MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Colazal® may be confused with Clozaril®
U.S. BRAND NAMES — Colazal®
PHARMACOLOGIC CATEGORY
5-Aminosalicylic Acid Derivative
Anti-inflammatory Agent
DOSING: ADULTS — Ulcerative colitis: Oral: 2.25 g (three 750 mg capsules) 3 times/day for 8-12 weeks
DOSING: PEDIATRIC — Ulcerative colitis: Oral: Children 5-17 years: 750 mg 3 times/day for up to 8 weeks or 2.25 g (three 750 mg capsules) 3 times/day for 8 weeks
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — No information available with balsalazide; renal toxicity has been observed with other 5-aminosalicylic acid products; use with caution.
DOSING: HEPATIC IMPAIRMENT — No specific dosage adjustment available.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, as disodium: 750 mg
Colazal®: 750 mg [contains sodium ~86 mg/capsule]
DOSAGE FORMS: CONCISE
Capsule: 750 mg
Colazal®: 750 mg
GENERIC EQUIVALENT AVAILABLE — Yes
ADMINISTRATION — Capsules should be swallowed whole or may be opened and sprinkled on applesauce. Applesauce mixture may be chewed; swallow immediately, do not store mixture for later use. When sprinkled on food, may cause staining of teeth or tongue.
USE — Treatment of mild-to-moderate active ulcerative colitis
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Headache (children 15%; adults 8%)
Gastrointestinal: Abdominal pain (children 12% to 13%; adults 6%)
1% to 10%:
Central nervous system: Insomnia (adults 2%), fatigue (children 4%; adults 2%), fever (children 6%; adults 2%)
Endocrine & metabolic: Dysmenorrhea (children 3%)
Gastrointestinal: Diarrhea (children 9%; adults 5%), ulcerative colitis exacerbation (children 6%; adults 1%), nausea (children 4%; adults 5%), vomiting (children 10%; adults 4%), hematochezia (children 4%), stomatitis (children 3%), anorexia (adults 2%), dyspepsia (adults 2%), flatulence (adults 2%), cramps (adults 1%), constipation (adults 1%), xerostomia (adults 1%)
Genitourinary: Urinary tract infection (adults 1%)
Neuromuscular & skeletal: Arthralgia (adults 4%), back pain (adults 2%), myalgia (adults 1%)
Respiratory: Respiratory infection (adults 4%), cough (children 3%; adults 2%), pharyngitis (children 6%; adults 2%), pharyngolaryngeal pain (children 3%), rhinitis (adults 2%)
Miscellaneous: Flu-like syndrome (children 4%; adults 1%)
<1% (Limited to important or life-threatening): Alopecia, cholestatic jaundice, cirrhosis, hepatocellular damage, hepatotoxicity, jaundice, hypersensitivity pericarditis, Kawasaki-like syndrome, liver failure, liver necrosis, liver function tests increased, myocarditis
CONTRAINDICATIONS — Hypersensitivity to balsalazide, metabolites to balsalazide, salicylates, or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Colitis: May exacerbate symptoms of ulcerative colitis.
Disease-related concerns: Pyloric stenosis: Use with caution in patients with pyloric stenosis; prolonged gastric retention of capsules may occur, delaying release of drug in the colon. Renal impairment: Use with caution in patients with renal impairment; renal toxicity has been observed with other mesalamine (5-aminosalicylic acid) products.
Special populations: Pediatrics: Safety and efficacy have not been established in children <5 years of age.
Other warnings/precautions: Duration of therapy: Safety and efficacy of use beyond 12 weeks in adults or 8 weeks in children have not been established.
DRUG INTERACTIONS
Cardiac Glycosides: 5-ASA Derivatives may decrease the absorption of Cardiac Glycosides. Risk C: Monitor therapy
Thiopurine Analogs: 5-ASA Derivatives may decrease the metabolism of Thiopurine Analogs. Risk C: Monitor therapy
Varicella Virus-Containing Vaccines: 5-ASA Derivatives may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. The primary concern is the potential development of Reye's Syndrome, a condition that has been associated with the use of salicylates in children with varicella infections. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — B (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies have been done in pregnant women. Balsalazide should be used in pregnant women only if clearly needed.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — Colazal® 750 mg capsule contains sodium ~86 mg.
PRICING — (data from drugstore.com)
Capsules (Balsalazide Disodium)
750 mg (280): $319.98
Capsules (Colazal)
750 mg (280): $449.96
MONITORING PARAMETERS — Improvement or worsening of symptoms
INTERNATIONAL BRAND NAMES — Balzide (IT); Basazyde (TW); Benoquin (AR); Calazide (AU); Colazal (KP); Colazid (NO, SE); Colazide (AT, GB); Garian (UY); Premid (DK)
MECHANISM OF ACTION — Balsalazide is a prodrug, converted by bacterial azoreduction to 5-aminosalicylic acid (mesalamine, active), 4-aminobenzoyl-ß-alanine (inert), and their metabolites. 5-aminosalicylic acid may decrease inflammation by blocking the production of arachidonic acid metabolites topically in the colon mucosa.
PHARMACODYNAMICS / KINETICS
Onset of action: Delayed; may require several days to weeks
Absorption: Very low and variable
Protein binding: Balsalazide: ≥ 99%
Metabolism: Azoreduced in the colon to 5-aminosalicylic acid (active), 4-aminobenzoyl-ß-alanine (inert), and N-acetylated metabolites
Half-life elimination: Primary effect is topical (colonic mucosa); systemic half-life not determined
Time to peak: Balsalazide: 1-2 hours
Excretion: Feces (65% as 5-aminosalicylic acid, 4-aminobenzoyl-ß-alanine, and N-acetylated metabolites); urine (25% as N-acetylated metabolites); Parent drug: Urine or feces (<1%)
PATIENT INFORMATION — Capsules should be swallowed whole or may be opened and sprinkled on applesauce. Report abdominal pain, unresolved diarrhea, severe headache, or chest pain to prescriber.
Sunday, May 30, 2010
Balsalazide
MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Colazal® may be confused with Clozaril®
U.S. BRAND NAMES — Colazal®
PHARMACOLOGIC CATEGORY
5-Aminosalicylic Acid Derivative
Anti-inflammatory Agent
DOSING: ADULTS — Ulcerative colitis: Oral: 2.25 g (three 750 mg capsules) 3 times/day for 8-12 weeks
DOSING: PEDIATRIC — Ulcerative colitis: Oral: Children 5-17 years: 750 mg 3 times/day for up to 8 weeks or 2.25 g (three 750 mg capsules) 3 times/day for 8 weeks
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — No information available with balsalazide; renal toxicity has been observed with other 5-aminosalicylic acid products; use with caution.
DOSING: HEPATIC IMPAIRMENT — No specific dosage adjustment available.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, as disodium: 750 mg
Colazal®: 750 mg [contains sodium ~86 mg/capsule]
DOSAGE FORMS: CONCISE
Capsule: 750 mg
Colazal®: 750 mg
GENERIC EQUIVALENT AVAILABLE — Yes
ADMINISTRATION — Capsules should be swallowed whole or may be opened and sprinkled on applesauce. Applesauce mixture may be chewed; swallow immediately, do not store mixture for later use. When sprinkled on food, may cause staining of teeth or tongue.
USE — Treatment of mild-to-moderate active ulcerative colitis
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Headache (children 15%; adults 8%)
Gastrointestinal: Abdominal pain (children 12% to 13%; adults 6%)
1% to 10%:
Central nervous system: Insomnia (adults 2%), fatigue (children 4%; adults 2%), fever (children 6%; adults 2%)
Endocrine & metabolic: Dysmenorrhea (children 3%)
Gastrointestinal: Diarrhea (children 9%; adults 5%), ulcerative colitis exacerbation (children 6%; adults 1%), nausea (children 4%; adults 5%), vomiting (children 10%; adults 4%), hematochezia (children 4%), stomatitis (children 3%), anorexia (adults 2%), dyspepsia (adults 2%), flatulence (adults 2%), cramps (adults 1%), constipation (adults 1%), xerostomia (adults 1%)
Genitourinary: Urinary tract infection (adults 1%)
Neuromuscular & skeletal: Arthralgia (adults 4%), back pain (adults 2%), myalgia (adults 1%)
Respiratory: Respiratory infection (adults 4%), cough (children 3%; adults 2%), pharyngitis (children 6%; adults 2%), pharyngolaryngeal pain (children 3%), rhinitis (adults 2%)
Miscellaneous: Flu-like syndrome (children 4%; adults 1%)
<1% (Limited to important or life-threatening): Alopecia, cholestatic jaundice, cirrhosis, hepatocellular damage, hepatotoxicity, jaundice, hypersensitivity pericarditis, Kawasaki-like syndrome, liver failure, liver necrosis, liver function tests increased, myocarditis
CONTRAINDICATIONS — Hypersensitivity to balsalazide, metabolites to balsalazide, salicylates, or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Colitis: May exacerbate symptoms of ulcerative colitis.
Disease-related concerns: Pyloric stenosis: Use with caution in patients with pyloric stenosis; prolonged gastric retention of capsules may occur, delaying release of drug in the colon. Renal impairment: Use with caution in patients with renal impairment; renal toxicity has been observed with other mesalamine (5-aminosalicylic acid) products.
Special populations: Pediatrics: Safety and efficacy have not been established in children <5 years of age.
Other warnings/precautions: Duration of therapy: Safety and efficacy of use beyond 12 weeks in adults or 8 weeks in children have not been established.
DRUG INTERACTIONS
Cardiac Glycosides: 5-ASA Derivatives may decrease the absorption of Cardiac Glycosides. Risk C: Monitor therapy
Thiopurine Analogs: 5-ASA Derivatives may decrease the metabolism of Thiopurine Analogs. Risk C: Monitor therapy
Varicella Virus-Containing Vaccines: 5-ASA Derivatives may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. The primary concern is the potential development of Reye's Syndrome, a condition that has been associated with the use of salicylates in children with varicella infections. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — B (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies have been done in pregnant women. Balsalazide should be used in pregnant women only if clearly needed.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — Colazal® 750 mg capsule contains sodium ~86 mg.
PRICING — (data from drugstore.com)
Capsules (Balsalazide Disodium)
750 mg (280): $319.98
Capsules (Colazal)
750 mg (280): $449.96
MONITORING PARAMETERS — Improvement or worsening of symptoms
INTERNATIONAL BRAND NAMES — Balzide (IT); Basazyde (TW); Benoquin (AR); Calazide (AU); Colazal (KP); Colazid (NO, SE); Colazide (AT, GB); Garian (UY); Premid (DK)
MECHANISM OF ACTION — Balsalazide is a prodrug, converted by bacterial azoreduction to 5-aminosalicylic acid (mesalamine, active), 4-aminobenzoyl-ß-alanine (inert), and their metabolites. 5-aminosalicylic acid may decrease inflammation by blocking the production of arachidonic acid metabolites topically in the colon mucosa.
PHARMACODYNAMICS / KINETICS
Onset of action: Delayed; may require several days to weeks
Absorption: Very low and variable
Protein binding: Balsalazide: ≥ 99%
Metabolism: Azoreduced in the colon to 5-aminosalicylic acid (active), 4-aminobenzoyl-ß-alanine (inert), and N-acetylated metabolites
Half-life elimination: Primary effect is topical (colonic mucosa); systemic half-life not determined
Time to peak: Balsalazide: 1-2 hours
Excretion: Feces (65% as 5-aminosalicylic acid, 4-aminobenzoyl-ß-alanine, and N-acetylated metabolites); urine (25% as N-acetylated metabolites); Parent drug: Urine or feces (<1%)
PATIENT INFORMATION — Capsules should be swallowed whole or may be opened and sprinkled on applesauce. Report abdominal pain, unresolved diarrhea, severe headache, or chest pain to prescriber.
Sound-alike/look-alike issues:
Colazal® may be confused with Clozaril®
U.S. BRAND NAMES — Colazal®
PHARMACOLOGIC CATEGORY
5-Aminosalicylic Acid Derivative
Anti-inflammatory Agent
DOSING: ADULTS — Ulcerative colitis: Oral: 2.25 g (three 750 mg capsules) 3 times/day for 8-12 weeks
DOSING: PEDIATRIC — Ulcerative colitis: Oral: Children 5-17 years: 750 mg 3 times/day for up to 8 weeks or 2.25 g (three 750 mg capsules) 3 times/day for 8 weeks
DOSING: ELDERLY — Refer to adult dosing.
DOSING: RENAL IMPAIRMENT — No information available with balsalazide; renal toxicity has been observed with other 5-aminosalicylic acid products; use with caution.
DOSING: HEPATIC IMPAIRMENT — No specific dosage adjustment available.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, as disodium: 750 mg
Colazal®: 750 mg [contains sodium ~86 mg/capsule]
DOSAGE FORMS: CONCISE
Capsule: 750 mg
Colazal®: 750 mg
GENERIC EQUIVALENT AVAILABLE — Yes
ADMINISTRATION — Capsules should be swallowed whole or may be opened and sprinkled on applesauce. Applesauce mixture may be chewed; swallow immediately, do not store mixture for later use. When sprinkled on food, may cause staining of teeth or tongue.
USE — Treatment of mild-to-moderate active ulcerative colitis
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Headache (children 15%; adults 8%)
Gastrointestinal: Abdominal pain (children 12% to 13%; adults 6%)
1% to 10%:
Central nervous system: Insomnia (adults 2%), fatigue (children 4%; adults 2%), fever (children 6%; adults 2%)
Endocrine & metabolic: Dysmenorrhea (children 3%)
Gastrointestinal: Diarrhea (children 9%; adults 5%), ulcerative colitis exacerbation (children 6%; adults 1%), nausea (children 4%; adults 5%), vomiting (children 10%; adults 4%), hematochezia (children 4%), stomatitis (children 3%), anorexia (adults 2%), dyspepsia (adults 2%), flatulence (adults 2%), cramps (adults 1%), constipation (adults 1%), xerostomia (adults 1%)
Genitourinary: Urinary tract infection (adults 1%)
Neuromuscular & skeletal: Arthralgia (adults 4%), back pain (adults 2%), myalgia (adults 1%)
Respiratory: Respiratory infection (adults 4%), cough (children 3%; adults 2%), pharyngitis (children 6%; adults 2%), pharyngolaryngeal pain (children 3%), rhinitis (adults 2%)
Miscellaneous: Flu-like syndrome (children 4%; adults 1%)
<1% (Limited to important or life-threatening): Alopecia, cholestatic jaundice, cirrhosis, hepatocellular damage, hepatotoxicity, jaundice, hypersensitivity pericarditis, Kawasaki-like syndrome, liver failure, liver necrosis, liver function tests increased, myocarditis
CONTRAINDICATIONS — Hypersensitivity to balsalazide, metabolites to balsalazide, salicylates, or any component of the formulation
WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Colitis: May exacerbate symptoms of ulcerative colitis.
Disease-related concerns: Pyloric stenosis: Use with caution in patients with pyloric stenosis; prolonged gastric retention of capsules may occur, delaying release of drug in the colon. Renal impairment: Use with caution in patients with renal impairment; renal toxicity has been observed with other mesalamine (5-aminosalicylic acid) products.
Special populations: Pediatrics: Safety and efficacy have not been established in children <5 years of age.
Other warnings/precautions: Duration of therapy: Safety and efficacy of use beyond 12 weeks in adults or 8 weeks in children have not been established.
DRUG INTERACTIONS
Cardiac Glycosides: 5-ASA Derivatives may decrease the absorption of Cardiac Glycosides. Risk C: Monitor therapy
Thiopurine Analogs: 5-ASA Derivatives may decrease the metabolism of Thiopurine Analogs. Risk C: Monitor therapy
Varicella Virus-Containing Vaccines: 5-ASA Derivatives may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. The primary concern is the potential development of Reye's Syndrome, a condition that has been associated with the use of salicylates in children with varicella infections. Risk D: Consider therapy modification
PREGNANCY RISK FACTOR — B (show table)
PREGNANCY IMPLICATIONS — Teratogenic effects were not observed in animal studies. There are no adequate and well-controlled studies have been done in pregnant women. Balsalazide should be used in pregnant women only if clearly needed.
LACTATION — Excretion in breast milk unknown/use caution
DIETARY CONSIDERATIONS — Colazal® 750 mg capsule contains sodium ~86 mg.
PRICING — (data from drugstore.com)
Capsules (Balsalazide Disodium)
750 mg (280): $319.98
Capsules (Colazal)
750 mg (280): $449.96
MONITORING PARAMETERS — Improvement or worsening of symptoms
INTERNATIONAL BRAND NAMES — Balzide (IT); Basazyde (TW); Benoquin (AR); Calazide (AU); Colazal (KP); Colazid (NO, SE); Colazide (AT, GB); Garian (UY); Premid (DK)
MECHANISM OF ACTION — Balsalazide is a prodrug, converted by bacterial azoreduction to 5-aminosalicylic acid (mesalamine, active), 4-aminobenzoyl-ß-alanine (inert), and their metabolites. 5-aminosalicylic acid may decrease inflammation by blocking the production of arachidonic acid metabolites topically in the colon mucosa.
PHARMACODYNAMICS / KINETICS
Onset of action: Delayed; may require several days to weeks
Absorption: Very low and variable
Protein binding: Balsalazide: ≥ 99%
Metabolism: Azoreduced in the colon to 5-aminosalicylic acid (active), 4-aminobenzoyl-ß-alanine (inert), and N-acetylated metabolites
Half-life elimination: Primary effect is topical (colonic mucosa); systemic half-life not determined
Time to peak: Balsalazide: 1-2 hours
Excretion: Feces (65% as 5-aminosalicylic acid, 4-aminobenzoyl-ß-alanine, and N-acetylated metabolites); urine (25% as N-acetylated metabolites); Parent drug: Urine or feces (<1%)
PATIENT INFORMATION — Capsules should be swallowed whole or may be opened and sprinkled on applesauce. Report abdominal pain, unresolved diarrhea, severe headache, or chest pain to prescriber.
Balanced salt solution
PHARMACOLOGIC CATEGORY
Irrigating Solution
Ophthalmic Agent, Miscellaneous
DOSING: ADULTS — Irrigation: Based on standard for each surgical procedure
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, irrigation [preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (500 mL)
Solution, ophthalmic [irrigation; preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (18 mL, 500 mL)
AquaLase™ : Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (90 mL)
BSS®: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (15 mL, 30 mL, 250 mL, 500 mL)
BSS Plus®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018% (250 mL, 500 mL)
Navstel®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018%, hypromellose 0.125% to 0.173% (250 mL, 500 mL)
DOSAGE FORMS: CONCISE
Solution, irrigation [preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (500 mL)
Solution, ophthalmic [irrigation; preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (18 mL, 500 mL)
AquaLase™ : Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (90 mL)
BSS®: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (15 mL, 30 mL, 250 mL, 500 mL)
BSS Plus®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018% (250 mL, 500 mL)
Navstel®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018%, hypromellose 0.125% to 0.173% (250 mL, 500 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
USE
Irrigation solution for ophthalmic surgery:
AquaLase™ , BSS®: Intraocular or extraocular irrigating solution
BSS Plus®, Navstel®: Intraocular irrigating solution
Irrigation solution for eyes, ears, nose, or throat
ADVERSE REACTIONS SIGNIFICANT
>10%: Ocular: Intraocular pressure increased (11% to 12%), cataract (7% to 11%)
1% to 10%:
Central nervous system: Headache (3%)
Ocular: Discomfort (3% to 5%), dry eyes (3% to 5%), macular edema (4%), conjunctival hyperemia (3% to 4%), posterior capsule opacification (2% to 3%), iritis (1% to 3%), retinal hemorrhage (1% to 3%), blurred vision (1% to 2%)
CONTRAINDICATIONS — Injection or I.V. infusion; use during electrosurgical procedures
WARNINGS / PRECAUTIONS
Disease-related concerns: Diabetes: Use with caution in patients with diabetes mellitus; intraoperative lens changes have been observed when undergoing vitrectomy procedure.
Other warnings/precautions: Appropriate use: For use during surgical procedures with an expected duration ≤ 60 minutes.
DRUG INTERACTIONS — There are no known significant interactions.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/use caution
CANADIAN BRAND NAMES — BSS Plus®; BSS®; Eye-Stream®
INTERNATIONAL BRAND NAMES — Balanced Salt Solution (DK, FI, GB, NZ)
Irrigating Solution
Ophthalmic Agent, Miscellaneous
DOSING: ADULTS — Irrigation: Based on standard for each surgical procedure
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, irrigation [preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (500 mL)
Solution, ophthalmic [irrigation; preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (18 mL, 500 mL)
AquaLase™ : Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (90 mL)
BSS®: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (15 mL, 30 mL, 250 mL, 500 mL)
BSS Plus®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018% (250 mL, 500 mL)
Navstel®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018%, hypromellose 0.125% to 0.173% (250 mL, 500 mL)
DOSAGE FORMS: CONCISE
Solution, irrigation [preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (500 mL)
Solution, ophthalmic [irrigation; preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (18 mL, 500 mL)
AquaLase™ : Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (90 mL)
BSS®: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (15 mL, 30 mL, 250 mL, 500 mL)
BSS Plus®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018% (250 mL, 500 mL)
Navstel®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018%, hypromellose 0.125% to 0.173% (250 mL, 500 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
USE
Irrigation solution for ophthalmic surgery:
AquaLase™ , BSS®: Intraocular or extraocular irrigating solution
BSS Plus®, Navstel®: Intraocular irrigating solution
Irrigation solution for eyes, ears, nose, or throat
ADVERSE REACTIONS SIGNIFICANT
>10%: Ocular: Intraocular pressure increased (11% to 12%), cataract (7% to 11%)
1% to 10%:
Central nervous system: Headache (3%)
Ocular: Discomfort (3% to 5%), dry eyes (3% to 5%), macular edema (4%), conjunctival hyperemia (3% to 4%), posterior capsule opacification (2% to 3%), iritis (1% to 3%), retinal hemorrhage (1% to 3%), blurred vision (1% to 2%)
CONTRAINDICATIONS — Injection or I.V. infusion; use during electrosurgical procedures
WARNINGS / PRECAUTIONS
Disease-related concerns: Diabetes: Use with caution in patients with diabetes mellitus; intraoperative lens changes have been observed when undergoing vitrectomy procedure.
Other warnings/precautions: Appropriate use: For use during surgical procedures with an expected duration ≤ 60 minutes.
DRUG INTERACTIONS — There are no known significant interactions.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/use caution
CANADIAN BRAND NAMES — BSS Plus®; BSS®; Eye-Stream®
INTERNATIONAL BRAND NAMES — Balanced Salt Solution (DK, FI, GB, NZ)
Balanced salt solution
PHARMACOLOGIC CATEGORY
Irrigating Solution
Ophthalmic Agent, Miscellaneous
DOSING: ADULTS — Irrigation: Based on standard for each surgical procedure
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, irrigation [preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (500 mL)
Solution, ophthalmic [irrigation; preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (18 mL, 500 mL)
AquaLase™ : Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (90 mL)
BSS®: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (15 mL, 30 mL, 250 mL, 500 mL)
BSS Plus®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018% (250 mL, 500 mL)
Navstel®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018%, hypromellose 0.125% to 0.173% (250 mL, 500 mL)
DOSAGE FORMS: CONCISE
Solution, irrigation [preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (500 mL)
Solution, ophthalmic [irrigation; preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (18 mL, 500 mL)
AquaLase™ : Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (90 mL)
BSS®: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (15 mL, 30 mL, 250 mL, 500 mL)
BSS Plus®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018% (250 mL, 500 mL)
Navstel®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018%, hypromellose 0.125% to 0.173% (250 mL, 500 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
USE
Irrigation solution for ophthalmic surgery:
AquaLase™ , BSS®: Intraocular or extraocular irrigating solution
BSS Plus®, Navstel®: Intraocular irrigating solution
Irrigation solution for eyes, ears, nose, or throat
ADVERSE REACTIONS SIGNIFICANT
>10%: Ocular: Intraocular pressure increased (11% to 12%), cataract (7% to 11%)
1% to 10%:
Central nervous system: Headache (3%)
Ocular: Discomfort (3% to 5%), dry eyes (3% to 5%), macular edema (4%), conjunctival hyperemia (3% to 4%), posterior capsule opacification (2% to 3%), iritis (1% to 3%), retinal hemorrhage (1% to 3%), blurred vision (1% to 2%)
CONTRAINDICATIONS — Injection or I.V. infusion; use during electrosurgical procedures
WARNINGS / PRECAUTIONS
Disease-related concerns: Diabetes: Use with caution in patients with diabetes mellitus; intraoperative lens changes have been observed when undergoing vitrectomy procedure.
Other warnings/precautions: Appropriate use: For use during surgical procedures with an expected duration ≤ 60 minutes.
DRUG INTERACTIONS — There are no known significant interactions.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/use caution
CANADIAN BRAND NAMES — BSS Plus®; BSS®; Eye-Stream®
INTERNATIONAL BRAND NAMES — Balanced Salt Solution (DK, FI, GB, NZ)
Irrigating Solution
Ophthalmic Agent, Miscellaneous
DOSING: ADULTS — Irrigation: Based on standard for each surgical procedure
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Solution, irrigation [preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (500 mL)
Solution, ophthalmic [irrigation; preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (18 mL, 500 mL)
AquaLase™ : Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (90 mL)
BSS®: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (15 mL, 30 mL, 250 mL, 500 mL)
BSS Plus®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018% (250 mL, 500 mL)
Navstel®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018%, hypromellose 0.125% to 0.173% (250 mL, 500 mL)
DOSAGE FORMS: CONCISE
Solution, irrigation [preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (500 mL)
Solution, ophthalmic [irrigation; preservative free]: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (18 mL, 500 mL)
AquaLase™ : Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (90 mL)
BSS®: Sodium chloride 0.64%, potassium chloride 0.075%, calcium chloride 0.048%, magnesium chloride 0.03%, sodium acetate 0.39%, sodium citrate 0.17% (15 mL, 30 mL, 250 mL, 500 mL)
BSS Plus®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018% (250 mL, 500 mL)
Navstel®: Sodium chloride 0.71%, potassium chloride 0.038%, calcium chloride 0.015%, magnesium chloride 0.02%, sodium phosphate 0.042%, sodium bicarbonate 0.21%, dextrose 0.092%, glutathione 0.018%, hypromellose 0.125% to 0.173% (250 mL, 500 mL)
GENERIC EQUIVALENT AVAILABLE — Yes
USE
Irrigation solution for ophthalmic surgery:
AquaLase™ , BSS®: Intraocular or extraocular irrigating solution
BSS Plus®, Navstel®: Intraocular irrigating solution
Irrigation solution for eyes, ears, nose, or throat
ADVERSE REACTIONS SIGNIFICANT
>10%: Ocular: Intraocular pressure increased (11% to 12%), cataract (7% to 11%)
1% to 10%:
Central nervous system: Headache (3%)
Ocular: Discomfort (3% to 5%), dry eyes (3% to 5%), macular edema (4%), conjunctival hyperemia (3% to 4%), posterior capsule opacification (2% to 3%), iritis (1% to 3%), retinal hemorrhage (1% to 3%), blurred vision (1% to 2%)
CONTRAINDICATIONS — Injection or I.V. infusion; use during electrosurgical procedures
WARNINGS / PRECAUTIONS
Disease-related concerns: Diabetes: Use with caution in patients with diabetes mellitus; intraoperative lens changes have been observed when undergoing vitrectomy procedure.
Other warnings/precautions: Appropriate use: For use during surgical procedures with an expected duration ≤ 60 minutes.
DRUG INTERACTIONS — There are no known significant interactions.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Excretion in breast milk unknown/use caution
CANADIAN BRAND NAMES — BSS Plus®; BSS®; Eye-Stream®
INTERNATIONAL BRAND NAMES — Balanced Salt Solution (DK, FI, GB, NZ)
Baclofen
MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Baclofen may be confused with Bactroban®
Lioresal® may be confused with lisinopril, Lotensin®
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication (intrathecal administration) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
U.S. BRAND NAMES — Lioresal®
PHARMACOLOGIC CATEGORY
Skeletal Muscle Relaxant
DOSING: ADULTS
Spasticity:
Oral: 5 mg 3 times/day, may increase 5 mg/dose every 3 days to a maximum of 80 mg/day
Intrathecal:
Test dose: 50-100 mcg, doses >50 mcg should be given in 25 mcg increments, separated by 24 hours. A screening dose of 25 mcg may be considered in very small patients. Patients not responding to screening dose of 100 mcg should not be considered for chronic infusion/implanted pump.
Maintenance: After positive response to test dose, a maintenance intrathecal infusion can be administered via an implanted intrathecal pump. Initial dose via pump: Infusion at a 24-hourly rate dosed at twice the test dose. Avoid abrupt discontinuation.
Hiccups (unlabeled use): Oral: 10-20 mg 2-3 times/day
DOSING: PEDIATRIC — Spasticity:
(For additional information see "Baclofen: Pediatric drug information")
Oral (avoid abrupt withdrawal of drug) (unlabeled use): Caution: Pediatric dosing expressed as a daily amount, and NOT in mg/kg. Limited published data in children; the following is a compilation of small prospective studies (Albright, 1996; Milla, 1977; Scheinberg, 2006) and one large retrospective study (Lubsch, 2006):
<2 years: 10-20 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 40 mg daily
2-7 years: Initial: 20-30 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 60 mg daily
≥ 8 years: 30-40 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 120 mg daily
Note: Baclofen dose may need to be increased over time. One retrospective analysis (Lubsch, 2006) suggested that increased doses were needed as the time increased from spasticity onset, as age increased, and as the number of concomitant antispasticity medications increased. A small number of patients required daily doses exceeding 200 mg.
Intrathecal: Refer to adult dosing.
DOSING: ELDERLY — Oral (the lowest effective dose is recommended): Initial: 5 mg 2-3 times/day, increasing gradually as needed; if benefits are not seen withdraw the drug slowly.
DOSING: RENAL IMPAIRMENT — May be necessary to reduce dosage; no specific guidelines have been established
Hemodialysis: Poor water solubility allows for accumulation during chronic hemodialysis. Low-dose therapy is recommended. There have been several case reports of accumulation of baclofen resulting in toxicity symptoms (organic brain syndrome, myoclonia, deceleration and steep potentials in EEG) in patients with renal failure who have received normal doses of baclofen.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution, intrathecal [preservative free]:
Lioresal®: 50 mcg/mL (1 mL); 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL, 20 mL)
Tablet: 10 mg, 20 mg
DOSAGE FORMS: CONCISE
Injection, solution, intrathecal [preservative free]:
Lioresal®: 50 mcg/mL (1 mL); 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL, 20 mL)
Tablet: 10 mg, 20 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablets only
ADMINISTRATION — Intrathecal: For screening dosages, dilute with preservative-free sodium chloride to a final concentration of 50 mcg/mL for bolus injection into the subarachnoid space. For maintenance infusions, concentrations of 500-2000 mcg/mL may be used.
COMPATIBILITY — Stable in sterile, preservative free NS.
Compatibility when admixed: Compatible: Morphine.
USE — Treatment of reversible spasticity associated with multiple sclerosis or spinal cord lesions
Orphan drug: Intrathecal: Treatment of intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal disease (spinal ischemia or tumor, transverse myelitis, cervical spondylosis, degenerative myelopathy)
USE - UNLABELED / INVESTIGATIONAL — Intractable hiccups, intractable pain relief, bladder spasticity, trigeminal neuralgia, cerebral palsy, Huntington's chorea
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Drowsiness, vertigo, dizziness, psychiatric disturbances, insomnia, slurred speech, ataxia, hypotonia
Neuromuscular & skeletal: Weakness
1% to 10%:
Cardiovascular: Hypotension
Central nervous system: Fatigue, confusion, headache
Dermatologic: Rash
Gastrointestinal: Nausea, constipation
Genitourinary: Polyuria
<1% (Limited to important or life-threatening): Chest pain, dyspnea, dysuria, enuresis, hematuria, impotence, inability to ejaculate, nocturia, palpitation, syncope, urinary retention; withdrawal reactions have occurred with abrupt discontinuation (particularly severe with intrathecal use).
CONTRAINDICATIONS — Hypersensitivity to baclofen or any component of the formulation
WARNINGS / PRECAUTIONS
Boxed warnings: Abrupt withdrawal: .
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns: Renal impairment: Use with caution in patients with renal impairment. Seizure disorder. Use with caution in patients with a history of seizure disorder.
Special populations: Elderly: Use with caution in the elderly; may be more sensitive to adverse CNS effects, especially at higher doses.
Other warnings/precautions: Abrupt withdrawal: [U.S. Boxed Warning]: Avoid abrupt withdrawal of the drug; abrupt withdrawal of intrathecal baclofen has resulted in severe sequelae (hyperpyrexia, obtundation, rebound/exaggerated spasticity, muscle rigidity, and rhabdomyolysis), leading to organ failure and some fatalities. Risk may be higher in patients with injuries at T-6 or above, history of baclofen withdrawal, or limited ability to communicate.
DRUG INTERACTIONS
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce dosage of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Avoid ethanol (may increase CNS depression).
Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Enters breast milk (small amounts)/compatible
PRICING — (data from drugstore.com)
Tablets (Baclofen)
10 mg (30): $9.99
20 mg (30): $15.99
CANADIAN BRAND NAMES — Apo-Baclofen®; Gen-Baclofen; Lioresal®; Liotec; Nu-Baclo; PMS-Baclofen
INTERNATIONAL BRAND NAMES — Alpha-Baclofen (NZ); Alpha-Clofen (AU); Baclan (KP); Baclo (AU); Baclofen (PL); Baclofen-ratiopharm (LU); Baclofene (FR); Baclon (FI, TW); Baclopar (IE); Baclosal (IL, TH); Bacofen (KP); Baklofen (DK, NO); Clofen (AU, MY); Curofen (KP); Diafen (UY); Espast (PE); Liobac (TH); Lioresal (AE, AR, AT, AU, BB, BD, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CY, CZ, DE, DK, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KP, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, MY, NE, NG, NL, NO, OM, PH, PK, PT, PY, QA, RU, SA, SC, SD, SE, SG, SL, SN, SR, SY, TH, TN, TR, TT, TW, TZ, UG, VE, YE, ZA, ZM, ZW); Lioresyl (CN); Lyflex (GB, IE); Onelaxant-R (PH); Pacifen (NZ, TW); Solofen (TW); Spinax (TW); Stelax (AU, HK)
MECHANISM OF ACTION — Inhibits the transmission of both monosynaptic and polysynaptic reflexes at the spinal cord level, possibly by hyperpolarization of primary afferent fiber terminals, with resultant relief of muscle spasticity
PHARMACODYNAMICS / KINETICS
Onset of action: 3-4 days
Peak effect: 5-10 days
Absorption (dose dependent): Oral: Rapid
Protein binding: 30%
Metabolism: Hepatic (15% of dose)
Half-life elimination: 3.5 hours
Time to peak, serum: Oral: Within 2-3 hours
Excretion: Urine and feces (85% as unchanged drug)
PATIENT INFORMATION
(For additional information see "Baclofen: Patient drug information")
Intrathecal: It is important not to miss scheduled appointments for refills. Contact prescriber immediately if symptoms of withdrawal occur (high fever, confusion, increased spasticity, or muscle rigidity).
Oral: Take with food or milk; abrupt withdrawal after prolonged use may cause anxiety, hallucinations, tachycardia, or spasticity. May cause drowsiness and impair coordination and judgment.
Sound-alike/look-alike issues:
Baclofen may be confused with Bactroban®
Lioresal® may be confused with lisinopril, Lotensin®
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication (intrathecal administration) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
U.S. BRAND NAMES — Lioresal®
PHARMACOLOGIC CATEGORY
Skeletal Muscle Relaxant
DOSING: ADULTS
Spasticity:
Oral: 5 mg 3 times/day, may increase 5 mg/dose every 3 days to a maximum of 80 mg/day
Intrathecal:
Test dose: 50-100 mcg, doses >50 mcg should be given in 25 mcg increments, separated by 24 hours. A screening dose of 25 mcg may be considered in very small patients. Patients not responding to screening dose of 100 mcg should not be considered for chronic infusion/implanted pump.
Maintenance: After positive response to test dose, a maintenance intrathecal infusion can be administered via an implanted intrathecal pump. Initial dose via pump: Infusion at a 24-hourly rate dosed at twice the test dose. Avoid abrupt discontinuation.
Hiccups (unlabeled use): Oral: 10-20 mg 2-3 times/day
DOSING: PEDIATRIC — Spasticity:
(For additional information see "Baclofen: Pediatric drug information")
Oral (avoid abrupt withdrawal of drug) (unlabeled use): Caution: Pediatric dosing expressed as a daily amount, and NOT in mg/kg. Limited published data in children; the following is a compilation of small prospective studies (Albright, 1996; Milla, 1977; Scheinberg, 2006) and one large retrospective study (Lubsch, 2006):
<2 years: 10-20 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 40 mg daily
2-7 years: Initial: 20-30 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 60 mg daily
≥ 8 years: 30-40 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 120 mg daily
Note: Baclofen dose may need to be increased over time. One retrospective analysis (Lubsch, 2006) suggested that increased doses were needed as the time increased from spasticity onset, as age increased, and as the number of concomitant antispasticity medications increased. A small number of patients required daily doses exceeding 200 mg.
Intrathecal: Refer to adult dosing.
DOSING: ELDERLY — Oral (the lowest effective dose is recommended): Initial: 5 mg 2-3 times/day, increasing gradually as needed; if benefits are not seen withdraw the drug slowly.
DOSING: RENAL IMPAIRMENT — May be necessary to reduce dosage; no specific guidelines have been established
Hemodialysis: Poor water solubility allows for accumulation during chronic hemodialysis. Low-dose therapy is recommended. There have been several case reports of accumulation of baclofen resulting in toxicity symptoms (organic brain syndrome, myoclonia, deceleration and steep potentials in EEG) in patients with renal failure who have received normal doses of baclofen.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution, intrathecal [preservative free]:
Lioresal®: 50 mcg/mL (1 mL); 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL, 20 mL)
Tablet: 10 mg, 20 mg
DOSAGE FORMS: CONCISE
Injection, solution, intrathecal [preservative free]:
Lioresal®: 50 mcg/mL (1 mL); 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL, 20 mL)
Tablet: 10 mg, 20 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablets only
ADMINISTRATION — Intrathecal: For screening dosages, dilute with preservative-free sodium chloride to a final concentration of 50 mcg/mL for bolus injection into the subarachnoid space. For maintenance infusions, concentrations of 500-2000 mcg/mL may be used.
COMPATIBILITY — Stable in sterile, preservative free NS.
Compatibility when admixed: Compatible: Morphine.
USE — Treatment of reversible spasticity associated with multiple sclerosis or spinal cord lesions
Orphan drug: Intrathecal: Treatment of intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal disease (spinal ischemia or tumor, transverse myelitis, cervical spondylosis, degenerative myelopathy)
USE - UNLABELED / INVESTIGATIONAL — Intractable hiccups, intractable pain relief, bladder spasticity, trigeminal neuralgia, cerebral palsy, Huntington's chorea
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Drowsiness, vertigo, dizziness, psychiatric disturbances, insomnia, slurred speech, ataxia, hypotonia
Neuromuscular & skeletal: Weakness
1% to 10%:
Cardiovascular: Hypotension
Central nervous system: Fatigue, confusion, headache
Dermatologic: Rash
Gastrointestinal: Nausea, constipation
Genitourinary: Polyuria
<1% (Limited to important or life-threatening): Chest pain, dyspnea, dysuria, enuresis, hematuria, impotence, inability to ejaculate, nocturia, palpitation, syncope, urinary retention; withdrawal reactions have occurred with abrupt discontinuation (particularly severe with intrathecal use).
CONTRAINDICATIONS — Hypersensitivity to baclofen or any component of the formulation
WARNINGS / PRECAUTIONS
Boxed warnings: Abrupt withdrawal: .
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns: Renal impairment: Use with caution in patients with renal impairment. Seizure disorder. Use with caution in patients with a history of seizure disorder.
Special populations: Elderly: Use with caution in the elderly; may be more sensitive to adverse CNS effects, especially at higher doses.
Other warnings/precautions: Abrupt withdrawal: [U.S. Boxed Warning]: Avoid abrupt withdrawal of the drug; abrupt withdrawal of intrathecal baclofen has resulted in severe sequelae (hyperpyrexia, obtundation, rebound/exaggerated spasticity, muscle rigidity, and rhabdomyolysis), leading to organ failure and some fatalities. Risk may be higher in patients with injuries at T-6 or above, history of baclofen withdrawal, or limited ability to communicate.
DRUG INTERACTIONS
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce dosage of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Avoid ethanol (may increase CNS depression).
Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Enters breast milk (small amounts)/compatible
PRICING — (data from drugstore.com)
Tablets (Baclofen)
10 mg (30): $9.99
20 mg (30): $15.99
CANADIAN BRAND NAMES — Apo-Baclofen®; Gen-Baclofen; Lioresal®; Liotec; Nu-Baclo; PMS-Baclofen
INTERNATIONAL BRAND NAMES — Alpha-Baclofen (NZ); Alpha-Clofen (AU); Baclan (KP); Baclo (AU); Baclofen (PL); Baclofen-ratiopharm (LU); Baclofene (FR); Baclon (FI, TW); Baclopar (IE); Baclosal (IL, TH); Bacofen (KP); Baklofen (DK, NO); Clofen (AU, MY); Curofen (KP); Diafen (UY); Espast (PE); Liobac (TH); Lioresal (AE, AR, AT, AU, BB, BD, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CY, CZ, DE, DK, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KP, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, MY, NE, NG, NL, NO, OM, PH, PK, PT, PY, QA, RU, SA, SC, SD, SE, SG, SL, SN, SR, SY, TH, TN, TR, TT, TW, TZ, UG, VE, YE, ZA, ZM, ZW); Lioresyl (CN); Lyflex (GB, IE); Onelaxant-R (PH); Pacifen (NZ, TW); Solofen (TW); Spinax (TW); Stelax (AU, HK)
MECHANISM OF ACTION — Inhibits the transmission of both monosynaptic and polysynaptic reflexes at the spinal cord level, possibly by hyperpolarization of primary afferent fiber terminals, with resultant relief of muscle spasticity
PHARMACODYNAMICS / KINETICS
Onset of action: 3-4 days
Peak effect: 5-10 days
Absorption (dose dependent): Oral: Rapid
Protein binding: 30%
Metabolism: Hepatic (15% of dose)
Half-life elimination: 3.5 hours
Time to peak, serum: Oral: Within 2-3 hours
Excretion: Urine and feces (85% as unchanged drug)
PATIENT INFORMATION
(For additional information see "Baclofen: Patient drug information")
Intrathecal: It is important not to miss scheduled appointments for refills. Contact prescriber immediately if symptoms of withdrawal occur (high fever, confusion, increased spasticity, or muscle rigidity).
Oral: Take with food or milk; abrupt withdrawal after prolonged use may cause anxiety, hallucinations, tachycardia, or spasticity. May cause drowsiness and impair coordination and judgment.
Baclofen
MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Baclofen may be confused with Bactroban®
Lioresal® may be confused with lisinopril, Lotensin®
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication (intrathecal administration) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
U.S. BRAND NAMES — Lioresal®
PHARMACOLOGIC CATEGORY
Skeletal Muscle Relaxant
DOSING: ADULTS
Spasticity:
Oral: 5 mg 3 times/day, may increase 5 mg/dose every 3 days to a maximum of 80 mg/day
Intrathecal:
Test dose: 50-100 mcg, doses >50 mcg should be given in 25 mcg increments, separated by 24 hours. A screening dose of 25 mcg may be considered in very small patients. Patients not responding to screening dose of 100 mcg should not be considered for chronic infusion/implanted pump.
Maintenance: After positive response to test dose, a maintenance intrathecal infusion can be administered via an implanted intrathecal pump. Initial dose via pump: Infusion at a 24-hourly rate dosed at twice the test dose. Avoid abrupt discontinuation.
Hiccups (unlabeled use): Oral: 10-20 mg 2-3 times/day
DOSING: PEDIATRIC — Spasticity:
(For additional information see "Baclofen: Pediatric drug information")
Oral (avoid abrupt withdrawal of drug) (unlabeled use): Caution: Pediatric dosing expressed as a daily amount, and NOT in mg/kg. Limited published data in children; the following is a compilation of small prospective studies (Albright, 1996; Milla, 1977; Scheinberg, 2006) and one large retrospective study (Lubsch, 2006):
<2 years: 10-20 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 40 mg daily
2-7 years: Initial: 20-30 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 60 mg daily
≥ 8 years: 30-40 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 120 mg daily
Note: Baclofen dose may need to be increased over time. One retrospective analysis (Lubsch, 2006) suggested that increased doses were needed as the time increased from spasticity onset, as age increased, and as the number of concomitant antispasticity medications increased. A small number of patients required daily doses exceeding 200 mg.
Intrathecal: Refer to adult dosing.
DOSING: ELDERLY — Oral (the lowest effective dose is recommended): Initial: 5 mg 2-3 times/day, increasing gradually as needed; if benefits are not seen withdraw the drug slowly.
DOSING: RENAL IMPAIRMENT — May be necessary to reduce dosage; no specific guidelines have been established
Hemodialysis: Poor water solubility allows for accumulation during chronic hemodialysis. Low-dose therapy is recommended. There have been several case reports of accumulation of baclofen resulting in toxicity symptoms (organic brain syndrome, myoclonia, deceleration and steep potentials in EEG) in patients with renal failure who have received normal doses of baclofen.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution, intrathecal [preservative free]:
Lioresal®: 50 mcg/mL (1 mL); 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL, 20 mL)
Tablet: 10 mg, 20 mg
DOSAGE FORMS: CONCISE
Injection, solution, intrathecal [preservative free]:
Lioresal®: 50 mcg/mL (1 mL); 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL, 20 mL)
Tablet: 10 mg, 20 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablets only
ADMINISTRATION — Intrathecal: For screening dosages, dilute with preservative-free sodium chloride to a final concentration of 50 mcg/mL for bolus injection into the subarachnoid space. For maintenance infusions, concentrations of 500-2000 mcg/mL may be used.
COMPATIBILITY — Stable in sterile, preservative free NS.
Compatibility when admixed: Compatible: Morphine.
USE — Treatment of reversible spasticity associated with multiple sclerosis or spinal cord lesions
Orphan drug: Intrathecal: Treatment of intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal disease (spinal ischemia or tumor, transverse myelitis, cervical spondylosis, degenerative myelopathy)
USE - UNLABELED / INVESTIGATIONAL — Intractable hiccups, intractable pain relief, bladder spasticity, trigeminal neuralgia, cerebral palsy, Huntington's chorea
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Drowsiness, vertigo, dizziness, psychiatric disturbances, insomnia, slurred speech, ataxia, hypotonia
Neuromuscular & skeletal: Weakness
1% to 10%:
Cardiovascular: Hypotension
Central nervous system: Fatigue, confusion, headache
Dermatologic: Rash
Gastrointestinal: Nausea, constipation
Genitourinary: Polyuria
<1% (Limited to important or life-threatening): Chest pain, dyspnea, dysuria, enuresis, hematuria, impotence, inability to ejaculate, nocturia, palpitation, syncope, urinary retention; withdrawal reactions have occurred with abrupt discontinuation (particularly severe with intrathecal use).
CONTRAINDICATIONS — Hypersensitivity to baclofen or any component of the formulation
WARNINGS / PRECAUTIONS
Boxed warnings: Abrupt withdrawal: .
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns: Renal impairment: Use with caution in patients with renal impairment. Seizure disorder. Use with caution in patients with a history of seizure disorder.
Special populations: Elderly: Use with caution in the elderly; may be more sensitive to adverse CNS effects, especially at higher doses.
Other warnings/precautions: Abrupt withdrawal: [U.S. Boxed Warning]: Avoid abrupt withdrawal of the drug; abrupt withdrawal of intrathecal baclofen has resulted in severe sequelae (hyperpyrexia, obtundation, rebound/exaggerated spasticity, muscle rigidity, and rhabdomyolysis), leading to organ failure and some fatalities. Risk may be higher in patients with injuries at T-6 or above, history of baclofen withdrawal, or limited ability to communicate.
DRUG INTERACTIONS
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce dosage of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Avoid ethanol (may increase CNS depression).
Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Enters breast milk (small amounts)/compatible
PRICING — (data from drugstore.com)
Tablets (Baclofen)
10 mg (30): $9.99
20 mg (30): $15.99
CANADIAN BRAND NAMES — Apo-Baclofen®; Gen-Baclofen; Lioresal®; Liotec; Nu-Baclo; PMS-Baclofen
INTERNATIONAL BRAND NAMES — Alpha-Baclofen (NZ); Alpha-Clofen (AU); Baclan (KP); Baclo (AU); Baclofen (PL); Baclofen-ratiopharm (LU); Baclofene (FR); Baclon (FI, TW); Baclopar (IE); Baclosal (IL, TH); Bacofen (KP); Baklofen (DK, NO); Clofen (AU, MY); Curofen (KP); Diafen (UY); Espast (PE); Liobac (TH); Lioresal (AE, AR, AT, AU, BB, BD, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CY, CZ, DE, DK, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KP, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, MY, NE, NG, NL, NO, OM, PH, PK, PT, PY, QA, RU, SA, SC, SD, SE, SG, SL, SN, SR, SY, TH, TN, TR, TT, TW, TZ, UG, VE, YE, ZA, ZM, ZW); Lioresyl (CN); Lyflex (GB, IE); Onelaxant-R (PH); Pacifen (NZ, TW); Solofen (TW); Spinax (TW); Stelax (AU, HK)
MECHANISM OF ACTION — Inhibits the transmission of both monosynaptic and polysynaptic reflexes at the spinal cord level, possibly by hyperpolarization of primary afferent fiber terminals, with resultant relief of muscle spasticity
PHARMACODYNAMICS / KINETICS
Onset of action: 3-4 days
Peak effect: 5-10 days
Absorption (dose dependent): Oral: Rapid
Protein binding: 30%
Metabolism: Hepatic (15% of dose)
Half-life elimination: 3.5 hours
Time to peak, serum: Oral: Within 2-3 hours
Excretion: Urine and feces (85% as unchanged drug)
PATIENT INFORMATION
(For additional information see "Baclofen: Patient drug information")
Intrathecal: It is important not to miss scheduled appointments for refills. Contact prescriber immediately if symptoms of withdrawal occur (high fever, confusion, increased spasticity, or muscle rigidity).
Oral: Take with food or milk; abrupt withdrawal after prolonged use may cause anxiety, hallucinations, tachycardia, or spasticity. May cause drowsiness and impair coordination and judgment.
Sound-alike/look-alike issues:
Baclofen may be confused with Bactroban®
Lioresal® may be confused with lisinopril, Lotensin®
High alert medication: The Institute for Safe Medication Practices (ISMP) includes this medication (intrathecal administration) among its list of drugs which have a heightened risk of causing significant patient harm when used in error.
U.S. BRAND NAMES — Lioresal®
PHARMACOLOGIC CATEGORY
Skeletal Muscle Relaxant
DOSING: ADULTS
Spasticity:
Oral: 5 mg 3 times/day, may increase 5 mg/dose every 3 days to a maximum of 80 mg/day
Intrathecal:
Test dose: 50-100 mcg, doses >50 mcg should be given in 25 mcg increments, separated by 24 hours. A screening dose of 25 mcg may be considered in very small patients. Patients not responding to screening dose of 100 mcg should not be considered for chronic infusion/implanted pump.
Maintenance: After positive response to test dose, a maintenance intrathecal infusion can be administered via an implanted intrathecal pump. Initial dose via pump: Infusion at a 24-hourly rate dosed at twice the test dose. Avoid abrupt discontinuation.
Hiccups (unlabeled use): Oral: 10-20 mg 2-3 times/day
DOSING: PEDIATRIC — Spasticity:
(For additional information see "Baclofen: Pediatric drug information")
Oral (avoid abrupt withdrawal of drug) (unlabeled use): Caution: Pediatric dosing expressed as a daily amount, and NOT in mg/kg. Limited published data in children; the following is a compilation of small prospective studies (Albright, 1996; Milla, 1977; Scheinberg, 2006) and one large retrospective study (Lubsch, 2006):
<2 years: 10-20 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 40 mg daily
2-7 years: Initial: 20-30 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 60 mg daily
≥ 8 years: 30-40 mg daily divided every 8 hours; titrate dose every 3 days in increments of 5-15 mg/day to a maximum of 120 mg daily
Note: Baclofen dose may need to be increased over time. One retrospective analysis (Lubsch, 2006) suggested that increased doses were needed as the time increased from spasticity onset, as age increased, and as the number of concomitant antispasticity medications increased. A small number of patients required daily doses exceeding 200 mg.
Intrathecal: Refer to adult dosing.
DOSING: ELDERLY — Oral (the lowest effective dose is recommended): Initial: 5 mg 2-3 times/day, increasing gradually as needed; if benefits are not seen withdraw the drug slowly.
DOSING: RENAL IMPAIRMENT — May be necessary to reduce dosage; no specific guidelines have been established
Hemodialysis: Poor water solubility allows for accumulation during chronic hemodialysis. Low-dose therapy is recommended. There have been several case reports of accumulation of baclofen resulting in toxicity symptoms (organic brain syndrome, myoclonia, deceleration and steep potentials in EEG) in patients with renal failure who have received normal doses of baclofen.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Injection, solution, intrathecal [preservative free]:
Lioresal®: 50 mcg/mL (1 mL); 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL, 20 mL)
Tablet: 10 mg, 20 mg
DOSAGE FORMS: CONCISE
Injection, solution, intrathecal [preservative free]:
Lioresal®: 50 mcg/mL (1 mL); 500 mcg/mL (20 mL); 2000 mcg/mL (5 mL, 20 mL)
Tablet: 10 mg, 20 mg
GENERIC EQUIVALENT AVAILABLE — Yes: Tablets only
ADMINISTRATION — Intrathecal: For screening dosages, dilute with preservative-free sodium chloride to a final concentration of 50 mcg/mL for bolus injection into the subarachnoid space. For maintenance infusions, concentrations of 500-2000 mcg/mL may be used.
COMPATIBILITY — Stable in sterile, preservative free NS.
Compatibility when admixed: Compatible: Morphine.
USE — Treatment of reversible spasticity associated with multiple sclerosis or spinal cord lesions
Orphan drug: Intrathecal: Treatment of intractable spasticity caused by spinal cord injury, multiple sclerosis, and other spinal disease (spinal ischemia or tumor, transverse myelitis, cervical spondylosis, degenerative myelopathy)
USE - UNLABELED / INVESTIGATIONAL — Intractable hiccups, intractable pain relief, bladder spasticity, trigeminal neuralgia, cerebral palsy, Huntington's chorea
ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Drowsiness, vertigo, dizziness, psychiatric disturbances, insomnia, slurred speech, ataxia, hypotonia
Neuromuscular & skeletal: Weakness
1% to 10%:
Cardiovascular: Hypotension
Central nervous system: Fatigue, confusion, headache
Dermatologic: Rash
Gastrointestinal: Nausea, constipation
Genitourinary: Polyuria
<1% (Limited to important or life-threatening): Chest pain, dyspnea, dysuria, enuresis, hematuria, impotence, inability to ejaculate, nocturia, palpitation, syncope, urinary retention; withdrawal reactions have occurred with abrupt discontinuation (particularly severe with intrathecal use).
CONTRAINDICATIONS — Hypersensitivity to baclofen or any component of the formulation
WARNINGS / PRECAUTIONS
Boxed warnings: Abrupt withdrawal: .
Concerns related to adverse effects: CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks which require mental alertness (eg, operating machinery or driving).
Disease-related concerns: Renal impairment: Use with caution in patients with renal impairment. Seizure disorder. Use with caution in patients with a history of seizure disorder.
Special populations: Elderly: Use with caution in the elderly; may be more sensitive to adverse CNS effects, especially at higher doses.
Other warnings/precautions: Abrupt withdrawal: [U.S. Boxed Warning]: Avoid abrupt withdrawal of the drug; abrupt withdrawal of intrathecal baclofen has resulted in severe sequelae (hyperpyrexia, obtundation, rebound/exaggerated spasticity, muscle rigidity, and rhabdomyolysis), leading to organ failure and some fatalities. Risk may be higher in patients with injuries at T-6 or above, history of baclofen withdrawal, or limited ability to communicate.
DRUG INTERACTIONS
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce dosage of CNS depressant agents by 50% with initiation of concomitant methotrimeprazine therapy. Further CNS depressant dosage adjustments should be initiated only after clinically effective methotrimeprazine dose is established. Risk D: Consider therapy modification
ETHANOL / NUTRITION / HERB INTERACTIONS
Ethanol: Avoid ethanol (may increase CNS depression).
Herb/Nutraceutical: Avoid valerian, St John's wort, kava kava, gotu kola.
PREGNANCY RISK FACTOR — C (show table)
LACTATION — Enters breast milk (small amounts)/compatible
PRICING — (data from drugstore.com)
Tablets (Baclofen)
10 mg (30): $9.99
20 mg (30): $15.99
CANADIAN BRAND NAMES — Apo-Baclofen®; Gen-Baclofen; Lioresal®; Liotec; Nu-Baclo; PMS-Baclofen
INTERNATIONAL BRAND NAMES — Alpha-Baclofen (NZ); Alpha-Clofen (AU); Baclan (KP); Baclo (AU); Baclofen (PL); Baclofen-ratiopharm (LU); Baclofene (FR); Baclon (FI, TW); Baclopar (IE); Baclosal (IL, TH); Bacofen (KP); Baklofen (DK, NO); Clofen (AU, MY); Curofen (KP); Diafen (UY); Espast (PE); Liobac (TH); Lioresal (AE, AR, AT, AU, BB, BD, BE, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CY, CZ, DE, DK, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, GY, HK, HN, HR, HU, ID, IE, IL, IN, IQ, IR, IT, JM, JO, JP, KE, KP, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, MY, NE, NG, NL, NO, OM, PH, PK, PT, PY, QA, RU, SA, SC, SD, SE, SG, SL, SN, SR, SY, TH, TN, TR, TT, TW, TZ, UG, VE, YE, ZA, ZM, ZW); Lioresyl (CN); Lyflex (GB, IE); Onelaxant-R (PH); Pacifen (NZ, TW); Solofen (TW); Spinax (TW); Stelax (AU, HK)
MECHANISM OF ACTION — Inhibits the transmission of both monosynaptic and polysynaptic reflexes at the spinal cord level, possibly by hyperpolarization of primary afferent fiber terminals, with resultant relief of muscle spasticity
PHARMACODYNAMICS / KINETICS
Onset of action: 3-4 days
Peak effect: 5-10 days
Absorption (dose dependent): Oral: Rapid
Protein binding: 30%
Metabolism: Hepatic (15% of dose)
Half-life elimination: 3.5 hours
Time to peak, serum: Oral: Within 2-3 hours
Excretion: Urine and feces (85% as unchanged drug)
PATIENT INFORMATION
(For additional information see "Baclofen: Patient drug information")
Intrathecal: It is important not to miss scheduled appointments for refills. Contact prescriber immediately if symptoms of withdrawal occur (high fever, confusion, increased spasticity, or muscle rigidity).
Oral: Take with food or milk; abrupt withdrawal after prolonged use may cause anxiety, hallucinations, tachycardia, or spasticity. May cause drowsiness and impair coordination and judgment.
Bacitracin, neomycin, polymyxin B, and pramoxin
U.S. BRAND NAMES — Neosporin® + Pain Relief Ointment [OTC]; Tri Biozene [OTC]
PHARMACOLOGIC CATEGORY
Antibiotic, Topical
DOSING: ADULTS — Topical: Apply 1-3 times/day to infected areas; cover with sterile bandage if needed
DOSING: PEDIATRIC — Topical: Children ≥ 2 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, topical: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine hydrochloride 10 mg (15 g, 30 g)
Neosporin® + Pain Relief Ointment: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine hydrochloride 10 mg per g (15 g, 30 g)
Tri Biozene: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine hydrochloride 10 mg per g (15 g)
DOSAGE FORMS: CONCISE
Ointment, topical: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine 10 mg (15 g, 30 g)
Neosporin® + Pain Relief Ointment [OTC]: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine 10 mg (15 g, 30 g)
Tri Biozene: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine 10 mg (15 g)
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Prevention and treatment of susceptible superficial topical infections and provide temporary relief of pain or discomfort
CONTRAINDICATIONS — Hypersensitivity to bacitracin, neomycin, polymyxin B, pramoxine, or any component of the formulation
WARNINGS / PRECAUTIONS
Other warnings/precautions:
PHARMACOLOGIC CATEGORY
Antibiotic, Topical
DOSING: ADULTS — Topical: Apply 1-3 times/day to infected areas; cover with sterile bandage if needed
DOSING: PEDIATRIC — Topical: Children ≥ 2 years: Refer to adult dosing.
DOSING: ELDERLY — Refer to adult dosing.
DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Ointment, topical: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine hydrochloride 10 mg (15 g, 30 g)
Neosporin® + Pain Relief Ointment: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine hydrochloride 10 mg per g (15 g, 30 g)
Tri Biozene: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine hydrochloride 10 mg per g (15 g)
DOSAGE FORMS: CONCISE
Ointment, topical: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine 10 mg (15 g, 30 g)
Neosporin® + Pain Relief Ointment [OTC]: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine 10 mg (15 g, 30 g)
Tri Biozene: Bacitracin 500 units, neomycin 3.5 mg, polymyxin B 10,000 units, and pramoxine 10 mg (15 g)
GENERIC EQUIVALENT AVAILABLE — Yes
USE — Prevention and treatment of susceptible superficial topical infections and provide temporary relief of pain or discomfort
CONTRAINDICATIONS — Hypersensitivity to bacitracin, neomycin, polymyxin B, pramoxine, or any component of the formulation
WARNINGS / PRECAUTIONS
Other warnings/precautions:
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