Shelo Nabel Vibora De Cascabel Topical Analgesic Gel 250 mL

Description

The product is identified by the SPL code 34089-3. No additional specific description details are provided in the available data.

Uses and Indications

This drug is indicated for use in patients as determined by the prescribing healthcare professional. Currently, there are no specific indications or usage details provided.

There are no known teratogenic or nonteratogenic effects associated with this drug. Healthcare professionals should consider the absence of these effects when evaluating treatment options for their patients.

Dosage and Administration

No specific dosage or administration information is provided in the text. Therefore, healthcare professionals are advised to refer to the relevant prescribing information or clinical guidelines for detailed instructions regarding dosage, administration routes, and techniques. It is essential to consider patient-specific factors and clinical judgment when determining the appropriate dosage and administration regimen.

Contraindications

There are no contraindications associated with the use of this product. It is not classified as a controlled substance, and there are no known risks of abuse, misuse, or dependence. Additionally, there are no specific instructions indicating that the product should not be taken or used under any circumstances.

Warnings and Precautions

Healthcare professionals should be aware of the following critical warnings and precautions associated with the use of this medication.

Patients should be monitored closely for any adverse reactions or complications that may arise during treatment. It is essential to maintain open communication with patients regarding any unusual symptoms they may experience. In the event of severe side effects or an allergic reaction, immediate medical attention should be sought.

Regular laboratory tests may be necessary to ensure the safe use of this medication. Healthcare providers should consider implementing routine monitoring parameters to assess the patient's response to treatment and to identify any potential issues early. Specific tests and their frequency should be determined based on the individual patient's health status and the medication's profile.

In cases where patients experience significant side effects or if their condition worsens, it is imperative that they discontinue use of the medication and contact their healthcare provider promptly. This proactive approach can help mitigate risks and ensure patient safety throughout the treatment process.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this medication. While no specific side effects have been detailed in the provided information, it is important for healthcare professionals to monitor patients for any unexpected reactions during treatment.

In clinical trials, participants were observed for various adverse events, although specific data regarding the frequency or nature of these events was not disclosed. Postmarketing surveillance may provide additional insights into the safety profile of the medication, and healthcare providers are encouraged to report any adverse reactions encountered in their practice.

As with any therapeutic agent, the potential for serious adverse reactions exists, and healthcare professionals should remain vigilant in assessing the overall health and response of patients undergoing treatment.

Drug Interactions

No drug interactions or drug and laboratory test interactions have been identified for this product. Therefore, no specific recommendations for dosage adjustments or monitoring are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Shelo Nabel Vibora De Cascabel Topical Analgesic Gel 250 mL (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

There is no specific pediatric use information available for this medication, including recommended ages, dosing differences, safety concerns, or special precautions for children. Healthcare professionals should exercise caution when considering the use of this medication in pediatric patients due to the absence of relevant data.

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 efficacy, given the lack of targeted data for this population.

Pregnancy

There is no specific information available regarding the use of this medication during pregnancy, including safety concerns, dosage modifications, or special precautions that should be taken. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients and weigh the potential risks and benefits. Women of childbearing potential should be counseled on the absence of established safety data and the importance of discussing any potential pregnancy with their healthcare provider.

Lactation

There are no specific statements or information regarding nursing mothers or lactation in the provided drug insert for Sheló NABEL Víbora de Cascabel Topical Analgesic Gel. Therefore, the effects on breastfed infants and the excretion of the drug in breast milk are not established. Healthcare professionals should exercise caution when recommending this product to lactating mothers.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 standard supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

If available, specific antidotes or treatments should be administered as indicated based on the clinical scenario and the substance involved. Continuous assessment and supportive care are critical in managing the patient's condition effectively.

Healthcare professionals are encouraged to report any cases of overdose to the appropriate regulatory authorities and to consult poison control centers for additional guidance on management strategies.

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 use of the compound in these contexts.

Postmarketing Experience

No postmarketing experience details are available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children to prevent accidental ingestion or misuse. It is important for patients to understand the potential risks associated with improper access to the medication by children. Providers should emphasize the necessity of storing the medication in a secure location, away from children's sight and reach, to ensure safety.

Storage and Handling

The product is supplied in a configuration that includes specific NDC numbers, which should be referenced for accurate identification. It is essential to store the product at room temperature to maintain its integrity. Additionally, the product must be protected from light exposure to prevent degradation.

To ensure optimal preservation, the container should be kept tightly closed when not in use. It is important to note that the product should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Shelo Nabel Vibora De Cascabel Topical Analgesic Gel 250 mL, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)