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Piroxicam, methyl salicylate, menthol, eugenol.
Piroxicam + Methyl Salicylate + Menthol + Eugenol (FlanaxPlus) is smooth, clear, light amber gel, free from visible impurities with strong odor of methyl salicylate.
Each gram of gel contains: Piroxicam, USP 5 mg, Methyl Salicylate, USP 102 mg, Menthol, USP 54.3 mg, Eugenol, USP 13.7 mg.
Excipients/Inactive Ingredients: Isopropyl Alcohol; Propylene Glycol; Glycerin; Dipropylene Glycol; Tetrahydroxypropyl Ethylenediamine; Carbomer; Hydroxypropyl Cellulose; Purified Water.
Therapeutic Class: Topical Antirheumatics & Analgesics.
Pharmacology: Pharmacological Effects and Mechanism of Action: Piroxicam works by inhibiting the enzyme cyclooxygenase (COX), which is responsible for producing prostaglandins- chemicals that trigger inflammation, pain, and swelling. By blocking prostaglandin synthesis at the site of application, Piroxicam reduces localized pain and inflammation, providing targeted relief for conditions like arthritis, sprains and muscle strains.
Provides relief by reducing inflammation, blocking pain signals, and creating a cooling or warming sensation that distracts from deeper pain.
Piroxicam + Methyl Salicylate + Menthol + Eugenol (FlanaxPlus) is used for the relief of pain and local treatment of osteoarthritis and arthrosis.
Apply to the affected area not more than 3 to 4 times daily. Rub or massage gently. For external application only. No occlusive dressing should be employed. Spread the gel evenly on the skin surface.
Average duration of treatment: 8 days at 1 g per application x 3/day.
Missed Dose: If the patient regularly uses the medicine, apply the missed dose as soon as remembered. If it is close to the time for the next dose, skip the missed dose and go back to the regular time of application.
Do not put on two doses at the same time or apply extra doses.
Do not use more than what is advised by the physician.
Symptoms: Application of significant quantities is reported to cause: Severe abdominal pain, nausea, vomiting, vertigo, ataxia, drowsiness, and coma; instant collapse in infants after the local application of menthol to their nostrils.
Specific antidotes: If the patient suspects that there might have been an overdose, call the physician or contact the Local Poison Center immediately. Be ready to show what drug was used, the amount applied and when it happened.
Do not use this medicine if the patient: has previously shown a hypersensitivity to the gel or piroxicam/methyl salicylate/menthol/eugenol in any of its dosage forms; has an open wound at the affected area, or if the skin is injured or damaged.
Initially apply a small amount to a limited skin area and observe whether there is discomfort or itch before applying to a larger skin area. Discontinue use if irritation or allergic/hypersensitivity develops.
To prevent additive toxicity, do not use concomitantly with another dosage form of piroxicam, methyl salicylate, menthol or eugenol.
Avoid contact with the eyes and mucous membranes and avoid direct application into nostrils.
Do not apply over large areas of the body or bandage or use with heating pads.
Avoid applying the product near open fire, hot water or microwave ovens.
If symptoms persist and/or worsen, consult the doctor.
Use in Children: The use of Piroxicam + Methyl Salicylate + Menthol + Eugenol (FlanaxPlus) among children is not recommended.
The safety of Piroxicam + Methyl Salicylate + Menthol + Eugenol (FlanaxPlus) during pregnancy or lactation has not been established.
This effect, as with other non-steroidal anti-inflammatory agents has been associated with an increased incidence of dystocia and delayed parturition in pregnant animals when piroxicam administration was continued into late pregnancy. Non-steroidal anti-inflammatory drugs are also known to induce closure of the ductus arteriosus in infants.
A preliminary study indicates the following oral administration, piroxicam exists in maternal milk in a concentration of approximately 1% of that reached in plasma after oral administration. Piroxicam + Methyl Salicylate + Menthol + Eugenol (FlanaxPlus) is not recommended for use in nursing mothers as the clinical safety has not been established.
Mild to moderate local irritation, erythema, rash, pityroid desquamation, pruritus, and related local reactions at the application site.
Mild but transient skin discoloration and staining of clothing have been noted when the gel is not rubbed-in completely.
Before using this product, inform the health care provider about all the medicines the patient uses including prescription and over-the-counter drugs.
Store at temperatures not exceeding 30°C.
Shelf-life: 36 months.
M02AA07 - piroxicam ; Belongs to the class of non-steroidal antiinflammatory preparations for topical use. Used in the treatment of joint and muscular pains.
FlanaxPlus topical gel
25 g x 1's;50 g x 1's (P219.75/box)
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