Taking clobazam with opioid medications (such as codeine, hydrocodone) may increase your risk of very serious side effects, including death. To lower your risk, your doctor should have you take the smallest dose of clobazam that works, and take it for the shortest possible time. Get medical help right away if any of these very serious side effects occur: slow/shallow breathing, unusual lightheadedness, severe drowsiness/dizziness, difficulty waking up.Who should not take Onfi?
This medication is used with other medications to help control seizures. It belongs to a class of medications called benzodiazepines, which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).
Take this medication by mouth with or without food as directed by your doctor. If unable to swallow tablets, they may be crushed and mixed with applesauce. If you are using the liquid form of this medication, shake the bottle well before each dose. Carefully measure the dose using a special measuring device/syringe. Do not use a household spoon because you may not get the correct dose. Read the Instructions for Use on how to properly use the special measuring device/syringe. If you have any questions, ask your pharmacist.
Dosage is based on your medical condition and response to treatment. In infants, the dosage may also be based on weight.
Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time(s) each day.
This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as headaches, trouble sleeping, restlessness, hallucinations/confusion, nausea, seizures) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away.
Though it helps many people, this medication may sometimes cause addiction. This risk may be higher if you have a substance use disorder (such as overuse of or addiction to drugs/alcohol). Do not increase your dose, take it more often, or use it for a longer time than prescribed. Properly stop the medication when so directed.
When used for an extended period, this medication may not work as well and may require different dosing. Talk with your doctor if this medication stops working well.
Tell your doctor if your condition persists or worsens.
See also Warning section.
Drowsiness, dizziness, tiredness, headache, constipation, weight gain, fever, cough, drooling, trouble sleeping, or nausea may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor right away if any of these unlikely but serious side effects occur: mental/mood/behavior changes (e.g., agitation, nervousness, confusion, memory loss), muscle weakness, loss of coordination, shaking (tremor) of the fingers, vision changes (e.g., blurred vision, double vision), slurred speech, decrease in sexual interest, painful urination.
A small number of people who take anticonvulsants for any condition may experience depression, suicidal thoughts/attempts, or other mental/mood problems. Tell your doctor right away if you or your family/caregiver notice any unusual/sudden changes in your mood, thoughts, or behavior including signs of depression, suicidal thoughts/attempts, thoughts about harming yourself.
Get medical help right away if you have any very serious side effects, including: slow/shallow breathing.
Clobazam may rarely cause very serious (possibly fatal) skin reactions, especially during the first 8 weeks of treatment or when restarting treatment with this medication. Get medical help right away if you develop any of the following symptoms: skin rash/blisters/peeling, itching, or mouth sores. If you have a very serious skin reaction and your doctor says it was caused by clobazam, you should not take the medication again. Ask your doctor or pharmacist for more details.
A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Before taking clobazam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (e.g., diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: myasthenia gravis, personal or family history of a substance use disorder (such as overuse of or addiction to drugs/alcohol), kidney disease, liver disease, glaucoma, mental/mood disorders (e.g., depression, psychosis), brain disorders (e.g., head injury, brain damage), breathing problems (e.g., asthma, chronic obstructive pulmonary disease-COPD, sleep apnea), muscle disorders (e.g., weakness, loss of coordination).
Before having surgery, tell your doctor or dentist that you are taking this medication.
This drug may make you dizzy or drowsy. Alcohol or marijuana can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana. Alcohol may also increase the drug levels.
Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially drowsiness. This drug may also cause excitement instead of drowsiness in the elderly.
Caution is advised when using this drug in children because they are more sensitive to the effects. This drug can often cause excitement in young children instead of drowsiness.
During pregnancy, this medication should be used only when clearly needed. It may harm an unborn baby. However, since untreated seizures are a serious condition that can harm both a pregnant woman and her unborn baby, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately talk to your doctor about the benefits and risks of using this medication during pregnancy. Since birth control pills, patches, implants, and injections may not work if taken with this medication (see also Drug Interactions section), discuss reliable forms of birth control with your doctor.
This drug passes into breast milk and could have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.
See also Warning section.
Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
The risk of serious side effects (such as slow/shallow breathing, severe drowsiness/dizziness) may be increased if this medication is taken with other products that may also cause drowsiness or breathing problems. Tell your doctor or pharmacist if you are taking other products such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana, drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).
This medication may decrease the effectiveness of hormonal birth control such as pills, patch, or ring. This could cause pregnancy. Discuss with your doctor or pharmacist if you should use additional reliable birth control methods while using this medication. Also tell your doctor if you have any new spotting or breakthrough bleeding, because these may be signs that your birth control is not working well.
If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: confusion, weakness, severe drowsiness/dizziness, slow/shallow breathing, loss of consciousness, slowed/decreased reflexes.
Laboratory and/or medical tests (e.g., complete blood count, liver/kidney/thyroid function) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.
If using the liquid form of this medication, store it upright in its original bottle and throw away any unused medication after 90 days.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised August 2017. Copyright(c) 2017 First Databank, Inc.
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