Diacerein ......................................... 50 mg
Excipients q.s ............................. 1 capsule
Hard capsule.
Box of 3 blisters x 10 capsules.
Dialamic with the active ingredient Diacerein is an anthraquinone derivative which has moderate anti-inflammatory activity. Some studies have shown that diacerein and its active metabolite rhein inhibit the production and activity of proinflammatory and pre-catabolic cytokines interleukin - 1beta, both shallow and deep layers of the cartilage, in synovium and synovial fluid while stimulating the transforming growth factor - beta production (TGf - b) and components of extracellular basic substances such as proteoglycans, aggrecans, hyaluronic acid and type II collagen. In addition, these substances are also able to inhibit phagocytosis and macrophage migration. Dialamic has no effect on gastric stimulation because the drug does not inhibit prostaglandin synthesis.
Orally administered diacerein undergoes a hepatic first-pass effect and is totally deacetylated to rhein. Plasma diacerein peak concentrations arise at a mean 2.5 hours. The bioavailability increases when being intaken with food. Protein binding is very strong (99%) and mainly consists in high-affinity binding to albumin. The elimination half-life of rhein is approximately 4.5 hours. The total quantity excreted in the urine is around 30%. About 80% of the rhein excreted in urine is in sulpho-and glucuroconjugated form and 20% is excreted in unchanged form.
The drug does not affect the ability to drive and operate machinery.
The drug is contraindicated in these subjects.
Do not use diacerein concurrently with laxatives. Avoid co-administration with the drugs containing salts, aluminum oxides or hydroxides, calcium, and magnesium (the interval between two ingestions is about 2 hrs).
Intake of diacerein can lead to diarrhoea and hypokalaemia. Caution must be exercised in the concomitant administration of diuretics (high-ceiling loop and thiazides) and/or cardiac glycosides (digitoxin, digoxin), as the risk of arrhythmia is increased (see the Special warnings and precautions for use).
Cardiovascular thrombotic events (see the Special warnings and precautions for use)
GASTROINTESTINAL DISORDERS:
Very common (> 1/10): diarrhoea, abdominal pain.
Common (> 1/100 and < 1/10): frequent bowel movements, flatulence.
As a rule, these effects abate with continuing treatment. In some cases, diarrhoea was severe with complications such as dehydration and disorders of fluid and electrolyte balance.
HEPATOBILIARY DISORDERS:
Uncommon (> 1/1000 and < 1/100): Cases of elevated hepatic enzymes in serum.
SKIN AND SUBCUTANEOUS TISSUE DISORDERS:
Common (> 1/100 and < 1/10): pruritus, rash, eczema.
Inform your physician about any adverse effects occur during the treatment.
POST-MARKETING SURVEILLANCE:
HEPATOBILIARY DISORDERS: Cases of acute liver injury, including elevated serum hepatic enzymes and cases of hepatitis have been reported in the post-marketing phase with diacerein. Most of them occurred during the first months of treatment. Patients should be monitored for signs and symptoms of hepatic injury (see the Special warnings and precautions for use).
Profuse diarrhea may occur in the event of overdose. Symptomatic treatment should then be instituted and electrolyte disorders and dehydration corrected if necessary.
Store in dry places, not exceeding 300C, protect from light.
Diarrhoea
Frequent intake of diacerein leads to diarrhoea (see the Adverse effects) that can consequently lead to dehydration and hypokalaemia.
Patients should be advised to stop diacerein treatment in case of diarrhoea and contact their physician to discuss treatment alternatives.
Caution should be exercised in patients receiving diuretics, because dehydration and hypokalaemia may occur. Particular caution should also be exercised in case of hypokalaemia in patients treated with cardiac glycosides (digitoxin, digoxin).
Concomitant intake of laxatives should be avoided.
Hepatotoxicity:
Elevated serum hepatic enzyme levels and symptomatic acute hepatic injury have been reported with diacerein in the post-marketing phase (see the Adverse effects).
Before treatment with diacerein is initiated, the patient should be questioned about possible comorbid conditions and past or concurrent liver disease and screened for major causes of active hepatic disease. A diagnosis of liver disease is a contraindication to diacerein use (see the Contraindications).
Signs of hepatic injury should be monitored and caution should be exercised when diacerein is used concomitantly with other medicinal products associated with hepatic injury. Patients should be advised to limit their alcohol intake while on treatment with diacerein.
Treatment with diacerein should be stopped if elevation of hepatic enzymes or suspected signs or symptoms of liver damage are detected. Patients should be advised about the signs and symptoms of hepatotoxicity and must be advised to immediately contact their physician in case of appearance of symptoms suggestive of liver damage.
Cardiovascular thrombotic events:
Nonsteroidal anti-inflammatory drugs (NSAIDs), non-aspirin, by systemic route, have shown an increased risk of cardiovascular thrombotic events, including myocardial infarction, and stroke, which can be fatal. This risk may occur early in treatment and may increase with duration of use. The increase in cardiovascular thrombotic risk has been observed most consistently at higher doses. Physicians should remain alert for the development of such events, even in the absence of previous cardiovascular symptoms. Patients should be informed about the symptoms of serious cardiovascular events and the steps to take if they occur. To minimize the potential risk for an adverse cardiovascular event in Dialamic-treated patients, use the lowest effective daily dose for the shortest duration possible.
Symptomatic treatment through delayed effectiveness of osteoarthritis of the hip and knee.
Treatment with diacerein is not recommended in patients with rapidly progressive hip osteoarthritis, as they may have a weaker response to diacerein.
Hypersensitivity to any components of the drug. In patients with a known history of anthraquinone. In patients with current and/or history of liver disease.
The treatment should be initiated by specialists experienced in the treatment of osteoarthritis.
Adults: As some patients may experience loose stools or diarrhea, the recommended starting dose is 50 mg once daily with evening meal for the first 2 to 4 weeks of treatment, after which the recommended daily dose is 50mg twice daily. The treatment should be taken with food (one with breakfast and the other with evening meal). The capsules must be swallowed whole, (without opening them), together with a glass of water.
Renal sufficiency alters the pharmacokinetics of diacerein. In severe renal insufficiency (creatinine clearance below 30 ml/min), the daily dosage is to be halved.
Patients older than 65 years are advised not to take diacerein.
Or as directed by the physician.
Read the directions carefully before use.
Consult the physician for more information.
The drug is for prescription only.
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