Description: Sodium chloride injection instructions by the State Drug Administration on April 29, 2002 Drug Administration Note letter [2002] No. 125 "on the publication of the fifth batch of chemical drug instructions directory of the notice" issued. State Drug Administration published the instructions is standardized after the revision of the proposed reference sample, the enterprise has any doubt, can put forward modifications. Indications] should be consistent with the original approved content; [adverse reactions], [drug interactions] and other items, the enterprise to provide the instructions can not be less than those listed in the sample. For the sample specification of the empty or not listed in the full project, should require companies to fill in according to the actual situation, such as trade names, specifications, etc..
Drug Name
Generic Name: Sodium Chloride Injection
Previously Used Name:
Trade Name:
English Name: Sodium Chloride Injection
Chinese Pinyin: Luhuana Zhusheye
The main components of this product and its chemical name Sodium Chloride
Its structural formula is: NaCl
Molecular Formula: NaCl
Molecular Weight: 58.44
Properties
The product is a colorless, clear liquid; slightly salty taste.
Pharmacology and Toxicology
Sodium chloride is an electrolyte replacement drug. Sodium and chloride are important electrolytes in the body, mainly in the extracellular fluid, and play a very important role in maintaining normal blood and extracellular fluid volume and osmotic pressure. Normal serum sodium concentration is 135-145 mmol/L, accounting for 92% of plasma cations and 90% of total osmotic pressure, so plasma sodium plays a decisive role in osmotic pressure. Normal serum chloride concentration of 98 ~ 106mmol / L, the body's sodium, chloride ions mainly through the hypothalamus, the posterior pituitary gland and the kidney to regulate, to maintain the volume of body fluids and osmotic pressure stability.
Pharmacokinetics
Sodium chloride enters the blood circulation directly after intravenous injection and is widely distributed in the body, but mainly present in the extracellular fluid. Sodium and chloride ions are filtered by glomeruli and partially reabsorbed by renal tubules. They are excreted by the kidneys in the urine, and only a small portion is excreted from sweat.
Indications
Various causes of water loss, including hypotonic, isotonic and hypertonic water loss; hypertonic non-ketotic diabetic coma, the application of isotonic or hypotonic sodium chloride can be corrected by the loss of water and hypertonic state; hypochloremic metabolic alkalosis; external use of saline rinsing the eyes, washing wounds, etc.; but also used for obstetrics water bladder induction of labor.
Dosage
1. Hypertonic water loss Hypertonic water loss in patients with brain cells and cerebrospinal fluid osmotic concentration increases, if the treatment so that the plasma and extracellular fluid sodium concentration and osmotic concentration decreased too quickly, can lead to cerebral edema. Therefore, it is generally accepted that plasma sodium concentration should not fall by more than 0.5 mmol/L per hour within 48 hours of the start of treatment.
If the patient is in shock, sodium chloride injection should be given first and colloid supplementation should be given as appropriate, and when shock is corrected, with a blood sodium of >155 mmol/L, and plasma osmolality concentration of >350 mO *** /L, 0.6% hypotonic sodium chloride injection. When the plasma osmolality is <330mO *** /L, switch to 0.9% sodium chloride injection. The total amount of rehydration fluid was calculated according to the following formula as a reference:
Generally, half of the rehydration fluid was given on the first day, and the remaining amount was given in the next 2-3 days, and was adjusted according to the cardiorespiratory and renal functions as appropriate.
2. Isotonic water loss In principle, isotonic solutions are given, such as 0.9% sodium chloride injection or compound sodium chloride injection, but the chlorine concentration of the above solutions is significantly higher than plasma, and large amounts of individual use can lead to hyperchloremia, so 0.9% sodium chloride injection and 1.25% sodium bicarbonate or 1.86% (1/6M) lactate in the ratio of 7:3 after preparation and replenishment. The latter has a chloride concentration of 107 mmol/L and corrects metabolic acidosis. The amount of rehydration can be calculated by body weight or erythrocyte pressure volume as a reference. ① Calculated by body weight: rehydration volume (L) (weight loss (kg) × 142)/154; ② Calculated by erythrocyte pressure volume: rehydration volume (L) (actual erythrocyte pressure volume - normal erythrocyte pressure volume × body weight (kg) × 0.2)/ normal erythrocyte pressure volume. Normal erythrocyte product is 48% for men and 42% for women.
3. Hypotonic water loss In severe hypotonic water loss, intracellular solutes in the brain are reduced to maintain cell volume. If the treatment makes the plasma and extracellular fluid sodium concentration and osmotic concentration rapidly rebound, can lead to brain cell injury. It is generally accepted that when blood sodium is less than 120 mmol/L, treatment causes blood sodium to rise at a rate of 0.5 mmol/L per hour, with patching exceeding 1.5 mmol/L per hour.
When blood sodium is less than 120 mmol/L or when central nervous system symptoms are present, a relieving titration of 3% to 5% sodium chloride injection may be given. It is generally required to raise the blood sodium concentration above 120 mmol/L within 6 hours. Sodium supplementation (mmol/L) = [142 - actual blood sodium concentration (mmol/L)] × body weight (kg) × 0.2. When the blood sodium is raised back above 120～125 mmol/L, isotonic solution can be used instead or isotonic solution with hypertonic glucose injection or 10% sodium chloride injection as appropriate.
4. Low-chlorine alkalosis Give 500-1000ml of 0.9% sodium chloride injection or compound sodium chloride injection (Ringer's solution), and decide the dosage according to the alkalosis later.
5. For external use, wash the wound and flush the eyes with physiologic sodium chloride solution.
Adverse reactions
(1) Infusion of too much fluid, too fast, can lead to sodium retention, causing edema, elevated blood pressure, increased heart rate, chest tightness, respiratory distress, and even acute left heart failure.
(2) Too much and too fast administration of hypotonic sodium chloride can lead to hemolysis, cerebral edema and so on.
Contraindications
Precautions
(1) the following conditions should be used with caution: (1) edematous diseases, such as nephrotic syndrome, cirrhosis, ascites, congestive heart failure, acute left heart failure, cerebral edema, and idiopathic edema, etc.; (2) acute renal failure oliguric stage, chronic renal failure with reduced urine output and poor response to diuretics; (3) hypertension; (4) hypokalemia.
(2) According to clinical needs, check the serum concentration of sodium, potassium and chloride ions; the balance of acid and alkaline concentrations in the blood, renal function and blood pressure and cardiopulmonary function.
Drugs for pregnant and lactating women
Prohibited in hypertensive syndrome of pregnancy.
Children
The amount and rate of rehydration should be strictly controlled.
Medication for elderly patients
The volume and rate of rehydration should be strictly controlled.
Drug interactions
When used as a solvent or diluent of a drug, contraindications between drugs should be observed.
Overdose
Can cause hypernatremia and hypokalemia, and can cause bicarbonate loss.
Specifications
(1) 10 ml: 90 mg (2) 100 ml: 0.9 g (3) 250 ml: 2.25 g
(4) 500 ml: 4.5 g (5) 1000 ml: 9 g
Storage
Kept tightly closed.
Packing
Expiry date
Approval number
Manufacturer
Name of the company:
Address:
Postal code:
Telephone number:
Fax number:
Website address:
Packing
Packing
Storage
Confined.