Buscapina

Description

Buscapina is a combination medication consisting of acetaminophen, caffeine, and pyrilamine maleate, formulated as tablets. Each package contains three packs, with each pack containing two caplets, totaling six caplets per package. The product is identified by the National Drug Code (NDC) 69729-132-06.

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. For children under 12 years of age, it is recommended to consult a healthcare professional prior to administration. It is imperative that the recommended dosage is not exceeded to ensure safety and efficacy.

Contraindications

Use of this product is contraindicated in the following situations:

• Co-administration with any other drug containing acetaminophen, whether prescription or nonprescription, 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.

• History of allergic reaction to this product or any of its ingredients, as this may lead to severe hypersensitivity reactions.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen. Healthcare professionals should advise patients to adhere strictly to the maximum daily dosage of 6 caplets within a 24-hour period. Caution is particularly warranted if patients are concurrently using other medications that contain acetaminophen or if they consume three or more alcoholic drinks daily while using this product.

Acetaminophen may also provoke severe skin or allergic reactions. Symptoms indicative of such reactions can include skin reddening, blisters, rash, hives, facial swelling, wheezing, and shock. In the event of any skin or general allergic reaction, patients must discontinue use immediately and seek medical assistance.

It is imperative that this product not be used in conjunction with any other medications containing acetaminophen, whether prescription or nonprescription. Patients should be encouraged to consult with a healthcare provider or pharmacist if there is any uncertainty regarding the presence of acetaminophen in other medications. Additionally, individuals with a history of allergic reactions to this product or any of its components should avoid its use.

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

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

Side Effects

Severe liver damage may occur in patients who exceed the maximum daily dosage of 6 caplets within a 24-hour period, take this product in conjunction with other medications containing acetaminophen, or consume 3 or more alcoholic drinks daily while using this product.

Patients should be aware of the potential for severe skin or 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.

This product should not be used in conjunction with any other drug containing acetaminophen, whether prescription or nonprescription. Patients with a history of allergic reactions to this product or any of its ingredients should also refrain from use.

Prior to using this product, patients should consult a healthcare professional if they have liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or breathing problems such as emphysema or chronic bronchitis. Additionally, patients taking blood-thinning medications such as warfarin or those using sedatives or tranquilizers should seek advice from a doctor or pharmacist before use.

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, and the combination of alcohol, sedatives, and tranquilizers may exacerbate drowsiness. Patients are also advised to limit the intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients should discontinue use and consult a doctor 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 for more than 3 days.

Pregnant or breastfeeding patients should seek guidance from a healthcare professional before using this product. It is essential to keep this product out of reach of children. In the event of an overdose, immediate medical attention should be sought, or contact with a Poison Control Center is recommended, as prompt medical intervention is critical for both adults and children, even if no signs or symptoms are initially apparent.

Drug Interactions

Concurrent use 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.

Patients taking anticoagulants such as warfarin should consult a healthcare professional prior to using this medication. The combination may enhance the anticoagulant effect, necessitating careful monitoring of INR levels and potential dosage adjustments.

Additionally, caution is advised for individuals using sedatives or tranquilizers. The concomitant use of this medication with these agents may lead to increased sedation and drowsiness. It is recommended that patients seek guidance from a healthcare provider before initiating treatment in such cases.

Furthermore, the consumption of alcohol alongside this medication may exacerbate drowsiness, and patients should be advised to limit or avoid alcohol intake to mitigate this risk.

Packaging & NDC

Below are the non-prescription pack sizes of Buscapina (acetaminophen, caffeine, 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 use. For adolescents aged 12 years and older, the recommended dosage is 2 caplets taken with water, which may be repeated every 6 hours as needed, without exceeding 6 caplets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, prompt medical attention is essential for both adults and pediatric patients, even if no signs or symptoms are immediately apparent.

Geriatric Use

Elderly patients may not have specific dosage adjustments, safety concerns, or special precautions outlined in the drug insert for Buscapina. As such, healthcare providers should exercise caution when prescribing this medication to geriatric patients, considering the general principles of pharmacotherapy in this population.

Due to the lack of specific data, it is advisable for healthcare providers to monitor elderly patients closely for any adverse effects or changes in therapeutic response. Individual patient factors, including comorbidities and concurrent medications, should be taken into account when determining the appropriateness of Buscapina for geriatric patients.

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 considered in these populations to ensure the safety of both the mother and the fetus or 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 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 exercise caution when using this product, which contains acetaminophen. Severe liver damage may occur if patients exceed the maximum daily dosage of 6 caplets within a 24-hour period. Additionally, patients should avoid concomitant use with other medications containing acetaminophen, as this can further increase the risk of liver injury.

It is also advised that patients with compromised liver function refrain from consuming 3 or more alcoholic drinks daily while using this product, as alcohol can exacerbate the potential for liver damage.

Before initiating treatment, patients with a history of liver disease should consult a healthcare professional to assess the appropriateness of this product for their condition. Monitoring of liver function may be warranted in these patients to ensure safety and prevent adverse effects.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of observable signs or symptoms.

Healthcare professionals should be aware that the lack of immediate symptoms does not preclude the potential for serious health consequences. Therefore, it is essential to monitor the patient closely and provide appropriate care as needed.

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

Acetaminophen has been associated with severe skin and 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 seek immediate medical assistance or contact a Poison Control Center in the event of an overdose, as prompt medical attention is crucial for both adults and children, even if no signs or symptoms are apparent.

Patients should be informed not to use this product in conjunction with any other medications that contain acetaminophen, whether prescription or nonprescription. If patients are uncertain about the presence of acetaminophen in their medications, they should consult a doctor or pharmacist for clarification.

It is important to counsel patients to avoid using this product if they have a history of allergic reactions to it or any of its ingredients. Patients should be instructed to discontinue use and consult a doctor if they experience new symptoms, or if they notice any redness or swelling. Additionally, they should be advised to stop use and seek medical advice if pain worsens or persists for more than 10 days, or if fever intensifies or lasts longer than 3 days.

Patients should be made aware that drowsiness may occur while using this product, and they should be cautioned against consuming alcoholic beverages during this time. It is also important to inform patients that excitability may be experienced, particularly in children. They should be advised that the use of alcohol, sedatives, and tranquilizers may enhance drowsiness.

When using this product, patients should be careful when driving or operating machinery due to the potential for drowsiness. They should also limit their intake of caffeine-containing medications, foods, or beverages, as excessive caffeine may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat. The recommended dose of this product contains approximately the same amount of caffeine as a cup of coffee.

Patients should be encouraged to 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 taking the blood-thinning medication warfarin, as well as those on sedatives or tranquilizers, should seek advice from a doctor or pharmacist prior to use.

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

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a health professional prior to use. It is essential to keep the medication out of reach of children. In the event of an overdose, patients should seek immediate medical assistance or contact a Poison Control Center, as prompt attention is crucial for both adults and children, even in the absence of noticeable symptoms.

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)