- Approval Id
- 47e31b4211617d75
- Drug Name
- PRECEDEX™ IN 0.9% SODIUM CHLORIDE INJECTION 4MCG/ML
- Product Name
- PRECEDEX™ IN 0.9% SODIUM CHLORIDE INJECTION 4MCG/ML
- Approval Number
- SIN15689P
- Approval Date
- 2019-05-23
- Registrant
- PFIZER PRIVATE LIMITED
- Licence Holder
- PFIZER PRIVATE LIMITED
- Drug Type
- Therapeutic
- Forensic Classification
- Prescription Only
- Dosage Form
- INFUSION, SOLUTION
- Dosage
- **2 DOSAGE AND ADMINISTRATION**
**2.1 Dosing Guidelines**
- PRECEDEX dosing should be individualized and titrated to desired clinical response.
- PRECEDEX is not indicated for infusions lasting longer than 24 hours.
- PRECEDEX should be administered using a controlled infusion device.
**2.2 Dosage Information**
**2.3 Dosage Adjustment**
Due to possible pharmacodynamic interactions, a reduction in dosage of PRECEDEX or other concomitant anesthetics, sedatives, hypnotics or opioids may be required when co-administered \[ _see Drug Interactions (7.1)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].
Dosage reductions may need to be considered for **adult** patients with hepatic impairment, and geriatric patients \[ _see Warnings and Precautions (5.8), Use in Specific Populations (8.5), Clinical Pharmacology (12.3)_ – _please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information_\].
**2.4 Preparation of Solution**
Strict aseptic technique must always be maintained during handling of PRECEDEX.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if product is discolored or if precipitate matter is present.
PRECEDEX in 0.9% Sodium Chloride Injection, 200 mcg/50 mL (4 mcg/mL)
PRECEDEX in 0.9% Sodium Chloride Injection is supplied in glass containers containing a premixed, ready to use dexmedetomidine hydrochloride solution in 0.9% sodium chloride in water. No further dilution of these preparations are necessary.
**2.5 Administration with Other Fluids**
PRECEDEX infusion should not be co-administered through the same intravenous catheter with blood or plasma because physical compatibility has not been established.
PRECEDEX has been shown to be incompatible when administered with the following drugs: amphotericin B, diazepam.
PRECEDEX 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 solution
**2.6 Compatibility with Natural Rubber**
Compatibility studies have demonstrated the potential for absorption of PRECEDEX to some types of natural rubber. Although PRECEDEX is dosed to effect, it is advisable to use administration components made with synthetic or coated natural rubber gaskets.
- Route Of Administration
- INTRAVENOUS
- Indication Info
- **1 INDICATIONS AND USAGE**
**1.1 Intensive Care Unit Sedation**
PRECEDEX is indicated for sedation of initially intubated and mechanically ventilated patients during treatment in an intensive care setting. PRECEDEX should be administered by continuous infusion not to exceed 24 hours.
PRECEDEX has been continuously infused in mechanically ventilated patients prior to extubation, during extubation, and post-extubation. It is not necessary to discontinue PRECEDEX prior to extubation.
**1.2 Procedural Sedation**
PRECEDEX is indicated for sedation of non-intubated patients prior to and/or during surgical and other procedures.
- Contraindications
- **4 CONTRAINDICATIONS**
Hypersensitivity to PRECEDEX or any of the excipients.
- Atc Code
- N05CM18
- Atc Item Name
- dexmedetomidine
- Pharma Manufacturer Name
- PFIZER PRIVATE LIMITED
- Company Detail Path
- /organization/pfizer-private-limited
