Voluntary recall of orphenadrine
On March 21, 2022, Sandoz issued a voluntary
Highlights for orphenadrine
- Orphenadrine oral tablet is only available as a generic drug. It doesn’t have a brand-name version.
- Orphenadrine comes as an oral extended-release tablet, an intravenous (IV) injection, and an intramuscular (IM) injection. The injections are only given by a healthcare provider.
- Orphenadrine oral tablet is used to treat muscle pain from musculoskeletal conditions.
- Lightheadedness warning: This drug may cause lightheadedness, dizziness, or loss of consciousness. These effects are due to a sudden drop in blood pressure. This drug can make it difficult for you to do activities that require alertness. You should not drive or use machinery until you know how this drug affects you.
- Dementia warning:
Researchhas indicated that this medication, which is a drug called an anticholinergic, can raise your risk of dementia.
Orphenadrine is a prescription drug. It comes as an extended-release oral tablet. An extended-release tablet releases the drug into your body slowly. This drug also comes as an intravenous (IV) injection and an intramuscular (IM) injection, which are only given by a healthcare provider.
Orphenadrine oral tablet is only available as a generic drug.
This drug may be used as part of a combination therapy. This means you may need to take it with other medications.
Why it’s used
Orphenadrine is used to treat muscle pain from musculoskeletal conditions. It’s used with rest, physical therapy, and other treatments.
How it works
Orphenadrine belongs to a class of drugs called anticholinergic drugs. A class of drugs is a group of medications that work in a similar way. These drugs are often used to treat similar conditions.
It’s not fully understood how this drug works to relieve muscle pain. It may act on your brain to stop muscle spasms and pain.
Orphenadrine oral tablet may cause drowsiness, and it can also cause other side effects.
More common side effects
The more common side effects of orphenadrine can include:
- dry mouth
- fast heart rate
- trouble urinating
- blurry vision
- dilated pupils
- higher blood pressure in your eyes
- itching, hives, or rash on your skin
If these effects are mild, they may go away within a few days or a couple of weeks. If they’re more severe or don’t go away, talk to your doctor or pharmacist.
Serious side effects
Call your doctor right away if you have serious side effects. Call 911 if your symptoms feel life-threatening or if you think you’re having a medical emergency. Serious side effects and their symptoms can include the following:
- Nervous system side effects. Symptoms can include:
- hallucinations (seeing or hearing things that aren’t there)
- Anemia. Symptoms can include:
- fast heart rate
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this information includes all possible side effects. This information is not a substitute for medical advice. Always discuss possible side effects with a healthcare provider who knows your medical history.
Orphenadrine oral tablet can interact with other medications, vitamins, or herbs you may be taking. An interaction is when a substance changes the way a drug works. This can be harmful or prevent the drug from working well.
To help avoid interactions, your doctor should manage all of your medications carefully. Be sure to tell your doctor about all medications, vitamins, or herbs you’re taking. To find out how this drug might interact with something else you’re taking, talk to your doctor or pharmacist.
Examples of drugs that can cause interactions with orphenadrine are listed below.
Increased side effects from other drugs
Taking orphenadrine with certain medications raises your risk of side effects from these drugs. Examples of these drugs include:
- Propoxyphene. Increased side effects can include confusion, anxiety, and tremors. If you have these side effects, your doctor may lower your dosage or stop your treatment with either drug.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs interact differently in each person, we cannot guarantee that this information includes all possible interactions. This information is not a substitute for medical advice. Always speak with your healthcare provider about possible interactions with all prescription drugs, vitamins, herbs and supplements, and over-the-counter drugs that you are taking.
This drug comes with several warnings.
This drug can cause a severe allergic reaction. Symptoms can include:
- trouble breathing
- swelling of your throat or tongue
If you develop these symptoms, call 911 or go to the nearest emergency room.
Don’t take this drug again if you’ve ever had an allergic reaction to it. Taking it again could be fatal (cause death).
Alcohol interaction warning
Drinking alcohol can increase your risk of drowsiness and dizziness from this drug. If you drink alcohol, talk to your doctor.
Warnings for people with certain health conditions
For people with heart problems: If you have heart failure, reduced blood flow to your heart, or a fast or irregular heart rate, ask your doctor if this drug is safe for you. This drug may make your condition worse.
For people with eye problems: This drug can increase the blood pressure in your eyes. You should not use this drug if you have glaucoma. It can make your glaucoma worse. Tell your doctor if you have a history of eye problems before taking this drug.
For people with stomach problems: You should not use this drug if you have certain kinds of ulcers or any blockage in your digestive tract. Tell your doctor if you have a history of stomach problems. Your doctor will decide if this drug is safe for you.
For people with prostate or bladder problems: You should not use this drug if you have an enlarged prostate or a blockage of your urinary bladder neck. Tell your doctor if you have a history of prostate or bladder problems. Your doctor will decide if this drug is safe for you.
For people with myasthenia gravis: You should not use this drug. It can make your condition worse.
Warnings for other groups
For pregnant women: This drug is a category C pregnancy drug. That means two things:
- Research in animals has shown adverse effects to the fetus when the mother takes the drug.
- There haven’t been enough studies done in humans to be certain how the drug might affect a pregnancy.
Talk to your doctor if you’re pregnant or plan to become pregnant. This drug should only be used if the potential benefit justifies the potential risk to the pregnancy.
If you become pregnant while taking this drug, call your doctor right away.
For women who are breastfeeding: It isn’t known if this drug passes into breast milk. If it does, it may cause side effects in a child who is breastfed. Talk to your doctor if you breastfeed your child. You may need to decide whether to stop breastfeeding or stop taking this medication.
For children: This medication has not been studied in children. It should not be used in children younger than 18 years.
All possible dosages and drug forms may not be included here. Your dosage, drug form, and how often you take the drug will depend on:
- your age
- the condition being treated
- the severity of your condition
- other medical conditions you have
- how you react to the first dose
Dosage for muscle pain
- Form: oral tablet
- Strength: 100 mg
Adult dosage (ages 18 years and older)
- Typical starting dosage: 200 mg per day. You’ll take one 100-mg tablet in the morning and one 100-mg tablet in the evening.
Child dosage (ages 0–17 years)
This medication has not been studied in children. It should not be used in children younger than 18 years.
Disclaimer: Our goal is to provide you with the most relevant and current information. However, because drugs affect each person differently, we cannot guarantee that this list includes all possible dosages. This information is not a substitute for medical advice. Always speak with your doctor or pharmacist about dosages that are right for you.
Orphenadrine oral tablet is used for short-term treatment. The safety of this drug for long-term treatment has not been established.
This drug comes with serious risks if you don’t take it as prescribed.
If you stop taking the drug suddenly or don’t take it at all: Your muscle pain may not get better.
If you miss doses or don’t take the drug on schedule: Your medication may not work as well or may stop working completely. For this drug to work well, a certain amount needs to be in your body at all times.
If you take too much: You could have dangerous levels of the drug in your body. Symptoms of an overdose of this drug can include:
- dry mouth
- trouble urinating
- blurry vision
If you think you’ve taken too much of this drug, call your doctor or seek guidance from the American Association of Poison Control Centers at 1-800-222-1222 or through their online tool. But if your symptoms are severe, call 911 or go to the nearest emergency room right away.
What to do if you miss a dose: Take your dose as soon as you remember. But if you remember just a few hours before your next scheduled dose, take only one dose. Never try to catch up by taking two doses at once. This could result in dangerous side effects.
How to tell if the drug is working: You should have less pain and stiffness.
Keep these considerations in mind if your doctor prescribes orphenadrine for you.
- You can take this drug with or without food.
- Take this drug at the time(s) recommended by your doctor.
- Do not crush or chew the tablet. Swallow the tablet whole.
- Store this drug at room temperature. Keep it between 59°F and 86°F (15°C and 30°C).
- Keep this drug away from light.
- Don’t store this medication in moist or damp areas, such as bathrooms.
A prescription for this medication is refillable. You should not need a new prescription for this medication to be refilled. Your doctor will write the number of refills authorized on your prescription.
When traveling with your medication:
- Always carry your medication with you. When flying, never put it into a checked bag. Keep it in your carry-on bag.
- Don’t worry about airport X-ray machines. They can’t harm your medication.
- You may need to show airport staff the pharmacy label for your medication. Always carry the original prescription-labeled container with you.
- Don’t put this medication in your car’s glove compartment or leave it in the car. Be sure to avoid doing this when the weather is very hot or very cold.
Not every pharmacy stocks this drug. When filling your prescription, be sure to call ahead to make sure your pharmacy carries it.
Many insurance companies require a prior authorization for this drug. This means your doctor may need to get approval from your insurance company before your insurance company will pay for the prescription.
There are other drugs available to treat your condition. Some may be better suited for you than others. Talk to your doctor about other drug options that may work for you.
Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up-to-date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.