"The cystic fibrosis (CF) drug Orkambi (Vertex Pharmaceuticals) has received a green light from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP).
Orkambi is a fixed-dose oral combination "...
(Generic versions may still be available.)
ARAMINE (metaraminol) contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Caution should be used to avoid excessive blood pressure response. Rapidly induced hypertensive responses have been reported to cause acute pulmonary edema, arrhythmias, cerebral hemorrhage, or cardiac arrest.
Patients with cirrhosis should be treated with caution, with adequate restoration of electrolytes if diuresis ensues. Fatal ventricular arrhythmia was reported in one patient with Laennec's cirrhosis while receiving metaraminol bitartrate. In several instances, ventricular extrasystoles that appeared during infusion of this vasopressor subsided promptly when the rate of infusion was reduced.
With the prolonged action of ARAMINE (metaraminol) , a cumulative effect is possible. If there is an excessive vasopressor response there may be a prolonged elevation of blood pressure even after discontinuation of therapy.
When vasopressor amines are used for long periods, the resulting vasoconstriction may prevent adequate expansion of circulating volume and may cause perpetuation of shock. There is evidence that plasma volume may be reduced in all types of shock, and that the measurement of central venous pressure is useful in assessing the adequacy of the circulating blood volume. Therefore, blood or plasma volume expanders should be used when the principal reason for hypotension or shock is decreased circulating volume.
Because of its vasoconstrictor effect ARAMINE (metaraminol) should be given with caution in heart or thyroid disease, hypertension, or diabetes. Sympathomimetic amines may provoke a relapse in patients with a history of malaria.
See DRUG INTERACTIONS section.
Studies in animals have not been performed to evaluate the mutagenic or carcinogenic potential of ARAMINE (metaraminol) or its potential to affect fertility.
Pregnancy Category C. Animal reproduction studies have not been conducted with ARAMINE (metaraminol) . It is not known whether ARAMINE (metaraminol) can cause fetal harm when given to a pregnant woman or can affect reproduction capacity. ARAMINE (metaraminol) should be given to a pregnant woman only if clearly needed.
It is not known whether this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when ARAMINE (metaraminol) is given to a nursing woman.
Safety and effectiveness in children have not been established.This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 12/8/2004
Additional Aramine Information
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