Clobazam

(kloe' ba zam)

PCI  : Contraindicated in pregnancy

LCI  : Contraindicated in lactation

Molecule Info

 | See TERMINOLOGY & ABBREVIATIONS |

Indication(s) & Dosage

Oral Short-term management of anxiety, Adjunct in epilepsy Adult:  20-30 mg as a single dose at night or as daily divided doses, increased to 60 mg/day in severe conditions.Child: 3-12 yr:  125 mcg/kg bid increased every 5 days. Usual maintenance dose:  250 mcg/kg bid. Max:  500 mcg/kg bid. Elderly: or debilitated patients:  10-20 mg daily. Renal impairment: Dose adjustment may be needed. Hepatic impairment: Dose adjustment may be needed. Special Populations: Debilitated patients:  10-20 mg daily.

Administration

Should be taken with food.

Overdosage

Drowsiness, mental confusion, lethargy, ataxia, hypotonia, hypotension, respiratory depression, coma and very rarely death. Treatment includes emptying stomach by inducing vomiting (if within 1 hr) or gastric lavage. Activated charcoal may be used to reduce absorption. Monitor respiratory and CV functions. Flumazenil may be given if necessary. Forced diuresis or haemodialysis unlikely to be effective.

Contraindications

Hypersensitivity; history of drug dependence; myasthaenia gravis; pregnancy (1sttrimester), lactation; serious liver damage; sleep apnoea syndrome; impaired respiratory function.

Special Precautions

May impair ability to perform skilled tasks and hazardous activities; elderly; renal or hepatic impairment; alcoholics; obesity; withdrawal should be gradual.

Adverse Drug Reaction(s)

Constipation, anorexia, nausea; dizziness, fine tremors; worsening of respiratory symptoms in predisposed individuals; ataxia, drowsiness, headache, confusion; loss of libido, motor dysfunction; dependence; visual disturbances and weight gain.Potentially Fatal: Respiratory depression.

Drug Interactions

Increased hepatic clearance of clobazam when administered with phenytoin, phenobarbital or carbamazepine. Cimetidine may increase levels of clobazam.Potentially Fatal: Concurrent alcohol, hypnotics and sedative antidepressants can potentiate CNS side effects of clobazam.Click to view more clobazam Drug Interactions

Storage

Store at 15-30°C.

Pharmacology

Clobazam binds to one or more specific GABA receptors at several sites within the CNS including the limbic system and reticular formation. Increased permeability of neuronal membrane to chloride ions results in GABA's inhibitory effect leading to hyperpolarisation and stabilisation. Absorption: Well absorbed from the GI tract (oral); peak plasma concentrations after 1-4 hr.Distribution: Rapidly crosses the blood-brain barrier. Protein-binding:  85%. Metabolism: Hepatic by demethylation and hydroxylation.Excretion: Urine (as unchanged drug and metabolites); 18-42 hr (elimination half-life).

ATC Classification

N05BA09 - clobazam; Belongs to the class of benzodiazepine derivatives anxiolytics. Used in the management of anxiety, agitation or tension.

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Brand/Product Info


Total Products : 17                 
Brand Name Manufacturer/Marketer Composition Dosage Form Pack Size & Price
CALM Biopharma Laboratories Ltd Clobazam 10mg Tablet 100's: 276.00 MRP
CLOB Opsonin Pharma Limited Clobazam 10mg Tablet 100's: 275.00 MRP
CLOBAM 10 Square Pharmaceuticals Ltd. Clobazam 10mg Tablet 10x10's: 402.00 MRP
CLOBID Medimet Pharmaceuticals Ltd Clobazam 10mg Tablet 100's: 275.00 MRP
CLOZAM Navana Pharmaceuticals Limited Clobazam 10mg Tablet 100's: 281.00 IP
COLAX Pharmadesh Laboratories Limited Clobazam 10mg Tablet 50's: 137.50 MRP
COSIUM The Acme Laboratories Ltd. Clobazam 10mg Tablet 100's: 351.00 MRP
EBAZAM Edruc Limited Clobazam 10mg Tablet 100's: 300.00 IP
EPSON Zenith Pharmaceuticals Ltd. Clobazam 10mg Tablet 100's: 280.00 MRP
FRISIUM Sanofi Clobazam 10mg Tablet 100's: 355.00 MRP
KEOLAX Beximco Pharmaceuticals Ltd Clobazam BP 10mg Tablet 100's: 277.00 MRP
NEBIUM Globe Pharmaceuticals Ltd Clobazam 10mg Tablet 100's: 255.00 MRP
PREZIUM Nipa Pharmaceuticals Ltd. Clobazam 10mg Tablet 100's: 250.00 MRP
PROCALM Kemiko Pharmaceuticals Ltd Clobazam 10mg Tablet 100's: 300.00 MRP
TENSNIL Alco Pharma Ltd Clobazam 10mg Tablet 100's: 255.00 MRP
TRANQUIL IBN SINA Pharmaceutical Industry Ltd. Clobazam 10mg Tablet 100's: 400.00 IP
VENIUM Hudson Pharmaceuticals Ltd Clobazam 10mg Tablet 100's: 270.00 MRP

Gen. MedInfo

Why is this medication prescribed?

Clobazam is used with other medication(s) to control seizures in adults and children 2 years of age and older who have Lennox-Gastaut syndrome (a disorder that causes seizures and often causes developmental delays). Clobazam is in a class of medications called benzodiazepines. It works by decreasing abnormal electrical activity in the brain.

How should this medicine be used?

Clobazam may come as a tablet to take by mouth. It is usually taken once or twice a day, with or without food. Take clobazam at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor to explain any part you do not understand.

If you are unable to swallow the tablets whole, you may crush them and mix with a small amount of applesauce.

Your doctor will probably start you on a low dose of clobazam and gradually increase your dose, not more than once every week.

Some people may respond differently to clobazam based on their heredity or genetic makeup. Your doctor may order a blood test to help find the dose of clobazam that is best for you.

Clobazam can be habit forming. Take clobazam exactly as directed. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Clobazam may help control your condition but will not cure it. Continue to take clobazam even if you feel well. Do not stop taking clobazam without talking to your doctor. If you suddenly stop taking clobazam, you may experience withdrawal symptoms such as new or worsening seizures, hallucinating (seeing things or hearing voices that do not exist), behavior changes, depressed mood, loss of contact with reality, restlessness, irritability, panic attacks, difficulty concentrating, anxiety, difficulty falling asleep or staying asleep, headache, blurred vision, eye sensitivity to light, uncontrollable shaking of a part of your body, fast heartbeat, sweating, muscle pain and stiffness, stomach or muscle cramps, nausea, diarrhea, or weight loss. Your doctor will probably decrease your dose gradually.

Your doctor will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with clobazam and each time you refill your prescription. Read the information carefully and ask your doctor if you have any questions.

What special precautions should I follow?

Before taking clobazam,

•          tell your doctor if you are allergic to clobazam, any other medications, or any of the ingredients in clobazam tablets.

•          tell your doctor what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following:  antidepressants; fluconazole ; fluvoxamine ; hormonal contraceptives ; medications for anxiety, mental illness, pain, or seizures; omeprazole ; sedatives; sleeping pills; ticlopidine ; or tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Many other medications may also interact with clobazam, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list.

•          tell your doctor if you drink or have ever drunk large amounts of alcohol or use or have ever used street drugs or excessive amounts of prescription medications. Also tell your doctor if you have or have ever had depression, mood problems, or thoughts about harming or killing yourself, or planning or trying to do so; or lung, kidney, or liver disease.

•          tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you are using hormonal contraceptives, you should know that this type of birth control may not work well when used with clobazam. Hormonal contraceptives should not be used as your only method of birth control while you are taking clobazam and for 28 days after you stop taking it. Talk to your doctor about birth control methods that will work for you. If you become pregnant while taking clobazam, call your doctor.

talk to your doctor about the risks and benefits of taking this medication if you are 65 years of age or older. Older adults should receive low doses of clobazam because higher doses may not work better and may cause serious side effects.

•          you should know that clobazam may make you drowsy and affect your thinking, ability to make decisions, and coordination. Do not drive a car, operate machinery, or do other dangerous activities until you know how this medication affects you.

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

•          you should know that your mental health may change in unexpected ways and you may become suicidal  while you are taking clobazam. A small number of adults and children 5 years of age and older  who took anticonvulsants, such as clobazam, to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms:  panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania ; thinking about harming or killing yourself, or planning or trying to do so; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Clobazam may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

•          tiredness

•          problems with coordination

•          difficulty speaking or swallowing

•          drooling

•          change in appetite

•          vomiting

•          constipation

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately or get emergency medical treatment:

•          difficult, painful, or frequent urination

•          difficulty breathing

•          rash

•          hives

•          peeling or blistering skin

•          fever

Clobazam may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store clobazam in a safe place so that no one else can take it accidentally or on purpose. Store it at room temperature and away from excess heat and moisture . Throw away any medication that is outdated or no longer needed.

In case of emergency/overdose

In case of overdose, consult your Doctor. If the victim has collapsed or is not breathing, consult local medical emergency services.

Symptoms of overdose may include the following:

•          drowsiness

•          confusion

•          lack of energy

•          problems with coordination

•          slow, shallow breathing

•          decreased urge to breathe

•          fainting

•          blurred vision

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else take your medication. Clobazam is a controlled substance. Prescriptions may be refilled only a limited number of times; ask your pharmacist if you have any questions.

It is important for you to keep a written list of all of the prescription and nonprescription  medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

 

 


This information is provided for reference only and not a replacement for and should only be used in conjunction with full consultation with a registered medical practitioner. It may not contain all the available information you require and cannot substitute professional medical care, nor does it take into account all individual circumstances. Although great effort has been made to ensure content accuracy, mph-bd shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise.