Fulnite 1 Tablet
Eszopiclone
1mg
Sun Pharmaceutical Industries Ltd.
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Available as:
Indications
Fulnite 1 Tablet is used for:
Insomnia
Adult Dose
Oral
Insomnia
Adult: 1 mg immediately before bedtime, may increase to 2 or 3 mg if necessary. Max: 3 mg daily.
Elderly: Max: 2 mg daily.
Hepatic impairment: Severe: Max: 2 mg daily.
Child Dose
Safety and efficacy not established
Renal Dose
Administration
Should be taken on an empty stomach. Take immediately before going to bed. Avoid taking after a heavy meal.
Contra Indications
Hypersensitivity
Precautions
Initiate treatment only after careful evaluation of patients; failure of insomnia to remit after 7-10 days of treatment may indicate presence of primary psychiatric and/or medical illness requiring evaluation. May be associated with abnormal thoughts and behaviour changes e.g. bizarre behavior, agitation, hallucinations, depersonalization, decreased inhibition. Complex sleep-related behaviours with no memory of the incident such as "sleep-driving", preparing and eating food, making phone calls, having sex while not fully awake have been reported.
Caution in patients with history of drug or alcohol dependence and/or abuse. Worsening of depression, emergence of suicidality have been reported. Eszopiclone has rapid onset of action and must be taken immediately before bedtime or after experiencing difficulty sleeping. May impair ability to drive or operate machinery. Hypersensitivity reaction including angioedema involving the tongue, glottis or larynx, and symptoms suggestive of anaphylaxis have been reported. Abrupt discontinuance or rapid dose reduction may cause withdrawal symptoms. Caution in hepatic impairment; elderly/debilitated patients. Safety and efficacy have not been established in children <18 yr. Pregnancy and lactation.
Lactation: excretion in milk unknown; use with caution
Pregnancy-Lactation
Interactions
Concurrent use of CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, clarithromycin, nefazodone, troleandomycin, ritonavir, nelfinavir) may decrease metabolism and increase plasma concentrations of Eszopiclone; dosage reduction of Eszopiclone may be needed. Concurrent use with CYP3A4 inducers (e.g. rifampicin) may reduce concentrations of Eszopiclone.
May enhance adverse CNS effects when used with alcohol, anticonvulsants, antihistamines, or other psychotropic drugs. Concurrent use with flumazenil may diminish the sedative effect of nonbenzodiazepine hypnotics.
Adverse Effects
Side effects of Eszopiclone :
>10%
Headache (13-21%),Unpleasant taste (17-34% in non-elderly)
1-10%
Abnormal dreams (elderly),Accidental injury (elderly),Diarrhea,Dizziness,Dry mouth,Dyspepsia,Nervousness,Neuralgia,Pain,Pruritus,Rash (in non-elderly),Somnolence,Unpleasant taste (elderly),UTI
<1%
Agitation,Alopecia,Angioedema,Asthma,Anorexia,Cystitis,Dysphagia,Fever,Epistaxis,Hypertension,Hostility,Hypercholesterolemia,Hypokalemia
Potentially Fatal: Anaphylaxis reactions, angioedema involving the tongue, glottis or larynx.
Mechanism of Action
Eszopiclone is an S-enantiomer of zopiclone; a nonbenzodiazepine hypnotic of the cyclopyrrolone class. It is structurally unrelated to pyrazolopyrimidines, imidazopyridines, benzodiazepines, barbiturates, or other known drugs with similar hypnotic activity. The exact mechanism of action is unknown, its effect is associated with the interaction with gamma-aminobutyric acid (GABA)-receptor complex at binding domains found near to or allosterically coupled to benzodiazepine receptors.
Note
Fulnite 1 1mg Tablet manufactured by Sun Pharmaceutical Industries Ltd.. Its generic name is Eszopiclone. Fulnite 1 is availble in Nepal.
Farmaco Nepal drug index information on Fulnite 1 Tablet is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.