Sanmyd-P Special Precautions

Careful Administration: This product should be administered with care in the following patient: 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 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 Tropicamide + Phenylephrine Hydrochloride (Sanmyd-P) 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 Tropicamide + Phenylephrine Hydrochloride (Sanmyd-P) 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.
Precautions concerning Use: Route of administration: Ophthalmic use only.
At the time of administration: (Tropicamide + Phenylephrine Hydrochloride (Sanmyd-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 min. while the lacrimal sac is compressed appropriately.
Be careful not to touch the tip of the bottle to the eye directly in order to avoid the contamination of the drug.
Others: Do not use Tropicamide + Phenylephrine Hydrochloride (Sanmyd-P) if it is discolored or contains a precipitate.
Use in 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 or apnea occurred. In 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.