Robinul Forte 2mg Tablets
It is used to treat GI (gastrointestinal) ulcers.It may be given to you for other reasons. Talk with the doctor.
Drug Class
Anticholinergic, Antispasmodic
Pharmacologic Class
Muscarinic receptor antagonist
Pregnancy Category
Category B
FDA Approved
Jul 1961
DEA Schedule
Not Controlled
Overview
What is this medicine?
Glycopyrrolate is a medication that helps reduce stomach acid, muscle spasms in the digestive system, and excessive body secretions like saliva and sweat. It's often used to treat stomach ulcers or to help with conditions like excessive drooling or sweating.
How to Use This Medicine
Taking Your Medication
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
To use this medication correctly, follow your doctor's instructions and read all the information provided. Continue taking the medication as directed by your doctor or healthcare provider, even if you start to feel better.
Storing and Disposing of Your Medication
Store the medication at room temperature in a dry location, avoiding the bathroom. Keep all medications in a safe place, out of the reach of children and pets. Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so. If you have questions about disposing of medications, consult your pharmacist. You may also want to check if there are drug take-back programs available in your area.
Missing a Dose
If you miss a dose, take it as soon as you remember. However, if it's close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not take two doses at the same time or take extra doses to make up for the missed one.
Lifestyle & Tips
- Take this medication on an empty stomach, at least one hour before meals or two hours after meals, for best absorption.
- Stay well-hydrated to help manage dry mouth and prevent constipation.
- Avoid activities that may lead to overheating (e.g., strenuous exercise in hot weather) as this medication can reduce sweating and increase the risk of heatstroke.
- Use caution when driving or operating machinery until you know how this medication affects you, as it can cause blurred vision or dizziness.
- If you experience dry mouth, try sugar-free candy, gum, or artificial saliva products.
Available Forms & Alternatives
Available Strengths:
Generic Alternatives:
Dosing & Administration
Adult Dosing
Standard Dose:
2 mg orally two or three times a day
Dose Range:
1 - 8 mg
Condition-Specific Dosing:
pepticUlcer:
1 mg three times a day or 2 mg two or three times a day. Some patients may require 2 mg three times a day. Maximum recommended daily dosage is 8 mg.
Pediatric Dosing
Neonatal:
Not established for peptic ulcer. Off-label use for sialorrhea (drooling) is weight-based and titrated.
Infant:
Not established for peptic ulcer. Off-label use for sialorrhea (drooling) is weight-based and titrated.
Child:
Not established for peptic ulcer. Off-label use for sialorrhea (drooling) is weight-based and titrated (e.g., 0.02 mg/kg/dose, 2-3 times daily, max 0.1 mg/kg/dose or 2 mg/dose).
Adolescent:
Not established for peptic ulcer. Off-label use for sialorrhea (drooling) is weight-based and titrated.
Dose Adjustments
Renal Impairment:
Mild:
No specific adjustment recommended, but monitor for increased anticholinergic effects.
Moderate:
Use with caution. Consider dose reduction (e.g., 50% of usual dose) and monitor for increased anticholinergic effects.
Severe:
Contraindicated in severe renal impairment (e.g., ESRD) due to primary renal excretion and potential for accumulation.
Dialysis:
Not dialyzable. Contraindicated in patients on dialysis.
Hepatic Impairment:
Mild:
No specific adjustment recommended.
Moderate:
No specific adjustment recommended, as hepatic metabolism is minimal.
Severe:
No specific adjustment recommended, as hepatic metabolism is minimal.
Pharmacology
Mechanism of Action
Glycopyrrolate is a synthetic quaternary ammonium anticholinergic agent. It competitively antagonizes the action of acetylcholine at muscarinic receptors located on smooth muscles, cardiac muscle, secretory glands, and in peripheral ganglia. In the gastrointestinal tract, it reduces gastric acid secretion, gastric motility, and intestinal spasms. It also reduces salivary, bronchial, and sweat gland secretions.
Pharmacokinetics
Absorption:
Bioavailability:
<10% (oral)
Tmax:
1-3 hours
FoodEffect:
Food significantly decreases the extent of absorption (up to 65%) and delays Tmax. Should be taken on an empty stomach.
Distribution:
Vd:
0.2-0.6 L/kg
ProteinBinding:
10-30%
CnssPenetration:
Limited (due to quaternary ammonium structure, does not readily cross the blood-brain barrier)
Elimination:
HalfLife:
0.8-1.2 hours (oral)
Clearance:
Not readily available for oral form, primarily renal clearance of unchanged drug.
ExcretionRoute:
Primarily renal (85% unchanged in urine), with some fecal excretion (5%).
Unchanged:
Approximately 85% (in urine)
Pharmacodynamics
OnsetOfAction:
Within 1 hour (oral)
PeakEffect:
1-3 hours
DurationOfAction:
Approximately 4-6 hours (for antisecretory effect)
Safety & Warnings
Side Effects
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.
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.
Seek Immediate Medical Attention If You Experience:
- Severe or persistent constipation
- Inability to urinate or difficulty passing urine
- Severe blurred vision or eye pain
- Rapid or irregular heartbeat
- Confusion, disorientation, or hallucinations
- Severe dizziness or fainting
- Signs of heatstroke (e.g., fever, hot dry skin, confusion, rapid pulse)
Before Using This Medicine
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 any symptoms.
Certain health conditions, including:
+ Heart problems caused by bleeding
+ Glaucoma
+ Gastrointestinal (GI) issues, such as bowel blockage, slow-moving GI tract, colitis, or 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 GI tract movement 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 anticholinergic, 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 other medications and health conditions. Never start, stop, or change the dose of any medication without consulting 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 any symptoms.
Certain health conditions, including:
+ Heart problems caused by bleeding
+ Glaucoma
+ Gastrointestinal (GI) issues, such as bowel blockage, slow-moving GI tract, colitis, or 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 GI tract movement 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 anticholinergic, 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 other medications and health conditions. Never start, stop, or change the dose of any medication without consulting your doctor.
Precautions & Cautions
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.
Discuss the use of alcohol, marijuana, or other forms of cannabis, as well as prescription or over-the-counter (OTC) 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 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, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Before operating a vehicle or engaging in activities that require 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 (OTC) 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 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, exercise caution when using this medication, as you may be more susceptible to side effects.
If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to both you and your baby.
Overdose Information
Overdose Symptoms:
- Exaggerated anticholinergic effects such as severe dry mouth, dilated pupils, blurred vision, flushing, fever, rapid and irregular pulse, elevated blood pressure, nausea, vomiting, difficulty swallowing, muscle weakness, paralysis, central nervous system stimulation (e.g., restlessness, tremor, irritability, convulsions, delirium, hallucinations), or depression (e.g., stupor, coma).
What to Do:
Seek immediate medical attention or call a poison control center (1-800-222-1222). Treatment is supportive and symptomatic. Physostigmine may be used as an antidote for severe central anticholinergic effects.
Drug Interactions
Contraindicated Interactions
- Potassium chloride (solid oral dosage forms) - increased risk of GI lesions due to slowed GI transit.
Major Interactions
- Other anticholinergics (e.g., atropine, scopolamine, tricyclic antidepressants, antihistamines, phenothiazines, quinidine, disopyramide) - additive anticholinergic effects (e.g., dry mouth, urinary retention, constipation, blurred vision, tachycardia).
- Drugs that prolong QT interval (use with caution, theoretical risk with anticholinergics).
Moderate Interactions
- Antacids - may decrease absorption of glycopyrrolate; administer glycopyrrolate at least 1 hour before antacids.
- Digoxin (oral) - glycopyrrolate may increase digoxin absorption due to decreased GI motility.
- Ketoconazole, Itraconazole - decreased absorption due to increased gastric pH; administer glycopyrrolate at least 2 hours after these agents.
- Levodopa - decreased absorption of levodopa.
- Metoclopramide - antagonistic effects on GI motility.
Monitoring
Baseline Monitoring
Renal function (e.g., serum creatinine, eGFR)
Rationale: Glycopyrrolate is primarily renally excreted; impairment can lead to accumulation and increased side effects.
Timing: Prior to initiation, especially in elderly or those with suspected renal impairment.
Baseline symptoms (e.g., ulcer pain, drooling, sweating)
Rationale: To assess treatment efficacy.
Timing: Prior to initiation.
Routine Monitoring
Symptom control (e.g., ulcer pain, drooling, sweating)
Frequency: Regularly, as clinically indicated (e.g., weekly initially, then monthly).
Target: Reduction or resolution of target symptoms.
Action Threshold: Lack of efficacy or worsening symptoms may require dose adjustment or alternative therapy.
Anticholinergic side effects (e.g., dry mouth, constipation, urinary retention, blurred vision, tachycardia)
Frequency: Regularly, especially during dose titration.
Target: Tolerable level of side effects.
Action Threshold: Intolerable or severe side effects may require dose reduction or discontinuation.
Bowel habits
Frequency: Regularly
Target: Regular bowel movements.
Action Threshold: Significant constipation may require intervention (e.g., laxatives) or dose adjustment.
Urinary output/hesitancy
Frequency: Regularly
Target: Normal urinary flow.
Action Threshold: Urinary retention or significant hesitancy requires immediate medical attention.
Symptom Monitoring
- Dry mouth
- Blurred vision
- Constipation
- Urinary hesitancy or retention
- Tachycardia or palpitations
- Dizziness
- Headache
- Nausea
- Vomiting
- Nervousness
- Drowsiness
- Weakness
- Heat intolerance (due to decreased sweating)
Special Patient Groups
Pregnancy
Category B. Animal reproduction studies have shown no evidence of impaired fertility or harm to the fetus. However, there are no adequate and well-controlled studies in pregnant women. Use during pregnancy only if clearly needed and the potential benefit outweighs the potential risk to the fetus.
Trimester-Specific Risks:
First Trimester:
No specific increased risk identified in animal studies.
Second Trimester:
No specific increased risk identified in animal studies.
Third Trimester:
No specific increased risk identified in animal studies. May theoretically inhibit uterine contractions or cause fetal tachycardia, but unlikely with oral doses.
Lactation
Glycopyrrolate is excreted in breast milk. Due to the potential for serious adverse reactions in nursing infants (e.g., anticholinergic effects, decreased milk production), a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Infant Risk:
L3 (Moderately safe, possible risk). Potential for anticholinergic effects (e.g., constipation, dry mouth, drowsiness) in the infant. May decrease milk supply due to anticholinergic effects on prolactin and fluid balance.
Pediatric Use
Safety and efficacy for the treatment of peptic ulcer in pediatric patients have not been established. Off-label use for sialorrhea (drooling) is common, with dosing based on weight and titrated to effect and tolerability. Children may be more susceptible to anticholinergic side effects.
Geriatric Use
Elderly patients may be more sensitive to the anticholinergic effects of glycopyrrolate, particularly central nervous system effects (e.g., confusion, memory impairment), urinary retention, and constipation. Use with caution, starting with lower doses and titrating slowly. Monitor closely for adverse effects.
Clinical Information
Clinical Pearls
- Glycopyrrolate's quaternary ammonium structure limits its ability to cross the blood-brain barrier, resulting in fewer central nervous system side effects (e.g., confusion, delirium) compared to tertiary amines like atropine or scopolamine.
- Oral bioavailability is poor, which contributes to its relatively low systemic side effect profile at therapeutic doses.
- Taking the medication on an empty stomach is crucial for optimal absorption and efficacy.
- Often used off-label for hyperhidrosis (excessive sweating) and sialorrhea (excessive drooling) due to its potent antisialagogue and anhidrotic effects.
- Patients should be advised about the potential for heat intolerance due to reduced sweating, especially in warm environments or during physical activity.
Alternative Therapies
- For peptic ulcer: Proton pump inhibitors (e.g., omeprazole, pantoprazole), H2-receptor antagonists (e.g., famotidine, ranitidine).
- For sialorrhea: Atropine drops, scopolamine transdermal patch, botulinum toxin injections (into salivary glands).
- For hyperhidrosis: Topical antiperspirants (e.g., aluminum chloride), botulinum toxin injections, iontophoresis, oral oxybutynin.
Cost & Coverage
Average Cost:
$15 - $50 per 30 tablets (generic 2mg)
Generic Available:
Yes
Insurance Coverage:
Tier 1 or 2 (generic), Tier 3 or 4 (brand)
General Drug Facts
If your symptoms or health issues persist or worsen, it's essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so be sure to check with your pharmacist for more information. If you have any questions or concerns about your medication, don't hesitate to reach out to your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek medical attention. When seeking help, be prepared to provide details about the medication, including the amount taken and the time it happened, to facilitate prompt and effective treatment.