DexPak 10 Day TaperPak (Oral)

Dexamethasone helps reduce swelling 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 issues, and flare-ups of multiple sclerosis. Dexamethasone is a corticosteroid (a type of steroid). It acts on the immune system to help lessen swelling, redness, itching, and allergic reactions.

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

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

If you are taking this medicine for a long time, it is very important for your doctor to check you regularly for any side effects that may be caused by this medicine. You may need blood or urine tests to check for these side effects.

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

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

Taking too much of this medicine or using it for a long time may increase your risk of adrenal gland problems. Contact your doctor immediately 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. Speak with your doctor if you have concerns about this risk.

While being treated with dexamethasone, do not get any immunizations (vaccines) without your doctor's approval. Dexamethasone may lower your body's resistance, affecting how well the vaccine works or increasing your chance of getting the infection the vaccine is meant to prevent. Also, you should avoid being around anyone in your household who receives live virus vaccines, as they could pass the virus to you. Examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Keep your distance and do not spend long periods in the same room with them. If you have questions about this, talk to your doctor.

Contact your doctor immediately 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).

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, tell the doctor if you think your child is not growing properly.

This medicine may cause muscle problems (myopathy). Contact your doctor right away if you have new or worsening unexplained muscle pain, tenderness, or weakness.

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

Make sure any doctor or dentist treating you knows 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 nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medication or any other medicines. Additionally inform 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 issues 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. However, 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 chance when using this medicine during breastfeeding. Weigh the potential benefits against the potential chances prior to taking this medication while breastfeeding.

Interactions with Drugs

Although certain medications 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 doctor may want to change the dose, or other precautions may be necessary. When you are using this medication, it is especially essential that your healthcare professional know if you are using 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 medication with any of the following medications is not recommended. Your doctor may decide not to treat you with this medicine or change some of the other medicines you take.

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

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

• 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 side effects, but using both drugs may be the best therapy for you. If both medicines are prescribed together, your clinician may change the dose or how often you use one or both of the medications.

• 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 medicines 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 additionally cause interactions to occur. Discuss with your healthcare professional the use of your medication with food, alcohol, or tobacco.

Other Medical Issues

The presence of other medical issues may affect the use of this medicine. Make sure you inform your physician if you have any other medical issues, 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 problems (eg, depression) or
• Myasthenia gravis (serious muscle weakness) or
• Osteoporosis or
• Peptic ulcer, active or history of or
• Personality changes or
• Stomach or intestinal problems (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 intended effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, they may require medical attention.

Contact your doctor right away if you experience any of the following side effects:

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

• Severe abdominal or stomach cramping and/or burning 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
• Severe and continuous heartburn and/or indigestion
• 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 typically do not need medical attention. These side effects may resolve during treatment as your body adapts to the medicine. Additionally, your healthcare professional may have suggestions to help prevent or lessen some of these side effects. Consult your healthcare professional if any of the following side effects persist 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 mentioned may also happen in some patients. If you notice any other effects, consult your healthcare professional.

Call your doctor for medical advice about side effects. You can 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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