AK-Tob

Name: AK-Tob

Uses of AK-Tob

  • It is used to treat eye infections.

What do I need to tell my doctor BEFORE I take AK-Tob?

  • If you have an allergy to tobramycin or any other part of AK-Tob (tobramycin eye drops).
  • If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
  • If you are breast-feeding or plan to breast-feed.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take AK-Tob?

  • Tell all of your health care providers that you take AK-Tob. This includes your doctors, nurses, pharmacists, and dentists.
  • Use care when driving or doing other tasks that call for clear eyesight.
  • Do not use longer than you have been told. A second infection may happen.
  • Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.

How is this medicine (AK-Tob) best taken?

Use AK-Tob as ordered by your doctor. Read all information given to you. Follow all instructions closely.

  • To gain the most benefit, do not miss doses.
  • Use as you have been told, even if your signs get better.
  • For the eye only.
  • Take out contact lenses before using this medicine.
  • Do not put contacts back in if eyes are irritated or infected.
  • Do not touch the container tip to the eye, lid, or other skin.
  • Tilt your head back and drop drug into the eye.
  • After use, keep your eyes closed. Put pressure on the inside corner of the eye. Do this for 1 to 2 minutes. This keeps the drug in your eye.

What do I do if I miss a dose?

  • Use a missed dose as soon as you think about it.
  • If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
  • Do not use 2 doses at the same time or extra doses.

How do I store and/or throw out AK-Tob?

  • Store at room temperature. Do not freeze.
  • Protect from heat.
  • Keep lid tightly closed.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Tobramycin ophthalmic Breastfeeding Warnings

There are no data on the excretion of tobramycin ophthalmic into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue the drug or to discontinue nursing, taking into account the importance of the drug to the mother.

Tobramycin Levels and Effects while Breastfeeding

Summary of Use during Lactation

Tobramycin is poorly excreted into breastmilk. Newborn infants apparently absorb small amounts of other aminoglycosides, but serum levels with typical three times per day dosages are far below those attained when treating newborn infections and systemic effects of tobramycin are unlikely. Older infants would be expected to absorb even less tobramycin. Because there is little variability in the milk tobramycin levels during multiple daily dose regimens, timing breastfeeding with respect to the dose is of little or no benefit in reducing infant exposure. Data are not available with single daily dose regimens. Monitor the infant for possible effects on the gastrointestinal flora, such as diarrhea, candidiasis (e.g., thrush, diaper rash) or rarely, blood in the stool indicating possible antibiotic-associated colitis.

Maternal use of an ear drop or eye drop that contains tobramycin presents little or no risk for the nursing infant [4]

Drug Levels

Maternal Levels. After a single 80 mg intramuscular dose of tobramycin in 5 women, milk levels were measured every hour for 6 hours. Only trace levels were detected in 4 of the samples from 1 to 8 hours after the dose. In the fifth woman, milk levels ranged from 0.4 to 0.52 mg/L over 8 hours, with the highest level found at 4 hours after the dose.[2]

In one patient who received 80 mg of tobramycin every 8 hours by intramuscular injection, milk levels were 0.6 mg/L 1 hour after the dose and 0.58 mg/L 8 hours after the dose.[3]

At 2 months postpartum, a woman was receiving intravenous tobramycin 150 mg 3 times daily plus meropenem for cystic fibrosis. Four days after beginning, milk tobramycin levels were undetectable (<0.18 mg/L) before the infusion and in 6 milk samples take from 1 to 5 hours after the infusion.[4]

Infant Levels. Relevant published information was not found as of the revision date.

Effects in Breastfed Infants

An infant was breastfed (extent not stated) until the 4th month postpartum. At 2 months of age, his mother was given a 2-week course of tobramycin 150 mg three times daily plus meropenem for a cystic fibrosis exacerbation. infant displayed no change in stool pattern during the maternal treatment and had normal renal function at 6 months of age.[4][5]

Effects on Lactation and Breastmilk

Relevant published information was not found as of the revision date.

References

1. Niebyl JR. Use of antibiotics for ear, nose, and throat disorders in pregnancy and lactation. Am J Otolaryngol. 1992;13:187-92. PMID: 1503194

2. Takase Z, Shirafuji H, Uchida M et al. Laboratory and clinical studies on tobramycin in the field of obstetrics and gynecology. Chemotherapy. (Tokyo). 1975;23:1402-7.

3. Uwaydah M, Bibi S, Salman S. Therapeutic efficacy of tobramycin--a clinical and laboratory evaluation. J Antimicrob Chemother. 1975;1:429-37. PMID: 1107297

4. Festini F, Ciuti R, Taccetti G et al. Breast-feeding in a woman with cystic fibrosis undergoing antibiotic intravenous treatment. J Matern Fetal Neonatal Med. 2006;19:375-6. PMID: 16801316

5. Festini F, Ciuti R, Repetto T et al. Safety of breast-feeding during an IV tobramycin course for infants of CF women. Pediatr Pulmonol Suppl. 2004;27:288-9. Abstract. DOI: doi:10.1002/ppul.20143

Tobramycin Identification

Substance Name

Tobramycin

CAS Registry Number

32986-56-4

Drug Class

Antiinfective Agents

Antibacterial Agents

Aminoglycosides

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