Buscapina

Description

No description information is available for the 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 over are advised to take 2 tablets with water every 6 hours as needed. The total daily dosage must not exceed 6 tablets. 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.

• In individuals with a history of allergic reactions 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 recommended dosage, which is a maximum of 6 tablets 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 induce 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 should be instructed to discontinue use immediately and seek medical assistance.

In cases of overdose, it is imperative to obtain emergency medical help or contact a Poison Control Center (1-800-222-1222) without delay. Prompt medical intervention is crucial for both adults and children, even in the absence of noticeable signs or symptoms.

Patients should be advised to stop taking the product and consult a healthcare provider if any of the following occur: the emergence of new symptoms, the presence of redness or swelling, worsening pain lasting more than 10 days, or a fever that worsens or persists for more than 3 days. Monitoring for these signs is essential to ensure patient safety and effective management of any adverse effects.

Side Effects

Severe liver damage may occur in patients taking this product containing acetaminophen if they exceed the maximum daily dosage 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 also experience severe skin or allergic reactions associated with acetaminophen. Symptoms of such reactions can include skin reddening, blisters, rash, hives, facial swelling, asthma (wheezing), and in extreme cases, shock.

It is advised that patients discontinue 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.

Patients should seek medical advice prior to using this product if they have a history of liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or any breathing problems such as emphysema or chronic bronchitis. Additionally, patients taking the blood-thinning medication warfarin or those on sedatives or tranquilizers should consult a doctor or pharmacist before use.

Drug Interactions

The concomitant use of warfarin, an anticoagulant, with this product containing acetaminophen may elevate the risk of bleeding. It is advisable to monitor patients closely for signs of increased bleeding and to consider dosage adjustments of warfarin as necessary.

Additionally, the use of alcohol, sedatives, and tranquilizers in conjunction with this product, which contains acetaminophen, caffeine, and pyrilamine maleate, may enhance drowsiness. Patients should be cautioned about the potential for increased sedation and advised to avoid activities that require full alertness until they are aware of how the combination affects them.

No specific drug interactions or laboratory test interactions have been identified for this product beyond those mentioned.

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 tablets taken with water, which may be repeated every 6 hours as needed, without exceeding 6 tablets in a 24-hour period.

Caution is advised as excitability may occur, particularly in children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center (1-800-222-1222) should be contacted. Prompt medical attention is essential for both adults and children, even if no signs or symptoms are 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 potential 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 safety of this drug during pregnancy has not been established, and potential risks to fetal outcomes are not fully understood. Therefore, it is essential for women of childbearing potential to seek medical advice to weigh the benefits and risks associated with the use of this medication 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 on the excretion of this drug 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 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 and monitoring.

Hepatic Impairment

Patients with hepatic impairment should be closely monitored when using this product, which contains acetaminophen. It is important to note that severe liver damage may occur if patients exceed the maximum daily dosage of 6 tablets within a 24-hour period. Additionally, patients should avoid concomitant use of other medications containing acetaminophen, as this can further increase the risk of liver injury.

Patients with compromised liver function are also advised to limit alcohol consumption. Specifically, the intake of 3 or more alcoholic drinks per day while using this product may significantly heighten the risk of severe liver damage. Therefore, careful consideration of liver function and adherence to the recommended dosage guidelines is essential to minimize the potential for adverse effects in this population. Regular monitoring of liver function tests may be warranted in patients with existing hepatic impairment to ensure safety and efficacy during treatment.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant regarding the potential for overdose with this medication. In cases where an overdose is suspected, immediate medical attention should be sought.

Healthcare providers are advised to monitor patients closely for any signs or symptoms that may arise from an overdose. Common symptoms may include, but are not limited to, severe drowsiness, confusion, respiratory distress, or any other unusual clinical manifestations.

Management of an overdose should be tailored to the individual patient and may involve supportive care, including monitoring vital signs and providing symptomatic treatment as necessary. In cases of significant overdose, consultation with a poison control center or a medical toxicologist is recommended to determine the most appropriate course of action.

It is crucial for healthcare professionals to educate patients and caregivers about the importance of adhering to prescribed dosages and to provide guidance on what to do in the event of a suspected overdose.

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 assessment of potential risks associated with the use of the compound in question.

Postmarketing Experience

Postmarketing experience has revealed reports of severe skin reactions, including skin reddening, blisters, rash, hives, and facial swelling. Additionally, cases of asthma characterized by wheezing and instances of shock have been reported. These events were identified through voluntary reporting and surveillance programs.

Patient Counseling

Healthcare providers should advise patients to seek immediate medical assistance or contact a Poison Control Center (1-800-222-1222) 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 be encouraged to consult with a doctor or pharmacist.

It is important to instruct patients to discontinue use and consult a doctor if they experience new symptoms, or if they notice any redness or swelling. Additionally, patients should be advised to stop using the product if their pain worsens or persists for more than 10 days, or if their fever intensifies or lasts longer than 3 days.

Patients should be made aware that drowsiness may occur while using this product, and they should avoid alcoholic beverages during its use. Excitability may also be a side effect, particularly in children. Furthermore, patients should be cautioned that the combination of this product with alcohol, sedatives, or tranquilizers may enhance drowsiness, and they should exercise caution when driving or operating machinery.

Healthcare providers should recommend that patients limit their intake of caffeine-containing medications, foods, or beverages, as excessive caffeine can 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 be advised to consult a doctor before using this product. Additionally, patients taking the blood-thinning medication warfarin, or those on sedatives or tranquilizers, should also seek guidance 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 maintained at room temperature, specifically within the range of 68-77°F (20-25°C). Proper handling and storage conditions are crucial to ensure 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 healthcare 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 at 1-800-222-1222, as prompt medical attention is crucial for both adults and children, even if no symptoms are apparent.

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)