Dispersible tablet of meloxicam_8464

Document Sample
Dispersible tablet of meloxicam_8464 Powered By Docstoc
					Dispersible tablet of meloxicam

Specific information:

】 【is not prescription prescription

】 【is not whether health care

The main components of meloxicam, chemical known as 2 – methyl -4– hydroxy
– N-(5 – methyl -2– thiazolyl)-2H-1, 2 – benzothiazine -3– carboxamide
1,1 – dioxide.

Indications of the type used to treat the symptoms of rheumatoid arthritis,
pain, osteoarthritis (arthritis, back-shaped bone and joint disease) to treat
the symptoms.

Usage Dosage of oral, swallowing water or liquid delivery service. RA: 15 mg
per day (2), according to treatment reflects the dose can be reduced to 7.5 mg
(1 tablet) / day. Osteoarthritis: 7.5 mg (1) / day, if necessary, the dose may
be increased to 15 mg (2 tablets) / day. For the poor, a likely increase
patients: treatment of a starting dose of 7.5 mg (1 tablet) / day. tension
dialysis patients with renal failure Time: Dose should not exceed 7.5 mg (1
tablet) / day. separation of meloxicam tablets daily maximum recommended dose
is 15 mg (2.) dose combined with young children has not been established,
currently limited to adults.

adverse reflection of oceanic research data, according to reports: The
following list reflects the adverse tied separation of meloxicam tablets after
administration, but their frequency is based on the results of clinical trial
records, and no matter Merlot Kang Xi separation film is not a causal
relationship between drug use. This information is based on 3750 patients over
18 months, suffering from clinical trials to patients daily oral meloxicam
tablets or capsules or doses of 7.5 15 mg (the average time for drug treatment
127 days). gastrointestinal tract: the frequency of more than 1%: dyspepsia,
nausea, vomiting, abdominal pain, constipation, flatulence, diarrhea. the
frequency range between 0.1% and 1%: transient effectiveness indicator of
liver abnormalities (such as transaminases or bilirubin). esophagitis, gastric
ulcer, hidden or visible gastrointestinal bleeding. frequency of less than
0.1%: Gastrointestinal perforation, colitis. Blood: The frequency of more than
1%: anemia; between 0.1% and 1%: blood count disorders, including white blood
cell differential count, leukopenia and thrombocytopenia, and bone marrow
toxicity of potential drugs to use, especially methotrexate, is causing a
factor in reducing blood cells. dermatitis Studies: Frequency more than 1%:
pruritus, rash; between 0.1% and 1%: stomatitis, urticaria rash; less than
0.1%: photosensitivity. respiratory tract: the frequency is less than 0.1% :
has been reported in the use of aspirin or other NSAID, including meloxicam
tablets, after a separation of individuals with acute asthma. central nervous
tissues: frequency more than 1%: slight dizziness, headache; between 0.1% and
1 % between: vertigo, tinnitus, lethargy. cardiovascular: frequency more than
1%: Edema; ranged between 0.1% and 1% of: high blood pressure, heart
palpitations, flushing. urinary reproductive system: between 0.1% and 1%:
abnormal renal effect indicators (serum creatinine and / or elevated serum
ammonium nitrate).

taboo disable the following: the drug meloxicam active ingredient or its
excipients have known allergy, and acetylsalicylic acid and other NSAID may be
allergic to reflect the intertwined. of acetylsalicylic acid or other NSAID
use after the asthma, nasal polyps, angioedema or urticaria rashes and other
symptoms of the patients not to use meloxicam Hong separation film. – active
peptic ulcer disease – effect of liver insufficiency stress – effect of non-
dialysis renal insufficiency tension – children and adolescents younger than
15 years old – pregnant or breastfeeding are

【Note matters】 as the use of other NSAID, for with a history of upper
gastrointestinal tract and patients are using anticoagulants separation of
meloxicam tablets should be noted that the event of peptic ulcer or
gastrointestinal bleeding should contain the use of meloxicam separation film.
for the occurrence of adverse reflection mucosa of patients with skin should
pay special attention to curb use and think about separation of meloxicam
tablets. NSAID in the maintenance of renal perfusion in kidney from front to
support the effectiveness of the synthesis of a prostaglandin inhibition
effect. is For the reduction of renal blood flow and blood volume of patients,
the use of NSAID may contribute to significant renal decompensation, but
disable the NSAID, the renal effects are usually returned to the level before
treatment. The following patients are most likely to reflect the above:
dehydrated patients. hyperemia heart failure patients, liver cirrhosis
patients. nephrotic syndrome patients. obvious renal disease patients.
diuretics therapy. as a result of bigger blood volume reduction surgery
patients caused. in the treatment of patients with early stage of the diuretic
capacity and renal effects of carefully monitored. have rarely NSAID may cause
interstitial nephritis. glomerular nephritis, renal medullary necrosis or
nephrotic syndrome. hemodialysis patients with advanced renal failure with
separation of meloxicam piece should not exceed 7.5 mg dose. For moderate or
mild renal damage may not reduce patient dose (ie, creatinine clearance
greater than 25ml / min in patients). and most of the other NSAID use, as
sometimes reported that serum transaminase effect of elevated liver parameters
or other persons, in most cases only a very small scale and short-lived than
nothing. If this anomaly as a significant or sustained, should be discontinued
meloxicam tablets for separation of follow-up examinations. For the clinically
stable liver sclerosis patient dose can be diminished. because of weakness or
failure, poor patient tolerance for sub-effectiveness, it should be carefully
monitoring. As with other NSAID, as a possible renal. liver and heart failure
in elderly patients effects, medication should be careful. drugs on driving
ability and the impact of the use of machinery did not do special studies.
However, when adverse reflection, such as dizziness and drowsiness occur,
recommend limiting these activities.

】 【athletes with caution if

【Description】 This product is light yellow tablets.

pharmacological effect】 pharmacological effects: This product is non-
steroidal anti-inflammatory drugs. In animal models, have analgesic, anti-
inflammatory and antipyretic effects. The mechanism may be a front with the
inhibition of prostaglandin synthesis. Toxicology: Carcinogenicity: Rats of
the goods 0.8mg/kg / day (converted to body surface area by about one to 0.4
times the clinically recommended dose ) Continuous oral administration of 104
weeks and mice of this product 8mg/kg / day (converted to body surface area by
about one to 2.2 times the clinical recommended dose) continuous oral
administration of 99 weeks showed no carcinogenic effect of this product.
Genetic Toxicity: Ames test this product. human lymphocyte chromosome
aberration test and mouse bone marrow micronucleus test were negative.
reproductive toxicity: male rats and female rats administered oral doses of
this product respectively 9mg/kg / day and 5mg/kg / day (based on body surface
area were converted to the clinical recommended dose for adult and 2.5 times,
4.9 times), the female and male rats had no effect on fertility. But female
rats 2 weeks before mating and embryo the early development of oral dose given
to the goods ≥ 1mg/kg / day (converted to body surface area according to the
clinical recommended dose for adult is 0.5 times), the stillbirth rate
increased. rabbits throughout the period of organ formation 60mg/kg by mouth
to give the product / day (according to body surface area converted to human
clinical recommended dose on the 64.5-fold) can lead to cardiac septal defects
(this is a rare sign of) the incidence of higher doses of ≥ 5mg/kg / day
(converted to body surface area by about were 5.4 times the clinical
recommended dose), the stillbirth rate increased. The product formation in
organs of rats given oral doses of up to 4mg/kg / day (converted by body
surface area to about one times the clinically recommended dose of 2.2) is no
teratogenic, but the doses ≥ 1mg/kg / day when the stillbirth rate increased.
It can be used through the placental barrier. There is no control of the goods
in full and strict clinical study of pregnant patients to confirm the above
reproductive toxicity, but The results from the animal point of view, the
period of pregnancy should not be using this service, unless the potential
benefit justifies the potential harm to the fetus during sex. rats in late
pregnancy and lactation by mouth to give the product ≥ 0.125mg/kg / day
( according to body surface area is converted to the clinical recommended dose
for adult 0.07 times) may cause birth index, live birth rate and survival rate
of decline in neonatal offspring. has not been carried out to evaluate the
impact of chemicals on the ductus arteriosus closure of clinical research,
should be avoided The first 6-9 months of pregnancy to the FDA. This product
rat oral dose ≥ 1mg/kg / day (converted to body surface area according to the
clinical recommended dose for adult is 0.5 times), the stillbirth rate of
growth, delivery delays and prolonged birth; period of organ formation in rats
by oral administration of 4mg/kg / day (converted to body surface area
according to the clinical recommended dose for adult is 2.1 times) in late
pregnancy and lactation by oral administration of ≥ 0.125mg/kg / day (the
same as described before), can lead to reduced offspring survival. Currently
the product has not yet been secreted in human milk in the study, but the
goods in the milk of rats was higher than its plasma concentrations. In view
of the chemicals on breast-feeding infants reflects underlying tension bad, to
think hard about the importance of the mother of the goods, should decide
whether to breastfeed or curb to curb drug use.

Pharmacokinetics reported in the literature, according to oceanic: separation
of meloxicam tablets can be given by the oral or anal good absorption. tablets,
suppositories and capsules have the same bioequivalence. eating drugs had no
effect on the absorption of oral 7.5 mg and 15 mg doses concentrations were
proportional to its dose. three to five days to enter steady state, continuous
treatment of patients with more than one year for the first time in vivo drug
concentrations and similar patients into a steady state. in the plasma, 99% of
the drug and plasma albumen combination. once-daily dose resulting in plasma
concentrations of drugs to shut in a small valley between the peak of a wave,
the volatility of 7.5 mg scale 0.4-1.0mcg/ml, 15 mg dose, plasma concentration
of scale 0.8-2.0mcg/ml. Just at this scale has been observed outside of the
data (minimum and maximum plasma concentration at steady state plasma
concentrations.) separation of meloxicam tablets penetrate well into synovial
fluid, the concentration in plasma Banbi close . meloxicam tablets metabolism
is very thorough separation from the urine excretion of less than a day to
maintain the original shape of the dose of 5%; only trace amounts of unchanged
original compound from the urine, the main metabolic pathway is oxidation of
the material part of the methyl-thiazolyl, and then the metabolites in the
urine or the urine excreted, about Banbi is excreted in the urine. The rest is
excreted from the urine. separation of meloxicam tablets excluded from the
body, the average half-life is 20 hours. insufficiency or mild hepatic effects.
moderate renal insufficiency effect separation of the United States meloxicam
tablets no greater impact on pharmacokinetics. The average plasma clearance
rate was 8ml/min, the elderly decreased clearance, distribution of small size,
average of 11 liters, differences between individuals can reach 30-40%.

】 【each utility – large doses of other NSAID, including salicylic acid salt:
while more than one NSAID use may be effective through the collaborative The
growth of gastrointestinal ulcers and bleeding of the possibilities. – oral
anticoagulants, ampicillin thiophene piperidine, system use of heparin,
thrombolytic agents, could increase the possibility of bleeding. If the
combination therapy is unavoidable, must closely monitor the anticoagulant
effectiveness. – Lithium: NSAID, according to reports of increased lithium
plasma concentrations. it is suggested that the opening of modulating and
disable meloxicam separate piece monitoring of plasma lithium levels. –
methotrexate: with other NSAID similar to meloxicam separation film will
increase the blood methotrexate toxicity. In this case, it is recommended
strict monitoring of blood cells. – Contraception: It is reported, NSAID will
reduce the palace

Overdosage addition because there is no known poisons, Therefore, to be taken
in overdose cases of gastric emptying and supportive therapy, clinical trials
showed that cholestyramine can promote the separation of meloxicam tablets

】 【young children in the combined dose of medication not yet been determined,
young children and adolescents younger than 15 years old is disabled.

】 【white old man on medication may have liver, kidney and heart failure in
elderly patients effects should be used with caution.

【】 though pregnant women and nursing in clinical trials before the invention
of teratogenic effect, but the separation of meloxicam tablets should not be
used by pregnant women and breastfeeding.
【Formulation】 tablets

(Xinmin Editor: Xin Wang Yi)

Shared By: