DIAZEPAM INTENSOL solution, concentrate

国: アメリカ合衆国

言語: 英語

ソース: NLM (National Library of Medicine)

有効成分:

DIAZEPAM (UNII: Q3JTX2Q7TU) (DIAZEPAM - UNII:Q3JTX2Q7TU)

から入手可能:

Hikma Pharmaceuticals USA Inc.

INN（国際名）:

DIAZEPAM

構図:

DIAZEPAM 5 mg in 5 mL

投与経路:

ORAL

処方タイプ:

PRESCRIPTION DRUG

適応症:

Diazepam is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety. Anxiety or tension associated with the stress of everyday life usually does not require treatment with an anxiolytic. In acute alcohol withdrawal, diazepam may be useful in the symptomatic relief of acute agitation, tremor, impending or acute delirium tremens and hallucinosis. Diazepam is a useful adjunct for the relief of skeletal muscle spasm due to reflex spasm to local pathology (such as inflammation of the muscles or joints, or secondary to trauma), spasticity caused by upper motor neuron disorders (such as cerebral palsy and paraplegia), athetosis, and stiff-man syndrome. Oral diazepam may be used adjunctively in convulsive disorders, although it has not proved useful as the sole therapy. The effectiveness of diazepam 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

製品概要:

Diazepam Intensol™ Oral Solution (Concentrate) The 25 mg per 5 mL (5 mg/mL) oral solution (concentrate) is supplied as a clear, yellow solution. NDC 0054-3185-44: Bottle of 30 mL with calibrated oral syringe [graduations of 0.1 mL (0.5 mg), 0.2 mL (1 mg), 0.3 mL (1.5 mg), 0.4 mL (2 mg), 0.5 mL (2.5 mg), 0.6 mL (3 mg), 0.7 mL (3.5 mg), 0.8 mL (4 mg), 0.9 mL (4.5 mg) and 1 mL (5 mg) on the oral syringe.] Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard opened bottle after 90 days. PROTECT FROM LIGHT. Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 C50000471/01 Revised November 2022

認証ステータス:

Abbreviated New Drug Application

情報リーフレット

Hikma Pharmaceuticals USA Inc.
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MEDICATION GUIDE
MEDICATION GUIDE
Diazepam Intensol™ Oral Solution (Concentrate), CIV
25 mg/ 5 mL (5 mg/mL)
(dye az’ e pam)
What is the most important information I should know about
Diazepam IntensolTM Oral Solution?
•
Diazepam IntensolTMOral Solution is a benzodiazepine
medicine. Taking benzodiazepines with opioid medicines,
alcohol, or other central nervous system depressants (CNS)
(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:
o
shallow or slowed breathing
o
breathing stops (which may lead to the heart stopping)
o
excessive sleepiness (sedation)
Do not drive or operate heavy machinery until you know how
taking Diazepam IntensolTM Oral Solution with opioids affects
you.
•
Risk of abuse, misuse, and addiction. There is a risk of abuse,
misuse, and addiction with benzodiazepines, including
Diazepam IntensolTM Oral Solution, 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, including Diazepam IntensolTM Oral
Solution. 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 Diazepam
IntensolTM Oral Solution exactly as prescribed by your
healthcare provider.
o
Take Diazepam IntensolTM Oral Solution exactly as your
healthcare provider prescribed.
o
Do not share your Diazepam IntensolTM Oral Solution
with other people.
o
Keep Diazepam IntensolTM Oral Solutionin a safe place
and away from children.
•
Physical dependence and withdrawal reactions. Diazepam
IntensolTM Oral Solution can cause physical dependence and
withdrawal reactions, especially if

製品の特徴

DIAZEPAM INTENSOL- DIAZEPAM INTENSOL SOLUTION, CONCENTRATE
HIKMA PHARMACEUTICALS USA INC.
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DIAZEPAM _INTENSOL_™ ORAL SOLUTION (CONCENTRATE), CIV
25 MG PER 5 ML (5 MG/ML)
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 IN PATIENTS FOR WHOM
ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
LIMIT DOSAGES AND DURATIONS TO THE MINIMUM REQUIRED.
•
•
•
DESCRIPTION
Each mL of Diazepam _Intensol_
Oral Solution (Concentrate) contains:
diazepam,
USP.........................................................5 mg
alcohol......................................................................19%
_Inactive Ingredients_
FOLLOW PATIENTSFOR SIGNS AND SYMPTOMS OF RESPIRATORY DEPRESSION
AND SEDATION (SEE WARNINGS AND PRECAUTIONS).
THE USE OF BENZODIAZEPINES, INCLUDING DIAZEPAM, 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 DIAZEPAM AND
THROUGHOUT TREATMENT, ASSESS EACH PATIENT’S RISK FOR ABUSE,
MISUSE, AND ADDICTION (SEE WARNINGS).
THE CONTINUED USE OF BENZODIAZEPINES, INCLUDING DIAZEPAM, 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 DIAZEPAM 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
DIAZEPAM OR REDUCE THE DOSAGE (SEE DOSAGE AND ADMINISTRATION
AND WARNINGS).
TM
alcohol, D&C Yellow No. 10, polyethylene glycol, propylene gly