SODIUM BICARBONATE injection

দেশ: মার্কিন যুক্তরাষ্ট্র

ভাষা: ইংরেজি

সূত্র: NLM (National Library of Medicine)

সক্রিয় উপাদান:

SODIUM BICARBONATE (UNII: 8MDF5V39QO) (BICARBONATE ION - UNII:HN1ZRA3Q20)

থেকে পাওয়া:

HF Acquisition Co LLC, DBA HealthFirst

প্রশাসন রুট:

INTRAVENOUS

প্রেসক্রিপশন টাইপ:

PRESCRIPTION DRUG

থেরাপিউটিক ইঙ্গিত:

Sodium Bicarbonate Injection, USP is indicated in the treatment of metabolic acidosis which may occur in severe renal disease, uncontrolled diabetes, circulatory insufficiency due to shock or severe dehydration, extracorporeal circulation of blood, cardiac arrest and severe primary lactic acidosis. Sodium bicarbonate is further indicated in the treatment of certain drug intoxications, including barbiturates (where dissociation of the barbiturate-protein complex is desired), in poisoning by salicylates or methyl alcohol and in hemolytic reactions requiring alkalinization of the urine to diminish nephrotoxicity of hemoglobin and its breakdown products. Sodium bicarbonate also is indicated in severe diarrhea which is often accompanied by a significant loss of bicarbonate. Treatment of metabolic acidosis should, if possible, be superimposed on measures designed to control the basic cause of the acidosis – e.g., insulin in uncomplicated diabetes, blood volume restoration in shock. But since an appreciable time interval may elapse before all of the ancillary effects are brought about, bicarbonate therapy is indicated to minimize risks inherent to the acidosis itself. Vigorous bicarbonate therapy is required in any form of metabolic acidosis where a rapid increase in plasma total CO2 content is crucial – e.g., cardiac arrest, circulatory insufficiency due to shock or severe dehydration, and in severe primary lactic acidosis or severe diabetic acidosis. Sodium Bicarbonate Injection, USP is contraindicated in patients who are losing chloride by vomiting or from continuous gastrointestinal suction, and in patients receiving diuretics known to produce a hypochloremic alkalosis.

পণ্য সারাংশ:

Sodium Bicarbonate Injection, USP is supplied in the following dosage forms: NDC 51662-1383-1 SODIUM BICARBONATE INJECTION USP, 8.4% 50 mEq/50 mL (1 mEq/mL) LUER-JET™ SYR NDC 51662-1383-2 SODIUM BICARBONATE INJECTION USP, 8.4% 50 mEq/50 mL (1 mEq/mL) LUER-JET™ SYR IN A POUCH NDC 51662-1383-3 A CASE CONTAINING 10 SODIUM BICARBONATE INJECTION USP, 8.4% 50 mEq/50 mL (1 mEq/mL) LUER-JET™ SYR HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms In 50 mL single-dose packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. 10 individual cartons shrink wrapped as a group of 10 cartons. Syringe Assembly Directions: USE ASEPTIC TECHNIQUE Do not assemble until ready to use. *CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. Store at 20° to 25°C (68° to 77°F). Excursions allowed between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature.] PROTECT FROM FREEZING. © INTERNATIONAL MEDICATION SYSTEMS, LIMITED 2016 SO. EL MONTE, CA 91733, U.S.A. An Amphastar Pharmaceuticals Company Rev. 1-16 6933520E

অনুমোদন অবস্থা:

Abbreviated New Drug Application

পণ্য বৈশিষ্ট্য

SODIUM BICARBONATE- SODIUM BICARBONATE INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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SODIUM BICARBONATE INJECTION USP, 8.4% 50 MEQ/50 ML (1 MEQ/ML)
LUER-JET™ SYR
SPL UNCLASSIFIED
Rx Only
FOR THE CORRECTION OF METABOLIC ACIDOSIS AND OTHER CONDITIONS
REQUIRING SYSTEMIC
ALKALINIZATION
DESCRIPTION
Sodium Bicarbonate Injection, USP is a sterile, nonpyrogenic,
hypertonic solution of sodium bicarbonate
(NaHCO3) in water for injection for administration by the intravenous
route as an electrolyte replenisher and
systemic alkalizer.
Solution is offered in 8.4% concentration. See table in HOW SUPPLIED
section for contents and characteristics.
The solution has an approximate pH of 8.0 (7.5 to 8.5). Carbon dioxide
may have been added to adjust the pH
of the solution to approximately 8.0.
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is intended only for use as a
single-dose injection. When smaller doses are required, the unused
portion should be discarded with the entire
unit.
Sodium bicarbonate, 84 mg is equal to one milliequivalent each of Na+
and HCO3¯ . Sodium Bicarbonate, USP
is chemically designated NaHCO3, a white crystalline powder soluble in
water. Water for Injection, USP is
chemically designated H2O.
CLINICAL PHARMACOLOGY
Intravenous sodium bicarbonate therapy increases plasma bicarbonate,
buffers excess hydrogen ion
concentration, raises blood pH and reverses the clinical
manifestations of acidosis.
Sodium bicarbonate in water dissociates to provide sodium (Na+) and
bicarbonate (HCO3¯ ) ions. Sodium
(Na+) is the principal cation of the extracellular fluid and plays a
large part in the therapy of fluid and
electrolyte disturbances. Bicarbonate (HCO3¯ ) is a normal
constituent of body fluids and the normal plasma
level ranges from 24 to 31 mEq/liter. Plasma concentration is
regulated by the kidney through acidification of
the urine when there is a deficit or by alkalinization of the urine
when there is an excess. Bicarbonate anion is
considered “labile” since a