G-Ipra 250 mcg/ml

Description

Indications
Nebuliser Solution: It is indicated for the treatment of reversible bronchospasm associated with chronic obstructive pulmonary disease (COPD). It is also indicated, when used concomitantly with inhaled beta 2-agonists, for treatment of reversible airway obstruction as in acute and chronic asthma.

Inhaler: As a bronchodilator in the treatment of chronic reversible airway obstruction as in asthma and chronic obstructive pulmonary disease, including chronic bronchitis and emphysema. Also used for the treatment of acute reversible airway obstruction.

Pharmacology
Ipratropium Bromide is a quaternary ammonium compound with anticholinergic properties. It inhibits vagal reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve. Anticholinergics prevent the increase in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) caused by the interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.

Dosage
Nebuliser Solution:
Adults (including elderly) and children over 12 years: 250-500 micrograms (1 ml or 2 ml) 3 to 4 times daily.
For acute bronchospasm: 500 micrograms/2 ml. It is advisable not to exceed the recommended daily dose. Daily doses exceeding 2 mg should only be given under medical supervision.
Children 6-12 years: 250 micrograms (1 ml) up to a total daily dose of 1 mg (4 ml). The physician may determine the time interval between doses.
Children 0-5 years (for acute asthma only): 125-250 micrograms (0.5 ml-1 ml) up to a total daily dose of 1 mg (4 ml). Administer no more frequently than every 6 hours in children under 5 years.

Ipratropium Nebuliser Solution may be combined with a short-acting beta 2-agonist in the same nebulizer chamber and should be used immediately after mixing. The solution may need dilution with sterile sodium chloride 0.9% to obtain a suitable volume for the nebulizer (usually 2-4 ml). It is intended only for inhalation and should not be taken orally or administered parenterally.

Inhaler:
Adults: 1-2 puffs (20 mcg/spray) three to four times daily. A single dose up to 80 mcg (4 puffs) may be needed initially. Do not exceed 12 inhalations in 24 hours.
Children 6-12 years: 1-2 puffs two to three times daily.
Children below 6 years: 1 puff (20 mcg) three times daily, with adult supervision.

Administration
Correct and regular use of the inhaler ensures effective treatment and reduces asthma attack severity. Follow these steps for proper use:

• Remove the cap and shake the inhaler at least six times before each use.
• If new or unused for a week, release one puff into the air before use.
• Breathe out fully, hold the inhaler upright, and place the mouthpiece between the teeth.
• While inhaling deeply, press down firmly to release the medicine.
• Remove the inhaler and hold the breath for 10 seconds or as long as comfortable.
• If another dose is required, wait 1 minute, shake the inhaler, and repeat.
• Rinse mouth with water after use.

Cleaning Instructions:
Clean the inhaler at least once a week. Remove the canister, rinse the plastic actuator and cap in warm water, dry thoroughly, and reassemble. Do not immerse the metal canister in water.

Interaction
Inhaler: It has been used concomitantly with sympathomimetic bronchodilators, methylxanthines, steroids, and cromolyn sodium without adverse interactions. However, no comprehensive studies exist evaluating the interaction effects.

Contraindications
Nebuliser Solution: Hypersensitivity to atropine or its derivatives or any other component.
Inhaler: Hypersensitivity to Ipratropium, Atropine, or its derivatives. Also contraindicated in patients allergic to soya lecithin, soybean, or peanut.

Side Effects
Nebuliser Solution:

• Common: Headache, dizziness, cough, dry mouth, vomiting, inhalation-induced bronchospasm.
• Uncommon: Urticaria, tachycardia, skin rash, pruritus.
• Rare: Anaphylactic reactions, eye pain, mydriasis, increased intraocular pressure, palpitations, atrial fibrillation, nausea.

Inhaler:

• Common: Dry mouth, cough, headache, nausea, dizziness, blurred vision, irritation from aerosol.
• Less Frequent: Tachycardia, nervousness, paresthesia, drowsiness, coordination difficulty, itching, hives, flushing, alopecia, constipation, tremor, mucosal ulceration.
• Rare: Allergic reactions, angioedema, laryngospasm, anaphylaxis.

Pregnancy & Lactation
The safety of Ipratropium Nebulizer Solution during pregnancy has not been established. Use should be considered only if the benefits outweigh the risks. It is unknown whether it is excreted in breast milk; caution is advised when administering to nursing mothers.

Precautions & Warnings
Nebuliser Solution:

• Requires close medical supervision, especially during initial dosing.
• Caution in patients with narrow-angle glaucoma, prostatic hyperplasia, bladder-outflow obstruction, or cystic fibrosis.
• Avoid contact with eyes to prevent ocular complications.
• Use a mouthpiece for administration; if using a mask, ensure a proper fit.

Inhaler:

• May cause temporary vision blurring or exacerbate narrow-angle glaucoma if sprayed into eyes.
• Seek immediate medical attention if symptoms worsen despite recommended dosage.
• Not for initial treatment of acute bronchospasm; faster-acting drugs should be considered first.

Overdose Effects
Acute overdose by inhalation is unlikely as it is poorly absorbed systemically. High doses may cause increased heart rate and palpitations. Large oral doses may cause mild anticholinergic side effects but generally do not require specific treatment.

Therapeutic Class
Anticholinergic bronchodilators

Storage Conditions
As the product contains no preservative, use a fresh ampoule for each dose. Do not store above 25°C. Keep ampoules in the outer carton. Any remaining solution in an opened ampoule should be discarded.

Use this medication only as directed by a registered physician.