Amikin

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, call your doctor. Do not use anti-diarrhea medicine unless your doctor tells you to.

Amikacin can harm your kidneys. This effect is increased when you also use certain other medicines, including: antivirals, chemotherapy, injected antibiotics, medicine for bowel disorders, medicine to prevent organ transplant rejection, injectable osteoporosis medication, and some pain or arthritis medicines (including aspirin, Tylenol, Advil, and Aleve).

Tell your doctor about all your current medicines and any you start or stop using, especially:

• a diuretic or "water pill";
• any other antibiotic.

This list is not complete. Other drugs may interact with amikacin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

1-10%

Neurotoxicity

Nephrotoxicity (if trough >10 mg/L)

Ototoxicity

<1%

Hypotension

Headache

Drug fever

Rash

Nausea

Vomiting

Eosinophilia

Paresthesia

Tremor

Arthralgia

Weakness

Allergic reaction

IV Incompatibilities

Additive: aminophylline in dextrose-containing diluents, amphotericin B, ampicillin, cefazolin, cefotaxime(?), ceftazidime, chloramphenicol, chlorothiazide, heparin, phenytoin, thiopental, vitamin B/C

Syringe: heparin

Y-site: allopurinol, amphotericin B cholesteryl sulfate, azithromycin, hetastarch, propofol

IV Compatibilities

Solution: compatible with most common solvents

Additive (partial list): aminophylline (in LR, NS, Ringer's, Na-Lactate 1/6M), ascorbic acid, CaCl2, cefepime, ceftriaxone, ciprofloxacin, clindamycin, dexamethasone Na-phosphate(? may be conc-dep), diphenhydramine, fluconazole, furosemide, metronidazole, prochlorperazine, promethazine, NaHCO3, KCl (may not be in dextran6%/NS), succinylcholine, vancomycin

Syringe: caffeine, clindamycin, doxapram

Y-site (partial list): acyclovir, amiodarone, diltiazem, enalaprilat, fluconazole, furosemide, levofloxacin, linezolid, lorazepam, MgSO4, midazolam, milrinone, morphine, ondansetron, warfarin, zidovudine

IV Preparation

Dilute 500 mg to 100 or 200 mL sterile diluent (0.9% NaCl or D5W)

IV/IM Administration

IM: Administer undiluted to upper outer quadrant of buttocks

IV: Infuse over 30-60 min in adults and children; infuse over 1-2 hr in infants

Amikacin sulfate injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species.

Clinical studies have shown amikacin sulfate injection to be effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and post operative infections (including post vascular surgery). Clinical studies have shown amikacin also to be effective in serious complicated and recurrent urinary tract infections due to these organisms. Aminoglycosides, including amikacin sulfate injection, are not indicated in uncomplicated initial episodes of urinary tract infections unless the causative organisms are not susceptible to antibiotics having less potential toxicity.

Bacteriologic studies should be performed to identify causative organisms and their susceptibilities to amikacin. Amikacin may be considered as initial therapy in suspected Gram-negative infections and therapy may be instituted before obtaining the results of susceptibility testing. Clinical trials demonstrated that amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa. The decision to continue therapy with the drug should be based on results of the susceptibility tests, the severity of the infection, the response of the patient and the important additional considerations contained in the DESCRIPTION: WARNINGS box.

Amikacin has also been shown to be effective in staphylococcal infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacteriumora staphylococcus, infections due to susceptible strains of staphylococci in patients allergic to other antibiotics, and in mixed staphylococcal/Gram-negative infections.

In certain severe infections such as neonatal sepsis, concomitant therapy with a penicillin-type drug may be indicated because of the possibility of infections due to Gram-positive organisms such as streptococci or pneumococci.

Amikacin is an antibiotic that fights bacteria.

Amikacin is used to treat severe or serious bacterial infections.

Amikacin may also be used for purposes not listed in this medication guide.

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

If your or your child's symptoms do not improve within a few days, or if they become worse, check with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. If you think you have become pregnant while using the medicine, tell your doctor right away.

This medicine may cause serious allergic reactions, including anaphylaxis, which can be life-threatening and require immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; shortness of breath; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth after you receive this medicine.

Stop using this medicine and check with your doctor right away if you or your child have sudden decrease in hearing or loss of hearing, which may be accompanied by dizziness and ringing in the ears. Tell your doctor if you or your child have dizziness or lightheadedness; feeling of constant movement of self or surroundings; or sensation of spinning. These may be symptoms of a damage to your hearing or sense of balance.

Tell your doctor right away if you have trouble using your muscles or trouble breathing while receiving this medicine.

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

This medicine may cause nerve problems. Check with your doctor right away if you or your child have numbness, skin tingling, muscle twitching, or seizures.

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.

Amikacin sulfate is a semi-synthetic aminoglycoside antibiotic derived from kanamycin. It is C22H43N5O13•2H2SO4. D-Streptamine, O-3-amino-3-deoxy-α-D-glucopyranosyl - (1→6)-O- [6-amino-6-deoxy-α-D-glucopyranosyl- (1→4)]-N1-(4-amino-2-hydroxy-1-oxobutyl)-2-deoxy-, (S)-,sulfate (1:2) (salt).

The dosage form is supplied as a sterile, colorless to light straw colored solution for IM or IV use. The 100 mg per 2 mL vial contains per each mL: 50 mg amikacin (as the sulfate), 0.13% sodium bisulfite and 0.5% sodium citrate dihydrate with pH adjusted to 4.5 with sulfuric acid. The 500 mg per 2 mL vial and the 1 g per 4 mL vial contain per each mL: 250 mg amikacin (as the sulfate), 0.66% sodium bisulfite and 2.5% sodium citrate dihydrate with pH adjusted to 4.5 with sulfuric acid.

Vial headspace contains nitrogen.

See WARNINGS box above.

Aminoglycosides can cause fetal harm when administered to a pregnant woman. Aminoglycosides cross the placenta and there have been several reports of total irreversible, bilateral congenital deafness in children whose mothers received streptomycin during pregnancy. Although serious side effects to the fetus or newborns have not been reported in the treatment of pregnant women with other aminoglycosides, the potential for harm exists. Reproduction studies of amikacin have been performed in rats and mice and revealed no evidence of impaired fertility or harm to the fetus due to amikacin. There are no well controlled studies in pregnant women, but investigational experience does not include any positive evidence of adverse effects to the fetus. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Contains sodium bisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than nonasthmatic people.

If you are injecting amikacin at home, your healthcare provider will give you detailed instructions on how and where to inject the medication. If you do not understand these directions, do not attempt to inject the medication. Contact your healthcare provider for further instructions.

Amikacin may cause damage to the kidneys and/or nerves. Kidney function and drug levels in the blood may be monitored with blood tests during treatment. Tell your doctor if you experience hearing loss, dizziness, numbness, skin tingling, muscle twitching, or seizures which may be signs of nerve damage.

Contact your doctor if a dose is missed.