Ozobax

What is Ozobax used for?

Ozobax is  a prescription medicine that is used to treat spasms in patients with MS (multiple sclerosis) or spinal cord disease. Ozobax may be given to you for other reasons.

Description

OZOBAX (baclofen) oral solution is a gamma-aminobutyric acid (GABA-ergic) agonist available as 5 mg/5 mL solution for oral administration. Its chemical name is 4-amino-3-(4-chlorophenyl)-butanoic acid, and its structural formula is:

Molecular formula is C1OH12CINO2.

Molecular Weight is 213.66.

Baclofen USP is a white to off-white, odorless or practically odorless crystalline powder. It is slightly soluble in water, very slightly soluble in methanol, and insoluble in chloroform.

The OZOBAX (baclofen) oral solution inactive ingredients are: citric acid anhydrous, glycerin, natural grape flavor, methylparaben, propylparaben, purified water, sodium citrate dihydrate, and sucralose. May also contain sodium hydroxide or hydrochloric acid for pH adjustment.

Mechanism of Action

The precise mechanism of action of baclofen is not fully understood. Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level, possibly by decreasing excitatory neurotransmitter release from afferent terminals, although actions at supraspinal sites may also occur and contribute to its clinical effect. Baclofen is a structural analog of the inhibitory neurotransmitter gamma- aminobutyric acid (GABA), and may exert its effects by stimulation of the GABAB receptor subtype.

Before taking Ozobax, tell your doctor:

• If you are allergic to Ozobax; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Ozobax with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Ozobax?

• Tell all of your health care providers that you take Ozobax. This includes your doctors, nurses, pharmacists, and dentists.
• Avoid driving and doing other tasks or actions that call for you to be alert until you see how Ozobax affects you.
• Do not stop taking Ozobax all of a sudden without calling your doctor. You may have a greater risk of side effects. If you need to stop Ozobax, you will want to slowly stop it as ordered by your doctor.
• Talk with your doctor before you drink alcohol or use other drugs and natural products that slow your actions.
• Use with care in children. Talk with the doctor.
• Taking Ozobax during pregnancy may lead to withdrawal in the newborn.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Ozobax best taken?

Use Ozobax as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Measure liquid doses carefully. Use the measuring device that comes with Ozobax. If there is none, ask the pharmacist for a device to measure Ozobax.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are the side effects of Ozobax that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad dizziness or passing out.
• Feeling confused.
• Change in how often urine is passed.
• Mental, mood, or behavior changes that are new or worse.

What are some other side effects of Ozobax?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, sleepy, tired, or weak.
• Trouble sleeping.
• Upset stomach or throwing up.
• Headache.
• Constipation.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Ozobax?

• Store in a refrigerator. Do not freeze.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PACKAGE LABEL. PRINCIPAL DISPLAY PANEL