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The accumulation index for the group that received 2 inhalations twice daily was 1.77 for formoterol. Peak steady-state plasma concentrations of budesonide administered by DPI in adults with asthma averaged 0.6 and 1.6 nmol/L at doses of 180 mcg and 360 mcg twice daily, respectively. In asthmatic patients, budesonide showed a linear increase in AUC and Cmax with increasing dose after both single and repeated dosing of inhaled budesonide. Glaucoma, increased intraocular pressure, and cataracts have been reported in patients with asthma and COPD following the long-term administration of inhaled corticosteroids, including budesonide, a component of SYMBICORT.
Talk with your doctor before changing or stopping the use of any of medications for your asthma or chronic obstructive pulmonary disorder symptoms. If you suddenly stop taking your medication, including Symbicort, you may have trouble breathing and your condition may worsen. This can lead to complications such as being less active, having lung infections, having trouble breathing that requires care right away, or needing a hospital stay. A randomized, double-blind, parallel-group, safety study compared SYMBICORT with budesonide, each administered as 2 inhalations twice daily over 26 weeks .
In two additional 2-year studies in male Fischer and Sprague-Dawley rats, budesonide caused no gliomas at an oral dose of 50 mcg/kg (approximately equivalent to the MRHDID in adults and children on a mcg/m² basis). The concurrent reference corticosteroids in these two studies showed similar findings. This drug and its metabolites was excreted in the breast milk of lactating rats given oral doses of 50 mcg/kg, and growth and survival of the pups were decreased when lactating rats were given oral doses greater than 1 mg/kg/day. A study in rats showed increased postnatal mortality at maternal oral doses of 0.2 mg/kg/day or greater, and retardation of pup growth at 15 mg/kg/day. The amount of drug found in animal milk was less than 2% of that in maternal plasma.
The following lists contain some of the key side effects that may occur while taking Symbicort. Side effects might differ slightly between people with asthma and people with chronic obstructive pulmonary disorder . The typical dosage of Symbicort for people with chronic obstructive pulmonary disorder is two puffs of the 160-mcg/4.5-mcg strength of Symbicort twice a day. Prednisone is a bad medicine and can cause lots of bad side effects.
There is insufficient evidence to determine ifdialysis is beneficial for overdosage of formoterol. Other beta-agonist drugs have similarly demonstrated increases in leiomyomas of the genital tract in female rodents. SYMBICORT, like all medications containing sympathomimetic amines, should be used with caution in patients with convulsive disorders or thyrotoxicosis and in those who are unusually responsive to sympathomimetic amines. Doses of the related beta2-adrenoceptor agonistalbuterol, when administered intravenously, have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. 3 Number of patients with event that occurred within 6 months after the first use of study drug or 7 days after the last date of study drug, whichever date was later. Patients can have one or more events, but only the first event was counted for analysis.
No formal drug interaction studies have been performed with SYMBICORT. If you have a condition such as osteoporosis or osteopenia in which you have low bone density, tell your doctor before taking Symbicort. An active drug in Symbicort is called budesonide, and it’s a corticosteroid.
For SYMBICORT, small mean increases in serum glucose and decreases in serum potassium (+0.44 mmol/L and -0.18 mmol/L at the highest dose, respectively) were observed with increasing doses of formoterol, compared to budesonide. In ECGs, SYMBICORT produced small dose-related mean increases in heart rate , and QTc intervals (3-6 msec) compared to budesonide alone. No teratogenic effects were observed at doses up to 3800 times the MRHDID (on a mcg/m² basis at maternal oral doses up to 3500 mcg/kg/day). No tumorigenicity was seen in male and female rats at respective oral doses up to 25 and 50 mcg/kg (approximately equivalent to the MRHDID in adults and children on a mcg/m² basis).
Serious side effects from Symbicort aren’t common, but they can occur. Call your doctor right away if you have serious side effects. A generic drug is an exact copy of the active drug in a brand-name medication. The generic is considered to be just as safe and effective as the original drug. The Food and Drug Administration approves prescription drugs such as Symbicort to treat certain conditions.
Drug Interaction ClassificationThese classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication.
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