Zona

Contraindications

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What is the most important information I should know about Zona?

For short-term use of Zona according to the life - hypersensitivity to Zona. For intraarticular administration and injection directly into the lesion: previous arthroplasty, abnormal bleeding (endogenous or caused by the use of anticoagulants), intra-articular fracture, infection (septic) inflammatory process in joints and periarticular infections (including history), and also general infectious disease marked juxta-articular osteoporosis, lack of signs of inflammation in the joint ("dry" joint, such as osteoarthrosis without synovitis), marked bone destruction and deformity of joints (sharp narrowing of joint space, ankylosis), instability of the joint as a result of arthritis, aseptic necrosis of the epiphyses of bones forming the joint.

For external use: bacterial, viral, fungal skin diseases, tuberculosis, skin, cutaneous manifestations of syphilis, tumors of the skin, post-vaccination period, violation of the integrity of the skin (ulcers, wounds), children's age (up to 2 years, with itching in the anal area - up to 12 years), rosacea, acne vulgaris, perioral dermatitis.

For use in ophthalmology: bacterial, viral, fungal eye diseases, tuberculosis eye disease, trachoma, violation of the integrity of the eye epithelium.

Undesirable effects

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What are the possible side effects of Zona?

The following adverse reactions are discussed in greater detail in other sections of the labeling:

The following additional local adverse reactions have been reported infrequently with topical corticosteroids but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, drying, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety data derived from Zona clinical trials reflect exposure to Zona twice daily for up to four weeks in separate clinical trials involving pediatric subjects 3 months to 18 years of age with mild to moderate atopic dermatitis.

Adverse reactions shown in the tables below include those for which there is some basis to believe there is a causal relationship to Zona.

The following adverse reactions have been identified during post approval use of Zona. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Skin: Erythema, rash and application site irritation.

Therapeutic indications

For parenteral use of Zona: acute adrenal insufficiency, allergic reactions of immediate type, asthmatic status, prevention and treatment of shock, myocardial infarction complicated by cardiogenic shock, thyrotoxic crisis, thyroiditis, congenital adrenal hyperplasia, hypercalcemia due to tumor disease, short or additional therapy in acute rheumatic diseases, collagen diseases, pemphigus, bullous Dermatitis herpetiformis (Duhring disease), polymorphic bullous erythema, exfoliative dermatitis, granulosarcoid, severe forms of psoriasis and seborrheic dermatitis, severe acute and chronic allergic and inflammatory processes with eyes involvement, symptomatic sarcoidosis, Loeffler syndrome if not amenable to other forms of therapy, berylliosis, focal or disseminated form of tuberculosis during anti tuberculosis chemotherapy, aspiration pneumonitis, adult idiopathic thrombocytopenic purpura (only IV), adult secondary thrombocytopenia, acquired (autoimmune) hemolytic anemia, erythroblastopenia, congenital (erythroid) anemotrophy, palliative therapy in leukemia and lymphoma adults with acute leukemia in children, to enhance diuresis and to reduce proteinuria in nephrotic syndrome without uremia, with nephrotic syndrome of idiopathic type or lupus erythematosus, in a critical stage of ulcerative colitis, and regional enteritis (as a systemic treatment), tuberculous meningitis with subarachnoid block or the development of its stake (in conjunction with antituberculosis chemotherapy), trichinosis with nervous system or myocardium, bronchial asthma, diseases of the joints.

For local use: inflammation of the anterior eyeball in intact epithelium of the cornea and after injury and surgery on the eyeball.

For external use: allergic dermatitis, seborrhea, various forms of eczema, atopic dermatitis, psoriasis, pruritus, red flat verrucous zoster.

Zona topical is used to help relieve redness, itching, swelling, or other discomfort caused by skin conditions (e.g., atopic dermatitis, seborrheic dermatitis). Zona is a corticosteroid (cortisone-like medicine or steroid).

Zona is available only with your doctor's prescription.

Name of the medicinal product

Qualitative and quantitative composition

Zona 100 mg contains Zona sodium succinate equivalent to Zona 100 mg, monobasic sodium phosphate 1 mg, dibasic sodium 9 mg and sodium hydroxide 10%.

Zona 100 mg/2 mL contains Zona sodium succinate equivalent to Zona 100 mg/2 mL, monobasic sodium phosphate 1 mg, dibasic sodium 10 mg and sodium hydroxide 10%.

Zona 250 mg/2 mL contains Zona sodium succinate equivalent to Zona 250 mg/2 mL, monobasic sodium phosphate 2 mg, dibasic sodium phosphate 25 mg and sodium hydroxide 10%.

Zona 500 mg/4 mL contains Zona sodium succinate equivalent to Zona 500 mg/4 mL, monobasic sodium phosphate 5 mg, dibasic sodium phosphate 52 mg and sodium hydroxide 10%.

Zona sodium succinate or pregn-4-ene-3,20-dione,21-(3-carboxy-1-oxopropoxy)-11,17-dihydroxy; monosodium salt,(11β) is an anti-inflammatory adrenocortical steroid. This highly water-soluble sodium succinate ester of Zona permits the immediate IV administration of high doses of Zona in a small volume of diluent and is particularly useful where high blood levels of Zona are required rapidly.

When necessary, the pH of Zona was adjusted with sodium hydroxide so that the pH of the reconstituted solution is within the USP specified range of 7-8.

Special warnings and precautions for use

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

• Apply a small amount of medicine to the affected area. Gently rub it in until it is evenly distributed. Wash your hands after applying Zona solution, unless your hands are part of the treated area.
• Do not bandage or wrap the affected area unless directed otherwise by your doctor.
• If you miss a dose of Zona solution, 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 Zona solution.

This medication is used to treat a variety of skin conditions (e.g., insect bites, poison oak/ivy, eczema, dermatitis, allergies, rash, itching of the outer female genitals, anal itching). Zona reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a mild corticosteroid.

There are many Zona products available. Many can be purchased without a prescription. Some products require a prescription. Consult your doctor or pharmacist on the choice of the product that is best for you.

Use this medication on the skin only. However, do not use it on the face or underarms unless directed to do so by your doctor. Some products are meant to be used on the scalp for various conditions. To correctly use these products, follow the directions on the product package.

Wash and dry your hands before using. Clean and dry the affected area. If you are using the lotion or foam, shake it well just before using. If you are using the spray, check the product package to see if it needs to be shaken before each use. Apply a small amount of medication to the affected area and gently rub in, usually up to 4 times a day or as directed by your doctor or the product package. Dosage and length of treatment depends on the type of condition being treated. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. If used in or near the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands, unless the hands are being treated. Avoid getting this medication in the eyes, nose, or mouth. If you get the medication in these areas, rinse with plenty of water. If irritation occurs or continues, contact your doctor right away.

Use this medication only for the condition for which it was prescribed or a condition that is listed on the product package. Do not use it for longer than directed by the product package or your doctor.

Tell your doctor if your condition persists or worsens after 7 days or if you think you may have a serious medical problem.

Dosage (Posology) and method of administration

Zona cream, 0.1% (lipophilic) is not for oral, ophthalmic, or intravaginal use. Therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of the diagnosis may be necessary. Before prescribing for more than 2 weeks, any additional benefits of extending treatment to 4 weeks should be weighed against the risk of HPA axis suppression and local adverse events. The safety and efficacy of Zona cream, 0.1% (lipophilic) has not been established beyond 4 weeks of use.

Apply a thin film to the affected skin areas two or three times daily, depending on the severity of the condition. Rub in gently.

Apply a thin film to the affected skin areas two times daily. Rub in gently.

Zona cream, 0.1% (lipophilic) should not be used with occlusive dressings or applied in the diaper area unless directed by a physician.

Interaction with other medicinal products and other forms of interaction

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What other drugs will affect Zona?

With simultaneous use of Zona increases the toxicity of cardiac glycosides (because of the emerging hypokalemia increases the risk of arrhythmias); with acetylsalicylic acid - accelerates its excretion and reduces its concentration in blood plasma (with the abolition of Zona concentration of salicylates in the blood increases, and increases the risk of side effects); with paracetamol - increased risk of hepatotoxic action of paracetamol (induction of hepatic enzymes and formation of a toxic metabolite of paracetamol); with cyclosporine - increased side effects of Zona as a result of inhibition of its metabolism; with ketoconazole - increased side effects of Zona as a result of reduction of its clearance.

Zona reduces the effectiveness of hypoglycemic; intensifies the effect of indirect anticoagulants of coumarin derivatives.

Zona reduces the effect of vitamin D on the absorption of calcium ions into the lumen of the intestine. Ergocalciferol and parathyroid hormone hinder the development of osteopathy caused by GCS.

Zona increases the metabolism of isoniazid, meksiletina (especially in "fast acetylators"), which leads to a decrease in their plasma concentrations; increases (with prolonged therapy) the content of folic acid reduces the concentration of praziquantel in blood.

Zona in high doses reduces the effect somatropina.

Hypokalemia caused by GCS, may increase the severity and duration of muscle blockade on the background of muscle relaxants.

Antacids reduce the absorption of the GCS.

At simultaneous application with SCS thiazides, carbonic anhydrase inhibitors, other GCS, amphotericin B increase the risk of hypokalemia, drugs containing sodium ions - swelling and increase blood pressure.

NSAIDs and ethanol increases the risk of gastrointestinal ulcerations and bleeding, in combination with NSAIDs to treat arthritis may reduce the dose of GCS due to summation of therapeutic effect. Indomethacin displacing the SCS from its association with albumin, increases the risk of its side effects.

Amphotericin B and carbonic anhydrase inhibitors increase the risk of osteoporosis.

The therapeutic effect of GCS is reduced under the influence of inducers of microsomal liver enzymes (including phenytoin, barbiturates, ephedrine, theophylline, rifampin) due to increased rate of metabolism of these substances.

Inhibitors of the function of the adrenal cortex (including mitotan) may necessitate higher doses of GCS.

Clearance GCS increased against the background of preparations of thyroid hormones.

Immunosuppressants increase the risk of infection and lymphoma or other lymphoproliferative disorders associated with Epstein-Barr virus.

Estrogens (including oral contraceptives containing estrogen) reduce the clearance of GKS, lengthens T1/2 and their therapeutic and toxic effects. The appearance of hirsutism and acne promotes the simultaneous use of other steroid hormone funds - androgens, estrogens, anabolic steroids, oral contraceptives.

Tricyclic antidepressants may increase the severity of depression caused by GCS (not shown for the treatment of these side effects).

The risk of developing cataracts increases with the application against other GCS antipsychotic funds (neuroleptics), carbutamide and azathioprine. Simultaneous of Zona with the appointment of m-cholinoblockers, as well as with means having m-anticholinergic action (including antihistamines, tricyclic antidepressants), with nitrates improves the intraocular pressure.

With simultaneous application of SCS with live vaccines and antiviral compared to other types of immunization increases the risk of activation of viruses and development of infections.