Indocap (Generic Indomethacin Capsules)

Indocap (Generic Indomethacin Capsules)
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Indocap (Generic Indomethacin Capsules) is
nonsteroidal anti-inflammatory medicine used for the
treatment of moderate to severe rheumatoid arthritis
including acute flares of chronic disease, moderate to
severe ankylosing spondylitis, moderate to severe
osteoarthritis, acute painful shoulder (bursitis and/or
tendinitis) and acute gouty arthritis.
Since Indometacin is not a simple analgesic, its use
should be limited to the above conditions.

Indocap Capsules are manufactured by Jagsonpal Pharmaceuticals
Limited, India in the strengths of 25 mg and 75 mg SR.

Chemical Structure - Indomethacin

The active ingredient contained in Indocap
Capsules is Indomethacin.
Each Indocap Capsule contains 25 mg or 75
mg of Indomethacin.

Uses of Indocap 25 mg and 75 mg Capsules:
Indocap (Generic Indomethacin Capsules) is a nonsteroidal anti-inflammatory
drug (NSAID) used to treat mild to moderate acute pain and relieve symptoms of
arthritis (osteoarthritis and rheumatoid arthritis), bursitis, tendonitis or gout,
such as inflammation, swelling, stiffness, and joint pain.
It works by blocking your body's production of certain natural substances that cause
inflammation. This effect helps to decrease swelling and painHowever, Indocap
does not cure arthritis and will help you only as long as you continue to take it.
Indocap is also used to treat ankylosing spondylitis, which is a type of arthritis that
affects the joints in the spine. This medicine may also be used to treat painful
shoulder caused by bursitis or tendinitis.
In certain conditions (such as arthritis), it may take up to 4 weeks when this
medicine is taken regularly before you notice the full benefits.

Recommended Adult Dosage
The dose of Indocap (Generic Indomethacin Capsules) for the
treatment of moderate to severe rheumatoid arthritis including acute
flares of chronic disease, moderate to severe ankylosing spondylitis
and moderate to severe osteoarthritisis is 25 mg twice a day or
three times a day.
If this is well tolerated, increase the daily dosage by 25 mg or by 50
mg, if required by continuing symptoms, at weekly intervals until a
satisfactory response is obtained or until a total daily dose of 150
to 200 mg is reached. Doses above this amount generally do not
increase the effectiveness of the medication.

Recommended Adult Dosage
Acute Painful Shoulder (Bursitis And/Or Tendinitis): Indocap (Generic
Indomethacin Capsules)75 to 150 mg daily in 3 or 4 divided doses.
The medicine should be discontinued after the signs and symptoms of
inflammation have been controlled for several days. The usual course
of treatment is 7 to 14 days.
Acute Gouty Arthritis: Indocap (Generic Indomethacin Capsules) 50
mg three times a day until pain is tolerable. The dose should then be
rapidly reduced to complete cessation of the medication. Definite
relief of pain has been reported within 2 to 4 hours. Tenderness and
heat usually subside in 24 to 36 hours, and swelling gradually
disappears in 3 to 5 days.

Contraindications
➔
Indocap capsules are contraindicated in patients with a known
hypersensitivity (e.g., anaphylactic reactions and serious skin
reactions) to Indomethacin or any component of the tablet.
➔
History of asthma, urticaria, or other allergic-type reactions
after taking aspirin or other NSAIDs. Severe, sometimes fatal,
anaphylactic reactions to NSAIDs have been reported in such
patients.
➔
In the setting of coronary artery bypass graft (CABG) surgery.

Storage Instructions
Indocap (Indomethacin 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.

Indocap Capsules Warnings
Hepatotoxicity: Inform patients of warning signs and symptoms of
hepatotoxicity. Discontinue if abnormal liver tests persist or worsen
or if clinical signs and symptoms of liver disease develop.
Hypertension: Patients taking some antihypertensive medications
may have impaired response to these therapies when taking NSAIDs.
Monitor blood pressure
Heart Failure and Edema: Avoid use ofIndocap Capsules in patients
with severe heart failure unless benefits are expected to outweigh
risk of worsening heart failure.
Anaphylactic Reactions: Seek emergency help if an anaphylactic
reaction occurs.

Renal Toxicity: Monitor renal function in patients with renal or
hepatic impairment, heart failure, dehydration, or hypovolemia.
Avoid use of Indocap Capsules in patients with advanced renal
disease unless benefits are expected to outweigh risk of worsening
renal function
Exacerbation of Asthma Related to Aspirin Sensitivity: Indocap
Capsules are contraindicated in patients with aspirin-sensitive
asthma. Monitor patients with preexisting asthma (without aspirin
sensitivity).
Serious Skin Reactions: Discontinue Indocap Capsules at first
appearance of skin rash or other signs of hypersensitivity.

Premature Closure of Fetal Ductus Arteriosus: Avoid use in
pregnant women starting at 30 weeks gestation.
Hematologic Toxicity: Monitor hemoglobin or hematocrit
in patients with any signs or symptoms of anemia.

Possible Side Effects
Most common Indomethacin (Indocap Capsules) side
effects with an incidence rate of greater than or equal
to 3% were headache, dizziness, dyspepsia and
nausea.

Possible Side Effects
The following side effects occurred in more than 1% of patients
during clinical trials: Nausea with or without vomiting, dyspepsia
(including indigestion, heartburn and epigastric pain),
diarrhea, abdominal distress or pain, constipation, headache
(11.7%), dizziness, vertigo, somnolence, depression and fatigue
(including malaise and listlessness), tinnitus.

Indocap Capsules Overdosage
Symptoms following acute NSAID overdosages have
been typically limited to lethargy, drowsiness, nausea,
vomiting, and epigastric pain, which have been
generally reversible with supportive care.
Gastrointestinal bleeding has occurred. Hypertension,
acute renal failure, respiratory depression, and coma
have occurred, but were rare.

Treatment of Indocap Capsules Overdosage
Patients should be managed with symptomatic and supportive care
following an NSAID overdosage. There are no specific antidotes for
Indomethacin (Indocap Capsules).
Consider emesis and/or activated charcoal (60 to 100 grams in adults, 1
to 2 grams per kg of body weight in pediatric patients) and/or osmotic
cathartic in symptomatic patients seen within four hours of ingestion or
in patients with a large overdosage (5 to 10 times the recommended
dosage).
Forced diuresis, alkalinization of urine, hemodialysis, or hemoperfusion
may not be useful due to high protein binding.

Indocap Capsules During Pregnancy
Indomethacin (Indocap Capsules) has been classified by the US FDA as
Pregnancy Category C (Pregnancy Category D If Indomethacin is taken
during the third trimester of pregnancy).
Use of NSAIDs, including Indomethacin capsules, during the third
trimester of pregnancy increases the risk of premature closure of the fetal
ductus arteriosus. Avoid use of NSAIDs, including indomethacin capsules,
in pregnant women starting at 30 weeks of gestation (third trimester).
There are no adequate and well-controlled studies of indomethacin
capsules in pregnant women. Data from observational studies regarding
potential embryofetal risks of NSAID use in women in the first or second
trimesters of pregnancy are inconclusive.

Indocap Capsules are manufactured by
Jagsonpal Pharmaceuticals Limited, India.
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Indocap (Generic Indomethacin Capsules)

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