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Product Name
:
NOMIGRA
Chemical Name
:
Ergotamine Tartrate+Paracetamol +Meprobamate +Belladonna+Caffeine+Phenobarbital
Therapeutic Category
:
Central nervous system drugs
Pharmacologic Category
:
Antimigraine Agent; - Ergot Derivative
Pharmaceutical Form
:
Tablets
Composition
:
Ergotamine Tartrate 1mg+Paracetamol 250mg+Meprobamate 150mg+Belladonna 0.1mg+Caffeine 50mg+Phenobarbital 10mg
Monitoring Parameters
Dosing
 
Dosing: Adult
One or two tablets at the onset of the prodromal symptoms.
Use
 
Migraine headache attacks (Migraine).
Adverse Reactions
 
Frequency not defined.
Cardiovascular: Absence of pulse, bradycardia, cardiac valvular fibrosis, cyanosis, edema, ECG changes, gangrene, hypertension, ischemia, precordial distress and pain, tachycardia, vasospasm
Central nervous system: Vertigo
Dermatologic: Itching
Gastrointestinal: Nausea, vomiting
Genitourinary: Retroperitoneal fibrosis
Neuromuscular & skeletal: Muscle pain, numbness, paresthesia, weakness
Respiratory: Pleuropulmonary fibrosis
Miscellaneous: Cold extremities
Contraindications
 
Hypersensitivity to ergotamine or any component of the formulation; peripheral vascular disease; hepatic or renal disease; coronary artery disease; hypertension; sepsis; ergot alkaloids are contraindicated with strong inhibitors of CYP3A4 (includes protease inhibitors, azole antifungals, and some macrolide antibiotics); pregnancy
Warnings / Precautions Drug
 
Prolonged use of this drug may in rare cases cause allergic reactions and decrease in the number of leucocytes as all pyrazolone derivatives. Therefore leucocytes count must be done and drug administration discontinued if there is any decrease in the number of granulocytes. Patients should be warned not to drive cars or operate machinery.
Interactions
 
Increase of Ergotamine concentration in plasma have been reported in patients given erythromycin in addition to ergotamine. Peripheral vasoconstriction was reported in a patient when coadministered with propranolol The product should not be coadministered with sumatriptan or zolmetripten.
Pregnancy
 
X
Pregnancy Implications
May cause prolonged constriction of the uterine vessels and/or increased myometrial tone leading to reduced placental blood flow. This has contributed to fetal growth retardation in animals.
Lactation
 
Enters breast milk/not recommended
Mechanism of Action
 
Ergotamine
Has partial agonist and/or antagonist activity against tryptaminergic, dopaminergic and alpha-adrenergic receptors depending upon their site; is a highly active uterine stimulant; it causes constriction of peripheral and cranial blood vessels and produces depression of central vasomotor centers
Pharmacodynamics / Kinetics
 
Ergotamine
Absorption: Oral: Erratic; enhanced by caffeine coadministration
Metabolism: Extensively hepatic
Half-life elimination: 2 hours
Time to peak, serum: 0.5-3 hours
Excretion: Feces (90% as metabolites)
 
   
 
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