Kickas.org Forums Treatments, Drugs and Alternatives AS Pharmacy Vioxx (Rofecoxib)

BRAND NAMES

Dolib (India); Flanax (Colombia); Rofetab (India); Sivoz (Colombia); Vioxx (Australia, New-Zealand, France, Germany, Colombia, Mexico, Peru, Hong-Kong, Philippines, Thailand, South-Africa, Israel)

DRUG CLASS

Rofecoxib is a nonsteroidal anti-inflammatory agent.

MECHANISM OF ACTION

Rofecoxib, a methylsulfonylphenyl-substituted furanone derivative, is a nonsteroidal anti-inflammatory agent (NSAIA). Rofecoxib is a selective inhibitor of cyclooxygenase-2 (COX-2) and is structurally and pharmacologically related to celecoxib (celebrex). Because the goal of selective inhibitors of COX-2 is to inhibit COX-2 but not COX-1, the drugs also have been referred to as COX-1-sparing NSAIAs. Rofecoxib differs structurally and, to some extent, pharmacologically from prototypical NSAIAs, which inhibit cyclooxygenase-1 (COX-1) and -2 (COX-2).

Although the overall structures of COX-1 and -2 are similar, an important difference between the 2 isoforms of cyclooxygenase is the presence of a much larger NSAIA binding site on COX-2 compared with the NSAIA binding site on COX-1. It has been postulated that this larger binding site gives access to a sidepocket that may be the binding site for many selective COX-2 inhibitors.

Rofecoxib is a selective inhibitor of the cyclooxygenase-2 (COX-2) isoform of prostaglandin endoperoxide synthase (prostaglandin G/H synthase, PGSH). It exhibits many of the pharmacologic actions of other NSAIAs, including anti-inflammatory, analgesic, and antipyretic activity via the inhibition of prostaglandin synthesis.

CONTRAINDICATIONS

Significant - ASA allergy, severe renal function impairment, predisposition to gastrointestinal hemorrhage, history of peptic ulcer, methotrexate*.

Possibly Significant - extrinsic asthma (allergic, childhood asthma), congestive heart failure, dehydration, edema, hepatic function impairment, hypertension, anticoagulants, lithium.

SPECIAL CONCERNS

Limited information is available on the acute toxicity of rofecoxib in humans.

There are no adequate or controlled studies to date using rofecoxib in pregnant women or during labor and delivery, and the drug should be used during pregnancy only when the potential benefits justify the possible risks to the fetus. Rofecoxib should not be used during the third trimester of pregnancy, since inhibitions of prostaglandin synthesis may have adverse effects on the fetal cardiovascular system (e.g., premature closure of the ductus arteriosus). The manufacturer maintains a registry to monitor pregnancy outcomes in women exposed to rofecoxib during pregnancy. Patients may be enrolled by calling 800-986-8999.

Additionally, because of the potential for serious adverse reactions to rofecoxib in nursing infants, a decision should be made whether to discontinue nursing or the drug, taking into account the importance of the drug to the woman.

SIDE EFFECTS

Less Frequent - hypertension, influenza-type disease, peripheral edema, sinusitis, upper respiratory infection, urinary tract infection, abdominal pain, asthenia/fatigue, back pain, bronchitis, diarrhea, dizziness, dyspepsia, headache, heartburn, nausea, abdominal tenderness, abscess, angina pectoris, asthma, atrial fibrillation, basal cell carcinoma, chest pain, conjunctivitis, bruising/contusion, cystitis, diaphragmatic hernia, esophagitis, fungal infection, infectious gastroenteritis, hematochezia (bloody stools), herpes zoster infection, irregular heartbeat, otitus media, palpitations, pneumonia, postoperative pain, premature ventricular contraction, syncope (fainting), tachycardia, tonsillitis, venous insufficiency, abdominal distension, acid reflux, allergic rhinitis, allergy, alopecia, anxiety, aphthous stomatitis, appetite change, arm pain, arthralgia, atopic dermatitis, blister of skin, blurred vision, bradycardia, breast mass, bursitis, chills, constipation, contact dermititis, cough, dental caries, dental pain, depression, digestive gas symptoms, dry mouth, dry throat, dysguesia, dyspnea, dysuria, epistaxis, fever, flatulence, fluid retention, flushing, gastritis, gastroenteritis, hemmoroids, herpes simplex, hypercholesterolemia, hypesthesia/paresthesia, injury/trauma, insomnia, joint swelling, laceration, laryngitis, menstrual disorder, decreased mental activity, migrane, muscle cramps, muscle weakness, muscular spasm, musculoskeletal pain, musculoskeletal stiffness, nail unit disorder, nasal congestion, nocturia, oral cavity disorders, osteoarthrosis, otic pain, pain, pelvic pain, pharyngitis, pruritus, pulmonary congestion, rash, sciatica, skin erythema, somnolence, tendonitis, tinnitus, urinary retention, urticaria, vaginitis, vertigo, vomiting, weight gain.

*Re: Methotrexate/Refecoxib Drug Interactions: Clinically important drug interactions may occur when rofecoxib is used concomitantly with methotrexate. Studies may indicate a decreased renal clearance of methotrexate in patients receiving methotrexate and refecoxib treatment concurrently. Thus, patients receiving rofecoxib and methotrexate should be monitored for possible methotrexate toxicity.

SOURCES

http://www.medscape.com
http://www.mdconsult.com; Mosby's Drug Consult

Edited by Strutsy on 03/18/02 04:19 PM (server time).

Vioxx (rofecoxib)

DESCRIPTION

Vioxx/Rofecoxib

Brand Name: Vioxx
Generic: Rofecoxib
Strength(s): 12.5mg & 25mg tablets or 12.5mg/5ml & 25mg/5ml suspension
Dosage Form(s): Tablets and oral suspension
Approved: May 21, 1999
Class: NSAID (COX-2 Inhibitors)
Manufactured by: Merck & Co., Inc.
Availability: Prescription only

What is Vioxx used for?

Vioxx is used to relieve:

Signs and symptoms of osteoarthritis
Acute pain in adults
Painful menstrual cycles.

Who should not take Vioxx?

You should not take Vioxx if you have experienced asthma, hives, or allergic-type reactions after taking aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs). A few examples of other NSAIDs are ibuprofen, naproxen, diclofenac, nabumetone, and ketoprofen.

Special Warnings with Vioxx:

Serious problems from stomach ulcers, such as bleeding, are well-known complications in people treated with NSAIDs. Similar problems have occurred in people treated with Vioxx, although very rarely. The likelihood of stomach problems increases the longer you take drugs like Vioxx. However, even short-term treatment is not without risk. These problems can happen without any warning, but in some people may cause symptoms such as gnawing or burning stomach pain, black or tarry stools, or vomiting. If this happens, stop taking Vioxx and call your health care provider right away.

Check with your health care provider. Vioxx may not be right for you, if you:

have had ulcers or stomach bleeding
have had asthma, hives, or allergic-type reactions after taking aspirin or other NSAIDs
have severe kidney problems
have severe liver problems
are pregnant

General Precautions with Vioxx:

Do not stop taking any medications that you have been prescribed without first talking to your doctor.

Serious problems such as liver damage have occurred in people treated with NSAIDs. Some of the warning signs of liver damage can be nausea, vomiting, fatigue, loss of appetite, itching, yellow coloring of skin or eyes, "flu-like" symptoms and dark urine. If you experience any of these symptoms, call your health care provider right away.

Vioxx can cause your body to retain fluid and swell. Your health care provider will decide if Vioxx is right for you, if you:

retain fluids
have high blood pressure
have heart failure

If you have asthma, you may have aspirin-sensitive asthma. If an aspirin-sensitive asthmatic takes aspirin it can cause severe narrowing of the airway (bronchospasm), and even death. Since this type of reaction to aspirin and other NSAIDs have occurred in aspirin-sensitive patients, Vioxx should not be given to aspirin-sensitive patients.

The safety and effectiveness of Vioxx in patients below the age of 18 years has not been determined.

How should I take Vioxx?

Read the patient information that comes with Vioxx before you start taking it and every time you renew your prescription in case the information has been updated.

You can take Vioxx with or without food. Your doctor will determine the dose you should take, depending on your condition and medical history.

Avoid taking Vioxx with antacids that contain calcium carbonate and magnesium/aluminum combination products, because they may reduce the amount of Vioxx your body absorbs.

Shake the liquid form of Vioxx before using.

What should I avoid while taking Vioxx?

Tell your health care provider if you are trying to become pregnant, are already pregnant, or are breast-feeding.

Because certain other medications can interact with Vioxx, review all medications that you are taking with your health care provider, including those that you take without a prescription.

Your health care provider may have to adjust your dose or monitor you more closely if you take:

certain blood pressure medications called ACE-inhibitors
furosemide
lithium
methotrexate
rifampin
warfarin
aspirin

What are some possible side effects of Vioxx? (This is NOT a complete list of side effects reported with Vioxx. Your health care provider can discuss with you a more complete list of side effects.)

Side effects can include:

Upper respiratory tract infection
Diarrhea
Nausea
Heartburn
Swelling of the lower legs or feet
High blood pressure

Rarely, serious ulcers have occurred in patients taking Vioxx.

For more detailed information about Vioxx, ask your health care provider.

SOURCE: US Food and Drug Administration, Consumer Drug Information
taken from Arthritis.about.com


Somedays it just doesn't pay to get out of bed.

I take 50 mg of vioxx and it works good for hands, knees and ankles but doesn't seem too good on back inflamation caused by A.S.



Somedays it just doesn't pay to get out of bed.

I take 25mg twice a day and it works great on my back.

Doug


Doug wanna lift?

Hi Phil,

I take 25 mg twice a day. It helped me in the beginning but now it isn't doing as good as it did. I does help with the pain for a few hours after I take it but should be lasting a lot longer. I hope it continues to work for everyone else. Gotta keep in mind...what works for one person might not work for everyone else.

Take care and hugggggggs,

Lisa

HAVE A SAFE, HAPPY AND PAIN FREE NEW YEAR !

In my case, Vioxx worked as it should - reducing inflamatiom without causing stomach dificulties - but unfortunately it caused the very disturbing symptoms of reversable depression.
I say reversable, because I stopped taking it and it went away. Depression is listed as one of the possible side effects. Anyone suffering from depression now has my full attention and sympathy - it is a mighty and terrible beast indeed.

Cheers,
  Loz  

I take 50mg of vioxx 1x per day. I find it keeps the pain at a just unberable level without taking it in combination with another pain med. I have found this of mose NSAIDS though.

Daniel


Keep on keepin on Kicking some AS

Edited by Strutsy on 01/05/02 01:49 PM (server time).

Hi Phil--
I was given Vioxx in May 2001, as I went to my Rheumy with major flares and difficulty breathing, etc...my rheumy normally gives out Celebrex, but the drug company that makes Vioxx gives samples, so she gave me many.....

well, after the entire summer on Vioxx, I developed symptoms of stomach bleeding....several times, mildly, and then once seriously...as well as elevated liver enzymes in blood tests....I stopped taking it and started taking alternative supplements that I'd taken before....MSM, Flax Seed Oil, Glucosamine Sulfate, SAMe, Grape Seed Extract...hey, whatever works for inflamation....!!!!

I'm fine at the moment, thank the powers that be!!!! I will take natural pills over the doc's any day....just from my experience..

Peace
Linc

Linc O'Brien

has anyone ever try vioxx and what do you think of it? Thanks.
i was diagnosed with a/s 12 years ago...went trough surgery, had 7 disks removed, first 7 in lower back, am now having problems with my neck, am now on vioxx and morphene fpr pain caused by a pinched nurve during surgery, great pain in right leg. I am new here so if anyone out there can help me it would be greatly apreciated. Thanks,



Edited by nbguy0 on 02/01/02 11:35 PM (server time).

Hi... I'm kinda new too. I didn't try Vioxx, but did try Celebrex and it did nothing for me. Others have said that Vioxx did something for them when Celebrex didnt.
I have been diagnosed for only 2 weeks, on diclofenac (an NSAID) and doxycyclene.
Got about 50% benefit from those meds, nothing more.
Darla