Altipres

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the loosening of phlegm (mucus) and thinning of bronchial secretions to facilitate drainage of the bronchial tubes. It also provides temporary relief of nasal congestion associated with the common cold and alleviates cough due to minor throat and bronchial irritation.

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

Dosage and Administration

Adults and children aged 12 years and older are advised to take 2 teaspoonfuls (10 mL) every 4 hours, not to exceed 6 doses within a 24-hour period. For children aged 6 to under 12 years, the recommended dosage is 1 teaspoonful (5 mL) every 4 hours, also adhering to the maximum of 6 doses in a 24-hour timeframe.

For children aged 2 years to under 6 years, the dosage is 1/2 teaspoonful (2.5 mL) every 4 hours, with the same limitation of 6 doses per day. It is important to consult a physician for children under 2 years of age before administration.

Contraindications

Use is contraindicated in patients currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) for depression, psychiatric or emotional conditions, or Parkinson's disease, and for 2 weeks following the discontinuation of the MAOI. Additionally, this product should not be administered to children under 2 years of age.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product. Prior to use, it is imperative to consult a physician if the patient has any of the following conditions: heart disease, high blood pressure, thyroid disease, diabetes, difficulty urinating due to prostate gland enlargement, a cough associated with excessive phlegm, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

While using this product, it is crucial to adhere strictly to the recommended dosage. Exceeding the advised amount may lead to adverse effects.

Patients should be advised to discontinue use and seek medical advice if they experience symptoms such as nervousness, dizziness, or insomnia. 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 evaluation is warranted, as these may indicate a serious underlying condition.

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

Side Effects

Patients using this product should be aware of several important warnings and potential adverse reactions. It is advised that individuals consult a healthcare professional prior to use if they have a history of heart disease, high blood pressure, thyroid disease, diabetes, or difficulty urinating due to prostate gland enlargement. Additionally, those experiencing a cough associated with excessive phlegm, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema should seek medical advice before use.

While using this product, it is crucial not to exceed the recommended dosage. Patients are instructed to discontinue use and consult a doctor if they experience symptoms such as 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 7 days, recurs, or is associated with fever, rash, or a persistent headache, these may indicate a serious underlying condition that requires medical evaluation.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

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

Pediatric Use

Pediatric patients under 2 years of age should not use this medication. For children aged 2 years to under 6 years, the recommended dosage is 1/2 teaspoonful (2.5 mL) every 4 hours. Children aged 6 to under 12 years should take 1 teaspoonful (5 mL) every 4 hours. In adolescents and adults aged 12 years and over, the dosage is 2 teaspoonfuls (10 mL) every 4 hours. For any child under 2 years of age, consultation with a healthcare professional is advised before use.

Geriatric Use

Elderly patients may not have specific information regarding the use of this medication, including dosage adjustments, safety concerns, or special precautions. Therefore, healthcare providers should exercise caution when prescribing this medication to geriatric patients. It is advisable to monitor these patients closely for any potential adverse effects or changes in efficacy, given the lack of targeted data for this population.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is important to assess the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers can offer guidance based on individual circumstances and the latest clinical data.

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 mothers.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in 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 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 overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may indicate an overdose. These may include, but are not limited to, increased severity of known side effects, unusual behavioral changes, or any other atypical clinical manifestations.

Management of an overdose should be guided by the clinical presentation of the patient. Supportive care is paramount, and symptomatic treatment should be initiated as necessary. It is recommended that healthcare professionals consult local poison control centers or relevant toxicology resources for specific guidance on the management of overdose cases.

In summary, while specific overdosage data is not available, healthcare professionals should exercise caution, remain observant for potential overdose symptoms, and implement appropriate management strategies in the event of an overdose.

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

Postmarketing experience has revealed reports of various adverse reactions. These include allergic reactions such as rash, pruritus, and urticaria. Additionally, gastrointestinal disturbances have been reported, including nausea and vomiting. Central nervous system effects, specifically dizziness and drowsiness, have also been noted. These events were reported voluntarily or identified through surveillance programs.

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 product quality, it is essential to protect the product from light and keep the container tightly closed. Additionally, any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is also important to instruct patients to keep the medication out of reach of children and to seek medical assistance or contact a Poison Control Center immediately in the event of an overdose.

Drug Information (PDF)

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

View product document (PDF)