Articaine: Difference between revisions
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{{DrugProjectFormSinglePage | {{DrugProjectFormSinglePage | ||
|authorTag= | |authorTag={{RB}} | ||
|genericName=Articaine hydrochloride and epinephrine | |||
|aOrAn=a | |aOrAn=a | ||
| | |drugClass=amide local anesthetic | ||
|adverseReactions=<!--Black Box Warning--> | |indicationType=procedure | ||
|indication=local, infiltrative, or conductive anesthesia in both simple and complex dental procedures | |||
|adverseReactions=headache and pain | |||
<!--Black Box Warning--> | |||
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | |blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span> | ||
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | |blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i> | ||
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<!--FDA-Labeled Indications and Dosage (Adult)--> | <!--FDA-Labeled Indications and Dosage (Adult)--> | ||
|fdaLIADAdult===== | |fdaLIADAdult=====Indications==== | ||
* Articadent, an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. | |||
====General Dosing Information==== | |||
* Table 1 (below) summarizes the recommended volumes and concentrations of Articadent for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block. | |||
: | : [[File:Articaine Dosage.png|none|500px]] | ||
The recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given. | |||
The onset of anesthesia, and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes because the incidence of side effects may be dose-related. | |||
: | For most routine dental procedures, Articadent containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Articadent containing epinephrine 1:100,000 may be used. | ||
2.2 Maximum Recommended Dosages | |||
Adults: For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg (0.175 mL/kg). | |||
Pediatric Patients Ages 4 to 16 Years: The quantity of articaine HCl in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of articaine HCl should not exceed 7 mg/kg (0.175 mL/kg) [see USE IN SPECIFIC POPULATIONS (8.4)]. | |||
Safety and effectiveness of Articadent in pediatric patients below the age of 4 years have not been established. | |||
2.3 Dosing in Special Populations | |||
Dose reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver dysfunction. Caution should be used in patients with severe liver disease | |||
====DOSAGE FORMS AND STRENGTHS==== | |||
Injection (clear colorless solution) containing: | |||
: | Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000 (as epinephrine bitartrate 0.009 mg/mL) | ||
Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL) | |||
|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= | |offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients. | ||
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= | |fdaLIADPed=There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients. | ||
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= | |offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
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= | |offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | ||
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients. | |||
<!--Contraindications--> | <!--Contraindications--> |
Revision as of 17:25, 30 January 2015
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]
Disclaimer
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Overview
Articaine is a amide local anesthetic that is FDA approved for the procedure of local, infiltrative, or conductive anesthesia in both simple and complex dental procedures. Common adverse reactions include headache and pain.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
- Articadent, an amide local anesthetic containing a vasoconstrictor, is indicated for local, infiltrative, or conductive anesthesia in both simple and complex dental procedures.
General Dosing Information
- Table 1 (below) summarizes the recommended volumes and concentrations of Articadent for various types of anesthetic procedures. The dosages suggested in this table are for normal healthy adults, administered by submucosal infiltration or nerve block.
The recommended doses serve only as a guide to the amount of anesthetic required for most routine procedures. The actual volumes to be used depend on a number of factors such as type and extent of surgical procedure, depth of anesthesia, degree of muscular relaxation, and condition of the patient. In all cases, the smallest dose that will produce the desired result should be given.
The onset of anesthesia, and the duration of anesthesia are proportional to the volume and concentration (i.e., total dose) of local anesthetic used. Caution should be exercised when employing large volumes because the incidence of side effects may be dose-related.
For most routine dental procedures, Articadent containing epinephrine 1:200,000 is preferred. However, when more pronounced hemostasis or improved visualization of the surgical field are required, Articadent containing epinephrine 1:100,000 may be used.
2.2 Maximum Recommended Dosages Adults: For normal healthy adults, the maximum dose of articaine HCl administered by submucosal infiltration and/or nerve block should not exceed 7 mg/kg (0.175 mL/kg). Pediatric Patients Ages 4 to 16 Years: The quantity of articaine HCl in children ages 4 to 16 years of age to be injected should be determined by the age and weight of the child and the magnitude of the operation. The maximum dose of articaine HCl should not exceed 7 mg/kg (0.175 mL/kg) [see USE IN SPECIFIC POPULATIONS (8.4)]. Safety and effectiveness of Articadent in pediatric patients below the age of 4 years have not been established. 2.3 Dosing in Special Populations Dose reduction may be required in debilitated patients, acutely ill patients, elderly patients, and pediatric patients commensurate with their age and physical condition. No studies have been performed in patients with renal or liver dysfunction. Caution should be used in patients with severe liver disease
DOSAGE FORMS AND STRENGTHS
Injection (clear colorless solution) containing:
Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:200,000 (as epinephrine bitartrate 0.009 mg/mL) Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000 (as epinephrine bitartrate 0.018 mg/mL)
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Articaine in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Articaine in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding FDA-Labeled Use of Articaine in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Articaine in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Articaine in pediatric patients.
Contraindications
- Condition1
Warnings
- Description
Precautions
- Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Articaine 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 Articaine 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
- Australian Drug Evaluation Committee (ADEC) Pregnancy Category
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Articaine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Articaine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Articaine with respect to nursing mothers.
Pediatric Use
There is no FDA guidance on the use of Articaine with respect to pediatric patients.
Geriatic Use
There is no FDA guidance on the use of Articaine with respect to geriatric patients.
Gender
There is no FDA guidance on the use of Articaine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Articaine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Articaine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Articaine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Articaine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Articaine in patients who are immunocompromised.
Administration and Monitoring
Administration
- Oral
- Intravenous
Monitoring
There is limited information regarding Monitoring of Articaine in the drug label.
- Description
IV Compatibility
There is limited information regarding IV Compatibility of Articaine in the drug label.
Overdosage
Acute Overdose
Signs and Symptoms
- Description
Management
- Description
Chronic Overdose
There is limited information regarding Chronic Overdose of Articaine in the drug label.
Pharmacology
There is limited information regarding Articaine Pharmacology in the drug label.
Mechanism of Action
Structure
Pharmacodynamics
There is limited information regarding Pharmacodynamics of Articaine in the drug label.
Pharmacokinetics
There is limited information regarding Pharmacokinetics of Articaine in the drug label.
Nonclinical Toxicology
There is limited information regarding Nonclinical Toxicology of Articaine in the drug label.
Clinical Studies
There is limited information regarding Clinical Studies of Articaine in the drug label.
How Supplied
Storage
There is limited information regarding Articaine Storage in the drug label.
Images
Drug Images
{{#ask: Page Name::Articaine |?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::Articaine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}
Patient Counseling Information
There is limited information regarding Patient Counseling Information of Articaine in the drug label.
Precautions with Alcohol
- Alcohol-Articaine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
- ®[1]
Look-Alike Drug Names
- A® — B®[2]
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Empty citation (help)
- ↑ "http://www.ismp.org". External link in
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