"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
(Generic versions may still be available.)
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.
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fibrosis, and vascular shutdown have shown a high incidence of regression once Sansert® (methysergide maleate) is withdrawn.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) 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.
INFORMATION FOR PATIENTS
Sansert® (methysergide maleate) is intended for use as a preventive agent in the treatment of vascular headaches. It should not be used for acute migraine attacks. If, after a 3-week trial period, Sansert® (methysergide maleate) has not been effective in decreasing the frequency or intensity of headaches, it is unlikely that longer administration of Sansert® (methysergide maleate) will be beneficial.
Patients should be advised to report the following symptoms immediately 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. There must be a drug-free interval of 3-4 weeks after each 6-month course of treatment.
Sansert® (methysergide maleate) should be taken with meals. Weight gain may necessitate modification of diet.
Pregnancy Category X
Sansert® (methysergide maleate) is contraindicated in pregnancy due to its oxytocic actions.
There are no specific studies on the use of Sansert® (methysergide maleate) in nursing mothers. Ergot alkaloids, in general, appear in mothers milk.
Sansert® (methysergide maleate) is a semi-synthetic compound structurally related to ergotamine, and thus it may appear in breast milk. Ergot alkaloids have been reported to cause nausea, vomiting, diarrhea and weakness in the nursing infant and suppression of prolactin secretion and lactation in the mother.
Because of the potential for serious adverse reactions in nursing infants from Sansert® (methysergide maleate), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and effectiveness in pediatric patients have not been established.
Last reviewed on RxList: 1/14/2005
This monograph has been modified to include the generic and brand name in many instances.
Additional Sansert Information
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