Proprinal

Description

Proprinal is a prescription medication available in tablet form. Each tablet contains 500 mg of the active ingredient, Propranolol. The inactive ingredients include lactose monohydrate, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate. The tablets are characterized as white to off-white, round, and biconvex in shape, with the imprint "PROPRINAL 500 mg" on one side. The SPL code for Proprinal is 34089-3.

Uses and Indications

This drug is indicated for the temporary relief of minor aches and pains associated with various conditions, including headache, muscular aches, backache, minor arthritis pain, the common cold, toothache, 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

Adults and children 12 years of age and over 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 no more than 6 tablets are taken within a 24-hour period unless specifically directed by a healthcare professional.

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

Contraindications

Use is contraindicated in patients with a history of allergic reactions to any 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 such reactions may include hives, rash, shock, facial swelling, asthma (wheezing), skin reddening, and blisters. Healthcare professionals should remain vigilant for these signs and ensure appropriate management is in place.

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

Healthcare providers should advise patients to consult a physician prior to use if any of the following conditions apply: a history of stomach bleeding, previous stomach problems such as heartburn, concurrent use of diuretics, or existing medical conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease.

In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center should be contacted at 1-800-222-1222.

Patients should be instructed to discontinue use and contact their healthcare provider if they experience any of the following: signs of an allergic reaction, worsening fever lasting more than three days, worsening pain lasting more than ten days, redness or swelling in the affected area, the emergence of new symptoms, or any indications of stomach bleeding, such as feeling faint, vomiting blood, passing bloody or black stools, or persistent stomach pain.

Side Effects

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

Additionally, there is a significant risk of severe stomach bleeding, especially in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, or who take the medication for an extended period or at higher than recommended doses. The risk is further elevated in patients who are concurrently using blood thinning (anticoagulant) or steroid medications, consume three or more alcoholic beverages daily, or take other non-steroidal anti-inflammatory drugs (NSAIDs) such as aspirin, ibuprofen, or naproxen.

Patients are advised to discontinue use and seek medical attention if they experience any signs of an allergic reaction, if fever worsens or persists beyond three days, if pain intensifies or lasts longer than ten days, if there is redness or swelling in the affected area, or if new symptoms arise. Furthermore, any indications of stomach bleeding, such as feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain, warrant immediate medical consultation.

Before using this product, patients should consult a healthcare provider if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. It is also recommended that patients inform their doctor if they are taking diuretics, have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Patients should also seek advice from a healthcare professional if they are under medical care for any serious condition, are taking any other NSAID-containing medications, or are using blood thinning (anticoagulant) or steroid drugs. It is important to note that the use of ibuprofen may diminish the cardioprotective effects of aspirin when taken for heart attack or stroke prevention.

Drug Interactions

Ibuprofen may interact with several classes of medications, leading to significant clinical effects that warrant careful consideration.

Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) and Aspirin Ibuprofen has the potential to diminish the cardioprotective effects of aspirin when both medications are taken concurrently for the prevention of heart attack or stroke. It is advisable for patients to consult with a healthcare professional regarding the use of ibuprofen in conjunction with aspirin.

Anticoagulants and Corticosteroids The concomitant use of ibuprofen with anticoagulants or steroid medications may elevate the risk of gastrointestinal bleeding. Patients should be monitored closely for signs of bleeding and may require dosage adjustments or alternative therapies based on their individual risk factors.

Diuretics Patients taking diuretics should seek medical advice before using ibuprofen, as there may be an increased risk of renal impairment. Monitoring of renal function is recommended in these cases.

Other NSAIDs Patients are advised to consult a healthcare provider if they are using any other medications that contain NSAIDs, as the combined use may increase the risk of adverse effects.

Packaging & NDC

Below are the non-prescription pack sizes of Proprinal (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 tablet every 4 to 6 hours as needed for symptom relief. If pain or fever does not adequately respond to 1 tablet, 2 tablets may be administered. It is important not to exceed 6 tablets in 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. It is essential for healthcare providers to exercise caution when prescribing this medication to geriatric patients, especially if they have a history of gastrointestinal issues, such as heartburn, or if they have comorbid conditions including high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Before initiating treatment, healthcare providers should inquire about the presence of any of these risk factors in elderly patients. Close monitoring for signs of gastrointestinal bleeding is recommended in this population to ensure patient safety and to mitigate potential adverse effects.

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 while breastfeeding. It is particularly important to avoid the use of ibuprofen during the last three months of pregnancy unless specifically directed by a healthcare provider, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data provided 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 in lactating mothers.

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 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 strategies 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 definitely directed to do so by a doctor, as it may cause problems in the unborn child or complications 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 revealed reports of serious adverse reactions associated with the use of ibuprofen. These include cardiovascular events such as heart attack and stroke. Additionally, gastrointestinal complications such as bleeding, ulceration, and perforation have been documented. Severe allergic reactions, including anaphylaxis and angioedema, have also been reported. Hepatic reactions, such as liver failure and hepatitis, as well as renal reactions, including acute renal failure, have been noted. Furthermore, skin reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis, have been observed in postmarketing surveillance.

Patient Counseling

Healthcare providers should advise patients to keep this medication out of reach of children. In the event of an overdose, patients should seek medical help or contact a Poison Control Center immediately at 1-800-222-1222.

Patients should be informed not to use this medication if they have ever experienced an allergic reaction to any other pain reliever or fever reducer. Additionally, it is important to instruct patients not to use the medication right before or after heart surgery.

Patients should be counseled to stop using the medication and consult a doctor if they experience any allergic reactions, if their fever worsens or lasts more than three days, if their pain worsens or lasts more than ten days, or if there is redness or swelling in the painful area. They should also be advised to seek medical attention if new symptoms occur.

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. If any of these symptoms occur, they should stop using the medication and contact a doctor immediately.

When using this product, patients should take it with food or milk if they experience stomach upset. It is also important to inform patients that long-term continuous use may increase the risk of heart attack or stroke.

Patients should be encouraged to ask a doctor before use if the stomach bleeding warning applies to them, especially if they have a history of stomach problems such as heartburn. They should also consult a doctor before use if they are taking a diuretic, have high blood pressure, heart disease, liver cirrhosis, or kidney disease.

Furthermore, patients should be advised to consult a doctor or pharmacist if they are under a doctor's care for any serious condition, if they are taking any other drug containing a nonsteroidal anti-inflammatory drug (NSAID), or if they are taking a blood-thinning (anticoagulant) or steroid drug. Lastly, patients should be informed to ask a doctor or pharmacist if they are taking aspirin for heart attack or stroke, as ibuprofen may decrease the benefit of aspirin.

Storage and Handling

The product is supplied in packaging that ensures its integrity and safety. 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 efficacy. Additionally, the product must be kept out of reach of children. Once opened, the product should be discarded to ensure safety and effectiveness.

Additional Clinical Information

The medication is administered orally. Clinicians should advise patients who are pregnant or breastfeeding to consult a healthcare professional prior to use. It is particularly crucial 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 instructed to keep the medication out of reach of children. In the event of an overdose, immediate medical assistance should be sought, or the Poison Control Center can be contacted at 1-800-222-1222.

Drug Information (PDF)

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

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