Baclofen injection is available as a preservative-free injection for intrathecal use only at a concentration of 0.5 mg/mL in 20-mL ampuls, vials, and prefilled syringes; at a concentration of 1 mg/mL in 20-mL vials and prefilled syringes; and at a concentration of 2 mg/mL in 5-mL ampuls and 20-mL ampuls, vials, and prefilled syringes.2899; 2900 Each mL of solution contains baclofen 0.5, 1, or 2 mg (500, 1000, or 2000 mcg, respectively) with sodium chloride 9 mg in water for injection.2899; 2900
Baclofen injection is also available as a preservative-free injection for intrathecal use only at a concentration of 0.05 mg/mL in 1-mL ampuls and prefilled syringes for use in screening.2899; 2900 Each mL of solution contains baclofen 0.05 mg (50 mcg) with sodium chloride 9 mg in water for injection.2899; 2900
pH
Gablofen: from 5.5 to 7.5.2900 Lioresal Intrathecal: from 5 to 7.2899
Tonicity
Baclofen injection is an isotonic solution.2899; 2900
Trade Name(s)
Gablofen, Lioresal Intrathecal
For screening, 1-mL ampuls or prefilled syringes containing 50 mcg/mL of baclofen are used in the delivery of the drug by direct intrathecal injection via lumbar puncture or spinal catheter over at least one minute using barbotage.2899; 2900
For maintenance treatment, baclofen injection is administered intrathecally by chronic, continuous infusion through an implantable infusion pump.2899; 2900 Baclofen injection (Gablofen) is intended for use only with the Medtronic SynchroMed II Programmable pump or other pumps labeled for intrathecal administration of Gablofen;2900 baclofen injection (Lioresal Intrathecal) is intended for use only in implantable pumps specifically labeled for the administration of Lioresal Intrathecal.2899 The concentration of the solution to be infused is dependent upon the rate of infusion and the total daily dosage, which is titrated according to the patient's response.2899; 2900 For concentrations other than those that are commercially available, the drug must be diluted only with sterile, preservative-free sodium chloride.2899; 2900 The drug may also require dilution in sterile, preservative-free sodium chloride when used with certain implantable infusion pumps;2899 the pump manufacturer's manual should be consulted for specific details.2899
The pump manufacturer's instructions for programming of the pump and filling and refilling of the pump reservoir should be followed.2899; 2900
Baclofen injection should be stored at temperatures not exceeding 30°C and protected from freezing.2899; 2900 The product is intended for use in implantable infusion pumps and is stable at a temperature of 37°C.2899; 2900 It should not be heat sterilized.2899; 2900 Each ampul, vial, or prefilled syringe contains no preservatives and is intended for single-use only; unused portions must be discarded.2899; 2900
If necessary, baclofen injection must be diluted only with sterile, preservative-free sodium chloride.2899; 2900 The drug is also compatible with cerebrospinal fluid.2899; 2900
Implantable Pumps
Baclofen 0.5 mg/mL was filled into an implantable pump (Fresenius model VIP 30) and associated capillary tubing and stored at 37°C. No baclofen loss and no contamination from components of pump materials occurred during eight weeks of storage.1903
For a list of references cited in the text of this monograph, search the monograph titled References.