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{{Drugbox|
Sandbox drug2
|IUPAC_name = N-(4-Nitro-2-phenoxyphenyl)methanesulfonamide
| image=nimesulide.png
| width=200px
| CAS_number=51803-78-2
| ATC_prefix=M01
| ATC_suffix=AX17
| ATC_supplemental=
| PubChem=4495
| DrugBank=
| C=13 | H=12 | N=2 | O=5 | S=1
| molecular_weight =308.311
| protein_bound = >97.5%
| metabolism = Hepatic
| elimination_half-life = 1.8-4.7h
| excretion = Renal(50%) Fecal(29%)
| legal_status =Prescription only Drug
| routes_of_administration= oral, rectal, topical
}}


{{CMG}}
Sandbox drug2®


Black Box Warning


Adult Indications and Dosage


'''Nimesulide''' is a prescription non-[[steroidal]] [[anti-inflammatory]] [[drug]] (NSAID) with [[analgesic]] and [[antipyretic]] properties and its approved indications are the [[Pharmacotherapy|treatment]] of acute pain, the [[symptom]]atic treatment of [[osteoarthrosis]] and primary [[dysmenorrhoea]] in [[adolescent]]s and [[adult]]s above 12 years old.
Pediatric Indications and Dosage
Nimesulide is among the top 5 non-steroidal anti-inflammatory drugs worldwide.


==History==
Contraindications


It was launched in [[Italy]] for the first time as Aulin and Mesulid in 1985 and is presently available in more than 50 countries worldwide, among others [[France]], [[Portugal]], [[Greece]], [[Switzerland]], [[Belgium]], [[Mexico]], [[Brazil]]. Nimesulide has never been filed for [[FDA]] evaluation in the [[United States]], where it is not marketed.
Warnings


In 2002 nimesulide benefit/risk profile was reviewed by the [[EMEA]] following decision to temporarily suspend the drug from the market in March 2002, in relation to the reporting of hepatic adverse effects in patients apparently treated with nimesulide.
Adverse Reactions
It was later demonstrated that the occurrence of hepatic reactions with nimesulide is similar to that of any other [[NSAIDs]] as confirmed by a study published by the British Medical Journal in 2003. <ref>[http://www.bmj.com/cgi/content/abstract/327/7405/18?ck=nck No differences between nimesulide and other NSAIDs liver toxicity]</ref>


=== EMEA reports favourable benefit/risk ratio ===
Drug Interactions


On August 1, 2003 the Committee for Proprietary Medicinal Products ([[CPMP]]) of the [[European Medicines Agency|EMEA]] reported that the benefit/risk profile of nimesulide containing medicinal products (Aulin, Mesulide, Nimed and associated product names) for systemic and topical use is favourable and that Marketing Authorisations should be maintained/granted. The CPMP recommended to restrict the use of nimesulide to the indications of treatment of acute pain, symptomatic treatment of painful osteoarthritis and primary dysmenorrhoea for the systemic formulations and symptomatic relief of pain associated with sprains and acute [[tendinitis]] for the topical formulation. <ref>[http://www.emea.europa.eu/pdfs/human/press/pr/375403en.pdf European Commission CPMP favourable opinion on nimesulide]</ref>
Use in Specific Populations


[[Alembic]] Ltd. issued a circular asking wholesalers and retailers to withdraw all stocks of Nimegesic Drops (a pediatric dosage form of nimesulide) in 2003, consistent with the fact that nimesulide is, like most NSAIDs, not indicated in children.<ref>[http://www.pharmabiz.com/article/detnews1.asp?articleid=15959&sectionid=47 The end begins]</ref>
Administration and Monitoring


=== Irish Medicines Board (IMB) suspends Nimesulide containing drugs (15 May 2007) ===
IV Compatibility


The Irish Medicines Board (IMB) has decided to suspend Nimesulide from the Irish market and refer it to the EU Committee for Human Medicinal Products (CHMP) for a review of its benefit/risk profile. The decision is due to the reporting of six (6) cases of potentially related liver failures to the IMB by the National Liver Transplant Unit, St Vincent Hospital. These cases occurred in the period from 1999 to 2006.<ref>[http://www.imb.ie/safety.asp?nav=70&action=view&safety_item_id=64 IMB Announces Immediate Suspension of the Marketing of Medicines Containing Nimesulide]</ref>
Overdosage


=== Singapore Health Science Authority suspends Nimesulide containing drugs ===
Pharmacology
Pending review of the drug's safety by the EMEA, nimesulide has been suspended with immediate effect (June 15, 2007)<ref>[http://www.channelnewsasia.com/stories/singaporelocalnews/view/282397/1/.html]</ref>
<ref>[http://www.hsa.gov.sg/docs/HSAPressRelease_HSASuspendsSalesOfProductsContainingNimesulide_15Jun07.pdf</ref>


=== EMEA confirms the positive benefit/risk ratio ===
Clinical Studies
On September 21, 2007 the EMEA released a press release on their review on the liver-related safety of nimesulide. The EMEA has concluded that the benefits of these medicines outweigh their risks, but that there is a need to limit the duration of use to ensure that the risk of patients developing liver problems is kept to a minimum. Therefore the EMEA has limited the use of systemic formulations (tablets, solutions, suppositories) of nimesulide to 15 days. <ref>[http://www.emea.europa.eu/pdfs/general/direct/pr/43260407en.pdf EMEA press release on nimesulide September 2007]</ref>


===[[Radio Telefís Éireann|RTE's]] [[Prime Time]] Investigates===
How Supplied
On December 03rd, 2007 Ireland's RTÉ aired an investigative programme highlighting the deadly side affects of Nimesulide and how it has been linked to over 300 cases of liver disease throughout Europe. Despite several attempts to get it banned; it remains on the market due mainly to EU Bureaucratic red tape{{Fact|date=December 2007}}. It has been responsible for the deaths of many people both in Ireland and worldwide, it should be avoided especially when safer alternatives are available.


==Availability==
Images


It is available in a variety of forms: tablets, powder for dissolution in water, suppositories and topical gel.
Patient Counseling Information
A recent evaluation from EMEA (the European Medicines Agency) concluded that the overall benefit/risk profile of nimesulide is favourable and in line with that of the other NSAIDs (such as for example, diclofenac, ibuprofen, naproxen).


===Trade names===
Precautions with Alcohol


Nimesulide is available through the world as original product with the following trademarks: Aulin, Ainex, Drexel, Donulide, Edrigyl, Eskaflam, Heugan, Mesulid, Minapon, Nexen, Nimed, Nimedex,Nimutab, Nisulid, Scaflam, Scaflan. Sulidene and Zolan for veterinary use. Many generic and copy-products also exist (Coxtral, Lusemin, Medicox, Nidol, Nimalox, Nimesil, Nimotas, Nimulid, Nise, Ventor, Willgo among others).
Brand Names


==Pharmacokinetics==
Look-Alike Drug Names


Nimesulide is rapidly absorbed following oral administration<ref name="clinpharmacokinet">Bernareggi A. Clinical pharmacokinetics of nimesulide. Clin.Pharmacokinet. 1998; 35: 247-274</ref>.
Drug Shortage Status


Nimesulide undergoes extensive biotransformation, mainly to 4-hydroxynimesulide (which also appears to be biologically active).<ref name="clinpharmacokinet"/>.
Price


Food, gender and advanced age have negligible effects on nimesulide pharmacokinetics<ref name="clinpharmacokinet"/>.
For patient information regarding , click [[{{{genericName}}} (patient information)|here]].


Moderate renal impairment does not necessitate dosage adjustment while patients with severe renal impairment or hepatic impairment are contraindicated<ref>http://www.emea.europa.eu/pdfs/human/referral/nimesulide/308603en.pdf</ref>
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];


Nimesulide has a relatively rapid onset of action, with meaningful reductions in pain and inflammation observed within 15 minutes from drug intake<ref name="currmedresopin">KD Rainsford and Members of the Consensus Report Group on Nimesulide. Nimesulide – a multifactorial approach to inflammation and pain: scientific and clinical consensus. Curr. Med. Res. Opin 2006; 22 (6): 1161-1170</ref><ref>Bianchi M and Broggini M. A Randomized, Double-Blind, Clinical Trial Comparing the Efficacy of Nimesulide, Celecoxib and Rofecoxib in osteoarthritis of the Knee. Drugs, 2003; 63, Suppl. 1: 37-46</ref>.
Disclaimer
As many as almost 498 million patients have been treated with nimesulide from its launch until today{{Fact|date=June 2007}}.
The therapeutic effects of Nimesulide are the result of its complete mode of action which targets a number of key mediators of the inflammatory process such as: COX-2 mediated prostaglandins, free radicals, proteolytic enzymes and histamine<ref name="currmedresopin"/>.
Clinical evidence is available to support a particularly good profile in terms of gastrointestinal tolerability<ref>Laporte JR et al. Upper Gastrointestinal Bleeding Associated with the Use of NSAIDs. Drug Safety, 2004; 27 (6): 411-420</ref>.


As all anti-inflammatory drugs, it should be taken in compliance with the recommendations included in the patient leaflet.
WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.


==Side effects==
Black Box Warning


Like most drugs in NSAID category, nimesulide is known to be [[hepatotoxic]] (damaging to the liver) in rare but unpredictable cases and should be taken with care. The patient information leaflet informs that the use of nimesulide in children under the age of 12 is contraindicated.
ConditionName:


==References==
See full prescribing information for complete boxed warning.


<references/>
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==External links==
Content


*[http://www.nimesulide.net Official page]
Overview
*[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=15144234&query_hl=12&itool=pubmed_docsum PubMed document]
*[http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=pubmed&cmd=Retrieve&dopt=AbstractPlus&list_uids=16846549&query_hl=7&itool=pubmed_docsum NCBI document]


{{NSAIDs}}
Sandbox drug2 is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
{{Anti-inflammatory and antirheumatic products}}
[[pt:Nimesulida]]
[[ro:Nimesulid]]
[[sr:Нимезулид]]


[[Category:Non-steroidal anti-inflammatory drugs]]
Adult Indications and Dosage
[[Category:Antipyretics]]
[[Category:Analgesics]]
[[Category:Drugs]]


[[tr:Nimesulid]]
FDA-Labeled Indications and Dosage (Adult)Condition1
Dosing Information


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Off-Label Use and Dosage (Adult)Guideline-Supported UseCondition1
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There is limited information regarding Off-Label Guideline-Supported Use of Sandbox drug2 in adult patients.
 
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There is limited information regarding Off-Label Non–Guideline-Supported Use of Sandbox drug2 in adult patients.
 
Pediatric Indications and Dosage
 
FDA-Labeled Indications and Dosage (Pediatric)Condition1
Dosing Information
 
Dosage
 
Condition2
 
There is limited information regarding FDA-Labeled Use of Sandbox drug2 in pediatric patients.
 
Off-Label Use and Dosage (Pediatric)
 
Guideline-Supported UseCondition1
Developed by:
 
Class of Recommendation:
 
Strength of Evidence:
 
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Condition2
 
There is limited information regarding Off-Label Guideline-Supported Use of Sandbox drug2 in pediatric patients.
 
Non–Guideline-Supported Use
 
Condition1
Dosing Information
 
Dosage
 
Condition2
 
There is limited information regarding Off-Label Non–Guideline-Supported Use of Sandbox drug2 in pediatric patients.
 
Contraindications
 
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Warnings
 
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See full prescribing information for complete boxed warning.
 
ConditionName:
 
Content
 
Description
 
Precautions
Description
 
Adverse ReactionsClinical Trials Experience
 
There is limited information regarding Clinical Trial Experience of Sandbox drug2 in the drug label.
 
Body as a Whole
 
CardiovascularDigestiveEndocrineHematologic and LymphaticMetabolic and NutritionalMusculoskeletalNeurologicRespiratorySkin and Hypersensitivy ReactionsSpecial SensesUrogenitalMiscellaneousPostmarketing Experience
 
There is limited information regarding Postmarketing Experience of Sandbox drug2 in the drug label.
 
Body as a Whole
 
CardiovascularDigestiveEndocrineHematologic and LymphaticMetabolic and NutritionalMusculoskeletalNeurologicRespiratorySkin and Hypersensitivy ReactionsSpecial SensesUrogenitalMiscellaneousDrug Interactions
Drug
 
Description
 
Use in Specific PopulationsPregnancy
 
Pregnancy Category (FDA):
 
Pregnancy Category
 
Pregnancy Category (AUS):
 
Australian Drug Evaluation Committee (ADEC) Pregnancy Category
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sandbox drug2 in women who are pregnant.
 
Labor and Delivery
 
There is no FDA guidance on use of Sandbox drug2 during labor and delivery.
 
Nursing Mothers
 
There is no FDA guidance on the use of Sandbox drug2 with respect to nursing mothers.
 
Pediatric Use
 
There is no FDA guidance on the use of Sandbox drug2 with respect to pediatric patients.
 
Geriatic Use
 
There is no FDA guidance on the use of Sandbox drug2 with respect to geriatric patients.
 
Gender
 
There is no FDA guidance on the use of Sandbox drug2 with respect to specific gender populations.
 
Race
 
There is no FDA guidance on the use of Sandbox drug2 with respect to specific racial populations.
 
Renal Impairment
 
There is no FDA guidance on the use of Sandbox drug2 in patients with renal impairment.
 
Hepatic Impairment
 
There is no FDA guidance on the use of Sandbox drug2 in patients with hepatic impairment.
 
Females of Reproductive Potential and Males
 
There is no FDA guidance on the use of Sandbox drug2 in women of reproductive potentials and males.
 
Immunocompromised Patients
 
There is no FDA guidance one the use of Sandbox drug2 in patients who are immunocompromised.
 
Administration and Monitoring
 
Administration
Oral
 
Intravenous
 
Monitoring
 
There is limited information regarding Monitoring of Sandbox drug2 in the drug label.
 
Description
 
IV Compatibility
 
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Overdosage
 
Acute OverdoseSigns and Symptoms
Description
 
Management
Description
 
Chronic Overdose
 
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Pharmacology
 
Mechanism of Action
 
Structure
 
File:Sandbox drug201.png
 
This image is provided by the National Library of Medicine.
 
Pharmacodynamics
 
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Pharmacokinetics
 
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Nonclinical Toxicology
 
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Clinical Studies
 
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How Supplied
 
Images
 
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There is limited information regarding Patient Counseling Information of Sandbox drug2 in the drug label.
 
Precautions with Alcohol
 
Alcohol-Sandbox drug2 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
 
Brand Names
®[1]
 
Look-Alike Drug Names
A® — B®[2]
 
Drug Shortage StatusPrice
 
References
 
The contents of this FDA label are provided by the National Library of Medicine.
 
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Revision as of 19:47, 9 January 2015

Sandbox drug2

Sandbox drug2®

Black Box Warning

Adult Indications and Dosage

Pediatric Indications and Dosage

Contraindications

Warnings

Adverse Reactions

Drug Interactions

Use in Specific Populations

Administration and Monitoring

IV Compatibility

Overdosage

Pharmacology

Clinical Studies

How Supplied

Images

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

For patient information regarding , click [[{{{genericName}}} (patient information)|here]].

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

ConditionName:

See full prescribing information for complete boxed warning.

ConditionName:

Content

Overview

Sandbox drug2 is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)Condition1 Dosing Information

Dosage

Condition2 Dosing Information

Dosage

Condition3 Dosing Information

Dosage

Condition4 Dosing Information

Dosage

Off-Label Use and Dosage (Adult)Guideline-Supported UseCondition1 Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Sandbox drug2 in adult patients.

Non–Guideline-Supported Use

Condition1 Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sandbox drug2 in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)Condition1 Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Sandbox drug2 in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported UseCondition1 Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Sandbox drug2 in pediatric patients.

Non–Guideline-Supported Use

Condition1 Dosing Information

Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sandbox drug2 in pediatric patients.

Contraindications

Condition1

Warnings

ConditionName:

See full prescribing information for complete boxed warning.

ConditionName:

Content

Description

Precautions Description

Adverse ReactionsClinical Trials Experience

There is limited information regarding Clinical Trial Experience of Sandbox drug2 in the drug label.

Body as a Whole

CardiovascularDigestiveEndocrineHematologic and LymphaticMetabolic and NutritionalMusculoskeletalNeurologicRespiratorySkin and Hypersensitivy ReactionsSpecial SensesUrogenitalMiscellaneousPostmarketing Experience

There is limited information regarding Postmarketing Experience of Sandbox drug2 in the drug label.

Body as a Whole

CardiovascularDigestiveEndocrineHematologic and LymphaticMetabolic and NutritionalMusculoskeletalNeurologicRespiratorySkin and Hypersensitivy ReactionsSpecial SensesUrogenitalMiscellaneousDrug Interactions Drug

Description

Use in Specific PopulationsPregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Sandbox drug2 in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Sandbox drug2 during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Sandbox drug2 with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Sandbox drug2 with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Sandbox drug2 with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Sandbox drug2 with respect to specific gender populations.

Race

There is no FDA guidance on the use of Sandbox drug2 with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Sandbox drug2 in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Sandbox drug2 in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Sandbox drug2 in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Sandbox drug2 in patients who are immunocompromised.

Administration and Monitoring

Administration Oral

Intravenous

Monitoring

There is limited information regarding Monitoring of Sandbox drug2 in the drug label.

Description

IV Compatibility

There is limited information regarding IV Compatibility of Sandbox drug2 in the drug label.

Overdosage

Acute OverdoseSigns and Symptoms Description

Management Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Sandbox drug2 in the drug label.

Pharmacology

Mechanism of Action

Structure

File:Sandbox drug201.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Sandbox drug2 in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Sandbox drug2 in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Sandbox drug2 in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Sandbox drug2 in the drug label.

How Supplied

Images

Drug Images

Drug Name: Ingredient(s): Imprint: Dosage: {{{dosageValue}}} {{{dosageUnit}}} Color(s): Shape: Size (mm): Score: NDC:

Drug Label Author:

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Package and Label Display Panel

File:Sandbox drug211.png

This image of the FDA label is provided by the National Library of Medicine.

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Sandbox drug2 in the drug label.

Precautions with Alcohol

Alcohol-Sandbox drug2 interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names ®[1]

Look-Alike Drug Names A® — B®[2]

Drug Shortage StatusPrice

References

The contents of this FDA label are provided by the National Library of Medicine.

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