Flex-Prin

Description

Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID) utilized for its analgesic and antipyretic properties. The drug is presented in a FLEX PRIN BOX, which contains the necessary packaging for storage and distribution. An image of the drug is available for reference, labeled as Ibuprofen.jpg.

Uses and Indications

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

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 1 tablet every 4 to 6 hours as needed while symptoms persist. In cases where pain or fever does not adequately respond to 1 tablet, a dosage of 2 tablets may be administered. It is imperative that the total daily dosage does not exceed 6 tablets within a 24-hour period, unless otherwise directed by a healthcare professional. The smallest effective dose should always be utilized to minimize potential risks.

For children under 12 years of age, it is recommended to consult a physician for appropriate dosing guidance.

Contraindications

There are no contraindications listed for the use of this product. It is important to evaluate each patient's individual circumstances and medical history before prescribing.

Warnings and Precautions

Ibuprofen is associated with several important warnings and precautions that healthcare professionals should consider when prescribing or recommending this medication.

Allergy Alert Ibuprofen has the potential to induce severe allergic reactions. Symptoms may include hives, shock, facial swelling, and asthma characterized by wheezing. It is imperative that patients are advised to discontinue use and seek immediate medical attention if any signs of an allergic reaction occur.

Alcohol Warning Patients who consume three or more alcoholic beverages daily should consult their healthcare provider prior to using Ibuprofen or any other pain relievers or fever reducers. The combination of alcohol and Ibuprofen may increase the risk of adverse effects, particularly gastrointestinal bleeding.

Gastrointestinal Risks Ibuprofen may cause stomach bleeding, which can occur without warning. Healthcare professionals should advise patients to be vigilant for signs of gastrointestinal distress and to report any symptoms promptly.

Contraindications Ibuprofen should not be used in individuals with a history of allergic reactions to any pain reliever or fever reducer. It is crucial to assess the patient's medical history for such contraindications before prescribing.

Pre-Use Consultation Patients should be instructed to consult a healthcare provider before using Ibuprofen if they experience stomach pain or have a history of serious side effects from pain relievers or fever reducers. Additionally, it is advisable for patients to seek guidance if they are under medical care for any serious condition, are taking other medications, or are using any products that contain Ibuprofen or other pain relievers/fever reducers.

Monitoring and Follow-Up Patients should be advised to discontinue Ibuprofen and contact their healthcare provider if any of the following occur:

• An allergic reaction

• Worsening pain that persists beyond 10 days

• Fever that worsens or lasts more than 3 days

• Increasing stomach pain or upset

• The emergence of new symptoms

• Redness or swelling in the area of pain

Regular monitoring and patient education are essential to ensure the safe use of Ibuprofen and to mitigate potential risks associated with its use.

Side Effects

Patients using ibuprofen may experience a range of adverse reactions, some of which can be serious. Notably, ibuprofen has the potential to cause severe allergic reactions, which may manifest as hives, shock, facial swelling, or asthma symptoms such as wheezing. In such cases, immediate medical attention is required.

Additionally, ibuprofen is associated with the risk of gastrointestinal complications, including stomach bleeding. Patients are advised to discontinue use and consult a healthcare professional if they experience any signs of an allergic reaction or if their pain worsens or persists beyond 10 days. Similarly, if fever intensifies or lasts more than 3 days, or if stomach pain or upset becomes more severe or prolonged, medical advice should be sought. The appearance of any new symptoms or the presence of redness or swelling in the affected area also warrants consultation with a doctor.

Furthermore, patients who consume three or more alcoholic beverages daily should discuss the use of ibuprofen or other pain relievers with their healthcare provider to ensure safety and avoid potential interactions.

Drug Interactions

Patients are advised to consult a healthcare professional prior to using this medication if they are currently taking any other drugs. This precaution is particularly important for those who are using products that contain Ibuprofen or any other pain reliever or fever reducer, as concurrent use may increase the risk of adverse effects.

Additionally, an alcohol warning is in place for individuals who consume three or more alcoholic beverages daily. Such patients should seek medical advice regarding the safety of using Ibuprofen or other pain relievers and fever reducers, as the combination may pose significant health risks. Monitoring for potential interactions and adverse effects is recommended in these cases.

Packaging & NDC

Below are the non-prescription pack sizes of Flex-Prin (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 and adults aged 12 years and older, the recommended dosage is 1 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, a maximum of 2 tablets may be administered. It is crucial not to exceed 6 tablets within a 24-hour period unless directed by a healthcare provider. The smallest effective dose should always be utilized.

Additionally, this medication must be kept out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

Geriatric Use

Elderly patients may not have specific recommendations or precautions outlined in the prescribing information. Additionally, there are no dosage adjustments specifically indicated for this population. The absence of outlined safety concerns suggests that the medication may be considered safe for use in geriatric patients; however, healthcare providers should remain vigilant in monitoring for any potential adverse effects. Furthermore, no special precautions are indicated for elderly patients, but standard clinical judgment should be applied when prescribing to this demographic.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of Ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery.

Lactation

Lactating mothers are advised to consult a health 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 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 Ibuprofen 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 these patients to ensure safety and efficacy.

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 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 implement supportive care measures, which may include maintaining airway patency, providing supplemental oxygen, and monitoring vital signs.

Additionally, it is recommended to consult local poison control centers or toxicology experts for guidance on specific management protocols and interventions tailored to the substance involved.

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

Nonclinical Toxicology

It is especially important not to use Ibuprofen during the last three months of pregnancy unless directed to do so by a doctor, as it may cause problems in the unborn child or complications during delivery. No non-teratogenic effects have been specified 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 gastrointestinal bleeding, renal impairment, and elevations in liver enzymes. Hypersensitivity reactions have been noted, including anaphylaxis, as well as various skin reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis.

Cardiovascular events, including myocardial infarction and stroke, have also been reported, alongside hypertension and asthma exacerbation. Additional serious adverse events include gastrointestinal perforation, thrombocytopenia, agranulocytosis, liver failure, acute kidney injury, interstitial nephritis, and pancreatitis.

Other reported reactions encompass dizziness, headache, tinnitus, and visual disturbances. Allergic reactions, including hives and facial swelling, have also been documented.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is crucial to emphasize the importance of safety in the home environment, particularly for households with young children.

In the event of an overdose, healthcare providers should instruct patients to seek medical help immediately or contact a Poison Control Center. Patients should be made aware of the signs of overdose and the urgency of obtaining assistance to ensure their safety and well-being.

Storage and Handling

The product is supplied in packaging that includes specific NDC numbers. It should be stored at a temperature range of 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It is essential to protect the product from light to maintain its integrity. Additionally, the product must be kept out of reach of children, and any unused portion should be discarded after opening to ensure safety and efficacy.

Additional Clinical Information

The route of administration for the medication is oral. Clinicians should counsel patients on several important considerations. Pregnant or breastfeeding patients are advised to consult a healthcare professional before use. It is particularly crucial for patients to avoid Ibuprofen during the last trimester of pregnancy unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery.

Patients should also be informed to keep the medication out of reach of children and to seek immediate medical assistance or contact a Poison Control Center in the event of an overdose. An alcohol warning is applicable; patients who consume three or more alcoholic drinks daily should consult their doctor regarding the use of Ibuprofen or other pain relievers and fever reducers. Additionally, if gastrointestinal upset occurs, it is recommended to take the medication with food or milk.

Drug Information (PDF)

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

View product document (PDF)