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Lioresal
Overview
What is Lioresal?
Lioresal, baclofen USP, is a muscle relaxant and antispastic, available as 10-mg and 20-mg tablets for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)- butanoic acid, and its structural formula is
Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder, with a molecular weight of 213.66. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform.
Inactive Ingredients.
What does Lioresal look like?
What are the available doses of Lioresal?
Sorry No records found.
What should I talk to my health care provider before I take Lioresal?
Sorry No records found
How should I use Lioresal?
Sorry No records found
What interacts with Lioresal?
Hypersensitivity to baclofen.
What are the warnings of Lioresal?
a. Abrupt Drug Withdrawal:
Hallucinations and seizures have occurred on abrupt withdrawal of Lioresal. Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.
b. Impaired Renal Function:
Because Lioresal is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.
c. Stroke:
Lioresal has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.
d. Pregnancy:
Lioresal has been shown to increase the incidence of omphaloceles (ventral hernias) in fetuses of rats given approximately 13 times the maximum dose recommended for human use, at a dose which caused significant reductions in food intake and weight gain in dams. This abnormality was not seen in mice or rabbits. There was also an increased incidence of incomplete sternebral ossification in fetuses of rats given approximately 13 times the maximum recommended human dose, and an increased incidence of unossified phalangeal nuclei of forelimbs and hindlimbs in fetuses of rabbits given approximately 7 times the maximum recommended human dose. In mice, no teratogenic effects were observed, although reductions in mean fetal weight with consequent delays in skeletal ossification were present when dams were given 17 or 34 times the human daily dose. There are no studies in pregnant women. Lioresal should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.
What are the precautions of Lioresal?
Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of Lioresal may be additive to those of alcohol and other CNS depressants.
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Lioresal should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.
Array
In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking Lioresal.
Array
It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
Array
A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with Lioresal.
Array
Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with Lioresal for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.
What are the side effects of Lioresal?
The most common is transient drowsiness (10%-63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving Lioresal compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5%-15%), weakness (5%-15%) and fatigue (2%-4%). Others reported:
Neuropsychiatric:
Confusion (1%-11%), headache (4%-8%), insomnia (2%-7%); and, rarely, euphoria, excitement, depression, hallucinations, paresthesia, muscle pain, tinnitus, slurred speech, coordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizure.
Cardiovascular:
Hypotension (0%-9%). Rare instances of dyspnea, palpitation, chest pain, syncope.
Gastrointestinal:
Nausea (4%-12%), constipation (2%-6%); and, rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhea, and positive test for occult blood in stool.
Genitourinary:
Urinary frequency (2%-6%); and, rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, hematuria.
Other:
Instances of rash, pruritus, ankle edema, excessive perspiration, weight gain, nasal congestion. Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy.
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The following laboratory tests have been found to be abnormal in a few patients receiving Lioresal: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.
What should I look out for while using Lioresal?
Hypersensitivity to baclofen.
What might happen if I take too much Lioresal?
How should I store and handle Lioresal?
Tablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 NovartisTablets 10 mg – oval, white, scored (imprinted Lioresal on one side and 10 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0023-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0023-61Tablets 20 mg – capsule - shaped, white, scored (imprinted Lioresal on one side and 20 twice on the scored side) Bottles of 100………………………………………………….NDC 0028-0033-01 Unit Dose (blister pack) Box of 100 (strips of 10)………………………………………NDC 0028-0033-61Do not store above 30ºC (86ºF). Dispense in tight container (USP).667794 C98-22 (Rev. 4/98)Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936©1998 Novartis
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Hypersensitivity to baclofen.Ketorolac is highly bound to human plasma protein (mean 99.2%).
The binding of to plasma proteins is only slightly reduced by ketorolac tromethamine (99.5% control vs. 99.3%) when ketorolac plasma concentrations reach 5 to 10 mcg/mL. Ketorolac does not alter protein binding. studies indicate that, at therapeutic concentrations of (300 mcg/mL), the binding of ketorolac was reduced from approximately 99.2% to 97.5%, representing a potential two-fold increase in unbound ketorolac plasma levels. Therapeutic concentrations of , , , , , , and did not alter ketorolac tromethamine protein binding.
In a study involving 12 volunteers, ketorolac tromethamine tablets were coadministered with a single dose of 25 mg , causing no significant changes in pharmacokinetics or pharmacodynamics of warfarin. In another study, Ketorolac Tromethamine Injection was given with two doses of 5000 U of to 11 healthy volunteers, resulting in a mean template bleeding time of 6.4 minutes (3.2 to 11.4 min) compared to a mean of 6.0 minutes (3.4 to 7.5 min) for heparin alone and 5.1 minutes (3.5 to 8.5 min) for placebo. Although these results do not indicate a significant interaction between ketorolac tromethamine and warfarin or heparin, the administration of ketorolac tromethamine to patients taking anticoagulants should be done extremely cautiously, and patients should be closely monitored (see and ).
Ketorolac Tromethamine Injection reduced the diuretic response to in normo-volemic healthy subjects by approximately 20% (mean sodium and urinary output decreased 17%).
Concomitant administration of ketorolac tromethamine tablets and resulted in decreased clearance of ketorolac and significant increases in ketorolac plasma levels (total AUC increased approximately three-fold from 5.4 to 17.8 mcg/h/mL) and terminal half-life increased approximately two-fold from 6.6 to 15.1 hours. Therefore, concomitant use of ketorolac tromethamine and probenecid is contraindicated.
Inhibition of renal clearance, leading to an increase in plasma lithium concentration, has been reported with some prostaglandin synthesis-inhibiting drugs. The effect of ketorolac tromethamine on plasma lithium has not been studied, but cases of increased lithium plasma levels during ketorolac tromethamine therapy have been reported.
Concomitant administration of and some NSAIDs has been reported to reduce the clearance of methotrexate, enhancing the toxicity of methotrexate. The effect of ketorolac tromethamine on methotrexate clearance has not been studied.
In postmarketing experience there have been reports of a possible interaction between Ketorolac Tromethamine Injection andthat resulted in apnea. The concurrent use of ketorolac tromethamine with muscle relaxants has not been formally studied.
Concomitant use of may increase the risk of renal impairment, particularly in volume-depleted patients.
Sporadic cases of seizures have been reported during concomitant use of ketorolac tromethamine and (phenytoin, carbamazepine).
Hallucinations have been reported when ketorolac tromethamine was used in patients taking (fluoxetine, thiothixene, alprazolam).
Ketorolac Tromethamine Injection has been administered concurrently within several clinical trials of postoperative pain without evidence of adverse interactions. Do not mix ketorolac tromethamine and morphine in the same syringe.
There is no evidence in animal or human studies that ketorolac tromethamine induces or inhibits hepatic enzymes capable of metabolizing itself or other drugs.
Because of the possibility of sedation, patients should be cautioned regarding the operation of automobiles or other dangerous machinery, and activities made hazardous by decreased alertness. Patients should also be cautioned that the central nervous system effects of Lioresal may be additive to those of alcohol and other CNS depressants.
Lioresal should be used with caution where spasticity is utilized to sustain upright posture and balance in locomotion or whenever spasticity is utilized to obtain increased function.
In patients with epilepsy, the clinical state and electroencephalogram should be monitored at regular intervals, since deterioration in seizure control and EEG have been reported occasionally in patients taking Lioresal.
It is not known whether this drug is excreted in human milk. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.
A dose-related increase in incidence of ovarian cysts and a less marked increase in enlarged and/or hemorrhagic adrenal glands was observed in female rats treated chronically with Lioresal.
Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with Lioresal for up to one year. In most cases these cysts disappeared spontaneously while patients continued to receive the drug. Ovarian cysts are estimated to occur spontaneously in approximately 1% to 5% of the normal female population.
The most common is transient drowsiness (10%-63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving Lioresal compared to 36% of those in the placebo group. Other common adverse reactions are dizziness (5%-15%), weakness (5%-15%) and fatigue (2%-4%). Others reported:
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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Interactions
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