Migranal Spray Uses

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What is Migranal Spray?

Migranal Spray is in a group of drugs called ergot alkaloids (ER-got AL-ka-loids). It works by narrowing the blood vessels around the brain and affects blood flow patterns that are associated with certain types of headaches.

Migranal Spray injection is used to treat a migraine or cluster headache attack. This medication will only treat a headache that has already begun. It will not prevent headaches or reduce the number of attacks.

Migranal Spray injection should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches. Migranal Spray is not for daily use.

Migranal Spray injection may also be used for purposes not listed in this medication guide.

Migranal Spray indications

An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray is not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

How should I use Migranal Spray?

An extra patient leaflet is available with Migranal Spray spray. Talk to your pharmacist if you have questions about this information.

Ask your health care provider any questions you may have about how to use Migranal Spray spray.

Uses of Migranal Spray in details

There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
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Use: Labeled Indications

Cluster headaches (injection): Acute treatment of cluster headaches.

Migraines (intranasal; injection): Acute treatment of migraine headaches with or without aura; not intended for the prophylactic therapy of migraine or for the management of hemiplegic or basilar migraine.

Off Label Uses

Medication-overuse headache or intractable migraine headache (status migrainosus)

Data from nonblinded, nonrandomized descriptive and observational trials suggest that Migranal Spray may be beneficial for the treatment of medication-overuse headache or intractable migraine headache. Additional data may be necessary to further define the role of Migranal Spray in this condition. Optimal dosing has not been established nor has the optimal treatment for this condition been established.

Migranal Spray description

A 9,10alpha-dihydro derivative of ergotamine. It is used as a vasoconstrictor, specifically for the therapy of migraine disorders. [PubChem]

Migranal Spray dosage

The solution used in Migranal Spray (Migranal Spray mesylate spray) ® (Migranal Spray mesylate, USP) Nasal Spray (4 mg/mL) is intended for intranasal use and must not be injected.

In clinical trials, Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray has been effective for the acute treatment of migraine headaches with or without aura. One spray (0.5 mg) of Migranal Spray (Migranal Spray mesylate spray) ® (Migranal Spray mesylate, USP) Nasal Spray should be administered in each nostril. Fifteen minutes later, an additional one spray (0.5 mg) of Migranal Spray (Migranal Spray mesylate spray) ® (Migranal Spray mesylate, USP) Nasal Spray should be administered in each nostril, for a total dosage of four sprays (2.0 mg) of Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray. Studies have shown no additional benefit from acute doses greater than 2.0 mg for a single migraine administration. The safety of doses greater than 3.0 mg in a 24 hour period and 4.0 mg in a 7 day period has not been established.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray, should not be used for chronic daily administration. Prior to administration, the pump must be primed (i.e., squeeze 4 times) before use. Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug in opened vial ) after 8 hours.

Prior to administration, the pump must be primed (i.e., squeeze 4 times) before use.

Once the nasal spray applicator has been prepared, it should be discarded (with any remaining drug in opened vial after 8 hours).

How supplied

Migranal Spray®(Migranal Spray mesylate, USP) Nasal Spray is available (as a clear, colorless to faintly yellowsolution) in 3.5 mL amber glass vials containing 4 mg of Migranal Spray mesylate, USP.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray is provided as a package of 8 units, administration instruction sheet, and one package insert. Each unit consists of one vial and one sprayer. (NDC 0187-0245-03)

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

Manufactured by: MiPharm S.p. A, Milan, Italy. Distributed by: Valeant Pharmaceuticals North America, One Enterprise, Aliso Viejo, CA 92656. www.Migranal Spray (Migranal Spray mesylate spray).com. June 2007.

Migranal Spray interactions

See also:
What other drugs will affect Migranal Spray?

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Vasoconstrictors

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray should not be used with peripheral vasoconstrictors because the combination may cause synergistic elevation of blood pressure.

Sumatriptan

Sumatriptan has been reported to cause coronary artery vasospasm, and its effect could be additive with Migranal Spray (Migranal Spray mesylate spray) ® (Migranal Spray mesylate, USP) Nasal Spray. Sumatriptan and Migranal Spray (Migranal Spray mesylate spray) ® (Migranal Spray mesylate, USP) Nasal Spray should not be taken within 24 hours of each other.

Beta Blockers

Although the results of a clinical study did not indicate a safety problem associated with the administration of Migranal Spray (Migranal Spray mesylate spray) ® (Migranal Spray 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

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 co-administered 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 Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray or D.H.E. 45®.

Oral Contraceptives

The effect of oral contraceptives on the pharmacokinetics of Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray has not been studied.

Migranal Spray side effects

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What are the possible side effects of Migranal Spray?

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

Serious cardiac events, including some that have been fatal, have occurred following use of the parenteral form of Migranal Spray mesylate (D.H.E. 45® Injection), but are extremely rare. Events reported have included coronary artery vasospasm, transient myocardial ischemia, myocardial infarction, ventricular tachycardia, and ventricular fibrillation..

Fibrotic complications have been reported in association with long term use of injectable Migranal Spray mesylate.

Incidence in Controlled Clinical Trials

Of the 1,796 patients and subjects treated with Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray doses 2 mg or less in U.S. and foreign clinical studies, 26 (1.4%) discontinued because of adverse events. The adverse events associated with discontinuation were, in decreasing order of frequency: rhinitis 13, dizziness 2, facial edema 2, and one each due to cold sweats, accidental trauma, depression, elective surgery, somnolence, allergy, vomiting, hypotension, and paraesthesia.

The most commonly reported adverse events associated with the use of Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray during placebo-controlled, double-blind studies for the treatment of migraine headache and not reported at an equal incidence by placebo-treated patients were rhinitis, altered sense of taste, application site reactions, dizziness, nausea, and vomiting. The events cited reflect experience gained under closely monitored conditions of clinical trials in a highly selected patient population. In actual clinical practice or in other clinical trials, these frequency estimates may not apply, as the conditions of use, reporting behavior, and the kinds of patients treated may differ.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray was generally well tolerated. In most instances these events were transient and self-limited and did not result in patient discontinuation from a study. The following table summarizes the incidence rates of adverse events reported by at least 1% of patients who received Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray for the treatment of migraine headaches during placebo-controlled, double-blind clinical studies and were more frequent than in those patients receiving placebo.

Table 3: Adverse events reported by at least 1% of the Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray treated patients and occurred more frequently than in the placebo-group in the migraine placebo-controlled trials

Migranal Spray®

N=597

Placebo

N=631

Respiratory System
Rhinitis 26% 7%
Pharyngitis 3% 1%
Sinusitis 1% 1%
Gastrointestinal System
Nausea 10% 4%
Vomiting 4% 1%
Diarrhea 2% < 1%
Special Senses, Other
Altered Sense of Taste 8% 1%
Application Site
Application Site Reaction 6% 2%
Central and Peripheral Nervous System
Dizziness 4% 2%
Somnolence 3% 2%
Paraesthesia 2% 2%
Body as a Whole, General
Hot Flashes 1% < 1%
Fatigue 1% 1%
Asthenia 1% 0%
Autonomic Nervous System
Mouth Dry 1% 1%
Musculoskeletal System
Stiffness 1% < 1%

Other Adverse Events During Clinical Trials

In the paragraphs that follow, the frequencies of less commonly reported adverse clinical events are presented. Because the reports include events observed in open and uncontrolled studies, the role of Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray in their causation cannot be reliably determined. Furthermore, variability associated with adverse event reporting, the terminology used to describe adverse events, etc., limit the value of the quantitative frequency estimates provided. Event frequencies are calculated as the number of patients who used Migranal Spray (Migranal Spray mesylate spray) ® (Migranal Spray mesylate, USP) Nasal Spray in placebo-controlled trials and reported an event divided by the total number of patients (n=1796) exposed to Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray. All reported events are included except those already listed in the previous table, those too general to be informative, and those not reasonably associated with the use of the drug. Events are further classified within body system categories and enumerated in order of decreasing frequency using the following definitions: frequent adverse events are defined as those occurring in at least 1/100 patients; infrequent adverse events are those occurring in 1/100 to 1/1,000 patients; and rare adverse events are those occurring in fewer than 1/1,000 patients.

Skin and Appendages: Infrequent: petechia, pruritus, rash, cold clammy skin; Rare: papular rash, urticaria, herpes simplex.

Musculoskeletal: Infrequent: cramps, myalgia, muscular weakness, dystonia; Rare: arthralgia, involuntary muscle contractions, rigidity.

Central and Peripheral Nervous System: Infrequent: confusion, tremor, hypoesthesia, vertigo; Rare: speech disorder, hyperkinesia, stupor, abnormal gait, aggravated migraine.

Autonomic Nervous System: Infrequent: increased sweating.

Special Senses: Infrequent: sense of smell altered, photophobia, conjunctivitis, abnormal lacrimation, abnormal vision, tinnitus, earache; Rare: eye pain.

Psychiatric: Infrequent: nervousness, euphoria, insomnia, concentration impaired; Rare: anxiety, anorexia, depression.

Gastrointestinal: Infrequent: abdominal pain, dyspepsia, dysphagia, hiccup; Rare: increased salivation, esophagospasm.

Cardiovascular: Infrequent: edema, palpitation, tachycardia; Rare: hypotension, peripheral ischemia, angina.

Respiratory System: Infrequent: dyspnea, upper respiratory tract infections; Rare: bronchospasm, bronchitis, pleural pain, epistaxis.

Urinary System: Infrequent: increased frequency of micturition, cystitis.

Reproductive, Female: Rare: pelvic inflammation, vaginitis.

Body as a Whole - General: Infrequent: feeling cold, malaise, rigors, fever, periorbital edema; Rare: flu-like symptoms, shock, loss of voice, yawning.

Application Site: Infrequent: local anesthesia.

Post-introduction Reports

Voluntary reports of adverse events temporally associated with Migranal Spray products used in the management of migraine that have been received since the introduction of the injectable formulation are included in this section save for those already listed above. Because of their source (open and uncontrolled clinical use), whether or not events reported in association with the use of Migranal Spray are causally related to it cannot be determined. There have been reports of pleural and retroperitoneal fibrosis in patients following prolonged daily use of injectable Migranal Spray mesylate. Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray is not recommended for prolonged daily use.

Drug Abuse And Dependence

Currently available data have not demonstrated drug abuse or psychological dependence with Migranal Spray. However, cases of drug abuse and psychological dependence in patients on other forms of ergot therapy have been reported. Thus, due to the chronicity of vascular headaches, it is imperative that patients be advised not to exceed recommended dosages.

Migranal Spray contraindications

See also:
What is the most important information I should know about Migranal Spray?

There have been a few reports of serious adverse events associated with the coadministration of Migranal Spray and potent CYP 3A4 inhibitors, such as protease inhibitors and macrolide antibiotics, resulting in vasospasm that led to cerebral ischemia and/or ischemia of the extremities. The use of potent CYP 3A4 inhibitors (ritonavir, nelfinavir, indinavir, erythromycin, clarithromycin, troleandomycin, ketoconazole, itraconazole) with Migranal Spray is, therefore contraindicated.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray should not be given to patients with ischemic heart disease (angina pectoris, history of myocardial infarction, or documented silent ischemia) or to patients who have clinical symptoms or findings consistent with coronary artery vasospasm including Prinzmetal's variant angina.

Because Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray may increase blood pressure, it should not be given to patients with uncontrolled hypertension.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray, 5-HT1 agonists (e.g., sumatriptan), ergotamine-containing or ergot-type medications or methysergide should not be used within 24 hours of each other.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray should not be administered to patients with hemiplegic or basilar migraine.

In addition to those conditions mentioned above, Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray may cause fetal harm when administered to a pregnant woman. Migranal Spray possesses oxytocic properties and, therefore, should not be administered during pregnancy. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

There are no adequate studies of Migranal Spray in human pregnancy, but developmental toxicity has been demonstrated in experimental animals. In embryofetal development studies of Migranal Spray mesylate nasal spray, intranasal administration to pregnant rats throughout the period of organogenesis resulted in decreased fetal body weights and/or skeletal ossification at doses of 0.16 mg/day (associated with maternal plasma Migranal Spray exposures [AUC] approximately 0.4 -1.2 times the exposures in humans receiving the MRDD of 4 mg) or greater. A no effect level for embryo-fetal toxicity was not established in rats. Delayed skeletal ossification was also noted in rabbit fetuses following intranasal administration of 3.6 mg/day (maternal exposures approximately 7 times human exposures at the MRDD) during organogenesis. A no effect level was seen at 1.2 mg/day (maternal exposures approximately 2.5 times human exposures at the MRDD). When Migranal Spray mesylate nasal spray was administered intranasally to female rats during pregnancy and lactation, decreased body weights and impaired reproductive function (decreased mating indices) were observed in the offspring at doses of 0.16 mg/day or greater. A no effect level was not established. Effects on development occurred at doses below those that produced evidence of significant maternal toxicity in these studies. Migranal Spray-induced intrauterine growth retardation has been attributed to reduced uteroplacental blood flow resulting from prolonged vasoconstriction of the uterine vessels and/or increased myometrial tone.

Migranal Spray® (Migranal Spray mesylate, USP) Nasal Spray is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids.

Migranal Spray mesylate should not be used by nursing mothers.

Migranal Spray mesylate should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure.



Active ingredient matches for Migranal Spray:

Dihydroergotamine


List of Migranal Spray substitutes (brand and generic names)

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Unit description / dosage (Manufacturer)Price, USD
HYPORAL 200MG TABLET 1 strip / 10 tablets each (Makers Laboratories Ltd)$ 3.16
Hyporal 200mg Tablet (Makers Laboratories Ltd)$ 0.32
Solution; Oral; Dihydroergotamine Mesylate 2 mg / ml (Pierre Fabre)
Ikaran 100 mg/50 mL x 50 mL x 1 Bottle (Pierre Fabre)
Ikaran 5 mg x 30 Tablet (Pierre Fabre)
Solution; Oral; Dihydroergotamine Mesylate 2 mg / ml
Capsule; Oral; Dihydroergotamine Mesylate
Injectable; Injection; Dihydroergotamine Mesylate 4 mg / ml
Spray, Metered-Dose; Nasal; Dihydroergotamine Mesylate 0.5 mg / dose
1 milliliter in 1 vial
Migranal spray 4 mg/mL (Valeant Pharmaceuticals North America LLC (US))
Injectable; Injection; Dihydroergotamine Mesylate
Injectable; Injection; Dihydroergotamine Mesylate 0.1% (Amdipharm)
Rayor 1 mg
Capsule; Oral; Dihydroergotamine Mesylate 5 mg
Solution; Oral; Dihydroergotamine Mesylate 2 mg / ml
Seglor 5 mg x 30's
Capsule; Oral; Dihydroergotamine Mesylate 5 mg
Solution; Oral; Dihydroergotamine Mesylate 2 mg / ml
Seglor 5 mg x 30's
Powder; Oral; Dihydroergotamine Mesylate 5 mg
Powder; Oral; Dihydroergotamine Mesylate 5 mg
Capsule; Oral; Dihydroergotamine Mesylate 3 mg
Tamik 3 mg x 60 Tablet
Solution; Oral; Dihydroergotamine Mesylate (Verla)

References

  1. PubChem. "dihydroergotamine". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
  2. DrugBank. "dihydroergotamine". http://www.drugbank.ca/drugs/DB00320 (accessed September 17, 2018).
  3. MeSH. "Vasoconstrictor Agents". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).

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