Aristospan

Name: Aristospan

Aristospan Precautions

Serious side effects have been reported with topical triamcinolone including the following:

  • Burning, drying and itching of the skin
  • Convulsions
  • Depression
  • Increased blood pressure
  • Muscle weakness
  • Nervousness
  • Psychosis
  • Sleepiness
  • Changes in menstrual cycle
  • Swelling in lower extremities
  • Water retention
  • Worsening of diabetes or ulcers

Serious side effects have been reported with injectable triamcinolone including the following:

  • Stomach upset
  • Muscle weakness or atrophy
  • Adrenal insufficiency
  • Increased blood pressure
  • Water and salt retention
  • Increased susceptibility to infection

Glaucoma, cataracts, optic nerve damage, and ocular infections have been reported with the ophthalmic injections of triamcinolone.

Triamcinolone can cause dizziness. Do not drive or operate heavy machinery until you know how triamcinolone affects you.

Do not take triamcinolone if you are allergic to triamcinolone or to any of its ingredients.

Before Using Aristospan

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of triamcinolone injection in the pediatric population. However, because of this medicine's toxicity, it should be used with caution especially in premature babies.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of triamcinolone injection in the elderly.

Pregnancy

Pregnancy Category Explanation
All Trimesters C Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

  • Desmopressin
  • Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Aldesleukin
  • Bemiparin
  • Ceritinib
  • Idelalisib
  • Nadroparin
  • Pixantrone
  • Ritonavir

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

  • Alcuronium
  • Aspirin
  • Atracurium
  • Fosphenytoin
  • Gallamine
  • Hexafluorenium
  • Licorice
  • Metocurine
  • Phenytoin
  • Primidone
  • Saiboku-To

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

  • Bone problems (e.g., osteoporosis) or
  • Cataracts or
  • Cirrhosis (liver problem) or
  • Congestive heart failure or
  • Depression or
  • Emotional problems or
  • Glaucoma or
  • Heart attack, recent or
  • Heart disease or
  • Hypertension (high blood pressure) or
  • Intracranial hypertension (increased pressure in the head) or
  • Kaposi's sarcoma or
  • Kidney disease, severe or
  • Mental illness or
  • Myasthenia gravis (severe muscle weakness) or
  • Stomach or bowel problems (e.g., diverticulitis, ulcers, ulcerative colitis) or
  • Thyroid problems—Use with caution. May make these conditions worse.
  • Brain injury, traumatic or
  • Cerebral malaria or
  • Herpes infection of the eye or
  • Idiopathic thrombocytopenic purpura (low platelet count)—Should not be used in patients with this condition.
  • Infection (bacteria, virus, fungus, parasite, or protozoa)—May decrease your body's ability to fight infection.
  • Tuberculosis infection, inactive—Should be treated first before starting therapy with this medicine.

Aristospan - Clinical Pharmacology

Glucocorticoids, naturally occurring and synthetic, are adrenocortical steroids that are readily absorbed from the gastrointestinal tract.

Naturally occurring glucocorticoids (hydrocortisone and cortisone), which also have salt-retaining properties, are used as replacement therapy in adrenocortical deficiency states.

Their synthetic analogs are primarily used for their anti-inflammatory effects in disorders of many organ systems. When injected intralesionally or sublesionally, triamcinolone hexacetonide can be expected to be absorbed slowly from the injection site.

Indications and Usage for Aristospan

The intralesional administration of Aristospan (triamcinolone hexacetonide injectable suspension, USP) 5 mg/mL is indicated for alopecia areata; discoid lupus erythematosus; keloids; localized hypertrophic, infiltrated, inflammatory lesions of granuloma annulare, lichen planus, lichen simplex chronicus (neurodermatitis), and psoriatic plaques; necrobiosis lipoidica diabeticorum. Aristospan may also be useful in cystic tumors of an aponeurosis or tendon (ganglia).

Contraindications

Aristospan is contraindicated in patients who are hypersensitive to any components of this product.

Intramuscular corticosteroid preparations are contraindicated for idiopathic thrombocytopenic purpura.

Aristospan Dosage and Administration

NOTE: CONTAINS BENZYL ALCOHOL (see PRECAUTIONS)

General

The initial dosage of Aristospan (triamcinolone hexacetonide injectable suspension, USP) may vary from 2 to 48 mg per day depending on the specific disease entity being treated. However, in certain overwhelming, acute, life-threatening situations, administration in dosages exceeding the usual dosages may be justified and may be in multiples of the oral dosages.

It Should Be Emphasized That Dosage Requirements Are Variable and Must Be Individualized on the Basis of the Disease Under Treatment and the Response of the Patient. After a favorable response is noted, the proper maintenance dosage should be determined by decreasing the initial drug dosage in small decrements at appropriate time intervals until the lowest dosage which will maintain an adequate clinical response is reached. Situations which may make dosage adjustments necessary are changes in clinical status secondary to remissions or exacerbations in the disease process, the patient’s individual drug responsiveness, and the effect of patient exposure to stressful situations not directly related to the disease entity under treatment. In this latter situation it may be necessary to increase the dosage of the corticosteroid for a period of time consistent with the patient’s condition. If after long-term therapy the drug is to be stopped, it is recommended that it be withdrawn gradually rather than abruptly.

In pediatric patients, the initial dose of triamcinolone may vary depending on the specific disease entity being treated. The range of initial doses is 0.11 to 1.6 mg/kg/day in three or four divided doses (3.2 to 48 mg/m2bsa/day).

For the purpose of comparison, the following is the equivalent milligram dosage of the various glucocorticoids:

Cortisone, 25

Triamcinolone, 4

Hydrocortisone, 20

Paramethasone, 2

Prednisolone, 5

Betamethasone, 0.75

Prednisone, 5

Dexamethasone, 0.75

Methylprednisolone, 4

These dose relationships apply only to oral or intravenous administration of these compounds. When these substances or their derivatives are injected intramuscularly or into joint spaces, their relative properties may be greatly altered.

Directions for Use

Strict aseptic administration technique is mandatory.

Topical ethylchloride spray may be used locally before injection.

The syringe should be gently agitated to achieve uniform suspension before use. Since this product has been designed for ease of administration, a small bore needle (not smaller than 23 gauge) may be used.

Dilution

Aristospan suspension may also be mixed with 1% or 2% Lidocaine Hydrochloride, using the formulations which do not contain parabens. Similar local anesthetics may also be used. Diluents containing methylparaben, propylparaben, phenol, etc. should be avoided since these compounds may cause flocculation of the steroid. These dilutions will retain full potency for one week, but care should be exercised to avoid contamination of the vial’s contents and the dilutions should be discarded after 7 days.

Aristospan suspension 5 mg/mL may also be diluted, if desired, with Dextrose and Sodium Chloride Injection USP, (5% and 10% Dextrose), Sodium Chloride Injection USP, or Sterile Water for Injection USP.

The optimum dilution, i.e., 1:1, 1:2, 1:4, should be determined by the nature of the lesion, its size, the depth of injection, the volume needed, and location of the lesion. In general, more superficial injections should be performed with greater dilution. Certain conditions, such as keloids, require a less dilute suspension such as 5 mg/mL, with variation in dose and dilution as dictated by the condition of the individual patient. Subsequent dosage, dilution, and frequency of injections are best judged by the clinical response.

Intralesional or Sublesional

Average Dose

Up to 0.5 mg per square inch of affected skin injected intralesionally or sublesionally. The frequency of subsequent injections is best determined by the clinical response. If desired, the vial may be diluted as indicated under Directions for Use.

A lesser initial dosage range of Aristospan may produce the desired effect when the drug is administered to provide a localized concentration. The site of the injection and the volume of the injection should be carefully considered when Aristospan is administered for this purpose.

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