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Symbitrol 12/400
DBL Pharmaceuticals Ltd.
Generic: Budesonide + Formoterol Fumarate
Safety Advices
বাংলা
English
UNSAFE
It is unsafe to consume alcohol with Symbitrol 12/400.
CONSULT YOUR DOCTOR
Symbitrol 12/400 may be unsafe to use during pregnancy. Although there are limited studies in humans, animal studies have shown harmful effects on the developing baby. Your doctor will weigh the benefits and any potential risks before prescribing it to you. Please consult your doctor.
SAFE IF PRESCRIBED
Symbitrol 12/400 is probably safe to use during breastfeeding. Limited human data suggests that the drug does not represent any significant risk to the baby.
Medicine Overview of Symbitrol 12/400 400mcg+12mcg sykonahaler
Introduction
Symbitrol 12/400 is a combination of two medicines in one inhaler. It relieves the long-term symptoms of asthma and COPD, making breathing easier. It works by inhibiting the release of certain chemical messengers that cause inflammation (swelling) and relaxes the muscles in the airways. Your doctor will tell you how often you need to use your inhaler. The effect of this medicine may be noticeable after a few days but will only reach its maximum after a few weeks. This medicine must be used regularly to be effective, so go on taking it even if you don't have any symptoms....
... Show moreUses of Symbitrol 12/400
- Asthma
- Chronic obstructive pulmonary disease (COPD)
Side effects of Symbitrol 12/400
Common
- Cough
- Fungal infection of mouth
- Headache
- Hoarseness of voice
- Increased heart rate
- Musculoskeletal (bone, muscle or joint) pain
- Nausea
- Respiratory tract infection
- Sore throat
- Vomiting
How to use Symbitrol 12/400
Rotacaps must not be swallowed. Check the label for directions before use. Place the capsule at the base of rotahaler, not in the mouthpiece. Twist the mouthpiece completely until your hear a click and breathe in deeply through the mouthpiece. Hold your breath for up to 10 seconds. If some powder remains in the rotahaler repeat the process.
How Symbitrol 12/400 works
Symbitrol 12/400 is a combination of two medicines: Formoterol and Budesonide. Formoterol is a long-acting bronchodilator which works by relaxing the muscles in the airways and widens the airways. Budesonide is a steroid. It works by stopping the release of certain chemical messengers that cause inflammation (swelling) of the airways. Together, they make breathing easier.
Quick Tips
- It contains two medicines in one inhaler for control of long term asthma and COPD symptoms.
- It does not relieve sudden symptoms. Always use a rescue inhaler to treat sudden symptoms.
- Tell your doctor immediately if your breathing problem worsens, or if rescue inhaler does not relieve symptoms.
- Do not discontinue unless advised by your doctor.
- Rinse your mouth with water after each use to prevent infections in the mouth and throat.
- Carry your rescue inhaler wherever you go.
Brief Description
Indication
Asthma, COPD
Adult Dose
Asthma Maintenance and reliever therapy: Adults and adolescents (12 years and older) - As both maintenance and reliever therapy: Adults and adolescents (12 years and older): The recommended maintenance dose is 1 puff twice daily or 2 puffs once daily. For some patients a maintenance dose of 2 puffs twice daily may be appropriate (for 160/4.5 mcg/inhalation only). Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, the additional puff should be taken. Not more than 6 puffs should be taken on any single occasion. Convicap/cozycap: Maintenance dose: 100 Convicap...
... Show moreChild Dose
<12 years: Safety and efficacy not established
Contraindication
Primary treatment of status asthmaticus or other acute episodes of asthma. Hypersensitivity to Budesonide, Formoterol or to Lactose.
Mode 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.
Precaution
Treatment with Budesonide and Formoterol combination should not be initiated to treat a severe exacerbation or if patients have significantly worsening or acutely deteriorating asthma. May produce paradoxical bronchospasm which is life-threatening. Caution when used in patients with CV diseases, especially coronary insufficiency, cardiac arrhythmias and hypertension. Chronic use may further decrease bone mineral content when used in patients with advanced age, osteoporosis, poor nutrition, sedentary lifestyle or tobacco use. May reduce growth velocity when used in paediatric patients. Caution when used in patients with active or quiescent tuberculosis infection of the respiratory tract, untreated systemic fungal, bacterial, viral or...
... Show moreSide Effect
>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%)
Pregnancy Category Note
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...
... Show moreInteraction
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 hypokalaemia.
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