Methysergide warnings and precautions

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Methysergide
SANSERT® FDA Package Insert
Indications and Usage
Dosage and Administration
Contraindications
Warnings and Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Overdosage
Description
Clinical Pharmacology
Nonclinical Toxicology
How Supplied/Storage and Handling
Patient Counseling Information
Clinical Trials on Methysergide
ClinicalTrials.gov

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

Warnings

With long-term, uninterrupted administration, retroperitoneal fibrosis or related conditions — pleuropulmonary fibrosis and cardiovascular disorders with murmurs or vascular bruits have been reported. Patients must be warned to report immediately the following symptoms and to discontinue the drug: cold, numb, and painful hands and feet; leg cramps on walking; any type of girdle, flank, or chest pain, shortness of breath, or any associated symptomatology. Should any of these symptoms develop, methysergide should be discontinued.

Continuous administration should not exceed 6 months. There must be a drug-free interval of 3-4 weeks after each 6-month course of treatment. The dosage should be reduced gradually during the last 2-3 weeks of each treatment course to avoid “headache rebound.”

The drug is not recommended for use in children.

Precautions

General

All patients receiving Sansert® (methysergide maleate) should remain under constant supervision of the physician and be examined regularly for the development of fibrotic or vascular complications. (See ADVERSE REACTIONS)

The manifestations of retroperitoneal fibrosis, pleuropulmonary fibrosis, and vascular shutdown have shown a high incidence of regression once Sansert® (methysergide maleate) is withdrawn. These facts should be borne in mind to avoid unnecessary surgical intervention. Cardiac murmurs, which may indicate endocardial fibrosis, have shown varying degrees of regression, with complete disappearance in some and persistence in others.

Sansert® (methysergide maleate) has been specifically designed for the prophylaxis of vascular headache and has no place in the management of the acute attack.

Sansert® (methysergide maleate) tablets contain FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible individuals. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.[1]

References

  1. "SANSERT (METHYSERGIDE MALEATE) TABLET, COATED [NOVARTIS PHARMACEUTICALS CORPORATION]".

Adapted from the FDA Package Insert.