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MYDCOMBI is a sterile, clear, colorless fixed dose combination of an anticholinergic (tropicamide) and an alpha-adrenergic receptor agonist (phenylephrine hydrochloride) for topical ophthalmic use. The 2 active ingredients are represented by the chemical structures below.
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Chemical Name: Benzeneacetamide, N-ethyl-α-(hydroxymethyl)-N-(4-pyridinylmethyl)-
Molecular Formula: C17H20N2O2
Molecular Weight: 284.35 g/mol
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Chemical Name: (R)-3-hydroxy-α[(methylamino)methyl]benzenemethanol hydrochloride
Molecular Formula: C9H13NO2•HCl
Molecular Weight: 203.67 g/mol
Each mL of MYDCOMBI ophthalmic spray (sterile) contains: ACTIVES: Phenylephrine Hydrochloride 2.5% (25 mg) equivalent to 20.6 mg of phenylephrine base, Tropicamide 1% (10 mg); INACTIVE: Hydrochloric Acid and/or Sodium Hydroxide may be added to adjust pH (pH 4.8-5.2), Water for Injection; PRESERVATIVE: Benzalkonium Chloride 0.01% (0.1 mg).
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.
Administer one metered spray to the cornea of each eye to be dilated. Repeat after 5 minutes.
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.
The following steps should be followed sequentially:
Figure 1: MYDCOMBI Dispenser Front (L) and Back (R) View
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MYDCOMBI is a sterile, clear, colorless, topical ophthalmic spray containing tropicamide 1% (w/w) and phenylephrine hydrochloride 2.5% (w/w). Each metered spray delivers 0.008 mL which contains 0.08 mg tropicamide and 0.2 mg phenylephrine hydrochloride.
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 81046-0111-01. Carton containing one replacement sterile drug cartridge
NDC 81046-0111-02. Box containing one carton with one sterile drug cartridge, and one carton with one base unit
NDC 81046-0111-05. 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.
Store at room temperature 15°C to 25°C (59°F to 77°F).
Manufactured for Eyenovia, Inc. by Alcami Corporation. Revised: May 2023
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. The most common adverse reactions (incidence < 2%) were transient blurred vision, reduced visual acuity, photophobia, and mild eye discomfort.
Transient blurred vision, reduced visual acuity, photophobia, superficial punctate keratitis, and mild eye discomfort may occur. Increased intraocular pressure has been reported following the use of mydriatics.
Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs.
A marked increase in blood pressure has been reported with the use of phenylephrine, particularly, but not limited to, low weight premature neonates, infants, and hypertensive patients.
Phenylephrine in MYDCOMBI may enhance the pressor effects of atropine-like drugs and induce tachycardia in some patients.
Tropicamide in MYDCOMBI may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.
Phenylephrine in MYDCOMBI may potentiate the cardiovascular depressant effects of some inhalation anesthetic agents.
Included as part of the PRECAUTIONS section.
MYDCOMBI is not indicated for injection.
Caution should be exercised with the use of MYDCOMBI in pediatric patients less than 5 years of age and patients with hyperthyroidism, or cardiovascular disease. The post-treatment blood pressure of patients with cardiac and endocrine diseases and any patients who develop symptoms should be carefully monitored.
Tropicamide in MYDCOMBI may cause CNS disturbances which may be dangerous in pediatric patients. The possibility of psychotic reactions and behavioral disturbances due to hypersensitivity to anticholinergic drugs should be considered.
Mydriatics may produce a transient elevation of intraocular pressure.
Rebound miosis has been reported one day after receiving phenylephrine hydrochloride ophthalmic solution, and re-administration of the drug produced a lesser mydriatic effect.
Advise patients that they may experience sensitivity to light and blurred vision while their pupils are dilated.
Advise patients not to drive, use machinery, or do any activity that requires clear vision until they are sure they can perform such activities safely.
No Information provided
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.
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 child from MYDCOMBI.
Tropicamide in MYDCOMBI may rarely cause CNS disturbances which may be dangerous in pediatric patients. Psychotic reactions, behavioral disturbances, and vasomotor or cardiorespiratory collapse in children have been reported with the use of anticholinergic drugs [see WARNINGS AND PRECAUTIONS].
No overall differences in safety or effectiveness of MYDCOMBI have been observed between patients 65 years of age and older and younger adult patients.
Overdosage of MYDCOMBI may cause a rapid rise in blood pressure. It may also cause headache, anxiety, nausea and vomiting, and ventricular arrhythmias. Prompt injection of a rapidly acting alpha-adrenergic blocking agent such as phentolamine has been recommended.
Contraindicated in persons showing known hypersensitivity to any component of the formulation.
Tropicamide, the anticholinergic component of MYDCOMBI, blocks the responses of the sphincter muscle of the iris, dilating the pupil (mydriasis). Phenylephrine hydrochloride, the alpha-1 adrenergic agonist component of MYDCOMBI, acts as a mydriatic agent by contracting the dilator muscle of the iris.
MYDCOMBI acts in 15 to 30 minutes with maximal mydriasis occurring in 20 to 90 minutes. Darker irides tend to dilate slower than lightly pigmented irides and to achieve maximal effect may require more doses than lighter irides.
Mydriasis will reverse spontaneously with time, with recovery after 3 to 8 hours. Complete recovery from mydriasis in some individuals may require 24 hours.
Two Phase 3 clinical trials were conducted to evaluate the efficacy of MYDCOMBI for achievement of mydriasis. The MIST-1 study was a prospective, double-masked, active-controlled, 3-period cross-over, superiority study to compare the pupil dilating effect of MYDCOMBI to tropicamide 1% and to phenylephrine 2.5%, with all solutions topically administered by the Optejet® Dispenser (N = 64 subjects; 128 eyes). The MIST-2 study was a prospective, multicenter, double-masked, placebo-controlled, 3-period crossover, superiority study to compare the pupil dilating effect of MYDCOMBI to placebo (eyewash solution), with both solutions topically administered by the Optejet Dispenser (N = 70 subjects; 140 eyes).
The primary efficacy endpoint for both studies was the mean change in 35-minute pupil diameter compared to baseline as measured by digital pupillometry in highly photopic conditions. Data from the 2 studies are presented in Table 1. At 35 minutes post-dose, the mean change in pupil diameter was 4.7 mm with MYDCOMBI, 4.1 mm with tropicamide, and 0.9 mm with phenylephrine in MIST-1, and was 4.8 mm with MYDCOMBI and 0.1 mm with placebo in MIST- 2. MYDCOMBI was statistically superior to tropicamide administered alone and phenylephrine administered alone.
Table 1 : Pupil Size and Change in Diameter from Baseline at 35 Minutes Post-Dose (MIST-1 and MIST-2) (Per-Protocol Population [1])
| Visit | MIST-1 | MIST-2 | |||
| MYDCOMBI (N = 124) |
Tropicamide Alone (N = 124) |
Phenylephrine Alone (N = 124) |
MYDCOMBI (N = 138) |
Placebo (N = 138) |
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| Mean Baseline (SD) | 2.6 (0.05) |
2.6 (0.05) |
2.6 (0.05) |
2.6 (0.04) |
2.6 (0.04) |
| 35-Minutes Post-Dose (SD) | 7.3 (0.08) |
6.7 (0.08) |
3.5 (0.08) |
7.3 (0.07) |
2.7 (0.05) |
| Change from Baseline (SD) | 4.7 (0.07) |
4.1 (0.06) |
0.9 (0.08) |
4.8 (0.07) |
0.1 (0.04) |
| Difference from MYDCOMBI (95% CI) [2] | 0.6 (0.4, 0.8) |
3.9 (3.7, 4.1) |
4.7 (4.5, 4.8) |
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| SD=Standard Deviation [1] The per-protocol (PP) population included all randomized subjects who received at least one dose of study medication and completed all planned assessments (related to the primary endpoint) without major protocol violations. Two subjects in MIST-1 and one subject in MIST-2 who withdrew consent after their first treatment visit were not included in the PP populations which resulted in 62 completed subjects (124 eyes) in MIST-1 and 69 completed subjects (138 eyes) in MIST-2 comprised the PP populations. Sensitivity analysis performed on the intent-to-treat (ITT) population including all randomized subjects resulted in consistent efficacy results. [2] Treatment differences and 95% confidence interval estimates were based on a mixed model including treatment, eye, baseline diameter, and carryover effect (for MIST-2 study only). In both studies, an unstructured covariance structure was used to account for within-subject correlation between eyes. |
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MYDCOMBI provided a clinically significant effect in the proportion of eyes achieving pupil diameter of ≥ 6 mm at 35-minute post-dose in 94% of eyes compared to 78% of eyes administered tropicamide alone and 1.6% of eyes administered phenylephrine alone, and 0% of eyes administered placebo. As shown in Figure 2, peak effect was measured at the 80-minute evaluation when the mean change from baseline was 5.2 mm. Treatment differences in mydriasis were observed as early as 20 minutes and still present at 180 minutes post-dose, the end of the protocol-specified observation period.
Figure 2: MIST-1 and MIST-2 pooled, mean pupil diameter vs measurement time, by treatment group. Vertical bars show 95% confidence interval for the mean at each point. Smooth curves are based on an 8 degrees of freedom (df) generalized additive model (GAM) smooth through time, adjusting for baseline pupil diameter. Confidence intervals are not adjusted for correlation.
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INSTRUCTIONS FOR USE
MydCombi™
Ophthalmic Spray
This “Instructions for Use” document has information about the administration of MydCombi™ (Tropicamide and Phenylephrine HCI Ophthalmic Spray) 1%/2.5%.
MydCombi™ is packaged in a dispenser that mists drug solution onto the eye. It has 2 parts – the cartridge that holds the drug solution, and the base that holds electronics.
Getting to know MydCombi™
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How the MydCombi™ Dispenser Works
Understanding the Mist and Battery Lights
The Mist Light and the Battery Light show the status of the MydCombi™ dispenser.
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Important Reminders and Cleaning Instructions
Storing the MydCombi™ Base and Cartridges
Store MydCombi™ bases and cartridges at room temperature 15°C to 25°C (59°F to 77°F). Protect from light and excessive heat.
The MydCombi™ base contains a lithium-ion battery. Damage to the base can cause fire. Do not puncture base or expose to excessive heat (≥ 50°C).
Li-Ion batteries may pose environmental and safety hazards and should be disposed of in accordance with all applicable Federal and State Laws. Check with all governing travel bodies for current requirements before air travel.
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Troubleshooting Tips
1. If no mist comes out when Mist Button is pressed, confirm Fill Button has been pressed down completely, and has returned to the “up” position.
2. If solution is not administered within 1 minute after loading, it will be automatically discharged - the MIST Light will blink blue while the Battery Light blinks red and blue. The MydCombi™ dispenser must be reset using the steps below.
To reset dispenser:
To report suspected adverse reactions please contact Eyenovia, Inc at 1-833-393-6684 (Option 1) or FDA at 1-800-FDA- 1088 or https://www.fda.gov/medwatch.
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1. Charging the Mydcombi™ Base
NOTE: Do not use base if packaging is opened or damaged. Get a new package by contacting your Eyenovia sales representative or calling 1-833-393-6684 (choose Option 1).
Type of Charger: Micro-USB to USB Cable with Wall Plug or USB port (see section 2 for specifications)
Charge Mydcombi™ Base Before First Use
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Base Specifications
| Parameter | Specifications |
| Operating power | 4.1VDC |
| Power source | Internally powered, Lithium-Ion Battery |
| Instrument make / model | Eyenovia / Mydcombi™ Base |
| Dimensions | 50 length, 120mm height, 40mm width (When assembled with cartridge) |
| Weight (system) | < 100g (When assembled with cartridge) |
| Allowed operating temperature range | 15°C to 25°C (59°F to 77°F) |
| Allowed shipping and storage temperature range | 15°C to 25°C (59°F to 77°F) at relative humidity of 15% to 90% RH, non-condensing |
| Allowed operation, storage, and shipping humidity range | 15°C to 25°C (59°F to 77°F) at relative humidity of 15% to 90% RH, non-condensing |
| Allowed operation, storage, and shipping atmospheric pressure | 700hPa to 1060hPa |
| Electrical shock protection - Classification / Degree | Internally powered Class I |
| Battery life | 2-4 weeks, if used as indicated. |
| Use Life | Do not use base longer than 12 months from date of first use, or after Use By Date |
| Software version | Software version number can be obtained by calling the manufacturer. |
Charger Specifications (Micro-USB to USB Cable with Wall Plug or USB port)
| Parameter | Specifications |
| Type | Switching Power Supply |
| Input | 100-240V~, 50/60 Hz 200mA |
| Output | 5V, 1A |
| USB Cable Minimum Requirements | 5V, 1A |
| USB cable must be UL Listed. Must meet US Standard Level VI energy efficiency. Must meet DOE & CEC regulatory requirements. Examples of acceptable cables include those with UL number E178074 or Homespot Model S005AYU0500100. | |
3. EMC
This device has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in professional medical equipment. This equipment generates, uses, and radiates radio frequency energy and, if not prepared and used in accordance with instructions, may cause harmful interference to radio communications. There is no guarantee, however, that interference will not occur in a particular setting. If this device does cause harmful interference to radio or television reception, which can be determined by turning the device off/on, the user is encouraged to try to correct the interference by one or more of the following measures:
Note: Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the device.
Guidance and Manufacturer’s Declaration
This device is intended for use in the electromagnetic environment specified below. The device user should assure use in such an environment.
| Electromagnetic emissions | |||
| Emissions Test | Compliance | ||
| RF emissions CISPR 11 | Group 1 | ||
| RF emissions CISPR 11 | Class B | ||
| Harmonic Emissions IEC 61000-3-2 | Class B | ||
| Voltage Fluctuations/Flicker emissions IEC 61000-3-3 | Complies | ||
Electromagnetic immunity
| Phenomena of a continuous nature | Shall operate as intended. Shall be no degradation of performance. Shall be no loss of function. | ||
| Phenomena of transient nature | Functions shall be self-recoverable. Shall operate as intended after recovering. Shall be no degradation of performance, | ||
| Power interruption exceeding a certain time | Functions shall be recoverable by the operator. Shall operate as intended after recovering. Shall be no degradation of performance. |
| Immunity Test | IEC 60601 Test Level | Compliance Level | |
| Electrostatic fast transient/burst IEC 61000-4-4 (Charging Only) | ±2 kV for power supply lines | ±2 kV for power supply lines | |
| Surge IEC 61000-4-5 EN/IEC 61000-4-3 L-N (Charging Only) | ±1 kV differential mode | ±1 kV differential mode | |
| EN/IEC 61000-4-3 (Charging Only) | Radiated Immunity 3 V/m, 80 - 2700 MHz 80% AM at 1 kHz & Proximity Fields from RF Wireless Communications Equipment | Radiated Immunity 3 V/m, 80 - 2700 MHz 80% AM at 1 kHz & Proximity Fields from RF Wireless Communications Equipment | |
| Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11 | Voltage Dips 30% reduction, 25/30 periods At 0° | Voltage Dips 30% reduction, 25/30 periods At 0° | |
| Voltage Dips > 95% reduction, 0.5 period At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315° | Voltage Dips > 95% reduction, 0.5 period At 0°, 45°, 90°, 135°, 180°, 225°, 270°, and 315° | ||
| Voltage Dips > 95 reduction, 1 period At 0° | Voltage Dips > 95 reduction, 1 period At 0° | ||
| Voltage Interruptions > 95% reduction, 250/300 periods | Voltage Interruptions > 95% reduction, 250/300 periods | ||
| Conducted RF EN/IEC 61000-4-6 | Continuous Conducted RF, 80% AM (1 kHz) 3 Vrms, 0.15-80 MHz 6 Vrms in ISM and amateur radio Bands within 150kHz - 80MHz | Continuous Conducted RF, 80% AM (1 kHz) 3 Vrms, 0.15-80 MHz 6 Vrms in ISM and amateur radio Bands within 150kHz - 80MHz | |
| Magnetic field IEC 61000-4-8 | Power Frequency Magnetic Field 30Arms/m at 50/60Hz | Power Frequency Magnetic Field 30Arms/m at 50/60Hz | |
Immunity to RF Wireless Communications Equipment
| Test Frequency (MHz) | Band a) (MHz) | Service a) | Modulation b) | Max. Power (W) | Distance (m) | Immunity test level (V/m) |
| 385 | 380 -390 | TETRA 400 | Pulse b) 18 Hz | 1.8 | 0.3 | 27 |
| 450 | 430 - 470 | GMRS 460, FRS 460 | FM c) ± 5 kHz Deviation 1 kHz sine | 2 | 0.3 | 28 |
| 710 745 780 | 704 - 787 | LTE Band 13, 17 | Pulse b) 217 Hz | 0.2 | 0.3 | 9 |
| 810 870 930 | 800 - 960 | GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 | Pulse b) 18 Hz | 2 | 0.3 | 28 |
| 1720 1845 1970 | 1 700 - 1 990 | GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS | Pulse b) 217 Hz | 2 | 0.3 | 28 |
| 2450 | 2 400 - 2 570 | Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 | Pulse b) 217 Hz | 2 | 0.3 | 28 |
| 5240 5500 5785 | 5 100 - 5 800 | WLAN 802.11 a/n | Pulse b) 217 Hz | 0.2 | 0.3 | 9 |
| a) For some services, only uplink frequencies are included. b) The carrier shall be modulated using a 50% duty cycle square wave signal. c) As an alternative to FM modulation, 50% pulse modulation at 18 Hz may be used because, while it does not represent actual modulation, it would be worst case. |
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Recommended separation distances between portable and mobile RF communications equipment and the device, except for the distances indicated in the following table “Immunity to RF Wireless Communications Equipment”.
The device is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. Users can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the device as recommended below, according to the maximum output power of the communications equipment.
| Rated maximum output power of transmitter (W) |
Separation distance according to frequency of transmitter (m) | ||
| 150 kHz to 80 MHz d = 1.2√P | 80 MHz to 800 MHz d = 1.2√P | 800 MHz to 2.7 GHz d = 2.3√P | |
| 0.01 | 0.12 | 0.12 | 0.23 |
| 0.1 | 0.38 | 0.38 | 0.73 |
| 1 | 1.2 | 1.2 | 2.3 |
| 10 | 3.8 | 3.8 | 7.3 |
| 100 | 12 | 12 | 23 |
| For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. |
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4. Disposal
5. Notes on Safety
Warnings and Recommendations
Recharge base using a micro-USB cable (not included). Use of a charger other than that specified in Section 2 - Specifications could result in increased electromagnetic emissions or decreased electromagnetic immunity of the base, resulting in improper operation.
CAUTION – For professional use
Federal law restricts this device to sale by or on the order of a physician (21 CFR§801.109(b)(1)).
CAUTION – Radiation emission
This device emits electromagnetic radiation.
6. Reporting to Manufacturer and Authorities
If a serious incident occurs in connection with this device that affects the user or another person, please report incident to Eyenovia by calling 1-833-393-6684 (choose Option 1) or FDA at 1-800-FDA-1088 or https://www.fda.gov/medwatch.
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