Bromhexine: Safety in Special Population

<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:TrackMoves/> <w:TrackFormatting/> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:DoNotPromoteQF/> <w:LidThemeOther>EN-MY</w:LidThemeOther> <w:LidThemeAsian>X-NONE</w:LidThemeAsian> <w:LidThemeComplexScript>X-NONE</w:LidThemeComplexScript> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> <w:SplitPgBreakAndParaMark/> <w:DontVertAlignCellWithSp/> <w:DontBreakConstrainedForcedTables/> <w:DontVertAlignInTxbx/> <w:Word11KerningPairs/> <w:CachedColBalance/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> <m:mathPr> <m:mathFont m:val="Cambria Math"/> <m:brkBin m:val="before"/> <m:brkBinSub m:val="--"/> <m:smallFrac m:val="off"/> <m:dispDef/> <m:lMargin m:val="0"/> <m:rMargin m:val="0"/> <m:defJc m:val="centerGroup"/> <m:wrapIndent m:val="1440"/> <m:intLim m:val="subSup"/> <m:naryLim m:val="undOvr"/> </m:mathPr></w:WordDocument></xml><![endif]--><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><div class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"><b>Availability</b></span></span></div><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Tab Bromhexine HCl 8mg</span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Syrup Bromhexine HCl 4mg/5ml</span></span></li></ul><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><div class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"><b>Pharmacokinetic</b></span></span></div><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Metabolism: Extensive hepatic first-pass metabolism </span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Excretion: Via urine (approx 85-90%, mainly as metabolites)</span></span></li></ul><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><div class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"><b>Liver Impairment</b></span></span></div><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">There is no pharmacokinetic data available in the elderly or in patients with renal or liver insufficiency. </span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Extensive clinical experience did not give rise to relevant safety concerns in these populations. </span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">However, reduced clearance of bromhexine parent substance may be expected in the case of severe liver disease</span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">A transient rise in serum aminotransferase values was seen</span></span></li></ul><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><div class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"><b>Renal Impairment</b></span></span></div><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">In the case of severe renal insufficiency, accumulation of metabolites cannot be ruled out</span></span></li></ul><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><div class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"><b>Pregnancy </b></span></span></div><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed. </span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Bromhexine crosses the placental barrier. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/fetal development, parturition or postnatal development. </span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Clinical experience to date has shown no evidence of harmful effects on the fetus during pregnancy. Nonetheless, the usual precautions regarding the use of drugs during pregnancy should be observed. Especially during the first trimester, the use of BISOLVON is not recommended.</span></span></li></ul><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><div class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"><b>Lactation</b></span></span></div><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Bromhexine is excreted in breast milk. Although unfavourable effects on breastfed infants would not be expected, BISOLVON CHESTY is not recommended for use in breastfeeding mothers.</span></span></li></ul><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><div class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"><b>References:</b></span></span></div><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;"> </span></span><ol start="1" style="margin-top: 0cm;" type="1"><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">Bisolvan Product Information Leaflet</span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">MIMS</span></span></li><li class="MsoNormal"><span style="font-family: "Trebuchet MS",sans-serif;"><span style="font-size: small;">NPRA- Package Insert Template</span></span></li></ol>

contraindication Indication Bromhexine: Safety in Special Population

Availability Tab Bromhexine HCl 8mg Syrup Bromhexine HCl 4mg/5ml Pharmacokinetic Metabolism: Extensive hepatic first-pass...

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IM Dicofenac : can it be given as IV?

<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:TrackMoves/> <w:TrackFormatting/> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:DoNotPromoteQF/> <w:LidThemeOther>EN-MY</w:LidThemeOther> <w:LidThemeAsian>X-NONE</w:LidThemeAsian> <w:LidThemeComplexScript>X-NONE</w:LidThemeComplexScript> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> <w:SplitPgBreakAndParaMark/> <w:DontVertAlignCellWithSp/> <w:DontBreakConstrainedForcedTables/> <w:DontVertAlignInTxbx/> <w:Word11KerningPairs/> <w:CachedColBalance/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> <m:mathPr> <m:mathFont m:val="Cambria Math"/> <m:brkBin m:val="before"/> <m:brkBinSub m:val="--"/> <m:smallFrac m:val="off"/> <m:dispDef/> <m:lMargin m:val="0"/> <m:rMargin m:val="0"/> <m:defJc m:val="centerGroup"/> <m:wrapIndent m:val="1440"/> <m:intLim m:val="subSup"/> <m:naryLim m:val="undOvr"/> </m:mathPr></w:WordDocument></xml><![endif]--> <div class="MsoNormal"><b>Availability </b></div><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal" style="mso-list: l2 level1 lfo1; tab-stops: list 36.0pt;">Injection Diclofenac Injection 75mg/3ml (Dicloran)</li></ul><div class="MsoNormal"><b>Route of administration</b></div><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal" style="mso-list: l0 level1 lfo2; tab-stops: list 36.0pt;">Based on product information, mode of administration specified is Intramuscular</li><li class="MsoNormal" style="mso-list: l0 level1 lfo2; tab-stops: list 36.0pt;">No information on administration via other routes</li></ul><div class="MsoNormal"><b>Administration via Intravenous Route</b></div><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal" style="mso-list: l1 level1 lfo3; tab-stops: list 36.0pt;">There are several products available that can be given as IV</li><li class="MsoNormal" style="mso-list: l1 level1 lfo3; tab-stops: list 36.0pt;">However these products are specifically made for such routes / should not be interchanged</li><li class="MsoNormal" style="mso-list: l1 level1 lfo3; tab-stops: list 36.0pt;">Complications of wrong administration</li><li class="MsoNormal" style="mso-list: l1 level1 lfo3; tab-stops: list 36.0pt;">Not much information on effect and management of IM injection administered as IV</li><li class="MsoNormal" style="mso-list: l1 level1 lfo3; tab-stops: list 36.0pt;">Based on several case reports of administration intravenously into arterial route, symptoms seen are gangrene and burning sensations.</li><li class="MsoNormal" style="mso-list: l1 level1 lfo3; tab-stops: list 36.0pt;">Vasospasm, intravascular thrombosis, chemical endoarteritis are the proposed pathophysiological mechanism</li><li class="MsoNormal" style="mso-list: l1 level1 lfo3; tab-stops: list 36.0pt;">Intravenous drug administration has been associated with the occurrence of Thrombophlebitis</li><li class="MsoNormal" style="mso-list: l1 level1 lfo3; tab-stops: list 36.0pt;">Rare adverse events (based on IV diclofenac): cannula site reaction, infusion site discomfort or burning, injection site stinging, or pyrexia</li></ul><div class="MsoNormal"><b>Contraindications for IV Route</b></div><ul style="margin-top: 0cm;" type="disc"><li class="MsoNormal" style="mso-list: l4 level1 lfo4; tab-stops: list 36.0pt;">Concomitant NSAID or anticoagulant use (including low dose heparin). </li><li class="MsoNormal" style="mso-list: l4 level1 lfo4; tab-stops: list 36.0pt;">History of haemorrhagic diathesis, a history of confirmed or suspected cerebrovascular bleeding. </li><li class="MsoNormal" style="mso-list: l4 level1 lfo4; tab-stops: list 36.0pt;">Operations associated with a high risk of haemorrhage. </li><li class="MsoNormal" style="mso-list: l4 level1 lfo4; tab-stops: list 36.0pt;">A history of asthma. </li><li class="MsoNormal" style="mso-list: l4 level1 lfo4; tab-stops: list 36.0pt;">Moderate or severe renal impairment (serum creatinine >160μmol/l).</li><li class="MsoNormal" style="mso-list: l4 level1 lfo4; tab-stops: list 36.0pt;">Hypovolaemia or dehydration from any cause </li></ul><div class="MsoNormal"><b>References:</b></div><ol start="1" style="margin-top: 0cm;" type="1"><li class="MsoNormal" style="mso-list: l3 level1 lfo5; tab-stops: list 36.0pt;"><a href="https://www.ncbi.nlm.nih.gov/pubmed/25738031">https://www.ncbi.nlm.nih.gov/pubmed/25738031</a></li><li class="MsoNormal" style="mso-list: l3 level1 lfo5; tab-stops: list 36.0pt;">https://www.medicines.org.uk/emc/medicine/1339</li><li class="MsoNormal" style="mso-list: l3 level1 lfo5; tab-stops: list 36.0pt;"><a href="http://www.apicareonline.com/letters-to-editor-accidental-intra-arterial-injection-of-diclofenac-sodium-and-their-consequences-report-of-two-cases/">http://www.apicareonline.com/letters-to-editor-accidental-intra-arterial-injection-of-diclofenac-sodium-and-their-consequences-report-of-two-cases/</a></li></ol>

Administration contraindication IM Dicofenac : can it be given as IV?

Availability Injection Diclofenac Injection 75mg/3ml (Dicloran) Route of administration Based on product information, mode of adm...

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Albendazole & Mebendazole : Pregnancy

<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:TrackMoves/> <w:TrackFormatting/> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:DoNotPromoteQF/> <w:LidThemeOther>EN-MY</w:LidThemeOther> <w:LidThemeAsian>X-NONE</w:LidThemeAsian> <w:LidThemeComplexScript>X-NONE</w:LidThemeComplexScript> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> <w:SplitPgBreakAndParaMark/> <w:DontVertAlignCellWithSp/> <w:DontBreakConstrainedForcedTables/> <w:DontVertAlignInTxbx/> <w:Word11KerningPairs/> <w:CachedColBalance/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> <m:mathPr> <m:mathFont m:val="Cambria Math"/> <m:brkBin m:val="before"/> <m:brkBinSub m:val="--"/> <m:smallFrac m:val="off"/> <m:dispDef/> <m:lMargin m:val="0"/> <m:rMargin m:val="0"/> <m:defJc m:val="centerGroup"/> <m:wrapIndent m:val="1440"/> <m:intLim m:val="subSup"/> <m:naryLim m:val="undOvr"/> </m:mathPr></w:WordDocument></xml><![endif]--> <br /><div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;"><b><span style="font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">Albendazole</span></b><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></div><ul><li><b><span style="font-family: "verdana" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Pregnancy category: C</span></b></li><li><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">Albendazole has been shown to have teratogenic and embryotoxic potential in rats and rabbits.</span></li><li><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">It should not be used during pregnancy, if at all possible.</span></li><li><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">Manufacturer recommends a pregnancy test prior to therapy in women of reproductive potential.</span></li><li><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">Women should be advised to avoid pregnancy during and for at least 1 month following therapy.</span></li><li><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">Discontinue treatment if pregnancy occurs during treatment.</span></li></ul><div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;"><span style="font-family: "verdana" , "sans-serif"; font-size: 12.0pt; line-height: 150%;"> <b><span style="background: white;">Mebendazole</span></b></span><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt; line-height: 150%;"></span></div><ul type="disc"><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><b><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">Pregnancy category: C</span></b><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">The available evidences showed no difference in congenital anomalies in the children of women treated with mebendazole during mass treatment programs compared with those who were not.</span><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">In mass treatment programs for which the World Health Organization (WHO) has determined that the benefit of treatment outweighs the risk, WHO allows use of mebendazole in the 2nd and 3rd trimesters of pregnancy.</span><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">CDC suggests postponing therapy until third trimester when possible.</span><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></li></ul><div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;"><i><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt; line-height: 150%;">Note <br style="mso-special-character: line-break;" /></span></i><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt; line-height: 150%;"></span></div><div class="MsoNormal" style="line-height: 150%; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; text-align: justify;"><b><i><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 10.0pt; line-height: 150%;">Pregnancy Category C:</span></i></b><i><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 10.0pt; line-height: 150%;"> Either studies in animals have revealed adverse effects on the fetus (teratogenic or embryocidal, or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.</span></i><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt; line-height: 150%;"></span></div><div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;"><br /></div><div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;"><b><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">References:</span></b><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></div><ol start="1" type="1"><li class="MsoNormal" style="line-height: normal; mso-list: l2 level1 lfo3; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">Centers for Disease Control and Prevention </span><span style="font-family: "verdana" , "sans-serif"; font-size: 12.0pt;"><a href="https://www.cdc.gov/parasites/pinworm/health_professionals/"><span style="color: blue;">https://www.cdc.gov/parasites/pinworm/health_professionals/</span></a><span style="background: white;"> </span></span><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l2 level1 lfo3; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">WHO: Drugs Used in Parasitic Disease</span><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l2 level1 lfo3; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "verdana" , "sans-serif"; font-size: 12.0pt;"><a href="http://apps.who.int/medicinedocs/en/d/Jh2922e/3.2.1.html"><span style="color: blue;">http://apps.who.int/medicinedocs/en/d/Jh2922e/3.2.1.html</span></a></span><span style="font-family: "times new roman" , "serif"; font-size: 12.0pt;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l2 level1 lfo3; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="background: white; font-family: "verdana" , "sans-serif"; font-size: 12.0pt;">Lexicomp Drug Information Handbook</span></li></ol><!--[if gte mso 9]><xml> <w:LatentStyles DefLockedState="false" DefUnhideWhenUsed="true" DefSemiHidden="true" DefQFormat="false" DefPriority="99" LatentStyleCount="267"> <w:LsdException Locked="false" Priority="0" SemiHidden="false" UnhideWhenUsed="false" QFormat="true" Name="Normal"/> <w:LsdException Locked="false" Priority="9" SemiHidden="false" UnhideWhenUsed="false" QFormat="true" Name="heading 1"/> <w:LsdException Locked="false" Priority="9" 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contraindication Albendazole & Mebendazole : Pregnancy

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Metronidazole: Trichomoniasis in Pregnancy

<!--[if gte mso 9]><xml> <w:WordDocument> <w:View>Normal</w:View> <w:Zoom>0</w:Zoom> <w:TrackMoves/> <w:TrackFormatting/> <w:PunctuationKerning/> <w:ValidateAgainstSchemas/> <w:SaveIfXMLInvalid>false</w:SaveIfXMLInvalid> <w:IgnoreMixedContent>false</w:IgnoreMixedContent> <w:AlwaysShowPlaceholderText>false</w:AlwaysShowPlaceholderText> <w:DoNotPromoteQF/> <w:LidThemeOther>EN-MY</w:LidThemeOther> <w:LidThemeAsian>X-NONE</w:LidThemeAsian> <w:LidThemeComplexScript>X-NONE</w:LidThemeComplexScript> <w:Compatibility> <w:BreakWrappedTables/> <w:SnapToGridInCell/> <w:WrapTextWithPunct/> <w:UseAsianBreakRules/> <w:DontGrowAutofit/> <w:SplitPgBreakAndParaMark/> <w:DontVertAlignCellWithSp/> <w:DontBreakConstrainedForcedTables/> <w:DontVertAlignInTxbx/> <w:Word11KerningPairs/> <w:CachedColBalance/> </w:Compatibility> <w:BrowserLevel>MicrosoftInternetExplorer4</w:BrowserLevel> <m:mathPr> <m:mathFont m:val="Cambria Math"/> <m:brkBin m:val="before"/> <m:brkBinSub m:val="--"/> <m:smallFrac m:val="off"/> <m:dispDef/> <m:lMargin m:val="0"/> <m:rMargin m:val="0"/> <m:defJc m:val="centerGroup"/> <m:wrapIndent m:val="1440"/> <m:intLim m:val="subSup"/> <m:naryLim m:val="undOvr"/> </m:mathPr></w:WordDocument></xml><![endif]--> <ul type="disc"><li class="MsoNormal" style="line-height: normal; mso-list: l4 level1 lfo1; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Treatment reduces symptoms and signs of <i>T. vaginalis</i> infection and might reduce transmission. Likelihood of adverse outcomes in women with HIV also is reduced with <i>T. vaginalis</i> therapy</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li></ul><div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;"><b><i><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Recommended Regimen</span></i></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></div><ul type="disc"><li class="MsoNormal" style="line-height: normal; mso-list: l3 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Metronidazole</span></b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"> 2 g orally in a single dose<br /> OR</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l3 level1 lfo2; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Tinidazole</span></b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"> 2 g orally in a single dose</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li></ul><div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;"><b><i><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Alternative Regimen</span></i></b><b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"> </span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></div><ul type="disc"><li class="MsoNormal" style="line-height: normal; mso-list: l0 level1 lfo3; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Metronidazole</span></b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"> 500 mg orally twice a day for 7 days</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li></ul><ul type="disc"><li class="MsoNormal" style="line-height: normal; mso-list: l2 level1 lfo4; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">The nitroimidazoles are the only class of antimicrobial medications known to be effective against <i>T. vaginalis</i> infections.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l2 level1 lfo4; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Of these drugs, metronidazole and tinidazole have been cleared by FDA for the oral or parenteral treatment of trichomoniasis</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li></ul><div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;"><b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Rationale in Pregnancy</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></div><ul type="disc"><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Pregnancy Category : B. Use of metronidazole for trichomoniasis is contraindicated during the first trimester; the manufacturer makes no further recommendations regarding use during pregnancy</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><i><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">T. vaginalis</span></i><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"> infection in pregnant women is associated with adverse pregnancy outcomes, particularly premature rupture of membranes, preterm delivery, and delivery of a low birthweight infant </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Although metronidazole treatment produces parasitologic cure, certain trials have shown no significant difference in perinatal morbidity following metronidazole treatment. </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">One trial suggested the possibility of increased preterm delivery in women with <i>T. vaginalis</i> infection who received metronidazole treatment, yet study limitations prevented definitive conclusions regarding the risks of treatment. </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">More recent, larger studies have shown no positive or negative association between metronidazole use during pregnancy and adverse outcomes of pregnancy </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">If treatment is considered, the recommended regimen in pregnant women is metronidazole 2 g orally in a single dose. </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Symptomatic pregnant women, regardless of pregnancy stage, should be tested and considered for treatment. </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Treatment of <i>T. vaginalis</i> infection can relieve symptoms of vaginal discharge in pregnant women and reduce sexual transmission to partners. </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Although perinatal transmission of trichomoniasis is uncommon, treatment also might prevent respiratory or genital infection of the newborn</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Although metronidazole crosses the placenta, data suggest that it poses a low risk to pregnant women </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">No evidence of teratogenicity or mutagenic effects in infants has been found in multiple cross-sectional and cohort studies of pregnant women </span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l1 level1 lfo5; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Women can be treated with 2 g metronidazole in a single dose at any stage of pregnancy.</span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li></ul><div class="MsoNormal" style="line-height: normal; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto;"><b><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;">Reference:</span></b><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></div><ol start="1" type="1"><li class="MsoNormal" style="line-height: normal; mso-list: l5 level1 lfo6; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"><a href="https://www.cdc.gov/std/tg2015/trichomoniasis.htm"><span style="color: blue;">https://www.cdc.gov/std/tg2015/trichomoniasis.htm</span></a></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li><li class="MsoNormal" style="line-height: normal; mso-list: l5 level1 lfo6; mso-margin-bottom-alt: auto; mso-margin-top-alt: auto; tab-stops: list 36.0pt;"><span style="font-family: "Verdana","sans-serif"; font-size: 12.0pt; mso-bidi-font-family: "Times New Roman"; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"><a href="https://www.drugs.com/pregnancy/metronidazole.html"><span style="color: blue;">https://www.drugs.com/pregnancy/metronidazole.html</span></a></span><span style="font-family: "Times New Roman","serif"; font-size: 12.0pt; mso-fareast-font-family: "Times New Roman"; mso-fareast-language: EN-MY;"></span></li></ol>

contraindication other Metronidazole: Trichomoniasis in Pregnancy

Treatment reduces symptoms and signs of T. vaginalis infection and might reduce transmission. Likelihood of adverse outcomes in w...

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