Pronunciation:

kap-ree-oh-MYE-sin

Brand Names:

• Capastat Sulfate

Warnings:

The use of capreomycin may be associated with worse clinical outcomes, ie, decreased effectiveness and increased mortality, compared with other parenteral therapy for pulmonary multidrug-resistant tuberculosis (MDR-TB). In patients who require parenteral treatment for pulmonary MDR-TB, reserve capreomycin for those with resistance to injectable aminoglycosides and limited treatment options.The use of capreomycin in patients with renal insufficiency or preexisting auditory impairment must be undertaken with great caution, and the risk of additional cranial nerve VIII impairment or renal injury should be weighed against the benefits to be derived from therapy.Since other parenteral antituberculosis agents (streptomycin, viomycin) also have similar and sometimes irreversible toxic effects, particularly on cranial nerve VIII and renal function, simultaneous administration of these agents with capreomycin is not recommended. Use with other drugs (polymyxin A sulfate, colistin sulfate, amikacin, gentamicin, tobramycin, vancomycin, kanamycin, and neomycin) having ototoxic or nephrotoxic potential should be undertaken only with great caution .

Classifications:

Chemical—

Aminoglycoside

Uses of This Medicine:

Capreomycin injection is used together with other medicines to treat tuberculosis (TB) in patients who have received other medicines that did not work well. Capreomycin is an aminoglycoside antibiotic that works by killing bacteria or preventing their growth.

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 capreomycin injection in the pediatric population. 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 capreomycin injection in the elderly. However, elderly patients are more likely to have heart, kidney, liver, and hearing problems, which may require caution and an adjustment in the dose for patients receiving capreomycin.

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.

• Ataluren

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.

• Alcuronium
• Aspirin
• Atracurium
• Cholera Vaccine, Live
• Cisatracurium
• Colistimethate Sodium
• Doxacurium
• Emtricitabine
• Fazadinium
• Foscarnet
• Furosemide
• Gallamine
• Hexafluorenium
• LetibotulinumtoxinA-wlbg
• Metocurine
• Mivacurium
• Pancuronium
• Pipecuronium
• Rapacuronium
• Rocuronium
• Tacrolimus
• Tenofovir Alafenamide
• Tubocurarine
• Vecuronium

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:

• Hearing problems or
• Kidney disease—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or clinic setting. This medicine is given as a shot into a muscle or into a vein.

Missed dose—

This medicine needs to be given on a fixed schedule. If you miss a dose or forget to use your medicine, call your doctor or pharmacist for instructions.

Precautions While Using This Medicine:

Your doctor will check your progress closely while you are receiving this medicine. This will allow your doctor to see if the medicine is working properly and to decide if you should continue to receive it. Blood, urine, and hearing tests may be needed to check for unwanted effects.

Check with your doctor right away if you have a sudden decrease in hearing or loss of hearing, ringing in the ears, dizziness or lightheadedness, a feeling of constant movement of self or surroundings, or a sensation of spinning. These may be symptoms of a serious hearing or balance problem.

Check with your doctor right away if you have blood in the urine, a change in frequency of urination or amount of urine, difficulty with breathing, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of the feet or lower legs, or weakness. These may be symptoms of a serious kidney problem.

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

blood in the urine

change in the frequency of urination or amount of urine

chest pain

chills

cough

difficult breathing

dizziness

drowsiness

feeling of fullness in the ears

fever

increased thirst

loss of appetite

loss of balance

loss of hearing

nausea or vomiting

painful or difficult urination

ringing or buzzing in the ears

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swelling of the feet or lower legs

swollen glands

trouble with hearing

unusual bleeding or bruising

unusual tiredness or weakness

Rare

Bleeding gums

pinpoint red spots on the skin

Incidence not known

Confusion

continuous ringing or buzzing or other unexplained noise in the ears

decreased urine

dizziness or lightheadedness

dry mouth

feeling of constant movement of self or surroundings

irregular heartbeats

muscle cramps in the hands, arms, feet, legs, or face

muscle spasms (tetany) or twitching

numbness and tingling around the mouth, fingertips, or feet

seizures

sensation of spinning

stomach cramps

tremor

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

Hives or welts, itching, or skin rash

pain, bleeding, or hard lump at the injection site

redness of the skin

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.