لورازپام
Lorazepam (Ativan)
لورازپام

نام ژنریک

Lorazepam

شکل دارویی

اشكال دارويي:


Tablet: 1,2mg


Injection: 2, 4 mg/ml

موارد مصرف

موارد و مقدار مصرف


الف) اضطراب، فشار عصبي، آشفتگي، تحريك پذيري بخصوص در نِورُز اضطرابي يا اختلالات عضوي (بخصوص اختلالات گوارشي يا قلبي- عروقي).


بزرگسالان: در ابتدا mg 3-2 روزانه در 2 تا 3 دوز منقسم مصرف مي‌شود. دوز معمول mg/day 6-2 و حداكثر دوز روزانه mg 10 مي‌باشد.


سالمندان و افراد ناتوان: در ابتدا mg 2-1 در دوزهاي منقسم مصرف شده و سپس برحسب نياز دوز افزايش داده شده و به‌صورت منقسم مصرف مي‌شود.


ب) بي‌خوابي.


بزرگسالان: مقدار 4-2 ميلي‌گرم هنگام خواب مصرف مي‌شود.


پ) درمان تهوع و استفراغ ناشي از شيمي درماني.


بزرگسالان: مقدار mg 5/2 خوراكي، عصر روز قبل از شيمي درماني مصرف شده و پس از شروع شيمي درماني تكرار مي‌شود.


مكانيسم اثر


اثر ضداضطراب و خواب آور: لورازپام CNS را در بخشهاي زيرقشري و ليمبيك مغز تضعيف مي‌كند. اين دارو باعث تحريك گيرنده‌هاي اسيد گاماآمينوبوتيريك (GABA) در سيستم فعال كننده مشبك (ARAS) شده و بعد از تحريك تشكيلات مشبك تنه مغزي، اثر مهاري را افزايش داده و تحريك قشر مغز و سيستم ليمبيك را مسدود مي‌سازد.

موارد منع مصرف

تداخل دارويي


لورازپام اثرات مضعف CNS‌ داروهايي مانند فنوتيازينها، مخدرها، باربيتوراتها، الكل، ضد هيستامينها، مهاركننده‌هاي مونوآمين اكسيداز (MAO)، بيهوشي كننده‌هاي عمومي، و داروهاي ضد افسردگي را تشديد مي‌كند.


سايمتيدين در صورت مصرف همزمان با لورازپام متابوليسم كبدي اين دارو را كاهش و در نتيجه غلظت پلاسمايي آن را افزايش مي‌دهد.


استعمال زياد دخانيات متابوليسم لورازپام را تسريع مي‌كند و موجب كاهش اثربخشي باليني آن مي‌شود.


لورازپام ممكن است باعث افزايش سطح سرمي ديگوكسين شود.


لورازپام ممكن است اثرات لوودوپا را كاهش دهد.

موارد قابل توجه

-

تداخل دارویی

اثر بر آزمايشهاي تشخيصي


لورازپام ممكن است نتايج آزمونهاي عملكرد كبد ( ALT، AST، ALP و LDH) را افزايش دهد.

مکانیزم اثر

اثر بر آزمايشهاي تشخيصي


لورازپام ممكن است نتايج آزمونهاي عملكرد كبد ( ALT، AST، ALP و LDH) را افزايش دهد.

فارماكوكینتیك

موارد منع مصرف و احتياط


موارد منع مصرف: حساسيت مفرط شناخته شده به دارو يا هر يك از اجزاي فرمولاسيون، گلوكوم حاد با زاويه باز، اغما (اثر كاهنده فشار خون يا تسكين بخش دارو ممكن است طولاني يا تشديد شود)، مسموميت شديد با الكل همراه با تضعيف علائم حياتي (موجب تشديد ضعف CNS مي‌شود )، بارداري.


موارد احتياط : اختلالات رواني (به دليل بي‌اثر بودن دارو و احتمال بروز واكنشهاي متناقض)، مياستني گراويس يا بيماري پاركينسون (ممكن است موجب تشديد اين موارد گردد)، نارسايي عملكرد كبدي (اين حالت دفع دارو را طولاني مي‌سازد)، بيماران سالخورده يا ناتوان (معمولاً نسبت به اثرات CNS دارو حساس تر هستند )، بيماران مستعد به اعتياد يا سوء استفاده از دارو، نارسايي عملكرد دستگاه تنفسي، مانند بيماري مزمن انسدادي ريوي، افرادي كه در كار خود نياز به هوشياري كامل دارند (مثل رانندگي، كار با ماشين‌آلات و ... ).

سایر اطلاعات

طبقه‌بندي فارماكولوژيك: بنزوديازپين.


طبقه‌بندي درماني: ضداضطراب، تسكين بخش، خواب آور.


طبقه‌بندي مصرف در بارداري: رده D


ملاحظات اختصاصي


علاوه بر ملاحظات مربوط به تمامي بنزوديازپينها، رعايت موارد زير نيز توصيه مي‌شود:


1- لورازپام يكي از بنزوديازپين‌هاي ترجيحي در بيماران مبتلا به بيماري كبدي است.


2- براي جلوگيري از خواب آلودگي بيش از حد، بايد كمترين مقدار مؤثر مصرف شود.


3- لورازپام بايد در مقادير منقسم مصرف شود. بيشترين دوز، قبل از خواب استفاده شود.


4- به دليل طولاني بودن اثر لورازپام، اين دارو ديگر به ‌عنوان داروي قبل از جراحي مصرف نمي‌شود، ولي ممكن است در اعمال طولاني مؤثر باشد.


5- پس از مصرف طولاني مدت، دارو نبايد بطور ناگهاني قطع شود بلكه اين كار بايد طي چند هفته به صورت تدريجي صورت گيرد.


نكات قابل توصيه به بيمار


1- هرگونه تغيير در مصرف دارو بايد زير نظر پزشك انجام گيرد.


2- براي جلوگيري از صدمه ديدن، به آهستگي تغيير وضعيت دهيد و به آرامي قدم بزنيد.


3- از مصرف مقادير زياد فرآورده‌هاي حاوي كافئين خودداري كنيد، زيرا ممكن است در اثربخشي لورازپام تداخل كند.


4- مصرف طولاني مدت دارو ممكن است موجب بروز وابستگي فيزيکي و رواني به آن شود.


مصرف در سالمندان


1- بيماران سالخورده نسبت به اثرات مضعف CNS لورازپام حساس تر هستند. اين بيماران در شروع درمان يا بعد از افزايش مقدار مصرف ، ممكن است براي انجام فعاليت روزانه احتياج به كمك داشته باشند.


2- در اين بيماران به دليل كاهش دفع دارو، اغلب مقادير كمتر دارو مؤثر است.


مصرف در كودكان:


1- ايمني مصرف لورازپام در كودكان كوچكتر از 12 سال ثابت نشده است.


2- در صورت مصرف طولاني مدت لورازپام در دوران بارداري، بايد نشانه‌هاي قطع مصرف دارو در نوزادان به دقت بررسي شود.


مصرف در شيردهي: لورازپام ممكن است در شير ترشح شود. اين دارو نبايد در دوران شيردهي مصرف شود .


عوارض جانبي


اعصاب مركزي: بي‌قراري ، فراموشي، عدم آگاهي به زمان و مكان، افسردگي، خواب آلودگي، افوريا، آتاكسي، سرگيجه، اختلال تكلم، لرزش، هيجان متناقض، ضعف، سردرد، بي‌خوابي.


ساير عوارض: سندرم قطع مصرف حاد (پس از قطع ناگهاني مصرف دارو در بيماران وابسته به آن).


توجه: در صورت بروز حساسيت مفرط يا واكنشهاي متناقض مانند حالت هيجان مفرط حاد، اضطراب، توهم، اسپاسم عضلاني، بي‌خوابي يا خشم، مصرف دارو بايد قطع شود.


مسموميت و درمان


تظاهرات باليني: خواب ‌آلودگي، کانفيوژن، اغما، كاهش رفلکسها، تنگي نفس، اشكال در تنفس، افت فشار خون، براديكاردي، اختلال تكلم، عدم تعادل در حرکت.


درمان: شامل حفظ فشار خون و تنفس، تا قطع اثر دارو، است. علائم حياتي بيماري بايد پيگيري شود. تهويه مكانيكي براي حفظ مسير تنفسي و ورود اكسيژن كافي به بدن ممكن است ضروري باشد.


براي درمان افت فشار خون، در صورت لزوم، مي‌توان از مايعات تزريقي و داروهاي بالابرنده فشار خون، مانند دوپامين و فنيل افرين استفاده كرد. در صورت هوشيار بودن بيمار، بايد او را وادار به استفراغ كرد. در صورت بلع اخير دارو، مي‌ توان معده را شستشو داد ولي بايد از آسپيراسيون جلوگيري كرد. بعد از استفراغ يا شستشوي معده، ذغال فعال با يك مسهل به صورت مقدار واحد به بيمار داده مي‌شود. دياليز ارزشي كمي دارد.

Lorazepam (Ativan)

Ativan®
(lorazepam) Tablets

DRUG DESCRIPTION

Ativan (lorazepam), an antianxiety agent, has the chemical formula, 7-chloro-5-(o-chlorophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one:

Ativan (lorazepam) structural formula illustration.

C15H10Cl2N2O2 MW: 321.16

It is a nearly white powder almost insoluble in water. Each Ativan (lorazepam) tablet, to be taken orally, contains 0.5 mg, 1 mg, or 2 mg of lorazepam. The inactive ingredients present are lactose monohydrate, magnesium stearate, microcrystalline cellulose, polacriline potassium.

What are the possible side effects of lorazepam (Ativan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • confusion, depressed mood, thoughts of suicide or hurting yourself;
  • hyperactivity, agitation, hostility;
  • hallucinations; or
  • feeling light-headed, fainting.

Less serious side effects may include:

  • drowsiness, dizziness, tiredness;
  • blurred vision;
  • sleep problems...

Read All Potential Side Effects and See Pictures of Ativan »

What are the precautions when taking lorazepam (Ativan)?

Before taking lorazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as alprazolam, clonazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, glaucoma, lung/breathing problems (such as sleep apnea), mental/mood disorders (such as depression, psychosis), drug/alcohol abuse.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform...

Read All Potential Precautions of Ativan »

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Ativan (lorazepam) is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic.

The effectiveness of Ativan (lorazepam) 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.

DOSAGE AND ADMINISTRATION

Ativan (lorazepam) is administered orally. For optimal results, dose, frequency of administration, and duration of therapy should be individualized according to patient response. To facilitate this, 0.5 mg, 1 mg, and 2 mg tablets are available.

The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the daily dosage may vary from 1 to 10 mg/day.

For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.

For insomnia due to anxiety or transient situational stress, a single daily dose of 2 to 4 mg may be given, usually at bedtime.

For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.

The dosage of Ativan (lorazepam) should be increased gradually when needed to help avoid adverse effects. When higher dosage is indicated, the evening dose should be increased before the daytime doses.

HOW SUPPLIED

Ativan® (lorazepam) Tablets are available in the following dosage strengths: 0.5 mg, white, five-sided tablet with a raised "A" on one side and "BPI" and "63" impressed on reverse side.

NDC 64455-063-01 - Bottles of 100 tablets

1 mg, white, five-sided tablet with a raised "A" on one side and "BPI" and "64" impressed on scored reverse side

NDC 64455-064-01 - Bottles of 100 tablets
NDC 64455-064-10 - Bottles of 1000 tablets

2 mg, white, five-sided tablet with a raised "A" and impressed "2" on one side and "BPI" and "65" impressed on scored reverse side.

NDC 64455-065-01 - Bottles of 100 tablets

The appearance of these tablets is a registered trademark of Biovail Laboratories Incorporated.

BOTTLES:
Keep tightly closed.
Store at controlled room temperature 20° to 25° C (68° to 77° F).
Dispense in a tight container.

Manufactured by: Wyeth Pharmaceuticals Inc., Philadelphia, PA, 19101, USA
Distributed by: Biovail Pharmaceuticals, Inc., Bridgewater, NJ, 08807, USA
Rev 03/07
FDA rev date: 4/18/2007

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Most adverse reactions to benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses.

In a sample of about 3500 patients treated for anxiety, the most frequent adverse reaction to Ativan (lorazepam) was sedation (15.9%), followed by dizziness (6.9%), weakness (4.2%), and unsteadiness (3.4%). The incidence of sedation and unsteadiness increased with age.

Other adverse reactions to benzodiazepines, including lorazepam are fatigue, drowsiness, amnesia, memory impairment, confusion, disorientation, depression, unmasking of depression, disinhibition, euphoria, suicidal ideation/attempt, ataxia, asthenia, extrapyramidal symptoms, convulsions/seizures tremor, vertigo, eye-function/visual disturbance (including diplopia and blurred vision), dysarthria/slurred speech, change in libido, impotence, decreased orgasm; headache, coma; respiratory depression, apnea, worsening of sleep apnea, worsening of obstructive pulmonary disease; gastrointestinal symptoms including nausea, change in appetite, constipation, jaundice, increase in bilirubin, increase in liver transaminases, increase in alkaline phosphatase; hypersensitivity reactions, anaphylactic/oid reactions; dermatological symptoms, allergic skin reactions, alopecia; SIADH, hyponatremia; thrombocytopenia, agranulocytosis, pancytopenia; hypothermia; and autonomic manifestations.

Paradoxical reactions, including anxiety, excitation, agitation, hostility, aggression, rage, sleep disturbances/insomnia, sexual arousal, and hallucinations may occur. Small decreases in blood pressure and hypotension may occur but are usually not clinically significant, probably being related to the relief of anxiety produced by Ativan (lorazepam).

Read the Ativan (lorazepam) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Clinically Significant Drug Interactions

The benzodiazepines, including Ativan (lorazepam), produce increased CNS-depressant effects when administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative/hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, anticonvulsants, and anesthetics.

Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, hypotension, ataxia, delirium, and respiratory arrest.

Concurrent administration of lorazepam with valproate results in increased plasma concentrations and reduced clearance of lorazepam. Lorazepam dosage should be reduced to approximately 50% when coadministered with valproate.

Concurrent administration of lorazepam with probenecid may result in a more rapid onset or prolonged effect of lorazepam due to increased half-life and decreased total clearance. Lorazepam dosage needs to be reduced by approximately 50% when coadministered with probenecid.

The effects of probenecid and valproate on lorazepam may be due to inhibition of glucuronidation.

Administration of theophylline or aminophylline may reduce the sedative effects of benzodiazepines, including lorazepam.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Pre-existing depression may emerge or worsen during use of benzodiazepines including lorazepam. Ativan (lorazepam) is not recommended for use in patients with a primary depressive disorder or psychosis.

Use of benzodiazepines, including lorazepam, both used alone and in combination with other CNS depressants, may lead to potentially fatal respiratory depression. (See PRECAUTIONS, Clinically Significant Drug Interactions)

Use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence.

As with all patients on CNS-depressant drugs, patients receiving lorazepam should be warned not to operate dangerous machinery or motor vehicles and that their tolerance for alcohol and other CNS depressants will be diminished.

Physical And Psychological Dependence

The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence. The risk of dependence increases with higher doses and longer term use and is further increased in patients with a history of alcoholism or drug abuse or in patients with significant personality disorders. The dependence potential is reduced when lorazepam is used at the appropriate dose for short-term treatment. Addiction-prone individuals (such as drug addicts or alcoholics) should be under careful surveillance when receiving lorazepam or other psychotropic agents.

In general, benzodiazepines should be prescribed for short periods only (e.g. 2- 4 weeks). Extension of the treatment period should not take place without reevaluation of the need for continued therapy. Continuous long-term use of product is not recommended. Withdrawal symptoms (e.g. rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of product should be avoided and a gradual dosage-tapering schedule followed after extended therapy.

Abrupt termination of treatment may be accompanied by withdrawal symptoms. Symptoms reported following discontinuation of benzodiazepines include headache, anxiety, tension, depression, insomnia, restlessness, confusion, irritability, sweating, rebound phenomena, dysphoria, dizziness, derealization, depersonalization, hyperacusis, numbness/tingling of extremities, hypersensitivity to light, noise, and physical contact/perceptual changes, involuntary movements, nausea, vomiting, diarrhea, loss of appetite, hallucinations/delirium, convulsions/seizures, tremor, abdominal cramps, myalgia, agitation, palpitations, tachycardia, panic attacks, vertigo, hyperreflexia, short-term memory loss, and hyperthermia. Convulsions/seizures may be more common in patients with pre-existing seizure disorders or who are taking other drugs that lower the convulsive threshold such as antidepressants.

There is evidence that tolerance develops to the sedative effects of benzodiazepines.

Lorazepam may have abuse potential, especially in patients with a history of drug and/or alcohol abuse.

PRECAUTIONS

In patients with depression, a possibility for suicide should be borne in mind; benzodiazepines should not be used in such patients without adequate anti-depressant therapy.

Lorazepam should be used with caution in patients with compromised respiratory function (e.g. COPD, sleep apnea syndrome).

Elderly or debilitated patients may be more susceptible to the sedative effects of lorazepam. Therefore, these patients should be monitored frequently and have their dosage adjusted carefully according to patient response; the initial dosage should not exceed 2 mg.

Paradoxical reactions have been occasionally reported during benzodiazepine use. Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued.

The usual precautions for treating patients with impaired renal and hepatic function should be observed. As with all benzodiazepines, the use of lorazepam may worsen hepatic encephalopathy; therefore, lorazepam should be used with caution in patients with severe hepatic insufficiency and/or encephalopathy.

Dosage for patients with severe hepatic insufficiency should be adjusted carefully according to patient response; lower doses may be sufficient in such patients.

In patients where gastrointestinal or cardiovascular disorders coexist with anxiety, it should be noted that lorazepam has not been shown to be of significant benefit in treating the gastrointestinal or cardiovascular component.

Esophageal dilation occurred in rats treated with lorazepam for more than one year at 6 mg/kg/day. The no-effect dose was 1.25 mg/kg/day (approximately 6 times the maximum human therapeutic dose of 10 mg per day). The effect was reversible only when the treatment was withdrawn within two months of first observation of the phenomenon. The clinical significance of this is unknown. However, use of lorazepam for prolonged periods and in geriatric patients requires caution, and there should be frequent monitoring for symptoms of upper G.I. disease.

Safety and effectiveness of Ativan (lorazepam) in children of less than 12 years have not been established.

Essential Laboratory Tests

Some patients on Ativan (lorazepam) have developed leukopenia, and some have had elevations of LDH. As with other benzodiazepines, periodic blood counts and liver-function tests are recommended for patients on long-term therapy.

Carcinogenesis And Mutagenesis

No evidence of carcinogenic potential emerged in rats during an 18-month study with Ativan (lorazepam). No studies regarding mutagenesis have been performed.

Pregnancy

Reproductive studies in animals were performed in mice, rats, and two strains of rabbits. Occasional anomalies (reduction of tarsals, tibia, metatarsals, malrotated limbs, gastroschisis, malformed skull, and microphthalmia) were seen in drug-treated rabbits without relationship to dosage. Although all of these anomalies were not present in the concurrent control group, they have been reported to occur randomly in historical controls. At doses of 40 mg/kg and higher, there was evidence of fetal resorption and increased fetal loss in rabbits which was not seen at lower doses.

The clinical significance of the above findings is not known. However, an increased risk of congenital malformations associated with the use of minor tranquilizers (chlordiazepoxide, diazepam, and meprobamate) during the first trimester of pregnancy has been suggested in several studies. Because the use of these drugs is rarely a matter of urgency, the use of lorazepam during this period should be avoided. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered. Patients should be advised that if they become pregnant, they should communicate with their physician about the desirability of discontinuing the drug.

In humans, blood levels obtained from umbilical cord blood indicate placental transfer of lorazepam and lorazepam glucuronide. Infants of mothers who ingested benzodiazepines for several weeks or more preceding delivery have been reported to have withdrawal symptoms during the postnatal period. Symptoms such as hypoactivity, hypotonia, hypothermia, respiratory depression, apnea, feeding problems, and impaired metabolic response to cold stress have been reported in neonates born of mothers who have received benzodiazepines during the late phase of pregnancy or at delivery.

Nursing Mothers

Lorazepam has been detected in human breast milk; therefore, it should not be administered to breast-feeding women, unless the expected benefit to the woman outweighs the potential risk to the infant.

Sedation and inability to suckle have occurred in neonates of lactating mothers taking benzodiazepines. Infants of lactating mothers should be observed for pharmacological effects (including sedation and irritability).

Geriatric Use

Clinical studies of Ativan (lorazepam) generally were not adequate to determine whether subjects aged 65 and over respond differently than younger subjects; however, the incidence of sedation and unsteadiness was observed to increase with age (see ADVERSE REACTIONS).

Age does not appear to have a significant effect on lorazepam kinetics (see CLINICAL PHARMACOLOGY).

Clinical circumstances, some of which may be more common in the elderly, such as hepatic or renal impairment, should be considered. Greater sensitivity (e.g., sedation) of some older individuals cannot be ruled out. In general, dose selection for an elderly patient should be cautious, and lower doses may be sufficient in these patients (see DOSAGE AND ADMINISTRATION).

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

In postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs. Therefore, in the management of overdosage , it should be borne in mind that multiple agents may have been taken.

Symptoms

Overdosage of benzodiazepines is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion, paradoxical reactions, dysarthria and lethargy. In more serious cases, and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, cardiovascular depression, respiratory depression, hypnotic state, coma, and death. MANAGEMENT

General supportive and symptomatic measures are recommended; vital signs must be monitored and the patient closely observed. When there is a risk of aspiration, induction of emesis is not recommended. Gastric lavage may be indicated if performed soon after ingestion or in symptomatic patients. Administration of activated charcoal may also limit drug absorption. Hypotension, though unlikely, usually may be controlled with norepinephrine bitartrate injection. Lorazepam is poorly dialyzable. Lorazepam glucuronide, the inactive metabolite, may be highly dialyzable.

The benzodiazepine antagonist flumazenil may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.

CONTRAINDICATIONS

Ativan (lorazepam) is contraindicated in patients with

  • hypersensitivity to benzodiazepines or to any components of the formulation.
  • acute narrow-angle glaucoma.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

Studies in healthy volunteers show that in single high doses Ativan (lorazepam) has a tranquilizing action on the central nervous system with no appreciable effect on the respiratory or cardiovascular systems.

Ativan (lorazepam) is readily absorbed with an absolute bioavailability of 90 percent. Peak concentrations in plasma occur approximately 2 hours following administration. The peak plasma level of lorazepam from a 2 mg dose is approximately 20 ng/mL.

The mean half-life of unconjugated lorazepam in human plasma is about 12 hours and for its major metabolite, lorazepam glucuronide, about 18 hours. At clinically relevant concentrations, lorazepam is approximately 85% bound to plasma proteins. Ativan (lorazepam) is rapidly conjugated at its 3-hydroxy group into lorazepam glucuronide which is then excreted in the urine. Lorazepam glu-curonide has no demonstrable CNS activity in animals.

The plasma levels of lorazepam are proportional to the dose given. There is no evidence of accumulation of lorazepam on administration up to six months.

Studies comparing young and elderly subjects have shown that advancing age does not have a significant effect on the pharma-cokinetics of lorazepam. However, in one study involving single intravenous doses of 1.5 to 3 mg of Ativan Injection, mean total body clearance of lorazepam decreased by 20% in 15 elderly subjects of 60 to 84 years of age compared to that in 15 younger subjects of 19 to 38 years of age.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

To assure the safe and effective use of Ativan (lorazepam), patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

To assure the safe and effective use of Ativan (lorazepam), patients should be informed that, since benzodiazepines may produce psychological and physical dependence, it is advisable that they consult with their physician before either increasing the dose or abruptly discontinuing this drug.

Last reviewed on RxList: 10/4/2010
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Ativan Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

LORAZEPAM - ORAL

(lor-AYE-zeh-pam)

COMMON BRAND NAME(S): Ativan

USES: This medication is used to treat anxiety. Lorazepam belongs to a class of drugs known as benzodiazepines which act on the brain and nerves (central nervous system) to produce a calming effect. This drug works by enhancing the effects of a certain natural chemical in the body (GABA).

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

If directed by your doctor, this drug may also be used to reduce the symptoms of alcohol withdrawal, to prevent nausea and vomiting due to chemotherapy, and for trouble sleeping (insomnia).

HOW TO USE: Take this medication by mouth with or without food as directed by your doctor. The dosage is based on your medical condition and response to treatment.

If directed by your doctor, use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses (more than 1-4 weeks) or if you have a history of alcoholism, drug abuse, or personality disorder. Withdrawal symptoms (such as seizures, trouble sleeping, mental/mood changes, nausea, vomiting, diarrhea, loss of appetite, stomach pain, hallucinations, numbness/tingling of arms and legs, muscle pain, fast heartbeat, short-term memory loss, very high fever, and increased reactions to noise/touch/light) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Report any withdrawal reactions immediately.

Along with its benefits, this medication may rarely cause abnormal drug-seeking behavior (addiction). This risk may be increased if you have abused alcohol or drugs in the past. Take this medication exactly as prescribed to lessen the risk of addiction.

Do not suddenly stop using this drug without consulting your doctor. Some conditions may become worse when this drug is abruptly stopped. Your dose may need to be gradually decreased.

When this medication is used for a long time, it may not work as well. Talk with your doctor if this medication stops working well.

Tell your doctor if your condition persists or worsens.

Disclaimer

Ativan Consumer (continued)

SIDE EFFECTS: Drowsiness, dizziness, loss of coordination, headache, nausea, blurred vision, change in sexual interest/ability, constipation, heartburn, or change in appetite may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any unlikely but serious side effects, including: mental/mood changes (such as hallucinations, depression, thoughts of suicide), slurred speech or difficulty talking, vision changes, unusual weakness, trouble walking, memory problems, signs of infection (such as fever, persistent sore throat), trouble breathing (especially during sleep).

Get medical help right away if you have any rare but very serious side effects, including: yellowing eyes or skin, seizures.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Ativan (lorazepam) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before taking lorazepam, tell your doctor or pharmacist if you are allergic to it; or to other benzodiazepines (such as alprazolam, clonazepam, diazepam); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, glaucoma, lung/breathing problems (such as sleep apnea), mental/mood disorders (such as depression, psychosis), drug/alcohol abuse.

This drug may make you dizzy or drowsy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Avoid alcoholic beverages.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Older adults may be more sensitive to the side effects of this drug, especially loss of coordination and drowsiness. Also, the elderly may not experience relief of anxiety with lorazepam. It may have the opposite effect on the elderly, causing symptoms including mental/mood changes, sleeping problems, increase in sexual interest, or hallucinations.

Children may not experience relief of anxiety with lorazepam. It may have the opposite effect on children, causing symptoms including agitation, shaking, or hallucinations.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Tell the doctor right away if you notice symptoms in your newborn baby such as slowed breathing, feeding problems, or constant crying. Consult your doctor for more details.

This drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Ativan Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: clozapine, kava, sodium oxybate (also known as gamma hydroxybutyrate or GHB).

Tell your doctor or pharmacist if you are taking other products that cause drowsiness including certain antihistamines (such as diphenhydramine), other medicines for sleep or anxiety (such as diazepam, zolpidem), muscle relaxants, narcotic pain relievers (such as codeine), psychiatric medicines (such as chlorpromazine, risperidone, amitriptyline, trazodone).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include confusion, slow reflexes, clumsiness, deep sleep, and loss of consciousness.

NOTES: Lifestyle changes such as starting a stress reduction program may increase the effectiveness of this medication. Talk to your doctor or pharmacist about lifestyle changes that might benefit you.

Do not share this medication with others. It is against the law.

Laboratory and/or medical tests (such as blood counts, liver function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: If you miss a dose and are taking more than 1 dose daily, do not take it if it is almost time for the next dose. Instead, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up. If you take it once daily at bedtime and miss a dose, do not take it the following morning. Call your doctor to find out what to do.

STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-800-854-1166 (US) or 1-800-668-1507 (Canada).

Information last revised February 2012. Copyright(c) 2012 First Databank, Inc.

Ativan Patient Information Including Side Effects

Brand Names: Ativan

Generic Name: lorazepam (oral) (Pronunciation: lor A ze pam)

What is lorazepam (Ativan)?

Lorazepam is in a group of drugs called benzodiazepines (ben-zoe-dye-AZE-eh-peens). Lorazepam affects chemicals in the brain that may become unbalanced and cause anxiety.

Lorazepam is used to treat anxiety disorders.

Lorazepam may also be used for other purposes not listed in this medication guide.

Ativan 0.5 mg

pentagonal, white, imprinted with A, WYETH81

Ativan 1mg

pentagonal, white, imprinted with A, 64 WYETH

Ativan 2 mg

pentagonal, white, imprinted with A, 65 WYETH

Lorazepam 0.5 mg-GG

round, white, imprinted with 91, GG

Lorazepam 0.5 mg-MYL

round, white, imprinted with M, 321

Lorazepam 0.5 mg-TEV

round, white, imprinted with I, L

Lorazepam 0.5 mg-WAT

round, white, imprinted with WATSON, 240 0.5

Lorazepam 1 mg-MUT

round, white, imprinted with MP 39

Lorazepam 1 mg-MYL

round, white, imprinted with MYLAN457

Lorazepam 1 mg-PP

round, white, imprinted with 59, R

Lorazepam 1 mg-TEV

round, white, imprinted with I 1, 4821

Lorazepam 1 mg-WAT

round, white, imprinted with 241 1, WATSON

Lorazepam 2 mg-GG

round, white, imprinted with GG 93

Lorazepam 2 mg-MUT

round, white, imprinted with MP 96

Lorazepam 2 mg-MYL

round, white, imprinted with MYLAN 777

Lorazepam 2 mg-TEV

round, white, imprinted with I 2, 4822

Lorazepam 2 mg-WAT

round, white, imprinted with 242 2, WATSON

What are the possible side effects of lorazepam (Ativan)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any of these serious side effects:

  • confusion, depressed mood, thoughts of suicide or hurting yourself;
  • hyperactivity, agitation, hostility;
  • hallucinations; or
  • feeling light-headed, fainting.

Less serious side effects may include:

  • drowsiness, dizziness, tiredness;
  • blurred vision;
  • sleep problems (insomnia);
  • muscle weakness, lack of balance or coordination;
  • amnesia or forgetfulness, trouble concentrating;
  • nausea, vomiting, constipation;
  • appetite changes; or
  • skin rash.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ativan (lorazepam) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about lorazepam (Ativan)?

Do not use this medication if you are allergic to lorazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), or oxazepam (Serax).

Before taking lorazepam, tell your doctor if you have any breathing problems, glaucoma, kidney or liver disease, or a history of depression, suicidal thoughts, or addiction to drugs or alcohol.

Do not drink alcohol while taking lorazepam. This medication can increase the effects of alcohol.

Avoid using other medicines that make you sleepy. They can add to sleepiness caused by lorazepam.

Lorazepam may be habit-forming and should be used only by the person it was prescribed for. Lorazepam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

It is dangerous to try and purchase lorazepam on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of lorazepam purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

Side Effects Centers

Ativan Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking lorazepam (Ativan)?

It is dangerous to try and purchase lorazepam on the Internet or from vendors outside of the United States. Medications distributed from Internet sales may contain dangerous ingredients, or may not be distributed by a licensed pharmacy. Samples of lorazepam purchased on the Internet have been found to contain haloperidol (Haldol), a potent antipsychotic drug with dangerous side effects. For more information, contact the U.S. Food and Drug Administration (FDA) or visit www.fda.gov/buyonlineguide.

Do not use this medication if you have narrow-angle glaucoma, or if you are allergic to lorazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), or oxazepam (Serax).

Before taking lorazepam, tell your doctor if you are allergic to any drugs, or if you have:

  • glaucoma;
  • asthma, emphysema, bronchitis, chronic obstructive pulmonary disorder (COPD), or other breathing problems;
  • kidney or liver disease;
  • a history of depression or suicidal thoughts or behavior; or
  • a history of drug or alcohol addiction.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take this medication.

FDA pregnancy category D. Lorazepam can cause birth defects in an unborn baby. Do not use lorazepam without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.

It is not known whether lorazepam passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

The sedative effects of lorazepam may last longer in older adults. Accidental falls are common in elderly patients who take benzodiazepines. Use caution to avoid falling or accidental injury while you are taking lorazepam.

Do not give this medication to a child younger than 12 years old.

How should I take lorazepam (Ativan)?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from this medication.

Measure the liquid form of lorazepam with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Lorazepam should be used for only a short time. Do not take this medication for longer than 4 months without your doctor's advice.

Lorazepam may be habit-forming and should be used only by the person it was prescribed for. Lorazepam should never be shared with another person, especially someone who has a history of drug abuse or addiction. Keep the medication in a secure place where others cannot get to it.

Contact your doctor if this medicine seems to stop working as well in treating your symptoms.

Do not stop using lorazepam suddenly without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Your symptoms may return when you stop using lorazepam after using it over a long period of time. You may also have seizures or withdrawal symptoms when you stop using lorazepam. Withdrawal symptoms may include tremor, sweating, muscle cramps, stomach pain, vomiting, unusual thoughts or behavior, and seizure (convulsions).

To be sure this medication is not causing harmful effects, your doctor may need to check your progress on a regular basis. Do not miss any scheduled visits to your doctor.

Store lorazepam at room temperature away from moisture, heat, and light.

Store the liquid form of lorazepam in the refrigerator.

Keep track of how many pills have been used from each new bottle of this medicine. Benzodiazepines are drugs of abuse and you should be aware if any person in the household is using this medicine improperly or without a prescription.

Side Effects Centers

Ativan Patient Information including If I Miss a Dose

What happens if I miss a dose (Ativan)?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose (Ativan)?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of lorazepam can be fatal.

Overdose symptoms may include extreme drowsiness, confusion, muscle weakness, fainting, or coma.

What should I avoid while taking lorazepam (Ativan)?

Do not drink alcohol while taking lorazepam. This medication can increase the effects of alcohol.

Lorazepam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by lorazepam. Tell your doctor if you regularly use any of these other medicines.

What other drugs will affect lorazepam (Ativan)?

Before taking lorazepam, tell your doctor if you are using any of the following drugs:

  • a barbiturate such as amobarbital (Amytal), butabarbital (Butisol), mephobarbital (Mebaral), secobarbital (Seconal), or phenobarbital (Luminal, Solfoton);
  • an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate);
  • medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), pimozide (Orap), or thioridazine (Mellaril);
  • narcotic medications such as butorphanol (Stadol), codeine, hydrocodone (Lortab, Vicodin), levorphanol (Levo-Dromoran), meperidine (Demerol), methadone (Dolophine, Methadose), morphine (Kadian, MS Contin, Oramorph), naloxone (Narcan), oxycodone (OxyContin), propoxyphene (Darvon, Darvocet); or
  • antidepressants such as amitriptyline (Elavil, Etrafon), amoxapine (Asendin), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), or trimipramine (Surmontil).

This list is not complete and there may be other drugs that can interact with lorazepam. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about lorazepam.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 7.07. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com