Rematex

Description

REMATEX is a sterile, non-pyrogenic, isotonic solution intended for intravenous administration. Each 100 mL of REMATEX contains the following active ingredients: 0.9 g of Sodium Chloride, 0.2 g of Sodium Bicarbonate, 0.04 g of Potassium Chloride, 0.02 g of Calcium Chloride, 0.01 g of Magnesium Sulfate, and 5 g of Dextrose. The pH of the solution is maintained within the range of 7.0 to 7.5.

The solution is supplied in a 100 mL flexible plastic container. Inactive ingredients include Water for Injection, Sodium Citrate, Hydrochloric Acid for pH adjustment, and Sodium Hydroxide for pH adjustment.

Uses and Indications

This drug is indicated for the temporary relief of minor pain associated with muscles and joints in patients experiencing conditions such as arthritis, simple backache, strains, sprains, and bruises.

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

Dosage and Administration

For adults and children over 18 years of age, the recommended application involves generously applying the product to the affected area. The area should be massaged until the formulation is thoroughly absorbed into the skin. This process may be repeated as necessary, but should not exceed 3 to 4 applications per day. It is essential to wash hands with soap and water immediately after use to prevent accidental contact with sensitive areas.

For children 18 years or younger, it is advised to consult a healthcare professional before use.

Contraindications

There are no contraindications listed for this product.

However, it is advised to discontinue use and consult a healthcare professional if the condition worsens, if symptoms persist for more than 7 days, or if symptoms resolve and then recur within a few days. Additionally, if redness or irritation develops, medical advice should be sought.

Warnings and Precautions

FOR EXTERNAL USE ONLY. This product should be utilized strictly as directed. It is imperative to avoid bandaging the treated area tightly and to refrain from using it in conjunction with a heating pad. Contact with the eyes or mucous membranes must be avoided to prevent irritation. The product should not be applied to wounds, damaged, broken, or irritated skin.

Upon application, a transient burning sensation may occur; however, this typically resolves within several days. Should a severe burning sensation arise, the use of the product must be discontinued immediately, and a healthcare professional should be contacted.

It is crucial to avoid exposing the treated area to heat or direct sunlight to prevent adverse effects.

In the event of accidental ingestion, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Healthcare professionals should advise patients to discontinue use and consult a doctor if any of the following occur: the condition worsens, symptoms persist for more than 7 days, symptoms clear up and then recur within a few days, or if redness or irritation develops.

Side Effects

Patients using this product should be aware that it is intended for external use only. Upon application, a transient burning sensation may occur; however, this sensation typically resolves within several days. In the event that a severe burning sensation is experienced, patients are advised to discontinue use immediately and consult a healthcare professional.

Patients should also be instructed to stop use and seek medical advice if their condition worsens, if symptoms persist for more than 7 days, or if symptoms clear up and then recur within a few days. Additionally, the presence of redness or the development of irritation warrants discontinuation of use and consultation with a healthcare provider.

Drug Interactions

There are no specific drug interactions identified for this medication. Additionally, no laboratory test interactions have been reported. 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 Rematex (rematex pain relievingcream). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients 18 years of age or younger should consult a healthcare professional before use. It is essential to evaluate the appropriateness of treatment and dosage for this population, as specific recommendations may vary based on individual health needs and conditions.

Geriatric Use

There is no specific information available 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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

Lactation

Lactating mothers are advised to consult a healthcare professional prior to using this medication. There is no specific data available regarding the excretion of this medication in 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 may not have specific information regarding dosage adjustments, special monitoring, or safety considerations outlined in the prescribing information. Therefore, healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the lack of detailed guidance necessitates careful clinical judgment and individualized patient assessment. Regular monitoring of renal function is advisable to ensure patient safety and optimal therapeutic outcomes.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no 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

If pregnant or breastfeeding, it is advised to consult a healthcare professional prior to use.

A transient burning sensation may occur upon application; however, this sensation typically resolves within several days. In the event of a severe burning sensation, it is recommended to discontinue use immediately and seek medical advice.

No relevant information is available regarding carcinogenicity, mutagenicity, or impairment of fertility. Additionally, there is no pertinent data provided in the context of animal pharmacology and toxicology.

Postmarketing Experience

A transient burning sensation has been reported upon application, typically resolving within several days. In cases where a severe burning sensation occurs, it is advised to discontinue use immediately and consult a healthcare professional.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event that the medication is swallowed, patients should be instructed to seek medical help immediately or contact a Poison Control Center at 1-800-222-1222 for assistance. It is essential for patients to understand the importance of these precautions to ensure their safety and the safety of others.

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 20° to 25°C (68° to 77°F) to maintain its efficacy. Care should be taken to avoid direct sunlight during storage to prevent degradation of the product.

Additional Clinical Information

The product is administered topically, with adults and children over 18 years advised to apply it generously to the affected area and massage until fully absorbed. This application may be repeated as necessary, not exceeding 3-4 times daily, and hands should be washed with soap and water immediately after use. For children under 18 years, consultation with a doctor is recommended prior to use.

Clinicians should counsel patients to seek advice from a healthcare professional if they are pregnant or breastfeeding before using the product. No additional information is available regarding laboratory tests, abuse potential, or postmarketing experiences.

Drug Information (PDF)

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

View product document (PDF)