Adult Bisolvine

Uses and Indications

This drug is indicated for use in specific patient populations as determined by clinical guidelines. Currently, there are no detailed indications or usage specifications provided. Healthcare professionals are advised to refer to the latest clinical data and guidelines for appropriate prescribing information. There are no known teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Administration should be conducted orally, with a dosage of 2 teaspoonfuls (10 ml) every 4 hours for adults and children aged 12 years and older. It is imperative that the total number of doses does not exceed 6 doses within a 24-hour period.

For children under 12 years of age, the use of this medication is not recommended.

Contraindications

Use of this product is contraindicated in the following situations:

Patients with persistent or chronic cough, including those associated with smoking, asthma, or emphysema, or if the cough is accompanied by excessive phlegm (mucus), unless directed by a healthcare professional. This is due to the potential for exacerbating underlying conditions.

Additionally, the product should not be used in conjunction with prescription monoamine oxidase inhibitors (MAOIs) or within 2 weeks of discontinuing such medications. MAOIs are commonly prescribed for depression, psychiatric, or emotional conditions, as well as for Parkinson's Disease. If there is uncertainty regarding the presence of an MAOI in a prescription medication, consultation with a healthcare provider is advised.

Warnings and Precautions

Patients should adhere strictly to the recommended dosage to avoid potential adverse effects. Exceeding the prescribed dosage may lead to serious complications.

A persistent or chronic cough may indicate an underlying serious condition. Healthcare professionals should advise patients to seek medical consultation if a cough persists for more than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache.

This product is not indicated for the treatment of persistent or chronic coughs 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 provider.

Patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or who have taken one within the last two weeks should not use this product. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's Disease. If patients are uncertain whether their prescription includes an MAOI, they should consult a healthcare professional or pharmacist prior to using this product.

Side Effects

Patients should be aware of the potential adverse reactions associated with the use of this medication. It is crucial not to exceed the recommended dosage, as doing so may lead to serious complications.

A persistent or chronic cough may indicate a serious underlying condition. If patients experience a cough that persists for more than one week, recurs frequently, or is accompanied by additional symptoms such as fever, rash, or a persistent headache, they are advised to consult a healthcare professional promptly. This caution is essential to ensure timely evaluation and management of any serious health issues that may arise.

Drug Interactions

The concomitant use of this product with monoamine oxidase inhibitors (MAOIs) is contraindicated. MAOIs are commonly prescribed for the treatment of depression, psychiatric disorders, or Parkinson's Disease. Patients should avoid using this product while on MAOIs and for a period of two weeks following the discontinuation of MAOI therapy.

It is essential for patients to consult with a healthcare professional, such as a doctor or pharmacist, to confirm whether their current prescription includes an MAOI before initiating treatment with this product. Monitoring for potential adverse effects is advised if there is any uncertainty regarding the presence of an MAOI in the patient's medication regimen.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should not use this medication. For adolescents aged 12 years and older, the recommended dosage is 2 teaspoonfuls (10 ml) every 4 hours, with a maximum of 6 doses in a 24-hour period. It is important to keep this medication out of reach of children to prevent accidental ingestion.

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

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. It is important to assess the potential risks and benefits associated with the use of this medication during pregnancy and lactation. In the event of an accidental overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted without delay.

Lactation

Lactating mothers are advised to consult a health professional prior to using this medication if they are pregnant or breastfeeding. In the event of an accidental overdose, it is crucial to seek medical assistance or contact a Poison Control Center immediately. There is no specific data provided regarding the excretion of this medication in breast milk or its effects on breastfed infants.

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 absence of specific information regarding overdosage, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response.

In the event of an overdose, immediate medical attention should be sought. Healthcare providers should implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or relevant toxicology resources for guidance on specific management protocols and antidotes, if applicable.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective treatment and follow-up care.

Nonclinical Toxicology

There are no teratogenic effects associated with the compound. Additionally, no non-teratogenic effects have been identified. The available data does not provide any information regarding nonclinical toxicology, animal pharmacology, or toxicology.

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.

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 specifically directed by a healthcare professional.

Additionally, it is crucial to inform patients not to use this product if they are currently taking a prescription monoamine oxidase inhibitor (MAOI), which includes certain medications for depression, psychiatric or emotional conditions, or Parkinson's Disease. Patients should also be cautioned against using this product for at least two weeks after discontinuing an MAOI. If patients are uncertain whether their prescription medication contains an MAOI, they should be encouraged to consult with their doctor or pharmacist prior to using this product.

Storage and Handling

This product is supplied in various package configurations, with specific NDC numbers available upon request. It is essential to store the product within a temperature range of 15°C to 30°C (59°F to 86°F) to maintain its efficacy and stability. Proper storage conditions should be observed to ensure the product's integrity throughout its shelf life.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)