Triamcin Ace 40mg/ml Inj, 10ml

Manufacturer AMNEAL Active Ingredient Triamcinolone Injection(trye am SIN oh lone) Pronunciation trye am SIN oh lone
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
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Pharmacologic Class
Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Aug 1961
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Triamcinolone is a type of steroid medicine that helps reduce swelling, redness, itching, and allergic reactions in the body. It works by calming down your body's immune response. It is given as an injection into a muscle, joint, or skin lesion, not into a vein.
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How to Use This Medicine

Taking Your Medication Correctly

To ensure safe and effective use, take this medication exactly as directed by your doctor. Carefully read all the information provided to you and follow the instructions closely.

Administration

When administered in the knee: This medication is given as an injection directly into the knee joint.
For other indications: The medication is administered via 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 procedures.

Missed Dose

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

  • Avoid contact with people who have infections (e.g., chickenpox, measles) as your immune system may be weakened.
  • Report any signs of infection immediately.
  • Do not stop this medication suddenly, especially if on long-term therapy, without consulting your doctor, as it can lead to withdrawal symptoms.
  • Follow a diet rich in calcium and vitamin D, and consider supplements, especially for long-term use, to protect bone health.
  • Limit sodium intake to help prevent fluid retention.
  • Regular exercise, if appropriate for your condition, can help maintain muscle strength and bone density.

Dosing & Administration

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Adult Dosing

Standard Dose: Highly variable depending on indication and route of administration. Examples: Intramuscular (IM) 40-80 mg once every 1-4 weeks; Intra-articular (IA) 2.5-60 mg depending on joint size; Intralesional (IL) 1 mg/site (max 30 mg/day).
Dose Range: 2.5 - 100 mg

Condition-Specific Dosing:

Systemic (IM): 40-80 mg, repeated every 1-4 weeks as needed.
Large Joint (IA): 25-60 mg
Small Joint (IA): 2.5-15 mg
Bursitis/Tenosynovitis: 10-40 mg
Intralesional: 1 mg per site, not to exceed 30 mg total daily dose.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established
Child: Dosing is highly individualized based on disease and response. Generally, 0.11-1.6 mg/kg/day IM in divided doses for systemic effects, or 3.3-48 mg/m2/day IM in divided doses. Intra-articular/intralesional doses are scaled down from adult doses based on joint size/lesion area.
Adolescent: Similar to adult dosing, individualized based on disease and response.
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Dose Adjustments

Renal Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required.
Severe: No specific dose adjustment generally required, but monitor for fluid retention and electrolyte imbalances.
Dialysis: Triamcinolone is not significantly removed by hemodialysis. No specific dose adjustment needed, but monitor clinical response.

Hepatic Impairment:

Mild: No specific dose adjustment generally required.
Moderate: No specific dose adjustment generally required, but monitor for increased systemic effects due to altered metabolism.
Severe: No specific dose adjustment generally required, 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 binds to specific cytoplasmic glucocorticoid receptors in target cells. This complex then translocates to the nucleus, where it modulates gene expression by binding to glucocorticoid response elements (GREs) in DNA. This leads to the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines like IL-1, IL-6, TNF-alpha). It also suppresses the migration of polymorphonuclear leukocytes and fibroblasts, reverses capillary permeability, and lysosomal stabilization.
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Pharmacokinetics

Absorption:

Bioavailability: Varies by route of administration; systemic absorption occurs after IM, IA, and intralesional administration.
Tmax: IM: 8-24 hours (for systemic effects); IA/IL: Local effects are rapid, systemic absorption is slower and prolonged.
FoodEffect: Not applicable for injectable formulation.

Distribution:

Vd: Approximately 0.9-1.5 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: Plasma half-life: Approximately 2-5 hours; Biologic half-life (duration of action): 18-36 hours (due to tissue binding and slow release from injection site).
Clearance: Not precisely quantified, but primarily hepatic.
ExcretionRoute: Renal (primarily as metabolites), small amount in feces.
Unchanged: Less than 10% (renal)
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Pharmacodynamics

OnsetOfAction: IM: 24-48 hours for systemic effects; IA/IL: Within hours for local effects.
PeakEffect: IM: 1-2 days for systemic effects; IA/IL: 1-2 days for local effects.
DurationOfAction: IM: 1-6 weeks (due to slow release from injection site); IA/IL: Days to weeks depending on dose and site.

Safety & Warnings

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Side Effects

Serious 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: rash, hives, itching, red, swollen, blistered, or peeling skin (with or without fever), wheezing, tightness in the chest or throat, difficulty breathing, swallowing, or talking, unusual hoarseness, or swelling of the mouth, face, lips, tongue, or throat. In rare cases, allergic reactions can be fatal.
Signs of infection: fever, chills, severe sore throat, ear or sinus pain, cough, increased or changed sputum production, painful urination, mouth sores, or a wound that won't heal.
Signs of Cushing's syndrome: weight gain in the upper back or abdomen, moon face, severe headache, or slow wound healing.
Signs of adrenal insufficiency: severe nausea or vomiting, severe dizziness or fainting, muscle weakness, fatigue, mood changes, decreased appetite, or weight loss.
Signs of high blood sugar: confusion, drowsiness, increased thirst or hunger, frequent urination, flushing, rapid breathing, or fruity-smelling breath.
Signs of high blood pressure: severe headache or dizziness, fainting, or changes in vision.
Signs of low potassium levels: muscle pain or weakness, muscle cramps, or an irregular heartbeat.
Signs of pancreatitis: severe abdominal pain, severe back pain, or severe nausea and vomiting.
Shortness of breath, significant weight gain, or 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 vomit.
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 Side Effects

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

Difficulty sleeping.
Nausea 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 about side effects, 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:

  • Signs of infection (fever, chills, severe sore throat, unusual fatigue)
  • Severe stomach pain, black or tarry stools, or vomiting blood
  • Unusual swelling in hands, ankles, or feet
  • Significant mood changes (depression, anxiety, confusion, insomnia)
  • Blurred vision or eye pain
  • Unusual bruising or bleeding
  • Muscle weakness or severe fatigue
  • Persistent high blood sugar symptoms (increased thirst, urination, hunger)
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Before Using This Medicine

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

To ensure safe treatment, inform your doctor of the following:

Any allergies you have to this medication, its components, or other substances, including foods and drugs. Describe the allergic reactions you've experienced.
Stomach or bowel problems, such as diverticulitis, diverticulosis, ulcerative colitis, or ulcers.
Any current infections, including bacterial, viral, or fungal infections, as well as specific conditions like:
+ Amoeba infection (e.g., traveler's diarrhea)
+ Herpes infection of the eye
+ Malaria infection in the brain
+ Threadworm infestation
+ 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 bleeding disorder (for intramuscular injections).

It's 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 determine if it's safe to take this medication with your other treatments. Never start, stop, or adjust the dosage of any medication without consulting your doctor first.
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Precautions & Cautions

It is essential to 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 crucial to monitor your condition. Additionally, if you are taking this medication for an extended period, you may need to undergo eye pressure and bone density checks.

This medication may interfere with allergy skin tests, so it is vital to notify your doctor and laboratory personnel that you are taking this drug. You may need to reduce your salt intake and increase your potassium consumption; consult with your doctor to determine the best approach for your situation.

If you have diabetes, it is crucial to closely monitor your blood sugar levels. Before receiving any vaccines, discuss the potential risks and benefits with your doctor, as some vaccines may not be effective or may increase the risk of infection when taken with this medication.

It is essential to be aware that steroid medications like this one can increase the risk of severe infections, including chickenpox and measles. If you have not had these illnesses before, avoid contact with anyone who has them, and if you are exposed, consult your doctor immediately. Steroid medications can also worsen existing infections and make it more challenging to detect signs of infection. To minimize the risk of infection, practice good hygiene by washing your hands frequently, avoid close contact with people who have infections, colds, or flu, and notify your doctor if you experience any symptoms of infection.

Some infections, such as tuberculosis and hepatitis B, may reactivate in patients taking medications like this one. If you have a history of these infections, inform your doctor.

This medication may decrease the natural production of steroids in your body. If you experience a fever, infection, undergo surgery, or are injured, consult your doctor, as you may require additional oral steroid doses to help your body cope with these stresses. It is recommended that you carry a warning card indicating that you may need extra steroids in certain situations.

It is crucial to note that administering medications like this one into the spine (epidural) has been associated with severe health problems, including paralysis, loss of vision, stroke, and death. The safety and efficacy of this medication for spinal administration have not been established, and it is not approved for this use. Discuss the potential risks with your doctor.

If you are 65 or older, use this medication with caution, as you may be more susceptible to side effects. If you have been taking this medication for an extended period, consult your doctor before stopping, as you may need to gradually taper off the medication. If you experience symptoms such as fatigue, weakness, shakiness, rapid heartbeat, confusion, sweating, or dizziness after missing a dose or stopping the medication, notify your doctor.

Long-term use of this medication may increase the risk of osteoporosis (weak bones) and eye problems, such as cataracts or glaucoma. Discuss your individual risk factors and any concerns with your doctor.

Some formulations of this medication may contain benzyl alcohol, which can be harmful to newborns and infants. If possible, avoid products containing benzyl alcohol in these age groups, and consult your doctor to determine if this product contains benzyl alcohol.

Prolonged use of medications like this one has been associated with an increased risk of Kaposi's sarcoma, a type of cancer. Discuss this potential risk with your doctor.

This medication may affect growth in children and adolescents; regular growth checks may be necessary. Inform your doctor if you are pregnant, plan to become pregnant, or are breastfeeding, as you will need to discuss the potential benefits and risks to 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, and psychiatric disturbances (e.g., psychosis, depression).

What to Do:

There is no specific antidote. Treatment is supportive and symptomatic. Call 911 or Poison Control (1-800-222-1222) immediately.

Drug Interactions

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Major Interactions

  • Live or live attenuated vaccines (risk of disseminated infection)
  • Ketoconazole, Itraconazole (CYP3A4 inhibitors - increased triamcinolone levels)
  • Rifampin, Phenytoin, Carbamazepine, Barbiturates (CYP3A4 inducers - decreased triamcinolone levels)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) (increased risk of GI ulceration/bleeding)
  • Anticoagulants (warfarin) (altered anticoagulant effect, monitor INR)
  • Diuretics (thiazide, loop) (increased risk of hypokalemia)
  • Antidiabetic agents (insulin, oral hypoglycemics) (decreased glycemic control)
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Moderate Interactions

  • Cardiac glycosides (increased risk of toxicity with hypokalemia)
  • Neuromuscular blocking agents (prolonged blockade)
  • Cholestyramine, Colestipol (decreased triamcinolone absorption if oral)
  • Oral contraceptives (increased triamcinolone levels)
  • Cyclosporine (increased levels of both drugs, increased risk of seizures)
  • Aminoglutethimide (decreased triamcinolone effect)
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Minor Interactions

  • Aspirin (use with caution in hypoprothrombinemia)
  • Growth hormone (somatropin) (inhibition of growth-promoting effect)

Monitoring

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Baseline Monitoring

Blood pressure

Rationale: Corticosteroids can cause hypertension.

Timing: Prior to initiation.

Serum electrolytes (Na, K)

Rationale: Risk of fluid retention and hypokalemia.

Timing: Prior to initiation.

Blood glucose

Rationale: Corticosteroids can cause hyperglycemia.

Timing: Prior to initiation.

Weight

Rationale: Monitor for fluid retention.

Timing: Prior to initiation.

Bone mineral density (DEXA scan)

Rationale: For patients on long-term therapy due to risk of osteoporosis.

Timing: Prior to initiation for long-term use.

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Routine Monitoring

Blood pressure

Frequency: Regularly, especially during initial therapy and dose changes.

Target: Normal range for patient.

Action Threshold: Sustained elevation requiring intervention.

Serum electrolytes (Na, K)

Frequency: Periodically, especially with higher doses or concomitant diuretics.

Target: Na: 135-145 mEq/L, K: 3.5-5.0 mEq/L

Action Threshold: Hypokalemia (<3.5 mEq/L) or significant fluid retention.

Blood glucose (fasting or HbA1c)

Frequency: Periodically, more frequently in diabetics or those at risk.

Target: Fasting: <100 mg/dL; HbA1c: <5.7% (non-diabetic)

Action Threshold: Persistent hyperglycemia requiring intervention.

Weight

Frequency: Regularly.

Target: Stable.

Action Threshold: Significant, unexplained weight gain.

Growth (pediatric patients)

Frequency: Regularly (e.g., every 3-6 months).

Target: Normal growth velocity for age.

Action Threshold: Growth suppression.

Ophthalmic exam (intraocular pressure, cataracts)

Frequency: Annually for long-term therapy (>6 weeks).

Target: Normal.

Action Threshold: Elevated IOP or cataract formation.

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Symptom Monitoring

  • Signs of infection (fever, chills, sore throat, malaise)
  • Gastrointestinal upset (abdominal pain, black/tarry stools)
  • Mood changes (depression, euphoria, insomnia, irritability)
  • Fluid retention (swelling in ankles/feet, weight gain)
  • Muscle weakness or pain
  • Vision changes
  • Skin changes (thinning, bruising, acne)
  • Signs of adrenal insufficiency upon withdrawal (fatigue, weakness, nausea, vomiting, hypotension)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Corticosteroids have been shown to be teratogenic in animal studies. Human data are limited but suggest a possible association with cleft palate and intrauterine growth restriction.

Trimester-Specific Risks:

First Trimester: Potential for increased risk of cleft palate (animal data, limited human data).
Second Trimester: Risk of intrauterine growth restriction (IUGR) with prolonged use.
Third Trimester: Risk of IUGR and adrenal suppression in the neonate if used in late pregnancy. Neonates should be carefully observed for signs of hypoadrenalism.
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Lactation

Triamcinolone is excreted into breast milk. Caution should be exercised when administered to a nursing mother. Monitor the infant for signs of adrenal suppression (e.g., poor weight gain, delayed development) and other adverse effects.

Infant Risk: Low to moderate risk. Potential for growth suppression, interference with endogenous corticosteroid production, and other adverse effects in the infant. Consider lowest effective dose and monitor infant.
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Pediatric Use

Corticosteroids can cause growth retardation in children. Monitor growth and development carefully. Pediatric patients may be more susceptible to systemic adverse effects, especially with prolonged use. Adrenal suppression can occur. Dosing should be individualized to achieve the desired therapeutic effect with the lowest possible dose for the shortest duration.

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Geriatric Use

Elderly patients may be at increased risk for adverse effects such as osteoporosis, fluid retention, hypertension, and diabetes. Use the lowest effective dose and monitor closely for adverse effects.

Clinical Information

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Clinical Pearls

  • Triamcinolone acetonide injectable suspension is NOT for intravenous (IV) use. Accidental IV administration can lead to severe adverse events, including death.
  • This formulation is a suspension and should be shaken well before use to ensure uniform distribution of the drug.
  • Local injection site reactions (e.g., post-injection flare, skin atrophy, sterile abscess) can occur.
  • Patients on long-term corticosteroid therapy should carry a steroid card or medical alert identification.
  • Withdrawal of corticosteroids after prolonged therapy should be gradual to prevent adrenal insufficiency.
  • Patients should be advised to avoid vaccination with live or live attenuated vaccines while on immunosuppressive doses of corticosteroids.
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Alternative Therapies

  • Other injectable corticosteroids (e.g., methylprednisolone acetate, betamethasone acetate/phosphate, dexamethasone sodium phosphate)
  • Oral corticosteroids (e.g., prednisone, prednisolone, dexamethasone)
  • Non-steroidal anti-inflammatory drugs (NSAIDs) for inflammatory conditions
  • Disease-modifying antirheumatic drugs (DMARDs) or biologics for chronic inflammatory diseases
  • Topical corticosteroids for dermatologic conditions
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Cost & Coverage

Average Cost: $50 - $200 per 10ml vial (40mg/ml)
Generic Available: Yes
Insurance Coverage: Tier 1 or Tier 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 for further guidance. 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 otherwise, do not flush medications down the toilet or pour them down the drain. If you are unsure about the proper 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 amount, and the time it occurred.