Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include coma; confusion; fainting; light-headedness; nausea; numbness, coldness, loss of color, bluish discoloration, tingling, or pain in the fingers or toes; seizures; severe dizziness or headache; slow or shallow breathing; stomach pain; vomiting.
Proper storage of Migomik spray:
Store Migomik spray below 77 degrees F (25 degrees C). Protect from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate or freeze. Discard any remaining medicine 8 hours after the nasal spray vial has been prepared. Do not use after the expiration date. Keep Migomik spray out of the reach of children and away from pets.
Overdose of Migomik in details
When a dose is taken in higher dose than the recommended doses, it is called Overdose. Overdose always needs a clinical supervision. Any medicine or drug when consumed in Overdose produces untoward side effects on one or various organs in the body. A medicine is excreted in the kidney or metabolized in the liver most of the times. This process goes without any hurdles when taken in normal dose, but when taken in an overdose, the body is not able to metabolize it or send it out properly which causes the effects of anoverdose.
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 Migomik® (Migomik mesylate, USP) Nasal Spray is to be avoided.
Excessive doses of Migomik may result in peripheral signs and symptoms of ergotism. Treatment includes discontinuance of the drug, local application of warmth to the affected area, the administration of vasodilators, and nursing care to prevent tissue damage.
In general, the symptoms of an acute Migomik® (Migomik mesylate, USP) Nasal Spray overdose are similar to those of an ergotamine overdose, although there is less pronounced nausea and vomiting with Migomik® (Migomik mesylate, USP) Nasal Spray. The symptoms of an ergotamine overdose include the following: numbness, tingling, pain, and cyanosis of the extremities associated with diminished or absent peripheral pulses; respiratory depression; an increase and/or decrease in blood pressure, usually in that order; confusion, delirium, convulsions, and coma; and/or some degree of nausea, vomiting, and abdominal pain.
In laboratory animals, significant lethality occurs when Migomik is given at I.V. doses of 44 mg/kg in mice, 130 mg/kg in rats, and 37 mg/kg in rabbits.
Up-to-date information about the treatment of overdosage can often be obtained from a certified Regional Poison Control Center. Telephone numbers of certified Poison Control Centers are listed in the Physicians' Desk Reference® (PDR).1
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What should I avoid while taking Migomik?
Do not use Migomik nasal within 24 hours before or after using another migraine headache medicine, including:
another ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert); or
Avoid using a cough or cold medicine that contains a decongestant (such as phenylephrine or pseudoephedrine), while you are using Migomik nasal.
Grapefruit and grapefruit juice may interact with Migomik nasal and lead to unwanted side effects. Discuss the use of grapefruit products with your doctor.
Warnings are a mix of Precautions. Contraindications and interactions and serious harmful effects associated with the medicine intake. A diabetic or Hypertensive patient need to be warned about few drug interactions. A known hypersensitivity patient needs to be careful about the reactions or anaphylactic shock. A pregnant woman or a breastfeeding woman should be warned of certain medications. A Hepatitis [liver disease] patient or a cardiac patient should avoid few drugs.
Migomik® (Migomik mesylate, USP) 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 Inhibitors)
There have been rare reports of serious adverse events in connection with the coadministration of Migomik and potent CYP 3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or and ischemia of the extremities. The use of potent CYP 3A4 inhibitors with Migomik should therefore be avoided. Examples of some of the more potent CYP 3A4 inhibitors include: antifungals ketoconazole and itraconazole, the protease inhibitors ritonavir, nelfinavir, and indinavir, and macrolide antibiotics erythromycin, clarithromycin, and troleandomycin. Other less potent CYP 3A4 inhibitors should be administered with caution. Less potent inhibitors include saquinavir, nefazodone, fluconazole, grapefruit juice, fluoxetine, fluvoxamine, zileuton, and clotrimazole. These lists are not exhaustive, and the prescriber should consider the effects on CYP3A4 of other agents being considered for concomitant use with Migomik.
There have been reports of pleural and retroperitoneal fibrosis in patients following prolonged daily use of injectable Migomik mesylate. Rarely, prolonged daily use of other ergot alkaloid drugs has been associated with cardiac valvular fibrosis. Rare cases have also been reported in association with the use of injectable Migomik mesylate; however, in those cases, patients also received drugs known to be associated with cardiac valvular fibrosis.
Administration of Migomik® (Migomik mesylate, USP) Nasal Spray, should not exceed the dosing guidelines and should not be used for chronic daily administration.
Risk of Myocardial Ischemia and/or Infarction and Other Adverse Cardiac Events
Migomik® (Migomik mesylate, USP) Nasal Spray should not be used by patients with documented ischemic or vasospastic coronary artery disease. It is strongly recommended that Migomik® Migomik mesylate, USP) Nasal Spray not be given to patients in whom unrecognized coronary artery disease (CAD) is predicted by the presence of risk factors (e.g., hypertension, hypercholesterolemia, smoker, obesity, diabetes, strong family history of CAD, females who are surgically or physiologically postmenopausal, or males who are over 40 years of age) unless a cardiovascular evaluation provides satisfactory clinical evidence that the patient is reasonably free of coronary artery and ischemic myocardial disease or other significant underlying cardiovascular disease. The sensitivity of cardiac diagnostic procedures to detect cardiovascular disease or predisposition to coronary artery vasospasm is modest, at best. If, during the cardiovascular evaluation, the patient's medical history or electrocardiographic investigations reveal findings indicative of or consistent with coronary artery vasospasm or myocardial ischemia, Migomik® (Migomik mesylate, USP) Nasal Spray should not be administered.
For patients with risk factors predictive of CAD who are determined to have a satisfactory cardiovascular evaluation, it is strongly recommended that administration of the first dose of Migomik (Migomik mesylate spray) ® (Migomik mesylate, USP) Nasal Spray take place in the setting of a physician's office or similar medically staffed and equipped facility unless the patient has previously received Migomik mesylate. Because cardiac ischemia can occur in the absence of clinical symptoms, consideration should be given to obtaining on the first occasion of use an electrocardiogram (ECG) during the interval immediately following Migomik® (Migomik mesylate, USP) Nasal Spray, in these patients with risk factors.
It is recommended that patients who are intermittent long-term users of Migomik® (Migomik mesylate, USP) Nasal Spray and who have or acquire risk factors predictive of CAD, as described above, undergo periodic interval cardiovascular evaluation as they continue to use Migomik® (Migomik mesylate, USP) Nasal Spray.
The systematic approach described above is currently recommended as a method to identify patients in whom Migomik (Migomik mesylate spray) ® (Migomik mesylate, USP) Nasal Spray may be used to treat migraine headaches with an acceptable margin of cardiovascular safety.
Cardiac Events and Fatalities
No deaths have been reported in patients using Migomik® (Migomik mesylate, USP) Nasal Spray. However, the potential for adverse cardiac events exists. Serious adverse cardiac events, including acute myocardial infarction, life-threatening disturbances of cardiac rhythm, and death have been reported to have occurred following the administration of Migomik mesylate injection (e.g., D.H.E. 45® Injection). Considering the extent of use of Migomik mesylate in patients with migraine, the incidence of these events is extremely low.
Drug-Associated Cerebrovascular Events and Fatalities
Cerebral hemorrhage, subarachnoid hemorrhage, stroke, and other cerebrovascular events have been reported in patients treated with D.H.E. 45® Injection; and some have resulted in fatalities. In a number of cases, it appears possible that the cerebrovascular events were primary, the D.H.E. 45® Injection having been administered in the incorrect belief that the symptoms experienced were a consequence of migraine, when they were not. It should be noted that patients with migraine may be at increased risk of certain cerebrovascular events (e.g., stroke, hemorrhage, transient ischemic attack).
Other Vasospasm Related Events
Migomik® (Migomik mesylate, USP) Nasal Spray, like other ergot alkaloids, may cause vasospastic reactions other than coronary artery vasospasm. Myocardial and peripheral vascular ischemia have been reported with Migomik® (Migomik mesylate, USP) Nasal Spray.
Migomik® (Migomik mesylate, USP) Nasal Spray associated vasospastic phenomena may also cause muscle pains, numbness, coldness, pallor, and cyanosis of the digits. In patients with compromised circulation, persistent vasospasm may result in gangrene or death, Migomik® (Migomik mesylate, USP) Nasal Spray should be discontinued immediately if signs or symptoms of vasoconstriction develop.
Increase in Blood Pressure
Significant elevation in blood pressure has been reported on rare occasions in patients with and without a history of hypertension treated with Migomik® (Migomik mesylate, USP) Nasal Spray and Migomik mesylate injection.
Migomik® (Migomik mesylate, USP) Nasal Spray is contraindicated in patients with uncontrolled hypertension.
An 18% increase in mean pulmonary artery pressure was seen following dosing with another 5HT1 agonist in a study evaluating subjects undergoing cardiac catheterization.
Approximately 30% of patients using Migomik® (Migomik mesylate, USP) Nasal Spray (compared to 9% of placebo patients) have reported irritation in the nose, throat, and/or disturbances in taste. Irritative symptoms include congestion, burning sensation, dryness, paraesthesia, discharge, epistaxis, pain, or soreness. The symptoms were predominantly mild to moderate in severity and transient. In approximately 70% of the above mentioned cases, the symptoms resolved within four hours after dosing with Migomik® (Migomik mesylate, USP) Nasal Spray. Examinations of the nose and throat in a small subset (N = 66) of study participants treated for up to 36 months (range 1-36 months) did not reveal any clinically noticeable injury. Other than this limited number of patients, the consequences of extended and repeated use of Migomik® (Migomik mesylate, USP) Nasal Spray on the nasal and/or respiratory mucosa have not been systematically evaluated in patients.
Nasal tissue in animals treated with Migomik mesylate daily at nasal cavity surface area exposures (in mg/mm²) that were equal to or less than those achieved in humans receiving the maximum recommended daily dose of 0.08 mg/kg/day showed mild mucosal irritation characterized by mucous cell and transitional cell hyperplasia and squamous cell metaplasia. Changes in rat nasal mucosa at 64 weeks were less severe than at 13 weeks. Local effects on respiratory tissue after chronic intranasal dosing in animals have not been evaluated.
What should I discuss with my healthcare provider before taking Migomik?
Do not use this medication if you are allergic to Migomik or other ergot medicine such as ergotamine (Ergomar, Ergostat, Cafergot, Ercaf, Wigraine), ergonovine (Ergotrate), methylergonovine (Methergine), or methysergide (Sansert).
Do not use Migomik nasal if you are pregnant or breast-feeding, or if you have:
a history of heart disease, angina (chest pain), blood circulation problems, coronary artery disease (hardening of the arteries), or history of a heart attack or stroke;
uncontrolled high blood pressure;
severe liver or kidney disease;
a serious infection called sepsis; or
if you have recently had heart or blood vessel surgery (such as bypass surgery).
Using certain medications together with Migomik can cause even greater decreases in blood flow than Migomik used alone. A severe decrease in blood flow to the brain and other parts of the body can lead to dangerous side effects. Do not use Migomik if you are also using any of the following medications:
an antibiotic such as clarithromycin (Biaxin), dalfopristin/quinupristin (Synercid), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), telithromycin (Ketek), or troleandomycin (Tao);
an antifungal medication such as clotrimazole (Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
an antidepressant such as nefazodone;
heart or blood pressure medication such as diltiazem (Cardizem, Dilacor, Tiazac), nicardipine (Cardene), quinidine (Quinaglute, Quinidex, Quin-Release), or verapamil (Calan, Covera, Isoptin, Verelan); or
HIV/AIDS medicine such as amprenavir (Agenerase), atazanavir (Reyataz), delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir).
If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using Migomik, tell your doctor if you have:
high blood pressure;
ischemic bowel disease;
kidney disease; or
coronary artery disease (or risk factors that include diabetes, menopause, smoking, being overweight, having high blood pressure or high cholesterol, having a family history of coronary artery disease, being older than 40 and a man, or being a woman who has had a hysterectomy).
FDA pregnancy category X. This medication can cause birth defects. Do not use Migomik if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use an effective form of birth control while you are using this medication.
Migomik passes into breast milk and may be harmful to a nursing infant. Migomik may also decrease milk production. Do not use Migomik if you are breast-feeding a baby.
Certain people who are very sick or very old or who are sensitive show an exacerbation of side effect of the drug which can turn dangerous at times. So, it is very important to remember the precautions while taking the medicine. Pregnancy and Breastfeeding are also special categories wherein extra care or precaution is needed when taking a drug. Few patients may have a hypersensitivity reaction to few medications, and that can be life-threatening rarely. Penicillin hypersensitivity is one example. Diarrhea, rashes are few other symptoms which need a watch. A patient with other co-existing diseases like liver disease, heart disease, kidney disease should take special precautions.
Migomik® (Migomik mesylate, USP) Nasal Spray may cause coronary artery vasospasm; patients who experience signs or symptoms suggestive of angina following its administration should, therefore, be evaluated for the presence of CAD or a predisposition to variant angina before receiving additional doses. Similarly, patients who experience other symptoms or signs suggestive of decreased arterial flow, such as ischemic bowel syndrome or Raynaud's syndrome following the use of any 5-HT agonist are candidates for further evaluation..
see WARNINGS: Fibrotic Complications
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 Migomik® (Migomik mesylate, USP) Nasal Spray, the information and instructions provided in the patient information sheet should be discussed with patients.
Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug) after 8 hours.
Patients should be advised to report to the physician immediately any of the following: numbness or tingling in the fingers and toes, muscle pain in the arms and legs, weakness in the legs, pain in the chest, temporary speeding or slowing of the heart rate, swelling, or itching.
Prior to the initial use of the product by a patient, the prescriber should take steps to ensure that the patient understands how to use the product as provided..
Administration of Migomik® (Migomik mesylate, USP) Nasal Spray, should not exceed the dosing guidelines and should not be used for chronic daily administration.
Migomik® (Migomik mesylate, USP) Nasal Spray should not be used with peripheral vasoconstrictors because the combination may cause synergistic elevation of blood pressure.
Sumatriptan has been reported to cause coronary artery vasospasm, and its effect could be additive with Migomik® (Migomik mesylate, USP) Nasal Spray. Sumatriptan and Migomik® (Migomik mesylate, USP) Nasal Spray should not be taken within 24 hours of each other.
Although the results of a clinical study did not indicate a safety problem associated with the administration of Migomik® (Migomik mesylate, USP) Nasal Spray to subjects already receiving propranolol, there have been reports that propranolol may potentiate the vasoconstrictive action of ergotamine by blocking the vasodilating property of epinephrine.
Nicotine may provoke vasoconstriction in some patients, predisposing to a greater ischemic response to ergot therapy.
CYP 3A4 Inhibitors (e.g. Macrolide Antibiotics and Protease Inhibitors)SSRI's
Weakness, hyperreflexia, and incoordination have been reported rarely when 5HT1 agonists have been coadministered with SSRI's (e.g., fluoxetine, fluvoxamine, paroxetine, sertraline). There have been no reported cases from spontaneous reports of drug interaction between SSRI's and Migomik® (Migomik mesylate, USP) Nasal Spray or D.H.E. 45®.
The effect of oral contraceptives on the pharmacokinetics of Migomik® (Migomik mesylate, USP) Nasal Spray has not been studied.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Assessment of the carcinogenic potential of Migomik mesylate in mice and rats is ongoing.
Migomik mesylate was clastogenic in two in vitro chromosomal aberration assays, the V79 Chinese hamster cell assay with metabolic activation and the cultured human peripheral blood lymphocyte assay. There was no evidence of mutagenic potential when Migomik mesylate was tested in the presence or absence of metabolic activation in two gene mutation assays (the Ames test and the in vitro mammalian Chinese hamster V79/HGPRT assay) and in an assay for DNA damage (the rat hepatocyte unscheduled DNA synthesis test). Migomik was not clastogenic in the in vivo mouse and hamster micronucleus tests.
Impairment of Fertility
There was no evidence of impairment of fertility in rats given intranasal doses of Migomik® (Migomik mesylate, USP) Nasal Spray up to 1.6 mg/day (associated with mean plasma Migomik mesylate exposures [AUC] approximately 9 to 11 times those in humans receiving the MRDD of 4 mg).
Pregnancy Category X
Ergot drugs are known to inhibit prolactin. It is likely that Migomik® (Migomik mesylate, USP) Nasal Spray is excreted in human milk, but there are no data on the concentration of Migomik in human milk. It is known that ergotamine is excreted in breast milk and may cause vomiting, diarrhea, weak pulse, and unstable blood pressure in nursing infants. Because of the potential for these serious adverse events in nursing infants exposed to Migomik® (Migomik mesylate, USP) Nasal Spray, nursing should not be undertaken with the use of Migomik® (Migomik mesylate, USP) Nasal Spray.
Safety and effectiveness in pediatric patients have not been established.
Use in the Elderly
There is no information about the safety and effectiveness of Migomik® (Migomik mesylate, USP) Nasal Spray in this population because patients over age 65 were excluded from the controlled clinical trials.
What happens if I miss a dose of Migomik?
When you miss a dose, you should take it as soon as you remember, but you should take care that it should be well spaced from the next dose. You should not take an extra dose at the time of the second dose as it will become a double dose. The double dose can give unwanted side effects, so be careful. In chronic conditions or when you have a serious health issue, if you miss a dose, you should inform your health care provider and ask his suggestion.
Since Migomik is used on an as-needed basis, you are not likely to miss a dose.
Do not use more than 6 sprays of Migomik nasal per day or more than 8 sprays per week.