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Rhemofenax


DESCRIPTION
RHEMOFENAX CAPSULE 25 MG: A size 2 - brown /grey capsule, with 'DUO 861' marking.
RHEMOFENAX CAPSULE 50 MG: A size 2 - maroon / maroon capsule, with 'DUO 861' marking.
RHEMOFENAX TABLET 25 MG : A (light) blue, 11 mm caplet with 'DUO' on one side and scored 'DUO' on another side. RHEMOFENAX TABLET 50 MG : A blue, 11 mm caplet with 'd 861' marking on one side and scored on another side. PHEMOFENAX 100 MG SR CAPSULE: A green I green, size 3 capsule with 'DUO 861' marking printed on the capsule.


COMPOSITION
RHEMOFENAX CAPSULE 25 MG: Each capsule contains Diclofenac Sodium 25 mg.
RHEMOFENAX CAPSULE 50 MG: Each capsule contains Diclofenac Sodium 50 mg.

RHEMOFENAX TABLET 25 MG : Each tablet contains Diclofenac Sodium 25 mg.

RHEMOFENAX TABLET 50 MG : Each tablet contains Diclofenac Sodium 50 mg.
RHEMOFENAX 100 MG SR CAPSULE: Each capsule contains Diclofenac Sodium as Diclofenac Sodium pellets 100 mg.


PHARMACODYNAMICS
Antirheumatic, anti-inflammatory, analgesic, inhibition of prostaglandin biosynthesis, is considered to be fundamental to the mechanism of action of diclofenac. Prostaglandins play a major role in the pathogenesis of inflammation, pain and fever.


In rheumatic diseases, the anti-inflammatory and analgesic properties of Diclofenac Sodium elicit a clinical response characterized by marked relief from signs and symptoms, eg. pain at rest, pain on movement, morning stiffness and swelling of the joints, and by an improvement in function. Diclofenac Sodium is particularly suitable for the treatment of patients requiring a daily dosage improvement in function. Diclofenac Sodium is particularly suitable for the treatment of patients requiring a daily dosage of 100 mg. The fact that it allows once-daily administration facilitates long-term treatment in particular and helps to prevent the possible dosage errors. In vitro Diclofenac Sodium does not suppress proteoglycan biosynthesis in cartilage at concentrations equivalent to those reached in the human body.


PHARMACOKINETICS:

Absorption.
Tablet / capsule: As with other NSAIDs, its mode of action is not known; however, its ability to inhibit prostaglandin synthesis may be involved in the anti-inflammatory effect. Diclofenac is completely absorbed after their passage through the stomach. Following ingestion of one tablet with or after a meal, its passage through the stomach is slower than when it is taken before a meal, but the amount of active substance absorbed remains the same. In fasting subjects, the mean peak plasma concentration of 1.5 mcg/mL (5 mcmol/liter) is attained on average 2 hours after ingestion of one tablet of 50 mg. Suppositories of 50 mg produce a corresponding mean peak plasma concentration of 1.2 mcg / mL (4 mcmol/liter). The plasma concentrations, as measured by the area under the time-concentration curve, are in linear relation to the size of the dose.


SR capsule: Diclofenac is completely absorbed from the slow-release capsules. Owing to slow release of the active substance, peak plasma concentrations are lower than those attained after administration of standard dosage forms On the other hand, measurable concentrations can still be detected several hours after administration. Absorption begins later when Rhemofenax SR 100 is taken with or after a meal than when it is given on an empty stomach, but this does not influence the amount of active substance absorbed. Mean peak plasma concentrations of 0.4 mcg I ml (1.25 Ámol/L) are reached about 5 hrs on average after administration clone slow-release capsule.


Distribution. No accumulation in plasma occurs after repeated oral administration if the recommended dosage intervals are observed. 99.7% of diclofenac is bound to serum proteins mainly to albumin (99.4%). Diclofenac enters the synovial fluid, where peak concentrations are measured 2.4 hrs after the peak plasma levels have been reached. The apparent elimination half-life from the synovial fluid is 3-6 hrs. This means that concentrations of active substance in the synovial fluid are already higher than plasma concentrations 4-6 hrs. after administration and they remain higher for up to 12 hrs.

 

Metabolism. About half of the active substance is metabolized during its first passage through the liver ("first pass effect"), which means that the area under the concentration curve (AUC) is about half as large following oral or rectal administration as it is following parenteral administration of the same dose. Biotransformation of diclofenac takes place by glucuronidation partly of the intact molecule, but mainly by glucuronidation after single and multiple hydroxylation.


Elimination. The active substance is eliminated from the plasma with a systemic clearance of 263 ▒ 56 mL (x t SD). The terminal half-life is 1-2 hrs. Approximately 60% of the dose administered is excreted via the kidneys in the form of metabolites; < 1% is excreted as unchanged substance. The rest of the dose is eliminated in the form of metabolites through the bile in the faeces. Kinetics in special clinical situations: No relevant age-dependent differences in absorption, metabolism and excretion have been observed. In patients with impaired renal function. no accumulation of the unchanged active substance can be inferred from the single-dose kinetics under the usual dosage schedule. At a creatinine clearance of < 10 mL / min, the theoretic) steady-state plasma levels of metabolites are about 4 times higher than in patients with impaired hepatic function. The metabolites are nevertheless ultimately cleared through the bile. In patients with impaired hepatic function (chronic hepatitis, nondecompensated cirrhosis), the kinetics and metabolism of diclofenac are the same as in patients without liver disease.


INDICATIONS
Inflammatory and degenerative forms of rheumatism; rheumatoid arthritis and ankylosing spondylitis, osteoarthritis and spondylarthritis; painful syndromes of the vertebral column; non-articular rheumatism, painful post-traumatic and postoperative inflammation and swelling.


RECOMMENDED DOSAGE
Tablet and capsule

Adults: The initial dosage is usually 100-150 mg. In elderly patients, particularly patients with a low body weight the initial dosage is 75-150 mg daily.

 

SR Capsule
Adults: Generally, 1 cap daily. If necessary, the daily dosage can be increased to 150 mg by giving diclofenac sodium tablets in addition. In milder cases, where a lower dosage is sufficient, alternative dosage forms of diclofenac sodium can be used. If symptoms are not severe during the night or in the morning, the SR capsule should be taken preferably in the evening. The SR capsules should not be broken or chewed. They should be swallowed with liquid and taken preferably at mealtimes.


Children: Owing to their high active substance content, diclofenac sodium SR capsules are not suitable for use in children.


After assessing the risk/ benefit ratio in each individual patient, the lowest effective dose for the shortest possible duration should be used.
 

CONTRAINDICATIONS
Peptic ulcer. Known hypersensitivity to the active substance. Like other non-steroidal anti-inflammatory agents, diclofenac is contraindicated in patients in whom attacks of asthma, urticaria or acute rhinitis have been precipitated by acetylsalicyclic acid or other prostaglandin-synthetase inhibitors.

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