Sedil Tablet

Indication
Diazepam is indicated for the management of anxiety disorders or for the shortterm relief of the symptoms of anxiety. Anxiety or tension associated with the?ÿstress?ÿof everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, Diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute?ÿdelirium tremens?ÿand hallucinosis.Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper?ÿmotor neuron disorders (such as?ÿcerebral palsy and paraplegia), athetosis, and stiff-man syndrome.Oral Diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy.The effectiveness of Diazepam in long-term use, that is, more than 4 months, has not been assessed by systematic clinical studies. The physician should periodically reassess the usefulness of the drug for the individual patient.

Pharmacology
Diazepam, like other members of the benzodiazepine family, binds to receptors in various regions of the brain, such as the spinal cord, brain stem, cerebellum, limbic system and cerebral cortex. Binding of diazepam to the benzodiazepine receptor potentiates the inhibitory actions of gamma-aminobutyric acid (GABA) mediated through chloride channel, thereby enhancing GABA-facilitated, inhibitory synaptic transmission.

Dosage
Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects. ADULTS: Management of Anxiety Disorders and Relief of Symptoms of Anxiety: Depending upon severity of symptoms 2 mg to 10 mg, 2 to 4 times dailySymptomatic Relief in Acute Alcohol Withdrawal: 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as neededAdjunctively for Relief of Skeletal Muscle Spasm: 2 mg to 10 mg, 3 or 4 times dailyAdjunctively in Convulsive Disorders: 2 mg to 10 mg, 2 to 4 times dailyGeriatric Patients, or in the presence of debilitating disease: 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in pediatric patients under 6 months: 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated

Interaction
Diazepam may potentiate or interact with the effects of other CNS acting drugs such as alcohol, narcotics, hypnotics, sedative antihistamines, antipsychotics, anxiolytics/ sedatives, anesthetics, antidepressants and anticonvulsants. Besides these diazepam may interact with phenytoin, cimetidine, levodopa, lithium.

Contradiction
Patients with known hypersensitivity to benzodiazepines, & myasthenia gravis are contraindicated to diazepam.

Side Effect
Drowsiness and light headedness the next day; confusion and ataxia (specially in the elderly); amnesia may occur; dependence; paradoxical increase in aggression; occasionally headache, vertigo, hypotension, gastrointestinal disturbances, visual disturbances, dysarthria, tremor, changes in libido, incontinence, urinary retention, blood disorders and jaundice reported.

Pregnancy
Category D: The use of Diazepam during the first trimester of pregnancy should almost always be avoided as it bears a risk of congenital malformation.Diazepam has been detected in breast milk. If possible the use of diazepam should be avoided during lactation.

Precaution
Diazepam is not recommended for use in patients with depressive disorders or psychosis. Patients should be advised against the concurrent use of alcohol and other CNS depressant drugs. Patients with known or presumed dependence from alcohol or drugs should not take benzodiazepines.Since Diazepam has a CNS depressant effect, patients should be warned against driving, operating dangerous machinery, or engaging in other hazardous activities requiring mental alertness and physical coordination.

Overdose
Symptoms: Somnolence, ataxia, confusion, dysarthria, little or no resp depression, hypotension, muscular weakness, deep coma, severe depression, diminished reflexes. Management: Symptomatic and supportive treatment. Empty stomach by vomiting or gastric lavage. Activated charcoal may help reduce absorption. Flumazenil may be used for the complete or partial reversal of the sedative effects but there is a risk of seizure esp in long-term benzodiazepine users and in cyclic antidepressant overdose.

Storage
Store between 15-30?øC. Protect from light. Inj: Avoid freezing.