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Lorazepam EU brand, Ativan generic
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Indications and usage:
Lorazepam (Ativan) is a benzodiazepine indicated for the treatment of:
short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms (such as trouble sleeping, nervousness, tension)
borderline personality disorder
chemotherapy-induced nausea and vomiting
certain types of seizure disorders (active seizures, status epilepticus)
insomnia (to induce sleep)
for acute coronary syndrome due to cocaine use
for recreational purposes
during surgery for light anesthesia, sedation and to interfere with memory formation
Dosage and administration:
Lorazepam (Ativan) tablets are 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, 2 mg, and 2.5 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 two times a day or three times a day.
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 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.
Dosage forms and strengths:
Ativan (Lorazepam) tablets are available in the following dosage strengths: 0.5 mg, 1 mg, 2 mg, 2.5 mg.
In post-marketing experience, overdose with Lorazepam (Ativan) has occurred predominantly in combination with alcohol and/or other drugs.
With benzodiazepines, including lorazepam, symptoms of mild overdosage include drowsiness, mental confusion and lethargy. In more serious overdoses, symptoms may include ataxia, hypotonia, hypotension, hypnosis, Stages I to III coma, and, very rarely, death.
Symptoms can range in severity and include, in addition to the above, dysarthria, paradoxical reactions, CNS depression, respiratory depression, and cardiovascular depression.
In the case of an oral overdose, if vomiting has not occurred spontaneously and the patient is fully awake, emesis may be induced with syrup of ipecac 20-30 mL (where there is risk of aspiration, induction of emesis is not recommended). Gastric lavage should be instituted as soon as possible and 50-100 g of activated charcoal should be introduced to and left in the stomach.
Ativan (Lorazepam) is poorly dialyzable. Lorazepam glucuronide, the inactive metabolite, may be highly dialyzable.
Ativan (Lorazepam) pills are contraindicated in patients with:
hypersensitivity to benzodiazepines or to any components of the formulation
acute narrow-angle glaucoma
Risks from concomitant use with opioids: concomitant use of benzodiazepines, including Lorazepam (Ativan), and opioids may result in profound sedation, respiratory depression, coma, and death. Because of these risks, reserve concomitant prescribing of these drugs in patients for whom alternative treatment options are inadequate.
Abuse, misuse, and addiction: the use of benzodiazepines, including Ativan (Lorazepam), exposes users to the risks of abuse, misuse, and addiction, which can lead to overdose or death. Abuse and misuse of benzodiazepines often (but not always) involve the use of doses greater than the maximum recommended dosage and commonly involve concomitant use of other medications, alcohol, and/or illicit substances, which is associated with an increased frequency of serious adverse outcomes, including respiratory depression, overdose, or death.
Dependence and withdrawal reactions: patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages, and those who have had longer durations of use.
In patients with depression, a possibility for suicide should be borne in mind; benzodiazepines should not be used in such patients without adequate antidepressant therapy.
Lorazepam should be used with caution in patients with compromised respiratory function.
Elderly or debilitated patients may be more susceptible to the sedative effects of Ativan.
Paradoxical reactions have been occasionally reported during benzodiazepine use.
The usual precautions for treating patients with impaired renal or hepatic function should be observed.
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.
Safety and effectiveness of this medication in children of less than 12 years have not been established.
Information for patients:
Risks from concomitant use with opioids
Advise both patients and caregivers about the risks of potentially fatal respiratory depression and sedation when Ativan is used with opioids and not to use such drugs concomitantly unless supervised by a health
care provider. Advise patients not to drive or operate heavy machinery until the effects of concomitant use with the opioid have been determined.
Abuse, misuse, and addiction
Inform patients that the use of lorazepam even at recommended doses, exposes users to risks of abuse, misuse, and addiction, which can lead to overdose and death, especially when used in combination with other medications (e.g., opioid analgesics), alcohol, and/or illicit substances. Inform patients about the signs and symptoms of benzodiazepine abuse, misuse, and addiction; to seek medical help if they develop these signs and/or symptoms; and on the proper disposal of unused drug.
Inform patients that the continued use of this medicine may lead to clinically significant physical dependence and that abrupt discontinuation or rapid dosage reduction of Ativan (Lorazepam) may precipitate acute withdrawal reactions, which can be life-threatening. Inform patients that in some cases, patients taking benzodiazepines have developed a protracted withdrawal syndrome with withdrawal symptoms lasting weeks to more than 12 months. Instruct patients that discontinuation or dosage reduction of this drug may require a slow taper.
Adverse reactions, side effects:
The most common adverse reactions to Ativan and benzodiazepines, including CNS effects and respiratory depression, are dose dependent, with more severe effects occurring with high doses.
The most frequent adverse reaction to 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.
To report suspected adverse reactions of Ativan (Lorazepam) tablets, contact Pfizer, Inc. pharmaceutical company or your local FDA.
The following may interact with Lorazepam (Ativan):
narcotic analgesics (pain relievers, opioids): taking lorazepam and opioids may cause severe drowsiness, trouble breathing, coma, death
medicines used to treat anxiety and insomnia
sedative/hypnotics (sleeping pills)
monoamine oxidase inhibitors (MAOIs) and other antidepressants
drugs used to treat mental health problems such as haloperidol, clozapine
medications used to prevent seizures such as valproate
anesthetics, used during surgery
probenecid, used to treat gout
medicines used to treat breathing problems such as theophylline, aminophylline
Use in specific populations:
Ativan (Lorazepam) tablets should not be used during pregnancy. Several studies have suggested an increased risk of congenital malformations associated with the use of the benzodiazepines chlordiazepoxide and diazepam, and meprobamate, during the first trimester of pregnancy.
Lorazepam has been detected in human breast milk; therefore it should not be administered to breast-feeding women, unless the expected benefit to the mother outweighs the potential risk to the infant.
Clinical studies of Lorazepam (Ativan) 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.
Drug abuse and dependence:
Ativan contains lorazepam, which is a controlled substance in some countries (for example, Schedule IV in the United States and Canada).
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