Clinical Pharmacology of Estazolam (Prosom):rxlist:"ProSom tablets have been found to be equivalent in absorption to an orally administered solution of estazolam. Independent of concentration, estazolam in plasma is 93% protein bound. In healthy subjects who received up to three times the recommended dose of ProSom, peak estazolam plasma concentrations occurred within two hours after dosing (range 0.5 to 6.0 hours) and were proportional to the administered dose, suggesting linear pharmacokinetics over the dosage range tested. The range of estimates for the mean elimination half-life of estazolam varied from 10 to 24 hours. The clearance of benzodiazepines is accelerated in smokers compared to nonsmokers, and there is evidence that this occurs with estazolam. This decrease in half-life, presumably due to enzyme induction by smoking, is consistent with other drugs with similar hepatic clearance characteristics. In all subjects and at all doses, the mean elimination half-life appeared to be independent of the dose. In a small study (N=8) using various doses in older subjects (59 to 68 years), peak estazolam concentrations were found to be similar to those observed in younger subjects with a mean elimination half-life of 18.4 hours (range 13.5 to 34.6 hours)."
http://www.rxlist.com/cgi/generic2/estaz_cp.htm

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estazolam (prosom) special precautions:medlineplus:"tell your doctor and pharmacist if you are allergic to estazolam, alprazolam (Xanax), chlordiazepoxide (Librium, Librax), clonazepam (Klonopin), clorazepate (Tranxene), diazepam (Valium), flurazepam (Dalmane), lorazepam (Ativan), oxazepam (Serax), prazepam (Centrax), temazepam (Restoril), triazolam (Halcion), or any other drugs. tell your doctor and pharmacist what prescription and nonprescription medications you are taking, especially antihistamines; cimetidine (Tagamet); digoxin (Lanoxin); disulfiram (Antabuse); medications for depression, seizures, Parkinson's disease, pain, asthma, colds, or allergies; muscle relaxants; isoniazid (INH, Laniazid, Nydrazid); oral contraceptives; probenecid (Benemid); rifampin (Rifadin); sedatives; sleeping pills; theophylline (Theo-Dur); tranquilizers; and vitamins. These medications may add to the drowsiness caused by estazolam. tell your doctor if you have or have ever had glaucoma; seizures; or lung, heart, or liver disease. tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking estazolam, call your doctor immediately. if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking estazolam. you should know that this drug may make you drowsy. Do not drive a car or operate machinery until you know how this drug affects you. remember that alcohol can add to the drowsiness caused by this drug. tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this drug"
Office of Communications and Public Liaison National Library of Medicine
8600 Rockville Pike Bethesda, Maryland 20894
Phone: (301) 496-6308 Fax: (301) 496-4450 email: publicinfo@nlm.nih.gov
http://www.nlm.nih.gov/medlineplus/druginfo/medmaster/a691003.html#precautions

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estazolam (prosom) side effects and reasons to call the doctor:healthandage:"Feeling sleepy, lightheaded, or unable to think clearly. Avoid driving, doing other tasks or activities that require you to be alert until you see how this medicine affects you. Dry mouth. Frequent mouth care, sucking hard candy, or chewing gum may help. Signs of a life-threatening reaction. These include wheezing; tightness in the chest; fever; itching; bad cough; blue skin color; fits; swelling of face, lips, tongue, or throat. Changes in balance, feeling shaky or unsteady. Too tired or sleepy. Any rash"
http://www.healthandage.com/html/res/com/ConsDrugs/Estazolamcd.html#SideEffects

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Possible food and drug interactions when taking Estazolam (Prosom):gettingwell.com:"Do not drink alcohol while you are taking ProSom; this combination could make you comatose or dangerously slow your breathing. For the same reason, do not combine ProSom with any other medication that might calm or slow the functioning of your central nervous system. Among such drugs are: Antiseizure drugs such as Dilantin, Tegretol, and Depakene, Antihistamines such as Benadryl and Chlor-Trimeton, Major tranquilizers such as Haldol and Mellaril, Barbiturates such as phenobarbital, MAO inhibitors such as the antidepressants Nardil and Parnate, Narcotics such as Percodan and Tylox, Tranquilizers such as Valium and Xanax. If you smoke, you will tend to process and eliminate ProSom fairly quickly compared with a nonsmoker"
http://www.gettingwell.com/drug_info/rxdrugprofiles/drugs/PRO1359.shtml

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Estazolam (Prosom) drug comparision:drugdigest:"Several drug classes have been used to treat insomnia and sleep disorders. The medications are to be used only short-term and should be used in combination with good sleep-hygiene. Benzodiazepines are commonly used for the management of sleep disorders. Shorter-acting benzodiazepines are less likely than long-acting benzodiazepines to be associated with drowsiness or sluggishness the next morning. Benzodiazepines should be only be used occasionally for sleep disorders, and they should not be discontinued abruptly because rebound insomnia (i.e. worsening of insomnia) may result. Estazolam (ProSom) Versus Flurazepam (Dalmane)"
http://www.drugdigest.org/DD/Comparison/NewComparison/0,10621,18-22,00.html

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Estazolam (Prosom) special precautions:healthsquare:"Since ProSom may cloud your thinking, impair your judgment, or interfere with your normal physical coordination, do not drive, climb, or perform hazardous tasks until you know your reaction to this medication. It is important to remember that the tablet you took in the evening may continue to affect you well into the following day. If you are older or physically run-down, or if you have liver or kidney damage or breathing problems, you will be particularly vulnerable to side effects from ProSom, and you should use this medication with special caution. Do not take ProSom if you are sensitive or allergic to it, or if you have ever had an adverse reaction to another Valium-type medication. Do not take ProSom if you are pregnant or planning to become pregnant. Drugs in this class may cause damage to the unborn child."
HealthSquare.com
68 East Main St
Somerville, NJ 08876
E-mail: comments@healthsquare.com
http://www.healthsquare.com/newrx/pro1359.htm

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Who should not take Estazolam (Prosom):drugs.com:"Do not take estazolam if you have narrow-angle glaucoma. Estazolam may worsen this condition. Before taking this medication, tell your doctor if you have kidney disease; have liver disease; have asthma, bronchitis, emphysema, or another respiratory disease; or are depressed or have suicidal thoughts. You may not be able to take estazolam, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above. Estazolam must not be taken if you are pregnant. It is in the FDA pregnancy category X. This means that it will cause birth defects in an unborn baby. Do not take estazolam if you are pregnant or are planning a pregnancy. It is not known whether estazolam passes into breast milk. Do not take estazolam without first talking to your doctor if you are breast-feeding a baby. If you are over 60 years of age, you may be more likely to experience side effects from estazolam. You may require a lower dose of this medication. Estazolam is not approved for use in children younger than 18 years of age"
http://www.drugs.com/xq/cfm/pageID_0/htm_D00915A1.htm/bn_estazolam/qx/index.htm

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Summary of Data Reported and Evaluation of Estazolam (Prosom):htdocs:"Estazolam was tested for carcinogenicity in one experiment in mice and one experiment in rats by oral administration in the diet. No increase in the incidence of tumours was found. Estazolam is rapidly and almost completely absorbed in humans. It is extensively metabolized to at least 11 metabolites and excreted mainly in the urine. The elimination half-life is 14-19 h. Metabolism is extensive in various animal species. Rabbits and dogs excrete the metabolites principally in urine, while in mice, rats and guinea-pigs the excretion is mainly in faeces. Some metabolites are species-specific. There were no data available on reproductive effects of estazolam. The data available on genetic effects were negative"
http://193.51.164.11/htdocs/monographs/vol66/estazolam.html



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