Actinel Dm

Description

ACTINEL DM is a pharmaceutical product formulated for specific medical applications. The active ingredient is denoted as ACTINEL DM, which is characterized by its unique chemical properties. The product is available in a dosage form suitable for administration as indicated in the prescribing information. The appearance of ACTINEL DM is consistent with standard pharmaceutical formulations, ensuring proper identification and usage in clinical settings. Further details regarding its molecular weight and chemical formula are essential for understanding its pharmacological profile and therapeutic efficacy.

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

The recommended dosage for adults and children aged 12 years and older is 5 mL (1 teaspoon) every 4 hours, as needed, without exceeding 6 doses in a 24-hour period. For children under 12 years of age, it is advised to consult a physician for appropriate dosing guidance.

Healthcare professionals should ensure that patients are informed about the importance of adhering to the prescribed dosage and frequency to avoid potential overdose.

Contraindications

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Warnings and Precautions

The use of this product is contraindicated in individuals currently taking a prescription monoamine oxidase inhibitor (MAOI) or within 2 weeks of discontinuing such medication. MAOIs are commonly prescribed for depression, psychiatric or emotional conditions, and Parkinson's disease. Healthcare professionals should advise patients to consult a doctor or pharmacist if they are uncertain whether their prescription includes an MAOI.

Prior to administration, it is essential to evaluate the patient's medical history. Consultation with a healthcare provider is recommended for individuals with the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate enlargement, or a cough associated with excessive phlegm. Additionally, patients with a persistent or chronic cough, such as that which may occur with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice before use.

Patients should be cautioned against the concurrent use of this product with other oral nasal decongestants or stimulants without prior consultation with a healthcare professional. It is imperative to adhere to the recommended dosage; exceeding this may lead to adverse effects.

Monitoring for specific symptoms is crucial. Patients should discontinue use and seek medical advice if they experience nervousness, dizziness, or sleeplessness. Furthermore, if symptoms do not improve within 7 days or are accompanied by fever, or if a cough persists for more than one week, recurs, or is associated with fever, rash, or a persistent headache, medical evaluation is warranted. A persistent cough may indicate a serious underlying condition.

For pregnant or breastfeeding individuals, consultation with a healthcare professional is advised prior to use.

In the event of an 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 the use of this product. Serious adverse reactions may occur, particularly in individuals with pre-existing conditions. It is contraindicated for patients currently taking a prescription monoamine oxidase inhibitor (MAOI) or within two weeks of discontinuing such medication. Patients with heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate enlargement should consult a healthcare professional before use. Additionally, those experiencing a cough accompanied by excessive phlegm or a persistent cough, such as that associated with smoking, asthma, chronic bronchitis, or emphysema, should seek medical advice prior to use.

Common adverse reactions may include nervousness, dizziness, or sleeplessness. Patients are advised to discontinue use and consult a doctor if these symptoms occur. Furthermore, if symptoms do not improve within seven days or are accompanied by fever, or if a cough persists for more than one week, recurs, or is accompanied by 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 medical help or contact a Poison Control Center immediately. Patients who are pregnant or breastfeeding should also consult a healthcare professional before using this product. It is important to adhere to the recommended dosage to minimize the risk of adverse reactions.

Drug Interactions

The concomitant use of this medication with prescription monoamine oxidase inhibitors (MAOIs) is contraindicated. Patients should not use this medication while taking MAOIs, which are commonly prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease, and for a period of two weeks following the discontinuation of an MAOI.

Additionally, it is advisable for patients to consult a healthcare professional, such as a doctor or pharmacist, prior to using this medication if they are currently taking any other oral nasal decongestants or stimulants. This precaution is essential to avoid potential adverse interactions.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before use. For adolescents aged 12 years and older, the recommended dosage is 5 mL (1 teaspoon), with a maximum of 6 doses within a 24-hour period. Caution is advised in the administration of this medication to younger children.

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. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

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 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 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 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 specific substance is known, targeted therapies may be employed as indicated.

It is essential for healthcare providers to remain vigilant and act swiftly in the management of overdose situations to ensure optimal patient outcomes.

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

Serious side effects have been reported voluntarily through various channels. Individuals are encouraged to report any serious adverse events to the designated phone number available for this purpose. Reports can be made on weekdays from 8 AM to 4 PM AST.

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 with a safety seal that must remain intact; it should not be used if the seal is torn, broken, or missing.

For optimal storage, the product should be maintained at a controlled room temperature between 15°C and 30°C (59°F and 86°F). It is essential to avoid exposure to excessive heat or humidity to ensure the integrity and efficacy of the product.

Additional Clinical Information

The medication is administered orally and should be taken every 4 hours, or as directed by a healthcare professional. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is important to keep the medication out of reach of children, and in the event of an overdose, patients should seek medical assistance or contact a Poison Control Center immediately.

No additional information is available regarding laboratory tests, abuse potential, or postmarketing experience.

Drug Information (PDF)

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

View product document (PDF)