Symbitrol Sykonahaler MDPI
Budesonide + Formoterol Fumarate
200/6
DBL Pharmaceuticals ltd.
| Pack size | 1's pack |
|---|---|
| Dispensing mode | |
| Source | |
| Agent | |
| Retail Price | 900.00 AED |
Available as:
Indications
Symbitrol Sykonahaler MDPI is used for:
Asthma, Chronic Obstructive Pulmonary Disease (COPD)
Adult Dose
Adults
COPD
Maintenance therapy
Convicap
200 Convicap: 2 Convicaps twice daily.
400 Convicap: 1 Convicap twice daily
Inhalation aerosol (Inhaler)
2 inhalations of 160/4.5 twice daily.
Asthma
Treatment of asthma:
Inhalation aerosol (Inhaler)
The recommended maintenance dose is:
2 inhalations of 80/4.5 mcg or 160/4.5 mcg twice daily. The starting dosage is based on asthma severity
Convicap/cozycap:
Maintenance dose: 100 or 200 Convicap twice daily.
Child Dose
<12 years: Safety and efficacy not established
Child12 years and older
COPD
Maintenance therapy
Convicap
200 Convicap: 2 Convicaps twice daily.
400 Convicap: 1 Convicap twice daily
Inhalation aerosol (Inhaler)
2 inhalations of 160/4.5 twice daily.
Asthma
Treatment of asthma in patients 12 years and older:
Inhalation aerosol (Inhaler)
The recommended dose is:
2 inhalations of 80/4.5 mcg or 160/4.5 mcg twice daily. The starting dosage is based on asthma severity
Convicap/cozycap:
100 or 200 Convicap twice daily.
Treatment of asthma in patients aged 6 to less than 12 years:
2 inhalations of 80/4.5 mcg twice daily.
Renal Dose
Renal Impairment
Formal pharmacokinetic studies using Budesonide + Formoterol Fumarate have not been conducted in patients with renal impairment.
Administration
Prime before first use by releasing 2 test sprays into air, shaking well for 5 seconds before each spray; repeat priming if inhaler is unused for >7 days or has been dropped
After inhalation, rinse mouth with water without swallowing
Contra Indications
Hypersensitivity to budesonide, formoterol fumarate, or to any of the excipients.
Not indicated for the relief of acute bronchospasm.
Precautions
LABA as monotherapy (without an inhaled corticosteroid) is associated with an increased risk of serious asthma-related events.
Do not initiate in acutely deteriorating COPD. Do not use to relieve acute symptoms.
Do not use in combination with an additional therapy containing a LABA because of the risk of overdosage.
Oropharyngeal candidiasis may occur. Monitor patients periodically.
Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
Increased risk of pneumonia in patients with COPD. Monitor patients for signs and symptoms of pneumonia.
Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal courses of chickenpox or measles can occur in susceptible patients.
Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Budesonide + Formoterol Fumarate.
Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, consider appropriate therapy.
If paradoxical bronchospasm occurs, discontinue Budesonide + Formoterol Fumarate and institute alternative therapy.
Cardiovascular effects may occur. Use with caution in patients with cardiovascular disorders because of beta-adrenergic stimulation.
Assess for the decrease in bone mineral density initially and periodically thereafter.
Glaucoma and cataracts may occur with long-term use of ICS. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Budesonide + Formoterol Fumarate long term.
Use with caution in patients with convulsive disorders, thyrotoxicosis, diabetes mellitus, and ketoacidosis.
Be alert to hypokalemia and hyperglycemia.
Monitor COPD patients for signs and symptoms of pneumonia and lung infections
Pregnancy-Lactation
Pregnancy
In women with poorly or moderately controlled asthma, there is increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in neonate; pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control
There are no well-controlled human studies that have investigated the effects of therapy during labor and delivery; because of potential for beta-agonist interference with uterine contractility, use of therapy during labor should be restricted to those patients in whom the benefits clearly outweigh risk
Lactation
There are no available data on the breastfed child or on milk production; budesonide, like other inhaled corticosteroids, is present in human milk; there are no available data on the presence of formoterol fumarate in human milk; formoterol fumarate is present in rat milk; the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for therapy and any potential adverse effects on the breastfed infant from therapy or from underlying maternal condition
Interactions
Concomitant admin with CYP3A4 inhibitor e.g. itraconazole, clarithromycin, erythromycin may inhibit the metabolism of budesonide.
Concurrent use with nonpotassium-sparing diuretics may lead to ECG changes and/or hypokalemia.
Strong cytochrome P450 3A4 inhibitors (e.g. ritonavir): Use with caution. May cause systemic corticosteroid effects.
Diuretics, xanthine derivatives or steroids: May potentiate hypokalemia or ECG changes. Use with caution.
Monoamine oxidase inhibitors and tricyclic antidepressants: Use with extreme caution. May potentiate the effect of formoterol fumarate on cardiovascular system.
Beta-blockers: Use with caution. May block the bronchodilatory effects of beta-agonists and produce severe bronchospasm.
Contraindicated (0)
Serious (72)
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chlorpromazine
clarithromycin
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disopyramide
dofetilide
doxepin
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epinephrine
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pitolisant
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trazodone
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trimipramine
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ziprasidone
Adverse Effects
Side effects of Budesonide + Formoterol Fumarate :
>10%
Upper respiratory tract infection (URTI) (8-11%),Headache (7-11%),Nasopharyngitis (7-11%)
1-10%
Pharyngolaryngeal pain (6-9%),Stomach discomfort (1-7%),Sinusitis (5-6%),Oral candidiasis (1-6%),Bronchitis (5%),Viral URTI (4%),Backache (2-3%),Influenza (2-3%),Nasal congestion (2-3%),Vomiting (1- 3%)
Mechanism of Action
Budesonide is a corticosteroid that has mainly glucocorticoid activity. It prevents and controls inflammation by controlling the rate of protein syntheis, decreasing the migration of polymorphonuclear leucocytes/fibroblasts and reversing capillary permeability.
Formoterol fumarate is a selective beta2-adrenergic agonist. It causes bronchodilation by catalysing the conversion of adenosine triphosphate to cyclic-3', 5'-adenosine monophosphate (cyclic AMP) resulting in bronchial smooth muscle relaxation.
Note
Symbitrol Sykonahaler 200/6 MDPI manufactured by DBL Pharmaceuticals ltd.. Its generic name is Budesonide + Formoterol Fumarate. Symbitrol Sykonahaler is availble in Bangladesh.
Farmaco BD drug index information on Symbitrol Sykonahaler MDPI is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.
Some other brands of Budesonide + Formoterol Fumarate :
Inhalation Capsule
Budemet 200 Convicap
200mcg + 6mcg
Incepta Pharmaceuticals Ltd.
Inhalation Capsule
Budemet 400 Convicap
400mcg + 6mcg
Incepta Pharmaceuticals Ltd.
Inhaler
Budison F 160
160mcg + 4.5mcg/Puff
Aristopharma Limited
Inhaler
Budison F 80
80mcg + 4.5mcg/Puff
Aristopharma Limited
Cozycap
Bufocort 200
200mcg + 6mcg
Square Pharmaceuticals PLC.