Orthocure

Intramuscular

Renal colic

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

Ophthalmic

Post-photorefractive keratectomy pain

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

Oral

Migraine

Adult: As Orthocure 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 Orthocure Na: 100 mg once daily.

Topical/Cutaneous

Actinic keratoses

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

Topical/Cutaneous

Osteoarthritis

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

Transdermal

Acute pain

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

Orthocure 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, Orthocure does not cure osteoarthritis and will help you only as long as you continue to use it.

Orthocure 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 Orthocure helps this condition is unknown.

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

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

Orthocure is available only with your doctor's prescription.

General Dosing Instructions

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

The effectiveness of Orthocure when taken with food has not been studied in clinical studies. Taking Orthocure with food may cause a reduction in effectiveness compared to taking Orthocure 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 Orthocure compared to patients with normal hepatic function. As with other Orthocure products, start treatment at the lowest dose. If efficacy is not achieved with the lowest dose, discontinue use.

Non-Interchangeability With Other Formulations Of Orthocure

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

How supplied

Dosage Forms And Strengths

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

Orthocure (Orthocure) 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

Orthocure (Orthocure) 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 Orthocure?

Hypersensitivity to Orthocure sodium or to any of the excipients of Orthocure.

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 Orthocure (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 Orthocure (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 Orthocure 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 Orthocure may increase with dose and duration of exposure, Orthocure should always be prescribed at the lowest effective daily dose and for the shortest duration possible.

Renal Impairment: Orthocure 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 Orthocure to patients with mild to moderate renal impairment.

Hepatic Impairment: Orthocure 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 Orthocure to patients with mild to moderate hepatic impairment.

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

• Orthocure solution comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Orthocure solution refilled.
• Do not apply Orthocure solution to infected skin; open wounds; or red, swollen, or peeling skin.
• Wash your hands immediately before and after using Orthocure solution.
• Wash the affected area and dry completely before using Orthocure solution.
• To apply Orthocure solution, dispense 10 drops at a time onto the knee or into your hand. Spread Orthocure 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 Orthocure 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 Orthocure solution.
• If you miss a dose of Orthocure 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 Orthocure solution.

Orthocure is used to relieve pain from various conditions. This form of Orthocure is used to treat migraine headaches. Orthocure 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 Orthocure

Read the Medication Guide provided by your pharmacist before you start taking Orthocure 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 Orthocure 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 Orthocure?

Aspirin: Concomitant administration of Orthocure and aspirin is not recommended because Orthocure 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 Orthocure 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 Orthocure and warfarin, requires close monitoring of patients to be certain that no change in their anticoagulant dosage is required.

Digoxin, Methotrexate, Cyclosporine: Orthocure, like other NSAIDs, may affect renal prostaglandins and increase the toxicity of certain drugs. Ingestion of Orthocure may increase serum concentrations of digoxin and methotrexate and increase cyclosporine's nephrotoxicity. Patients who begin taking Orthocure or who increase their Orthocure 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: Orthocure decreases lithium renal clearance and increases lithium plasma levels. In patients taking Orthocure and lithium concomitantly, lithium toxicity may develop.

Oral Hypoglycemics:

Diuretics: Orthocure 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 Orthocure. Phenobarbital toxicity has been reported to have occurred in a patient on chronic phenobarbital treatment following the initiation of Orthocure therapy.

See also:
What are the possible side effects of Orthocure?

Fluid Retention and Edema: Fluid retention and edema have been observed in some patients taking Orthocure. Therefore, as with other NSAIDs, Orthocure 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 Orthocure 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 Orthocure, 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 Orthocure 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 Orthocure 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 Orthocure, the possibility of it being related to Orthocure should be considered.

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

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

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

Each mL of oral drops contains Diclofenac resinate equivalent to Orthocure 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: