Topik

Each gram of Topik (Topik*) Cream* contains: 640 mcg Topik dipropionate (equivalent to 500 mcg Topik).

Each gram of Topik (Topik*) Ointment* contains: 640 mcg Topik dipropionate (equivalent to 500 mcg Topik).

Topik (Topik*) Cream and Ointment contain Topik dipropionate, a synthetic corticosteroid with anti-inflammatory activity to be administered topically.

Topik dipropionate is a white to creamy white odorless crystalline powder insoluble in water; freely soluble in acetone and in chloroform; sparingly soluble in alcohol. It has a molecular weight of 504.16 and the empirical formula C₂₈H₃₇FO₇; a chemical name of 9-fluoro-11β,17,21-trihydroxy-16β-methylpregna-1,4-diene-3,20-dione,17,21-dipropionate.

Topik Suspension is indicated for the treatment of acute and chronic corticosteroid-responsive disorders. Corticosteroid hormone therapy is an adjunct to, and not a replacement for conventional therapy.

Musculoskeletal and Soft Tissue Conditions: Rheumatoid arthritis, osteoarthritis, bursitis, ankylosing spondylitis, epicondylitis, radiculitis, coccydynia, sciatica, lumbago, torticollis, ganglion cyst, exostasis and fasciitis.

Allergic Conditions: Chronic bronchial asthma (including adjunctive therapy for status asthmaticus), hay fever, angioneurotic edema, allergic bronchitis, seasonal or perennial allergic rhinitis, drug reactions, serum sickness and insect bites.

Dermatologic Conditions: Atopic dermatitis (nummular eczema), neurodermatitis (circumscribed lichen simplex), contact dermatitis, severe solar dermatitis, urticaria, hypertrophic lichen planus, necrobiosis lipoidica diabeticorum, alopecia areata, discoid lupus erythematosus, psoriasis, keloids, pemphigus, dermatitis herpetiformis and cystic acne.

Collagen Diseases: Disseminated lupus erythematosus, scleroderma, dermatomyositis, periarteritis nodosa.

Neoplastic Diseases: Palliative management of leukemias and lymphomas in adults; acute leukemia of childhood.

Other Conditions: Adrenogenital syndrome, ulcerative colitis, regional ileitis, sprue, podiatric conditions (bursitis under heloma durum, hallux rigidus, digiti quinti varus), affections requiring subconjunctival injection, corticosteroid-responsive blood dyscrasias, nephritis and nephrotic syndrome.

Primary or secondary adrenocortical insufficiency may be treated with Topik Suspension but should be supplemented with mineralocorticosteroids, if applicable.

Topik Suspension is recommended for intramuscular injection in conditions responsive to systemic corticosteroids; injection directly into the affected soft tissues where indicated; intra-articular and periarticular injection in arthritides; intralesional injection in various dermatologic conditions; and local injection in certain inflammatory and cystic disorders of the foot.

Topik sodium phosphate and Topik acetate combination injection provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, lung or breathing problems, blood or bone marrow problems, eye or vision problems, lupus, serious skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Topik sodium phosphate and Topik acetate combination is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

Topik sodium phosphate and Topik acetate is to be given only by or under the direct supervision of your doctor.

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Kit, Injection:

Pod-Care 100C: Topik sodium phosphate 3 mg and Topik acetate 3 mg per 1 mL [contains benzalkonium chloride, disodium edta]

ReadySharp Topik: Topik sodium phosphate 3 mg and Topik acetate 3 mg per 1 mL [contains benzalkonium chloride, disodium edta]

Suspension, Injection:

Topik: Topik sodium phosphate 3 mg and Topik acetate 3 mg per 1 mL (5 mL) [contains benzalkonium chloride, edetate disodium]

Generic: Topik sodium phosphate 3 mg and Topik acetate 3 mg per 1 mL (5 mL)

Dosing: Adult

Note: Dosages expressed as combined amount of Topik sodium phosphate and Topik acetate; 1 mg is equivalent to Topik sodium phosphate 0.5 mg and Topik acetate 0.5 mg.

Usual dosage range: IM: Initial: 0.25 to 9 mg/day (based on severity of disease and patient response).

Indication-specific dosing:

Antenatal fetal maturation (off-label use): IM: 12 mg every 24 hours for a total of 2 doses (ACOG 171 2016). A single course of Topik is recommended for women between 24 and 34 weeks of gestation, including those with ruptured membranes or multiple gestations, who are at risk of delivering within 7 days. A single course may be appropriate in some women beginning at 23 weeks gestation or late preterm (between 34 0/7 weeks and 36 6/7 weeks gestation). A single repeat course may be considered in some women with pregnancies less than 34 weeks gestation at risk for delivery within 7 days and who had a course of antenatal corticosteroids >14 days prior (ACOG 171 2016; ACOG 713 2017, ACOG 188 2018).

Bursitis (other than of foot): Intra-articular: 3 to 6 mg (0.5 to 1 mL) for one dose; additional injections may be required for acute exacerbations or chronic conditions; generally, injections should be separated by a minimum of 4 to 6 weeks and limited to ≤4 injections per year. If symptoms are not improved after 1 or 2 injections, additional injections are unlikely to provide benefit (Cardone 2002); following resolution of acute episodes, reduced doses may be warranted for chronic conditions.

Dermatologic conditions: Intradermal: 1.2 mg/cm displayed a good or excellent response (Chowdri, 1994). Another trial (n=25, age range: 7 weeks to 2 years) used lower doses of 3 to 12 mg (in combination with triamcinolone); 16 patients experienced a marked response (Kushner, 1985).

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

You should not use this medication if you are allergic to Topik, or if you have a fungal infection anywhere in your body.

Before taking Topik, tell your doctor about all of your medical conditions, and about all other medicines you are using. There are many other diseases that can be affected by steroid use, and many other medicines that can interact with steroids.

Your steroid medication needs may change if you have any unusual stress such as a serious illness, fever or infection, or if you have surgery or a medical emergency. Tell your doctor about any such situation that affects you during treatment.

Steroid medication can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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 medication.

Do not receive a "live" vaccine while you are taking Topik. Vaccines may not work as well while you are taking a steroid.

Do not stop using Topik suddenly, or you could have unpleasant withdrawal symptoms. Talk to your doctor about how to avoid withdrawal symptoms when stopping the medication.

Carry an ID card or wear a medical alert bracelet stating that you are taking a steroid, in case of emergency.

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

• Take Topik solution by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Use the dropper that comes with Topik solution to measure your dose. Ask your pharmacist for help if you are unsure of how to measure your dose.
• If Topik solution needs to be stopped (or if a different medicine is added to therapy) by your doctor, this will be done gradually. The risk of side effects may be increased if Topik solution is suddenly stopped.
• If you miss a dose of Topik solution, take 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 take 2 doses at once.

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

This medication is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Topik reduces the swelling, itching, and redness that can occur in these types of conditions. This medication is a medium-strength corticosteroid.

How to use Topik topical

Use this medication on the skin only. However, do not use it on the face, groin, or underarms unless directed to do so by your doctor.

Wash and dry your hands before using. Clean and dry the affected area. Apply a thin film of medication to the affected area and gently rub in, usually 1-3 times daily or as directed by your doctor. Do not bandage, cover, or wrap the area unless directed to do so by your doctor. If used in the diaper area on an infant, do not use tight-fitting diapers or plastic pants.

After applying the medication, wash your hands unless you are using this medication to treat the hands. When applying this medication near the eyes, avoid getting it in the eyes because this may worsen or cause glaucoma. Also, avoid getting this medication in the nose or mouth. If you get the medication in these areas, rinse with plenty of water.

Use this medication only for the condition for which it was prescribed. Do not use it for longer than prescribed.

Inform your doctor if your condition persists or worsens after 2 weeks.

See also:
What other drugs will affect Topik?

There are no known drug interactions with topical Topik dipropionate.

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

Applies to Topik topical: topical application cream, topical application foam, topical application gel/jelly, topical application lotion, topical application ointment

Other dosage forms:

• topical application cream, topical application lotion, topical application ointment, topical application spray

In addition to its needed effects, some unwanted effects may be caused by Topik topical (the active ingredient contained in Topik). In the event that any of these side effects do occur, they may require medical attention.

Major Side Effects

You should check with your doctor immediately if any of these side effects occur when taking Topik topical:

More common:

• Burning, itching, or stinging at the application site

• Hair loss
• thinning of the hair

• Blistering, burning, crusting, dryness, or flaking of the skin
• irritation
• itching, scaling, severe redness, soreness, or swelling of the skin
• redness and scaling around the mouth
• thinning of the skin with easy bruising, especially when used on where the skin folds together (e.g. between the fingers)

Minor Side Effects

Some of the side effects that can occur with Topik topical may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

Less common:

• Acne or pimples
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

• Burning and itching of the skin with pinhead-sized red blisters
• burning, itching, and pain in hairy areas, or pus at the root of the hair
• increased hair growth on the forehead, back, arms, and legs
• lightening of normal skin color
• lightening of treated areas of dark skin
• reddish purple lines on the arms, face, legs, trunk, or groin
• softening of the skin