Bumetanide (Page 3 of 3)
OVERDOSAGE
Overdosage can lead to acute profound water loss, volume and electrolyte depletion, dehydration, reduction of blood volume and circulatory collapse with a possibility of vascular thrombosis and embolism. Electrolyte depletion may be manifested by weakness, dizziness, mental confusion, anorexia, lethargy, vomiting and cramps. Treatment consists of replacement of fluid and electrolyte losses by careful monitoring of the urine and electrolyte output and serum electrolyte levels.
DOSAGE AND ADMINISTRATION
Dosage should be individualized with careful monitoring of patient response.
Parenteral Administration
Bumetanide Injection may be administered parenterally (IV or IM) to patients in whom gastrointestinal absorption may be impaired or in whom oral administration is not practical.
Parenteral treatment should be terminated and oral treatment instituted as soon as possible.
The usual initial dose is 0.5 to 1 mg intravenously or intramuscularly. Intravenous administration should be given over a period of 1 to 2 minutes. If the response to an initial dose is deemed insufficient, a second or third dose may be given at intervals of 2 to 3 hours, but should not exceed a daily dosage of 10 mg.
Miscibility and Parenteral Solutions
The compatibility tests of bumetanide injection with 5% Dextrose Injection in Water, 0.9% Sodium Chloride Injection, and Lactated Ringer’s Injection in both glass and plasticized PVC (Viaflex) containers have shown no significant absorption effect with either containers, nor a measurable loss of potency due to degradation of the drug. However, solutions should be freshly prepared and used within 24 hours.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
HOW SUPPLIED
Bumetanide Injection, USP, 0.25 mg/mL is a sterile, clear, colorless to slightly yellow solution supplied in amber vials as follows:
4 mL Single-Dose Vial packaged in 10s (NDC 68083-496-10)
Discard unused portion.
10 mL Multiple-Dose Vial packaged in 10s (NDC 68083-497-10)
This container closure is not made with natural rubber latex.
Storage
Store at 20°C to 25°C (68°F to 77°F), excursions permitted to 15°C to 30° C (59°F to 86°F) [See USP Controlled Room Temperature]. Protect from light.
To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma Limited at 864-879-9994 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Manufactured by:
Gland Pharma Limited
Hyderabad, India
ML No: 2/MD/TS/2015/F/G
Revised date: May 2022
PRINCIPAL DISPLAY PANEL
Vial Label (1 mg):
NDC 68083-496-01 Rx only
Bumetanide
Injection, USP
1 mg/4 mL (0.25 mg/mL)
For Intravenous or Intramuscular Use
4 mL Single-Dose Vial
Carton Label (1 mg):
NDC 68083-496-10 Rx only
Bumetanide Injection, USP
1 mg/4 mL (0.25 mg/mL)
For Intravenous or Intramuscular Use
10 x 4 mL Single-Dose Vials
Vial Label (2.5 mg):
NDC 68083-497-01 Rx only
Bumetanide
Injection, USP
2.5 mg/10 mL (0.25 mg/mL)
For Intravenous or Intramuscular Use
10 mL Multiple-Dose Vial
Carton Label (2.5 mg):
NDC 68083-497-10 Rx only
Bumetanide Injection, USP
2.5 mg/10 mL (0.25 mg/mL)
For Intravenous or Intramuscular Use
10 x 10 mL Multiple-Dose Vials
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Labeler — Gland Pharma Limited (918601238) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Gland Pharma Limited | 858971074 | ANALYSIS (68083-496), ANALYSIS (68083-497), MANUFACTURE (68083-496), MANUFACTURE (68083-497), PACK (68083-496), PACK (68083-497) |
Revised: 06/2022 Gland Pharma Limited
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