Manufacturer/Distributor: Square Pharmaceuticals Ltd.
Generic Name: Budesonide 400 mcg + Formoterol Fumarate 12 mcg Cozycap
Inhalation
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Bufocort 400 Cozycap 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. That means it's doing its job. If you stop taking it your symptoms may get worse. This medicine should not be used to relieve sudden shortness of breath. If sudden shortness of breath occurs, use your rescue inhaler. To get the benefit from this medicine you need to make sure you get your inhaler technique right, otherwise, it does not work as well. The most common side effects are nausea, vomiting, respiratory tract infection, hoarseness of voice, fungal infections in the mouth, cough, headache, sore throat, musculoskeletal (bone, muscle or joint) pain, and increased heart rate. If you get there, don't stop taking it but do talk to your doctor. You can prevent some of these symptoms by rinsing your mouth and throat with water or brushing your teeth after using your inhaler. There are other, rarer side effects which can be serious. Talk to your doctor if you're worried about them. Before taking it, you should tell your doctor if you have any kidney or liver diseases so that your doctor can prescribe a suitable dose for you. You should also tell your doctor if you are pregnant, planning pregnancy or breastfeeding.
Uses of Bufocort 400 Cozycap
Side effects of Bufocort 400 Cozycap
Common
How to use Bufocort 400 Cozycap
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 Bufocort 400 Cozycap works
Bufocort 400 Cozycap 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.
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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 twice daily. 200 Convicap twice daily. Reliever dose: 1 additional Convicap as needed in response to symptoms. If symptoms persist after a few minutes, an additional Convicap should be taken. COPD 200 Convicap: 2 Convicaps twice daily. 400 Convicap: 1 Convicap twice daily
Child 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 parasitic infections, or ocular herpes simplex. Pregnancy and lactation. Lactation: No data; weigh risks of therapy against benefits, and either discontinue drug or do not nurse
Side 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 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
Interaction
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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