Instructions for Dexmedetomidine Hydrochloride Injection

Drug name

Generic name: Dexmedetomidine Hydrochloride Injection

English name: Dexmedetomidine injection

Hanyu pinyin: tomidine injection with beautiful phlogistic acid

Powdering

The main component of this product is dexmedetomidine hydrochloride and the auxiliary material is sodium chloride.

gender

This product is a colorless or almost colorless clear liquid.

adapt to

Used for sedation during tracheal intubation and mechanical ventilation in patients undergoing general anesthesia surgery.

measure

2ml∶200ug (calculated by dexmedetomidine)

dosage

Adult dosage: the preparation concentration is 4g/ml, the dosage is 1g/kg, and the infusion time exceeds 10 minute.

Before taking, this product must be diluted to 4g/ml with 0.9% sodium chloride solution.

Generally speaking, before intravenous administration, the particulate matter and color change of the drug should be visually inspected.

Dose adjustment:

Due to the possible pharmacodynamic interaction, it may be necessary to reduce the dosage when taking this product with other anesthetics, sedatives, sleeping pills or opioids at the same time (see drug interaction).

Patients with hepatic and renal insufficiency and elderly patients may need to consider reducing the dose.

Drug compatibility:

Due to the uncertainty of physical compatibility, this product should not be administered simultaneously with blood or plasma through the same intravenous catheter. When this product is administered simultaneously with the following drugs: amphotericin B and diazepam.

When this product is administered simultaneously with the following intravenous injections and drugs, it has shown compatibility: 0.9% sodium chloride aqueous solution and 5% glucose aqueous solution.

It has been proved that some types of natural rubber may absorb this product, so it is recommended to use synthetic or coated rubber pad drug delivery device.

Medication for pregnant and lactating women

There are not enough good clinical studies on pregnant women. Only when the potential benefits outweigh the potential risks to the fetus should pregnant women use dexmedetomidine.

The safety of this product for pregnant women has not been studied. Therefore, it is not recommended to use this product during childbirth, including caesarean section.

It is not clear whether this product is secreted into breast milk. Dexmedetomidine, which was traced by radioisotope, was injected subcutaneously into lactating female rats and then secreted into milk. Because many drugs are secreted in human milk, lactating women should use this product with caution.

Children's medication

The safety and effectiveness of this product for children under 18 years old are not clear. Therefore, this product is not recommended for this group of people.

Sealed from light and stored at room temperature (10 ~ 30℃).

package

Xilin bottle packaging. 5 bottles/box; 10 bottle/box.

term of validity

18 months.

executive standard

YBH06092009

Registration authentication number

National medicine Zhunzi H20090248

Storage method

Sealed from light and stored at room temperature (10 ~ 30℃).

Matters needing attention

This product can only be used by professionals equipped with medical monitoring equipment. Because of the known pharmacological effects of this product, patients should be continuously monitored when infusion of this product. Hypotension, bradycardia and sinus arrest It is reported that healthy young volunteers with high vagus nerve tension or different administration methods (such as rapid intravenous injection or push injection) have clinically obvious bradycardia and sinus arrest after giving this product. It is reported that hypotension and bradycardia are related to the infusion of this product. If medical treatment is needed, the treatment may include reducing or stopping the infusion of this product, increasing the flow rate of intravenous fluid, raising the lower limbs, and using drugs to raise blood pressure. Because this product may aggravate the bradycardia caused by vagus nerve stimulation, clinicians should be prepared to intervene. Intravenous anticholinergic drugs (such as glycopyrrolate and atropine) should be considered to reduce vagus nerve tension. In clinical trials, atropine or glycopyrrolate can effectively treat most bradycardia events caused by this product. However, for some patients with obvious cardiovascular dysfunction, further emergency measures are needed. Care should be taken when using this product for patients with advanced heart block and/or severe ventricular dysfunction. Because this product will reduce the activity of sympathetic nervous system, hypovolemia, diabetes or chronic hypertension and elderly patients may have more hypotension and/or bradycardia. When giving other vasodilators or drugs with negative frequency effect, giving this product at the same time may have additional drug effects, so it should be used with caution. Temporary hypertension The occurrence of temporary hypertension is mainly observed during the loading dose period, which is related to the peripheral vasoconstriction of this product. Temporary hypertension usually does not require treatment, however, it may be desirable to reduce the speed of load infusion. Awakening ability When stimulated, it can be observed that some patients taking this product are awake and alert. In the absence of other clinical signs and symptoms, this in itself should not be regarded as evidence of lack of curative effect. Sedation of withdrawal symptoms in intensive care unit: If the product is given for more than 24 hours and suddenly stops, it may lead to withdrawal symptoms similar to clonidine (another α2 adrenergic drug). These symptoms include tension, excitement and headache, accompanied or followed by a rapid increase in blood pressure and an increase in plasma catecholamine concentration. Procedural sedation: short-term infusion of this product (