Zhuanggu Gao Pain Relieving

Description

No description information is available for the specified drug.

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

For adults and children aged 2 years and older, the protective film from the plaster should be removed prior to application. The plaster is to be applied to the affected area no more than 3 to 4 times daily.

For children under 2 years of age, it is recommended to consult a physician before use.

Contraindications

Use of this product is contraindicated in the following situations:

The product should not be applied to wounds, as this may impede healing and increase the risk of infection. It is also contraindicated for use on irritated or damaged skin due to the potential for exacerbating the condition. Patients with known allergies to any ingredient in this product must avoid its use to prevent allergic reactions.

Additionally, contact with the eyes or mucous membranes should be strictly avoided. The product should not be tightly bandaged, as this may restrict circulation. Application of heat in the form of heating pads, hot water bottles, or lamps is contraindicated, as it significantly increases the risk of serious burns. Finally, placement on extremely hairy areas of skin should be avoided to minimize irritation during removal.

Warnings and Precautions

For external use only. This product contains natural rubber latex, which may cause allergic reactions in sensitive individuals.

It is imperative to adhere to the following precautions to ensure safe use. The product should not be applied to wounds, irritated, or damaged skin. Additionally, individuals with known allergies to any ingredient in this product should refrain from use.

Healthcare professionals should advise patients to discontinue use and seek medical attention if any of the following occur: the condition worsens; symptoms persist for more than 7 days; symptoms resolve and then recur within a few days; excessive skin irritation develops; gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash manifest; or if the patient experiences actual pain, blistering, or burning after application (a warming or cooling sensation is expected).

In cases where the product is used for arthritis pain, patients should be instructed to consult a physician if pain persists for more than 10 days, if redness is present, or if the product is being used on children under 12 years of age.

To prevent accidental poisoning, this product should be kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact with a Poison Control Center is recommended.

Side Effects

Patients using this product should be aware that it is for external use only. There is an allergy alert associated with this product, as it contains natural rubber latex, which may lead to allergic reactions in susceptible individuals.

In clinical practice, patients are advised to stop use and consult a healthcare professional if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms resolve and then recur within a few days, excessive skin irritation develops, or gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, diarrhea, or skin rash manifest. Additionally, if patients experience actual pain, blistering, or burning after application—beyond the expected warming or cooling sensation—medical advice should be sought.

For patients using this product specifically for arthritis pain, it is recommended to discontinue use and consult a doctor if pain persists for more than 10 days, if redness is present, or if the product is being used in children under 12 years of age.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Zhuanggu Gao Pain Relieving (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 2 years of age should consult a physician prior to use. For children aged 2 years and older, the protective film from the plaster should be removed before application to the affected area, which may be done no more than 3 to 4 times daily.

Healthcare professionals should be aware of specific warnings for pediatric patients under 12 years of age. If any of the following occur, the product should be discontinued, and a doctor should be consulted: worsening of the condition, persistence of symptoms beyond 7 days, recurrence of symptoms after initial improvement, excessive skin irritation, or the onset of nausea, vomiting, abdominal discomfort, diarrhea, or skin rash. Additionally, if actual pain, blistering, or burning occurs after application—beyond the expected warming or cooling sensation—medical advice should be sought. For cases involving arthritis pain, if pain persists for more than 10 days or if redness is present, a healthcare professional should be consulted.

Geriatric Use

There is no specific information regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those planning to become pregnant should not use this product. It is essential for women of childbearing potential to consult their healthcare provider prior to using this product to discuss potential risks and benefits. The safety of this product during pregnancy has not been established, and caution is advised to avoid any adverse fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this product in lactating mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there is no information available regarding dosage adjustments, special monitoring requirements, or precautions 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 warranted in these patients to ensure safety and therapeutic effectiveness.

Overdosage

There is currently no specific information available regarding overdosage for this medication. Healthcare professionals are advised to monitor patients closely for any unusual symptoms or adverse effects that may arise. In the event of suspected overdosage, it is recommended to initiate supportive care and symptomatic treatment as necessary.

Healthcare providers should consider contacting a poison control center or a medical toxicologist for guidance on management strategies tailored to the individual patient's needs. Continuous assessment and monitoring of vital signs and clinical status are essential in managing any potential complications associated with overdosage.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

Serious side effects have been reported voluntarily through various channels, including surveillance programs. Healthcare professionals and patients are encouraged to report any adverse events to the designated contact number for further evaluation and monitoring.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental poisoning. In the event of ingestion, patients should seek medical assistance or contact a Poison Control Center immediately.

Patients should be instructed not to use the product on wounds, irritated, or damaged skin. It is essential to inform patients that they should not use the product if they are allergic to any of its ingredients.

Healthcare providers should counsel patients to discontinue use and consult a doctor if their condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Patients should also be advised to stop using the product and seek medical advice if they experience excessive skin irritation, nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash.

Patients should be informed that it is normal to feel a warming or cooling sensation after application; however, they should stop use and consult a doctor if they experience actual pain, blistering, or burning. When using the product for arthritis pain, patients should be advised to seek medical advice if pain persists for more than 10 days or if redness is present.

For children under 12 years of age, healthcare providers should recommend consulting a doctor before use. Patients should be cautioned to avoid contact with the eyes or mucous membranes while using the product. Additionally, they should not bandage the area tightly or apply heat in the form of heating pads, hot water bottles, or lamps, as this increases the risk of serious burns.

Finally, patients should be encouraged to avoid placing the product on extremely hairy areas of skin to minimize irritation during removal. Healthcare providers should remind patients to consult a doctor or pharmacist if they have any concerns regarding the use of this product.

Storage and Handling

Plasters are supplied in a zip-lock pouch, which should be kept tightly closed to maintain product integrity. For optimal storage conditions, plasters should be stored at a temperature range of 15 to 30°C (59 to 86°F). It is essential to keep them in a dry place, away from direct sunlight, to ensure their effectiveness and longevity.

Additional Clinical Information

The transdermal route of administration is indicated for patients aged 2 years and older, with application to the affected area not exceeding 3 to 4 times daily. For children under 2 years of age, consultation with a physician is recommended prior to use. No further information is available regarding laboratory tests, abuse potential, patient counseling, or postmarketing experience.

Drug Information (PDF)

This file contains official product information for Zhuanggu Gao Pain Relieving, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)