Altipres

Description

Altiprespediatric is identified by the SPL code 34089-3. This formulation is specifically designed for pediatric use, providing a targeted therapeutic option for younger patients.

Uses and Indications

This drug is indicated for the temporary relief of cough associated with minor throat and bronchial irritation, which may occur due to the common cold. It also aids in loosening phlegm (mucus) and thinning bronchial secretions, facilitating drainage of the bronchial tubes. Additionally, this drug provides temporary relief from nasal congestion resulting from the common cold.

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 4 teaspoonfuls (20 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 2 teaspoonfuls (10 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 teaspoonful (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.

Healthcare professionals should ensure that patients are aware of the dosing intervals and the importance of not exceeding the maximum daily limit.

Contraindications

Use is contraindicated in the following situations:

• In children who are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or within 2 weeks of discontinuing such medication, due to the potential for serious interactions.

• In children under 2 years of age, as safety and efficacy have not been established in this age group.

Warnings and Precautions

Healthcare professionals should exercise caution when recommending this product, particularly in pediatric patients. Prior to use, it is imperative to consult a physician if the child has any of the following medical 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 administering this product, it is crucial to adhere strictly to the recommended dosage. Exceeding this dosage may lead to adverse effects.

Healthcare providers should advise caregivers to discontinue use and seek medical advice if the child experiences 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, further 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 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. It is important to consult a healthcare professional before use 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 that produces excessive phlegm, or a chronic cough related to smoking, asthma, chronic bronchitis, or emphysema.

In clinical practice, it is advised that the recommended dosage not be exceeded. Patients should discontinue use and seek medical advice 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, these may indicate a serious underlying condition that requires further evaluation.

Drug Interactions

The concomitant use of this product with Monoamine Oxidase Inhibitors (MAOIs) is contraindicated. This includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. The use of this product in children who are currently taking an MAOI, or within 2 weeks of discontinuing an MAOI, may lead to serious adverse effects.

Healthcare professionals are advised to confirm whether a child's prescription medication contains an MAOI prior to the administration of this product. It is essential to consult with a doctor or pharmacist for clarification and guidance on safe usage.

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 should be evaluated by a healthcare professional before use if they have any of 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, caution is advised for children with chronic coughs related to smoking, asthma, chronic bronchitis, or emphysema.

The recommended dosages for pediatric patients are as follows: for adults and children aged 12 years and older, the dosage is 4 teaspoonfuls (20 mL) every 4 hours; for children aged 6 to under 12 years, the dosage is 2 teaspoonfuls (10 mL) every 4 hours; and for children aged 2 to under 6 years, the dosage is 1 teaspoonful (5 mL) every 4 hours. It is important to note that children under 2 years of age should not use this medication without consulting a doctor.

Parents and caregivers should be advised to stop use and consult a healthcare professional if the child experiences nervousness, dizziness, or sleeplessness, if symptoms do not improve within 7 days, or if the cough persists for more than 7 days, returns, or is accompanied by fever, rash, or persistent headache, as these may indicate a serious condition.

This medication should not be used in children who are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI) or within 2 weeks of stopping an MAOI. It is crucial to adhere to the recommended dosages to avoid potential adverse effects.

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. 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 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 currently no available data regarding the excretion of this medication in human breast milk or its effects on breastfed infants. Therefore, caution is recommended when administering this medication to lactating individuals.

Renal Impairment

There is no specific information available 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 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

Exceeding the recommended dosage of this product may lead to serious health consequences. Healthcare professionals are advised to monitor patients closely for any signs of overdosage and to educate patients on the importance of adhering to the prescribed dosage guidelines.

In the event of suspected overdosage, it is crucial to assess the patient for potential symptoms, which may vary depending on the specific product and individual patient factors. Common symptoms associated with overdosage may include, but are not limited to, gastrointestinal disturbances, neurological effects, and cardiovascular complications.

Management of overdosage should be initiated promptly. Healthcare providers should consider the following steps:

1. Immediate Assessment: Conduct a thorough evaluation of the patient's clinical status, including vital signs and any presenting symptoms.

2. Supportive Care: Provide supportive care as necessary, which may include intravenous fluids, monitoring of vital signs, and symptomatic treatment.

3. Consultation: In cases of severe overdosage, consultation with a poison control center or a medical toxicologist is recommended for further guidance on management strategies.

4. Documentation: Ensure that all findings, interventions, and patient responses are documented in the medical record for ongoing assessment and care planning.

It is imperative that healthcare professionals remain vigilant and proactive in preventing and managing overdosage to ensure patient safety and optimal therapeutic outcomes.

Nonclinical Toxicology

If pregnant or breastfeeding, it is advised to consult a health professional prior to use. No non-teratogenic effects have been specified in the available data. Additionally, there are no details provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified the following adverse reactions reported voluntarily or through surveillance programs: nervousness, dizziness, and sleeplessness. These events have been documented in the context of routine pharmacovigilance activities.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help immediately or contact a Poison Control Center.

It is crucial to inform patients that this medication should not be used in children who are currently taking a prescription Monoamine Oxidase Inhibitor (MAOI), which includes certain medications prescribed for depression, psychiatric or emotional conditions, or Parkinson's disease. Additionally, patients should be cautioned against using this medication for at least 2 weeks after discontinuing an MAOI. If there is any uncertainty regarding whether a child's prescription includes an MAOI, patients should be encouraged to consult with a doctor or pharmacist prior to using this product.

Furthermore, healthcare providers should emphasize that this medication is not recommended for use in children under 2 years of age.

Storage and Handling

The product is supplied in a container that must be kept tightly closed to maintain integrity. 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). It is essential to protect the product from light to prevent degradation. Once opened, the product should be discarded to ensure safety and efficacy.

Additional Clinical Information

The medication is administered orally. There are no additional details available regarding laboratory tests, abuse information, patient counseling, or postmarketing experience.

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)