LORAZEPAM tablet

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LORAZEPAM (UNII: O26FZP769L) (LORAZEPAM - UNII:O26FZP769L)

Available from:

Aphena Pharma Solutions - Tennessee, LLC

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Lorazepam tablets are 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 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. Lorazepam is contraindicated in patients with: - hypersensitivity to benzodiazepines or to any components of the formulation - acute narrow-angle glaucoma. Controlled Substance Lorazepam tablets contain lorazepam, a Schedule IV controlled substance. Abuse Lorazepam tablets are a benzodiazepine and a CNS depressant with a potential for abuse and addiction. Abuse is the intentional, non-therapeutic use of a drug, even once, for its desirable psychological or physiological effects. Misuse is the intentional use, for therapeutic purposes, of a drug by an individual in a way other than prescribed by a health care provider or for whom it was not prescribed. Drug addiction is a cluster of behavioral, cognitive, and physiological phenomena that may include a strong desire to take the drug, difficulties in controlling drug use (e.g., continuing drug use despite harmful consequences, giving a higher priority to drug use than other activities and obligations), and possible tolerance or physical dependence. Even taking benzodiazepines as prescribed may put patients at risk for abuse and misuse of their medication. Abuse and misuse of benzodiazepines may lead to addiction. 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. Benzodiazepines are often sought by individuals who abuse drugs and other substances, and by individuals with addictive disorders (see WARNINGS: Abuse, Misuse, and Addiction). The following adverse reactions have occurred with benzodiazepine abuse and/or misuse: abdominal pain, amnesia, anorexia, anxiety, aggression, ataxia, blurred vision, confusion, depression, disinhibition, disorientation, dizziness, euphoria, impaired concentration and memory, indigestion, irritability, muscle pain, slurred speech, tremors, and vertigo. The following severe adverse reactions have occurred with benzodiazepine abuse and/or misuse: delirium, paranoia, suicidal ideation and behavior, seizures, coma, breathing difficulty, and death. Death is more often associated with polysubstance use (especially benzodiazepines with other CNS depressants such as opioids and alcohol). Dependence Physical Dependence Lorazepam tablets may produce physical dependence from continued therapy. Physical dependence is a state that develops as a result of physiological adaptation in response to repeated drug use, manifested by withdrawal signs and symptoms after abrupt discontinuation or a significant dose reduction of a drug. Abrupt discontinuation or rapid dosage reduction of benzodiazepines or administration of flumazenil, a benzodiazepine antagonist, may precipitate acute withdrawal reactions, including seizures, which can be life-threatening. Patients at an increased risk of withdrawal adverse reactions after benzodiazepine discontinuation or rapid dosage reduction include those who take higher dosages (i.e., higher and/or more frequent doses) and those who have had longer durations of use (see WARNINGS: Dependence and Withdrawal Reactions). To reduce the risk of withdrawal reactions, use a gradual taper to discontinue lorazepam tablets or reduce the dosage (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of lorazepam tablets and WARNINGS). Acute Withdrawal Signs and Symptoms Acute withdrawal signs and symptoms associated with benzodiazepines have included abnormal involuntary movements, anxiety, blurred vision, depersonalization, depression, derealization, dizziness, fatigue, gastrointestinal adverse reactions (e.g., nausea, vomiting, diarrhea, weight loss, decreased appetite), headache, hyperacusis, hypertension, irritability, insomnia, memory impairment, muscle pain and stiffness, panic attacks, photophobia, restlessness, tachycardia, and tremor. More severe acute withdrawal signs and symptoms, including life-threatening reactions, have included catatonia, convulsions, delirium tremens, depression, hallucinations, mania, psychosis, seizures and suicidality. Protracted Withdrawal Syndrome Protracted withdrawal syndrome associated with benzodiazepines is characterized by anxiety, cognitive impairment, depression, insomnia, formication, motor symptoms (e.g., weakness, tremor, muscle twitches), paresthesia, and tinnitus that persists beyond 4 to 6 weeks after initial benzodiazepine withdrawal. Protracted withdrawal symptoms may last weeks to more than 12 months. As a result, there may be difficulty in differentiating withdrawal symptoms from potential re-emergence or continuation of symptoms for which the benzodiazepine was being used. Tolerance Tolerance to lorazepam tablets may develop from continued therapy. Tolerance is a physiological state characterized by a reduced response to a drug after repeated administration (i.e., a higher dose of a drug is required to produce the same effect that was once obtained at a lower dose). Tolerance to the therapeutic effect of lorazepam tablets may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

Product summary:

Lorazepam Tablets, USP are available in the following dosage strengths: Lorazepam tablets, USP 0.5 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX7 ” on one side and plain on the other side. They are supplied as follows: Bottles of 90 (with Child Resistant Cap)…………………………NDC 63304-772-90 Bottles of 100 (with Child Resistant Cap)…………………………NDC 63304-772-01 Bottles of 500………………………………………………………..NDC 63304-772-05 Bottles of 1000………………………………………………………..NDC 63304-772-10 Lorazepam tablets, USP 1 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX ” above the bisect and “773 ” below the bisect on one side and plain on the other side. They are supplied as follows: Bottles of 90 (with Child Resistant Cap)…………………………NDC 63304-773-90 Bottles of 100 (with Child Resistant Cap)…………………………NDC 63304-773-01 Bottles of 500……………………………………………………….NDC 63304-773-05 Bottles of 1000……………………………………………………….NDC 63304-773-10 Lorazepam tablets, USP 2 mg, white to off-white, round, flat faced, beveled edged tablets, debossed with “RX ” above the bisect and “774 ” below the bisect on one side and plain on the other side. They are supplied as follows: Bottles of 90 (with Child Resistant Cap)…………………………NDC 63304-774-90 Bottles of 100 (with Child Resistant Cap)…………………………NDC 63304-774-01 Bottles of 500……………………………………………………….NDC 63304-774-05 Bottles of 1000……………………………………………………….NDC 63304-774-10 Keep out of reach of children. Store at 20° - 25° C (68° - 77° F) [See USP Controlled Room Temperature]. Dispense in a tight container. Keep tightly closed. Manufactured by: Ohm Laboratories Inc. New Brunswick, NJ 08901 Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Revised: 04/2023

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

Aphena Pharma Solutions - Tennessee, LLC
----------
Dispense with Medication Guide available at:
https://www.sunpharma.com/usa/products
MEDICATION GUIDE
Lorazepam (lor az' e pam) Tablets, USP
CIV
What is the most important information I should know about lorazepam
tablets?
•
Lorazepam tablets are a benzodiazepine medicine. Taking
benzodiazepines with opioid medicines, alcohol, or
other central nervous system depressants (including street drugs) can
cause severe drowsiness, breathing
problems (respiratory depression), coma and death. Get emergency help
right away if any of the following
happens:
•
shallow or slowed breathing
•
breathing stops (which may lead to the heart stopping)
•
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how taking
lorazepam tablets with opioids affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines
including lorazepam tablets which can lead to overdose and serious
side effects including coma and death.
•
Serious side effects including coma and death have happened in people
who have abused or misused
benzodiazepines, including lorazepam tablets. These serious side
effects may also include delirium,
paranoia, suicidal thoughts or actions, seizures, and difficulty
breathing. Call your healthcare provider or
go to the nearest hospital emergency room right away if you get any of
these serious side effects.
•
You can develop an addiction even if you take lorazepam tablets
exactly as prescribed by your healthcare
provider.
•
Take lorazepam tablets exactly as your healthcare provider prescribed.
•
Do not share your lorazepam tablets with other people.
•
Keep lorazepam tablets in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Lorazepam tablets can
cause physical dependence and
withdrawal reactions.
•
Do not suddenly stop taking lorazepam tablets. Stopping lorazepam
tablets suddenly can cause serious and life-
threatening side effec

Summary of Product characteristics

LORAZEPAM- LORAZEPAM TABLET
APHENA PHARMA SOLUTIONS - TENNESSEE, LLC
----------
LORAZEPAM TABLETS, USP CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN
PROFOUND SEDATION, RESPIRATORY DEPRESSION, COMA, AND DEATH. RESERVE
CONCOMITANT PRESCRIBING OF THESE DRUGS FOR PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE. LIMIT DOSAGES AND
DURATIONS TO THE MINIMUM REQUIRED. FOLLOW PATIENTS FOR SIGNS AND
SYMPTOMS OF RESPIRATORY DEPRESSION AND SEDATION (SEE
WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING LORAZEPAM TABLETS, EXPOSES
USERS TO RISKS OF ABUSE, MISUSE, AND ADDICTION, WHICH CAN LEAD TO
OVERDOSE OR DEATH. ABUSE AND MISUSE OF BENZODIAZEPINES COMMONLY
INVOLVE CONCOMITANT USE OF OTHER MEDICATIONS, ALCOHOL, AND/OR ILLICIT
SUBSTANCES, WHICH IS ASSOCIATED WITH AN INCREASED FREQUENCY OF
SERIOUS ADVERSE OUTCOMES. BEFORE PRESCRIBING LORAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE, MISUSE,
AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING LORAZEPAM TABLETS,
MAY LEAD TO CLINICALLY SIGNIFICANT PHYSICAL DEPENDENCE. THE RISKS OF
DEPENDENCE AND WITHDRAWAL INCREASE WITH LONGER TREATMENT DURATION
AND HIGHER DAILY DOSE. ABRUPT DISCONTINUATION OR RAPID DOSAGE
REDUCTION OF LORAZEPAM TABLETS AFTER CONTINUED USE MAY PRECIPITATE
ACUTE WITHDRAWAL REACTIONS, WHICH CAN BE LIFE-THREATENING. TO REDUCE
THE RISK OF WITHDRAWAL REACTIONS, USE A GRADUAL TAPER TO DISCONTINUE
LORAZEPAM TABLETS OR REDUCE THE DOSAGE (DOSAGE AND
ADMINISTRATION AND WARNINGS).
DESCRIPTION
Lorazepam USP, an antianxiety agent, has the chemical formula,
7-chloro-5-(_o_-
chlorophenyl)-1,3-dihydro-3-hydroxy-2_H_-1,4-benzodiazepin-2-one:
It is a white or practically white, crystalline powder, practically
insoluble in water,
sparingly soluble in Ethanol (96%), slightly soluble in Chloroform and
Ether, sparingly or
slightly soluble in Dichloromethane. Sol