Pronunciation:

SOE-dee-um thye-oh-SUL-fate

Brand Names:

• Pedmark

Dosage Forms:

• Solution

Classifications:

Therapeutic—

Otic Agent

Uses of This Medicine:

Sodium thiosulfate may be used to lessen some of the side effects of cisplatin (a cancer medicine). It is also used with another medicine in the emergency treatment of cyanide poisoning.

Sodium thiosulfate is also used to reduce the risk of hearing loss in children 1 month of age and older who are receiving medicines (eg, cisplatin) for cancer that have not spread throughout the body.

This medicine is to be given only by or under the immediate 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—

Although there is no specific information comparing use of sodium thiosulfate in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Appropriate studies have not been performed on the relationship of age to the effects of Pedmark® in children younger than 1 month of age or in children with cancer that has spread (metastatic). Safety and efficacy have not been established.

Use in children younger than 1 month of age is not recommended because Pedmark® may increase the risk of hypernatremia (high sodium levels in the blood).

Older adults—

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing the use of sodium thiosulfate in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

No information is available on the relationship of age to the effects of Pedmark® in geriatric patients.

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

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:

• Allergy to sulfites, history of or
• Asthma or
• Hypernatremia (high sodium levels in the blood) or
• Hypokalemia (low potassium levels in the blood)—Use with caution. May make these conditions worse.

• Edema (swelling of feet or lower legs) or
• Heart disease or
• High blood pressure (hypertension) or
• Kidney disease or
• Liver disease or
• Toxemia of pregnancy—Sodium thiosulfate may cause the body to retain (keep) water, which may make these conditions worse.

• Kidney disease—Use with caution. The effects may be increased because of the slower removal of the medicine from the body.

Proper Use of This Medicine:

Pedmark®: A nurse or other trained health professional will give you this medicine in a medical facility. It is given through a needle placed into one of your veins. It must be given slowly, so the needle will need to stay in place for at least 15 minutes.

This medicine is given 6 hours after receiving cancer medicine (eg, cisplatin).

You may also receive other medicine (eg, allergy medicine, steroid medicine) or medicine to prevent nausea or vomiting before receiving this medicine.

Precautions While Using This Medicine:

It is very important that your doctor check your or your child's progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Check with your doctor right away if you have chest pain, cough, difficulty swallowing, dizziness, fast heartbeat, hives, itching, or skin rash, puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue, trouble breathing, or unusual tiredness or weakness.

This medicine may increase sodium and decrease potassium in your blood. Check with your doctor right away if you have muscle weakness, seizures, or unusual tiredness or weakness.

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:

More common

Black, tarry stools

bone pain

chills

cough or hoarseness

decreased urine

dizziness

dry mouth

fast heartbeat

fever

high blood pressure

increased thirst

irritability

loss of appetite

lower back or side pain

mood changes

muscle pain, cramps, or twitching

nausea

numbness or tingling in the hands, feet, or lips

painful or difficult urination

pale skin

seizures

sore throat

swelling of the feet or lower legs

trouble breathing

ulcers, sores, or white spots in the mouth

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

Incidence not known

Blurred vision

chest tightness

confusion

difficulty swallowing

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

drowsiness

headache

hives, itching, or skin rash

muscle tremors

nervousness

pounding in the ears

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

restlessness

slow or fast heartbeat

stomach cramps

sweating

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose

Agitation

blurred vision

mental changes

muscle cramps

nausea and vomiting

pain in the joints

ringing in the ears

seeing, hearing, or feeling things that are not there

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:

More common

Swelling or inflammation of the mouth

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.