MIDAZOLAM HYDROCHLORIDE injection

Ülke: ABD

Dil: İngilizce

Kaynak: NLM (National Library of Medicine)

Aktif bileşen:

MIDAZOLAM HYDROCHLORIDE (UNII: W7TTW573JJ) (MIDAZOLAM - UNII:R60L0SM5BC)

Mevcut itibaren:

Wockhardt USA LLC.

INN (International Adı):

MIDAZOLAM HYDROCHLORIDE

Kompozisyon:

MIDAZOLAM 1 mg in 1 mL

Uygulama yolu:

INTRAMUSCULAR

Reçete türü:

PRESCRIPTION DRUG

Terapötik endikasyonlar:

Midazolam hydrochloride injection, USP is indicated: - intramuscularly or intravenously for preoperative sedation/anxiolysis/amnesia; - intravenously as an agent for sedation/anxiolysis/amnesia prior to or during diagnostic, therapeutic or endoscopic procedures, such as bronchoscopy, gastroscopy, cystoscopy, coronary angiography, cardiac catheterization, oncology procedures, radiologic procedures, suture of lacerations and other procedures either alone or in combination with other CNS depressants; - intravenously for induction of general anesthesia, before administration of other anesthetic agents. With the use of narcotic premedication, induction of anesthesia can be attained within a relatively narrow dose range and in a short period of time. Intravenous midazolam hydrochloride can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); - continuous intravenous infusion for sedation of intubated

Ürün özeti:

Package configurations containing midazolam hydrochloride equivalent to 1 mg midazolam USP/mL : 64679-762-01            1 mg/mL, 2 mL vial, carton of 10 vials. 64679-762-02            1 mg/mL, 5 mL vial, carton of 10 vials. 64679-762-03            1 mg/mL, 10 mL vial, carton of 10 vials. 64679-762-04            1 mg/mL, 2 mL vial, carton of 25 vials. 64679-762-05            1 mg/mL, 5 mL vial, carton of 25 vials. 64679-762-06            1 mg/mL, 10 mL vial, carton of 25 vials. Package configurations containing midazolam hydrochloride equivalent to 5 mg midazolam USP/mL : 64679-763-01            5 mg/mL, 1 mL vial, carton of 10 vials. 64679-763-02            5 mg/mL, 2 mL vial, carton of 10 vials. 64679-763-03            5 mg/mL, 5 mL vial, carton of 10 vials. 64679-763-04            5 mg/mL, 10 mL vial, carton of 10 vials. 64679-763-05            5 mg/mL, 1 mL vial, carton of 25 vials. 64679-763-06            5 mg/mL, 2 mL vial, carton of 25 vials. 64679-763-07            5 mg/mL, 5 mL vial, carton of 25 vials. 64679-763-08            5 mg/mL, 10 mL vial, carton of 25 vials. Store at 20°-25°C (68°-77°F). [See USP controlled room temperature]. Discard unused portion.

Yetkilendirme durumu:

Abbreviated New Drug Application

Ürün özellikleri

MIDAZOLAM HYDROCHLORIDE- MIDAZOLAM HYDROCHLORIDE INJECTION
WOCKHARDT USA LLC.
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MIDAZOLAM HYDROCHLORIDE INJECTION, USP CIV
FOR INTRAVENOUS OR INTRAMUSCULAR USE
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
WARNINGS
PERSONNEL AND EQUIPMENT FOR MONITORING AND RESUSCITATION
_ADULTS AND PEDIATRICS: _INTRAVENOUS MIDAZOLAM HYDROCHLORIDE HAS BEEN
ASSOCIATED WITH
RESPIRATORY DEPRESSION AND RESPIRATORY ARREST, ESPECIALLY WHEN USED
FOR SEDATION IN
NONCRITICAL CARE SETTINGS. IN SOME CASES, WHERE THIS WAS NOT
RECOGNIZED PROMPTLY AND
TREATED EFFECTIVELY, DEATH OR HYPOXIC ENCEPHALOPATHY HAS RESULTED.
INTRAVENOUS MIDAZOLAM
HYDROCHLORIDE SHOULD BE USED ONLY IN HOSPITAL OR AMBULATORY CARE
SETTINGS, INCLUDING
PHYSICIANS' AND DENTAL OFFICES, THAT PROVIDE FOR CONTINUOUS MONITORING
OF RESPIRATORY AND
CARDIAC FUNCTION, E.G., PULSE OXIMETRY. IMMEDIATE AVAILABILITY OF
RESUSCITATIVE DRUGS AND AGE-
AND SIZE-APPROPRIATE EQUIPMENT FOR BAG/VALVE/MASK VENTILATION AND
INTUBATION, AND
PERSONNEL TRAINED IN THEIR USE AND SKILLED IN AIRWAY MANAGEMENT SHOULD
BE ASSURED (SEE
WARNINGS). FOR DEEPLY SEDATED PEDIATRIC PATIENTS, A DEDICATED
INDIVIDUAL, OTHER THAN THE
PRACTITIONER PERFORMING THE PROCEDURE, SHOULD MONITOR THE PATIENT
THROUGHOUT THE
PROCEDURE.
RISKS FROM CONCOMITANT USE WITH OPIOIDS
CONCOMITANT USE OF BENZODIAZEPINES AND OPIOIDS MAY RESULT IN PROFOUND
SEDATION,
RESPIRATORY DEPRESSION, COMA, AND DEATH_. _MONITOR PATIENTS FOR
RESPIRATORY DEPRESSION AND
SEDATION (SEE WARNINGS, PRECAUTIONS/DRUG INTERACTIONS).
INDIVIDUALIZATION OF DOSAGE
MIDAZOLAM HYDROCHLORIDE MUST NEVER BE USED WITHOUT INDIVIDUALIZATION
OF DOSAGE. THE
INITIAL INTRAVENOUS DOSE FOR SEDATION IN ADULT PATIENTS MAY BE AS
LITTLE AS 1 MG, BUT SHOULD NOT
EXCEED 2.5 MG IN A NORMAL HEALTHY ADULT. LOWER DOSES ARE NECESSARY FOR
OLDER (OVER 60
YEARS) OR DEBILITATED PATIENTS AND IN PATIENTS RECEIVING CONCOMITANT
NARCOTICS OR OTHER
CENTRAL NERVOUS SYSTEM (CNS) DEPRESSANTS. THE INITIAL DOSE AND ALL
SUBSEQUENT DOSES
SHOULD ALWAYS BE TITRATED SLOWLY; ADMINISTER OVER AT LEAST 2 MINUTE