Medicinal Products

DYNASTAT 20 mg

Generic drug of the therapeutic class: Anti-inflammatories
active ingredients: Parecoxib
laboratory: Pharmacia Europe Eeig

Powder for solution for injection
Box of 10 vials of 20 mg
All forms

Indication

Short-term treatment of postoperative pain.

Dosage DYNASTAT 20 mg Powder for solution for injection Box of 10 vials of 20 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 Instructions for Use, Handling and Disposal for instructions for reconstitution).
- Elderly: No dosage adjustment is usually required for elderly subjects (> = 65 years of age). However, in elderly subjects with a body weight of less than 50 kg, initiate treatment at half the usual recommended dose of Dynastat and reduce the maximum daily dose to 40 mg (see section 5.2 Pharmacokinetic properties).
- Hepatic impairment: No dosage 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 impairment: Based on pharmacokinetic parameters, no dose adjustment is required in patients with mild to moderate renal impairment (creatinine clearance 30-80 ml / min) or severe (creatinine clearance <30). ml / min). However, caution is advised in patients with renal impairment or in those who may be susceptible to fluid retention (see sections cautionary and precautions for use and pharmacokinetics).
- Children and adolescents: Dynastat has not been studied in patients under 18 years of age. Its use is not recommended in these patients.

Against indications

CONTRAINDICATED:
- History of hypersensitivity to the active substance or to any of the excipients.
- Known hypersensitivity to sulfonamides (see sections cautionary and precautions for use and adverse effects).
- Progressive peptic ulcer or gastrointestinal bleeding (GI).
Patients with a history of asthma, acute rhinitis, nasal polyps, angioneurotic edema, urticaria or other allergic-type reactions triggered by taking acetylsalicylic acid or NSAIDs including COX-2 (cyclooxygenase-2).
- Severe hepatic insufficiency (serum albumin = 10).
Inflammatory disease of the intestine.
- Severe congestive heart failure (NYHA III-IV).
- Third trimester of pregnancy and lactation:
. Pregnancy: The use of Dynastat is contraindicated during the last trimester of pregnancy because, like other drugs known to inhibit prostaglandin synthesis, it may result in premature closure of the ductus arteriosus or uterine inertia.
. Breast-feeding: Parecoxib, valdecoxib (its active metabolite) and an active metabolite of valdecoxib are excreted in female milk. The passage of valdecoxib in human breast milk is unknown. Dynastat should not be given to women who are breastfeeding.
- Treatment of postoperative pain after coronary bypass (see sections adverse effects and pharmacodynamic properties).
NOT RECOMMENDED :
- Pregnancy: Like other drugs that inhibit COX-2, Dynastat is not recommended for women who want to start a pregnancy. There is insufficient data on the use of parecoxib sodium in pregnant women or during labor. Studies in animals have shown effects on reproduction. The potiential risk to humans is unknown. Dynastat should not be used during the first two trimesters of pregnancy, or during labor, unless the potential benefit to the patient is greater than the potential risk to the fetus.
- Children and adolescents: Dynastat has not been studied in patients under 18 years of age. Its use is not recommended in these patients.

Dynastat side effects

Among patients treated with Dynastat in controlled clinical trials, 1962 patients had postoperative pain.
- The following adverse events were more frequent 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 dental, gynecological, orthopedic or coronary bypass surgery or preoperative surgery in dental and orthopedic surgery. 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, = 1/1000 = 1/10000, <1/1000); Very rare (<1/10000 including isolated cases)].
- Infections:
Uncommon : abnormal serous drainage of the sternal wound, wound infection.
- Blood and lymphatic system disorders:
. Frequent : postoperative anemia
. Uncommon : thrombocytopenia
- Metabolism and nutrition disorders:
Frequent : hypokalemia.
- Psychiatric disorders:
Frequent : agitation, insomnia.
- Central and peripheral nervous system disorders:
. Frequent : hypoesthesia
. Uncommon : cerebrovascular disorders
- Cardiac disorders:
Uncommon : bradycardia.
- Vascular disorders (extracardiacs):
. Common : Hypertension, hypotension
. Uncommon : aggravated hypertension.
- Respiratory, thoracic and mediastinal disorders:
Common : pharyngitis, respiratory failure.
- Gastrointestinal disorders:
. Frequent : alveolar osteitis (alveolitis), dyspepsia, flatulence.
. Uncommon : gastroduodenal ulceration.
- Skin and subcutaneous tissue disorders:
. Frequency : pruritus.
. Uncommon : bruise.
- Musculoskeletal and Connective Tissue Disorders:
Frequent : back pain.
- Urinary and renal system disorders:
Frequent : oliguria.
- General disorders and problems encountered at the site of administration:
Frequent : peripheral edema.
- Investigations:
. Frequent : elevation of creatinine.
. Uncommon : elevation of ASAT, elevation of ALT, elevation of blood urea.
- The following rare adverse events have been reported with NSAID use and can not be ruled out for Dynastat: bronchospasm and hepatitis.
- After coronary artery bypass, patients receiving Dynastat have 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 rare and serious adverse events have been reported in association with the use of parecoxib: acute renal failure and congestive heart failure, erythema multiforme, and hypersensitivity reactions including anaphylaxis and angioedema (see section 4.4). and precautions for use).
- Following the marketing of valdecoxib, the following reactions have been reported: myocardial infarction (very rare), exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis (see section on warnings and precautions for use) and can not be be excluded for parecoxib.

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