Important questions to ask yourself before you take Sumatriptan Nasal Spray:1. 4.4 Special Warnings and Special Precautions for Use . ScienceDirect ® is a registered trademark of Elsevier B.V.URL: https://www.sciencedirect.com/science/article/pii/B9780323083409000359URL: https://www.sciencedirect.com/science/article/pii/B9780128026533000555URL: https://www.sciencedirect.com/science/article/pii/S007297521097036XURL: https://www.sciencedirect.com/science/article/pii/B9780702040849000574URL: https://www.sciencedirect.com/science/article/pii/B9780323033541500638URL: https://www.sciencedirect.com/science/article/pii/S0072975210970619URL: https://www.sciencedirect.com/science/article/pii/B9780323033541500602URL: https://www.sciencedirect.com/science/article/pii/B9782810101238000206URL: https://www.sciencedirect.com/science/article/pii/B9780444537171016012Kanai, Saito, & Hoka, 2006; Kanai, Suzuki, Osawa, & Hoka, 2006TRIGEMINAL AUTONOMIC CEPHALALGIAS: CLUSTER HEADACHE AND RELATED CONDITIONSUeberall, 1999; Winner et al., 2000, 2006; Ahonen et al., 2004Traité de médecine ostéopathique du crâne et de l'articulation temporomandibulaireScienceDirect ® is a registered trademark of Elsevier B.V. Since clinical data to determine the frequency of serious adverse events in pediatric patients who might receive injectable, oral, or intranasal sumatriptan are not presently available, the use of sumatriptan in patients aged younger than 18 years is not recommended. The changes observed in both species are not considered to be signs of either preneoplastic or neoplastic transformation.Local effects on nasal and respiratory tissues after chronic intranasal dosing in animals have not been studied.In patients taking MAO-A inhibitors, sumatriptan plasma levels attained after treatment with recommended doses are 2-fold (following subcutaneous administration) to 7-fold (following oral administration) higher than those obtained under other conditions.
Six of these 8 patients had ECG changes consistent with transient ischemia, but without accompanying clinical symptoms or signs. Although most of the people who have taken sumatriptan have not had any serious side effects, some have had serious heart problems. Event frequencies are calculated as the number of patients who used sumatriptan nasal spray (5, 10, or 20 mg in controlled and uncontrolled trials) and reported an event divided by the total number of patients (N = 3,711) exposed to sumatriptan nasal spray. Sumatriptan is contraindicated in patients with uncontrolled hypertension (see CONTRAINDICATIONS).
The nasal spray should be administered into one nostril only.
The daily limit is three tablets.
It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of sumatriptan (C 14 H 21 N 3 O 2 S). Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hours after treatment with Sumatriptan Nasal Spray.Safety and effectiveness of sumatriptan in pediatric patients under 18 years of age have not been established; therefore, Sumatriptan Nasal Spray is not recommended for use in patients under 18 years of age.Two controlled clinical trials evaluated sumatriptan nasal spray (5 to 20 mg) in 1,248 adolescent migraineurs aged 12 to 17 years who treated a single attack.
In addition, 12 volunteers were administered a total daily dose of 60 mg (20 mg 3 times daily) for 3.5 days without significant adverse events.Overdose in animals has been fatal and has been heralded by convulsions, tremor, paralysis, inactivity, ptosis, erythema of the extremities, abnormal respiration, cyanosis, ataxia, mydriasis, salivation, and lacrimation.
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