Lorazepam Ativan 2mg by Wyeth 1 Strip

Description

(Lorazepam)

DESCRIPTION

Active ingredients, active moieties Lorazepam (INN)

Lorazepam is awhile or almost white, almost odorless crystalline powder. Practically insoluble in water; sparingly soluble in alcohol; slightly soluble in chloroform; sparingly or slightly soluble in dichloromethane.

Chemical Name

7-chloro-5-(o-ch!orophenyl)-1,3-dihydro-3-hydroxy-2H-1,4-benzodiazepin-2-one.

Molecular Formula

C15H10CI2N202   .

Molecular Weight

321.2

Pharmacological Class, Therapeutic Class, Benzodiazepine, AnxioiytK

ATC code: N05BA06

Dosage forms and Intended routes of administration Oral tablets

Composition and Pharmaceutical Characteristics

Tablet contains 1.0 mg or 2.0 mg of lorazepam.

INDICATIONS

• Short-term management of anxiety disorders, including the following:

Short-term relief of symptoms of anxiety Generalized anxiety disorders Anxiety in psychotic states Anxiety associated with somatic symptoms Anxiety associated with depression or depressive symptoms • Reactive anxiety

• Insomnia associated with anxiety
• Alcohol withdrawal
• Prevention of delirium tremens
• Surgical premedication
• Adjunctive therapy to standard antiemetic drugs forthe prophylactic and symptomatic treatment of nausea and vomiting associated with cancer chemotherapy

DOSAGE AND ADMINISTRATION

Dosage and duration of therapy should be individualized. The lowest effective dose should be prescribed for the shortest duration possible. The risk of withdrawal and rebound phenomena is greaterafter abrupt discontinuation; therefore, the drug should be discontinued gradually (see section SPECIAL WARNINGS).

Extension of the treatment period should not take place without re-evaluation of the need for continued therapy.

The recommended dosage range is 2 to 6 mg/day, but the daily dosage may vary from 1 to 10 ma/day. Increases in the dosage of lorazepam should be made gradually to help avoid adverse effects. The evening dose should be increased before the daytime doses.

Short-term management of anxiety disorders

The initial recommended dose is 2 to 3 mg / day, in divided doses 2 or 3 times daily.

Insomnia Associated with Anxiety

The recommended dose is 0.5 mg to 4 mg/day, at bedtime.

Alcohol Withdrawal

The initial recommended dose is 2 to 3 mg/day, in divided doses 2 or 3 times daily.

Prevention of Delirium Tremens

The initial recommended dose is 2 to 3 mg/day, in divided doses 2 or 3 times daily.

Surgical Premedlcatlon

The recommended dosage is 2 to 4 mg the night before a procedure and/or 1 to 2 hours pre-procedure-Adjunctive therapy to standard antiemetic drugs for the prophylactic and symptomatic treatment of nausea and vomiting associated with cancer chemotherapy.The recommended dosage is 1 mg at bedtime the night before chemotherapy and/or 1 mg given 60 minutes prior to chemotherapy, and repeated 6 hours and 12 hours after chemotherapy, if needed.

Elderly and Debilitated Patients

For elderly and debilitated patients reduce the initial dose by approximately 50% and adjust the dosage as needed and tolerated-

Use in Patients with Hepatic Impairment

Dosage for patients with severe hepatic insufficiency should be adjusted carefully according to patient’s response. Lower doses may be sufficient in such patients. See section PRECAUTIONS.

Use in Patients with Renal Impairment

No specific dosage recommendations. See section PHARMACOKINETICS.

CONTRAINDICATIONS

Hypersensitivity to benzodiazepines or to any components of the formulation-

SPECIAL WARNINGS

Use of benzodiazepines, including iorazepam, may lead to potentially fatal respiratory depression.

The use of benzodiazepines, including lorazepam, may lead to physical and psychological dependence (see section ABUSE AND DEPENDENCE).

Severe anaphylactic / anaphylactoid reactions have been reported with the use of benzodiazepines. Cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of benzodiazepines. Some patients taking benzodiazepines have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with a benzodiazepine should not be rechalienged with the drug.

PRECAUTIONS

Ativan (lorazepam) should be used with caution in patients with compromised respiratory function (e.g., COPD, sleep apnea syndrome).Pre-existing depression may emerge or worsen during use of benzodiazepines. including lorazepam.The use of benzodiazepines may unmask suicidal tendencies in depressed patients and should not be used without adequate antidepressant therapy.Elderly or debilitated patients may be more susceptible to the effects of lorazepam; therefore, these patients should be monitored frequently and have their dosage adjusted carefully according to patient response (see section DOSAGE AND ADMINISTRATION). Pa/adoxical reactions have been occasionally reporteo during benzodiazepine use (see section ADVERSE REACTIONS).

Such reactions may be more likely to occur in children and the elderly. Should these occur, use of the drug should be discontinued.

Use In Patients with Hepatic Impairment

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.

PREGNANCY

Ativan (lorazepam) should not be used during pregnancy. An increased risk of congenital malformations associated with the use of benzodiazepines during the first trimester of pregnancy has been suggested in several studies, in humans, umbilical cord blood samples indicate placenta) transfer of benzodiazepines and their glucuronide metabolites. 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 coid stress have been reported in neonates born of mothers who have received benzodiazepines during the late phase of pregnancy or at delivery.

LACTATION

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 o) lactating mothers should be observed for pharmacological effects (including sedation and irritability).

GERIATRIC USE

See sections DOSAGE AND ADMINISTRATION and PRECAUTIONS.

INTERACTIONS

The benzodiazepines, including lorazepam, produce additive  CNS  depressant  effects  when co-administered with other CNS depressants such as alcohol, barbiturates, antipsychotics, sedative / hypnotics, anxiolytics, antidepressants, narcotic analgesics, sedative antihistamines, ahticonvulsants, and anesthetics. Concomitant use of clozapine and lorazepam may produce marked sedation, excessive salivation, and ataxia. Concurrent administration of iorazepam with valproate may result 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.

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

EFFECTS ON ACTIVITIES REQUIRING CONCENTRATION AND PERFORMANCE

As with all patients on CNS-acting drugs, patients should be warned not to operate dangerous machinery or motor vehicles until it is known that they do not become drowsy or dizzy from lorazepam.

ABUSE AND DEPENDENCE

The use of benzodiazepines may lead to physfcal 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. In general. benzodiazepines should be prescribed for short periods only (e.g., 2 to 4 weeks). Continuous long-term use of lorazepam is not recommended.