Mydrephrine-P

Mydrephrine-P

Manufacturer:

Nitto Medic

Distributor:

Four Star
/
Main Life
Full Prescribing Info
Contents
Tropicamide, phenylephrine hydrochloride.
Description
Composition: See Table 1.

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Tropicamide: 5 mg per mL.
Nonproprietary name: Tropicamide.
Chemical name: (2RS)-N-Ethyl-3-hydroxy-2-phenyl-N-(pyridine-4-ylmethyl) propanamide.
Molecular formula: C17H20N2O2.
Molecular weight: 284.35.
Description: Tropicamide occurs as a white crystalline powder. It is odorless and has a bitter taste.
It is freely soluble in ethanol (95) and in chloroform, slightly soluble in water and in diethyl ether, and practically insoluble in petroleum ether. It dissolves in dilute hydrochloric acid.
When 1.0 g of tropicamide is dissolved in 500 mL of water, the pH of the solution is between 6.5 and 8.0.
Melting point: 96~99°C.
Phenylephrine Hydrochloride: 5 mg per mL.
Nonproprietary name: Phenylephrine Hydrochloride.
Chemical name: (1R)-1-(3-Hydroxyphenyl)-2-methylaminoethanol monohydrochloride.
Molecular formula: C9H13NO2 · HCl.
Molecular weight: 203.67.
Description: Phenylephrine hydrochloride occurs as white crystals or crystalline powder. It is odorless and has a bitter taste.
It is very soluble in water, freely soluble in ethanol (95), and practically insoluble in diethyl ether.
When 1.0 g of phenylephrine hydrochloride is dissolved in 100 mL of water, the pH of the solution is between 4.5 and 5.5.
Melting point: 140~145°C.
Action
Pharmacology: Bioequivalence study: Mydrephrine-P Ophthalmic Solution and the standard preparation (ophthalmic solution, tropicamide 0.5% / phenylephrine hydrochloride 0.5%) were tested using the two treatments, two periods, crossover design. One drop of each drug was instilled once into the conjunctival sac of healthy adult male subjects. Based on the result of statistical analyses performed using the maximum pupil diameter change before and after instillation, and the area under the pupil diameter change-time curve as parameters for judging bioequivalence, these two drugs were validated as bioequivalent. (See Table 2 and figure.)

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The values of the parameters of the differences in the maximum pupil diameter and the area under the differences in the pupil diameter time-curve may vary depending on the test conditions, including the selection of subjects, number of measurements, and timing of measurements.
Indications/Uses
Mydriasis and cycloplegia for diagnostic or treatment purposes.
Dosage/Direction for Use
To induce mydriasis, usually, one or two drops are instilled at a time, or one drop is instilled twice with a three- to five-minute interval between the doses.
To induce cycloplegia, usually, one drop is instilled two or three times with a three- to five-minute interval between the doses.
The dose should be adjusted depending on the symptom.
Contraindications
This product is contraindicated in the following patients: Patients with a predisposition to ocular hypertension, such as glaucoma, narrow-angle, and shallow anterior chamber [acute angle-closure glaucoma may occur]; Patients with a history of hypersensitivity to any of the ingredients in this product.
Special Precautions
Careful Administration: This product should be administered with special caution in the following patients: Pediatric patients [see Use in Children as follows]; Patients with hypertension [the symptom may worsen due to the hypertensive effect of phenylephrine]; Patients with arteriosclerosis [the symptom may worsen due to the hypertensive effect of phenylephrine]; Patients with heart disease, such as coronary insufficiency and heart failure [the symptom may worsen due to the β1 effect of phenylephrine]; Patients with diabetes [the symptom may worsen due to the gluconeogenesis-promoting effect of phenylephrine]; Patients with hyperthyroidism [sympathomimetic symptoms of palpitation and tachycardia are found in a certain percentage of patients with hyperthyroidism, and these symptoms may worsen after using this product].
Important Precautions: Because the onset of symptoms during funduscopy, including bradycardia and apnea, has been reported in low birth weight infants, this product should be administered with care, and close observation is required while using this product. [See Use in Children as follows.]
Because this product induces mydriasis or cycloplegia, patients who use this product should be cautioned against operating potentially hazardous machinery, for example, driving a car until mydriasis or cycloplegia resolves. Moreover, patients should be instructed to wear sunglasses or use other protection to avoid looking directly at sunlight or other intense light.
Use in Elderly: Generally elderly patients have declined physiological functions and this product should be administered with caution.
Use in Children: Because systemic adverse reactions tend to occur when this product is used by children, this product should be administered with care and adequate observation.
In particular, the onset of symptoms of bradycardia, apnea, and gastrointestinal hypomotility (e.g. abdominal distention, decreased amount of milk intake) has been reported in low birth weight infants; thus, the patient should be monitored. If any abnormality is observed, the use of this product should be discontinued immediately, and adequate measures should be implemented. It is recommended to dilute this product as needed before use.
Adverse Reactions
This product has not been investigated to determine the incidence of adverse reactions.
If any systemic symptoms appear, the use of this product should be discontinued.
Clinically Significant Adverse Reactions (Frequency unknown): Shock, anaphylaxis: Because shock and anaphylaxis may occur, adequate observation of patients is required. If any symptom of erythema, eruption, dyspnea, decreased blood pressure, and eyelid edema is observed, the use of this product should be discontinued, and adequate measures should be implemented.
Other Adverse Reactions: If any of the following adverse reactions is observed, appropriate measures should be taken including discontinuation of treatment. (See Table 3.)

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Drug Interactions
Precautions for co-administration: See Table 4.

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Caution For Usage
Precautions Concerning Use: If discoloration or precipitation occurs, do not use this product.
Route of administration: Ophthalmic use only.
Administration: 1) In principle, keep the patient in a supine position while instillation, open the eyelid of the affected eye wide, instill this drug into the conjunctival sac, close the eyelids for one to five minutes, and apply slight pressure to the lacrimal sac before opening the eye.
2) To prevent contamination of the drug solution, the user should be instructed to be careful not to directly touch the eye with the dropper tip while instilling the drug.
Precautions for Handling: Stability study: The result of a long-term stability study (25°C, relative humidity 60%, 3 years) of Mydrephrine-P Ophthalmic Solution filled in a polypropylene container confirmed that this product is stable for three years under ordinary marketing conditions.
Storage
Store at or below 25°C.
Shelf life: 3 years.
MIMS Class
ATC Classification
S01FA56 - tropicamide, combinations ; Belongs to the class of anticholinergics used as mydriatics and cycloplegics.
Presentation/Packing
Ophth soln 5 mL (clear, colorless to pale yellow, sterile, aqueous solution) x 10's.
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