An indication is a term used for the list of condition or symptom or illness for which the medicine is prescribed or used by the patient. For example, acetaminophen or paracetamol is used for fever by the patient, or the doctor prescribes it for a headache or body pains. Now fever, headache and body pains are the indications of paracetamol. A patient should be aware of the indications of medications used for common conditions because they can be taken over the counter in the pharmacy meaning without prescription by the Physician.
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For the short term treatment of acute pain and post-operative pain i.e., oral surgery, abdominal hysterectomy, myomectomy, total knee replacement, total hip arthroplasty, laparoscopic cholecystectomy, inguinal hernia repair and other general surgery like diagnostic laparoscopy, gastrectomy, hernioplasty, appendectomy, hemithyroidectomy and splenectomy.
It may be used pre-operatively to prevent or reduce post-operative pain; and it can reduce opioid requirements when they are used concomitantly.
The decision to prescribe a selective COX-2 inhibitor should be based on an assessment of the individual patients overall risks.
Dynastat 40mg is only indicated for patients with a need for parenteral therapy and for whom a similar benefit could not be obtained from alternative oral therapy. It is recommended that patients be transitioned to alternative oral therapy as soon as clinically indicated.
Uses of Dynastat 40mg in details
There are specific as well as general uses of a drug or medicine. A medicine can be used to prevent a disease, treat a disease over a period or cure a disease. It can also be used to treat the particular symptom of the disease. The drug use depends on the form the patient takes it. It may be more useful in injection form or sometimes in tablet form. The drug can be used for a single troubling symptom or a life-threatening condition. While some medications can be stopped after few days, some drugs need to be continued for prolonged period to get the benefit from it.
Dynastat 40mg is used in adults for short term treatment of pain after surgery.
Dynastat 40mg description
Dynastat 40mg sodium (Dynastat 40mg) 40 mg vial: Each vial contains: See table.
For reconstitution with 2 mL of solvent. After reconstitution, the final concentration of Dynastat 40mg is 20 mg/mL.
Dynastat 40mg sodium (hereafter referred to as Dynastat 40mg) is the prodrug for the pharmacologically active moiety, valdecoxib. Following injection, Dynastat 40mg is rapidly and completely hydrolyzed enzymatically to valdecoxib.
Dynastat 40mg sodium (Dynastat 40mg) is chemically designated: N-[[4-(5-methyl-3-phenyl-4 isoxazoyl)phenyl]sulfonyl] propanamide, sodium salt. It has the chemical formula of C19H17N2O4SNa and its molecular weight is 392.41.
Dynastat 40mg sodium (Dynastat 40mg) is a white to off-white solid that is very soluble in water. The formulated drug product is soluble in normal (0.9%) saline at >50 mg/mL.
Dynastat 40mg dosage
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Dynastat 40mg may be administered as single or multiple I.V. or I.M. doses on a regular or as needed schedule. After initiation of therapy, dosage should be adjusted based on patient response. Clinical studies with Dynastat 40mg were conducted using up to 7 days of treatment.
Dynastat 40mg is only indicated for patients with a need for parenteral therapy and for whom a similar benefit could not be obtained from alternative oral therapy. It is recommended that patients be transitioned to alternative oral therapy as soon as clinically indicated.
As the cardiovascular risk of cyclooxygenase-2 (COX-2) specific inhibitors may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used. However, the relevance of these findings for the short-term use of Dynastat 40mg in the post-operative setting has not been evaluated.
Management of Acute Pain: The recommended single or initial dose for treatment of acute pain is 40 mg, administered either I.V. or I.M., followed by 20 or 40 mg every 6 to 12 hours, as required, up to a maximum daily dosage of 80 mg. The IV bolus injection may be given directly into a vein or into an existing I.V. line. The IM injection should be given slowly and deeply into the muscle.
Prevention or Reduction of Post-operative Pain: The recommended dose is 40 mg administered I.V. or IM (but preferably I.V.) 30-45 minutes prior to surgical incision. Continued medication with Dynastat 40mg post-operatively may be needed for adequate analgesic effect.
Concomitant Use with Opioid Analgesics: Opioid analgesics can be used concurrently with Dynastat 40mg, dosing as described above. In clinical trials, the daily requirement for opioids was significantly reduced (20%-40%) when co-administered with Dynastat 40mg. An optimal effect is achieved when Dynastat 40mg is given prior to opioid administration. In all clinical assessments Dynastat 40mg was administered at a fixed time interval whereas the opioids were administered on as needed basis (PRN).
Elderly: No dosage adjustment is generally necessary. However, for elderly patients weighing less than 50 kg, it is advisable to reduce the initial dose of Dynastat 40mg by 50%. The maximum daily dose should be reduced to 40 mg in elderly patients weighing less than 50 kg.
Children: Safety and efficacy have not been established in children under 18 years of age.
Hepatic Impairment: No dosage adjustment is necessary in patients with mild hepatic impairment (Child-Pugh Class A). Treatment with Dynastat 40mg should be initiated at the lowest recommended dose in patients with moderate hepatic impairment (Child-Pugh Class B).
Patients with severe hepatic impairment (Child-Pugh Class C) have not been studied. The use of Dynastat 40mg in these patients is not recommended.
Renal Impairment: In patients with severe renal impairment (creatinine clearance <30 mL/min), or patients who may be predisposed to fluid retention, Dynastat 40mg should be initiated at the lowest recommended dose and the patient's kidney function closely monitored.
Co-administration with Fluconazole: When Dynastat 40mg is co-administered with fluconazole, the lowest recommended dose of Dynastat 40mg should be used.
Dynastat 40mg interactions
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General: The drug interaction studies were performed with either Dynastat 40mg or the active moiety (valdecoxib).
In humans, Dynastat 40mg undergoes extensive hepatic metabolism involving P450 isoenzymes 3A4 and 2C9, and non-P450 dependent pathways (i.e., glucuronidation). Concomitant administration of Dynastat 40mg with known CYP 3A4 and 2C9 inhibitors can result in increased AUC of Dynastat 40mg.
Drug-Specific: Interaction of Dynastat 40mg with warfarin or similar agents: See Precautions.
Fluconazole and Ketoconazole: Co-administration of fluconazole, a CYP2C9 inhibitor, and ketoconazole, a CYP3A4 inhibitor, enhanced the AUC of valdecoxib by 62% and 38%, respectively. When Dynastat 40mg is co-administered with fluconazole, the lowest recommended dose of Dynastat 40mg should be used. No dosage adjustment is necessary when Dynastat 40mg is co-administered with ketoconazole.
Antihypertensives Including ACE Inhibitors, Angiotensin II Antagonists, Beta-Blockers and Diuretics: Inhibition of prostaglandins may diminish the effect of angiotensin converting enzyme (ACE) inhibitors, angiotensin II antagonists, beta-blockers and diuretics. This interaction should be given consideration in patients receiving Dynastat 40mg concomitantly with ACE-inhibitors, angiotensin II antagonists, beta-blockers and diuretics. In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with ACE inhibitors and/or angiotensin II antagonists, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible.
Therefore, the concomitant administration of these drugs should be done with caution. Patients should be adequately hydrated and the need to monitor the renal function should be assessed at the beginning of the concomitant treatment and periodically thereafter.
Diuretics: Clinical studies have shown that NSAIDs, in some patients, can reduce the natriuretic effect of furosemide and thiazides by inhibition of renal prostaglandin synthesis.
Cyclosporine: Because of their effect on renal prostaglandins, NSAIDs may increase the risk of nephrotoxicity with cyclosporine.
Methotrexate: A pharmacokinetic interaction study was conducted using valdecoxib and methotrexate and no clinically important interactions were seen. However caution is advised when methotrexate is administered concurrently with NSAIDs, because NSAID administration may result in increased plasma levels of methotrexate.
Lithium: Valdecoxib produced significant decreases in lithium serum clearance (25%) and renal clearance (30%) resulting in a 34% higher serum AUC compared to lithium alone. Lithium serum concentrations should be monitored closely when initiating or changing Dynastat 40mg therapy in patients receiving lithium.
Other: Interaction studies were conducted between Dynastat 40mg and I.V. or oral midazolam, heparin, propofol, fentanyl and alfentanil. Interaction studies were also conducted between valdecoxib and glibenclamide (glyburide), oral contraceptives (ethinyl estradiol/norethindrone), phenytoin, omeprazole and diazepam. No clinically important interactions were seen in these studies.
Dynastat 40mg may be co-administered with opioid analgesics. In clinical trials, the daily requirement for PRN opioids was significantly reduced when co-administered with Dynastat 40mg.
No formal interaction studies were performed with Dynastat 40mg and inhalation anesthetic agents such as nitrous oxide and isoflurane; however, no evidence of a drug interaction was observed in clinical studies.
Dynastat 40mg does not interfere with the antiplatelet effect of low-dose aspirin. Because of its lack of platelet effects, Dynastat 40mg is not a replacement for aspirin in the prophylactic treatment of cardiovascular disease.
Dynastat 40mg side effects
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Clinical Trials: The following adverse reactions were reported in patients who received Dynastat 40mg (N=5,402) in 28 placebo-controlled clinical trials.
Following coronary artery bypass graft surgery, patients administered Dynastat 40mg have a higher risk of adverse events such as cardiovascular thromboembolic events (e.g., myocardial infarction and cerebrovascular accident), deep surgical infections or sternal wound healing complications.
Post-Marketing Surveillance: In post-marketing experience, the following rare, serious adverse events have been reported in association with the use of Dynastat 40mg: Circulatory collapse, erythema multiforme, Stevens-Johnson syndrome, renal failure, and hypersensitivity reactions including anaphylaxis and angioedema.
In post-marketing experience, in addition to the severe cutaneous adverse reaction erythema multiforme and Stevens-Johnson's syndrome, toxic epidermal necrolysis has been reported in association with the use of valdecoxib and cannot be ruled out for Dynastat 40mg.
Dynastat 40mg contraindications
Hypersensitivity to Dynastat 40mg or to any of the excipients of Dynastat 40mg.
History of previous serious allergic drug reaction of any type, especially cutaneous reactions eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, erythema multiforme or patients with known hypersensitivity to sulphonamides.
Active peptic ulceration or GI bleeding.
Patients who have experienced bronchospasm, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic-type reactions after taking acetylsalicylic acid or NSAIDs including COX-2 inhibitors.
Severe hepatic dysfunction (serum albumin <25 g/L or Child-Pugh score ≥10).
Inflammatory bowel disease.
Congestive heart failure (NYHA II-IV).
Treatment of postoperative pain following CABG surgery.
Established ischaemic heart disease, peripheral arterial disease and/or cerebrovascular disease.
Use in pregnancy: Dynastat 40mg sodium is suspected to cause serious birth defects when administered during the last trimester of pregnancy because as with other medicinal products known to inhibit prostaglandin synthesis, it may cause premature closure of the ductus arteriosus or uterine inertia.
Dynastat 40mg is contraindicated in the last trimester of pregnancy.
Like other medicinal products that inhibit COX-2, Dynastat 40mg is not recommended in women attempting to conceive.
There are no adequate data from the use of Dynastat 40mg sodium in pregnant women or during labour. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. Dynastat 40mg should not be used during the first 2 trimesters of pregnancy unless clearly necessary (ie, the potential benefit to the patient outweighs the potential risk to the foetus).
Use in lactation: Dynastat 40mg, valdecoxib (its active metabolite) and a valdecoxib active metabolite are excreted in the milk of rats. It is not known whether valdecoxib is excreted in human milk. Dynastat 40mg should not be administered to women who breastfeed.
The results of a survey conducted on ndrugs.com for Dynastat 40mg are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Dynastat 40mg. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.
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