- Approval Id
- 384ddc716746e05e
- Drug Name
- DICLECTIN DELAYED RELEASE TABLETS 10MG/10MG
- Product Name
- DICLECTIN DELAYED RELEASE TABLETS 10MG/10MG
- Approval Number
- SIN15301P
- Approval Date
- 2017-07-20
- Registrant
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Licence Holder
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- TABLET, DELAYED RELEASE
- Dosage
- <p><strong>2. DOSAGE AND ADMINISTRATION</strong></p>
<p><strong>2.1 Dosage Information</strong></p>
<p>Initially, take two DICLECTIN delayed-release tablets orally at bedtime (Day 1). If this dose adequately controls symptoms the next day, continue taking two tablets daily at bedtime. However, if symptoms persist into the afternoon of Day 2, take the usual dose of two tablets at bedtime that night then take three tablets starting on Day 3 (one tablet in the morning and two tablets at bedtime). If these three tablets adequately control symptoms on Day 4, continue taking three tablets daily. Otherwise take four tablets starting on Day 4 (one tablet in the morning, one tablet mid-afternoon and two tablets at bedtime).</p>
<p>The maximum recommended dose is four tablets (one in the morning, one in the mid-afternoon and two at bedtime) daily.</p>
<p>Take on an empty stomach with a glass of water <em>[see Clinical Pharmacology (12.3)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>. Swallow tablets whole. Do not crush, chew, or split DICLECTIN tablets.</p>
<p>Take as a daily prescription and not on an as needed basis. Reassess the woman for continued need for DICLECTIN as her pregnancy progresses.</p>
- Route Of Administration
- ORAL
- Indication Info
- <p><strong>1. INDICATIONS AND USAGE</strong></p>
<p>DICLECTIN is indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.</p>
<p><strong>Limitations of Use</strong></p>
<p>DICLECTIN has not been studied in women with hyperemesis gravidarum.</p>
- Contraindications
- <p><strong>4. CONTRAINDICATIONS</strong></p>
<p>DICLECTIN is contraindicated in women with any of the following conditions:</p>
<ul>
<li>Known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any inactive ingredient in the formulation.</li>
<li>Monoamine oxidase (MAO) inhibitors intensify and prolong the adverse central nervous system effects of DICLECTIN <em>[see Drug Interactions (7.1)</em> – <em>please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information</em><em>]</em>.</li>
</ul>
- Atc Code
- R06AA59
- Atc Item Name
- doxylamine, combinations
- Pharma Manufacturer Name
- UNITED ITALIAN TRADING CORPORATION (PRIVATE) LIMITED
