1FELDENE

INDICATIONS
Variety of conditions requiring anti-inflammatory and/or analgesic activity eg, rheumatoid arthritis,
juvenile rheumatoid arthritis, osteoarthritis (arthrosis and degenerative joint disease), ankylosing
spondylitis, acute musculoskeletal disorders, acute gout, pain after operative intervention and following
acute trauma.

Treatment of primary dysmenorrhea in patients ≥12 years.

Relief of fever and pain with acute upper respiratory tract inflammation.

CONTAINDICATIONS

Acute peptic ulceration.

Patients who are hypersensitive to Feldene and its components (see Description). The potential exists for
cross-sensitivity to aspirin and other nonsteroidal anti-inflammatory drugs. Patients in whom aspirin or
other nonsteroidal anti-inflammatory drugs induce the symptoms of asthma, nasal polyps, angioedema or
urticaria.

ADVERSE

Feldene is generally well tolerated. Gastrointestinal symptoms are the most commonly encountered adverse
reactions, but in most instances do not interfere with the course of therapy. These adverse reactions include:
Stomatitis, anorexia, epigastric distress, nausea, constipation, abdominal discomfort, flatulence, diarrhea,
abdominal pain and indigestion. Gastrointestinal bleeding, perforation and ulceration (see Precautions)
have been reported with Feldene. Objective evaluations of gastric mucosal appearances and intestinal blood
loss show that 20 mg/day of Feldene administered either in single or divided daily doses is significantly
less irritating to the gastrointestinal tract than acetylsalicylic acid.

Long-term administration of doses of ≥30 mg carries an increased risk of gastrointestinal side effects. Other
than the gastrointestinal symptoms, edema, mainly ankle edema, has been reported in small percentage of
patients. CNS effects eg, dizziness, headache, somnolence, insomnia, depression, nervousness,
hallucinations, mood alterations, dream abnormalities, mental confusion, paresthesias and vertigo have
been reported rarely.

Swollen eyes, blurred vision and eye irritations have been reported. Routine ophthalmoscopy and slit-lamp
examination have revealed no evidence of ocular changes. Malaise and tinnitus may occur.

Dermal hypersensitivity reactions, usually in the form of skin rash and pruritus have been reported.
Onycholysis and alopecia have rarely been reported. Photoallergic reactions have frequently been
associated with therapy. As with other nonsteriodal anti-inflammatory drugs, toxic epidermal necrolysis
(Lyell's disease), and Stevens-Johnson syndrome may develop in rare cases. Vesiculo bullous reactions
have been reported rarely. Hypersensitivity reactions eg, anaphylaxis, bronchospasm, urticaria/angioedema,
vasculitis and serum sickness have been reported rarely.

Reversible elevations of BUN and creatinine have been reported. (See Precautions).

Decrease in hemoglobin and hematocrit, unassociated with obvious gastrointestinal bleeding have occurred.
Anemia has been reported. Thrombocytopenia and non-thrombocytopenic purpura (Henoch-Schonlein),
leukopenia and eosinophilia have been reported. Rare cases of aplastic anemia and hemolytic anemia are
also reported.
Epistaxis has rarely been reported.

Changes in different liver function parameters have been observed. As with most other nonsteroidal anti-
inflammatory agents, some patients may develop increased serum transaminase level during treatment with
Feldene. Severe hepatic reactions, including jaundice and cases of fatal hepatitis have been reported with
Feldene. Although some reactions are rare, if abdominal liver function test persist or worsen, if clinical
signs and symptoms consistent with liver disease develop, or if systemic manifestation occur (eg,
eosinophilia, rash, etc), Feldene should be discontinued.

Rare cases of pancreatitis have been reported.

Palpitations and dyspnea have been reported rarely.

Anecdotal cases of positive ANA and hearing impairment have been reported rarely in patients receiving
Feldene.

Metabolic abnormalities eg, hypoglycemia, hyperglycemia, increased or decreased weight have been
reported rarely.

CLASIFCATIUON
M01AC01 - Piroxicam ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products,
oxicams.

2Parecoxib Na
Management of acute pain. It may be used preoperatively to prevent or reduce postoperative pain and can
reduce opioid requirements when they are used concomitantly.
Dosage
Parecoxib may be administered as single or multiple IV/IM doses on a regular or as-needed schedule. After
initiation of therapy, dosage should be adjusted based on patient response. Clinical studies with parecoxib
were conducted using up to 7 days of treatment.
Contraindications…..
Hypersensitivity to parecoxib or to any other ingredient of Dynastat. Patients who have
demonstrated allergic-type reactions to sulfonamides, acetylsalicylic acid (aspirin) or nonsteroidal anti-
inflammatory drugs (NSAIDS) including other cyclooxygenase-2 (COX-2) specific inhibitors; asthma and
urticaria.
Adverse effect
Clinical Trials: The following adverse events were reported at an incidence rate of ≥0.5% and greater than
or equal to placebo in patients who received parecoxib in 13 controlled general and oral surgery trials:

Events Occurring ≥1% and <10%: Autonomic Nervous System: Hypotension.

Body as a Whole: Back pain.

Central and Peripheral Nervous System: Dizziness.

GI System: Alveolar osteitis (dry socket), constipation and flatulence.

Platelet, Bleeding and Clotting: Ecchymosis.

Psychiatric: Agitation and insomnia.

Skin and Appendages: Increased sweating and pruritus.

Events Occurring ≥0.5% and <1%: Application Site: Injection site pain.

Autonomic Nervous System: Dry mouth.

Body as a Whole: Asthenia and peripheral edema.

Hearing and Vestibular: Earache.

Heart Rate and Rhythm: Bradycardia.

Metabolic and Nutritional: Hyperglycemia.

Musculoskeletal System: Arthralgia.

Respiratory System: Pharyngitis.

Skin and Appendages: Rash and skin postoperative complications.

Urinary System: Oliguria.

Following coronary artery bypass graft surgery, patients administered parecoxib may have a higher risk of
adverse events eg, cerebrovascular accident, renal dysfunction, or sternal wound complication.

Post-Marketing Surveillance: In post-marketing experience, the following events have been reported in
association with the use of valdecoxib and cannot be ruled out for parecoxib: Anaphylactic reactions,
angioedema, erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal
necrolysis.

Clasificatio.
M01AH04 - Parecoxib ; Belongs to the class of non-steroidal antiinflammatory and antirheumatic products,
coxibs.
3.Cefuroxime Na
Indications
Acute & chronic bronchitis, infected bronchiectasis, bacterial pneumonia, lung abscess & post-op chest
infections, sinusitis, tonsillitis, pharyngitis & otitis media, acute & chronic pyelonephritis, cystitis &
symptomatic bacteriuria, cellulitis, erysipelas & wound infections, osteomyelitis & septic arthritis, O & G
infections, pelvic inflammatory diseases, gonorrhea, septicemia, meningitis & peritonitis, prophylaxis
against infection in abdominal, pelvic, orthopedic, cardiac, pulmonary, esophageal & vascular surgery.
Contraindications
Hypersensitivity to cephalosporins.
Special Precautions
Anaphylactic reaction to penicillins. Monitor renal function. Pregnancy & lactation.
Adverse Drug Reactions
Rarely, skin rash, urticaria, pruritus, interstitial nephritis, drug fever, erythema multiforme, Stevens-
Johnson syndrome & toxic epidermal necrolysis.
clsification
J01DC02 - Cefuroxime ; Belongs to the class of second-generation cephalosporins. Used in the systemic
treatment of infections.

Tramadol
uicidal patients, acute alcoholism; head injuries; raised intracranial pressure; severe renal impairment;
lactation.
Special Precautions
Hypothyroidism; adrenocortical insufficiency; renal or hepatic impairment; history of epilepsy or increased
risk of seizures; inflammatory or obstructive bowel disease; myasthaenia gravis; respiratory depression;
prostatic hyperplasia. Pregnancy.
Adverse Drug Reactions
Sweating, dizziness, nausea, vomiting, dry mouth, fatigue, asthenia, somnolence, confusion, constipation,
flushing, headache, vertigo, tachycardia, palpitations, miosis, insomnia, orthostatic hypotension, seizures,
CNS stimulation e.g. hallucinations.
Potentially Fatal: Respiratory depression.
Drug Interactions
Possible increase in anticoagulation with warfarin. Increased risk of seizures with SSRI, TCA. Increased
risk of serotonin syndrome with mirtazapine, venlafaxine, SSRI and MAOI; tramadol should not be given
to patients receiving MAOIs or within 14 days of their discontinuation. Reduced analgesic efficacy of
tramadol with carbamazepine, 5-HT3-receptor antagonist e.g. ondansetron. Increased respiratory and CNS
depression with CNS depressants e.g. alcohol, opioids, anaesthetic agents, narcotics, phenothiazines,
tranquilisers or sedative hypnotics.