Tinova^®

Tinova is a combination of Beclometasone Dipropionate, Formoterol and Glycopyrronium. Beclometasone Dipropionate has anti-inflammatory action within the lungs. Glucocorticoids are widely used for the suppression of inflammation in chronic inflammatory diseases of the airways. Their action is mediated by the binding to glucocorticoid receptors in the cytoplasm resulting in the increased transcription of genes coding for anti-inflammatory proteins. Formoterol is a selective beta2-adrenergic agonist that produces relaxation of bronchial smooth muscle in patients with reversible airways obstruction. Glycopyrronium is a high-affinity, long-acting muscarinic receptor antagonist used for inhalation as bronchodilator treatment. Glycopyrronium works by blocking the bronchoconstrictor action of acetylcholine on airway smooth muscle cells, thereby dilating the airways.

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Tinova is indicated for Maintenance treatment in adult patients with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist or a combination of a long-acting beta2-agonist and a long-acting muscarinic antagonist.
Maintenance treatment of asthma, in adults not adequately controlled with a maintenance combination of a long-acting beta2-agonist and medium dose of inhaled corticosteroid.

Route of administration:
Tinova® should be taken as inhaler in oral route.
The recommended dose of Tinova® is two inhalations twice daily. Patients should be advised to take Tinova® every day even when asymptomatic. If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief.

Asthma
When choosing the starting dose strength of Tinova®, the patients' disease severity, their previous asthma therapy including the inhaled corticosteroid (ICS) dose, the patient’s current control of asthma symptoms and risk of future exacerbation should be considered.

Stepping-down treatment
Patients should be regularly reassessed by a doctor so that dosage remain optimal and is only changed on medical advice. The doses should be titrated to the lowest doses at which effective control of asthma symptoms is maintained.

Pregnancy: There are no adequate and well-controlled studies in pregnant women with this combination. The combination should not be used during pregnancy.
Lactation: There is no information regarding the presence of this combination in human milk, the effects on the breastfed infant or the effects on milk production.

Use in children and adolescents
The safety and efficacy in children and adolescents aged below 18 years have not been established.

The combination is not indicated for the treatment of acute episodes of bronchospasm or to treat an acute disease exacerbation. It should be used with caution in patients with cardiac arrhythmias especially third degree atrioventricular block and tachyarrhythmia, idiopathic subvalvular aortic stenosis, hypertrophic obstructive cardiomyopathy, severe heart disease, occlusive vascular diseases, arterial hypertension, aneurysm, thyrotoxicosis, diabetes mellitus, pheochromocytoma, hypokalaemia, narrow-angle glaucoma, prostatic hyperplasia and in patients with severe hepatic and renal impairment. There’s a risk of paradoxical bronchospasm, deterioration of disease, pneumonia in patients with COPD, systemic corticosteroid effects, hyperglycaemia, oropharyngeal infections following administration of this combination. Caution should be taken and patients should be advised to rinse their mouth or gargle with water or brush their teeth after inhaling the prescribed dose. Patients should be regularly reassessed and abrupt withdrawal should be avoided. If anaesthesia with halogenated anaesthetics is planned, it should be ensured that the combination is not administered for at least 12 hours before the start of anaesthesia as there is a risk of cardiac arrhythmias.

The most common side effects are pneumonia (in COPD patients), pharyngitis, oral candidiasis, urinary tract infection, nasopharyngitis, headache and dysphonia.

It is contraindicated in patient with hypersensitivity to beclometasone dipropionate, formoterol, glycopyrronium or any other components of this product.

Drug interaction with medication: Caution should be taken in concomitant use with beta-adrenergic drugs, quinidine, disopyramide, procainamide, antihistamines, monoamine oxidase inhibitors, tricyclic antidepressants and phenothiazines, L-dopa, L-thyroxine, oxytocin, xanthine derivatives, steroids or diuretics as there’s a risk of adverse reactions. Non-cardioselective beta blockers (including eye drops) should be avoided in patients taking inhaled formoterol. The long term co-administration of this combination with other anticholinergic drugs is not recommended.

Drug interaction with food and others: Not applicable

In cases of overdose, proper monitoring and general supportive measures should be initiated.

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No Data

Each actuation delivers Formoterol Fumarate Dihydrate BP 6 µg, Glycopyrronium 10 µg as Glycopyrronium Bromide BP and Beclometasone Dipropionate BP 100 µg.

Storage
Store in a refrigerator at 2°C-8°C. Do not freeze. After first use, store the inhaler below 25°C for up to 3 months. Do not put the using inhaler back into the refrigerator. Keep away from the reach of children.

Packing
Tinova: Each canister contains 120 metered actuations.