRIPTAN tablets in patients with severe renal impairment (creatinine clearance <15 mL/min) is contraindicated (see CONTRAINDICATIONS).
Hepatic Impairment:
Hepatic disease/functional impairment causes prolongation of the half- life of orally administered TEVA-NARATRIPTAN. Consequently, if treatment is deemed advisable in the presence of hepatic impairment, a maximum single dose of 1 mg should be administered.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Naratriptan in Canada.
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No more than a total of 2 mg should be taken in any 24 hour period (see ACTION AND CLINICAL PHARMACOLOGY). Administration of TEVA-NARATRIPTAN tablets in patients with severe hepatic impairment (Child-Pugh grade C) is contraindicated (see CONTRAINDICATIONS).
Hypertension:
TEVA-NARATRIPTAN should not be used in patients with uncontrolled or severe hypertension. Patients with mild to moderate controlled hypertension should be treated cautiously at the lowest effective dose. OVERDOSAGE For management of a suspected drug overdose, contact your regional Poison Control Centre.
In clinical studies, numerous patients (n=222) and healthy subjects (n=196) have received naratriptan hydrochloride tablets at doses of 5 to 25 mg. In the majority of cases, no serious adverse events were reported. 5 mg dose experienced ischemic ECG changes, which were likely due to coronary vasospasm.
This event was not associated with a serious clinical outcome. A patient who was mildly hypertensive experienced a significant increase in blood pressure (baseline value of 150/98 to 204/144 mmHg at 225 minutes) beginning 30 minutes after the administration of a 10 mg dose (4 times the maximum recommended single dose).
The event resolved with antihypertensive treatment. Administration of 25 mg (10 times the maximum recommended single dose) in one healthy male subject increased blood pressure from 120/67 mmHg pre-treatment up to 191/113 mmHg at approximately 6 hours post-dose and resulted in adverse events including lightheadedness, tension in the neck, tiredness and loss of coordination.
Blood pressure returned to near baseline by 8 hours after dosing without any pharmacological intervention. The elimination half-life of naratriptan is about 5 to 8 hours (see ACTION AND CLINICAL PHARMACOLOGY), and therefore monitoring of patients after overdose with TEVA- NARATRIPTAN Tablets should continue for at least 24 hours or longer if symptoms or signs persist.
Standard supportive treatment should be applied as required. If the patient presents with TEVA-NARATRIPTAN Page 17 of 32 chest pain or other symptoms consistent with angina pectoris, electrocardiogram monitoring should be performed for evidence of ischemia.
, nitroglycerin or other coronary artery vasodilators) should be administered as required. It is unknown what effect hemodialysis or peritoneal dialysis has on the serum concentrations of TEVA-NARATRIPTAN. ACTION AND CLINICAL PHARMACOLOGY Mechanism of Action Naratriptan hydrochloride has been demonstrated to be a selective agonist for a vascular 5- hydroxytryptamine receptor subtype (probably a member of the 5-HT1B/1D family) with little or no binding affinity for 5-HT2/3 receptor subtypes, alpha1-, alpha2-, or beta-adrenergic; dopamine1; dopamine2; muscarinic; or benzodiazepine receptors.
Naratriptan did not exhibit agonist or antagonist activity in ex vivo assays of 5-HT4 and 5-HT7 receptor-mediated activities. […]