MANNITOL injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

Mannitol (UNII: 3OWL53L36A) (Mannitol - UNII:3OWL53L36A)

Commercializzato da:

General Injectables & Vaccines, Inc

INN (Nome Internazionale):

Mannitol

Composizione:

Mannitol 250 mg in 1 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Mannitol Injection is indicated for the reduction of: - intracranial pressure and treatment of cerebral edema. - elevated intraocular pressure. Mannitol Injection is contraindicated in patients with: - Known hypersensitivity to mannitol [see WARNINGS AND PRECAUTIONS (5.1)]. - Anuria [see WARNINGS AND PRECAUTIONS (5.2)]. - Severe hypovolemia [see WARNINGS AND PRECAUTIONS (5.4)]. - Pre-existing severe pulmonary vascular congestion or pulmonary edema [see WARNINGS AND PRECAUTIONS (5.5)]. - Active intracranial bleeding except during craniotomy. 8.1 Pregnancy Risk Summary The available case report data with mannitol over decades of use have not identified a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Mannitol crosses the placenta and may cause fluid shifts that could potentially result in adverse effects in the fetus (see DATA).No adverse developmental effects from mannitol were reported in published animal studies; however, fluid shifts occurred in fetal ewes i

Dettagli prodotto:

Mannitol Intravenous (Mannitol Injection, USP) is supplied in single-dose containers as follows: NOTE: Crystals may form in mannitol solutions especially if the solutions are chilled. To dissolve the crystals, warm the bottle in hot water at 80°C and periodically shake vigorously. 25% Mannitol Injection, USP may be autoclaved at 121°C for 20 minutes at 15 psi. Remove cover from fliptop vial and cleanse stopper with antiseptic before use. Cool to body temperature or less before administering. When infusing 25% mannitol concentrations, the administration set should include a filter. Protect from freezing. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

MANNITOL- MANNITOL INJECTION, SOLUTION
GENERAL INJECTABLES & VACCINES, INC
----------
HIGHLIGHTS OF PRESCRIBING INFORMATION
HIGHLIGHTSOF PRESCRIBING INFORMATIONTHESE HIGHLIGHTS DO NOT INCLUDE
ALL THE
INFORMATION NEEDED TO USE MANNITOL INJECTION SAFELY AND EFFECTIVELY.
SEE FULL PRESCRIBING
INFORMATION FOR MANNITOL INJECTION.MANNITOL INJECTION, FOR INTRAVENOUS
USE
INITIAL U.S. APPROVAL: 1964
RECENT MAJOR CHANGES
Indications and Usage (removed, revised) (1)
03/2020
Contraindications (4)
03/2020
Warnings and Precautions (5.1, 5.2, 5.3, 5.4, 5.5, 5.6, 5.7)
03/2020
INDICATIONS AND USAGE
Mannitol Injection is an osmotic diuretic, indicated for the reduction
of: (2)
intracranial pressure and treatment of cerebral edema. (1)
elevated intraocular pressure. (1)
DOSAGE AND ADMINISTRATION
Administration Instructions (2.1): (3)
For intravenous infusion, preferably through a central venous
catheter.
Prior to administration, evaluate renal, cardiac and pulmonary status
and correct fluid and electrolyte
imbalances.
Recommended Dosage (2.2): (3)
The dosage, concentration and rate of administration depend on the
age, weight and condition of the
patient, including fluid requirement, urinary output and concomitant
therapy.
Reduction of Intracranial Pressure and Treatment of Cerebral Edema:
0.25 g/kg administered every 6 to 8
hours as an intravenous infusion over at least 30 minutes.
Reduction of Intraocular Pressure: 1.5 to 2 g/kg administered as a
single dose intravenously over at least
30 minutes. Administer 60 to 90 minutes before surgery to achieve
maximal effect. (3)
DOSAGE FORMS AND STRENGTHS
Mannitol Injection 25%, USP: 12.5 g/50 mL (0.25 g/mL) in a single-dose
vial (3) (4)
CONTRAINDICATIONS
Known hypersensitivity to mannitol. (4, 5.1)
Anuria. (4, 5.2)
Severe hypovolemia. (4, 5.4)
Pre-existing severe pulmonary vascular congestion or pulmonary edema.
(4, 5.5)
Active intracranial bleeding except during craniotomy. (4)
WARNINGS AND PRECAUTIONS
Hypersensitivity Reactions, Including Anaphylaxis: Stop infusion
immediately if hyperse