PresVu Pilocarpine Hydrochloride Ophthalmic Solution USP 1.25% w/v Eye Drops – 5 mL | Prescription Eye Drops for Presbyopia in Adults

PresVu Eye Drops contain Pilocarpine Hydrochloride USP 1.25% w/v in a sterile ophthalmic solution. The product is formulated as a clear, colourless eye drop for topical ocular use and is indicated for the treatment of presbyopia in adults.

Pilocarpine is a cholinergic muscarinic receptor agonist. When applied to the eye, it acts on the iris sphincter and ciliary muscle, producing pupil constriction and supporting near and intermediate visual function in adults with presbyopia.

PresVu is supplied in a 5 mL ophthalmic bottle and is intended for use under the direction of a registered medical practitioner.

Prescription medicine – use only as directed by an ophthalmologist/registered medical practitioner.

Key Ingredients

1. Pilocarpine Hydrochloride USP – 1.25% w/v

The active pharmaceutical ingredient. Each mL contains 12.5 mg of pilocarpine hydrochloride, equivalent to 1.06% w/v (10.6 mg) pilocarpine free base.

2. Benzalkonium Chloride BP – 0.0075% w/v

Used as the preservative in the ophthalmic formulation.

Full Ingredient Composition

• Pilocarpine Hydrochloride USP – 1.25% w/v
• Equivalent to Pilocarpine USP free base – 1.06% w/v
• Benzalkonium Chloride BP – 0.0075% w/v
• Boric Acid
• Borax
• Hydroxypropylmethylcellulose
• Disodium Edetate
• Glycerin
• Sodium Hyaluronate
• Water for Injection
• Other excipients – q.s.

Key Benefits

• Designed for the management of presbyopia in adults.
• Helps support near visual acuity.
• Helps improve intermediate visual acuity.
• Pilocarpine produces controlled pupil constriction, which can support a pinhole-like optical effect.
• Acts on the ciliary muscle and iris sphincter to influence the eye's focusing mechanism.
• Supplied as a sterile ophthalmic solution for topical ocular administration.
• Clear and colourless formulation designed for convenient eye-drop administration.

Important: PresVu is a prescription medicine and should not be promoted as a permanent cure for presbyopia.

How PresVu Works

PresVu contains pilocarpine hydrochloride, a muscarinic cholinergic agonist.

After instillation into the eye, pilocarpine stimulates muscarinic receptors in structures including the iris sphincter muscle and ciliary muscle.

This action:

1. Contracts the iris sphincter muscle.
2. Constricts the pupil.
3. Can improve the optical conditions for near and intermediate vision.
4. Contracts the ciliary muscle, shifting the eye toward a more myopic state.
5. Together, these effects can help adults with presbyopia perform near-vision tasks.

Indication

PresVu Eye Drops are indicated for the treatment of presbyopia in adults.

Presbyopia is an age-associated reduction in the eye's ability to focus clearly on nearby objects.

How to Use

Use PresVu exactly as prescribed by your doctor.

Typical dosage stated in the supplied product information:

• Instil 1 drop into each eye once daily.
• If more than one topical ophthalmic product is being used, allow at least 5 minutes between different eye-drop products.
• Do not change the dose or frequency without medical advice.

Eye-Drop Administration

1. Wash and dry your hands.
2. Tilt your head back and look upward.
3. Gently pull down the lower eyelid.
4. Instil the prescribed drop without allowing the nozzle to touch the eye, eyelid, or any other surface.
5. Close the eye gently after administration.
6. Replace the cap securely after use.

Contact Lens Instructions

Contact lens wearers should:

• Remove contact lenses before applying PresVu™.
• Wait 10 minutes after instillation before reinserting contact lenses.
• Follow their ophthalmologist's instructions regarding contact-lens use.

Important Precautions

PresVu can cause changes in vision, including blurred vision or accommodative effects. Avoid driving or operating machinery if your vision is not clear.

Extra caution is required during night driving or other activities performed in poor illumination.

The supplied product information also warns about the rare possibility of retinal complications with miotic medicines such as pilocarpine. Patients with pre-existing retinal disease may have increased risk.

Seek urgent ophthalmic medical attention if you experience:

• Sudden flashes of light
• New or sudden floaters
• Sudden loss or significant change of vision

A retinal examination is advised before starting therapy according to the supplied prescribing information.

PresVu is not recommended when iritis is present, because adhesions between the iris and lens may develop.

Possible Side Effects

Possible adverse effects associated with pilocarpine ophthalmic therapy may include:

• Headache
• Eye irritation
• Eye redness/conjunctival hyperemia
• Blurred vision
• Eye pain
• Visual impairment
• Increased tearing
• Visual disturbances such as floaters

Rare but important retinal events, including retinal tear or retinal detachment, have been reported with pilocarpine/miotic ophthalmic therapy.

If you experience sudden flashes, a sudden increase in floaters or vision loss, seek immediate medical attention.

Contraindications

PresVu should not be used in individuals with a known hypersensitivity to pilocarpine hydrochloride or any component of the formulation.

Use in patients with retinal disease or iritis requires appropriate medical assessment and caution.

Pregnancy and Breastfeeding

The supplied product information states that there are no adequate and well-controlled studies in pregnant women to establish the drug-associated risk.

There is also limited information regarding the presence of pilocarpine in human breast milk and its effects on breastfed infants.

Pregnant or breastfeeding patients should discuss the use of PresVu™ with their treating physician before starting treatment.

Use in Children

Presbyopia does not generally occur in the pediatric population. PresVu™ is indicated for adults with presbyopia and should not be used in children unless specifically prescribed by a qualified medical professional.

Drug Interactions

The supplied product information states that no known drug interactions were identified for PresVu.

However, patients should inform their doctor about all eye drops, medicines and supplements they are currently using.

When multiple topical ophthalmic products are prescribed, separate their administration by at least 5 minutes.

Overdose / Accidental Ingestion

Excessive exposure to pilocarpine may potentially produce systemic cholinergic effects.

The supplied information describes possible symptoms following excessive exposure or accidental ingestion, including:

• Sweating
• Increased salivation
• Nausea
• Tremors
• Gastrointestinal overactivity
• Slowing of the pulse
• Decreased blood pressure

Do not intentionally use more drops than prescribed. Seek medical attention in case of accidental ingestion or suspected overdose.

Storage Instructions

• Store below 30°C.
• Keep the container tightly closed.
• Do not freeze.
• Keep out of reach of children.
• Protect the product from contamination during use.
• Do not touch the dispensing tip to the eye, eyelid, fingers or other surfaces.
• Use the solution within 1 month after opening.
• If the solution becomes cloudy or dark brown, discontinue use and discard it.

Product Details

Frequently Asked Questions

1. What is PresVu Eye Drops used for?

PresVu contains pilocarpine hydrochloride 1.25% w/v and is indicated for the treatment of presbyopia in adults.

2. What is the active ingredient in PresVu?

The active ingredient is Pilocarpine Hydrochloride USP 1.25% w/v, equivalent to 1.06% w/v pilocarpine free base.

3. Is PresVu a lubricating eye drop?

No. PresVu is a prescription ophthalmic medicine containing pilocarpine. It is not simply an artificial tear or lubricating eye drop.

4. How often should PresVu be used?

The supplied product information recommends one drop in each eye once daily, unless your doctor gives you different instructions.

5. Can I wear contact lenses after using PresVu?

Remove contact lenses before applying the drops. According to the supplied information, wait 10 minutes before reinserting them.

6. Can PresVu permanently cure presbyopia?

No. PresVu is intended to help manage the visual effects of presbyopia. It should not be described as a permanent cure.

7. Can I drive after using PresVu?

Vision may become blurred or otherwise affected. Do not drive or operate machinery if your vision is not clear. Extra caution is recommended during night driving.

8. What should I do if I miss a dose?

Follow your doctor's instructions. Do not compensate for a missed dose by using extra drops unless specifically advised by your healthcare professional.

9. How long can I use the bottle after opening?

The supplied product information states that the solution should be used within one month after opening.

10. Can I use PresVu with other eye drops?

It may be possible when prescribed, but different ophthalmic products should generally be separated by at least 5 minutes, as stated in the product information.

11. What if the eye-drop solution changes colour?

Do not use the solution if it becomes cloudy or dark brown. The supplied instructions advise discarding such a solution.

12. Is PresVu available without a prescription?

The supplied bottle is labelled as a Schedule H prescription medicine and states that it should be sold only on the prescription of a Registered Medical Practitioner.