Naramig

/ GSK

Naratriptan should be taken as early as possible after the onset of a migraine headache but they are effective if taken at a later stage. Naratriptan is recommended as monotherapy for the acute treatment of a migraine attack. The drug should not be used prophylactically.
Adults (18-65 years of age): The recommended dose of Naramig Tablets is a single 2.5mg tablet. The total dose should not exceed two 2.5mg tablets in any 24 hour period. If symptoms of migraine should recur, following an initial response, a second dose may be taken provided that there is a minimum interval of four hours between the two doses. If a patient does not respond to a first dose of Naramig Tablets a second dose should not be taken for the same attack, as it is unlikely to be of benefit. However Naramig Tablets may be used for subsequent migraine attacks.
Adolescents (12-17 years of age): Efficacy of Naramig Tablets at single doses of 0.25, 1.0 and 2.5mg was not demonstrated to be greater than placebo in a placebo-controlled study in adolescents (12 to 17 years). Therefore, the use of Naramig Tablets in patients under 18 years of age is not recommended.
Children (under 12 years of age): There are no data available on the use of naratriptan in children under 12 years of age therefore its use in this age group is not recommended.
Elderly (over 65 years of age): The safety and effectiveness of naratriptan in individuals over age 65 have not been evaluated and therefore, its use in this age group can not be recommended. There is a moderate decrease in clearance with age.
Renal Impairment: Naramig should be used with caution in patients with renal impairment. The maximum dose in any 24 hour treatment period is a single 2.5mg tablet. The use of Naramig is contraindicated in patients with severe renal impairment (creatinine clearance < 15mL/min).
Hepatic Impairment: Naramig should be used with caution in patients with hepatic impairment. The maximum dose in any 24 hour treatment period is a single 2.5mg tablet. The use of Naramig is contraindicated in patients with severe hepatic impairment (Child-Pugh grade C).
Method of administration: Naramig Tablets should be swallowed whole with water.

Acute migraine, with or without aura.

Hypersensitivity to naratriptan or to any of the excipients.
As with other 5-hydroxytryptamine1 (5-HT1) receptor agonists naratriptan should not be used in patients who have had a myocardial infarction or have ischaemic heart disease, or Prinzmetal’s angina/coronary vasospasm, peripheral vascular disease or patients who have symptoms or signs consistent with ischaemic heart disease.
Naratriptan should not be administered to patients with a history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA).
The use of naratriptan in patients with moderate or severe hypertension, and mild uncontrolled hypertension is contraindicated.
The concomitant administration of ergotamine, derivatives or ergotamine (including methysergide) or/and any triptan/5-hydroxytryptamine1 (5-HT1) receptor agonist with naratriptan is contraindicated.
Naratriptan is contraindicated in patients with severely impaired renal (creatinine clearance <15 ml/min) or hepatic function (Child-Pugh grade C).

Naratriptan should only be used where there is a clear diagnosis of migraine.
Naratriptan is not indicated for use in the management of hemiplegic, basilar or
ophthalmoplegic migraine.
As with other acute migraine therapies, before treating headaches in patients not previously diagnosed as migraineurs, and in migraineurs who present with atypical symptoms, care should be taken to exclude other potentially serious neurological conditions. It should be noted that migraineurs may be at risk of certain cerebrovascular events (eg. CVA or TIA).
The safety and efficacy of naratriptan when administered during the aura phase, prior to the onset of migraine headache, has yet to be established.
As with other 5-HT1 receptor agonists, naratriptan should not be given to patients with risk factors for ischaemic heart disease, including those patients who are heavy smokers or users of nicotine substitution therapy without prior cardiovascular evaluation. Special consideration should be given to postmenopausal women and males over 40 with these risk factors. These evaluations however, may not identify every patient who has cardiac disease and, in very rare cases, serious cardiac events have occurred in patients without underlying cardiovascular disease when 5-HT1 agonists have been administered.
Following administration, naratriptan can be associated with transient symptoms including chest pain and tightness which may be intense and involve the throat. Where such symptoms are thought to indicate ischaemic heart disease, no further doses of naratriptan should be taken and appropriate evaluation should be carried out.
Reports of transient and permanent blindness and significant partial vision loss have been reported with the use of 5-HT1 agonists. Since visual disorders may be part of a migraine attack, a causal relationship between these events and the use of 5-HT1 agonists have not been clearly established.
Serotonin syndrome (including altered mental status, autonomic instability and
neuromuscular abnormalities) has been reported following concomitant treatment with triptans and selective serotonin reuptake inhibitors (SSRIs)/serotonin noradrenaline reuptake inhibitors (SNRIs). If concomitant treatment with naratriptan and an SSRI/SNRI is clinically warranted, appropriate observation of the patient is advised, particularly during treatment initiation, with dose increases, or with addition of another serotonergic medication.
Naratriptan contains a sulphonamide component therefore there is a theoretical risk of a hypersensitivity reaction in patients with known hypersensitivity to sulphonamides.
The recommended dose of naratriptan should not be exceeded.
Prolonged use of any type of painkiller for headaches can make them worse. If this situation is experienced or suspected, medical advice should be obtained and treatment should be discontinued. The diagnosis of MOH should be suspected in patients who have frequent or daily headaches despite (or because of) the regular use of headache medications.
Undesirable effects may be more common during concomitant use of triptans and herbal preparations containing St John’s Wort (Hypericum perforatum).
This medicinal product contains anhydrous lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Common: Tingling. This is usually of short duration, may be severe and may
affect any part of the body including the chest or throat. Dizziness and
somnolence. Nausea and vomiting. Sensations of heat, malaise/fatigue.
See prescribing information for full details.

Serotonin syndrome (including altered mental status, autonomic instability and
neuromuscular abnormalities) has been reported following concomitant treatment with triptans and SSRIs/SNRIs.
There is no evidence of a pharmacokinetic interaction with β-blockers, tricyclic
antidepressants, selective serotonin reuptake inhibitors, alcohol or food.
Co-administration of naratriptan with ergotamine, dihydroergotamine, or sumatriptan did not result in clinically significant effects on blood pressure, heart rate or ECG or affect naratriptan exposure. However, an increased risk of coronary vasospasm is a theoretical possibility and concomitant administration with preparations containing ergotamine or another triptan/5-HT1 receptor agonist is contraindicated.
At least 24 hours should elapse after the administration of naratriptan before an
ergotamine-containing preparation or any triptan/5-HT1 receptor agonist is given.
Conversely, at least 24 hours should elapse after the administration of an ergotaminecontaining preparation before naratriptan is given.
Naratriptan does not inhibit monoamine oxidase enzymes; therefore interactions with monoamine oxidase inhibitors are not anticipated. In addition, the limited metabolism of naratriptan and the wide range of cytochrome P450 isoenzymes involved suggest that significant drug interactions with naratriptan are unlikely.
Oral contraceptives decrease the total clearance of naratriptan by 30%, and smoking increases total clearance by 30%. But no dosing adjustments are required.
Since 60% of naratriptan is excreted renally with active renal secretion representing approximately 30% of total clearance, interactions might be possible with other drugs that are also renally secreted. However due to the safety profile of naratriptan, inhibition of naratriptan secretion is probably of minor importance, while the possibility of naratriptan to inhibit other drugs actively secreted should be considered.

Pregnancy: The safe use of naratriptan in pregnant women has not been established. Evaluation of experimental animal studies does not indicate any direct teratogenic effects or harmful effects on peri- and postnatal development. Because animal reproduction studies are not always predictive of human response administration of naratriptan should only be considered if the expected benefit to the mother is greater than any possible risk to the foetus.
Lactation: Naratriptan and/or drug related metabolites are secreted into the milk of lactating rats. No studies have been conducted to determine the level of transference of naratriptan into breast milk of nursing women. It is recommended that infant exposure be minimised by avoiding breast-feeding for 24 hours after treatment. Caution should be exercised when considering administration of naratriptan to nursing women.

Symptoms and Signs: Administration of a high dose of 25mg naratriptan in one healthy male subject increased blood pressure by up to 71mmHg and resulted in adverse events including light-headedness, tension in the neck, tiredness and a loss of co-ordination. Blood pressure returned to baseline by 8 hours after dosing without other pharmacological intervention. It is unknown what effect haemodialysis or peritoneal dialysis has on the plasma concentrations of naratriptan.
Treatment: If overdose with naratriptan occurs, the patient should be monitored for at least 24 hours and standard supportive treatment applied as required.