Bupivacaine is an anesthetic (numbing medicine) that is used as a local (in only one area) anesthetic.

Bupivacaine is given as an epidural injection into the spinal column to produce numbness during labor, surgery, or certain medical procedures.

Bupivacaine is also used as an anesthetic for dental procedures.

Bupivacaine may also be used for purposes not listed in this medication guide.

Bupivacaine side effects

Get emergency medical help if you have signs of an allergic reaction: hives, red rash, itching; sneezing, difficulty breathing; severe dizziness, vomiting; swelling of your face, lips, tongue, or throat.

Tell your caregivers at once if you have any of these serious side effects:

• feeling anxious, restless, confused, dizzy, drowsy, or like you might pass out;
• ringing in your ears, problems with speech or vision;
• metallic taste in your mouth, numbness or tingling around your mouth;
• muscle twitching, tremors, seizure (convulsions);
• weak or shallow breathing;
• fast heart rate, gasping, feeling unusually hot;
• slow heart rate, weak pulse; or
• little or no urination.

Seek medical attention right away if you develop a serious condition called methemoglobinemia. Symptoms include headache, fast heartbeats, shortness of breath, feeling tired or light-headed, or skin that looks pale, gray, or blue-colored.

Common side effects include:

• weakness, long-lasting numbness or tingling;
• feeling restless or drowsy;
• tremors;
• headache, blurred vision;
• fast or slow heartbeats;
• breathing problems;
• chills or shivering;
• back pain; or
• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

Warnings

Tell your doctor if you have ever had an allergic reaction to any type of numbing medicine.

Some epidural numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from bupivacaine.

Before taking this medicine

Tell your doctor if you have ever had an allergic reaction to any type of numbing medicine, or if you’ve ever had:

• anemia (lack of red blood cells);
• kidney or liver disease;
• a bleeding or blood clotting disorder;
• syphilis, polio, a brain or spinal cord tumor;
• numbness or tingling;
• chronic back pain, headache caused by surgery;
• low or high blood pressure;
• abnormal curvature of the spine; or
• arthritis.

It is not known whether bupivacaine will harm an unborn baby. If you are not receiving bupivacaine during childbirth, tell your doctor if you are pregnant.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

How is bupivacaine given?

Bupivacaine is injected through a needle directly into or near the area to be numbed. You will receive this injection in a dental or hospital setting.

For an epidural, bupivacaine is given as an injection through a needle placed into an area of your middle or lower back near your spine.

Your breathing, blood pressure, oxygen levels, or other vital signs will be watched closely.

For a dental procedure, bupivacaine is injected directly into the mouth near the tooth or teeth your dentist will be working on.

Some epidural numbing medications can have long-lasting or permanent effects on certain body processes such as sexual function, bowel or bladder control, and movement or feeling in your legs or feet. Talk with your doctor about your specific risk of nerve damage from bupivacaine.

What happens if I miss a dose?

Since bupivacaine is given as needed before a surgery or dental procedure, you are not likely to be on a dosing schedule.

What happens if I overdose?

Since bupivacaine is given in a medical setting, you will be watched closely to make sure you do not receive too much of bupivacaine. Your caregivers will quickly treat you if you have overdose symptoms.

What should I avoid after receiving bupivacaine?

This medicine can cause numbness over a large portion of your body. After an epidural you not be able to feel or move your lower body. Take care to avoid injury while you are still numb.

After a dental procedure, avoid eating, chewing gum, or drinking a hot beverage until your mouth is no longer numb.

What other drugs will affect bupivacaine?

Tell your doctor about all other medicines you use, especially:

• an antidepressant or antipsychotic medication;
• anti-nausea medicine such as prochlorperazine (Compazine) or promethazine (Phenergan);
• blood pressure medicine–carteolol, carvedilol, labetalol, nadolol, propranolol, sotalol, timolol;
• a blood thinner such as warfarin (Coumadin, Jantoven);
• ergot medicine–dihydroergotamine, ergotamine, ergonovine, methylergonovine; or
• an MAO inhibitor–isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, tranylcypromine, and others.

Baclofen belongs to a class of medications called skeletal muscle relaxants. Baclofen is an antispasmodic agent that acts on spinal cord nerves and decreases the number and severity of muscle spasms in patients with certain conditions affecting the spinal cord.

Baclofen is used in adults and children at least 12 years old to treat certain types of spasticity (muscle stiffness and tightness) and muscle pain in people with multiple sclerosis or a spinal cord injury or other spinal cord diseases.

Baclofen relieves pain and improves muscle movement.

Warnings

Do not use baclofen at a time when you need muscle tone for safe balance and movement during certain activities. Baclofen may make you drowsy. Do not drive or operate heavy machinery until you know how this medicine affects you.

Do not stop using this medicine suddenly, or you could have unpleasant withdrawal symptoms.

Ask your doctor about the safe use of alcoholic beverages while you are taking baclofen. Alcohol can make the side effects from baclofen worse.

Before taking this medicine

You should not use this medicine if you are allergic to baclofen.

To make sure this medicine is safe for you, tell your doctor if you have ever had:

• mental illness or psychosis;
• epilepsy or other seizure disorder;
• problems with balance;
• cerebral palsy;
• Parkinson’s disease;
• schizophrenia or a confused state;
• high blood pressure, or fast heart rate;
• a rheumatic disease;
• a stroke or blood clot; or
• kidney disease.

Using baclofen may increase your risk of developing an ovarian cyst. Talk with your doctor about your own risk.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed. If you take baclofen while pregnant or breastfeeding, withdrawal symptoms such as tremors, stiff muscles, or seizure may occur in the baby.

How should I take baclofen?

Take baclofen exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Shake the oral suspension (liquid).

Measure a dose with the supplied measuring device (not a kitchen spoon).

Shake and pour the entire oral granules packet to dissolve in your mouth or swallow whole at once, with or without liquids.

You may also mix the granules with liquids (milk, or apple juice) or soft food (apple sauce, yogurt, or pudding).

The oral granules can also be given through a feeding tube. Ask your doctor or pharmacist if you do not understand these instructions.

Call your doctor if your symptoms do not improve, or if they get worse.

You may have withdrawal symptoms if you stop using baclofen suddenly. Ask your doctor before stopping the medicine.

Store the oral suspension (liquid) at room temperature away from moisture and heat. Throw Fleqsuvy away after 2 months of first opening.

Store Ozobax in the refrigerator, do not freeze.

Dosing information

Usual Adult Dose for Spasticity:

Oral:
-Initial dose: The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day for 3 days
-Maintenance dose: Should be individualized.
-Maximum dose: 80 mg/day (20 mg orally 4 times a day).

Usual Pediatric Dose for Spasticity:

12 years and older:
Oral:
-Initial dose: The following gradually increasing dosage regimen is suggested, but should be adjusted to suit individual patient requirements: 5 mg orally 3 times a day for 3 days, then 10 mg orally 3 times a day for 3 days, then 15 mg orally 3 times a day for 3 days, then 20 mg orally 3 times a day for 3 days
-Maintenance dose: Should be individualized.
-Maximum dose: 80 mg/day (20 mg orally 4 times a day)

Comments:
-The lowest dose compatible with an optimal response is recommended.
-Slowly withdraw therapy if benefits are not evident after a reasonable period.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line .

Overdose symptoms may include increasing drowsiness, dizziness, sleepiness, trouble focusing on objects, shallow breathing, seizure, or muscle weakness leading to loss of consciousness.

What should I avoid while taking baclofen?

Avoid drinking alcohol.

Avoid driving or hazardous activity until you know how baclofen will affect you. Your reactions could be impaired.

Do not share this medicine with another person, even if they have the same symptoms you have.

Baclofen side effects

Get emergency medical help if you have signs of an allergic reaction to baclofen: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Baclofen may cause serious side effects. Call your doctor at once if you have:

• severe drowsiness, breathing problems;
• confusion, hallucinations;
• muscle weakness, itching, tingling, or twitching in your hands, arms, feet, or legs; or
• fever.