Parafon Forte DSC

Storage

Oral

15–30°C.a i

• CNS depressant with sedative and skeletal muscle relaxant effects.b

• Inhibits multisynaptic reflex arcs at the level of the spinal cord and subcortical areas of the brain; results in reduction of skeletal muscle spasm with relief of pain and increased mobility of involved muscles.a i

• Importance of informing clinician if any early signs or symptoms of possible liver dysfunction (e.g., fatigue, anorexia, nausea and/or vomiting, fever, rash, jaundice, dark urine, right upper quadrant pain) occur.100 102

• Potential to impair mental alertness or physical coordination, especially with concomitant use of alcohol or other CNS depressants; use caution when driving or operating machinery.a i

• Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as concomitant illnesses.a i

• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.a i

• 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.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Along with its needed effects, a medicine 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 immediately if any of the following side effects occur:

• Bloody or black, tarry stools
• clay-colored stools
• constipation
• cough
• dark urine
• decreased appetite
• difficulty swallowing
• dizziness
• fast heartbeat
• fever
• headache
• hives
• itching
• large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
• loss of appetite
• nausea and vomiting
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• severe stomach pain
• shortness of breath
• skin rash
• swelling of the feet or lower legs
• tightness in the chest
• unusual tiredness or weakness
• vomiting of blood or material that looks like coffee grounds
• wheezing
• yellow eyes or skin

Get emergency help immediately if any of the following symptoms of overdose occur:

• Diarrhea
• difficult or troubled breathing
• drowsiness
• general feeling of discomfort or illness
• headache
• irregular, fast or slow, or shallow breathing
• lightheadedness
• nausea
• pale or blue lips, fingernails, or skin
• sluggishness
• vomiting

Some side effects 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:

• Bruising
• large, flat, blue, or purplish patches in the skin
• small red or purple spots on the skin

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

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

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling sleepy.
• Dizziness.
• Feeling tired or weak.
• Feeling nervous and excitable.
• Change in color of urine.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Each caplet (capsule shaped tablet) contains:

Inactive ingredients: FD&C Blue No. 1, microcrystalline cellulose, docusate sodium, lactose (hydrous), magnesium stearate, sodium benzoate, sodium starch glycolate, pregelatinized corn starch, D&C Yellow No. 10.

Serious (including fatal) hepatocellular toxicity has been reported rarely in patients receiving chlorzoxazone. The mechanism is unknown but appears to be idiosyncratic and unpredictable. Factors predisposing patients to this rare event are not known. Patients should be instructed to report early signs and/or symptoms of hepatotoxicity such as fever, rash, anorexia, nausea, vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice. Chlorzoxazone should be discontinued immediately and a physician consulted if any of these signs or symptoms develop. Chlorzoxazone use should also be discontinued if a patient develops abnormal liver enzymes (e.g. AST, ALT, alkaline phosphatase and bilirubin).

The concomitant use of alcohol or other central nervous system depressants may have an additive effect.

Usage in Pregnancy

The safe use of Parafon Forte DSC chlorzoxazone has not been established with respect to the possible adverse effects upon fetal development. Therefore, it should be used in women of childbearing potential only when, in the judgment of the physician, the potential benefits outweigh the possible risks.

Parafon Forte DSC chlorzoxazone should be used with caution in patients with known allergies or with a history of allergic reactions to drugs. If a sensitivity reaction occurs such as urticaria, redness, or itching of the skin, the drug should be stopped.

If any symptoms suggestive of liver dysfunction are observed, the drug should be discontinued.

NDC 50458-625-60

Parafon
Forte® DSC
(CHLORZOXAZONE)

500 mg

100 caplets

Rx only

janssen