CLAVULANATE POTASSIUM
Drugs in Pregnancy and Lactation.
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Name: CLAVULANATE POTASSIUM
Class: Anti-infective
Risk Factor: BM
Fetal Risk Summary
Clavulanic acid is a b-lactamase inhibitor produced by Streptomyces clavuligerus that is combined, as the potassium salt, with the penicillin antibiotics, amoxicillin or ticarcillin, to broaden their antibacterial spectrum of activity. No adverse fetal effects were observed in mice, rats, and pigs administered potassium clavulanate in combination with amoxicillin or ticarcillin during gestation (1,2,3,4 and 5).
Following a single oral dose of amoxicillin (250 mg) and potassium clavulanate (125 mg) in humans, both agents crossed the placenta to the fetus (6,7). Cord blood levels were found 1 hour after the dose with peak levels occurring at 2–3 hours. In one study, the mean peak maternal serum and umbilical cord blood levels occurred at 2 hours with values of 2.20 and 1.23 µg/mL, respectively (fetal:maternal ratio 0.56) (7). Both amoxicillin and potassium clavulanate have been demonstrated in the amniotic fluid (6,7 and 8), with peak concentrations of clavulanate (0.44 µg/mL) measured 5.5 hours after administration (7). A study using in vitro perfused human placentas demonstrated the transfer of potassium clavulanate when concentrations on the maternal side were 10–13 µg/mL, but not at 2–6 µg/mL (8). A fetal/maternal gradient of 1:1 was obtained at the higher concentrations.
Several studies have described the use of amoxicillin and potassium clavulanate for various infections in pregnant women (7, 9,10 and 11). No adverse effects in the fetus or newborn attributable to the combination were observed (see also Amoxicillin and Ticarcillin).
In a surveillance study of Michigan Medicaid recipients involving 229,101 completed pregnancies conducted between 1985 and 1992, 556 newborns had been exposed to clavulanic acid (presumably in combination with penicillins) during the 1st trimester (F. Rosa, personal communication, FDA, 1993). A total of 24 (4.3%) major birth defects were observed (24 expected). Specific data were available for six defect categories, including (observed/expected) 5/6 cardiovascular defects, 2/1 oral clefts, 1/2 polydactyly, 0/1 limb reduction defects, 1/1 hypospadias, and 2/0.3 spina bifida. Only with the latter defect is there a suggestion of a possible association, but other factors, including the mother's disease, concurrent drug use, and chance may be involved.
Breast Feeding Summary
Both amoxicillin and ticarcillin are excreted into breast milk (see Amoxicillin and Ticarcillin), but data pertaining to potassium clavulanate have not been located. Excretion probably occurs because of the low molecular weight (about 237). The effects of the b-lactamase inhibitor on the nursing infant are unknown.
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References
- Baldwin JA, Schardein JL, Koshima Y. Reproduction studies of BRL14151K and BRL25000. I. Teratology studies in rats. Chemotherapy (Tokyo) 1983;31(Suppl 2):238–51.
- Baldwin JA, Schardein JL, Koshima Y. Reproduction studies of BRL14151K and BRL25000. II. Peri- and post-natal studies in rats. Chemotherapy (Tokyo) 1983;31(Suppl 2):252–62.
- Hirakawa T, Suzuki T, Sano Y, Tamura K, Koshima Y, Hiura KI, Fujita K, Hardy TL. Reproduction studies of BRL14151K and BRL25000. III. Fertility studies in rats. Chemotherapy (Tokyo) 1983;31(Suppl 2):263–72.
- James PA, Hardy TL, Koshima Y. Reproduction studies of BRL 25000. IV. Teratology in pig. Chemotherapy (Tokyo) 1983;31(Suppl 2):274–9.
- Tasker TCG, Cockburn A, Jackson D, Mellows G, White D. Safety of ticarcillin/potassium clavulanate. J Antimicrob Chemother 1986;17:225–32.
- Matsuda S, Tanno M, Kashiwagura T, Seida A. Fundamental and clinical studies on BRL25000 (clavulanic acid-amoxicillin) in the field of obstetrics and gynecology. Chemotherapy (Tokyo) 1982;30(Suppl 2):538–47.
- Takase Z, Shirafuji H, Uchida M. Clinical and laboratory studies on BRL25000 (clavulanic acid-amoxicillin) in the field of obstetrics and gynecology. Chemotherapy (Tokyo) 1982;30(Suppl 2):579–86.
- Fortunato SJ, Bawdon RE, Swan KF, Bryant EC, Sobhi S. Transfer of Timentin (ticarcillin and clavulanic acid) across the in vitro perfused human placenta: comparison with other agents. Am J Obstet Gynecol 1992;167:1595–9.
- Matsuda S. Augmentin treatment in obstetrics and gynaecology. Augmentin: Proceedings of an International Symposium, Montreux, Switzerland. July 1981. Leigh DA, Robinson OPW, ed. Excerpta Medica 1982:179–91.
- Mayer HO, Jeschek H, Kowatsch A. Augmentin in the treatment of urinary tract infection in pregnant women and pelvic inflammatory disease. Proceedings of the European Symposium on Augmentin, Scheveningen, June 1982, 1983:207–17.
- Pedler SJ, Bint AJ. Comparative study of amoxicillin-clavulanic acid and cephalexin in the treatment of bacteriuria during pregnancy. Antimicrob Agents Chemother 1985;27:508–10.
Q&A about Clavulanate Potassium
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I pay just $1,5 per pill
I am taking the medication for a sinus infection. This medication is making me nauseated(which is normal) But I feel like I'm congested or I have a slight fever. I don't have shortness of breath or swelling so I don't know if its an allergic reaction. I have been taking Nyquil Sinus or Benadryl for the usual symptoms. I was just wondering if anyone had this reaction to the pills.
Hi, my sister has a swollen lymph node in her neck and the Dr has prescribed Amoxicillin/clavulanate potassium. At $60.00 a bottle, I am wondering if a cheaper antibiotic could have been prescribed?
My boyfriend got bit on both hands seperating our 2 pitbulls from fighting and he got some series bites on both hands. Anyways the doctor prescribed this antibiotic to him to take the chewable tablets 3 times a day and he is getting sick. I read of the symptoms online and all the side effects he is having compared to an overdose. But the last time he took the antibiotic was yesterday one time cause it made him very nauseated. He got bit last friday. Any advice to save us a trip to the hospital for a large bill?
You may also want to take yogurt or acidophilus pills/cultures, as the replacement of intestinal flora is known to decrease intestinal discomfort and diarrhea related to Augmentin intake.
Finally, if he had animal bites and is taking the drug due to this, DO NOT discontinue the drug until a doctor tells you so. You still may want to call the physician if he cannot tolerate the side effects, but taking the meds is important to prevent him from getting a serious bacterial blood and/or skin infection.
Amox+Clav K is the generic name while Augmentin is the brand name.
Yes it is safe to pregnant lady and her baby.
To Mickie(top contributor), dont answer the question if you are not really sure!
My daughter has taken Amoxicillin before with no complications. She's recently been diagnosed with pneumonia and was prescribed Augmentin. She broke out in hives from it. Can she be allergic to the clavulanate potassium?
Call her physician to change her medicine for this infection. Write down this allergy so you can tell all her future health care practitioners. Its important that you inform them that she can take the Amoxicillin, but that the Augmentin caused a problem, so that her physicians and pharmacy will know its not the amoxicillin, but the clavulanic acid
Good luck!
