Formatide 4.5/160 HFA - Inhaler Budesonide + Formoterol Fumarate - 160mcg+4.5mcg/Puff 1 120 metered doses(s) / 120 metered doses Unimed Unihealth Pharmaceuticals Ltd. Introduction: Formatide 4.5/160 HFA 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... Uses of Formatide 4.5/160 HFA: AsthmaChronic obstructive pulmonary disease (COPD) Side effects of Formatide 4.5/160 HFA: CoughFungal infection of mouthHeadacheHoarseness of voiceIncreased heart rateMusculoskeletal (bone, muscle or joint) painNauseaRespiratory tract infectionSore throatVomiting How to use Formatide 4.5/160 HFA: 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 Formatide 4.5/160 HFA works: Formatide 4.5/160 HFA 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. 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... 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... 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... 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.