Biocotron

Description

Biocotron is presented in a liquid dosage form. The effective date of the insert is December 23, 2020.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritations, which may occur due to a cold. Additionally, it aids in loosening phlegm (mucus) and thinning bronchial secretions, thereby making coughs more productive.

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

Dosage and Administration

Adults and children aged 12 years and over are advised to take 2 teaspoonfuls (10 mL) every 4 hours, not exceeding 6 doses within a 24-hour period unless otherwise directed by a physician. For children aged 6 years to under 12 years, the recommended dosage is 1 teaspoonful (5 mL) every 4 hours. For children under 6 years of age, it is recommended to consult a physician before administration.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson’s disease. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult their healthcare provider or pharmacist if they are uncertain about the presence of an MAOI in their current medication regimen.

Warnings and Precautions

Healthcare professionals are advised to exercise caution when recommending this product. Prior to use, patients should be instructed to consult a physician if they experience a cough that is associated with excessive phlegm (mucus) or if they have a chronic cough, particularly in cases related to smoking, asthma, chronic bronchitis, or emphysema.

It is imperative that patients adhere strictly to the recommended dosage. Exceeding the advised dosage may lead to adverse effects.

Patients should be informed to discontinue use and seek medical advice if their cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate an underlying serious condition that requires further evaluation.

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

Overall, careful monitoring of the patient's symptoms and adherence to these guidelines is essential to ensure safe and effective use of the product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this product. It is important to consult a healthcare professional prior to use if the patient has a cough that occurs with excessive phlegm (mucus) or if the cough is chronic, such as that which may occur with smoking, asthma, chronic bronchitis, or emphysema.

During the use of this product, patients must adhere to the recommended dosage. Exceeding the recommended dosage may lead to adverse effects. Patients are advised to discontinue use and seek medical advice if the cough persists for more than 7 days, recurs, or is accompanied by additional symptoms such as fever, rash, or a persistent headache. A persistent cough may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are typically prescribed for the treatment of depression, psychiatric or emotional conditions, and Parkinson’s disease. Patients should not take this product while on MAOIs or within 2 weeks of discontinuing an MAOI. It is essential for patients to consult with their healthcare provider or pharmacist to confirm whether they are currently taking any prescription medications that contain an MAOI before initiating treatment with this product.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 6 years of age should consult a healthcare professional before use. For children aged 6 years to under 12 years, the recommended dosage is 1 teaspoonful (5 mL) every 4 hours. In contrast, adults and children aged 12 years and older may take 2 teaspoonfuls (10 mL) every 4 hours. It is important to adhere to these dosing guidelines to ensure safety and efficacy in pediatric populations.

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 in these populations to ensure the safety of both the mother and the fetus or infant.

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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment and monitoring of these patients.

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

Exceeding the recommended dosage of the medication may lead to serious adverse effects. Healthcare professionals are advised to monitor patients closely for any signs of overdosage.

Symptoms of Overdosage

Patients who have ingested an excessive amount of the medication may exhibit a range of symptoms. These can vary depending on the specific drug involved and the extent of the overdose. Common symptoms may include, but are not limited to, gastrointestinal disturbances, central nervous system effects, and cardiovascular irregularities.

Recommended Actions

In the event of suspected overdosage, immediate medical attention is essential. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. It is crucial to assess the patient's clinical status and consider the need for further interventions, such as activated charcoal or other decontamination methods, depending on the time elapsed since ingestion and the severity of symptoms.

Management Procedures

Management of overdosage should be tailored to the individual patient and may involve hospitalization for close monitoring and treatment. Continuous assessment of vital signs and laboratory evaluations may be warranted to guide therapeutic decisions. In cases of severe toxicity, consultation with a poison control center or a medical toxicologist is recommended to ensure optimal management strategies are employed.

Healthcare professionals are reminded to adhere strictly to the recommended dosage guidelines to minimize the risk of overdosage and its associated complications.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

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 reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in packaging that ensures its integrity and stability. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F).

To maintain its efficacy, the product must be protected from light and kept tightly closed when not in use. It is important to discard any unused portion after opening to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients to consult a doctor prior to use if they have a cough accompanied by excessive phlegm or if the cough is chronic, as seen in conditions such as smoking, asthma, chronic bronchitis, or emphysema. Additionally, patients who are pregnant or breastfeeding should seek guidance from a health professional before using the medication. It is important to keep the product out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

Drug Information (PDF)

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

View product document (PDF)