Cobix (Celecoxib Capsules) is used for the management of the signs and symptoms of Osteoarthritis (OA), Rheumatoid Arthritis (RA), Juvenile Rheumatoid Arthritis (JRA) in patients 2 years and older and Ankylosing Spondylitis (AS). This medicine is also used for the management of acute pain in adults and for the management of primary dysmenorrhea.

1. Celecoxib Capsules
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Cobix (Celecoxib Capsules) is
used for the management of the
signs and symptoms of
Osteoarthritis (OA), Rheumatoid
Arthritis (RA), Juvenile
Rheumatoid Arthritis (JRA) in
patients 2 years and older and
Ankylosing Spondylitis (AS).
This medicine is also used for
the management of acute pain
in adults and for the
management of primary
dysmenorrhea.

2. Cobix Capsules
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Cobix (Celecoxib Capsules) are
manufactured by Cipla Ltd. , India in
the strengths of 100 mg and 200 mg.
(Website: www.cipla.com)

3. Celecoxib Capsules – Brand Names
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Celecoxib Capsules are available as
Celebrex , Cobix, Colcibra, Revibra,
Celact, Celcox, Celecap, Celemax,
Celetop, Celib, Orthocel and Zycel.

4. Active Ingredient
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The active ingredient contained in Cobix
capsules is Celecoxib. Each Cobix capsules
contains 100 mg or 200 mg of Celecoxib.

5. Chemical Structure
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The structure of Celecoxib is given below:

6. Uses of Cobix Capsules
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Cobix (Celecoxib Capsules), belong to a
group of medicinal products called
nonsteroidal anti-inflammatory drugs
(NSAID) and are used for the relief of signs
and symptoms of rheumatoid arthritis,
osteoarthritis and ankylosing spondylitis in
adults.

7. Cobix Dosage
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➢For Osteoarthritis, the dosage is 200 mg per
day administered as a single dose or as 100
mg twice daily.
➢For Rheumatoid Arthritis, the dosage is 100
mg to 200 mg twice daily.
➢For Juvenile Rheumatoid Arthritis, the dosage
for pediatric patients (age 2 years and older) is
based on weight. For patients 10 kg and
above up to 25 kg the recommended dose is
50 mg twice daily. For patients more than 25 kg
the recommended dose is 100 mg twice daily.
The adult dosage of Cobix capsules (Celecoxib)
is given below.

8. Celecoxib Capsules Dosage
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➢For Ankylosing Spondylitis, the dosage of Cobix is
200 mg daily in single (once per day) or divided (twice
per day) doses. In case no effect is observed after 6
weeks, a trial of 400 mg daily may be worthwhile. If no
effect is observed after 6 weeks on 400 mg daily, a
response is not likely and alternate treatment options
must be considered.
➢For management of Acute Pain and Treatment of
Primary Dysmenorrhea, the dosage is 400 mg initially,
followed by an additional 200 mg dose if needed on the
first day. On subsequent days, the recommended dose
is 200 mg twice daily as needed.
The dosage of Cobix (Celecoxib Capsules) is
given below:

9. Storage Instructions
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Cobix (Celecoxib Capsules) have to be
stored at controlled room temperature
i.e. from 20°C to 25°C (68°F to 77°F)
with excursions permitted between 15°
to 30°C (59° to 86°F).
Keep this as well as all other medicines
away from children and pets.

10. Cobix Warnings
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Serious and potentially fatal cardiovascular (CV)
thrombotic events, myocardial infarction, and stroke.
Patients with known CV disease/risk factors may
be at greater risk.
There is a possibility of serious gastrointestinal (GI)
adverse events, which can be fatal. This risk is
greater in patients with a prior history of ulcer
disease or GI bleeding, and in patients at high risk
for GI events, especially the elderly.
Elevated liver enzymes and, rarely, severe hepatic
reactions. Stop using Cobix (Celecoxib Capsules)
immediately if abnormal liver enzymes persist or
worsen.
New onset or worsening of hypertension.

11. Cobix Warnings
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Fluid retention and edema. Celecoxib Capsules
must be used with caution in patients with fluid
retention or heart failure.
Renal papillary necrosis and other renal injury with
long term use.
Anaphylactoid reactions can occur. Do not use
Cobix in patients with the aspirin triad.
Serious skin adverse events such as exfoliative
dermatitis, Stevens-Johnson syndrome (SJS), and
toxic epidermal necrolysis
(TEN), which can be fatal and can occur without
warning even without known prior sulfa allergy.
Discontinue Cobix (Celecoxib Capsules)
immediately in case at rash or skin reactions are
observed.

12. Cobix Capsules
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Contraindications
Cobix is contraindicated in patients with a
hypersensitivity to Celecoxib or any other
component of this medication.
Cobix (Celecoxib Capsules) must not be used in
patients with a history of asthma, urticaria, or
other allergic-type reactions after taking aspirin or
other NSAIDs.
Use of Celecoxib during the perioperative period
in the setting of coronary artery bypass graft
(CABG) surgery is contraindicated.

13. Celecoxib Capsules Side Effects
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➢Cobix (Celecoxib Capsules) side
effects with an incidence rate of 2% or
more and higher than placebo can
include abdominal pain, diarrhea,
dyspepsia, flatulence, peripheral
edema, accidental injury, dizziness,
pharyngitis, rhinitis, sinusitis, upper
respiratory tract infection and rash.

14. Cobix Overdose
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Doses up to 2400 mg/day for up to 10 days
administered to 12 patients did not result in
serious toxicity.
Symptoms following acute NSAID overdoses are
normally limited to lethargy, drowsiness,
nausea, vomiting, and epigastric pain, which are
generally reversible with supportive care.
Gastrointestinal bleeding can occur.
Hypertension, acute renal failure, respiratory
depression and coma may take place, but are
rare. Anaphylactoid reactions have been
observed with therapeutic ingestion of NSAIDs,
and may occur following an overdose.

15. Celecoxib Capsules Overdose
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Patients should be managed by symptomatic
and supportive care following an Celecoxib
Capsules overdose. Specific antidotes are not
currently known.
No information is available regarding the removal
of celecoxib by hemodialysis, but based on its
high degree of plasma protein binding (greater
than 97%) dialysis is not likely to be useful in
overdose.
Emesis and/or activated charcoal (60 to 100 g in
adults, 1 to 2 g/kg in children) and/or osmotic
cathartic may be prescribed to patients seen
within 4 hours of ingestion with symptoms or
following a large Celecoxib overdose.

16. Celecoxib During Pregnancy
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Celecoxib (Cobix Capsules) has been
classified by the US FDA as Pregnancy
Category C. ( Pregnancy category D from
30 weeks of gestation onward)
Controlled studies with animals have
shown caused an increased incidence of
ventricular septal defects, a rare event, and
fetal alterations, such as ribs fused,
sternebrae fused and sternebrae
misshapen when rabbits were treated
throughout organogenesis with
approximately 2-fold human exposure.

17. Celecoxib During Pregnancy
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There are no studies in pregnant women.
Celecoxib (Cobix Capsules) should be
used during pregnancy only if the potential
benefit justifies the potential risk to the
fetus.

18. Cobix Capsules
For more details on
Cobix Capsules click here
© Clearsky Pharmacy
Cobix (Celecoxib Capsules) by Cipla
Limited, India.