Kenalog-40 Injection

DRUG DESCRIPTION

Kenalog®-40 Injection (triamcinolone acetonide injectable suspension, USP) is a synthetic glucocorticoid corticosteroid with anti-inflammatory action. THIS FORMULATION IS SUITABLE FOR INTRAMUSCULAR AND INTRAARTICULAR USE ONLY. THIS FORMULATION IS NOT FOR INTRADERMAL INJECTION.

Each mL of the sterile aqueous suspension provides 40 mg triamcinolone acetonide, with sodium chloride for isotonicity, 0.99% (w/v) benzyl alcohol as a preservative, 0.75% carboxymethylcellulose sodium, and 0.04% polysorbate 80. Sodium hydroxide or hydrochloric acid may be present to adjust pH to 5.0 to 7.5. At the time of manufacture, the air in the container is replaced by nitrogen.

The chemical name for triamcinolone acetonide is 9-Fluoro-11?,16?,17,21- tetrahydroxypregna-1,4-diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural formula is:

Kenalog®-40 (triamcinolone acetonide) Structural Formula Illustration

Triamcinolone acetonide occurs as a white to cream-colored, crystalline powder having not more than a slight odor and is practically insoluble in water and very soluble in alcohol.

What are the precautions when taking triamcinolone acetonide injectable suspension (Kenalog-40 Injection)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., methylprednisolone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: untreated active fungal infections.

If your have a certain bleeding disorder (idiopathic thrombocytopenic purpura), consult your doctor before injecting this medication into a muscle.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems,...

Read All Potential Precautions of Kenalog-40 Injection »


Kenalog-40 Injection Consumer (continued)

SIDE EFFECTS: Redness or pain at the injection site, stomach upset, headache, dizziness, menstrual period changes, trouble sleeping, or weight gain may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: bone pain, easy bruising/bleeding, black stools, vomit that looks like coffee grounds, severe stomach/abdominal pain, increased thirst/urination, fast/pounding/irregular heartbeat, shortness of breath, swelling of the ankles/feet, persistent weight gain, puffy face, unusual hair growth, thinning skin, slow wound healing, signs of infection (e.g., persistent fever/cough/sore throat, painful urination, eye pain/discharge), muscle weakness/pain, mental/mood changes (e.g., mood swings, depression, agitation), vision changes, seizures, unusual skin growths.

If you have received injection of this medication into the joint, temporary discomfort of the joint may occur. Tell your doctor immediately if you have fever, increased/severe pain with swelling of the joint, weakness in the joint, or decreased range of motion in the joint.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other corticosteroids (e.g., methylprednisolone); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: untreated active fungal infections.

If your have a certain bleeding disorder (idiopathic thrombocytopenic purpura), consult your doctor before injecting this medication into a muscle.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, history of blood clots, brittle bones (osteoporosis), high blood pressure, certain heart problems (e.g., congestive heart failure), diabetes, certain eye diseases (e.g., cataracts, herpes infection, glaucoma), kidney disease, current infections (e.g., tuberculosis, threadworm), severe liver disease (cirrhosis), certain mental/mood conditions (e.g., psychosis, depression), head injury, previously infected joint, seizures, stomach/intestinal problems (e.g., diverticulitis, ulcer, ulcerative colitis), thyroid problems, untreated mineral problems (e.g., low potassium or calcium).

This medication may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely.

This medication may mask signs of infection or put you at greater risk of developing very serious infections. Report any injuries or signs of infection (e.g., persistent sore throat/cough/fever, pain during urination, muscle aches) that occur while using this medication or within 12 months after stopping it.

Using corticosteroid medications for a long time can make it more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used this medication within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. If you will be using this medication for a long time, carry a warning card or medical ID bracelet that identifies your use of this medication.

Do not have immunizations, vaccinations, or skin tests while you are using this drug unless specifically directed by your doctor. Avoid contact with people who have recently received oral polio vaccine.

Avoid exposure to chickenpox or measles infection while using this medication. If you are exposed to these infections, seek immediate medical attention.

If you have a history of ulcers or take large doses of aspirin or other arthritis medication, limit alcoholic beverages while using this drug. Alcohol may increase the risk of stomach/intestinal bleeding.

If you have diabetes, this drug may increase your blood sugar levels. Check your blood glucose levels regularly as directed by your doctor. Tell your doctor immediately if you have symptoms such as increased thirst and urination. Your anti-diabetic medication or diet may need to be adjusted.

This medication may slow down a child's growth if used for a long time. Consult the doctor or pharmacist for more details. See the doctor regularly so your child's height and growth can be checked.

Injecting this medication into a muscle is not recommended for children younger than six years. Consult your doctor for more details.

This medication should be used only when clearly needed during pregnancy. There have been rare reports of harm to an unborn baby when corticosteroids are used during pregnancy. Discuss the risks and benefits with your doctor. Infants born to mothers who have been using this medication for an extended time may have low levels of corticosteroid hormone. Tell your doctor immediately if you notice symptoms such as persistent nausea/vomiting, severe diarrhea, or weakness in your newborn.

This medication passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.



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