Clinical Pharmacology Details


SUMATRIPTAN


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Indications & Dose:

Acute relief of migraine attacks with or without aura. 


DOSAGE AND ADMINISTRATION:


Sumatriptan should not be used prophylactically. It is advisable that sumatriptan be given as early as possible after the onset of a migraine headache. It is equally effective at whatever stage of the attack it is administered.


• Adults  50 mg once daily up to 100 mg dily. If a patient does not respond to the first dose of sumatriptan, a second dose should not be taken for the same attack. Sumatriptan fast disintegrating tablets may be taken for subsequent attacks. If the patient has responded to the first dose, but the symptoms recur a second dose may be given in the next 24 h, provided that not more than 300 mg is taken in any 24-h period. The tablets should be swallowed whole with water. Patients with swallowing difficulties may choose to disperse a tablet in a small amount of water before administration. Sumatriptan fast disintegrating tablets dispersed in water have a bitter taste.


• Children The safety and effectiveness of sumatriptan fast disintegrating tablets in children has not yet been established.


• Elderly (over 65 years of age) Experience of the use of standard sumatriptan tablets in patients aged over 65 years is limited. The pharmacokinetics do not differ significantly from a younger population, but until further clinical data are available, the use of sumatriptan fast disintegrating tablets in patients aged over 65 years is not recommended. 

Contraindications:

Hypersensitivity, history of myocardial infarction or have ischemic heart disease (IHD), Prinzmetal’s angina/coronary vasospasm, peripheral vascular disease or patients who have symptoms or signs consistent with IHD. history of previous cerebrovascular accident (CVA) or transient ischaemic attack (TIA). - The use of sumatriptan in patients with uncontrolled hypertension is contraindicated.  severe hepatic impairment.


- The concomitant use of ergotamine or derivatives of ergotamine (including methysergide) is contraindicated. - Concurrent administration of monoamine oxidase inhibitors (MAOIs) and sumatriptan is contraindicated. Sumatriptan must not be used within 2 weeks of discontinuation of therapy with MAOIs

Side Effects:

Cautions:

Precautions:

Interaction:

DRUGS


Antidepressants, lithium: Increased risk of serious adverse effects ergotamine-containing drugs: Possibly additive or prolonged vasoconstrictive effects fluoxetine, fluvoxamine, paroxetine, sertraline: Possibly incoordination, hyperreflexia, and weakness


MAO inhibitors: Risk of decreased sumat-riptan clearance, increased risk of serious adverse effects


selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, other triptans: Increased risk of serotonin syndrome

Warnings:

 Monitor patient closely for serotonin syndrome exhibited by agitation, hallucinations, coma, tachycardia, labile blood pressure, hyperthermia, hyperre-flexia, incoordination, nausea, vomiting, or diarrhea. Notify prescriber immediately because serotonin syndrome may be life threatening and provide supportive care.


PATIENT TEACHING


•Advise patient to use sumatriptan as soon as possible after the onset of migraine symptoms.


• Urge patient to contact prescriber and avoid taking sumatriptan if headache symptoms aren’t typical.


• Remind patient not to exceed prescribed daily dosage. Inform him that overuse of the drug for 10 or more days per month may lead to exacerbation of headache and may require detoxification. If his use of the drug increases, advise him to notify his prescriber.


•Advise patient to swallow tablets whole and drink fluids to disguise unpleasant taste.


• Show patient suitable sites for subcutane-ous injection, and teach him how to load, administer, and discard autoinjector. Or, explain how to administer drug using needle-free drug delivery system, Sumavel DosePro. (Snap off plastic tip, flip back lever into active position, and press end of device to the skin of abdomen or thigh.)


• Instruct patient to administer no more than two subcutaneous doses in 24 hours and not to take a second dose if first dose doesn’t provide significant relief.


• Inform patient that he may experience burning, pain, and redness for 10 to 30 minutes after subcutaneous injection. Suggest that he apply ice to relieve pain and redness.


• Teach patient how to use nasal form correctly.


• To avoid cross-contamination, advise patient not to use the same nasal container for more than one person.


• Encourage patient to lie down in a dark, quiet room after taking drug to help relieve migraine.


• Instruct patient to seek emergency care for chest, jaw, or neck tightness after drug use because drug may cause coronary artery vasospasm; subsequent doses may require EGG monitoring.


• Urge patient to report palpitations or rash to prescriber.


• Advise patient to avoid potentially hazard-ous activities until drug’s CNS effects are known.


• Alert patient with seizure disorder that drug may lower seizure threshold.


• Encourage yearly ophthalmologic exami-nations for patients who require pro-longed drug therapy.


• Inform woman who is breastfeeding that she should avoid breastfeeding for 12 hours after treatment with sumatriptan to minimize infant exposure to the drug.


• Urge patient to inform all prescribers of sumatriptan therapy because of potentially dangerous drug interactions

Adverse Effects:

Lactations:

Special Precautions:

Counselling:

Side Effects Or Adverse Reactions:

CNS: Anxiety, atypical sensations, dizzinessdrowsiness, fatigue, fever, headache, malaise, sedation, serotonin syndrome, seizures, vertigo, weakness


CV: Arrhythmias; chest heaviness, pain, pressure, or tightness; coronary artery vasospasm;


EGG changes; hypertension; hypotension; palpitations; peripheral vascular ischemia


EENT: Abnormal vision, blindness or partial vision loss, jaw or mouth discomfort,fnasal burning (P.O., subcutaneous), nasal irritation (nasal), nose or throat discomfort, photophobia (P.O., subcutaneous), taste perversion (nasal), tongue numbness or soreness


GI: Abdominal discomfort, bloody diarrhea, colonic ischemia, dysphagia


MS: Jaw discomfort, muscle cramps, myalgia, neck pain or stiffness


SKIN: Dermatitis, diaphoresis, erythema, flushing, pallor, photosensitivity (P.O., subcutaneous), pruritus, rash, urticaria


Other: Injection-site burning, pain, and redness 


Nursing Considerations


• Be aware that sumatriptan shouldn’t be given to elderly patients because they’re more likely to have decreased hepatic function, coronary artery disease (CAD), and more pronounced blood pressure increases.


• Assess patient for chest pain, and monitor blood pressure in patients with CAD before and for at least 1 hour after sumatriptan administration.


• Don’t give sumatriptan within 24 hours of another 5-HTj-receptor agonist, such as naratriptan, rizatriptan, or zolmitriptan with the exception of a single dose of another sumatriptan product, provided the doses are separated by at least 1 hour. Don’t give an ergotamine-containing or ergottype drug within 24 hours of sumatriptan therapy. Doing so increases risk of serious adverse interactions and effects.


• After nasal administration, rinse tip of bottle with hot water (don’t suction water into bottle) and dry with a clean tissue. Replace cap after cleaning.


• Inspect injection solution for particles and discoloration before administering. Discard solution if you detect these changes.


• Be aware that drug shouldn’t be adminis-tered I.V. because this may precipitate coronary artery vasospasm.


•Assess patients with risk factors for CAD for arrhythmias, chest pain, and other signs of heart disease.


• For patients with seizure disorder, institute seizure precautions according to facility policy because sumatriptan may lower seizure threshold.

Patient And Carer Advice: