Parafon Forte DSC

Name: Parafon Forte DSC

Side Effects of Parafon Forte DSC

Serious side effects have been reported with Parafon Forte DSC. See the "Drug Precautions" section.

Common side effects of Parafon Forte DSC include the following:

  • overstimulation
  • light-headedness
  • dizziness
  • drowsiness
  • discomfort

This is not a complete list of Parafon Forte DSC side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

Uses for Parafon Forte DSC

Muscular Conditions

Adjunct to rest, physical therapy, analgesics, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions.a i

If pharmacologic therapy is required for acute low back pain (usually a benign and self-limiting condition105 106 108 ), an analgesic (e.g., acetaminophen, NSAIA) generally is recommended.104 105 106 108 117 Skeletal muscle relaxants may be used alone or in combination with analgesics for short-term relief; however, consider high incidence of adverse effects (e.g., CNS effects).104 106 107 108 Use skeletal muscle relaxants with caution and weigh risks against benefits.104 106 107 108

Various skeletal muscle relaxants appear to have comparable efficacy for low back pain relief.103 104 106 108

Chlorzoxazone is ineffective in the treatment of skeletal muscle hyperactivity secondary to chronic neurologic disorders (e.g., cerebral palsy) and other dyskinesias.b

Cautions for Parafon Forte DSC

Contraindications

  • Known intolerance to chlorzoxazone or any ingredient in the formulation.a i

Warnings/Precautions

Warnings

Hepatotoxicity

Serious, possibly fatal, hepatotoxicity reported rarely; may be associated with increased serum AST, ALT, alkaline phosphatase, and bilirubin concentrations and increased sulfobromophthalein sodium (BSP) retention.100 101 102 Mechanism unknown but appears idiosyncratic and unpredictable.100 101 102

Perform liver function tests periodically in patients receiving long-term therapy.101

If elevated liver function tests or bilirubin reported or if signs and symptoms of hepatic dysfunction (e.g., fever, rash, anorexia, nausea/vomiting, fatigue, right upper quadrant pain, dark urine, or jaundice) occur, discontinue chlorzoxazone immediately.100 102 a

CNS Effects

Performance of activities requiring mental alertness or physical coordination may be impaired.a i

Concurrent use of other CNS depressants may potentiate CNS depression.a i (See Specific Drugs under Interactions.)

Sensitivity Reactions

Sensitivity reactions (e.g., urticaria, redness, petechiae, pruritus) reported rarely; angioedema and anaphylactic reactions are extremely rare.a i Use with caution in patients with allergies or with a history of allergic drug reactions.a b i

Specific Populations

Pregnancy

Category C.i

Lactation

Not known whether chlorzoxazone is distributed into milk; use with caution.b

Pediatric Use

Safety and efficacy not established.a i

Common Adverse Effects

Drowsiness, dizziness.b

Consumer Information Use and Disclaimer

  • If your symptoms or health problems do not get better or if they become worse, call your doctor.
  • Do not share your drugs with others and do not take anyone else's drugs.
  • Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
  • Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
  • Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Parafon Forte DSC, please talk with your doctor, nurse, pharmacist, or other health care provider.
  • If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Parafon Forte DSC. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Parafon Forte DSC (chlorzoxazone).

Review Date: October 4, 2017

Parafon Forte DSC Dosage and Administration

Usual Adult Dosage

One caplet three or four times daily. If adequate response is not obtained with this dose, it may be increased to 1 ½ caplets (750 mg) three or four times daily. As improvement occurs dosage can usually be reduced.

How is Parafon Forte DSC Supplied

PARAFON FORTE® DSC (chlorzoxazone) 500 mg caplets, (capsule shaped tablet, colored light green, imprinted "Parafon Forte DSC" and "McNEIL," scored).

NDC 50458-625-60, bottles of 100.

Dispense in tight container as defined in the official compendium.

Store at controlled room temperature (15°–30°C, 59°–86°F).

Product of Taiwan.

Manufactured by:
Janssen Ortho, LLC
Gurabo, Puerto Rico 00778

Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560

© Janssen Pharmaceuticals, Inc.

Revised: March 2012

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