Omnitrenidol (Page 8 of 8)

1.9.1 Dosage

SYSTEMIC

The suggested initial dose is 60 mg, injected deeply into the gluteal muscle. Atrophy of subcutaneous fat may occur if the injection is not properly given. Dosage is usually adjusted within the range of 40 mg to 80 mg, depending upon patient response and duration of relief. However, some patients may be well controlled on doses as low as 20 mg or less.

Hay fever or pollen asthma: Patients with hay fever or pollen asthma who are not responding to pollen administration and other conventional therapy may obtain a remission of symptoms lasting throughout the pollen season after a single injection of 40 mg to 100 mg.

In the treatment of acute exacerbations of multiple sclerosis, daily doses of 160 mg of triamcinolone for a week followed by 64 mg every other day for one month are recommended (see PRECAUTIONS: Neuro-Psychiatric).

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 3 or 4 divided doses (3.2 to 48 mg/m2 bsa/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.

LOCAL

Intra-articular administration: A single local injection of triamcinolone acetonide is frequently sufficient, but several injections may be needed for adequate relief of symptoms.

Initial dose: 2.5 mg to 5 mg for smaller joints and from 5 mg to 15 mg for larger joints, depending on the specific disease entity being treated. For adults, doses up to 10 mg for smaller areas and up to 40 mg for larger areas have usually been sufficient. Single injections into several joints, up to a total of 80 mg, have been given.

Administration

GENERAL

STRICT ASEPTIC TECHNIQUE IS MANDATORY. The vial should be shaken before use to ensure a uniform suspension. Prior to withdrawal, the suspension should be inspected for clumping or granular appearance (agglomeration). An agglomerated product results from exposure to freezing temperatures and should not be used. After withdrawal, triamcinolone acetonide injectable suspension should be injected without delay to prevent settling in the syringe. Careful technique should be employed to avoid the possibility of entering a blood vessel or introducing infection.

SYSTEMIC

For systemic therapy, injection should be made deeply into the gluteal muscle (see WARNINGS). For adults, a minimum needle length of 1½ inches is recommended. In obese patients, a longer needle may be required. Use alternative sites for subsequent injections.

LOCAL

For treatment of joints, the usual intra-articular injection technique should be followed. If an excessive amount of synovial fluid is present in the joint, some, but not all, should be aspirated to aid in the relief of pain and to prevent undue dilution of the steroid.

With intra-articular administration, prior use of a local anesthetic may often be desirable. Care should be taken with this kind of injection, particularly in the deltoid region, to avoid injecting the suspension into the tissues surrounding the site, since this may lead to tissue atrophy.

In treating acute nonspecific tenosynovitis, care should be taken to ensure that the injection of the corticosteroid is made into the tendon sheath rather than the tendon substance. Epicondylitis may be treated by infiltrating the preparation into the area of greatest tenderness.

1.10 HOW SUPPLIED

Triamcinolone Acetonide Injectable SuspensionTriamcinolone Acetonide Injectable Suspension, USP is supplied in vials providing 40 mg triamcinolone acetonide per mL.

40 mg/mL, 1 mL single-dose vial

MCKESSON ALCOHOL PREP PAD- isopropyl alcohol swab

Drug Facts

Active ingredient

Isopropyl Alcohol 70% v/v

Purpose

First Aid Antiseptic

Use

For preparation of the skin prior to an injection

Warnings

  • For external use only
  • Flammable, keep away from fire or flame
  • Do not use with electrocautery procedures
  • Do not use in the eyes
  • Do not apply to irritated skin
  • Stop use if pain, irritation, redness, or swelling occurs, discontinue use and consult a physician.
  • Keep out from reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • Open packet
  • Remove pad
  • Apply topically as needed to cleanse intended area. Discard after single use.

Other information

  • Store at room temperature 59-86°F (15-30°C)
  • Contents sterile in unopened, undamaged package

Inactive ingredients

purified water

Contents:

1 — 50mL 1% Lidocaine HCL (10mg/mL)

1 — 1mL Triamcinolone Acetonide (40mg/mL)

1 — 5cc Syringe w/ 18-22 Gauge 1-1 1/2 in Needle (Draw)

1 — 27 Gauge 1/2 in Needle (Administer)

1 — 3×3 Gauze Sponge Sterile Square

1 — Bandage 1×3 in

4 — Alcohol Prep Pads

Assembled and Distributed by IT3 Medical, LLC

190 E Stacy Road; STE 306-298 Allen, TX 75002-8734

For questions or comments:
info@IT3-Medical.com, www.IT3-Medical.com

PACKAGING-KIT COMPONENTS LABELING

image description
(click image for full-size original)

OMNITRENIDOL
lidocaine hydrochloride, triamcinolone acetonide kit
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70529-052
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:70529-052-01 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 VIAL, MULTI-DOSE 50 mL
Part 2 1 VIAL 1 mL
Part 3 4 PACKET 4 mL
Part 1 of 3
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride injection, solution
Product Information
Item Code (Source) NDC:0409-4276
Route of Administration INFILTRATION, PERINEURAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
METHYLPARABEN 1 mg in 1 mL
Packaging
# Item Code Package Description Multilevel Packaging
1 50 mL in 1 VIAL, MULTI-DOSE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088299 07/12/2005
Part 2 of 3
TRIAMCINOLONE ACETONIDE
triamcinolone acetonide injection, suspension
Product Information
Item Code (Source) NDC:70121-1049
Route of Administration INTRA-ARTICULAR, INTRAMUSCULAR DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TRIAMCINOLONE ACETONIDE (TRIAMCINOLONE ACETONIDE) TRIAMCINOLONE ACETONIDE 40 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
BENZYL ALCOHOL
POLYSORBATE 80
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Product Characteristics
Color white (white to cream-color) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 VIAL None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA207550 12/11/2017
Part 3 of 3
MCKESSON ALCOHOL PREP PAD
isopropyl alcohol swab
Product Information
Item Code (Source) NDC:68599-5804
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ISOPROPYL ALCOHOL (ISOPROPYL ALCOHOL) ISOPROPYL ALCOHOL 0.7 mL in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 1 mL in 1 PACKET None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 04/09/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088299 11/01/2018
Labeler — IT3 Medical LLC (079971231)

Revised: 02/2022 IT3 Medical LLC

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