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Clobazam

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WARNING

If taken with certain drugs, clobazam may raise the risk of serious or life-threatening respiratory issues, sedation, or coma. Antidepressants, medications for anxiety, seizures, and mental illness; sedatives; sleeping pills; opioids such as codeine, fentanyl (Duragesic, Subsys), morphine (Astramorph, Kadian), or oxycodone (in Percocet, in Roxicet, and other products); or tranquillizers should all be disclosed to your doctor. Your doctor will closely monitor you and may need to adjust the dosage of your drugs. Call your doctor right once or go to the hospital right away if you have any of the following symptoms when taking clobazam with any of these drugs: Unusual lightheadedness, drowsiness, breathing that is sluggish or difficult, or inability to respond. If you are unable to seek treatment on your own, make sure your carer or family members are aware of any symptoms that may be dangerous so they can contact the doctor or emergency services.

Clobazam might cause dependence. Never exceed the recommended dosage, frequency, or duration. Always follow your doctor’s instructions. Inform your doctor if you use or have ever used illicit drugs, consumed excessive amounts of alcohol, or have ever misused any prescription drugs. Don’t consume alcohol or use illicit substances while receiving treatment. Using illicit substances or drinking alcohol while taking clobazam increases your risk of developing these severe, sometimes fatal side effects. Additionally let your doctor know if you suffer from depression or any other mental disease now or in the past.

If you take clobazam for several days to weeks, especially, you run the risk of developing a physical dependence, which manifests as unpleasant physical symptoms if a medication is abruptly withdrawn or taken in reduced dosages. Without first seeing your doctor, never stop taking this drug or reduce your dose. Sudden discontinuation of clobazam can exacerbate your disease and result in withdrawal symptoms that could last anywhere from a few weeks to over a year. Your dosage of clobazam will probably be gradually reduced by your doctor. If you notice any of the following signs, contact your physician right away or seek emergency care: Unusual movements, ringing in the ears, anxiety, memory issues, difficulty concentrating, sleep issues, seizures, shaking, muscle twitching, changes in mental health, depression, burning or prickling sensations in the hands, arms, legs, or feet, seeing or hearing things that others do not see or hear, suicidal thoughts, excessive excitement, or losing touch with reality are all signs that something is wrong.

Why is this medication prescribed?

When used with additional medication(s), clobazam helps adults and kids with Lennox-Gastaut syndrome who are at least two years old control their seizures (a disorder that causes seizures and often causes developmental delays). The drug clobazam belongs to the benzodiazepine drug class. It functions by reducing the brain’s aberrant electrical activity.

How should this medicine be used?

The drug clobazam is available as a tablet, a suspension (liquid) to be swallowed, as well as a film to place on the tongue. With or without food, it is often taken once or twice day. Take clobazam every day at roughly the same time(s). Ask your doctor or pharmacist to explain any instructions on your prescription label that you are unsure about following.

The tablets can be broken in half on the score mark or crushed and combined with a tiny amount of applesauce if you are unable to swallow them whole.

Together with the liquid are two oral dosing syringes and an adapter. Save the second oral dosing syringe and only use one of the two to measure your dose. The second oral syringe that is offered might be used in its place if the first one is lost or damaged.

To take the liquid, do the following:

  1. Uncap the bottle and firmly insert the adapter into the neck until the adapter top is level with the bottle top before the first usage. Throughout the time you are using this bottle, do not remove the adaptor.
  2. Before each usage, give the beverage a good shake to evenly distribute the medication.
  3. To measure your dose, fully depress the syringe’s plunger and place it into the upright bottle’s adaptor. Then, invert the container and gradually pull the plunger back until the black ring corresponds to the recommended dose.
  4. Take the syringe out of the bottle adapter and slowly inject the liquid into your mouth’s corner.
  5. After each usage, cover the adaptor with the bottle cap.
  6. Each time you use the oral syringe, wash it. Remove the plunger entirely, wash the barrel and plunger with soap and water, rinse, and let the syringe air dry to clean it. The syringe components should not be put in the dishwasher.

Do the following actions to watch the movie:

  1. The film should be taken out of the foil pouch. Make sure your hands are clean and dry.
  2. Put the movie on your tongue’s surface.
  3. Swallow your saliva regularly while closing your mouth. While the film degrades, avoid talking, chewing, and spitting. Take without liquids.
  4. Sanitise your hands.

When taking more than one film per dose as prescribed by your doctor, wait until the first film has completely dissolved before using the second film.

Clobazam will likely be prescribed to you at a modest starting dose by your doctor, who will then likely progressively raise it over time possibly once every week.

The genetic make-up or heredity of some people may affect how they react to clobazam. To assist determine the dosage of clobazam that is most effective for you, your doctor can request a blood test.

Although it won’t treat your disease, clobazam may help you manage it. Even if you feel well, keep taking clobazam. Without first consulting your doctor, do not discontinue taking clobazam.

Each time you refill your prescription for clobazam, your doctor or pharmacist will provide you the manufacturer’s patient information leaflet (Medication Guide). If you have any questions, carefully read the material and contact your doctor or pharmacist. The Medication Guide is also available on the manufacturer’s website or the Food and Drug Administration (FDA) website.

Other uses for this medicine

Ask your doctor or pharmacist for more details if you believe this drug should be used for something else.

What special precautions should I follow?

Before taking clobazam,

  • If you have an allergy to clobazam, any other medications, or any of the substances in clobazam tablets, suspension, or film, let your doctor and pharmacist know right once. For a list of the ingredients, consult the Medication Guide or speak with your pharmacist.
  • Inform your doctor and pharmacist about any additional prescription and over-the-counter drugs, vitamins, dietary supplements, and herbal products you are now taking or intend to use. Mention any of the following medications as well as any of the ones listed in the IMPORTANT WARNING section: antihistamines, dextromethorphan (Delsym, in Nuedexta, in Robitussin DM), fluconazole (Diflucan), fluvoxamine (Luvox), omeprazole (Prilosec, in Zegerid), or ticlopidine. Your physician might need to adjust the dosage of your drugs or keep a close eye on you for side effects. Tell your doctor about all the drugs you are taking, even any not on this list, since many other drugs may also interact with clobazam.
  • Inform your doctor if you have lung, kidney, or liver illness, if you have ever planned to injure or kill yourself, or if you have ever had such thoughts.
  • If you are pregnant or plan to become pregnant, let your doctor know. Your infant can develop withdrawal symptoms after birth if you routinely took clobazam during the final few months of your pregnancy. If your infant exhibits any of the following symptoms, contact your doctor straight away: irritability, hyperactivity, disturbed sleep, high-pitched crying, excessive shaking of a body part, vomiting, or diarrhoea. Call your doctor if you become pregnant while taking clobazam.
  • If you use hormonal birth control, such as tablets, patches, rings, implants, injections, or intrauterine devices, you should be aware that clobazam may impair the effectiveness of these methods of birth control. For the 28 days following your final dosage of clobazam and while you are taking it, you shouldn’t utilise hormonal contraceptives as your exclusive method of birth control. See your doctor about effective nonhormonal birth control options.
  • If you are breastfeeding, let your doctor know. If you are breastfeeding and using clobazam, let your doctor know if your child is not eating or sleeping a lot.
  • If you are 65 years of age or older, discuss the advantages and disadvantages of using this medicine with your doctor. Little doses of clobazam should be administered to elderly patients since bigger doses may not be as effective and may have harmful side effects.
  • You should be aware that clobazam may cause drowsiness and have an impact on your thinking, decision-making, and coordination. Before you are aware of how this drug affects you, avoid operating machinery, operating a vehicle, or engaging in any other risky activity.
  • You should be aware that while using clobazam, your mental health may alter in unexpected ways and that you could become suicidal (thinking about injuring or killing yourself, preparing to do so, or trying to do so). In clinical studies, a small proportion of patients receiving anticonvulsants like clobazam to treat various conditions about 1 in 500 adults and children aged 5 and older became suicidal while receiving medication. Some of these individuals started exhibiting suicidal thoughts and actions as little as one week after beginning the medicine. Whether the hazards of using an anticonvulsant drug outweigh the dangers of not using it will be decided by you and your doctor. Any of the following symptoms should prompt you, your family, or your carer to call your doctor immediately away: panic attacks, agitation or restlessness, as well as newly-appearing or worsening irritation, worry, or depression; acting on risky impulses; trouble falling or staying asleep; hostile, furious, or violent behaviour; mania (frenzied, excessively enthusiastic mood); thoughts of self-harm or suicide, or preparations for or attempts at self-harm; or any other odd changes in behaviour or mood. Make sure your family or carer is aware of any symptoms that could be significant so they can contact the doctor on your behalf if you are unable to call for help.

What special dietary instructions should I follow?

Keep eating normally unless your doctor instructs you otherwise.

What should I do if I forget a dose?

If you miss a dosage, take it as soon as you recall. If the next dose is soon due, skip the missed one and carry on with your regular dosing plan. To make up for a missing dose, do not take a second one.

What side effects can this medication cause?

Side effects are possible with clobazam. If any of these symptoms are severe or do not go away, let your doctor know right once:

  • Tiredness
  • Difficulty coordinating
  • Speaking or swallowing challenges
  • Drooling
  • Alteration in appetite
  • Vomiting
  • Constipation
  • Cough
  • Joints hurt

Some adverse effects may be severe. Call your doctor right away or seek emergency medical attention if you notice any of the symptoms or those detailed in the SPECIAL PRECAUTIONS or IMPORTANT WARNING sections:

  • Frequent, painful, or challenging urinating
  • Cough, breathing issues, and fever
  • Hives, a rash, mouth sores, peeling skin, or blistering skin
  • Fever

Further negative effects of clobazam are possible. If you experience any strange issues while taking this medicine, contact your doctor right away.

You or your doctor can submit a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting programme online or by phone if you have a serious side event (1-800-332-1088).

What should I know about storage and disposal of this medication?

Keep this medication tightly closed in the original container and out of the reach of children. Wait until you are about to use the film before opening the foil pouch. Clobazam should be kept in a secure location to prevent accidental or intentional theft. Keep it away from excessive heat and moisture at room temperature (not in the bathroom). Clobazam suspension (liquid) should be kept upright during storage. If you haven’t used the liquid within 90 days of opening the bottle, throw it away.

Although many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and are simple for young children to open, it is crucial to keep all medications out of sight and out of reach of children. Always lock safety caps and promptly stash medication up and away from young children where it is out of their sight and reach to prevent poisoning. http://www.upandaway.org

Unused prescriptions must be disposed of carefully to prevent pets, kids, and other people from ingesting them. You should not, however, dispose of this medication in the toilet. Instead, utilising a medicine take-back programme is the easiest approach to get rid of your medication. To find out about take-back programmes in your area, speak with your pharmacist or the garbage/recycling department in your city. If you do not have access to a take-back programme, see the FDA’s Safe Disposal of Medications website at http://goo.gl/c4Rm4p for additional information.

In case of emergency/overdose

Call the poison control hotline at 1-800-222-1222 in the event of an overdose. Moreover, information can be found online at https://www.poisonhelp.org/help. Call 911 right once if the person has collapsed, experienced a seizure, is having difficulty breathing, or cannot be roused.

Symptoms of overdose may include the following:

  • Drowsiness
  • Confusion
  • Not enough energy
  • Difficulty coordinating
  • Shallow, sluggish breathing
  • Less need to breathe
  • Fainting
  • Fuzzy vision

What other information should I know?

Keep all of your doctor’s appointments.

No one else should take your medication. A controlled substance is clobazam. Only a limited amount of refills are permitted for prescriptions; if you have any doubts, speak with your pharmacist.

You should keep a written record of every medication you take, including any over-the-counter (OTC) items, prescription drugs, and dietary supplements like vitamins and minerals. This list should be brought with you whenever you see a doctor or are admitted to the hospital. You should always have this information with you in case of emergencies.

Brand names

  • Onfi®
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