Land: USA
Språk: engelska
Källa: NLM (National Library of Medicine)
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)
Proficient Rx LP
LIDOCAINE HYDROCHLORIDE ANHYDROUS
LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
PRESCRIPTION DRUG
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
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.
New Drug Application
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 Läs hela dokumentet