Vazalore

Description

SPL Code 34089-3 is packaged in a 30 count blister carton and a 30 count bottle carton. The product is designed for professional use, ensuring convenient access and storage.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with 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.

Dosage and Administration

Patients should take each dose with a full glass of water to ensure proper hydration and absorption.

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. Due to the potential for severe allergic responses, administration in these patients is not recommended.

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. If any changes in behavior accompanied by nausea and vomiting occur while using this product, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of this rare but serious illness.

Aspirin may provoke severe allergic reactions in some individuals. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (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 patients who meet any of the following criteria: individuals aged 60 years or older, those with a history of stomach ulcers or bleeding disorders, patients taking anticoagulants or steroid medications, individuals using other NSAIDs (including aspirin, ibuprofen, or naproxen), those consuming three or more alcoholic beverages daily while using this product, or patients who exceed the recommended dosage or duration of use.

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

Patients should be advised to discontinue use and consult a healthcare provider if any of the following occur: signs of an allergic reaction, symptoms indicative of stomach bleeding (such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain), worsening pain lasting more than 10 days, a fever that worsens or persists beyond three days, tinnitus or hearing loss, redness and swelling in the affected area, or the emergence of any new symptoms that may suggest serious underlying conditions.

Side Effects

Patients using this product should be aware of several serious and common adverse reactions associated with its use.

Reye’s syndrome is a rare but serious illness that may occur in children and teenagers who have or are recovering from chicken pox or flu-like symptoms. It is crucial for these individuals to avoid this product. If patients experience 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, a component of this product, may cause severe allergic reactions in some patients. Symptoms of such reactions can include hives, facial swelling, shock, and asthma (wheezing). Patients experiencing any signs of an allergic reaction should seek medical help right away.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of stomach bleeding. This risk is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking blood thinners 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 consult a doctor.

Common adverse reactions may include worsening pain or fever lasting more than 10 days or three days, respectively. Patients should also be aware of potential auditory effects, such as ringing in the ears or loss of hearing, as well as redness and swelling in the painful area. Any new symptoms that arise should be reported to a healthcare provider, as they could indicate serious conditions.

Patients with a history of stomach problems, high blood pressure, heart disease, liver cirrhosis, or kidney disease should consult a doctor before using this product. Additionally, those taking diuretics or medications for diabetes, gout, or arthritis should seek advice from a healthcare professional or pharmacist prior to use.

Drug Interactions

Aspirin has several notable interactions that may impact patient safety and treatment efficacy.

Anticoagulants Aspirin may enhance the effects of blood-thinning medications, leading to an increased risk of bleeding. It is advisable for healthcare providers to monitor patients closely for signs of bleeding and consider dosage adjustments of anticoagulants as necessary.

Nonsteroidal Anti-Inflammatory Drugs (NSAIDs) Concurrent use of aspirin with other NSAIDs, such as ibuprofen or naproxen, may further elevate the risk of bleeding. Patients should be counseled to avoid using multiple NSAIDs simultaneously and to consult with a healthcare professional before combining these medications.

Other Drug Interactions Aspirin may also interact with medications used for diabetes, gout, or arthritis. It is recommended that patients consult their healthcare provider or pharmacist prior to using aspirin in conjunction with these treatments to ensure safe and effective use.

Packaging & NDC

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

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should consult a healthcare professional before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye’s syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur, medical advice should be sought immediately, as these may be early signs of Reye’s syndrome.

For adolescents aged 12 years and older, the recommended dosage is 1 or 2 capsules every 4 hours or 3 capsules every 6 hours, not to exceed 12 capsules in a 24-hour period while symptoms persist.

Geriatric Use

Elderly patients, particularly those aged 60 and older, may have an increased risk of stomach bleeding. This heightened risk necessitates careful consideration and monitoring when prescribing medications that could exacerbate this condition.

Additionally, it is advisable for healthcare providers to inquire about the presence of comorbidities such as high blood pressure, heart disease, liver cirrhosis, or kidney disease before initiating treatment in geriatric patients. These conditions are more prevalent in this population and may influence the safety and efficacy of the prescribed therapy. Close monitoring and appropriate dose adjustments may be required to mitigate potential risks associated with these underlying health issues.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional prior to use. The use of aspirin during the last trimester of pregnancy is particularly cautioned against, as it may lead to adverse effects on fetal outcomes or complications during delivery. Healthcare providers should carefully evaluate the risks and benefits before recommending aspirin to pregnant patients, especially in the later stages of pregnancy.

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 available 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 relation to the use of 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 on 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, healthcare professionals are advised to exercise caution and adhere to general principles of management in cases of suspected overdose.

It is essential to monitor the patient 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, immediate medical attention should be sought. Healthcare providers should initiate supportive care and symptomatic treatment as necessary. This may include monitoring vital signs, providing respiratory support, and administering intravenous fluids if indicated.

Additionally, healthcare professionals should consider contacting a poison control center for guidance on specific management protocols tailored to the substance involved in the overdose.

Documentation of the incident, including the amount and timing of the substance taken, is crucial for effective management and follow-up care.

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 detailed findings regarding nonclinical toxicology or animal pharmacology and toxicology provided in the current information.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions associated with the use of the product. Reports indicate that gastrointestinal bleeding has occurred, particularly in patients with a history of ulcers or those concurrently using anticoagulants. Additionally, allergic reactions, including hives, facial swelling, and shock, have been documented. Furthermore, cases of Reye's syndrome have been reported in children and teenagers who used the product during viral infections. These events were reported voluntarily or through surveillance programs and do not imply a causal relationship.

Patient Counseling

Healthcare providers should advise patients to keep the 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 the medication if they have a history of allergic reactions to aspirin or any other pain reliever or fever reducer. They should be counseled to stop using the medication and consult a doctor if they experience any signs of an allergic reaction, such as difficulty breathing or swelling of the face or throat, and to seek medical assistance right away.

Additionally, patients should be made aware of the signs of stomach bleeding, which include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. They should also be advised to seek medical attention 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.

Patients should be encouraged to consult a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also important to discuss any existing conditions such as high blood pressure, heart disease, liver cirrhosis, or kidney disease, as well as the use of diuretics or asthma medications.

Finally, patients should be advised to speak with a doctor or pharmacist before using the medication if they are taking drugs for diabetes, gout, or arthritis to ensure safe and effective use.

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 above 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

Patients should take the medication with a full glass of water. For adults and children aged 12 years and older, the recommended dosage is 1 or 2 capsules every 4 hours, or 3 capsules every 6 hours, not to exceed 12 capsules in a 24-hour period. For children under 12 years, consultation with a doctor is advised.

Clinicians should counsel patients to keep the medication out of reach of children and to seek medical help or contact a Poison Control Center immediately in the event of an overdose. Pregnant or breastfeeding patients should consult a healthcare professional before use, particularly noting that aspirin should be avoided during the last trimester of pregnancy unless specifically directed by a physician, due to potential risks to the unborn child or complications during delivery.

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)