Ibugesic (Generic Ibuprofen Tablets)

Ibugesic (Generic Ibuprofen Tablets)
© The Swiss Pharmacy

Ibugesic (Generic Ibuprofen Tablets) is used for its analgesic and anti-
inflammatory effects in the treatment of Rheumatoid arthritis
(including Juvenile rheumatoid arthritis or Still's disease),
Osteoarthritis, other non-rheumatoid (seronegative) arthropathies,
ankylosing spondylitis, Primary dysmenorrhoea, and Pyrexia.
This medicine is also used in the treatment of non-articular rheumatic
conditions, Ibugesic is indicated in periarticular conditions such as
frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis and low
back pain; Ibugesic can also be used in soft tissue injuries such as
sprains and strains.
Ibugesic is also indicated for its analgesic effect in the relief of mild to
moderate pain, dental and post-operative pain and for symptomatic
relief of headache, including migraine headache.

Ibugesic is manufactured by Cipla Limited, India in the strengths of 400
mg and 600 mg.

Chemical Structure - Ibuprofen

The active pharmaceutical ingredient
present in Ibugesic tablets is Ibuprofen.
Each Ibugesic tablet contains 400 mg or
600 mg of Ibuprofen.
Active Ingredient

The recommended initial dosage of
Ibugesic (Generic Ibuprofen Tablets) is 1200 mg to
1800 mg daily in divided doses. Some patients can be
maintained on 600 to 1200 mg daily.
In severe or acute conditions it can be advantageous to
increase the dosage until the acute phase is brought
under control, providing that the total daily dosage does
not exceed 2400 mg in divided doses.
Recommended Adult Dosage

Primary Dysmenorrhoea:
For the treatment of dysmenorrhea, beginning with the earliest
onset of such pain or menstrual bleeding, Ibuprofen tablets
should be given in a dose of 400 mg every 4 to 6 hours as
necessary with a maximum total daily dose of 1,600 mg.
Maintenance Dose:
In all indications the dose should be adjusted for each patient and
the smallest dose that results in acceptable control of the
symptoms employed. In general, patients with Rheumatoid
Arthritis and Osteoarthritis tend to require higher doses than
patients with other conditions.
Recommended Adult Dosage

Paediatric Dosage:
The daily dosage of Ibugesic tablets (Ibuprofen) is 20 mg per
kg of body weight in divided doses. In Juvenile Rheumatoid
Arthritis up to 40 mg per kg of body weight in divided doses
may be given.
In children weighing less than 30 kg the total dose should not
exceed 500 mg in a 24 hour period.
Recommended Dosage

Mild to Moderate Pain:
The recommended adult dosage is 400 mg every 4 to 6 hours
as necessary for relief of pain.
It is recommended that patients with sensitive stomachs take
Ibugesic with food. If taken shortly after eating, the onset of
action of Ibugesic may be delayed. To be taken preferably with
or after food, with plenty of fluid. Ibugesic tablets should be
swallowed whole and not chewed, broken, crushed or sucked
on to avoid oral discomfort and throat irritation.
Recommended Dosage

Contraindications
Ibugesic Tablets is contraindicated in patients with the following
conditions:
➔Hypersensitivity to Ibuprofen, or any inactive component of this
medication.
➔Ibuprofen should not be given to patients who have experienced
asthma, urticaria, or allergic-type reactions after taking aspirin or
other NSAIDs.
➔Ibuprofen is contraindicated for the treatment of peri-operative
pain in the setting of coronary artery bypass graft (CABG) surgery.

Contraindications
Ibugesic Tablets is contraindicated in patients with the following conditions:
➔Ibugesic is also contraindicated in patients with a history of
gastrointestinal bleeding or perforation, related to previous NSAID
therapy. Ibugesic should not be used in patients with active, or history of,
recurrent peptic ulcer or gastrointestinal haemorrhage (two or more
distinct episodes of proven ulceration or bleeding).
➔Ibugesic should not be given to patients with conditions involving an
increased tendency to bleeding.
➔Ibugesic is contraindicated in patients with severe heart failure (NYHA
Class IV), hepatic failure and renal failure.
➔Ibugesic is contraindicated during the last trimester of pregnancy.

Side Effects of Ibugesic Tablets
The common side effects of Ibuprofen (Ibugesic Tablets) are
nausea, epigastric pain, heartburn, diarrhea, abdominal
distress, nausea and vomiting, indigestion, constipation,
abdominal cramps or pain, fullness of GI tract (bloating and
flatulence), dizziness, headache, nervousness, rash (including
maculopapular type), pruritus, tinnitus, decreased appetite,
edema, and fluid retention.

The rare side effects of Ibuprofen (Ibugesic tablets) include Gastic
or duodenal ulcer with bleeding and/or perforation, gastrointestinal
hemorrhage, melena, gastritis, hepatitis, jaundice, abnormal liver
function tests; pancreatitis, Depression, insomina, confusion, emotional
lability, somnolence, aseptic meningitis with fever and coma,
vesiculobullous eruptions, urticaria, erythema multiforme, Stevens-
Johnson syndrome, alopecia, hearing loss, amblyopia (blurred and/or
diminished vision, scotomata and/or changes in color vision).

The rare side effects of Ibuprofen (Ibugesic tablets) include
neutropenia, agranulocytosis, aplastic anemia, hemolytic anemia
(sometimes Coombs Positive), thrombocytopenia with or without
purpura, eosinophilia, decreases in hemoglobin and hematocrit,
congestive heart failure in patients with marginal cardiac function,
elevated blood pressure, palpitations, Syndrome of abdominal pain,
fever, chills, nausea and vomiting; anaphylaxis; bronchospasm, acute
renal failure, decreased creatinine clearance, polyuria, azotemia,
cystitis, hematuria, dry eyes and mouth, gingival ulcer and rhinitis.

Warnings And Precautions
➔
Cardiovascular Thrombotic Events: Increased risk of serious
cardiovascular (CV) thrombotic events, myocardial infarction, and stroke,
which can be fatal. All NSAIDs, both COX-2 selective and nonselective,
may have a similar risk.
➔
Hypertension: NSAIDs, including Ibuprofen, can lead to onset of new
hypertension or worsening of preexisting hypertension, either of which
may contribute to the increased incidence of cardiovascular events.
➔
Congestive Heart Failure and Edema: Fluid retention and edema have
been observed in some patients taking NSAIDs. Ibuprofen should be used
with caution in patients with fluid retention or heart failure.

➔Gastrointestinal Effects: NSAIDs, including Ibuprofen
(Ibugesic tablets), can cause serious gastrointestinal (GI) adverse
events including inflammation, bleeding, ulceration, and
perforation of the stomach, small intestine, or large intestine,
which can be fatal.
➔
Renal Effects: Long-term administration of NSAIDs has resulted
in renal papillary necrosis and other renal injury.
➔
Advanced Renal Disease: Treatment with Ibuprofen tablets is
not recommended in these patients with advanced renal disease.

➔
Anaphylactic/Anaphylactoid Reactions: As with other NSAIDs, anaphylactic /
anaphylactoid reactions may occur in patients without known prior exposure to
Ibuprofen. Ibuprofen should not be given to patients with the aspirin triad. This
symptom complex typically occurs in asthmatic patients who experience rhinitis with
or without nasal polyps, or who exhibit severe, potentially fatal bronchospasm after
taking aspirin or other NSAIDs.
➔
Skin Reactions: NSAIDs, including Ibuprofen, can cause serious skin adverse
events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic
epidermal necrolysis (TEN), which can be fatal. These serious events may occur
without warning. Patients should be informed about the signs and symptoms of
serious skin manifestations and use of the drug should be discontinued at the first
appearance of skin rash or any other sign of hypersensitivity.

➔
Infections and infestations: Exacerbation of skin infection-related
inflammations (e.g. development of necrotising fasciitis) coinciding
with the use of NSAIDs has been described. If signs of an infection
occur or get worse during use of ibuprofen the patient is therefore
recommended to go to a doctor without delay.
➔
Pregnancy: In late pregnancy, as with other NSAIDs, Ibugesic tablets
should be avoided because it may cause premature closure of the
ductus arteriosus.

➔
Infections and infestations: Exacerbation of skin infection-related
inflammations (e.g. development of necrotising fasciitis) coinciding with the
use of NSAIDs has been described. If signs of an infection occur or get worse
during use of Ibuprofen tablets the patient is therefore recommended to go to a
doctor without delay.
➔
Respiratory disorder: Caution is required if Ibuprofen is administered to
patients suffering from, or with a previous history of bronchial asthma, chronic
rhinitis or allergic diseases since Ibuprofen has been reported to cause
bronchospasm, urticarial or angioedema in such patients.
➔
Ophthalmological effects: Adverse ophthalmological effects have been
observed with NSAIDs; accordingly, patients who develop visual
disturbances during treatment with Ibuprofen should have an
ophthalmological examination.

Effects On Ability To Drive And Use Machines
Following treatment with Ibuprofen (Ibugesic tablets), the
reaction time of patients may be affected.
Care should be taken when driving or operating machinery
as the activity may be affected by dizziness, drowsiness,
fatigue and visual disturbance. This applies to a greater
extent in combination with alcohol.

Ibuprofen (Ibugesic tablets) Overdose Symptoms
The range of Ibuprofen (Ibugesic tablets)overdose symptoms
observed has included nausea, vomiting, abdominal pain,
drowsiness, nystagmus, diplopia, headache, tinnitus, impaired renal
function, coma and hypotension lethargy, central nervous system
depression, seizures, metabolic acidosis, coma, rhabdomyolysis,
hypothermia, fulminant hepatic failure, apnea (primarily in very
young children), cardiovascular toxicity including bradycardia,
tachycardia and atrial fibrillation.

Treatment of Ibugesic Tablets Overdose
Appropriate interventions to decontaminate the gastrointestinal tract
may be beneficial within the first four hours after ingestion. Routine
symptomatic and supportive treatment is then recommended.
In cases of acute overdose of Ibuprofen (Ibugesic tablets), the stomach
should be emptied by vomiting or lavage, although little of the drug will
be likely to be recovered if it is more than an hour since ingestion.
Since the medication is acidic and excreted in the urine, it is
theoretically beneficial to administer alkali and induce diuresis. In
addition to supportive measures, the use of oral activated charcoal may
help reduce the absorption and reabsorption of Ibuprofen.

Ibuprofen Tablets During Pregnancy
Ibuprofen (Ibugesic tablets) has been classified by the US FDA as
Pregnancy Category C , Category D at 30 weeks or greater of gestation,
due to the potential for premature closure of the ductus arteriosus.
Reproductive studies conducted in rats and rabbits have not demonstrated
evidence of developmental abnormalities. However, animal reproduction
studies are not always predictive of human response. There are no
adequate and well-controlled studies in pregnant women. Ibuprofen
(Ibugesic tablets) should be used in pregnancy only if the potential benefit
justifies the potential risk to the fetus.
Because of the known effects of NSAIDs on the fetal cardiovascular system
(closure of ductus arteriosus), use during late pregnancy should be
avoided.

Ibugesic Tablets manufactured by
Cipla Limited, India
For more information click here

Ibugesic (Generic Ibuprofen Tablets)

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