Lorazepam Ativan 2mg by Wyeth 1 Strip

Description

What is Lorazepam?

Lorazepam is in a group of drugs called benzodiazepines. It affects chemicals in the brain that may become unbalanced and cause anxiety. This results in a reduction in nervous tension.

Lorazepam is used to treat anxiety or anxiety associated with symptoms of depression.

Lorazepam may also be used for purposes other than those listed here.

 

Important information about Lorazepam

 

Don`t use this medication if you are sensitive to Lorazepam or to other benzodiazepines, such as alprazolam (Xanax), chlordiazepoxide (Librium), clorazepate (Tranxene), diazepam (Valium), or oxazepam (Serax). This medication can cause birth defects in an unborn baby. Don`t use Lorazepam if you are heavy with child.

 

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

 

Don`t drink alcohol while using Lorazepam. This medicine can increase the effects of alcohol.

 

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

 

Lorazepam may become addiction and should be used only by the person it was prescribed for. Lorazepamshould 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.

Withdrawal symptoms (e.g., rebound insomnia) can appear following cessation of recommended doses after as little as one week of therapy. Abrupt discontinuation of torazepam 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,   dereatization,   depersonalization, hyperacusis, numbness/tingiing 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.

Alivan (lorazepam) may have abuse potential, especially in patients with a history of drug and/or alcohol abuse-

ADVERSE REACTIONS

Adverse reactions are listed in the Table in CIOMS frequency categories;

Very Common s 10% Common:     £, 1% Uncommon:   s 0.1% and1°’o Rare;        £ 0.01^l‘oa^d0.1% Very rare:     < 0.0l°a

Body As A Whole
Frequency	Hypersensitivity reactions,
undetermined;	anaphylactic/oid reactions,
	anoioedema Hypothermia
	SIADH, nyponatremia
Common:	Muscle weakness, asthenia
Cardiovascular
Frequency	Hypotension, lowering in
undetermined:	blood pressure
Digestive
Uncommon:	Nausea
Frequency	Constipation, increase in
undetermined:	bilirubin, jaundice, increase
‘ in liver transaminases,
increase in alkaline
phosphatase
Hematolog icaf/Lymphatic
Frequency	Thrombocytopenia.
undetermined:	agranulocytosis,
pancytopenia
Nervous system and special senses
Frequency Benzodiazepine effects on
undetermined: the CNS are dose-
dependent, with more
severe CNS depression
occurring with high doses.
Extrapyramidal symptoms,
tremor, vertigo, visual
disturbances (including
dipiopia and blurred
vision), dysarthria/slurred
speech,headache,
convulsions/seizures,
amnesia, disinhibition,
euphoria, coma, suicidal
ideation/attempt, impaired
attention/concentration,
balance disorder.
Paradoxical reactions,
including anxiety, agitation,
excitation, hostility,
aggression, rage, sleep
disturbances/ insomnia,
sexual arousal,
hallucinations.

Very common:	Sedation, fatigue, drowsiness
Common:	Ataxia. confusion. depression, unmasking of depression, dizziness
Uncommon:	Change in libido, impotence, decreased orgasm
Respiratory
Frequency Respiratory depression, undetermined: apnea, worsening of sleep apnea (the extent of respiratory depression with benzodiazepines is dosedependent, with more severe depression occurring with high doses). Worsening of obstructive i pulmonary disease
Skin
Frequency undetermined:	Allergic skin reactions, alopecia.

OVERDOSAGE

in postmarketing experience, overdose with lorazepam has occurred predominantly in combination with alcohol and/or other drugs.

Symptoms

Symptoms can range in severity and include drowsiness. mental confusion, lethargy, dysarthria, ataxia, paradoxical reactions, CNS depression, hypotonia, hypotension, respiratory depression, cardiovascular depression, coma, and death.

Treatment

General supportive and symptomatic measures are recommended; vital signs must be monrtored.

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. Lorazepam is poorly dialyzabie. Lorazepam glucuronide, the inactive metabolile, may be highly dialyzabie.The benzodiazepine antagonist, fiumazenil, may be used in hospitalized patients as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. The physician should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose.

MODE OF ACTION

Ativan (lorazepam} is a benzodiazepine that interacts with the -aminobutyric acid (GABA)-benzodiazepine receptor complex and enhances the affinity of GABA.

PHARMACODYNAMICS, CLINICAL EFFICACY

The   pharmacodynamic   consequences   of benzodiazepine ago nist. actions include antianxiety .effects, sedation, and reduction of seizure activity. The intensity of action is directly related to the degree of benzodiazepine receptor occupancy.

PHARMACOKINETICS

Absorption

Absolute bioavaifability is greater than 90% following oral and sublingual administration to healthy subjects.

Peak plasma concentration occurs in approximately 2 hours following oral administration to healthy subjects.

Distribution

The volume of distribution is approximately 1.3 L/kg. Unbound lorazepam penetrates the blood/brain barrier freely by passive diffusion. Lorazepam is approximately 92% bound to human plasma proteins at lorazepam concentration of 160 ng/mL.

Metabolism

Lorazepam is rapidly conjugated at its 3-hydroxy group into lorazepam glucuronide, an inactive metabolite.

Elimination •

The elimination half-life of unconjugated lorazepam in human piasma is approximately 12 to 16 hours. Following a single 2 mg oral dose of C-lorazepam to 8 healthy suojects, approximately 88% of the administered dose was recovered in urine and 7% was recovered in feces. Approximately 74% of lorazepam glucuronide was recovered in the urine.

Elderly

Elderly patients typically respond to lower benzodiazepine doses than younger patients.

Renal Insufficiency

Single-dcse pharmacokinetic studies in patients with degrees of renai insufficiency ranging from mild impairment to renal failure have reported no significant changes in ‘absorption, clearance, or excretion of lorazepam. Hemodialysis did not have any significant effect on the pharmacokinetics of intact lorazepam, but substantially removed the inactive giucuronide from the plasma.

Hepatic Insufficiency

No change in the clearance of torazepam was reported in patients with mild to moderate hepatic impairment (i.e., hepatitis, alcoholic cirrhosis).

Concentration-effect Relationship

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

PRECUNICAL SAFETY DATA

Lorazepam giucuronide, the major metabotite of lorazepam, has no demonstrable CNS activity in animals.

Carclnogeniclty

No evidence of carcinogenic potential emerged in rats and mice during an 18-month study with oral lorazepam.

Mutagenicity

A study of the mutagenic activity of lorazepam on Drosophila melanogaster indicated that this agent was mutationaliy inactive.

Impairment of fertility

A pre-implantation study in rats was performed with oral lorazepam at a 20 mg/kg dose that showed no impairment of fertility.

STORAGE

Store below 30°C.

Protect from heal light and moisture.

Keep all medicines out of the reach of children.