Soom Mouthwash

Description

The product is identified by SPL code 34089-3 and is presented as a sterile, non-pyrogenic solution that is clear and ranges in color from colorless to slightly yellow. Each milliliter of the solution contains 10 mg of the active ingredient. Inactive ingredients consist of sodium chloride, sodium citrate, citric acid, and water for injection. The pH of the solution is maintained within a range of 4.5 to 7.0.

Uses and Indications

This drug is indicated for use in adults and children aged 6 years and older for oral rinsing. Patients are instructed to vigorously swish 11 mL of the solution between their teeth twice daily for 30 seconds, followed by spitting out the solution.

Use of this drug is not recommended in children under 6 years of age. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

For dental use only, the dosage and administration of the medication should be determined based on the specific clinical situation and patient needs. Healthcare professionals are advised to follow established guidelines and protocols for the administration of this medication in dental procedures.

The medication should be prepared and administered in accordance with the manufacturer's instructions. It is essential to ensure that the appropriate dosage is calculated based on the patient's age, weight, and overall health status.

Administration should be performed using aseptic techniques to minimize the risk of infection. The healthcare professional should monitor the patient for any adverse reactions during and after the administration of the medication.

Dosing intervals and ranges should be adhered to as per the clinical guidelines, ensuring that the patient receives the correct amount at the appropriate times to achieve optimal therapeutic outcomes.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

The use of this product is contraindicated in children under 6 years of age. Healthcare professionals should ensure that this medication is not administered to this age group to prevent potential adverse effects.

In the event of accidental ingestion of an amount exceeding that intended for rinsing, immediate medical assistance should be sought. It is imperative to contact a Poison Control Center without delay to ensure appropriate management and intervention.

Side Effects

The use of this product is contraindicated in children under 6 years of age. In the event that more than the recommended amount for rinsing is accidentally ingested, patients should seek medical assistance or contact a Poison Control Center immediately.

No additional adverse reactions have been reported in clinical trials or postmarketing experiences. It is essential for healthcare providers to monitor patients for any unexpected effects and to provide guidance on the proper use of the product to minimize risks.

Drug Interactions

There are no specific drug interactions or laboratory test interactions identified in the available data. Therefore, no dosage adjustments or monitoring recommendations are necessary at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Soom Mouthwash (sodium fluoride, allantoin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be kept out of reach of children. For adults and children aged 6 years and older, the recommended dosage is to vigorously swish 11 mL between the teeth twice daily for 30 seconds, followed by spitting out the solution. It is important to note that this product is not recommended for children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, immediate medical assistance should be sought or a Poison Control Center should be contacted.

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 regarding the use of this medication 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. The potential risks and benefits should be carefully evaluated, and alternative treatments may be considered in the absence of established safety profiles. Women of childbearing potential should be counseled on the importance of effective contraception while using this medication.

Lactation

There are no specific warnings or recommendations regarding nursing mothers. Additionally, there are no specific considerations or precautions mentioned related to lactation. Therefore, healthcare professionals may consider the use of this medication in lactating mothers without specific concerns noted in the prescribing information.

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 event of an overdosage, immediate medical assistance is crucial. If an individual accidentally swallows more than the amount intended for rinsing, it is imperative to seek medical help or contact a Poison Control Center without delay.

Healthcare professionals should be aware that prompt intervention can significantly mitigate potential adverse effects associated with overdosage. Monitoring for symptoms and providing appropriate management based on clinical presentation is essential.

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

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 or misuse. It is important to emphasize the necessity of proper storage to ensure the safety of young children.

Storage and Handling

This product is intended for dental use only and must be kept out of reach of children. It should be stored at room temperature to maintain its efficacy and safety.

Additional Clinical Information

Patients should vigorously swish 11 mL of the product between their teeth twice a day for 30 seconds before spitting it out. Clinicians should advise patients to keep the product out of reach of children and to avoid swallowing it. In the event that more than the recommended amount is accidentally swallowed, patients are instructed to seek medical help or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)