Isopto Carpine 1.0% 15ml

Manufacturer ALCON VISION Active Ingredient Pilocarpine Eye Drops (Isopto Carpine)(pye loe KAR peen) Pronunciation pye loe KAR peen
It is used to treat glaucoma.It is used to lower high eye pressure.It may be given to you for other reasons. Talk with the doctor.
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Drug Class
Miotics, Antiglaucoma Agents
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Pharmacologic Class
Cholinergic Agonists (Direct-Acting), Muscarinic Agonists
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Pregnancy Category
Category C
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FDA Approved
Jan 1970
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Pilocarpine eye drops are used to lower high pressure inside your eye, which can damage your vision. It works by helping fluid drain better from your eye. This medicine can make your pupils smaller and may cause temporary blurry vision, especially in dim light.
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How to Use This Medicine

Proper Use of This Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. This medication is for use in the eyes only.

Administration Instructions

1. Wash your hands before and after using this medication.
2. Remove contact lenses before applying the medication. You can put them back in 10 minutes after use, but avoid doing so if your eyes are irritated or infected.
3. To avoid contamination, do not touch the container tip to your eye, lid, or surrounding skin, as this can lead to bacterial infection and potentially severe eye problems or vision loss.
4. Tilt your head back and gently drop the medication into your eye.
5. After application, keep your eyes closed and apply gentle pressure to the inner corner of your eye for 1 to 2 minutes. This helps the medication stay in your eye.
6. Continue using the medication as directed, even if your symptoms improve.

Using Multiple Eye Medications

If you are using more than one medication in the same eye, apply each medication at least 5 minutes apart.

Storage and Disposal

1. Store this medication at room temperature, avoiding freezing.
2. Keep all medications in a safe place, out of the reach of children and pets.
3. 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. Consult your pharmacist for guidance on the best disposal method, and consider participating in local drug take-back programs.

Missed Dose Instructions

If you miss a dose, use it as soon as you remember. However, if it is close to the time for your next scheduled dose, skip the missed dose and resume your regular dosing schedule. Do not use two doses at once or take extra doses.
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Lifestyle & Tips

  • Do not drive or operate machinery if your vision is blurred or if you experience difficulty with night vision after using these drops.
  • Avoid activities requiring sharp vision in low light conditions.
  • Wash hands thoroughly before and after administering eye drops.
  • Do not touch the dropper tip to any surface to prevent contamination.
  • If using other eye drops, wait at least 5-10 minutes between applications.

Dosing & Administration

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Adult Dosing

Standard Dose: 1 to 2 drops (1% solution) in the affected eye(s) up to 4 times daily, or as directed by physician.
Dose Range: 1 - 4 mg

Condition-Specific Dosing:

glaucoma: 1 to 2 drops (1% solution) in the affected eye(s) up to 4 times daily.
miosisInduction: 1 drop (1% solution) prior to procedure.
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Pediatric Dosing

Neonatal: Not established (use with extreme caution, potential for systemic effects)
Infant: Not established (use with extreme caution, potential for systemic effects)
Child: Not established (use with caution, generally not first-line for glaucoma)
Adolescent: Similar to adult dosing, but generally not first-line for glaucoma.
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)
Dialysis: No specific considerations (minimal systemic absorption)

Hepatic Impairment:

Mild: No adjustment needed (minimal systemic absorption)
Moderate: No adjustment needed (minimal systemic absorption)
Severe: No adjustment needed (minimal systemic absorption)

Pharmacology

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Mechanism of Action

Pilocarpine is a direct-acting cholinergic parasympathomimetic agent that acts by stimulating muscarinic receptors. When applied topically to the eye, it causes miosis (pupil constriction) by contracting the iris sphincter muscle and ciliary muscle contraction. This ciliary muscle contraction opens the trabecular meshwork, facilitating the outflow of aqueous humor and thereby reducing intraocular pressure (IOP).
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Pharmacokinetics

Absorption:

Bioavailability: Not precisely quantified for ophthalmic use (minimal systemic absorption)
Tmax: Approximately 10-30 minutes (for miosis and IOP reduction)
FoodEffect: Not applicable (ophthalmic administration)

Distribution:

Vd: Not clinically relevant for ophthalmic use (primarily local ocular distribution)
ProteinBinding: Not significant for ophthalmic use
CnssPenetration: Limited (minimal systemic absorption)

Elimination:

HalfLife: Approximately 1.5-2 hours (systemic, but not clinically relevant for ophthalmic action)
Clearance: Not clinically relevant for ophthalmic use
ExcretionRoute: Primarily local metabolism; minimal systemic excretion via urine if absorbed.
Unchanged: Not precisely quantified for ophthalmic use
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Pharmacodynamics

OnsetOfAction: Miosis: 10-30 minutes; IOP reduction: 30-60 minutes
PeakEffect: Miosis: 30 minutes to 1 hour; IOP reduction: 1-2 hours
DurationOfAction: Miosis: 4-8 hours; IOP reduction: 4-8 hours (can vary with concentration and individual)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention 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 help 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
Changes in eyesight, eye pain, or severe eye irritation
Severe eye problems, including:
+ Retinal tear or detachment (especially in people with pre-existing retinal disease)
+ Sudden symptoms such as:
- Flashing lights
- Floaters
- A curtain-like shadow coming across your eye
- Sudden eyesight loss

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, contact your doctor for advice:

Headache
Eye irritation
Blurred eyesight
Eye redness
Temporary dim or dark eyesight

Reporting Side Effects

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

  • Sudden, severe eye pain
  • Sudden vision changes or loss
  • Signs of allergic reaction (e.g., rash, itching, swelling of face/tongue/throat, severe dizziness, trouble breathing)
  • Persistent or worsening eye irritation or redness
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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. Be sure to describe the allergic reaction you experienced, including any symptoms that occurred.
If you have a specific eye condition called iritis.

This list is not exhaustive, and it is crucial to discuss all your medications (including prescription, over-the-counter, natural products, and vitamins) and health issues with your doctor and pharmacist. They will help determine if it is safe to take this medication with your other medications and health conditions.

Remember, do not start, stop, or change the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. When taking this drug, exercise caution when driving or performing tasks that require clear vision, as it may affect your eyesight. Additionally, be particularly careful when driving at night or engaging in activities in low-light environments. Regularly schedule appointments with your doctor to monitor your eye pressure and vision, as advised. If you are pregnant, planning to become pregnant, or are breastfeeding, notify your doctor, as you will need to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Systemic overdose from ophthalmic use is rare but could include:
  • Nausea, vomiting, diarrhea
  • Abdominal cramps
  • Increased salivation, sweating, tearing
  • Bradycardia (slow heart rate)
  • Hypotension (low blood pressure)
  • Bronchospasm (difficulty breathing)
  • Urinary urgency

What to Do:

If systemic overdose is suspected, seek immediate medical attention or call a Poison Control Center (1-800-222-1222). Treatment is supportive and may involve atropine for severe cholinergic symptoms.

Drug Interactions

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Moderate Interactions

  • Anticholinergic ophthalmic agents (e.g., atropine, cyclopentolate): May antagonize the miotic and IOP-lowering effects of pilocarpine.
  • Other ophthalmic agents (e.g., beta-blockers, prostaglandin analogs): May have additive effects on IOP reduction, but generally not considered an interaction requiring dose adjustment unless excessive IOP lowering occurs.

Monitoring

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Baseline Monitoring

Intraocular Pressure (IOP)

Rationale: To establish baseline and assess efficacy of treatment for glaucoma.

Timing: Prior to initiation of therapy

Visual Acuity

Rationale: To establish baseline and monitor for changes or side effects (e.g., blurred vision, myopia).

Timing: Prior to initiation of therapy

Ophthalmic Examination (e.g., slit lamp, fundoscopy)

Rationale: To assess ocular health and rule out contraindications or pre-existing conditions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Intraocular Pressure (IOP)

Frequency: Regularly, as determined by ophthalmologist (e.g., 2-4 weeks after initiation, then every 3-6 months)

Target: Individualized, typically <21 mmHg or target set by physician

Action Threshold: IOP not adequately controlled, or significant fluctuations

Visual Acuity

Frequency: Periodically, as determined by ophthalmologist

Target: Stable or improved

Action Threshold: Significant decrease in vision, especially if persistent or severe

Ocular Side Effects (e.g., headache, blurred vision, eye pain, redness)

Frequency: At each follow-up visit and patient self-monitoring

Target: Minimal to none

Action Threshold: Persistent or severe side effects impacting quality of life or adherence

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Symptom Monitoring

  • Blurred vision (especially at night or in dim light)
  • Headache (especially frontal or periorbital)
  • Eye pain or discomfort
  • Eye redness or irritation
  • Difficulty with night vision
  • Brow ache
  • Increased tearing

Special Patient Groups

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Pregnancy

Pilocarpine is Pregnancy Category C. Use only if the potential benefit justifies the potential risk to the fetus. Minimal systemic absorption is expected with ophthalmic use, but animal studies have shown adverse effects at high doses.

Trimester-Specific Risks:

First Trimester: Potential risk, but minimal systemic exposure from ophthalmic use.
Second Trimester: Potential risk, but minimal systemic exposure from ophthalmic use.
Third Trimester: Potential risk, but minimal systemic exposure from ophthalmic use.
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Lactation

Pilocarpine is considered L3 (Moderately Safe) for lactation. While minimal systemic absorption is expected, caution is advised. Monitor the infant for signs of cholinergic effects (e.g., diarrhea, bradycardia).

Infant Risk: Low risk due to minimal systemic absorption, but theoretical risk of cholinergic effects.
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Pediatric Use

Safety and efficacy in pediatric patients have not been fully established. Use with caution, especially in infants and young children, due to potential for increased systemic absorption and cholinergic side effects. Generally not a first-line treatment for pediatric glaucoma.

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Geriatric Use

No specific dose adjustments are required. Elderly patients may be more susceptible to visual side effects such as blurred vision or difficulty with night vision due to age-related changes in the eye. Monitor closely for these effects.

Clinical Information

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Clinical Pearls

  • Pilocarpine is a classic miotic agent, often used for acute angle-closure glaucoma or as a diagnostic aid.
  • Patients should be warned about the potential for blurred vision and difficulty with night vision, especially when starting therapy.
  • Proper instillation technique is crucial to maximize efficacy and minimize systemic absorption.
  • Headache, particularly frontal or periorbital, is a common initial side effect that often subsides with continued use.
  • Not typically a first-line agent for chronic open-angle glaucoma due to side effect profile (miosis, accommodative spasm) compared to newer agents.
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Alternative Therapies

  • Prostaglandin analogs (e.g., latanoprost, travoprost, bimatoprost)
  • Beta-blockers (e.g., timolol, betaxolol)
  • Alpha-adrenergic agonists (e.g., brimonidine, apraclonidine)
  • Carbonic anhydrase inhibitors (e.g., dorzolamide, brinzolamide)
  • Rho kinase inhibitors (e.g., netarsudil)
  • Combination products (e.g., Cosopt, Combigan)
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Cost & Coverage

Average Cost: Varies, typically $15-$40 per 15ml bottle (1% solution)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (Generic)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor promptly. To ensure safe and effective treatment, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist for more information. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide details about the overdose, including the medication taken, the amount, and the time it occurred.