LORAZEPAM solution, concentrate

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

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

可用日期:

Hikma Pharmaceuticals USA Inc.

INN（国际名称）:

LORAZEPAM

组成:

LORAZEPAM 2 mg in 1 mL

给药途径:

ORAL

处方类型:

PRESCRIPTION DRUG

疗效迹象:

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 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: Lorazepam is a Schedule IV controlled substance. Lorazepam is 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 healthcare 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). Physical Dependence Lorazepam 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 or reduce the dosage (see DOSAGE AND ADMINISTRATION: Discontinuation or Dosage Reduction of Lorazepam and WARNINGS ). Tolerance Tolerance to lorazepam 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 may develop; however, little tolerance develops to the amnestic reactions and other cognitive impairments caused by benzodiazepines.

產品總結:

Lorazepam Intensol ™ Oral Concentrate, USP The 2 mg per mL oral concentrate is supplied as a clear colorless solution. NDC 0054-3532-44: Bottle of 30 mL with calibrated syringe (graduations 0.05 mL on the syringe). PROTECT FROM LIGHT Store at cold temperature. Refrigerate at 2° to 8°C (36° to 46°F) Dispense only in the bottle and only with the calibrated oral syringe provided. Discard opened bottle after 90 days . Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000716/01 Revised January 2023

授权状态:

Abbreviated New Drug Application

资料单张

West-Ward Pharmaceuticals Corp.
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Medication Guide
Lorazepam Intensol™ Oral Concentrate, USP, CIV
(lor A ze pam)
What is the most important information I should know about lorazepam?
•
Lorazepam is 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 with opioids
affects you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with
benzodiazepines including lorazepam which can lead to overdose and
serious side effects including
coma and death.
o
Serious side effects including coma and death have happened in people
who have abused or
misused benzodiazepines, includinglorazepam. 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.
o
You can develop an addiction even if you take lorazepam exactly as
prescribed by your healthcare
provider.
o
Take lorazepam exactly as your healthcare provider prescribed.
o
Do not share your lorazepam with other people.
o
Keep lorazepam in a safe place and away from children.
•
Physical dependence and withdrawal reactions. Lorazepam can cause
physical dependence and
withdrawal reactions.
o
Do not suddenly stop taking lorazepam. Stopping lorazepam suddenly can
cause serious and life-
threatening side effects, including, unusual movements, responses or
expressions, seizures, sudden
and severe mental or nervous system changes, depression, seeing or
hearing things that others do
not see

产品特点

LORAZEPAM- LORAZEPAM SOLUTION, CONCENTRATE
WEST-WARD PHARMACEUTICALS CORP.
----------
LORAZEPAM _INTENSOL_™ ORAL CONCENTRATE, USP, CIV
RX ONLY
WARNING: RISKS FROM CONCOMITANT USE WITH OPIOIDS; ABUSE,
MISUSE, AND ADDICTION; AND DEPENDENCE AND WITHDRAWAL
REACTIONS
•
•
•
DESCRIPTION
Lorazepam, an antianxiety agent, has the chemical formula,
2_H_-1,4-benzodiazepin-2-
one, 7-chloro-5-(2-chlorophenyl)-1,3-dihydro-3-hydroxy-, (±)-:
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, 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, 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 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 OR REDUCE THE DOSAGE (DOSAGE AND ADMINISTRATION
AND WARNINGS).
C
H
Cl
N O MW: 321.16
Lorazepam, USP is a white or a practically white powder almost
insoluble in water. Each
mL of Lorazepam _Intensol_™ for oral administration contains 2 mg of
lorazepam. The
inactive i