MIGRANAL Nasal spray (2019)

Βιβλιογραφική αναφορά

Συγγραφείς

Bausch Health US, LLC

Λέξεις κλειδιά

0187-0245

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1. Description

MIGRANAL is ergotamine hydrogenated in the 9,10 position as the mesylate salt. MIGRANAL is known chemically as ergotaman-3', 6', 18-trione, 9,10-dihydro-12'-hydroxy-2'-methyl-5'- (phenylmethyl), (5'α) ...

2. Clinical Pharmacology

Mechanism of Action Dihydroergotamine binds with high affinity to 5-HT1Dα and 5-HT1Dβ receptors. It also binds with high affinity to serotonin 5-HT1A, 5-HT2A ...

3. Indications and Usage

MIGRANAL (dihydroergotamine mesylate) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura. MIGRANAL (dihydroergotamine mesylate) Nasal Spray is not intended for ...

4. Contraindications

There have been a few reports of serious adverse events associated with the coadministration of dihydroergotamine and potent CYP 3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, ...

5. Warnings

MIGRANAL (dihydroergotamine mesylate) Nasal Spray should only be used where a clear diagnosis of migraine headache has been established. CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease ...

6.1. General

MIGRANAL (dihydroergotamine mesylate) Nasal Spray may cause coronary artery vasospasm; patients who experience signs or symptoms suggestive of angina following its administration should, therefore, be ...

6.2. Information for Patients

The text of a patient information sheet is printed at the end of this insert. To assure safe and effective use of MIGRANAL (dihydroergotamine mesylate) Nasal Spray, the information and instructions provided ...

6.4. Drug Interactions

Vasoconstrictors MIGRANAL (dihydroergotamine mesylate) Nasal Spray should not be used with peripheral vasoconstrictors because the combination may cause synergistic elevation of blood pressure. Sumatriptan ...

6.6. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis Assessment of the carcinogenic potential of dihydroergotamine mesylate in mice and rats is ongoing. Mutagenesis Dihydroergotamine mesylate was clastogenic in two in vitro chromosomal aberration ...

6.7. Pregnancy

See CONTRAINDICATIONS.

6.9. Nursing Mothers

Ergot drugs are known to inhibit prolactin. It is likely that MIGRANAL (dihydroergotamine mesylate) Nasal Spray is excreted in human milk, but there are no data on the concentration of dihydroergotamine ...

6.10. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

6.11. Geriatric Use

There is no information about the safety and effectiveness of MIGRANAL (dihydroergotamine mesylate) Nasal Spray in this population because patients over age 65 were excluded from the controlled clinical ...

7. Adverse Reactions

During clinical studies and the foreign postmarketing experience with MIGRANAL (dihydroergotamine mesylate) Nasal Spray there have been no fatalities due to cardiac events. Serious cardiac events, ...

8. Drug Abuse and Dependence

Currently available data have not demonstrated drug abuse or psychological dependence with dihydroergotamine. However, cases of drug abuse and psychological dependence in patients on other forms of ergot ...

9. Overdosage

To date, there have been no reports of acute overdosage with this drug. Due to the risk of vascular spasm, exceeding the recommended dosages of MIGRANAL (dihydroergotamine mesylate) Nasal Spray is to be ...

10. Dosage and Administration

The solution used in MIGRANAL (dihydroergotamine mesylate) Nasal Spray (4 mg/mL) is intended for intranasal use and must not be injected. In clinical trials, MIGRANAL (dihydroergotamine mesylate) ...

11. How Supplied

MIGRANAL (dihydroergotamine mesylate) Nasal Spray is available (as a clear, colorless to light yellow aqueous solution) in 3.5 mL amber glass vials containing 4 mg of dihydroergotamine mesylate. MIGRANAL ...

12. Storage and Handling

Store below 25°C (77°F). Do not refrigerate or freeze.

BOXED WARNING SECTION

Serious and/or life-threatening peripheral ischemia has been associated with the coadministration of DIHYDROERGOTAMINE with potent CYP 3A4 inhibitors including protease inhibitors and macrolide antibiotics. ...