Glycopyrrolate 0.2mg/ml Inj, 20ml

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. Its quaternary ammonium structure limits its ability to cross the blood-brain barrier, resulting in minimal central nervous system effects at therapeutic doses. It reduces salivary, tracheobronchial, and pharyngeal secretions, and gastric acid secretion.

Serious Side Effects: Seek Medical Help Immediately

Although rare, this medication can cause severe and potentially life-threatening side effects. If you experience 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. 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
- Bleeding ulcer
+ Myasthenia gravis
+ Urinary retention or difficulty passing urine
A history of 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 consult your doctor or pharmacist if you are unsure.
Concurrent use of anticholinergic medications, such as ipratropium or oxybutynin. If you are unsure whether any of your medications are anticholinergics, ask your doctor.

This list is not exhaustive, and it is crucial to discuss all your medications (prescription, over-the-counter, natural products, and vitamins) and health conditions with your doctor and pharmacist. They will help you determine whether it is safe to take this medication with your existing medications and health conditions. Never start, stop, or modify the dosage of any medication without 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 any activity that requires alertness and clear vision, wait until you understand how this medication affects you.

Discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter medications that may cause drowsiness, with your doctor before consumption.

If you experience constipation, consult your doctor, as there may be ways to mitigate this side effect.

Be cautious in hot weather and during 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, exercise caution when using this medication, as you may be more susceptible to side effects.

For pediatric patients, use this medication with caution, as the risk of certain side effects may be higher in children.

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 serious 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 solid dosage forms): Increased risk of GI lesions due to decreased GI motility.
• Cholinesterase inhibitors (e.g., donepezil, rivastigmine, galantamine): Antagonistic effects, reducing efficacy of cholinesterase inhibitors.

• Other anticholinergic drugs (e.g., atropine, scopolamine, tricyclic antidepressants, phenothiazines, antihistamines): Additive anticholinergic effects (dry mouth, blurred vision, urinary retention, constipation, tachycardia).
• Opioid analgesics: Increased risk of severe constipation and paralytic ileus.
• Antacids: May decrease absorption of oral glycopyrrolate (not relevant for injection).
• Drugs that prolong QT interval: Theoretical risk of additive QT prolongation, though not a primary effect of glycopyrrolate.

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

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

L3 (Moderately Safe). Limited human data suggest low levels in breast milk. May decrease milk production due to anticholinergic effects. Monitor infant for anticholinergic effects (e.g., constipation, dry mouth, drowsiness).

Dosing is weight-based. Use with caution in infants and young children due to increased susceptibility to anticholinergic effects and potential for hyperthermia. Not recommended for routine use in neonates.

Use with caution due to increased susceptibility to anticholinergic side effects (e.g., urinary retention, constipation, confusion, dry mouth, blurred vision). Start with lower doses and titrate carefully. Patients with prostatic hypertrophy are at higher risk for urinary retention.

• Glycopyrrolate is preferred over atropine for reversal of neuromuscular blockade due to its slower onset and longer duration of action, which better matches that of neostigmine/pyridostigmine, and its limited CNS penetration, reducing central anticholinergic side effects.
• Its quaternary ammonium structure means it does not readily cross the blood-brain barrier, making it less likely to cause central anticholinergic effects (e.g., delirium, sedation) compared to tertiary amines like atropine.
• Effective in reducing salivary and bronchial secretions, making it useful as a pre-anesthetic agent, especially in procedures where a dry field is critical or to prevent aspiration.
• Can cause dose-dependent tachycardia; monitor heart rate carefully, especially in patients with pre-existing cardiac conditions.
• Always ensure adequate hydration and monitor for urinary retention, particularly in elderly males with benign prostatic hyperplasia.

• Atropine (for anticholinergic effects, but with more CNS penetration and different pharmacokinetics)
• Scopolamine (for antisialagogue effects, but with significant CNS effects)
• Hyoscyamine (for GI antispasmodic effects, but different indications for injection)

If your symptoms or health problems do not improve or worsen over time, it is essential to contact your doctor for further evaluation and guidance.

To ensure safe use, do not share your medication with others, and never take someone else's medication. Store all medications in a secure location, out of the reach of children and pets, to prevent accidental ingestion.

Proper disposal of unused or expired medications is crucial. Do not flush medications down the toilet or pour them down the drain unless specifically instructed to do so by a healthcare professional or pharmacist. If you are unsure about the best method for disposing of medications, consult with your pharmacist, who can provide guidance on safe disposal practices. Additionally, you may want to inquire about potential drug take-back programs in your area.

Some medications may come with an additional patient information leaflet. If you have questions or concerns about your medication, it is recommended that you consult with your pharmacist, who can provide further information and clarification.

In the event of a suspected overdose, it is critical to seek immediate medical attention or contact your local poison control center. When reporting the incident, be prepared to provide detailed information about the medication taken, including the amount and time of ingestion, to ensure prompt and effective treatment.