Jewim Pharmaceutical (Shandong) Co., Ltd.

Zomiptrium Nasal Spray

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  Pharmaceuticals and Biochemicals

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• Product description :

  Zolmitriptan Nasal Spray
  1. NAME OF THE MEDICINAL PRODUCT
   Zolmitriptan Nasal Spray
  2. QUALITATIVE AND QUANTITATIVE COMPOSITION
   Zolmitriptan Nasal Spray is an aqueous solution containing 50 mg/ml zolmitriptan, buffered to pH 5.0. The device delivers a unit dose of 5 mg and is intended for a single use only.
  3. PHARMACEUTICAL FORM
   Nasal Spray
  4. CLINICAL PARTICULARS
  4.1 Therapeutic indications
   Zolmitriptan Nasal Spray is indicated for the acute treatment of migraine with or without aura.
  4.2 Posology and method of administration
   The recommended dose of Zolmitriptan Nasal Spray Nasal Spray to treat a migraine attack is 5 mg.
   Zolmitriptan Nasal Spray Nasal Spray is administered as a single dose into one nostril. Zolmitriptan Nasal Spray Nasal Spray provides particularly rapid onset of relief of migraine with the first signs of efficacy apparent within 15 minutes of dosing.
   Zolmitriptan Nasal Spray Nasal Spray provides an alternative non–oral formulation of zolmitriptan to that of Zolmitriptan Nasal Spray oral tablets and orodispersible tablets. This formulation may also be beneficial where a non–oral route of treatment is either needed or preferred.
   If symptoms persist or return within 24 hours a second dose has been shown to be effective. If a second dose is required, it should not be taken within 2 hours of the initial dose.
   Zolmitriptan Nasal Spray is effective whenever the nasal spray is administered during a migraine attack; although it is advisable that Zolmitriptan Nasal Spray Nasal Spray is taken as early as possible after the onset of migraine headache.
   In the event of recurrent attacks, it is recommended that the total intake of Zolmitriptan Nasal Spray in a 24 hour period should not exceed 10 mg.
   Zolmitriptan Nasal Spray is not indicated for prophylaxis of migraine.
  Use in children (under 12 years of age)
   Safety and efficacy of Zolmitriptan Nasal Spray Nasal Spray in paediatric patients have not been evaluated. Use of Zolmitriptan Nasal Spray Nasal Spray in children is therefore not recommended.
  Adolescents (12-17 years of age)
   Safety and efficacy of Zolmitriptan Nasal Spray Nasal Spray in adolescents have not been evaluated. Use of Zolmitriptan Nasal Spray Nasal Spray in adolescents is therefore not recommended.
  Use in Patients Aged Over 65 years
   Safety and efficacy of Zolmitriptan Nasal Spray in individuals aged over 65 years have not been systematically evaluated.
  Patients with Renal Impairment
   No dosage adjustment required (see Section 5.2 Pharmacokinetic Properties).
  4.3 Contraindications
   Zolmitriptan Nasal Spray is contraindicated in patients with:
   ? known hypersensitivity to any component of the product
   ? uncontrolled hypertension
   ? ischaemic heart disease
   ? coronary vasospasm/Prinzmetal's angina
   ? A history of cerebrovascular accident (CVA) or transient ischaemic attack (TIA)
   ? Concomitant administration of Zolmitriptan Nasal Spray with ergotamine or ergotamine derivatives or other 5-HT1 receptor agonists.
  4.4 Special warnings and precautions for use
   Zolmitriptan Nasal Spray should only be used where a clear diagnosis of migraine has been established. Care should be taken to exclude other potentially serious neurological conditions. There are no data on the use of Zolmitriptan Nasal Spray in hemiplegic or basilar migraine. Migraneurs may be at risk of certain cerebrovascular events. Cerebral haemorrhage, subarachnoid haemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with 5HT1B/1D agonists.
   Zolmitriptan Nasal Spray should not be given to patients with symptomatic Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathways.
   As with other 5HT 1B/1D agonists transient increases in systemic blood pressure have been reported in patients with and without a history of hypertension; very rarely these increases in blood pressure have been associated with significant clinical events.
  4.5 Undesirable effects
   Zolmitriptan Nasal Spray is well tolerated. Adverse reactions are typically mild/moderate, transient, not serious and resolve spontaneously without additional treatment.
   Possible adverse reactions tend to occur within 4 hours of dosing and are no more frequent following repeated dosing.
  4.6 Overdose
   There has been no experience of overdose with zolmitriptan nasal spray. Volunteers receiving single oral doses of 50 mg commonly experienced sedation.
   The elimination half-life of zolmitriptan following intranasal administration is 3 hours, (see Section 5.2 Pharmacokinetic Properties) and therefore monitoring of patients after overdose with Zolmitriptan Nasal Spray Nasal Spray should continue for at least 15 hours or while symptoms or signs persist.
  5. PHARMACOLOGICAL PROPERTIES
   In pre-clinical studies, zolmitriptan has been demonstrated to be a selective agonist for the vascular human recombinant 5HT1B and 5HT1D receptor subtypes. Zolmitriptan is a high affinity 5HT1B/1D receptor agonist with modest affinity for 5HT1A receptors.Zolmitriptan has no significant affinity (as measured by radioligand binding assays) or pharmacological activity at 5HT2-, 5HT3-, 5HT4-, alpha1-, alpha2-, or beta1-, adrenergic; H1-, H2-, histaminic; muscarinic; dopaminergic1, or dopaminergic2 receptors.
   The 5HT1B/1D receptor is predominantly located presynaptically at both the peripheral and central synapses of the trigeminal nerve and preclinical studies have shown that zolmitriptan is able to act at both these sites.
   One controlled clinical trial in 696 adolescents with migraine failed to demonstrate superiority of zolmitriptan tablets at doses of 2.5 mg, 5 mg and 10 mg over placebo. Efficacy was not demonstrated.
  6. PHARMACEUTICAL PARTICULARS
  6.1 Shelf life
   30 months.
  6.2 Special precautions for storage
   Do not store above 25°C.
  6.3 Special precautions for disposal and other handling
   The protection cover must not be removed until immediately before use. For instructions for use see the patient information leaflet.