ROXOGESIC

ROXOGESIC

- Loxoprofen is a drug belongs to a class of NSAID (nonsteroidal anti-inflammatory drug). It has an activity to treat inflammatory rheumatoid diseases and relieve acute pain. It is effective against period pains, pain after surgery, and fever.

- ROXOGESIC is a prodrug with powerful analgesic, antipyretic and anti-inflammatory properties.

- ROXOGESIC is powerful NSAID

ROXOGESIC was found useful or extremely useful by patients of Rheumatoid arthritis and osteoarthritis.
ROXOGESIC displays more powerful analgesic and anti-inflammatory properties than diclofenac and ibuprofen.
The analgesic effect of ROXOGESIC is 10:20 times more potent than Ketoprofen, Naproxen & Indomethacin.

- ROXOGESIC is fast

The active metabolite of ROXOGESIC is distributed quickly to the inflamed synovium.
The analgesic effects of ROXOGESIC were perceived within 15 minutes.
ROXOGESIC provides faster antipyretic effects than ibuprofen.

- ROXOGESIC is more safe

ROXOGESIC is a prodrug which is rapidly absorbed from the digestive tract in unchanged form and then converted to an active metabolite to minimize gastro-intestinal side effects.
ROXOGESIC is well tolerated by 97% of patients.

Active Ingredient

Loxoprofen sodium.
Therapeutic Class: Nonsteroidal anti-inflammatory.

Mechanism of Action

Loxoprofen is a drug belongs to a class of NSAID (nonsteroidal anti-inflammatory drug) acts by inhibiting isoforms of cyclo-oxygenase enzyme and Inhibition of prostaglandin biosynthesis constitutes the mechanism of action of this drug, the site of action being cyclooxygenase.
When administered orally, Loxoprofen sodium is absorbed from the gastrointestinal tract as an unchanged compound with only a modest gastric-mucosal irritation. It is then rapidly bio-transformed into the active metabolite trans-OH form (SRS coordination) with a potent inhibitory effect on prostaglandin biosynthesis to exert its pharmacologic effects.

Indications & Uses

Analgesic, anti-inflammatory & antipyretic in:

• • Degenerative joint disease: osteoarthritis, ankylosing spondylitis &low back pain.
• • Inflammatory joint disease: rheumatoid arthritis and septic arthritis.
• • Acute musculoskeletal disorders: trauma and soft tissue rheumatism.
• • Antipyretic: fever due to inflammation.
• • Pain after tooth extraction.

Dosage & Administration

One tablet, three times / day

Forms & Strengths

Carton box of 2 blisters, each contains 10 tablets, each tablet contains 68 mg Loxoprofen sodium dehydrate eq. to 60 mg as Loxoprofen sodium

Contraindication & Cautions

ROXOGESIC is contraindicated in the following patients:

- Patients with peptic ulcers [Peptic ulcers may be aggravated due to reduced gastric blood flow resulting from inhibition of prostaglandin biosynthesis.
- Patients with severe hematological abnormalities, Platelet dysfunction may occur and the abnormality may be worsened
- Patients with severe hepatic dysfunction [Liver damage has been reported as an adverse reaction, and the patient’s liver dysfunction may be aggravated.
- Patients with severe renal dysfunction, adverse reactions such as acute renal failure, nephrotic syndrome, etc.
- Patients with severe cardiac function failure, Cardiac symptoms may be exacerbated because inhibition of prostaglandin biosynthesis in the kidneys may cause edema and an increase in circulating body fluid volume, with a consequent increase in cardiac work.
- Patients with a history of hypersensitivity to any of the components of this product
- Patients with or with a history of aspirin-induced asthma (induction of asthmatic attack with nonsteroidal anti-inflammatory-analgesics, etc.) May induce an aspirin-induced asthmatic attack.
- Women in the late stages of pregnancy

Pregnancy & Breastfeeding

There are no adequate and well-controlled studies of Roxogesic in pregnant women, Roxogesic should not be used during pregnancy unless the potential benefit justifies the potential risk to the fetus, Roxogesic should not be administered to women during late pregnancy.
It is not known whether Roxogesic is excreted in human milk, but a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother

F.A.Q

How is the efficacy of ROXOGESIC?

ROXOGESIC has excellent analgesic, anti-inflammatory and antipyretic properties, with particularly potent analgesic activity. Loxoprofen sodium is a prodrug which, after being absorbed from the GI, is bio-transformed into an active metabolite to exert its actions.

Analgesic effect
ROXOGESIC has been demonstrated analgesic effect 10 to 20 times as potent as the reference drugs Ketoprofen, naproxen and indomethacin. As assessed using the rat thermal inflammatory pain test ROXOGESIC proved to be as potent as naproxen and 3 to 5 times more potent than Ketoprofen and indomethacin.
In the chronic arthritis pain test ROXOGESIC produced the most profound analgesic effect 4 to 6 times more potent as compared with indomethacin, Ketoprofen and naproxen.

Anti-inflammatory effect
ROXOGESIC produces an anti-inflammatory effect essentially comparable with the effects of Ketoprofen and naproxen on acute and chronic inflammations.

Antipyretic effect
ROXOGESIC was demonstrated to exert an antipyretic effect, essentially comparable with the effects of Ketoprofen and naproxen and about three times more potent than the effect of indomethacin.

What should be done if effect was not enough?

If no effect is observed or is insufficient with one tablet of ROXOGESIC, then the dose may be increased to two tablets. If the effect remains insufficient after increasing the dose, the involvement of pain not mediated by prostaglandins (prostaglandins are said to be involved in 97% or more cases, as the mechanism of action of NSAIDs) or a non-responder should be suspected. In such cases, ROXOGESIC should be discontinued and changed to other drugs with a different mechanism of action.

Does ROXOGESIC affect platelet aggregation?

A platelet aggregation test showed that oral dose of ROXOGESIC 100 mg/kg caused no significant changes in the platelet aggregation

What about its interaction with other medical products?

Roxogesic should be administered with care when co-administered with the following drugs
- Coumarine-type anticoagulants as warfarin, sulphonyl urea hypoglycemic drugs as tolbutamide, new quinolone antibacterial drugs as enoxacin, lithium preparation as lithium carbonate and benzothiadiazine diuretics as hydroflumethiazide and hydrochlorothiazide