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Overview

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This medicine contains an important and useful components, as it consists of
Aluminium hydroxide gel, Magnesium hydroxide, Dimethiconeis available in the market in concentration

Name

Celecoxib

Precaution

- **Special Populations**: Celecoxib is classified as a pregnancy category C drug, meaning it may pose risks during pregnancy, particularly during the third trimester, due to its effects on fetal cardiovascular development. It should be avoided during pregnancy unless clearly needed and prescribed by a healthcare provider. Celecoxib is excreted in breast milk, so its use during breastfeeding should be approached with caution, as it could potentially affect the infant. Care should also be taken in elderly patients or those with cardiovascular disease, as Celecoxib can increase the risk of heart attack, stroke, and blood clot formation. - **Monitoring Parameters**: Patients using Celecoxib should undergo regular monitoring of liver and kidney function, particularly if they have a history of liver disease or renal impairment. Blood pressure should be checked regularly, especially in patients with a history of hypertension. Additionally, if the patient has a history of gastrointestinal issues (e.g., ulcers, bleeding), close monitoring is recommended as Celecoxib can increase the risk of gastrointestinal adverse effects. - **Misuse or Dependency**: Celecoxib has no known risk of misuse or dependency. However, chronic overuse or misuse, especially in high doses, can increase the risk of serious adverse cardiovascular events and gastrointestinal complications, which could be life-threatening. It should be used only at the prescribed dose and for the shortest duration necessary to manage the condition.

Indication

- **Primary Indications**: Celecoxib is a nonsteroidal anti-inflammatory drug (NSAID) primarily used for the relief of pain and inflammation associated with conditions such as: - **Osteoarthritis**: Celecoxib reduces joint pain, stiffness, and swelling in patients with osteoarthritis. - **Rheumatoid Arthritis**: It helps control pain and inflammation in patients with rheumatoid arthritis. - **Ankylosing Spondylitis**: Celecoxib is used to treat inflammation and pain in the spine and other joints. - **Acute Pain and Dysmenorrhea**: It is effective in providing relief from short-term pain, including pain from menstruation. - **Familial Adenomatous Polyposis**: Celecoxib is approved for the prevention of colorectal polyps in patients with this hereditary condition, as it reduces polyp formation. - **Off-Label Uses**: Celecoxib may be used off-label for conditions such as juvenile arthritis, gout, and the management of pain after surgery. It is sometimes used to help manage other chronic inflammatory conditions, though these uses are less commonly prescribed. - **Evidence-Based Context**: Celecoxib is favored over traditional NSAIDs in certain populations due to its more selective inhibition of COX-2 (cyclooxygenase-2), which is primarily involved in inflammation, while sparing COX-1, which is involved in protecting the stomach lining. This selectivity helps reduce the gastrointestinal side effects seen with non-selective NSAIDs.

Contra indication

- **Exclusion Criteria**: Celecoxib is contraindicated in patients with: - **Known hypersensitivity** to Celecoxib or any component of the formulation. - **History of allergic reactions** (such as urticaria, asthma, or anaphylaxis) to sulfonamides, as Celecoxib is a sulfonamide derivative. - **Active gastrointestinal bleeding or ulcers**, as it can increase the risk of bleeding or perforation. - **Severe hepatic impairment** or active liver disease, as the drug is metabolized by the liver, and dysfunction could lead to toxicity. - **Severe renal impairment** (e.g., in patients with end-stage renal disease) without dialysis, as Celecoxib may further impair renal function. - **Pregnancy** (especially third trimester) due to the risk of fetal harm and premature closure of the ductus arteriosus. - **Rationale**: The contraindications are primarily focused on the risks of serious cardiovascular, gastrointestinal, hepatic, and renal adverse effects that are heightened in certain patient populations, such as those with existing organ impairments or known allergies to sulfonamides.

Side Effect

- **Common Side Effects**: - **Gastrointestinal**: Abdominal pain, dyspepsia (indigestion), nausea, and diarrhea are common. These effects are less severe compared to non-selective NSAIDs due to Celecoxib's COX-2 selectivity. - **Headache and Dizziness**: Mild headaches or dizziness can occur, particularly when starting the medication or adjusting the dose. - **Peripheral Edema**: Swelling in the extremities may occur, especially in patients with cardiovascular or renal conditions. - **Serious Side Effects**: - **Cardiovascular Risks**: Celecoxib may increase the risk of heart attack, stroke, or blood clots, especially with long-term use or in high-risk patients (e.g., those with preexisting cardiovascular disease). - **Gastrointestinal Ulcers and Bleeding**: Although Celecoxib is less likely to cause ulcers than non-selective NSAIDs, it can still lead to serious gastrointestinal bleeding or perforation. - **Renal Impairment**: Celecoxib can impair kidney function, particularly in patients with preexisting renal conditions. Acute kidney injury is a rare but serious risk. - **Hepatotoxicity**: Liver enzyme elevations or liver damage may occur, although this is rare. - **Mitigation and Monitoring**: If any signs of gastrointestinal bleeding (e.g., black tarry stools, vomit resembling coffee grounds) or signs of a cardiovascular event (e.g., chest pain, shortness of breath) occur, immediate medical attention is required. Regular monitoring of blood pressure, renal function, and liver enzymes is recommended for patients on long-term therapy.

Pregnancy Category ID

3

Mode of Action

- **Mechanism**: Celecoxib is a selective cyclooxygenase-2 (COX-2) inhibitor. COX-2 is an enzyme that plays a crucial role in the inflammatory response by converting arachidonic acid into prostaglandins, which mediate pain, fever, and inflammation. By selectively inhibiting COX-2, Celecoxib reduces the production of prostaglandins in the inflamed tissues, leading to decreased pain, swelling, and inflammation without significantly affecting COX-1, which is responsible for maintaining the integrity of the stomach lining and kidney function. - **Pharmacodynamics and Pharmacokinetics**: After oral administration, Celecoxib is well-absorbed, with peak plasma concentrations occurring within 3 hours. It has a half-life of around 11 hours, which allows for once- or twice-daily dosing. Celecoxib is extensively metabolized in the liver via the cytochrome P450 system (CYP2C9) and has an elimination route through both the urine and feces. - **Distinctive Action**: Unlike traditional NSAIDs, Celecoxib specifically targets COX-2, which leads to a lower risk of gastrointestinal side effects such as ulcers and bleeding. This selectivity makes it a preferred option for long-term management of inflammatory conditions, particularly in patients at high risk for gastrointestinal complications.

Interaction

- **Drug-Drug Interactions**: - **Anticoagulants**: Celecoxib may enhance the effects of anticoagulants like warfarin, increasing the risk of bleeding. Co-administration requires careful monitoring of INR (International Normalized Ratio) and regular assessments of bleeding risk. - **ACE Inhibitors and Diuretics**: Celecoxib can reduce the effectiveness of ACE inhibitors and diuretics, potentially leading to fluid retention or increased blood pressure. - **Lithium**: Celecoxib can increase the levels of lithium in the blood, leading to a risk of lithium toxicity. Close monitoring of lithium levels is required if both drugs are used together. - **Other NSAIDs or Corticosteroids**: Using Celecoxib with other NSAIDs or corticosteroids increases the risk of gastrointestinal adverse effects, including ulcers and bleeding. - **Cytochrome P450 Inhibitors**: Drugs that inhibit the cytochrome P450 enzyme system, such as fluconazole, can increase Celecoxib levels and heighten the risk of side effects. - **Food and Alcohol Interactions**: Celecoxib can be taken with or without food, although taking it with food can help reduce gastrointestinal discomfort. Alcohol consumption should be minimized as it may increase the risk of gastrointestinal bleeding when combined with Celecoxib. - **Clinical Recommendations**: Careful monitoring of patients on anticoagulants, diuretics, or lithium is necessary when Celecoxib is used. Avoid combining Celecoxib with other NSAIDs to reduce gastrointestinal risks. Patients should be informed about potential risks related to gastrointestinal bleeding, especially when consuming alcohol.

Pregnancy Category Note

Pregnancy category: C; D at >30 weeks' gestation (may cause premature closure of ductus arteriosus)

Adult Dose

- **Standard Dosage**: - **For Osteoarthritis and Rheumatoid Arthritis**: The typical dose is 200 mg daily, either as a single dose or divided into two doses (100 mg twice daily). - **For Acute Pain or Dysmenorrhea**: The recommended dose is 400 mg initially, followed by 200 mg after 12 hours if needed. Maintenance doses of 200 mg daily may be used thereafter. - **For Ankylosing Spondylitis**: The usual dose is 200 mg daily, with possible dose adjustments depending on patient response. - **For Familial Adenomatous Polyposis**: 400 mg twice daily is used to prevent the development of colorectal polyps. - **Maximum Dosage**: The maximum dose for most conditions is 400 mg per day, but higher doses may be prescribed under medical supervision for specific conditions, such as familial adenomatous polyposis.

Child Dose

- **Pediatric Dosing**: Celecoxib is not generally recommended for use in children under 2 years of age. For children aged 2 years and older, the dosing is typically based on weight: - **For Juvenile Rheumatoid Arthritis**: The dose ranges from 2–4 mg/kg/day, depending on the child’s weight, divided into two doses. The maximum recommended dose is 200 mg per day. - **For other conditions**: Dosing should be tailored to the individual, and the lowest effective dose should be used. - **Pediatric Monitoring**: Due to the risk of cardiovascular and gastrointestinal effects, children on Celecoxib should be monitored for any adverse reactions.

Renal Dose

- **Renal Impairment**: In patients with mild to moderate renal impairment, no dose adjustment is necessary for Celecoxib. However, for severe renal impairment (creatinine clearance less than 30 mL/min), the dose should be reduced, and renal function should be monitored closely during treatment. Celecoxib should be avoided in patients with end-stage renal disease. - **Monitoring Recommendations**: Renal function should be checked periodically, especially in patients with preexisting kidney disease, as Celecoxib can worsen renal function in such individuals.

Administration

Information not available