Gliclazide: Difference between revisions

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| IUPAC_name = 3-(7-azabicyclo[3.3.0]oct-7-yl)-<br />1-(4-methylphenyl)sulfonyl-urea
|authorTag=<!--Overview-->
| image =
|aOrAn=a
| CAS_number = 21187-98-4
|drugClass=
| ATC_prefix = A10
|indicationType=
| ATC_suffix = BB09
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| PubChem = 3475
|hasBlackBoxWarning=Yes
| DrugBank = APRD00460
|adverseReactions=<!--Black Box Warning-->
| C = 15 |H = 21 |N = 3 |O = 3 |S = 1
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| molecular_weight = 323.412 [[Gram|g]]/[[Mole (unit)|mol]]
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: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
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{{SI}}
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<!--Nonclinical Toxicology-->
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==Overview==
<!--Clinical Studies-->
'''Gliclazide''' is an oral hypoglycemic ([[anti-diabetic drug]]) and is classified as a [[sulfonylurea]]. It is marketed as '''Diamicron MR®'''.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
'''DIAMICRON MR''' is also distributed as:
Diabeton MR, Diamicron 30mg, Diamicron LM 30mg, Diamicron MR 30 mg, Diamicron Uno 30mg, Dianormax MR, Diaprel MR and Uni Diamicron.  


== Form and Composition: ==
<!--How Supplied-->
|howSupplied=*
Each tablet contains 80 mg of gliclazide.
|storage=
|packLabel=
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


Not marketed in the United States.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.


== Indication: ==
<!--Brand Names-->
   
|brandNames=* ®<ref>{{Cite web | title = | url =  }}</ref>
Control of [[hyperglycemia]] in gliclazide responsive [[diabetes mellitus]] of stable, mild, non-[[ketosis]] prone, maturity onset or adult type which cannot be controlled by proper dietary management and exercise, or when [[insulin]] therapy is not appropriate.


== Dosage: ==
<!--Look-Alike Drug Names-->
   
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
40 to 240 mg depending on response, once or twice daily before food, no more that 160 mg at a time.


== Properties: ==
<!--Drug Shortage Status-->
|drugShortage=
[[Hypoglycemic]] [[sulfonylurea]], restoring first peak of [[insulin]] secretion, increasing [[insulin sensitivity]].
}}
[[Glycemia]]-independent hemovascular effects, [[antioxidant]] effect.
{{PillImage
No active circulating [[metabolite]]s.
|fileName=No image.jpg
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->


== Contraindications: ==
[[type 1 diabetes]],
hypersensitivity to [[sulfonylureas]],
severe [[renal failure|renal]] or [[hepatic failure]],
[[pregnancy]] and [[lactation]],
[[miconazole]] coprescription.


== Interactions: ==
[[Hyperglycemic]] action may be caused by [[danazol]], [[chlorpromazine]], [[glucocorticoids]], [[progestogens]], β-2 agonists.
Its [[hypoglycemic]] action may be potentiated by [[phenylbutazone]], [[alcohol]], [[fluconazole]], [[β-blockers]], possibly [[ACE inhibitors]].


== Adverse effects: ==
<!--Label Display Image-->
[[Hypoglycemia]], [[gastrointestinal]] disturbance (reported), [[skin]] reactions (rare), [[hematological]] disorders (rare), [[hepatic]] [[enzyme]] rises (exceptional).


== Overdosage: ==
Possible severe [[hypoglycemia]] requiring urgent [[IV]] [[glucose]] and monitoring.


==External links==
*[http://www.diamicronmr.com Official site for Diamicron MR]


{{Oral_hypoglycemics}}


[[Category:Sulfonylureas]]
[[Category:Endocrinology]]


[[fr:Gliclazide]]
<!--Category-->


{{WikiDoc Help Menu}}
[[Category:Drug]]
{{WikiDoc Sources}}

Revision as of 17:47, 24 December 2014

Gliclazide
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

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

Disclaimer

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Black Box Warning

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content

Overview

Gliclazide is a that is FDA approved for the of . 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 Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1
  • Developed by:
  • Class of Recommendation:
  • Strength of Evidence:
  • Dosing Information
  • Dosage
Condition2

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

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

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

Contraindications

  • Condition1

Warnings

ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
  • Content
  • Description

Precautions

  • Description

Adverse Reactions

Clinical Trials Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Postmarketing Experience

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

Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous

Drug Interactions

  • Drug
  • Description

Use in Specific Populations

Pregnancy

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 Gliclazide in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

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

Pediatric Use

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

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

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

  • Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

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

Pharmacology

There is limited information regarding Gliclazide Pharmacology in the drug label.

Mechanism of Action

Structure

File:Gliclazide01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

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

Clinical Studies

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

How Supplied

Storage

There is limited information regarding Gliclazide Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Gliclazide |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Gliclazide |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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

  1. ↑ Empty citation (help)
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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