Lumigan 0.01% Ophth Soln 7.5ml

Manufacturer ALLERGAN Active Ingredient Bimatoprost Eye Drops(bi MAT oh prost) Pronunciation bi-MAT-oh-prost
It is used to treat glaucoma.It is used to lower high eye pressure.
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Drug Class
Antiglaucoma Agent
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Pharmacologic Class
Prostaglandin F2Îą Analog
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Pregnancy Category
Category C
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FDA Approved
Sep 2008
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Bimatoprost eye drops are used to lower high pressure inside the eye, which can damage your vision if not treated. It works by helping fluid drain out of your eye more effectively.
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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. Continue using the medication as directed, even if your symptoms improve.

Administration Instructions

Apply this medication in the evening, only to the eye.
Wash your hands before and after use.
Remove contact lenses before applying the medication. You can put them back in 15 minutes after application, unless your eyes are irritated or infected.
Avoid touching the container tip to your eye, lid, or skin, as this can introduce bacteria and lead to severe eye problems or vision loss.
Tilt your head back, drop the medication into your eye, and then keep your eyes closed.
Apply gentle pressure to the inside corner of your eye for 1 to 2 minutes to help the medication stay in your eye.

Using Multiple Eye Medications

If you are using more than one medication in the same eye, wait at least 5 minutes between applications.

Storage and Disposal

Store this medication at room temperature in a dry place, away from the bathroom. Keep the lid tightly closed and store the container upright with the cap on.

Missed Dose

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

  • Remove contact lenses before applying drops and wait at least 15 minutes before reinserting them.
  • Do not touch the dropper tip to your eye or any other surface to avoid contamination.
  • If using other eye drops, wait at least 5 minutes between applications.
  • Apply once daily in the evening. Using it more often may make it less effective.
  • Wipe away any excess solution on the cheek to minimize potential skin darkening.

Dosing & Administration

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Adult Dosing

Standard Dose: One drop in the affected eye(s) once daily in the evening.

Condition-Specific Dosing:

glaucoma: One drop in the affected eye(s) once daily in the evening.
ocular_hypertension: One drop in the affected eye(s) once daily in the evening.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Not established
Adolescent: Not established
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Dose Adjustments

Renal Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed
Dialysis: No adjustment needed; low systemic exposure

Hepatic Impairment:

Mild: No adjustment needed
Moderate: No adjustment needed
Severe: No adjustment needed

Pharmacology

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Mechanism of Action

Bimatoprost is a synthetic prostamide, structurally related to prostaglandin F2Îą. It is believed to lower intraocular pressure (IOP) in humans by increasing the outflow of aqueous humor through both the trabecular meshwork and uveoscleral pathways. The primary mechanism of action is increased uveoscleral outflow.
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Pharmacokinetics

Absorption:

Bioavailability: Low systemic (after ocular administration)
Tmax: Approximately 10 minutes (plasma) after ocular administration
FoodEffect: Not applicable (ophthalmic)

Distribution:

Vd: Approximately 0.67 L/kg (systemic)
ProteinBinding: Approximately 88% (in vitro)
CnssPenetration: Limited

Elimination:

HalfLife: Approximately 45 minutes (systemic)
Clearance: Not available (systemic)
ExcretionRoute: Primarily renal (67%) and fecal (25%)
Unchanged: <1% (in urine)
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Pharmacodynamics

OnsetOfAction: Approximately 4 hours
PeakEffect: Approximately 8-12 hours
DurationOfAction: Approximately 24 hours

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Attention Immediately

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice 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
Sensitivity to bright lights
Eye discharge
Eye color changes, which may turn brown and may not return to normal. If you notice any changes in eye color, contact your doctor. These changes can occur months to years after starting treatment.

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. Contact your doctor or seek medical help if you experience any of the following side effects or if they bother you or do not go away:

Eye irritation
Dark eyelids (usually reversible after stopping the medication)
Dry eyes
Feeling of something in the eye
Burning sensation
Signs of a common cold
Eyelash changes, such as darkening, thickening, or increased growth (usually reversible after stopping the medication)

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:

  • Severe eye pain
  • Sudden changes in vision
  • Signs of eye infection (e.g., redness, swelling, discharge)
  • Increased sensitivity to light
  • New or worsening eye irritation
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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 an eye infection or any other eye problems, as this may affect your ability to safely use this medication.

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

Remember, do not start, stop, or change the dose of any medication without first consulting your doctor to ensure your safety.
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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 performing tasks that require clear vision, such as driving, exercise caution to ensure your safety. Regularly schedule check-ups with your doctor to monitor your eye pressure and vision, as advised. If you experience an eye infection, suffer an eye injury, or are scheduled to undergo eye surgery, notify your doctor promptly. Be aware that the use of this medication has been associated with the development of cataracts. This medication is not intended for children under the age of 16. If you are pregnant, planning to become pregnant, or are breastfeeding, consult your doctor to discuss the potential benefits and risks to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Unlikely with topical ophthalmic administration due to low systemic absorption. If accidentally ingested, symptoms are not well-defined but may include gastrointestinal upset.

What to Do:

If accidental ingestion occurs, contact a poison control center immediately (e.g., 1-800-222-1222). For ocular overdose, flush the eye with water.

Drug Interactions

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Moderate Interactions

  • Other prostaglandin analogs (e.g., latanoprost, travoprost): Concomitant use may reduce the IOP-lowering effect.

Monitoring

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Baseline Monitoring

Intraocular Pressure (IOP)

Rationale: To establish baseline and assess severity of glaucoma/ocular hypertension.

Timing: Prior to initiation of therapy

Ophthalmic Examination (slit lamp, fundus, visual acuity)

Rationale: To assess ocular health and rule out other conditions.

Timing: Prior to initiation of therapy

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Routine Monitoring

Intraocular Pressure (IOP)

Frequency: Regularly, as determined by ophthalmologist (e.g., every 3-6 months)

Target: Individualized, typically <21 mmHg or target pressure to prevent progression

Action Threshold: IOP not adequately controlled, or signs of disease progression

Ophthalmic Examination (iris pigmentation, eyelash changes, macular edema)

Frequency: Annually or as clinically indicated

Target: Not applicable

Action Threshold: Significant or bothersome changes in iris color, eyelash growth, or signs of ocular inflammation/edema

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Symptom Monitoring

  • Eye irritation
  • Conjunctival hyperemia (redness)
  • Eyelash changes (increased length, thickness, pigmentation, number)
  • Iris pigmentation changes (brown discoloration)
  • Eyelid skin darkening
  • Blurred vision
  • Foreign body sensation
  • Photophobia
  • Ocular pruritus (itching)

Special Patient Groups

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Pregnancy

Pregnancy Category C. Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Studies in animals have shown adverse effects on fetal development at high systemic doses.

Trimester-Specific Risks:

First Trimester: Potential risk, but human data are limited.
Second Trimester: Potential risk, but human data are limited.
Third Trimester: Potential risk, but human data are limited.
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Lactation

It is unknown whether bimatoprost is excreted in human milk. Caution should be exercised when bimatoprost is administered to a nursing woman. The decision to discontinue nursing or discontinue the drug should be made taking into account the importance of the drug to the mother.

Infant Risk: Risk to breastfed infant cannot be ruled out (LactMed L4).
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Pediatric Use

Safety and effectiveness in pediatric patients have not been established. Use is generally not recommended.

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Geriatric Use

No overall differences in safety or effectiveness have been observed between elderly and younger patients. No specific dose adjustment is required.

Clinical Information

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Clinical Pearls

  • Bimatoprost can cause permanent brown discoloration of the iris, especially in patients with mixed-color irides. This change may be subtle and develop over months to years.
  • It can also cause increased length, thickness, pigmentation, and number of eyelashes, as well as darkening of the eyelid skin.
  • Instruct patients to administer the drops once daily in the evening. More frequent administration may actually decrease the IOP-lowering effect.
  • Patients should be advised to wipe off any excess solution on the cheek or other skin areas to minimize potential skin darkening and unwanted hair growth.
  • For patients wearing contact lenses, advise removal prior to instillation and waiting 15 minutes before reinsertion.
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Alternative Therapies

  • Latanoprost (Xalatan, Xelpros)
  • Travoprost (Travatan Z)
  • Tafluprost (Zioptan)
  • Timolol (Timoptic, Betimol)
  • Dorzolamide (Trusopt)
  • Brimonidine (Alphagan P)
  • Brinzolamide (Azopt)
  • Pilocarpine (Isopto Carpine)
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Cost & Coverage

Average Cost: Varies, typically $100-$200 for brand (Lumigan 0.01% 7.5mL), significantly less for generic per 7.5mL bottle
Generic Available: Yes
Insurance Coverage: Tier 2 or Tier 3 (for brand); Tier 1 or Tier 2 (for 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 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 it's a good idea to check with your pharmacist. 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 detailed information about the overdose, including the medication taken, the amount, and the time it occurred.