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Analgesics & Antipyretics

Meloxicam STADA® 7.5 mg

 

Pack size: 

Box of 5 blisters x 10 tablets.
 

Compostion:

Each tablet contains meloxicam 7.5 mg.

 

Shelf-life:

36 months from the date of manufacturing.

Store in a well-closed container, in a dry place. Protect from moisture.

Do not store above 30oC.

 

  • Indications and Dosage & Administration
  • Contraindications
  • Adverse reactions
  • Precautions

Administered orally in:

  • Management of rheumatoid arthritis.
    A usual dose of 15 mg daily as a single dose. Those with an increased risk of adverse reactions should be started on 7.5 mg daily. A dose of 7.5 mg daily is recommended for long-term treatment in the elderly.
  • Short-term symptomatic treatment of acute exacerbations of osteoarthritis.
    The usual daily dose of meloxicam is 7.5 mg, increased if necessary to a maximum of 15 mg daily given as a single dose.
  • Symptomatic treatment of ankylosing spondylitis.
    A usual dose of 15 mg daily as a single dose. Those with an increased risk of adverse reactions should be started on 7.5 mg daily. A dose of 7.5 mg daily is recommended for long-term treatment in the elderly.
  • May also be used in the treatment of juvenile idiopathic arthritis.
    In children aged 2 years and over: The recommended oral dose is 125 micrograms/kg once daily, up to a maximum of 7.5 mg daily.
    According to body-weight, in those aged 12 to 18 years who are intolerant of other NSAIDs:
    Less than 50 kg: 7.5 mg once daily.
    Over 50 kg: 15 mg once daily.
  • In renal impairment:
    Meloxicam is normally contraindicated in patients with severe renal impairment. However, dialysed patients may be given in an oral dose of 7.5 mg daily.


Or as prescribed by physicians.
 

  • Known hypersensitivity to meloxicam or to any ingredient of the drug.
  • History of urticaria, angioedema, bronchospasm, severe rhinitis, or shock precipitated by aspirin or other NSAIDs.
  • History of aspirin sensitivity, asthma, and nasal polyps.
  • Severely impaired liver function.
  • Non-dialysed severe renal failure.
  • Gastrointestinal bleeding, history of cerebrovascular.

     

  • Risk of cardiovascular thrombotic events (see Precautions).

Very common:

  • Dyspepsia, nausea, vomiting, abdominal pain, constipation, flatulence, diarrhoea.

Common:

  • Headache.

Uncommon:

  • Macroscopic gastrointestinal haemorrhage, stomatitis, gastritis, eructation, anaemia, dizziness, somnolence. Pruritus, rash, flushing, raised transaminases or bilirubin.

Rare:

  • Colitis, gastroduodenal ulcer, oesophagitis, Stevens-Johnson syndrome, urticaria, allergic reactions or anaphylactoid reactions, palpitation, tinnitus, photosensitivity reaction.

     

  • Systemic non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) cause an increased risk of serious cardiovascular thrombotic events, including myocardial infarction and stroke, either of which can be fatal. This risk may occur as early as the first weeks of treatment and may increase with duration of use. The cardiovascular thrombotic risk has been observed most consistently at higher doses.
    Physicians should assess periodically appearance of cardiovascular adverse events, even in the absence of previous cardiovascular symptoms. Patients should be warned about the symptoms of serious cardiovascular events and seek physicians immediately if these symptoms occur.
    To minimize the risk for an adverse cardiovascular event in patients treated with Meloxicam STADA®  7.5 mg, prescribe the  lowest effective daily dose for the shortest duration possible.
  • Risk of serious GI effects (e.g., bleeding, ulceration, perforation), which can occur at any time with or without warning signs or symptoms. Concomitant therapies that may increase risk include a history of GI bleeding or ulceration, longer duration of NSAIDs therapy, treatment with anticoagulants or oral corticosteroids, smoking, alcohol dependence, poor general health, or older age (higher risk of fatal GI complications).
  • Use of NSAIDs, including meloxicam, can result in the onset of hypertension or worsening of preexisting hypertension; either of these occurrences may contribute to the increased incidence of cardiovascular events.
  • Renal papillary necrosis or other renal medullary changes may occur with long-term administration of NSAIDs.
  • Sensitivity reactions, including anaphylactoid reactions, possible in patients without prior exposure to meloxicam.
    Serious skin reactions (e.g., exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis) can occur in patients receiving meloxicam.
  • Anemia has been reported, principally in patients receiving long-term (6 months'duration) therapy with meloxicam.
  • Pregnancy: Avoid use in the third trimester because of possible premature closure of the ductus arteriosus.
    The ability to slow labour taking the drug in the end of pregnancy.
  • Lactation: Meloxicam is distributed into milk in rats; discontinue nursing or drug because of potential risk in nursing infants.
  • There are no specific studies of the ability to drive and use machinery.
     

Contact us

FACTORY 1: K63/1 Nguyen Thi Soc St., Xuan Thoi Dong, Hoc Mon, HCMC
Tel: +84 28 3718 2141 - Fax: +84 28 3718 2140

FACTORY 2: 40 Tu Do Avenue, VietNam-Singapore Industrial Park, Binh Duong
Tel: +84 274 376 7470 - Fax: +84 274 376 7469
Email : stada@stada.com.vn
Website: www.stada.com.vn



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