- Approval Id
- 7635bc617f4b6816
- Drug Name
- FORTACIN CUTANEOUS SPRAY SOLUTION 7.5MG/DOSE + 2.5MG/DOSE
- Product Name
- FORTACIN CUTANEOUS SPRAY SOLUTION 7.5MG/DOSE + 2.5MG/DOSE
- Approval Number
- SIN16538P
- Approval Date
- 2022-07-05
- Registrant
- ORIENT EUROPHARMA PTE LTD
- Licence Holder
- ORIENT EUROPHARMA PTE LTD
- Drug Type
- Therapeutic
- Forensic Classification
- PRESCRIPTION ONLY MEDICINES
- Dosage Form
- SPRAY, METERED
- Dosage
- <p><strong>4.2 Posology and method of administration</strong></p>
<p><u>Posology</u></p>
<p>The recommended dose is 3 actuations applied to cover the glans penis. Each dose consists of a total of 22.5 mg lidocaine and 7.5 mg prilocaine per application (1 dose is equal to 3 actuations).<br>
A maximum of 3 doses can be used within 24 hours with at least 4 hours between doses.</p>
<p><u>Special populations</u></p>
<p><em>Elderly</em><br>
Dosage adjustments are not required in the elderly.</p>
<p>There is limited data on the efficacy and safety of Fortacin in patients 65 years and over.</p>
<p><em>Renal impairment</em><br>
Clinical studies have not been performed in patients with impaired renal function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required.</p>
<p><em>Hepatic impairment</em><br>
Clinical studies have not been performed in patients with impaired hepatic function, however due to its method of administration and very low systemic absorption, no dosage adjustment is required. Caution is advised in case of severe hepatic impairment (see section 4.4 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>).</p>
<p><em>Paediatric population</em><br>
There is no relevant use of Fortacin in the paediatric population for the indication of treatment of primary premature ejaculation in adult men.</p>
<p><u>Method of administration</u></p>
<p>Cutaneous use.</p>
<p>Fortacin is only indicated for application to the glans penis.<br>
Before initial use, the spray container should be briefly shaken and then primed by spraying it into the air three times.</p>
<p>Before each subsequent use, it should be briefly shaken and then the spray container should be re-primed by spraying it once.</p>
<p>Any foreskin should be retracted from the glans penis. Once the can is held upright (valve up), 1 dose of Fortacin should be applied to the entire glans penis, by actuating the valve 3 times. One third of the glans penis should be covered with each actuation. After 5 minutes any excess spray should be wiped off prior to intercourse.</p>
- Route Of Administration
- CUTANEOUS
- Indication Info
- <p><strong>4.1 Therapeutic indications</strong></p>
<p>Fortacin is indicated for the treatment of primary premature ejaculation in adult men.</p>
- Contraindications
- <p><strong>4.3 Contraindications</strong></p>
<p>Hypersensitivity of the patient or their partner to the active substances or to any of the excipients listed in section 6.1 – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em>.</p>
<p>Patients or their partner with a known history of sensitivity to local anaesthetics of the amide type.</p>
- Atc Code
- N01BB20
- Atc Item Name
- combinations
- Pharma Manufacturer Name
- ORIENT EUROPHARMA PTE LTD
