Actfit Gel

Intramuscular

Renal colic

Adult: As Actfit Gel Na: 75 mg, may repeat once after 30 min if needed. Max: 150 mg/day. Max period: 2 days.

Intramuscular

Bursitis, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis, Acute gout, Dysmenorrhoea

Adult: As Actfit Gel Na: 75 mg once daily, injected into the gluteal muscle, may increase to 75 mg bid in severe conditions. Max period: 2 days.

Intravenous

Postoperative pain

Adult: As Actfit Gel Na: 75 mg infusion in glucose 5% or NaCl 0.9% (previously buffered w/ Na bicarbonate) given over 30-120 min or as bolus inj, may repeat after 4-6 hr if necessary. Max period: 2 days.

Intravenous

Prophylaxis of postoperative pain

Adult: As Actfit Gel Na: Initially, 25-50 mg infusion given after surgery over 15-60 min followed by 5 mg/hr. Alternatively, initial dose may be given as bolus inj over 5-60 sec followed by additional inj, may repeat after 4-6 hr if necessary. Max: 150 mg/day. Max period: 2 days.

Ophthalmic

Postoperative ocular inflammation

Adult: As Actfit Gel Na (0.1% soln): Instill into the appropriate eye 4 times daily starting 24 hr after surgery for up to 28 days.

Ophthalmic

Inflammation and discomfort after strabismus surgery

Adult: As Actfit Gel Na (0.1% soln): Instill 1 drop 4 times daily for the 1st wk; then tid in the 2nd wk, bid in the 3rd wk, and as required for the 4th wk.

Ophthalmic

Pain and discomfort after radial keratotomy

Adult: As Actfit Gel Na (0.1% soln): Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.

Ophthalmic

Pain after accidental trauma

Adult: As Actfit Gel Na (0.1% soln): Instill 1 drop 4 times daily for up to 2 days.

Ophthalmic

Control of inflammation after argon laser trabeculoplasty

Adult: As Actfit Gel Na (0.1% soln): Instill 1 drop 4 times during the 2 hr before procedure followed by 1 drop 4 times daily, up to 7 days after procedure.

Ophthalmic

Prophylaxis of intra-operative miosis

Adult: As Actfit Gel Na (0.1% soln): Instill into appropriate eye 4 times w/in 2 hr before surgery.

Ophthalmic

Post-photorefractive keratectomy pain

Adult: As Actfit Gel Na (0.1% soln): Instill into the affected eye twice, an hr before surgery, then 1 drop twice at 5-min intervals immediately after surgery, then every 2-5 hr while awake for up to 24 hr.

Ophthalmic

Seasonal allergic conjunctivitis

Adult: As Actfit Gel Na (0.1% soln): Instill 1 drop before surgery followed by 1 drop immediately after surgery, and then 1 drop 4 times daily for up to 2 days.

Oral

Bursitis, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis, Acute gout, Dysmenorrhoea

Adult: As Actfit Gel Na: 75-150 mg/day in divided doses. Max: 150 mg/day.

Oral

Migraine

Adult: As Actfit Gel K: Initially, 50 mg taken at the 1st sign of an attack, an additional dose of 50 mg may be taken after 2 hr if symptoms persist. If needed, further doses of 50 mg may be taken 4-6 hrly. Max: 200 mg/day.

Rectal

Acute gout, Bursitis, Dysmenorrhoea, Pain and inflammation associated with musculoskeletal and joint disorders, Rheumatoid arthritis, Sprains, Strains, Tendinitis

Adult: As Actfit Gel Na: 100 mg once daily.

Topical/Cutaneous

Actinic keratoses

Adult: As Actfit Gel Na (3% gel): Apply bid for 60-90 days.

Topical/Cutaneous

Osteoarthritis

Adult: As Actfit Gel Na (1.6% soln): Apply in small amounts (20 or 40 drops) onto affected area 4 times daily. As Na: (1% gel): Apply to the affected area 4 times daily. Max: 32 g/day over the affected area.

Topical/Cutaneous

Local symptomatic relief of pain and inflammation

Adult: As Actfit Gel Na (1% gel): Apply onto affected area 3 or 4 times daily.

Transdermal

Acute pain

Adult: Sprains, strains, contusions: 1 patch bid.

Actfit Gel is a nonsteroidal anti-inflammatory drug (NSAID) used to treat pain and other symptoms of arthritis of the joints (eg, osteoarthritis), such as inflammation, swelling, stiffness, and joint pain. However, Actfit Gel does not cure osteoarthritis and will help you only as long as you continue to use it.

Actfit Gel topical 3% gel is also used to treat actinic keratosis, a skin problem that may become cancerous if not treated. The exact way that topical Actfit Gel helps this condition is unknown.

Actfit Gel topical solution is used to treat pain and swelling caused by osteoarthritis of the knees.

Actfit Gel topical patch is used to treat acute pain caused by minor strains, sprains, and contusions (bruises).

Actfit Gel is available only with your doctor's prescription.

General Dosing Instructions

Carefully consider the potential benefits and risks of Actfit Gel and other treatment options before deciding to use Actfit Gel. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals.

The effectiveness of Actfit Gel when taken with food has not been studied in clinical studies. Taking Actfit Gel with food may cause a reduction in effectiveness compared to taking Actfit Gel on an empty stomach.

Acute Pain

For management of mild to moderate acute pain, the dosage is 18 mg or 35 mg orally three times daily.

Osteoarthritis Pain

For management of osteoarthritis pain, the dosage is 35 mg orally three times daily.

Dosage Adjustments In Patients With Hepatic Impairment

Patients with hepatic disease may require reduced doses of Actfit Gel compared to patients with normal hepatic function. As with other Actfit Gel products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.

Non-Interchangeability With Other Formulations Of Actfit Gel

Actfit Gel capsules are not interchangeable with other formulations of oral Actfit Gel even if the milligram strength is the same. Actfit Gel capsules contain Actfit Gel free acid whereas other Actfit Gel products contain a salt of Actfit Gel, i.e., Actfit Gel potassium or sodium. A 35 mg dose of Actfit Gel is approximately equal to 37.6 mg of sodium Actfit Gel or 39.5 mg of potassium Actfit Gel. Therefore, do not substitute similar dosing strengths of other Actfit Gel products without taking this into consideration.

How supplied

Dosage Forms And Strengths

Actfit Gel (Actfit Gel) capsules: 18 mg - blue body and light green cap (imprinted IP-203 on the body and 18 mg on the cap in white ink).

Actfit Gel (Actfit Gel) capsules: 35 mg - blue body and green cap (imprinted IP-204 on the body and 35 mg on the cap in white ink).

Storage And Handling

Actfit Gel (Actfit Gel) capsules are supplied as:

• 18 mg - blue body and light green cap (imprinted IP-203 on the body and 18 mg on the cap in white ink)

NDC (42211-203-23), Bottles of 30 capsules

NDC (42211-203-29), Bottles of 90 capsules

• 35 mg - blue body and green cap (imprinted IP-204 on the body and 35 mg on the cap in white ink)

NDC (42211-204-23), Bottles of 30 capsules

NDC (42211-204-29), Bottles of 90 capsules

Storage

Store at room temperature 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F).

Store in the original container and keep the bottle tightly closed to protect from moisture. Dispense in a tight container if package is subdivided.

Manufactured (under license from iCeutica Pty Ltd) for and Distributed by: Iroko Pharmaceuticals, LLC, One Kew Place, 150 Rouse Boulevard, Philadelphia, PA 19112. Revised: May 2016

See also:
What is the most important information I should know about Actfit Gel?

Hypersensitivity to Actfit Gel sodium or to any of the excipients of Actfit Gel.

Active gastric or intestinal ulcer, bleeding or perforation.

Last trimester of pregnancy.

Hepatic, renal and severe cardiac failure.

Patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid and/or other drugs with prostaglandin-synthetase inhibitory activity.

Treatment of peri-operative pain in setting of coronary artery bypass graft (CABG) surgery.

The use of high dose Actfit Gel (150 mg/day) for >4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension.

Established Cardiovascular Disease or Significant Cardiovascular Risk Factors: The use of high dose Actfit Gel (150mg/day) for >4 weeks is contraindicated in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If Actfit Gel treatment is needed, patients with established cardiovascular disease, uncontrolled hypertension or significant cardiovascular risk factors (eg, hypertension, hyperlipidaemia, diabetes mellitus and smoking) should be treated only after careful consideration and at doses ≤100 mg daily if the treatment is for >4 weeks. As the cardiovascular risks of Actfit Gel may increase with dose and duration of exposure, Actfit Gel should always be prescribed at the lowest effective daily dose and for the shortest duration possible.

Renal Impairment: Actfit Gel is contraindicated in patients with renal failure. No specific studies have been carried out in patients with renal impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Actfit Gel to patients with mild to moderate renal impairment.

Hepatic Impairment: Actfit Gel is contraindicated in patients with hepatic failure. No specific studies have been carried out in patients with hepatic impairment, therefore, no specific dose adjustment recommendations can be made. Caution is advised when administering Actfit Gel to patients with mild to moderate hepatic impairment.

Use Actfit Gel solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Actfit Gel solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Actfit Gel solution refilled.
• Do not apply Actfit Gel solution to infected skin; open wounds; or red, swollen, or peeling skin.
• Wash your hands immediately before and after using Actfit Gel solution.
• Wash the affected area and dry completely before using Actfit Gel solution.
• To apply Actfit Gel solution, dispense 10 drops at a time onto the knee or into your hand. Spread Actfit Gel solution evenly around the front, back, and sides of the knee. Repeat until you have used the whole dose.
• Be sure that you cover your entire knee with your dose of Actfit Gel solution. Do not use more than the recommended amount.
• Do not apply sunscreens, cosmetics, insect repellants, other topical medicines, or any other substance to the treated area until it is completely dry.
• Do not put on clothes over the treated area until it is completely dry.
• Do not wrap, bandage, or apply heat to the treated area.
• Let the treated skin dry before touching it or letting it touch anyone else's skin.
• Do not shower, bathe, or wash the treated area for at least 30 minutes after you use Actfit Gel solution.
• If you miss a dose of Actfit Gel solution, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Actfit Gel solution.

Actfit Gel is used to relieve pain from various conditions. This form of Actfit Gel is used to treat migraine headaches. Actfit Gel is a nonsteroidal anti-inflammatory drug (NSAID). It works by blocking your body's production of certain natural substances that cause inflammation. This effect helps to decrease swelling, pain, or fever.

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This medication may also be used to treat gout attacks.

How to use Actfit Gel

Read the Medication Guide provided by your pharmacist before you start taking Actfit Gel and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth as directed by your doctor. Empty the contents of one packet into a cup containing 1 to 2 ounces (30 to 60 milliliters) of water. Mix well and drink all of it right away. Do not mix with any liquid other than water. If stomach upset occurs while taking this medication, take it with food, milk, or an antacid. However, if you take this medication with a meal high in fat, it may not work as well.

There are different brands and forms of this medication available. Because different forms do not have the same effects at equal strengths, do not switch forms of Actfit Gel unless your doctor tells you to.

To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose. Do not increase your dose or take it more often than prescribed.

Pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has worsened, the medication may not work as well.

Tell your doctor if your condition persists or worsens.

See also:
What other drugs will affect Actfit Gel?

Aspirin: Concomitant administration of Actfit Gel and aspirin is not recommended because Actfit Gel is displaced from its binding sites during the concomitant administration of aspirin, resulting in lower plasma concentrations, peak plasma levels and AUC values.

Anticoagulants: While studies have not shown Actfit Gel to interact with anticoagulants of the warfarin type, caution should be exercised, nonetheless, since interactions have been seen with other NSAIDs. Because prostaglandins play an important role in hemostasis and NSAIDs affect platelet function as well, concurrent therapy with all NSAIDs, including Actfit Gel and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.

Digoxin, Methotrexate, Cyclosporine: Actfit Gel, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Actfit Gel may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Actfit Gel or who increase their Actfit Gel dose or any other NSAID while taking digoxin, methotrexate or cyclosporine may develop toxicity characteristics for these drugs. They should be observed closely, particularly if renal function is impaired. In the case of digoxin, serum levels should be monitored.

Lithium: Actfit Gel decreases lithium renal clearance and increases lithium plasma levels. In patients taking Actfit Gel and lithium concomitantly, lithium toxicity may develop.

Oral Hypoglycemics:

Diuretics: Actfit Gel and other NSAIDs can inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels.

Other Drugs: In small groups of patients (7-10/interaction study), the concomitant administration of azathioprine, gold, chloroquine, D-penicillamine, prednisolone, doxycycline or digitoxin did not significantly affect the peak levels and AUC values of Actfit Gel. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Actfit Gel therapy.

See also:
What are the possible side effects of Actfit Gel?

Fluid Retention and Edema: Fluid retention and edema have been observed in some patients taking Actfit Gel. Therefore, as with other NSAIDs, Actfit Gel should be used with caution in patients with history of cardiac decompensation, hypertension or other conditions predisposing to fluid retention.

Hematological Effects: Anemia is sometimes seen in patients receiving Actfit Gel or other NSAIDs. This may be due to fluid retention, GI blood loss or an incompletely described effect upon erythropoiesis.

Renal Effects: As a class, NSAIDs have been associated with renal papillary necrosis and other abnormal renal pathology in long-term administration to animals. In patients treated with Actfit Gel, rare cases of interstitial nephritis and papillary necrosis have been reported. A second form of renal toxicity, generally associated with NSAIDs, is seen in patients with conditions leading to a reduction in renal blood flow or blood volume, where renal prostaglandins have a supported role in the maintenance of renal perfusion. In these patients, administration of an NSAID results in a dose-dependent decrease in prostaglandin synthesis and secondarily, in a reduction of renal blood flow, which may precipitate over the renal failure. Patients at greater risk of this reaction are those with impaired renal function, heart failure, liver dysfunction, those taking diuretics and the elderly.

Porphyria: The use of Actfit Gel in patients with hepatic porphyria should be avoided.

Aseptic Meningitis: As with other NSAIDs, aseptic meningitis with fever and coma has been observed in rare occasions in patients on Actfit Gel therapy. Although it is probably more likely to occur in patients with systemic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease. If signs or symptoms of meningitis develop in a patient on Actfit Gel, the possibility of it being related to Actfit Gel should be considered.

There may be pain and occasionally tissue damage at the site of injection when given IM.

Actfit Gel potassium is potassium-o-[(2,6-dichlorophenyl)-amino]-phenyl-acetate.

Actfit Gel resinate is [o-[(2, 6-dichlorophenyl)-amino]-phenyl-acetate resinate.

Each mL of oral drops contains Diclofenac resinate equivalent to Actfit Gel potassium 15 mg (0.5 mg/drop).

Excipients/Inactive Ingredients: Tablet: Core: Magnesium stearate, povidone, anhydrous colloidal silica, sodium starch glycollate, maize starch, calcium phosphate. Sugar-Coat: Microcrystalline cellulose, polyethylene glycol 8000, red iron oxide (E172) and titanium dioxide (E171) (dispersed Anstead), povidone, talc, sucrose. Polish: Polyethylene glycol 8000, sucrose.

Oral Drops: