Kemstro

Baclofen comes as a tablet to take by mouth. It usually is taken three times a day at evenly spaced intervals. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take baclofen exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor. This drug must be taken regularly for a few weeks before its full effect is felt.

Continue to take baclofen even if you feel well. Do not stop taking baclofen without talking to your doctor, especially if you have taken large doses for a long time. Your doctor probably will want to decrease your dose gradually.

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KEMSTRO™  (baclofen orally disintegrating tablets) 10 mg are white, round, orange-flavored, scored and engraved "10" on the unscored side and "SP" above and "351" below the score on the other side. They are supplied as follows:

Bottles of 100                       NDC 0091-3351-01

KEMSTRO™  (baclofen orally disintegrating tablets) 20 mg are white, round, orange-flavored, scored and engraved "20" on the unscored side and "SP" above and "352" below the score on the other side. They are supplied as follows:

Bottles of 100                               NDC 0091-3352-01

Dispense in a tight container as defined in the USP/NF with a child-resistant closure.

Store at controlled room temperature 20° - 25°C (68° - 77°F); excursions permitted between 15° - 30°C (59° - 86°F). Protect from moisture.

Manufactured for: SCHWARZ PHARMA., Milwaukee, WI 53201, USA. By: CIMA., Eden Prairie, MN 55344, USA. FDA rev date:

The most common adverse reaction during treatment with baclofen is transient drowsiness (10-63%). In one controlled study of 175 patients, transient drowsiness was observed in 63% of those receiving baclofen 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: increased SGOT, elevated alkaline phosphatase, and elevation of blood sugar.

The adverse experience profile seen with KEMSTRO™ was similar to that seen with baclofen tablets.

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 depressant effects of baclofen may be additive to those of alcohol and other CNS depressants.

Phenylketonurics

Phenylketonuric patients should be informed that KEMSTRO™ (baclofen) contains phenylalanine 3.9 mg per 10 mg orally disintegrating tablet and 7.9 mg per 20 mg orally disintegrating tablet.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Baclofen falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans, though. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Abrupt Drug Withdrawal

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

Impaired Renal Function

Because baclofen is primarily excreted unchanged by the kidneys, it should be given with caution and it may be necessary to reduce the dosage in patients with impaired renal function.

Stroke

Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerability to the drug.

Applies to baclofen: oral powder for suspension, oral tablet

Other dosage forms:

• intrathecal kit, intrathecal solution

Along with its needed effects, baclofen (the active ingredient contained in Kemstro) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor as soon as possible if any of the following side effects occur while taking baclofen:

• Bloody or dark urine
• chest pain
• fainting
• hallucinations (seeing or hearing things that are not there)
• mental depression or other mood changes
• ringing or buzzing in the ears
• skin rash or itching

• Blurred or double vision
• convulsions (seizures)
• muscle weakness (severe)
• shortness of breath or unusually slow or troubled breathing
• vomiting

Some side effects of baclofen may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Confusion
• dizziness or lightheadedness
• drowsiness
• nausea
• unusual weakness, especially muscle weakness

• Abdominal or stomach pain or discomfort
• clumsiness, unsteadiness, trembling, or other problems with muscle control
• constipation
• diarrhea
• difficult or painful urination or decrease in amount of urine
• false sense of well-being
• frequent urge to urinate or uncontrolled urination
• headache
• loss of appetite
• low blood pressure
• muscle or joint pain
• numbness or tingling in hands or feet
• pounding heartbeat
• sexual problems in males
• slurred speech or other speech problems
• stuffy nose
• swelling of ankles
• trouble in sleeping
• unexplained muscle stiffness
• unusual excitement
• unusual tiredness
• weight gain

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

• Convulsions (seizures)
• hallucinations (seeing or hearing things that are not there)
• increase in muscle spasm, cramping, or tightness
• mood or mental changes
• unusual nervousness or restlessness

Applies to baclofen: compounding powder, intrathecal solution, oral suspension, oral tablet

Cardiovascular

Common (1% to 10%): Cardiac output decreased, hypotension, hypertension, diminished cardiovascular functions, peripheral edema
Rare (less than 0.1%): Arrhythmias, palpitations, chest pain
Frequency not reported: Bradycardia, orthostatic hypotension[Ref]

Dermatologic

Common (1% to 10%): Rash, hyperhidrosis, urticaria/pruritus, facial edema
Uncommon (0.1% to 1%): Alopecia, diaphoresis
Frequency not reported: Rash, sweating, contact dermatitis, skin ulcer[Ref]

Endocrine

Common (1% to 10%): Ovarian cysts are palpable in 4% of women treated with for up to one year[Ref]

Gastrointestinal

Very common (10% or more): Nausea (especially at start of therapy) (up to 11%)
Common (1% to 10%): Dry mouth, GI disorder/disturbance, constipation, diarrhea, retching, vomiting, increased salivation
Uncommon (0.1% to 1%): Dysphagia, dehydration, ileus, decreased taste sensation
Rare (less than 0.1%): Colicky abdominal pain, anorexia
Frequency not reported: GI hemorrhage[Ref]

Genitourinary

Very common (10% or more): Urinary retention (up to 12%)
Common (1% to 10%): Urinary incontinence, urination impaired, sexual dysfunction, urinary frequency, enuresis, dysuria
Rare (less than 0.1%): Erectile dysfunction
Frequency not reported: Dysuria, abnormal ejaculation, oliguria, vaginitis[Ref]

Hematologic

Frequency not reported: Leukocytosis, petechial rash[Ref]

Hepatic

Rare (less than 0.1%): Disorders of hepatic function (e.g., increased AST)[Ref]

Immunologic

Common (1% to 10%): Pneumonia
Uncommon (0.1% to 1%): Septicemia[Ref]

Metabolic

Common (1% to 10%): Decreased appetite
Frequency not reported: Blood glucose increased[Ref]

Musculoskeletal

Very common (10% or more): Hypotonia (up to 52%), lower extremity weakness (up to 15%), disturbances of gait and balance
Common (1% to 10%): Muscular weakness, myalgia, upper extremity weakness, back pain, muscular hypertonia[Ref]

Nervous system

Very common (10% or more): Somnolence (up to 28%), drowsiness (up to 18%), headache (up to 16%), seizures (especially on discontinuation of therapy) (up to 15%), sedation, dizziness (up to 12%)
Common (1% to 10%): Fatigue, ataxia, tremor, lightheadedness, lassitude, exhaustion, numbness/itching/tingling, slurred speech, lethargy, hypertonia, paresthesia
Rare (less than 0.1%): Dysarthria, dysgeusia, syncope, dyskinesia, coma, potentially life-threatening withdrawal symptoms (as a result of sudden interruption of drug delivery)[Ref]

Other

Common (1% to 10%): Tinnitus, pain, asthenia
Uncommon (0.1% to 1%): Accidental injury, weight loss
Very rare (less than 0.01%): Hypothermia
Frequency not reported: Drug withdrawal syndrome
Uncommon (0.1% to 1%): Subdural hemorrhage, accidental injury, weight loss[Ref]

Ocular

Common (1% to 10%): Nystagmus, visual impairment, accommodation disorder, blurred vision, double vision, amblyopia[Ref]

Psychiatric

Common (1% to 10%): Confusional state, hallucination, depression, insomnia, euphoric mood, nightmare, personality changes
Uncommon (0.1% to 1%): Memory loss/impairment, suicidal ideation, attempted suicide
Rare (less than 0.1%): Excitement[Ref]

Renal

Very rare (less than 0.01%): Kidney calculus[Ref]

Respiratory

Common (1% to 10%): Respiratory depression, hypoventilation, dyspnea, bradypnea, feeling of pressure in the chest[Ref]

Some side effects of Kemstro may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.