Sun Pharmaceuticals Industries Inc.
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Sun Pharmaceuticals Industries Inc. Drugs
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Excedrin Extra Strength Geltabs
2.1 Dosing Guidelines
Dexmedetomidine hydrochloride injection dosing should be individualized and titrated to desired clinical response. Dexmedetomidine hydrochloride injection is not indicated for infusions lasting longer than 24 hours. Dexmedetomidine hydrochloride injection should be administered using a controlled infusion device.2.2 Dosage Information
Table 1: Dosage Information
INDICATION DOSAGE AND ADMINISTRATION Initiation of Procedural Sedation For adult patients:a loading infusion of one mcg/kg over 10 minutes. For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable. For awake fiberoptic intubation in adult patients:a loading infusion of one mcg/kg over 10 minutes. For patients over 65 years of age:a loading infusion of 0.5 mcg/kg over 10 minutes [see Use in Specific Populations(8.5)]. For adult patients with impaired hepatic function:a dose reduction should be considered [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. Maintenance of Procedural Sedation For adult patients:the maintenance infusion is generally initiated at 0.6 mcg/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation. For awake fiberoptic intubation in adult patients:a maintenance infusion of 0.7 mcg/kg/hour is recommended until the endotracheal tube is secured. For patients over 65 years of age:a dose reduction should be considered [see Use in Specific Populations (8.5)]. For adult patients with impaired hepatic function:a dose reduction should be considered [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].2.3 Dosage Adjustment
Due to possible pharmacodynamic interactions, a reduction in dosage of Dexmedetomidine Hydrochloride Injection or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [see Drug Interactions (7.1)].
Dosage reductions may need to be considered for adult patients with hepatic impairment and geriatric patients [see Warnings and Precautions (5.7), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.4 Preparation of Solution
Strict aseptic technique must always be maintained during handling of dexmedetomidine hydrochloride injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dexmedetomidine Hydrochloride Injection, 200mcg/2mL (100mcg/mL) Dexmedetomidine hydrochloride injection must be diluted with 0.9% sodium chloride injection to achieve required concentration (4 mcg/mL) prior to administration.
Preparation of solutions is the same, whether for the loading dose or maintenance infusion.
To prepare the infusion, withdraw 2 mL of dexmedetomidine hydrochloride injection, and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.
2.5 Administration with Other Fluids
Dexmedetomidine hydrochloride injection infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.
Dexmedetomidine hydrochloride injection has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.
Dexmedetomidine hydrochloride injection has been shown to be compatible when administered with the following intravenous fluids:
0.9% sodium chloride in water 5% dextrose in water 20% mannitol Lactated Ringer’s solution 100 mg/mL magnesium sulfate solution 0.3% potassium chloride solution2.6 Compatibility with Natural Rubber
Compatibility studies have demonstrated the potential for absorption of dexmedetomidine hydrochloride injection to some types of natural rubber. Although dexmedetomidine hydrochloride injection is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.
2.1 Dosing Guidelines
Dexmedetomidine hydrochloride injection dosing should be individualized and titrated to desired clinical response. Dexmedetomidine hydrochloride injection is not indicated for infusions lasting longer than 24 hours. Dexmedetomidine hydrochloride injection should be administered using a controlled infusion device.2.2 Dosage Information
Table 1: Dosage Information
INDICATION DOSAGE AND ADMINISTRATION Initiation of Procedural Sedation For adult patients:a loading infusion of one mcg/kg over 10 minutes. For less invasive procedures such as ophthalmic surgery, a loading infusion of 0.5 mcg/kg given over 10 minutes may be suitable. For awake fiberoptic intubation in adult patients:a loading infusion of one mcg/kg over 10 minutes. For patients over 65 years of age:a loading infusion of 0.5 mcg/kg over 10 minutes [see Use in Specific Populations(8.5)]. For adult patients with impaired hepatic function:a dose reduction should be considered [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)]. Maintenance of Procedural Sedation For adult patients:the maintenance infusion is generally initiated at 0.6 mcg/kg/hour and titrated to achieve desired clinical effect with doses ranging from 0.2 to 1 mcg/kg/hour. The rate of the maintenance infusion should be adjusted to achieve the targeted level of sedation. For awake fiberoptic intubation in adult patients:a maintenance infusion of 0.7 mcg/kg/hour is recommended until the endotracheal tube is secured. For patients over 65 years of age:a dose reduction should be considered [see Use in Specific Populations (8.5)]. For adult patients with impaired hepatic function:a dose reduction should be considered [see Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].2.3 Dosage Adjustment
Due to possible pharmacodynamic interactions, a reduction in dosage of Dexmedetomidine Hydrochloride Injection or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered [see Drug Interactions (7.1)].
Dosage reductions may need to be considered for adult patients with hepatic impairment and geriatric patients [see Warnings and Precautions (5.7), Use in Specific Populations (8.6), Clinical Pharmacology (12.3)].
2.4 Preparation of Solution
Strict aseptic technique must always be maintained during handling of dexmedetomidine hydrochloride injection.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
Dexmedetomidine Hydrochloride Injection, 200mcg/2mL (100mcg/mL) Dexmedetomidine hydrochloride injection must be diluted with 0.9% sodium chloride injection to achieve required concentration (4 mcg/mL) prior to administration.
Preparation of solutions is the same, whether for the loading dose or maintenance infusion.
To prepare the infusion, withdraw 2 mL of dexmedetomidine hydrochloride injection, and add to 48 mL of 0.9% sodium chloride injection to a total of 50 mL. Shake gently to mix well.
2.5 Administration with Other Fluids
Dexmedetomidine hydrochloride injection infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.
Dexmedetomidine hydrochloride injection has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.
Dexmedetomidine hydrochloride injection has been shown to be compatible when administered with the following intravenous fluids:
0.9% sodium chloride in water 5% dextrose in water 20% mannitol Lactated Ringer’s solution 100 mg/mL magnesium sulfate solution 0.3% potassium chloride solution2.6 Compatibility with Natural Rubber
Compatibility studies have demonstrated the potential for absorption of dexmedetomidine hydrochloride injection to some types of natural rubber. Although dexmedetomidine hydrochloride injection is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.
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