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Sansert

"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"...

Sansert

Discontinued Warning IconPlease Note: This Brand Name drug is no longer available in the US.
(Generic versions may still be available.)

INDICATIONS

For the prevention or reduction of intensity and frequency of vascular headaches in the following kinds of patients:

1. Patients suffering from one or more severe vascular headaches per week.

2. Patients suffering from vascular headaches that are uncontrollable or so severe that preventive therapy is indicated regardless of the frequency of the attack.

DOSAGE AND ADMINISTRATION

Usual adult dose 4-8 mg daily. Tablets to be given with meals.

Note: There must be a medication-free interval of 3-4 weeks after every 6-month course of treatment. (See WARNINGS) No pediatric dosage has been established.

If, after a 3-week trial period, efficacy has not been demonstrated, longer administration of Sansert® (methysergide maleate) is unlikely to be of benefit.

HOW SUPPLIED

Sansert® (methysergide maleate) tablets, USP Tablets 2 mg

Bright yellow, coated tablets with "SANDOZ" imprinted on one side, "78-58" imprinted on the other side, in black.

Bottle of 100.....................................................NDC 0078-0058-05

Store and Dispense

Below 86°F (30°C); tight container.

ANIMAL PHARMACOLOGY AND TOXICOLOGY

Serotonin Antagonism

Considering structure/effect relationships, it has been demonstrated that methylation of the indole nitrogen in the lysergic acid ring of the alkanolamides fundamentally alters their pharmacologic behavior and is associated with inhibition or blockade of a great variety of serotonin-induced effects:

1. Methysergide maleate is 6 times more active than methylergonovine maleate in antagonizing the effect of serotonin on the rat uterus in vitro.

2. Greater inhibition of the serotonin-induced edema in the rats paw is revealed by the ED50 of 12.9 µg/kg for methysergide maleate as against 37.4 µg/kg for methylergonovine maleate

3. The more complex effects of serotonin on the cardiovascular system are equally subject to inhibition by methysergide maleate as is evident from the subsequent record of various circulatory parameters in the dog before and after administration of 10 µg/kg.



Acute Toxicity

 

LD50 in mg/kg

 

Mice

Rabbits

Rats

Compound

i.v.

oral

i.v.

i.v.

oral

Methysergide maleate

185

581

28

125

2100

methylergonovine maleate

85

187

2.6

23

93

Chronic Toxicity

Rats

Daily Oral Doses mg/kg

No. of Weeks Animals Tested

Mortality

5

50

4/16

20

50

2/16

50

50

2/16

150

17

8/30

450

17

17/30

Control

50

1/16

Dogs

Oral administration of 1, 2, and 5 mg/kg/day of methysergide maleate failed to produce any major signs of toxicity over a period of 6 months.

*Trademark of Medical Economics Company, Inc.

Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936,

REV: NOVEMBER 2000, PRINTED IN USA, T2000-69 89011201

Last reviewed on RxList: 1/14/2005
This monograph has been modified to include the generic and brand name in many instances.

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