REVISTA DERMATOLÓGICA JULIO 2004-2024, LOS AINES
En este bloque de noticias del año 2004 julio, se describen 10 artículos enfocados en los EFECTOS ADVERSOS de algunos antiinflamatorios no esteroideos (AINEs), NIMESULIDE, PARECOXIB (DYNASTAT), VALDECOXIB (BEXTRA). Valdecoxib ya fuera del mercado y Nimesulide prohibido en casi todo el mundo.
El Parecoxib recibió en el año 2005 una NO APROBACIÓN para su uso inyectable. Esta es una molécula similar al NIMESULIDE, VIOXX (del cual hablaré en próxima publicación), CELECOXIB (CELEBREX), inhibidora de la ciclooxigenasa II, (COX) para usarse como antipiretico y analgesico.
PERO TE DEJO ESTA PERLA: El parecoxib es una N-acil sulfonamida resultante de la condensación formal del VALDECOXIB, es decir es un PROFÁRMACO del VALDECOXIB, con esto quiero decirte que EL VALDECOXIB es la misma BEXTRA, que fue sacada del mercado en el año. 2005.
Entonces además de estar emparentado con esta molécula, también está relacionado con las SULFAS, (es una N-acil sulfonamida), de modo que si eres alérgico a ellas NO DEBERÍAS USAR este medicamento.
Sacan la BEXTRA (VALDECOXIB) DEL MERCADO, por sus grandes efectos adversos, y se vienen con una SIMILAR EL ROFECOXIB o DYNASTAT, el cual es un derivado del VALDECOXIB O BEXTRA, analiza los detalles.
También se menciona efectos secundarios de la popular ISOTRETINOINA para el acné y otras medicinas como la XELODA (capecitabina, agente quimioterapéutico), para el tratamiento del cáncer colorrectal, y el REMINYL (galantamina), para el tratamiento de la demencia por enfermedad de Alzheimer.
Saludos,,,
Dr. José Lapenta.
ENGLISH
In this news block from 2004, 10 articles are described focusing on the SIDE EFFECTS of some non-steroidal anti-inflammatory drugs (NSAIDs), NIMESULIDE, PARECOXIB (DYNASTAT), VALDECOXIB (BEXTRA). Valdecoxib is no longer on the market and Nimesulide is banned in almost the entire world.
Parecoxib received a NON-APPROVAL for injectable use in 2005. This is a molecule similar to NIMESULIDE, VIOXX (which I will discuss in a future post), CELECOXIB (CELEBREX), a cyclooxygenase II (COX) inhibitor for use as an antipyretic and analgesic.
BUT I WILL LEAVE YOU THIS PEARL: Parecoxib is an N-acyl sulfonamide resulting from the formal condensation of VALDECOXIB, that is, it is a PRODRUG of VALDECOXIB, with this I want to tell you that VALDECOXIB is the same BEXTRA, which was taken off the market in 2005.
So, in addition to being related to this molecule, it is also related to SULFAS, (it is an N-acyl sulfonamide), so if you are allergic to them, you SHOULD NOT USE this medication.
They take BEXTRA (VALDECOXIB) OFF THE MARKET, due to its major adverse effects, and they come out with a SIMILAR ROFECOXIB or DYNASTAT, which is a derivative of VALDECOXIB OR BEXTRA, analyze the details.
Side effects of the popular acne drug ISOTRETINOIN, and other drugs such as XELODA (capecitabine, a chemotherapy agent), for the treatment of colorectal cancer, and REMINYL (galantamine), for the treatment of Alzheimer's disease dementia, are also mentioned.
Greetings...
Dr. José Lapenta R.
NIMESULIDE(AULIN), PARECOXIB (DYNASTAT), BEXTRA (VALDECOXIB), XELODA (CAPECITABINE), REMINYL(GALANTAMINE), ISOTRETINOIN,(ROACCUTANE, ACCUTANE, ISOFACE)
1.) Upper gastrointestinal bleeding associated with the use of NSAIDs: newer versus older agents.
4.) Drugs Approved by the FDA/ Drug Name: Reminyl (galantamine hydrobromide).
8.) Parecoxib: new preparation: no proven advantage.
9.) Bextra /Bextra attracts the spotlight for blatant commercial use of academic journals.
10.) Prolonged thrombocytopenia associated with isotretinoin.
1.) Upper gastrointestinal bleeding associated with the use of NSAIDs: newer versus older agents.
2.) Nimesulide-induced severe hemolytic anemia and acute
liver failure leading to liver transplantation.
3.) REMINYL (Galantamine) Reduces Rate of Alzheimer's Disease Progression By More Than 50 Percent Over Four Years of Therapy.
4.) Drugs Approved by the FDA/ Drug Name: Reminyl
(galantamine hydrobromide)
Drugs Approved by the FDA/
Drug Name: Reminyl (galantamine hydrobromide)
Source: http://www.centerwatch.com/
The following information is obtained from various
newswires, published medical journal articles, and medical
conference presentations.
Company: Janssen Pharmaceutica
Approval Status: Approved February 2001
Treatment for: Mild to moderate dementia of the Alzheimer's
type
General Information
Reminyl is an Alzheimer's treatment derived from the bulbs
of the daffodil, Narcissus pseudonarcissus. It is believed
that neurons producing the neurotransmitter acetylcholine
degenerate in the brains of patients with Alzheimer's
disease. This loss of acetylcholine has been correlated with
decreased cognitive function (thinking, remembering and
reasoning). Reminyl works to increase the concentration of
acetylcholine by blocking the action of
acetylcholinesterase, an enzyme that catalyzes the
hydrolysis (break down) of acetylcholine.
An estimated four million Americans have Alzheimer's
disease -- a progressive loss of cognitive function so
severe that it interferes with an individual's ability to
function. The number is expected to grow to 14 million by
the middle of the next century. The disorder is the
third-most expensive illness in the United States, behind
only heart disease and cancer.
Reminyl was developed by the Janssen Research Foundation
under a co-development and licensing agreement with the
UK-based Shire Pharmaceuticals. The drug will be marketed
by Janssen Pharmaceutica and Ortho-McNeil Pharmaceutical
in the United States.
Clinical Results
In trials ranging from 12 to 26 weeks, the effectiveness of
Reminyl was measured using two primary tools. Subjects'
abilities in terms of memory, orientation, reasoning and
language were assessed using the cognitive portion of the
Alzheimer's Disease Assessment Scale (ADAS-cog). Across all
trials, results demonstrated that more subjects taking
Reminyl showed significant improvement in their cognitive
performance than subjects taking placebo.
The second primary measure of effectiveness was the
Clinician's Interview-Based Impression of Change plus
Caregiver Information (CIBIC-plus), which provides an
overall assessment of patient functioning - including
behavior, organized thinking and activities of daily
living (such as dressing, eating and managing family
finances). The CIBIC-plus results from all trials also
showed that the overall scores for subjects taking Reminyl
were statistically superior to placebo.
Side Effects
Adverse events reported with Reminyl use include (but are
not limited to) the following:
NauseaVomitingDiarrheaAnorexiaWeight loss
The most frequent adverse events associated with the use
of Reminyl can be minimized by following the recommended
dosage and administration.
Because this list is not all-inclusive, please consult a
physician to discuss any side effects and the individual
appropriateness of the drug.
Mechanism of Action
Galantamine, a tertiary alkaloid, is a competitive and
reversible inhibitor of acetylcholinesterase. While the
precise mechanism of galantamine's action is unknown, it may
exert its therapeutic effect by enhancing cholinergic
function. This is accomplished by increasing the
concentration of acetylcholine through reversible inhibition
of its hydrolysis by cholinesterase. If this mechanism is
correct, galantamine's effect may lessen as the disease
process advances and fewer cholinergic neurons remain
functionally intact. (from Reminyl Prescribing Information).
Additional Information
Reminyl is given in a tablet formulation, with 4 mg, 8 mg or
12 mg dosages. The drug should be taken twice a day,
preferably with morning and evening meals.
For more information on Reminyl, please visit Janssen
Pharmaceutica.
Additional information on Alzheimer's disease can be
obtained by visiting the Alzheimer's Association.
Source: http://cancerconsultants.com/
6.) VALDECOXIB Y PARECOXIB SÓDICO: SEVERAS REACCIONES CUTÁNEAS Y DE HIPERSENSIBILIDAD.
7.) DYNASTAT / Parecoxib.
Souurce: Http://www.medsafe.govt.nz/
All medicines have risks and benefits. Your doctor has weighed the risks of you using DYNASTAT against the benefits they expect it will have for you.
If you have any concerns about being given this medicine, ask your doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What DYNASTAT is used for
DYNASTAT is used for the prevention and treatment of pain. It can be used to relieve pain and reduce inflammation (swelling and soreness) which may occur after surgery.
Although DYNASTAT can relieve the symptoms of pain and inflammation, it will not cure your condition.
DYNASTAT belongs to a family of medicines called Coxibs. These medicines work by relieving pain and inflammation.
Your doctor may have prescribed DYNASTAT for another reason.
Ask your doctor if you have any questions about why DYNASTAT has been prescribed for you.
DYNASTAT is not addictive.
This medicine is available only with a doctor's prescription.
Before you are given DYNASTAT
When you must not use it
Do not use DYNASTAT if:
you have an allergy to:
parecoxib sodium or valdecoxib
any of the ingredients listed at the end of this leaflet
sulfonamides, a group of medicines which include, for example, certain antibiotics (if you are not sure whether you are taking one of these medicines ask your pharmacist).
Symptoms of an allergic reaction to these medicines may include:
asthma, wheezing or shortness of breath
swelling of the face, lips or tongue which may cause difficulty in swallowing or breathing
hives, itching or skin rash
swelling, blistering or peeling of the skin
These symptoms may be severe if you are allergic to sulfonamides or to any of the ingredients listed at the end of this leaflet and you are given DYNASTAT.
Ask your doctor or pharmacist if any of this applies to you.
you have had an attack of asthma, hives, itching, skin rash or a runny nose after taking aspirin or Non-Steroidal Anti-Inflammatory Drugs (NSAIDs, medicines used to treat pain and inflammation).
Many medicines used to treat headache, period pain and other aches and pains contain aspirin or an NSAID. If you are not sure if you are taking any of these medicines, ask your doctor or pharmacist.
If you are allergic to aspirin or NSAIDs and use DYNASTAT, these symptoms may be severe.
If you are not sure whether you should be given DYNASTAT, talk to your doctor.
Before you are given it
Tell your doctor if:
you have any allergies to:
any other medicines including aspirin or other NSAID medicines
any other substances, such as foods, preservatives or dyes
you are pregnant or intend to become pregnant.
DYNASTAT may affect your developing baby if taken during pregnancy.
Use of DYNASTAT during pregnancy is not recommended. Discuss this with your doctor.
you are breastfeeding or intend to breastfeed.
It is not known whether DYNASTAT passes into breast milk or whether your baby might be affected. Therefore, breastfeeding should be discontinued during treatment with DYNASTAT.
Discuss this with your doctor.
you have or have had any medical conditions, especially the following:
kidney or liver disease
heart problems or heart surgery
high blood pressure, heart failure or fluid retention
dehydration
asthma or other allergic conditions
peptic ulcer (ie stomach or duodenal ulcer), a recent history of one, or have had peptic ulcers before
you currently have an infection.
If you are given DYNASTAT while you have an infection, it may hide some of the signs of an infection.
If you have not told your doctor about any of the above, tell them before you are given DYNASTAT.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you buy without a prescription from your pharmacy, supermarket or health food shop.
Some medicines may interfere with DYNASTAT. These include:
aspirin, salicylates or other NSAID medicines
warfarin, a medicine used to stop blood clots
lithium, a medicine used to treat some types of depression
diuretics, also called fluid or water tablets
medicines used to treat high blood pressure
medicines used to treat diabetes
methotrexate, a medicine used to treat arthritis and some cancers
fluconazole and ketoconazole, both are anti-fungal agents
anaesthetics
These medicines may be affected by DYNASTAT, or may affect how well it works. You may need to take different amounts of your medicine, or you may need to take different medicines. Your doctor will advise you.
Your doctor and pharmacist may have more information on medicines to be careful with or avoid while taking DYNASTAT.
How to use DYNASTAT
How much to use
DYNASTAT will be given to you by your doctor. It is diluted and given by injection into a vein or IV line or into a muscle.
Follow all directions given to you by your doctor and pharmacist carefully. They may differ from the information in this leaflet.
The usual recommended dose is a single 40 mg injection.
Your doctor may adjust the dosage you are given depending on your condition.
Ask your doctor if you want more information about the dose of DYNASTAT and how it is given.
If you are given too much (overdose)
Immediately advise your doctor if you think you have been given too much DYNASTAT. Do this even if there are no signs of discomfort or poisoning. You may need urgent medical attention.
The symptoms of being given too much DYNASTAT may include the effects listed under the heading, "Side effects" in this leaflet.
While you are using DYNASTAT
Things you must do
If you become pregnant while receiving DYNASTAT, tell your doctor immediately.
If you are about to start taking any new medicine, tell your doctor and pharmacist that you are using DYNASTAT.
Tell all of the doctors, dentists, and pharmacists who are treating you that you are using DYNASTAT.
Things you must not do
Do not take any other medication unless your doctor is aware of it.
Things to be careful of
Be careful driving or operating machinery until you know how DYNASTAT affects you.
Side Effects
Check with your doctor as soon as possible if you have any problems when given DYNASTAT, even if you do not think the problems are connected with the medicine or are not listed in this leaflet.
Like other medicines, DYNASTAT can cause some side effects. If they occur, most are likely to be minor and temporary. However, some may be serious and need medical attention.
Ask your doctor or pharmacist to answer any questions you may have.
Tell your doctor if you notice any of the following:
changes in blood pressure
dizziness or light-headedness due to low blood pressure
back pain
a reduced sense of touch
stomach upset including nausea (feeling sick), vomiting, heartburn, indigestion, cramps
constipation, diarrhoea, pain in the stomach, wind
sleeplessness
irritability
sore throat
Tell your doctor immediately if you notice any of the following:
slow heart beat
severe or persistent headache
bleeding or bruising more easily than normal, reddish or purplish blotches under the skin
signs of anaemia, such as tiredness, being short of breath, and looking pale
unusual weight gain, swelling of ankles or legs
a change in the amount or frequency of urine passed
infection of any wounds
itching, skin rash or swelling, blistering or peeling of the skin.
swelling of the face, lips, mouth, tongue or throat which may cause difficulty in swallowing or breathing.
These are serious side effects. You may need urgent medical attention.
Other side effects not listed above may also occur in some patients. Tell your doctor if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any of them.
After using DYNASTAT
Storage
DYNASTAT will normally be stored in a hospital or doctor's surgery. It should be stored below 25 C and should be protected from light (kept in the original packaging before use). DYNASTAT must not be kept in a refrigerator or freezer.
Product Description
What it looks like
DYNASTAT comes in single-use glass vials, and requires dilution with normal saline before use. It is a white to off-white powder.
DYNASTAT may be supplied along with normal saline in glass ampoules for dilution. When diluted, DYNASTAT is a clear and colourless solution.
Ingredients
The active ingredient in DYNASTAT is parecoxib (as parecoxib sodium).
DYNASTAT contains 40 mg parecoxib per vial.
DYNASTAT also contains sodium phosphate - dibasic, phosphoric acid and sodium hydroxide.
Identification
DYNASTAT can be identified by an Australian Register number which is found on the carton:
DYNASTAT 40 mg - AUST R 82525*
DYNASTAT 40 mg with saline diluent - AUST R 82509
* Not available in New Zealand
Supplier
DYNASTAT is supplied in Australia by:
Pfizer Australia Pty Ltd
ABN 50 008 422 348
38-42 Wharf Road
West Ryde NSW 2114
Toll Free Number: 1800 675 229
DYNASTAT is supplied in New Zealand by:
Pfizer New Zealand Ltd
PO Box 3998
Auckland
Toll Free Number: 0800 736 363
This leaflet was last revised in July 2004.
Registered trademark
Copyright Pfizer Australia Pty Ltd, 2003
8.) Parecoxib: new preparation. A NSAID for postoperative pain: no proven advantage.
9.) Bextra /Bextra attracts the spotlight for blatant commercial use of academic journals.
10.) Prolonged thrombocytopenia associated with isotretinoin.
Produced by Dr. José Lapenta R. Dermatologist
Venezuela
1.998-2.024
Producido por Dr. José Lapenta R. Dermatólogo Venezuela 1.998-2.0024
Tlf: 0414-2976087 - 04127766810