Caffeine/Pyrilamine maleate/Acetaminophen

Description

Buscramps is a pharmaceutical formulation indicated for the management of specific medical conditions. The active ingredient is buspirone, which is characterized by its chemical formula C21H31N5O2S and a molecular weight of 425.57 g/mol. The dosage form is typically presented as oral tablets. The appearance of Buscramps is a white to off-white solid, ensuring consistency in formulation. Inactive ingredients may include excipients that facilitate the tablet's stability and bioavailability, although specific components are not detailed in this description.

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

There are no specific contraindications listed for this product. However, it is essential to keep the product out of reach of children to prevent accidental ingestion. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center for guidance.

Warnings and Precautions

Severe liver damage may occur with the use of this product, which contains acetaminophen, if the maximum daily dosage of 6 gelcaps is exceeded within a 24-hour period. This risk is further heightened when combined with other medications containing acetaminophen or when consuming three or more alcoholic drinks daily while using this product.

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. In the event of any skin or general allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

This product should not be used concurrently with any other medications containing acetaminophen, whether prescription or over-the-counter. Healthcare professionals should advise patients to consult a doctor or pharmacist if they are uncertain whether a drug contains acetaminophen, or if they have a history of allergic reactions to this product or any of its components.

Patients with liver disease, glaucoma, difficulty urinating due to prostate gland enlargement, or respiratory conditions such as emphysema or chronic bronchitis should consult a physician prior to use. Additionally, it is advisable for patients taking anticoagulants like warfarin or those on sedatives or tranquilizers to seek guidance from a healthcare provider before using this product.

Caution is warranted as this product may cause 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. Furthermore, the consumption of caffeine-containing medications, foods, or beverages should be limited, as excessive caffeine intake may lead to nervousness, irritability, sleeplessness, and, in some cases, rapid heartbeat.

Patients should discontinue use and consult a physician 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 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 signs or 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 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 doctor 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

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 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 concomitant 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 or respiratory depression 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

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.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to using this medication. It is essential to evaluate the potential risks and benefits associated with the use of this drug during pregnancy and lactation. Healthcare providers should consider the available data and individual patient circumstances when advising on the use of this medication in these populations.

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 of these patients.

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 known liver disease consult a healthcare professional prior to using this product to assess the appropriateness of treatment and to discuss potential risks. 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, concurrent consumption of 3 or more alcoholic beverages daily while using this product significantly increases the risk of liver injury.

Healthcare professionals should be vigilant in monitoring patients for symptoms indicative of liver damage, which may include nausea, vomiting, loss of appetite, confusion, jaundice, and abdominal pain.

In the event of suspected overdosage, immediate medical attention is warranted. Management may involve the administration of activated charcoal if the ingestion occurred within a suitable timeframe, as well as the consideration of N-acetylcysteine as an antidote to mitigate liver damage. Continuous assessment of liver function and supportive care should be provided as necessary.

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 reactions and severe allergic reactions, as reported in postmarketing surveillance. Symptoms of these reactions may include skin reddening, blisters, rash, hives, facial swelling, 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 specified temperature range may compromise the product's integrity.

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.

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