Pilopine-HS (Ophthalmic)

Pilocarpine is used to treat glaucoma and other eye conditions. Vuity® eye drops and Qlosi™ eye drops are used to treat presbyopia (an age-related eye or vision problem).

This medicine is available only with your doctor's prescription.

If you will be using this medicine for more than a few weeks, your eye doctor will check your eyes regularly to ensure it is working properly and not causing unwanted effects.

Serious eye or vision problems (for example, retinal detachment, retinal tear) may occur during treatment with this medicine. Contact your doctor immediately if you notice flashes or sparks of light, floating spots before your eyes, or a veil or curtain appearing over part of your vision.

For patients using the eye drops or eye gel:

• This medicine may cause blurred vision and may make it hard for you to see at night or in dim light. Do not drive, operate machines, or do anything else that could be dangerous if you cannot see clearly.

For patients using the eye insert:

• For the first several hours after you insert this unit in your eye, your vision may be blurred or you may notice a change in your near or far vision, especially at night. Therefore, insert this unit in your eye at bedtime, unless your doctor tells you otherwise. If you insert this unit in your eye at any other time of the day, make sure your vision is clear before you drive, operate machines, or do anything else that could be dangerous if you cannot see well.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits. This is a decision you and your doctor will make. For this medicine, consider the following:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also inform your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Vuity® eye drops and Qlosi™ eye drops are not for use in children.

Geriatric

There have not been appropriate studies on how age affects the effects of pilocarpine eye drops in older adults. However, there are no expected geriatric-specific problems that would limit the usefulness of this medicine in the elderly.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction might happen. In these situations, your doctor may want to change the dose, or other precautions may be necessary. It is especially important for your healthcare professional to know if you are taking any of the medicines listed below while using this medicine. The following interactions have been chosen based on their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be necessary in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Tegafur

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used around the time of eating food or certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical problems may affect the use of this medicine. Make sure to tell your doctor if you have any other medical issues, especially:

• Asthma or
• Eye disease (e.g., retinal problems)—Use with caution. May worsen these conditions.

• Iritis (swelling of the colored part of the eye)—Use is not recommended in patients with this condition.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Increased sweating
• Muscle tremors
• Nausea, vomiting, or diarrhea
• Redness of the white part of the eyes or inside of the eyelids
• Trouble breathing
• Watering of mouth

Less common

• Blurred vision
• Eye irritation or pain
• Watering of the eyes

Incidence not known

• Chest tightness
• Fast heartbeat
• Fever
• Hives, itching, skin rash
• Irritation
• Joint pain, stiffness, or swelling
• Redness of the skin
• Seeing flashes or sparks of light
• Seeing floating spots before the eyes, or a veil or curtain appearing across part of vision
• Swelling of the eyelids, face, lips, hands, or feet
• Trouble breathing

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Decrease in night vision
• Headache

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Isopto Carpine
• Ocu-Carpine
• Ocusert Pilo
• Pilocar
• Pilopine-HS
• Qlosi

In Canada

• Minims Pilocarpine 2%
• Minims Pilocarpine 4%

Available Dosage Forms:

• Solution

Therapeutic Class: Direct Acting Miotic

Pharmacologic Class: Cholinergic System

Use this medicine only as directed by your doctor. Do not use more of it, do not use it more often, and do not use it for a longer time than your doctor ordered. To do so may increase the chance of too much medicine being absorbed into the body and the chance of side effects.

To use the eye drops:

• Wash your hands with soap and water before and after using this medicine.
• Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the eyelid away from the eye to make a space. Drop the medicine into this space.
• Let go of the eyelid and gently close the eye. Do not blink. Keep the eye closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, repeat the process with another drop.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines.

To use the eye gel:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of gel into this space. A 1½-cm (approximately ½-inch) strip of gel is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• Immediately after using the eye gel, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye gel, wipe the tip of the gel tube with a clean tissue and keep the tube tightly closed.

To use the eye insert:

• This medicine usually comes with patient directions. Read them carefully before using this medicine.
• If you think this medicine unit may be damaged, do not use it. If you have any questions about this, check with your health care professional.
• If the unit seems to be releasing too much medicine into your eye, remove it and replace with a new unit. If you have any questions about this, check with your doctor.

If you wear contact lenses, take them out before you use this medicine. Wait at least 10 minutes before you put your contact lenses back in.

If you are using more than one eye product, apply these medicines at least 5 minutes apart.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops): For chronic glaucoma: Adults and children—Instill one drop 1 to 4 times a day. For acute angle-closure glaucoma: Adults and children—Instill one drop every 5 to 10 minutes for three to six doses. Then one drop every one to three hours until eye pressure is reduced. For presbyopia: Adults— Qlosi™: Instill one drop in each eye. You may instill another drop in each eye 2 to 3 hours after the first dose. This medicine can be used every day, up to 2 times each day. Vuity®: Instill one drop in each eye once a day. You may instill another drop in each eye 3 to 6 hours after the first dose. Children—Use is not recommended.
• For ophthalmic dosage form (eye gel): For glaucoma: Adults and teenagers—Use once a day at bedtime. Children—Use and dose must be determined by your doctor.
• For ophthalmic dosage form (eye insert): For glaucoma: Adults and children—Insert one ocular system every seven days. Infants—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Store the Qlosi™ vial in the refrigerator. Once the pouch is open, you may store it at room temperature and use within 30 days. Throw away opened vials after use.