Dekpak 13 Day Taperpak (Oral)

Dexamethasone helps reduce inflammation in different parts of the body. It is used to treat various conditions, including inflammation (swelling), severe allergies, adrenal issues, arthritis, asthma, blood or bone marrow disorders, kidney problems, skin conditions, and flare-ups of multiple sclerosis. Dexamethasone is a corticosteroid (similar to cortisone or a steroid). It affects the immune system to help reduce swelling, redness, itching, and allergic reactions.

Dexamethasone tablets are also used together with other anti-myeloma drugs to treat adults with multiple myeloma.

You can only get this medicine with a prescription from your doctor.

If you will be taking this medicine for a long time, it is very important that your doctor checks you regularly for any side effects that may be caused by this medicine. Blood or urine tests may be needed to monitor for side effects.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to prevent pregnancy during treatment and for 1 month after your last dose. If you think you have become pregnant while using this medicine, tell your doctor immediately.

If you are using this medicine for a long time, inform your doctor about any additional stress or anxiety in your life, including other health issues and emotional stress. Your dose of this medicine may need to be adjusted temporarily during times of extra stress.

Using too much of this medicine or using it for a long time may increase your risk of having adrenal gland problems. Contact your doctor right away if you experience more than one of these symptoms while using this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

Using this medicine may increase your risk of cancer, including Kaposi's sarcoma. Discuss any concerns about this risk with your doctor.

While you are being treated with dexamethasone, do not receive any immunizations (vaccines) without your doctor's approval. Dexamethasone may weaken your immune system, making the vaccine less effective, or you may contract the infection the vaccine is intended to prevent. Additionally, avoid close contact with anyone in your household who is receiving live virus vaccines, as they could potentially pass the virus to you. Examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not be close to them and do not stay in the same room with them for extended periods. If you have questions about this, consult your doctor.

Contact your doctor right away if you experience blurred vision, difficulty reading, or any other changes in vision during or after treatment. Your doctor may want you to see an ophthalmologist (eye doctor) for an eye examination.

This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Inform your doctor if you have any bone pain or an increased risk for osteoporosis. If your child is using this medicine, let the doctor know if you believe your child is not growing properly.

This medicine may cause myopathy. Notify your doctor immediately if you experience new or worsening unexplained muscle pain, tenderness, or weakness.

This medicine may lead to changes in mood or behavior for some patients. Inform your doctor right away if you experience depression, mood swings, an unusual sense of well-being, trouble sleeping, or personality changes while taking this medicine.

Ensure that any doctor or dentist treating you is aware that you are using this medicine. This medicine may affect the results of certain skin tests.

Talk to your doctor before using this medicine if you plan to have children. Some men who use Hemady™ have become infertile (unable to have children).

Do not take other medicines unless you have discussed them with your doctor. This includes prescription or over-the-counter (OTC) medicines and herbal or vitamin supplements.

In deciding to use a medication, the risks of taking the drug must be weighed against the beneficial it will do. This is a decision you and your physician will make. For this drug, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medication or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Appropriate studies have not been performed on the relationship of age to the effects of Hemady™ in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific issues that would limit the usefulness of dexamethasone in children. Nevertheless, pediatric patients are more likely to have slower growth and bone problems if dexamethasone is used for a long time. Advised doses should not be exceeded, and the patient should be carefully monitored during therapy.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific issues that would limit the usefulness of dexamethasone in the elderly. Nevertheless, elderly patients are more likely to have osteoporosis (weak bones) and age-related liver, kidney, or heart issues, which may require caution and an adjustment in the dose for elderly patients receiving dexamethasone.

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential chances prior to using this medicine while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medications may be used together even if an interaction might occur. In these cases, your physician may want to change the dose, or other precautions may be necessary. When you are using this drug, it is especially critical that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not advised. Your clinician may decide not to treat you with this medication or change some of the other medications you take.

• Artemether
• Desmopressin
• Praziquantel
• Rilpivirine
• Rotavirus Vaccine, Live

Using this medication with any of the following medicines is normally not recommended, but may be required in some cases. If both drugs are prescribed together, your physician may change the dose or how frequently you use one or both of the drugs.

• Abametapir
• Aceclofenac
• Acemetacin
• Aldesleukin
• Alfentanil
• Amiodarone
• Amtolmetin Guacil
• Apalutamide
• Aspirin
• Atazanavir
• Atogepant
• Balofloxacin
• Bemiparin
• Benzhydrocodone
• Besifloxacin
• Boceprevir
• Bromfenac
• Bufexamac
• Buprenorphine
• Bupropion
• Carbamazepine
• Celecoxib
• Ceritinib
• Cholestyramine
• Choline Salicylate
• Ciprofloxacin
• Clarithromycin
• Clonixin
• Cobicistat
• Codeine
• Conivaptan
• Dabrafenib
• Daclatasvir
• Darunavir
• Desogestrel
• Dexibuprofen
• Dexketoprofen
• Diclofenac
• Dienogest
• Diflunisal
• Dihydrocodeine
• Dipyrone
• Doxorubicin
• Doxorubicin Hydrochloride Liposome
• Dronedarone
• Drospirenone
• Droxicam
• Efavirenz
• Elvitegravir
• Enoxacin
• Enzalutamide
• Estetrol
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Etodolac
• Etofenamate
• Etonogestrel
• Etoricoxib
• Etravirine
• Fedratinib
• Felbinac
• Fenoprofen
• Fentanyl
• Fepradinol
• Feprazone
• Fexinidazole
• Fleroxacin
• Floctafenine
• Flufenamic Acid
• Flumequine
• Flurbiprofen
• Fosamprenavir
• Fosphenytoin
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Hemin
• Hydrocodone
• Ibuprofen
• Idelalisib
• Indinavir
• Indomethacin
• Itraconazole
• Ketoconazole
• Ketoprofen
• Ketorolac
• Lapatinib
• Lenacapavir
• Levofloxacin
• Levonorgestrel
• Lomefloxacin
• Lopinavir
• Lornoxicam
• Loxoprofen
• Lumacaftor
• Lumateperone
• Lumiracoxib
• Lurasidone
• Lutetium Lu 177 Dotatate
• Macimorelin
• Meclofenamate
• Medroxyprogesterone
• Mefenamic Acid
• Meloxicam
• Meperidine
• Mestranol
• Methadone
• Mitotane
• Morniflumate
• Moxifloxacin
• Nabumetone
• Nadifloxacin
• Nadroparin
• Naproxen
• Nefazodone
• Nelfinavir
• Nepafenac
• Nevirapine
• Nifedipine
• Niflumic Acid
• Nilotinib
• Nimesulide
• Nimesulide Beta Cyclodextrin
• Nimodipine
• Nirmatrelvir
• Nomegestrol
• Norelgestromin
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Omaveloxolone
• Oxaprozin
• Oxycodone
• Oxyphenbutazone
• Parecoxib
• Pazufloxacin
• Pefloxacin
• Pentazocine
• Phenobarbital
• Phenylbutazone
• Phenytoin
• Piketoprofen
• Piperaquine
• Piroxicam
• Posaconazole
• Pranoprofen
• Primidone
• Proglumetacin
• Propyphenazone
• Proquazone
• Prulifloxacin
• Rifampin
• Ritonavir
• Rofecoxib
• Rufloxacin
• Salicylic Acid
• Salsalate
• Saquinavir
• Sargramostim
• Segesterone
• Sodium Salicylate
• Somatrogon-ghla
• Sparfloxacin
• St John's Wort
• Sufentanil
• Sulindac
• Sunitinib
• Tacrolimus
• Telaprevir
• Telithromycin
• Tenoxicam
• Thalidomide
• Tiaprofenic Acid
• Tolfenamic Acid
• Tolmetin
• Tosufloxacin
• Tramadol
• Ubrogepant
• Ulipristal
• Valdecoxib
• Velpatasvir
• Vincristine Sulfate Liposome
• Voriconazole
• Voxilaprevir
• Zolpidem
• Zuranolone

Using this medication with any of the following medications may cause an increased risk of certain adverse effects, but using both drugs may be the best therapy for you. If both drugs are prescribed together, your physician may change the dose or how frequently you use one or both of the medicines.

• Alcuronium
• Aminoglutethimide
• Aprepitant
• Atracurium
• Auranofin
• Caspofungin
• Fluindione
• Fosaprepitant
• Fosnetupitant
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Netupitant
• Ospemifene
• Pancuronium
• Rifapentine
• Saiboku-To
• Vecuronium
• Warfarin

Interactions with Food/Tobacco/Alcohol

Certain medications should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may as well cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical issues may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood clots or
• Cataracts or
• Congestive heart failure or
• Cushing's syndrome (adrenal gland problem) or
• Diabetes or
• Eye infection or
• Fluid retention or
• Glaucoma or
• Heart attack, recent or
• Hyperglycemia (high blood sugar) or
• Hypertension (high blood pressure) or
• Mental health issues (eg, depression) or
• Myasthenia gravis (serious muscle weakness) or
• Osteoporosis or
• Peptic ulcer, active or history of or
• Personality changes or
• Stomach or intestinal issues (eg, diverticulitis, perforation, ulcerative colitis) or
• Thyroid issues or
• Tuberculosis, inactive—Use with caution. May make these conditions worse.

• Fungal infections or
• Herpes simplex eye infection—Should not be used in patients with these conditions.

• Infection—May lower your body's ability to fight infections.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

More common

• Aggression
• agitation
• anxiety
• blurred vision
• decrease in the amount of urine
• dizziness
• fast, slow, pounding, or irregular heartbeat or pulse
• headache
• irritability
• mental depression
• mood changes
• nervousness
• noisy, rattling breathing
• numbness or tingling in the arms or legs
• pounding in the ears
• swelling of the fingers, hands, feet, or lower legs
• trouble thinking, speaking, or walking
• troubled breathing at rest
• weight gain

Incidence not known

• Abdominal or stomach cramping and/or burning (severe) or pain
• backache
• bloody, black, or tarry stools
• cough or hoarseness
• darkening of the skin
• decrease in height
• decreased vision
• diarrhea
• dry mouth
• eye pain
• eye tearing
• facial hair growth in females
• fainting
• fatigue
• fever or chills
• flushed, dry skin
• fractures
• fruit-like breath odor
• full or round face, neck, or trunk
• heartburn and/or indigestion (severe and continuous)
• increased hunger
• increased thirst
• increased urination
• loss of appetite
• loss of sexual desire or ability
• lower back or side pain
• menstrual irregularities
• muscle pain or tenderness
• muscle wasting or weakness
• nausea
• pain in the back, ribs, arms, or legs
• painful or difficult urination
• skin rash
• sleeplessness
• sweating
• trouble healing
• trouble sleeping
• unexplained weight loss
• unusual tiredness or weakness
• vision changes
• vomiting
• vomiting of material that looks like coffee grounds

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may be able to tell you how to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Increased appetite

Incidence not known

• Abnormal fat deposits on the face, neck, and trunk
• acne
• dry scalp
• lightening of normal skin color
• red face
• reddish purple lines on the arms, face, legs, trunk, or groin
• swelling of the stomach area
• thinning of the scalp hair

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Baycadron Elixer
• Decadron
• Dekpak 13 Day Taperpak
• Dexamethasone Intensol
• DexPak
• DexPak 10 Day TaperPak
• DexPak Jr
• Zema-Pak

Available Dosage Forms:

• Tablet
• Elixir
• Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Take this medicine exactly as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance for unwanted effects.

Measure the oral liquid with a marked measuring spoon, oral syringe, or medicine cup. The average household teaspoon may not hold the right amount of liquid.

The Dexamethasone Intensol™ solution is a concentrated liquid. Measure the concentrated liquid with the special oral dropper that comes with the package. The liquid should be added to water, juice, soda or a soda-like beverage, applesauce, or pudding. Stir the mixture well and drink or eat it right away. Do not store the mixture for future use.

You may take Hemady™ with or without food.

If you use this medicine for a long time, do not suddenly stop using it without checking first with your doctor. You may need to slowly decrease your dose before stopping it completely.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For oral dosage forms (solution, tablets): Dose depends on medical condition: Adults—At first, 0.75 to 9 milligrams (mg) per day. Your doctor may adjust your dose as needed. Children—Dose is based on body weight and must be determined by your doctor. At first, 0.02 to 0.3 mg per kilogram (kg) of body weight per day, divided and taken 3 or 4 times a day. Your doctor may adjust your dose as needed. For multiple myeloma: Adults—20 or 40 milligrams (mg) once a day. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Throw away any unused Dexamethasone Intensol™ solution 90 days after the bottle is opened for the first time.

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