Honibe

Description

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Uses and Indications

This drug is indicated for the symptomatic relief of conditions requiring oral administration in adults and children aged 5 years and older. The recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed.

For children under 5 years of age, it is advised to consult a healthcare professional prior to use.

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

Dosage and Administration

The recommended dosage for the oral lozenge is as follows:

For adults and children aged 12 years and older, the typical dose is one lozenge every 2 to 4 hours as needed. The maximum dosage should not exceed 10 lozenges in a 24-hour period.

For children aged 6 to 11 years, the recommended dose is one lozenge every 4 to 6 hours as needed, with a maximum of 6 lozenges in a 24-hour period.

The lozenge should be allowed to dissolve slowly in the mouth and should not be chewed or swallowed whole. It is advised to maintain adequate hydration while using the lozenge to enhance its effectiveness.

Healthcare professionals should monitor patients for any adverse reactions and adjust the dosage accordingly based on individual response and clinical judgment.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history when considering treatment options.

Warnings and Precautions

In cases where a sore throat is severe, persists for more than two days, or is accompanied or followed by additional symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it is imperative that the healthcare professional advises the patient to consult a doctor promptly. These accompanying symptoms may indicate a serious underlying condition that requires immediate medical attention.

Healthcare professionals should remain vigilant in monitoring patients presenting with these symptoms, as timely intervention can be critical in preventing complications. It is essential to educate patients on the importance of seeking medical advice under these circumstances to ensure appropriate management and care.

Side Effects

Patients should be aware of the potential for serious adverse reactions associated with the use of this medication. In particular, if a patient experiences a severe sore throat that persists for more than two days or is accompanied or followed by symptoms such as fever, headache, rash, swelling, nausea, or vomiting, it is imperative that they consult a doctor promptly. These symptoms may indicate a serious condition that requires immediate medical attention.

Healthcare providers should monitor patients for these adverse reactions and educate them on the importance of seeking medical advice if they experience any of the aforementioned symptoms.

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 Honibe (menthol). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients should be advised to keep the medication out of reach of children. For adults and children aged 5 years and older, the recommended dosage is to dissolve 1 drop slowly in the mouth, with the option to repeat every 2 hours as needed. For children under 5 years of age, it is essential to consult a healthcare professional before 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 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 HONIBE - menthol lozenge during pregnancy. The prescribing information does not provide safety concerns, dosage modifications, or special precautions for pregnant patients. Therefore, healthcare professionals should exercise caution when considering the use of this product in women of childbearing potential and weigh the potential benefits against any unknown risks to fetal outcomes.

Lactation

There are no specific warnings or recommendations regarding the use of this medication in nursing mothers. Additionally, no specific guidance is provided concerning lactation. Therefore, healthcare professionals should consider the absence of data when advising lactating mothers about the use of this medication.

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

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 lack of data when prescribing this medication to patients with liver problems.

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

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 important to emphasize the potential risks associated with children accessing the medication, including serious health consequences. Providers should encourage patients to store the medication in a secure location and to be vigilant about monitoring its use.

Storage and Handling

This product is supplied in configurations that ensure optimal use and safety. It is essential to keep the product out of reach of children to prevent accidental ingestion.

For storage, the product should be kept in a cool, dry place, away from direct light exposure. It is crucial to protect the product from light to maintain its efficacy. Additionally, the product must not be frozen, as freezing may compromise its integrity. Once opened, the product should be discarded after use to ensure safety and effectiveness.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)