Dactive

Dactive

zolpidem

Manufacturer:

Cadila Healthcare

Distributor:

Metro Drug

Marketer:

Zydus Healthcare Phils
Concise Prescribing Info
Contents
Zolpidem tartrate
Indications/Uses
Short term treatment of insomnia characterized by difficulties w/ sleep initiation.
Dosage/Direction for Use
Adult 10 mg once daily. Should not exceed 10 mg/day. Elderly, debilitated & patient w/ hepatic insufficiency 5 mg daily.
Administration
Should be taken on an empty stomach: Do not take w/ or immediately after a meal.
Contraindications
Hypersensitivity. Anaphylaxis & angioedema.
Special Precautions
Evaluate patients manifesting physical &/or psychiatric disorder before initiating treatment. Rare cases of angioedema involving the tongue, glottis or larynx; dyspnea, throat closing or nausea & vomiting. Decreased inhibition (eg, aggressiveness & extroversion); visual & auditory hallucinations; sleep-driving; worsening of depression, including suicidal thoughts & actions. W/drawal effects following rapid dose decrease or abrupt discontinuation. Patients w/ concomitant illness, depression. May impair ability to drive or operate machinery. Childn. Elderly &/or debilitated patients.
Adverse Reactions
Anaphylactic & anaphylactoid reactions; abnormal thinking, behaviour changes & complex behaviour; w/drawal effects; CNS depressant effects.
Drug Interactions
Potentially enhanced the CNS-depressant effects w/ CNS-depressant drugs. Additive effect on psychomotor performance w/ alcohol. Increased t½ w/ fluoxetine. Increased exposure w/ CYP3A inhibitors. Increased AUC0-∞ w/ itraconazole. Significant reduction in the pharmacodynamic effects w/ rifampin. May enhance sedative effects w/ ketoconazole.
ATC Classification
N05CF02 - zolpidem ; Belongs to the class of benzodiazepine related agents. Used as hypnotics and sedatives.
Presentation/Packing
Form
Dactive FC tab 10 mg
Packing/Price
100's
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