Triamcinolone Ace 40mg/ml, 1ml

Manufacturer AMNEAL Active Ingredient Triamcinolone Injection(trye am SIN oh lone) Pronunciation trye-am-SIN-oh-lone A-set-oh-nide
It is used to treat arthritis of the knee.It is used for many health problems like allergy signs, asthma, adrenal gland problems, blood problems, skin rashes, or swelling problems. This is not a list of all health problems that this drug may be used for. Talk with the doctor.
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Drug Class
Corticosteroid, Anti-inflammatory
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Pharmacologic Class
Glucocorticoid Receptor Agonist
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Pregnancy Category
Category C
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FDA Approved
Aug 1958
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Triamcinolone acetonide is a type of steroid medication that reduces inflammation and calms down the immune system. It's given as an injection, often into joints, muscles, or skin lesions, to treat conditions like arthritis, allergies, and skin problems.
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How to Use This Medicine

Taking Your Medication

To use this medication correctly, follow your doctor's instructions and read all the information provided. It's essential to follow the instructions carefully.

Administration

This medication can be administered in two ways:
- Intra-articular Injection (Knee): The medication is injected directly into the knee joint.
- Other Administration: The medication is given as an injection.

Storage and Disposal

If you need to store this medication at home, consult with your doctor, nurse, or pharmacist for guidance on proper storage.

Missed Dose

If you miss a dose, contact your doctor to determine the best course of action.
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Lifestyle & Tips

  • Report any signs of infection (fever, chills, sore throat) immediately, as steroids can mask symptoms.
  • Avoid close contact with people who are sick or have infections (e.g., chickenpox, measles).
  • Do not receive live vaccines while on high doses of steroids.
  • Follow a diet rich in calcium and vitamin D, and consider supplements, especially with long-term use, to protect bone health.
  • Limit sodium intake to reduce fluid retention.
  • Monitor blood sugar if you have diabetes or are at risk.
  • Carry a steroid warning card if receiving systemic injections, especially for long periods.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable based on indication and route of administration.

Condition-Specific Dosing:

Intra-articular (large joints): 20-40 mg (e.g., knee, hip, shoulder)
Intra-articular (small joints): 5-10 mg (e.g., fingers, toes)
Intramuscular (systemic): 40-60 mg, repeated every 1-6 weeks as needed
Intralesional (dermatologic): 1 mg/mL to 10 mg/mL, total dose not exceeding 1 mg/kg or 50 mg per week
Intrabursal: 10-40 mg
Tendon Sheath: 10-20 mg
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Intramuscular: 0.11-1.6 mg/kg/day in 3-4 divided doses (for systemic effects, not typically depot). Intra-articular/lesional: Doses must be individualized based on joint size/lesion and body surface area, generally lower than adult doses.
Adolescent: Dosing similar to adult for intra-articular/lesional, but systemic IM doses should be carefully considered based on weight and condition.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed.
Dialysis: Not significantly dialyzable. No specific adjustment needed, but monitor for fluid retention.

Hepatic Impairment:

Mild: No specific adjustment needed.
Moderate: No specific adjustment needed.
Severe: No specific adjustment needed, but monitor for increased systemic effects due to altered metabolism.

Pharmacology

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Mechanism of Action

Triamcinolone acetonide is a synthetic corticosteroid that acts as a potent glucocorticoid receptor agonist. It exerts its anti-inflammatory and immunosuppressive effects by inhibiting the migration of leukocytes and fibroblasts, reversing increased capillary permeability, and lysosomal stabilization. It also inhibits the synthesis of prostaglandins and leukotrienes, key mediators of inflammation.
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Pharmacokinetics

Absorption:

Bioavailability: Variable; depends on route of administration. Systemic absorption occurs after local injection, with peak plasma levels typically reached within 8-24 hours after intramuscular injection.
Tmax: 8-24 hours (IM injection)
FoodEffect: Not applicable for injection.

Distribution:

Vd: Approximately 0.2-0.4 L/kg
ProteinBinding: Approximately 60-70% (primarily to albumin and transcortin)
CnssPenetration: Limited, but can cross the blood-brain barrier to some extent.

Elimination:

HalfLife: Biological half-life is 18-36 hours (for systemic effects); plasma half-life is approximately 2-3 hours. The duration of action for the depot formulation is significantly longer due to slow release from the injection site.
Clearance: Approximately 1 L/hr/kg
ExcretionRoute: Renal (primarily as metabolites), some biliary excretion.
Unchanged: <10%
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Pharmacodynamics

OnsetOfAction: Hours to days (for anti-inflammatory effects, depending on route and condition)
PeakEffect: Days to weeks (for depot effect)
DurationOfAction: Several weeks to months (e.g., 3-6 weeks for intra-articular, up to 6 weeks for IM systemic effects)

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

Although rare, some people may experience severe and potentially life-threatening side effects while taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Note: In rare cases, allergic reactions can be fatal.
Signs of infection, including:
+ Fever
+ Chills
+ Severe sore throat
+ Ear or sinus pain
+ Cough
+ Increased or changed sputum production
+ Painful urination
+ Mouth sores
+ Wounds that won't heal
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow wound healing
Signs of adrenal gland problems, including:
+ Severe stomach upset or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Fatigue
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of high blood sugar, such as:
+ Confusion
+ Drowsiness
+ Increased thirst or hunger
+ Frequent urination
+ Flushing
+ Rapid breathing
+ Fruity-smelling breath
Signs of high blood pressure, including:
+ Severe headache or dizziness
+ Fainting
+ Changes in vision
Signs of low potassium levels, such as:
+ Muscle pain or weakness
+ Muscle cramps
+ Abnormal heartbeat
Signs of pancreatitis, including:
+ Severe stomach pain
+ Severe back pain
+ Severe stomach upset or vomiting
Shortness of breath
Sudden weight gain
Swelling in the arms or legs
Abnormal heartbeat (fast, slow, or irregular)
Chest pain
Stomach pain
Black, tarry, or bloody stools
Vomiting blood or coffee ground-like material
Unexplained bruising or bleeding
Bone pain
Joint pain or swelling
Muscle pain or weakness
Fatigue or weakness
Redness or white patches in the mouth or throat
Changes in vision
New or worsening mental, mood, or behavioral changes
Changes in menstrual periods
Seizures
Skin changes (acne, stretch marks, slow healing, hair growth)
Purple, red, blue, brown, or black bumps or patches on the skin or in the mouth
Burning, numbness, or tingling sensations
Redness or swelling at the injection site

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you're concerned about any of the following side effects or if they persist, contact your doctor:

Trouble sleeping
Upset stomach or vomiting
Weight gain
Restlessness
Excessive sweating
Hair thinning

This is not an exhaustive list of possible side effects. If you have questions or concerns, consult your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe pain or swelling at the injection site
  • Signs of infection (fever, chills, body aches)
  • Unusual weight gain or swelling in hands/feet
  • Extreme tiredness or weakness
  • Blurred vision or eye pain
  • Persistent stomach pain, black/tarry stools
  • Mood changes, depression, or anxiety
  • Muscle weakness or cramps
  • Slow wound healing
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following conditions before starting this medication:

Any allergies you have, including allergies to this drug, its components, or other substances, such as foods or medications. Be sure to describe the symptoms you experienced with the allergy.
Stomach or bowel problems, including diverticulitis, diverticulosis, ulcerative colitis, or ulcers.
Any current infections, including bacterial, viral, or fungal infections, as well as specific infections like amoeba infection (e.g., traveler's diarrhea), herpes infection of the eye, cerebral malaria, threadworm infestation, or other infections.
If you have an infection at the site where the injection will be administered (for intramuscular injections).
* If you have idiopathic thrombocytopenic purpura (ITP), a condition affecting platelet count (specifically for intramuscular injections).

Additionally, it is crucial to discuss all your medications, including prescription and over-the-counter drugs, natural products, and vitamins, with your doctor and pharmacist. This will help ensure that it is safe to take this medication with your other medications and health conditions. Do not start, stop, or change the dose of any medication without first consulting your doctor.
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Precautions & Cautions

Important Information About Your Medication

It is crucial that you inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication. Regular blood tests, as directed by your doctor, are necessary to monitor your health. If you are taking this medication long-term, you may also need to have your eye pressure and bone density checked.

Special Considerations

- Allergy Testing: This medication may interfere with allergy skin tests. Ensure that your doctor and laboratory personnel are aware that you are taking this medication.
- Diet and Potassium: You may need to reduce your salt intake and increase your potassium consumption. Discuss this with your doctor to determine the best approach for your situation.
- Diabetes Management: If you have diabetes, it is essential to closely monitor your blood sugar levels.
- Vaccinations: Before receiving any vaccines, consult with your doctor. The use of certain vaccines with this medication may increase the risk of infection or reduce the vaccine's effectiveness.

Infection Risks

- Chickenpox and Measles: These infections can be severe or even fatal in individuals taking steroid medications like this one. Avoid exposure to anyone with chickenpox or measles if you have not previously had these infections. If you have been exposed, notify your doctor immediately.
- General Infection Risk: Steroid medications increase the risk of infections, which can range from mild to severe and potentially life-threatening. The risk is higher with higher doses. To minimize this risk, practice good hygiene by washing your hands frequently, avoid close contact with individuals who have infections, colds, or flu, and promptly report any signs of infection to your doctor.
- Reactivation of Infections: Certain infections, such as tuberculosis and hepatitis B, can reactivate in patients taking medications like this one. Inform your doctor if you have a history of these infections.

Steroid Replacement

- Stressful Situations: This medication may decrease your body's natural production of steroids. In situations of stress, such as fever, infection, surgery, or injury, you may require additional oral steroids. Carry a warning card indicating that you may need extra steroids under these conditions.

Safety Precautions

- Epidural Administration: The use of this medication via epidural (spinal) injection is not approved due to risks of paralysis, loss of vision, stroke, and death. Discuss the risks and benefits with your doctor.
- Age Considerations: If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects.
- Stopping the Medication: If you have been taking this medication for an extended period, consult with your doctor before stopping. A gradual tapering of the dose may be necessary to avoid withdrawal symptoms such as tiredness, weakness, shakiness, fast heartbeat, confusion, sweating, or dizziness.

Long-term Use Considerations

- Osteoporosis: Long-term use of this medication can lead to weak bones (osteoporosis). Discuss your risk factors with your doctor.
- Eye Health: There is an increased risk of cataracts or glaucoma with long-term use. Regular eye exams are recommended.
- Benzyl Alcohol: Some formulations of this medication contain benzyl alcohol, which can be harmful to newborns and infants. If possible, avoid products containing benzyl alcohol in these age groups.

Rare but Serious Risks

- Kaposi's Sarcoma: There is a rare risk of developing Kaposi's sarcoma, a type of cancer, associated with long-term use of medications like this one.
- Growth Effects in Children and Teens: This medication may affect growth in younger patients. Regular growth checks are recommended.

Pregnancy and Breastfeeding

Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. It is essential to discuss the potential benefits and risks of this medication to both you and your baby.
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Overdose Information

Overdose Symptoms:

  • Acute overdose is rare but may include: fluid retention, hypertension, hyperglycemia, muscle weakness, psychiatric disturbances.

What to Do:

No specific antidote. Treatment is supportive and symptomatic. Gradual withdrawal of the drug may be necessary if chronic overdose occurs. Call 1-800-222-1222 (Poison Control).

Drug Interactions

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Contraindicated Interactions

  • Live or live attenuated vaccines (during immunosuppressive doses)
  • Systemic fungal infections (unless used for specific indications like adrenal insufficiency)
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Major Interactions

  • CYP3A4 inducers (e.g., rifampin, phenytoin, barbiturates) - may decrease corticosteroid levels
  • CYP3A4 inhibitors (e.g., ketoconazole, ritonavir, clarithromycin) - may increase corticosteroid levels
  • Anticoagulants (e.g., warfarin) - may alter anticoagulant effect (increase or decrease)
  • NSAIDs - increased risk of GI ulceration/bleeding
  • Diuretics (potassium-depleting) - increased risk of hypokalemia
  • Digoxin - increased risk of digitalis toxicity with hypokalemia
  • Antidiabetic agents - may increase blood glucose, requiring dose adjustment of antidiabetics
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Moderate Interactions

  • Cholestyramine - may decrease absorption of corticosteroids
  • Cyclosporine - increased risk of seizures and other CNS effects
  • Estrogens/Oral Contraceptives - may increase corticosteroid levels
  • Neuromuscular blockers - may prolong neuromuscular blockade
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Minor Interactions

  • Not available

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Before initiation

Blood glucose

Rationale: Corticosteroids can cause hyperglycemia.

Timing: Before initiation

Electrolytes (especially potassium)

Rationale: Risk of hypokalemia.

Timing: Before initiation

Weight

Rationale: Risk of fluid retention and weight gain.

Timing: Before initiation

Ophthalmic exam (if long-term use anticipated)

Rationale: Risk of cataracts and glaucoma.

Timing: Before initiation

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Routine Monitoring

Blood pressure

Frequency: Periodically, especially with systemic use

Target: Normal for patient

Action Threshold: Sustained elevation requiring intervention

Blood glucose

Frequency: Periodically, more frequently in diabetics

Target: Fasting <100 mg/dL, Postprandial <140 mg/dL

Action Threshold: Persistent hyperglycemia requiring intervention

Electrolytes (especially potassium)

Frequency: Periodically, especially with concomitant diuretics

Target: 3.5-5.0 mEq/L

Action Threshold: Potassium <3.5 mEq/L

Weight

Frequency: Periodically

Target: Stable

Action Threshold: Significant, unexplained weight gain

Growth (in pediatric patients)

Frequency: Regularly

Target: Normal growth curve

Action Threshold: Growth retardation

Bone mineral density (if long-term systemic use)

Frequency: Baseline and periodically (e.g., every 1-2 years)

Target: T-score > -1.0

Action Threshold: Osteopenia/osteoporosis

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat)
  • Unusual bruising or bleeding
  • Swelling in ankles or feet
  • Increased thirst or urination
  • Muscle weakness or pain
  • Mood changes (depression, euphoria, insomnia)
  • Vision changes
  • Stomach pain or black, tarry stools
  • Slow wound healing
  • Pain or swelling at injection site

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenicity. Observe infants born to mothers who received substantial doses of corticosteroids during pregnancy for signs of hypoadrenalism.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cleft palate in animal studies; human data are limited and conflicting.
Second Trimester: Risk of fetal growth restriction and adrenal suppression.
Third Trimester: Risk of fetal growth restriction and adrenal suppression; observe neonates for hypoadrenalism.
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Lactation

Corticosteroids are excreted in breast milk. Use with caution. Consider the risk of infant exposure versus the benefits of breastfeeding and maternal treatment. High doses or prolonged use may cause adverse effects in the infant (e.g., growth suppression, interference with endogenous corticosteroid production).

Infant Risk: L3 (Moderate risk - use with caution)
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth and development carefully. Use the lowest effective dose for the shortest possible duration. Adrenal suppression can occur. Intra-articular injections should be used cautiously in children due to potential effects on growth plates.

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Geriatric Use

Elderly patients may be more susceptible to adverse effects, particularly osteoporosis, fluid retention, hypertension, and diabetes. Use the lowest effective dose and monitor closely for adverse reactions.

Clinical Information

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Clinical Pearls

  • Triamcinolone acetonide injection is a suspension and should be shaken well before use.
  • Do not inject intravenously. Accidental intravascular injection can lead to serious adverse events, including anaphylaxis, severe pain, and tissue necrosis.
  • Avoid injecting into infected sites or unstable joints.
  • Repeated injections into the same joint or site should be avoided due to potential for joint damage or skin atrophy.
  • Patients should be advised that local injections do not eliminate the underlying cause of inflammation and may require other treatments.
  • Systemic effects can still occur even with local injections, especially with higher doses or frequent administration.
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Alternative Therapies

  • Oral corticosteroids (e.g., prednisone, methylprednisolone)
  • NSAIDs (for inflammatory conditions)
  • Physical therapy
  • Disease-modifying antirheumatic drugs (DMARDs) for chronic inflammatory conditions
  • Topical corticosteroids (for dermatologic conditions)
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Cost & Coverage

Average Cost: $20 - $100 per 1ml vial (40mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health problems persist or worsen, it is essential to contact your doctor promptly. To ensure safe use, never share your medication with others, and do not take medication prescribed for someone else. Store all medications in a secure location, out of reach of children and pets, to prevent accidental ingestion. Dispose of unused or expired medications properly. Unless instructed to do so by a healthcare professional, avoid flushing medications down the toilet or pouring them down the drain. If you are unsure about the correct disposal method, consult your pharmacist, who can also inform you about potential drug take-back programs in your area. Some medications may come with an additional patient information leaflet, which your pharmacist can provide. If you have any questions or concerns about your medication, discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately contact your local poison control center or seek emergency medical attention. Be prepared to provide information about the medication taken, the quantity, and the time of ingestion.