Tycon may be available in the countries listed below.
Cefadroxil monohydrate (a derivative of Cefadroxil) is reported as an ingredient of Tycon in the following countries:
Tioconazole is reported as an ingredient of Tycon in the following countries:
International Drug Name Search
Temporarily relieving symptoms of hay fever, allergies, or the common cold, including nasal congestion, runny nose, sneezing, itching of the nose and throat, and itchy/watery eyes. It may also be used for other conditions as determined by your doctor.
D-Tann Chewable Tablets are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with D-Tann Chewable Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with D-Tann Chewable Tablets. Tell your health care provider if you are taking any other medicines, especially if any of the following apply to you:
This may not be a complete list of all interactions that may occur. Ask your health care provider if D-Tann Chewable Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use D-Tann Chewable Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use D-Tann Chewable Tablets.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Constipation; diarrhea; dizziness; drowsiness; dry mouth, nose, or throat; excitability (especially in children); headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; decreased coordination; difficulty urinating; fast or irregular heartbeat; fever; hallucinations; seizure; severe dizziness and drowsiness; severe nervousness, anxiety, or restlessness; tremors; unusual weakness.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: D-Tann side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include bluish-colored skin; difficulty breathing; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness or dizziness; severe excitability; severe nausea or vomiting; sweating; tremors.
Store D-Tann Chewable Tablets at room temperature, between 59 and 77 degrees F (15 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep D-Tann Chewable Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about D-Tann Chewable Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Cadigesic Extra may be available in the countries listed below.
Dextropropoxyphene hydrochloride (a derivative of Dextropropoxyphene) is reported as an ingredient of Cadigesic Extra in the following countries:
Paracetamol is reported as an ingredient of Cadigesic Extra in the following countries:
International Drug Name Search
Relieving itching, scaling, dryness, and flaking of the skin due to dandruff, eczema, psoriasis, and seborrhea. It may also be used for other conditions as determined by your doctor.
Original Tegrin Medicated Shampoo is a keratolytic. It works by slowing bacterial growth and loosing and softening scales and crust.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Original Tegrin Medicated Shampoo. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Original Tegrin Medicated Shampoo. However, no specific interactions with Original Tegrin Medicated Shampoo are known at this time.
This may not be a complete list of all interactions that may occur. Ask your health care provider if Original Tegrin Medicated Shampoo may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Original Tegrin Medicated Shampoo as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Original Tegrin Medicated Shampoo.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Itching, burning, tenderness, or redness; sensitivity to sunlight.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); excessive dryness; irritation.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Original Tegrin Medicated side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.
Store Original Tegrin Medicated Shampoo at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Original Tegrin Medicated Shampoo out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Original Tegrin Medicated Shampoo. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
Indobufene EG may be available in the countries listed below.
Indobufen is reported as an ingredient of Indobufene EG in the following countries:
International Drug Name Search
Class: GABA-derivative Skeletal Muscle Relaxants
VA Class: MS200
Chemical Name: 4-Amino-3-(4-chlorophenyl)-butanoic acid
Molecular Formula: C10H12ClNO2
CAS Number: 1134-47-0
Brands: Lioresal
Abrupt discontinuation of intrathecal baclofen may result in seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity; in rare cases, progression to rhabdomyolysis, multisystem organ failure, and death may occur.113
Give careful attention to programming and monitoring of infusion system, refill scheduling and procedures, and pump alarms to prevent abrupt discontinuance.113 (See Warnings under Cautions.)
Advise patients and caregivers of the importance of keeping scheduled refill visits and of the early signs and symptoms of baclofen withdrawal.113
Give special attention to patients at apparent risk for withdrawal (e.g., spinal cord injury at T6 level or above, communication difficulties, history of withdrawal symptoms from oral or intrathecal baclofen).113
Skeletal muscle relaxant and antispasticity agent; a GABA derivative.113 128
Oral management of spasticity and its sequelae secondary to severe chronic disorders such as multiple sclerosis and other types of spinal cord lesions.112 128
Intrathecal management of severe spasticity of spinal cord origin in patients who do not tolerate or respond adequately to oral baclofen;109 110 113 114 115 116 117 118 119 120 considered an alternative to destructive neurosurgical procedures.113 Also, intrathecal management of intractable spasticity secondary to severe chronic disorders such as multiple sclerosis and other types of spinal diseases such as spinal ischemia, spinal tumor, transverse myelitis, cervical spondylosis, and degenerative myelopathy.112
Intrathecal management of severe spasticity of cerebral origin, including cerebral palsy and acquired brain injury;113 121 122 123 124 125 126 127 considered an alternative to destructive neurosurgical procedures.113 Patients with spasticity secondary to traumatic brain injury should wait ≥1 year after the injury before considering long-term intrathecal baclofen therapy.113
Efficacy not established for the management of stroke or Parkinson's disease; use not recommended.128
Clinical goal is to maintain muscle tone as close to normal as possible and to minimize frequency and severity of spasms without inducing intolerable adverse effects.113 115 May be important to maintain some degree of muscle tone and allow occasional spasms to help support circulatory function, minimize risk of DVT occurrence, and optimize activities of daily living and ease of care.113
Individualize dosage according to patient’s requirements and response; use lowest dosage that produces optimum response without adverse effects.113 128
Some patients require 1–2 months of oral treatment for full benefit.b If benefits are not evident after a reasonable trial period, discontinue therapy by slowly reducing daily dosage.128
Prior to implantation of pump for chronic intrathecal baclofen therapy, patient must exhibit positive response (clinically important decrease in muscle tone and/or frequency and/or severity of spasms over 4- to 8-hour observation period) to initial intrathecal test dose(s) (screening phase).110 113 115
Tolerance may develop during chronic intrathecal baclofen therapy.113 115 No firm recommendations regarding amelioration of tolerance; patients occasionally have been hospitalized and intrathecal baclofen dosage decreased gradually over 2- to 4-week period, during which baclofen was alternated with other methods of spasticity management.113 115 Sensitivity to baclofen may return after a few days, and continuous intrathecal baclofen therapy may be resumed at the previously effective initial dosage.113 115
Administer orally or intrathecally.113 127 128
Baclofen injection for intrathecal administration is not recommended or intended for IV, IM, sub-Q, or epidural administration.113 115
Avoid abrupt discontinuance (because of risk of precipitating withdrawal).113 127 128 Reduce dosage slowly when discontinuing drug, except for serious adverse reactions.113 128 (See Warnings under Cautions.)
Administer orally 3 times daily.128
For solution and drug compatibility information, see Compatibility under Stability.
Administer test dose(s) during screening phase by direct intrathecal injection (via lumbar puncture or catheter) over ≥1 minute employing barbotage.110 113 114 115
Administer maintenance regimen by continuous intrathecal infusion into a lumbar intrathecal space via an implantable controlled-infusion device (e.g., Medtronic SynchroMed pump).110 113 114 115
Consult manufacturer's labeling for specialized administration techniques.113
Consult manual provided by manufacturer of implantable infusion device for specific instructions and precautions for programming pump and/or refilling reservoir and for drug delivery specifications.113
To prepare test doses for screening phase, use 1-mL ampuls containing 50 mcg of baclofen without further dilution.113 Ampuls are for single use only; discard any unused portion.113
For maintenance therapy in patients receiving concentrations other than the commercially available strengths (i.e., 0.5 or 2 mg/mL), injection concentrate must be diluted with sterile, preservative-free 0.9% sodium chloride injection.113
Test dose(s): Direct intrathecal injection by barbotage over ≥1 minute.113
Maintenance regimen: Continuous intrathecal infusion.113
Children ≥12 Years of Age: Initially, 5 mg 3 times daily.128 Increase daily dosage by 15 mg (in 3 divided doses) at 3-day intervals (i.e., 5 mg 3 times daily for 3 days, then 10 mg 3 times daily for 3 days, then 15 mg 3 times daily for 3 days, then 20 mg 3 times daily for 3 days) until optimum effect is achieved.128
Usual dosage in children ≥12 years of age is 40–80 mg daily.128
Administer test dose of 50 mcg (1 mL of 50-mcg/mL solution) into intrathecal space by barbotage over ≥1 minute; may consider an initial dose of 25 mcg in very small children.113
If response observed at 4–8 hours after initial test dose is less than desired, administer a second test dose of 75 mcg (1.5 mL of a 50-mcg/mL solution) 24 hours after first test dose.113
If response remains inadequate, administer a final test dose of 100 mcg (2 mL of a 50-mcg/mL solution) 24 hours after second test dose.113
Patients not responding to 100-mcg test dose are not candidates for chronic intrathecal therapy.110 113 115
Following establishment of responsiveness to intrathecal baclofen, administer initial daily dose over 24 hours.113 115
Initial daily dose is twice the test dose that produced a positive response with a duration not >8 hours.113 115 If positive response to test dose persisted >8 hours, initial dose is the same as the test dose that produced a positive response.113 115
Following the initial infusion dose in children with spasticity of spinal cord or cerebral origin, increase daily dosage slowly (by 5–15% increments at 24-hour intervals) until desired clinical response is achieved.113 115
May need to adjust maintenance dosage often during initial months of therapy.113 115 During periodic pump refills, increase the 24-hour dose by up to 10–40% in patients with spasticity of spinal cord origin or up to 5–20% in those with spasticity of cerebral origin as necessary to maintain adequate control of symptoms.113 115 In patients who develop intolerable adverse effects, reduce the 24-hour dose by 10–20%.113 115
Patients achieving relatively satisfactory relief may derive further benefit from more complex dosing schedules.110 113 115 For example, patients who commonly experience an exacerbation of spasticity that disrupts sleep may require a 20% increase in the hourly infusion rate (programmed to begin approximately 2 hours before the time of desired clinical benefit).110 113 115
Maintenance dosage in most children >12 years of age: 300–800 mcg daily (range: 12–2003 mcg daily) in those with spasticity of spinal cord origin;110 113 115 90–703 mcg daily (range: 22–1400 mcg daily) in those with spasticity of cerebral origin.113
Average maintenance dosage in children <12 years of age: 274 mcg daily (range: 24–1199 mcg daily).113
Initially, 5 mg 3 times daily.128 Increase daily dosage by 15 mg (in 3 divided doses) at 3-day intervals (i.e., 5 mg 3 times daily for 3 days, then 10 mg 3 times daily for 3 days, then 15 mg 3 times daily for 3 days, then 20 mg 3 times daily for 3 days) until optimum effect is achieved.128
Usual dosage is 40–80 mg daily.128
Administer test dose of 50 mcg (1 mL of 50-mcg/mL solution) into intrathecal space by barbotage over ≥1 minute.113
If response observed at 4–8 hours after initial test dose is less than desired, administer a second test dose of 75 mcg (1.5 mL of a 50-mcg/mL solution) 24 hours after first test dose.113
If response remains inadequate, administer a final test dose of 100 mcg (2 mL of a 50-mcg/mL solution) 24 hours after second test dose.113
Patients not responding to 100-mcg test dose are not candidates for chronic intrathecal therapy.110 113 115
Following establishment of responsiveness to intrathecal baclofen, administer initial daily dose over 24 hours.113 115
Initial daily dose is twice the test dose that produced a positive response with a duration not >8 hours.113 115 If positive response to test dose persisted >8 hours, initial dose is the same as the test dose that produced a positive response.113 115
Following the initial infusion dose, increase daily dosage slowly until the desired clinical response is achieved: increase dosage by 10–30% increments at 24-hour intervals in adults with spasticity of spinal cord origin and by 5–15% increments at 24-hour intervals in adults with spasticity of cerebral origin.113 115
May need to adjust maintenance dosage often during initial months of therapy.113 115 During periodic pump refills, increase the 24-hour dose by up to 10–40% in patients with spasticity of spinal cord origin or up to 5–20% in those with spasticity of cerebral origin as necessary to maintain adequate control of symptoms.113 115 In patients who develop intolerable adverse effects, reduce the 24-hour dose by 10–20%.113 115
Patients achieving relatively satisfactory relief may derive further benefit from more complex dosing schedules.110 113 115 For example, patients who commonly experience an exacerbation of spasticity that disrupts sleep may require a 20% increase in the hourly infusion rate (programmed to begin approximately 2 hours before the time of desired clinical benefit).110 113 115
Maintenance dosage in most patients: 300–800 mcg daily (range: 12–2003 mcg daily) in those with spasticity of spinal cord origin;110 113 115 90–703 mcg daily (range: 22–1400 mcg daily) in those with spasticity of cerebral origin.113
Some clinicians suggest that daily dosages up to 150 mg are well tolerated and provide additional therapeutic benefit in some patients; however, one manufacturer states that dosage should not exceed 80 mg daily (20 mg 4 times daily).128
Limited experience with maintenance dosages >1000 mcg daily.113
Some clinicians suggest that daily dosages up to 150 mg are well tolerated and provide additional therapeutic benefit in some patients; however, one manufacturer states that dosage should not exceed 80 mg daily (20 mg 4 times daily).128
Limited experience with maintenance dosages >1000 mcg daily.113
Reduction of oral or intrathecal dosage may be necessary.113 128
Increase oral dosage more gradually.b
Increase oral dosage more gradually.b
Known hypersensitivity to baclofen or any ingredient in the formulation.113 128
Abrupt discontinuance of oral baclofen may result in hallucinations and seizures.127 128
Abrupt discontinuance of intrathecal baclofen may result in seizures, high fever, altered mental status, exaggerated rebound spasticity, and muscle rigidity; in rare cases, progression to rhabdomyolysis, multisystem organ failure, and death may occur.113
Symptoms usually appear within hours to days following interruption of therapy.113 Early symptoms may include return of baseline spasticity, pruritus, hypotension, and paresthesias.113 Advanced withdrawal syndrome may resemble autonomic dysreflexia, sepsis, malignant hyperthermia, neuroleptic malignant syndrome, or other conditions associated with a hypermetabolic state or widespread rhabdomyolysis.113
Rapid, accurate diagnosis and treatment in emergency room or intensive care setting are needed to prevent potentially life-threatening CNS and systemic effects.113
Restore intrathecal baclofen therapy at or near the dosage used prior to interruption.113
If reinstitution of intrathecal delivery is delayed, drugs that enhance GABA effects (e.g., oral or enteral baclofen; oral, enteral, or IV benzodiazepines) may prevent potentially fatal sequelae.113 However, do not rely on oral or enteral baclofen alone to halt progression of intrathecal baclofen withdrawal.113
Should be administered intrathecally only by qualified individuals familiar with the administration techniques and patient management problems.113 115
Initial test for responsiveness to intrathecal baclofen, implantation of pump, and subsequent periods of dosage titration must be performed in a medically supervised setting that is adequately equipped for the management of potential complications; resuscitative equipment should be readily available.113 115
Potentially life-threatening CNS depression, cardiovascular collapse, and respiratory failure reported following intrathecal administration.113 Fatalities (including 2 cases of sudden and unexpected death occurring within 2 weeks of pump implantation) reported rarely during intrathecal therapy; however, manufacturer states that causal relationship not established.113
Patients, caregivers, and health-care providers should receive adequate information regarding the risks of intrathecal baclofen therapy, including information on recognition and management of potential overdosage and proper care of the pump and catheter insertion site.113
Delay implantation of controlled-infusion device until response to test dose(s) is adequately evaluated.113
Familiarization with the implantable infusion device (e.g., dilution and delivery rates, instructions and precautions for pump programming and refilling) is essential.113
Fill drug reservoir under aseptic conditions, following the directions provided by the device’s manufacturer; only fully trained and qualified personnel should fill reservoir.113 Follow proper refill frequency to avoid depletion of drug reservoir during use.113 114 115
Monitor patient carefully, particularly during the initial phase of pump use, dosage titration, and reservoir refilling to ensure an acceptable, reasonably stable response.113
Any sudden increase in dosage requirement should suggest the possibility of pump and/or catheter malfunction.113 If no increase in response is observed with upward titration of dosage, check pump function and catheter patency.113 115
Signs of intrathecal baclofen overdose may appear suddenly or over a period of time.113
Acute, massive overdose may present as coma.113
Less sudden and/or less severe forms of overdose may present with drowsiness, lightheadedness, dizziness, somnolence, respiratory depression, seizures, rostral progression of hypotonia, and loss of consciousness progressing to coma.113
Overdose generally related to pump malfunction or dosing error.113
If overdose appears likely, immediately take patient to hospital for assessment and emptying of pump reservoir.113
Fill pump with extreme caution; refill only through the pump reservoir.113 Some pumps are equipped with a catheter access port that allows direct access to the intrathecal catheter; direct injection into this catheter may cause life-threatening overdose.113
Use intrathecal baclofen with caution in patients with a history of autonomic dysreflexia; the presence of nociceptive stimuli or abrupt withdrawal of therapy may precipitate episode of dysreflexia.113
Performance of activities requiring mental alertness may be impaired.113 128
Concurrent use of other CNS depressants may potentiate CNS depression.113 128 (See Specific Drugs under Interactions.)
Use with caution and titrate dosage carefully when spasticity is necessary to sustain upright posture and balance in locomotion or whenever spasticity is used to obtain optimal function and care.113 128
Possible exacerbation of psychotic disorders, schizophrenia, or confusional states; use with caution and monitor such patients carefully.113
Possible deterioration in seizure control and EEG in epileptic patients; monitor patient’s clinical state and EEG at regular intervals.128
If intrathecal therapy is to be employed, attempt to discontinue concomitant oral antispasmodic drugs to avoid possible overdose and drug interactions, either prior to screening phase or following implantation of infusion device.113 Monitor patient carefully; avoid abrupt dosage reduction or discontinuance of concomitant antispasmodics.113
Presence of infection may interfere with assessment of the patient's response to baclofen test dose(s),113 increase surgical complications after pump implantation, and complicate attempts to adjust dosage.113 115
Patients being considered for intrathecal baclofen therapy should be without concurrent infection.113
Ovarian cysts found in about 4% of multiple sclerosis patients receiving oral baclofen for up to 1 year; cysts disappeared spontaneously despite continued baclofen use in most patients.113 128 Estimated rate of occurrence in healthy females is approximately 1–5%.113 128
Category C.113
Distributed into milk following oral administration; not known whether baclofen distributes into milk following intrathecal administration.113
Nursing not recommended in women receiving oral baclofen.128 Women receiving intrathecal baclofen should nurse infant only if potential benefit justifies potential risks to infant.113
Safety and efficacy of oral baclofen not established in children <12 years of age; use not recommended.128
Safety and efficacy of intrathecal baclofen not established in children <4 years of age.113
Children being considered for intrathecal therapy should have sufficient body mass to accommodate the pump.113 Consult directions provided by the device’s manufacturer.113
Excreted principally in urine as unchanged drug; use with caution in patients with impaired renal function.113 128 (See Renal Impairment under Dosage and Administration.)
For oral baclofen, drowsiness, dizziness, weakness, fatigue.128
For intrathecal baclofen in patients with spasticity of spinal cord origin, somnolence, dizziness, nausea, hypotension, headache, seizures, hypotonia.113
For intrathecal baclofen in patients with spasticity of cerebral origin, agitation, constipation, somnolence, leukocytis, chills, urinary retention, hypotonia.113
Drug | Interaction |
|---|---|
CNS depressants (e.g., alcohol) | Additive CNS depression.113 128 |
Morphine (epidural) | Hypotension and dyspnea may occur when administered with intrathecal baclofen.113 |
Rapidly and almost completely absorbed following oral administration,128 with peak blood concentrations attained within 2–3 hours.b
Following intrathecal administration, plasma concentrations are 100 times less than those achieved following oral administration.113
Oral administration: Onset in hours to weeks.b
Intrathecal injection: Onset in 0.5–1 hour; peak effect in about 4 hours.113
Continuous intrathecal infusion: Onset at 6–8 hours; peak effect at 24–48 hours.113
Onset and peak response may vary depending on dose and severity of symptoms.113
Following intrathecal injection, effects may last 4–8 hours.113 Duration may vary depending on dose and severity of symptoms.113
Widely distributed following oral administration, but only small amounts cross the blood-brain barrier.8 16 109 b
Crosses the placentab and distributes into milk following oral administration.113
30%.b
About 15% of a dose is metabolized in the liver, mostly by deamination.b
Excreted mainly (70–80%) in urine as unchanged drug or metabolites; remainder is excreted in feces.b
Serum half-life: 2.5–4 hours.b
CSF elimination half-life: 1.51 hours for the first 4 hours following intrathecal injection.113 Following intrathecal administration, CSF clearance of baclofen approximates CSF turnover.113
Tight containers at 15–30°C.128
≤30°C.113 Refrigeration not required.113 Do not freeze or autoclave.113
For information on systemic interactions resulting from concomitant use, see Interactions.
Compatible |
|---|
Sodium chloride 0.9% |
Compatible |
|---|
Clonidine HCl |
Morphine sulfate |
Decreases frequency and amplitude of muscle spasms (tonic reflexes) that arise in response to muscle stretching in patients with various spinal cord lesions.b
Simultaneously and equally suppresses cutaneous reflexes and muscle tone but only slightly depresses amplitude of tendon jerks (phasic reflexes).b
Inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from primary afferent terminals; actions at supraspinal sites also may occur and contribute to drug's clinical effect.113 128
Intrathecal administration in animals increases antinociception and decreases muscle rigidity and spasticity.106 107 108
Importance of not abruptly discontinuing therapy.113 128 For patients receiving intrathecal baclofen, importance of keeping scheduled refill visits and of recognizing early signs and symptoms of withdrawal.113
If baclofen is to be administered intrathecally, risks associated with intrathecal baclofen therapy, recognition and management of overdosage, and proper care of pump and catheter insertion site.113
Risk of drowsiness; exercise caution when driving or operating machinery.113 128
Potential for additive CNS depression if other CNS depressants (e.g., alcohol) are used concomitantly.113 128
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.113 128
Importance of women informing their clinician if they are or plan to become pregnant or to breast-feed.113 128
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral | Tablets | 10 mg* | Baclofen (with povidone; scored) | Alpharma, Major, Teva, Upsher-Smith, Vintage, Watson |
20 mg* | Baclofen (with povidone; scored) | Alpharma, Major, Teva, Upsher-Smith, Vintage, Watson | ||
Parenteral | For injection concentrate, for intrathecal administration via compatible infusion device or for intrathecal injection | 50 mcg/mL | Lioresal Intrathecal (additive-free) | Medtronic |
0.5 mg/mL | Lioresal Intrathecal (additive-free) | Medtronic | ||
2 mg/mL | Lioresal Intrathecal (additive-free) | Medtronic |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Baclofen 10MG Tablets (UPSHER-SMITH): 30/$13.99 or 90/$34.98
Baclofen 20MG Tablets (UPSHER-SMITH): 30/$17.99 or 90/$45.97
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
Only references cited for selected revisions after 1984 are available electronically.
7. Hudgson P, Weightman D. Baclofen in the treatment of spasticity. Br Med J. 1971; 4:15-7. [IDIS 21127] [PubMed 4938243]
8. Anon. Control of spasticity. Br Med J. 1973; 4:751-2. [PubMed 4758569]
13. Jones RF, Lance JW. Baclofen (Lioresal) in the long-term management of spasticity. Med J Aust. 1976; 1:654-7. [IDIS 70798] [PubMed 820953]
14. Duncan GW, Shahani BT, Young RR. An evaluation of baclofen treatment for certain symptoms in patients with spinal cord lesions. Neurology. 1976; 28:441-6.
16. Brogden RN, Speight TM, Avery GS. Baclofen: a preliminary report of its pharmacological properties and therapeutic efficacy in spasticity. Drugs. 1974; 8:1-14. [IDIS 47602] [PubMed 4154834]
106. Yaksh TL, Reddy SVR. Studies in the primate on the analgetic effects associated with intrathecal actions of opiates, α-adrenergic agonists and baclofen. Anesthesiology. 1981; 54:451-67. [PubMed 6112935]
107. Wilson PR, Yaksh TL. Baclofen is antinociceptive in the spinal intrathecal space of animals. Eur J Pharm. 1978; 51:323-30.
108. Sawynok J, Dickson C. D-Baclofen is an antagonist at baclofen receptors mediating antinociception in the spinal cord. Pharmacology. 1985; 31:248-59. [PubMed 2999839]
109. Knutsson E, Lindblom U, Martensson A. Plasma and cerebrospinal fluid levels of baclofen (Lioresal) at optimal therapeutic responses in spastic paresis. J Neurol Sci. 1974; 23:473-84. [PubMed 4154365]
110. Penn RD, Savoy SM, Corcos D et al. Intrathecal baclofen for severe spinal spasticity. New Engl J Med. 1989; 320:1517-21. [IDIS 254995] [PubMed 2657424]
111. Medtronic, Inc, Boston, MA: Personal communication.
112. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food Drug and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to June 28, 1996. Rockville, MD; 1996 Jul.
113. Medtronic Inc. Lioresal intrathecal (baclofen injection) prescribing information. Minneapolis, MN; 2002 Nov.
114. Penn RD, Kroin JS. Long-term intrathecal baclofen infusion for treatment of spasticity. J Neurosurg. 1987; 66:181-5. [PubMed 3806200]
115. Medtronic Inc. Lioresal (baclofen) intrathecal injection SynchroMed infusion pump product monograph. Minneapolis, MN; 1992 (UC9202606EN NP-1564)
116. Parke B, Penn RD, Savoy SM et al. Functional outcome after delivery of intrathecal baclofen. Acta Phys Med Rehabil. 1989; 70:30-2.
117. Penn RD. Intrathecal baclofen for spasticity of spinal origin: seven years of experience. J Neurosurg. 1992; 77:236-40. [PubMed 1625011]
118. Kravitz HM, Corcos DM, Hansen G et al. Intrathecal baclofen. Effects on nocturnal leg muscle spasticity. Am J Phys Med Rehabil. 1992; 71:48-52. [PubMed 1739446]
119. Latash ML, Penn RD, Corcos DM et al. Effects of intrathecal baclofen on voluntary motor control in spastic paresis. J Neurosurg. 1990; 72:388-92. [PubMed 2303873]
120. Latash ML, Penn RD, Corcos DM et al. Short-term effects of intrathecal baclofen in spasticity. Exp Neurol. 1989; 103:165-72. [PubMed 2912760]
121. Albright AL, Barron WB, Fasick MP et al. Continuous intrathecal baclofen infusion for spasticity of cerebral origin.
122. Albright AL, Cervi A, Singletary J. Intrathecal baclofen for spasticity in cerebral palsy. JAMA. 1991; 265:1418-22. [IDIS 279342] [PubMed 1999883]
123. Lazorthes Y, Sallerin-Caute B, Verdie JC et al. Chronic intrathecal baclofen administration for control of severe spasticity. J Neurosurg. 1990; 72:393-402. [PubMed 2303874]
124. Rifici C, Kofler M, Kronenberg M et al. Intrathecal baclofen application in patients with supraspinal spasticity secondary to severe traumatic brain injury. Funct Neurol. 1994; 9:29-34. [PubMed 8082851]
125. Medtronic Inc., Minneapolis, MN: Personal communication.
126. Medtronic Inc. Investigation of the administration of Lioresal intrathecal (baclofen injection) for the management of spasticity of cerebral origin: treatment IND protocol. Protocol No. NVD94-043/version 1.1a. Minneapolis, MN: Medtronic Inc; 1994 Dec.
127. Geigy. Lioresal (baclofen) tablets prescribing information. Summit, NJ; 1996 Mar.
128. Watson Laboratories, Inc. Baclofen tablets, USP prescribing information. Corona, CA; 1998 Apr.
b. AHFS drug information 2003. McEvoy GK, ed. Baclofen. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1314-8.
HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:204-5.
Class: Prostaglandin Analogs
VA Class: OP109
Chemical Name: (Z) - 7 - [(1R,2R,3R,5S) - 3,5,Dihydroxy - 2 - [1E,3S) - 3 - hydroxy - 5 - phenyl - 1 - pentenyl]cyclopentyl] - 5 - N - ethylheptenamide
Molecular Formula: C25H37NO4
Brands: Lumigan
Ocular hypotensive agent; a synthetic prostaglandin analog.1
Reduction of elevated intraocular pressure (IOP) in patients with open-angle glaucoma or ocular hypertension who are intolerant of other IOP-lowering drugs or who have not responded adequately (i.e., failed to achieve target IOP as determined after multiple measurements over time) to another IOP-lowering drug.1
Safety and efficacy not established for the treatment of angle-closure, inflammatory, or neovascular glaucoma.1
At least as effective as latanoprost 0.005% in controlling diurnal IOP;2 7 may be more effective than timolol 0.5% in reducing IOP in patients with open-angle glaucoma or ocular hypertension.2 5
Apply topically to the affected eye(s).1
Avoid contamination of the solution container.1
If more than one topical ophthalmic drug is used, administer the drugs at least 5 minutes apart.1
One drop of a 0.03% solution in the affected eye(s) once daily in the evening.1 More frequent dosing may paradoxically diminish the IOP-lowering effect of the drug.1
Known hypersensitivity to bimatoprost or any ingredient in the formulation.1
Increases in brown pigmentation of the iris and periorbital tissue (eyelid) or increases in length, thickness, number, and pigmentation of eyelashes reported;7 may be permanent.1
Increased pigmentation of iris develops slowly; may not be evident until after several months to years of bimatoprost therapy.1 Long-term effects of these changes are unknown.1 Patients should be examined regularly; therapy may be discontinued if increased pigmentation persists.1
Macular edema, including cystoid macular edema, reported.1 Use with caution in aphakic patients, in pseudophakic patients with a torn posterior lens capsule, or in patients with known risk factors for macular edema.1
Use with caution in patients with active intraocular inflammation (e.g., uveitis).1
Category C.1
Distributed into milk in animals.1 Caution if used in nursing women.1
Safety and efficacy not established in children.1 7
No substantial differences in safety and efficacy relative to younger adults.1
Conjunctival hyperemia,1 2 growth of eyelashes,1 2 ocular pruritus,1 2 ocular dryness,1 2 visual disturbance,1 ocular burning,1 foreign body sensation,1 ocular pain,1 pigmentation of the periocular skin,1 blepharitis,1 cataract,1 superficial punctate keratitis,1 eyelid erythema,1 ocular irritation,1 eyelash darkening.1
Adverse systemic events include infection (primarily colds and upper respiratory tract infections).1
No formal drug interaction studies have been performed.7 The manufacturer states that pharmacokinetic interactions are unlikely.7
Following once-daily topical ocular administration for 2 weeks, peak blood concentrations were attained within 10 minutes and were below the lower limit of detection within 1.5 hours.1 Steady-state blood levels were achieved during the first week of dosing.1
Reduction in IOP generally occurs within 4 hours after topical application and peaks within 8–12 hours.1
Moderately distributed into body tissues with a steady-state volume of distribution of 0.67 L/kg.1 In human blood, bimatoprost resides mainly in the plasma.1
Bimatoprost is distributed into milk in animals; it is not known whether the drug distributes into milk in humans.1
88%.1
Undergoes oxidation, N-deethylation, and glucuronidation to form various metabolites.1
Approximately 67% excreted in urine and 25% excreted in feces after IV administration.1
45 minutes after IV administration.1
15–25°C in the original container.1
Prostamide; a synthetic prostaglandin analog.1 2
Mimics the effects of endogenous prostamides and exhibits little or no pharmacologic activity at prostanoid receptors.1 3 4 7
Appears to reduce intraocular pressure (IOP) by facilitating outflow of aqueous humor through both the trabecular meshwork and uveoscleral routes.1 6 7
Risk of changes in eyelashes and permanent darkening of iris, eyelashes, or skin around the eyes associated with therapy.1 Potential for disparity between eyes if only one eye is treated.1
Importance of learning and adhering to proper administration techniques to avoid contamination of the solution with common bacteria that can cause ocular infections.1 Serious damage to the eye and subsequent loss of vision may result from using contaminated ophthalmic solutions.1
Importance of informing clinicians if an intercurrent ocular condition (e.g., trauma, infection) develops or ocular surgery is planned.1 Importance of immediately reporting ocular reactions, particularly conjunctivitis and eyelid reactions.1
Importance of delaying insertion of contact lenses for at least 15 minutes after bimatoprost instillation, since benzalkonium chloride preservative may be absorbed by soft lenses.1
Importance of administering different topical ophthalmic preparations at least 5 minutes apart.1
Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs as well as any concomitant illnesses.1
Importance of women informing clinicians if they are or intend to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information. (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Ophthalmic | Solution | 0.03% | Lumigan (with benzalkonium chloride) | Allergan |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Lumigan 0.03% Solution (ALLERGAN): 7/$259.98 or 22/$739.97
Lumigan 0.03% Solution (ALLERGAN): 2/$91.99 or 7/$257.96
Lumigan 0.03% Solution (ALLERGAN): 5/$176 or 10/$339.95
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Allergan, Inc. Lumigan (bimatoprost) ophthalmic solution 0.03% prescribing information. Irvine, CA; 2001 Mar.
2. Cantor LB. Bimatoprost: a member of a new class of agents, the prostamides, for glaucoma management. Expert Opin Investig Drugs. 2001; 10:721-31. [PubMed 11281821]
3. Woodward DF, Krauss AHP, Burk RM et al. Lumigan (AGN 192024): studies on a pharmacologically novel ocular hypotensive agent. Abstract presented at Third International Glaucoma Symposium. Prague, Czech Republic: 2001 Mar 21-5. From .
4. Krauss AHP, Chen J, Woodward DF. The pharmacology of AGN 192024 (Lumigan), a novel ocular hypotensive agent. Abstract presented at Third International Glaucoma Symposium. Prague, Czech Republic: 2001 Mar 21-5. From .
5. Sherwood M, Brandt J for the Bimatoprost Study Groups 1 and 2. Six-month comparison of bimatoprost once-daily and twice-daily with timolol twice-daily in patients with elevated intraocular pressure. Surv Ophthalmol. 2001; 45(Suppl):S361-8.
6. Brubaker RF, Schoff EO, Nau CB et al. Effects of AGN 192024, a new ocular hypotensive agent, on aqueous dynamics. Am J Opththalmol. 2001; 131:19-24.
7. Allergan, Irvine, CA: Personal communication.
a. Allergan, Inc. Lumigan (bimatoprost) ophthalmic solution 0.03% prescribing information. Irvine, CA; 2002 May.
