Clozam

Introduction
Clozam belongs to a class of medicines known as benzodiazepines. It is a prescription medicine used to treat epilepsy (seizures) and severe anxiety. It alters brain activity, calms it and provides relief from panic attacks by relaxing the nerves. Clozam may be taken with or without food. However, it is advised to take it at the same time each day as this helps to maintain a consistent level of medicine in the body. Take this medicine in the dose and duration as advised by your doctor as it has a high potential of habit forming. If you have missed a dose, take it as soon as you remember and finish the full course of treatment even if you feel better. It is important that this medication is not stopped suddenly without talking to your doctor as it may increase seizure frequency. Some common side effects of this medicine include tiredness, slurred speech, fever, cough, drooling, constipation, and difficulty in passing urine. It may cause dizziness and sleepiness, so do not drive or do anything that requires mental focus until you know how this medicine affects you. It is important to consult the doctor if you notice blisters on the skin or inside your mouth. If you have been taking this medicine for a long time than regular monitoring of blood and liver functions may be required.

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Uses of Clozam
Severe anxiety
Epilepsy/Seizures
Side effects of Clozam
Common
Aggressive behavior
Breathing problems
Constipation
Cough
Difficulty in urination
Drooling
Fever
Insomnia (difficulty in sleeping)
Sleepiness
Slurred speech
Tiredness
How to use Clozam
Take this medicine in the dose and duration as advised by your doctor. Swallow it as a whole. Do not chew, crush or break it. Clozam may be taken with or without food, but it is better to take it at a fixed time.
How Clozam works
Clozam is a benzodiazepine. It works by increasing the action of a chemical messenger (GABA) which suppresses the abnormal and excessive activity of the nerve cells in the brain.
Quick Tips
The addiction / habit-forming potential of this medicine is very high. Take it only as per the dose and duration advised by your doctor
It may cause dizziness. Do not drive or do anything that requires mental focus until you know how this medicine affects you.
Avoid consuming alcohol as it may increase dizziness and drowsiness.
Inform your doctor if you are pregnant, planning to conceive or breastfeeding.
Inform your doctor if you notice sores or blisters on your skin, lips, or inside your mouth.
Do not stop taking medication suddenly without talking to your doctor as that may lead to nausea, anxiety, agitation, flu-like symptoms, sweating, tremor, and confusion.
Brief Description
Indication
Anxiety, tension, irritability, restlessness, epilepsy.
Administration
May be taken with or without food. Individualize weight-based dose according to clinical efficacy and tolerability Doses above 5 mg/day should be administered in divided doses twice daily (5 mg dose can be administered as a single daily dose) May be administered whole, or crushed and mixed in applesauce When discontinuing, withdraw gradually; taper by decreasing the total daily dose by 5-10 mg/day on a weekly basis until discontinued

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Adult Dose
Seizures Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years or older >30 kg: Initiate at 5 mg PO q12hr; may titrate as tolerated up to 40 mg/day divided q12hr Dose escalation should not proceed more rapidly than once weekly Hepatic impairment Limited data to characterize the effect of hepatic impairment on the pharmacokinetics; proceed with low and slow titration Mild-to-moderate (Child-Pugh 5-9): Starting dose should be 5 mg/day and titrated according to weight, but to half the typical adult dose; additional titration to the maximum dose (20 mg/day or 40 mg/day), depending on the weight group may be started on day 21 Severe hepatic impairment: Not recommended

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Child Dose
Seizures Indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients aged 2 years or older <30 kg Starting dose: 5 mg PO qDay; titrate as tolerated up to 20 mg PO daily After 7 days, may increase to 5 mg PO q12hr; if needed, may increase to 10 mg PO q12hr after an additional 7 days >30 kg Starting dose: 5 mg PO q12hr; titrate as tolerated up to 40 mg PO daily After 7 days, may increase to 10 mg PO q12hr; if needed, may increase to 20 mg PO q12hr after an additional 7 days

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Renal Dose
Renal impairment Mild or moderate renal impairment: No dose adjustment required Severe renal impairment or ESRD: No experience

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Contraindication
Hypersensitivity; history of drug dependence; myasthaenia gravis; pregnancy (1st trimester), lactation; serious liver damage; sleep apnoea syndrome; impaired respiratory function.
Mode of Action
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.
Precaution
May impair ability to perform skilled tasks and hazardous activities; elderly; renal or hepatic impairment; alcoholics; obesity; withdrawal should be gradual. Lactation: Excreted in breast milk; effects of exposure on infants unknown

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Side Effect
>10% Somnolence or sedation (26%),Somnolence (22%),Pyrexia (13%),Upper respiratory tract infection (12%) 1-10% Drooling (9%),Aggression (8%),Irritability (7%),Vomiting (7%),Insomnia (5%),Ataxia (5%),Sedation (5%),Constipation (5%),Fatigue (5%),Cough (5%),Psychomotor hyperactivity (4%),Pneumonia (4%),Urinary tract infection (4%),Dysarthria (3%),Decreased appetite (3%),Increased appetite (3%),Bronchitis (2%),Dysphagia (2%) Potentially Fatal: Respiratory depression.

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Pregnancy Category Note
Pregnancy There are no adequate and well-controlled studies in pregnant women; available data suggest that the class of benzodiazepines is not associated with marked increases in risk for congenital anomalies; although some early epidemiological studies suggested a relationship between benzodiazepine drug use in pregnancy and congenital anomalies such as cleft lip and or palate, these studies had considerable limitations; more recently completed studies of benzodiazepine use in pregnancy have not consistently documented elevated risks for specific congenital anomalies; there is insufficient evidence to assess effect of benzodiazepine pregnancy exposure on neurodevelopment There are clinical considerations regarding exposure to benzodiazepines during second and third trimester of pregnancy or immediately prior to or during childbirth; these risks include decreased fetal movement and/or fetal heart rate variability, “floppy infant syndrome,” dependence, and withdrawal Administration of clobazam to pregnant rats and rabbits during period of organogenesis or to rats throughout pregnancy and lactation resulted in developmental toxicity, including increased incidences of fetal malformations and mortality, at plasma exposures for clobazam and its major active metabolite, N-desmethylclobazam, below those expected at therapeutic doses in patients; data for other benzodiazepines suggest possibility of long-term effects on neurobehavioral and immunological function in animals following prenatal exposure to benzodiazepines at clinically relevant doses; drug should be used during pregnancy only if potential benefit to mother justifies potential risk to fetus; advise a pregnant woman and women of childbearing age of potential risk to a fetus Infants born to mothers who have taken benzodiazepines during later stages of pregnancy can develop dependence, and subsequently withdrawal, during postnatal period; clinical manifestations of withdrawal or neonatal abstinence syndrome may include hypertonia, hyperreflexia, hypoventilation, irritability, tremors, diarrhea, and vomiting; these complications can appear shortly after delivery to 3 weeks after birth and persist from hours to several months depending on degree of dependence and pharmacokinetic profile of the benzodiazepine; symptoms may be mild and transient or severe; standard management for neonatal withdrawal syndrome has not yet been defined; observe newborns who are exposed to drug in utero during later stages of pregnancy for symptoms of withdrawal and manage accordingly Laber and delivery Administration of benzodiazepines immediately prior to or during childbirth can result in a floppy infant syndrome, which is characterized by lethargy, hypothermia, hypotonia, respiratory depression, and difficulty feeding; floppy infant syndrome occurs mainly within first hours after birth and may last up to 14 days; observe exposed newborns for these symptoms and manage accordingly Lactation Drug is excreted in human milk; postmarketing experience suggests that breastfed infants of mothers taking benzodiazepines, may have effects of lethargy, somnolence and poor sucking; effect of drug on milk production is unknown; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for drug and any potential adverse effects on breastfed infant from drug or from underlying maternal condition; if exposing a breastfed infant to drug, observe for any potential adverse effects

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Interaction
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

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