ProSom ( Estazolam ) data sheet

ProSom ( Estazolam )

Estazolam
Estazolam (ProSom)
Estazolam
(es-TAYZ-oh-lam)
Pregnancy Category: X ProSom (C-IV) (Rx)
Classification: Hypnotic, benzodiazepine
See Also: See also Tranquilizers, Antimanic Drugs, and Hypnotics.
Action/Kinetics: Peak plasma levels: 2 hr. t1/2: 10-24 hr. The clearance is increased in smokers compared with nonsmokers. Metabolized in the liver and excreted mainly in the urine. Two metabolites--4'-hydroxy estazolam and 1-oxo-estazolam--have minimal pharmacologic activity although at the levels present they do not contribute significantly to the hypnotic effect.
Uses: Short-term use for insomnia characterized by difficulty in falling asleep, frequent awakenings, and/or early morning awakenings.
Contraindications: Pregnancy. Use during labor and delivery and during lactation.
Special Concerns: Use with caution in geriatric or debilitated clients, in those with impaired renal or hepatic function, in those with compromised respiratory function, and in those with depression or who show suicidal tendencies. Safety and efficacy have not been determined in children less than 18 years of age.
How Supplied: Tablet: 1 mg, 2 mg
Dosage
.Tablets
Adults: 1 mg at bedtime (although some clients may require 2 mg). The initial dose in small or debilitated geriatric clients is 0.5 mg. Prolonged use is not recommended or necessary.Available In
Tablets Why Prescribed
To treat insomnia. How It Works
In general, estazolam produces a mild sedative effect by depressing activity in the central nervous system (the brain and spinal cord). In particular, estazolam appears to enhance the effect of gamma-aminobutyric acid (GABA), a natural chemical that inhibits the firing of neurons and dampens the transmission of nerve signals, thus decreasing nervous excitation. Range and Frequency
Adults: 1 or 2 mg taken at bedtime. Onset of Effect
Unknown. Duration of Action
Unknown. Dietary Advice
No special restrictions. Storage
Store in a tightly sealed container away from heat and direct light. Missed Dose
Take it as soon as you remember, unless it is late at night. Do not take the medicine unless your schedule permits a full night's sleep. Stopping the Drug
The decision to stop taking the drug should be made in consultation with your doctor. Stopping it abruptly may cause withdrawal symptoms. Prolonged Use
Estazolam can lead to psychological or physical dependence. Short-term therapy (8 weeks or less) is typical; do not take it for a longer period unless so advised by your doctor. Never take more than the prescribed daily dose. Over 60
Adverse reactions are more likely and more severe. A lower dose may be warranted. Driving and Hazardous Work
Estazolam can impair mental alertness and physical coordination. Adjust your activities accordingly. Alcohol
Avoid alcohol. Pregnancy
Estazolam should not be used during the first 3 months (first trimester) of pregnancy and only with great caution and close medical supervision later in pregnancy. Overuse of estazolam during pregnancy may cause drug dependence in the unborn child. Breast Feeding
Estazolam passes into breast milk; do not take it while nursing. Infants and Children
Safety and effectiveness have not been determined for children under age 18. Special Concerns
Estazolam use can lead to psychological or physical dependence. Overdose Symptoms
Extreme drowsiness, confusion, slurred speech, slow reflexes, poor coordination, staggering gait, tremor, slowed breathing, loss of consciousness. What to Do
Call your doctor, emergency medical services (EMS), or the nearest poison control center immediately. Drug Interactions
Other drugs may interact with estazolam. Consult your doctor for specific advice if you are taking any drugs that depress the central nervous system; these include antihistamines, antidepressants or other psychiatric medications, barbiturates, sedatives, cough medicines, decongestants, and painkillers. Be sure your doctor knows about any over-the-counter medication you may take. Food Interactions
None reported. Disease Interactions
Caution is advised when taking estazolam. Consult your doctor if you have a history of alcohol or drug abuse, stroke or other brain disease, any chronic lung disease, hyperactivity, depression or other mental illness, myasthenia gravis, sleep apnea, epilepsy, porphyria, kidney disease, or liver disease. Serious Side Effects
Difficulty concentrating, outbursts of anger, other behavior problems, depression, seizures, hallucinations, low blood pressure (causing faintness or confusion), memory impairment, muscle weakness, skin rash or itching, sore throat, fever and chills, sores or ulcers in throat or mouth, unusual bruising or bleeding, extreme fatigue, yellowish tinge to eyes or skin. Call your doctor immediately. Common Side Effects
Drowsiness, loss of coordination, unsteady gait, dizziness, lightheadedness, slurred speech. Less Common Side Effects
Change in sexual desire or ability, constipation, false sense of well-being, nausea and vomiting, urinary problems, unusual fatigue. DRUGS
Estazolam - Interactions

5-HTP
Excessive drowsiness may occur when taken together. Use with caution.
GABA
Excessive drowsiness may occur when taken together. Use with caution.
kava
Excessive drowsiness may occur when taken together. Use with caution.
melatonin
Excessive drowsiness may occur when taken together. Use with caution.
melissa
Excessive drowsiness may occur when taken together. Use with caution.
valerian
Excessive drowsiness may occur when taken together. Use with caution.




 
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