Buscapina

Description

No description information is available for the specified drug.

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 caplets with water. This dosage may be repeated every 6 hours as needed, with a maximum limit of 6 caplets per day. It is imperative that the recommended dosage is not exceeded.

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

Contraindications

Use of this product is contraindicated in the following situations:

Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, is prohibited due to the risk of acetaminophen overdose. If there is uncertainty regarding the presence of acetaminophen in other medications, consultation with a healthcare professional is advised.

Additionally, this product should not be used in individuals with a history of allergic reactions to this product or any of its ingredients, as this may lead to severe adverse reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients that the risk of liver injury increases if they exceed the maximum daily dosage of 6 tablets within a 24-hour period, use other medications containing acetaminophen concurrently, or consume three or more alcoholic beverages daily while taking this product.

Acetaminophen may also lead to severe skin or allergic reactions. Symptoms indicative of such reactions can include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and shock. In the event of any skin or general allergic reaction, patients should be instructed to discontinue use immediately and seek medical assistance.

Healthcare providers should recommend that patients consult a physician prior to using this product if they have a history of liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or respiratory conditions such as emphysema or chronic bronchitis. Additionally, patients should be advised to seek guidance from a doctor or pharmacist if they are currently taking blood thinners, such as warfarin, or sedatives and tranquilizers.

In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center without delay. Prompt medical attention is crucial for both adults and children, even if no signs or symptoms are immediately apparent.

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

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily amount of 6 tablets within 24 hours, use other medications containing acetaminophen concurrently, or consume 3 or more alcoholic drinks daily while using this product.

Patients may experience severe skin or allergic reactions, which can manifest as skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), or shock. In the event of any skin or general allergic reaction, it is imperative that patients discontinue use and seek medical assistance immediately.

Participants should be advised 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 intensifies or lasts longer than 3 days.

While using this product, patients may experience drowsiness and should avoid alcoholic beverages, as well as be cautious when driving or operating machinery. Excitability may occur, particularly in children. The use of alcohol, sedatives, and tranquilizers may enhance drowsiness. Additionally, patients are advised to limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients with liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or breathing problems such as emphysema or chronic bronchitis should consult a healthcare professional prior to use. Furthermore, individuals taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should seek advice from a doctor or pharmacist before using this product.

Quick medical attention is critical for both adults and children in the event of an overdose, even if no signs or symptoms are immediately apparent.

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 Buscapina (acetaminophen, caffeine and pyrilamine maleate). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients under 12 years of age should consult a healthcare professional before using this product. When administered, excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and children, even if no signs or symptoms are immediately apparent.

For dosing, the product is indicated for adults and children aged 12 years and older, with a recommended dosage of 2 caplets taken with water every 6 hours as needed, not to exceed 6 caplets in a 24-hour period.

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 its use during pregnancy and lactation. The safety of this medication in pregnant women has not been established, and caution is advised to ensure the well-being of both the mother and the fetus.

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 no specific information regarding dosage adjustments, special monitoring, or safety considerations provided in the drug insert. Therefore, healthcare professionals should exercise caution when prescribing this medication to individuals with reduced kidney function, as the lack of data necessitates careful clinical judgment.

Hepatic Impairment

Patients with hepatic impairment should be aware that this product contains acetaminophen, which carries a risk of severe liver damage. It is crucial for patients to adhere to the following guidelines to minimize the risk of hepatotoxicity:

• The maximum recommended dosage is 6 tablets within a 24-hour period. Exceeding this limit may lead to severe liver damage.

• Patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

• Consumption of 3 or more alcoholic drinks daily while using this product is not advised, as it may exacerbate liver damage.

Additionally, patients with a history of liver disease should consult a healthcare professional prior to using this product to ensure safety and appropriateness of use. Regular monitoring of liver function may be warranted in patients with compromised liver function to detect any potential adverse effects early.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center. Prompt medical intervention is crucial for both adults and children, regardless of whether any signs or symptoms are initially apparent.

Healthcare professionals should be aware that the absence of symptoms does not preclude the possibility of serious complications arising from an overdose. Therefore, vigilance and swift action are essential in managing potential overdose situations effectively.

Nonclinical Toxicology

There is currently no available information regarding teratogenic or non-teratogenic effects associated with the compound. Additionally, no data has been provided concerning nonclinical toxicology, including animal pharmacology and toxicology. As such, the assessment of these aspects remains incomplete.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Notable among these are severe skin reactions, which include skin reddening, blisters, rash, hives, and facial swelling. Additionally, reports have indicated occurrences of severe allergic reactions, such as asthma (wheezing) and shock. These events have been reported voluntarily or through surveillance programs, contributing to the ongoing assessment of the product's safety profile.

Patient Counseling

Healthcare providers should advise patients to keep this product out of reach of children to prevent accidental ingestion. Patients should be instructed not to use this product in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. If patients are uncertain whether a drug contains acetaminophen, they should be encouraged to consult a doctor or pharmacist.

Patients must be informed not to use this product if they have a history of allergic reactions to it or any of its ingredients. They should be advised to discontinue use and seek medical advice if new symptoms arise, if redness or swelling occurs, if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

It is important to inform patients that this product may cause drowsiness. They should be cautioned to avoid alcoholic beverages while using this product, as well as to be aware that excitability may occur, particularly in children. Additionally, patients should be made aware that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

Patients should be advised to exercise caution when driving or operating machinery while using this product. They should also limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and occasionally rapid heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Healthcare providers should recommend that patients consult a doctor before using this product if they have liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing problems such as emphysema or chronic bronchitis. Furthermore, patients should be encouraged to seek advice from a doctor or pharmacist if they are taking the blood-thinning medication warfarin or any sedatives or tranquilizers.

Storage and Handling

The product is supplied in a tamper-evident package. It is essential to avoid using the product if the package is opened or if the blister unit is torn, broken, or shows any signs of tampering.

For optimal storage, the product should be kept at room temperature, specifically within the range of 68-77°F (20-25°C). Proper handling and storage conditions are crucial to maintain the integrity and safety of the product.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)