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Tacrine — (Cognex; THA)

International Brand Names

Cognex (Austria, Belgium, Chile, China, France, Germany, Peru); Cognitiv (Argentina); Tacrinal (Brazil); Talem (Argentina)

Drug Class Alzheimer’s disease agents; Cholinesterase inhibitors
Indications Alzheimer’s dementia
Mechanism Reversible cholinesterase inhibitor
Dosage With Qualifiers Alzheimer’s dementia—begin 10 mg PO qid × 4 w; increase by 10 mg qid q4w based on response

  • Contraindications —hypersensitivity to drug or class, tacrine hepatotoxicity, hepatic dysfunction, cardiac conduction defects

  • Caution —unknown

Maternal Considerations Tacrine elevates ACh in the cerebral cortex by slowing the degradation of ACh released by still-intact cholinergic neurons. It also may reduce excitatory amino acid toxicity. There is no evidence it alters the underlying dementia process. Plasma concentrations are 50% higher in women than men. There are no adequate reports or well-controlled studies of tacrine in pregnant women. The published literature is limited to case reports 3 decades ago when it was used as a general anesthetic adjunct during cesarean delivery.
Side effects include hepatotoxicity, bradycardia, seizures, N/V, diarrhea, constipation, flatulence, abdominal pain, dyspnea, anorexia, weight loss, rash, agitation, insomnia, ataxia, and confusion.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether tacrine crosses the human placenta. Rodent teratogenicity studies have not been conducted.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether tacrine enters human breast milk.
Drug Interactions Increases the theophylline t/2 and plasma level by about twofold. Monitoring of the plasma concentrations and appropriate dose reduction of theophylline are recommended.
Cimetidine increases the C max and AUC by approximately 54% and 64%, respectively.
May interfere with the activity of anticholinergic medications.
A synergistic effect is to be expected if used with succinylcholine, cholinesterase inhibitors, or cholinergic agonists such as bethanechol.
Fluvoxamine increased the tacrine C max and AUC five- and eightfold, respectively, increasing the likelihood of N/V, sweating, and diarrhea.
References Takada-Takatori Y, Kume T, Sugimoto M, et al. Eur J Pharmacol 2006; 549:19-26.
Summary Pregnancy Category: C
Lactation Category: U

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

Tacrolimus — (FK 506; Prograf, Protopic)

International Brand Names

Mustopic Oint (India); Prograf (Argentina, Brazil, Canada, Chile, Colombia, Denmark, England, France, Germany, Hong Kong, Ireland, Japan, Korea, Malaysia, Mexico, Paraguay, Philippines, Singapore, South Africa, Taiwan, Thailand, Uruguay); Protopic (England, France, Hong Kong, Ireland)

Drug Class Immunosuppressants; Transplantation agents; Eczema agents
Indications Prophylaxis against liver or kidney transplant rejection
Mechanism Inhibits T-cell activation
Dosage With Qualifiers Transplant rejection prophylaxis—0.1–0.2 mg/kg/d PO in 2 divided doses; alternatively, 0.03–0.05 mg/kg/d as continuous IV infusion

  • Contraindications —hypersensitivity to drug or class

  • Caution —hepatic or renal dysfunction

Maternal Considerations A growing number of obstetric patients have benefited from organ transplantation. Pregnancy is considered reasonable following kidney transplant if the patient is 2 y posttransplantation, has good renal function without proteinuria, no uncontrolled arterial hypertension, and no evidence of ongoing rejection. However, these women, and women with other organ transplants, are at very high risk for an adverse outcome and should be followed at a tertiary care hospital by a multidisciplinary team. There are no adequate reports or well-controlled studies of tacrolimus in pregnant women. Though it has been used widely during pregnancy without obvious adverse effect, the published experience is limited to case series. There are a few reports of tacrolimus use for treating lupus nephritis flare or maintaining stable disease during pregnancy. Whole blood total concentrations decrease as pregnancy advances; however, unbound drug concentrations increase. Research suggests a potential role for tacrolimus in the treatment of recurrent implantation failure in women with abnormal peripheral T-1 helper cell levels.
Side effects include thrombocytopenia, nephrotoxicity, hypertension, hyperkalemia, seizures, diabetes mellitus, immunosuppression, malignancy, nausea, diarrhea, headache, insomnia, abdominal pain, tremor, weakness, fever, hyperglycemia, anemia, itching, elevated LFTs, anorexia, and renal dysfunction.
Fetal Considerations There are no well-controlled studies in human fetuses. Tacrolimus crosses the human placenta and is measurable in cord blood, amniotic fluid, and newborn serum. Human studies reveal no obvious evidence of teratogenicity, although neonatal hyperkalemia and renal dysfunction are associated with tacrolimus exposure. One study noted that infants with lower birth weights had higher tacrolimus concentrations. Immunosuppression is a theoretic concern. Tacrolimus given orally to pregnant rabbits and rats at 0.5 to 6 × the clinical dose was associated with increased maternal toxicity, fetal loss, and malformation including cardiovascular, skeletal, omphalocele, and gallbladder agenesis.
Breastfeeding Safety Tacrolimus enters human breast milk at a very low concentration (< 2 ng/mL); the relative infant dose is reportedly less than 0.6%. Considering the low bioavailability of tacrolimus (< 32%), the amount absorbed by the infant would be even lower (0.02%–0.5% of the mother’s weight-adjusted dose).
Drug Interactions Care should be taken when given with drugs associated with renal dysfunction due to the potential for additive or synergistic impairment. These drugs include, but are not limited to, aminoglycosides, amphotericin B, cisplatin, and possibly cyclosporine. Patients switched from cyclosporine to tacrolimus should receive the first tacrolimus dose no sooner than 24 h after the last cyclosporine dose.
Metabolized mainly by CYP3A, and substances that inhibit these isozymes may decrease the metabolism or increase the bioavailability of tacrolimus. In contrast, drugs known to induce CYP3A may increase the metabolism of tacrolimus or decrease bioavailability, thereby decreasing plasma levels. Monitoring with appropriate dose adjustments is essential. Drugs that may increase tacrolimus blood levels include calcium channel blockers (e.g., diltiazem, nicardipine, nifedipine, verapamil ), antifungal agents (e.g., clotrimazole, fluconazole, itraconazole, ketoconazole, voriconazole ), macrolide antibiotics (e.g., clarithromycin, erythromycin, troleandomycin ), gastrointestinal prokinetic drugs (e.g., cisapride, metoclopramide ), and other drugs (e.g., bromocriptine, chloramphenicol, cimetidine, danazol, ethinyl estradiol, lansoprazole, magnesium-aluminum hydroxide, methylprednisolone, nefazodone, omeprazole, and protease inhibitors).
Drugs that may decrease tacrolimus blood levels include anticonvulsants (e.g., carbamazepine, phenobarbital, phenytoin ), antimicrobials (e.g., caspofungin, rifabutin, rifampin ), St. John’s wort, and sirolimus . Frequent monitoring of tacrolimus blood levels and appropriate dose adjustments are essential.
May affect the pharmacokinetics of other drugs (e.g., phenytoin ) and increase their concentration.
Grapefruit juice affects CYP3A-mediated metabolism and should be avoided.
The use of live vaccines should be avoided; live vaccines include, but are not limited to, measles, mumps, rubella, oral polio, BCG, yellow fever, and TY 21a typhoid.
Interaction studies with tacrolimus ointment have not been conducted. Based on its minimal absorption, interactions of tacrolimus ointment with systemically administered drugs are unlikely. Use of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be undertaken with caution. Examples of such drugs are calcium channel blockers, cimetidine, erythromycin, fluconazole, itraconazole, and ketoconazole.
References Armenti VT, Moritz MJ, Davison JM. Drug Saf 1998; 19:219-32.
Bramham K, Chusney G, Lee J, et al. Clin J Am Soc Nephrol 2013; 8:563-7.
Farley DE, Shelby J, Alexander D, Scott JR. Transplantation 1991; 52:106-10.
French AE, Soldin SJ, Soldin OP, Koren G. Ann Pharmacother 2003; 37:815-8.
Garcia-Donaire JA, Acevedo M, Gutiérrez MJ, et al. Transplant Proc 2005; 37:3754-5.
Gardiner SJ, Begg EJ. Obstet Gynecol 2006; 107:453-5.
Gouraud A, Bernard N, Millaret M, et al. Transplantation 2012; 94:e38-40.
Jain A, Venkataramanan R, Fung JJ, et al. Transplantation 1997; 64:559-65.
Kainz A, Harabacz I, Cowlrick IS, et al. Transplantation 2000; 70:1718-21.
Nakagawa K, Kwak-Kim J, Kuroda K, et al. Am J Reprod Immunol 2017 Sep; 78(3).
Webster P, Wardle A, Bramham K, et al. Lupus 2014; 23:1192-6.
Zheng A, Easterline TR, Hays K, et al. Br J Clini Pharmacol 2013; 76:988-96.
Summary Pregnancy Category: C
Lactation Category: S (probably)

  • Although tacrolimus is widely used in transplantation patients, there is limited information on its reproductive effects.

  • Current experience suggests the benefits of tacrolimus far exceed its theoretic risks to the pregnancy and newborn.

Tadalafil — (Adcirca; Cialis)

International Brand Names

Drug Class Unknown
Indications Erectile dysfunction, benign prostatic hyperplasia, pulmonary hypertension.
Mechanism Phosphodiesterase 5 inhibitor
Dosage With Qualifiers Erectile dysfunction—10 mg (adjusted to 5–20 mg based on tolerability) PO qd
Benign prostatic hyperplasia—5 mg PO qd
Pulmonary hypertension—40 mg PO qd
Note: Adjust dose to 2.5 mg PO qd when administered with CYP3A4 inhibitors. When used with finasteride to initiate BPH therapy, the recommended duration of therapy is ≤ 26 weeks. Renal dosing. May be used off-label for Raynaud phenomenon.

  • Contraindications —hypersensitivity to drug or class, nitrates

  • Caution — hepatic or renal dysfunction

Maternal Considerations Tadalafil is generally not indicated for use in women. There are no adequate reports or well-controlled studies in pregnant women. The impact of pregnancy on tadalafil pharmacokinetics is unknown. However, phosphodiesterase 5 inhibitors have been used increasingly for the treatment of early onset preeclampsia associated with early onset IUGR; this includes tadalafil . The use of tadalafil in women with PE or FGR is limited to few case reports. One case study reported improvement and prolonged pregnancy (14 d) with tadalafil in a 35-y-old primigravid woman who presented at around 27 w with severe PE and FGR. Its benefits appear limited.
Side effects include headache, dyspepsia, back pain, myalgia, nasal congestion, flushing, limb pain, and prolonged erection in males.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether tadalafil crosses the human placenta. Tadalafil crosses the rodent placenta. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses greater than 10 × the MRHD. Maternal toxicity and decreased pup survival observed at doses > 10 × the MRHD in rats.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether tadalafil enters human breast milk. Tadalafil enters rodent milk.
Drug Interactions Use of CYP3A4 inhibitors (e.g., erythromycin, ketoconazole ) or inducers (e.g., rifampin, St. John’s wort ) may affect tadalafil metabolism leading to altered tadalafil exposure.
Co-administration of tadalafil with α-blockers may lead to hypotension.
Use with nitrates may also induce life-threatening hypotensive crisis.
References Sakamoto M, Osato K, Kubo M, et al. J Med Case Rep 2016; 10:317.
Tanaka H, Kubo M, Nii M, et al. J Obstet Gynaecol Res 2017; 43:1205-8.
Summary Pregnancy Category: B
Lactation Category: U

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

Tamoxifen — (Dignotamoxi; Nolvadex; Valodex)

International Brand Names

Exiphen (El Salvador, Guatemala, Honduras, Panama); Gynatam (Philippines); Istubol (Canada); Kessar (France, Germany, Greece, Italy, Philippines, South Africa, Switzerland); Mamofen (India); Moxafen (Korea); Noltam (England); Nolvadex-D (Hong Kong, Israel, Malaysia); Novofen (Taiwan, Thailand); Oncetam (France); Tadex (Finland, Taiwan); Tamaxin (Denmark, Sweden); Tamifen (Indonesia, Israel); Tamofen (China, Denmark, England, Finland, Germany, Indonesia, Israel, New Zealand, Norway, Singapore, Thailand); Tamofene (France); Tamoplex (Netherlands, Peru, Philippines, South Africa, Switzerland); Tamosin (Australia); Tamoxasta (Germany); Tamoxen (Israel); Tamoxi (Israel); Tamoxsta (Philippines); Taxus (Colombia, Peru); Tecnofen (Mexico); Zitazonium (China, Hong Kong, Hungary, Philippines, Thailand)

Drug Class Antineoplastics; Antineoplastics, antiestrogen; SERMs
Indications Breast cancer, mastalgia, ovulation induction
Mechanism Partial estrogen receptor antagonist/agonist
Dosage With Qualifiers Breast cancer, metastatic—10–20 mg PO qd or bid
Breast cancer, adjuvant—10 mg PO bid × 5 y
Breast cancer, ductal in situ —10 mg PO bid × 5 y after surgery and radiation therapy
Breast cancer, prophylaxis—10 mg PO bid × 5 y for high-risk women begun during menses after a negative hCG test
Mastalgia—10 mg PO qd × 4 mo
Ovulation induction—5–40 mg PO bid × 4 d

  • Contraindications —hypersensitivity to drug or class, undiagnosed genital bleeding, history of thromboembolism, coumarin anticoagulation

  • Caution —bone metastases, thrombocytopenia, leukopenia

Maternal Considerations Tamoxifen is a SERM. The effect of SERMs on estrogen receptors is tissue-dependent. Tamoxifen is an antagonist in the breast and in clinical trials reduces the rates of both primary and recurrent ER + invasive and noninvasive cancer. Tamoxifen does not suppress estradiol concentrations but rather may convey protection via its inhibitory action on the estrogen receptor. Tamoxifen is an agonist in the uterus, increasing the risk of endometrial cancer and sarcoma. It is associated with an increased risk of thromboembolic disease. Tamoxifen does not cause infertility. Rather, it appears equal to clomiphene for ovulation induction in anovulatory women. There are no adequate reports or well-controlled studies of tamoxifen in pregnant women. Breast cancers diagnosed during pregnancy and lactation typically are aggressive and present at an advanced stage. All women should be counseled on fertility preservation options. The timing of treatment modalities in pregnant women is complex and requires multidisciplinary input. Alternatives that are relatively safe for both
mother and fetus are available, though unforeseen risks may exist. The published literature includes numerous cases of breast cancer diagnosed during pregnancy, with surgery followed by tamoxifen therapy usually after the first trimester. There were no obvious drug-related complications. Pregnancy does not seem to influence the overall prognosis. Most adverse obstetric outcomes are related to preterm delivery, which should, whenever possible, be avoided.
The addition of tamoxifen to a regimen of misoprostol for medical abortion is unnecessary.
Side effects include thromboembolism, CVA, endometrial cancer, endometrial hyperplasia, hot flashes, vaginal discharge, irregular menses, increased bone or tumor pain, hypercalcemia, thrombocytopenia, leukopenia, pancytopenia, leiomyomas, ovarian cysts, retinopathy, cataracts, dizziness, peripheral edema, fatigue, headache, visual changes, vulvar pruritus, hair loss, anorexia, and elevated LFTs.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether tamoxifen crosses the human placenta. Tamoxifen has effects on genital tract development similar to estrogen. There are several reports suggesting an association between first-trimester exposure and craniofacial abnormalities. In the registry maintained by the manufacturer, tamoxifen was administered during 138 pregnancies. There were 16 live births with malformations and 122 live births without malformations. The registry also included 12 spontaneous abortions, 17 terminations without known fetal defects and 6 with fetal defects, 1 stillbirth without fetal defects, 2 stillbirths with fetal defects, and 57 unknown outcomes. In rodents, tamoxifen inhibits uteroplacental artery dilation, decreases placental and fetal weights, and as a consequence increases the risk of fetal death.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether tamoxifen enters human breast milk. However, several studies suggest it can inhibit lactation early postpartum. It is generally recommended women not breastfeed while taking tamoxifen.
Drug Interactions May augment the anticoagulant effects of coumarin. Careful monitoring of INR is recommended.
There is an increased risk of thromboembolic events occurring when cytotoxic agents are used in combination.
Reduces letrozole plasma levels by one-third.
Plasma levels are reduced when used with rifampin or aminoglutethimide, probably due to the induction of CYP3A4.
Tamoxifen interacts with various CYP enzymes, which may increase or decrease the metabolism of other substrate drugs.
Phenobarbital may lower the steady-state tamoxifen levels.
Use with bromocriptine increases serum tamoxifen and N -desmethyltamoxifen levels.
Grapefruit juice may decrease the metabolism of tamoxifen.
References Berger JC, Clericuzio CL. Am J Genet A 2008; 146A:2141-4.
Boostanfar R, Jain JK, Mishell DR Jr, Paulson RJ. Fertil Steril 2001; 75:1024-6.
Boostanfar R, Jain JK, Park M, Mishell DR Jr. Contraception 1999; 60:353-6.
Braems G, Denys H, De Wever O, et al. Oncologist 2011; 16:1547-51.
Helewa M, Levesque P, Provencher D, et al. J Obstet Gynaecol Can 2002; 24:164-80.
Issacs RJ, Hunter W, Clark K. Gynecol Oncol 2001; 80:405-8.
Kelly HL, Collichio FA, Dees EC. Breast Dis 2005-2006; 23:95-101.
Mocellin S, Pilati P, Briarava M, Nitti D. J Natl Cancer Inst 2015; 108. pii: djv318.
Nakai M, Uchida K, Teuscher C. J Androl 1999; 20:626-34.
[No authors]. Obstet Gynecol 2002; 100:835-43.
Sadek S, Bell SC. Br J Obstet Gynaecol 1996; 103:630-41.
Shandley LM, Spencer JB, Fothergill A, Mertens AC, Manatunga A, Paplomata E, Howards PP. Fertil Steril. 2017; 107:243-252.e5.
Tewari K, Bonebrake RG, Asrat T, Shanberg AM. Lancet 1997; 350:183.
Woo JC, Yu T, Hurd TC. Arch Surg 2003; 138:91-8.
Summary Pregnancy Category: D
Lactation Category: NS (possibly)

  • Tamoxifen should be avoided during pregnancy and lactation unless maternal survival requires it.

Tazarotene topical — (Tazorac)

International Brand Names

Zorac (England, France, Germany, Ireland, Israel, South Africa)

Drug Class Dermatologics; Retinoids
Indications Psoriasis, acne vulgaris
Mechanism Unknown; retinoid
Dosage With Qualifiers Psoriasis—apply to affected area qhs
Acne vulgaris—apply to affected area qhs
NOTE: Obtain pregnancy test before initiating therapy; available in cream (0.05%) and gel (0.05%, 0.1%) formats.

  • Contraindications —hypersensitivity to drug or class, pregnancy

  • Caution —avoid sun

Maternal Considerations Tazarotene is a third-generation retinoid. There is no published experience during pregnancy. The maternal systemic concentration is reportedly low.
Side effects include birth defects, pruritus, burning, erythema, and irritation.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether tazarotene crosses the human placenta. The maternal systemic concentration is reportedly low, and rodent teratogenicity studies are reassuring. Other drugs in this group are potent teratogens in mammals. Rodents treated topically with doses approximating 20% of the surface area have a greater risk of embryo loss and fetal malformation, including neural tube and cardiac anomalies.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether tazarotene enters human breast milk. It is excreted into rodent milk. However, considering the dose and route, it is unlikely the breastfed neonate would ingest clinically relevant amounts.
Drug Interactions Use with other dermatologic medications and cosmetics with a strong drying effect should be avoided. It is advisable to “rest” a patient’s skin until the effects of such preparations subside before using tazarotene cream.
References Duvic M. Cutis 1998; 61:22-6.
Summary Pregnancy Category: X
Lactation Category: U

  • Tazarotene is a known teratogen in rodents even at levels below the MRHD and should probably be avoided during pregnancy and lactation pending the availability of additional study confirming safety.

Technetium-99m ( 99m Tc) — (Cardiolite; Cardiotec; Cardiotech; Ceretec; Miraluma; Neurolite; NeoTect; RBC-Scan; Ultratag)

International Brand Names

None identified.

Drug Class Diagnostics, radiopharmaceutical
Indications Diagnostic imaging
Mechanism Radioactive label attached to a variety of peptides with assorted binding profiles
Dosage With Qualifiers Available in multiple formats bound to a variety of peptides for imaging of structures such as the heart, brain, and biliary system, and for localization of malignancy and bleeding

  • Contraindications —hypersensitivity to drug or class

  • Caution —unknown

Maternal Considerations Technetium-99m decays by isomeric transition with a t/2 of 6 h. Its clearance is reduced in women. There are no adequate reports or well-controlled studies of technetium-99m in pregnant women. There is a long clinical experience that supports its use during pregnancy when medically indicated. A diagnostically indicated test should not be withheld because of pregnancy.
Side effects include metallic taste, burning at the injection site, facial swelling, numbness of hand/arm, hypotension, and nausea.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Technetium-99m crosses the human placenta but delivers a maximal total fetal dose of < 5 mGy, far below the 50 mGy considered the threshold for concern. Rodent teratogenicity studies have not been performed.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. Technetium-99m is excreted in human milk during lactation for about 24 h after administration. Although formula feedings for at least 24 h after testing may seem prudent, a single case report suggests this may not be necessary. In this instance, sample radioactivity concentration peaked at 15 h and decayed monoexponentially (half-clearance time was 4.8 h). The estimated effective dose to the infant from ingestion alone was approximately 0.02 mSv, suggesting interruption of breastfeeding may not be necessary during early lactation.
Drug Interactions No clinically relevant interactions identified.
References Adelstein SJ. Teratology 1999; 59:236-9.
McCauley E, Mackie A. Br J Radiol 2002; 75:464-6.
Owunwanne A, Omu A, Patel M, et al. J Nucl Med 1998; 39:1810-3.
Romney BM, Nickoloff EL, Esser PD, Alderson PO. Radiology 1986; 160:549-54.
Summary Pregnancy Category: C
Lactation Category: S (likely)

  • Technetium-99m should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

  • Pregnancy is not a valid reason to withhold a diagnostically indicated test.

Tegaserod — (Zelnorm)

International Brand Names

Colonaid (Chile); Tegibs (India); Zelmac (Colombia, Hong Kong, Indonesia, Israel, Korea, Malaysia, Singapore, Taiwan, Thailand); Zelnorm (Canada, Philippines)

Drug Class Gastrointestinals; Serotonin receptor agonists
Indications Irritable bowel syndrome in women characterized by constipation
Mechanism 5-HT 4 agonist stimulating peristalsis while decreasing visceral sensitivity
Dosage With Qualifiers Irritable bowel syndrome—6 mg PO 30–60 min ac bid × 4–6 w; may repeat × 1

  • Contraindications —hypersensitivity to drug or class, severe renal dysfunction, moderate to severe hepatic disease, history of bowel obstruction, abdominal adhesions, sphincter of Oddi dysfunction, symptomatic gallbladder disease, diarrhea

  • Caution —mild hepatic dysfunction

Maternal Considerations There are no published reports of tegaserod use during pregnancy.
Side effects include cholecystitis, headache, nausea, abdominal pain, flatulence, diarrhea, and dizziness.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether tegaserod crosses the human 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. Tegaserod enters rodent breast milk. Its impact on the neonate is unknown.
Drug Interactions Bioavailability is decreased by 40%–65% and C max is decreased by 20%–40% when taken with food. Tegaserod should be taken on an empty stomach 30 minutes before meals.
References There is no published experience in pregnancy or during lactation.
Summary Pregnancy Category: B
Lactation Category: U

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

  • There are alternative agents for which there is more experience regarding use during pregnancy and lactation that may suffice in the short term.

Telmisartan — (Micardis)

International Brand Names

Micardis (Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Hong Kong, Indonesia, Malaysia, Mexico, Nicaragua, Panama, Paraguay, Peru, Philippines, Singapore, Thailand, Uruguay); Predxal (Mexico); Pritor (Argentina, Australia, Korea, Mexico, Peru, Philippines, Venezuela); Pritoral (Chile); Telma-20 (India)

Drug Class ACEI/A2R-antagonists
Indications Hypertension
Mechanism AT-1 antagonist
Dosage With Qualifiers Hypertension—begin 40 mg PO qd if monotherapy; max 80 mg/d

  • Contraindications —hypersensitivity to drug or class, pregnancy

  • Caution —history of ACEI-related angioedema, renal artery stenosis, hepatic or renal dysfunction, CHF, hyponatremia

Maternal Considerations The plasma concentration of telmisartan is 2–3 × higher in females than in males. There is no published experience with telmisartan during pregnancy. Inhibitors of the renin-angiotensin system should be avoided during pregnancy for fetal indications. The lowest effective dose should be used if telmisartan is required during pregnancy for BP control.
Side effects include angioedema, hypotension, dizziness, URI symptoms, back pain, diarrhea, fatigue, dyspepsia, neutropenia, leukopenia, and hyperkalemia.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether telmisartan crosses the human placenta. Inhibitors of the renin-angiotensin system are considered contraindicated throughout pregnancy as their use has been associated with cranial hypoplasia, anuria, reversible or irreversible renal failure, death, oligohydramnios, prematurity, IUGR, and PDA. If oligohydramnios is observed, telmisartan should be discontinued unless considered lifesaving for the mother. Antenatal surveillance (e.g., BPP) may be appropriate, depending on gestational age. Oligohydramnios may not appear until after irreversible injury. The literature is limited to case reports of neonatal renal failure after antenatal exposure. Neonates exposed should be closely observed for hypotension, oliguria, and hyperkalemia. 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 telmisartan enters human breast milk. It is excreted into rodent milk.
Drug Interactions Increases in digoxin peak (49%) and trough levels (20%). Thus digoxin levels should be monitored when initiating, adjusting, and discontinuing telmisartan.
References Pietrement C, Malot L, Santerne B, et al. J Perinatol 2003; 23:254-5.
Sahay M, Ismal K, Vali PS, et al. 2014; 24:249-51.
Summary Pregnancy Category: C (first trimester), D (second and third trimesters)
Lactation Category: U

  • Telmisartan is likely a human teratogen, and should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

  • There are fetal risks throughout pregnancy. The lowest effective dose should be used when telmisartan is required during pregnancy for BP control.

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

Temazepam — (Euhypnos; Levanxol; Normison; Planum; Restoril)

International Brand Names

Cerepax (Argentina); Lenal (Argentina); Levanxene (Argentina)

Drug Class Benzodiazepines; Hypnotics; Sedatives
Indications Insomnia
Mechanism Benzodiazepine and possibly GABA receptor agonist
Dosage With Qualifiers Insomnia, short-term—7.5–30 mg PO qhs

  • Contraindications —hypersensitivity to drug or class

  • Caution —azole antifungal

Maternal Considerations Residual medication effects (“hangover”) are essentially absent with temazepam, and early morning awakening, a particular problem for the geriatric patient, is significantly reduced compared to similar agents. REM sleep is unchanged. There are no adequate reports or well-controlled studies of temazepam in pregnant women. One case report suggested an association with a fetal demise.
Side effects include respiratory depression, seizures, coma, drowsiness, headache, fatigue, nervousness, lethargy, dizziness, N/V, anxiety, depression, dry mouth, diarrhea, abdominal pain, euphoria, weakness, blurred vision, nightmares, and vertigo.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Temazepam crosses the second-trimester human placenta, achieving an F:M ratio approximating 0.38 1 h after 10 mg IV. The ratio was stable between 60 and 120 min, but it rose with advancing gestation. Third-trimester data are unavailable. Several studies suggest an increased prevalence of fetal malformation after diazepam use during the first-trimester use. Decreased fetal movement frequently follows IV diazepam administration, and prolonged CNS depression may occur in neonates due to their inability to metabolize the drug. It is unknown whether the effect of temazepam is similar. There is a single case report of an unresponsive infant from a mother prescribed 20 mg temazepam . The study reported an infant plasma level of 145 μg/L (20–100 μg/L) 6 h after maternal intake. The shortest course and the lowest dose should be used if indicated during pregnancy. Rodent teratogenicity studies reveal an increased prevalence of skeletal abnormalities and embryo loss.
Breastfeeding Safety Temazepam is excreted into breast milk. In one report, at concentrations of 26 − 28 mcg/L for the pre- and postfeed samples, the M:P ratio for temazepam ranged from < 0.09 to < 0.63 (mean < 0.18).
Drug Interactions CNS depressants increase the effects of temazepam.
References Cooper J, Jauniaux E, Gulbis B, Bromley L. Reprod Biomed Online 2001; 2:165-71.
Damen L, Visser DH, Sie SD, et al. Case Rep Pediatr 2014:650605.
Lebedevs TH, Wojnar-Horton RE, Yapp P, et al. Br J Clin Pharmacol 1992; 33:204-6.
Summary Pregnancy Category: X
Lactation Category: S (possibly)

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

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

  • Although it is unlikely a one-time use would cause harm, continuous use should be avoided during pregnancy and lactation.

Temozolomide — (Temodar; Temoxol)

International Brand Names

Temodal (Australia, Canada, Hong Kong, Indonesia, Israel, Korea, Mexico, Philippines, Singapore, Thailand); Temoxol (South Africa)

Drug Class Antineoplastics, alkylating agent
Indications Astrocytoma, refractory
Mechanism Alkylates guanine
Dosage With Qualifiers Astrocytoma, refractory—multiple dosing regimens based on response and side effects

  • Contraindications —hypersensitivity to drug or class, hypersensitivity to DTIC

  • Caution —hepatic or renal dysfunction

Maternal Considerations The published experience with temozolomide during pregnancy is limited to a few case reports, mostly describing brief exposure, elective preterm delivery, and a normal newborn.
Side effects include myelosuppression, N/V, abdominal pain, constipation, diarrhea, headache, fever, convulsions, hemiparesis, amnesia, insomnia, and viral infection.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether temozolomide crosses the human placenta. Rodent teratogenicity studies reveal an increased prevalence of multiple malformations.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether temozolomide enters human breast milk. However, its molecular size and low protein binding suggest it would. Any temozolomide in the milk would be orally available to the infant.
Drug Interactions Valproic acid decreases oral clearance by about 5%.
References McGrane J, Bedford T, Kelly S. Clin Oncol (R Coll Radiol). 2012; 24:311.
Nolan B, Balakrishna M, George M. World J Oncol 2012; 3:286-7.
Summary Pregnancy Category: D
Lactation Category: NS

  • Temozolomide should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk; it is reserved for life-threatening circumstances.

Tenecteplase — (TNKase)

International Brand Names

Metalyse (Israel, Taiwan); TNKase (Canada)

Drug Class Anticoagulants; Thrombolytics
Indications MI
Mechanism Tissue plasminogen activator
Dosage With Qualifiers MI, acute—30–50 mg IV × 1, weight dependent; max 50 mg

  • Contraindications —hypersensitivity to drug or class, active internal bleeding, stroke, aneurysm, intracranial/spinal surgery or trauma, bleeding diathesis, uncontrolled hypertension

  • Caution —severe hepatic disease, hypertension, recent surgery or trauma, CVD, GPIIb/IIIa use, endocarditis, acute pericarditis, LV thrombus

Maternal Considerations The published experience with tenecteplase during pregnancy is limited to case reports of women with embolus in either the pulmonary artery or involving a prosthetic cardiac valve including some in the first trimester.
Side effects include intracranial hemorrhage, stroke, severe bleeding, arrhythmia, and angioedema.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether tenecteplase crosses the human placenta. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Embryotoxicity occurs with high doses.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether tenecteplase enters human breast milk.
Drug Interactions Anticoagulants (e.g., heparin, vitamin K antagonists) and drugs that alter platelet function (e.g., aspirin, dipyridamole, GP IIb/IIIa inhibitors) may increase the risk of bleeding.
References Bessereau J, Desvignes O, Huon B, et al. Arch Mal Coeur Vaiss 2007; 100:955-8.
Camacho Pulido A, Jimenez Sanchez JM, Montijano Vizcaino A, et al. An Med Interna 2008; 25:31-2.
Maegdefessel L, Issa H, Scheler C, et al. Internist 2008; 49:868-72.
Summary Pregnancy Category: C
Lactation Category: U

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

Tenofovir Disoproxil Fumarate — (Viread)

International Brand Names

Viread (Argentina, Canada)

Drug Class Antivirals; NRTIs
Indications HIV infection, HBV infection
Mechanism Reverse transcriptase inhibitor
Dosage With Qualifiers HIV infection—300 mg PO qd in combination with other retrovirals
HBV infection—300 mg PO qd in combination hepatitis B immunoglobulin and the hepatitis B vaccine
NOTE: Renal dosing.

  • Contraindications —hypersensitivity to drug or class, CrCl < 60 mL/min, lactic acidosis

  • Caution— alcoholism, hepatic dysfunction

Maternal Considerations Tenofovir disoproxil fumarate is a pro-drug form of tenofovir . Intrapartum and neonatal single-dose nevirapine are essential components in the prevention of perinatal HIV in resource-constrained settings, but they can induce resistance to NNRTIs. A single dose of tenofovir plus emtricitabine at delivery reduced by half the rate of resistance to NNRTIs 6 w after delivery. The clearance of some NRTIs is increased during pregnancy. A pharmacokinetic study reported lower tenofovir AUC and troughs during pregnancy. In a cohort of 200 HBeAg-positive mothers with high viral load (> 200,000 IU/mL) during the third trimester, the rate of mother-to-child transmission was lower among those who received tenofovir disoproxil fumarate therapy than among those who received usual care without antiviral therapy.
The literature is conflicting. One study RCTs compared tenofovir -based regimens to those with alternative nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs). The most common comparison was tenofovir and emtricitabine vs. zidovudine and lamivudine . There was no apparent difference between tenofovir -based regimens and alternatives in maternal outcomes, including serious laboratory adverse events (low certainty) and serious clinical adverse events (moderate certainty). There was no difference between NRTIs in vertical transmission of HIV. There was moderate certainty for evidence that tenofovir / emtricitabine increased the risks of stillbirth, early neonatal mortality, and preterm birth <34 weeks. Another study published around the same time reached the opposite conclusion.
Side effects include lactic acidosis, hepatomegaly with steatosis, N/V, diarrhea, anorexia, and flatulence.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Transplacental passage with chronic tenofovir use during pregnancy is high. According to data collected by the Antiretroviral Pregnancy Registry, there is no increased risk of birth defects after first-trimester exposure. Tenofovir- based antiretroviral therapy is generally considered safe. Tenofovir crosses the rhesus monkey placenta sufficiently well to lower the fetal viral load. In doing so, there is a transient delay in bone growth that may be IGF-I mediated. 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. One study evaluated 7-d treatment with 1% tenofovir vaginal gel during lactation. Tenofovir was detected at low levels in maternal serum, milk, and infant serum but demonstrated no anti-HIV activity in milk. However, it is excreted into macaque and rodent milk. Breastfeeding is contraindicated in HIV-infected nursing women where formula is available to reduce the risk of neonatal transmission.
Drug Interactions Increases the C max and AUC of didanosine by an unknown mechanism. Higher didanosine levels increase the risk of didanosine -associated pancreatitis and neuropathy. In adults weighing > 60 kg, the didanosine dose should be reduced to 250 mg. Data are not available to recommend a dose adjustment of didanosine for patients weighing < 60 kg. Tenofovir and didanosine should be used together only with caution; patients receiving this combination should be closely monitored for didanosine -associated adverse events.
Drugs that reduce renal function or compete for active tubular secretion may increase serum concentrations of tenofovir and/or increase the concentrations of other renally eliminated drugs (e.g., acyclovir, adefovir, cidofovir, dipivoxil, ganciclovir, valacyclovir, valganciclovir ).
Atazanavir and lopinavir/ritonavir increase tenofovir levels by an unknown mechanism. Patients should be monitored for tenofovir -associated adverse events.
Decreases the AUC and C min of atazanavir. It is recommended that atazanavir 300 mg be given with ritonavir 100 mg if used with tenofovir.
In vitro studies reported that tenofovir disoproxil fumarate is a dual substrate of ABCB1 and ABCG2 but not of ABCC2. In contrast, tenofovir transport was not influenced by any of these transporters.
References Best BM, Burchett S, Li H, et al. HIV Med 2015; 16:502-11.
Chi BH, Sinkala M, Mbewe F, et al. Lancet 2007; 370:1698-705.
Ehrhardt S, Xie C, Guo N, et al. Clin Infect Dis 2015; 15; 60:275-8.
Greenup AJ, Tan PK, Nguyen V, et al. J Hepatol 2014; 61:502-7.
Malaba TR, Phillips T, Le Roux S, et al. Int J Epidemiol 2017; 46:1678-89.
Noguchi LM, Montgomery ET, Biggio JR, et al. Antimicrob Agents Chemother 2016; 60:5616-9.
Nurutdinova D, Onen NF, Hayes E, et al. Ann Pharmacother 2008; 42:1581-5.
Pan CQ, Duan Z, Dai E, et al. N Engl J Med 2016; 374:2324-34.
Siemieniuk RA, Foroutan F, Mirza R, et al. BMJ Open 2017; 7:e019022.
Tarantal AF, Castillo A, Ekert JE, et al. J Acquir Immune Defic Syndr 2002; 29:207-20.
Zash R, Jacobson DL, Diseko M, et al. JAMA Pediatr 2017; 171:e172222.
Summary Pregnancy Category: B
Lactation Category: NS

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

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

  • Breastfeeding is contraindicated in HIV-infected nursing women where formula is available to reduce the risk of neonatal transmission.

  • Physicians are encouraged to register pregnant women under the Antiretroviral Pregnancy Registry (1-800-258-4263) for a better follow-up of the outcome while under treatment with tenofovir.

Terbinafine — (Lamisil)

International Brand Names

Binasil (Korea); Curasil (Korea); Dermafin (Malaysia); Exifine (Malaysia); Interbi (Indonesia); Labijin (Korea); Lamifen (Philippines); Lamisil (China, Hong Kong, India, Indonesia, Japan, Korea, Malaysia, Philippines, Taiwan, Thailand); Lamisil Dermgel (France, New Zealand); Lapiderm (Korea); Lespo (Korea); Micoset (Chile); Micosil (Korea); Namuzol (Korea); Sulmedin (Taiwan); Terbifin (Hong Kong); Terbinex (Korea); Terbisil (Singapore); Terekol (Argentina); Terfine (Taiwan); Termisil (Indonesia)

Drug Class Antifungals; Dermatologics
Indications Onychomycosis, tinea
Mechanism Inhibits squalene epoxidase, reducing cell membrane ergosterol synthesis
Dosage With Qualifiers Onychomycosis—250 mg PO qd × 6 w (fingernails) or 12 w (toenails)
Tinea—250 mg PO qd × 2 w
NOTE: Check LFTs at baseline; CBC count if > 6 w.

  • Contraindications —hypersensitivity to drug or class

  • Caution —hepatic or renal dysfunction

Maternal Considerations There is no published experience with terbinafine during pregnancy. It is considered an alternative agent should clotrimazole , miconazole, and nystatin fail.
Side effects include hepatic failure, hepatotoxicity, Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis, rash, pruritus, neutropenia, headache, diarrhea, dyspepsia, nausea, abdominal pain, constipation, flatulence, and urticaria.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether terbinafine crosses the human 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. The manufacturer reports terbinafine achieves an M:P ratio of 7:1 after oral administration. In animal models, terbinafine has been associated with testicular atrophy, especially newborns. Until data to the contrary become available, breastfeeding should be avoided, and another of several options, such as clotrimazole or miconazole, be used.
Drug Interactions Inhibits CYP2D6-mediated metabolism. This may be of clinical relevance for compounds predominantly metabolized by this enzyme, such as TCAs, β-blockers, SSRIs, and MAO-B inhibitors, if they have a narrow therapeutic range.
Increases the clearance of cyclosporine by 15%.
Rifampin , a CYP inducer, increases terbinafine clearance by 100%. Cimetidine, a CYP inhibitor, decreases terbinafine clearance by 33%.
References There is no published experience in pregnancy or during lactation.
Summary Pregnancy Category: B
Lactation Category: NS (possibly)

  • Terbinafine should be used during pregnancy only if the benefit justifies the potential perinatal risk.

  • Terbinafine should probably be avoided during breastfeeding.

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

Terbutaline — (Brethaire; Brethancer; Brethine; Bricanyl; Monovent; Syntovent)

International Brand Names

Asmabet (Indonesia); Asthmasian (Thailand); Ataline (Hong Kong, Malaysia, Thailand); Blucodil (Philippines); Brasmatic (Indonesia); Bricanyl retard (Denmark, Netherlands); Bricasma (Indonesia); Bronchodam (Philippines); Bronco Asmo (Thailand); Bucanil (Singapore); Bucaril (Thailand); Butylin (Hong Kong); Contimit (Germany); Draconyl (Greece); Glin (Taiwan); Lanterbine SR (Hong Kong); Nairet (Indonesia); Taziken (Mexico); Terasma (Indonesia); Terbasmin (Italy, Spain); Terbron (Hong Kong); Terbulin (Israel); Terburop (Colombia); Tismalin (Indonesia); Tolbin (Singapore); Vacanyl (Thailand)

Drug Class Adrenergic agonists; β-Agonists; Bronchodilators
Indications Asthma, tocolysis
Mechanism β 2 -Agonist
Dosage With Qualifiers Asthma—5 mg PO q6h prn; max 15 mg/d; or 2 puffs INH q4–6 h; or 0.25 mg SC q15–30 min × 2
Tocolysis—0.25 mg SC q30min; max 1 mg/4 h; or 2.5–10 mcg/min IV, max 30 mcg/min
NOTE: Available in oral, inhaler, or parenteral forms.

  • Contraindications —hypersensitivity to drug or class

  • Caution —diabetes mellitus, infection (with tocolysis), hypertension, hyperthyroidism, arrhythmia, seizures, hypokalemia

Maternal Considerations Terbutaline is a popular and effective agent for the treatment of asthma during pregnancy. Although generally considered a selective β 2 -agonist based on in vitro study, its clinical profile is less specific. As with all other β-mimetics and most tocolytic agents, terbutaline is associated with an ∼ 48-h delay in delivery compared to placebo in women with preterm labor. Pregnancy outcome is altered only when coupled with antenatal steroid administration. As it is for all other currently available drugs, the use of either oral or continuous SC treatment is ineffective preterm labor prophylaxis. Maternal side effects are common and often lead to discontinuation of therapy. Serious adverse reactions, including pulmonary edema and maternal death, have been reported with terbutaline. In rodents, LPS enhances the tocolytic effect of terbutaline . Several reviews have concluded that nifedipine and indomethacin are more cost-effective tocolytic agents than either terbutaline or magnesium sulfate because of the cost of monitoring and treating adverse events. Not surprisingly, several large meta-analyses conclude that, of the currently available agents, nifedipine is the tocolytic of choice.
Terbutaline has also been used in the setting of fetal bradycardia while plans for delivery were under way. In one RCT, 110 women had nonreassuring FHR tracings in labor; 57 women received terbutaline and 53 women nitroglycerin. The rate of successful intrauterine resuscitation rates was similar ( terbutaline 71.9% and nitroglycerin 64.2%; P = 0.38). Terbutaline resulted in lower contraction rates and a decreased prevalence of uterine tachysystole. Maternal MAP decreased with nitroglycerin but not terbutaline. Terbutaline also seems useful for the correction of oxytocin -induced tachysystole, but it is probably medically indicated only when associated with an FHR abnormality.
Side effects include pulmonary edema, hypotension, tachycardia, palpitations, arrhythmia, nervousness, tremor, headache, N/V, drowsiness, sweating, muscle cramps, and hyperglycemia.
Fetal Considerations Terbutaline crosses the human placenta, achieving an F:M ratio between 0.11 and 0.48 after a single IV dose immediately prior to elective cesarean delivery. Levels approach unity after several hours. Multiple case reports suggest it has a chronotropic effect on fetuses with complete heart block. The effect, if any, is often transient perhaps because β-adrenergic innervation is still relatively immature even at birth. Allegations that terbutaline exposure during pregnancy caused autism cannot be sustained on any level because of the high doses studied coupled to a lack of evidence that terbutaline crosses the fetal blood-brain barrier. Paradoxically, there is no receptor desensitization demonstrable in the fetal rat heart exposed chronically to terbutaline. Rodent studies are reassuring, showing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Terbutaline increases the frequency of fetal breathing. Chronic terbutaline exposure increases cardiac size and HR in fetal guinea pigs. Overall, it appears long-term terbutaline use has measurable fetal effects at least in rodents.
Breastfeeding Safety Terbutaline is excreted into human breast milk, reaching M:P ratios in excess of 2. The relative infant dose is less than 0.3%, and the neonatal level undetectable.
Drug Interactions Other sympathomimetic agents should not be used with terbutaline because their combined effect on the CV system may be deleterious.
Use with caution in patients being treated with MAOIs or TCAs, as the action of terbutaline on the vascular system may be potentiated.
β-Adrenergic blocking agents not only block the pulmonary effect of terbutaline but may trigger a severe attack in asthmatic patients.
References Auman JT, Seidler FJ, Slotkin TA. Am J Physiol Regul Integr Comp Physiol 2001; 281:R1079-89.
Bergman B, Bokström H, Borgå O, et al. Eur J Respir Dis Suppl 1984; 134:81-6.
Goldenberg RL. Obstet Gynecol 2002; 100:1020-37.
Guinn DA, Goepfert AR, Owen J, et al. Am J Obstet Gynecol 1998; 179:874-8.
Hallak M, Moise K Jr, Lira N, et al. Am J Obstet Gynecol 1992; 167:1059-63.
Hayes E, Moroz L, Pizzi L, Baxter J. Am J Obstet Gynecol 2007; 197:383.e1-6.
Klukovits A, Marki A, Paldy E, et al. Nauyn Schmiedebergs Arch Pharmacol 2008; Dec 3 [Epub ahead of print].
Lindberg C, Boreus LO, de Chateau P, et al. Eur J Respir Dis Suppl 1984; 134:87-91.
[No authors]. Ann Allergy Asthma Immunol 2000; 84:475-80.
Pacheco LD, Rosen MP, Gei AF, et al. Am J Perinatol 2006; 23:377-80.
Petersen R, Carter LS, Chescheir NC, et al. Am J Obstet Gynecol 1989; 161:509-12.
Pullen KM, Riley ET, Waller SA, et al. Am J Obstet Gynecol 2007; 197:414.e1-6.
Robinson BV, Ettedgui JA, Sherman FS. Cardiol Young 2001; 11:683-6.
Tsatsaris V, Papatsonis D, Goffinet F, et al. Obstet Gynecol 2001; 97:840-7.
Wenstrom KD, Weiner CP, Merrill D, Niebyl J. Am J Perinatol 1997; 14:87-91.
Summary Pregnancy Category: C
Lactation Category: S

  • Terbutaline is a first-line treatment of asthma during pregnancy and lactation.

  • There are alternative agents for tocolysis, such as nifedipine, that are more effective and have a superior safety profile.

Terconazole — (Terazol)

International Brand Names

Fungistat (Mexico); Fungistat 3 (Puerto Rico); Fungistat 5 (Colombia, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama); Gyno-Terazol (Belgium, Israel, Netherlands, Portugal); Gyno-Terazol 3 (Czech Republic); Terazol 3 (Canada); Terazol 7 (Canada); Tercospor (Germany)

Drug Class Antifungals; Dermatologics
Indications Vulvovaginal candidiasis
Mechanism Unknown
Dosage With Qualifiers Vulvovaginal candidiasis—1 applicator 4% qhs × 7 d, or 8% × 3 d, or 1 suppository PV qhs × 3 d
NOTE: Available in cream (0.4%, 0.8%) and suppository (80 mg).

  • Contraindications —hypersensitivity to drug or class

  • Caution —unknown

Maternal Considerations Terconazole is a member of a series of imidazoles whose effectiveness appears similar. There are no adequate reports or well-controlled studies of terconazole in pregnant women. Topical imidazole appears to be more effective than nystatin for treating symptomatic vaginal candidiasis in pregnancy. Treatment periods of 7 d may be necessary during pregnancy rather than the shorter courses typically recommended.
Side effects include irritation, headache, and pruritus.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether terconazole crosses the human placenta. Rodent studies are generally reassuring, revealing no evidence of teratogenicity or IUGR until the dose exceeds 20 × the MRHD, when skeletal abnormalities and embryotoxicity are noted. The no-effect oral dose (10 mg/kg/d) produces a mean peak plasma level in pregnant rats 44 × the mean peak plasma levels seen after intravaginal administration.
Breastfeeding Safety There is no published experience in nursing women. At high doses, terconazole enters rodent breast milk. It is unknown whether terconazole enters human breast milk. In all likelihood, any levels are probably too low to be clinically relevant.
Drug Interactions May decrease effect of progesterone .
References Young GL, Jewell D. Cochrane Database Syst Rev 2001; (4):CD000225.
Summary Pregnancy Category: C
Lactation Category: S (likely)

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

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

Tetanus immune globulin — (Hyper-Tet; Hypertet)

International Brand Names

BayTet (Canada, Israel, Philippines); IG tetano/tetanus immune globulin (Israel, Philippines); Tetabulin (Austria, Hong Kong, Italy, Korea, Switzerland); Tetabuline (Belgium); Tetagam (Germany, Indonesia, South Africa); Tetagamma (Italy); Tetagam-P (Greece); Tetaglobulin (Germany); Tetaglobuline (Israel, Malaysia, Philippines, South Africa, Thailand); Tetagloman (Austria); Tetamyn enzimatico liofilizado (Mexico); Tetanobulin (Taiwan); Tetanogamma (Dominican Republic); Tetanosson (Greece); Tetuman berna (Hong Kong, Malaysia, Peru, Philippines, South Africa)

Drug Class Immune globulins
Indications Tetanus prophylaxis following injury with unknown/uncertain vaccination history, active tetanus
Mechanism Passive immunity
Dosage With Qualifiers Tetanus prophylaxis following injury with unknown/uncertain vaccination history—250 IU deep IM; administer in different extremities, and with separate syringes, tetanus and diphtheria toxoids
Active tetanus—dose depends on severity; see package insert

  • Contraindications —hypersensitivity to drug or class

  • Caution —thrombocytopenia, bleeding disorder

Maternal Considerations Tetanus immune globulin creates passive immunity to the toxin of C. tetani. Naturally acquired immunity to tetanus toxin is rare in the United States. Universal primary vaccination with subsequent timed boosters to maintain adequate antitoxin levels is required for all age groups. There are no adequate reports or well-controlled studies of tetanus immune globulin in pregnant women. Tetanus is a highly lethal disease and a significant cause of maternal death in some locales. It appears the antibodies produced in response to tetanus toxoid during pregnancy have low protective capacity, strengthening the importance of tetanus immune globulin prophylaxis during pregnancy. The long clinical experience suggests safety.
Side effects include injection site soreness, fever, angioneurotic edema, and nephrotic syndrome.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Tetanus immune globulin crosses the human placenta and provides at least partial coverage for the neonate. Maternal immunization does not interfere with neonatal response to the DPT series. The degree of IgG transfer is lower in the preterm compared to the term neonate, and there appears to be a maximal transfer rate. Rodent teratogenicity studies have not been performed, but there is no reason to hypothesize the antibody may damage the fetus.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether tetanus immune globulin enters human breast milk. However, the long clinical experience in humans is reassuring. It does enter the colostrum of horses and actually can reduce the foal’s response to vaccination.
Drug Interactions Antibodies in immunoglobulin preparations may interfere with the response to live viral vaccines such as measles, mumps, polio, and rubella. Use of such vaccines should be delayed approximately 3 mo after tetanus immune globulin.
References Kutukculer N, Kurugol Z, Egemen A, et al. J Trop Pediatr 1996; 42:308-9.
Morell A, Sidiropoulos D, Herrmann U, et al. Pediatr Res 1986; 20:933-6.
Okoko BJ, Wesuperuma LH, Ota MO, et al. J Health Popul Nutr 2001; 19:59-65.
Pasetti MF, Dokmetjian J, Brero ML, et al. Am J Reprod Immunol 1997; 37:250-6.
Wesumperuma HL, Perera AJ, Pharoah PO, Hart CA. Ann Trop Med Parasitol 1999; 93:169-77.
Wilson WD, Mihalyi JE, Hussey S, Lunn DP. Equine Vet J 2001; 33:644-50.
Summary Pregnancy Category: C
Lactation Category: S

  • Tetanus immune globulin is considered safe and effective during pregnancy and lactation.

Tetanus toxoid — (Tetanus toxoid adsorbed)

International Brand Names

Anatetall (Malaysia, Philippines, Thailand); Anatoxal Tetanica Berna (Peru); Clostet (England); TE Anatoxal (Austria); TE Anatoxal Berna (Switzerland); Tetanol (Ecuador, Germany, Greece, Honduras, Mexico, South Africa); Tetatox (Italy); Tetavax (England, Germany, Hong Kong, Malaysia, Philippines, South Africa, Thailand); Tet-Tox (New Zealand)

Drug Class Vaccines
Indications Tetanus susceptibility
Mechanism Active immunization
Dosage With Qualifiers Tetanus susceptibility— primary immunization: 0.5 mL IM q4–8 w × 2, then 0.5 mL IM 6–12 mo after the second trimester; booster: 0.5 mL IM q10y

  • Contraindications —hypersensitivity to drug or class, acute respiratory infection or other active infection (unless emergency), immunosuppressive agents

  • Caution —unknown

Maternal Considerations Serologic tests demonstrate naturally acquired immunity to tetanus toxin is rare in the United States. Universal primary vaccination, with subsequent timed boosters to maintain adequate antitoxin levels, is required for all age groups. Tetanus is a highly lethal disease and a significant cause of maternal death in some locales. Tetanus toxoid is a highly effective antigen; a completed primary series generally induces protection that persists ≥ 10 y. Increasing the interval between primary immunizing doses to 6 mo or longer does not interfere with the final immunity. Any dose of tetanus toxoid received, even a decade earlier, is counted as the first immunizing injection. Tetanus still is a common cause of maternal death in the 24 countries where there is no immunization. There are no adequate reports or well-controlled studies of tetanus toxoid in pregnant women. Pregnant women do respond. Prepregnancy Tdap vaccination significantly increases maternal antibody concentrations in consecutive infants. Similar to the effect of Tdap vaccination during pregnancy, immune responses of later-born infants born to mothers who received a prepregnancy immunization are blunted. In many geographic locales, a cogent argument can be made for routine immunization with at least 1 dose during pregnancy to protect both mother and newborn.
Side effects include injection site soreness, fever, malaise, lymphadenopathy, generalized aches, hypotension, and pruritus.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. The antibodies generated in response to tetanus toxoid appear to cross the human placenta and are capable of stimulating active immunity in the term fetus. The long clinical experience with immunization during pregnancy is reassuring. Maternal immunization protects against neonatal tetanus and should be public policy in many geographic locales.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether tetanus toxoid enters human breast milk.
Drug Interactions No clinically relevant interactions identified.
References Czeizel AE, Rockenbauer M. In J Gynaecol Obstet 1999; 64:254-8.
Gupta SD, Keyl PM. Pediatr Infect Dis J 1998; 17:316-21.
Maertens K, Tran TMP, Hens N, et al. J Infect Dis 2017; 215:1855-61.
Maral MI, Cirak M, Aksakal FN, et al. Eur J Epidemiol 2001; 17:661-5.
Rochat R, Akhter HH. Lancet 1999; 354:565.
Thwaites CL, Beeching NJ, Newton CR. Lancet 2015; 385:362-70.
Vanderbeeken Y, Sarfati M, Bose R, Delespesse G. Am J Reprod Immunol Microbiol 1985; 8:39-42.
Summary Pregnancy Category: C
Lactation Category: S

  • Tetanus toxoid is considered safe and effective during pregnancy and lactation.

Tetracaine — (Ak-T-Caine; Dermacaine; Pontocaine; Tetocain)

International Brand Names

Ametop (South Africa); Pantocain (Indonesia); Tetocaine (Taiwan)

Drug Class Anesthetics, local
Indications Spinal anesthetic
Mechanism Blocks Na/K channels, inhibiting nerve impulse transmission
Dosage With Qualifiers Spinal anesthesia—5–15 mg intraspinal between L2 and L4
NOTE: Volume load to minimize the risk of hypotension.

  • Contraindications —hypersensitivity to drug or class; associated conditions that increase the risks of spinal anesthesia, including generalized septicemia (relative), injection site infection (absolute), increased ICP (absolute), uncontrolled hypotension (absolute)

  • Caution —arrhythmia, hypotension, hypovolemia, shock

Maternal Considerations Tetracaine produces 2–3 h of surgical anesthesia depending on the site of surgery (i.e., intraabdominal vs. lower limb/perineal). The extent and degree of anesthesia depend on dose, specific gravity of the anesthetic solution, volume used, and the position of the patient during and immediately after injection. There are no adequate reports or well-controlled studies of tetracaine in pregnant women. Although once routinely used (mixed with either 10% glucose or 10% procaine ) for spinal anesthesia for cesarean delivery, tetracaine has been supplanted by bupivacaine as the spinal agent of choice for cesarean delivery.
Side effects of spinal anesthesia include those related to systemic hypotension–associated medullary/pontine hypoperfusion (e.g., unconsciousness, respiratory/cardiac arrest, N/V) as well as those related to post–dural puncture headache (e.g., tinnitus, blurry vision, occipitofrontal cephalgia).
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether tetracaine crosses the human placenta. Considering the dose and route, it is unlikely the maternal systemic concentration will reach a clinically relevant level. Rodent teratogenicity studies have not been performed.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether tetracaine enters human breast milk. Other local anesthetics are excreted. Considering the indication and dosing, one-time tetracaine use is unlikely to pose a clinically significant risk to the breastfeeding neonate.
Drug Interactions Avoid use with a sulfonamide.
References Pan PM, Lin ZF, Lim J, et al. Ma Zui Xue Za Zhi 1989; 27:349-52.
Summary Pregnancy Category: C
Lactation Category: S

  • Although supplanted by bupivacaine for cesarean delivery, tetracaine is still a popular agent for spinal anesthesia for longer surgical procedures.

Tetracycline — (Achromycin; Acrimicina; Actisite; Ala-Tet; Alphacycline; Ambramycin; Austramycin; Bekatetracyn; Biocycline; Bristacycline; Brodspec; Cofarcilina; Cyclopar; Emtet-500; Hydracycline; Maviciclina; Nelmicyn; Nor-Tet; Panmycin; Polfamycine; Robitet; Sarocycline; Sumycin; Supramycin; Tega-Cycline; Teline; Telmycin; Tetocyn; Tetracap; Tetrachel; Tetraciclina; Tetracitro-S; Tetracon; Tetracyn; Tetralan; Tetram; Tetramed; Topicycline; Upcyclin; Wesmycin; Wintellin; Wintrex; Xepacycline)

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