Zolmitriptan Tablets

Zolmitriptan is a selective 5-HT1B/1D receptor agonist. It stimulates 5-HT1B/1D receptors on intracranial blood vessels (including arteriovenous anastomoses) and sympathetic nerves of the trigeminal nervous system, causing intracranial vasoconstriction and inhibiting the release of pro-inflammatory neuropeptides. It is used to treat headaches with or without aura in adults.

(S)-4-{[3-[2-(Dimethylamino)ethyl]-1H-indol-5-yl]methyl}-2-oxazolidin-2-one.

This product is a film-coated tablet, which appears white or off-white after removing the coating.

Indicated for the acute treatment of migraine with or without aura.

The recommended dose for treating migraine attacks is 2.5 mg (half a tablet). If symptoms persist or recur within 24 hours, taking the drug again will still be effective. If a second dose is required, the time should be at least 2 hours apart from the first dose. If the headache is not relieved satisfactorily after taking 2.5 mg (half a tablet) of this product, 5 mg (1 tablet) can be used in subsequent attacks. The effect is usually most obvious within 1 hour of taking the medicine. No matter when you take this product during a migraine attack, it is equally effective. It is recommended to take it as soon as possible after the onset of the disease. In case of recurrent attacks, it is recommended to take no more than 15 mg (3 tablets) in total within 24 hours. This product is not used as a preventive drug for migraine. Patients with renal impairment do not need to adjust the dose when using this product.

This product is well tolerated. Adverse reactions are mild/mild, transient, and resolve spontaneously without treatment. Possible adverse reactions often occur within 4 hours of taking the drug and do not increase with continued use. The most common adverse reactions include: occasional nausea, dizziness, drowsiness, warmth, weakness, and dry mouth. Paresthesias or sensory disturbances have been reported. Heaviness, tightness, and pressure may occur in the throat, neck, limbs, and chest (with no evidence of ischemic changes on the electrocardiogram), as well as myalgia and muscle weakness.

It is contraindicated for patients who are allergic to any of the ingredients in this product. It should not be used by patients with uncontrolled blood pressure.

Precautions for children: This experiment has not been conducted and there are no reliable references. Precautions for pregnancy and lactation: There are currently no studies on the use of this product in pregnant women. This product should only be considered for use when the benefit to the mother outweighs the potential risk to the fetus. Mammalian studies have shown that zolmitriptan can enter breast milk, but there is no data on human use. Therefore, breastfeeding women should use it with caution. Precautions for the elderly: The safety and effectiveness of this product for patients over 65 years old have not yet been determined.

1. There is no evidence that the use of preventive migraine drugs (such as beta-blockers, oral dihydroergotamine, pizotifen) has any effect on the efficacy of this product. Acute symptomatic treatment, such as the use of paracetamol, metoclopramide and ergotamine, does not affect the pharmacokinetics and tolerance of this product. In healthy individuals, no pharmacokinetic interaction between this product and ergotamine has been seen. This product is well tolerated when used in combination with ergotamine/caffeine, and there is no increase in adverse reactions and no change in blood pressure compared to the use of this product alone. 2. Selegiline (a monoamine oxidase-B inhibitor) and fluoxetine (a selective serotonin reuptake inhibitor) have no effect on the pharmacokinetic parameters of this product. Other 5HT1D agonists should be avoided within 12 hours of treatment with this product. After using moclobemide (a specific monoamine oxidase-A inhibitor), the area under the curve of zolmitriptan increased slightly (26%), and the area under the curve of the active metabolite increased threefold. Therefore, for patients using monoamine oxidase-A inhibitors, the recommended maximum dose of this product within 24 hours is 7.5 mg. 3. When used in combination with cimetidine and oral contraceptives, the blood concentration of this product can also be increased. When used in combination with propranolol, the metabolism of this product can be delayed.

It should be stored in an environment below 30°C.

5 mg

Tentatively set at 36 months.

Shandong Newtime Pharmaceutical Co., Ltd.

• Founded in:

  2001-03-30

• Address:

  No. 1 North Outer Ring Road, Fei County, Shandong

• Tax NO.:

  9137130072755352X1

• Registered Funds:

  358.238 million yuan

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