Orstanorm 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.
Orstanorm 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.
Orstanorm injection should not be used to treat common tension headaches or any headache that seems to be different from your usual migraine headaches. Orstanorm is not for daily use.
Orstanorm injection may also be used for purposes not listed in this medication guide.
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.
Orstanorm® (Orstanorm, USP) Nasal Spray is indicated for the acute treatment of migraine headaches with or without aura.
Orstanorm® (Orstanorm, 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 Orstanorm?
An extra patient leaflet is available with Orstanorm spray. Talk to your pharmacist if you have questions about this information.
Orstanorm spray comes with an additional patient leaflet. Read it carefully and reread it each time you get Orstanorm spray refilled.
Check with your doctor before eating grapefruit or drinking grapefruit juice while taking Orstanorm spray.
Orstanorm spray is for use in the nose only. It is not to be injected.
Assemble the device according to the instructions provided with Orstanorm spray.
Before you use Orstanorm spray, you will need to prime it. Remove the cap from the spray unit, hold the vial upright, and point the nasal sprayer away from your face. Pump the spray unit 4 times. Do not pump it more than 4 times.
Spray 1 time into each nostril. Do NOT sniff or tilt your head back while spraying Orstanorm spray or immediately after.
If more than 1 spray per nostril is to be used, wait 15 minutes between sprays. Do not exceed the recommended dose.
After using Orstanorm spray, carefully throw away the nasal spray pump with the vial. Once a nasal spray vial has been opened, it must be thrown away after 8 hours.
Do not assemble another vial of Orstanorm spray until you are ready to use it.
If you miss a dose of Orstanorm spray and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are unsure what to do if you miss a dose. Do not take Orstanorm spray more often than prescribed. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Orstanorm spray.
Uses of Orstanorm 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.
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 Orstanorm 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 Orstanorm in this condition. Optimal dosing has not been established nor has the optimal treatment for this condition been established.
A 9,10alpha-dihydro derivative of ergotamine. It is used as a vasoconstrictor, specifically for the therapy of migraine disorders. [PubChem]
The solution used in Orstanorm (Orstanorm spray) ® (Orstanorm, USP) Nasal Spray (4 mg/mL) is intended for intranasal use and must not be injected.
In clinical trials, Orstanorm® (Orstanorm, USP) Nasal Spray has been effective for the acute treatment of migraine headaches with or without aura. One spray (0.5 mg) of Orstanorm (Orstanorm spray) ® (Orstanorm, USP) Nasal Spray should be administered in each nostril. Fifteen minutes later, an additional one spray (0.5 mg) of Orstanorm (Orstanorm spray) ® (Orstanorm, USP) Nasal Spray should be administered in each nostril, for a total dosage of four sprays (2.0 mg) of Orstanorm® (Orstanorm, 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.
Orstanorm® (Orstanorm, 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).
Orstanorm®(Orstanorm, USP) Nasal Spray is available (as a clear, colorless to faintly yellowsolution) in 3.5 mL amber glass vials containing 4 mg of Orstanorm, USP.
Orstanorm® (Orstanorm, 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.Orstanorm (Orstanorm spray).com. June 2007.
Orstanorm® (Orstanorm, 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 Orstanorm (Orstanorm spray) ® (Orstanorm, USP) Nasal Spray. Sumatriptan and Orstanorm (Orstanorm spray) ® (Orstanorm, 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 Orstanorm (Orstanorm spray) ® (Orstanorm, 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)
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 Orstanorm® (Orstanorm, USP) Nasal Spray or D.H.E. 45®.
The effect of oral contraceptives on the pharmacokinetics of Orstanorm® (Orstanorm, USP) Nasal Spray has not been studied.
During clinical studies and the foreign postmarketing experience with Orstanorm® (Orstanorm, 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 Orstanorm (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 Orstanorm.
Incidence in Controlled Clinical Trials
Of the 1,796 patients and subjects treated with Orstanorm® (Orstanorm, 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 Orstanorm® (Orstanorm, 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.
Orstanorm® (Orstanorm, 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 Orstanorm® (Orstanorm, 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 Orstanorm® (Orstanorm, USP) Nasal Spray treated patients and occurred more frequently than in the placebo-group in the migraine placebo-controlled trials
Special Senses, Other
Altered Sense of Taste
Application Site Reaction
Central and Peripheral Nervous System
Body as a Whole, General
Autonomic Nervous System
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 Orstanorm® (Orstanorm, 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 Orstanorm (Orstanorm spray) ® (Orstanorm, USP) Nasal Spray in placebo-controlled trials and reported an event divided by the total number of patients (n=1796) exposed to Orstanorm® (Orstanorm, 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.
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.
Voluntary reports of adverse events temporally associated with Orstanorm 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 Orstanorm 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 Orstanorm. Orstanorm® (Orstanorm, 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 Orstanorm. 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.
There have been a few reports of serious adverse events associated with the coadministration of Orstanorm 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 Orstanorm is, therefore contraindicated.
Orstanorm® (Orstanorm, 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 Orstanorm® (Orstanorm, USP) Nasal Spray may increase blood pressure, it should not be given to patients with uncontrolled hypertension.
Orstanorm® (Orstanorm, 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.
Orstanorm® (Orstanorm, USP) Nasal Spray should not be administered to patients with hemiplegic or basilar migraine.
In addition to those conditions mentioned above, Orstanorm® (Orstanorm, USP) Nasal Spray is also contraindicated in patients with known peripheral arterial disease, sepsis, following vascular surgery, and severely impaired hepatic or renal function.
Orstanorm® (Orstanorm, USP) Nasal Spray may cause fetal harm when administered to a pregnant woman. Orstanorm 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 Orstanorm in human pregnancy, but developmental toxicity has been demonstrated in experimental animals. In embryofetal development studies of Orstanorm 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 Orstanorm 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 Orstanorm 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. Orstanorm-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.
Orstanorm® (Orstanorm, USP) Nasal Spray is contraindicated in patients who have previously shown hypersensitivity to ergot alkaloids.
Orstanorm should not be used by nursing mothers.
Orstanorm should not be used with peripheral and central vasoconstrictors because the combination may result in additive or synergistic elevation of blood pressure.
The results of a survey conducted on ndrugs.com for Orstanorm are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Orstanorm. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
Consumer reported useful
No survey data has been collected yet
Consumer reported price estimates
No survey data has been collected yet
Consumer reported time for results
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Consumer reported age
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