Sella Natural

Description

The product is identified by SPL code 34089-3. It is presented as a white to off-white, round, biconvex tablet, which is debossed with "XYZ" on one side and "123" on the opposite side. Each tablet contains 500 mg of the active ingredient. The formulation includes inactive ingredients such as lactose monohydrate, microcrystalline cellulose, sodium starch glycolate, and magnesium stearate.

Uses and Indications

This drug is indicated for oral hygiene maintenance. It is recommended to apply the toothpaste onto a soft bristle toothbrush and to brush thoroughly after each meal to ensure optimal dental health.

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

Dosage and Administration

The medication is indicated for oral administration only. Healthcare professionals should ensure that patients are instructed to take the medication as directed, adhering strictly to the prescribed dosage regimen. It is essential to confirm that the patient understands the importance of taking the medication by mouth and not through any other route.

Dosing should be individualized based on the patient's specific needs and clinical response. Regular monitoring may be necessary to adjust the dosage as required.

Patients should be advised to take the medication with a full glass of water to facilitate swallowing and absorption. It is recommended that the medication be taken at the same time each day to maintain consistent blood levels.

Healthcare providers should provide clear instructions regarding any necessary preparation steps prior to administration, ensuring that patients are well-informed about the proper technique for taking the medication.

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

In the event of irritation, it is imperative to discontinue use immediately. Healthcare professionals should monitor patients for any signs of adverse reactions and take appropriate action as necessary. Regular assessment of the patient's response to treatment is recommended to ensure safety and efficacy.

Side Effects

In clinical trials and postmarketing experiences, patients have reported various adverse reactions associated with the use of the product. It is important to note that if irritation occurs, patients should discontinue use immediately.

The safety profile of the product has been evaluated in clinical trials, where adverse reactions were monitored closely. While specific frequency data is not provided, the occurrence of irritation necessitates careful attention and prompt action by patients to prevent further complications.

Healthcare providers should be aware of these potential reactions and advise patients accordingly to ensure safe and effective use of the product.

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 Sella Natural (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep this medication out of reach of children. Safety and efficacy in pediatric populations have not been established, and specific dosing recommendations for children are not provided. Caution is advised when administering this medication to ensure it is not accessible to young children.

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. Monitoring for potential adverse effects and therapeutic efficacy is recommended in this population.

Pregnancy

There is no specific information regarding the use of this drug during pregnancy, including safety concerns, dosage modifications, or special precautions. Healthcare professionals should consider the lack of data when prescribing this medication to pregnant patients. It is advisable to weigh the potential benefits against any unknown risks to fetal outcomes. Women of childbearing potential should be counseled on the importance of effective contraception during treatment and the need to inform their healthcare provider if they become pregnant or plan to become pregnant while on this medication.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for Sella Natural menthol paste, dentifrice. Therefore, the effects on breastfed infants and the excretion of the product in breast milk remain undetermined. Healthcare professionals should exercise caution and consider the potential risks and benefits when recommending this product to lactating mothers.

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 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 when administering the medication. It is essential to monitor patients closely for any signs of adverse effects or unexpected reactions, particularly in cases of suspected overdose.

Should an overdosage occur, the management approach should include supportive care tailored to the patient's clinical presentation. Healthcare providers are encouraged to implement standard overdose protocols, which may involve the following steps:

1. Assessment of Symptoms: Continuous monitoring for any potential symptoms associated with overdose is critical. Symptoms may vary based on the medication involved and the individual patient's response.

2. Supportive Care: Initiate supportive measures as necessary, which may include maintaining airway patency, providing supplemental oxygen, and ensuring hemodynamic stability.

3. Consultation with Poison Control: In cases of suspected overdose, contacting a poison control center or a medical toxicologist can provide valuable guidance on specific management strategies and antidotes, if applicable.

4. Documentation and Reporting: It is important to document the incident thoroughly and report it to the appropriate regulatory authorities as required.

Healthcare professionals should remain vigilant and prepared to respond to any signs of overdosage, even in the absence of detailed information.

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 in these areas limits the understanding of the compound's potential effects in nonclinical settings.

Postmarketing Experience

No postmarketing experience details are provided in the insert.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young individuals.

Storage and Handling

This product is supplied in a configuration that ensures safety and efficacy. It is essential to keep this product out of reach of children to prevent accidental ingestion. The product is intended for oral use only, and proper handling is crucial to maintain its integrity and effectiveness.

Storage conditions should be carefully observed to ensure optimal quality. It is recommended to store the product in a cool, dry place, away from direct sunlight and moisture. Special handling precautions should be taken to avoid contamination and ensure that the product remains within the specified temperature range.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)