ReadySharp Anesthetics Plus MethylPrednisolone 80 (Page 12 of 12)

ADVERSE REACTIONS

The following adverse reactions have been reported with DEPO-MEDROL or other corticosteroids:

Allergic reactions : Allergic or hypersensitivity reactions, anaphylactoid reaction, anaphylaxis, angioedema.

Cardiovascular: Bradycardia, cardiac arrest, cardiac arrhythmias, cardiac enlargement, circulatory collapse, congestive heart failure, fat embolism, hypertension, hypertrophic cardiomyopathy in premature infants, myocardial rupture following recent myocardial infarction (see WARNINGS), pulmonary edema, syncope, tachycardia, thromboembolism, thrombophlebitis, vasculitis.

Dermatologic: Acne, allergic dermatitis, cutaneous and subcutaneous atrophy, dry scaly skin, ecchymoses and petechiae, edema, erythema, hyperpigmentation, hypopigmentation, impaired wound healing, increased sweating, rash, sterile abscess, striae, suppressed reactions to skin tests, thin fragile skin, thinning scalp hair, urticaria.

Endocrine: Decreased carbohydrate and glucose tolerance, development of cushingoid state, glycosuria, hirsutism, hypertrichosis, increased requirements for insulin or oral hypoglycemic agents in diabetes, manifestations of latent diabetes mellitus, menstrual irregularities, secondary adrenocortical and pituitary unresponsiveness (particularly in times of stress, as in trauma, surgery, or illness), suppression of growth in pediatric patients.

Fluid and electrolyte disturbances: Congestive heart failure in susceptible patients, fluid retention, hypokalemic alkalosis, potassium loss, sodium retention.

Gastrointestinal: Abdominal distention, bowel/bladder dysfunction (after intrathecal administration), elevation in serum liver enzyme levels (usually reversible upon discontinuation), hepatomegaly, increased appetite, nausea, pancreatitis, peptic ulcer with possible subsequent perforation and hemorrhage, perforation of the small and large intestine (particularly in patients with inflammatory bowel disease), ulcerative esophagitis.

Metabolic: Negative nitrogen balance due to protein catabolism.

Musculoskeletal: Aseptic necrosis of femoral and humeral heads, calcinosis (following intra-articular or intra-lesional use), Charcot-like arthropathy, loss of muscle mass, muscle weakness, osteoporosis, pathologic fracture of long bones, postinjection flare (following intra-articular use), steroid myopathy, tendon rupture, vertebral compression fractures.

Neurologic/Psychiatric: Convulsions, depression, emotional instability, euphoria, headache, increased intracranial pressure with papilledema (pseudotumor cerebri) usually following discontinuation of treatment, insomnia, mood swings, neuritis, neuropathy, paresthesia, personality changes, psychic disorders, vertigo.

Ophthalmic: Exophthalmoses, glaucoma, increased intraocular pressure, posterior subcapsular cataracts.

Other: Abnormal fat deposits, decreased resistance to infection, hiccups, increased or decreased motility and number of spermatozoa, injection site infections following non-sterile administration (see WARNINGS), malaise, moon face, weight gain.

The following adverse reactions have been reported with the following routes of administration:

Intrathecal/Epidural: Arachnoiditis, bowel/bladder dysfunction, headache, meningitis, parapareisis/paraplegia, seizures, sensory disturbances.

Intranasal: Allergic reactions, rhinitis, temporary/permanent visual impairment including blindness.

Ophthalmic : Increased intraocular pressure, infection, ocular and periocular inflammation including allergic reactions, residue or slough at injection site, temporary/permanent visual impairment including blindness.

Miscellaneous injection sites (scalp, tonsillar fauces, sphenopalatine ganglion): blindness.

OVERDOSAGE

Treatment of acute overdosage is by supportive and symptomatic therapy. For chronic overdosage in the face of severe disease requiring continuous steroid therapy, the dosage of the corticosteroid may be reduced only temporarily, or alternate day treatment may be introduced.

DOSAGE AND ADMINISTRATION

Because of possible physical incompatibilities, DEPO-MEDROL Sterile Aqueous Suspension should not be diluted or mixed with other solutions.

The initial dosage of parenterally administered DEPO-MEDROL will vary from 4 to 120 mg, 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.

A. Administration for Local Effect

Therapy with DEPO-MEDROL does not obviate the need for the conventional measures usually employed. Although this method of treatment will ameliorate symptoms, it is in no sense a cure and the hormone has no effect on the cause of the inflammation.

1. Rheumatoid Arthritis and Osteoarthritis. The dose for intra-articular administration depends upon the size of the joint and varies with the severity of the condition in the individual patient. In chronic cases, injections may be repeated at intervals ranging from one to five or more weeks, depending upon the degree of relief obtained from the initial injection. The doses in the following table are given as a general guide:

HOW SUPPLIED

DEPO-MEDROL Sterile Aqueous Suspension is available as single-dose vials in the following strengths and package sizes:

40 mg per mL		80 mg per mL
1 mL vials	NDC 0009-3073-01	1 mL vials	NDC 0009-3475-01
25 × 1 mL vials	NDC 0009-3073-03	25 × 1 mL vials	NDC 0009-3475-03

Principal Display Panel – Ampule Label

NDC 0409-4713-32

2 mL Single-dose Rx only

Preservative-Free

1%

LIDOCAINE HCl
Injection, USP
10 mg/mL

HOSPIRA, INC.
LAKE FOREST, IL 60045 USA

RL-0866 (11/04)

Principal Display Panel – Vial Label

10 mL (50 mg) NDC 0409-1560-10

SINGLE-DOSE VIAL-PRESERVATIVE FREE M-612

Marcaine ^® 0.5%

Bupivacaine HCl injection, USP

for NERVE BLOCK, CAUDAL, and EPIDURAL ANESTHESIA

NOT FOR SPINAL ANESTHESIA

Rx only Hospra

PRINCIPAL DISPLAY PANEL — Vial Label NDC 0009-3475-01

1 mL Single-Dose Vial

Depo-Medrol ®

(methylprednisolone — acetate injectable — suspension, USP)

80 mg/mL

Rx only

Principal Display Panel – Kit Label

ReadySharp Anesthetics + MethylPrednisolone 80

Lidocaine 1%, 2 mL)
Bupivacaine 0.5%, 10 mL

MethylPrednisolone 80mg, 1mL NDC 53225-4315-1

Lot #

Exp. Date

Terrain Pharmaceuticals

50 West Liberty Street

Suite 1080

Reno, NV 89501

877-985-8377

ReadySharp.us

READYSHARP ANESTHETICS PLUS METHYLPREDNISOLONE 80 lidocaine hydrochloride, bupivacaine hydrochloride, and methylprednisolone acetate kit

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:53225-4315

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:53225-4315-1 1 KIT in 1 KIT None

Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 VIAL, SINGLE-DOSE 1 mL Part 2 1 AMPULE 2 mL Part 3 1 VIAL, SINGLE-DOSE 10 mL

Part 1 of 3 DEPO-MEDROL methylprednisolone acetate injection, suspension

Product Information Item Code (Source) NDC:0009-3475 Route of Administration INTRALESIONAL, SOFT TISSUE, INTRAMUSCULAR, INTRA-ARTICULAR DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength METHYLPREDNISOLONE ACETATE (METHYLPREDNISOLONE) METHYLPREDNISOLONE ACETATE 80 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE POLYETHYLENE GLYCOL 3350 HYDROCHLORIC ACID SODIUM HYDROXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0009-3475-01 1 mL in 1 VIAL, SINGLE-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA011757 05/28/1959

Part 2 of 3 LIDOCAINE HYDROCHLORIDE lidocaine hydrochloride injection, solution

Product Information Item Code (Source) NDC:0409-4713 Route of Administration INFILTRATION 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 SODIUM HYDROXIDE WATER HYDROCHLORIC ACID

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-4713-32 2 mL in 1 AMPULE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA080408 05/16/1984

Part 3 of 3 MARCAINE bupivacaine hydrochloride injection, solution

Product Information Item Code (Source) NDC:0409-1560 Route of Administration EPIDURAL, INFILTRATION DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BUPIVACAINE HYDROCHLORIDE (BUPIVACAINE) BUPIVACAINE HYDROCHLORIDE ANHYDROUS 5 mg in 1 mL

Inactive Ingredients Ingredient Name Strength SODIUM CHLORIDE SODIUM HYDROXIDE HYDROCHLORIC ACID WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0409-1560-10 10 mL in 1 VIAL, SINGLE-DOSE None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA016964 05/04/2010

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA016964 12/29/2015

Labeler — Terrain Pharmaceuticals (078358750)

Revised: 12/2016 Terrain Pharmaceuticals