Dexamethasone (injection): Difference between revisions

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{{drugbox |
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| IUPAC_name = 9-fluoro-11β,17,21-trihydroxy-16a-<BR>methylpregna-1,4-diene-3,20-dione
|authorTag=<!--Overview-->
| image = Dexamethasone.png
|aOrAn=a
| CAS_number = 50-02-2
|hasBlackBoxWarning=Yes
| ATC_prefix = A01
|adverseReactions=<!--Black Box Warning-->
| ATC_suffix = AC02
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
| ATC_supplemental= {{ATC|C05|AA09}}, {{ATC|D07|AB19}}, {{ATC|H02|AB02}}, {{ATC|R01|AD03}}, {{ATC|S01|BA01}}, {{ATC|S02|BA06}}, {{ATC|S03|BA01}}
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| PubChem = 5743
 
| DrugBank = APRD00674
* Content
| C = 22 |H = 29 |F = 1 |O = 5
 
| molecular_weight = 392.464 g/mol
<!--Adult Indications and Dosage-->
| bioavailability = 80-90%
 
| protein_bound = 70%
<!--FDA-Labeled Indications and Dosage (Adult)-->
| metabolism = [[hepatic]]
|fdaLIADAdult======Condition1=====
| elimination_half-life = 36-54 hours
 
| excretion = renal
* Dosing Information
| pregnancy_AU =  
 
| pregnancy_US = C
:* Dosage
| pregnancy_category =  
 
| legal_status = Rx-only
=====Condition2=====
| routes_of_administration = Oral, [[Intravenous therapy|IV]], [[Intramuscular injection|IM]], [[Subcutaneous injection|SC]] and [[Intraosseous|IO]]
 
}}
* Dosing Information
 
:* Dosage
 
=====Condition3=====
 
* Dosing Information
 
:* Dosage
 
=====Condition4=====
 
* Dosing Information
 
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<!--Off-Label Use and Dosage (Adult)-->
 
<!--Guideline-Supported Use (Adult)-->
|offLabelAdultGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Non–Guideline-Supported Use (Adult)-->
|offLabelAdultNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
 
<!--Pediatric Indications and Dosage-->
 
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Off-Label Use and Dosage (Pediatric)-->
 
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
 
* Developed by:
 
* Class of Recommendation:
 
* Strength of Evidence:
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* Condition1
 
<!--Warnings-->
|warnings=* Description
 
====Precautions====
 
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<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} 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-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} 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-->
|drugInteractions=* Drug
:* Description
 
<!--Use in Specific Populations-->
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
<!--Administration and Monitoring-->
|administration=* Oral
 
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 
* Description
 
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
 
<!--Overdosage-->
|overdose====Acute Overdose===
 
====Signs and Symptoms====
 
* Description
 
====Management====
 
* Description


{{CMG}}
===Chronic Overdose===


There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


<!--Pharmacology-->


'''Dexamethasone''' is a potent synthetic member of the [[glucocorticoid]] class of [[steroid]] [[hormone]]s. It acts as an [[anti-inflammatory]] and [[immunosuppressive drug|immunosuppressant]]. Its potency is about 40 times that of [[hydrocortisone]].
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*


==Therapeutic use==
<!--Structure-->
Dexamethasone is used to treat many [[inflammation|inflammatory]] and [[autoimmune disease|autoimmune]] conditions, e.g., [[rheumatoid arthritis]]. It is also given to [[cancer]] patients undergoing [[chemotherapy]], to counteract certain [[Adverse drug reaction|side-effects]] of their antitumor treatment. Dexamethasone can augment the [[antiemetic]] effect of [[5-HT3 antagonist|5-HT<sub>3</sub> receptor antagonists]] like [[ondansetron]]. It is also given in small amounts (usually 5-6 tablets) before and/or after some forms of [[dental surgery]], such as the extraction of the [[wisdom teeth]], an operation which often leaves the patient with puffy, swollen cheeks.
|structure=*


In [[brain tumour]]s (primary or metastatic), dexamethasone is used to counteract the development of [[edema]], which could eventually compress other brain structures. Dexamethasone is also given in [[cord compression]] where a tumor is compressing the spinal cord.
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]


Dexamethasone is also used in certain [[hematological malignancy|hematological malignancies]], especially in the treatment of [[multiple myeloma]], in which dexamethasone is given alone or together with [[thalidomide]] (thal-dex) or a combination of [[adriamycin]] and [[vincristine]] (VAD).  It is injected into the heel when treating [[plantar fasciitis]], sometimes in conjunction with [[triamcinolone acetonide]].
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.


It is useful to counteract allergic shock, if given in high doses.  It is present in certain [[eye drop]]s and as a [[nasal spray]] (trade name '''Dexacort''').
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.


Dexamethasone can be used in the context of [[congenital adrenal hyperplasia]], to prevent [[virilisation]] of a female fetus.  If one or both parents are carriers of mutations to the CYP21A gene, the mother may start dexamethasone treatment within 7 weeks of [[conception]].  At the 12th week, a [[chorionic villus sampling|chorionic villus sample]] will determine whether the fetus is male (in which case the dexamethasone is stopped) or female. Subsequent DNA analysis can then reveal whether the female fetus is a carrier of the mutation, in which case dexamethasone treatment must continue until birth. The side-effects for the mother can be severe and the long-term impact on the child is not clear.
<!--Nonclinical Toxicology-->
|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.


Dexamethasone is used in the treatment of [[high altitude pulmonary edema]].
<!--Clinical Studies-->
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


==Diagnostic use==
<!--How Supplied-->
Dexamethasone is also used in a ''diagnostic'' context, namely in its property to suppress the natural [[Hypothalamic-pituitary-adrenal axis|pituitary-adrenal axis]].
|howSupplied=*
Patients presenting with clinical signs of [[glucocorticoid]] excess ([[Cushing's syndrome]]) are generally diagnosed by a 24-hour urine collection for [[cortisol]] or by a ''[[dexamethasone suppression test]]''. During the latter, the response of the body to a high dose of glucocorticoids is monitored. Various forms are performed. In the most common form, a patient takes a nighttime dose of either 1 or 4 mg of dexamethasone, and the serum [[cortisol]] levels are measured in the morning. If the levels are relatively high (over 5 µg/dl or 150 nmol/l), then the test is positive and the patient has an autonomous source of either [[cortisol]] or [[ACTH]], indicating [[Cushing's syndrome]] where the tumor does not have a feedback mechanism. If ACTH levels are lowered by at least 50%, this would indicate [[Cushing's Disease]], since the [[pituitary adenoma]] has a feedback mechanism that has been reset to a higher level of cortisol.  Longer versions rely on urine collections on oral dexamethasone over various days.


==Veterinary use==
<!--Patient Counseling Information-->
Combined with [[marbofloxacin]] and [[clotrimazole]], dexamethasone is available under the name ''Aurizon '', [[CAS number]] 115550-35-1, and used to treat difficult ear infections, especially in dogs.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.


==Contraindications==
<!--Precautions with Alcohol-->
Some of these [[contraindications]] are relative:
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
* Existing gastrointestinal [[ulceration]]
* [[Cushing's syndrome]]
* Severe forms of heart insufficiency
* Severe [[hypertension]]
* Uncontrolled [[diabetes mellitus]]
* Systemic [[tuberculosis]]
* Severe systemic viral, bacterial, and fungal infections
* Preexisting wide angle [[glaucoma]]
* [[Osteoporosis]]


==Side effects==
<!--Brand Names-->
If dexamethasone is given orally or by injection (parenteral) over a period of more than a few days, side-effects common to systemic glucocorticoids may occur. These may include:
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
* Stomach upset, increased sensitivity to stomach acid to the point of ulceration of esophagus, stomach, and duodenum
* Increased appetite leading to significant weight gain
* A latent diabetes mellitus often becomes manifest.  Glucose intolerance is worsened in patients with preexisting diabetes.
* Immunsuppressant action, particularly if given together with other immunosuppressants such as ciclosporine. Bacterial, viral, and fungal disease may progress more easily and can become life-threatening. Fever as a warning symptom is often suppressed.
* Psychiatric disturbances, including personality changes, irritability, euphoria, mania
* Osteoporosis under long term treatment, pathologic fractures (e.g., hip)
* Muscle atrophy, negative protein balance (catabolism)
* Elevated liver enzymes, fatty liver degeneration (usually reversible)
* Cushingoid (syndrome resembling hyperactive adrenal cortex with increase in adiposity, hypertension, bone demineralization, etc.)
* Depression of the adrenal gland is usually seen, if more than 1.5 mg daily are given for more than three weeks to a month.
* Hypertension, fluid and sodium retention, edema, worsening of heart insufficiency (due to mineral corticoid activity)  
* Dependence with withdrawal syndrome is frequently seen.
* Increased intraocular pressure, certain types of glaucoma, cataract (serious clouding of eye lenses)
* Dermatologic: Acne, allergic dermatitis, dry scaly skin, ecchymoses and petechiae, erythema, impaired wound-healing, increased sweating, rash, striae, suppression of reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.
* Allergic reactions (though infrequently): [[Anaphylactoid_reactions|Anaphylactoid reaction]], [[anaphylaxis]], [[angioedema]]. (Highly unlikely, since dexamethasone is given to ''prevent'' anaphylactoid reactions.)


Other side-effects have been noted, and should cause concern if they are more than mild.
<!--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>


The short time treatment for allergic reaction, shock, and diagnostic purposes usually does not cause serious side effects.
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==Interactions==
* NSAIDs and alcohol: increased risk of gastrointestinal ulceration
* Mineralocorticoids: increased risk of hypertension, edema and heart problems
* Oral antidiabetic drugs and insulin: antidiabetic therapy may have to be adjusted


Other interactions (with certain antibiotics, estrogens, ephedrine, digoxin) are known.


==Dosage==
<!--Label Display Image-->
* Shock: 4 to 8 mg intravenously initially, repeat if necessary to a total dose of 24 mg.
* Autoimmune diseases and inflammations: longterm therapy with 0.5 to 1.5 mg oral per day. Avoid more than 1.5 mg daily, because serious side effects are more frequently encountered with higher doses.
* Adjuvant to or part of chemotherapy: individual schedule
* Diagnostic purposes: special schedule


==Sports doping==
In [[2005]], [[Poland|Polish]] [[cross country skier]] [[Justyna Kowalczyk]] was disqualified from the Under 23 (U23) OPA (Alpine nations) Intercontinential Competition in [[Germany]] and issued a 2-year suspension for her doping offenses on dexamethasone.<ref>[http://www.fis-ski.com/data/document/info-kowalczyk.pdf June 13, 2005 FIS Doping Control statement on Kowalcyzk (Digitized version).] - Accessed [[July 30]], [[2006]]</ref> This was eventually reduced to one year during 2005 and later rescinded by the [[Court of Arbitration for Sport]] in December 2005.<ref>[http://www.fis-ski.com/data/document/fisnewsflash2005_12_14.pdf December 14, 2005 FIS Newsflash on her overturned suspension (Digitized version).] - Accessed July 30, 2006</ref> She would later earn a bronze in the women's 30 km freestyle mass start at the [[2006 Winter Olympics]] in [[Turin]].


==References==
<references/>




==External links==
* [http://www.myeloma.org/main.jsp?source=link&source_link_id=2117&type=article&tab_id=13&menu_id=94&id=1749 Understanding Dexamethasone and Other Steroids]


{{Corticosteroids}}
<!--Category-->
{{Stomatological preparations}}
{{Vasoprotectives}}
{{Corticosteroids for systemic use}}
{{Nasal preparations}}
{{Otologicals}}
[[Category:Glucocorticoids]]
[[Category:Organofluorides]]
<br>
[[de:Dexamethason]]
[[fr:Dexaméthasone]]
[[ja:デキサメサゾン]]
[[no:Deksametason]]
[[pl:Deksametazon]]
[[pt:Dexametasona]]
[[ru:Дексаметазон]]
[[sl:Deksametazon]]
[[sv:Dexametason]]


{{jb1}}
[[Category:Drug]]
{{WH}}
{{WS}}

Revision as of 19:40, 12 December 2014

Dexamethasone (injection)
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];

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Black Box Warning

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

Overview

Dexamethasone (injection) is a {{{drugClass}}} that is FDA approved for the {{{indicationType}}} 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 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 Dexamethasone (injection) in adult patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexamethasone (injection) 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 Dexamethasone (injection) 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 Dexamethasone (injection) in pediatric patients.

Non–Guideline-Supported Use

Condition1
  • Dosing Information
  • Dosage
Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Dexamethasone (injection) 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 Dexamethasone (injection) 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 Dexamethasone (injection) 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 Dexamethasone (injection) in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Dexamethasone (injection) during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Dexamethasone (injection) with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Dexamethasone (injection) with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Dexamethasone (injection) with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Dexamethasone (injection) with respect to specific gender populations.

Race

There is no FDA guidance on the use of Dexamethasone (injection) with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Dexamethasone (injection) in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Dexamethasone (injection) in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Dexamethasone (injection) in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Dexamethasone (injection) in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Oral
  • Intravenous

Monitoring

There is limited information regarding Monitoring of Dexamethasone (injection) in the drug label.

  • Description

IV Compatibility

There is limited information regarding IV Compatibility of Dexamethasone (injection) in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

  • Description

Management

  • Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Dexamethasone (injection) in the drug label.

Pharmacology

There is limited information regarding Dexamethasone (injection) Pharmacology in the drug label.

Mechanism of Action

Structure

File:Dexamethasone (injection)01.png
This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Dexamethasone (injection) in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Dexamethasone (injection) in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Dexamethasone (injection) in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Dexamethasone (injection) in the drug label.

How Supplied

Storage

There is limited information regarding Dexamethasone (injection) Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

{{#ask: Label Page::Dexamethasone (injection) |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Patient Counseling Information of Dexamethasone (injection) in the drug label.

Precautions with Alcohol

  • Alcohol-Dexamethasone (injection) 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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