MIDAZOLAM- midazolam hydrochloride injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Steriscience Specialties Private Limited

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Midazolam hydrochloride injection 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 can also be used as a component of intravenous supplementation of nitrous oxide and oxygen (balanced anesthesia); - continuous intravenous infusion for sedation of intubated and mechanically ventilated patients as a component of anesthesia or during treatment in a critical care setting. Injectable midazolam hydrochloride is contraindicated in patients with a known hypersensitivity to the drug. Benzodiazepines are contraindicated in patients with acute narrow- angle glaucoma. Benzodiazepines may be used in patients with open-angle glaucoma only if they are receiving appropriate therapy. Measurements of intraocular pressure in patients without eye disease show a moderate lowering following induction with midazolam hydrochloride; patients with glaucoma have not been studied. Midazolam contains midazolam, a Schedule IV control substance. Midazolam was actively self-administered in primate models used to assess the positive reinforcing effects of psychoactive drugs. Midazolam produced physical dependence of a mild to moderate intensity in cynomolgus monkeys after 5 to 10 weeks of administration. Available data concerning the drug abuse and dependence potential of midazolam suggest that its abuse potential is at least equivalent to that of diazepam. Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, hallucinations, tremor, abdominal and muscle cramps, vomiting and sweating), have occurred following abrupt discontinuation of benzodiazepines, including midazolam. Abdominal distention, nausea, vomiting, and tachycardia are prominent symptoms of withdrawal in infants. The more severe withdrawal symptoms have usually been limited to those patients who had received excessive doses over an extended period of time. Generally milder withdrawal symptoms (e.g., dysphoria and insomnia) have been reported following abrupt discontinuance of benzodiazepines taken continuously at therapeutic levels for several months. Consequently, after extended therapy, abrupt discontinuation should generally be avoided and a gradual dosage tapering schedule followed. There is no consensus in the medical literature regarding tapering schedules; therefore, practitioners are advised to individualize therapy to meet patient’s needs. In some case reports, patients who have had severe withdrawal reactions due to abrupt discontinuation of high-dose long-term midazolam, have been successfully weaned off of midazolam over a period of several days.

Povzetek izdelek:

Midazolam Injection, USP (Preservative-free) is supplied as follows: NDC Midazolam Injection, USP (Preservative-free) (1 mg per mL) Package Factor 82449-203-02 2 mg per 2 mL Single-Dose Vial 10 vials per carton 82449-204-02 5 mg per 5 mL Single-Dose Vial 10 vials per carton NDC Midazolam Injection, USP (Preservative-free) (5 mg per mL) Package Factor 82449-205-02 5 mg per 1 mL Single-Dose Vial 10 vials per carton 82449-206-02 10 mg per 2 mL Single-Dose Vial 10 vials per carton Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MIDAZOLAM- MIDAZOLAM HYDROCHLORIDE INJECTION, SOLUTION
STERISCIENCE SPECIALTIES PRIVATE LIMITED
----------
MIDAZOLAM INJECTION, USP
FOR INTRAVENOUS OR INTRAMUSCULAR USE
PRESERVATIVE FREE
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 minutes and allow an additional 2 or mo