Mydrin-P

Tropicamide, phenylephrine hydrochloride.

See Table 1.

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Pharmacology: Mydriatic Effect: When ophthalmic solutions containing tropicamide and phenylephrine hydrochloride at various concentrations is applied to the eyes of albino rabbits, mydriasis is produced by relaxation of the iris sphincter muscle by tropicamide and contraction of the iris dilator muscle by phenylephrine hydrochloride. The mydriatic effect was enhanced at the tropicamide-to-phenylephrine ratio of 1:1 by the synergistic effect of both ingredients.
Cycloplegic Effect: This product was applied to the eye once or twice in children with impaired visual acuity or convergent squint for refractometry, and the cycloplegic effect of this product was compared with that of 0.5% or 1% atropine after application 3 times a day for 3 days. This product was weaker in cycloplegic effect than atropine.
Clinical Studies: Mydriatic Effect: In some elderly individuals, who generally have small pupils, adequate mydriasis can not be achieved by topical application of tropicamide alone. It can be achieved by this product containing phenylephrine regardless of age and its effect was particularly remarkable in individuals aged 40 years or more.
Cycloplegic Effect: When 1 drop of this product was applied 3 times every 3 minutes into one eye each of 8 healthy individuals without ophthalmic disease other than refraction disorders, the cycloplegic effect of this product peaked at 20-30 minutes after the last application. Accommodative function returned to normal 5-6 hours after application.

Mydriasis and cycloplegia for the purpose of diagnosis or treatment.

For mydriasis, usually, apply 1-2 drops once or 1 drop twice at a 3-5 minute interval.
For cycloplegia, usually, apply 1 drop 2-3 times at 3-5 minute intervals.
The dosage may be adjusted according to the patient's symptoms.

Mydrin-P is contraindicated in: Patients with glaucoma or those predisposed to ocular hypertension as evidenced by a narrow angle or shallow anterior chamber [acute angle-closure glaucoma may occur]; Patients with a history of hypersensitivity to any ingredients of this product.

Careful Administration: Mydrin-P should be administered with care in the following patients.
Children: See Use in Children as follows.
Hypertensive patients: Symptoms may be aggravated due to hypertensive effect of phenylephrine.
Patients with arteriosclerosis: Symptoms may be aggravated due to hypertensive effect of phenylephrine.
Patients with heart disease, including coronary artery disease or heart failure: Symptoms may be aggravated due to β1 agonistic effect of phenylephrine.
Patients with diabetes: Symptoms may be aggravated due to the gluconeogenesis-promoting effect of phenylephrine.
Patients with hyperthyroidism: Because hyperthyroidism may be accompanied with the development of sympathomimetic symptoms such as palpitation and tachycardia, administration of this product may aggravate these symptoms.
Important Precautions: As bradycardia, apnea, etc. may occur when this product is administered to premature infants for the purpose of funduscopy, this product should be administered with care while closely observing the patient's condition. (See Use in Children as follows.)
Since this product causes mydriasis and/or cycloplegia, patients should be cautioned against engaging in potentially hazardous activities requiring clear vision, such as operating machinery or driving a car. Instruct the patients to protect their eyes from direct sunlight or other powerful light by wearing sunglasses or by other means.
Others: Do not use this product if it is discolored or contains a precipitate.
Use in the Elderly: Because physiological function is generally reduced in the elderly, caution should be exercised.
Use in Children: Since systemic adverse reactions are likely to occur when administered to pediatric patients, this product should be administered with care while observing the patient's condition. Especially when applied to premature infants, administer cautiously under close observation of the patient's condition, since it has been reported that bradycardia, apnea or gastrointestinal hypomotility (abdominal distension, decreased milk intake, etc.) have occurred. In the case of any abnormal findings, administration should be discontinued immediately and appropriate measures should be taken. It is advisable that this product should be diluted for use, if necessary.

This drug has not been investigated (drug use investigation etc.) to determine the incidence of adverse reactions. If systemic symptoms are observed, administration should be discontinued.
Clinically significant adverse reactions: Shock and anaphylaxis (incidence unknown): Since shock and anaphylaxis may occur, patients should be carefully observed. If any symptoms such as erythema, rash, dyspnoea, decreased blood pressure, and eyelid oedema, etc. are observed, administration should be discontinued and appropriate measures should be taken.
Other adverse reactions: If the following adverse reactions are observed, appropriate measures such as discontinuing administration should be taken. (See Table 2.)

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Precautions for co-administration: Mydrin-P should be administered with care when co-administered with the following drugs: See Table 3.

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Route of administration: Ophthalmic use only.
At the time of administration: (1) Mydrin-P should be applied into the conjunctival sac after eyelid retraction, while the patient is in a supine position. After application, the treated eye should be closed for 1-5 minutes while the lacrimal sac is compressed appropriately.
(2) Instruct the patient to be careful not to touch the tip of the bottle directly to the eye in order to avoid the contamination of the drug.

Store between 1-30°C in a tight container.

After the completion of funduscopy, etc. in a patient in whom this product is administered topically, the following instructions should be given to the patient.
1. Since your pupils are dilated, your vision will be blurred and light may seem brighter than usual for 4-5 hours. These symptoms will disappear on their own.
2. Avoid potentially hazardous activities requiring clear vision, such as driving a car, for half a day after this ophthalmological examination.
3. Tell the doctor in charge of the examination or consult with a local ophthalmologist immediately if you suffer from: (a) Headache or eye pain after the examination.
(b) The following conditions if they still persist the day after the examination: Larger pupils than usual (or different size of each pupil); Blurred vision; Light seems brighter than usual; Headache or eye pain (except known etiology, e.g., due to a common cold).
Note: After the examination, normal vision is regained more readily if a pilocarpine ophthalmic solution is applied topically.

Mydriatic Drugs

S01FA56 - tropicamide, combinations ; Belongs to the class of anticholinergics used as mydriatics and cycloplegics.

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