Active Substance: Polyvidone.
Overview
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This medicine contains an important and useful components, as it consists of
Polyvidoneis available in the market in concentration
Naproxen
Before using **Naproxen**, it is essential for patients to consult a healthcare provider, especially if they have any of the following conditions: - **Cardiovascular disease**: Naproxen, like other **nonsteroidal anti-inflammatory drugs (NSAIDs)**, may increase the risk of **heart attack**, **stroke**, and **high blood pressure**, especially when used long-term. Patients with existing **heart disease**, **hypertension**, or those at higher risk for cardiovascular issues should use Naproxen with caution, and regular monitoring of blood pressure may be necessary. - **Gastrointestinal issues**: Naproxen can cause **gastric irritation**, **ulcers**, or even **gastric bleeding**. Individuals with a history of **gastric ulcers**, **irritable bowel disease (IBD)**, or **gastritis** should use Naproxen cautiously. It is advised to take the medication with food to reduce gastrointestinal irritation. - **Kidney or liver disease**: People with **renal** or **hepatic impairment** may need dosage adjustments, as Naproxen can worsen kidney function and lead to fluid retention. Kidney function should be monitored during treatment, especially for prolonged use. - **Pregnancy and breastfeeding**: Naproxen is not recommended during **pregnancy**, particularly in the **third trimester**, due to the risk of premature closure of the **ductus arteriosus** (a blood vessel in the fetal heart). It is also excreted in breast milk, and its use while breastfeeding should be avoided unless necessary and prescribed by a healthcare provider. - **Asthma**: Some patients with **asthma** may experience **bronchospasm** when using NSAIDs like Naproxen. If there is a history of **aspirin-induced asthma**, Naproxen should generally be avoided.
Naproxen is used to treat a variety of conditions related to pain and inflammation: - **Pain relief**: It is commonly prescribed for the management of **mild to moderate pain**, including headaches, **dental pain**, **muscle pain**, and **menstrual cramps**. - **Arthritis**: Naproxen is highly effective for the management of **rheumatoid arthritis**, **osteoarthritis**, and **ankylosing spondylitis**, as it reduces inflammation, stiffness, and pain in the joints. - **Inflammatory conditions**: It is also used for conditions such as **bursitis**, **tendonitis**, and **gout**, where inflammation plays a key role in symptoms. - **Fever reduction**: Naproxen can also be used to **reduce fever**, often in combination with other treatments for illnesses such as **cold** or **flu**.
Naproxen should not be used in the following cases: - **Hypersensitivity**: People with a known **allergy** to Naproxen, other NSAIDs (like **ibuprofen** or **aspirin**), or any of its ingredients should avoid using this drug. Allergic reactions can include **skin rash**, **swelling**, and **difficulty breathing**. - **Active gastrointestinal bleeding or ulcers**: Naproxen should be avoided in patients with active **peptic ulcers**, **gastrointestinal bleeding**, or other serious **gastrointestinal disorders**. - **Severe liver or kidney disease**: Naproxen can worsen **renal function** and **liver impairment**, so it is contraindicated in patients with severe kidney disease (such as **end-stage renal disease**) or **active liver disease**. - **Pregnancy**: Naproxen should be avoided during **pregnancy**, particularly in the third trimester, due to its potential to cause complications such as **premature closure of the ductus arteriosus**, which can harm the fetus.
Common side effects of Naproxen include: - **Gastrointestinal issues**: **Stomach pain**, **nausea**, **heartburn**, or **indigestion**. More serious gastrointestinal side effects can include **ulcers**, **bleeding**, and **perforation**. - **Headaches**: Some people may experience **headaches**, particularly when first using Naproxen. - **Dizziness**: **Dizziness** or **drowsiness** is a common side effect, making it important for individuals to avoid operating heavy machinery or driving if they feel drowsy. - **Rash**: Mild skin rash or itching can occur, and this should be monitored to ensure it doesn't progress to more severe reactions. Serious side effects include: - **Cardiovascular issues**: Long-term use of Naproxen may increase the risk of heart-related issues such as **heart attack**, **stroke**, and **high blood pressure**. - **Gastrointestinal bleeding**: Severe **stomach ulcers**, **bleeding**, or **perforation** can occur, especially with prolonged use. Symptoms may include **bloody stools**, **vomiting blood**, or **severe abdominal pain**. - **Kidney damage**: Prolonged use of Naproxen can lead to **acute kidney injury**, particularly in patients with pre-existing kidney problems. - **Liver damage**: Rarely, Naproxen can cause **liver toxicity**, presenting as **yellowing of the skin** or **eyes** (jaundice), **dark urine**, or severe **abdominal pain**.
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Naproxen is a **nonsteroidal anti-inflammatory drug (NSAID)** that works by inhibiting the **cyclooxygenase (COX) enzymes**, specifically COX-1 and COX-2. These enzymes are involved in the production of **prostaglandins**, which are chemical messengers responsible for causing **inflammation**, **pain**, and **fever**. - **COX-1** is involved in the production of prostaglandins that protect the stomach lining and support kidney function, while **COX-2** is primarily involved in the production of prostaglandins that mediate pain and inflammation. By inhibiting both enzymes, Naproxen reduces inflammation, pain, and fever. However, the inhibition of COX-1 can also lead to gastrointestinal side effects like **ulcers** and **bleeding**.
Naproxen can interact with several medications, increasing the risk of side effects or affecting their effectiveness: - **Anticoagulants**: Naproxen can enhance the effects of blood thinners like **warfarin**, increasing the risk of **bleeding**. Patients taking anticoagulants should have their **INR** (International Normalized Ratio) closely monitored during treatment with Naproxen. - **Antihypertensive drugs**: Naproxen may interfere with the effectiveness of **ACE inhibitors**, **angiotensin II receptor blockers (ARBs)**, and **diuretics**, leading to **elevated blood pressure** or reduced kidney function. Blood pressure and renal function should be monitored. - **Lithium**: Naproxen can increase blood levels of **lithium**, potentially leading to **lithium toxicity**. The combination should be avoided, or lithium levels should be closely monitored. - **Methotrexate**: Co-administration of Naproxen and **methotrexate** (used for **cancer** or autoimmune diseases) can increase the toxicity of methotrexate, particularly affecting the **kidneys**. - **Other NSAIDs or aspirin**: Concurrent use with other NSAIDs or **aspirin** may increase the risk of gastrointestinal side effects, including **ulcers** and **bleeding**. - **Corticosteroids**: Combining Naproxen with **oral corticosteroids** increases the risk of gastrointestinal **ulceration** and **bleeding**.
Pregnancy category: C; D in 3rd trimester or near delivery.
The typical **adult dose** of **Naproxen** for various conditions is: - **Pain and inflammation** (e.g., arthritis, musculoskeletal pain): **250–500 mg twice daily**. - **Acute pain** (e.g., menstrual cramps, dental pain): **500 mg initially**, followed by **250 mg every 6-8 hours** as needed. Maximum daily dose should not exceed **1,250 mg** for the first day, and **1,000 mg** for subsequent days. - **Gout flare-ups**: Initial dose of **750 mg**, followed by **250 mg every 8 hours** for the next 48 hours. Patients should not exceed the recommended daily dose and should always follow the healthcare provider's instructions regarding duration of use.
For children aged **2 years and older**, the typical dose is based on weight. The recommended dosage for **pain or fever** is typically **5–10 mg/kg** every 12 hours, not exceeding **20 mg/kg per day**. Always consult a healthcare provider for the specific dosage based on the child's age and medical condition. Naproxen should not be used in children younger than **2 years old** without specific medical advice. As always, it is crucial to consult a healthcare provider before starting Naproxen, to ensure proper dosage, avoid potential drug interactions, and monitor for side effects during treatment.
For patients with **renal impairment**, Naproxen should be used with caution, as it can worsen kidney function. In mild to moderate renal impairment, the usual dose may be reduced, and **renal function** should be monitored regularly. In severe renal impairment, Naproxen is generally **contraindicated**.
Information not available