Minggu, 24 Juli 2011

Re: [Dokter Umum] Mohon informasinya... Efek samping cataflam 50mg untuk penggunaan jangka panjang

 

Hello,
Sangat luar biasa menggunakan obat prescriptions selama 2 tahun dg urus
diri sendiri, tanpa kontrol, tanpa pemeriksaan n monitoring.
Barangkali hal ini disebabkan oleh pola pikir bahwa: sakit apa; bom dg
obat apa yg menjadikanya.

Coba simak:
==========
Warnings
==========
Cardiovascular Effects:
Cardiovascular Thrombotic Events: Clinical trials of several
cyclooxygenase-2 (COX-2) selective and nonselective NSAIDs of up to 3
years in duration have shown an 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. Patients with known CV disease or risk factors for CV
disease may be at greater risk. To minimize the potential risk for an
adverse CV event in patients treated with an NSAID, the lowest effective
dose should be used for the shortest duration possible. Physicians and
patients should remain alert for the development of such events, even in
the absence of previous CV symptoms. Patients should be informed about
the signs and/or symptoms of serious CV events and the steps to take if
they occur.

There is no consistent evidence that concurrent use of aspirin mitigates
the increased risk of serious CV thrombotic events associated with NSAID
use. The concurrent use of aspirin and an NSAID does increase the risk
of serious GI events (see text on Gastrointestinal Effects).

Two large, controlled, clinical trials of a COX-2 selective NSAID for
the treatment of pain in the first 10-14 days following CABG surgery
found an increased incidence of myocardial infarction and stroke (see
Contraindications).

Hypertension: NSAIDs, including diclofenac, can lead to an onset of new
hypertension or worsening of preexisting hypertension, either of which
may contribute to the increased incidence of CV events.

Patients taking thiazides or loop diuretics may have impaired response
to these therapies when taking NSAIDs. NSAIDs, including diclofenac,
should be used with caution in patients with hypertension. Blood
pressure should be monitored closely during the initiation and
throughout the course of NSAID treatment.

Congestive Heart Failure and Edema: Fluid retention and edema have been
observed in some patients taking NSAIDs. Cataflam/Cataflam D should be
used with caution in patients with fluid retention or heart failure.

Gastrointestinal Effects: Risk of Ulcerations, Bleeding and
Perforations: NSAIDs, including diclofenac, can cause serious GI adverse
events including inflammation, bleeding, ulceration and perforation of
the stomach, small or large intestine, which can be fatal. These various
adverse events can occur any time, with or without warning symptoms, in
patients treated with NSAIDs. Only 1 in 5 patients who develop serious
upper GI adverse events while on NSAID therapy, is symptomatic. Upper GI
ulcers, gross bleeding or perforation caused by NSAIDs occur in
approximately 1% of patients treated for 3-6 months and in about 2-4% of
patients treated for 1 year. This trend continues with longer duration
of use, increasing the likelihood of developing a serious GI event at
some time during the course of therapy. However, even short-term therapy
is not without risk.

NSAIDs should be prescribed with extreme caution in those with a prior
history of ulcer disease or GI bleeding. Patients with a prior history
of peptic ulcer disease and/or GI bleeding who use NSAIDs have a
>10-fold increased risk of developing GI bleeding compared to patients
with neither of these risk factors. Other factors that increase the risk
of GI bleeding in patients treated with NSAIDs include concomitant use
of oral corticosteroids or anticoagulants, longer duration of NSAID
therapy, smoking, use of alcohol, older age and poor general health
status. Most spontaneous reports of fatal GI events are in the elderly
or in debilitated patients and therefore, special care should be taken
in treating this population.

To minimize the potential risk for an adverse GI event in patients
treated with an NSAID, the lowest effective dose should be used for the
shortest possible duration. Patients and physicians should remain alert
for signs and symptoms of GI ulceration and bleeding during NSAID
therapy and promptly initiate additional evaluation and treatment if a
serious adverse event is suspected. For high-risk patients, alternate
therapies that do not involve NSAIDs should be considered.

Gastrointestinal bleeding, ulceration or perforation, which can be
fatal, have been reported with all NSAIDs and may occur at any time
during treatment, with or without warning symptoms or a previous history
of serious GI events. They generally have more serious consequences in
the elderly. If GI bleeding or ulceration occur in patients receiving
Cataflam/Cataflam D, it should be withdrawn.

Renal Effects: Long-term administration of NSAIDs has resulted in renal
papillary necrosis and other renal injury. Renal toxicity has also been
seen in patients in whom renal prostaglandins have a compensatory role
in the maintenance of renal perfusion. In these patients, administration
of an NSAID may cause a dose-dependent reduction in prostaglandin
formation and secondarily, in renal blood flow, which may precipitate
overt renal decompensation. Patients at greatest risk of this reaction
are those with impaired renal function, heart failure, liver
dysfunction, those taking diuretics and angiotensin-converting enzyme
(ACE) inhibitors and the elderly. Discontinuation of NSAID therapy is
usually followed by recovery to the pre-treatment state.

Advanced Renal Disease: No information is available from controlled
clinical studies regarding the use of Cataflam/Cataflam D in patients
with advanced renal disease. Therefore, treatment with Cataflam/Cataflam
D is not recommended in these patients. If Cataflam/Cataflam D therapy
must be initiated, close monitoring of the patient's renal function is
advisable.

Anaphylactoid Reactions: As with other NSAIDs, anaphylactoid reactions
may occur in patients without known prior exposure to Cataflam/Cataflam
D. Cataflam/Cataflam D 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 (see
Contraindications). Emergency help should be sought in cases where
anaphylactoid reaction occur.

As with other NSAIDs, allergic reactions, including
anaphylactic/anaphylactoid reactions, can also occur in rare cases
without earlier exposure due to diclofenac.

Like other NSAIDs, Cataflam/Cataflam D may mask the sign and the
symptoms of infection due to its pharmacodynamic properties.

Skin Reactions: NSAIDs, including diclofenac, can cause serious skin
adverse events (very rarely) eg, exfoliative dermatitis, Stevens-Johnson
Syndrome and toxic epidermal necrolysis, which can be fatal. These
serious events may occur without warning. Patients appear to be at
highest risk of these reactions early in the course of therapy, the
onset of the reaction occurring in majority of cases within the 1st
month of treatment. Patients should be informed about the signs and
symptoms of serious skin manifestations and the use of Cataflam/Cataflam
D should be discontinued at the 1st appearance of skin rash or any other
sign of hypersensitivity.

================
Special Precautions
================
General: The concomitant use of Cataflam/Cataflam D with systemic
NSAIDs including COX-2 selective inhibitors, should be avoided due to
the absence of any evidence demonstrating synergistic benefits and the
potential for additive undesirable effects.

Cataflam tablets contain sucrose and therefore are not recommended for
patients with rare hereditary problems of fructose intolerance,
glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

Preexisting Asthma: In patients with asthma, seasonal allergic rhinitis,
swelling of the nasal mucosa (ie, nasal polyps), chronic obstructive
pulmonary diseases or chronic infections of the respiratory tract
(especially if linked to allergic rhinitis-like symptoms), reactions on
NSAIDs eg, asthma exacerbations (so-called intolerance to
analgesics/analgesics-asthma), Quincke's oedema or urticaria are more
frequent than in other patients. Therefore, special precaution is
recommended in such patients (readiness for emergency). This is
applicable as well for patients who are allergic to other substances eg,
with skin reactions, pruritus or urticaria.

Gastrointestinal Effects: As with all NSAIDs, including diclofenac,
close medical surveillance is imperative and particular caution should
be exercised when prescribing Cataflam/Cataflam D in patients with
symptoms indicative of GI disorders or with a history suggestive of
gastric or intestinal ulceration, bleeding or perforation (see Adverse
Reactions). The risk of GI bleeding is higher with increasing NSAID
doses and in patients with a history of ulcer (particularly if
complicated with haemorrhage or perforation) and in the elderly.

To reduce the risk of GI toxicity in patients with a history of ulcer
(particularly if complicated with haemorrhage or perforation) and in the
elderly, the treatment should be initiated and maintained at the lowest
effective dose.

Combination therapy with protective agents (eg, proton-pump inhibitors
or misoprostol) should be considered for these patients and also for
patients requiring concomitant use of medicinal products containing
low-dose acetylsalicylic acid (ASA)/aspirin or other medicinal products
likely to increase GI risk.

Patients with a history of GI toxicity, particularly the elderly, should
report any unusual abdominal symptoms (especially GI bleeding). Caution
is recommended in patients receiving concomitant medications which could
increase the risk of ulceration or bleeding eg, systemic
corticosteroids, anticoagulants, antiplatelet agents or selective
serotonin re-uptake inhibitors (see Interactions).

Close medical surveillance and caution should also be exercised in
patients with ulcerative colitis or Crohn's disease, as their condition
may be exacerbated (see Adverse Reactions).

Hepatic Effects: Close medical surveillance is required when prescribing
Cataflam/Cataflam D to patients with impaired hepatic function, as their
condition may be exacerbated.

As with other NSAIDs, including diclofenac, values of 1 or more liver
enzymes may increase. During prolonged treatment with Cataflam/Cataflam
D, regular monitoring of hepatic function is indicated as a
precautionary measure. If abnormal liver function tests persist or
worsen, if clinical signs or symptoms consistent with liver disease
develop, or if other manifestations occur (eg, eosinophilia, rash),
Cataflam/Cataflam D should be discontinued. Hepatitis may occur with the
use of diclofenac without prodromal symptoms.

Caution is called for when using Cataflam/Cataflam D in patients with
hepatic porphyria, since it may trigger an attack.

Renal Effects: As fluid retention and oedema have been reported in
association with NSAID therapy, including diclofenac, particular caution
is called for in patients with impaired cardiac or renal function,
history of hypertension, the elderly, patients receiving concomitant
treatment with diuretics or medicinal products that can significantly
impact renal function, and in those patients with substantial
extracellular volume depletion from any cause eg, before and after major
surgery (see Contraindications).

Monitoring of renal function is recommended as a precautionary measure
when using Cataflam/Cataflam D in such cases. Discontinuation of therapy
is normally followed by recovery to the pre-treatment state.

Haematological Effects: Use of Cataflam/Cataflam D is recommended only
for short-term treatment. If, however, Cataflam/Cataflam D is used for a
prolonged period, monitoring of the blood count is recommended, as with
other NSAIDs.

Like other NSAIDs, Cataflam/Cataflam D may temporarily inhibit platelet
aggregation. Patients with defects of haemostasis should be carefully
monitored.

Effects on the Ability to Drive and Use Machinery: Patients experiencing
visual disturbances, dizziness, vertigo, somnolence or other central
nervous system disturbances while taking Cataflam/Cataflam D, should
refrain from driving or using machines.

Impairment of Fertility: As with other NSAIDs, the use of
Cataflam/Cataflam D may impair female fertility and is not recommended
in women attempting to conceive. In women who have difficulties
conceiving or who are undergoing investigation of infertility,
withdrawal of Cataflam/Cataflam D should be considered.

Use in pregnancy & lactation: The use of diclofenac in pregnant women
has not been studied. Therefore, Cataflam/Cataflam D should not be used
during the 1st 2 trimesters of pregnancy unless the potential benefit to
the mother outweighs the risk to the foetus. As with other NSAIDs, use
of diclofenac during the 3rd trimester of pregnancy is contraindicated
owing to the possibility of uterine inertia and/or premature closure of
the ductus arteriosus (see Contraindications). Animal studies have not
shown any directly or indirectly harmful effects on pregnancy,
embryonal/fetal development, parturition or postnatal development (see
Toxicology under Actions).

Following oral doses of 50 mg administered every 8 hrs, diclofenac
passes into the breast milk in small amounts. Therefore,
Cataflam/Cataflam D should not be administered during breastfeeding in
order to avoid undesirable effects in the infant.

Use in the elderly: Caution is indicated in the elderly on basic medical
grounds. In particular, it is recommended that the lowest effective dose
be used in frail elderly patients or those with low body weight.

Jadi tdk sekedar siklus yg perlu diperhatikan,
Juga persolan kenapa jerawatnya demikian lebih butuh penanganan yg baik
n benar dari sekedar memberikan NSAIDs n merusak tatanan tubuh lainya yg
justru lebih kritikal n berbahaya.
Your body, your choice!
Kelihatanya dari tulisan anada bukan hendak menghentikan penggunaan
tetapi mencari pembenaran n meredam side effect.
Maka baca dg saksama diatas, n ambil keputusan.
Again, Your body, your choice!

Sallam,

On 7/25/2011 1:09 AM, RatnaA wrote:
> Dokter dan teman milis.. saya minta info nya untuk efek samping penggunaan cataflam 50mg. saya sudah mngkonsumsi slma 2 tahun. namun, saya mengkonsumsi hnaya ketika terjadi pembengkakan dan infeksi pada jeawat. saya konsumsi 1x sehari pada mlm hari selama 10 hari-an hingga jerawat saya sudah tidak infeksi lagi. sblmnya, saya dikasih resep oleh dokter, namun krn merasa cocok, saya konsumsi sendiri tanpa resep dokter krn saya jarang konsultasi ke dokter tsb.
> Apakah ada efek samping jjangka panjang? jika ya, apakah penghentian obat akan menyembuhkan efk samping tsb?
> selain itu saya juga pernah diberi roaccutant, dan saya pernah konsumsi lebih dari 2 tahun (sekitar saya kelas 2 smp - 2sma ) saya dengar efek samping yg bgtu berbahaya untuk rahim. dulu, saya belum ada pengetahuan yang cukup dan dokter pun tidak transparan dalam menjelaskan efek samping yang ada. kini, saya sudah hampir 6 tahun stop roaccutant, kata dokter, roaccutant akan sendirinya dinetralisir oleh tubuh dalam jangka waktu tertentu. apakah benar demikian??? jika tidak, apa yang harus saya lakukan untuk mengantisipasi efek jangka panjang roaccutant???
> *sekedar info, slm ini siklus haid saya normal dan tidak mengalami maslah serius..
>
> Mohon informasinya yaa teman milis sekalian. saya cukup takut juga dengan obat - obat yang diberikan oleh dokter kecantikan saya.
>
> Salam,
>
> Ratna
>
>
>
> ------------------------------------
>
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>
>
>
>

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