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Riboflavin

Name: Riboflavin drug & pharmaceuticals. Available Forms, Doses, Prices
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Published: 2021-11-11T10:10:10+00:00
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Riboflavin uses

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Riboflavin reviews
Indications and Usage (1.2) 7/2016
 1. INDICATIONS AND USAGE</H2> <p>PHOTREXA® VISCOUS and PHOTREXA® are indicated for use in corneal collagen cross-linking in combination with the KXL™ System for the treatment of <br><p><effectiveTime value="20160727"/> <excerpt> <highlight> <br><p>Riboflavin and PHOTREXA are photoenhancers indicated for use with the KXL System in corneal collagen cross-linking for the treatment of progressive keratoconus (<linkHtml href="#s011">1.1</linkHtml>) and corneal ectasia following refractive surgery (<linkHtml href="#s012">1.2</linkHtml>).<br><p></highlight> </excerpt> <component> <section ID="s011"> <id root="dd42434d-6370-4f57-96ec-12671bdc3169"/>
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<h3>SPL UNCLASSIFIED SECTION</H3> <title mediaType="text/x-hl7-title+xml">1.1	Progressive keratoconus</H3> <text/> <effectiveTime value="20160627"/> </section> </component> <component> <section ID="s012"> <id root="c2dc3f55-c229-4290-a580-1dd469d321fe"/>
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<h3>SPL UNCLASSIFIED SECTION</H3> <title mediaType="text/x-hl7-title+xml">1.2	Corneal ectasia following refractive surgery</H3> <text/> <effectiveTime value="20160627"/> </section> </component> </section> </component> <component> <section ID="s020"> <id root="932bdb3e-e5b3-4da2-b391-ccac4574fa75"/> <code code="34068-7" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE & ADMINISTRATION SECTION"/> <title mediaType="text/x-hl7-title+xml">2. DOSAGE AND ADMINISTRATION</H2> <p>Using topical anesthesia, debride the epithelium to a diameter of approximately 9 mm using standard aseptic technique. Post epithelial debridement, instill 1 drop of Riboflavin topically on the eye every 2 minutes for 30 minutes.<br><p>At the end of the 30 minute soaking period, examine the eye under the slit lamp for the presence of a yellow flare in the anterior chamber. If the yellow flare is not detected, instill 1 drop of Riboflavin every 2 minutes for an additional 2 to 3 drops and recheck for the presence of a yellow flare. This process can be repeated as necessary.<br><p>Once the yellow flare is observed, perform ultrasound pachymetry. If corneal thickness is less than 400 microns, instill 2 drops of PHOTREXA every 5 to 10 seconds until the corneal thickness increases to at least 400 microns. Irradiation should not be performed unless this 400 micron threshold is met and the yellow flare is seen.<br><p>Irradiate the eye for 30 continuous minutes at 3mW/cm<sup>2</sup> at a wavelength of 365 nm, centered over the cornea, using the KXL System as per the instructions in the KXL manual. During irradiation, continue topical instillation of Riboflavin onto the eye every 2 minutes for the 30 minute irradiation period.<br><p>For topical ophthalmic use. Do not inject.<br><p>Single use Riboflavin and PHOTREXA only. Discard syringe after use.<br><p>Riboflavin and PHOTREXA are for use with the KXL System only.<br><p>PLEASE REFER TO THE KXL OPERATOR’S MANUAL FOR SPECIFIC DEVICE INSTRUCTIONS.<br><p><effectiveTime value="20160727"/> <excerpt> <highlight> <list listType="unordered" styleCode="Disc"> <item>Debride the epithelium using standard aseptic technique using topical anesthesia (<linkHtml href="#s020">2</linkHtml>).</item> <item>Then instill 1 drop of Riboflavin topically on the eye every 2 minutes for 30 minutes (<linkHtml href="#s020">2</linkHtml>).</item> <item>After 30 minutes, examine the eye under slit lamp for presence of a yellow flare in the anterior chamber. If flare is not detected, instill 1 drop of Riboflavin every 2 minutes for an additional 2 to 3 drops and recheck for yellow flare. Repeat as necessary (<linkHtml href="#s020">2</linkHtml>).</item> <item>Once flare is observed, perform ultrasound pachymetry. If corneal thickness is less than 400 microns, instill 2 drops of PHOTREXA every 5 to 10 seconds until the corneal thickness increases to at least 400 microns (<linkHtml href="#s020">2</linkHtml>).</item> <item>Irradiation should not be performed unless this 400 micron threshold is met and the yellow flare is seen (<linkHtml href="#s020">2</linkHtml>).</item> <item>Irradiate the eye for 30 minutes at 3mW/cm<sup>2</sup> using the KXL System as per the instructions in the KXL manual. During irradiation, continue topical instillation of Riboflavin onto the eye every 2 minutes for the 30 minute irradiation period (<linkHtml href="#s020">2</linkHtml>).</item> <item>Refer to the <b><i>KXL Operator’s manual</i></b> for specific device instructions (<linkHtml href="#s020">2</linkHtml>).</item> </list> </highlight> </excerpt> </section> </component> <component> <section ID="s030"> <id root="534f6fc9-5e54-4ede-ad7a-d6dc6eed2d21"/> <code code="43678-2" codeSystem="2.16.840.1.113883.6.1" displayName="DOSAGE FORMS & STRENGTHS SECTION"/> <title mediaType="text/x-hl7-title+xml">3. DOSAGE FORMS AND STRENGTHS</H2> <effectiveTime value="20160426"/> <excerpt> <highlight> <list listType="unordered" styleCode="Disc"> <item>Riboflavin in a 3 mL glass syringe containing sterile 1.46 mg/mL Riboflavin 5’-phosphate in 20% dextran ophthalmic solution (<linkHtml href="#s031">3.1</linkHtml>)</item> <item>PHOTREXA in a 3 mL glass syringe containing sterile 1.46 mg/mL Riboflavin 5’-phosphate ophthalmic solution (<linkHtml href="#s032">3.2</linkHtml>)</item> </list> </highlight> </excerpt> <component> <section ID="s031"> <id root="eb137d2d-4421-4f46-881c-d030f232ef39"/>
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<h3>SPL UNCLASSIFIED SECTION</H3> <title mediaType="text/x-hl7-title+xml">3.1 Riboflavin</H3> <p>Riboflavin in a 3 mL glass syringe containing sterile 1.46 mg/mL Riboflavin 5’-phosphate in 20% dextran ophthalmic solution for topical administration.<br><p><effectiveTime value="20160426"/> </section> </component> <component> <section ID="s032"> <id root="02f2dedd-501a-4d6a-be5e-0325067f61ed"/>
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<h3>SPL UNCLASSIFIED SECTION</H3> <title mediaType="text/x-hl7-title+xml">3.2 PHOTREXA</H3> <p>PHOTREXA in a 3 mL glass syringe containing sterile 1.46 mg/mL Riboflavin 5’-phosphate ophthalmic solution for topical administration.<br><p><effectiveTime value="20160426"/> </section> </component> </section> </component> <component> <section ID="s040"> <id root="e911ef68-4a57-4d29-87af-400e5dfd53e9"/> <code code="34070-3" codeSystem="2.16.840.1.113883.6.1" displayName="CONTRAINDICATIONS SECTION"/> <title mediaType="text/x-hl7-title+xml">4. CONTRAINDICATIONS</H2> <p>None.<br><p><effectiveTime value="20160426"/> <excerpt> <highlight> <br><p>None <br><p></highlight> </excerpt> </section> </component> <component> <section ID="s050"> <id root="4a80f67d-91be-4e1a-bd70-408869f8d39e"/> <code code="43685-7" codeSystem="2.16.840.1.113883.6.1" displayName="WARNINGS AND PRECAUTIONS SECTION"/> <title mediaType="text/x-hl7-title+xml">5. WARNINGS AND PRECAUTIONS</H2> <p>Ulcerative keratitis can occur. Monitor for resolution of epithelial defects. [<i>See <linkHtml href="#s060">Adverse Reactions (6)</linkHtml> </i>].<br><p><effectiveTime value="20160426"/> <excerpt> <highlight> <br><p>Ulcerative keratitis can occur. Monitor for resolution of epithelial defects (<linkHtml href="#s050">5</linkHtml>)<br><p></highlight> </excerpt> </section> </component> <component> <section ID="s060"> <id root="172eb20a-6583-4878-a865-bdf5bc91afe3"/> <code code="34084-4" codeSystem="2.16.840.1.113883.6.1" displayName="ADVERSE REACTIONS SECTION"/> <title mediaType="text/x-hl7-title+xml">6. ADVERSE REACTIONS</H2> <p>The following clinically significant adverse reactions are described elsewhere in the labeling:<br><p>Ulcerative keratitis [<i>Warnings and Precautions</i> (<i> <linkHtml href="#s050">5</linkHtml> </i>)]<br><p><effectiveTime value="20160727"/> <excerpt> <highlight> <br><p>In progressive keratoconus patients, the most common ocular adverse reactions in any CXL-treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision (<linkHtml href="#s061">6.1</linkHtml>). In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision (<linkHtml href="#s061">6.1</linkHtml>). <br><p><b>To report SUSPECTED ADVERSE REACTIONS, contact Avedro at 1-844-528-3376 or FDA at 1-800-FDA-1088 or </b> <content styleCode="bold italics underline">www.fda.gov/medwatch</content> <b>.</b> <br><p></highlight> </excerpt> <component> <section ID="s061"> <id root="d6e889f5-6c89-42a5-9cc9-7c6478faa0a0"/>
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<h3>SPL UNCLASSIFIED SECTION</H3> <title mediaType="text/x-hl7-title+xml">6.1 Clinical Trials Experience</H3> <p>Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.<br><p>The safety of the corneal collagen cross-linking procedure was evaluated in 3 randomized, parallel-group, open-label, sham-controlled trials; patients were followed up for 12 months. Study 1 enrolled patients with progressive keratoconus or corneal ectasia following refractive surgery. Study 2 enrolled only patients with progressive keratoconus, and Study 3 enrolled only patients with corneal ectasia following refractive surgery. In each study, only one eye of each patient was designated as the study eye. Study eyes were randomized to receive one of the two study treatments at the baseline visit and were followed up at Day 1, Week 1, and Months 1, 3, 6, and 12. At Month 3 or later, sham study eyes and non-study eyes had the option of receiving CXL treatment, and were followed-up for 12 months from the time of receiving CXL treatment. Each CXL treated eye received a single course of CXL treatment only.<br><p>Safety data were obtained from: 193 randomized CXL study eyes (102 keratoconus, 91 corneal ectasia), 191 control eyes, and 319 nonrandomized CXL non-study eyes (191 keratoconus, 128 corneal ectasia). Overall, 512 eyes (293 keratoconus, 219 corneal ectasia) in 364 patients received CXL treatment. <br><p>In progressive keratoconus patients, the most common ocular adverse reactions in any CXL-treated eye were corneal opacity (haze), punctate keratitis, corneal striae, corneal epithelium defect, eye pain, reduced visual acuity, and blurred vision (<linkHtml href="#table1">Table 1</linkHtml>).<br><p>In corneal ectasia patients, the most common ocular adverse reactions were corneal opacity (haze), corneal epithelium defect, corneal striae, dry eye, eye pain, punctate keratitis, photophobia, reduced visual acuity, and blurred vision. These events are expected sequelae following epithelial corneal debridement and occurred at a higher incidence than observed in control patients, who did not undergo debridement or exposure to UVA light (<linkHtml href="#table1">Table 1</linkHtml>).<br><p>Adverse events reported in non-study, non-randomized CXL treated were similar in terms of preferred terms and frequency to those seen in randomized study eyes.<br><p>The majority of adverse events reported resolved during the first month, while events such as corneal epithelium defect, corneal striae, punctate keratitis, photophobia, dry eye and eye pain, and decreased visual acuity took up to 6 months to resolve and corneal opacity or haze took up to 12 months to resolve. In 1-2% of patients, corneal epithelium defect, corneal edema, corneal opacity and corneal scar continued to be observed at 12 months. In 6% of corneal ectasia patients, corneal opacity continued to be observed at 12 months. <br><p><table styleCode="Noautorules" width="700" ID="table1"> <caption>Table 1:	Most Common (≥1%) Ocular Adverse Reactions in CXL-Treated Study Eye in the Pooled Randomized Safety Population – N (%)</caption> <col width="28%"/> <col width="18%"/> <col width="18%"/> <col width="18%"/> <col width="18%"/> <tfoot> <tr> <td colspan="5">1) Results are presented as the number (%) of patients with an event from baseline to Month 3.</td> </tr> <tr> <td colspan="5">2) Almost all cases of corneal opacity were reported as haze.</td> </tr> </tfoot> <tbody> <tr> <td styleCode="Toprule Rrule"/> <td styleCode="Toprule Botrule Lrule Rrule" colspan="2" align="center"> <b>Progressive Keratoconus Studies</b> </td> <td styleCode="Toprule Botrule Lrule" colspan="2" align="center"> <b>Corneal Ectasia<br><p>Studies</b> </td> </tr> <tr> <td styleCode="Botrule Rrule" valign="bottom"> <b>Preferred Term</b> </td> <td styleCode="Botrule" align="center"> <b>CXL<br><p>Group<br><p>(N=102)<sup>1</sup> </b> </td> <td styleCode="Botrule Rrule" align="center"> <b>Control<br><p>Group<br><p>(N=103)<sup>1</sup> </b> </td> <td styleCode="Botrule" align="center"> <b>CXL<br><p>Group<br><p>(N=91)<sup>1</sup> </b> </td> <td styleCode="Botrule" align="center"> <b>Control<br><p>Group<br><p>(N=88)<sup>1</sup> </b> </td> </tr> <tr> <td styleCode="Rrule">Anterior chamber cell</td> <td align="center">2 (2)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">2 (2)</td> <td align="center">1 (1)</td> </tr> <tr> <td styleCode="Rrule">Anterior chamber flare</td> <td align="center">4 (4)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">5 (6)</td> <td align="center">2 (2)</td> </tr> <tr> <td styleCode="Rrule">Asthenopia</td> <td align="center">1 (1)</td> <td align="center" styleCode="Rrule">1 (1)</td> <td align="center">2 (2)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Blepharitis</td> <td align="center">0</td> <td align="center" styleCode="Rrule">0</td> <td align="center">0</td> <td align="center">1 (1)</td> </tr> <tr> <td styleCode="Rrule">Corneal disorder</td> <td align="center">3 (3)</td> <td align="center" styleCode="Rrule">1 (1)</td> <td align="center">3 (3)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Corneal epithelium defect</td> <td align="center">24 (24)</td> <td align="center" styleCode="Rrule">1 (1)</td> <td align="center">26 (28)</td> <td align="center">3 (3)</td> </tr> <tr> <td styleCode="Rrule">Corneal oedema</td> <td align="center">3 (3)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">3 (3)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Corneal opacity<sup>2</sup> </td> <td align="center">65 (64)</td> <td align="center" styleCode="Rrule">9 (9)</td> <td align="center">65 (71)</td> <td align="center">8 (9)</td> </tr> <tr> <td styleCode="Rrule">Corneal striae</td> <td align="center">24 (24)</td> <td align="center" styleCode="Rrule">12 (12)</td> <td align="center">8 (9)</td> <td align="center">6 (7)</td> </tr> <tr> <td styleCode="Rrule">Corneal thinning</td> <td align="center">1 (1)</td> <td align="center" styleCode="Rrule">2 (2)</td> <td align="center">0</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Diplopia</td> <td align="center">2 (2)</td> <td align="center" styleCode="Rrule">1 (1)</td> <td align="center">1 (1)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Dry eye</td> <td align="center">6 (6)</td> <td align="center" styleCode="Rrule">2 (2)</td> <td align="center">13 (14)</td> <td align="center">4 (5)</td> </tr> <tr> <td styleCode="Rrule">Eye complication associated with device</td> <td align="center" valign="top">2 (2)</td> <td align="center" styleCode="Rrule" valign="top">0</td> <td align="center" valign="top">1 (1)</td> <td align="center" valign="top">0</td> </tr> <tr> <td styleCode="Rrule">Eye discharge</td> <td align="center">2 (2)</td> <td align="center" styleCode="Rrule">1 (1)</td> <td align="center">0</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Eye oedema</td> <td align="center">7 (7)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">0</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Eye pain</td> <td align="center">17 (17)</td> <td align="center" styleCode="Rrule">3 (3)</td> <td align="center">24 (26)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Eye pruritus</td> <td align="center">2 (2)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">0</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Eyelid oedema</td> <td align="center">5 (5)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">5 (6)</td> <td align="center">1 (1)</td> </tr> <tr> <td styleCode="Rrule">Foreign body sensation in eyes</td> <td align="center" valign="top">15 (15)</td> <td align="center" styleCode="Rrule" valign="top">1 (1)</td> <td align="center" valign="top">13 (14)</td> <td align="center" valign="top">2 (2)</td> </tr> <tr> <td styleCode="Rrule">Glare</td> <td align="center">4 (4)</td> <td align="center" styleCode="Rrule">1 (1)</td> <td align="center">2 (2)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Halo vision</td> <td align="center">1 (1)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">2 (2)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Keratitis</td> <td align="center">1 (1)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">3 (3)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Lacrimation increased</td> <td align="center">5 (5)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">9 (10)</td> <td align="center">1 (1)</td> </tr> <tr> <td styleCode="Rrule">Meibomian gland dysfunction</td> <td align="center" valign="top">1 (1)</td> <td align="center" styleCode="Rrule" valign="top">1 (1)</td> <td align="center" valign="top">3 (3)</td> <td align="center">2 (2)</td> </tr> <tr> <td styleCode="Rrule">Ocular discomfort</td> <td align="center">0</td> <td align="center" styleCode="Rrule">0</td> <td align="center">8 (9)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Ocular hyperaemia</td> <td align="center">14 (14)</td> <td align="center" styleCode="Rrule">2 (2)</td> <td align="center">7 (8)</td> <td align="center">4 (5)</td> </tr> <tr> <td styleCode="Rrule">Photophobia</td> <td align="center">11 (11)</td> <td align="center" styleCode="Rrule">0</td> <td align="center">17 (19)</td> <td align="center">0</td> </tr> <tr> <td styleCode="Rrule">Punctate keratitis</td> <td align="center">25 (25)</td> <td align="center" styleCode="Rrule">8 (8)</td> <td align="center">18 (20)</td> <td align="center">3 (3)</td> </tr> <tr> <td styleCode="Rrule">Vision blurred</td> <td align="center">16 (16)</td> <td align="center" styleCode="Rrule">2 (2)</td> <td align="center">15 (17)</td> <td align="center">4 (5)</td> </tr> <tr> <td styleCode="Rrule">Visual acuity reduced</td> <td align="center">10 (10)</td> <td align="center" styleCode="Rrule">9 (9)</td> <td align="center">10 (11)</td> <td align="center">1 (1)</td> </tr> <tr> <td styleCode="Rrule">Visual impairment</td> <td align="center">3 (3)</td> <td align="center" styleCode="Rrule">2 (2)</td> <td align="center">4 (4)</td> <td align="center">1 (1)</td> </tr> <tr> <td styleCode="Rrule Botrule">Vitreous detachment</td> <td align="center" styleCode="Botrule">2 (2)</td> <td align="center" styleCode="Rrule Botrule">0</td> <td align="center" styleCode="Botrule">0</td> <td align="center" styleCode="Botrule">0</td> </tr> </tbody> </table> <br><p>Headache was reported in between 4 to 8% of treated patients. <br><p><effectiveTime value="20160727"/> </section> </component> </section> </component> <component> <section ID="s080"> <id root="43e85ad0-7949-479d-a9b4-bee7c83144f4"/> <code code="43684-0" codeSystem="2.16.840.1.113883.6.1" displayName="USE IN SPECIFIC POPULATIONS SECTION"/> <title mediaType="text/x-hl7-title+xml">8. USE IN SPECIFIC POPULATIONS</H2> <effectiveTime value="20160727"/> <component> <section ID="s081"> <id root="6f7e860e-0a09-4357-8aab-20c2fb01b005"/> <code code="42228-7" codeSystem="2.16.840.1.113883.6.1" displayName="PREGNANCY SECTION"/> <title mediaType="text/x-hl7-title+xml">8.1. Pregnancy</H3> <p><content styleCode="underline">Risk Summary</content> <br><p>Animal development and reproduction studies have not been conducted with the PHOTREXA<sup>®</sup> VISCOUS/PHOTREXA<sup>®</sup>/KXL<sup>®</sup> System. Since it is not known whether the corneal collagen cross-linking procedure can cause fetal harm or affect reproduction capacity, it should not be performed on pregnant women. <br><p><effectiveTime value="20160727"/> </section> </component> <component> <section ID="s082"> <id root="ce8828e4-258b-4155-acee-2d7397cec892"/> <code code="77290-5" codeSystem="2.16.840.1.113883.6.1" displayName="LACTATION SECTION"/> <title mediaType="text/x-hl7-title+xml">8.2.	Lactation</H3> <p><content styleCode="underline">Risk Summary</content> <br><p>There are no data on the presence of Riboflavin or PHOTREXA in human milk, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered, along with the mother’s clinical need for the PHOTREXA/KXL corneal collagen cross-linking procedure and any potential adverse effects on the breastfed child from the PHOTREXA/KXL corneal collagen cross-linking procedure or from the underlying maternal condition.<br><p><effectiveTime value="20160426"/> </section> </component> <component> <section ID="s084"> <id root="25dc82a7-2f5e-4e42-b5f4-afbe6d47d27e"/> <code code="34081-0" codeSystem="2.16.840.1.113883.6.1" displayName="PEDIATRIC USE SECTION"/> <title mediaType="text/x-hl7-title+xml">8.4. Pediatric Use</H3> <p>The safety and effectiveness of corneal collagen cross-linking has not been established in pediatric patients below the age of 14 years.<br><p><effectiveTime value="20160727"/> </section> </component> <component> <section ID="s085"> <id root="e4af5fd1-6cf6-410f-914b-f34f2aa8e32b"/> <code code="34082-8" codeSystem="2.16.840.1.113883.6.1" displayName="GERIATRIC USE SECTION"/> <title mediaType="text/x-hl7-title+xml">8.5. Geriatric Use</H3> <p>No patients enrolled in the clinical studies were 65 years of age or older.<br><p><effectiveTime value="20160727"/> </section> </component> </section> </component> <component> <section ID="s110"> <id root="2d8364aa-d019-4a6e-9411-6eb936e964a6"/> <code code="34089-3" codeSystem="2.16.840.1.113883.6.1" displayName="DESCRIPTION SECTION"/> <title mediaType="text/x-hl7-title+xml">11. DESCRIPTION</H2> <p>Riboflavin (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% and PHOTREXA (riboflavin 5’-phosphate ophthalmic solution) 0.146% are intended for topical ophthalmic administration as part of corneal collagen cross-linking with the KXL System.<br><p>Riboflavin and PHOTREXA are supplied as:<br><p><list> <item>Riboflavin in a 3 mL glass syringe containing sterile 1.46 mg/mL Riboflavin 5’-phosphate in 20% dextran ophthalmic solution for topical administration.</item> <item>PHOTREXA in a 3 mL glass syringe containing sterile 1.46 mg/mL Riboflavin 5’-phosphate ophthalmic solution for topical administration.</item> </list> <br><p>Riboflavin (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146% is a yellow sterile buffered viscous solution containing 1.46 mg/mL Riboflavin 5’-phosphate and 20% dextran 500. The pH of the solution is approximately 7.1 and the osmolality is 301-339 mOsm/kg. Each 1 mL of solution contains 1.53 mg of Riboflavin 5’-phosphate sodium (equivalent to 1.20 mg Riboflavin). Riboflavin 5’-phosphate sodium USP is a mixture of the sodium salts of Riboflavin, Riboflavin monophosphates, and Riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, dextran, monobasic sodium phosphate, sodium chloride, and water for injection.<br><p>PHOTREXA (riboflavin 5’-phosphate ophthalmic solution) 0.146% is a yellow sterile buffered solution containing 1.46 mg/mL Riboflavin 5’-phosphate. The pH of the solution is approximately 7.1 and the osmolality is 157-177 mOsm/kg. Each 1 mL of solution contains 1.53 mg of Riboflavin 5’-phosphate sodium (equivalent to 1.20 mg Riboflavin). Riboflavin 5’-phosphate sodium USP is a mixture of the sodium salts of Riboflavin, Riboflavin monophosphates, and Riboflavin diphosphates. The inactive ingredients are dibasic sodium phosphate, monobasic sodium phosphate, sodium chloride, and water for injection.<br><p>The chemical formula for Riboflavin 5’-phosphate sodium (Vitamin B2) is C<sub>17</sub>H<sub>20</sub>N<sub>4</sub>NaO<sub>9</sub>P with a molecular mass of 478.33 g/mol.<br><p><renderMultiMedia referencedObject="photrexa-figure-1"/> <br><p>Please refer to the KXL System Operator’s Manual for a specific device description and instructions.<br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-1"> photrexa structure <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-1.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="s120"> <id root="e96c65dc-2a56-42d1-bf08-5de035195f68"/> <code code="34090-1" codeSystem="2.16.840.1.113883.6.1" displayName="CLINICAL PHARMACOLOGY SECTION"/> <title mediaType="text/x-hl7-title+xml">12. CLINICAL PHARMACOLOGY</H2> <effectiveTime value="20160426"/> <component> <section ID="s121"> <id root="381a5ab8-f212-4bfc-946e-1732587ee396"/> <code code="43679-0" codeSystem="2.16.840.1.113883.6.1" displayName="MECHANISM OF ACTION SECTION"/> <title mediaType="text/x-hl7-title+xml">12.1. Mechanism of Action</H3> <p>Riboflavin 5’-phosphate sodium (Vitamin B2) is the precursor of two coenzymes, flavin adenine dinucleotide and flavin mononucleotide, which catalyze oxidation/reduction reactions involved in a number of metabolic pathways.<br><p>Under the conditions used for corneal collagen cross-linking, Riboflavin 5‘-phosphate functions as a photoenhancer and generates singlet oxygen which is responsible for the cross-linking.<br><p><effectiveTime value="20160426"/> </section> </component> </section> </component> <component> <section ID="s130"> <id root="32203b80-a556-43c2-801d-67b0174fb5f0"/> <code code="43680-8" codeSystem="2.16.840.1.113883.6.1" displayName="NONCLINICAL TOXICOLOGY SECTION"/> <title mediaType="text/x-hl7-title+xml">13. NONCLINICAL TOXICOLOGY</H2> <effectiveTime value="20160426"/> <component> <section ID="s131"> <id root="fe812b90-4453-11e4-916c-0800200c9a66"/> <code code="34083-6" codeSystem="2.16.840.1.113883.6.1" displayName="CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION"/> <title mediaType="text/x-hl7-title+xml">13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility</H3> <p>Animal studies have not been conducted to determine the carcinogenic potential of photoexcited Riboflavin. Photoexcited Riboflavin has been shown to be genotoxic in the Ames Salmonella reverse mutation assay and in the SOS/umu test system.<br><p>The genotoxicity of Riboflavin, in the absence of photoexcitation has been examined in vitro in bacterial reverse mutation assays, sister chromatid exchange assay, chromosomal aberration assays and in vivo in a mouse micronucleus study. The overall weight of evidence indicates that Riboflavin, in the absence of photoexcitation, is not genotoxic.<br><p>Animal studies to determine the effects of the PHOTREXA/KXL corneal collagen cross-linking procedure on fertility were not conducted.<br><p><effectiveTime value="20160426"/> </section> </component> </section> </component> <component> <section ID="s140"> <id root="ccf557d5-8cfc-4bb8-8601-2917e951feff"/> <code code="34092-7" codeSystem="2.16.840.1.113883.6.1" displayName="CLINICAL STUDIES SECTION"/> <title mediaType="text/x-hl7-title+xml">14. CLINICAL STUDIES</H2> <p>Three prospective, randomized, parallel-group, open-label, sham-controlled trials were conducted to evaluate the safety and effectiveness of Riboflavin ophthalmic solution/UVA irradiation for performing corneal collagen cross-linking. These trials were sham-controlled for the first 3 months and had a total duration of 12 months for safety and efficacy evaluations. Study 1 enrolled 58 patients with progressive keratoconus and 49 patients with corneal ectasia following refractive surgery. Study 2 enrolled 147 patients with progressive keratoconus, and Study 3 enrolled 130 patients with corneal ectasia following refractive surgery. In each study, patients had one eye designated as the study eye and were randomized to receive one of two study treatments (CXL or sham) in their study eye at the baseline visit. The patients were evaluated at Day 1, Week 1, and Months 1, 3, 6, and 12. At Month 3 or later, patients had the option of receiving CXL treatment in both the sham study eyes and non-study eyes and were followed-up for 12 months from the time of receiving CXL treatment. <br><p>Approximately 56% and 89% of the sham study eyes in patients with progressive keratoconus received CXL treatment by Month 3 and Month 6, respectively. The average age of keratoconus patients was 33 years. The average baseline K<sub>max</sub> value was 61 diopters. For corneal ectasia patients in Study 1 and Study 3, approximately 60% and 90% of the sham study eyes received CXL treatment by Month 3 and Month 6, respectively. The average age of corneal ectasia patients was 43 years and the average baseline K<sub>max</sub> was 55 diopters. A majority (93%) of the corneal ectasia patients had LASIK only, 5 (3%) patients had photorefractive keratectomy (PRK) only, and 8 (4%) patients had both LASIK and PRK.<br><p>In each study, the maximum corneal curvature (K<sub>max</sub>) was assessed at baseline, Months 1, 3, and 12. The CXL-treated eyes showed increasing improvement in K<sub>max</sub> from Month 3 through Month 12 (<linkHtml href="#fig1">Figure 1</linkHtml>). Progressive keratoconus patients had an average K<sub>max</sub> reduction of 1.4 diopters in Study 1 and 1.7 diopters in Study 2 at Month 12 in the CXL-treated eyes while the sham eyes had an average increase of 0.5 diopter in Study 1 and 0.6 diopter in Study 2 at Month 12; the difference (95% CI) between the CXL and sham groups in the mean change from baseline K<sub>max</sub> were -1.9 (-3.4, -0.3) diopters in Study 1 and -2.3 (-3.5, -1.0) diopters in Study 2. <br><p>For corneal ectasia patients, at Month 12, the CXL-treated eyes had an average K<sub>max</sub> reduction of 1.0 diopter in Study 1 and 0.5 diopter in Study 3 while the sham eyes had an average increase of 1.0 diopter in Study 1 and 0.5 diopter in Study 3; the treatment difference between the CXL and sham groups was: -2.0 (-3.0, -1.1) diopters in Study 1 and -1.1 (-1.9, -0.3) diopters in Study 3.<br><p><paragraph ID="fig1"> <b>Figure 1: Mean (SD) (Diopter) Baseline Kmax and Change from Baseline Kmax</b> <br><p><renderMultiMedia referencedObject="photrexa-figure-2"/> <br><p>Post-baseline missing data were imputed using last available K<sub>max</sub> value. For the sham study eyes that received CXL treatment after baseline, the last K<sub>max</sub> measurement recorded prior to receiving CXL treatment was used in the analysis for later time points. In Study 3, four patients in the CXL group had missing baseline K<sub>max</sub> value and were excluded from the analysis. <br><p><effectiveTime value="20160727"/> <component> <observationMedia ID="photrexa-figure-2"> Figure 1 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-2.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="s160"> <id root="36c886d1-45ae-445f-bc3e-59726eda425f"/> <code code="34069-5" codeSystem="2.16.840.1.113883.6.1" displayName="HOW SUPPLIED SECTION"/> <title mediaType="text/x-hl7-title+xml">16. HOW SUPPLIED/STORAGE AND HANDLING</H2> <p>PHOTREXA<sup>®</sup> VISCOUS and PHOTREXA<sup>®</sup> are provided in a bulk pack of 10 (ten), single-use foil pouches. Each foil pouch contains a 3 mL glass syringe of Riboflavin or PHOTREXA contained within a Tyvek<sup>®</sup> pouch.<br><p>The entire bulk pack should be stored at 15°-25°C (59°-77°F) and care should be taken to minimize exposure of the syringe to light once removed from its protective packaging. Discard syringe after use.<br><p>For topical ophthalmic use.<br><p>Riboflavin and PHOTREXA should be used with the KXL System only.<br><p><effectiveTime value="20160727"/> </section> </component> <component> <section ID="s170"> <id root="847ebda3-3ec6-4faa-b148-638b444de750"/> <code code="34076-0" codeSystem="2.16.840.1.113883.6.1" displayName="INFORMATION FOR PATIENTS SECTION"/> <title mediaType="text/x-hl7-title+xml">17. PATIENT COUNSELING INFORMATION</H2> <list listType="unordered" styleCode="Disc"> <item>Patients should be advised not to rub their eyes for the first five days after their procedure. </item> <item>Patients may be sensitive to light and have a foreign body sensation. Patients should be advised that there may be discomfort in the treated eye and that sunglasses may help with light sensitivity. </item> <item>If patients experience severe pain in the eye or any sudden decrease in their vision, they should be advised to contact their physician immediately.</item> <item>If the bandage contact lens that was placed on the patient’s eye on the day of treatment falls out or becomes dislodged, the patient should be advised not to replace it and to contact their physician immediately.</item> </list> <br><p>PHOTREXA<sup>®</sup> VISCOUS (riboflavin 5’-phosphate in 20% dextran ophthalmic solution) 0.146%, PHOTREXA<sup>®</sup> (riboflavin 5’-phosphate ophthalmic solution) 0.146% and the KXL<sup>®</sup> System are marketed by: Avedro, 230 Third Avenue, Waltham, MA, 02451.<br><p>Version:<br><p>Issued July 2016<br><p><effectiveTime value="20160727"/> </section> </component> <component> <section ID="pdp1"> <id root="174b6ace-d114-43d7-9cb5-1785592626b8"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <H2>PRINCIPAL DISPLAY PANEL - NDC 25357-022-01 - Riboflavin 3mL Syringe Label</H2> <p><renderMultiMedia referencedObject="photrexa-figure-3"/> <br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-3"> Principal Display Panel - Riboflavin 3ml Syringe Label - NDC 25357-022-01 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-3.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="pdp2"> <id root="522adc38-0738-4883-a4e7-b4cbb5ef3164"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <H2>PRINCIPAL DISPLAY PANEL - NDC 25357-022-01 - Riboflavin 3mL Foil Pouch Label</H2> <p><renderMultiMedia referencedObject="photrexa-figure-4"/> <br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-4"> Principal Display Panel - Riboflavin 3ml Foil Pouch Label - NDC 25357-022-01 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-4.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="pdp3"> <id root="021c2116-200c-42b6-b3ea-dec9061c5f4f"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <H2>PRINCIPAL DISPLAY PANEL - NDC 25357-022-01- Riboflavin Tyvek Pouch Label</H2> <p><renderMultiMedia referencedObject="photrexa-figure-5"/> <br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-5"> Principal Display Panel - Riboflavin Tyvek Pouch Label - NDC 25357-022-01 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-5.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="pdp4"> <id root="ece8b4a9-7e73-405c-8372-516c9e878d00"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <H2>PRINCIPAL DISPLAY PANEL - NDC 25357-022-01 - Riboflavin Box</H2> <p><renderMultiMedia referencedObject="photrexa-figure-6"/> <br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-6"> Principal Display Panel - Riboflavin Box - NDC 25357-022-01 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-6.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="pdp5"> <id root="c45be57a-6384-47da-bd00-c3d1e41b2d99"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <H2>PRINCIPAL DISPLAY PANEL - NDC 25357-023-01 - Photrexa Syringe Label</H2> <p><renderMultiMedia referencedObject="photrexa-figure-7"/> <br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-7"> Principal Display Panel - Photrexa Syringe Label- NDC 25357-023-01 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-7.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="pdp6"> <id root="5d0a1de7-6e7c-4bfa-bae0-cb076abc572f"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <H2>PRINCIPAL DISPLAY PANEL - NDC 25357-023-01 - Photrexa 3mL Foil Pouch Label</H2> <p><renderMultiMedia referencedObject="photrexa-figure-8"/> <br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-8"> Principal Display Panel - Photrexa 3ml Foil Pouch Label - NDC 25357-023-01 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-8.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="pdp7"> <id root="1b833afb-f5b4-444c-98e8-1af815d81146"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <H2>PRINCIPAL DISPLAY PANEL - NDC 25357-023-01 - Photrexa Tyvek Pouch Label</H2> <p><renderMultiMedia referencedObject="photrexa-figure-9"/> <br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-9"> Principal Display Panel - Photrexa Tyvek Pouch Label - NDC 25357-023-01 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-9.jpg"/> </value> </observationMedia> </component> </section> </component> <component> <section ID="pdp8"> <id root="19bfad53-7631-45c5-91b5-49d5cee8aca5"/> <code code="51945-4" codeSystem="2.16.840.1.113883.6.1" displayName="PACKAGE LABEL.PRINCIPAL DISPLAY PANEL"/> <H2>PRINCIPAL DISPLAY PANEL - NDC 25357-023-01 - Photrexa Box</H2> <p><renderMultiMedia referencedObject="photrexa-figure-10"/> <br><p><effectiveTime value="20160426"/> <component> <observationMedia ID="photrexa-figure-10"> Principal Display Panel - Photrexa Box - NDC 25357-023-01 <value mediaType="image/jpeg" xsi:type="ED"> <reference value="photrexa-figure-10.jpg"/> </value> </observationMedia> </component> </section> </component><br><p>


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<H3>Riboflavin pharmaceutical active ingredients containing related brand and generic drugs:</H3>

<p>

<ul>
<li class="nav"><a href="/?c=ing&s=vitamin%20b2">Vitamin B2</a> 
</ul><br>
</p>
<H3>Riboflavin available forms, composition, doses:</H3>

<p>
 <table class="brd" width="100%" cellspacing="1" cellpadding=4>
 <tr bgcolor="#FFFFFF"><td width="80%"></td><td align="center"><b>Price</b></td></tr>
<tr bgcolor="#FFFFFF"><td class="br">Ribo 100 mg tablet</td><td align="center">0.04 USD</td></tr>
<tr bgcolor="#FFFFFF"><td class="br">Riboflavin 100 mg tablet</td><td align="center">0.09 USD</td></tr>
<tr bgcolor="#FFFFFF"><td class="br">Riboflavin 50 mg tablet</td><td align="center">0.08 USD</td></tr>
<tr bgcolor="#FFFFFF"><td class="br">Riboflavin powder</td><td align="center">0.44 USD</td></tr>
<tr bgcolor="#FFFFFF"><td class="br">Tablets; Oral; Vitamin B2 5 mg</td><td align="center"></td></tr>
<tr bgcolor="#FFFFFF"><td class="br">Vitamin b-2 25 mg tablet</td><td align="center">0.02 USD</td></tr>
<tr bgcolor="#FFFFFF"><td class="br">Vitamin b-2 50 mg tablet</td><td align="center">0.08 USD</td></tr>
</table>
</ul><br>
</p>
<H3>Riboflavin destination | category:</H3>

<p>

<ul>
<li class="nav">Human:
<li class="nav">Vitamin B complex
<li class="nav">Vitamin supplements
</ul><br>


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</p>
<H3>Riboflavin Anatomical Therapeutic Chemical codes:</H3>

<p>

<ul>
<li class="nav"><a href="/?c=atc&s=a11ha04">A11HA04</a> - Riboflavin (Vitamin B2)
</ul><br>
</p>
<H3>Riboflavin pharmaceutical companies:</H3>

<p>

<ul>
<li class="nav"><a href="/?c=firm&s=stanley%20pharmaceuticals">Stanley Pharmaceuticals</a>
</ul><br>
</p>


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<a name="reference"></a>
<h2>References</h2><ol>
<li>Dailymed."ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". <a href="https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=M.V.I.-12" rel="nofollow">https://dailymed.nlm.nih.gov/dailym...</a> (accessed August 28, 2018).</li>
<li>"riboflavin". <a href="https://pubchem.ncbi.nlm.nih.gov/compound/493570" rel="nofollow">https://pubchem.ncbi.nlm.nih.gov/co...</a> (accessed August 28, 2018).</li>
<li>"riboflavin". <a href="http://www.drugbank.ca/drugs/DB00140" rel="nofollow">http://www.drugbank.ca/drugs/DB0014...</a> (accessed August 28, 2018).</li>
</ol>
<h2>Frequently asked Questions</h2>
<b>Can i drive or operate heavy machine after consuming Riboflavin?</b><p>Depending on the reaction of the Riboflavin after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Riboflavin not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.</p>
<b>Is Riboflavin addictive or habit forming?</b><p>Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.</p><p>Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.</p>
<a name="review"></a>

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<h2>Review</h2> sdrugs.com conducted a study on Riboflavin, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Riboflavin consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
<h3>Visitor reports</h3><div class="vote_result">
<h4>Visitor reported useful</h4>
No survey data has been collected yet<br>
</div><br>
<div class="vote_result">
<h4>Visitor reported side effects</h4>
No survey data has been collected yet<br>
</div><br>
<div class="vote_result">
<h4>Visitor reported price estimates</h4>
No survey data has been collected yet<br>
</div><br>
<div class="vote_result">
<h4>Visitor reported frequency of use</h4>
No survey data has been collected yet<br>
</div><br>
<div class="vote_result">
<h4>One visitor reported doses</h4>
<b>What is the dose of Riboflavin drug you are taking?</b><br>According to the survey conducted among sdrugs.com website users, the maximum number of people are using the following dose 6-10mg. Few medications come in only one or two doses. Few are specific for adult dose and child dose. The dose of the medicine given to the patient depends on the severity of the symptom/disease. There can be dose adjustments made by the doctor, based on the progression of the disease. Follow-up is important.<table class="brd" width="100%" cellspacing="1" cellpadding="5">
<tr bgcolor="#FFFFFF"><th width="45%"></th><th colspan="2">Visitors</th><th align="center" width="5%">%</th></tr>
<tr bgcolor="#FFFFFF"><td>6-10mg</td><td width="5%" align="center">1</td><td><div class="progress"><span class="progress_selected" style="width:100.0%"></span></div></td><td>100.0%</td></tr>
</table>
</div><br>
<div class="vote_result">
<h4>Visitor reported time for results</h4>
No survey data has been collected yet<br>
</div><br>
<div class="vote_result">
<h4>Visitor reported administration</h4>
No survey data has been collected yet<br>
</div><br>
<div class="vote_result">
<h4>Visitor reported age</h4>
No survey data has been collected yet<br>
</div><br>
 <H3>Visitor reviews</H3>
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<p>The information was verified by <a class="editor" href="/?editor=rachana-salvi">Dr. Rachana Salvi, MD Pharmacology</a></p>  <div class="bottom_menu">
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