Pronunciation:

bay-ta-METH-a-sone SOE-dee-um FOS-fate, bay-ta-METH-a-sone AS-e-tate

Brand Names:

• Celestone Soluspan

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Endocrine-Metabolic Agent

Pharmacologic—

Betamethasone

Uses of This Medicine:

Betamethasone sodium phosphate and betamethasone acetate combination injection provides relief for inflamed areas of the body. It is used to treat a number of different conditions, such as inflammation (swelling), severe allergies, adrenal problems, arthritis, lung or breathing problems, blood or bone marrow problems, eye or vision problems, lupus, serious skin conditions, kidney problems, ulcerative colitis, and flare-ups of multiple sclerosis. Betamethasone sodium phosphate and betamethasone acetate combination is a corticosteroid (cortisone-like medicine or steroid). It works on the immune system to help relieve swelling, redness, itching, and allergic reactions.

This medicine is to be given only by or under the direct supervision of your doctor.

Before Using This Medicine:

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

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of betamethasone sodium phosphate and betamethasone acetate combination injection in children 2 years of age and younger to treat nephrotic syndrome and in children 1 month of age and younger to treat cancer (eg, lymphoma, leukemia). Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of betamethasone sodium phosphate and betamethasone acetate combination injection in the elderly. However, elderly patients are more sensitive to the effects of this medicine than younger adults.

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 risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines 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 receiving this medicine, it is especially important 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 recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Desmopressin

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

• Aldesleukin
• Aspirin
• Atazanavir
• Balofloxacin
• Bemiparin
• Besifloxacin
• Bupropion
• Carbamazepine
• Ciprofloxacin
• Cobicistat
• Cosyntropin
• Darunavir
• Desogestrel
• Dienogest
• Drospirenone
• Enoxacin
• Estradiol
• Ethinyl Estradiol
• Ethynodiol
• Fleroxacin
• Flumequine
• Gatifloxacin
• Gemifloxacin
• Gestodene
• Levofloxacin
• Levonorgestrel
• Lomefloxacin
• Lutetium Lu 177 Dotatate
• Macimorelin
• Mestranol
• Moxifloxacin
• Nadifloxacin
• Nadroparin
• Nirmatrelvir
• Nomegestrol
• Norethindrone
• Norfloxacin
• Norgestimate
• Norgestrel
• Ofloxacin
• Pazufloxacin
• Pefloxacin
• Prulifloxacin
• Ritonavir
• Rufloxacin
• Sargramostim
• Somatrogon-ghla
• Sparfloxacin
• Tosufloxacin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alcuronium
• Atracurium
• Auranofin
• Fosphenytoin
• Gallamine
• Hexafluorenium
• Licorice
• Metocurine
• Phenobarbital
• Phenytoin
• Primidone
• Rifampin
• Rifapentine
• Saiboku-To

Other interactions—

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

• Adrenal gland problems or
• Cataracts or
• Congestive heart failure or
• Glaucoma or
• Heart attack, recent
• Hypertension (high blood pressure) or
• Kidney disease or
• Liver disease (eg, cirrhosis) or
• Mental illness or
• Myasthenia gravis (severe muscle weakness) or
• Osteoporosis (weak bones) or
• Stomach or bowel problems (eg, diverticulitis, ulcers, ulcerative colitis) or
• Thyroid problems or
• Tuberculosis, inactive—Use with caution. May make these conditions worse.

• Brain injury, traumatic or
• Cerebral malaria or
• Fungal infections, systemic or
• Herpes simplex eye infection, active or—Should not be used in patients with these conditions.

• Idiopathic thrombocytopenic purpura (low platelet count)—Patients with this condition should not receive betamethasone as a shot into the muscle.

• Infection (eg, virus, bacteria, fungi, parasite, or protozoa)—May decrease your body's ability to fight infection.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine. It may be given as a shot into a muscle, joint, or skin, or as a shot into a lesion on your skin.

You may need to be on a salt-restricted diet or take potassium supplements when you receive this medicine. Talk to your doctor if you have concerns.

Precautions While Using This Medicine:

It is very important that your doctor check you or your child's progress at regular visits to make sure this medicine is working properly and to decide if you should continue to receive it. Blood or urine tests may be needed to check for unwanted effects.

This medicine may cause a serious allergic reaction, called anaphylaxis. This can be life-threatening and requires immediate medical attention. Tell your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth after receiving this medicine.

Your blood pressure might get too high while you are using this medicine. This may cause headaches, dizziness, or blurred vision. You might need to measure your blood pressure at home. If you think your blood pressure is too high, call your doctor right away.

Receiving too much of this medicine or receiving it for a long time may increase your and your child's risk of having adrenal gland problems. Talk to your doctor right away if you or your child have more than one of these symptoms while receiving this medicine: blurred vision, dizziness or fainting, a fast, irregular, or pounding heartbeat, increased thirst or urination, irritability, or unusual tiredness or weakness.

This medicine may cause you or your child to get more infections than usual. Avoid people who are sick or have infections and wash your hands often. If you or your child are exposed to chickenpox or measles, tell your doctor right away. If you or your child start to have a fever, chills, sore throat, or any other sign of an infection, call your doctor right away.

Tell your doctor if you or your child have recently spent time in a tropical climate or have unexplained diarrhea before receiving this medicine.

While you are being treated with betamethasone sodium phosphate and betamethasone acetate combination injection, do not have any immunizations (vaccines) without your doctor's approval. Betamethasone may lower your body's resistance and the vaccine may not work as well or you might get the infection the vaccine is meant to prevent. In addition, you should not be around other persons living in your household who receive live virus vaccines because there is a chance they could pass the virus on to you. Some examples of live vaccines include measles, mumps, influenza (nasal flu vaccine), poliovirus (oral form), rotavirus, and rubella. Do not get close to them and do not stay in the same room with them for very long. If you have questions about this, talk to your doctor.

Check with your doctor right away if blurred vision, difficulty in reading, eye pain, or any other change in vision occurs during treatment with this medicine for more than 6 weeks. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).

This medicine may increase your risk for cancer (eg, Kaposi's sarcoma) when used for a long time. Talk with your doctor if you have concerns.

This medicine may increase your risk for stomach or bowel perforation (tear or hole). Check with your doctor right away if you have stomach cramps or pain, black, tarry stools, diarrhea, fever, or severe vomiting, sometimes with blood.

If you receive this medicine for a long time, tell your doctor about any extra stress or anxiety in your life, including other health concerns and emotional stress. Your dose of this medicine might need to be changed for a short time while you have extra stress.

This medicine might cause thinning of the bones (osteoporosis) or slow growth in children if used for a long time. Tell your doctor if you have any bone pain or if you have 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 changes in mood or behavior for some patients. Tell your doctor right away if you or your child have depression, mood swings, a false or unusual sense of well-being, trouble with sleeping, or personality changes while receiving this medicine.

Make sure any doctor or dentist who treats you knows that you are receiving this medicine. This medicine may affect the results of certain skin tests.

Do not stop receiving this medicine suddenly without checking first with your doctor. Your doctor may want you or your child to gradually reduce the amount you are receiving before stopping it completely.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

Incidence not known

Blindness

bloating

bloody or black, tarry stools

blue lips and fingernails

blurred vision

bone pain

bowel or bladder dysfunction

bulging soft spot on the head of an infant

change in ability to see colors, especially blue or yellow

changes in skin color, pain, tenderness, or swelling of the foot or leg

chest pain or discomfort

chills

constipation

cough

coughing that sometimes produces a pink frothy sputum

darkened urine

decrease in height

decrease in the amount of urine

decreased urine

decreased vision

difficult, fast, noisy breathing

difficulty swallowing

dilated neck veins

discouragement

dry mouth

extreme tiredness or weakness

eye pain

eyeballs bulge out of the eye sockets

fast, pounding, or irregular heartbeat or pulse

feeling sad or empty

fever

general feeling of discomfort or illness

headache

hives, skin rash

impaired wound healing

increased sweating

increased thirst

indigestion

irregular breathing

irritability

lack of appetite

large, hive-like swelling on face, eyelids, lips, tongue, throat, hands, legs, feet, or genitals

lightheadedness, dizziness, or fainting

loss of appetite

loss of interest or pleasure

lower back or side pain

mood changes

muscle cramp, pain, tenderness, wasting, or weakness

nausea

nervousness

numbness or tingling in the hands, feet, or lips

pain in the back, ribs, arms, or legs

pain in the chest, groin, or legs, especially the calves

painful, swollen joints

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

pounding in the ears

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

redness, soreness, or itching skin

right upper abdominal pain and fullness

seizures

severe, sudden headache

slow heartbeat

slurred speech

sores, welts, or blisters

stomach distention

stomach pain or burning

sudden loss of coordination

sudden, severe weakness or numbness in the arm or leg

swelling of the face, fingers, feet, or lower legs

tearing

tightness in the chest

trouble concentrating

trouble sleeping

troubled breathing at rest

unusual tiredness or weakness

vision changes

vomiting

weight gain

yellow eyes or skin

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. Also, your health care professional may be able to tell you about ways 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:

Incidence not known

Abnormal fat deposits

darkening or lightening of normal skin color

dry, scaly skin

increased appetite

increased sweating

lightening of treated areas of dark skin

moon face

thinning hair

weight gain

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.