Glycopyrrolate 0.4mg/2ml Inj, 2ml

Glycopyrrolate is a synthetic quaternary ammonium anticholinergic agent. It competitively blocks the action of acetylcholine at muscarinic receptors located on smooth muscles, cardiac muscle, secretory glands, and in peripheral ganglia. This antagonism leads to a reduction in salivary, tracheobronchial, and pharyngeal secretions, and can prevent bradycardia and other muscarinic effects associated with cholinergic agents (e.g., neostigmine, pyridostigmine) used to reverse neuromuscular blockade.

Serious Side Effects: Seek Medical Help Immediately

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention right away:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Inability to sweat during physical activity or in warm temperatures
Difficulty urinating
Chest pain or pressure, rapid heartbeat, or irregular heartbeat
Rapid breathing
Fever
Enlarged pupils
Changes in vision, eye pain, or severe eye irritation
Confusion
Diarrhea or constipation
Bloating
Abdominal swelling
Stomach pain
Erectile dysfunction

Other Possible Side Effects

Like all medications, this drug can cause side effects. While many people may not experience any side effects or only minor ones, it's essential to discuss any concerns with your doctor. If you experience any of the following side effects or any other unusual symptoms that bother you or persist, contact your doctor:

Dry mouth
Upset stomach or vomiting
Nasal congestion
Dizziness, drowsiness, fatigue, or weakness
Blurred vision
Flushing
Changes in taste
Headache
Nervousness or excitability
Sleep disturbances

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects not mentioned here. If you have questions or concerns about side effects, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Describe the allergic reaction you experienced, including the symptoms that occurred.
Certain health conditions, including:
+ Heart problems caused by bleeding
+ Glaucoma
+ Gastrointestinal (GI) issues, such as bowel blockage, slow-moving GI tract, colitis, or bleeding ulcers
+ Myasthenia gravis
+ Difficulty urinating
A history of having an enlarged colon
Current use of potassium tablets
Use of medications that can slow the movement of the GI tract or increase the risk of bowel blockage. There are many medications that can cause this effect, so ask your doctor or pharmacist if you are unsure.
Use of anticholinergic medications, such as ipratropium or oxybutynin. If you are unsure whether any of your medications are anticholinergic, consult your doctor.

This is not an exhaustive list of all potential interactions between this medication and other substances. Therefore, it is crucial to inform your doctor and pharmacist about all the medications you are taking, including:

Prescription and over-the-counter (OTC) medications
Natural products
* Vitamins

Your doctor needs to be aware of all your medications and health conditions to ensure it is safe for you to take this medication. Do not start, stop, or change the dose of any medication without first consulting your doctor.

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

Before operating a vehicle or engaging in activities that require alertness and clear vision, wait until you understand how this medication affects you.

Consult your doctor before consuming alcohol, using marijuana or other cannabis products, or taking prescription or over-the-counter medications that may impair your reactions.

If you experience constipation, discuss this with your doctor, as there may be ways to minimize this side effect.

Be cautious when exposed to high temperatures or engaging in physical activity, as this medication can increase the risk of heat stroke.

Unless your doctor advises you to limit fluid intake, drink plenty of non-caffeinated liquids after taking this medication.

You may be sensitive to bright lights; wearing sunglasses can help alleviate this issue.

If you are 65 years or older, use this medication with caution, as you may be more susceptible to side effects.

When administering this medication to children, exercise caution, as the risk of certain side effects may be higher in this population.

Some formulations of this product contain benzyl alcohol. If possible, avoid using products with benzyl alcohol in newborns or infants, as high doses of benzyl alcohol can cause severe side effects, particularly when combined with other medications containing benzyl alcohol. Consult your doctor to determine if this product contains benzyl alcohol.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor, as you will need to discuss the potential benefits and risks to both you and your baby.

• Potassium chloride (oral forms): Increased risk of GI lesions due to decreased GI motility.
• Other anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines): Additive anticholinergic effects (e.g., dry mouth, blurred vision, urinary retention, constipation, tachycardia).

• Opioid analgesics: Increased risk of severe constipation and/or paralytic ileus.
• Antacids: May decrease absorption of oral glycopyrrolate (not relevant for injectable form, but good to note for general drug class).
• Digoxin: May increase digoxin levels due to decreased GI motility (oral form).
• Corticosteroids: May increase intraocular pressure.

• Cholinergic agents (e.g., donepezil, rivastigmine): Glycopyrrolate may antagonize their effects.

• Dry mouth
• Blurred vision
• Urinary retention
• Constipation
• Tachycardia
• Dizziness
• Headache
• Nausea/vomiting
• Nervousness
• Flushing

Category B. Animal studies have not shown fetal harm, but human studies are limited. Use only if clearly needed.

L3 (Moderately Safe). Excreted in breast milk in small amounts. Potential for anticholinergic effects in the infant (e.g., dry mouth, constipation, decreased milk production). Use with caution, monitor infant for adverse effects.

Generally safe for use in pediatric patients for approved indications (preoperative, reversal of NMB). Dosing is weight-based. Caution in infants due to potential for increased sensitivity to anticholinergic effects.

Use with caution in elderly patients due to increased susceptibility to anticholinergic side effects (e.g., dry mouth, constipation, urinary retention, confusion, glaucoma exacerbation). Start with lower doses and titrate carefully.

• Glycopyrrolate is preferred over atropine for reversal of neuromuscular blockade in patients with pre-existing tachycardia or cardiac disease due to its lesser effect on heart rate.
• Its quaternary ammonium structure limits CNS penetration, making it less likely to cause central anticholinergic side effects (e.g., delirium, hallucinations) compared to tertiary amines like atropine.
• Often co-administered with neostigmine or pyridostigmine to counteract their muscarinic side effects (bradycardia, salivation, GI hypermotility).
• Ensure adequate hydration to mitigate dry mouth and constipation.
• Monitor for urinary retention, especially in elderly males with prostatic hypertrophy.

• Atropine (for antisialagogue or bradycardia, but with more CNS effects)
• Scopolamine (for antisialagogue, but with more CNS effects)
• Suxamethonium (for rapid sequence intubation, but different mechanism)
• Sugammadex (for reversal of rocuronium/vecuronium, different mechanism)

If your symptoms or health problems persist or worsen, it is essential to contact your doctor for further guidance. To ensure safe use, never share your medication with others, and do not take medication prescribed to someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, do not flush medications down the toilet or pour them down the drain. If you are unsure about the correct disposal method, consult your pharmacist for advice. Many communities have drug take-back programs, which your pharmacist can help you locate. Some medications may come with an additional patient information leaflet; check with your pharmacist to see if this applies to your prescription. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the amount, and the time it was taken to ensure prompt and effective treatment.