IMIGRAN Nasal Spray
Sumatriptan nasal prep
10mg/Spray
GLAXOSMITHKLINE S.p.A.
| Pack size | 2's Blister (2 Single Dose Spray Units) |
|---|---|
| Dispensing mode | POM |
| Source | ITALY |
| Agent | AL BAKER TRADING EST. |
| Retail Price | 35.50 AED |
Available as:
Indications
IMIGRAN Nasal Spray is used for:
Acute treatment of migraine with or without aura.
Adult Dose
Acute treatment of migraine attack with or without aura
Intranasal spray
Preparation 10mg/spray or 20mg/spray
The recommended adult dose of Sumatriptan Nasal Spray for the acute treatment of migraine is 10 mg, or 20 mg once daily.
The dose is administer as a single nasal spray in 1 nostril.
If the migraine has not resolved by 2 hours after taking Sumatriptan Nasal Spray, or returns after a transient improvement,
1 additional dose may be administered at least 1 hour after the first 10 mg single dose or 2 hours after the first 20 mg single dose.
If headache returns, may repeat 10 mg single dose once after 1 hr; not to exceed 30 mg/day
If headache returns, may repeat 20 mg single dose once after 2 hr; not to exceed 40 mg/day
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Administration
Contra Indications
Current/history of: ischemic cardiac, cerebrovascular, or peripheral vascular syndromes (angina, MI, stroke, TIA, ischemic bowel disease)
Uncontrolled hypertension
Coadministration of MAO-A inhibitors or use within 2 weeks after discontinuing MAO-A inhibitors
Use within 24 hr of any ergotamine-containing or ergot-type medication (eg, dihydroergotamine or methysergide)
Use within 24 hr of other 5-HT1 agonists
Hypersensitivity
Precautions
Overuse of acute migraine drugs (eg, ergotamine, triptans, opioids, or combination of these drugs for ≥10 days/month) may lead to exacerbation of headache (medication overuse headache)
Serious cardiac and cerebrovascular events, including cerebral hemorrhage, subarachnoid hemorrhage, stroke, acute MI, arrhythmias, and death reported within a few hours after administration
Chest discomfort and jaw or neck tightness reported infrequently following intranasal administration (relatively common following SC injection)
Not for use with unrecognized CAD as predicted by risk factors (eg, hypertension, hypercholesterolemia, smoking, obesity, diabetes, strong family history of CAD, female with surgical or physiological menopause, male aged >40 yr)
Local irritation of nose and throat reported
Pregnancy-Lactation
Pregnancy Category: C
Reproductive toxicity studies for sumatriptan by intranasal route have not been conducted; embryolethality and blood vessel abnormalities observed with PO or IV doses in pregnant rabbits during organogenesis
Lactation: Excreted in human breast milk in very low levels; minimize infant to potential exposure by avoiding breastfeeding for 8-12 hr after administration
Interactions
Adverse Effects
Side effects of Sumatriptan nasal prep :
>10%
Bad/unusual taste (13.5-24.5%)
Gastrointestinal: nausea/vomiting (11-13.5%)
1-10%
Disorder/discomfort of nasal cavity/sinuses (2.5-3.8%)
Throat discomfort (0.8-2.4%)
Dizziness/vertigo (1-1.7%)
Burning sensation (0.4-1.4%)
Frequency Not Defined
Atypical Sensations: Tingling, numbness, pressure sensation, cold sensation, feeling of tightness
Cardiovascular: Flushing, hypertension, palpations, tachycardia, arrhythmia, edema
Chest tightness/discomfort, chest pressure/heaviness
Disturbance of hearing, ear infections
Eye irritation and visual disturbances
Gastrointestinal: Abdominal discomfort, diarrhea, dysphagia, GERD, dry mouth, thirst
Musculoskeletal: Neck pain/stiffness, backache, weakness, joint symptoms, arthritis, myalgia, muscle cramps
Neurological: Drowsiness/sedation, anxiety, sleep disturbances, tremors, syncope, chills, depression, agitation, confusion
Respiratory: Dyspnea, lower respiratory infection
Skin: Rash/skin eruption, pruritus, erythema
Urogenital: Dysuria, dysmenorrhea
Mechanism of Action
Selective 5-HT1 receptor agonist in cranial arteries; elicits vasoconstrictive and anti-inflammatory effects; associated with antidromic neuronal transmission and relief of migraine headache
Note
IMIGRAN 10mg/Spray Nasal Spray manufactured by GLAXOSMITHKLINE S.p.A.. Its generic name is Sumatriptan nasal prep. IMIGRAN is availble in United Arab Emirates.
Farmaco UAE drug index information on IMIGRAN Nasal Spray is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.