CLOBAZAM- clobazam suspension
Accord Healthcare Inc.
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MEDICATION GUIDE
Clobazam Oral Suspension, C-IV (KLOE-ba-zam) |
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What is the most important information I should know about clobazam oral suspension?
Call your healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you: |
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How can I watch for early symptoms of suicidal thoughts and actions?
Call your healthcare provider between visits as needed, especially if you are worried about symptoms. Stopping a seizure medicine suddenly in a patient who has epilepsy can cause seizures that will not stop (status epilepticus). Suicidal thoughts or actions can be caused by things other than medicines. If you have suicidal thoughts or actions, your healthcare provider may check for other causes. |
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What is Clobazam oral suspension?
It is not known if clobazam oral suspension is safe and effective in children less than 2 years old. |
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Do not take Clobazam oral suspension if you:
Before you take clobazam oral suspension, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking clobazam oral suspension with certain other medicines can cause side effects or affect how well clobazam oral suspension or the other medicines work. Do not start or stop other medicines without talking to your healthcare provider. |
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How should I take Clobazam oral suspension?
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What should I avoid while taking Clobazam oral suspension?
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What are the possible side effects of Clobazam oral suspension? Clobazam may cause serious side effects, including: See “What is the most important information I should know about clobazam oral suspension?” The most common side effects of clobazam oral suspension include: |
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These are not all the possible side effects of clobazam oral suspension. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. |
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How should I store clobazam oral suspension?
Oral Suspension
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General information about the safe and effective use of Clobazam oral suspension. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use clobazam oral suspension for a condition for which it was not prescribed. Do not give clobazam oral suspension to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about clobazam oral suspension that is written for health professionals. For more information, go to www.accordhealthcare.us or call Accord Healthcare Inc. at 1-866-941-7875. |
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What are the ingredients in Clobazam oral suspension?
Oral SuspensionActive ingredient: clobazam
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Manufactured For:
Manufactured By:
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Instructions for Use Clobazam Oral Suspension, CIV
(KLOE-ba-zam)
Read this Instructions for Use before using Clobazam oral suspension and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your healthcare provider about your medical condition or treatment.
Prepare Clobazam Oral Suspension DoseYou will need the following supplies: See Figure A
Figure A
Step 1. Remove the clobazam oral suspension bottle, bottle adapter, and 1 oral syringe from the box.
Step 2. Shake the bottle well before each use. See Figure B
Figure B
Step 3. Uncap the bottle and firmly insert the bottle adapter into the bottle until the adapter top is even with the bottle top. See Figure C
Figure C
Once the bottle adapter is in place, it should not be removed.
Step 4. Check your dose in milliliters (mL) as prescribed by your healthcare provider. Find this number on the oral syringe. Do not take more than the prescribed total dose in 1 day. See Figure D
Figure D
Step 5. Push the plunger all the way down and then insert the syringe into the upright bottle through the opening in the bottle adapter. See Figure E
Figure E
Step 6. With the oral syringe in place, turn the bottle upside down. Pull the plunger to the number of mLs needed (the amount of liquid medicine in Step 4). See Figure F
Figure F
Measure the mLs of medicine using the tip of the purple plunger. See Figure G
Figure G
Step 7. Remove the oral syringe from the bottle adapter. Slowly squirt clobazam oral suspension directly into the corner of your mouth or your child's mouth until all of the liquid medicine in the oral syringe is given. See Figure H
Figure H
Step 8. Cap the bottle tightly with the adapter in place. If the cap does not fit securely, check to see if the adapter is fully inserted. See Figure I
Figure I
Step 9. Wash the oral syringe after each use.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured For:
Accord Healthcare, Inc.,
1009 Slater Road,
Suite 210-B,
Durham, NC 27703,
USA
Manufactured By:
Intas Pharmaceuticals Limited,
Plot No. 5 to 14, Pharmez,
Near Village Matoda, Sarkhej-Bavla Highway,
No. 8-A, Taluka Sanand, Ahmedabad,
Gujarat 382213, India.
51 4923 0 726217
Issued August 2022