Vazalore

Description

VALAZORE (aspirin) is presented in a capsule dosage form, containing 325 mg of the active ingredient, aspirin. The product is available in two packaging options: a 325 mg bottle and a 325 mg carton. Visual references for the packaging include the bottle image (vaz00-0000-02.jpg) and the carton image (vaz00-0000-01.jpg).

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, backache, muscular aches, the common cold, toothache, minor pains of arthritis, and premenstrual and menstrual cramps. Additionally, it is indicated for the temporary reduction of fever.

Healthcare professionals are advised to consult with patients regarding other potential uses of aspirin capsules. There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication with a full glass of water for optimal efficacy.

For adults and children aged 12 years and older, the recommended dosage is as follows: 1 or 2 capsules may be taken every 4 hours, or alternatively, 3 capsules may be taken every 6 hours, as needed while symptoms persist. It is imperative that the total dosage does not exceed 12 capsules within a 24-hour period.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a history of allergic reactions to aspirin or any other pain reliever or fever reducer.

Warnings and Precautions

Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional immediately, as these may be early signs of Reye’s syndrome.

Aspirin may induce severe allergic reactions, which can manifest as hives, facial swelling, shock, or asthma symptoms such as wheezing. Healthcare professionals should be vigilant for these signs and advise patients to seek immediate medical attention if they occur.

This product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a risk of stomach bleeding. The likelihood of this adverse effect is increased in individuals who are 60 years of age or older, have a history of stomach ulcers or bleeding disorders, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic beverages daily, or exceed the recommended dosage or duration of use.

Healthcare providers should advise patients to consult a physician prior to using this product if they have a history of stomach issues, such as heartburn, or if they have conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or those with asthma should seek medical advice before use.

In the event of an overdose, it is crucial to obtain emergency medical assistance or contact a Poison Control Center immediately.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any signs of an allergic reaction, such as hives or swelling. They should also seek medical attention if they notice symptoms indicative of stomach bleeding, including feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Other concerning symptoms that warrant immediate medical consultation include worsening pain lasting more than 10 days, fever that worsens or persists beyond three days, ringing in the ears or hearing loss, redness and swelling in the affected area, or the emergence of any new symptoms that could suggest serious conditions.

Side Effects

Patients using this product may experience a range of adverse reactions, some of which can be serious.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. It is crucial that these individuals do not use this product. If patients exhibit changes in behavior accompanied by nausea and vomiting while using this product, they should consult a doctor immediately, as these symptoms could indicate the onset of Reye’s syndrome.

Aspirin may also provoke severe allergic reactions in some patients, which can manifest as hives, facial swelling, shock, or asthma (wheezing). Patients with a known history of allergic reactions to aspirin or other pain relievers or fever reducers should not use this product.

The use of this product carries a warning for potential stomach bleeding, particularly in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, consume three or more alcoholic drinks daily, or use other NSAIDs concurrently. Patients should be vigilant for signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain. If any of these symptoms occur, patients should stop using the product and seek medical attention.

Patients are advised to discontinue use and consult a doctor if pain worsens or persists for more than 10 days, if fever worsens or lasts more than three days, if they experience ringing in the ears or loss of hearing, if redness and swelling occur in the painful area, or if any new symptoms arise that could indicate serious conditions.

Before using this product, patients should consult a doctor if they have a history of stomach problems, such as heartburn, or if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Additionally, patients taking diuretics or medications for diabetes, gout, or arthritis should also seek medical advice prior to use.

Drug Interactions

Patients should consult a healthcare professional prior to using this medication if they are concurrently taking drugs for diabetes, gout, or arthritis, as these conditions may influence the medication's efficacy or safety profile.

In terms of pharmacodynamic interactions, the concomitant use of this medication with anticoagulants or steroid drugs may increase the risk of gastrointestinal bleeding. Therefore, careful monitoring for signs of bleeding is advised in patients receiving these combinations.

Additionally, the risk of gastrointestinal bleeding is also elevated when this medication is used alongside other nonsteroidal anti-inflammatory drugs (NSAIDs), including both prescription and over-the-counter options such as aspirin, ibuprofen, and naproxen. It is recommended that patients avoid the concurrent use of these NSAIDs to minimize the risk of adverse effects.

No specific laboratory test interactions have been identified in the available data.

Packaging & NDC

Below are the non-prescription pack sizes of Vazalore (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product due to the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur, it is essential to consult a doctor, as these may be early signs of this condition.

For dosing, adults and children aged 12 years and older may take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist, with a maximum of 12 capsules in a 24-hour period. For children under 12 years of age, consultation with a doctor is advised before use.

Geriatric Use

Elderly patients, particularly those aged 60 years and older, are at an increased risk of gastrointestinal bleeding when using this product, which contains a nonsteroidal anti-inflammatory drug (NSAID). The risk is further elevated in individuals with a history of stomach ulcers or bleeding disorders, as well as those concurrently using anticoagulants or steroid medications.

Additionally, caution is advised for geriatric patients who are taking other medications that contain NSAIDs, whether prescription or over-the-counter, such as aspirin, ibuprofen, or naproxen. The potential for adverse effects is also heightened in patients who consume three or more alcoholic beverages daily while using this product.

Healthcare providers should closely monitor elderly patients for signs of gastrointestinal bleeding and consider dose adjustments or alternative therapies as necessary, particularly in those who exceed the recommended dosage or duration of use.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. The use of aspirin during the last trimester of pregnancy is particularly concerning, as it may lead to adverse effects on fetal outcomes or complications during delivery. Therefore, it is crucial that pregnant patients only use aspirin in this period if explicitly directed by a healthcare provider.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin during the last three months of pregnancy unless specifically directed by a doctor, as it may pose risks to the unborn child or lead to complications during delivery. 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 considering the use of this medication while breastfeeding.

Renal Impairment

There is no specific information regarding dosage adjustments, special monitoring, or safety considerations for patients with renal impairment. Healthcare professionals should exercise caution when prescribing to patients with reduced kidney function, as the absence of detailed guidance necessitates careful clinical judgment. Regular monitoring of renal function may be advisable in this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in clinical trials for this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data regarding its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific information regarding overdosage in the provided sections of the Summary of Product Characteristics (SPL), healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdosage.

Healthcare providers should monitor patients closely for any potential symptoms that may arise from an overdose. Symptoms can vary widely depending on the substance involved and the individual patient's response. In the event of an overdose, it is recommended that healthcare professionals initiate supportive care and symptomatic treatment as necessary.

Management procedures should include the following steps:

1. Assessment: Conduct a thorough assessment of the patient's clinical status, including vital signs and level of consciousness.

2. Supportive Care: Provide supportive care tailored to the patient's needs, which may include intravenous fluids, oxygen supplementation, or other interventions as indicated.

3. Consultation: Consider consulting a poison control center or a medical toxicologist for guidance on specific management strategies based on the substance involved and the severity of the overdose.

It is imperative that healthcare professionals remain vigilant and prepared to respond to any complications that may arise from an overdosage scenario.

Nonclinical Toxicology

It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No specific non-teratogenic effects have been identified in the available data. Additionally, there are no details regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs.

Allergic reactions have been noted, including manifestations such as hives, facial swelling, shock, and asthma (wheezing). Additionally, cases of stomach bleeding have been reported, particularly in patients aged 60 years or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulant or steroid medications, patients using other drugs containing prescription or nonprescription NSAIDs, and those consuming three or more alcoholic drinks daily while using this product. Prolonged use or exceeding the recommended dosage may also increase the risk of this adverse event.

Furthermore, Reye’s syndrome has been reported in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. Early signs of this serious condition may include changes in behavior accompanied by nausea and vomiting.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use this medication if they have ever experienced an allergic reaction to aspirin or any other pain reliever or fever reducer. It is essential for patients to consult with their healthcare provider before use if any of the following conditions apply: a history of stomach bleeding, stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, kidney disease, or if they are taking a diuretic. Additionally, patients with asthma should also seek advice from their doctor prior to use.

Patients should be instructed to stop using the medication and contact their healthcare provider if they experience any signs of an allergic reaction, which may require immediate medical attention. They should also be made aware of the signs of stomach bleeding, including feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Furthermore, patients should seek medical advice if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, if they experience ringing in the ears or loss of hearing, if there is redness and swelling in the painful area, or if any new symptoms arise that could indicate serious conditions.

Lastly, patients should be encouraged to consult with their healthcare provider or pharmacist before using this medication if they are currently taking drugs for diabetes, gout, or arthritis.

Storage and Handling

The product is supplied in a carton that contains essential directions and warnings, which should be retained for reference. It is important to store the product at a temperature range of 15-30°C (59-86°F) to ensure its efficacy. Care should be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F). Additionally, the integrity of the packaging is crucial; the product should not be used if the blue band around the capsule is missing or broken.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

View product document (PDF)