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| Drug class description : | Neuraminidase inhibitors (antivirals). |
| Generic Name : | Zanamivir |
| Drug description : | Each pre-dispensed quantity of inhalation powder (one blister) contains 5 mg zanamivir. Each delivered inhalation (the amount that leaves the mouthpiece of the Diskhaler) contains 4.0 mg zanamivir. |
| Presentation : | Relenza 5mg/dose, inhalation powder, pre-dispensed. |
| Indications : | Relenza is indicated for treatment of both influenza A and B in adults and adolescents ( 12 years) who present with symptoms typical of influenza when influenza is circulating in the community. |
| Adult Dosage : | Treatment should begin as soon as possible, within 48 hours after onset of symptoms. Relenza is for administration to the respiratory tract by oral inhalation only, using the Diskhaler device provided. One blister should be utilised for each inhalation. The recommended dose of Relenza is two inhalations (2 x 5 mg) twice daily for five days, providing a total daily inhaled dose of 20 mg. Inhaled drugs, e.g. asthma medication, should be administered prior to administration of Relenza (See Special Precautions). Impaired Renal or Hepatic Function: No dose modification is required. |
| Child Dosage : | Under 12 years, not recommended. |
| Elderly Dosage : | No dose modification is required. |
| Contra Indications : | Hypersensitivity to any ingredient of the preparation. |
| Special Precautions : | Due to the limited number of patients with severe asthma or with other chronic respiratory disease, patients with unstable chronic illnesses or immunocompromised patients who have been treated, it has not been possible to demonstrate the efficacy and safety of Relenza in these groups. Efficacy of zanamivir in elderly patients 65 years has not been established. There have been very rare reports of patients being treated with Relenza who have experienced bronchospasm and/or decline in respiratory function which may be acute and/or serious. Some of these patients did not have any previous history of respiratory disease. Any patients experiencing such reactions should discontinue Relenza and seek medical evaluation immediately. Due to the limited experience, patients with severe asthma require a careful consideration of the risk in relation to the expected benefit, and Relenza should not be administered unless close medical monitoring and appropriate clinical facilities are available in case of bronchoconstriction. In patients with persistent asthma or severe COPD, management of the underlying disease should be optimised during therapy with Relenza. Should zanamivir be considered appropriate for patients with asthma or chronic obstructive pulmonary disease, the patient should be informed of the potential risk of bronchospasm with Relenza and should have a fast acting bronchodilator available. Patients on maintenance inhaled bronchodilating therapy should be advised to use their bronchodilators before taking Relenza (See Dosage). |
| Interactions : | Zanamivir is not protein bound and not hepatically metabolised or modified. Clinically significant drug interactions are unlikely. Zanamivir, when given for 28 days, did not impair the immune response to influenza vaccine. Pregnancy and lactation Pregnancy: The safe use of Relenza during pregnancy has not been established. In rats and rabbits zanamivir has been shown to cross the placenta. High doses of zanamivir were not associated with malformations in rats or rabbits and only minor alterations were reported. The potential risk for humans is unknown. Relenza should not be used in pregnancy unless the expected benefit to the mother is thought to outweigh any possible risk to the foetus. Lactation: In rats zanamivir has been shown to be secreted into milk. There is no information on secretion into breast milk in humans. The use of zanamivir is not recommended in mothers who are breast feeding. |
| Adverse Reactions : | There have been rare reports of patients with previous history of respiratory disease (asthma, COPD) and very rare reports of patients without previous history of respiratory disease, who have experienced acute bronchospasm and/or serious decline in respiratory function after use of Relenza (See Special Precautions). The adverse events considered at least possibly related to the treatment are listed below by body system, organ class and absolute frequency. Frequencies are defined as very common >1/10), common >1/100, <1/10), uncommon >1/1000, <1/100), rare >1/10,000, <1/1000), very rare (<1/10,000). Immune system disorders Very rare: allergic-type reaction including facial and oropharyngeal oedema Respiratory, thoracic and mediastinal disorders: Very rare: bronchospasm, dyspnea, throat tightness or constriction Skin and subcutaneous tissue disorders: Very rare: rash, urticaria |
| Manufacturer : | GlaxoSmithKline(GSK) |
| Drug Availability : | (POM) |
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