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BACLOFEN
Overview
What is BACLOFEN?
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.
Baclofen USP is a white to off-white, odorless or practically odorless
crystalline powder. It is slightly soluble in water, very slightly soluble in
methanol, and insoluble in chloroform. The structural formula is represented
below:
BACLOFEN STRUCTURE IIMAGE
Baclofen Tablets USP 10 mg and 20 mg contain the following inactive ingredients:
magnesium stearate, microcrystalline cellulose, povidone and starch (corn).
What does BACLOFEN look like?
What are the available doses of BACLOFEN?
Sorry No records found.
What should I talk to my health care provider before I take BACLOFEN?
Sorry No records found
How should I use BACLOFEN?
Baclofen is useful for the alleviation of signs and symptoms of
spasticity resulting from multiple sclerosis, particularly for the relief of
flexor spasms and concomitant pain, clonus, and muscular rigidity.
Patients should have reversible spasticity so that baclofen treatment will
aid in restoring residual function.
Baclofen may also be of some value in patients with spinal cord injuries and
other spinal cord diseases.
Baclofen is not indicated in the treatment of skeletal muscle spasm resulting
from rheumatic disorders.
The efficacy of baclofen in stroke, cerebral palsy, and Parkinson’s disease
has not been established and, therefore, it is not recommended for these
conditions.
The determination of optimal dosage requires individual
titration. Start therapy at a low dosage and increase gradually until optimum
effect is achieved (usually between 40-80 mg daily).
The following dosage titration schedule is suggested:
5 mg t.i.d. for 3 days
10 mg t.i.d. for 3 days
15 mg t.i.d. for 3 days
20 mg t.i.d. for 3 days
Thereafter additional increases may be necessary but the total daily dose
should not exceed a maximum of 80 mg daily (20 mg q.i.d.).
The lowest dose compatible with an optimal response is recommended. If
benefits are not evident after a reasonable trial period, patients should be
slowly withdrawn from the drug (see ).
What interacts with BACLOFEN?
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What are the warnings of BACLOFEN?
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What are the precautions of BACLOFEN?
Sorry No Records found
What are the side effects of BACLOFEN?
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What should I look out for while using BACLOFEN?
Hypersensitivity to baclofen.
What might happen if I take too much BACLOFEN?
Signs and symptoms:
Treatment:
How should I store and handle BACLOFEN?
StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]StorageStore Pantoprazole sodium delayed-release tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.]Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Dispense in a tight container with a child-resistant closure.Store at controlled room temperature 15°-30°C (59°-86°F).Watson Laboratories, Inc.Corona, CA 92880 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Dispense in a tight container with a child-resistant closure.Store at controlled room temperature 15°-30°C (59°-86°F).Watson Laboratories, Inc.Corona, CA 92880 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Dispense in a tight container with a child-resistant closure.Store at controlled room temperature 15°-30°C (59°-86°F).Watson Laboratories, Inc.Corona, CA 92880 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Dispense in a tight container with a child-resistant closure.Store at controlled room temperature 15°-30°C (59°-86°F).Watson Laboratories, Inc.Corona, CA 92880 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Dispense in a tight container with a child-resistant closure.Store at controlled room temperature 15°-30°C (59°-86°F).Watson Laboratories, Inc.Corona, CA 92880 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Dispense in a tight container with a child-resistant closure.Store at controlled room temperature 15°-30°C (59°-86°F).Watson Laboratories, Inc.Corona, CA 92880 USARev: January 2004Baclofen Tablets USP 10 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Baclofen Tablets USP 20 mg are scored, round, white tablets imprinted and supplied in bottles of 100 and 500.Dispense in a tight container with a child-resistant closure.Store at controlled room temperature 15°-30°C (59°-86°F).Watson Laboratories, Inc.Corona, CA 92880 USARev: January 2004
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Non-Clinical Toxicology
Hypersensitivity to baclofen.Nifedipine is mainly eliminated by metabolism and is a substrate of CYP3A. Inhibitors and inducers of CYP3A4 can impact the exposure to nifedipine and consequently its desirable and undesirable effects. and data indicate that nifedipine can inhibit the metabolism of drugs that are substrates of CYP3A, thereby increasing the exposure to other drugs. Nifedipine is a vasodilator, and co-administration of other drugs affecting blood pressure may result in pharmacodynamic interactions.
Antiarrhythmics
Flecainide:
Calcium Channel Blockers
Diltiazem:
Verapamil:
ACE Inhibitors
Benazepril:
Angiotensin-II Blockers
Irbesartan: In vitro
Candesartan:
Beta-blockers
Nifedipine extended-release tablet was well tolerated when administered in combination with beta-blockers in 187 hypertensive patients in a placebo-controlled clinical trial. However, there have been occasional literature reports suggesting that the combination of nifedipine and beta-adrenergic blocking drugs may increase the likelihood of congestive heart failure, severe hypotension, or exacerbation of angina in patients with cardiovascular disease. Clinical monitoring is recommended, and a dose adjustment of nifedipine should be considered.
Timolol:
Central Alpha1-Blockers
Doxazosin:
Digitalis
Digoxin:
Antithrombotics
Coumarins:
Platelet Aggregation Inhibitors
Clopidogrel:
Tirofiban:
Antifungal Drugs
Ketoconazole, itraconazole, and fluconazole are CYP3A inhibitors and can inhibit the metabolism of nifedipine and increase the exposure to nifedipine during concomitant therapy. Blood pressure should be monitored and a dose reduction of nifedipine considered.
Antisecretory Drugs
Omeprazole:
Pantoprazole:
Ranitidine:
Cimetidine:
Antibacterial Drugs
Quinupristin/Dalfopristin: In vitro
Erythromycin:
Antitubercular Drugs
Rifampin:
Rifapentine:
Antiviral Drugs
CNS Drugs
Nefazodone
Valproic acid
Phenytoin:
Phenobarbitone and carbamazepine
Antiemetic Drugs
Dolasetron:
Immunosuppressive Drugs
Sirolimus:
Glucose Lowering Drugs
Pioglitazone:
Rosiglitazone:
Metformin:
Miglitol:
Repaglinide:
Acarbose:
Drugs Interfering with Food Absorption
Orlistat:
Dietary Supplements
Grapefruit Juice:
Herbals
St. John’s Wort:
CYP2D6 Probe Drug
Safe use of baclofen in pediatric patients under age 12 has not been established, and it is, therefore, not recommended for use in pediatric patients.
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 baclofen may be additive to those of alcohol and other CNS depressants.
Baclofen 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 baclofen.
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 baclofen.
Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen 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 baclofen 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:
Cardiovascular:
Gastrointestinal:
Genitourinary:
Other:
Some of the CNS and genitourinary symptoms may be related to the underlying disease rather than to drug therapy. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.
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
Interactions
A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).