Stona

Description

Stona Troche is presented in a carton packaging. The formulation is designed for oral administration, providing a convenient dosage form. The specific composition and additional details regarding the active and inactive ingredients are not provided in the extracted facts.

Uses and Indications

This drug is indicated for the temporary relief of cough due to minor throat and bronchial irritation associated with a cold or inhaled irritants.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to allow 1 or 2 lozenges to dissolve slowly in the mouth every 4 hours, with a maximum of 12 lozenges within a 24-hour period. For children aged 6 years to under 12 years, the recommended dosage is 1 lozenge to be dissolved slowly in the mouth every 4 hours, not exceeding 6 lozenges in a 24-hour timeframe.

For children under 6 years of age, it is recommended to consult a physician before administration.

The administration frequency may be once or twice daily, preferably in the morning and evening, as needed or as directed by a healthcare professional. It is advisable to initiate treatment with the minimum effective dose and subsequently adjust the dosage to accommodate the individual's bowel condition.

Contraindications

Use of this product is contraindicated in patients with persistent or chronic cough, including those associated with smoking, asthma, or emphysema. Additionally, it should not be used if the cough is accompanied by excessive phlegm (mucus) unless directed by a healthcare professional. This is due to the potential for masking underlying conditions that may require specific treatment.

Warnings and Precautions

The use of this product is contraindicated for individuals experiencing persistent or chronic cough, particularly those associated with smoking, asthma, or emphysema. Additionally, it should not be used if the cough is accompanied by excessive phlegm (mucus) unless directed by a healthcare professional.

Healthcare professionals are advised to exercise caution and recommend that patients consult a doctor or pharmacist prior to use if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued such medication within the past two weeks. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson’s disease. It is crucial to ascertain whether any current prescription contains an MAOI. Persistent cough may indicate a serious underlying condition; therefore, if a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or persistent headache, a healthcare provider should be consulted.

For patients who are pregnant or breastfeeding, it is essential to seek advice from a health professional before using this product.

In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Side Effects

Patients should be aware of the potential adverse reactions associated with this product. Serious adverse reactions may occur, particularly in individuals with specific health conditions. The product is contraindicated for use in patients with persistent or chronic cough, such as that associated with smoking, asthma, or emphysema, unless directed by a healthcare professional. Additionally, if a cough is accompanied by excessive phlegm (mucus), medical advice should be sought prior to use.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have stopped taking an MAOI within the last two weeks should consult a doctor or pharmacist before using this product. A persistent cough may indicate a serious underlying condition; therefore, if a cough persists for more than one week, recurs, or is accompanied by symptoms such as fever, rash, or persistent headache, patients are advised to seek medical attention.

For pregnant or breastfeeding individuals, it is recommended to consult a health professional before use to ensure safety for both the mother and child.

In the event of accidental overdose, it is crucial to seek immediate medical assistance or contact a Poison Control Center. This precaution is particularly important to ensure the safety and well-being of children, as the product should be kept out of their reach.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have discontinued an MAOI within the past two weeks. MAOIs are commonly prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. The combination of this medication with an MAOI may lead to significant pharmacodynamic interactions, potentially resulting in serious adverse effects. Monitoring and dosage adjustments may be necessary based on the clinical judgment of the healthcare provider.

Packaging & NDC

Below are the non-prescription pack sizes of Stona (dextromethorphan hydrobromide). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients aged 6 years to under 12 years may take 1 lozenge every 4 hours, with a maximum of 6 lozenges in a 24-hour period. For children under 6 years of age, it is advised to consult a doctor before use.

Geriatric Use

There is no specific information available 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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. The potential risks and benefits must be carefully considered, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to discuss their individual circumstances with a healthcare provider to ensure safe use during pregnancy and lactation.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication. There is currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

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 overall clinical context when prescribing to this patient population, as the lack of specific guidance necessitates careful evaluation of renal function and potential impacts on drug efficacy and safety.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this medication. Consequently, there are no 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 prescribing information.

Overdosage

In the event of an accidental overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt intervention is crucial to mitigate potential adverse effects associated with overdosage.

Healthcare professionals should be vigilant for symptoms that may arise from an overdose, although specific symptoms are not detailed in the provided information. The management of an overdose typically involves supportive care and symptomatic treatment, tailored to the individual patient's needs.

It is essential for healthcare providers to remain informed about the appropriate protocols for managing overdose situations, ensuring that patients receive timely and effective care.

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 safety profile 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 product out of reach of children to prevent accidental ingestion. In the event of an accidental overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product is not intended for use in cases of persistent or chronic cough, such as those associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional.

It is important for patients to consult with a doctor or pharmacist before using this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or have stopped taking an MAOI within the past two weeks. If patients are unsure whether their prescription medication contains an MAOI, they should be encouraged to ask their healthcare provider for clarification.

Additionally, patients should be made aware that a persistent cough may indicate a serious underlying condition. They should be advised to consult a doctor if their cough persists for more than one week, tends to recur, or is accompanied by symptoms such as fever, rash, or a persistent headache.

Storage and Handling

The product is available in various package configurations, identified by their respective NDC numbers. Specific storage and handling instructions are not provided; therefore, standard practices for pharmaceutical products should be followed. It is recommended to store the product in a controlled environment, ensuring that it is kept at appropriate temperatures to maintain its integrity. Containers should be kept sealed and protected from light and moisture to prevent degradation. Special handling requirements are not specified, but general precautions should be taken to ensure the product's quality and safety during storage and transportation.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)