Formatide HFA 4.5/160 Inhaler

Indications of Formatide HFA 4.5/160 Inhaler

This is used to treat asthma on a regular basis. They're also used to treat the symptoms of severe chronic obstructive pulmonary disease (COPD) in those who have had repeated exacerbations despite taking long-acting bronchodilators.

Pharmacology of Formatide HFA 4.5/160 Inhaler

Budesonide: It is an anti-inflammatory corticosteroid with strong glucocorticoid activity and weak mineralocorticoid activity. Inflammation is an important part of the pathogenesis of asthma. Corticosteroids affect a variety of cell types (such as mast cells, eosinophils, neutrophils, macrophages, and lymphocytes) and mediators involved in allergic and non-allergic mediation of inflammation (such as histamine, eicosanoids), Leukotrienes and cytokines) have a wide range of inhibitory activities. These anti-inflammatory effects of corticosteroids may contribute to their effectiveness in asthma.

Formoterol Fumarate Dihydrate: It is a long-acting selective β2 adrenergic agonist with rapid onset. Inhaled formoterol fumarate dihydrate BP acts as a bronchodilator locally in the lungs. The pharmacological effects of β2 adrenergic receptor agonist drugs are due to the stimulation of intracellular adenylate cyclase, which catalyzes the conversion of adenosine triphosphate (ATP) to cyclic AMP. Elevated levels of cyclic AMP cause relaxation of bronchial smooth muscle and inhibit cells, especially mast cells, from releasing immediate hypersensitivity mediators.

Dosage & Administration of Formatide HFA 4.5/160 Inhaler

Inhaler (For Asthma)-
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, an additional puff should be taken. Not more than 6 puffs should be taken on any single occasion.

Children: The usual maintenance dose is 1 -2 puffs once or twice daily. Patients should take 1 additional puff as needed in response to symptoms. If symptoms persist after a few minutes, an additional puff should be taken. Not more than 4 puffs should be taken on any single occasion.

Inhalation Capsule (For Asthma): There are two alternative dosage regimens for the treatment of asthma the Budesonide and Formoterol combination. Budesonide and Formoterol 100 & 200 Inhalation Capsule maintenance and reliever therapy.
Adults and adolescents (12 years and older):

Maintenance dose: Budesonide and Formoterol 100 & 200 Inhalation Capsule twice daily

Reliever dose: 1 additional Inhalation Capsule as needed in response to symptoms. If symptoms persist after a few minutes, an additional Inhalation Capsule should be taken. Not more than 6 Inhalation capsules should be taken on any single occasion. A total daily dose of more than 8 Inhalation capsules is not normally needed, however, a total daily dose of up to 12 Inhalation capsules can be used temporarily.

Children (4 years and older):
Maintenance dose: Budesonide and Formoterol 100 Inhalation Capsule once daily.

Reliever dose: 1 additional Inhalation Capsule as needed in response to symptoms. If symptoms persist after a few minutes, an additional Inhalation Capsule should be taken. Not more than 4 Inhalation capsules should be taken on any single occasion. A total daily dose of more than 4 Inhalation capsules is not normally needed, however, a total daily dose of up to 8 Inhalation capsules could be used temporarily.

Inhalation Capsule (For COPD): Adults (40 years and older)
200 Inhalation Capsule: 2 Inhalation Capsules twice daily. Maximum daily maintenance dose: 4 Inhalation Capsule

400 Inhalation Capsule: 1 Inhalation Capsule twice daily. Maximum daily maintenance dose: 2 Inhalation capsules.

Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):

Take off the cap.

Shake the inhaler (at least six times) vigorously before each use.

If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.

Breathe out as fully as comfortably possible & hold the inhaler upright.

Place the actuator into the mouth between the teeth and close the lips around the mouthpiece.

While breathing deeply and slowly through the mouth, press down firmly and add fully to the canister to release medicine.

Remove the inhaler from the mouth. Continue holding your breath for at least for 10 seconds or as long as it is comfortable.

If the doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.

After use, replace the cap on the mouthpiece. After each treatment, rinse your mouth with water.

Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around the mouthpiece, or you may not be breathing in as you press the can. This indicates a failure of the technique. If this happens, repeat the procedure from step 4 carefully.

Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove the canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.

Interaction of Formatide HFA 4.5/160 Inhaler

Concomitant treatment with Ritonavir, Itraconazole, Ketoconazole, or other potent CYP3A4 inhibitors should be avoided.

Contraindications

Hypersensitivity to Budesonide, Formoterol, or to Lactose.

Side Effects of Formative HFA 4.5/160 Inhaler

Budesonide can cause hoarseness and mouth and throat candidiasis (thrush) in some persons. There have been reports of cutaneous hypersensitivity responses.

Tremors, palpitations, and headaches have all been reported after using formoterol fumarate dihydrate. Some patients may experience cardiac arrhythmias, muscle cramps, and hypersensitivity reactions such as rash, edema, and angioedema.

Pregnancy & Lactation

Budesonide and Formoterol Fumarate should only be used in pregnant women and nursing mothers if the estimated benefit to the mother outweighs any potential harm to the fetus.

Precautions & Warnings

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.

Storage Conditions

Protect from light, and store in a cool & dry place. Do not store above 30° C. Keep out of the reach of children. Protect from freezing.