Doctrust K

Description

The product is identified by SPL code 34089-3 and is presented as a white to off-white, round, biconvex tablet. Each tablet is debossed with "XYZ" on one side and "123" on the opposite side. It contains 500 mg of the active ingredient. The formulation includes several inactive ingredients: microcrystalline cellulose, croscarmellose sodium, magnesium stearate, talc, and coloring agents, as specified in the formulation.

Uses and Indications

This drug is indicated for the oral hygiene of adults and children aged 2 years and older. It is recommended that users brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician.

For children aged 2 to 6 years, it is advised to use only a pea-sized amount of the product and to supervise the child's brushing and rinsing to minimize the risk of swallowing. For children under 2 years of age, consultation with a dentist or physician is recommended prior to use.

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

Dosage and Administration

The product is indicated for dental use only. Healthcare professionals should ensure that the administration is performed in a controlled environment, adhering to standard dental practices.

Prior to administration, it is essential to prepare the site according to established protocols to minimize the risk of infection and ensure patient comfort. The dosage should be determined based on the specific dental procedure being performed, taking into account the patient's individual needs and clinical judgment.

Administration should be conducted using appropriate techniques to ensure efficacy and safety. It is recommended that healthcare professionals monitor the patient throughout the procedure for any adverse reactions or complications.

For optimal results, follow the guidelines for dosage intervals and frequency as per the specific clinical scenario, ensuring that the total dosage does not exceed the recommended limits.

Contraindications

Use of this product is contraindicated in individuals who cannot ensure it is kept out of reach of children. This precaution is necessary to prevent accidental ingestion or misuse by minors. No other contraindications have been identified in the provided data.

Warnings and Precautions

It is imperative to keep this product out of the reach of children under 6 years of age to prevent accidental ingestion and potential harm.

In the event that more than the recommended amount used for brushing is accidentally swallowed, immediate medical assistance should be sought. Healthcare professionals are advised to contact a Poison Control Center without delay to ensure appropriate management and care.

Side Effects

Patients should be aware of the following warnings associated with the use of this product. It is crucial to keep the product out of reach of children under 6 years of age to prevent accidental ingestion. In the event that more than the recommended amount used for brushing is accidentally swallowed, it is imperative to seek medical assistance or contact a Poison Control Center immediately.

These precautions are essential to ensure the safety and well-being of patients, particularly young children who may be more susceptible to adverse effects from improper use.

Drug Interactions

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

Packaging & NDC

Below are the non-prescription pack sizes of Doctrust K (sodium flouride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 2 years and older are advised to brush their teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or physician. For children aged 2 to 6 years, it is recommended to use only a pea-sized amount of the product and to supervise the child's brushing and rinsing to minimize the risk of swallowing.

For infants and children under 2 years of age, consultation with a dentist or physician is necessary before use. Additionally, the product should be kept out of reach of children under 6 years of age. In the event that more than the recommended amount is accidentally swallowed, immediate medical assistance or contact with a Poison Control Center is advised.

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 DOCTRUST K - sodium fluoride liquid in pregnant patients. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for use during pregnancy. Healthcare professionals should consider the lack of data when prescribing this medication to women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

Nursing mothers should consult a healthcare professional before using this product. There is a potential for excretion in breast milk; therefore, caution is advised when administering to nursing mothers. The effects on the nursing infant are not well studied; it is recommended to monitor for any adverse effects in the infant.

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

There is no information available regarding the use of this medication in patients with hepatic impairment. Consequently, no dosage adjustments, special monitoring requirements, or precautions for individuals with compromised liver function are specified in the prescribing information. Healthcare professionals should exercise caution and consider the individual patient's liver function when prescribing this medication.

Overdosage

In the event of an overdosage, it is critical to seek immediate medical assistance or contact a Poison Control Center if an amount exceeding that typically used for brushing is accidentally ingested.

Healthcare professionals should be aware that prompt intervention is essential in managing potential overdosage scenarios. Symptoms may vary depending on the specific substance involved, and monitoring for any adverse effects is recommended.

Management procedures should include supportive care and symptomatic treatment as necessary. It is advisable to have the product's labeling and any relevant patient information readily available when contacting medical professionals or poison control for guidance.

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 the medication out of reach of children to prevent accidental ingestion or misuse. It is essential to emphasize the importance of proper storage and handling to ensure the safety of young children.

Storage and Handling

This product is supplied in packaging that ensures safety and integrity. It is essential to keep the product out of reach of children to prevent accidental ingestion. The recommended storage condition is at room temperature, ensuring that the product maintains its efficacy and safety. No special handling requirements are noted; however, standard precautions should be observed to preserve the quality of the product.

Additional Clinical Information

The product is administered via the dental route. Clinicians should advise patients to keep the product out of reach of children and to use only a pea-sized amount for children aged 2 to 6 years, ensuring supervision during brushing and rinsing to minimize the risk of swallowing. In the event that more than the recommended amount is accidentally swallowed, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)