Medicinal Products

DYNASTAT 40 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Parecoxib
laboratory: Pfizer Limited

Powder for solution for injection
Box of 10 vials of 40 mg
All forms

Indication

Short-term treatment of postoperative pain.

The decision to prescribe a COX-2 selective inhibitor should be based on the assessment of all the risks specific to each patient (see sections Contraindications and Special Warnings and Precautions for Use ).

Dosage DYNASTAT 40 mg Powder for solution for injection Box of 10 vials of 40 mg

The recommended dose is 40 mg administered intravenously (IV) or intramuscularly (IM), followed every 6 to 12 hours by a dose of 20 mg or 40 mg as needed, without exceeding 80 mg / day. IV bolus injection can be done quickly and directly into a vein or an existing venous route. The IM injection should be done slowly and deeply into the muscle (see section Special precautions for disposal and handling for instructions for reconstitution).

Concomitant Use with Opioid Analgesics: Opioid analgesics may be used concurrently with parecoxib at the dosage indicated in the paragraph above. In all clinical evaluations, parecoxib was administered at fixed intervals, while opioids were administered on demand.

Since the cardiovascular risk associated with specific cyclooxygenase-2 (COX-2) inhibitors may increase with the dose and duration of use, the treatment should be administered for the shortest possible duration and at the same time. lowest effective daily dose.

Precipitation may occur when Dynastat is combined with other medicinal products and therefore Dynastat should not be mixed with any other drug, both during reconstitution and during injection. In patients whose same infusion tubing is used to inject another drug, the infusion tubing should be rinsed before and after the injection of Dynastat with a known compatibility solution.

Compatibility of solutions with infusion tubing :

After reconstitution with the appropriate solvents, Dynastat can only be injected IV or IM, or into infusion tubing delivering:

9 mg / ml sodium chloride solution (0.9%)

a solution for infusion of glucose at 50 g / l (5%)

4.5 mg / ml (0.45%) sodium chloride solution for injection and 50 g / l glucose (5%)

a solution for Ringer-Lactate injection.

Injection into perfusion tubing delivering 50 g / l (5%) glucose into Ringer-Lactate for Injection solution, or other IV solutions not listed above, is not recommended because of possible precipitation of the solution.

Elderly: No dosage adjustment is usually required for elderly subjects (> 65 years of age). However, in elderly patients with a body weight of less than 50 kg, initiate treatment at half the usual recommended Dynastat dose and reduce the maximum daily dose to 40 mg (see section 5.2 Pharmacokinetic properties ).

Hepatic impairment : No dose adjustment is usually required in patients with mild hepatic impairment (Child-Pugh score 5-6). Introduce Dynastat with caution and at half the usual recommended dose in patients with moderate hepatic impairment (Child-Pugh score 7-9) and reduce the maximum daily dose to 40 mg. There is no clinical experience in patients with severe hepatic impairment (Child-Pugh score ≥10), the use is contraindicated in these patients (see sections Contraindications and Pharmacokinetic Properties ).

Renal Insufficiency: Based on pharmacokinetic parameters, no dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance 30-80 ml / min). In patients with severe renal impairment (creatinine clearance <30 ml / min) or who may be at risk of fluid retention, parecoxib should be initiated at the lowest recommended dose and renal function should be closely monitored (see sections 4.4 Special warnings and precautions for use and Pharmacokinetic properties ).

Children and adolescents: There is no experience in children and adolescents. Its use is not recommended in these patients .

Against indications

Hypersensitivity to the active substance or to any of the excipients (see section List of excipients).

History of serious allergic drug reactions of any type, especially skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme, or patients with known hypersensitivity to sulfonamides (see sections 4.4 Special warnings and precautions for use and side effects ).

Progressive peptic ulcer or gastrointestinal bleeding (GI).

Patients with a history of asthma, acute rhinitis, nasal polyps, angioedema, urticaria, or other allergic-type reactions triggered by taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2).

Third trimester of pregnancy and lactation (see sections Pregnancy and lactation and Preclinical safety data).

Severe hepatic insufficiency (serum albumin <25 g / l or Child-Pugh score ≥ 10).

Inflammatory bowel disease.

Congestive heart failure (NYHA II-IV).

Treatment of postoperative pain after bypass surgery (see sections 4.8 Undesirable effects and Pharmacodynamic properties).

Known ischemic heart disease, peripheral arterial disease and / or history of stroke (including transient ischemic attack).

Dynastat side effects

Within each group frequency, adverse effects should be presented in order of decreasing severity.

Of the patients treated with Dynastat in controlled clinical trials, 1962 patients had postoperative pain.

The following adverse events occurred more frequently than placebo and were reported in 1543 patients treated with Dynastat 20 mg or 40 mg single or repeated dose (up to 80 mg / day) in 12 placebo-controlled trials after surgery. dental, gynecological, orthopedic or coronary bypass or preoperative during dental and orthopedic surgeries. The rate of discontinuation due to adverse events in these trials was 5.0% for patients receiving Dynastat and 4.3% for patients receiving placebo.

[Very common (≥ 1/10); Frequent (≥ 1/100, <1/10); Uncommon (≥ 1/1000, <1/100); Rare (≥ 1 / 10, 000, <1/1000); Very rare (<1 / 10, 000), Not known (can not be estimated from the available data)].

Infections and infestations

Uncommon: abnormal serous drainage of sternal wound, wound infection

Blood and lymphatic system disorders

Frequent: postoperative anemia

Uncommon: thrombocytopenia

Metabolism and nutrition disorders

Common: hypokalemia

Psychiatric disorders

Frequent: restlessness, insomnia

Central and Peripheral Nervous System Disorders

Frequent: hypoaesthesia,

Uncommon: cerebrovascular disorders

Heart conditions

Uncommon: bradycardia

Vascular disorders (extracardiacs)

Common: hypertension, hypotension

Uncommon: aggravated hypertension

Respiratory, thoracic and mediastinal disorders

Common: respiratory failure, pharyngitis

Gastrointestinal disorders

Common: alveolar osteitis (alveolitis), dyspepsia, flatulence

Uncommon: peptic ulceration

Skin and subcutaneous tissue disorders

Frequency: Pruritus

Uncommon: bruise

Musculoskeletal and systemic disorders

Frequent: back pain

Renal and urinary disorders

Common: oliguria

General disorders and administration site conditions

Common: peripheral edema

investigations

Frequent: elevation of creatinine

Uncommon: elevation of ASAT, elevation of ALT, elevation of blood urea

The following rare severe adverse events have been reported with NSAID use and can not be ruled out for Dynastat: bronchospasm and hepatitis.

After CABG, patients receiving Dynastat experienced an increased risk of adverse events such as cardiovascular / thromboembolic events, deep surgical infections, or complications of sternal wound healing. Cardiovascular / thromboembolic events include myocardial infarction, stroke / transient ischemic attack, pulmonary embolism and deep vein thrombosis (see sections Contraindications and Pharmacodynamic Properties ).

Following commercialization, the following reactions have been reported in association with the use of parecoxib:

Rare: acute renal failure, renal failure, myocardial infarction, congestive heart failure, abdominal pain, nausea, vomiting, dyspnea, tachycardia, and Stevens-Johnson syndrome.

Very rare: erythema multiforme, exfoliative dermatitis and hypersensitivity reactions including anaphylaxis and Quincke's edema (see section 4.4 Special warnings and precautions for use ).

Following the marketing of valdecoxib, the following reaction has been reported: toxic epidermal necrolysis (see section 4.4 ) and can not be ruled out for parecoxib.

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