Ergotamine mesylate sustained-release capsules

1. Pharmacological action Ergot alkaloids are a mixture of four dihydrogen derivatives of natural ergot alkaloids in equal proportions, including dihydroergocortin mesylate, dihydroergocin mesylate, dihydro-α-ergocryptine mesylate, and dihydro-β-ergocryptine mesylate. This mixture has partial agonist and/or antagonist effects on α-adrenaline, dopamine, and 5-hydroxytryptamine receptors. Administration of this product can reduce the content of homovanillic acid in dopamine metabolism, but does not reduce the content of 5-hydroxyindole (5-HIAA). Therefore, its clinical effect may be related to the dopamine-like activity of dihydroergot alkaloids that inhibits dopamine metabolism. This product can also shorten cerebral circulation time, improve brain electrical activity and metabolic activity of damaged tissues, but its mechanism is still unclear. 2. Toxicological studies (1) Genetic toxicity: The results of multiple genetic toxicity studies on ergot alkaloids were negative. (2) Reproductive toxicity: Animal experiments have found that it has a bed-inhibiting effect. Fetal death and hypoxic malformations were observed in animal experiments. Giving 1 mg of ergocornine to pregnant rats caused eye and heart defects in their fetuses. When rats were given 50 times the human dose of ergot alkaloid mesylate during pregnancy, the birth weight of the offspring was reduced. Reproductive tissues are rich in α-adrenergic receptors. In theory, taking dihydroergoline can change the activity of the reproductive tract, but there are no literature reports of adverse reactions related to this activity in experimental animals or humans.

The main ingredient of this product is dihydroergocornine mesylate, which is composed of equal amounts of dihydroergocornine mesylate, dihydroergocristine mesylate, dihydro-α-ergocryptine mesylate and dihydro-β-ergocryptine mesylate. Among them: R=CH(CH3)2 is dihydroergocornine mesylate 659.81 R=CH2C6H5 is dihydroergocristine mesylate 707.86 R=CH2CH(CH3)2 is dihydro-α-ergocryptine mesylate 673.84 R=CH(CH3)CH2CH3 is dihydro-β-ergocryptine mesylate 673.84

This product is a hard capsule, and the contents are white to off-white round particles.

Cerebral arteriosclerosis, sequelae of concussion, sequelae of stroke and senile dementia, etc.

Take 1 capsule twice daily (morning and evening) with meals, or as directed by a physician.

1. Circulatory system: bradycardia, hypotension, cerebral ischemia, flushing, excitability and palpitations may occur. 2. Allergic reactions: drug rash may occur, and itching is rare. If the above reactions occur, the drug should be discontinued. 3. Psychoneural system: headache, heaviness of the head, dizziness, insomnia, drowsiness, numbness and itching of the extremities and aggressive reactions may occur. 4. Digestive system: nausea, vomiting, constipation, abdominal pain, anorexia, dry mouth, heartburn, diarrhea and stomatitis may occur. 5. Liver: AST and ALT values may increase. 6. Others: Sometimes sensory abnormalities occur, such as tingling, stiffness and twisting of the tongue, chest discomfort, fatigue, discomfort, rare precordial pain, sweating disorders, nasal stenosis, and tinnitus.

Patients who are allergic to this product or ergot alkaloids are contraindicated.

Precautions for children: It is not recommended for children to take this drug (there is almost no clinical experience of safety in children). Precautions for pregnancy and lactation: - It is not recommended for pregnant and pregnant women to take this drug because their safety has not been determined. - This drug may inhibit milk secretion and is not recommended for breastfeeding women. Precautions for the elderly: Due to the high blood drug concentration in the elderly in pharmacokinetic studies, it is recommended to adjust the dosage for the elderly or follow the doctor's advice.

- Taking anticoagulants and antihypertensive drugs may increase the activity of this product. - Taking other ergot alkaloids may aggravate adverse reactions.

Keep tightly closed.

2.5 mg

Tentative 24 months