Search The Medical Knowledge Base

Drug Details

NARAMIG (migraine)

• Drug Class Description
  5HT1 -agonists.
• Generic Name
  Naratriptan
• Presentation
  Tablets
• Description
  Tablets containing 2.5mg of naratriptan as naratriptan hydrochloride.
• Indications
  

  Naramig Tablets are indicated for the acute treatment of migraine attacks with or without aura

• Adult Dosage
  

  Naramig Tablets are recommended as monotherapy for the acute treatment of a migraine attack.

  Naramig Tablets should not be used prophylactically.

  Naramig Tablets should be swallowed whole with water.

  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.

  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)

• Child Dosage
  

  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 Dosage
  

  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.

• Contra Indications
  

  Hypersensitivity to any component of the preparation.

  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 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 or hepatic function.

• Special Precautions
  

  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).

  As with other 5-HT1 receptor agonists, naratriptan should not be given to patients in whom unrecognised cardiac disease is likely without a prior evaluation for underlying cardiovascular disease. Such patients include postmenopausal women, males over 40 and patients with risk factors for coronary artery disease.

  If symptoms consistent with ischaemic heart disease occur appropriate evaluation should be carried out.

  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.

  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 thissituation 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).

• Interactions
  

  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.

  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.

• Adverse Drug Reactions
  

  At therapeutic doses of naratriptan the incidence of side effects reported in clinical trials was similar to placebo. Some of the symptoms may be part of the migraine attack.

  Undesirable effects are ranked under headings of frequency using the following convention: Very common (1/10), common (1/100 and <1/10), uncommon (1/1,000 and <1/100), rare (1/10,000 and <1/1,000) and very rare (<1/10,000).

  Immune system disorders

  Rare: Hypersensitivity reactions ranging from cutaneous hypersensitivity to rare cases of anaphylaxis.

  Nervous system disorders

  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 drowsiness.

  Eye disorders

  Uncommon: Visual disturbance.

  Cardiac disorders

  Uncommon: Bradycardia, tachycardia, palpitations.

  Very Rare: Coronary artery vasospasm, transient ischaemic ECG changes, angina and myocardial infarction have been reported very rarely (see Contraindications and Warnings and Precautions).

  Vascular disorders

  Very rare: Peripheral vascular ischaemia.

  Gastrointestinal

  Common: Nausea and vomiting.

  Rare: Ischaemic colitis.

  General disorders and administration site conditions:

  The following symptoms are usually of short duration, may be severe and may affect any part of the body including the chest or throat:

  Common: Pain, sensations of heat. Malaise/fatigue.

  Uncommon: Sensations of heaviness, pressure or tightness.