Carbachol: Difference between revisions

Carbachol
Clinical data
Trade names	Miostat
AHFS/Drugs.com	Monograph
Pregnancy; category	US: C (Risk not ruled out) ; ;
Routes of; administration	Oral-Tablet, Injectable-solution, Topical-eye drops
ATC code	N07AB01 (WHO) S01EB02 (WHO) Template:ATCvet;
Legal status
Legal status	In general: ℞ (Prescription only);
Pharmacokinetic data
Bioavailability	low
Metabolism	?
Elimination half-life	?
Excretion	?
Identifiers
	IUPAC name 2-[(Aminocarbonyl)oxy]-N,N,N-trimethylethanaminium chloride;
CAS Number	51-83-2 ;
PubChem CID	5831;
IUPHAR/BPS	298;
DrugBank	DB00411 ;
ChemSpider	5626 ;
UNII	8Y164V895Y;
KEGG	D00524 ;
ChEBI	CHEBI:3385 ;
ChEMBL	ChEMBL14 ;
E number	{{#property:P628}}
ECHA InfoCard	{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
Formula	C6H15ClN2O2
Molar mass	182.696 g/mol
3D model (JSmol)	Interactive image;
	SMILES [Cl-].O=C(OCC[N+](C)(C)C)N;
	InChI InChI=1S/C6H14N2O2.ClH/c1-8(2,3)4-5-10-6(7)9;/h4-5H2,1-3H3,(H-,7,9);1H ; Key:AIXAANGOTKPUOY-UHFFFAOYSA-N ;
(verify)

Carbachol
	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

VisualWikitext

Revision as of 19:48, 21 January 2015

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

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Overview

Carbachol is a cholinergic drug that is FDA approved for the {{{indicationType}}} of glaucoma, ocular hypertension, miosis induction. Common adverse reactions include corneal clouding, bullous keratopathy, retinal detachment, postoperative iritis, flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Intraocular use for obtaining miosis during surgery. In addition, MIOSTAT (carbachol intraocular solution, USP) reduces the intensity of intraocular pressure elevation in the first 24 hours after cataract surgery.

Dosage

Glaucoma: 2 drops 0.75-3% solution in affected eye(s) up to 3 times daily
Miosis induction - Surgical procedure: 0.5 mL of 0.01% solution INTRAOCULARLY, instilled into anterior chamber of the eye before or after securing sutures
Ocular hypertension, Postsurgical: INTRACAMERAL injection of 0.5 mL of 0.01% solution upon completion of cataract surgery

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

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

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

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

Non–Guideline-Supported Use

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

Contraindications

Should not be used in those persons showing hypersensitivity to any of the components of this preparation.

Warnings

For single-dose intraocular use only. Discard unused portion. Intraocular carbachol 0.01% should be used with caution in patients with acute cardiac failure, bronchial asthma, peptic ulcer, hyperthyroidism, G.I. spasm, urinary tract obstruction and Parkinson's disease.

Adverse Reactions

Clinical Trials Experience

Ocular: Corneal clouding, persistent bullous keratopathy, retinal detachment and postoperative iritis following cataract extraction have been reported.

Systemic: Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, and headache have been reported with topical or systemic application of carbachol.

Postmarketing Experience

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

Drug Interactions

There is limited information regarding Carbachol Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. MIOSTAT® (carbachol intraocular solution, USP) should be used during 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 Carbachol in women who are pregnant.

Labor and Delivery

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

Nursing Mothers

It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman.

Pediatric Use

Safety and efficacy in pediatric patients have not been established.

Geriatic Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients.

Gender

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

Race

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

Renal Impairment

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

Hepatic Impairment

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

Females of Reproductive Potential and Males

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

Immunocompromised Patients

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

Administration and Monitoring

Administration

Oral

Monitoring

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

IV Compatibility

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

Overdosage

There is limited information regarding Carbachol overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

Mechanism of Action

The exact mechanism by which carbachol lowers intraocular pressure is not precisely known.

Structure

MIOSTAT® (carbachol intraocular solution, USP) is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the chemical structure:

This image is provided by the National Library of Medicine.

Established name:

Carbachol

Chemical name:

Ethanaminium, 2-[(aminocarbonyl)oxy]-N,N,Ntrimethyl-, chloride.

Molecular Formula: C6H15CIN2O2

Molecular Weight: 182.65

Each mL contains: Active: carbachol 0.01%.

Inactives: sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride dehydrate 0.048%, magnesium chloride hexahydrate 0.03%, sodium acetate trihydrate 0.39%, sodium citrate dihydrate 0.17%, sodium hydroxide and/or hydrochloric acid (to adjust pH) and Water for Injection. pH range is 6.5-7.5.

Pharmacodynamics

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

Pharmacokinetics

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

Nonclinical Toxicology

Carcinogenesis

Studies in animals to evaluate the carcinogenic potential have not been conducted.

Clinical Studies

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

How Supplied

In a 2.0 mL glass vial with a 1.5 mL fill, grey butyl stopper and aluminum seal packaged twelve to a carton.

NDC 0065-0023-15

Storage

STORAGE: Store at 15° - 30°C (59° - 86°F).

Images

Drug Images

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

Patient Counseling Information

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

Precautions with Alcohol

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

Brand Names

MIOSTAT

Look-Alike Drug Names

There is limited information regarding Carbachol 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.

{{#subobject:

 |Page Name=Carbachol
 |Pill Name=No image.jpg
 |Drug Name=
 |Pill Ingred=|+sep=;
 |Pill Imprint=
 |Pill Dosage={{{dosageValue}}} {{{dosageUnit}}}
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 |Pill Shape=
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 |NDC=

}}

{{#subobject:

 |Label Page=Carbachol
 |Label Name=Miostat.jpg

}}

{{#subobject:

 |Label Page=Carbachol
 |Label Name=Miostat ingredients and appearance.png

}}

@@ Line 4: / Line 4: @@
 |aOrAn=a
 |drugClass=cholinergic drug
-|indication=[[glaucoma]], Ocular [[hypertension]], [[miosis]] induction
+|indication=[[glaucoma]], ocular [[hypertension]], [[miosis]] induction
 |adverseReactions=corneal clouding, bullous keratopathy, [[retinal detachment]], postoperative iritis, flushing, sweating, [[epigastric distress]], abdominal cramps, tightness in urinary bladder, [[headache]]
 |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
@@ Line 21: / Line 21: @@
 * Glaucoma: 2 drops 0.75-3% solution in affected eye(s) up to 3 times daily
 * Miosis induction - Surgical procedure: 0.5 mL of 0.01% solution INTRAOCULARLY, instilled into anterior chamber of the eye before or after securing sutures
-Ocular hypertension, Postsurgical: INTRACAMERAL injection of 0.5 mL of 0.01% solution upon completion of cataract surgery
+* Ocular hypertension, Postsurgical: INTRACAMERAL injection of 0.5 mL of 0.01% solution upon completion of cataract surgery
 |offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label 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.
@@ Line 33: / Line 33: @@
 '''Systemic''': Side effects such as flushing, sweating, epigastric distress, abdominal cramps, tightness in urinary bladder, and [[headache]] have been reported with topical or systemic application of carbachol.
 |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
+|useInPregnancyFDA='''Pregnancy'''
+Category C. There are no adequate and well-controlled studies in pregnant women. MIOSTAT® (carbachol intraocular solution, USP) should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
 |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.
+|useInNursing=* It is not known if this medication is excreted in breast milk. Exercise caution when administering to a nursing woman.
 |useInPed=* Safety and efficacy in pediatric patients have not been established.
 |useInGeri=* No overall differences in safety or effectiveness have been observed between elderly and younger patients.
@@ Line 49: / Line 51: @@
 |monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
 |IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
+|drugBox={{Drugbox
+| Watchedfields = changed
+| verifiedrevid = 457629915
+| IUPAC_name = 2-[(Aminocarbonyl)oxy]-''N'',''N'',''N''-trimethylethanaminium chloride
+| image = Carbachol chloride.png
+<!--Clinical data-->
+| tradename = Miostat
+| Drugs.com = {{drugs.com|monograph|carbachol}}
+| pregnancy_US = C
+| legal_status = Rx-only
+| routes_of_administration = Oral-Tablet, {{nowrap|Injectable-solution}}, {{nowrap|Topical-eye drops}}
+<!--Pharmacokinetic data-->
+| bioavailability = low
+| metabolism = ?
+| elimination_half-life = ?
+| excretion = ?
+<!--Identifiers-->
+| CASNo_Ref = {{cascite|correct|CAS}}
+| CAS_number_Ref = {{cascite|correct|??}}
+| CAS_number = 51-83-2
+| ATC_prefix = N07
+| ATC_suffix = AB01
+| ATC_supplemental = {{ATC|S01|EB02}} {{ATCvet|A03|AB92}}
+| PubChem = 5831
+| IUPHAR_ligand = 298
+| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
+ | DrugBank = DB00411
+| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
+| ChemSpiderID = 5626
+| UNII_Ref = {{fdacite|correct|FDA}}
+| UNII = 8Y164V895Y
+| KEGG_Ref = {{keggcite|correct|kegg}}
+| KEGG = D00524
+| ChEBI_Ref = {{ebicite|correct|EBI}}
+| ChEBI = 3385
+| ChEMBL_Ref = {{ebicite|correct|EBI}}
+| ChEMBL = 14
+<!--Chemical data-->
+ | C=6 | H=15 | N=2 | O=2 | Cl = 1
+| molecular_weight = 182.696 g/mol
+| smiles = [Cl-].O=C(OCC[N+](C)(C)C)N
+| InChI = 1/C6H14N2O2.ClH/c1-8(2,3)4-5-10-6(7)9;/h4-5H2,1-3H3,(H-,7,9);1H
+| InChIKey = AIXAANGOTKPUOY-UHFFFAOYAV
+| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
+| StdInChI = 1S/C6H14N2O2.ClH/c1-8(2,3)4-5-10-6(7)9;/h4-5H2,1-3H3,(H-,7,9);1H
+| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
+| StdInChIKey = AIXAANGOTKPUOY-UHFFFAOYSA-N
+}}
 |mechAction=* The exact mechanism by which carbachol lowers [[intraocular pressure]] is not precisely known.
 |structure=* MIOSTAT® (carbachol intraocular solution, USP) is a sterile balanced salt solution of carbachol for intraocular injection. The active ingredient is represented by the chemical structure:
@@ Line 71: / Line 125: @@
 |PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
 |PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
-|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
+|nonClinToxic='''Carcinogenesis'''
+* Studies in animals to evaluate the carcinogenic potential have not been conducted.
 |clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
 |howSupplied=* In a 2.0 mL glass vial with a 1.5 mL fill, grey butyl stopper and aluminum seal packaged twelve to a carton.

Carbachol: Difference between revisions

Revision as of 19:48, 21 January 2015

Disclaimer

Overview

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Non–Guideline-Supported Use

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Non–Guideline-Supported Use

Contraindications

Warnings

Adverse Reactions

Clinical Trials Experience

Postmarketing Experience

Drug Interactions

Use in Specific Populations

Pregnancy

Labor and Delivery

Nursing Mothers

Pediatric Use

Geriatic Use

Gender

Race

Renal Impairment

Hepatic Impairment

Females of Reproductive Potential and Males

Immunocompromised Patients

Administration and Monitoring

Administration

Monitoring

IV Compatibility

Overdosage

Pharmacology

Mechanism of Action

Structure

Pharmacodynamics

Pharmacokinetics

Nonclinical Toxicology

Clinical Studies

How Supplied

Storage

Images

Drug Images

Package and Label Display Panel

Patient Counseling Information

Precautions with Alcohol

Brand Names

Look-Alike Drug Names

Drug Shortage Status

Price

References

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