Drug Interaction:
Interactions - summary
Celecoxib + Cytochrome inhibitors
Excercise caution. Interfere with metabolism.
Celecoxib + Lithium
increase plasma levels of lithium when combined with celecoxib
Celecoxib +Fluconazole
two increase in celecoxib plasma conc.
Celecoxib + Furosemide,
potential to interact. Observe caution
Indication:
Symptomatic relief of rheumatoid arthiritis
Ankylosing spondylitis
Osteoarthiritis
LIST OF DRUGS DURING 2004
Sr.No- 251
Name of the Drug- Celecoxib Injection (100mg/ml) Pharmacological Classification- For acute pain
Date of Approval- 20-10-2004
Approved by U.S.FDA on 30-12-2004 (Ref- FDA approved List- 2004)
Approved by (DCI) Drug Controller GENERAL - India For Marketing
(Ref- IDMA Publication)
Name of Drug Indication Date of Approval
1. Celecoxib NSAID 22-02-2000
2. Celecoxib 100/200mg + Diacerin 19-07-2010
50.50mg
For the treatment of adult patients with osteoarthiritis of knee and
or Hip joints
3. Celecoxib injection 100mg/ml 28-10-2004
For acute pain
4. Celecoxib mouth dissolving tablets 25- 02- 2010
For the treatment of osteoarthiritis and rheumayoid arthiritis
Adverse Reaction:
Abdominal pain, diarrhoea, flatulance, dyspepsia,
nausea, backpain, peripheral edema.
dizziness, rhinitis, sinusitis,
upper respiratory tract interactions, rash.
Contra-Indications:
Hypersensitivity
Allergic-Type reactions to sulfonamides. Not to given to patients who have asthma, urticaria, or allergic type reactions after taking aspirin or NSAIDs.
Special precautions:
Safety for use below 18 years not established.
Not recommended in advanced kidney disease.
Pregnancy and lactation, heptic insufficiency.
Patients with long term use- check haemoglobin or hematocrit value.
Dosages/ Overdosage Etc:
Date of Approval 2000
Indication-
Symptomatic relief of rheumatoid arthiritis
Ankylosing spondylitis
Osteoarthiritis
Dosage-
Adults: 200mg per day administered as a single dose. or as twice a day
Other Information:
For Availability/supplies
Contact -
1.Indian Drug Manufacturers Association (IDMA)
Phone- 022- 24944624/ 24974308
Fax- 022- 24950723
Email- idma@vsnl.com
Website: www.idma-assn.org
2.Bulk Drug Manufacturers Association (India)(BDMA)
Phone - 040-23703910/ 23706718
Fax- 040-23704804
Email- info@bdmai.org
Website: www.info@bdmai.org
EVIDENCE BASED MEDICINE (MIMS -April 2003)
Pain of Osteoarthiritis
Comparative effectiveness of various interventions
Beneficial
1. Systemic simple analgesics (eg paracetamol for short term pain relief, and improvement in function)
2. Systemic NSAIDs (short term pain relief and improvement in function)
3. Topical agents (short term pain relief)
Likely to be beneficial
1. Education, dietary advice,empowerment and support ( improved knowledge of disease and pain relief)
2. Physical support (pain relief and improvement in function)
KEY POINTS
1. There is no good evidence that NSAIDs were superior to simple analgesics such as paracetamol or to suggest that any one of the many available NSAIDs had greater efficacy in relieving pain of osteoarthritis.
2. One systematic review of randomised controlled trials has found that topical agents provide pain relief in patients with osteoarthritis and offer a non-toxic alternative to systemic drug treatment. However there is no evidence to indicate whether the prescribed agents were superior to less expensive, non-prescribtion drugs over the counter (OTC) alternatives, or to other local treatments such as hot or cold packs.
Patient Information:
Pregnacy and lactation.
Caution in patients with consideration dehydration
Pharmacology/ Pharmacokinetics:
Pharmacology:
Celecoxib is NSAID agent which exerts its anti-inflammatory and analgesic effect by targetting COX-2. The specific inhibition of COX-2 isoenzyme confers the molecule the ability to exert potent anti-inflammatory activity, analgesic and anti-pyretic effect with minimal side effects.
Pharmacokinetics:
Peak plasma levels of Celecoxib are acheived in approximately 3 hrs after an oral dose. When celecoxib capsules are taken with a high fat meal, peak plasma levels were delayed for about an 1 to 2 hours. Celecoxib is eliminated predominantly by hepatic metabolism with little unchanged drug recovered in the urine and faces.
Interaction with Food:
Dose for QA/RA may be given with or without meals, but for FAP must be given with meals
Pregnancy and lactation:
Avoid during pregnancy and lactation