MYDCOMBI- tropicamide and phenylephrine hydrochloride spray, metered

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Tropicamide (UNII: N0A3Z5XTC6) (Tropicamide - UNII:N0A3Z5XTC6), Phenylephrine Hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV)

Available from:

Eyenovia, Inc.

Administration route:

OPHTHALMIC

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

MYDCOMBI (tropicamide and phenylephrine hydrochloride ophthalmic spray) 1% / 2.5% is indicated to induce mydriasis for diagnostic procedures and in conditions where short term pupil dilation is desired. Contraindicated in persons showing known hypersensitivity to any component of the formulation. Risk Summary There are no available data on MYDCOMBI use in pregnant women or animals to inform any drug-associated risks. It is also not known whether tropicamide or phenylephrine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. MYDCOMBI should be given to a pregnant woman only if clearly needed. Risk Summary There are no data on the presence of tropicamide or phenylephrine in human milk from the administration of MYDCOMBI, the effects on the breastfed infant, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for MYDCOMBI and any potential adverse effects on the breastfed

Product summary:

MYDCOMBI is supplied as sterile, clear, colorless solution in a 2 mL vial enclosed in a dispenser cartridge. Each MYDCOMBI cartridge holds approximately 180 sprays. Do not tamper with or attempt to open the MYDCOMBI cartridge. Such action may damage the dispenser causing an incorrect medication discharge volume; additionally, the dispenser base may not function properly. Only use the MYDCOMBI cartridge with the MYDCOMBI Dispenser base which may be supplied separately. The MYDCOMBI base will not work with any other cartridges. NDC 81046-0111-1. Carton containing one replacement sterile drug cartridge NDC 81046-0111-2. Box containing one carton with one sterile drug cartridge, and one carton with one base unit NDC 81046-0111-5. Box containing five cartons, each with one replacement sterile drug cartridge The MYDCOMBI cartridge must be used prior to the expiration date on the cartridge. Storage: Store at room temperature 15°C to 25°C (59°F to 77°F).

Authorization status:

New Drug Application

Summary of Product characteristics

MYDCOMBI- TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE SPRAY, METERED
EYENOVIA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
MYDCOMBI SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR MYDCOMBI.
MYDCOMBI (TROPICAMIDE AND PHENYLEPHRINE HYDROCHLORIDE OPHTHALMIC
SPRAY) 1%/2.5%, FOR
TOPICAL OPHTHALMIC USE
INITIAL U.S. APPROVAL: 2023
INDICATIONS AND USAGE
MYDCOMBI is a combination of tropicamide, an anticholinergic, and
phenylephrine hydrochloride, an alpha-
1 adrenergic receptor agonist indicated to induce mydriasis for
diagnostic procedures and in conditions
where short term pupil dilation is desired (1)
DOSAGE AND ADMINISTRATION
Administer one metered spray to the cornea of each eye to be dilated.
Repeat after 5 minutes. (2.1)
In pediatric patients younger than 1 year old, administer one metered
spray to the cornea of each eye
to be dilated, up to a maximum of 3 sprays per eye per day (2.1)
DOSAGE FORMS AND STRENGTHS
Ophthalmic spray containing tropicamide 1% and phenylephrine
hydrochloride 2.5%. Each metered spray
delivers 0.008 mL which contains 0.08 mg tropicamide and 0.2 mg
phenylephrine HCl (3)
CONTRAINDICATIONS
Known hypersensitivity to any component of the formulation (4.1)
WARNINGS AND PRECAUTIONS
Not for Injection: Topical ophthalmic use (5.1)
Significant Elevations in Blood Pressure: Caution in pediatric
patients less than 5 years of age, and in
patients with cardiovascular disease or hyperthyroidism. In patients
at high risk, monitor blood pressure
post treatment (5.2)
Central Nervous System Disturbances: Caution in pediatric patients
where rare incidences of central
nervous system disturbances have been reported (5.3)
Intraocular Pressure: May produce a transient elevation (5.4)
Rebound Miosis: Reported 1 day after administration (5.5)
ADVERSE REACTIONS
Most common ocular adverse reactions include transient blurred vision,
reduced visual acuity,
photophobia, superficial punctate keratitis, and mild eye discomfort.
Increa