Orphenate

Orphenadrine is used to help relax certain muscles in your body and relieve the stiffness, pain, and discomfort caused by strains, sprains, or other injury to your muscles. However, this medicine does not take the place of rest, exercise or physical therapy, or other treatment that your doctor may recommend for your medical problem .

Orphenadrine acts in the central nervous system (CNS) to produce its muscle relaxant effects .

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

This section provides information on the proper use of a number of products that contain orphenadrine. It may not be specific to Orphenate. Please read with care.

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins or into your muscle .

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 or nurse immediately if any of the following side effects occur:

• Cough
• difficulty swallowing
• dizziness
• fast heartbeat
• hives
• itching
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• shortness of breath
• skin rash
• tightness in chest
• unusual tiredness or weakness
• wheezing

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

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

• 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. 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:

• Anxiety
• deep or fast breathing with dizziness
• headache
• irritability
• itching skin
• mental confusion
• nervousness
• numbness of feet, hands and around mouth
• restlessness
• trembling or shaking of hands or feet shakiness in legs, arms, hands, or feet
• unusually large pupils of eyes
• weakness

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.

Applies to orphenadrine: oral tablet, oral tablet extended release

Other dosage forms:

• injection solution

Along with its needed effects, orphenadrine (the active ingredient contained in Orphenate) 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 while taking orphenadrine:

• 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

• 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 while taking orphenadrine:

• 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 of orphenadrine 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:

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

• 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

Applies to orphenadrine: compounding powder, injectable solution, oral tablet extended release

Nervous system

Nervous system side effects have included headache, light-headedness, dizziness, drowsiness, syncope and tremor. Infrequently, elderly patients have experienced mental confusion.[Ref]

Ocular

Ocular side effects have included blurred vision, dilatation of pupils, and increased ocular tension.[Ref]

Cardiovascular

Cardiovascular side effects have included tachycardia and palpitations.[Ref]

Genitourinary

Genitourinary side effects have included urinary hesitancy and retention.[Ref]

Gastrointestinal

Gastrointestinal side effects have included dry mouth, nausea, vomiting, and gastric irritation.[Ref]

Musculoskeletal

Musculoskeletal side effects have included weakness.[Ref]

Dermatologic

Dermatologic side effects have included pruritus, and rarely, urticaria and other dermatosis.[Ref]

Psychiatric

Psychiatric side effects have included hallucinations and agitation.[Ref]

Hematologic

Hematologic side effects have included very rare cases of aplastic anemia, however, no causal relationship has been established.[Ref]

Some side effects of Orphenate may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.