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Tranquil 10
The Ibn Sina Pharmaceutical Ind. Ltd.
Generic: Clobazam
Safety Advices
বাংলা
English
UNSAFE
Tranquil 10 may cause excessive drowsiness with alcohol.
CONSULT YOUR DOCTOR
Tranquil 10 may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
CONSULT YOUR DOCTOR
Tranquil 10 is probably unsafe to use during breastfeeding. Limited human data suggests that the drug may pass into the breastmilk and harm the baby.
Short-term use is not expected to cause any adverse effects in the breastfed baby, especially if the baby is older than 2 months. During long-term use, monitor for possible sleepiness.
UNSAFE
Tranquil 10 may cause side effects which could affect your ability to drive.
You may feel sleepy or have concentration or memory problems after taking Tranquil 10 and this may affect your ability to drive.
CAUTION
Tranquil 10 should be used with caution in patients with kidney disease. Dose adjustment of Tranquil 10 may be needed. Please consult your doctor.
Limited information is available on the use of Tranquil 10 in these patients. No dose adjustment is recommended in patients with mild to moderate kidney disease.
CAUTION
Tranquil 10 should be used with caution in patients with liver disease. Dose adjustment of Tranquil 10 may be needed. Please consult your doctor.
Limited information is available on use of Tranquil 10 in patients with severe liver disease.
Medicine Overview of Tranquil 10mg Tablet
Introduction
Tranquil 10 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. Tranquil 10 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...
... Show moreUses of Tranquil 10
- Severe anxiety
- Epilepsy/Seizures
Side effects of Tranquil 10
Common
- Aggressive behavior
- Breathing problems
- Constipation
- Cough
- Difficulty in urination
- Drooling
- Fever
- Insomnia (difficulty in sleeping)
- Sleepiness
- Slurred speech
- Tiredness
How to use Tranquil 10
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. Tranquil 10 may be taken with or without food, but it is better to take it at a fixed time.
How Tranquil 10 works
Tranquil 10 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
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),...
... Show moreChild 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 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
Renal Dose
Renal impairment
Mild or moderate renal impairment: No dose adjustment required
Severe renal impairment or ESRD: No experience
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
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.
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...
... Show moreInteraction
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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