Dolex Flex

Description

DOLEX® FLEX is a formulation of solubilized ibuprofen, presented in a dosage form of 200 mg per capsule. This product serves as a nonsteroidal anti-inflammatory drug (NSAID) indicated for the relief of pain and reduction of fever. Each package contains 20 softgels, which are liquid-filled capsules designed for enhanced solubility and absorption.

Uses and Indications

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

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should adhere strictly to the recommended dosage and not exceed the directed amount. The smallest effective dose should be utilized to manage symptoms effectively.

For adults and children aged 12 years and older, the recommended dosage is as follows: take 1 capsule every 4 to 6 hours while symptoms persist. If pain or fever does not adequately respond to 1 capsule, a maximum of 2 capsules may be administered. However, the total dosage must not exceed 6 capsules within a 24-hour period unless otherwise directed by a healthcare professional.

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any other pain reliever or fever reducer. Additionally, administration is contraindicated immediately before or after heart surgery due to potential complications associated with surgical recovery.

Warnings and Precautions

Ibuprofen may induce severe allergic reactions, particularly in individuals with a known allergy to aspirin. Symptoms indicative of an allergic response may include hives, facial swelling, wheezing, shock, skin reddening, rash, and blisters. In the event of an allergic reaction, it is imperative to discontinue use immediately and seek medical assistance.

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

Additionally, NSAIDs, excluding aspirin, are linked to an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is amplified when the medication is used in excess of the recommended dosage or for an extended period.

In cases of suspected overdose, immediate medical attention is required. Healthcare professionals should advise patients to contact a Poison Control Center or seek emergency medical help without delay (1-800-222-1222).

Patients should be instructed to discontinue use and consult their healthcare provider if any signs of an allergic reaction occur.

Side Effects

Patients may experience a range of adverse reactions associated with the use of this product. Serious adverse reactions include severe allergic reactions, which may manifest as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. These reactions are particularly concerning for individuals with a known allergy to aspirin.

Additionally, the use of this product, which contains a nonsteroidal anti-inflammatory drug (NSAID), carries a significant risk of severe stomach bleeding. This risk is heightened in patients who are 60 years of age or older, those with a history of stomach ulcers or bleeding problems, individuals taking anticoagulants or steroid medications, and those consuming three or more alcoholic drinks daily while using this product. Furthermore, the risk of stomach bleeding increases with prolonged use or higher than recommended dosages.

Patients should also be aware of the potential for cardiovascular events, as NSAIDs (excluding aspirin) have been associated with an increased risk of heart attack, heart failure, and stroke, which can be fatal. This risk is particularly pronounced in individuals who exceed the recommended dosage or duration of use.

Monitoring for these adverse reactions is essential, and patients should be advised to seek medical attention if they experience any severe symptoms.

Drug Interactions

The use of ibuprofen in conjunction with aspirin may diminish the cardioprotective effects of aspirin, particularly when aspirin is administered for the prevention of heart attack or stroke. Therefore, it is advisable to avoid concurrent use of these medications unless specifically directed by a healthcare professional.

Co-administration of ibuprofen with anticoagulants or steroid medications significantly elevates the risk of gastrointestinal bleeding. Clinicians should exercise caution and consider monitoring patients closely for signs of bleeding when these drugs are used together.

Additionally, the use of nonsteroidal anti-inflammatory drugs (NSAIDs), excluding aspirin, is associated with an increased risk of serious cardiovascular events, including heart attack, heart failure, and stroke. This risk is particularly pronounced when NSAIDs are used in higher doses or for extended periods. It is recommended that healthcare providers assess the necessity of NSAID therapy and consider alternative treatments or dosage adjustments to mitigate these risks.

Packaging & NDC

Below are the non-prescription pack sizes of Dolex Flex (ibuprofen). 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 1 capsule every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 capsule, 2 capsules may be administered. It is important not to exceed 6 capsules within a 24-hour period unless directed by a healthcare provider.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. This risk necessitates careful consideration and monitoring when prescribing medications associated with this warning. It is advised that healthcare providers inquire about the patient's age and the presence of any stomach bleeding warnings prior to initiating treatment.

Additionally, the risk of serious cardiovascular events, including heart attack, heart failure, and stroke, is heightened in geriatric patients, especially when medications are used in excess of the recommended dosage or for prolonged periods. Therefore, it is crucial for healthcare providers to adhere strictly to dosing guidelines and to evaluate the necessity of continued treatment in this population.

Special precautions should be implemented for elderly patients due to their increased sensitivity to side effects and the potential for diminished kidney function. Regular monitoring of renal function and assessment of the patient's overall health status are recommended to mitigate risks and ensure safe medication use in this vulnerable group.

Pregnancy

Pregnant patients should consult a healthcare professional before using this medication, especially if they are in the later stages of pregnancy or breastfeeding. It is particularly important to avoid the use of ibuprofen during the last trimester unless specifically directed by a physician. The use of ibuprofen in pregnancy may pose risks to the unborn child and could lead to complications during delivery. Therefore, careful consideration and professional guidance are essential for women of childbearing potential when contemplating the use of this medication.

Lactation

Lactating mothers are advised to consult a healthcare professional before using this medication. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a physician, 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 its use in lactating individuals.

Renal Impairment

Patients with renal impairment should consult a healthcare professional prior to use, particularly if they have a history of kidney disease. It is essential to assess the patient's overall health status, including any comorbid conditions such as high blood pressure, heart disease, liver cirrhosis, asthma, or a history of stroke, as these factors may influence the management of their renal function and the appropriateness of treatment. Monitoring and potential dosing adjustments may be necessary based on the patient's renal status to ensure safety and efficacy.

Hepatic Impairment

Patients with hepatic impairment should consult a healthcare professional prior to use, particularly if they have a history of liver cirrhosis. It is essential for these patients to receive appropriate evaluation and monitoring due to the potential impact of compromised liver function on the pharmacokinetics of the medication. Adjustments to dosage may be necessary based on the severity of liver impairment, and ongoing assessment of liver function is recommended to ensure safety and efficacy.

Overdosage

In the event of an overdose, it is imperative to seek immediate medical assistance or contact a Poison Control Center at 1-800-222-1222. Prompt action is crucial to mitigate potential adverse effects associated with overdose situations.

Healthcare professionals should be aware that symptoms of overdose may vary depending on the substance involved. Therefore, a thorough assessment of the patient's condition is essential. Management of overdose cases typically involves supportive care and symptomatic treatment, tailored to the specific symptoms presented.

It is recommended that healthcare providers remain vigilant and prepared to implement appropriate interventions based on the clinical presentation of the patient. Continuous monitoring and evaluation are critical components of effective overdose management.

Nonclinical Toxicology

It is especially important not to use ibuprofen 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 provided regarding nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

Postmarketing experience has identified several adverse reactions reported voluntarily or through surveillance programs. These include allergic reactions such as hives, facial swelling, asthma (wheezing), shock, skin reddening, rash, and blisters. Additionally, severe stomach bleeding has been noted, particularly in individuals over 60 years of age, those with a history of stomach ulcers or bleeding problems, and those concurrently using anticoagulants or other nonsteroidal anti-inflammatory drugs (NSAIDs). There is also an increased risk of heart attack, heart failure, and stroke associated with NSAID use, especially when used in doses higher than directed or for durations exceeding recommendations.

Patient Counseling

Patients should be advised to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. It is recommended that patients take the medication with food or milk if they experience stomach upset.

Healthcare providers should encourage patients to consult a doctor before using this medication if they have a warning regarding stomach bleeding. Additionally, patients with a history of problems or serious side effects from pain relievers or fever reducers should also seek medical advice prior to use.

Patients with a history of stomach issues, such as heartburn, should be advised to discuss their condition with a healthcare provider before starting the medication. Those with high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or a history of stroke should also consult a doctor before use.

It is important for patients taking a diuretic to ask their doctor before using this medication. Furthermore, patients under a doctor's care for any serious condition should consult with their healthcare provider or pharmacist prior to use.

Patients should be informed that if they are taking aspirin for the prevention of heart attack or stroke, they should discuss this with their doctor or pharmacist, as ibuprofen may reduce the effectiveness of aspirin. Lastly, patients are encouraged to consult a healthcare professional before using this medication if they are taking any other drugs.

Storage and Handling

The product is supplied in various package configurations, with specific NDC numbers available for identification. It should be stored at a controlled room temperature of 20-25°C (68-77°F). Care must be taken to avoid exposure to excessive heat, specifically temperatures exceeding 40°C (104°F), to maintain product integrity. Proper container requirements should be adhered to, ensuring that the product is kept in suitable conditions to prevent degradation. Special handling needs should be observed to ensure the product remains within the recommended temperature range throughout its storage and handling processes.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

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

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