INTERARTICULAR JOINT KIT- ammonia, lidocaine hydrochloride anhydrous, triamcinolone acetonide, povidone-iodine kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)

Available from:

Proficient Rx LP

INN (International Name):

LIDOCAINE HYDROCHLORIDE ANHYDROUS

Composition:

LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Where oral therapy is not feasible, injectable corticosteroid therapy, including Kenalog-40 Injection (triamcinolone acetonide injectable suspension, USP) is indicated for intramuscular use as follows: Allergic states: Control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in asthma, atopic dermatitis, contact dermatitis, drug hypersensitivity reactions, perennial or seasonal allergic rhinitis, serum sickness, transfusion reactions. Dermatologic diseases: Bullous dermatitis herpetiformis, exfoliative erythroderma, mycosis fungoides, pemphigus, severe erythema multiforme (Stevens-Johnson syndrome). Endocrine disorders: Primary or secondary adrenocortical insufficiency (hydrocortisone or cortisone is the drug of choice; synthetic analogs may be used in conjunction with mineralocorticoids where applicable; in infancy, mineralocorticoid supplementation is of particular importance), congenital adrenal hyperplasia, hypercalcemia associated with cancer, n

Product summary:

Kenalog® -40 Injection (triamcinolone acetonide injectable suspension, USP) is supplied in vials providing 40 mg triamcinolone acetonide per mL.           40 mg/mL, 1 mL vial NDC 0003-0293-05           40 mg/mL, 5 mL vial NDC 0003-0293-20           40 mg/mL, 10 mL vial NDC 0003-0293-28 Store at controlled room temperature, 20°–25°C (68°–77°F), avoid freezing and protect from light. Do not refrigerate. Lidocaine Hydrochloride Injection is preserved with 0.1% methylparaben and is available in the following concentrations: Product No. NDC No.   % Lidocaine HCl mg/mL Volume (mL) 920102* 63323-201-02 1 10 2 20110 63323-201-10 1 10 10 20202 63323-202-02 2 20 2 * Packaged in a Plastic Vial. All products available in packages of 25. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from light.

Authorization status:

New Drug Application

Summary of Product characteristics

INTERARTICULAR JOINT KIT- AMMONIA, LIDOCAINE HYDROCHLORIDE ANHYDROUS,
TRIAMCINOLONE
ACETONIDE, POVIDONE-IODINE
PROFICIENT RX LP
----------
KENALOG -40 INJECTION
(TRIAMCINOLONE ACETONIDE INJECTABLE SUSPENSION, USP)
NOT FOR USE IN NEONATES
CONTAINS BENZYL ALCOHOL
FOR INTRAMUSCULAR OR INTRA-ARTICULAR USE ONLY
NOT FOR INTRAVENOUS, INTRADERMAL, INTRAOCULAR, EPIDURAL, OR
INTRATHECAL USE
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 INTRA-ARTICULAR USE ONLY. THIS FORMULATION IS
NOT
FOR INTRADERMAL INJECTION.
Each mL of the sterile aqueous suspension provides 40 mg triamcinolone
acetonide, with 0.65%
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-11β,16α,17,21-tetrahydroxypregna-1,4-
diene-3,20-dione cyclic 16,17-acetal with acetone. Its structural
formula is:
MW 4 34 .50
MW 434.50
MW 434.50
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.
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. Synthetic analogs such
as triamcinolone are primarily used for their anti-inflammatory
effects in disorders of many organ
systems.
Kenalog-40 Injection has an extended duration of effect which may be
sustained over a period of
several weeks. S