Shexiang Zhuanggugao

Description

Shexiang Zhuanggugao Pain Relieving Plaster is a topical formulation designed for pain relief. The product is presented in a plaster dosage form, which allows for localized application. The effective time for this formulation is noted as December 19, 2024. An image of the product packaging is available in JPEG format, referenced as package.jpg.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with muscles and joints. Specifically, it is effective for conditions such as simple backache, arthritis, strains, bruises, and sprains.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Adults and children 12 years of age and older are instructed to apply one or two plasters to the affected area once daily. The plasters should be removed after 8 hours of application.

For children aged 2 to 12 years and adults with compromised health, the use of plasters should only occur under the guidance of a healthcare professional to ensure safety and efficacy.

The product is contraindicated for use in children under 2 years of age.

Contraindications

Use is contraindicated in individuals with a known allergy to salicylates or aspirin. Application to wounds or damaged skin is prohibited due to the potential for adverse effects. Tight bandaging is not recommended as it may exacerbate skin irritation or compromise circulation. Additionally, pregnant or breastfeeding individuals should consult a healthcare professional prior to use to ensure safety for both the mother and child.

Warnings and Precautions

For external use only, this product should be applied with caution to prevent adverse effects. It is imperative to avoid contact with the eyes and to refrain from applying it to wounds or damaged skin. Additionally, tight bandaging of the area where the product is applied is not recommended.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Users are advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Pregnant or breastfeeding individuals should seek guidance from a healthcare provider prior to use.

General precautions include consulting a doctor or pharmacist before use if there is a known allergy to salicylates or aspirin.

Side Effects

For external use only. Patients are advised to stop use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days.

It is important for patients who are pregnant or breastfeeding to seek guidance from a health professional prior to use. Additionally, individuals should consult a doctor or pharmacist before use if they have a known allergy to salicylates or aspirin.

Drug Interactions

Patients should consult a healthcare professional prior to use if they have a known allergy to salicylates or aspirin. This precaution is essential to avoid potential allergic reactions that may arise from the use of medications containing these compounds.

No specific drug or laboratory test interactions have been identified in the available data. Therefore, routine monitoring or dosage adjustments related to drug interactions are not indicated at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Shexiang Zhuanggugao (methyl salicylate and camphor (synthetic) and menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 to 12 years and adults with compromised health should use this product only under the guidance of a healthcare professional. The use of this product is not recommended for children under 2 years of age. For patients aged 12 years and older, the recommended application is one or two plasters to the affected area once daily, with removal after 8 hours.

Geriatric Use

Elderly patients, defined as those aged 65 years and older, may apply one or two plasters to the affected area once daily, with the plasters to be removed after 8 hours.

For geriatric patients, particularly those with compromised health, it is advised that the use of this treatment be conducted under the guidance of a healthcare provider. This recommendation is crucial to ensure safety and efficacy, as elderly patients may have different physiological responses and potential comorbidities that could affect treatment outcomes.

Healthcare providers should closely monitor elderly patients for any adverse effects or complications associated with the use of plasters, and consider individual health status when determining the appropriateness of this treatment.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data on the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

Renal impairment may necessitate dosage adjustments for patients with reduced kidney function. It is important to monitor renal function tests in these patients to ensure safety and efficacy. Additionally, a reduced dose should be considered for patients with decreased creatinine clearance to mitigate the risk of adverse effects.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the substance involved, estimated dose, and time of exposure, is crucial for effective management and follow-up care.

Nonclinical Toxicology

There is currently no available information regarding teratogenic effects. Additionally, no data has been provided concerning non-teratogenic effects. The nonclinical toxicology section lacks any specific information, and there are no details available related to animal pharmacology and toxicology.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center if the product is swallowed. It is important to instruct patients to avoid contact with the eyes while using this product. Additionally, they should be informed not to apply the product to wounds or damaged skin and to refrain from tightly bandaging the area after application.

Patients should be counseled to discontinue use and consult a healthcare provider if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. For those who are pregnant or breastfeeding, it is essential to recommend that they consult a health professional before using the product.

Furthermore, patients should be encouraged to speak with their doctor or pharmacist prior to use if they have a known allergy to salicylates or aspirin.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available upon request. It should be stored at a temperature range of 15°C to 30°C (59°F to 86°F). It is essential to keep the product away from heat to maintain its integrity and efficacy. Proper storage conditions must be adhered to in order to ensure optimal performance.

Additional Clinical Information

The product is administered topically, with specific guidelines for different age groups. Adults and children aged 12 years and older should apply one or two plasters to the affected area once daily, removing them after 8 hours. For children aged 2 to 12 years and adults with compromised health, use should be under the guidance of a healthcare professional. The product is not recommended for children under 2 years of age.

Clinicians should counsel patients to consult a health professional if they are pregnant or breastfeeding before use. It is important to keep the product out of reach of children, and in the event of accidental ingestion, medical assistance or contact with a Poison Control Center is advised.

Drug Information (PDF)

This file contains official product information for Shexiang Zhuanggugao, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)