Wakaya Ruru Topical Analgesic

Description

No relevant information is available for SPL code 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains of muscles and joints associated with 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 recommended application is to the affected area not more than 3 to 4 times per day. It is important to ensure that the application is limited to the specified frequency to avoid potential adverse effects.

For children under 2 years of age, it is advised to consult a physician prior to use to determine the appropriate course of action and ensure safety.

Contraindications

Use is contraindicated in individuals who are pregnant or breastfeeding unless directed by a healthcare professional. In the event of accidental ingestion, immediate medical assistance should be sought or contact with a poison control center is advised.

Warnings and Precautions

For external use only. It is imperative to avoid contact with the eyes to prevent irritation or injury. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, the use of this product should be discontinued immediately, and a physician should be consulted.

Users are advised not to bandage the affected area tightly, as this may exacerbate the condition or lead to adverse effects. Pregnant or breastfeeding individuals should seek guidance from a healthcare professional prior to using this product to ensure safety for both mother and child.

In cases of accidental ingestion, it is crucial to seek medical assistance or contact a poison control center without delay to address potential health risks associated with swallowing the product.

Side Effects

Patients should be aware that the product is intended for external use only and must avoid contact with the eyes. In the event that the condition worsens, or if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days, it is advised to discontinue use and consult a physician. Additionally, patients should not bandage the area tightly while using the product. These precautions are essential to ensure safe and effective use.

Drug Interactions

No specific drug interactions have been identified for this medication. Additionally, there are no reported interactions with laboratory tests. Therefore, no dosage adjustments or monitoring recommendations are necessary based on drug or laboratory test interactions.

Packaging & NDC

Below are the non-prescription pack sizes of Wakaya Ruru Topical Analgesic (external analgesic). 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 recommended application is to the affected area not more than 3 to 4 times per day.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in therapeutic response, given the lack of targeted data for this population.

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 considered in these populations to ensure the safety of both the mother and the fetus or infant.

Lactation

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

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 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, as the clinical presentation can vary depending on the substance involved and the individual patient's response. Common symptoms of overdose may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should initiate supportive care, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs. The use of activated charcoal may be considered if the patient presents within a suitable timeframe and if the ingestion was recent.

Furthermore, specific antidotes or treatments may be indicated based on the substance involved in the overdose. Consultation with a poison control center or a medical toxicologist is recommended to guide the management of the patient effectively.

Overall, vigilance and prompt intervention are critical in managing cases of suspected overdose, even in the absence of detailed information regarding specific overdosage effects.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been provided in the insert. Additionally, there is no information available regarding nonclinical toxicology or animal pharmacology and toxicology in the insert.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to inform patients that if they are pregnant or breastfeeding, they should consult a healthcare professional before using the medication to ensure safety for both the mother and child.

Additionally, patients should be made aware that if the medication is swallowed, they must seek medical help or contact a poison control center immediately. This prompt action is crucial in managing any potential adverse effects associated with accidental ingestion.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product in a cool, dry place to maintain its integrity and efficacy. Proper storage conditions are crucial to ensure the product remains effective throughout its shelf life.

Additional Clinical Information

Adults and children aged 2 years and older are advised to apply the product to the affected area no more than 3 to 4 times per day. For children under 2 years of age, consultation with a physician is recommended prior to use.

Clinicians should counsel patients to seek advice from a health professional if they are pregnant or breastfeeding. Patients should be informed to seek medical help or contact a poison control center immediately if the product is swallowed. It is important to avoid contact with the eyes. Patients should discontinue use and consult a physician if the condition worsens, symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, patients should not bandage the area tightly.

Drug Information (PDF)

This file contains official product information for Wakaya Ruru Topical Analgesic, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)