Supotaria Respirator Solution

Glycopyrrolate respirator solution is indicated for the long-term maintenance treatment for patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Glycopyrrolate is a long-acting muscarinic antagonist which has similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, it exhibits pharmacological effects through inhibition of M3 receptor at the smooth muscle leading to bronchodilation.

The Glycopyrronium nebulizer solution is intended only for inhalation with high-efficiency mesh nebulizer and should not be taken orally or administered parenterally. The recommended dose of Glycopyrrolate is the inhalation of the contents of one ampoule twice-daily with high-efficiency mesh nebulizer. Glycopyrrolate should be administered at the same time of the day, (1 ampoule in the morning and 1 ampoule in the evening), every day. More frequent administration or a greater number of inhalations (more than 1 ampoule twice daily) of Glycopyrronium Bromide inhalation solution is not recommended.

Store the ampoule in the blister foil, and only remove immediately before use. No dosage adjustment is required for geriatric patients, patients with hepatic impairment, or patients with mild to moderate renal impairment.

How to use:

• Open the packet and remove the blister. Carefully separate an ampoule from the blister.
• Twist of the top. Always hold the ampoule upright.
• Squeeze the desired amount of the Nebuliser Solution into the Nebuliser chamber.
• If dilution is needed follow the doctors instruction.

Sympathomimetics and Steroids: In clinical studies, concurrent administration of glycopyrrolate and other drugs commonly used in the treatment of COPD including sympathomimetics (long and short-acting beta2 agonists), anticholinergics (short-acting anti-muscarinic antagonists), oral and inhaled steroids showed no increases in adverse drug reactions.

Anticholinergics: There is a potential for an additive interaction with concomitantly used anticholinergic medications. Therefore, avoid unnecessary co-administration of glycopyrrolate with other anticholinergic containing drugs as this may lead to an increase in anticholinergic effects.

Glycopyrrolate is contraindicated in patients with a hypersensitivity to glycopyrrolate or any of the ingredients (Sodium Chloride, Citric Acid Monohydrate, Sodium Hydroxide, Hydrochloric Acid and Water for Injection).

The following adverse reactions are found:

• shortness of breath,
• urinary tract infection,
• wheezing,
• upper respiratory tract infection,
• runny nose,
• fatigue.

There are no adequate and well-controlled studies in pregnant women. Glycopyrrolate should only be used during pregnancy if the expected benefit to the patient outweighs the potential risk to the fetus. Glycopyrrolate is not indicated for use in children.

Do not initiate in acutely deteriorating COPD or to treat acute symptoms-

• If paradoxical bronchospasm occurs, discontinue Supotaria nebulizer solution immediately and institute alternative therapy
• Worsening of narrow-angle glaucoma may occur. Use with caution in patients with narrow-angle glaucoma & instruct patients to contact a physician immediately if symptoms occur
• Worsening of urinary retention may occur. Use with caution in patients with prostatic hyperplasia or bladder neck obstruction and instruct patients to consult a physician immediately if symptoms occur.
• As the product contains no preservative, a fresh ampoule should be used for each dose and ampoule should be opened immediately before administration. Do not store above 25°C.

An overdose of glycopyrrolate may lead to anticholinergic signs and symptoms such as nausea, vomiting, dizziness, lightheadedness, blurred vision, increased intraocular pressure (causing pain, vision disturbances, or reddening of the eye), obstipation or difficulties in voiding

Bronchodilator

Keep in a dry place and store below 30°C. Protect from light and keep out of the reach of children.