Orphenadrine (Oral)

Orphenadrine is used to help relax certain muscles in your body and relieve stiffness, pain, and discomfort caused by strains, sprains, or other muscle injuries. One form of orphenadrine is also used to relieve trembling caused by Parkinson's disease. However, this medicine does not replace rest, exercise, physical therapy, or other treatments that your doctor may recommend for your medical issue.

Orphenadrine works in the central nervous system (CNS) to provide its muscle relaxant effects. It also has other actions (anticholinergic) that help with symptoms of Parkinson's disease. The actions of orphenadrine in the CNS and its anticholinergic effects may also cause some side effects.

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

It is very important for your doctor to check your progress at regular visits to ensure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Orphenadrine may cause a serious allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Contact your doctor right away if you have a rash; itching; swelling of the face, tongue, and throat; trouble breathing; or chest pain after using this medicine.

This medicine may cause some people to feel dizzy, lightheaded, faint, or less alert than usual. It may also cause muscle weakness in some people. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are dizzy or not alert and able to see well.

This medicine may increase the effects of alcohol and other CNS depressants (medicines that slow down the nervous system, possibly causing drowsiness). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; barbiturates; medicine for seizures; other muscle relaxants; or anesthetics, including some dental anesthetics. Do not drink alcoholic beverages, and consult your doctor before taking any of the medicines listed above while using this medicine.

Orphenadrine may cause dryness of the mouth. For temporary relief, use sugarless candy or gum, melt bits of ice in your mouth, or use a saliva substitute. However, if dry mouth continues for more than 2 weeks, consult your dentist. Ongoing dry mouth may increase the risk of dental issues, including tooth decay, gum disease, and fungal infections.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

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

Pediatric

Suitable studies have not been done to assess how orphenadrine affects children. Safety and effectiveness have not been established.

Geriatric

There is no information available on how orphenadrine affects older patients. However, elderly patients are more likely to have age-related heart, liver, or kidney issues which may require caution when using orphenadrine.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medicine while breastfeeding. Weigh the potential benefits against the potential risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while in other cases, two different medicines can be used together, even if there might be an interaction. In these situations, your doctor may need to adjust the dose, or other precautions may be necessary. When taking this medicine, it is especially important that your healthcare professional knows if you are taking any of the medicines listed below. The following interactions have been selected based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Potassium Citrate

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 how often you take one or both of the medicines.

• Alfentanil
• Alprazolam
• Amantadine
• Amifampridine
• Benzhydrocodone
• Bromazepam
• Buprenorphine
• Butorphanol
• Calcium Oxybate
• Cannabidiol
• Cannabis
• Cetirizine
• Clobazam
• Clonazepam
• Clozapine
• Codeine
• Daridorexant
• Dexmedetomidine
• Dihydrocodeine
• Donepezil
• Doxylamine
• Esketamine
• Fentanyl
• Flibanserin
• Gabapentin
• Gabapentin Enacarbil
• Glucagon
• Glycopyrrolate
• Glycopyrronium Tosylate
• Hydrocodone
• Hydromorphone
• Ketamine
• Lacosamide
• Lemborexant
• Levocetirizine
• Levorphanol
• Lofexidine
• Loxapine
• Magnesium Oxybate
• Meperidine
• Methacholine
• Methadone
• Metoclopramide
• Midazolam
• Morphine
• Morphine Sulfate Liposome
• Nalbuphine
• Olanzapine
• Oxycodone
• Oxymorphone
• Pentazocine
• Phenobarbital
• Potassium Oxybate
• Pregabalin
• Primidone
• Quetiapine
• Remifentanil
• Remimazolam
• Revefenacin
• Ropeginterferon Alfa-2b-njft
• Scopolamine
• Secretin Human
• Sodium Oxybate
• Sufentanil
• Tapentadol
• Tiotropium
• Topiramate
• Tramadol
• Trazodone
• 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 change the dose or how often you use one or both of the medicines.

• Perphenazine

Interactions with Food/Tobacco/Alcohol

Some medicines should not be used at or around the time of eating food or certain types of food due to possible interactions. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Enlarged esophagus or
• Enlarged prostate or
• Glaucoma or
• Intestinal blockage or
• Myasthenia gravis or
• Stomach ulcer or
• Urinary tract blockage—Orphenadrine should not be used in patients with these conditions.

• Heart problems (e.g., fast or irregular heartbeats, heart failure)—Use with caution. Orphenadrine may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, you may need medical attention.

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

Rare

• Chest pain
• chills
• cough
• fever
• hallucinations (seeing, hearing, or feeling things that are not there)
• headache
• shortness of breath, troubled breathing, tightness in chest, and/or wheezing
• skin rash, hives, itching, or redness
• sores, ulcers, or white spots on lips or in mouth
• swollen and/or painful glands
• unusual bruising or bleeding
• unusual tiredness or weakness

Incidence not known

• Abdominal or stomach pain
• diarrhea
• fainting
• fast, pounding irregular heartbeat or pulse
• glaucoma
• joint or muscle pain
• nausea
• numbness or tingling of face, hands, or feet
• redness and soreness of eyes
• swelling of feet or lower legs
• vomiting

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

Symptoms of Overdose

• Blurred vision
• confusion, delirium, or hallucinations
• constipation
• difficult urination
• drowsiness
• dry eyes, mouth, nose, or throat
• eye pain
• flushing or redness of face
• troubled breathing

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. Your health care professional may also 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:

Less common or rare

• Dizziness or lightheadedness
• excitement, irritability, nervousness, or restlessness
• headache
• muscle weakness
• unusually large pupils of eyes

Incidence not known

• Anxiety
• deep or fast breathing with dizziness
• itching skin
• mental confusion
• numbness of feet, hands, and around mouth
• trembling or shaking of hands or feet, shakiness in legs, arms, hands, or feet

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.

• Norflex

Available Dosage Forms:

• Tablet, Extended Release

Therapeutic Class: Skeletal Muscle Relaxant, Centrally Acting

Pharmacologic Class: Antimuscarinic

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

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 (extended-release tablets):For relaxing stiff, sore muscles: Adults and teenagers—100 milligrams (mg) two times a day, one tablet each in the morning and evening. Children—Use and dose must be determined by your doctor.
• For oral dosage form (tablets):For relaxing stiff, sore muscles and for Parkinson's disease: Adults—50 milligrams (mg) three times a day. 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.