Caffeine/Pyrilamine maleate/Acetaminophen

Description

Buscolicos is a pharmaceutical compound characterized by its specific chemical properties. The molecular weight of Buscolicos is not specified in the provided data. The chemical formula is also not detailed. The drug is formulated in a dosage form suitable for its intended therapeutic use. Further information regarding its appearance and inactive ingredients is not available in the current dataset.

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 before 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 is required. Prompt intervention is critical for both adults and children, regardless of the presence of symptoms.

Warnings and Precautions

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

Acetaminophen may also provoke severe skin reactions or allergic responses. Symptoms indicative of such reactions include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of a skin or general allergic reaction, immediate cessation of use and prompt medical attention are imperative.

Healthcare professionals should advise patients against using this product in conjunction with any other medications containing acetaminophen, whether prescription or over-the-counter. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a doctor or pharmacist is recommended. Additionally, individuals with a history of allergic reactions to this product or its components should avoid its use.

Patients should seek medical advice prior to using this product if they have liver disease, glaucoma, difficulty urinating due to prostate enlargement, or respiratory conditions such as emphysema or chronic bronchitis. Furthermore, it is advisable to consult a healthcare provider or pharmacist if the patient is concurrently taking anticoagulants like warfarin or sedatives and tranquilizers.

Caution is warranted as this product may induce drowsiness. Patients are advised to avoid alcoholic beverages, as well as sedatives and tranquilizers, which may exacerbate drowsiness. Care should be taken when driving or operating machinery. Additionally, the consumption of caffeine-containing products should be limited, as excessive caffeine intake can lead to nervousness, irritability, insomnia, and, in some cases, rapid heartbeat. The recommended dosage of this product contains a caffeine level comparable to that of a standard cup of coffee.

In the event of an overdose, immediate medical assistance should be sought, or contact with a Poison Control Center is essential. Timely medical intervention is crucial for both adults and children, even in the absence of noticeable symptoms.

Patients should discontinue use and consult a healthcare professional 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.

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 advised 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 is observed, if pain worsens or persists for more than 10 days, or if fever intensifies 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 and potential hepatotoxicity.

Caution is advised when using this medication in conjunction with warfarin, a blood-thinning agent. Patients should consult a healthcare professional prior to use to assess the risk of increased bleeding.

The concomitant use of alcohol, sedatives, or tranquilizers may enhance drowsiness. Patients should be monitored for increased sedation and may require dosage adjustments of sedative medications to mitigate this effect.

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

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, 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, as well as any available data regarding fetal outcomes and lactation. Healthcare providers can offer guidance tailored to individual circumstances, ensuring the safety of both the patient and the developing fetus or nursing 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 data regarding dosage adjustments, special monitoring, or safety considerations. Therefore, healthcare professionals should exercise caution when prescribing this medication to patients with reduced kidney function, as the lack of information necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in these patients to ensure safety and efficacy.

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 to any other medications containing acetaminophen. Additionally, the risk of liver damage is significantly increased if the individual consumes 3 or more alcoholic drinks daily while using this product.

Healthcare professionals should be vigilant in monitoring patients for symptoms of liver damage, which may include jaundice, abdominal pain, nausea, vomiting, and confusion. In the event of suspected overdosage, immediate medical attention 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 and monitoring of liver function tests are also critical components of the management strategy. It is essential 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 alcohol consumption.

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 limits the understanding of the compound's potential effects in these areas.

Postmarketing Experience

Acetaminophen has been associated with severe skin reactions and severe allergic reactions, as reported in postmarketing surveillance. Symptoms of these reactions may 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 immediately and seek medical assistance.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is essential to emphasize the importance of safety in the home environment, particularly for families with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help or contact a Poison Control Center immediately. They should stress that quick medical attention is critical for both adults and children, even if no signs or symptoms of overdose are apparent. This proactive approach can significantly impact the outcome in cases of accidental overdose.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It is essential to store the product at room temperature, maintaining a range of 20-25 ºC (68-77 ºF) to ensure its stability and efficacy. Proper storage conditions must be adhered to, as deviations from the recommended temperature range may affect the product's quality.

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)