Medygraine Tablets / Film-coated
Sumatriptan
50mg
ACTAVIS HF
| Pack size | 2's Blister |
|---|---|
| Dispensing mode | POM |
| Source | ICELAND |
| Agent | PHARMATRADE |
| Retail Price | 26.50 AED |
Available as:
Indications
Medygraine Tablets / Film-coated is used for:
Migraine, Cluster headache
Adult Dose
Oral
Migraine
Adult: >18 yr: 50-100 mg repeated at 2-hr intervals if migraine recurs. Max: 200 mg/24 hr.
Mild to moderate hepatic impairment: Max single dose: 50 mg.
Severe hepatic impairment: Contraindicated
Child Dose
<18 years: Safety and efficacy not established
Renal Dose
Administration
May be taken with or without food.
Contra Indications
Not to be used prophylactically and in patients with basilar or hemiplegic or ophthalmoplegic migraine. History of MI or stroke, severe hepatic impairment, ischaemic heart disease, uncontrolled hypertension, peripheral vascular disease, hypersensitivity to sulfonamides.
Precautions
Conditions predisposing to seizures, presence of coronary risk factors, cardiac arrhythmias, renal or hepatic impairment, elderly, pregnancy, lactation.
Lactation: Excreted in breast milk at very low levels; minimize infant to potential exposure by avoiding breastfeeding for 8-12 hours after administration
Pregnancy-Lactation
Pregnancy
Data from a prospective pregnancy exposure registry and epidemiological studies of pregnant women have not detected increased frequency of birth defects or consistent pattern of birth defects among women exposed to sumatriptan compared with general population; in developmental toxicity studies in rats and rabbits, oral administration of sumatriptan to pregnant animals was associated with embryolethality, fetal abnormalities, and pup mortality; when administered by intravenous route to pregnant rabbits, sumatriptan was embryolethal
However, possible disease-associated maternal and/or embryo/fetal risk reported; several studies have suggested that women with migraine may be at increased risk of preeclampsia during pregnancy
Lactation
Sumatriptan is excreted in human milk following subcutaneous administration; there are no data on effects of sumatriptan on breastfed infant or effects of sumatriptan on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for injection and any potential adverse effects on breastfed infant from sumatriptan or from underlying maternal condition
Infant exposure to sumatriptan can be minimized by avoiding breastfeeding for 12 hr after therapy
Interactions
Concurrent use increased risk of vasospastic reaction with ergotamine and related compounds.
Potentially Fatal: Increased risk of serotonin syndrome with concurrent use of SSRI, MAOIs or within 14 days of stopping MAOIs. Admin of ergotamine or related compounds within the previous 24 hr.
Adverse Effects
Side effects of Sumatriptan :
>10%
Injection site reaction (<86%), Paresthesia (5-14%), Dizziness (12%), Warm/hot sensation (11%)
1-10%
Chest discomfort/pressure/tightness (2-5%), Jaw or neck tightness (1-5%), Diaphoresis (2%), Burning sensation (7%), Cold sensation (1%), Dysphagia, Sore throat (3%), Malaise (1%), Abdominal distress (1%)
Frequency Not Defined
Agitation, Cardiac arrhythmia: V-fib/V-tach (rare), Dysuria, Eye irritation, Flushing, MI and coronary artery vasospasm in patients with CAD risk factors (extremely rare), Nasal discomfort, Palpitations, Tingling, Weakness
Potentially Fatal: Cardiac arrhythmias, MI.
Mechanism of Action
Sumatriptan is a selective serotonin agonist that acts at 5-HT1 receptors. It causes vasoconstriction of cranial arteries and/or inhibition of neurogenic inflammatory processes in the CNS. A small but significant delay in gastric emptying also occurs.
Note
Medygraine 50mg Tablets / Film-coated manufactured by ACTAVIS HF. Its generic name is Sumatriptan. Medygraine is availble in United Arab Emirates.
Farmaco UAE drug index information on Medygraine Tablets / Film-coated is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.