Doctrust Doublex Tooth

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 the protection against cavities.

There are no teratogenic effects associated with this drug. Additionally, no nonteratogenic effects have been reported.

Dosage and Administration

Adults and children aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice daily, or as directed by a dentist or physician.

For children under 6 years of age, it is recommended to use a pea-sized amount of toothpaste to minimize the risk of swallowing. Caregivers should supervise the brushing process until proper oral hygiene habits are established.

For children under 2 years, consultation with a dentist or physician is necessary prior to use.

Contraindications

Use is contraindicated in children under 6 years of age. This precaution is necessary to prevent potential harm, as the safety and efficacy of the product have not been established in this age group. Additionally, it is advised to keep the product out of reach of children to avoid accidental ingestion or misuse.

Warnings and Precautions

The use of this product necessitates adherence to specific warnings and precautions to ensure safety and efficacy.

Warnings It is imperative that the product is not swallowed. Users should rinse their mouths thoroughly after application to mitigate any potential adverse effects. For children under the age of 6, it is recommended to use only a pea-sized amount of toothpaste, and this should be done under the supervision of a guardian to prevent the risk of sucking or swallowing. In the event that a child under 6 years of age ingests a large quantity of toothpaste, immediate consultation with a physician or dentist is advised. Additionally, this product must be kept out of reach of children under 6 years of age to prevent accidental ingestion.

General Precautions The product should consistently be stored out of the reach of children under 6 years of age to ensure their safety.

No laboratory tests are specified for monitoring parameters related to the use of this product.

Side Effects

Patients may experience various adverse reactions associated with the use of this product. It is important to note that the product should not be swallowed; users are advised to rinse their mouths thoroughly after use to minimize any potential side effects.

For children under 6 years of age, it is recommended to use only a pea-sized amount of toothpaste under the supervision of a guardian to prevent the risk of sucking or swallowing. In the event that a child under 6 years of age swallows a large amount of toothpaste, it is crucial to consult a physician or dentist immediately.

Additionally, the product should be kept out of reach of children under 6 years of age to ensure their safety. These precautions are essential to mitigate the risk of adverse reactions in this vulnerable population.

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 Doctrust Doublex Tooth (sodium fluoride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

For pediatric patients under 6 years of age, it is recommended to use small amounts of toothpaste under the supervision of a guardian to prevent sucking or swallowing. A pea-sized amount should be utilized to minimize the risk of swallowing, and guardians should supervise the brushing process until good oral hygiene habits are established. In the event that a child under 6 years old swallows a large quantity of toothpaste, immediate consultation with a physician or dentist is advised.

To ensure safety, toothpaste should be kept out of the reach of children under 6 years. For children aged 2 years and older, it is advised to brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. For children under 2 years, consultation with a dentist or doctor is recommended prior to use.

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 they may have altered pharmacokinetics and pharmacodynamics. Close monitoring is recommended to ensure safety and efficacy in 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. 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 accordingly.

Lactation

There is no specific information regarding nursing mothers or lactation considerations provided in the drug insert for DOCTRUST DOUBLEX TOOTH - sodium fluoride paste, dentifrice. Therefore, the effects on breastfed infants and the excretion of the drug in human milk are not established. Healthcare professionals should consider this lack of data when advising lactating mothers on the use of this product.

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 overdosage, particularly in pediatric patients, immediate medical consultation is essential. If a child under 6 years of age ingests a significant quantity of toothpaste, it is imperative to seek advice from a physician or dentist without delay.

Healthcare professionals should be aware that symptoms of overdosage may vary based on the specific formulation of the toothpaste ingested. Prompt assessment and management are crucial to mitigate potential adverse effects.

Recommended actions include monitoring the patient for any signs of distress and providing supportive care as necessary. It is advisable to have the product packaging available for reference during the consultation to facilitate appropriate treatment decisions.

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 available in the insert text.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of the reach of children under 6 years of age. It is important to emphasize the potential risks associated with accidental ingestion by young children and to encourage patients to store the medication in a secure location.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product within the recommended temperature range to maintain its efficacy.

Storage conditions must be carefully monitored; the product should not be exposed to high or low temperatures or direct sunlight. Proper handling and storage are crucial to ensure the integrity and quality of the product throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)