Parafon Forte DSC (Oral)

Chlorzoxazone is used to relax certain muscles in your body and help relieve discomfort from acute (short-term), painful muscle or bone conditions. However, this medicine does not replace rest, exercise, physical therapy, or other treatments that your doctor may suggest for your medical condition.

Chlorzoxazone is a skeletal muscle relaxant. It works on the central nervous system (CNS) to relax muscles.

This medicine is available only with your doctor's prescription.

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of these medicines while you are taking chlorzoxazone.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There is no information available about how chlorzoxazone affects children. Safety and effectiveness have not been established for this age group.

Geriatric

There is no information available about how chlorzoxazone affects elderly patients. However, older adults are more likely to have liver issues related to aging, which may require caution when taking chlorzoxazone.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits and risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may need to adjust the dose or take other precautions. When taking this medicine, it is especially important for your healthcare professional to know if you are taking any of the medicines listed below. The following interactions have been chosen based on their potential importance and do not include all possible interactions.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• Alfentanil
• Alprazolam
• Amobarbital
• Aprobarbital
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Butabarbital
• Butalbital
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Carisoprodol
• Cetirizine
• Chloral Hydrate
• Chlordiazepoxide
• Clobazam
• Clonazepam
• Clorazepate
• Codeine
• Dantrolene
• Daridorexant
• Dexmedetomidine
• Diazepam
• Dihydrocodeine
• Doxylamine
• Eliglustat
• Esketamine
• Estazolam
• Ethchlorvynol
• Fentanyl
• Flibanserin
• Flunitrazepam
• Flurazepam
• Gabapentin
• Gabapentin Enacarbil
• Halazepam
• Hydrocodone
• Hydromorphone
• Ketamine
• Ketazolam
• Lacosamide
• Lemborexant
• Levocetirizine
• Levoketoconazole
• Levorphanol
• Lofexidine
• Lorazepam
• Lormetazepam
• Loxapine
• Magnesium Oxybate
• Medazepam
• Meperidine
• Mephenesin
• Mephobarbital
• Meprobamate
• Metaxalone
• Methadone
• Methocarbamol
• Methohexital
• Methotrexate
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Nitrazepam
• Olanzapine
• Oxazepam
• Oxycodone
• Oxymorphone
• Pentazocine
• Pentobarbital
• Periciazine
• Phenobarbital
• Potassium Oxybate
• Prazepam
• Pregabalin
• Primidone
• Quazepam
• Remifentanil
• Remimazolam
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secobarbital
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Temazepam
• Thiopental
• Topiramate
• Tramadol
• Triazolam
• Zolpidem
• Zuranolone

Using this medicine with any of the following medicines may increase the risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may adjust the dose or frequency for one or both medicines.

• St John's Wort

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating food or specific types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you use this medicine. Be sure to inform your doctor if you have any other medical problems, especially:

• Liver disease—Use with caution. May increase the risk of serious side effects.

Along with its necessary effects, this medicine can cause some unwanted effects. Not all of these side effects may happen, but if they do, they may require medical attention.

Check with your doctor right away if any of the following side effects occur:

Rare

• 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 right away if you notice any of the following overdose symptoms:

Symptoms of overdose

• 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 happen that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also have 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:

Rare

• 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.

In the U.S.

• Lorzone
• Parafon Forte DSC
• Remular-S

Available Dosage Forms:

• Tablet

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage form (tablets):For relaxing muscles: Adults—500 milligrams (mg) three or four times a day. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.