Acetazolamide (injection): Difference between revisions

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{{DrugProjectFormSinglePage
{{DrugProjectFormSinglePage
|authorTag={{AV}}
|authorTag={{AV}}
|genericName=acetazolamide sodium(injection)
|genericName=acetazolamide sodium(injection)
 
|aOrAn=an
 
 
|aOrAn=
 
an
 
|drugClass=[[carbonic anhydrase]] [[inhibitor]]
|drugClass=[[carbonic anhydrase]] [[inhibitor]]
 
|indicationType=treatment
 
|indication=[[edema]] due to [[CHF|congestive heart failure]]; drug-induced [[edema]]; [[Epilepsy|centrencephalic epilepsies]] (petit mal, unlocalized [[seizures]]); chronic simple (open-angle) [[glaucoma]], [[glaucoma|secondary glaucoma]], and preoperatively in [[glaucoma|acute angle-closure glaucoma]]
 
|adverseReactions=[[paresthesias]], [[tinnitus]], [[loss of appetite]], [[taste alteration]], [[nausea]], [[vomiting]], [[diarrhea]], [[polyuria]], [[drowsiness]], and [[confusion]]
|indication= edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma
 
 
 
|hasBlackBoxWarning=
 
|adverseReactions=paresthesias, particularly a “tingling” feeling in the extremities, hearing dysfunction or tinnitus, loss of appetite, taste alteration and gastrointestinal disturbances such as nausea, vomiting and diarrhea; polyuria, and occasional instances of drowsiness and confusion.
 
 


<!--Black Box Warning-->
<!--Black Box Warning-->
 
|blackBoxWarningTitle=Title
|blackBoxWarningTitle=
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
Title
 
|blackBoxWarningBody=
<i><span style="color:#FF0000;">ConditionName: </span></i>


* Content
* Content
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<!--FDA-Labeled Indications and Dosage (Adult)-->
<!--FDA-Labeled Indications and Dosage (Adult)-->
 
|fdaLIADAdult=*For adjunctive treatment of: [[edema]] due to [[CHF|congestive heart failur]] ;drug-induced [[edema]]; [[epilepsy|centrencephalic epilepsies]] (petit mal, unlocalized [[seizures]]); [[glaucoma|chronic simple (open-angle) glaucoma]], [[glaucoma|secondary glaucoma]], and preoperatively in [[glaucoma|acute angle-closure glaucoma]] where delay of surgery is desired in order to lower intraocular pressure.
|fdaLIADAdult=
*For adjunctive treatment of: edema due to [[congestive heart failure;]] drug-induced edema; centrencephalic [[epilepsies]] (petit mal, unlocalized seizures); chronic simple (open-angle) [[glaucoma]], secondary [[glaucoma]], and preoperatively in acute angle-closure [[glaucoma]] where delay of surgery is desired in order to lower intraocular pressure.
====Dosing Information====
====Dosing Information====
*Preparation and Storage of Parenteral Solution
*Preparation and Storage of Parenteral Solution


*Each 500 mg vial containing sterile acetazolamide sodium should be reconstituted with at least 5 mL of Sterile Water for Injection prior to use. Store drug product at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Reconstituted solutions retain their physical and chemical properties for 3 days under refrigeration at 2° - 8°C (36° - 46°F), or 12 hours at room temperature 20° to 25°C (68° to 77°F). CONTAINS NO PRESERVATIVE. The direct intravenous route of administration is preferred.
*Each 500 mg vial containing sterile acetazolamide sodium should be reconstituted with at least 5 mL of Sterile Water for Injection prior to use. Store drug product at 20° to 25°C (68° to 77°F). Reconstituted solutions retain their physical and chemical properties for 3 days under refrigeration at 2° - 8°C (36° - 46°F), or 12 hours at room temperature 20° to 25°C (68° to 77°F). CONTAINS NO PRESERVATIVE. The direct intravenous route of administration is preferred.


*Intramuscular administration is not recommended.
*Intramuscular administration is not recommended.
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=====Epilepsy=====
=====Epilepsy=====


*It is not clearly known whether the beneficial effects observed in epilepsy are due to direct inhibition of [[carbonic anhydrase]] in the central nervous system or whether they are due to the slight degree of [[acidosis]] produced by the divided dosage. The best results to date have been seen in petit mal in children. Good results, however, have been seen in patients, both children and adult, in other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk patterns, etc. The suggested total daily dose is 8 to 30 mg per kg in divided doses. Although some patients respond to a low dose, the optimum range appears to be from 375 to 1000 mg daily. However, some investigators feel that daily doses in excess of 1 g do not produce any better results than a 1 g dose. When acetazolamide is given in combination with other [[anticonvulsants]], it is suggested that the starting dose should be 250 mg once daily in addition to the existing medications. This can be increased to levels as indicated above.
*It is not clearly known whether the beneficial effects observed in epilepsy are due to direct inhibition of [[carbonic anhydrase]] in the central nervous system or whether they are due to the slight degree of [[acidosis]] produced by the divided dosage. The best results to date have been seen in petit mal in children. Good results, however, have been seen in patients, both children and adult, in other types of seizures such as [[grand mal]], mixed [[seizure]] patterns, myoclonic jerk patterns, etc. The suggested total daily dose is 8 to 30 mg per kg in divided doses. Although some patients respond to a low dose, the optimum range appears to be from 375 to 1000 mg daily. However, some investigators feel that daily doses in excess of 1 g do not produce any better results than a 1 g dose. When acetazolamide is given in combination with other [[anticonvulsants]], it is suggested that the starting dose should be 250 mg once daily in addition to the existing medications. This can be increased to levels as indicated above.


*The change from other medications to acetazolamide should be gradual and in accordance with usual practice in epilepsy therapy.
*The change from other medications to acetazolamide should be gradual and in accordance with usual practice in [[epilepsy]] therapy.


=====Congestive Heart Failure=====
=====Congestive Heart Failure=====


*For [[diuresis]] in congestive heart failure, the starting dose is usually 250 to 375 mg once daily in the morning (5 mg per kg). If, after an initial response, the patient fails to continue to lose edema fluid, do not increase the dose but allow for kidney recovery by skipping medication for a day.
*For [[diuresis]] in [[congestive heart failure]], the starting dose is usually 250 to 375 mg once daily in the morning (5 mg per kg). If, after an initial response, the patient fails to continue to lose [[edema]] fluid, do not increase the dose but allow for kidney recovery by skipping medication for a day.


*Acetazolamide yields best [[diuretic]] results when given on alternate days, or for two days alternating with a day of rest.
*Acetazolamide yields best [[diuretic]] results when given on alternate days, or for two days alternating with a day of rest.


*Failures in therapy may be due to overdosage or too frequent dosage. The use of acetazolamide does not eliminate the need for other therapy such as digitalis, bed rest, and salt restriction.
*Failures in therapy may be due to overdosage or too frequent dosage. The use of acetazolamide does not eliminate the need for other therapy such as [[digitalis]], bed rest, and salt restriction.


=====Drug-Induced Edema=====
=====Drug-Induced Edema=====
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<!--Guideline-Supported Use (Adult)-->
<!--Guideline-Supported Use (Adult)-->
 
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Non–Guideline-Supported Use (Adult)-->
<!--Non–Guideline-Supported Use (Adult)-->
 
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


<!--Pediatric Indications and Dosage-->
<!--Pediatric Indications and Dosage-->


<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
 
|fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
|fdaLIADPed=
 
 
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.


<!--Off-Label Use and Dosage (Pediatric)-->
<!--Off-Label Use and Dosage (Pediatric)-->


<!--Guideline-Supported Use (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
 
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedGuideSupport=
 
 
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Non–Guideline-Supported Use (Pediatric)-->
<!--Non–Guideline-Supported Use (Pediatric)-->
 
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
|offLabelPedNoGuideSupport=
 
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.


<!--Contraindications-->
<!--Contraindications-->
 
|contraindications=* Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a [[sulfonamide]] derivative, cross sensitivity between acetazolamide, [[sulfonamides]] and other sulfonamide derivatives is possible.
|contraindications=
 
* Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a [[sulfonamide]] derivative, cross sensitivity between acetazolamide, [[sulfonamides]] and other sulfonamide derivatives is possible.


*Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in [[suprarenal gland failure]], and in [[hyperchloremic acidosis]]. It is contraindicated in patients with [[cirrhosis]] because of the risk of development of [[hepatic encephalopathy]].
*Acetazolamide therapy is contraindicated in situations in which sodium and/or potassium blood serum levels are depressed, in cases of marked kidney and liver disease or dysfunction, in [[suprarenal gland failure]], and in [[hyperchloremic acidosis]]. It is contraindicated in patients with [[cirrhosis]] because of the risk of development of [[hepatic encephalopathy]].
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<!--Warnings-->
<!--Warnings-->
 
|warnings=*Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including [[Stevens-Johnson syndrome]], [[toxic epidermal necrolysis]], fulminant hepatic necrosis, [[agranulocytosis]], [[aplastic anemia]], and other blood dyscrasias. Sensitizations may recur when a [[sulfonamide]] is readministered irrespective of the route of administration. If signs of [[hypersensitivity]] or other serious reactions occur, discontinue use of this drug.
|warnings=
 
*Fatalities have occurred, although rarely, due to severe reactions to sulfonamides including [[Stevens-Johnson syndrome]], [[toxic epidermal necrolysis]], fulminant hepatic necrosis, [[agranulocytosis]], [[aplastic anemia]], and other blood dyscrasias. Sensitizations may recur when a [[sulfonamide]] is readministered irrespective of the route of administration. If signs of [[hypersensitivity]] or other serious reactions occur, discontinue use of this drug.


*Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as [[anorexia]], [[tachypnea]], [[lethargy]], coma and death have been reported.
*Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as [[anorexia]], [[tachypnea]], [[lethargy]], coma and death have been reported.
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====Precautions====
====Precautions====


* Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or [[paresthesia]]. Increasing the dose often results in a decrease in diuresis. Under certain circumstances, however, very large doses have been given in conjunction with other diuretics in order to secure [[diuresis]] in complete refractory failure.
* Increasing the dose does not increase the [[diuresis]] and may increase the incidence of drowsiness and/or [[paresthesia]]. Increasing the dose often results in a decrease in diuresis. Under certain circumstances, however, very large doses have been given in conjunction with other diuretics in order to secure [[diuresis]] in complete [[refractory failure]].


<!--Adverse Reactions-->
<!--Adverse Reactions-->


<!--Clinical Trials Experience-->
<!--Clinical Trials Experience-->
 
|clinicalTrials=*Adverse reactions, occurring most often early in therapy, include [[paresthesias]], particularly a “tingling” feeling in the extremities, hearing dysfunction or [[tinnitus]], [[loss of appetite]], taste alteration and gastrointestinal disturbances such as [[nausea]], [[vomiting]] and [[diarrhea]]; [[polyuria]], and occasional instances of [[drowsiness]] and [[confusion]].
|clinicalTrials=
 
*Adverse reactions, occurring most often early in therapy, include [[paresthesias]], particularly a “tingling” feeling in the extremities, hearing dysfunction or [[tinnitus]], loss of appetite, taste alteration and gastrointestinal disturbances such as [[nausea]], [[vomiting]] and [[diarrhea]]; [[polyuria]], and occasional instances of [[drowsiness]] and [[confusion]].


*[[Metabolic acidosis]] and [[electrolyte imbalance]] may occur.
*[[Metabolic acidosis]] and [[electrolyte imbalance]] may occur.
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*Transient [[myopia]] has been reported. This condition invariably subsides upon diminution or discontinuance of the medication.
*Transient [[myopia]] has been reported. This condition invariably subsides upon diminution or discontinuance of the medication.


*Other occasional adverse reactions include urticaria, [[melena]], [[hematuria]], [[glycosuria]], [[hepatic insufficiency,]] [[flaccid paralysis]], [[photosensitivity]] and convulsions. Fatalities have occurred although rarely, due to severe reactions to [[sulfonamides]] including [[Stevens-Johnson syndrome]], [[toxic epidermal necrolysis]], [[fulminant hepatic necrosis]], agranulocytosis, [[aplastic anemia]] and other [[blood dyscrasias]]
*Other occasional adverse reactions include [[urticaria]], [[melena]], [[hematuria]], [[glycosuria]], [[hepatic insufficiency,]] [[flaccid paralysis]], [[photosensitivity]] and [[convulsions]]. Fatalities have occurred although rarely, due to severe reactions to [[sulfonamides]] including [[Stevens-Johnson syndrome]], [[toxic epidermal necrolysis]], [[fulminant hepatic necrosis]], agranulocytosis, [[aplastic anemia]] and other [[blood dyscrasias]]






<!--Postmarketing Experience-->
<!--Postmarketing Experience-->
 
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=
 
There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.




<!--Drug Interactions-->
<!--Drug Interactions-->
 
|drugInteractions=<!--Use in Specific Populations-->
|drugInteractions=
|FDAPregCat=C
 
|useInPregnancyFDA=* Pregnancy Category C
 
<!--Use in Specific Populations-->
 
|useInPregnancyFDA=
* Teratogenic Effects: Pregnancy Category C
*Acetazolamide, administered orally or parenterally, has been shown to be teratogenic (defects of the limbs) in mice, rats, hamsters and rabbits. There are no adequate and well-controlled studies in pregnant women. Acetazolamide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
*Acetazolamide, administered orally or parenterally, has been shown to be teratogenic (defects of the limbs) in mice, rats, hamsters and rabbits. There are no adequate and well-controlled studies in pregnant women. Acetazolamide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.
 
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) 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.
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.
|useInLaborDelivery=
|useInNursing=*Because of the potential for serious adverse reaction in nursing infants from acetazolamide, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInPed=*The safety and effectiveness of acetazolamide in children have not been established.
 
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInNursing=
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
*Because of the potential for serious adverse reaction in nursing infants from acetazolamide, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInPed=
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[renal impairment]].
*The safety and effectiveness of acetazolamide in children have not been established.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with [[hepatic impairment]].
|useInGeri=
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are [[immunocompromised]].
 
|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 and Monitoring-->
 
|administration=* [[Intravenous]]
|administration=
|monitoring=*To monitor for hematologic reactions common to all [[sulfonamides]], it is recommended that a baseline [[CBC]] and [[platelet]] count be obtained on patients prior to initiating acetazolamide therapy and at regular intervals during therapy. If significant changes occur, early discontinuance and institution of appropriate therapy are important. Periodic monitoring of serum electrolytes is recommended.
 
* Intravenous
 
|monitoring=
 
*To monitor for hematologic reactions common to all [[sulfonamides]], it is recommended that a baseline CBC and platelet count be obtained on patients prior to initiating acetazolamide therapy and at regular intervals during therapy. If significant changes occur, early discontinuance and institution of appropriate therapy are important. Periodic monitoring of serum electrolytes is recommended.


<!--IV Compatibility-->
<!--IV Compatibility-->
 
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=
 
There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.


<!--Overdosage-->
<!--Overdosage-->
|overdose=*No data are available regarding acetazolamide overdosage in humans as no cases of acute poisoning with this drug have been reported. Animal data suggest that acetazolamide is remarkably nontoxic. No specific antidote is known. Treatment should be symptomatic and supportive.


|overdose=
*Electrolyte imbalance, development of an [[acidotic]] state, and central nervous effects might be expected to occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
 
*No data are available regarding acetazolamide overdosage in humans as no cases of acute poisoning with this drug have been reported. Animal data suggest that acetazolamide is remarkably nontoxic. No specific antidote is known. Treatment should be symptomatic and supportive.


*Electrolyte imbalance, development of an acidotic state, and central nervous effects might be expected to occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
*Supportive measures are required to restore electrolyte and pH balance. The [[acidotic]] state can usually be corrected by the administration of [[bicarbonate]].


*Supportive measures are required to restore electrolyte and pH balance. The acidotic state can usually be corrected by the administration of [[bicarbonate]].
*Despite its high intraerythrocytic distribution and plasma protein binding properties, acetazolamide may be [[dialysis|dialyzable]]. This may be particularly important in the management of acetazolamide overdosage when complicated by the presence of [[renal failure]].
 
*Despite its high intraerythrocytic distribution and plasma protein binding properties, acetazolamide may be dialyzable. This may be particularly important in the management of acetazolamide overdosage when complicated by the presence of renal failure.
<!--Pharmacology-->
<!--Pharmacology-->


<!--Drug box 2-->
<!--Drug box 2-->
 
|drugBox={{Drugbox2
|drugBox=
{{Drugbox2
| verifiedrevid = 477238754
| verifiedrevid = 477238754
| IUPAC_name = ''N''-(5-sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide
| IUPAC_name = ''N''-(5-sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide
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<!--Mechanism of Action-->
<!--Mechanism of Action-->
 
|mechAction=* Acetazolamide is a potent [[carbonic anhydrase]] inhibitor, effective in the control of fluid secretion (e.g., some types of [[glaucoma]]), in the treatment of certain convulsive disorders (e.g., [[epilepsy]]) and in the promotion of [[diuresis]] in instances of abnormal fluid retention (e.g., [[cardiac edema]]).
|mechAction=
 
* Acetazolamide is a potent [[carbonic anhydrase inhibitor]], effective in the control of fluid secretion (e.g., some types of [[glaucoma]]), in the treatment of certain convulsive disorders (e.g., [[epilepsy]]) and in the promotion of [[diuresis]] in instances of abnormal fluid retention (e.g., [[cardiac edema]]).


*Acetazolamide is not a mercurial [[diuretic]]. Rather, it is a nonbacteriostatic sulfonamide possessing a chemical structure and pharmacological activity distinctly different from the bacteriostatic [[sulfonamides]].
*Acetazolamide is not a mercurial [[diuretic]]. Rather, it is a nonbacteriostatic sulfonamide possessing a chemical structure and pharmacological activity distinctly different from the bacteriostatic [[sulfonamides]].


<!--Structure-->
<!--Structure-->
 
|structure=*Acetazolamide, an inhibitor of the enzyme [[carbonic anhydrase]], is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2yl)-acetamide and has the following chemical structure:  
|structure=
 
*Acetazolamide, an inhibitor of the enzyme [[carbonic anhydrase]], is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2yl)-acetamide and has the following chemical structure:  
: [[File:{{PAGENAME}}01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}01.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
*Acetazolamide is available for intravenous use, and is supplied as a sterile powder requiring reconstitution. Each vial contains acetazolamide sodium equivalent to 500 mg of acetazolamide. The bulk solution is adjusted to pH 9.6 using sodium hydroxide and, if necessary, hydrochloric acid prior to [[lyophilization]].
*Acetazolamide is available for intravenous use, and is supplied as a sterile powder requiring reconstitution. Each vial contains acetazolamide sodium equivalent to 500 mg of acetazolamide. The bulk solution is adjusted to pH 9.6 using sodium hydroxide and, if necessary, hydrochloric acid prior to [[lyophilization]].
<!--Pharmacodynamics-->
<!--Pharmacodynamics-->
|PD=*Acetazolamide is an enzyme inhibitor that acts specifically on [[carbonic anhydrase]], the enzyme that catalyzes the reversible reaction involving the [[hydration]] of [[carbon dioxide]] and the [[dehydration]] of [[carbonic acid]]. In the eye, this inhibitory action of acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in cases of [[glaucoma]] and even in certain nonglaucomatous conditions. Evidence seems to indicate that acetazolamide has utility as an adjuvant in the treatment of certain dysfunctions of the central nervous system (e.g., [[epilepsy]]).


|PD=
*Inhibition of [[carbonic anhydrase]] in this area appears to retard abnormal, paroxysmal, excessive discharge from central nervous system neurons. The [[diuretic]] effect of acetazolamide is due to its action in the kidney on the reversible reaction involving hydration of [[carbon dioxide]] and [[dehydration]] of carbonic acid.
 
*Acetazolamide is an enzyme inhibitor that acts specifically on [[carbonic anhydrase]], the enzyme that catalyzes the reversible reaction involving the [[hydration]] of [[carbon dioxide]] and the [[dehydration]] of [[carbonic acid]]. In the eye, this inhibitory action of acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in cases of glaucoma and even in certain nonglaucomatous conditions. Evidence seems to indicate that acetazolamide has utility as an adjuvant in the treatment of certain dysfunctions of the central nervous system (e.g., [[epilepsy]]).
 
*Inhibition of [[carbonic anhydrase]] in this area appears to retard abnormal, paroxysmal, excessive discharge from central nervous system neurons. The [[diuretic]] effect of acetazolamide is due to its action in the kidney on the reversible reaction involving hydration of carbon dioxide and dehydration of carbonic acid.
<!--Pharmacokinetics-->
<!--Pharmacokinetics-->
 
|PK=*The result is renal loss of [[HCO3]] ion, which carries out sodium, water, and potassium. [[Alkalinization]] of the urine and promotion of [[diuresis]] are thus effected. Alteration in ammonia metabolism occurs due to increased reabsorption of [[ammonia]] by the renal tubules as a result of urinary [[alkalinization]].
|PK=
 
*The result is renal loss of [[HCO3]] ion, which carries out sodium, water, and potassium. [[Alkalinization]] of the urine and promotion of [[diuresis]] are thus effected. Alteration in ammonia metabolism occurs due to increased reabsorption of [[ammonia]] by the renal tubules as a result of urinary [[alkalinization]].
<!--Nonclinical Toxicology-->
<!--Nonclinical Toxicology-->
 
|nonClinToxic======Carcinogenesis, Mutagenesis, Impairment of Fertility=====
|nonClinToxic=
 
=====Carcinogenesis, Mutagenesis, Impairment of Fertility=====
*Long-term studies in animals to evaluate the carcinogenic potential of acetazolamide have not been conducted. In a bacterial [[mutagenicity]] assay, acetazolamide was not mutagenic when evaluated with and without metabolic activation. The drug had no effect on [[fertility]] when administered in the diet to male and female rats at a daily intake of up to 4 times the recommended human dose of 1000 mg in a 50 kg individual.
*Long-term studies in animals to evaluate the carcinogenic potential of acetazolamide have not been conducted. In a bacterial [[mutagenicity]] assay, acetazolamide was not mutagenic when evaluated with and without metabolic activation. The drug had no effect on [[fertility]] when administered in the diet to male and female rats at a daily intake of up to 4 times the recommended human dose of 1000 mg in a 50 kg individual.
<!--Clinical Studies-->
<!--Clinical Studies-->
 
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=
 
There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.


<!--How Supplied-->
<!--How Supplied-->
 
|howSupplied=* AcetaZOLAMIDE for Injection, USP (lyophilized) powder is supplied as follows:
|howSupplied=
 
* AcetaZOLAMIDE for Injection, USP (lyophilized) powder is supplied as follows:
: [[File:{{PAGENAME}}02.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
: [[File:{{PAGENAME}}02.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
*Store drug product at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
*Store reconstituted solution in a refrigerator between 2° and 8°C (36° and 46°F).


*Use within 12 hours of reconstitution. Discard unused portion.
*Use within 12 hours of reconstitution. Discard unused portion.
Line 352: Line 234:


<!--Patient Counseling Information-->
<!--Patient Counseling Information-->
|storage=*Store drug product at 20° to 25°C (68° to 77°F).
*Store reconstituted solution in a refrigerator between 2° and 8°C (36° and 46°F).
|packLabel=[[File:{{PAGENAME}}03.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
[[File:{{PAGENAME}}04.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=*Adverse reactions common to all sulfonamide derivatives may occur: [[anaphylaxis]], [[fever]], [[rash]] (including [[erythema multiforme]], [[Stevens-Johnson syndrome]], [[toxic epidermal necrolysis]]), [[crystalluria]], [[renal calculus]], [[bone marrow depression]], [[thrombocytopenic purpura]], [[hemolytic anemia]], [[leukopenia]], [[pancytopenia]] and [[agranulocytosis]]. Precaution is advised for early detection of such reactions and the drug should be discontinued and appropriate therapy instituted.


|fdaPatientInfo=
*In patients with pulmonary obstruction or [[emphysema]] where alveolar ventilation may be impaired, acetazolamide which may precipitate or aggravate [[acidosis]], should be used with caution.


*Adverse reactions common to all sulfonamide derivatives may occur: [[anaphylaxis]], [[fever]], [[rash]] (including [[erythema multiforme]], [[Stevens-Johnson syndrome]], [[toxic epidermal necrolysis]]), [[crystalluria]], [[renal calculus]], [[bone marrow depression]], [[thrombocytopenic purpura]], [[hemolytic anemia]], [[leukopenia]], [[pancytopenia]] and [[agranulocytosis]]. Precaution is advised for early detection of such reactions and the drug should be discontinued and appropriate therapy instituted.
*Caution is advised for patients receiving concomitant high-dose [[aspirin]] and acetazolamide, as [[anorexia]], [[tachypnea]], [[lethargy]], [[coma]] and death have been reported
 
*In patients with [[pulmonary obstruction]] or [[emphysema]] where alveolar ventilation may be impaired, acetazolamide which may precipitate or aggravate [[acidosis]], should be used with caution.
 
*Caution is advised for patients receiving concomitant high-dose [[aspirin]] and acetazolamide, as [[anorexia]], [[tachypnea]], [[lethargy]], [[coma]] and [[death]] have been reported
<!--Precautions with Alcohol-->
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|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking [[alcohol]] with this medication.
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* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking [[alcohol]] with this medication.


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<!--Brand Names-->
 
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Latest revision as of 17:09, 18 August 2015

Acetazolamide (injection)
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]; Associate Editor(s)-in-Chief: Aparna Vuppala, M.B.B.S. [2]

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.

Overview

Acetazolamide (injection) is an carbonic anhydrase inhibitor that is FDA approved for the treatment of edema due to congestive heart failure; drug-induced edema; centrencephalic epilepsies (petit mal, unlocalized seizures); chronic simple (open-angle) glaucoma, secondary glaucoma, and preoperatively in acute angle-closure glaucoma. Common adverse reactions include paresthesias, tinnitus, loss of appetite, taste alteration, nausea, vomiting, diarrhea, polyuria, drowsiness, and confusion.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Dosing Information

  • Preparation and Storage of Parenteral Solution
  • Each 500 mg vial containing sterile acetazolamide sodium should be reconstituted with at least 5 mL of Sterile Water for Injection prior to use. Store drug product at 20° to 25°C (68° to 77°F). Reconstituted solutions retain their physical and chemical properties for 3 days under refrigeration at 2° - 8°C (36° - 46°F), or 12 hours at room temperature 20° to 25°C (68° to 77°F). CONTAINS NO PRESERVATIVE. The direct intravenous route of administration is preferred.
  • Intramuscular administration is not recommended.
Glaucoma
  • Acetazolamide should be used as an adjunct to the usual therapy. The dosage employed in the treatment of chronic simple (open-angle) glaucoma ranges from 250 mg to 1 g of acetazolamide per 24 hours, usually in divided doses for amounts over 250 mg. It has usually been found that a dosage in excess of 1 g per 24 hours does not produce an increased effect. In all cases, the dosage should be adjusted with careful individual attention both to symptomatology and ocular tension. Continuous supervision by a physician is advisable.
  • In treatment of secondary glaucoma and in the preoperative treatment of some cases of acute congestive (closed-angle) glaucoma, the preferred dosage is 250 mg every four hours, although some cases have responded to 250 mg twice daily on short-term therapy. In some acute cases, it may be more satisfactory to administer an initial dose of 500 mg followed by 125 or 250 mg every four hours depending on the individual case. Intravenous therapy may be used for rapid relief of ocular tension in acute cases. A complementary effect has been noted when acetazolamide has been used in conjunction with miotics or mydriatics as the case demanded.
Epilepsy
  • It is not clearly known whether the beneficial effects observed in epilepsy are due to direct inhibition of carbonic anhydrase in the central nervous system or whether they are due to the slight degree of acidosis produced by the divided dosage. The best results to date have been seen in petit mal in children. Good results, however, have been seen in patients, both children and adult, in other types of seizures such as grand mal, mixed seizure patterns, myoclonic jerk patterns, etc. The suggested total daily dose is 8 to 30 mg per kg in divided doses. Although some patients respond to a low dose, the optimum range appears to be from 375 to 1000 mg daily. However, some investigators feel that daily doses in excess of 1 g do not produce any better results than a 1 g dose. When acetazolamide is given in combination with other anticonvulsants, it is suggested that the starting dose should be 250 mg once daily in addition to the existing medications. This can be increased to levels as indicated above.
  • The change from other medications to acetazolamide should be gradual and in accordance with usual practice in epilepsy therapy.
Congestive Heart Failure
  • For diuresis in congestive heart failure, the starting dose is usually 250 to 375 mg once daily in the morning (5 mg per kg). If, after an initial response, the patient fails to continue to lose edema fluid, do not increase the dose but allow for kidney recovery by skipping medication for a day.
  • Acetazolamide yields best diuretic results when given on alternate days, or for two days alternating with a day of rest.
  • Failures in therapy may be due to overdosage or too frequent dosage. The use of acetazolamide does not eliminate the need for other therapy such as digitalis, bed rest, and salt restriction.
Drug-Induced Edema
  • Recommended dosage is 250 to 375 mg of acetazolamide once a day for one or two days, alternating with a day of rest.

Note: The dosage recommendations for glaucoma and epilepsy differ considerably from those for congestive heart failure, since the first two conditions are not dependent upon carbonic anhydrase inhibition in the kidney which requires intermittent dosage if it is to recover from inhibitory effect of the therapeutic agent.

  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Acetazolamide (injection) in adult patients.

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Acetazolamide (injection) in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

  • Hypersensitivity to acetazolamide or any excipients in the formulation. Since acetazolamide is a sulfonamide derivative, cross sensitivity between acetazolamide, sulfonamides and other sulfonamide derivatives is possible.
  • Long-term administration of acetazolamide is contraindicated in patients with chronic noncongestive angle-closure glaucoma since it may permit organic closure of the angle to occur while the worsening glaucoma is masked by lowered intraocular pressure.

Warnings

  • Caution is advised for patients receiving concomitant high-dose aspirin and acetazolamide, as anorexia, tachypnea, lethargy, coma and death have been reported.

Precautions

  • Increasing the dose does not increase the diuresis and may increase the incidence of drowsiness and/or paresthesia. Increasing the dose often results in a decrease in diuresis. Under certain circumstances, however, very large doses have been given in conjunction with other diuretics in order to secure diuresis in complete refractory failure.

Adverse Reactions

Clinical Trials Experience

  • Transient myopia has been reported. This condition invariably subsides upon diminution or discontinuance of the medication.

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Acetazolamide (injection) in the drug label.

Drug Interactions

There is limited information regarding Acetazolamide (injection) Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): C

  • Pregnancy Category C
  • Acetazolamide, administered orally or parenterally, has been shown to be teratogenic (defects of the limbs) in mice, rats, hamsters and rabbits. There are no adequate and well-controlled studies in pregnant women. Acetazolamide should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.


Pregnancy Category (AUS):

  • Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

Labor and Delivery

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

Nursing Mothers

  • Because of the potential for serious adverse reaction in nursing infants from acetazolamide, a decision should be made whether to discontinue nursing or to discontinue the drug taking into account the importance of the drug to the mother.

Pediatric Use

  • The safety and effectiveness of acetazolamide in children have not been established.

Geriatic Use

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

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Monitoring

  • To monitor for hematologic reactions common to all sulfonamides, it is recommended that a baseline CBC and platelet count be obtained on patients prior to initiating acetazolamide therapy and at regular intervals during therapy. If significant changes occur, early discontinuance and institution of appropriate therapy are important. Periodic monitoring of serum electrolytes is recommended.

IV Compatibility

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

Overdosage

  • No data are available regarding acetazolamide overdosage in humans as no cases of acute poisoning with this drug have been reported. Animal data suggest that acetazolamide is remarkably nontoxic. No specific antidote is known. Treatment should be symptomatic and supportive.
  • Electrolyte imbalance, development of an acidotic state, and central nervous effects might be expected to occur. Serum electrolyte levels (particularly potassium) and blood pH levels should be monitored.
  • Supportive measures are required to restore electrolyte and pH balance. The acidotic state can usually be corrected by the administration of bicarbonate.
  • Despite its high intraerythrocytic distribution and plasma protein binding properties, acetazolamide may be dialyzable. This may be particularly important in the management of acetazolamide overdosage when complicated by the presence of renal failure.

Pharmacology

Template:Px
Template:Px
Acetazolamide (injection)
Systematic (IUPAC) name
N-(5-sulfamoyl-1,3,4-thiadiazol-2-yl)acetamide
Identifiers
CAS number 59-66-5
ATC code S01EC01
PubChem 1986
DrugBank DB00819
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 222.245 g/mol
SMILES eMolecules & PubChem
Pharmacokinetic data
Bioavailability ?
Metabolism None
Half life 2-4 hours
Excretion Urine (90%)
Therapeutic considerations
Pregnancy cat.

B3(AU) C(US)

Legal status

Prescription Only (S4)(AU) ?(CA) POM(UK) [[Prescription drug|Template:Unicode-only]](US)

Routes oral or intravenous

Mechanism of Action

  • Acetazolamide is a potent carbonic anhydrase inhibitor, effective in the control of fluid secretion (e.g., some types of glaucoma), in the treatment of certain convulsive disorders (e.g., epilepsy) and in the promotion of diuresis in instances of abnormal fluid retention (e.g., cardiac edema).
  • Acetazolamide is not a mercurial diuretic. Rather, it is a nonbacteriostatic sulfonamide possessing a chemical structure and pharmacological activity distinctly different from the bacteriostatic sulfonamides.

Structure

  • Acetazolamide, an inhibitor of the enzyme carbonic anhydrase, is a white to faintly yellowish white crystalline, odorless powder, weakly acidic, very slightly soluble in water and slightly soluble in alcohol. The chemical name for acetazolamide is N-(5-Sulfamoyl-1,3,4-thiadiazol-2yl)-acetamide and has the following chemical structure:
This image is provided by the National Library of Medicine.
  • Acetazolamide is available for intravenous use, and is supplied as a sterile powder requiring reconstitution. Each vial contains acetazolamide sodium equivalent to 500 mg of acetazolamide. The bulk solution is adjusted to pH 9.6 using sodium hydroxide and, if necessary, hydrochloric acid prior to lyophilization.

Pharmacodynamics

  • Acetazolamide is an enzyme inhibitor that acts specifically on carbonic anhydrase, the enzyme that catalyzes the reversible reaction involving the hydration of carbon dioxide and the dehydration of carbonic acid. In the eye, this inhibitory action of acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in cases of glaucoma and even in certain nonglaucomatous conditions. Evidence seems to indicate that acetazolamide has utility as an adjuvant in the treatment of certain dysfunctions of the central nervous system (e.g., epilepsy).
  • Inhibition of carbonic anhydrase in this area appears to retard abnormal, paroxysmal, excessive discharge from central nervous system neurons. The diuretic effect of acetazolamide is due to its action in the kidney on the reversible reaction involving hydration of carbon dioxide and dehydration of carbonic acid.

Pharmacokinetics

  • The result is renal loss of HCO3 ion, which carries out sodium, water, and potassium. Alkalinization of the urine and promotion of diuresis are thus effected. Alteration in ammonia metabolism occurs due to increased reabsorption of ammonia by the renal tubules as a result of urinary alkalinization.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility
  • Long-term studies in animals to evaluate the carcinogenic potential of acetazolamide have not been conducted. In a bacterial mutagenicity assay, acetazolamide was not mutagenic when evaluated with and without metabolic activation. The drug had no effect on fertility when administered in the diet to male and female rats at a daily intake of up to 4 times the recommended human dose of 1000 mg in a 50 kg individual.

Clinical Studies

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

How Supplied

  • AcetaZOLAMIDE for Injection, USP (lyophilized) powder is supplied as follows:
This image is provided by the National Library of Medicine.
  • Use within 12 hours of reconstitution. Discard unused portion.
  • Sterile, Nonpyrogenic, Preservative-free.
  • The container closure is not made with natural rubber latex.

Storage

  • Store drug product at 20° to 25°C (68° to 77°F).
  • Store reconstituted solution in a refrigerator between 2° and 8°C (36° and 46°F).

Images

Drug Images

{{#ask: Page Name::Acetazolamide (injection) |?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

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

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

Patient Counseling Information

  • In patients with pulmonary obstruction or emphysema where alveolar ventilation may be impaired, acetazolamide which may precipitate or aggravate acidosis, should be used with caution.

Precautions with Alcohol

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

Brand Names

  • Acetazolamide[1]

Look-Alike Drug Names

There is limited information regarding Acetazolamide (injection) Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

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

  1. ↑ "ACETAZOLAMIDE- acetazolamide sodium injection, powder, lyophilized, for solution".
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