Bactimicina Cough and Cold

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the relief of symptoms associated with colds, specifically nasal congestion and cough due to minor throat and bronchial irritation. It aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes.

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

Dosage and Administration

For individuals aged 12 years and older, the recommended dosage is 2 teaspoons (10 mL) administered every 4 hours as needed. It is important to note that no more than 6 doses should be taken within a 24-hour period. This product is not intended for use in children under 12 years of age.

Healthcare professionals should ensure that patients are aware of the dosing limits and the age restrictions associated with this medication.

Contraindications

Use of this product is contraindicated in patients currently taking a prescription monoamine oxidase inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of 2 weeks following the discontinuation of an MAOI. Patients should consult a healthcare professional if uncertain whether their prescription medication contains an MAOI. Additionally, it is contraindicated to exceed the directed dosage while using this product.

Warnings and Precautions

Patients should not 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. Additionally, use is contraindicated for a period of 2 weeks following the discontinuation of an MAOI. If there is uncertainty regarding whether a prescription drug contains an MAOI, it is imperative to consult a healthcare professional, such as a doctor or pharmacist, prior to using this product.

General precautions should be observed before using this product. Patients are advised to consult a healthcare provider if they have any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to an enlarged prostate gland, or a cough that is productive with excessive phlegm. Furthermore, individuals with a chronic cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before use. It is also recommended to consult a doctor or pharmacist if the patient is taking any other oral nasal decongestant or stimulant. Users must adhere strictly to the recommended dosage and should not exceed the directed amount.

Patients should discontinue use and contact a healthcare provider if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, medical attention should be sought, as these may indicate a serious condition.

In the event of an overdose, it is crucial to seek emergency medical assistance or contact a Poison Control Center immediately.

Side Effects

Patients may experience a range of adverse reactions while using this medication. Serious adverse reactions warrant immediate medical attention and include symptoms such as nervousness, dizziness, or sleeplessness. Patients should discontinue use and consult a healthcare professional if these symptoms occur.

Additionally, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than 7 days, recurs, or is associated with fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires further evaluation.

Before initiating treatment, patients should seek medical advice if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, individuals with a cough that produces excessive phlegm or those with chronic cough conditions, such as smoking-related cough, asthma, chronic bronchitis, or emphysema, should also consult a healthcare provider prior to use.

Drug Interactions

The use of Bactimicina Cough and Cold is contraindicated in patients who are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing an MAOI. Co-administration may result in serious interactions that could pose significant health risks.

No additional drug interactions or laboratory test interactions have been identified for Bactimicina Cough and Cold. Therefore, no further dosage adjustments or monitoring recommendations are necessary beyond the aforementioned contraindication.

Packaging & NDC

Below are the non-prescription pack sizes of Bactimicina Cough and Cold (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

This product is not intended for pediatric patients under 12 years of age. For adolescents aged 12 years and older, the recommended dosage is 2 teaspoons (10 mL) every 4 hours as needed. There are no established safety or efficacy profiles for use in children under 12, and therefore, it is contraindicated in this age group.

Geriatric Use

Elderly patients may exhibit increased sensitivity to side effects associated with this adult product. It is important for healthcare providers to exercise caution when prescribing this medication to geriatric patients, particularly those aged 65 and older.

Before initiating treatment, it is advisable to conduct a thorough assessment of the patient's medical history, especially in individuals with pre-existing conditions such as heart disease, high blood pressure, thyroid disease, diabetes, or urinary difficulties due to an enlarged prostate gland.

Due to the potential for heightened sensitivity, careful monitoring of elderly patients during treatment is recommended to ensure safety and efficacy. Adjustments to dosage may be necessary based on individual patient response and tolerance.

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 weighed, as the effects on fetal outcomes and lactation are not fully established. It is essential for women of childbearing potential to seek medical advice 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 no specific data available regarding the excretion of this medication in 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 lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to this drug. 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 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 the overdose.

Healthcare professionals should be aware that the specific symptoms of an overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential to determine the appropriate course of action.

Management of an overdose typically involves supportive care and symptomatic treatment. Continuous monitoring of the patient's vital signs and clinical status is recommended. In cases where the substance is known, specific antidotes or treatments may be indicated, and healthcare providers should refer to established guidelines for the management of the particular overdose scenario.

It is vital for healthcare professionals to remain vigilant and act swiftly in the event of an overdose to ensure optimal patient outcomes.

Nonclinical Toxicology

If pregnant or breast-feeding, it is advised to consult a health professional before 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

Postmarketing experience has revealed reports of several adverse reactions associated with the use of BACTIMICINA COUGH AND COLD. These include nervousness, dizziness, sleeplessness, rash, and persistent headache. The occurrence of these reactions has been documented through voluntary reports and surveillance programs.

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 overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients should be informed that this product should not be used if they are currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of stopping 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.

Healthcare providers should counsel patients to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or sleeplessness. Additionally, patients should be advised to stop using the product and consult a doctor if their symptoms do not improve within seven days or if they are accompanied by fever. They should also be informed to stop use and seek medical attention if a cough persists for more than seven days, returns, or is accompanied by fever, rash, or a persistent headache, as these may indicate a serious condition.

Patients should be reminded to adhere strictly to the recommended dosage and not exceed the directed amount. It is important for healthcare providers to ask patients about their medical history and advise them to consult a doctor before using this product if they have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to an enlarged prostate gland. Furthermore, patients should be encouraged to seek medical advice if they have a cough that produces excessive phlegm or if they have a chronic cough associated with smoking, asthma, chronic bronchitis, or emphysema.

Lastly, healthcare providers should recommend that patients consult with a doctor or pharmacist before using this product if they are taking any other oral nasal decongestant or stimulant.

Storage and Handling

The product is supplied in a configuration that includes a dosage cup for accurate measurement. It is essential to store the product at a temperature range of 15-30°C (59-86°F) to maintain its efficacy. Proper handling is crucial; therefore, it is recommended to use only the dosage cup provided for measuring the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)