- Approval Id
- 5bb6ef2911cba0dd
- Drug Name
- ZYRTEC-D
- Product Name
- ZYRTEC-D
- Approval Number
- SIN13139P
- Approval Date
- 2005-07-04
- Registrant
- GLAXOSMITHKLINE PTE LTD
- Licence Holder
- GLAXOSMITHKLINE PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- Pharmacy Only
- Dosage Form
- TABLET, FILM COATED
- Dosage
- <p><strong>Dosage and Administration</strong></p>
<p>The tablet should be swallowed whole with some liquid, and must not be broken, chewed or crushed. It may be taken with or without food.</p>
<p>After consultation with the doctor, duration of treatment should not exceed the period of acute symptoms, and should not exceed 2 to 3 weeks. After improvement of nasal symptoms, treatment should be continued only with cetirizine, where appropriate.</p>
<p><strong>Route of Administration</strong></p>
<p>For oral use.</p>
<p><strong>Adults and Children aged 12 years and older</strong></p>
<p>One tablet twice daily (morning and evening).</p>
<p><strong>Children under 12 years of age</strong></p>
<p>Zyrtec-D is contraindicated in children under 12 years of age (see Sections <em>Contraindications; Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><strong>Elderly</strong></p>
<p>Zyrtec-D should be used with caution in patients over 50 years of age. The dose should be reduced to one tablet daily for patients ≥ 77 years old.</p>
<p><strong>Renal Impairment</strong></p>
<p>The dose should be reduced to one tablet daily in patients with mild to moderate renal insufficiency. Zyrtec-D is contraindicated in severe renal insufficiency (see Section <em>Contraindications</em>).</p>
<p><strong>Hepatic Impairment</strong></p>
<p>The dose should be reduced to one tablet daily in patients with mild to moderate hepatic insufficiency.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>Indications</strong></p>
<p>Zyrtec-D is indicated for the treatment of symptoms associated with seasonal and perennial allergic rhinitis with nasal congestion, and hypersecretion, nose and/or eye itching and watery eyes.</p>
<p>It should be administered when both the anti-allergic properties of cetirizine dihydrochloride and the nasal decongestant activity of pseudoephedrine hydrochloride are desired.</p>
- Contraindications
- <p><strong>Contraindications</strong></p>
<p>Zyrtec-D is contraindicated in:</p>
<ul>
<li>known hypersensitivity to the active substances or excipients, to ephedrine or any other piperazines (such as hydroxyzine)</li>
<li>severe hypertension or uncontrolled hypertension (see Section <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>), or severe ischaemic heart disease,</li>
<li>Severe renal impairment (GFR <30 mL/ min) (see Section <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
<li>uncontrolled hyperthyroidism,</li>
<li>severe arrhythmias,</li>
<li>phaeochromocytoma,</li>
<li>elevated intraocular pressure,</li>
<li>urinary retention,</li>
<li>glaucoma,</li>
<li>history of stroke,</li>
<li>high risk of haemorrhagic stroke (see Section <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>),</li>
<li>concomitant administration of dihydroergotamine (see Section <em>Interactions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>),</li>
<li>concomitant treatment with monoamine oxidase (MAO) inhibitor and within 2 weeks after their discontinuation,</li>
<li>children under 12 years of age (see Section <em>Warnings and Precautions</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</li>
</ul>
- Atc Code
- R01BA52
- Atc Item Name
- pseudoephedrine, combinations
- Pharma Manufacturer Name
- GLAXOSMITHKLINE PTE LTD
