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Factor IX — (Alphanine; Bebulin VH; Immuno; Konyne 80; Mononine; Profilnine SD; Proplex T)

International Brand Names

Bebulin (Denmark, Spain); Bebulin S-Tim 4 (Austria); Bebulin Team 4 (Russia); Bebulin TIM 4 (Bulgaria, Hungary); Benefix (Argentina, Brazil, Chile, Mexico); Berinin P (Mexico); Betafact (Israel); Facnyne (Korea); Factor IX S-TIM (Germany); Immunine (Germany, Sweden); Immunine VH (Canada); Inmunine (Venezuela); Konyne 80 (Mexico); Mononine (Belgium, Denmark, England, France, Germany, Ireland, Netherlands, Spain, Sweden); Novact M (Japan); Octanine F (Uruguay); Profilnine HD (Philippines); Profilnine SD (Malaysia, Thailand); Proplex T (Indonesia, Taiwan); Replenine VF (Israel, Malaysia)

Drug Class Blood clotting factors; Blood components, substitute
Indications Factor IX deficiency (prevention and control of bleeding), treatment of anticoagulant overdose
Mechanism Factor IX replacement
Dosage With Qualifiers Bleeding—dose (IU) = kg ×% desired increase in factor IX × 1.2 (1.2 for recombinant, otherwise × 1 for concentrate), given slow IV push
Prophylaxis—20–30 IU/kg 1–2 ×/w given slow IV push
Anticoagulant overdose—dose (IU) = kg ×% desired increase in factor IX, given slow IV push

  • Contraindications —hypersensitivity to mouse proteins, hepatic dysfunction, DIC, hyperfibrinolytic states

  • Caution —thrombophilia

Maternal Considerations Factor IX is a stabile, lyophilized concentrate either recombinant or made from pooled human plasma. The latter is purified by immunoaffinity chromatography, which reduces the risk of virus transmission. There are no adequate reports or well-controlled studies in pregnant women. The published literature consists of case series and single reports. Factor IX deficiency is typically an X-linked disorder, and thus symptoms occur only in women with unbalanced lyonization. Postpartum hemorrhage is the most common complication, and it occurs more often in women receiving fewer than 4 d of factor IX replacement.
Side effects include thromboembolic disease, viral disease, flushing, tingling, fever, chills, N/V, urticaria, headache, BP changes, and injection site reaction.
Fetal Considerations There are no adequate reports or well-controlled studies of factor IX in human fetuses. Placental transfer is unlikely. Rodent teratogenicity studies have not been conducted.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether factor IX enters human breast milk. However, any ingested factor would likely be degraded.
Drug Interactions No clinically relevant interactions identified.
References Shobeiri SA, West EC, Kahn MJ, Nolan TE. Obstet Gynecol Surv 2000; 55:729-37.
Yang MY, Ragni MV. Haemophilia 2004; 10:483-90.
Summary Pregnancy Category: C
Lactation Category: S

  • Though rarely indicated in pregnancy or during lactation, factor IX replacement is likely safe during pregnancy.

Famciclovir — (Famvir)

International Brand Names

Combivent (Argentina, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Denmark, England, France, Hong Kong, Indonesia, Ireland, Korea, Mexico, Paraguay, Peru, Philippines, Thailand, Uruguay, Venezuela); Famtrex (India); Famvir (Australia, Canada, Ecuador, Hong Kong, Indonesia, Israel, Taiwan, Thailand); Oravir (France); Pentavir (Argentina)

Drug Class Antivirals
Indications Treatment of genital herpes and herpes zoster
Mechanism Inhibits viral DNA polymerase
Dosage With Qualifiers Genital herpes (first episode)—250 mg PO tid × 7 d
Genital herpes (recurrent)—125 mg PO bid × 5 d
Genital herpes (prophylaxis)—250 mg PO bid
Herpes zoster—500 mg PO tid × 7 d
NOTE: Renal dosing.

  • Contraindications —hypersensitivity

  • Caution —renal dysfunction

Maternal Considerations Famciclovir is metabolized to the active form of the drug penciclovir. There are no adequate reports or well-controlled studies in pregnant women. With a dose regimen simpler than acyclovir, drugs in this class decrease both asymptomatic shedding and the number of clinical recurrences. It is likely that the same is true during pregnancy, a supposition supported by randomized trials and cohort studies demonstrating a lower-than-expected asymptomatic shedding rate. Drug clearance is slower in nonpregnant women compared with men.
Side effects include headache, N/V, diarrhea, fatigue, itching, paresthesias, and flatulence.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether famciclovir crosses the human placenta. One postmarketing study linked a first-trimester episode of genital herpes to the presence of gastroschisis regardless of whether antivirals were taken (OR 3 without, 4.7 with, each greater than control but not different from each other). Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether famciclovir is excreted in human breast milk. Penciclovir is excreted in concentrations higher than plasma in lactating rats.
Drug Interactions Concurrent use with probenecid or other drugs eliminated by active renal tubular secretion may increase the plasma concentrations of penciclovir.
The conversion of 6-deoxypenciclovir to penciclovir is catalyzed by aldehyde oxidase. Interactions with other drugs metabolized by this enzyme are possible.
Cimetidine increases plasma concentrations of penciclovir.
Famciclovir increases plasma levels of digoxin .
Famciclovir may diminish the effectiveness of zoster vaccine and varicella virus vaccine. It is recommended to avoid use within 24 hr prior to vaccine administration.
References Ahrens KA, Anderka MT, Feldkamp ML et al. Paediatr Perinat Epidemiol. 2013;27:340-5.
Baker DA. Int J Fertil Womens Med 1998; 43:243-8.
Leung DT, Sacks SL. Drugs 2000; 60:1329-52.
Mubareka S, Leung V, Aoki FY, Vinh DC. Expert Opin Drug Saf 2010; 9:643-58.
Scott LL. Clin Obstet Gynecol 1999; 42:134-48.
Summary Pregnancy Category: B
Lactation Category: U

  • This class of agents has several potential applications during pregnancy.

  • Physicians are encouraged to register pregnant women under the Famciclovir Pregnancy Registry (1-888-669-6682) maintained by the manufacturer for a better follow-up of the outcome while under treatment with famciclovir.

Famotidine — (Pepcid)

International Brand Names

Agufam (Thailand); Amfamox (Australia); Antiflam (Uruguay); Apo-Famotidine (New Zealand); Apogastine (Israel); Asid (Brazil); Ausfam (Australia); Beilande (Hong Kong); Bestidine (Korea); Blocacid (Singapore); Brolin (Spain); Cepal (Greece); Durater (Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Panama); Facid (Indonesia); Fadin (Taiwan); Fadine (Hong Kong, Malaysia, Thailand); Fadul (Germany); Fafotin (Korea); Famine (Hong Kong); Famo (Germany, Israel); FamoABZ (Germany); Famoc (Singapore); Famocid (India); Famodil (Italy); Famodin (Bulgaria); Famogal (Colombia); Famogard (Russia); Famohexal (Australia); Famolta (Hong Kong); Famonerton (Germany); Famopril (Singapore); Famopsin (Hong Kong, Malaysia, Thailand); Famos (Indonesia); Famosan (Bulgaria); Famosia (Thailand); Famotal (Norway); Famotep (Portugal); Famotin (Ecuador, Singapore); Famotine (Peru); Famowal (India); Famox (Hong Kong, New Zealand, Taiwan); Famoxal (Mexico); Fanox (Spain); Fararidin (Korea); Farmotex (Mexico); Farotin (Korea); Fenox (Colombia); Ferotine (Korea); Fibonel (Chile, Ecuador); Fudone (South Africa); Fuweidin (Taiwan); Gardin (Korea); Gaster (China, Indonesia, Japan, Taiwan); Gastren (Paraguay); Gastridin (Italy); Gastrion (Spain); Gastro (Israel); Gastroflux (Philippines); H2 Bloc (Philippines); Incifam (Indonesia); Kemofam (Indonesia); Kimodin (Taiwan); Logos (South Africa); Motiax (Italy); Motidine (Hong Kong, Singapore); Pepcid (Australia, Canada, England, Ireland, South Africa, Sweden); Pepcidac (France); Pepcid AC (Canada, New Zealand); Pepcidin (Denmark, Finland, Netherlands, Norway, Sweden, Turkey); Pepcidina (Portugal); Pepcidine (Austria, Belgium, Costa Rica, Ecuador, El Salvador, Guatemala, Honduras, Hong Kong, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Philippines, Russia, Switzerland); Pepcidin Rapitab (Norway); Pepdif (Turkey); Pepdine (France); Pepdul (Germany); Pepfamin (Thailand); Peptan (Greece); Pepticon (Korea); Pepzan (Hong Kong, Malaysia, New Zealand, Thailand); Purifam (Indonesia); Quamatel (China, Hong Kong); Restadin (Indonesia); Rogasti (Israel); Sedanium-R (Greece); Stadin (Korea); Stomax (Israel); Supertidine (Taiwan); Tamin (Spain); Topcid (India); Ulcatif (Israel); Ulcedine (Hong Kong); Ulcefam (Philippines); Ulcelac (Argentina); Ulcenol (Venezuela); Ulceran (Hong Kong, Malaysia, Singapore); Ulcidine (Canada); Ulcofam (Thailand); Ulfadin (Colombia); Ulfagel (Ecuador); Ulfam (Indonesia); Ulfamid (Poland); Ulped (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama); Ulped AR (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama); Voker (Malaysia); Weimok (Taiwan); Winiful (Taiwan); Wiretin (Korea); Yamarin (South Africa)

Drug Class Antihistamines, H 2 ; Gastrointestinals
Indications Treatment of GERD, gastric ulcer disease, and Zollinger-Ellison syndrome
Mechanism H 2 -receptor antagonist
Dosage With Qualifiers GERD—20–40 mg PO qhs for 12 w
Gastric ulcer—20–40 mg PO qhs for 4–6 w
Zollinger-Ellison syndrome—20–60 mg PO q6h, max 160 mg PO q6h
NOTE: Renal dosing.

  • Contraindications —hypersensitivity, PKU

  • Caution —renal dysfunction

Maternal Considerations There are no adequate reports or well-controlled studies of famotidine in pregnant women. There are only rare reports of its use during pregnancy. A single dose of famotidine administered to parturients PO 3 h before surgery is more effective neutralizing gastric secretion than omeprazole. One epidemiologic study concluded the use of H 2 antagonists during pregnancy was associated with a higher prevalence of preterm birth.
Side effects include pancytopenia, leukopenia, thrombocytopenia, jaundice, bronchospasm, headache, taste change, constipation, diarrhea, acne, dizziness, dry skin, periorbital edema, myalgias, elevated LFTs, tinnitus, proteinuria, and elevated BUN/Cr levels.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Famotidine crosses the placenta, achieving an F:M ratio approaching unity. In general, exposure to H 2 -blockers has not been associated with increased rates of perinatal mortality, premature delivery, low birth weight, or low Apgar scores. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. Famotidine is excreted into human milk to a lesser extent than cimetidine and ranitidine . With a relative infant dose < 2%, it is the preferred agent if a drug of this class is indicated.
Drug Interactions Reduces the bioavailability of ketoconazole and itraconazole .
References Dicke JM, Johnson RF, Henderson GI, et al. Am J Med Sci 1988; 295:198-206.
Garbis H, Elefant E, Diav-Citrin O, et al. Reprod Toxicol 2005; 19:453-8.
Jacoby EB, Porter KB. Am J Perinatol 1999; 16:85-8.
Lin CJ, Huang CL, Hsu HW, Chen TL. Acta Anaesthesiol Sin 1996; 34:179-84.
Matok I, Gorodischer R, Koren G, et al. J Clin Pharmacol 2010; 50:81-7.
Wang X, Rytting E, Abdelrahman DR et al. Biomed Chromatogr. 2013;27:866-73.
Summary Pregnancy Category: B
Lactation Category: S

  • Famotidine is effective for the treatment of GERD and peptic ulcer disease, and it has a reassuring safety profile in animals.

  • There is little published experience during human pregnancy and lactation.

  • There are alternative agents for which there is more experience during pregnancy and lactation.

Felbamate — (Felbatol; Taloxa)

International Brand Names

Felbamyl (Argentina); Taloxa (France, Netherlands, Sweden)

Drug Class Anticonvulsants
Indications Second-line therapy for seizure disorders
Mechanism Unknown
Dosage With Qualifiers Seizure disorder—400–1200 mg PO tid, max 3600 mg/d
NOTE: Renal dosing.

  • Contraindications —hypersensitivity

  • Caution —hepatic or renal dysfunction, history of blood dyscrasias

Maternal Considerations Epilepsy is a common neurologic disorder affecting 1 million American reproductive-age women. Felbamate is considered a newer antiepileptic drug (e.g., lamotrigine , topiramate , levetiracetam , gabapentin , oxcarbazepine , eslicarbazepine , lacosamide , pregabalin , retigabine , rufinamide , stiripentol , tiagabine , vigabatrin , and zonisamide ). There are no adequate reports or well-controlled studies of felbamate in pregnant women. Because of the risk of serious side effects, felbamate is used only when there is no safer alternative. Drug interactions between enzyme-inducing antiepileptic drugs such as felbamate and hormonal contraceptives are well documented, increasing the risk of an unplanned pregnancy. Using either a higher-hormone-content oral contraceptive or a second contraceptive is suggested. Planned pregnancy is highly recommended and counseling before conception crucial, covering folic acid supplementation, optimal control of seizure activity, monotherapy with the lowest effective antiepileptic drug dose, and medication adherence. Drug dose adjustments are often necessary during pregnancy and should be based on clinical symptoms and not solely on serum drug concentrations.
Side effects include aplastic anemia, hepatic failure, anorexia, N/V, headache, insomnia, dizziness, somnolence, constipation, nervousness, tremor, diplopia, depression, abdominal pain, and ataxia.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether felbamate crosses the human placenta. Postmarketing studies have yet to yield any suggestion felbamate is a human teratogen. It does cross the rodent placenta. Rodent studies are reassuring, revealing no evidence of teratogenicity despite the use of doses higher than those used clinically. IUGR was noted.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. Felbamate is excreted into human breast milk, though the kinetics remain to be elucidated. Felbamate is excreted into rodent breast milk, and there is a higher death rate in breastfed pups. If breastfeeding continues, the infant should be monitored for possible adverse effects, the drug given at the lowest effective dose, and breastfeeding avoided at times of peak drug levels.
Drug Interactions The addition of felbamate to antiepileptic drugs (AEDs) affects the steady-state concentrations of AEDs. Briefly, the concentration of phenytoin is increased 20%–40%, valproate increased 10%–15%, carbamazepine decreased 30%, and carbamazepine-epoxide increased some 50%.
AEDs can also alter felbamate concentrations. Phenytoin causes a near doubling of felbamate clearance at steady state and therefore a 45% decrease in steady-state trough concentrations compared with the same dose of felbamate given as monotherapy. Carbamazepine causes a 50% increase in felbamate clearance at steady state and therefore the addition of carbamazepine results in a 40% decrease in the steady-state trough concentrations of felbamate compared with the same dose given as monotherapy.
Phenobarbital may reduce plasma felbamate concentrations.
References Chang SI, McAuley JW. Ann Pharmacother 1998; 32:794-801.
de Jong J, Garne E, de Jong-van den Berg LT, Wang H. Drugs Real World Outcomes 2016; 3:131-43.
Morrell MJ. Epilepsia 1996; 37(Suppl 6):S34-44.
Summary Pregnancy Category: C
Lactation Category: U

  • Felbamate is a second-line treatment for several seizure disorders.

  • Patients are encouraged to enroll in the North American Antiepileptic Drug (NAAED) Pregnancy Registry (1-888-233-2334).

  • Felbamate can have adverse side effects and should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

Felodipine — (Plendil)

International Brand Names

AGON SR (New Zealand); Dilahex (Philippines); Dilofen ER (Philippines); Dilopin (Korea); Fedil (Taiwan); Felim (Thailand); Felobal (Korea); Felo-BASF (Germany); Felo-BASF Retardtab (Germany); Felocor (Germany); Felocor Retardtab (Germany); Felodur ER (Australia); Felo ER (New Zealand); Felogamma Retard (Germany); Felogard (India); Felop (Philippines); Felopine-SR (Taiwan); Flodil LP (France); Hydac (Denmark, Finland, Sweden); Keydipin ER (Korea); Lodistad MR (Philippines); Modip (Germany); Munobal (Germany, Japan, Mexico, Philippines, Venezuela); Munobal Retard (Austria, Germany, Switzerland); Nirmadil (Indonesia); Penedil (Israel); Plendil (Argentina, Belgium, Bulgaria, Canada, Czech Republic, Denmark, England, Finland, Greece, Hong Kong, Hungary, Indonesia, Ireland, Malaysia, Mexico, Netherlands, Paraguay, Peru, Philippines, Poland, Russia, Sweden, Switzerland, Taiwan, Thailand, Turkey); Plendil Depottab (Norway); Plendil ER (Philippines); Plendil Retard (Austria); Polo (Taiwan); Renedil (Belgium, Canada); Selepine (Korea); Splendil (Japan); Splendil ER (Korea); Versant XR (Philippines)

Drug Class Antihypertensives; Calcium channel blockers
Indications Treatment of chronic hypertension
Mechanism Dihydropyridine calcium channel blocker
Dosage With Qualifiers Chronic hypertension—5 mg PO qd, max 20 mg/d

  • Contraindications —hypersensitivity

  • Caution —hepatic dysfunction, CHF

Maternal Considerations There are no adequate reports or well-controlled studies of felodipine in pregnant women. The published experience is limited to case reports where felodipine was used successfully for the treatment of severe hypertension during pregnancy without adverse effect. Calcium channel blockers are among the most effective tocolytic agents. Felodipine decreases placental blood flow and prolongs parturition in rabbits.
Side effects include edema, headache, flushing, dizziness, nausea, abdominal pain, diarrhea, rhinorrhea, chest pain, palpitations, muscle cramps, and weakness.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether felodipine crosses the human placenta. Animal studies reveal that felodipine crosses the placenta where it is associated with an increased prevalence of digital anomalies in rodents possibly secondary to the observed decrease in placental blood flow. Prolonged parturition is associated with an increased perinatal mortality.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether felodipine enters human breast milk. It is excreted into rodent milk.
Drug Interactions Felodipine is metabolized by CYP3A4. Its use with CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, erythromycin, grapefruit juice, cimetidine ) may lead to a several-fold increase in plasma felodipine levels, enhancing its effects (lower BP and increased HR).
Maximum plasma concentrations of felodipine are considerably lower in epileptic patients on long-term anticonvulsant therapy (e.g., phenytoin, carbamazepine, phenobarbital ) compared with healthy volunteers. Because a clinically significant interaction may be anticipated, alternative antihypertensive therapy should be considered for these women.
Ethanol increases felodipine absorption and may enhance hemodynamic effects.
References Casele HL, Windley KC, Prieto JA, et al. J Reprod Med 1997; 42:378-81.
Danielson MK, Danielsson BR. Arzneimittelforschung 1993; 43:106-9.
Danielsson BR, Reiland S, Rundqvist E, Danielson M. Teratology 1989; 40:351-8.
Lundgren Y, Thalen P, Nordlander M. Pharmacol Toxicol 1992; 71:361-4.
Summary Pregnancy Category: C
Lactation Category: U

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

  • There are other agents with a superior safety profile for which there is more experience during pregnancy and lactation.

Fenofibrate — (Tricor)

International Brand Names

Apo-Feno-Micro (Hong Kong, Malaysia); Aterolis (Uruguay); Bisterol SR (Korea); Climage (Greece); Controlip (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama); Durafenat (Germany); Durafenat Micro (Germany); Evothyl (Indonesia); Fegenor (France); Felosma (Indonesia); Fenobrate (Argentina); Fenofanton (Germany); Fenogal Lidose (Singapore); Fenox (Thailand); Fibrafen (Philippines); Hyperchol (Indonesia); Lexemin (Hong Kong, Singapore, Thailand); Lipanthyl (Belgium, Bulgaria, China, Cyprus, Czech Republic, France, Germany, Greece, Hong Kong, Hungary, Indonesia, Italy, Kuwait, Malaysia, Philippines, Poland, Russia, Switzerland, Taiwan, Thailand); Lipantil (England, Portugal); Liparison (Spain); Lipidax (Italy); Lipidil (Brazil, Chile, Ecuador, Germany); Lipidil Supra (Korea); Lipilo (China); Lipofen (Portugal); Lipolin (Taiwan); Lipovas (Spain); Lipsin (Austria, South Africa); Livesan Ge (France); Nopid 200 (Korea); Normalip (Germany); Normolip (Colombia); Nubrex (Philippines); Qualipantyl (Hong Kong); Rapidil (Korea); Redose 200 (Korea); Rorit (Korea); Secalip (France); Trichol (Indonesia); Trolip (Hong Kong, Indonesia, Philippines); Zerlubron (Greece); Zumafib (Indonesia)

Drug Class Antihyperlipidemics
Indications Hyperlipidemia
Mechanism Unclear; interferes with triglyceride synthesis
Dosage With Qualifiers Hypertriglyceridemia—begin 40 mg PO qd with meals, adjusting q4–8 w; max 160 mg qd
Hypercholesterolemia—begin 120 mg PO qd with meals, adjusting q4–8 w; max 160 mg qd
Mixed dyslipidemia—begin 120 mg PO qd with meals, adjusting q4–8 w; max 160 mg qd
NOTE: 54-mg tablet = 67-mg capsule.

  • Contraindications —hypersensitivity, hepatic or renal dysfunction, gallbladder disease

  • Caution —oral anticoagulants

Maternal Considerations There are no adequate reports or well-controlled studies of fenofibrate in pregnant women. The published literature is limited to a few case reports where it was used without evidence of teratogenicity. One rodent study concludes that pregnant and nonpregnant rats respond differently to fenofibrate and that high maternal doses were associated with delayed delivery. Because hyperlipidemia is not acutely life threatening, cessation of medication during pregnancy is suggested.
Side effects include hepatitis, pancreatitis, cholelithiasis, myositis, myopathy, elevated LFTs, abdominal pain, headache, constipation, rhinitis, and nausea.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether fenofibrate crosses the human placenta. Fenofibrate causes IUGR in rodents when given at doses equivalent to the MRHD and is embryotoxic and teratogenic (predominantly bone abnormalities) at doses 7–10 × the MRHD.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether fenofibrate enters human breast milk. Drugs that decrease maternal cholesterol are generally considered possibly unsafe during breastfeeding, as the newborn requires high levels of milk cholesterol for neurodevelopment.
Drug Interactions May increase the anticoagulant affect of warfarin -type drugs.
Use with HMG-CoA reductase inhibitors should be avoided unless the benefit of further alterations in lipid levels is likely to outweigh the increased risk of the combination.
Because bile acid sequestrants can bind drugs given concurrently, women should take fenofibrate at least 1 h before or 4–6 h after a bile acid–binding resin to avoid impeding its absorption.
Because cyclosporine can produce nephrotoxicity with decreases in CrCl and increases in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibrate, there is a risk that an interaction will lead to deterioration in renal function.
References Goldberg AS, Hegele RA. J Clin Endocrinol Metab 2012; 97:2589-96.
Soria A, Bocos C, Herrera E. J Lipid Res 2002; 43:74-81.
Sunman H, Canpolat U, Sahiner L, et al. Ann Pharmacother 2012; 46:e5.
Whitten AE, Lorenz RP, Smith JM. Obstet Gynecol 2011; 117:517-9.
Summary Pregnancy Category: C
Lactation Category: U

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

  • Hyperlipidemia is not acutely life threatening; cessation of medication during pregnancy is suggested.

  • There are alternative agents for which there is more experience during pregnancy and lactation.

Fenoldopam — (Corlopam)

International Brand Names

None identified.

Drug Class Adrenergic agonists; α 2 -Agonist; Antihypertensives; D 1 Agonists; Dopamine agonists
Indications Acute severe hypertension
Mechanism Dopamine D 1 -like and α 2 -adrenergic receptor agonist
Dosage With Qualifiers Severe hypertension—0.025–0.3 mcg/kg/min IV; increase q15min 0.0–0.1 mcg/kg/min until reaching max dose of 1.6 mcg/kg/min for 48 h

  • Contraindications —hypersensitivity

  • Caution —glaucoma, acute CVD, hypokalemia, sulfite allergy, asthma, hepatic dysfunction

Maternal Considerations Fenoldopam is an alternative for the treatment of a hypertensive crisis if unresponsive to sodium nitroprusside. There are no adequate reports or well-controlled studies of fenoldopam in pregnant women. In isolated systems, it causes relaxation of the rodent myometrium.
Side effects include reflex tachycardia, MI, CHF, arrhythmias, leukocytosis, hypokalemia, headache, flushing, N/V, sweating, back pain, abdominal pain, palpitations, constipation, and nasal congestion.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether fenoldopam crosses the human placenta. It relaxes thromboxane-constricted human umbilical arteries. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Fenoldopam induces diuresis in fetal sheep.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether fenoldopam enters human breast milk. It is excreted into rodent milk. Considering its poor oral bioavailability and short half-life, fenoldopam is unlikely to reach clinically relevant levels.
Drug Interactions Use with β-blockers should be avoided, as unexpected hypotension could result from β blockade of the sympathetic reflex response to fenoldopam.
Acetaminophen use increases fenoldopam levels.
References Estan L, Berenguer A, Martinez-Mir I, et al. Gen Pharmacol 1993; 24:397-401.
Sato N, Tanaka KA, Szlam F, et al. Anesth Analg 2003; 96:539-44.
Segar JL, Smith FG, Guillery EN, et al. Am J Physiol 1992; 263:R868-73.
Summary Pregnancy Category: B
Lactation Category: S (probably)

  • Fenoldopam is an alternative to sodium nitroprusside in women with hypertensive crisis unresponsive to other antihypertensive agents.

Fenoprofen — (Nalfon)

International Brand Names

Fenoprex (Argentina); Fenopron (England, Hong Kong, Ireland, Japan, Korea, South Africa, Venezuela); Fepron (Ireland, Italy, Netherlands); Nalfon (Austria, Canada, Denmark, Mexico, Russia, Spain); Nalgesic (France); Progesic (England); Trandor (Brazil)

Drug Class Analgesics, non-narcotic; NSAIDs
Indications Arthritis, mild to moderate pain
Mechanism Inhibits both cyclooxygenase and lipoxygenase; reduces prostaglandin synthesis
Dosage With Qualifiers Osteoarthritis or rheumatoid arthritis—300–600 mg PO tid or qid; max 3200 mg/d
Pain relief—200 mg PO q4–6 h prn
NOTE: Take with meals.

  • Contraindications —hypersensitivity to drug or class, NSAID asthma

  • Caution —GI bleeding, hypertension, CHF, nasal polyps

Maternal Considerations Fenoprofen is a nonsteroidal, antiinflammatory, antipyretic agent. There are no adequate reports or well-controlled studies of fenoprofen in pregnant women. Similar to other NSAIDs, it is effective for the relief of episiotomy pain. In rodents, fenoprofen prolongs parturition, and it reduces contractions of isolated myometrium from monkeys and humans.
Side effects include anaphylaxis, GI bleeding, renal failure, bronchospasm, thrombocytopenia, agranulocytosis, hepatic toxicity, dyspepsia, nausea, headache, constipation, abdominal pain, dizziness, rash, fluid retention, and tinnitus.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether fenoprofen crosses the human placenta. Fenoprofen prolongs gestation in rodents, as do other NSAIDs. It is otherwise poorly studied during pregnancy.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether fenoprofen enters human breast milk.
Drug Interactions NSAIDs can diminish the antihypertensive effect of ACEIs.
Aspirin decreases the biologic t/2 of fenoprofen.
Clinical studies and postmarketing observations show that fenoprofen may reduce the natriuretic effect of furosemide and thiazides. Observe closely for signs of renal failure when diuretics are used with NSAIDs.
NSAIDs increase plasma lithium and reduce renal lithium clearance. Patients should be observed carefully for signs of lithium toxicity.
NSAIDs competitively inhibit methotrexate accumulation in rabbit kidney slices. Caution should be used when NSAIDs are administered concomitantly with methotrexate.
The effects of warfarin and NSAIDs on GI bleeding are synergistic.
Chronic administration of phenobarbital may decrease the plasma t/2 of fenoprofen. A dosage adjustment of fenoprofen may be required if phenobarbital is added or withdrawn.
False elevation in free and total serum T 3 as measured by Amerlex-M kit.
In vitro studies reveal that fenoprofen may displace other drugs that are albumin bound from their binding sites. Patients receiving hydantoins, sulfonamides, or sulfonylureas should be observed for increased activity and, therefore, signs of toxicity from these drugs.
References Gruber CM, Bauer RO, Bettigole JB, et al. J Med 1979; 10:65-8.
Johnson WL, Harbert GM, Martin CB. Am J Obstet Gynecol 1975; 123:364-75.
Summary Pregnancy Category: C ( D in third trimester)
Lactation Category: U

  • Fenoprofen offers no clear advantage over other NSAIDs for which there is more experience during pregnancy and lactation.

Fentanyl — (Fentanyl Oralet; Oralet; Sublimaze)

International Brand Names

Beatryl (Israel); Fenodid (Mexico); Fentabbott (Brazil); Fentanest (Italy, Mexico, Spain); Leptanal (Norway, Sweden); Sublimaze (Argentina, England, Ireland, Philippines, South Africa); Trofentyl (India)

Drug Class Analgesics, narcotic; Anesthetics, general
Indications Anesthesia, preoperative analgesia, regional anesthesia, postoperative pain relief
Mechanism Binds to various opiate receptors
Dosage With Qualifiers Anesthesia, adjunct—2–50 mcg/kg IV depending on needs
Preoperative analgesia—50–100 mcg IV 30–60 min prior to surgery
Labor epidural anesthesia—approximately 25 mcg intrathecal; 40–50 mcg epidural: usually followed by a dose of 20–30 mcg/h mixed in solution of dilute local anesthetics (consult a specialty text)
Labor analgesia (IV)—begin 50 mcg IV, thereafter 25 mcg q20–30 min prn
Postoperative pain relief—50–100 mcg IV q1–2h prn
NOTE: Also available in oral and transdermal forms.

  • Contraindications —hypersensitivity to drug or class

  • Caution —hepatic, renal, or pulmonary dysfunction; bowel obstruction; CNS depressant use; hypotension; biliary disease; seizure disorder; inflammatory bowel disease

Maternal Considerations Fentanyl is a short-acting opiate with considerable risk of abuse. It is often combined during labor with local anesthetics to minimize motor blockade for epidural anesthesia. Fentanyl may be used safely in women with severe preeclampsia. It is a useful adjunct to a paracervical block for suction curettage. Its addition to 2.2 mL of 0.5% hyperbaric bupivacaine with 0.2 mL of morphine 0.2 mg intrathecally reduces the incidence and severity of intraoperative and postoperative shivering after spinal anesthesia for cesarean delivery without increasing other side effects.
Side effects include respiratory depression or arrest, dependency, laryngospasm, bronchospasm, arrhythmias, ileus, cardiac arrest, N/V, weakness, dry mouth, confusion, sweating, euphoria, itching, hypotension, and bradycardia.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Fentanyl rapidly crosses the human placenta, achieving an F:M ratio approximating unity. It crosses the fetal blood-brain barrier and has been used for fetal analgesia where a reduction in endorphin levels can be demonstrated. Rodent studies are generally reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. It is embryotoxic in rodents.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. Fentanyl enters human breast milk with a relative infant dose between 3% and 5%. Fentanyl may cause sedation and respiratory depression in a child breastfed by a sedated woman. The manufacturer recommends not breastfeeding for at least 48 h after last dose of fentanyl lozenge, or IV or IM administration. Breastfeeding is not recommended for at least 72 h after the last dose with a transdermal patch. Considering its short plasma half-life and poor oral bioavailability, fentanyl is not likely to pose a risk to the neonate of an alert, breastfeeding woman.
Drug Interactions Metabolized by the CYP3A4 isoform in the liver and intestinal mucosa to norfentanyl. Drugs that inhibit CYP3A4 activity may increase the bioavailability of oral fentanyl and decrease the systemic clearance. The expected clinical results would be increased or prolonged opioid effects. Patients who begin or end therapy with potent inhibitors of CYP3A4 such as macrolide antibiotics (e.g., erythromycin, clarithromycin ), azole antifungal agents (e.g., ketoconazole, itraconazole ), protease inhibitors (e.g., ritonavir, nelfinavir ), diltiazem, and nefazodone while receiving fentanyl should be monitored for a change in opioid effects. In contrast, agents that induce CYP3A4 activity (e.g., rifampin, carbamazepine, phenytoin, St. John’s wort ) may increase clearance of fentanyl and reduce its efficacy.
The concomitant use of fentanyl with other CNS depressants, including but not limited to other opioids, sedatives, hypnotics, tranquilizers (e.g., benzodiazepines), general anesthetics, phenothiazines, skeletal muscle relaxants, and alcohol, may cause respiratory depression, hypotension, and profound sedation, or potentially result in coma or death. The dose of one or both agents should be significantly reduced if such combined therapy is planned.
Not recommended for use in patients who have received MAOIs within 14 d, because severe and unpredictable potentiation by MAOIs has been reported with opioid analgesics.
References Birnbach DJ, Matut J, Stein DJ, et al. Anesth Analg 2001; 93:410-3.
Cheng CJ, Sia AT, Lim EH, et al. Can J Anaesth 2001; 48:570-4.
Cooper J, Jauniaux E, Gulbis B, et al. Br J Anaesth 1999; 82:929-31.
Fisk NM, Gitau R, Teixeira JM, et al. Anesthesiology 2001; 95:828-35.
Head BB, Owen J, Vincent RD Jr, et al. Obstet Gynecol 2002; 99:452-7.
Leuschen MP, Wolf LJ, Rayburn WF. Clin Pharm 1990; 9:336-7.
Techanivate A, Rodanant O, Tachawattanawisal W, Somsiri T. J Med Assoc Thai 2005; 88:1214-21.
Wong CY, Ng EH, Ngai SW, Ho PC. Hum Reprod 2002; 17:1222-5.
Summary Pregnancy Category: C
Lactation Category: S (probably)

  • Fentanyl is a short-acting opiate widely used during pregnancy for analgesia of multiple types.

  • Mothers should be informed of the risk of neonatal abstinence syndrome.

Ferrous gluconate — (Fergon)

International Brand Names

None identified.

Drug Class Hematinics; Vitamins/minerals
Indications Iron deficiency and supplementation
Mechanism Essential component in many proteins, including hemoglobin
Dosage With Qualifiers Iron deficiency—2–3 mg/kg elemental Fe PO qd in divided doses
Iron supplementation—15–30 mg elemental Fe qd
NOTE: 300 mg = 35 mg elemental Fe; do not take within 2 h of tetracyclines or antacids, which may bind the Fe. Also available in parenteral form.
NOTE: Available as ferrous fumarate and ferrous sulfate.

  • Contraindications —hypersensitivity to drug or class, hemochromatosis, hemolytic anemia, thalassemia, hemosiderosis, peptic ulcer disease, ulcerative colitis

  • Caution —chronic therapy

Maternal Considerations Iron is absorbed in the duodenum and upper jejunum. About 10% of the delivered dose is absorbed by replete women and 20%–30% in deficient women. Though iron supplementation is widely practiced during pregnancy in the industrialized world, there is little evidence it changes either long- or short-term outcomes. Severe anemia may be an important cause of maternal death, but there is a lack of convincing evidence regarding the risks of mild to moderate maternal anemia. One RCT performed in the United States on low-income women with adequate iron stores concluded that the mean birth weight was higher by 108 g ( P = 0.03 ) and the incidence of preterm delivery lower (8% vs. 14%; P = 0.05 ) with supplementation compared with the control group. In this trial, iron supplementation did not alter the prevalence of SGA infants or third-trimester iron status. Women who are anemic due to iron deficiency should first receive a reticulocytic dose followed by supplementation for the duration of pregnancy. Women with disorders of iron utilization (e.g., thalassemia) should not be routinely supplemented.
Side effects include dyspepsia, N/V, diarrhea, constipation, and dark stools.
Fetal Considerations There is no evidence that maternal iron supplementation influences the fetal iron status.
Breastfeeding Safety Maternal iron supplementation does not alter the iron concentration in breast milk.
Drug Interactions Drugs that alter gastric pH, such as antacids, H 2 -blockers, proton pump inhibitors, and some NSAIDs, may decrease absorption.
Iron may decrease the absorption of numerous compounds, including cefdinir, didanosine, levodopa, mycophenolate, penicillamine, quinolones, tetracycline, and thyroid hormones.
Cereals, dietary fiber, tea, coffee, eggs, and milk may decrease absorption.
Iron supplementation may reduce the dietary absorption of zinc
References Graves BW, Barger MK. J Midwifery Womens Health 2001; 46:159-66.
Harvey LJ, Dainty JR, Hollands WJ, et al. Am J Clin Nutr 2007;85:131-6.
Pena-Rosas JP, Viteri FE. Cochrane Database Syst Rev 2006; (3):CD004736.
Rasmussen K. J Nutr 2001; 131:590S-601S.
Siega-Riz AM, Hartzema AG, Turnbull C, et al. Am J Obstet Gynecol 2006; 194:512-9.
Summary Pregnancy Category: A
Lactation Category: S

  • Though the risk of routine iron supplementation during pregnancy and lactation is probably minimal, there is no clear improvement in perinatal outcome or reduction in maternal morbidity in the industrialized world.

Fexofenadine — (Allegra)

International Brand Names

Telfast (France, Germany, Hong Kong, Israel, South Africa, Thailand); Telfast BD (Indonesia)

Drug Class Antihistamines, H 1
Indications Allergic rhinitis, chronic urticaria
Mechanism Selective H 1 antagonist
Dosage With Qualifiers Allergic rhinitis—180 mg PO qd
Chronic urticaria—60 mg PO bid
NOTE: May be combined with pseudoephedrine.

  • Contraindications —hypersensitivity to drug or class

  • Caution —renal dysfunction

Maternal Considerations Fexofenadine is a second-generation antihistamine effective for the symptomatic relief of allergic rhinitis. Although increasingly preferred for its nonsedating properties, there are no published controlled trials or population studies of fexofenadine during pregnancy. The published clinical literature consists of a single case report where it was used to treat PUPPP.
Side effects include dysmenorrhea, drowsiness, nausea, flu-like symptoms, dyspepsia, and fatigue.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether fexofenadine crosses the human placenta. Although there is no evidence of teratogenicity in rodents, there is a dose-dependent increase in IUGR and a decrease in the survival of pups.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether fexofenadine enters human breast milk. However, there is one study of terfenadine, of which fexofenadine is the active metabolite. The average M:P ratio was 0.2. The authors estimated the relative infant dose would be < 1%.
Drug Interactions Use with ketoconazole or erythromycin increases the plasma fexofenadine level. Fexofenadine has no effect on the pharmacokinetics of erythromycin and ketoconazole. The changes in plasma levels are within the range of plasma levels achieved in adequate and well-controlled clinical trials and may be due to transport-related effects, such as P-glycoprotein.
Administration within 15 min of an aluminum- and magnesium-containing antacid (Maalox) decreased fexofenadine AUC by 41% and C max by 43%. Fexofenadine should not be taken closely in time with aluminum- and magnesium-containing antacids.
Fruit juices such as grapefruit, orange, and apple may reduce the bioavailability of fexofenadine by more than one-third.
High-fat meals may decrease the bioavailability of fexofenadine by half.
References Buccolo LS, Viera AJ. J Reprod Med 2005; 50:61-3.
Lucas BD Jr, Purdy CY, Scarim SK, et al. Clin Pharmacol Ther 1995; 57:398-402.
Mazzotta P, Loebstein R, Koren G. Drug Saf 1999; 20:361-75.
Summary Pregnancy Category: C
Lactation Category: S (probably)

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

  • There are alternative agents, including inhaled steroids and first-generation antihistamines such as chlorpheniramine, for which there is wide experience during pregnancy and lactation.

Filgrastim — (Neupogen)

International Brand Names

Biofigran (Colombia); Gran (Japan); Granulokine (Philippines); Grasin (Korea); Grimatin (Japan); Neotromax (Peru); Neutromax (Peru)

Drug Class Biologic response modifiers; Hematopoietic agents
Indications Severe chronic neutropenia, AIDS neutropenia, neutropenia post–bone marrow transplantation, chemotherapy-induced neutropenia, progenitor cell donors
Mechanism Human granulocyte colony-stimulating factor
Dosage With Qualifiers Severe chronic neutropenia—10 mcg/kg SC qd
AIDS neutropenia—1–10 mcg/kg SC qd
Neutropenia post–bone marrow transplantation—10 mcg/kg IV qd > 24 h after either chemotherapy or transplantation
Chemotherapy-induced neutropenia—5 mcg/kg SC/IV qd × 2 w; may increase by 5 mcg/kg per chemo cycle
Progenitor cell donors—10 mcg/kg SC qd

  • Contraindications —hypersensitivity to drug or class, hypersensitivity to E. coli proteins

  • Caution —hepatic or renal dysfunction

Maternal Considerations There are no adequate reports or well-controlled studies of filgrastim in pregnant women. It has been used to treat severe chronic neutropenia and chemotherapy-induced neutropenia during pregnancy without obvious adverse effect. The published literature is confined to case reports and usually complicated by polypharmacy.
Side effects include anaphylaxis; thrombocytopenia; N/V; musculoskeletal, abdominal, and bone pain; rash; splenomegaly; hypotension; local swelling; and erythema.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Literature reports have described transplacental passage of filgrastim in pregnant women when administered ≤30 h prior to preterm delivery (≤30 w gestation). There is no evidence to suggest it is a human teratogen. However, rodent studies using high doses reveal evidence of embryotoxicity, IUGR, and delayed external differentiation.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether filgrastim enters human breast milk. However, its high molecular weight and low oral bioavailability suggests safety.
Drug Interactions Drug interactions have not been fully evaluated. Drugs that may potentiate the release of neutrophils, such as lithium, should be used with caution.
Filgrastim may enhance the toxic effect of bleomycin , cyclophosphamide , and topotecan .
References Calhoun DA, Rosa C, Christensen RD. Am J Obstet Gynecol 1996; 174:1306-11.
Cottle TE, Fier CJ, Donadieu J, Kinsey SE. Semin Hematol 2002; 39:134-40.
Dale DC, Cottle TE, Fier CJ, et al. Am J Hematol 2003; 72:82-93.
Summary Pregnancy Category: C
Lactation Category: S (probably)

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

  • We suggest the lowest effective dose to maintain the absolute neutrophil count.

Flavoxate — (Urispas)

International Brand Names

Baduson (Taiwan); Bladderon (Japan); Bladuril (Colombia, Mexico, Peru); Cleanxate (Singapore); Flavate (India); Flavorin (Thailand); Flavo-Spa (Thailand); Fucotin (Taiwan); Genurin (China, Italy, Singapore, Taiwan); Harnin (Japan); Patricin (Japan); Spagerin (Korea); Spasdic (Thailand); Spasuret (Germany); Spasuri (Thailand); Tonlin (Taiwan); Urispadol (Denmark); Urispas (Austria, Belgium, Bulgaria, England, France, Hong Kong, India, Ireland, Malaysia, Portugal, Russia, Switzerland, Turkey); Urispas (200 mg) (Canada, Netherlands); Uronid (Spain); Uropeace (Korea); Uroxate (Taiwan, Thailand); Voxate (Thailand); Yungken (Taiwan)

Drug Class Anticholinergics; Antispasmodics
Indications Bladder spasm
Mechanism Antagonizes muscarinic receptors
Dosage With Qualifiers Bladder spasm—100–200 mg PO tid or qid

  • Contraindications —hypersensitivity to drug or class, intestinal obstruction, GI bleeding, achalasia

  • Caution —unknown

Maternal Considerations There is no published experience with flavoxate during pregnancy. In nonpregnant women, flavoxate first increases, then decreases, uterine contractions.
Side effects include leukopenia, N/V, dry mouth, dizziness, blurred vision, tachycardia, palpitations, headache, drowsiness, dysuria, urticaria, and fever.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether flavoxate crosses the placenta. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether flavoxate enters human breast milk.
Drug Interactions Flavoxate may alter the absorption of numerous drugs by slowing GI motility.
References Coutinho EM, Darze E, Gesteira SK. Int J Gynaecol Obstet 1980; 17:581-4.
Summary Pregnancy Category: B
Lactation Category: U

  • Flavoxate should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk. There are few if any indications.

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