What are the primary uses of Parafon Forte DSC 500 mg. How should this medication be taken for optimal results. What are the potential side effects and precautions associated with Parafon Forte DSC. How does Parafon Forte DSC interact with other medications.

Understanding Parafon Forte DSC: A Powerful Muscle Relaxant

Parafon Forte DSC, containing the active ingredient chlorzoxazone, is a widely prescribed medication for treating muscle spasms and associated pain. This potent muscle relaxant works by helping to relax the muscles, providing relief from discomfort and improving mobility. It’s often used in conjunction with other treatments such as rest and physical therapy to provide comprehensive care for patients suffering from musculoskeletal issues.

How does Parafon Forte DSC work to alleviate muscle spasms. The medication acts on the central nervous system, specifically targeting the spinal cord and subcortical areas of the brain. By doing so, it reduces muscle tension and promotes relaxation, ultimately leading to a decrease in pain and discomfort associated with muscle spasms.

Proper Usage and Dosage Guidelines for Parafon Forte DSC

When it comes to taking Parafon Forte DSC, following the prescribed dosage and guidelines is crucial for achieving optimal results and minimizing potential side effects. The typical dosage is 500 mg, but this may vary depending on individual factors and the severity of the condition being treated.

• Take the medication orally, with or without food
• Follow your doctor’s instructions regarding frequency and duration of use
• Do not exceed the prescribed dose or use the medication for longer than recommended
• If you miss a dose, take it as soon as you remember, unless it’s close to the time for your next dose

Can Parafon Forte DSC be taken on an empty stomach. While the medication can be taken with or without food, some patients find that taking it with food helps reduce the likelihood of stomach upset. If you experience gastrointestinal discomfort, consider taking the medication with a meal or snack.

Identifying and Managing Side Effects of Parafon Forte DSC

As with any medication, Parafon Forte DSC may cause side effects in some individuals. It’s important to be aware of these potential reactions and know when to seek medical attention. Common side effects are generally mild and may include:

• Drowsiness and dizziness
• Lightheadedness and fatigue
• Upset stomach or nausea
• Headache

How can you differentiate between normal side effects and those requiring medical attention. While the above-mentioned side effects are generally not cause for concern, there are certain symptoms that warrant immediate medical intervention. These include:

1. Signs of liver problems (e.g., persistent nausea/vomiting, abdominal pain, yellowing of eyes/skin, dark urine)
2. Symptoms of infection (e.g., persistent sore throat, fever)
3. Easy bruising or bleeding
4. Severe confusion or disorientation

If you experience any of these serious side effects, discontinue use of the medication and seek medical help immediately.

Precautions and Considerations Before Taking Parafon Forte DSC

Before starting treatment with Parafon Forte DSC, it’s essential to discuss your medical history and any current medications with your healthcare provider. This ensures that the medication is safe and appropriate for your individual needs.

What medical conditions may affect the use of Parafon Forte DSC. Patients with liver disease or a history of liver problems should exercise caution when using this medication. Additionally, inform your doctor if you have any allergies, as the inactive ingredients in Parafon Forte DSC may cause allergic reactions in some individuals.

Special Considerations for Specific Populations

• Elderly patients: May be more sensitive to side effects, particularly drowsiness and confusion
• Pregnant women: Should only use when clearly necessary; discuss risks and benefits with a doctor
• Breastfeeding mothers: Consult a healthcare provider before use, as it’s unknown if the drug passes into breast milk

Potential Drug Interactions with Parafon Forte DSC

Understanding potential drug interactions is crucial for ensuring the safe and effective use of Parafon Forte DSC. Certain medications and substances can interact with chlorzoxazone, potentially altering its effectiveness or increasing the risk of side effects.

Which types of medications are most likely to interact with Parafon Forte DSC. The following categories of drugs may interact with chlorzoxazone:

• Opioid pain relievers (e.g., codeine, hydrocodone)
• Medications for sleep or anxiety (e.g., alprazolam, lorazepam, zolpidem)
• Other muscle relaxants (e.g., carisoprodol, cyclobenzaprine)
• Antihistamines (e.g., cetirizine, diphenhydramine)
• Alcohol and marijuana

It’s important to inform your healthcare provider about all medications, supplements, and herbal products you’re taking to avoid potential interactions. Additionally, be cautious when using over-the-counter products, as some may contain ingredients that cause drowsiness and could interact with Parafon Forte DSC.

Lifestyle Considerations While Taking Parafon Forte DSC

When taking Parafon Forte DSC, it’s important to be aware of how the medication may affect your daily activities and make necessary adjustments to ensure your safety and well-being.

How does Parafon Forte DSC impact one’s ability to perform daily tasks. The medication can cause drowsiness and dizziness, which may affect your ability to drive, operate machinery, or perform tasks that require alertness. It’s advisable to avoid these activities until you know how the medication affects you personally.

Recommendations for Safe Use

• Avoid alcohol consumption while taking Parafon Forte DSC
• Be cautious when using marijuana, as it can increase drowsiness
• Inform your doctor or dentist about your use of Parafon Forte DSC before any surgical procedures
• Stay hydrated and maintain a balanced diet to support overall health

By following these guidelines and being mindful of the medication’s effects, you can safely incorporate Parafon Forte DSC into your daily routine while managing muscle spasms and associated pain.

Monitoring and Managing Long-Term Use of Parafon Forte DSC

For patients prescribed Parafon Forte DSC for extended periods, it’s essential to establish a monitoring plan with your healthcare provider to ensure continued safety and efficacy of the treatment.

What should be included in a long-term monitoring plan for Parafon Forte DSC use. A comprehensive monitoring plan may include:

1. Regular liver function tests to check for any adverse effects on the liver
2. Periodic assessments of the medication’s effectiveness in managing muscle spasms
3. Evaluation of any persistent side effects or changes in overall health
4. Adjustments to dosage or treatment plan as needed based on individual response

It’s crucial to maintain open communication with your healthcare provider throughout the course of treatment. Report any changes in symptoms, new side effects, or concerns promptly to ensure the best possible outcomes.

Alternative Treatments and Complementary Therapies for Muscle Spasms

While Parafon Forte DSC can be highly effective in treating muscle spasms, it’s often used as part of a comprehensive treatment approach. Understanding alternative and complementary therapies can help patients make informed decisions about their care.

What are some non-pharmacological approaches to managing muscle spasms. Several alternative treatments and lifestyle modifications can complement or, in some cases, replace medication:

• Physical therapy and targeted exercises
• Heat or cold therapy
• Massage and manual therapies
• Acupuncture
• Relaxation techniques and stress management
• Ergonomic adjustments to reduce muscle strain

Discussing these options with your healthcare provider can help you develop a well-rounded treatment plan that addresses your specific needs and preferences. Remember that the effectiveness of these approaches may vary depending on the underlying cause and severity of your muscle spasms.

Integrating Complementary Therapies with Parafon Forte DSC

When considering complementary therapies alongside Parafon Forte DSC, it’s important to consult with your healthcare provider to ensure safe and effective integration. Some therapies may enhance the effects of the medication, while others might help reduce the need for higher doses or prolonged use.

How can patients safely incorporate alternative treatments into their Parafon Forte DSC regimen. Consider the following steps:

1. Discuss your interest in complementary therapies with your doctor
2. Start with one alternative treatment at a time to gauge its effectiveness
3. Keep a journal of your symptoms and any changes you notice
4. Be patient, as some therapies may take time to show results
5. Regularly review your treatment plan with your healthcare provider

By taking a holistic approach to managing muscle spasms, patients can often achieve better outcomes and potentially reduce their reliance on medication alone.

Understanding the Impact of Parafon Forte DSC on Daily Life

Taking Parafon Forte DSC can significantly impact a patient’s daily life, both in terms of managing muscle spasms and potential side effects. It’s important to understand how this medication may affect various aspects of your routine and make necessary adjustments.

How might Parafon Forte DSC affect work and social activities. The medication’s potential to cause drowsiness and dizziness can impact your ability to perform certain tasks or engage in social activities. Consider the following:

• Inform your employer about your medication if it may affect your job performance
• Plan social activities during times when the medication’s effects are less pronounced
• Avoid alcohol consumption, especially in social settings, as it can intensify side effects
• Be prepared to explain your limitations to friends and family if necessary

By being proactive and communicating openly about your treatment, you can better manage expectations and maintain a balance between managing your condition and participating in daily activities.

Strategies for Minimizing Side Effects

While side effects are a potential concern with Parafon Forte DSC, there are strategies you can employ to minimize their impact on your daily life:

1. Take the medication at consistent times each day to establish a routine
2. Consider taking doses before bedtime if drowsiness is a significant issue
3. Stay well-hydrated to help combat potential side effects like headaches
4. Practice good sleep hygiene to maximize rest and reduce daytime fatigue
5. Engage in light exercise, as approved by your doctor, to improve overall well-being

Remember that everyone responds differently to medication, and it may take some time to find the right balance. Work closely with your healthcare provider to adjust your treatment plan as needed.

The Future of Muscle Spasm Treatment: Advancements and Research

As medical research continues to advance, new treatments and approaches for managing muscle spasms are being developed. While Parafon Forte DSC remains an effective option for many patients, it’s important to stay informed about emerging therapies and potential improvements in care.

What are some promising developments in the field of muscle spasm treatment. Ongoing research is exploring various avenues for improving muscle spasm management:

• Targeted drug delivery systems for more localized treatment
• Novel compounds with fewer side effects
• Gene therapy approaches for chronic muscle conditions
• Advanced physical therapy techniques and technologies
• Personalized medicine approaches based on genetic profiles

While these advancements are exciting, it’s important to remember that new treatments often take years to become widely available. In the meantime, working closely with your healthcare provider to optimize your current treatment plan, including the use of Parafon Forte DSC when appropriate, remains the best approach for managing muscle spasms.

Participating in Clinical Trials

For patients interested in contributing to the advancement of muscle spasm treatments, participating in clinical trials may be an option. Clinical trials offer the opportunity to access cutting-edge therapies and contribute to medical research.

How can patients learn about and participate in clinical trials for muscle spasm treatments. Consider the following steps:

1. Discuss your interest in clinical trials with your healthcare provider
2. Research ongoing trials through reputable databases like ClinicalTrials.gov
3. Carefully review eligibility criteria and potential risks and benefits
4. Ask questions and seek clarification before committing to participation
5. Maintain open communication with your healthcare team throughout the trial process

By staying informed about advancements in muscle spasm treatment and considering participation in research, patients can play an active role in shaping the future of care for this common condition.

Parafon Forte DSC Oral: Uses, Side Effects, Interactions, Pictures, Warnings & Dosing

Uses

Chlorzoxazone is used to treat muscle spasms/pain. It is usually used along with rest, physical therapy, and other treatment. It works by helping to relax the muscles.

How to use Parafon Forte DSC 500 Mg Tablet

Take this medication by mouth with or without food as directed by your doctor. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of side effects will increase.

The dosage is based on your medical condition and response to treatment.

Tell your doctor if your condition does not improve or if it worsens.

Side Effects

Drowsiness, dizziness, lightheadedness, tiredness, upset stomach, or headache may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

This medication may rarely cause your urine to turn orange or reddish-purple. This effect is harmless and will disappear when the medication is stopped.

Remember that this medication has been prescribed because your doctor 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: confusion, black/bloody stools, vomit that looks like coffee grounds, easy bruising/bleeding, signs of infection (such as sore throat that doesn’t go away, fever).

This medication may rarely cause very serious (possibly fatal) liver disease. Stop taking this medication and get medical help right away if you develop symptoms of liver disease, including: nausea/vomiting that doesn’t stop, stomach/abdominal pain, yellowing eyes/skin, dark urine.

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 or at www.fda.gov/medwatch.

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

Precautions

Before taking chlorzoxazone, 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: liver disease.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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, or confusion. These side effects can increase the risk of falling.

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

It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

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 such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), other muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

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.

Does Parafon Forte DSC 500 Mg Tablet interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. 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: nausea/vomiting, severe drowsiness, muscle weakness, fast/irregular breathing.

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.

If you are taking this medication for a long time, lab and/or medical tests (such as liver function) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

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. Take your next dose at the regular time. Do not double the dose to catch up.

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.

Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.

Parafon Forte DSC: Package Insert

Package insert / product label
Generic name: chlorzoxazone
Dosage form: caplets
Drug class: Skeletal muscle relaxants

Medically reviewed by Drugs.com. Last updated on Mar 22, 2023.

The Parafon Forte DSC brand name has been discontinued in the U.S. If generic versions of this product have been approved by the FDA, there may be generic equivalents available.

On This Page

• Description
• Indications and Usage
• Contraindications
• Warnings
• Precautions
• Adverse Reactions/Side Effects
• Dosage and Administration
• Overdosage
• How Supplied/Storage and Handling

For Painful Musculoskeletal Conditions

Parafon Forte DSC Description

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.

ACTIONS

Chlorzoxazone is a centrally-acting agent for painful musculoskeletal conditions. Data available from animal experiments as well as human study indicate that chlorzoxazone acts primarily at the level of the spinal cord and subcortical areas of the brain where it inhibits multisynaptic reflex arcs involved in producing and maintaining skeletal muscle spasm of varied etiology. The clinical result is a reduction of the skeletal muscle spasm with relief of pain and increased mobility of the involved muscles. Blood levels of chlorzoxazone can be detected in people during the first 30 minutes and peak levels may be reached, in the majority of the subjects, in about 1 to 2 hours after oral administration of chlorzoxazone. Chlorzoxazone is rapidly metabolized and is excreted in the urine, primarily in a conjugated form as the glucuronide. Less than one percent of a dose of chlorzoxazone is excreted unchanged in the urine in 24 hours.

INDICATIONS

Parafon Forte DSC chlorzoxazone is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense skeletal muscles in man.

Contraindications

Parafon Forte DSC chlorzoxazone is contraindicated in patients with known intolerance to the drug.

Warnings

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.

Precautions

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.

Adverse Reactions

Chlorzoxazone containing products are usually well tolerated. It is possible in rare instances that chlorzoxazone may have been associated with gastrointestinal bleeding. Drowsiness, dizziness, lightheadedness, malaise, or overstimulation may be noted by an occasional patient. Rarely, allergic-type skin rashes, petechiae, or ecchymoses may develop during treatment. Angioneurotic edema or anaphylactic reactions are extremely rare. There is no evidence that the drug will cause renal damage. Rarely, a patient may note discoloration of the urine resulting from a phenolic metabolite of chlorzoxazone. This finding is of no known clinical significance.

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.

Overdosage

Symptoms

Initially, gastrointestinal disturbances such as nausea, vomiting, or diarrhea together with drowsiness, dizziness, lightheadedness or headache may occur. Early in the course there may be malaise or sluggishness followed by marked loss of muscle tone, making voluntary movement impossible. The deep tendon reflexes may be decreased or absent. The sensorium remains intact, and there is no peripheral loss of sensation. Respiratory depression may occur with rapid, irregular respiration and intercostal and substernal retraction. The blood pressure is lowered, but shock has not been observed.

Treatment

Gastric lavage or induction of emesis should be carried out, followed by administration of activated charcoal. Thereafter, treatment is entirely supportive. If respirations are depressed, oxygen and artificial respiration should be employed and a patent airway assured by use of an oropharyngeal airway or endotracheal tube. Hypotension may be counteracted by use of dextran, plasma, concentrated albumin or a vasopressor agent such as norepinephrine. Cholinergic drugs or analeptic drugs are of no value and should not be used.

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

PRINCIPAL DISPLAY PANEL – 500 mg Caplet Bottle Label

NDC 50458-625-60

Parafon
Forte® DSC
(CHLORZOXAZONE)

500 mg

100 caplets

Rx only

janssen

Parafon Forte DSC chlorzoxazone tablet

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:50458-625 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength chlorzoxazone (chlorzoxazone) chlorzoxazone 500 mg

Inactive Ingredients Ingredient Name Strength cellulose, microcrystalline FD&C Blue No. 1 docusate sodium lactose magnesium stearate sodium benzoate starch, corn D&C Yellow No. 10 sodium starch glycolate type A potato

Product Characteristics Color GREEN (light green) Score 2 pieces Shape OVAL (capsule shaped) Size 17mm Flavor Imprint Code PARAFON;FORTE;DSC;MCNEIL Contains

Packaging # Item Code Package Description 1 NDC:50458-625-60 100 TABLET in 1 BOTTLE

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA011529 06/15/1987

Labeler – Janssen Pharmaceuticals, Inc. (063137772)

Janssen Pharmaceuticals, Inc.

More about Parafon Forte DSC (chlorzoxazone)

• Check interactions
• Compare alternatives
• Reviews (3)
• Drug images
• Side effects
• Dosage information
• During pregnancy
• Drug class: skeletal muscle relaxants

Patient resources

• Advanced Reading
• Parafon Forte DSC

Professional resources

• Prescribing Information
• Chlorzoxazone (FDA)

Other brands

Lorzone

Related treatment guides

• Muscle Spasm

Medical Disclaimer

Strong Parafon (Chlorzoxazone): Uses, Dosage, Side Effects, Interactions, Warning

• Generic Name: Chlorzoxazone
• Brand Name: Parafon Forte

• Product Description
• Indications and Dosage
• Adverse effects and drug interactions
• Warnings and Precautions
• Overdose and Contraindications
• Clinical Pharmacology
• Medication Guide

Product Description

DSC STRONG PARAFON
(chlorzoxazone) Caplets 500mg

DESCRIPTION

Each capsule ( tablet in the form of a capsule) contains:

Chlorzoxazone * 500 mg

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

* 5-chlorobenzoxazolinone

Indications and Dosage

INDICATIONS

Parafon FORTE DSC Chlorzoxazone is indicated as an adjunct to rest, physical therapy and other measures to relieve discomfort associated with acute, painful musculoskeletal problems. The mechanism of action of this drug has not been precisely established, but may be related to its sedative properties. Chlorzoxazone does not directly relax tense human skeletal muscles.

DOSAGE AND ADMINISTRATION

Usual adult dosage

One capsule three or four times a day. If an adequate response is not obtained with this dose, it may be increased to 1½ caplets (750 mg) three or four times a day. As improvement occurs, the dosage can usually be reduced.

HOW SUPPLIED

FORAFON FORTE DSC (chlorzoxazone) 500 mg caplets (capsule shaped tablet, light green, labeled “PARAFON FORTE DSC” and “McNEIL”, under evaluation).

NDC 50458-625-60, bottles of 100 pcs.

Pour into a tightly closed container as defined in the official guide.

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

Manufactured by: Janssen Ortho, LLC, Gurabo, Puerto Rico, 00778 Manufactured for: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Revised: March 2012

Adverse effects and drug interactions

SIDE EFFECTS

Products containing chlorzoxazone are generally well tolerated. In rare cases, it is possible that chlorzoxazone has been associated with gastrointestinal bleeding. Occasionally, patients may report drowsiness, dizziness, dizziness, malaise, or overstimulation. In rare cases, allergic-type skin rashes, petechiae, or ecchymosis may develop during treatment. Angioedema or anaphylactic reactions are extremely rare. There is no evidence that the drug can cause kidney damage. In rare cases, the patient may notice a discoloration of the urine due to the phenolic metabolite of chlorzoxazone. This finding has no known clinical significance.

DRUG INTERACTIONS

No information provided.

Warnings and Precautions

WARNINGS

Serious (including fatal) hepatocellular toxicity has rarely been reported in patients receiving chlorzoxazone. The mechanism is unknown, but seems unique and unpredictable. Factors predisposing patients to this rare event are unknown. 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. If any of these signs or symptoms occur, stop taking chlorzoxazone immediately and consult your doctor. Chlorzoxazone should also be discontinued if the patient develops abnormal liver enzymes (eg, AST, ALT, alkaline phosphatase, and bilirubin).

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

Use in Pregnancy

The safe use of Chlorzoxazone PARAFON FORTE DSC has not been established with respect to possible adverse effects on fetal development. Therefore, it should be used in women of childbearing potential only when, in the opinion of the physician, the potential benefits outweigh the possible risks.

PRECAUTIONS

Chlorzoxazone PARAFON FORTE DSC should be used with caution in patients with a known allergy or a history of allergic drug reactions. If a hypersensitivity reaction occurs, such as urticaria, redness or itching of the skin, the drug should be discontinued.

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

Overdose and contraindications

OVERDOSE

Symptoms

Gastrointestinal disturbances such as nausea, vomiting or diarrhea may initially occur, together with drowsiness, dizziness, vertigo or headache. At the beginning of the course, there may be malaise or lethargy, followed by a noticeable loss of muscle tone, which makes voluntary movements impossible. Deep tendon jerks may be reduced or absent. The sensorium remains intact and there is no peripheral sensory loss. Respiratory depression may be accompanied by rapid, irregular breathing and retraction of the intercostal and substernal muscles. Arterial pressure is lowered, but shock is not observed.

Maintenance

Gastric lavage or induction of vomiting followed by activated charcoal should be performed. Thereafter, treatment is fully supportive. If breathing is depressed, oxygen and artificial respiration should be used, and the airway should be secured with an oropharyngeal airway or endotracheal tube. Hypotension can be counteracted using dextran, plasma, concentrated albumin, or a vasoconstrictor such as norepinephrine. Cholinergic or analeptic drugs are of no value and should not be used.

CONTRAINDICATIONS

Chlorzoxazone PARAFON FORTE DSC is contraindicated in patients with a known intolerance to the drug.