formiget capsule uses

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Written by Dr. Rukhsar Zehra [PharmD, DOW University Of Health Sciences (DUHS)], Karachi, Pakistan.

Brand name:

Formiget

Generic name:

Budesonide + formoterol Fumerate Dihydrate

Available dosage forms and their doses

Dry Powder inhaler capsule

Available for administration as:

• Dry Powder Inhaler Capsules 200mcg + 6mcg

  Each capsule contains: Budesonide BP… 200mcg Formoterol fumarate dihydrate Ph.Eur… 6mcg

• Dry Powder Inhaler Capsules 400mcg + 12mcg

  Each capsule contains: Budesonide BP… 400mcg Formoterol fumarate dihydrate Ph.Eur… 12mcg

Price:

Rs.14/Cap or Rs. 140/strip

Therapeutic class:

Bronchodilator and Anti-Asthmatic.

Pharmacological class:

Budesonide is Corticosteroid and Formoterol fumarate dihydrate is a long-acting selective

β2 adrenoceptor agonist (LABA)

Manufacturer:

Getz Pharma

Storage

• Do not store above 30°C.

• Protect from sunlight and moisture.

Prescription drug:

Yes, it requires a prescription.

Clinical Pharmacology (mechanism of action):

Budesonide and Formoterol fumarate dihydrate have different modes of action and show additive effects in terms of reduction of asthma exacerbations and COPD exacerbations.

The specific properties of budesonide and formoterol allow the combination to be used

either as maintenance and reliever therapy or as maintenance treatment of asthma and for symptomatic treatment of patients with moderate to severe COPD.

Budesonide is a glucocorticosteroid which when inhaled has a dose-dependent anti -inflammatory action in the airways, resulting in reduced symptoms and fewer asthma

exacerbations.

Budesonide has also been shown to decrease airway reactivity to both direct and indirect challenges in hyperreactive patients.

Formoterol fumarate dihydrate is a selective β2 adrenoceptor agonist that when inhaled

results in rapid and long-acting relaxation of bronchial smooth muscle in patients with

reversible airway obstruction.

Indications and dosages:

Asthma:

Formiget (Budesonide + Formoterol fumarate dihydrate) is indicated in adults and adolescents (12 years and older) for the regular treatment of asthma, where the use of a

combination (inhaled corticosteroid and long-acting β2 adrenoceptor agonist) is appropriate

Chronic Obstructive Pulmonary Disease (COPD):

Formiget (Budesonide + Formoterol fumarate dihydrate) is indicated in adults, aged 18

years and older, for the symptomatic treatment of patients with COPD with forced expiratory volume in 1 second (FEV1)

Dosage & Administration:

Formiget is not intended for the initial management of asthma. The dosage of the

components of Formiget are individual and should be adjusted to the severity of the disease.

This should be considered when treatment with combination products is initiated and when the maintenance dose is adjusted.

Patients should be regularly reassessed so that the dosage of Formiget (Budesonide +

Formoterol fumarate dihydrate) remains optimal.

The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.

When long-term control of symptoms is maintained with the lowest recommended dosage, then the next step could include a test of inhaled corticosteroid alone.

In usual practice when control of symptoms is achieved with the twice-daily regimen, titration to the lowest effective dose could include Formiget given once daily.

Increasing use of a separate rapid-acting bronchodilator indicates a worsening of the underlying condition and warrants a reassessment of asthma therapy.

• Adults (18 years and older): The recommended dose for adults is 1-2 inhalations twice daily.

• Some patients may require up to a maximum of 4 inhalations twice daily.

• Adolescents (12 – 17 years): The recommended dose for adolescents is 1-2 inhalations twice daily.

Administration:

The capsule is taken through a device known as prohaler. (getz pharma)

Side Effects:

• Common: Candida infections in the oropharynx, pneumonia (in COPD patients), headache, tremor, palpitations, mild irritation in the throat, coughing and hoarseness.

  
  

• Uncommon: Aggression, psychomotor hyperactivity, anxiety, sleep disorders, dizziness, blurred vision, tachycardia, nausea, bruises and muscle cramps.

• Rare: Immediate and delayed hypersensitivity reactions, e.g. exanthema, urticaria, pruritus, dermatitis, angioedema and anaphylactic reaction, hypokalaemia, cardiac arrhythmias, e.g. atrial fibrillation, supraventricular tachycardia, extrasystoles and bronchospasm.

  
  

• Very rare: Cushing’s syndrome, adrenal suppression, growth retardation, decrease in bone mineral density, hyperglycaemia, depression, behavioural changes, taste disturbances, cataracts and glaucoma, angina pectoris. prolongation of QTc-interval and variations in blood pressure.

  
  

Interactions:

• Potent inhibitors of CYP3A4 (e.g. ketoconazole, itraconazole, voriconazole, posaconazole)

• clarithromycin

• telithromycin

• nefazodone

• HIV protease inhibitors are likely to increase plasma levels of budesonide and concomitant use should be avoided.

• β-adrenergic blockers can weaken or inhibit the effect of formoterol. Budesonide +Formoterol fumarate dihydrate should therefore not be given together with β-adrenergic blockers (including eye drops) unless there are compelling reasons.

• Concomitant treatment with quinidine, disopyramide, procainamide, phenothiazines, antihistamines (terfenadine) and tricyclic antidepressants can prolong the QTc-interval and increase the risk of ventricular arrhythmias.

• L-dopa, L-thyroxine, oxytocin and alcohol can impair cardiac tolerance towards β2 sympathomimetics.

• Concomitant treatment with monoamine oxidase inhibitors, including agents with similar properties such as furazolidone and procarbazine, may precipitate hypertensive reactions.

• There is an elevated risk of arrhythmias in patients receiving concomitant anaesthesia with halogenated hydrocarbons.

• Concomitant use of other β-adrenergic drugs or anticholinergic drugs can have a potentially additive bronchodilating effect.

• Hypokalaemia may increase the disposition towards arrhythmias in patients who are treated with digitalis glycosides.

• Hypokalaemia may result from β2-agonist therapy and may be potentiated by concomitant treatment with xanthine derivatives, corticosteroids and diuretics.

  
  

Pregnancy:

Only after special consideration should Budesonide + Formoterol fumarate dihydrate be used during the first 3 months and shortly before delivery. Because β-agonists, including formoterol may potentially interfere with uterine contractility, due to a relaxant effect on uterine smooth muscle, Budesonide + Formoterol fumarate dihydrate should be used during labour only if the potential benefit justifies the potential risk.

Lactation:

Budesonide is excreted in breast milk. Administration of Budesonide + Formoterol fumarate dihydrate to women who are breast-feeding should only be considered if the expected benefit to the mother is greater than any possible risk to the child

Precautions:

• It is recommended that the dose is tapered when the treatment is discontinued and should not be stopped abruptly.

  
  

• Serious asthma-related adverse events and exacerbations may occur during treatment with Budesonide + Formoterol fumarate dihydrate. Patients should be asked to continue treatment but to seek medical advice if asthma symptoms remain uncontrolled or worsen after initiation with Budesonide + Formoterol fumarate dihydrate.

  
  

• If the patient experiences paradoxical bronchospasm Budesonide + Formoterol fumarate dihydrate should be discontinued immediately, the patient should be assessed and an alternative therapy instituted, if necessary.

  
  

• Potential effects on bone density should be considered particularly in patients on high doses for prolonged periods that have co-existing risk factors for osteoporosis.

  
  

• If there is any reason to suppose that adrenal function is impaired from previous systemic steroid therapy, care should be taken when transferring patients to Budesonide + Formoterol fumarate dihydrate therapy.

  
  

• Budesonide + Formoterol fumarate dihydrate should be administered with caution in patients with thyrotoxicosis, phaeochromocytoma, diabetes mellitus, untreated hypokalaemia, hypertrophic obstructive cardiomyopathy, idiopathic subvalvular aortic stenosis, severe hypertension, aneurysm or other severe cardiovascular disorders, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

  
  

• Caution should be observed when treating patients with prolongation of the QTc-interval. Formoterol itself may induce prolongation of the QTc-interval.

  
  

• As for all β2 adrenoceptor agonists, additional blood glucose controls should be considered in diabetic patients.

  
  

• It is recommended that the height of children receiving prolonged treatment with inhaled corticosteroids is regularly monitored. If growth is slowed, therapy should be re-evaluated to reduce the dose of inhaled corticosteroid to the lowest dose at which effective control of asthma is maintained, if possible.

  
  

• Corticosteroids may mask some signs of infection and new infections may appear. A

  decreased resistance to localized infection has been observed during corticosteroid therapy.

  
  

• In patients with increased susceptibility to sympathomimetic amines (eg inadequately

  controlled hyperthyroidism), formoterol should be used with caution.

  
  

• Physicians should be alerted to eosinophilia, vasculitic rash, worsening pulmonary

  symptoms, cardiac complications and/or neuropathy presenting in the patients.

  
  

• This medicine contains lactose, for patients with rare hereditary problems of galactose

  intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not be taken.

Counselling Point:

To minimise the risk of oropharyngeal candida infection, the patient should be instructed to rinse their mouth out with water after inhaling the maintenance dose.