A Milestone Moment: FDA Approves Addyi® for Hypoactive Sexual Desire Disorder in Postmenopausal Women
December 17, 2025
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Brand Name :
Advil, Motrin, PediaCare Infant's Fever Reducer IB / Pain Reliever, PediaCare Children's Fever Reducer IB / Pain Reliever
Synonyms :
ibuprofen
Class :
Nonsteroidal anti-inflammatory drugs
Brand Name :
Advil, Motrin, PediaCare Infant's Fever Reducer IB / Pain Reliever, PediaCare Children's Fever Reducer IB / Pain Reliever
Synonyms :
ibuprofen
Class :
Nonsteroidal anti-inflammatory drugs
Dosage Forms & Strengths
oral suspension
40mg/mL
100mg/5mL
capsule
200mg
Chewable, tablet
100mg
50mg
tablet
800mg (Rx)
600mg (Rx)
400mg (Rx)
200mg
100mg
Over the counter: 200-400 mg orally every 4-6hours; should not exceed more than 1200 mg unless prescribed by doctor
Prescription: 400-800 mg orally every 6hours; should not exceed more than 3200 mg daily
400-800 mg orally every 6-8 hours; should not exceed more than 3200 mg daily
800 mg, 600 mg, 400 mg, or 300 mg orally every 6-8 hours; should not exceed more than 3200 mg daily
800 mg, 600 mg, 400 mg, or 300 mg orally every 6-8 hours; should not exceed more than 3200 mg daily
Dose Adjustments
Dosage Modifications
Renal function is significantly impaired: Monitor closely and consider lowering the dosage if necessary
Avoid use in those with severe hepatic impairment
Dosage Forms & Strengths
oral suspension
40mg/mL
100mg/5mL
capsule
200mg
Chewable, tablet
100mg
50mg
tablet
800mg (Rx)
600mg (Rx)
400mg (Rx)
200mg
100mg
Below 6 months
Safety and efficacy were not established
Above 6 months
5-10 mg/kg/dose Orally every 6-8 hours; should not exceed more than 40 mg/kg daily or 400 mg/dose
4-10 mg/kg/dose Orally every 6-8 hours is given for pain; should not exceed more than 40 mg/kg daily
30-50 mg/kg daily Orally divided every 8 hours; should not exceed more than 2.4 g/day
Below 4 yrs: Safety and efficacy were not established
Above 4 yrs: oral administration every 12 hours, adjusted to keep serum levels between 50 and 100 mcg/mL; may slow or stop disease development in younger individuals with the mild lung disease
(off-label):
Below 4 yrs: Safety and efficacy were not established
Above 4 yrs: oral administration every 12 hours, adjusted to keep serum levels between 50 and 100 mcg/mL; may slow or stop disease development in younger individuals with the mild lung disease
Refer to the adult dosing regimen
may diminish the serum concentration when combined with imatinib
may enhance the serum concentration when combined with pemetrexed
interaction with NSAIDs may lead to increased toxicity such as myelosuppression, renal toxicity, and GI toxicity
interaction with NSAIDs may lead to increased toxicity such as myelosuppression, renal toxicity, and GI toxicity
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
the efficacy of aspirin rectal may be decreased by ibuprofen
It may enhance the toxicity when combined with mipomersen
Combining Ibuprofen with pranlukast may cause a reduction in the Ibuprofen’s metabolism
When loracarbef is used together with ibuprofen, the risk or seriousness of nephrotoxicity is enhanced
When ibuprofen is used together with sertraline, the risk or seriousness of bleeding may be enhanced
When ibuprofen is used together with bufexamac, this leads to enhanced risk or seriousness of adverse outcomes
ibuprofen leads to a reduction in the rate of excretion of nitric oxide, which leads to an increased level of serum
When ibuprofen is used together with nifenazone, this leads to enhanced risk or seriousness of adverse events
When ibuprofen is used together with adenine, this leads to a reduction in the ibuprofen’s metabolism
When ibuprofen is used together with diazoxide, this leads to reduction in therapeutic effectiveness of diazoxide
it may decrease the excretion of CYP3A inhibitors
it may decrease the excretion of CYP3A inhibitors
it may decrease the excretion of CYP3A inhibitors
it may decrease the excretion of CYP3A inhibitors
it may decrease the excretion of CYP3A inhibitors
glycopyrrolate inhaled and formoterol
may decrease the toxic effects of each other by sedation
may enhance the risk of angioedema when combined with Ibuprofen
the toxicity of either of the drugs is increased due to pharmacokinetic synergism
by altering metabolism, the levels of ibuprofen may be reduced
piperacillin will increase the effect of ibuprofen IV by acidic drug competition.
when both drugs combine ibuprofen decreases the activity of melphalan.
sulfamethoxazole increases the effect of ibuprofen by altering hepatic CYP2C9/10 enzyme metabolism
Actions and spectrum
Ibuprofen is as non-selective COX inhibitors, which means that it affects both COX-1 and COX-2 enzyme. COX-2 inhibitors decrease the formation of prostaglandin that acts as an inflammatory mediator which also cause pain, fever and swelling. However, selective inhibition of COX-1 is responsible for side effects of ibuprofen such as gastrointestinal ulceration.
Frequency defined
1-10%
Epigastric pain (3-9%)
Dizziness (3-9%)
Heartburn (3-9%)
Nausea (3-9%)
Tinnitus (3-9%)
Rash (3-9%)
Constipation (1-3%)
<1%
Agranulocytosis
Erythema multiforme
Exfoliative dermatitis
Neutropenia
Toxic epidermal necrolysis
Aplastic anemia
Erythematous rashes
Black Box Warning:
It may increase the risk of serious cardiovascular thrombotic events such as myocardial infarction (MI) and stroke.
It can cause ulceration, gastrointestinal (GI) bleeding and perforation of the stomach or intestines which can be fatal.
Contraindication/Caution:
Contraindication:
Caution:
Pregnancy/Lactation
Pregnancy consideration: US FDA pregnancy category: Not assigned
Lactation: ibuprofen is considered safe to use while breastfeeding, as only small amounts are excreted in breast milk.
Pregnancy category:
Pharmacology
ibuprofen is a nonsteroidal anti-inflammatory drug that is selective for the enzymes cyclooxygenase-1 (COX-1) and cyclooxygenase -2 (COX-2). These enzymes synthesise prostaglandins that are believed to cause inflammation, pain and fever. It is a non-steroidal, anti-inflammatory drug that has pain relieving, anti-inflammatory and antipyretic effect because they interfere with the biosynthesis of prostaglandins by acting as inhibitors of COX enzymes.
Pharmacodynamics
It inhibits the production of prostaglandins by COX-1 and COX-2 inhibition which is one of the many ways it acts in several inflammatory pathways. Both peripheral and central nervous system areas experience pain alleviation, which influences how pain is transmitted through the dorsal horn and spinothalamic tract.
Pharmacokinetics
Absorption
Rate: Rapidly absorbed (85%)
Bioavailability: 80 to 100%.
Onset: Within 30 to 60 minutes.
Duration: Lasts 4 to 6 hours.
Peak Plasma Time
Adults
Conventional tablet: 120 minutes.
Chewable tablet: 62 minutes.
Oral suspension: 47 minutes.
Febrile Children
Chewable tablet: 86 minutes.
Oral suspension: 58 minutes.
Peak Plasma Concentration:
Conventional tablet: 20 mcg/mL.
Chewable tablet: 15 mcg/mL.
Oral suspension: 19 mcg/mL.
Distribution
Protein Binding: 90-99%; concentrations >20 mcg/mL.
Volume of Distribution (Vd):
Adults: 0. 12 L/kg.
Children: 0. 164 L/kg.
Metabolism
It is metabolized in the liver at a very fast rate, mainly by CYP2C9 enzyme; it is also metabolized by CYP2C19 by oxidation into inactive products.
Metabolites:
Metabolite A: Of these three the formula is I-(+)-2-[4’-(2-hydroxy-2-methylpropyl) phenyl] propionic acid.
Metabolite B: 2-[4-(2-carboxypropyl)phenyl]propionic acid, also known as ( + ) -2-[4 ’- (2-carboxypropyl)phenyl propionic acid.
Elimination/Excretion
Half-life:
Adults: 2 to 4 hours
Children (3 months to 1 year): 1. 6 hours
Children (day 3): 35 to 51 hours
Children (day 5): They spend between 20 to 33 hours in clinical practice each week. Mostly in the urine (50-60 %); less than 10% as the unchanged drug; the rest appeared in the feces within 24 hours.
Administration
It is administered orally or topically
Patient information leaflet
Generic Name: ibuprofen
Pronounced: EYE-bue-PROE-fen
Why do we use ibuprofen?
Ibuprofen is an anti-inflammatory drug that can be prescribed for inflammatory conditions, rheumatic diseases, pain, fever, menstrual pain and osteoarthritis.
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