Compound ammonia barbital injection

[Drug Name]

Generic Name: Compound Amobarbital Injection

Pinyin in Chinese：Fufang Anlin Babituo Zhusheye

【Achievement】

This product is a compound preparation, its components are: each vial contains aminopyrine0.1g, antipyrine40mg, barbiturate18mg, and sterile water for injection.

【Physical State】This product is a colorless or pale yellow clear liquid.

【Indications】Mainly used for urgent antipyretic treatment during acute high fever, it also alleviates headache symptoms associated with fever.

【Specification】2ml: Aminopyrine 0.1g, Antipyrine 40mg, Barbiturate 18mg

【Dosage and Administration】

Intramuscular injection. For adults, a single dose is 2ml, or as directed by a physician. Under monitored conditions, the maximum daily dosage is 6ml. For children under 2 years: a single dose is 0．5～1ml; for ages 2 to 5: a single dose is 1～2ml; for those over 5 years: a single dose is 2ml. This product should not be used continuously.

Adverse Reactions

1.Allergic shock, manifested by symptoms such as chest tightness, dizziness, nausea and vomiting, drop in blood pressure, and profuse sweating, requires immediate discontinuation of the medication and resuscitation.

2.Granulocyte deficiency, purpura, sometimes with an acute onset.

3.Rash, urticaria, epidermolysis, etc.

【Prohibition】

1.Contraindicated in patients allergic to pyrazolone or barbiturate drugs.

2.Those with a history of allergies to this product should refrain from using it.

[Precautions]

1.Before intramuscular injection, the patient should be asked if there is a history of allergy to pyrazolone or barbiturate drugs. Those with a history of allergies should avoid using this product, and caution should be taken with those who are allergic.

2.Must not be mixed with other medications for injection.

3.Long-term use can lead to neutropenia, aplastic anemia, and severe toxic reactions such as liver and kidney damage.

4.Use this product with caution for those with severe respiratory diseases and difficulty breathing.

5.Use with caution for those who are physically weak.

6.This product only treats symptoms; after alleviating high fever symptoms, it should be used for supportive treatment. If there is no significant effect when using this product, other treatment methods should be employed to avoid blind and excessive use of this product.

The use of medication for pregnant and breastfeeding women is still unclear.

The use of medication for children is still unclear.

[Medication for the Elderly]

Elderly patients have a certain degree of physiological decline in liver and kidney function, and a smaller treatment dosage should be used.

[Drug Interactions]

Barbiturates have an inhibitory effect on the respiratory center and enhance the effects of drugs that suppress respiration, such as gentamicin sulfate, and their simultaneous use should be prohibited.

The extent of 【drug overdose】 is still unclear.

【Pharmacology and Toxicology】

This product is an antipyretic and analgesic. Aminophenazone and antipyrine both belong to the pyrazolone class of antipyretic analgesics, which can inhibit the synthesis and release of hypothalamic prostaglandins, restoring the normal reactivity of the thermoregulation central sensory neurons, thus producing a defervescence effect; at the same time, they also exert analgesic effects by inhibiting the synthesis of prostaglandins and others. Aminophenazone can also inhibit the synthesis and release of prostaglandins in localized inflammatory tissues, stabilize lysosomal membranes, and affect the phagocytic activity of phagocytes, thereby exhibiting anti-inflammatory effects. When used in combination with barbiturates, the analgesic effect can be enhanced.

Pharmacokinetics

Aminopyrine t_1/2 is 1 to 4 hours, most of it is demethylated in the liver to become 4-aminoantipyrine, which is then acetylated to form N-acetylaminopyrine and excreted in urine. Antipyrine t_1/2 is about 12 hours, metabolized in the liver through hydroxylation and conjugated with glucuronic acid to be excreted in urine, with about 5% excreted unchanged in urine.

【Storage】Shade and keep in sealed.

【Packaging】Ampoule packaging, l0 pcs/box

【Validity Period】24 months

【Implementation Standards】Local Standards for Chemical Pharmaceuticals Rise to National Standards Volume 14WS-10001-(HD-1327)-2003

【Approval Number】National drug standard numberH52020853

【Drug Marketing Authorization Holder】/【Manufacturing Enterprise】

Name: Guizhou Tiandi Pharmaceutical Co., Ltd.

Address: No. 6 Baokang Road, Hongxing Pharmaceutical Industry Park, Dingxiao Town, Xingyi City, Qiannan Buyei and Miao Autonomous Prefecture, Guizhou Province6

postal code：562400

tel：0859-3119928

fax：0859-3118152

Website: www.gztiandi.com