Ramazodef  Film Coated Tablets

Dexibuprofen 400mg

 

Usage and indications:

Ramazodef is indicated in:

  • Symptomatic treatment for the relief of pain and inflammation associated with osteoarthritis.
  • Acute symptomatic treatment of pain during menstrual bleeding (primary dysmenorrhoea).
  •  Symptomatic treatment of other forms of mild to moderate pain, such as muscular-skeletal pain or dental pain.

Dosage and administration:

The dosage should be adjusted to the severity of the disorder and the complaints of the patient. During chronic administration, the dosage should be adjusted to the lowest maintenance dose that provides adequate control of symptoms.

Ramazodef film coated tablets can be taken with or without a meal. In general NSAIDs (non-steroidal anti-inflammatory drugs) are preferably taken with food to reduce gastrointestinal irritation, particularly during chronic use. However, a later onset of action in some patients may be anticipated when the tablets are taken with or directly after a meal.

-The recommended dosage is 600 to 900mg dexibuprofen daily, divided in up to three single doses.

For the treatment of mild to moderate pain: 

  • Initially single doses of 200mg dexibuprofen and daily doses of 600mg dexibuprofen are recommended.
  • The maximum single dose is 400mg dexibuprofen.
  • The dose may be temporarily increased up to 1200mg dexibuprofen per day in patients with acute conditions or exacerbations. The maximum daily dose is 1200mg.

For dysmenorrhoea:

  • A daily dose of 600 to 900mg dexibuprofen, divided in up to three single doses, is recommended.
  • The maximum single dose is 300mg, the maximum daily dose is 900mg.

In children and adolescents (<18 years):

Dexibuprofen has not been studied. Safety and efficacy have not been established and therefore it is not recommended in these age groups.

In elderly patients:

It is recommended to start the therapy at the lower end of the dosage range.

The dosage may be increased to that recommended for general population only after good general tolerance has been ascertained.

Hepatic dysfunction:

Patients with mild to moderate hepatic dysfunction should start therapy at reduced doses and be closely monitored. Dexibuprofen should not be used in patients with severe hepatic dysfunction.

Renal dysfunction:

The initial dosage should be reduced in patients with mild to moderate impaired renal function. Dexibuprofen should not be used in patients with severe renal dysfunction.

Undesirable effects:

Gastrointestinal:

Very common (>1/10): Dyspepsia, diarrhea.

Common (>1/100, <1/10): Nausea, vomiting, abdominal pain.

Uncommon (>1/1,000, <1/100): Gastrointestinal ulcers and bleeding, ulcerative stomatitis.

Rare (>1/10,000, <1/1,000): Gastrointestinal perforation, flatulence, constipation, esophagitis, and esophageal strictures. Exacerbation of diverticular disease, unspecific haemorrhagic colitis, colitis ulcerosa or Crohn's disease.

If gastrointestinal blood loss occurs, this may cause anaemia and haematemesis.

Skin and hypersensitivity reaction:

Common: Rash

Uncommon: Urticaria, pruritus, purpura (including allergic purpura), angiooedema, rhinitis, bronchospasm.

Rare: Anaphylactic reaction

Very rare (<1/10,000): Erythema multiforme, epidermal necrolysis, systemic lupus erythematosus, alopecia, photosensitivity reactions, severe skin reactions like Stevens-Johnson-Syndrome, acute toxic epidermal necrolysis (Lyell-Syndrome) and allergic vasculitis.

Generalized hypersensitivity reactions have not yet been reported with dexibuprofen but their occurrence cannot be excluded considering the clinical experience with racemic ibuprofen. The symptoms may include fever with rash, abdominal pain, headache, nausea and vomiting, signs of liver injury and even aseptic meningitis. In the majority of cases in which aseptic meningitis has been reported with ibuprofen, some form of underlying auto-immune disease (such as systemic lupus erythematosus or other collagen diseases) was present as a risk factor. In case of a severe generalized hypersensitivity reaction swelling of face, tongue and larynx, bronchospasm, asthma, tachycardia, hypotension and shock can occur.

Central nervous system:

Common: Fatigue or drowsiness, headache, dizziness, vertigo.

Uncommon: Insomnia, anxiety, restlessness, visual disturbances, tinnitus.

Rare: Psychotic reaction, agitation, irritability, depression, confusion or disorientation, reversible toxic amblyopia, impaired hearing.

Very rare: Aseptic meningitis (see hypersensitivity reactions).

Haematological:

Bleeding time: may be prolonged.

Rare cases of blood disorders include: Thrombocytopenia, leucopenia, granulocytopenia, pancytopenia, agranulocytosis, aplastic anemia or haemolytic anaemia.

Cardiovascular:

Peripheral edema has been reported in association with dexibuprofen treatment.

Patients with hypertension or renal impairment seem to be predisposed to fluid retention.

Hypertension or cardiac failure (especially in the elderly) may occur.

Renal:

According to the experience with NSAIDs in general, interstitial nephritis, nephrotic syndrome or renal failure cannot be excluded.

Hepatic:

Rare cases of abnormal liver function, hepatitis and jaundice have been observed with racemic ibuprofen.

Others:

In very rare cases infection related inflammation may be aggravated.

Warnings and precautions:

Cardiovascular risk:

NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction and stroke which can be fatal. This risk may increase with duration of use.

Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk. NSAIDs is contraindicated for the treatment of pre-operative pain in the setting of coronary artery bypass graft (CABG) surgery.

Gastrointestinal risk:

NSAIDs cause an increased risk of serious gastrointestinal adverse events including inflammation, bleeding, ulceration and perforation of the stomach or intestine,                         which can be fatal. These events can occur at any time during use and without warning symptoms.

Elderly patients are at greater risk for serious gastrointestinal events.

  • Care is recommended in conditions that predispose patients to the gastrointestinal adverse effects of NSAIDs such as dexibuprofen, including existing gastrointestinal disorders, previous gastric or duodenal ulcer, ulcerative colitis, Crohn's disease and alcoholism.
  • These patients should be closely monitored for digestive disturbances, especially gastrointestinal bleeding, when taking dexibuprofen or any other NSAID.
  • Gastrointestinal bleeding or ulceration/perforation have in general more serious consequences in the elderly. They can occur at any time during treatment with or without warning symptoms or a previous history of serious gastrointestinal events.
  • In the rare instances where gastrointestinal bleeding or ulceration occurs in patients receiving dexibuprofen, treatment should be immediately discontinued.
  • As with other NSAIDs, allergic reactions, including anaphylactic/anaphylactoid reactions, can also occur without earlier exposure to the drug.
  • In the treatment of patients with heart failure, hypertension, renal or hepatic disease, especially during concomitant diuretic treatment, the risk of fluid retention and                            a deterioration in renal function must be taken into account. If used in these patients, the dose of dexibuprofen should be kept as low as possible and renal function should be regularly monitored.
  • Caution must be exercised in the treatment of elderly patients, who generally                   have a greater tendency to experience side effects to NSAIDs.
  • Dexibuprofen should only be given with care to patients with systemic lupus erythematosus and mixed connective tissue disease, because such patients may be predisposed to NSAID-induced CNS and renal side effects.
  • Caution is required in patients suffering from, or with a previous history of, bronchial asthma since NSAIDs can cause bronchospasm in such patients.
  • NSAIDs may mask the symptoms of infections.
  • As with all NSAIDs, dexibuprofen can increase plasma urea nitrogen and creatinine. As with other inhibitors of NSAIDs, dexibuprofen can be associated with adverse effects on the renal system, which can lead to glomerular nephritis, interstitial nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure.
  • As with other NSAIDs, dexibuprofen can cause transient small increases in some liver parameters, and also significant increases in SGOT and SGPT. In case of a relevant increase in such parameters, therapy must be discontinued.
  • In common with other NSAIDs dexibuprofen may reversibly inhibit platelet aggregation and function and prolong bleeding time. Caution should be exercised when dexibuprofen is given concurrently with oral anticoagulants.
  • Patients receiving long-term treatment with dexibuprofen should be monitored as a precautionary measure (renal, hepatic functions and haematologic function/blood counts).
  • During long-term, high dose, off-label treatment with analgesic drugs, headaches can occur which must not be treated with higher doses of the medicinal product.

In general the habitual use of analgesics, especially the combination of different analgesic drug substances, can lead to lasting renal lesions with the risk of renal failure (analgesic nephropathy). Thus combinations with racemic ibuprofen or other NSAIDs (including OTC products) should be avoided.

The use of dexibuprofen, as with any other drug known to inhibit cyclooxygenase / prostaglandin synthesis, may impair fertility reversibly and is not recommended in women attempting to conceive. In women who have difficulty conceiving or who are undergoing investigation of infertility, withdrawal of Ramazodef should be considered.

Data of preclinical studies indicate that inhibition of platelet aggregation by low-dose acetylsalicylic acid may be impaired if ibuprofen is administrated concurrently; this interaction could reduce the cardiovascular-protective effect. Therefore if concomitant administration of low-dose acetylsalicylic acid is indicated special precaution is required if duration of treatment exceeds short term use.

Pack: Carton box containing one or two (AL/ PVC) blisters each of 10 film coated tablets.

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