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Gabapentin — (Neurontin)

International Brand Names

Dineurin (Chile); Gabatin (Korea); Gantin (Australia); Kaptin (Colombia); Neurontin (Austria, Belgium, Canada, Czech Republic, England, Finland, France, Germany, Greece, Hong Kong, Hungary, India, Indonesia, Ireland, Italy, Kenya, Korea, Malaysia, Norway, Philippines, Poland, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Uruguay, Venezuela); Nupentin (Australia); Pendine (Australia)

Drug Class Anticonvulsants
Indications Seizures (partial), postherpetic neuralgia, neuropathic pain
Mechanism Unknown
Dosage With Qualifiers Seizures (partial)—begin 300 mg PO qd × 1 d, then bid × 1 d, then tid; usual maintenance 1800–2400 mg qd; max 3600 mg/d
Postherpetic neuralgia—begin 300 mg PO qd × 1 d, then bid × 1 d, then tid; max 1800 mg/d
Neuropathic pain—begin 300 mg PO qd × 1 d, then bid × 1 d, then tid; max 3600 mg/d
NOTE: Renal dosing.

  • Contraindications —hypersensitivity to drug or class

  • Caution —renal dysfunction, abrupt withdrawal

Maternal Considerations Gabapentin is a second-generation anticonvulsant used mainly as an adjunct for partial seizures. The limited published experience during pregnancy and lactation suggests a higher safety margin compared with first-generation agents. The impact of pregnancy upon gabapentin metabolism apparently has not been studied. The dose may require adjustment during pregnancy and should be based on both serum concentration and clinical symptoms. Gabapentin has been used for chronic headache during early pregnancy. Although a relationship between hormones and seizure activity exists in many women, good options for catamenial epilepsy remain elusive. And although interactions between enzyme-inducing anticonvulsants and contraceptives are well documented, this is not true for gabapentin. Patients should be counseled to plan pregnancy and informed of the value of folate supplementation, the importance of medication adherence, and the risk of teratogenicity. Gabapentin has been given for restless leg syndrome, a disorder reportedly increased during pregnancy, and appears to reduce both the frequency and the severity of hot flashes in postmenopausal women in a dose-dependent manner. Several reports suggest it may be effective for the treatment of hyperemesis.
Side effects include leukopenia, dizziness, somnolence, fatigue, ataxia, tremor, blurred vision, N/V, nervousness, dysarthria, weight gain, and dyspepsia.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. There was no evidence of human teratogenicity in 294 first-trimester gabapentin -monotherapy exposures. There were 5 (1.7%) major congenital malformations reported, which compares well to the general population (1.6%–2.2%). Two of the registries reported the complication rates in a total of 261 singletons. There were roughly equivalent rates of preterm birth and maternal hypertension/eclampsia as in the general population. Gabapentin crosses the human placenta, achieving a F:M ratio of 1.7 (range: 1.3–2.1). Limited observations suggest active transport of gabapentin . This suggests the presence of L-type amino acid transporter 1 in the placenta. Rodent studies reveal fetotoxicity and an increased prevalence of minor malformations, including skeletal abnormalities (skull, spine, and limbs) and hydronephrosis.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. Gabapentin is excreted into human breast milk and appears to have a relative infant dose of about 6.6%. The plasma concentration in the breastfed infants approximates 12% of the mother’s plasma level, too low to have a clinically significant effect.
Drug Interactions Naproxen appears to increase gabapentin absorption by 12%–15%.
Gabapentin decreases hydrocodone C max and AUC values in a dose-dependent manner.
Morphine may increase the mean gabapentin AUC.
Cimetidine appears to modestly decrease the oral clearance of gabapentin by altering renal excretion of both gabapentin and creatinine.
The C max of norethindrone is 13% higher when given with gabapentin, though this interaction is not expected to be of clinical importance.
Antacids reduce the bioavailability of gabapentin by about 20%. It is recommended that gabapentin be taken at least 2 h after antacid use.
References Bar-Oz B, Nulman I, Koren G, Ito S. Paediatr Drugs 2000; 2:113-26.
Crawford P. CNS Drugs 2002; 16:263-72.
Djokanovic N, Garcia-Bournissen F, Koren G. J Obstet Gynaecol Can 2008; 30:505-7.
Gustus T, Kurlan R, McDermott MP, Kieburtz K. Obstet Gynecol 2003; 101:337-45.
Guttuso T Jr, Shaman M, Thornburg LL. Eur J Obstet Gynecol Reprod Biol. 2014;181:280-3. Lowe SA. Best Pract Res Clin Obstet Gynaecol 2001; 15:863-76.
Marcus DA. Expert Opin Pharmacother 2002; 3:389-93.
McAuley JW, Anderson GD. Clin Pharmacokinet 2002; 41:559-79.
Ohman I, Vitols S, Tomson T. Epilepsia 2005; 46:1621-4.
Wilton LV, Shakir S. Epilepsia 2002; 43:983-92.
Summary Pregnancy Category: C
Lactation Category: S (probably)

  • Limited study suggests a higher safety margin relative to first-generation anticonvulsants.

Gadoversetamide — (OptiMARK)

International Brand Names

OptiMARK (Argentina)

Drug Class Diagnostics, nonradioactive
Indications MRI
Mechanism A component, gadolinium, is paramagnetic.
Dosage With Qualifiers MRI—0.2 mL/kg at 1–2 mL/sec (alternatively 0.1 mmol/kg)

  • Contraindications —hypersensitivity to drug or class

  • Caution —hemolytic anemia, renal insufficiency

Maternal Considerations There is no published experience with gadoversetamide during pregnancy. Gadoversetamide releases gadolinium .
Side effects include body discomfort, headache, abdominal pain, asthenia, back pain, flushing, N/V, diarrhea, dyspepsia, dizziness, paresthesias, rhinitis, and taste alteration.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether gadoversetamide crosses the human placenta. It does cross the rodent placenta. Limited rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether gadoversetamide enters human breast milk. However, its molecular weight and chemistry render it unlikely to either enter breast milk or be absorbed orally. It is excreted in rat breast milk. Breastfeeding women should consider discarding their milk after injection for the first 24 h after the MRI; several US organizations feel there is no reason to interrupt breastfeeding.
Drug Interactions Drug interactions with other contrast agents and other drugs have not been studied.
References Wible JH, Troup CM, Hynes MR, et al. Invest Radiol 2001; 36:401-12.
Summary Pregnancy Category: C
Lactation Category: S (probably)

  • Gadoversetamide should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

Ganciclovir — (Cytovene)

International Brand Names

Cymevan (France); Cymeven (Germany); Cymevene (Argentina, Bangladesh, Brazil, Chile, Colombia, Ecuador, France, Germany, India, Ireland, Japan, Malaysia, Mexico, Pakistan, Paraguay, Peru, Poland, Puerto Rico, Slovenia, Uruguay, Venezuela); Cytovene (Canada); Denosine (Japan); Virgan (England, France, Ireland, Korea, Philippines)

Drug Class Antivirals
Indications CMV retinitis
Mechanism Inhibits viral DNA polymerase
Dosage With Qualifiers CMV retinitis—5 mg/kg IV over 1 h q12h × 14–21 d; then 5 mg/kg IV qd, then 1000 mg PO qd
NOTE: Renal dosing.

  • Contraindications —hypersensitivity to drug or class, bone marrow depression

  • Caution —renal dysfunction

Maternal Considerations There are no adequate reports or well-controlled studies in pregnant women. Case reports include ganciclovir use during the first trimester in one woman with a liver transplant, another with a kidney transplant, and a third with CMV hepatitis. Attention to hygiene coupled with behavioral interventions reduces seroconversion rates during pregnancy, though poor maternal compliance is a limiting factor.
Side effects include seizures, coma, thrombocytopenia, neutropenia, anemia, nephrotoxicity, fever, diarrhea, N/V, sweating, chills, pruritus, neuropathy, paresthesias, and elevated LFTs.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Ganciclovir crosses the human placenta by passive diffusion. It has been administered directly to CMV-infected fetuses with sonographically detected sequelae and no clear success: the viral load declined, but the fetus died. It also has been used to treat an infected fetus who developed primary CMV after maternal primary infection associated with a renal transplant. In this instance, the fetal CMV was reportedly eradicated. Any antenatal therapy, whether with antivirals or CMV hyperimmune globulin, should be offered only as part of a research protocol. Postnatally, ganciclovir remains a drug of choice for the treatment of symptomatic neonatal CMV with a cure rate of about 85%. Ganciclovir is embryotoxic in rats and mice. In rabbits, it is associated with cleft palate, microphthalmia, renal agenesis, and hydrocephaly.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. Fetuses with brain or abdominal findings have the worst prognoses and are potential candidates for fetal therapy. Ganciclovir enters human breast milk, though there is little study after oral or intravenous dosing. It is usually thought to be compatible with breastfeeding considering its use in neonates. Ganciclovir enters rat breast milk by passive diffusion, reaching near-maternal serum levels.
Drug Interactions Increased the steady-state didanosine AUC 111 ± 114%. The steady-state ganciclovir AUC decreased 21 ± 17% when didanosine was administered 2 h prior to ganciclovir. The ganciclovir AUC was not affected by the presence of didanosine when the two drugs were given together.
AUC decreased 17 ± 25% in the presence of zidovudine. Steady-state zidovudine AUC increased 19 ± 27% in the presence of ganciclovir. Because both zidovudine and ganciclovir have the potential to cause neutropenia and anemia, some patients may not tolerate concomitant therapy at full dosage.
AUC increased 53 ± 91% in the presence of probenecid. Renal clearance of ganciclovir decreased 22 ± 20%, which is consistent competition for renal tubular secretion.
Generalized seizures have been reported in patients receiving ganciclovir and imipenem-cilastatin. These drugs should not be used concomitantly unless the potential benefits outweigh the risks.
Drugs that inhibit replication of rapidly dividing cell populations such as bone marrow, spermatogonia, and germinal layers of skin and GI mucosa (e.g., amphotericin B, dapsone, doxorubicin, flucytosine, pentamidine, trimethoprim-sulfamethoxazole combinations, vinblastine, vincristine, or other nucleoside analogs) may have additive toxicity when administered with ganciclovir. The combined use should be considered only if the potential benefits outweigh the risks.
Increases in serum creatinine have occurred in patients also treated with cyclosporine or amphotericin B, drugs with known nephrotoxicity potential.
References Alcorn J, McNamara PJ. Antimicrob Agents Chemother 2002; 46:1831-6.
Bale JF, Miner L, Petheram SJ. Curr Treat Options Neurol 2002; 4:225-30.
Henderson GI, Hu ZQ, Yang Y, et al. Am J Med Sci 1993; 306:151-6.
Manuyama Y, Sameshina H, Kamitomo M, et al. J Obstet Gynaecol Res 2007; 33:619-23.
Miguelez M, Gonzalez A, Perez F. Scand J Infect Dis 1998; 30:304-5.
Miller BW, Howard TK, Goss JA, et al. Transplantation 1995; 60:1353-4.
Pescovitz MD. Transplantation 1999; 15:758-9.
Puliyanda DP, Silverman NS, Lehman D, et al. Transpl Infect Dis 2005; 7:71-4.
Summary Pregnancy Category: C
Lactation Category: U

  • Ganciclovir should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

Gatifloxacin — (Tequin)

International Brand Names

Bonoq (Germany); Bonoq-Uro (Germany); Gaticin (Indonesia); Gatiflo (Korea); Starox (Chile); Tequin (Argentina, Brazil, Canada, Indonesia, Malaysia, Mexico, Philippines, Singapore, South Africa, Thailand); Zymar (Singapore, Thailand); Zyquin (India)

Drug Class Antibiotics; Quinolones
Indications Bacterial infection; uncomplicated gonorrhea
Mechanism Bactericidal—inhibits DNA gyrase and topoisomerase IV
Dosage With Qualifiers Bacterial infections—200–400 mg PO/IV (infuse over 60 min) qd × 7–10 d
Uncomplicated gonorrhea—400 mg PO × 1
NOTE: Renal dosing.

  • Contraindications —hypersensitivity to drug or class, prolonged QT interval

  • Caution —CV disease, proarrhythmic condition, concurrent class IA, III antiarrhythmic agents

Maternal Considerations Gatifloxacin is a well-absorbed oral quinolone. There is no published experience with gatifloxacin during pregnancy.
Side effects include pseudomembranous colitis, superinfection, vaginitis, increased ICP, seizures, tendinitis, toxic psychosis, N/V, diarrhea, abdominal pain, headache, dyspepsia, dizziness, light-headedness, insomnia, rash, anxiety, confusion, increased LFTs, agitation, and photosensitivity.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether gatifloxacin crosses the human placenta. Quinolones are traditionally avoided during pregnancy out of concern for damage to the fetal joints. However, this concern appears to be overstated. Rodent studies using multiples of the MRHD reveal an increased risk of skeletal abnormalities and neonatal death rate.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether gatifloxacin enters human breast milk. Gatifloxacin does enter rat milk, and caution is recommended during lactation.
Drug Interactions Hypoglycemia has been reported after gatifloxacin in patients taking glyburide .
An increase in digoxin concentrations was observed in about one-third of subjects after beginning gatifloxacin. Patients taking digoxin should be monitored for signs and/or symptoms of toxicity.
Probenecid significantly increased gatifloxacin levels.
The concomitant administration of NSAIDs with a quinolone may increase the risks of CNS stimulation and convulsions.
References Gurpinar AN, Balkan E, Kilic N, et al. J Int Med Res 1997; 25:302-6.
van den Oever HL, Versteegh FG, Thewessen EA, et al. Eur J Pediatr 1998; 157:843-5.
Summary Pregnancy Category: C
Lactation Category: U

  • Gatifloxacin should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

  • There are other agents with more experience and a higher safety profile during pregnancy and lactation.

Gemfibrozil — (Lopid; Tripid)

International Brand Names

Apo-Gemfibrozil (New Zealand); Ausgem (Australia); Bolutol (Spain); Brozil (Malaysia); Chlorestrol (Thailand); Cholespid (Philippines); Clearol (Taiwan); Decrelip (Spain); Detrichol (Indonesia); Elmogan (Hong Kong); Fetinor (Indonesia); Fibralip (Indonesia); Fibrocit (Italy); Gedum (Argentina); Gemd (Taiwan); Gemfi (Germany); Gemfibril (Thailand); Gemfibromax (Australia); Gemizol (New Zealand); Gemlipid (Italy, Turkey); Gemnpid (Taiwan); Gemzil (Hong Kong); Gevilon (Czech Republic, Finland, Germany, Hungary, Poland, Switzerland); Gevilon Uno (Germany); Gozid (Thailand); Grifogemzilo (Peru); Hidil (Thailand); Hipolixan (Ecuador); Ipolipid (Hong Kong, Malaysia); Lanaterom (Indonesia); Lifibron (Indonesia); Lipazil (Australia); Lipidys (Thailand); Lipigem (India, Philippines); Lipira (Indonesia); Lipison (Hong Kong); Lipistorol (Hong Kong); Lipizyl (India); Lipofor (Hong Kong); Lipolo (Thailand); Lipostorol (Malaysia); Lipozid (Philippines); Lipozil (Dominican Republic, El Salvador, Guatemala); Lipur (France); Lopid (Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, Ecuador, England, Finland, Greece, Hong Kong, Indonesia, Ireland, Italy, Malaysia, Mexico, Netherlands, Peru, Philippines, Portugal, South Africa, Spain, Sweden, Taiwan, Thailand, Turkey, Uruguay, Venezuela); Lopid O.D. (Philippines); Lowin (Hong Kong); Manobrozil (Thailand); Mariston (Malaysia); Mersikol (Indonesia); Normolip (India); Panazil (Taiwan); Polyxit (Thailand); Progemzal (Indonesia); Recozil (Singapore); Reducel (Philippines); Synbrozil (Hong Kong); Triglizil (Colombia); Uragem (China); Zilop (Colombia, Indonesia)

Drug Class Antihyperlipidemics
Indications Hypertriglyceridemia, hypercholesterolemia (high LDL, triglycerides; low HDL)
Mechanism Decreases hepatic free fatty acid extraction, inhibits synthesis and increases clearance of the VLDL carrier apolipoprotein B, inhibits peripheral lipolysis
Dosage With Qualifiers Hypertriglyceridemia—600 mg PO bid 30 min ac
Hypercholesterolemia—600 mg PO bid 30 min ac

  • Contraindications —hypersensitivity to drug or class, gallbladder disease, cerivastatin use, hepatic dysfunction

  • Caution —renal dysfunction, use with other statins-class agents

Maternal Considerations There are no adequate reports or well-controlled studies of gemfibrozil in pregnant women. Hyperlipidemia is a chronic illness. Discontinuation of therapy during pregnancy is in most instances unlikely to alter the long-term outcome. Case reports document uncomplicated use of gemfibrozil in pregnant women with either hypertriglyceridemia or familial chylomicronemia or complications there of.
Side effects include myositis, cholelithiasis, cholestatic jaundice, thrombocytopenia, anemia, rhabdomyolysis, acute appendicitis, atrial fibrillation, increased LFTs, elevated CPK, N/V, dyspepsia, abdominal pain, diarrhea, and fatigue.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Based on a single case report, gemfibrozil crosses the human placenta. The level of gemfibrozil in the fetal venous and arterial cord blood was within the expected therapeutic range for adults. Despite extremely low fat in the maternal diet, the levels of essential fatty acids measured in the mother and in the fetal blood immediately postpartum were normal. Rodent studies reveal a dose-related increase in skeletal abnormalities at twice the MRHD.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether gemfibrozil enters human breast milk. The offspring of treated rodents have reduced weight during neonatal and weaning periods.
Drug Interactions The risk of myopathy and rhabdomyolysis is increased when combined with HMG-CoA reductase inhibitors. Myopathy or rhabdomyolysis with or without acute renal failure have been reported as early as 3 w after the initiation of combined therapy. There is no assurance that periodic monitoring of CK will prevent the occurrence of severe myopathy and kidney damage.
Caution should be exercised when anticoagulants are combined with gemfibrozil. The dose of the anticoagulant should be reduced to maintain the prothrombin time at the desired level.
Use with repaglinide causes a significant increase in repaglinide levels. Patients taking repaglinide should not start gemfibrozil; patients taking gemfibrozil should not start taking repaglinide. Concomitant use may enhance and prolong the hypoglycemic effect of repaglinide, and blood glucose levels should be monitored and repaglinide dose adjustments made as needed. Rare postmarketing events of serious hypoglycemia are reported in patients taking repaglinide and gemfibrozil together. In addition, gemfibrozil and itraconazole have a synergistic metabolic inhibitory effect on repaglinide. Patients taking repaglinide and gemfibrozil should not take itraconazole.
References Al-Shali K, Wang J, Fellows F, et al. Clin Biochem 2002; 35:125-30.
Fitzgerald JE, Petrere JA, de la Iglesia FA. Fundam Appl Toxicol 1987; 8:454-64.
Keilson LM, Vary CP, Sprecher DL, Renfrew R. Ann Intern Med 1987; 124:425-8.
Perronne G, Critelli C. Minerva Ginecol 1996; 48:573-6.
Tsai EC, Brown JA, Veldee MY, et al. BMC Pregnancy Childbirth 2004; 4:27.
Summary Pregnancy Category: C
Lactation Category: U

  • Gemfibrozil should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

Gentamicin — (Garamycin; Genoptic; Gentacidin; Gentak; G-Myticin; Ocu-Mycin)

International Brand Names

Adelanin (Philippines); Alcomicin (Belgium, Canada, Indonesia, Israel, South Africa, Thailand); Apigent (Israel); Azupel (Paraguay); Bactiderm (Philippines); Biogaracin (India); Cidomycin (England, Ireland, Israel, Malaysia, Puerto Rico, South Africa); Danigen (Indonesia); Dermogen (Malaysia); Diakarmon (Greece, Israel, South Africa); Dispagent (Uruguay); Epigent (Israel); Fermentmycin (South Africa); Garabiotic (Indonesia); Garalone (Portugal); Garamicin (Thailand); Garamicina (Brazil, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama); Garamicina Cream (Colombia); Garamicina Crema (Ecuador, Mexico); Garamicina Oftalmica (Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama); Garamycin (Australia, Bulgaria, Canada, Czech Republic, Denmark, Greece, Hong Kong, Hungary, India, Indonesia, Malaysia, Netherlands, Norway, Philippines, Poland, Russia, Sweden, Switzerland, Taiwan, Thailand, Turkey); Garbilocin (Greece); Gencin (South Africa); Gendril (Philippines); Genoptic (Hong Kong, New Zealand, South Africa, Taiwan); Genrex (Mexico); Gensumycin (Denmark, Finland, Norway, Sweden); Gentabiotic (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Peru); Gentabiox (Peru); Gentac (Taiwan); Gentacin (Hong Kong, Japan, Korea); Gentacor (Philippines); Gentacyl (Indonesia); Gentagram (Peru); Genta Grin (Mexico); Gental (Thailand); Gentalline (France); Gentalol (Japan); Gentalyn (Chile, Italy, Peru, Venezuela); Gentalyn Oftalmico-Otico (Peru); Gentamax (Ecuador); Gentame (Malaysia); Gentamedical (Spain); Gentamen (Israel); Gentamerck (Indonesia); Gentamina (Argentina, Paraguay, Uruguay); Gentamytrex (Germany, Hungary, Netherlands, Philippines, Poland); Gentamytrex Ophthiole (Malaysia); Gentarad (Israel); Gentasil (Peru); Gentasporin (India); Gentatrim (Israel); Genticin (England, Ireland, Israel, South Africa); Genticina (Spain); Genticyn (India); Gentiderm (Indonesia); Genum (Philippines); Geomycine (Belgium); Gevramycin (Spain); G-Mycin (Korea); Grammicin (Thailand); Hexamycin (Denmark); Konigen (Indonesia); Lacromycin (Israel); Lisagent (Taiwan); Migenta (Uruguay); Miragenta (Colombia); Miramycin (Hong Kong, Malaysia, Singapore, Taiwan, Thailand); Nichogencin (Indonesia); Obogen (Philippines); Ocugenta (Korea); Oftagen (Peru); Ophtagram (Belgium, Germany, Philippines, Switzerland); Opthagen (Philippines); Optigen (Hong Kong, Malaysia); Opti-Genta (Israel); Optimycin (South Africa); Ottogenta (Indonesia); Pyogenta (Indonesia); Refobacin (Austria, Germany); Rigaminol (Peru); Rocy Gen (Philippines); Rovixida (Argentina); Rupegen (Argentina); Sagestam eye drops (Indonesia); Sedanazin (Japan); Servigenta (Malaysia); Skinfect (Thailand); Sulmycin (Germany); Tangyn (Philippines); Terramycin N Augensalbe (Germany); Terramycin N Augentropfen (Germany); Versigen (Thailand); Yectamicina (Mexico)

Drug Class Aminoglycosides; Antibiotics; Dermatologics; Ophthalmics; Otics
Indications Bacterial infection, endocarditis prophylaxis
Mechanism Bactericidal—inhibits protein synthesis by binding the bacterial 30S ribosomal subunit
Dosage With Qualifiers Bacterial infection—1–3 mg/kg/d in 3 divided doses to achieve a peak 5–10 mcg/mL and trough < 2 mcg/mL
Endocarditis prophylaxis—1.5 mg/kg IV 30–60 min prior to the procedure
NOTE: Renal dosing; available for parenteral, topical, or ophthalmic administration.

  • Contraindications —hypersensitivity to drug or class

  • Caution —renal dysfunction, nephrotoxic agents, cochlear implant, myasthenia gravis

Maternal Considerations Gentamicin is commonly used in obstetric patients for the treatment of infections such as pyelonephritis. Though its clearance is increased during pregnancy and in the puerperium, routine monitoring of peak and trough levels is not required in otherwise healthy women with normal renal function. Coupled with clindamycin, it remains the treatment of choice for puerperal endomyometritis. Once-daily treatment postpartum (5 mg/kg) with clindamycin is as effective as and cheaper than tid dosing. Once the endometritis has resolved on IV therapy, there is no need for further oral therapy.
Side effects include nephro- and ototoxicity, thrombocytopenia, agranulocytosis, neurotoxicity, enterocolitis, pseudotumor cerebri, N/V, rash, pruritus, weakness, tremor, muscle cramps, anorexia, edema, headache, diarrhea, dyspepsia, tinnitus, and elevated BUN/Cr.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Gentamicin crosses the human placenta, reaching an F:M ratio approximating unity. In rodents, placental transfer is greater during early than in late gestation. Gentamicin interferes with renal protein reabsorption in fetal rats, and it depresses body weights, kidney weights, and median glomerular counts in newborn rats when administered systemically at multiples of the MRHD. However, the evidence for human fetal gentamicin toxicity is weak. In utero exposure to gentamicin does not appear to increase the risk of audiologic impairment. There is no evidence to support the practice in some locales of using gentamicin for ophthalmia neonatorum prophylaxis.
Breastfeeding Safety Gentamicin is poorly excreted into breast milk, and newborn infants absorb only small amounts orally. Older infants would be expected to absorb even less gentamicin. In one study, the mean M:P gentamicin ratios were 0.11 and 0.44 at 1 and 7 h, respectively. The relative infant dose approximates 2.3%.
Drug Interactions Drugs that decrease renal clearance increase the risk of gentamicin toxicity.
References Briggs GG, Ambrose P, Nageotte MP. Am J Obstet Gynecol 1989; 160:309-13.
Celiloglu M, Celiker S, Guven H, et al. Obstet Gynecol 1994; 84:263-5.
Czeizel AE, Rockenbauer M, Olsen J, Sorensen HT. Scand J Infect Dis 2000; 32:309-13.
Kirkwood A, Harris C, Timar N, Koren G. J Obstet Gynaecol Can 2007; 29:140-5.
Livingston JC, Llata E, Rinehart E, et al. Am J Obstet Gynecol 2003; 188:149-52.
Mackeen AD, Packard RE, Ota E, Speer L. Cochrane Database Syst Rev 2015 Feb 2;(2):CD001067.
Mitra AG, Whitten MK, Laurent SL, Anderson WE. Am J Obstet Gynecol 1997; 177:786-92.
Nichoga LA, Skosyreva AM, Voropareva SD. Antibiotiki 1982; 27:46-50.
Popović J, Grujić Z, Sabo A. J Clin Pharm Ther 2007; 32:595-602.
Smaoui H, Schaeverbeke M, Mallie JP, Schaeverbeke J. Pediatr Nephrol 1994; 8:447-50.
Summary Pregnancy Category: C
Lactation Category: S (probably)

  • Gentamicin is widely used during pregnancy and lactation without evidence of excess toxicity to mother or fetus.

Glatiramer acetate — (Copaxone)

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