I-Breath Plus

I-Breath Plus

ipratropium bromide + salbutamol

Manufacturer:

ACME

Distributor:

Bell-Kenz Pharma

Marketer:

Euro Generics
Full Prescribing Info
Contents
Salbutamol sulfate, ipratropium bromide.
Description
Each actuation delivers: Salbutamol (as sulfate) 100 mcg, Ipratropium bromide 20 mcg.
Action
Pharmacology: Salbutamol + Ipratropium bromide (i-BREATH PLUS) Metered Dose Inhaler (MDI) is a combination of Salbutamol (as sulfate) and Ipratropium Bromide. It is a hydrofluoroalkane (HFA) based environment friendly inhaler because it does not contain chlorofluorocarbon (CFC) as propellant which is one of the main reasons of ozone layer depletion.
Salbutamol is a short acting beta-adrenergic bronchodilator and Ipratropium bromide is an anticholinergic bronchodilator. When used in combination, Ipratropium bromide prevents the increase in intracellular concentration of cyclic guanosine monophosphate, which are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle. i-BREATH PLUS Inhalation Aerosol is expected to maximize the response of the treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms, anticholinergic (parasympatholytic) and sympathomimetic. Simultaneous administration of an anticholinergic (Ipratropium bromide) and a beta2-sympathomimetic (Salbutamol) is designed to benefit the patient by producing a greater bronchodilatory effect than when either drug is utilized alone at its recommended dosage.
Indications/Uses
Salbutamol + Ipratropium bromide (i-BREATH PLUS) Metered Dose Inhaler is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continues to have evidence of bronchospasm and who requires a second bronchodilator.
Dosage/Direction for Use
(See table.)

Click on icon to see table/diagram/image
Overdosage
The effects of overdosage are expected to be related primarily to Salbutamol sulfate. Manifestations of overdosage with Salbutamol may include angina pain, hypertension, hypokalemia and tachycardia.
Contraindications
Salbutamol + Ipratropium bromide (i-BREATH PLUS) Metered Dose Inhaler is contraindicated in patients with history of hypersensitivity to Soya-Lecithin or related food products such as soybean and peanut. It is also contraindicated in patients with hypersensitivity to any other components of the drug product or to atropine or its derivatives.
Special Precautions
Salbutamol + Ipratropium bromide (i-BREATH PLUS) Metered Dose Inhaler contains Ipratropium Bromide and, therefore, should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction. Preparations containing sympathomimetic amines such as Salbutamol sulfate should be used with caution in patients with convulsive disorders, hyperthyroidism, diabetes mellitus and in patients who are unusually responsive to sympathomimetic amines.
Use in Children: Not recommended for children.
Use In Pregnancy & Lactation
Ipratropium bromide: Pregnancy category B. Studies have demonstrated no teratogenic effects as a result of Ipratropium.
Salbutamol: Pregnancy category C. Salbutamol has been shown to be teratogenic in animals. There are, however no adequate and well-controlled studies of Salbutamol + Ipratropium bromide (i-BREATH PLUS) Metered Dose Inhaler (Salbutamol and Ipratropium bromide combination) in pregnant women. It should be used during pregnancy only if the potential benefit justifies the potential risk of the fetus. It is not known whether the components of the Salbutamol + Ipratropium bromide (i-BREATH PLUS) Inhalation Aerosol are excreted in human milk. As many drugs are excreted in human milk, Salbutamol + Ipratropium bromide (i- BREATH PLUS) should be cautiously administered to a nursing mother.
Adverse Reactions
Due to presence of Salbutamol, mild tremor and headache have been reported. These usually disappear with continuous treatment. There have been very rare reports of treatments muscle cramp, hypersensitivity reactions including angioedema, urticaria, bronchospasm and hypotension. For the presence of Ipratropium bromide, headache, influenza, chest pain, nausea, dyspnea, coughing, pharyngitis, sinusitis are rarely reported.
Drug Interactions
Salbutamol + Ipratropium bromide (i-BREATH PLUS) Metered Dose Inhaler has been used concomitantly with other drugs, including sympathomimetic bronchodilators, methylxanthines and steroids, commonly used in the treatment of COPD. No formal drug interaction studies have been performed with Salbutamol + Ipratropium bromide (i-BREATH PLUS) Metered Dose Inhaler and these or other medications commonly used in the treatment of COPD. Ipratropium Bromide should be co-administered cautiously with other anticholinergic agents and sympathomimetic agents, which may increase risk of adverse cardiovascular effects. Beta2-agonist containing drugs, like Salbutamol + Ipratropium bromide (i-BREATH PLUS) should be administered with extreme caution to patients with non-potassium sparing diuretics, monoamine oxidase inhibitors or tricyclic antidepressants.
Storage
Store at temperatures not exceeding 30°C. Protect from light.
Patient Counseling Information
How to Use Inhaler: 1. Take off the cap. Shake the inhaler (at least 6 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 air to make sure that it works.
2. Breathe out as full as comfortably possible & hold the inhaler upright.
3. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
4. While breathing deeply and slowly through the mouth, press down firmly and fully on the canister to release medicine.
5. Remove the inhaler from mouth. Continue holding breath for at least 10 seconds or as long as it is comfortable.
General Instructions: After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
Instructions for Cleaning Inhaler: Clean your inhaler at least once a week. Remove 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.
ATC Classification
R03AL02 - salbutamol and ipratropium bromide ; Belongs to the class of combination of adrenergics with anticholinergics, that may also include a corticosteroid. Used in the treatment of obstructive airway diseases.
Presentation/Packing
100 mcg/20 mcg MDI 200 doses x 1's.
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