K-Kort

Each actuation delivers K-Kort acetonide 55 mcg from the nasal actuator after an initial priming of 5 sprays. It will remain adequately primed for 2 weeks. If K-Kort is not used for >2 weeks, then it can be adequately reprimed with 1 spray. The contents of one 6.5-g bottle provide 30 actuations, and the contents of one 16.5-g bottle provide 120 actuations. After either 30 or 120 actuations, the amount of K-Kort acetonide delivered per actuation may not be consistent and the unit should be discarded. Each 30- and 120-actuation bottle contains Triamcinolone acetonide 3.575 and 9.075 mg, respectively.

K-Kort also contains the following excipients: Microcrystalline cellulose, carboxymethylcellulose sodium, polysorbate 80, dextrose, benzalkonium chloride and disodium edetate; hydrochloric acid or sodium hydroxide may be added to adjust the pH to a target of 5 within a range of 4.5 and 6.

K-Kort is an unscented, thixotropic, water-based metered-dose pump spray formulation unit containing a microcrystalline suspension of K-Kort acetonide in an aqueous medium.

K-Kort is a nonchlorofluorocarbon (non-CFC)-containing metered-dose pump spray.

K-Kort acetonide is 9-fluoro-11β,16α,17, 21-tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone (C₂₄H₃₁FO₆). It has a molecular weight of 434.51.

Ophthalmic Use

K-Kort™ (K-Kort acetonide injectable suspension) 80 mg/mL is indicated for:

• sympathetic ophthalmia,
• temporal arteritis,
• uveitis, and
• ocular inflammatory conditions unresponsive to topical corticosteroids.

Intramuscular Use

Where oral therapy is not feasible, K-Kort™ (K-Kort acetonide injectable suspension) 80 mg/mL is indicated for intramuscular use as follows:

Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions.

Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome).

Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, nonsuppurative thyroiditis.

Gastrointestinal diseases: To tide the patient over a critical period of the disease in regional enteritis and ulcerative colitis.

Hematologic disorders: Acquired (autoimmune) hemolytic anemia, Diamond-Blackfan anemia, pure red cell aplasia, selected cases of secondary thrombocytopenia.

Miscellaneous: Trichinosis with neurologic or myocardial involvement, tuberculous meningitis with subarachnoid block or impending block when used with appropriate antituberculous chemotherapy.

Neoplastic diseases: For the palliative management of leukemias and lymphomas.

Nervous system: Acute exacerbations of multiple sclerosis; cerebral edema associated with primary or metastatic brain tumor, craniotomy, or head injury.

Renal diseases: To induce diuresis or remission of proteinuria in idiopathic nephrotic syndrome or that due to lupus erythematosus.

Respiratory diseases: Berylliosis, fulminating or disseminated pulmonary tuberculosis when used concurrently with appropriate antituberculous chemotherapy, idiopathic eosinophilic pneumonias, symptomatic sarcoidosis.

Rheumatic disorders: As adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis; acute rheumatic carditis; ankylosing spondylitis; psoriatic arthritis; rheumatoid arthritis, including juvenile rheumatoid arthritis (selected cases may require low-dose maintenance therapy). For the treatment of dermatomyositis, polymyositis, and systemic lupus erythematosus.

Intra-articular Use

The intra-articular or soft tissue administration of K-Kort™ (K-Kort acetonide injectable suspension) (K-Kort acetonide injectable suspension) 80 mg/mL is indicated as adjunctive therapy for short-term administration (to tide the patient over an acute episode or exacerbation) in acute gouty arthritis, acute and subacute bursitis, acute nonspecific tenosynovitis, epicondylitis, rheumatoid arthritis, synovitis of osteoarthritis.

K-Kort is a steroid that prevents the release of substances in the body that cause inflammation.

K-Kort injection is used to treat many different types of inflammatory conditions, including severe allergic reactions, severe colitis, blood cell disorders, inflammatory eye disorders, lung disorders, acute gouty arthritis, rheumatic arthritis, and problems caused by low adrenal gland hormones.

K-Kort injection is also used to treat inflammation of the joints or tendons to treat arthritis, bursitis, or epicondylitis (tennis elbow). It is usually given in these conditions only as a short-term treatment of a severe or aggravated episode.

K-Kort is also used to treat certain skin disorders caused by autoimmune conditions such as lupus, psoriasis, lichen planus, and others.

K-Kort injection may also be used for purposes not listed in this medication guide.

Important Dosage and Administration Information

• K-Kort is administered as a single intra-articular extended-release injection of K-Kort acetonide, to deliver 32 mg (5 mL).
• K-Kort is for intra-articular use only and should not be administered by the following routes: epidural, intrathecal, intravenous, intraocular, intramuscular, intradermal, subcutaneous.
• K-Kort is not suitable for use in small joints, such as the hand.
• The efficacy and safety of repeat administration of K-Kort for the management of osteoarthritis pain of the knee have not been evaluated.
• The efficacy and safety of K-Kort for management of osteoarthritis pain of shoulder and hip have not been evaluated.

Preparation and Administration of Intra-Articular Suspension

Refer to the Instructions for Use for directions on the preparation and administration of K-Kort.

K-Kort is supplied as a single-dose kit containing a vial of K-Kort microsphere powder, a vial of sterile diluent, and a sterile vial adapter.

K-Kort must be prepared using the diluent supplied in the kit.

Preparation of K-Kort requires close attention to the Instructions for Use to ensure successful administration.

Use proper aseptic technique throughout the dose preparation and administration procedure.

K-Kort is a suspension product and it is normal for some residue to be left behind on the vial walls after withdrawing the contents.

Promptly inject K-Kort after preparation to avoid settling of the suspension. If needed, the K-Kort suspension can be stored in the vial for up to 4 hours at ambient conditions. Gently swirl the vial to resuspend any of the settled microspheres prior to preparing the syringe for injection.

The usual technique for intra-articular injection should be followed. Aspiration of synovial fluid may be performed based on clinical judgment prior to administration of K-Kort.

Non-Interchangeability with Other Formulations of K-Kort Acetonide for Intra-articular Use

K-Kort is not interchangeable with other formulations of injectable K-Kort acetonide.

See also:
What is the most important information I should know about K-Kort?

Do not use this medication in a child under 2 years old without the advice of a doctor. Some brands of K-Kort nasal are not made for use in children.

Do not use this medication if you are allergic to K-Kort.

Before using K-Kort nasal, tell your doctor if you are allergic to any drugs, or if you have tuberculosis, asthma, a history of glaucoma or cataracts, any type of infection, or if you have had recent surgery or injury to your nose.

It may take up to a week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 1 week of treatment, or if they get worse any time during treatment.

K-Kort nasal can lower the blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medicine.

Do not stop using K-Kort nasal suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the medication before stopping completely.

Use K-Kort spray as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with K-Kort spray. Talk to your pharmacist if you have questions about this information.
• Shake well before each use.
• Remove the cover and clip from the spray pump before use. Do not try to make the hole at the end of the spray tip bigger.
• Before the first use, prime the spray pump by rapidly and firmly pumping it 5 times (until a full spray appears).
• If you have not used the spray pump for more than 14 days, reprime it by shaking the bottle and pumping it once. Do not reprime the pump if you have used it more frequently.
• To use a nose spray, gently blow your nose. Sit down and tilt your head back slightly. Place the tip of the spray container into the nose. Using a finger from your other hand, press against the opposite nostril to close it off. Breathe gently through the open nostril and squeeze the spray container. If you are using more than 1 spray, wait for 1 to 2 minutes between sprays. After using the medicine, rinse the tip of the spray unit in hot water and dry with a clean tissue to prevent contamination.
• Replace the cover and clip to the container after each use.
• Do not blow your nose for 15 minutes after using K-Kort spray.
• If the pump becomes clogged, do not try to unclog it with a pin or sharp object. This will destroy the pump. Remove the cap and spray nozzle from the bottle. Soak the cap and spray nozzle in warm water for a few minutes, then rinse under cold water. Shake or tap off excess water and allow to air dry. Place the nozzle back on the pump, reprime until a fine mist is seen, and then use as normal.
• Use K-Kort spray on a regular schedule to get the most benefit from it. Using K-Kort spray at the same time each day will help you remember to use it.
• If you miss a dose of K-Kort spray, use it as soon as possible. If it is almost time for your next dose, 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 K-Kort spray.

This medication is used in a variety of conditions such as allergic disorders, arthritis, blood diseases, breathing problems, certain cancers, eye diseases, intestinal disorders, collagen and skin diseases. Talk to your doctor about the risks and benefits of K-Kort, especially if it is to be injected near your spine (epidural). Rare but serious side effects may occur with epidural use.

K-Kort acetonide is known as a corticosteroid hormone (glucocorticoid). It works by decreasing your body's immune response to these diseases and reduces symptoms such as swelling.

How to use K-Kort injection

This medication may be given by injecting into different locations such as a muscle (intramuscularly), a skin lesion (intradermally), or a joint (intra-articularly). Injections are usually given by a trained healthcare professional. If you are giving yourself intramuscular injection, you will be taught by your healthcare professional on how to properly use this medication. If any of the information is unclear, consult your healthcare professional.

The injection site, schedule, dosage, and length of treatment are based on your medical condition and response to treatment. Do not inject this medication into a vein (intravenously) or into the spine (epidurally). This medication is not recommended for injection around/into the eye or certain parts of the nose due to the risk for blindness or damage to the eye(s). Consult your doctor for more details.

Use this medication and follow the dosing schedule exactly as directed by your doctor in order to get the most benefit from it. Do not change your dose or use this medication for a longer time than prescribed. Be sure to ask your doctor or pharmacist if you have any questions about your treatment.

Wash hands with soap and water before using this medication. Before using, check this product visually for clumpy particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose intramuscularly, clean the injection site with rubbing alcohol. It is important to change the location of the injection site to avoid discomfort or problem areas. Your dose may need to be gradually decreased to reduce symptoms such as weakness, weight loss, nausea, and extreme fatigue.

Shake vial before use to evenly disperse the suspension. Inject the prescribed dose immediately after withdrawing it into the syringe to avoid settling of the medication in the syringe.

Learn how to store and discard syringes, needles, and medical supplies safely. Consult your pharmacist for more information.

If you have been using this medication for a long time, do not suddenly stop it without your doctor's approval. Some conditions may become worse when this drug is suddenly stopped.

This medication may be injected into a joint to treat conditions such as arthritis and bursitis. If you have received an injection into a joint, be careful how much stress you put on that joint, even if it is feeling better. Ask your doctor how much you can move the joint while it is healing.

Inform your doctor if your condition worsens or if you have new symptoms.

See also:
What other drugs will affect K-Kort?

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

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

Oral Hypoglycemics:

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

Protein Binding

In vitro, diclofenac interferes minimally or not at all with the protein binding of salicylic acid (20% decrease in binding), tolbutamide, prednisolone (10% decrease in binding), or warfarin. Benzylpenicillin, ampicillin, oxacillin, chlortetracycline, doxycycline, cephalothin, erythromycin, and sulfamethoxazole have no influence in vitro on the protein binding of diclofenac in human serum.

Drug/Laboratory Test Interactions

Effect on Blood Coagulation: K-Kort increases platelet aggregation time but does not affect bleeding time, plasma thrombin clotting time, plasma fibrinogen, or factors V and VII to XII. Statistically significant changes in prothrombin and partial thromboplastin times have been reported in normal volunteers. The mean changes were observed to be less than 1 second in both instances, however, and are unlikely to be clinically important. K-Kort is a prostaglandin synthetase inhibitor, however, and all drugs that inhibit prostaglandin synthesis interfere with platelet function to some degree; therefore, patients who may be adversely affected by such an action should be carefully observed.

See also:
What are the possible side effects of K-Kort?

Adults and Children 12 years of age and older

In controlled and uncontrolled studies, 1257 adult and adolescent patients received treatment with intranasal K-Kort acetonide. Adverse reactions are based on the 567 patients who received a product similar to the marketed K-Kort canister.

These patients were treated for an average of 48 days (range 1 to 117 days). The 145 patients enrolled in uncontrolled studies received treatment from 1 to 820 days (average 332 days). The most prevalent adverse experience was headache, being reported by approximately 18% of the patients who received K-Kort. Nasal irritation was reported by 2.8% of the patients receiving K-Kort. Other nasopharyngeal side effects were reported by fewer than 5% of the patients who received K-Kort and included: dry mucous membranes, naso-sinus congestion, throat discomfort, sneezing, and epistaxis. The complaints do not usually interfere with treatment and in the controlled and uncontrolled studies approximately 1% of patients have discontinued because of these nasal adverse effects. In the event of accidental overdose, an increased potential for these adverse experiences may be expected, but systemic adverse experiences are unlikely.

Children 6 through 11 years of age

Adverse event data in children 6 through 11 years of age are derived from two controlled clinical trials of two and four weeks duration. In these trials, 127 patients received fixed doses of 220 mcg/day of K-Kort acetonide for an average of 22 days (range 8 to 33 days).

Adverse events occurring at an incidence of 3% or greater and more common among children treated with 220 mcg K-Kort acetonide daily than vehicle placebo were:

Adverse events occurring at a rate of 3% or greater that were more common in the placebo group were upper respiratory tract infection, headache and concurrent infection.

Only 1.6% of patients discontinued due to adverse experiences. No patient discontinued due to a serious adverse event related to K-Kort therapy.

Though not observed in controlled clinical trials of K-Kort Nasal Inhaler in children, cases of nasal septum perforation among pediatric users have been reported in post-marketing surveillance of this product.