Amotriptan is a selective 5-hydroxytryptamine 1B/1D1B/1D receptor agonist, belonging to the triptan class of drugs, used for acute treatment of migraine attacks.

1、 Drug name

1. Product Name: AXERT ®

2. Common name: Amotriptan (Amotriptan malate) tablets

2、 Indications

This product is suitable for:

1. Acute treatment of migraine attacks in adults with or without premonitory symptoms.

2. Acute headache treatment for adolescents aged 12 to 17 with or without migraine attacks (usually lasting 4 hours or more without treatment).

3. Important restriction: Must be used after a clear diagnosis of migraine; Not used for preventive treatment of migraine; Not used for treating cluster headache; Not used for hemiplegic or basal migraine.

3、 Specifications and characteristics

1. Specification: 12.5mg tablets.

2. Appearance: White, coated, round, double convex tablets.

12.5mg tablets: printed with blue floral body "A".

4、 Main components

Active ingredient: Almotriptanmalate.

5、 Usage and dosage

1. Adults and adolescents aged 12-17: The recommended single dose is 6.25mg or 12.5mg (12.5mg may be more effective for adults). If the headache recurs after relief, it can be repeated 2 hours after the first administration. The maximum daily dose should not exceed 25mg.

2. Usage: Oral, can be taken with food or on an empty stomach. Tablets should be swallowed whole.

6、 Dose adjustment

1. Liver injury: The initial dose is 6.25mg, and the maximum dose within 24 hours should not exceed 12.5mg.

2. Renal injury: The initial dose for patients with severe renal injury is 6.25mg, and the maximum dose within 24 hours should not exceed 12.5mg.

3. Combination therapy with potent CYP3A4 inhibitors: The recommended starting dose is 6.25mg, and the maximum dose within 24 hours should not exceed 12.5mg. Combination therapy should be avoided for patients with liver and kidney dysfunction.

7、 Medication precautions

1. Meal/fasting: can be taken with food or on an empty stomach.

2. Repeat medication: If the headache recurs, it can be repeated 2 hours after the first dose. If the first dose is ineffective, it is not recommended to self administer and consult a doctor.

3. Omission handling: This product is taken on demand and does not require daily medication. If you forget to take it during a migraine attack, you should take it as soon as possible after discovery, but pay attention to the interval between the next dose and the maximum daily dose limit.

4. Vomiting: If vomiting occurs shortly after taking medication, an additional dose may be necessary, but a doctor should be consulted. If vomiting occurs after taking the medication for more than 2 hours, there is usually no need to take it again.

8、 Medication for special populations

1. Pregnancy: Animal studies have shown embryonic toxicity and fetal development effects. Use only when potential benefits prove reasonable for the fetus.

2. Breastfeeding: It is not yet clear whether it is secreted through human milk. In animal experiments, the drug concentration in breast milk is higher than that in plasma. Breastfeeding women should use it with caution.

3. Children: The safety and effectiveness of children under 12 years old have not yet been determined. The safety of adolescents aged 12 to 17 is similar to that of adults.

4. Elderly individuals: Due to insufficient clinical data, medication should be taken with caution, usually starting from 6.25mg.

9、 Adverse reactions

1. The most common adverse reactions in adults (with an incidence rate of not less than 1% and higher than placebo) are nausea, dry mouth, and sensory abnormalities.

2. The most common adverse reactions among adolescents (with an incidence rate of not less than 1%) are dizziness, drowsiness, headache, abnormal sensation, nausea, and vomiting.

3. Serious adverse reactions:

Cardiac events: myocardial ischemia, myocardial infarction, coronary artery spasm, arrhythmia. Patients with cardiovascular risk factors should take medication for the first time under the supervision of a doctor.

Cerebrovascular events: cerebral hemorrhage, stroke (including fatal).

Vasospasm related events: peripheral vascular ischemia, colon ischemia (manifested as abdominal pain and bloody diarrhea).

Serotonin syndrome: may occur when combined with selective serotonin reuptake inhibitors or serotonin norepinephrine reuptake inhibitors (manifested as agitation, hallucinations, tachycardia, blood pressure instability, high fever, hyperreflexia, etc.).

Drug overdose headache: Taking medication for more than 10 days per month may worsen the headache.

Elevated blood pressure: rare but may lead to serious clinical events.

10、 Contraindications

1. Ischemic heart disease, coronary artery spasm, or other significant underlying cardiovascular diseases.

2. Cerebrovascular syndrome (such as a history of stroke or transient ischemic attack).

3. Peripheral vascular diseases (including ischemic bowel disease).

4. Uncontrolled hypertension.

5. Used ergotamine or ergotamine containing drugs, or other serotonin 1 receptor agonists (such as another triptan) within 24 hours.

6. Hemiplegic or basal migraine.

7. Known to be allergic to amotriptan or any excipients.

11、 Drug interactions

1. Contains ergotamine or ergot drugs: Do not use them together within 24 hours as there is a theoretical risk of prolonging vasospasm reactions.

2. Other 5-hydroxytryptamine 1 receptor agonists (triptans): co administration within 24 hours is prohibited.

3. Selective serotonin reuptake inhibitors/serotonin norepinephrine reuptake inhibitors: may increase the risk of serotonin syndrome and require close monitoring.

4. Strong CYP3A4 inhibitors (such as ketoconazole, itraconazole, ritonavir): can significantly increase exposure to amotriptan and require dose adjustment (see dose adjustment section).

12、 Storage method

1. Store at room temperature of 25 ° C (77 ° F); Allow brief fluctuations to 15 ° C to 30 ° C (59 ° F to 86 ° F).

2. Keep out of reach of children.

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