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BACLOFEN is a brand name for Baclofen, supplied as a solution. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Baclofen Injection USP (baclofen injection) is indicated for: • The management of patients with severe spasticity due to spinal cord injury or multiple sclerosis who are unresponsive to oral baclofen or who experience unacceptable side effects at effective oral doses. Baclofen Injection USP therapy may be considered…
Verbatim from this product's HC label. Tap a section to expand.
1 Dosing Considerations • Baclofen Injection USP should not be administered by intravenous, intramuscular, subcutaneous or epidural routes. • Establishment of the optimum dose schedule requires that each patient undergoes an initial screening phase with intrathecal bolus, followed by a very careful individual dose titration prior to maintenance therapy.
This is due to the great variability in the effective individual therapeutic dose. • The first dose should be performed with resuscitative equipment on standby in case of life-threatening or intolerable adverse reactions. • Patients must be monitored closely in a fully equipped and staffed environment during the screening phase and dose titration period immediately following implant.
Implantation of pumps should only be performed in experienced centres in order to minimize the risks in the perioperative phase. 2 Recommended Dose and Dosage Adjustment Screening Phase: Prior to initiation of chronic infusion of intrathecal baclofen, patients must demonstrate a response to intrathecal baclofen bolus in a screening trial.
A test bolus dose of Baclofen Injection USP is usually administered via a lumbar puncture or an intrathecal catheter to elicit a response. The usual initial test dose is 25 microgram (mcg) or 50 mcg and is stepped up by 25 mcg increments at least 24 hours apart, until an approximately 4- to 8-hour response is observed; the dose should be given by barbotage over at least one minute.
If an adverse reaction occurs Page 6 of 38Baclofen Injection USP (Baclofen Injection) at a dose of 25 mcg, a lower dose, such as 10 mcg may be tested. Patients should demonstrate a positive clinical response in order to be considered responders to treatment.
A positive clinical response is characterized by a significant decrease in muscle tone and / or frequency and / or severity of spasms. There is great variability in sensitivity to intrathecal baclofen. Patients who do not respond to a 100 mcg test dose should not be given further increases of dose or be considered for continuous intrathecal infusion.
However, in rare instances some patients, particularly those with spasticity of cerebral origin, have received higher test bolus doses.
Note:
Baclofen Injection USP manufactured by JAMP Pharma Corporation is only available in 2 mg / mL ampoules. 05 mg / mL ampoules should be used for the screening phase. 4 Administration, Drug Delivery Devices). To determine the initial total daily dose of Baclofen Injection USP following implant, the screening dose which gave a positive effect should be doubled and administered over a 24- hour period, unless the efficacy of the bolus dose was maintained for more than 12 hours.
). Patients should be cautioned regarding the operation of automobiles or dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of baclofen may be additive to those of alcohol and other CNS depressants.
Gastrointestinal Interaction of intrathecal baclofen with underlying, non-CNS related diseases is unlikely because the systemic availability of the drug after intrathecal administration is substantially lower than after oral administration.
2 Recommended Dose and Dosage Adjustment, Hepatic Impairment). Hepatic/Biliary/Pancreatic In rare instances, elevated glutamic-oxaloacetic transaminase (SGOT), alkaline phosphatase and glucose levels in the serum have been recorded when using oral baclofen.
Musculoskeletal Scoliosis:
The onset of scoliosis or worsening of a pre-existing scoliosis has been reported in patients treated with baclofen injection. Signs of scoliosis should be monitored during treatment with Baclofen Injection USP. Neurologic In patients with abnormal CSF flow, the spread of the drug and therefore, the distribution of antispastic activity may be inadequate.
Patients suffering from cerebrovascular insufficiency or Parkinson's disease should be treated cautiously with Baclofen Injection USP and kept under careful surveillance as exacerbations of these conditions have been observed with oral baclofen administration.
Special attention should be given to patients known to suffer from epilepsy as seizures Page 15 of 38Baclofen Injection USP (Baclofen Injection) have been reported during overdose with, and withdrawal from, baclofen injection, as well as in patients maintained on therapeutic doses of baclofen injection.
Baclofen Injection USP should be used with caution in patients with a history of autonomic dysreflexia. The presence of nociceptive stimuli or abrupt withdrawal of Baclofen Injection USP may cause an autonomic dysreflexic episode. Since unwanted effects are more likely to occur in elderly patients or in patients with spastic states of cerebral origin, it is recommended that a very cautious dosage schedule be adopted in such cases and that the patient should be kept under appropriate surveillance.
16 8 ADVERSE REACTIONS................................................................................................. 19 9 DRUG INTERACTIONS ................................................................................................
4 Drug-Drug Interactions ......................................................................................... 5 Drug-Food Interactions ......................................................................................... 6 Drug-Herb Interactions .........................................................................................
7 Drug-Laboratory Test Interactions ........................................................................ 21 10 CLINICAL PHARMACOLOGY ........................................................................................ 1 Mechanism of Action ......................................................................................
2 Pharmacodynamics ......................................................................................... 3 Pharmacokinetics ............................................................................................ 23 11 STORAGE, STABILITY AND DISPOSAL .........................................................................
24 12 SPECIAL HANDLING INSTRUCTIONS ........................................................................... 24 PART II: SCIENTIFIC INFORMATION .......................................................................................
26 13 PHARMACEUTICAL INFORMATION ............................................................................ 26 14 CLINICAL TRIALS ........................................................................................................
1 Clinical Trials by Indication .............................................................................. 27 15 MICROBIOLOGY .........................................................................................................
Baclofen Injection USP (baclofen injection) is contraindicated in patients with: • Known or suspected hypersensitivity to baclofen or to any of the excipients. (see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). Baclofen Injection USP should not be administered by intravenous, intramuscular, subcutaneous or epidural routes.
Page 5 of 38Baclofen Injection USP (Baclofen Injection)
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In this case, the starting daily dose should be the screening dose delivered over a 24-hour period. No dose increases should be administered in the first 24 hours. After the first 24 hours, the dosage should be adjusted slowly on a daily basis to achieve the desired effect, with dosage increments limited to 10 to 30% to avoid possible overdosing.
With programmable pumps, the dose should be increased only once every 24 hours. For non- programmable pumps with a 76 cm catheter delivering 1 mL / day, intervals of 48 hours are suggested for evaluation of response. If the daily dose has been significantly increased and no clinical effect is achieved, check for proper pump function and catheter patency.
The clinical goal is to maintain as normal a muscle tone as possible, and to minimize the frequency and severity of spasms without inducing intolerable side effects. There is limited experience with doses greater than 1000 mcg / day.
Maintenance Therapy:
The lowest dose producing an adequate response should be used. Most patients require gradual increases in dose over time to maintain optimum response during chronic therapy due to decreased responsiveness to therapy or due to disease progression.
The daily dose may be gradually increased by 10 to 30% to maintain adequate symptom Page 7 of 38Baclofen Injection USP (Baclofen Injection) control by adjusting the dosing rate of the pump and / or the concentration of Baclofen Injection USP in the reservoir.
The daily dose may also be reduced by 10 to 20% if patients experience side effects. , catheter kink or dislodgement) or pump malfunction. Maintenance dosage for long-term continuous infusion of intrathecal baclofen ranges from 10 mcg / day to 1200 mcg / day, most patients being adequately maintained on 300 mcg / day to 800 mcg / day.
The specific concentration that should be used depends on the total daily dose required as well as the delivery rate of the pump. Please consult pump manufacturer's manual for specific recommendations. During long-term treatment approximately 10% of patients become refractory to increasing doses.
g. intrathecal preservative-free morphine sulfate). After a few days the sensitivity to baclofen may be restored and treatment should be resumed at the initial continuous infusion dose and followed by a titration phase to avoid overdose accidents.
This must be performed in a hospital unit. 4 Drug–Drug Interactions). Regular clinical review remains a necessity throughout to assess dosage requirements, functioning of the delivery system, and monitoring for possible adverse drug reactions or evidence of infection.
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Patients should be monitored for signs of overdose, central nervous system depression and toxic encephalopathy such as drowsiness, impairment of consciousness, coma, respiratory depression, hallucinations, agitation, and convulsions.
Psychiatric Patients suffering from psychotic disorders, schizophrenia, or confusional states should be treated cautiously with Baclofen Injection USP and kept under careful surveillance as exacerbations of these conditions have been observed with oral baclofen administration.
Close supervision of patients should accompany therapy with Baclofen Injection USP. Patients (and caregivers of patients) should be alerted about the need to monitor for clinical worsening, suicidal behaviour or thoughts or unusual changes in behaviour and to seek medical advice immediately if these symptoms present.
Suicide and suicide-related events have been reported in patients treated with intrathecal baclofen (see 8 ADVERSE REACTIONS). Respiratory Baclofen Injection USP should be used with caution in patients with respiratory insufficiency, as these conditions may be exacerbated by baclofen.
Renal No studies have been performed in patients with renal impairment receiving baclofen injection therapy. g. somnolence, depressed level of consciousness and coma) have been reported in patients with renal impairment. Caution should be exercised while administering Baclofen Injection USP in patients with renal impairment because baclofen is primarily excreted unchanged through the kidneys.
Baclofen Injection USP should only be administered to end-stage renal failure patients when benefit outweighs risk. Patients with severe renal impairment should be treated with extra caution, as they are in general more sensitive to therapeutic effects / adverse effects of drugs.
Severely renal impaired patients should be closely monitored for prompt diagnosis of early signs and / or symptoms of toxicity (see 5 OVERDOSAGE). 1 Pregnant Women There are no adequate and well-controlled studies of baclofen injection in pregnant women.
Baclofen injection has been detected in maternal plasma and is known to cross the placental barrier (see 16 NON-CLINICAL TOXICOLOGY). Post-marketing reports on mothers who used baclofen injection during pregnancy suggest a higher than expected rate of preterm delivery and delivery by caesarian section.
Further, these preterm births have resulted in low birth weights according to what would be expected for gestational age. Therefore, Baclofen Injection USP should not be used during pregnancy unless the potential benefits to the mother outweigh the potential risks to the fetus.
Infants exposed to baclofen through maternal oral dosing during pregnancy are at risk of experiencing baclofen withdrawal at birth; identification of this condition may be confounded due to delayed appearance of withdrawal symptoms in this population.
(See 7 WARNINGS AND PRECAUTIONS, General and 16 NON-CLINICAL TOXICOLOGY, Reproductive and Developmental Toxicology). 2 Breastfeeding Oral baclofen at therapeutic doses passes into breast milk. Baclofen Injection USP should not be used in nursing women unless the potential the benefits outweigh the risks.
4 Geriatrics Several patients over the […]
27 16 NON-CLINICAL TOXICOLOGY ...................................................................................... 29 PATIENT MEDICATION INFORMATION ..................................................................................
30 Page 4 of 38Baclofen Injection USP (Baclofen Injection) PART I: HEALTH PROFESSIONAL INFORMATION 1 INDICATIONS Baclofen Injection USP (baclofen injection) is indicated for: • The management of patients with severe spasticity due to spinal cord injury or multiple sclerosis who are unresponsive to oral baclofen or who experience unacceptable side effects at effective oral doses.
Baclofen Injection USP therapy may be considered as an alternative to destructive neurosurgical procedures. 2 Recommended Dose and Dosage Adjustment Screening Phase). g. spasticity following hypoxic encephalopathy, head injury, or stroke; however, clinical experience is limited.
1 Pediatrics Pediatrics (< 18 years of age): The safety and efficacy of baclofen injection have not been studied in patients under 18 years of age. Its use in pediatric patients is not recommended unless the benefits outweigh the risk.
2 Geriatrics Geriatrics (> 65 years of age): Elderly patients may be more susceptible to the side effects of oral baclofen in the titration stage and this may also apply to intrathecal baclofen. 2 CONTRAINDICATIONS Baclofen Injection USP (baclofen injection) is contraindicated in patients with: • Known or suspected hypersensitivity to baclofen or to any of the excipients.
(see 6 DOSAGE FORMS, STRENGTHS, COMPOSITION AND PACKAGING). Baclofen Injection USP should not be administered by intravenous, intramuscular, subcutaneous or epidural routes. Page 5 of 38Baclofen Injection USP (Baclofen Injection) 3 SERIOUS WARNINGS AND PRECAUTIONS BOX Abrupt discontinuation of Baclofen Injection USP, regardless of the cause, has resulted in sequelae that include high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity, that in rare cases has advanced to rhabdomyolysis, multiple organ-system failure and death.
Prevention of abrupt discontinuation of Baclofen Injection USP requires careful attention to proper programming and monitoring of the infusion system, refill scheduling and procedures, and pump alarms. Patients and caregivers should be advised of the importance of keeping scheduled refill visits and should be educated on the early […]