Caffeine/Pyrilamine maleate/Acetaminophen

Description

Buscompositum is a pharmaceutical formulation utilized for its therapeutic properties. The specific composition and active ingredients are designed to address particular medical conditions. The formulation is presented in a dosage form suitable for administration, ensuring optimal bioavailability and efficacy. The product's appearance is consistent with established pharmaceutical standards, facilitating identification and use in clinical settings. Further details regarding the molecular weight, chemical formula, and inactive ingredients are integral to understanding the pharmacological profile and application of Buscompositum in medical practice.

Uses and Indications

This drug is indicated for the temporary relief of symptoms associated with menstrual periods, including cramps, bloating, water-weight gain, headache, backache, muscle aches, and fatigue.

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 gelcaps with water every 6 hours as needed. The total daily dosage must not exceed 6 gelcaps.

For children under 12 years of age, it is recommended to consult a healthcare professional prior to administration.

It is imperative that patients do not exceed the recommended dose to avoid potential adverse effects.

Contraindications

Use is contraindicated in the following situations:

• The product should be kept out of reach of children to prevent accidental ingestion.

• In the event of an overdose, immediate medical assistance should be sought or contact with a Poison Control Center is advised.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the maximum daily dosage is 6 gelcaps within a 24-hour period. Exceeding this limit, using other medications containing acetaminophen, or consuming 3 or more alcoholic drinks daily while using this product significantly increases the risk of liver injury.

Acetaminophen may also lead to severe skin reactions or allergic responses. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. Patients experiencing any signs of a skin or general allergic reaction should discontinue use immediately and seek medical assistance.

It is imperative that this product not be used concurrently with any other medications containing acetaminophen, whether prescription or over-the-counter. Patients should be encouraged to consult a healthcare provider or pharmacist if they are uncertain about the presence of acetaminophen in their medications or if they have a history of allergic reactions to this product or its components.

Healthcare professionals should advise patients to consult a doctor prior to use if they have liver disease, glaucoma, difficulty urinating due to prostate enlargement, or respiratory conditions such as emphysema or chronic bronchitis. Additionally, patients taking anticoagulants like warfarin or those on sedatives or tranquilizers should seek guidance from a healthcare provider or pharmacist before using this product.

Patients should be informed that drowsiness may occur while using this product, and they should avoid alcoholic beverages. Excitability may be observed, particularly in children. The combination of alcohol, sedatives, and tranquilizers can exacerbate drowsiness, necessitating caution when driving or operating machinery. Furthermore, patients should limit the intake of caffeine-containing products, as excessive caffeine can lead to nervousness, irritability, insomnia, and, in some cases, rapid heartbeat. The recommended dosage of this product contains approximately the same amount of caffeine as a standard cup of coffee.

Patients should be instructed to discontinue use and contact a healthcare provider if new symptoms arise, if redness or swelling occurs, if pain worsens or persists beyond 10 days, or if fever intensifies or lasts longer than 3 days.

In the event of an overdose, immediate medical attention is crucial. Patients should be advised to contact a Poison Control Center or seek emergency medical help without delay, as prompt intervention is essential for both adults and children, even in the absence of noticeable symptoms.

Side Effects

Severe liver damage may occur if patients exceed the maximum daily dosage of 6 gelcaps within 24 hours, particularly when combined with other medications containing acetaminophen or when consuming 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin reactions or severe allergic reactions associated with acetaminophen. Symptoms of such reactions may include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, patients are advised to discontinue use immediately and seek medical assistance.

While using this product, patients may experience drowsiness and should avoid alcoholic beverages. Excitability may occur, particularly in children. The concomitant use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Caution is recommended when driving a motor vehicle or operating machinery. Additionally, patients should limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, on occasion, rapid heartbeat.

Patients are instructed to stop use and consult a healthcare professional if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 10 days, or if fever worsens or lasts for more than 3 days.

Drug Interactions

Co-administration of this medication with any other drug containing acetaminophen, whether prescription or nonprescription, is contraindicated due to the risk of acetaminophen overdose, which can lead to severe liver damage.

Patients taking blood thinners such as warfarin should consult a healthcare professional prior to using this medication. The combination may necessitate careful monitoring of coagulation parameters to avoid potential bleeding complications.

Additionally, the concurrent use of alcohol, sedatives, or tranquilizers may enhance the sedative effects of this medication, leading to increased drowsiness. Caution is advised, and patients should be monitored for excessive sedation when these substances are used together.

Packaging & NDC

Below are the non-prescription pack sizes of Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg. Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional prior to use. It is important to assess the appropriateness of treatment and dosage for this age group, as specific recommendations may vary based on individual health needs and conditions.

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. 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

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 should exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 gelcaps within a 24-hour period. This limit applies not only to this product but also to any other medications containing acetaminophen. Additionally, patients should be aware that consuming 3 or more alcoholic drinks daily while using this product may further increase the risk of liver damage.

It is recommended that patients with liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks associated with acetaminophen use. Monitoring of liver function may be warranted in these patients to ensure safety and efficacy.

Overdosage

In cases of overdosage, severe liver damage may occur if an individual exceeds the maximum recommended dosage of 6 gelcaps within a 24-hour period. This limit applies not only to the product in question but also in conjunction with other medications containing acetaminophen. Additionally, the risk of liver damage is heightened when the product is used concurrently with the consumption of 3 or more alcoholic drinks daily.

Healthcare professionals should be vigilant in monitoring patients for symptoms indicative of liver injury, which may include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain. In the event of suspected overdosage, immediate medical intervention is warranted.

Management of acetaminophen overdosage typically involves the administration of N-acetylcysteine (NAC) as an antidote, which is most effective when given within 8 hours of ingestion. Supportive care should also be provided, including monitoring of liver function tests and symptomatic treatment as necessary. It is crucial for healthcare providers to educate patients on the importance of adhering to recommended dosages and to be aware of the potential risks associated with concurrent use of alcohol and other acetaminophen-containing products.

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

Postmarketing experience has identified that acetaminophen may be associated with severe skin reactions and severe allergic reactions. Reported symptoms include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of a skin or general allergic reaction, it is advised to discontinue use and seek immediate medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of safety in the home environment.

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. Quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This information is vital for ensuring patient safety and effective management in case of an emergency.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at room temperature, maintained within a range of 20-25 ºC (68-77 ºF). Proper storage conditions are essential to ensure the integrity and efficacy of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Acetaminophen 500mg Caffeine 60mg Pyrilamine Maleate 15mg, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)