Iprex 20 mcg-puff

Description

Indications
Nebulizer Solution: This medication is indicated for the treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD). It is also recommended when used in combination with inhaled beta-2 agonists for the management of reversible airway obstruction, as seen in both acute and chronic asthma conditions.

Inhaler: The inhaler is used as a bronchodilator for treating chronic reversible airway obstruction, including in conditions like asthma and chronic obstructive pulmonary disease (COPD), which encompasses chronic bronchitis and emphysema. Additionally, it is effective in treating acute reversible airway obstruction.

This medication should only be used as directed by a registered healthcare provider.

Pharmacology
Ipratropium Bromide is a quaternary ammonium compound with anticholinergic properties. It works by inhibiting vagal reflexes, which are mediated by acetylcholine, a neurotransmitter released from the vagus nerve. This inhibition occurs through the antagonism of acetylcholine at the muscarinic receptor sites on bronchial smooth muscle. As a result, the compound prevents the increase in intracellular cyclic guanosine monophosphate (cGMP) that is typically caused by acetylcholine interaction with these receptors. This ultimately leads to bronchodilation and a reduction in bronchospasm.

Dosage
Nebulizer Solution

• Adults (including the elderly) and children over 12 years: The recommended dose is 250-500 micrograms (1 to 2 ml), administered 3 to 4 times daily.
• For acute bronchospasm: 500 micrograms (2 ml) per dose is advised. The daily dose should not exceed 2 mg in adults and children over 12 years unless under direct medical supervision.
• Children aged 6-12 years: The usual dose is 250 micrograms (1 ml) up to a maximum of 1 mg (4 ml) per day. The exact dosing schedule should be determined by the physician.
• Children aged 0-5 years (for acute asthma treatment only): The dosage ranges from 125-250 micrograms (0.5 ml to 1 ml) up to a maximum total daily dose of 1 mg (4 ml). The medication should be administered no more frequently than every 6 hours in children under 5 years, and repeated doses can be given until the patient is stable.

This nebulizer solution may be combined with short-acting beta-2 agonists in the same nebulizer chamber. Use the solution as soon as it is mixed and discard any unused portion. The medication can be administered using various commercially available nebulizing devices, and in some cases, it may need to be diluted (usually to 2-4 ml) using sterile 0.9% sodium chloride solution for compatibility with specific nebulizer types. The solution is intended solely for inhalation and should never be ingested or injected.

Inhaler

• Adults: The typical dose is 1-2 puffs (20 gm/spray) three to four times daily. In some instances, up to 4 puffs (80 gm) may be required during early treatment to achieve optimal therapeutic benefit. The total number of inhalations should not exceed 12 within a 24-hour period.
• Children aged 6-12 years: The usual dose is 1-2 puffs, two to three times daily.
• Children under 6 years: The recommended dose is 1 puff (20 gm) three times daily. It is essential that an adult supervises the use of the inhaler in children to ensure proper administration.

There is no specific guidance available for the use of this product in elderly patients, though clinical trials have included patients over 65 years without reporting any specific adverse reactions for this age group.

This medication should only be used as directed by a registered healthcare provider.

Administration
Proper inhaler use is essential for effective treatment. Many patients do not use their inhalers correctly, which can reduce the amount of medicine that reaches the lungs. Correct and consistent use of the inhaler can prevent or minimize the severity of asthma attacks.

Follow these steps to use the inhaler effectively (as outlined in the “National Asthma Guidelines for Medical Practitioners” from the Asthma Association):

• Remove the cap from the inhaler.
• Shake the inhaler vigorously (at least six times) before each use.
• If the inhaler is new or hasn’t been used for over a week, shake it well and release one puff into the air to ensure it works properly.
• Exhale fully, then hold the inhaler upright.
• Place the mouthpiece between your teeth and close your lips tightly around it.
• While breathing deeply and slowly through your mouth, press down on the canister to release the medicine.
• Remove the inhaler from your mouth and hold your breath for at least 10 seconds, or as long as comfortable.
• If more than one inhalation is prescribed, wait at least 1 minute between puffs, shake the inhaler again, and repeat steps 4 to 7.
• After use, replace the cap on the mouthpiece and rinse your mouth with water to minimize irritation.

It’s important to clean the inhaler regularly, at least once a week: Remove the canister and rinse the plastic parts (mouthpiece and cap) in warm water. Do not immerse the metal canister in water. After washing, dry the parts thoroughly and reassemble them.

This medication should only be used as prescribed by a registered healthcare provider.

Interaction
This product can be used with other drugs, such as sympathomimetic bronchodilators, methylxanthines, steroids, and cromolyn sodium, commonly prescribed for COPD. There have been no significant adverse drug reactions reported when used together with these treatments. However, there is a lack of comprehensive studies on the interaction effects between Ipratropium and these medications.

Contraindications

• Nebulizer Solution: This solution is contraindicated for individuals with known hypersensitivity to atropine or its derivatives, or to any other component of the formulation.
• Inhaler: This inhaler should not be used by individuals who have a known hypersensitivity to Ipratropium, Atropine, or its derivatives. It is also contraindicated for individuals with a history of hypersensitivity to soya lecithin or related products like soybean or peanuts.

Side Effects

• Nebulizer Solution
  Common side effects: Headache, dizziness, cough, inhalation-induced bronchospasm, dry mouth, vomiting.
  Less common: Urticaria, tachycardia, skin rash, itching.
  Rare side effects: Anaphylactic reactions, eye pain, pupil dilation, increased intraocular pressure, palpitations, atrial fibrillation, nausea.

• Inhaler
  Rare, potentially life-threatening effects: Severe adverse reactions from muscarinic receptor inhibition are theoretically possible but highly unlikely with metered-dose aerosols.
  Common side effects: Dry mouth, cough, irritation, headache, nausea, dizziness, blurred vision, and difficulty in accommodation.
  Serious adverse effects: Tachycardia, nervousness, paresthesias, drowsiness, difficulty with coordination, skin rash, hives, flushing, alopecia, constipation, tremors, and mucosal ulceration. There have been reports of narrow-angle glaucoma worsening, acute eye pain, and hypotension. Allergic reactions, including skin rashes, angioedema, laryngospasm, and anaphylaxis, have been reported in rare cases.

Pregnancy & Lactation
The safety of Ipratropium Nebulizer Solution during pregnancy has not been conclusively established. The potential benefits of using this solution during pregnancy must be carefully weighed against the possible risks to the fetus. It is also unclear whether Ipratropium is excreted into breast milk. Caution is recommended when using this solution while breastfeeding.

Precautions & Warnings

• Nebulizer Solution: Close medical supervision is recommended during initial dosing. Caution is necessary when using anticholinergic agents in patients with narrow-angle glaucoma, prostatic hyperplasia, bladder obstruction, or cystic fibrosis. Rare cases of hypersensitivity reactions, such as urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema, have been reported. If the nebulizer solution enters the eyes, it may lead to ocular complications such as mydriasis, increased intraocular pressure, or eye pain.
• Inhaler: If the aerosol comes into contact with the eyes, it can cause temporary blurred vision, eye pain, and potentially worsen narrow-angle glaucoma. Immediate medical attention should be sought if symptoms worsen or do not improve.

Overdose Effects
Overdose by inhalation is unlikely as Ipratropium is not well absorbed systemically after aerosol administration. Inhalation of 5 mg may lead to mild side effects such as an increased heart rate and palpitations. Oral ingestion of a single 30 mg dose has caused mild anticholinergic side effects, but these did not require specific treatment or reversal.

Therapeutic Class
Anticholinergic bronchodilators

Storage Conditions
This product does not contain preservatives, so each ampoule should be used fresh. Open the ampoule immediately before administration and discard any unused solution. Store the product below 25°C, and keep the ampoules in their outer carton to protect them from light.