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Drug Catalog - Product Detail

SODIUM BICARBONATE IV SOL 8.4% 50ML X 10

NDC Mfr Size Str Form
00548-3352-00 NA NA NA NA
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Description
DESCRIPTION Sodium Bicarbonate Injection, USP, is a sterile, aqueous, pyrogen-free preparation of sodium bicarbonate (NaHCO 3 ). It is available in three hypertonic solutions with concentrations expressed as follows: 4.2% 0.5 mEq (42 mg) / mL 1000 mOsmol /L (calc.) 5 mEq (0.42 g) / 10 mL 8.4% 1 mEq (84 mg) / mL 2000 mOsmol /L (calc.) 10 mEq (0.84 g) / 10 mL 50 mEq (4.2 g) / 50 mL The pH of the above solutions may have been adjusted by means of added carbon dioxide and is approximately 7.8 (USP pH limits: between 7.0 and 8.5). These preparations contain no preservatives and are intended only as single dose vials; once the units are assembled and used, any remaining portion of the solution must be discarded with the integral units.
How Supplied
HOW SUPPLIED Sodium Bicarbonate Injection, USP In unit-use packages containing a MIN-I-JET ® disposable syringe. Stock No. Size and Type Concentration NDC No. 1052 50 mL with 18 G. × 1 1/2 " needle 8.4% 0548-1052-00 In unit-use packages containing a MIN-I-JET ® disposable syringe with Luer-Lock and optional STICK-GARD ® Safety Needle. Stock No. Size and Type Concentration NDC No. 2052 50 mL with STICK-GARD ® 8.4% 0548-2052-00 Twenty-five unit-use packages per carton. Manufactured under U.S. Pat No. 4,834,716, Reissue No 33,617, STICK-GARD ® Safety Needle. In unit-use packages containing a Luer-Jet™ Luer-Lock Prefilled Syringe. Stock No. Size and Type Concentration NDC No. 3331 10 mL with LuerJet™ Luer-Lock 4.2% 0548-3331-00 3352 50 mL with LuerJet™ Luer-Lock 8.4% 0548-3352-00 Ten unit-use packages per carton. Syringe Assembly Directions The MIN-I-JET® syringe with needle, illustrated below, is the basic unit upon which all the other syringe systems are built; slight adaptations and/ or additional auxillary parts create the other syringe systems. Assembly directions remain essentially the same. USE ASEPTIC TECHNIQUE Do not assemble until ready to use. Remove protective caps. Align vial such that the injector needle is centered on the stopper. Thread vial into injector 3 half turns, or until needle penetrates stopper. CAUTION: IMPROPER ENGAGING MAY CAUSE GLASS BREAKAGE AND SUBSEQUENT INJURY. DO NOT PUSH VIAL INTO INJECTOR; THIS MAY CAUSE MISALIGNMENT. Remove needle cap and expel air. Fig1 Fig2 Fig3 Store at controlled room temperature 15° to 30°C (59° to 86°F).
Indications & Usage
INDICATIONS AND USAGE 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 blood pigments. Urinary alkalinization is also used in methotrexate therapy to prevent nephrotoxicity. 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 CO 2 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.
Dosage and Administration
DOSAGE AND ADMINISTRATION Please note that the optional STICK-GARD ® Safety Needle, featured with stock number 2052 is interchangeable with a standard needle. Sodium Bicarbonate Injection, USP is administered by the intravenous route, preferably into a large vein. Suitable concentrations range from 1.4% (isotonic) to 8.4% (undiluted), depending upon the clinical condition and requirement of the patient. The MIN-I-JET ® Luer-Lock disposable syringe features STICK-GARD ® , a recessed needle enclosed in a protective plastic sheath. The Stick-Gard ® Safety Needle is pre-attached to the Luer-Lock of the syringe injector. The Stick-Gard ® Safety Needle is intended for use onto the Y-site of an I.V. set or a heparin lock injection site. Since the Stick-Gard ® Safety Needle cannot be used for direct injection (I.V. or I.M.) or for entering glass I.V. bottles and certain plastic I.V. bags, the Stick-Gard ® Safety Needle should be replaced with a suitable needle when the above modes of administration are recommended or appropriate. The need for Sodium Bicarbonate Injection is dependent upon the pH of the serum and the clinical symptoms of the patient as well as the base (bicarbonate) deficit. However, the dose of sodium bicarbonate can be based primarily upon the plasma deficit. This is the difference between the average normal bicarbonate of the plasma (27 mEq/ L) and the value determined for the patient. If plasma bicarbonate of the patient with metabolic acidosis is unknown, a safe average of sodium bicarbonate is 5 mEq (420 mg) per kilogram of body weight. If the patient has severe metabolic acidosis, bicarbonate solutions containing 90–180 mEq/L (approximately 7.5 – 15 g) may be given at rates of 1–1.5 liters during the first hour. The concentration of bicarbonate solutions used for further management of the patient may be adjusted to the needs of the patient. Usual adult dosage Systemic alkalizer — In cardiac arrest: Intravenous, initially 1 mEq per kg of body weight; 0.5 mEq per kg of body weight may be repeated every ten minutes of continued arrest. In less urgent forms of metabolic acidosis: Intravenous infusion, 2 to 5 mEq per kg of body weight, administered over a period of 4 to 8 hours. Note: Frequency of administration and the size of the dose may be reduced after severe symptoms have abated. Urinary alkalizer — Intravenous, 2 to 5 mEq per kg of body weight, administered over a period of 4 to 8 hours. Usual pediatric dosage Systemic alkalizer — In cardiac arrest: Intravenous, 1 mEq per kg of body weight initially, then 0.5 mEq per kg body weight every ten minutes of continued arrest. In less urgent forms of metabolic acidosis: Older children — See Usual adult dosage . Urinary alkalizer — See Usual adult dosage . In cardiac arrest Sodium bicarbonate should be administered according to the result of arterial blood pH and PaC0 2 and calculation of base deficit. Caution should be observed where rapid infusion of large quantities of bicarbonate is indicated. Bicarbonate solutions are hypertonic and may produce an undesirable rise in plasma sodium concentration. In cardiac arrest however, the risks from acidosis exceed those of hypernatremia. In infants, (up to two years of age), the 4.2% solution is recommended for intravenous administration at a rate not to exceed 8 mEq / kg/ day. This dosage is recommended in neonates to guard against the possibility of producing hypernatremia, decreasing cerebrospinal fluid pressure and inducing intracranial hemorrhage. If base deficit is known, a calculated dose of 0.3 × kg × base deficit is given. If only 8.4% sodium bicarbonate is available, it may be diluted 1:1 with 5% dextrose in water before administration. In less urgent forms of metabolic acidosis Sodium Bicarbonate Injection, USP, may be added to other intravenous fluids. Desired dilutions may be prepared using sterile water, sodium chloride (0.9%), dextrose 5%, or other standard electrolyte solutions as diluent. The amount of bicarbonate to be given to older children and adults over a four-to eight-hour period depends upon the severity of the acidosis as judged by the lowering of total C0 2 content, blood pH and clinical condition of the patient. Bicarbonate therapy should always be planned in a stepwise fashion since the degree of response from a given dose is not precisely predicable. Initially an infusion of 2 to 5 mEq per kg body weight over a period of 4 to 8 hours will produce a measureable improvement in the abnormal acid-base status of the blood. Alternatively, estimates of the initial dose of sodium bicarbonate may be based on the following equation: 0.5 × body weight (kg) × desired increase in serum HCO 3 - (mEq / L) = bicarbonate dose (mEq) or 0.5 × body weight (kg) × base deficit (mEq / L)= bicarbonate dose (mEq). One-half of this calculated estimate is given. The next step of therapy is dependent upon the clinical response of the patient. If severe symptoms have abated, the frequency of administration and dose may be reduced. In general, it is unwise to attempt full correction of a low total CO 2 content during the first 24 hours of therapy, since this may be accompanied by an unrecognized alkalosis because of a delay in the readjustment of ventilation to normal. Owing to this lag, the achievement of total CO 2 content of about 20 mEq/ L at the end of the first day of therapy will usually be associated with a normal blood pH. Further modification of the acidosis to completely normal values usually occurs in the presence of normal kidney function when and if the cause of the acidosis can be controlled. Values for total CO 2 which are brought to normal or above normal within the first day of therapy are very likely to be associated with grossly alkaline values for blood pH, with ensuing undesirable side effects. NOTE: Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use the injection if it contains a precipitate.