P-Care D40G

DEPO-MEDROL®
(methylprednisolone acetate injectable suspension, USP)

Single-Dose Vial
Not For Intravenous Use

DEPO-MEDROL is an anti-inflammatory glucocorticoid for intramuscular, intra-articular, soft tissue or intralesional injection. It is available as single-dose vials in two strengths: 40 mg/mL, 80 mg/mL.

Each mL of these preparations contains:
Methylprednisolone acetate ..............................................40 mg ............80 mg
Polyethylene glycol 3350 ..................................................29 mg .............28 mg
Myristyl-gamma-picolinium chloride..............................0.195 mg .......0.189 mg

Sodium Chloride was added to adjust tonicity.

When necessary, pH was adjusted with sodium hydroxide and/or hydrochloric acid.

The pH of the finished product remains within the USP specified range (e.g., 3.0 to 7.0.)

The chemical name for methylprednisolone acetate is pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-11,17-dihydroxy-6-methyl-,(6α,11β)- and the molecular weight is 416.51. The structural formula is represented below:

Depo-Medrol Structure

DEPO-MEDROL Sterile Aqueous Suspension contains methylprednisolone acetate which is the 6-methyl derivative of prednisolone. Methylprednisolone acetate is a white or practically white, odorless, crystalline powder which melts at about 215° with some decomposition. It is soluble in dioxane, sparingly soluble in acetone, alcohol, chloroform, and methanol, and slightly soluble in ether. It is practically insoluble in water.

Serious Neurologic Adverse Reactions with Epidural Administration
Serious neurologic events, some resulting in death, have been reported with epidural injection of corticosteroids. Specific events reported include, but are not limited to, spinal cord infarction, paraplegia, quadriplegia, cortical blindness, and stroke. These serious neurologic events have been reported with and without use of fluoroscopy. The safety and effectiveness of epidural administration of corticosteroids have not been established, and corticosteroids are not approved for this use.

General
This product is not suitable for multi-dose use. Following administration of the desired dose, any remaining suspension should be discarded.

Injection of DEPO-MEDROL may result in dermal and/or subdermal changes forming depressions in the skin at the injection site.

In order to minimize the incidence of dermal and subdermal atrophy, care must be exercised not to exceed recommended doses in injections. Multiple small injections into the area of the lesion should be made whenever possible. The technique of intra-articular and intramuscular injection should include precautions against injection or leakage into the dermis. Injection into the deltoid muscle should be avoided because of a high incidence of subcutaneous atrophy.

It is critical that, during administration of DEPO-MEDROL, appropriate technique be used and care taken to ensure proper placement of drug.

Rare instances of anaphylactoid reactions have occurred in patients receiving corticosteroid therapy (see ADVERSE REACTIONS).

Increased dosage of rapidly acting corticosteroids is indicated in patients on corticosteroid therapy subjected to any unusual stress before, during, and after the stressful situation.

Results from one multicenter, randomized, placebo-controlled study with methylprednisolone hemisuccinate, an IV corticosteroid, showed an increase in early (at 2 weeks) and late (at 6 months) mortality in patients with cranial trauma who were determined not to have other clear indications for corticosteroid treatment. High doses of systemic corticosteroids, including DEPO-MEDROL, should not be used for the treatment of traumatic brain injury.

Cardio-renal
Average and large doses of corticosteroids can cause elevation of blood pressure, salt and water retention, and increased excretion of potassium. These effects are less likely to occur with synthetic derivatives when used in large doses. Dietary salt restriction and potassium supplementation may be necessary. All corticosteroids increase calcium excretion.

Literature reports suggest an apparent association between use of corticosteroids and left ventricular free wall rupture after a recent myocardial infarction; therefore, therapy with corticosteroids should be used with great caution in these patients.

Endocrine
Hypothalamic-pituitary adrenal (HPA) axis suppression. Cushing's syndrome, and hyperglycemia: Monitor patients for these conditions with chronic use.

Corticosteroids can produce reversible HPA axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Drug induced secondary adrenocortical insufficiency may be minimized by gradual reduction of dosage. This type of relative insufficiency may persist for months after discontinuation of therapy; therefore, in any situation of stress occurring during that period, hormone therapy should be reinstituted.

Infections
General
Persons who are on corticosteroids are more susceptible to infections than are healthy individuals. There may be decreased resistance and inability to localize infection when corticosteroids are used. Infections with any pathogen (viral, bacterial, fungal, protozoan, or helminthic) in any location of the body, may be associated with the use of corticosteroids alone or in combination with other immunosuppressive agents.

These infections may be mild, but can be severe and at times fatal. With increasing doses of corticosteroids, the rate of occurrence of infectious complications increases. Do not use intra-articularly, intrabursally, or for intratendinous administration for local effect in the presence of an acute infection. Corticosteroids may mask some signs of infection and new infections may appear during their use.

Fungal Infections
Corticosteroids may exacerbate systemic fungal infections and therefore should not be used in the presence of such infections unless they are needed to control drug interactions. There have been cases reported in which concomitant use of amphotericin B and hydrocortisone was followed by cardiac enlargement and congestive heart failure (see CONTRAINDICATIONS and PRECAUTIONS: Drug Interactions, Amphotericin B injection and potassium-depleting agents).

Special Pathogens
Latent disease may be activated or there may be an exacerbation of intercurrent infections due to pathogens, including those caused by Amoeba, Candida, Cryptococcus, Mycobacterium, Nocardia, Pneumocystis, and Toxoplasma.

It is recommended that latent amebiasis or active amebiasis be ruled out before initiating corticosteroid therapy in any patient who has spent time in the tropics or in any patient with unexplained diarrhea.

Similarly, corticosteroids should be used with great care in patients with known or suspected Strongyloides (threadworm) infestation. In such patients, corticosteroid-induced immunosuppression may lead to Strongyloides hyperinfection and dissemination with widespread larval migration, often accompanied by severe enterocolitis and potentially fatal gram-negative septicemia.

Corticosteroids should not be used in cerebral malaria. There is currently no evidence of benefit from steroids in this condition.

Tuberculosis
The use of corticosteroids in active tuberculosis should be restricted to those cases of fulminating or disseminated tuberculosis in which the corticosteroid is used for the management of the disease in conjunction with an appropriate antituberculous regimen.

If corticosteroids are indicated in patients with latent tuberculosis or tuberculin reactivity, close observation is necessary, as reactivation of the disease may occur. During prolonged corticosteroid therapy, these patients should receive chemoprophylaxis.

Vaccinations
Administration of live or live, attenuated vaccines is contraindicated in patients receiving immunosuppressive doses of corticosteroids. Killed or inactivated vaccines may be administered. However, the response to such vaccines cannot be predicted.

Immunization procedures may be undertaken in patients who are receiving corticosteroids as replacement therapy (e.g., for Addison's disease).

Viral Infections
Chicken pox and measles can have a more serious or even fatal course in pediatric and adult patients on corticosteroids. In pediatric and adult patients who have not had these diseases, particular care should be taken to avoid exposure. The contribution of the underlying disease and/or prior corticosteroid treatment to the risk is also not known. If exposed to chicken pox, prophylaxis with varicella zoster immune globulin (VZIG) may be indicated. If exposed to measles, prophylaxis with immunoglobulin (IG) may be indicated (see the respective package inserts for complete VZIG and IG prescribing information). If chicken pox develops, treatment with antiviral agents should be considered.

Ophthalmic
Use of corticosteroids may produce posterior subcapsular cataracts, glaucoma with possible damage to the optic nerves, and may enhance the establishment of secondary ocular infections due to bacteria, fungi, or viruses. The use of systemic corticosteroids is not recommended in the treatment of optic neuritis and may lead to an increase in the risk of new episodes. Corticosteroids should be used cautiously in patients with ocular herpes simplex because of corneal perforation. Corticosteroids should not be used in active ocular herpes simplex.

• Water

Gebauer's Pain Ease Medium Stream Spray and Mist Spray are vapocoolants (skin refrigerants) intended for topical application to skin, intact mucous membranes (oral cavity, nasal passage ways and the lips) and minor open wounds. Pain Ease instantly controls pain associated with injections (venipuncture, IV starts, cosmetic procedures), minor surgical procedures (such as lancing boils, incision and drainage of small abscesses and sutures) and the temporary relief of minor sports injuries (sprains, bruising, cuts and abrasions.

Press the actuator button firmly, allowing Pain Ease to spray from the can.

PRE-INJECTION & MINOR SURGICAL TOPICAL ANESTHESIA:
Have all necessary equipment ready and prepare the procedure site per facility's protocol. Hold the can upright, 3 to 7 inches (8 to 18 cm) from the procedure site, about a can's length away. Spray steadily 4 to 10 seconds or until the skin begins turning white, whichever comes first. Do not spray longer than 10 seconds. After spraying the site, immediately perform the procedure. The anesthetic effect of Pain Ease lasts about one minute. Reapply if necessary.

*Apply petrolatum to protect the adjacent area for minor surgical procedures.

TEMPORARY RELIEF OF MINOR SPORTS INJURIES

The pain of bruises, contusions, swelling, minor sprains, cuts and abrasions may be controlled with Pain Ease. The amount of cooling depends on the dosage. Dosage varies with duration of application. The smallest dose needed to produce the desired effect should be used. The anesthetic effect of Pain Ease rarely lasts more than a few seconds to a minute. This time interval is usually sufficient to help reduce or relieve the initial trauma of the injury. Hold the can upright, 3 to 7 inches (8 to 18 cm) from the target area, about a can's length away. Spray steadily 4 to 10 seconds or until the skin begins turning white, whichever comes first. Do not spray longer than 10 seconds. Reapply if necessary.

Made in India

NDC# 67777-121-13

Sterile Alcohol
Prep Pad

For External Use Only
Apply topically as needed
Discard after single use
Sterile Solution
Sterile unless pouch is
opened or damaged

dynarex

Not made with natural
latex rubber

1
Pad

Medium

Reorder No. 1113

Sterile Alcohol Prep Pad
For External Use Only

 Contents: One Prep Pad saturated
with 70% isopropyl alcohol.

See box for complete drug facts

Manufactured for:
Dynarex Corporation
Orangeburg, NY 10962
www.dynarex.com

Alcohol Prep Pad

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: aldesleukin, mifepristone, other drugs that can also cause bleeding/bruising (including antiplatelet drugs such as clopidogrel, "blood thinners" such as warfarin/dabigatran, NSAIDs such as ibuprofen, celecoxib, aspirin, salicylates).

If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.

Other medications can affect the removal of methylprednisolone from your body, which may affect how methylprednisolone works. Examples include azole antifungals (such as ketoconazole), boceprevir, cyclosporine, estrogens, HIV protease inhibitors (such as ritonavir), macrolide antibiotics (such as erythromycin), rifamycins (such as rifampin), St. John's wort, some drugs used to treat seizures (such as phenytoin, phenobarbital), telaprevir, among others.

This medication may interfere with certain laboratory tests (including skin tests), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as blood sugar/mineral levels, blood pressure, bone density tests, height/weight measurements, eye exams) should be performed periodically to monitor your progress or check for side effects during long-term treatment. Consult your doctor for more details.

Lifestyle changes that help reduce the risk of bone loss (osteoporosis) during long-term treatment include doing weight-bearing exercise, getting adequate calcium and vitamin D, stopping smoking, and limiting alcohol. Consult your doctor for specific advice.

Missed Dose

For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist right away to establish a new dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.Information last revised July 2017. Copyright(c) 2017 First Databank, Inc.