VUITY 12.5 mg/mL

Pilocarpine Hydrochloride · SOLUTION/ DROPS · AbbVie Inc.

No Recall HistoryCurrently in Shortage

Plain English

VUITY is a solution/ drops containing pilocarpine hydrochloride at 12.5 mg/mL, taken ophthalmic. Manufactured by AbbVie Inc..

Key Facts

Brand Name: VUITY
Generic Name: Pilocarpine Hydrochloride
NDC Code (Product): 0074-7098
Manufacturer: AbbVie Inc.
Strength: 12.5 mg/mL
Dosage Form: SOLUTION/ DROPS
Route: OPHTHALMIC
Marketing Status
Application #: NDA214028
Marketing Start: 10/28/2021

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective340 reports

headache307 reports

visual impairment186 reports

vision blurred173 reports

eye pain152 reports

eye irritation126 reports

nausea107 reports

dizziness102 reports

pain98 reports

fatigue91 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE VUITY ® is indicated for the treatment of presbyopia in adults. VUITY is a cholinergic muscarinic receptor agonist indicated for the treatment of presbyopia in adults. ( 1 )

Dosage & Administration

2 DOSAGE AND ADMINISTRATION The recommended dosage of VUITY is one drop in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. If more than one topical ophthalmic product is being used, the products should be administered at least 5 minutes apart. Instill one drop of VUITY in each eye once daily. A second dose (one additional drop in each eye) may be administered 3-6 hours after the first dose. ( 2 )

Contraindications

4 CONTRAINDICATIONS VUITY is contraindicated in patients with known hypersensitivity to the active ingredient or to any of the excipients. Hypersensitivity ( 4 )

Adverse Reactions

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Hypersensitivity [see Contraindications ( 4 )] Most common adverse reactions (>5%) are headache, conjunctival hyperemia, and eye irritation. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Allergan at 1-800-678-1605 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. VUITY dosed once daily was evaluated in 375 participants with presbyopia in two randomized, double-masked, vehicle-controlled studies (GEMINI 1 and GEMINI 2) of 30 days duration. The most common adverse reactions reported in >5% of participants were headache and conjunctival hyperemia. Ocular adverse reactions reported in 1-5% of participants were blurred vision, eye pain, visual impairment, eye irritation, and increased lacrimation. VUITY was also evaluated in 114 participants with presbyopia in a randomized, doub…

Frequently Asked Questions

What is VUITY used for?

VUITY contains Pilocarpine Hydrochloride. It is a solution/ drops taken ophthalmic. Consult your doctor for specific uses.

Is VUITY a controlled substance?

VUITY is not classified as a controlled substance by the DEA.

What is the generic name for VUITY?

The generic name for VUITY is Pilocarpine Hydrochloride. There are 11 other brand versions of Pilocarpine Hydrochloride.

What is the NDC code for VUITY 12.5 mg/mL?

The NDC (National Drug Code) for VUITY 12.5 mg/mL is 0074-7098, listed by AbbVie Inc..

Product NDC

0074-7098

Package NDC

0074-7098-04

Other Pilocarpine Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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