A Milestone Moment: FDA Approves Addyi® for Hypoactive Sexual Desire Disorder in Postmenopausal Women
December 17, 2025
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Brand Name :
Vioxx
Synonyms :
rofecoxib
Class :
Cox-2 inhibitors
Brand Name :
Vioxx
Synonyms :
rofecoxib
Class :
Cox-2 inhibitors
Dosage Forms & Strengths
Tablet
12.5 mg
25 mg
50 mg
Suspension
12.5 mg/5 ml
25 mg/5 ml
12.5
mg
Orally
once a day
Increase to 25 mg orally once a day
25 - 50
mg
Orally
once a day
50
mg
Orally
once a day
not more than 5 days
Dose Adjustments
Mild hepatic impairment: 60 mg daily
Moderate hepatic impairment: 30 mg once a day or 60 mg on alternate days
Take a dose of 12.5 mg orally one time in a day
Take a dose of 25 to 50 mg orally one time in a day
Take a dose of 50 mg orally one time in a day for not more than 5 days
Take a dose of 25 mg orally one time in a day
Dosage Forms & Strengths
Tablet
12.5 mg
25 mg
50 mg
Suspension
12.5 mg/5 ml
25 mg/5 ml
For 3 to 11 years old:
Take a dose of 1 mg/kg suspension orally and administered 45 minutes prior to induction of anesthesia
For 2 to 17 years old:
Take a dose of 0.6 mg /kg to a maximum of 25 mg orally daily
when bromazepam and rofecoxib are used together, there is a potential reduction in the bromazepam's metabolism
When loracarbef is used together with rofecoxib, the risk or seriousness of nephrotoxicity is enhanced
When rofecoxib is used together with bufexamac, this leads to enhanced risk or seriousness of adverse outcomes
may decrease triethylenetetramine elimination, raising serum levels
the rate of excretion of phosphoric acid may be decreased
Actions and Spectrum
Rofecoxib selectively inhibits the enzyme COX-2. It reduces the production of prostaglandins associated with inflammation, providing relief from pain and inflammation.
Frequency not defined
Cough
Headache
Heartburn
Sneezing
Congestion in chest
Fever
Loss of energy or weakness
Nausea
Stuffy or runny nose
Sore throat
Black Box Warning
None
Black Box Warning
None
Pregnancy consideration:
Pregnancy category: US FDA pregnancy category is C
Lactation: Excretion into human milk is unknown
Pregnancy Categories:
Category A: Studies that were well-controlled and met expectations revealed no risk to the fetus in either the first or second trimester.
Category B: There were a lack of studies on pregnant women and no evidence of risk to the fetus in animal experiments
Category C: There was evidence of risk of adverse effects in animal reproduction studies, and no adequate evidence in human studies must take care of potential risks in pregnant women.
Category D: Adequate data with sufficient evidence of human fetal risk from various platforms, but despite the potential risk, and used only in emergency cases for potential benefits.
Category X: Drugs listed in this category outweigh the risks over benefits. Hence, these categories of drugs need to be avoided by pregnant women.
Category N: There is no data available for the drug under this category.
Pharmacology
Rofecoxib selectively inhibits the COX-2 enzyme.
COX-2 is responsible for the conversion of arachidonic acid to prostaglandins, which play a role in inflammation, pain, and fever.
Pharmacodynamics
Prostaglandins are lipid compounds with various physiological effects, including inflammation, pain, and fever.
Rofecoxib decreases the synthesis of prostaglandins associated with inflammation, leading to anti-inflammatory effects.
Pharmacokinetics
Absorption
Rofecoxib is well-absorbed after oral administration.
Distribution
Rofecoxib is distributed throughout the body.
Metabolism
Rofecoxib undergoes extensive metabolism in the liver.
Elimination and excretion
Rofecoxib is excreted in both urine and feces.
Administration
Rofecoxib is taken orally, and it is available in the form of tablet, capsule, and suspension form.
Patient information leaflet
Generic Name: rofecoxib
Why do we use rofecoxib?
Rofecoxib is indicated for the treatment of osteoarthritis.
Rofecoxib is also used in the management of rheumatoid arthritis.
Rofecoxib is used for the management of acute pain and Dysmenorrhea.
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