Drugs Details

Drugs Info of BACLOFEN
Drugs Details
  • Drugs Type  : FDA
  • Date : 25th Dec 2014 12:27 am
  • Brand Name : BACLOFEN
  • Generic Name : (baclofen) Tablet
Descriptions

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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 (baclofen (baclofen (baclofen tablets) tablets) tablets) 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 structural formula illustration

C10H12ClNO2             M.W. 213.66

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) Tablets USP 10 mg and 20 mg contain the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone and starch (corn).

What are the precautions when taking baclofen tablets (Baclofen)?

Before taking baclofen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood disorders (such as schizophrenia), brain disorders (such as seizures, stroke).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs,...

Read All Potential Precautions of Baclofen »

This monograph has been modified to include the generic and brand name in many instances.

Indications

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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 (baclofen (baclofen (baclofen tablets) tablets) tablets) treatment will aid in restoring residual function.

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) may also be of some value in patients with spinal cord injuries and other spinal cord diseases.

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is not indicated in the treatment of skeletal muscle spasm resulting from rheumatic disorders.

The efficacy of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) in stroke, cerebral palsy, and Parkinson’s disease has not been established and, therefore, it is not recommended for these conditions.

Dosage Administration

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 WARNINGS, Abrupt Drug Withdrawal).

How Supplied

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) Tablets USP 10 mg are scored, round, white tablets imprinted DAN 5730 and 10 supplied in bottles of 100 and 500.

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) Tablets USP 20 mg are scored, round, white tablets imprinted DAN 5731 and 20 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 USA. Revised: January 2004. FDA rev date:

This monograph has been modified to include the generic and brand name in many instances.

Side Effects

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 (baclofen (baclofen (baclofen tablets) tablets) tablets) 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. The following laboratory tests have been found to be abnormal in a few patients receiving baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) : increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

Read the Baclofen (baclofen tablets) Side Effects Center for a complete guide to possible side effects

Interactions

No information provided.

This monograph has been modified to include the generic and brand name in many instances.

Warnings

Abrupt Drug Withdrawal: Hallucinations and seizures have occurred on abrupt withdrawal of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) . Therefore, except for serious adverse reactions, the dose should be reduced slowly when the drug is discontinued.

Impaired Renal Function: Because baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is primarily excreted unchanged through the kidneys, it should be given with caution, and it may be necessary to reduce the dosage.

Stroke: Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) has not significantly benefitted patients with stroke. These patients have also shown poor tolerability to the drug.

Pregnancy: Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) should be used during pregnancy only if the benefit clearly justifies the potential risk to the fetus.

Precautions

Safe use of baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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 (baclofen (baclofen (baclofen tablets) tablets) tablets) may be additive to those of alcohol and other CNS depressants.

Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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 (baclofen (baclofen (baclofen tablets) tablets) tablets) .

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 (baclofen (baclofen (baclofen tablets) tablets) tablets) .

Ovarian cysts have been found by palpation in about 4% of the multiple sclerosis patients that were treated with baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) 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.

This monograph has been modified to include the generic and brand name in many instances.

OverDose

Signs and symptoms: Vomiting, muscular hypotonia, drowsiness, accommodation disorders, coma, respiratory depression, and seizures.

Treatment: In the alert patient, empty the stomach promptly by induced emesis followed by lavage. In the obtunded patient, secure the airway with a cuffed endotracheal tube before beginning lavage (do not induce emesis). Maintain adequate respiratory exchange, do not use respiratory stimulants.

ContrainDications

Hypersensitivity to baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) .

This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

ACTIONS

The precise mechanism of action of baclofen is not fully known. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is capable of inhibiting both monosynaptic and polysynaptic reflexes at the spinal level, possibly by hyperpolarization of afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Although baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is an analog of the putative inhibitory neurotransmitter gamma-aminobutyric acid (GABA), there is no conclusive evidence that actions on GABA systems are involved in the production of its clinical effects. In studies with animals, baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) has been shown to have general CNS depressant properties as indicated by the production of sedation with tolerance, somnolence, ataxia, and respiratory and cardiovascular depression. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is rapidly and extensively absorbed and eliminated. Absorption may be dose-dependent, being reduced with increasing doses. Baclofen (baclofen (baclofen (baclofen tablets) tablets) tablets) is excreted primarily by the kidney in unchanged form and there is relatively large intersubject variation in absorption and/or elimination.

This monograph has been modified to include the generic and brand name in many instances.

 

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

BACLOFEN - ORAL

 

(BAK-loe-fen)

 

COMMON BRAND NAME(S): Lioresal

 

USES: Baclofen is used to treat muscle spasms caused by certain conditions (such as multiple sclerosis, spinal cord injury/disease). It works by helping to relax the muscles.

 

HOW TO USE: Take this medication by mouth with or without food as directed by your doctor, usually 3 times a day. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.

The dosage is based on your medical condition and response to treatment. Do not increase your dose or take it more often than prescribed.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Also, you may experience withdrawal symptoms such as hallucinations and seizures. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions immediately.

It may take 1 to 2 months or longer to get the full benefit from this medication. Tell your doctor if your condition does not improve or if it worsens.

Consumer Overview Side Effect

SIDE EFFECTS: Drowsiness, dizziness, weakness, tiredness, headache, trouble sleeping, nausea, or constipation may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as confusion, depression, hallucinations).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Baclofen (baclofen tablets) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before taking baclofen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, mental/mood disorders (such as schizophrenia), brain disorders (such as seizures, stroke).

This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially drowsiness and mental/mood changes (such as confusion).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), other muscle relaxants, and narcotic pain relievers (such as codeine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: vomiting, severe drowsiness, slow/shallow breathing, seizures.

 

NOTES: Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another condition unless your doctor directs you to do so. A different medication may be necessary in that case.

 

MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

 

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

Patient Detailed Side Effect

No Information Available!

Patient Detailed How Take

No Information Available!

Patient Detailed Avoid Taking

No Information Available!

Rx Scoops
Featured Topics
Advertisements
Copyrights ©2014: Rx Scoops - Designed & Developed By - GOIGI