SANMYD-P Tropicamide / Phenylephrine Hydrochloride 5mg / 5mg per mL Ophthalmic Solution 10mL
RXDRUG-DR-XY25408
Discreet Packaging
FDA-registered Products
FDA-licensed Pharmacies
Indications/Uses
Mydriasis and cycloplegia for the purpose of diagnosis or treatment.
Dosage/Direction for Use
For mydriasis, usually, instill 1 or 2 drops once or 1 drop twice every 3-5 minutes. For cycloplegia, usually, 1 drop 2 or 3 times every 3-5 minutes. The dosage may be adjusted according to the patient's symptoms.
Overdosage
Not particularly specified.
Contraindications
This product is contraindicated in the following patients: 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.
Patients with a history of hypersensitivity to any ingredients of this product.
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.
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.
Adverse Reactions
If the systemic symptoms are observed, administration should be discontinued.
Clinically significant adverse reactions (rarely: <0.1%, occasionally: 5% > ≥0.1%, and no specific designation: ≥5% or incidence unknown).
Shock, anaphylactoid reaction: Since shock and anaphylactoid reaction 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 1).
Clinically significant adverse reactions (rarely: <0.1%, occasionally: 5% > ≥0.1%, and no specific designation: ≥5% or incidence unknown).
Shock, anaphylactoid reaction: Since shock and anaphylactoid reaction 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 1).
Drug Interactions
Precautions for coadministration: This product should be administered with care when coadministered with the following drugs. (See Table 2).
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacology: Tropicamide + Phenylephrine Hydrochloride (Sanmyd-P) rapidly causes mydriasis required for funduscopy and cycloplegia for refractometry. These symptoms disappear in a comparatively short time after the completion of these examinations.
Tropicamide + Phenylephrine Hydrochloride (Sanmyd-P) is a mydriatic for diagnostic purposes, which contains tropicamide (a parasympatholytic agent) and phenylephrine hydrochloride (a sympathomimetic agent) and with the synergism between these two ingredients, it can be used to achieve mydriasis and cycloplegia, irrespective of the patient's age.
Pharmacodynamics: Mydriatic Effect: When ophthalmic solutions containing tropicamide and phenylephrine hydrochloride at various concentrations were instilled into the eyes of albino rabbits, mydriasis was produced by tropicamide-induced relaxation of the iris sphincter muscle and phenylephrine hydrochloride-induced contraction of the iris dilator muscle. 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 instilled into the eye once or twice for refractometry in children with impaired visual acuity or convergent squint, and the cycloplegic effect of this product was compared with that of 0.5% or 1% atropine after instillation 3 times daily for 3 days. This product was weaker in cycloplegic effect than atropine.
Tropicamide + Phenylephrine Hydrochloride (Sanmyd-P) is a mydriatic for diagnostic purposes, which contains tropicamide (a parasympatholytic agent) and phenylephrine hydrochloride (a sympathomimetic agent) and with the synergism between these two ingredients, it can be used to achieve mydriasis and cycloplegia, irrespective of the patient's age.
Pharmacodynamics: Mydriatic Effect: When ophthalmic solutions containing tropicamide and phenylephrine hydrochloride at various concentrations were instilled into the eyes of albino rabbits, mydriasis was produced by tropicamide-induced relaxation of the iris sphincter muscle and phenylephrine hydrochloride-induced contraction of the iris dilator muscle. 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 instilled into the eye once or twice for refractometry in children with impaired visual acuity or convergent squint, and the cycloplegic effect of this product was compared with that of 0.5% or 1% atropine after instillation 3 times daily for 3 days. This product was weaker in cycloplegic effect than atropine.
MedsGo Class
Mydriatic Drugs
Features
Brand
Sanmyd-P
Full Details
Dosage Strength
5 mg / 5 mg per mL
Drug Ingredients
- Phenylephrine
- Tropicamide
Drug Packaging
Ophthalmic Solution 10ml
Generic Name
Tropicamide / Phenylephrine Hydrochloride
Dosage Form
Ophthalmic Solution
Registration Number
DR-XY25408
Drug Classification
Prescription Drug (RX)
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