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Dacarbazine — (DTIC-Dome)

International Brand Names

Dacarbazin (Czech Republic); Dacarbazine DBL (Malaysia); Dacarbazine Dome (Denmark); Dacarbazine for Injection (Australia); Dacatic (Finland); Deticene (Czech Republic, France, Greece, Hong Kong, Israel, Italy, Malaysia, Mexico, Netherlands, Portugal, Russia, Switzerland, Turkey); Detimedac (Germany); DTI (Korea); DTIC (Austria, Canada, Germany, Japan, Sweden); D.T.I.C. (Australia); DTIC Dome (Ireland); DTIC-Dome (Belgium, England, Korea, New Zealand, Spain, Switzerland, Taiwan); D.T.I.C.-Dome (South Africa); DTIC-VHB (India)

Drug Class Antineoplastics, alkylating agent
Indications Melanoma, Hodgkin’s disease
Mechanism Primary action likely alkylation of nucleic acids
Dosage With Qualifiers Melanoma, Hodgkin’s disease—numerous dosing schedules depend on disease, response, and concomitant therapy: 375 mg/m 2 ; 850 mg/m 2 ; 250 mg/m 2 /d × 5 d; 2–4.5 mg/kg/d × 10 d; 650–1450 mg/m 2 are the most frequent regimens; intraarterial administration is no longer recommended

  • Contraindications —hypersensitivity to drug or class

  • Caution —hepatic or renal dysfunction

Maternal Considerations There are no adequate reports or well-controlled studies in pregnant women. There are many case reports of dacarbazine use during pregnancy with a good outcome. Dacarbazine is often used in combination with adriamycin , bleomycin , and vinblastine (ABVD) as part of the chemotherapeutic regimen for Hodgkin’s lymphoma. Women who conceive after ABVD experience normal outcomes.
Side effects include leukopenia, alopecia, thrombocytopenia, anorexia, N/V, hepatotoxicity, diarrhea, fever, myalgias, hepatic or renal dysfunction, and photosensitivity.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether dacarbazine crosses the human placenta. No teratogenic effects are described in human fetuses, and long-term follow-up studies of children exposed in utero in the first trimester are reassuring. Dacarbazine is both teratogenic and embryotoxic in rodents when given at multiples of the MRHD.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether dacarbazine enters human breast milk. The small molecular weight suggests ready transport. With a t/2 of less than 6 h, it would be wise to wait 48 h after the last dose before resuming breastfeeding.
Drug Interactions No clinically significant interactions identified.
References Aviles A, Neri N, Nambo MJ. Int J Cancer 2012; 131:2678-83.
Green DM, Zevon MA, Lowries G, et al. N Engl J Med 1991; 325:141-6.
Summary Pregnancy Category: C
Lactation Category: U

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

  • Women of childbearing potential should use contraception during therapy and for at least 4 mo after completion of therapy.

Daclizumab — (Zenapax)

International Brand Names

Zenapax (Argentina, Brazil, Canada, Chile, Colombia, Hong Kong, Israel, Mexico, Paraguay, Peru, Philippines, Taiwan, Uruguay, Venezuela)

Drug Class Immunosuppressants; Monoclonal antibodies
Indications Prevention of transplanted kidney rejection
Mechanism IL-2 receptor antagonist
Dosage With Qualifiers Prevention of transplant rejection—1 mg/kg IV q14d × 5 doses
NOTE: Begin within 24 h of pretransplant; interacts with Echinacea.

  • Contraindications —hypersensitivity to drug or class

  • Caution —unknown

Maternal Considerations Studies of cynomolgus monkeys report no daclizumab -related effects on maternal well-being and indirect fertility end points. It is recommended women of childbearing potential use contraception before and during therapy, and for 4 mo after completion of therapy with daclizumab.
Side effects include pulmonary edema, renal tubular necrosis, N/V, diarrhea, constipation, abdominal or chest pain, dyspepsia, tremor, headache, edema, dizziness, dysuria, dyspnea, fever, acne, and cough.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Of the 38 pregnancies reported in 36 daclizumab -exposed women (on treatment ≤ 6 months from last dose), there were 20 live births and 4 SABs (11%). One congenital heart defect (complex transposition of great vessels) occurred in a live birth where the daclizumab had been discontinued and interferon beta-1a and lisinopril used at conception. Eight women had an EAB, 2 an ectopic pregnancy, 2 lost to follow-up, and 2 outcomes were pending at publication. Studies of cynomolgus monkeys show no daclizumab-related effects on embryo-fetal development and pre- and postnatal development and growth. Though limited, the current information does not suggest daclizumab is a major teratogen.
Breastfeeding Safety There are no published reports in nursing mothers. It is unknown whether daclizumab enters human breast milk. Low levels of daclizumab (0.17%– 0.28% of maternal serum levels) were reported in the breast milk of a few cynomolgus monkeys given a 5- to 10-fold multiple of the maximum human dose.
Drug Interactions In a large clinical study of cardiac transplants, daclizumab as part of an immunosuppression regimen including cyclosporine, mycophenolate mofetil, and corticosteroids was associated with an increase in mortality, particularly in patients receiving concomitant antilymphocyte antibody therapy and in patients who developed severe infections.
References Gold R, Stefoski D, Selmaj K, et al. Neurol Ther. 2016 Jul 13. [Epub ahead of print]
Summary Pregnancy Category: C
Lactation Category: S (possibly)

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

Dactinomycin — (Cosmegen)

International Brand Names

Ac-De (Mexico, Peru); Cosmegen (Argentina, Brazil, Canada, Japan, Korea, Paraguay, Philippines, South Africa, Taiwan, Thailand); Cosmegen Lyovac (England, Hong Kong); Cosmogen (Israel); Cosmogen Lyovac (Hong Kong, Malaysia); Dacmozen (India); Lyovac (England); Trepar (Philippines)

Drug Class Antineoplastics, antibiotics
Indications GTN, Wilms’ tumor, uterine carcinoma, Ewing’s sarcoma
Mechanism Inhibits RNA and protein synthesis
Dosage With Qualifiers GTN—12 mcg/kg IV × 5 d
Wilms’ tumor—15 mcg/kg IV × 5 d
Rhabdomyosarcoma—15 mcg/kg IV × 5 d
Ewing’s sarcoma—protocols vary; most recommend dose should not exceed 15 mcg/kg or 400–600 mcg/m 2 IV qd × 5 d

  • Contraindications —hypersensitivity to drug or class, herpes zoster, varicella infection

  • Caution —hepatic or renal dysfunction (may enhance radiation injury to tissues)

Maternal Considerations Dactinomycin is a derivative of Streptomyces parvulus and extensively used to treat GTN. There are no adequate reports or well-controlled studies of dactinomycin in pregnant women. The impact on future fertility appears low. Although remission rates of 80%–90% are reported for dactinomycin, women with methotrexate- resistant GTN have a much lower remission rate (60%). Prediction of remission may be more closely related to hCG levels than to the WHO score alone. Women successfully treated for gestational trophoblastic disease have uncomplicated pregnancies if they wait at least 6 mo after completing therapy. Under 6 mo, there is an apparent increase in the SAB rate. No deleterious long-term effects are described in women treated with combination regimens that include dactinomycin for germ cell ovarian cancer.
Side effects include aplastic anemia, thrombocytopenia, leukopenia, pancytopenia, flushing, alopecia, acute folliculitis, N/V, fever, lethargy, abdominal pain, myalgias, anorexia, increased LFTs, hepatotoxicity, GI ulceration, pharyngitis, and stomatitis. Tissue necrosis after extravasation may manifest days to weeks after treatment.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether dactinomycin crosses the human placenta. No teratogenic effects are described in humans. In rodents, it is both embryotoxic and teratogenic when given at multiples of the MRHD.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether dactinomycin enters human breast milk. It is generally considered incompatible with breastfeeding. Mothers should wait at least 10 d before resuming breastfeeding.
Drug Interactions Dactinomycin may interfere with bioassay procedures that determine antibacterial drug levels. Concomitant administration of dactinomycin with live vaccines such as MMR, varicella, influenza, or rotavirus should be avoided.
Dactinomycin should not be administered along with radiation therapy or with regional perfusion therapy.
References Chen LM, Lengyel ER, Bethan Powell C. Gynecol Oncol 2004; 94:204-7.
Goldstein DP. Surg Forum 1967; 18:426-8.
Kendall A, Gillmore R, Newlands E. Curr Opin Obstet Gynecol 2002; 14:33-8.
Matsui H, Iitsuka Y, Suzuka K, et al. Gynecol Oncol 2003; 88:104-7.
Matsui H, Suzuka K, Iitsuka Y, et al. Gynecol Oncol 2000; 78:28-31.
Nagai K, Ikenoue T, Mori N. J Matern Fetal Med 2001; 10:136-40.
Suzuka K, Matsui H, Iitsuka Y, et al. Obstet Gynecol 2001; 97:431-4.
Summary Pregnancy Category: D
Lactation Category: U

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

Dalteparin — (Fragmin)

International Brand Names

Fragmin (Brazil, Canada, Chile, Colombia, Ecuador, Hong Kong, India, Japan, Korea, Peru, Philippines, Singapore, South Africa, Taiwan); Fragmine (France); Fragmin P Forte (Germany)

Drug Class Anticoagulants; Low-molecular-weight heparins
Indications Prophylaxis and treatment for DVT, unstable angina
Mechanism Binds to antithrombin III and accelerates its inhibition of thrombin and factor Xa
Dosage With Qualifiers DVT prophylaxis—begin 2500 U SC/IV 1–2 h preoperatively, then qd × 5–14 d; increase dose to 5000 U SC in high-risk women or during pregnancy
DVT treatment—200 U/kg/d SC in divided doses; max 18,000 U/dose, overlap with oral anticoagulation 2–3 d
Unstable angina—120 U/kg; max 10,000 U SC q12h
NOTE: 2500 U SC qd is of similar antithrombotic efficacy to 5000 U of unfractionated heparin bid.

  • Contraindications —hypersensitivity to drug or class, active bleeding, thrombocytopenia, epidural catheters, antibodies to drug, prosthetic heart valve, spinal puncture

  • Caution —diabetic retinopathy, hepatic or renal dysfunction, recent surgery or stroke, pregnancy, GI bleeding

Maternal Considerations Dalteparin is an LMWH (5000 MW) with improved bioavailability, increased plasma elimination t/2, and greater factor Xa inhibitory activity compared with unfractionated heparin. Dalteparin given once or twice daily (IV or SC) is as effective as unfractionated heparin for the initial treatment of acute DVT. LMWHs are increasingly popular during pregnancy for the treatment of various thrombophilias and the antiphospholipid syndrome, though evidence of their efficacy remains limited. LMWHs differ in pharmacologic profiles. The mean retention time of anti-Xa activity varies from 5.2 h ( dalteparin ) to 7 h ( enoxaparin, nadroparin ). The bioavailability of a prophylactic dose of LMWHs ranges from 86% ( dalteparin ) to 98% ( enoxaparin, nadroparin ). Though equal in efficacy and amenable to once-daily dosing for prophylaxis in the nonpregnant patient, they are more expensive than unfractionated heparin and have the same risks. Heparin and heparin products are not treatments for preeclampsia. However, dalteparin daily may lower the risk of recurrence. It does not protect against recurrent pregnancy loss of unknown origin. The therapeutic dose of dalteparin during pregnancy is based on maternal weight. Interpatient variability is wide during pregnancy, and clearance is significantly enhanced. Peak anti-Xa levels occur at 4 h postbolus in pregnancy, compared with 2 h in the nonpregnant state. The mean anti-Xa levels at 12, 24, and 36 w gestation are each significantly reduced 2 h postinjection, compared with the nonpregnant state. The lowest dose-response curve was at 36 w gestation. The initial prophylactic dose for most pregnant women in the first trimester is 5000 U daily. Anti-Xa activity is measured after initiating therapy and again periodically (at least each trimester) to confirm the adequacy of the prophylactic or therapeutic dose. A dose of 5000 U SC should produce an anti-Xa activity of 0.20–0.40 U/mL (0.4–0.7 U/mL for full anticoagulation) 3 h after injection. Women treated with LMWHs for the prevention of thromboembolic complications are at risk of developing an epidural or spinal hematoma after neuraxial anesthesia. It is prudent to wait at least 12 h after the removal of an epidural catheter before reinitiating LMWH. LMWHs are best replaced with unfractionated heparin at 36 w because of their long t/2s and inability to rapidly measure residual activity (anti-Xa levels). One prospective study of bone density in women receiving LMWH found no significant change in mean bone density between baseline and 6 w postpartum. Another suggested any decrease was consistent with the normal decline associated with pregnancy.
Side effects include bleeding, thrombocytopenia, fever, pruritus, osteoporosis, easy bruising, epistaxis, injection site reaction, and elevated LFTs.
Fetal Considerations Dalteparin, similar to other LMWHs and unfractionated heparin, does not cross the placenta. It is generally safe and effective for the noted indications during pregnancy. Rodent studies are reassuring, revealing no evidence of teratogenicity despite the use of doses higher than those used clinically.
Breastfeeding Safety Only trace amounts of dalteparin (2500 U × 1 IU and measured as anti-Xa activity) enter human breast milk. Considering the amount and the low oral absorption it is highly unlikely that puerperal treatment would have any clinically relevant effect on the nursing infant.
Drug Interactions Dalteparin should be used with care in patients receiving oral anticoagulants, platelet inhibitors, and thrombolytic agents because of increased risk of bleeding.
References Barbour LA, Oja JL, Schultz LK. Am J Obstet Gynecol 2004; 191:1024-9.
Blomback M, Bremme K, Hellgren M, Lindberg H. Blood Coagul Fibrinolysis 1998; 9:343-50.
Carlin AJ, Farquharson RG, Quenby SM, et al. Hum Reprod 2004; 19:1211-4.
Dunn CJ, Jarvis B. Drugs 2000; 60:203-37.
Ensom MH, Stephenson MD. J Soc Gynecol Investig 2004; 11:377-83.
Farquharson RG, Sephton V, Quenby SM. J Soc Gynecol Investig 2003; 10(Suppl):308A.
Laurent P, Dussarat GV, Bonal J, et al. Drugs 2002; 62:463-77.
Mastrolia SA, Novack L, Thachil J, et al. Thromb Haemost 2016; 116. [Epub ahead of print]
Mello G, Parretti E, Fatini C, et al. Hypertension 2005; 45:86-91.
O’Shaughnessy DF. Hematology 2000; 4:373-80.
Rey E, Rivard GE. Int J Gynaecol Obstet 2000; 71:19-24.
Richter C, Sitzmann J, Lang P, et al. Br J Clin Pharmacol 2001; 52:708-10.
Rodgers MA, Kahn SR, Cranney A, et al. J Thromb Haemost 2007; 5:1600-8.
Samama MM, Gerotziafas GT. Semin Thromb Hemost 2000; 26(Suppl 1):31-8.
Schleussner E, Kamin G, Seliger G, et al; ETHIG II group. Ann Intern Med 2015; 162:601-9.
Sephton V, Farquharson RG, Topping J, et al. Obstet Gynecol 2003; 101:1307-11.
Ulander V, Stenqvist P, Kaaja R. Thromb Res 2002; 106:13.
Summary Pregnancy Category: B
Lactation Category: S

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

  • The possibility of once-daily administration and the reduced need for laboratory monitoring may translate into a cost advantage compared with unfractionated heparin or warfarin. Unfortunately, this is not true during pregnancy, where the increased clearance generally necessitates twice-daily dosing and serial measurement of anti-Xa activity.

  • Dalteparin may reduce the risk of recurrent preeclampsia.

  • LMWHs are best replaced with unfractionated heparin at around 36 w because of their long t/2s, possible need for surgical delivery and/or neuraxial anesthesia, and inability to quickly obtain anti-Xa levels.

  • LMWHs may have lower frequencies of thrombocytopenia and osteoporosis compared with unfractionated heparin.

Danazol — (Danocrine; Danatrol; Danogen; Danokrin; Ectopal; Zoldan-A)

International Brand Names

Anargil (Hong Kong, Malaysia, Thailand); Azol (Australia, Malaysia, Taiwan); Bonzol (Japan); Cyclomen (Canada); Danasin (Turkey); Danatrol (Belgium, France, Greece, Italy, Netherlands, Portugal, Spain, Switzerland); Danazol (Korea, Poland); Danazol Jean Marie (Hong Kong); Danazol-Ratiopharm (Germany); Danocrine (Australia, Denmark, Finland, Hong Kong, Indonesia, Israel, Norway, Sweden); Danodiol (Egypt, Ghana, Iran, Iraq, Kenya, Kuwait, Mauritius, Puerto Rico, Tanzania); Danogar (Chile); Danogen (India, Russia); Danokrin (Austria); Danol (Czech Republic, England, Hungary, Ireland, Israel); Danoval (Bulgaria, Hungary, Poland); Danzocurine (Korea); Dorink (Taiwan); D-Zol (New Zealand); Ectopal (Taiwan, Thailand); Gonablok (India); Kendazol (Mexico); Ladazol (South Africa); Ladogal (Argentina, Bolivia, Brazil, Canada, Chile, Colombia, Ecuador, Malaysia, Mexico, Paraguay, Peru, Philippines, Taiwan, Thailand, Uruguay, Venezuela); Nazol (Malaysia); Norciden (Mexico); Vabon (Malaysia, Thailand); Winobanin (Germany); Zendol (India); Zoldan-A (Mexico)

Drug Class Hormones, other gynecologic
Indications Endometriosis, fibrocystic breast disease, hereditary angioedema
Mechanism Suppression of the pituitary-ovarian axis
Dosage With Qualifiers Endometriosis—begin 200–400 mg PO bid depending on severity; continue for 3- to 6-mo trial
Fibrocystic breast disease—50–200 mg PO bid for 2–6 mo, then adjust dose
Hereditary angioedema—200 mg PO tid until response, then half dose for 1–3 mo
NOTE: Begin during menstruation.

  • Contraindications —hypersensitivity to drug or class, undiagnosed genital bleeding, pregnancy, breastfeeding, porphyria

  • Caution —hepatic, renal, or cardiac dysfunction, epilepsy, migraine

Maternal Considerations There are no indications during pregnancy for danazol. It should be discontinued if the patient becomes pregnant. Danazol is not an effective contraceptive. It decreases the maternal progesterone level if taken during the first trimester.
Side effects include alteration of the lipid profile (low HDL), contraceptive failure, pseudotumor cerebri, weight gain, acne and seborrhea, mild hirsutism, virilization, edema, hair loss, hoarseness, menstrual irregularities, flushing, sweating, vaginal dryness, reduction in breast size, hypertension, anxiety, and thromboembolism.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether danazol crosses the human placenta. Though the FDA classifies danazol as category X, there is no reason a priori to terminate an exposed pregnancy. Danazol can have an androgenic effect on female fetuses (vaginal atresia, clitoral hypertrophy, labial fusion, ambiguous genitalia). Thus exposed fetuses should undergo a detailed ultrasound examination. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Danazol is associated with inhibition of fetal development in rabbits.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether danazol enters human breast milk. It is generally considered contraindicated during breastfeeding.
Drug Interactions Prolongation of PT occurs in patients stabilized on warfarin.
Danazol may cause an increase in carbamazepine.
References Bianchi S, Busacca M, Agnoli B, et al. Hum Reprod 1999; 14:1335-7.
Brunskill PJ. Br J Obstet Gynaecol 1992; 99:212-5.
Igarashi M, Iizuka M, Abe Y, Ibuki Y. Hum Reprod 1998; 13:1952-6.
Kingsbury AC. Med J Aust 1985; 143:410-1.
Rabe T, Kiesel L, Franke C, et al. Biol Res Pregnancy Perinatol 1984; 5:149-52.
Schwartz R. Am J Dis Child 1982; 136:474.
Zayed F, Abu-Heija A. Obstet Gynecol Surv 1999; 54:121-30.
Summary Pregnancy Category: X
Lactation Category: NS (possibly)

  • There are no indications for danazol during pregnancy; it is considered contraindicated.

  • A pregnancy test is recommended immediately prior to initiating therapy.

  • Danazol may virilize a female fetus (vaginal atresia, clitoral hypertrophy, labial fusion, urogenital sinus defect, ambiguous genitalia), but these abnormalities have not been reported if discontinued by 8 w.

Dantrolene — (Danlene; Dantralen; Dantrium; Dantrium IV)

International Brand Names

Anorex (Korea); Dantamacrin (Austria, Bulgaria, Switzerland); Dantrium (Belgium, Canada, Chile, Denmark, England, France, Greece, Ireland, Italy, Japan, Netherlands, Portugal, South Africa); Dantrolen (Austria, Bulgaria, Czech Republic, Russia)

Drug Class Muscle relaxants
Indications Chronic spasticity, malignant hyperthermia
Mechanism Interferes with the release of the calcium from sarcoplasmic reticulum
Dosage With Qualifiers Chronic spasticity—begin 25 mg PO qd; max 400 mg/d
Malignant hyperthermia prevention—4–8 mg/kg/d PO q6–8 h 1–2 d preoperatively with last dose 3–4 h prior to surgery; same dose postcrisis
Malignant hyperthermia crisis—1–2.5 mg/kg IV × 1, may repeat q5min until patient improves; max 10 mg/kg
Neuroleptic malignant syndrome—1 mg/kg IV × 1, repeat until symptoms improve; max 10 mg/kg
NOTE: Monitor LFTs.

  • Contraindications —hypersensitivity to drug or class, cirrhosis

  • Caution —age > 35 y, pulmonary disease, cardiomyopathy

Maternal Considerations There are no adequate reports or well-controlled studies of dantrolene in pregnant women, though it has been used for both the prevention and treatment of acute malignant hyperthermia and neuroleptic malignant syndrome, where it may be lifesaving. However, prevention of malignant hypertension is not usually recommended. Instead, a nontriggering anesthetic should be selected.
Side effects include hepatic dysfunction, pleural effusion, pericarditis, constipation, bowel obstruction, abdominal pain, diarrhea, dizziness, pruritus, vomiting, tachycardia, depression, seizure, headache, aplastic anemia, and myalgia.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It readily crosses the placenta, achieving equal maternal and fetal whole blood levels by delivery. No adverse neonatal effects are reported. Dantrolene is embryocidal in rodents when administered at a multiple of the MRHD.
Breastfeeding Safety Dantrolene is excreted in human breast milk and achieves a relative infant dose of 7.9%. The highest concentration in human breast milk is seen 36 h after the first dose. It may be wise to stop breastfeeding for 2 d.
Drug Interactions Binding to plasma proteins is reduced by warfarin and clofibrate, and increased by tolbutamide.
The combination of IV dantrolene and calcium channel blockers, such as verapamil, should not be used for the management of malignant hyperthermia until further research is completed.
May potentiate vecuronium -induced neuromuscular block.
Use with CNS depressants such as sedatives and tranquilizing agents may increase drowsiness.
Increased toxicity when used along with estrogens.
References Ben Abraham R, Cahana A, Krivosic-Horber RM, Perel A. Q J Med 1997; 90:13-8.
Fricker RM, Hoerauf KH, Drewe J, Kress HG. Anesthesiology 1998; 89:1023-5.
Russell CS, Lang C, McCambridge M, Calhoun B. Obstet Gynecol 2001; 98:906-8.
Shime J, Gare D, Andrews J, Britt B. Am J Obstet Gynecol 1988; 159:831-4.
Summary Pregnancy Category: C
Lactation Category: NS (possibly)

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

  • Dantrolene should not be administered in preparation for surgery or labor and delivery.

Dapsone — (Avlosulfon; Dapsoderm-X; Dapson)

International Brand Names

Avlosulfon (Canada); Daps (Argentina); Dapsoderm-X (Mexico); Dapson (Denmark, Egypt, Netherlands, Norway, Sweden); Dapsona (Paraguay); Dapsone (Australia); Dapson-Fatol (Germany); Diaphenylsulfon (Hungary, Netherlands); Disulone (Czech Republic, Poland); Dopsan (Thailand); Lennon-Dapsone (South Africa); Lepravir (Philippines); Novasulfon (Mexico); Protogen (Japan); Servidapsone (Thailand); Sulfona (Portugal, Spain)

Drug Class Antimycobacterials
Indications PCP, dermatitis herpetiformis, malaria suppression, leprosy
Mechanism Bactericidal/bacteriostatic by competing with para-aminobenzoic acid and inhibits folic acid synthesis
Dosage With Qualifiers PCP—100 mg PO qd; usually given with trimethoprim (20 mg/kg qd × 3 w)
Dermatitis herpetiformis—begin 50 mg PO qd, increase to 300 mg qd as needed
Malaria suppression—100 mg PO qw, give with pyrimethamine 12.5 mg PO qw
Leprosy prophylaxis—100 mg PO qd × 24 mo
Leprosy treatment—50 mg PO qd
Acne—5% gel applied bid

  • Contraindications —hypersensitivity to drug or class

  • Caution —cardiac, renal, or hepatic dysfunction, G6PD deficiency

Maternal Considerations There are no adequate reports or well-controlled studies of dapsone in pregnant women. However, dapsone, alone or in combination with pyrimethamine, trimethoprim-sulfamethoxazole, or pentamidine, is the most commonly used drug for PCP prophylaxis. Dapsone is often administered in combination with one or more antileprosy drugs to avoid resistance. Dapsone is frequently considered during pregnancy in areas where P. falciparum resistance to chloroquine and pyrimethamine - sulfadoxine is rapidly increasing. Mild degrees of hemolysis occur consistently with continued therapy but may be less likely with intermittent treatment. Most reported adverse effects have occurred after long-term use.
Side effects include hemolysis, aplastic anemia, peripheral neuropathy, N/V, abdominal pains, pancreatitis, vertigo, blurred vision, tinnitus, insomnia, fever, headache, fatigue, malaise, psychosis, pulmonary eosinophilia, albuminuria, nephrotic syndrome, renal papillary necrosis, exfoliative dermatitis, erythema multiforme, toxic epidermal necrolysis, phototoxicity, drug-induced lupus-like syndrome, and infectious mononucleosis–like syndrome.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Transfer across the human placenta likely occurs, as there are reports of neonatal methemoglobinemia after maternal dapsone. Dapsone appears unassociated with fetal abnormalities in humans. Of 924 reported cases of fetal dapsone exposure, 2 congenital abnormalities were observed but lacked any clear causal association. Animal studies have revealed no evidence of teratogenicity.
Breastfeeding Safety Dapsone is excreted in breast milk in substantial amounts, achieving a relative infant dose of 6.3%–22.5%. Hemolytic anemia has been reported at least once. Dapsone may be compatible with breastfeeding, but caution is advised. Dapsone should be avoided in infants at risk for G6PD deficiency or hyperbilirubinemia. Breastfeeding is contraindicated in HIV-infected nursing women where formula is available to reduce the risk of neonatal transmission.
Drug Interactions Rifampin lowers dapsone 7- to 10-fold by enhancing plasma clearance.
Folic acid antagonists such as pyrimethamine may increase the likelihood of hematologic reactions.
Amprenavir , trimethoprim , delavirdine , and probenecid increase dapsone levels.
References Bhargava P, Kuldeep CM, Mathur NK. Int J Lepr Other Mycobact Dis 1996; 64:457-8.
Brabin BJ, Eggelte TA, Parise M, Verhoeff F. Drug Saf 2004; 27:633-48.
Braunstein I, Werth V. Dermatol Ther 2013; 26:354-63.
Butler DC, Helier MM, Murase JE. J Am Acad Dermatol 2014; 70:417.e1-417.e10.
Edstein MD, Veenendaal JR, Newman K, Hyslop R. Br J Clin Pharmacol 1986; 22:733-5.
Erstad BL. Clin Pharm 1992; 11:800-5.
Kabra NS, Nanavati RN, Srinivasan G. Indian Pediatr 1998; 35:553-5.
Kahn G. J Am Acad Dermatol 1985; 13:838-9.
Lush R, Iland H, Peat B, Young G. Aust N Z J Med 2000; 30:105-7.
Summary Pregnancy Category: C
Lactation Category: NS (possibly)

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

  • Hemolysis in neonates is the most common adverse effect seen in patients with or without G6PD deficiency.

Daunorubicin — (Cerubidine; DaunoXome)

International Brand Names

Daunoxome (Sweden)

Drug Class Antineoplastics, antibiotics
Indications HIV-associated Kaposi’s sarcoma, AML, acute lymphoblastic leukemia
Mechanism Inhibits topoisomerase and binds DNA
Dosage With Qualifiers Kaposi’s sarcoma—dose varies with protocol; most recommend 40 mg/m 2 IV
AML—dose varies with protocol; most recommend 40 mg/m 2 IV
Acute lymphoblastic leukemia—dose varies with protocol; most recommend 40 mg/m 2 IV

  • Contraindications —hypersensitivity to drug or class

  • Caution —hepatic, renal, or cardiac dysfunction; myelosuppression

Maternal Considerations Daunorubicin is an anthracycline antibiotic. DaunoXome is an encapsulated form designed to maximize selectivity for solid tumors such as Kaposi’s sarcoma. The specific mechanism by which the daunorubicin citrate liposome delivers the drug to solid tumors is not known. It is also commonly used in combination with other drugs for the treatment of breast cancer. It has been well studied in combination with cytarabine for AML treatment. There are no adequate reports or well-controlled studies of daunorubicin in pregnant women. There are multiple reports of its use during pregnancy with a successful outcome.
Side effects include bone marrow suppression, hepatic and cardiac toxicity, alopecia, N/V, diarrhea, mucositis, back pain, flushing, chest tightness, fever, and local tissue necrosis at the site of drug extravasation.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Daunorubicin crosses the human placenta, but in the isolated perfused model the global transfer was < 3%. Not surprisingly, there are multiple reports of its use during pregnancy, including during the first trimester, either without evidence of an adverse fetal effect or, on occasion, with a report of anemia, thrombocytopenia, and neutropenia. Though children (and presumably fetuses) have greater sensitivity to the cardiotoxic effects of daunorubicin than do adults, there are no such reports in exposed fetuses. Follow-up of fetuses exposed to fluorouracil, doxorubicin, and cyclophosphamide (FAC) for the treatment of breast cancer until age 7 is reassuring. Rodent studies reveal, at doses a fraction of those used in the human, an increased prevalence of anophthalmia, microphthalmia, and incomplete ossification when given alone, and esophageal atresia with tracheoesophageal fistula if daunorubicin is combined with doxorubicin.
Breastfeeding Safety Daunorubicin is excreted into human breast milk, but in the only case reported, the total amount delivered in the milk (maximum concentration of active antibiotic: 0.24 mg/L) was low but prolonged. Caution is recommended until additional data are available.
Drug Interactions Concurrent use of daunorubicin with cyclophosphamide increases risk of cardiotoxicity.
Concurrent use of daunorubicin with methotrexate increases risk of liver toxicity.
References Achtari C, Hohlfeld P. Am J Obstet Gynecol 2000; 183:511-2.
Dezube BJ. Expert Rev Anticancer Ther 2002; 2:193-200.
Egan PC, Costanza ME, Dodion P, et al. Cancer Treat Rep 1985; 69:1387-89.
Grohard P, Akbaraly JP, Saux MC, et al. J Gynecol Obstet Biol Reprod (Paris) 1989; 18:595-600.
Kerr JR. Pharmacotherapy 2005; 25:438-41.
Leslie KK. Clin Obstet Gynecol 2002; 45:153-64.
Merei JM, Farmer P, Hasthorpe S, et al. Anat Rec 1997; 249:240-8.
Murthy RK, Theriault RL, Barnett CM, et al. Breast Cancer Res 2014; 16:500.
Summary Pregnancy Category: D
Lactation Category: NS (possibly)

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

Deferoxamine — (Desferal)

International Brand Names

Desferal (Argentina, Brazil, Canada, Chile, China, Hong Kong, India, Indonesia, Korea, Taiwan, Thailand, Venezuela); Desferin (Spain)

Drug Class Antidotes; Chelators
Indications Iron toxicity
Mechanism Chelation
Dosage With Qualifiers Acute iron intoxication—1 g IM × 1, then 500 mg IM q4h × 2, may repeat; do not exceed 6 g/24 h
Chronic iron overload—500–1000 mg IM qd, plus 2000 mg IV (not to exceed 15 mg/kg/h) with each transfused unit of PRBCs

  • Contraindications —hypersensitivity to drug or class, severe renal disease or anuria

  • Cautions —IV route should be used only in instances of CV collapse or with blood transfusion

Maternal Considerations There are no adequate reports or well-controlled studies of deferoxamine in pregnant women. There are case reports of its use during pregnancy and lactation in women with transfusion-dependent homozygous β-thalassemia.
Side effects include ocular disturbances such as blurred vision, cataracts, decreased acuity, color perception, and night vision; injection site irritation; pruritus; tachycardia; hypotension; shock; N/V; diarrhea; and abdominal pain.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether deferoxamine crosses the human placenta. However, there are more than 50 published cases without evidence of adverse fetal effects. One case suggested decreased fetal iron. Rodent studies reveal an increased incidence of delayed ossification and skeletal anomalies when administered at multiples of the MRHD.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether deferoxamine enters human breast milk. Case reports suggest deferoxamine therapy does not alter the iron content of human breast milk.
Drug Interactions Treatment in combination with prochlorperazine may lead to temporary impairment of consciousness.
Imaging results may be distorted by the rapid urinary excretion of deferoxamine -bound gallium-67. Deferoxamine should be discontinued 48 h prior to scintigraphy.
Ascorbic acid may enhance toxicity of deferoxamine.
References Diamantidis MD, Neokleous N, Agapidou A, et al. Int J Hematol 2016; 103:537-44.
Pafumi C, Zizza G, Caruso S, et al. Ann Hematol 2000; 79:571-3.
Pearson HA. J Pediatr Hematol Oncol 2007; 29:160-2.
Perniola R, Magliari F, Rosatelli MC, De Marzi CA. Gynecol Obstet Invest 2000; 49:137-9.
Singer ST, Vichinsky EP. Am J Hematol 1999; 60:24-6.
Surbek DV, Glanzmann R, Nars PW, Holzgreve W. J Perinat Med 1998; 26:240-3.
Summary Pregnancy Category: C
Lactation Category: U

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

Delavirdine — (Rescriptor)

International Brand Names

None identified.

Drug Class Non-nucleoside reverse transcriptase inhibitors; Retrovirals
Indications HIV
Mechanism NNRTI that induces allosteric changes in HIV-1 reverse transcriptase, rendering it incapable of converting viral RNA to DNA
Dosage With Qualifiers HIV—400 mg PO tid

  • Contraindications —hypersensitivity to drug or class

  • Caution —unknown

Maternal Considerations There are no adequate reports or well-controlled studies in pregnant women. Because delavirdine increases the plasma concentrations of several protease inhibitors, it may also be beneficial as a component of salvage therapy in combination with protease inhibitors.
Side effects include skin rash (up to 20%), angioedema, Stevens-Johnson syndrome, anemia, GI bleeding, pancreatitis, thrombocytopenia, neutropenia, pancytopenia, granulocytosis, fatigue, N/V, diarrhea, abdominal pain, hematuria, dry skin, elevated LFTs, flulike symptoms, bradycardia, headache, anxiety, and edema.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether delavirdine crosses the human placenta. In rodents, delavirdine causes embryotoxicity and VSDs at doses that are multiples of the MRHD.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether delavirdine enters human breast milk. Breastfeeding is contraindicated in HIV-infected nursing women where formula is available to reduce the risk of neonatal transmission.
Drug Interactions Delavirdine has numerous recognized and predicted drug interactions. All prescribers should review the package insert before adding a new drug.
Delavirdine inhibits the metabolism of many drugs (e.g., antiarrhythmics, calcium channel blockers, sedative-hypnotics, and others), and serious and/or life-threatening drug interactions may result from the inappropriate use of some drugs. Further, some drugs markedly reduce delavirdine plasma concentrations, resulting in suboptimal antiviral activity and the emergence of drug resistance.
Inhibits CYP3A and to a lesser extent CYP2C9, CYP2D6, and CYP2C19. Administration with drugs primarily metabolized by CYP3A (e.g., HMG-CoA reductase inhibitors and sildenafil ) may increase plasma levels of the co-administered drug and may increase or prolong both therapeutic and adverse effects.
Use of lovastatin or simvastatin is not recommended, and caution should be exercised if delavirdine must be used with other HMG-CoA reductase inhibitors also metabolized by CYP3A4 (e.g., atorvastatin, cerivastatin ). The risk of myopathy, including rhabdomyolysis, may increase when delavirdine is used in this circumstance.
The use of St. John’s wort with NNRTIs, including delavirdine, may substantially decrease NNRTI concentrations and lead to the loss of virologic response and the emergence of resistance to delavirdine or to the class of NNRTIs.
Use with drugs that induce CYP3A, such as rifampin and rifabutin, may decrease delavirdine plasma concentrations, reduce its therapeutic effect, and increase the chance of resistance to this class of NNRTIs. Not surprisingly, drugs that inhibit CYP3A may increase delavirdine plasma concentrations.
Phenytoin, phenobarbital, and carbamazepine may lead to loss of virologic response and possible resistance to delavirdine or to the class of NNRTIs.
Cisapride, pimozide, astemizole, and terfenadine are contraindicated due to the potential for serious and/or life-threatening reactions such as cardiac arrhythmias.
Dihydroergotamine, ergonovine, ergotamine, and methylergonovine may cause serious and/or life-threatening reactions such as acute ergot toxicity characterized by peripheral vasospasm and ischemia of the extremities and other tissues.
Use with nifedipine -like calcium channel antagonists is contraindicated, as it may trigger serious and/or life-threatening reactions such as cardiac arrhythmias.
Administration of didanosine (buffered tablets) and delavirdine should be separated by at least 1 h.
A dose reduction of either saquinavir or indinavir should be considered when given with delavirdine.
Delavirdine may increase the concentrations of amiodarone, bepridil, clarithromycin, cyclosporine, flecainide, lidocaine (systemic), methadone, quinidine, propafenone, rapamycin, tacrolimus, and warfarin.
Delavirdine increases immunosuppressant concentrations.
References Watts H. Curr HIV/AIDS Rep. 2007; 4:135-40.
Summary Pregnancy Category: C
Lactation Category: U

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

  • 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 delavirdine.

Demeclocycline — (Bioterciclin; Clortetrin; Declomycin; Ledermycin)

International Brand Names

Declomycin (Canada); Ledermicina (Italy, Peru); Ledermycin (Australia, Austria, Belgium, England, India, Ireland, Japan, Korea, Netherlands); Ledermycine (France)

Drug Class Antibiotics; tetracyclines
Indications Bacterial infections (gram-negative microorganisms: H. ducreyi (chancroid), Yersinia pestis, Francisella tularensis, P. pestis, P. tularensis, Bartonella, Bacteroides species, Vibrio species , Brucella, E. coli, Enterobacter aerogenes, Shigella, H. influenzae, Klebsiella; gram-positive microorganisms: S. aureus, S. pyogenes, S. faecalis, S. pneumoniae, N. gonorrhoeae, Listeria monocytogenes, Clostridium, B. anthracis, Fusobacterium fusiforme [Vincent’s infection], Rickettsiae, T. pallidum, Actinomyces , amebiasis)
Mechanism Bacteriostatic—inhibits protein synthesis
Dosage With Qualifiers Bacterial infection, amebiasis, rickettsiae—150 mg PO qid or 300 mg PO bid
Gonorrhea—600 mg PO × 1; follow with 300 mg q12h × 4 d
NOTE: Renal dosing.

  • Contraindications —hypersensitivity to drug or class, diabetes insipidus

  • Caution —hepatic or renal dysfunction

Maternal Considerations There are no adequate reports or well-controlled studies of demeclocycline during pregnancy. Outside of pregnancy, demeclocycline may cause a diabetes insipidus–like syndrome (polyuria, polydipsia, and weakness) that is nephrogenic in origin, dose-dependent, and reversible on discontinuation.
Side effects include photosensitization, diabetes insipidus syndrome, pseudotumor cerebri, thrombocytopenia, hemolytic anemia, hepatic or renal dysfunction, increased BUN, glossitis, enterocolitis, acute fatty liver disease, and vaginal candidiasis.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Demeclocycline crosses the placenta with cord concentrations averaging 65% of maternal blood levels. Other tetracyclines may cause a permanent discoloration of the teeth (yellow-gray/brown teeth) when given during the latter half of pregnancy or during childhood prior to 8 y of age. In rodents, exposure to demeclocycline is associated with tooth discoloration. Exposure to other tetracyclines is associated with delayed bone growth.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether demeclocycline enters human breast milk; however, it likely enters human breast milk, as do other tetracyclines, and is generally considered incompatible with breastfeeding.
Drug Interactions Tetracyclines may depress plasma prothrombin activity, necessitating a decrease in anticoagulant dosage.
May interfere with the bactericidal action of penicillins.
May render oral contraceptives less effective. Breakthrough bleeding has been reported.
Serum levels may be decreased with food or dairy products.
References Hendeles L, Trask PA. J Am Dent Assoc 1983; 107:12.
Iwamoto HK, Brennan WR. Toxicol Appl Pharmacol 1969; 14:33-40.
Jha VK, Jayachandran C, Singh MK. Vet Res Commun 1989; 13:225-30.
Thomas JP, Bradley EL Jr. Ala J Med Sci 1973; 10:89-97.
Zyngier S, Schmuziger P. Rev Farm Bioquim Univ Sao Paulo 1970; 8:173-6.
Summary Pregnancy Category: D
Lactation Category: NS

  • There are alternative agents that can be used during pregnancy for almost all indications.

Desipramine — (Deprexan; Norpramin; Pertofrane)

International Brand Names

Deprexan (Israel); Nebril (Argentina); Norpramin (Canada, Mexico); Nortimil (Italy); Pertofran (Austria, Belgium, England, France, Netherlands, New Zealand); Petylyl (Bulgaria, Czech Republic, Germany, Poland, Russia)

Drug Class Antidepressants; Tricyclics
Indications Depression
Mechanism Inhibits NE and serotonin reuptake
Dosage With Qualifiers Depression—begin 25–75 mg PO qam, increase gradually to a maximum of 300 mg/d (typical 100–200 mg qd)

  • Contraindications —hypersensitivity to drug or class, usage of MAOIs in the past 14 d, CAD

  • Caution —heart disease, glaucoma, thyroid disease, seizure disorder

Maternal Considerations Depression is a commonly overlooked and undertreated disorder during pregnancy and the puerperium. Pregnancy is not a reason a priori to discontinue psychotropic drugs. Women with a history of depression are at high risk for recurrence during pregnancy and the puerperium. TCAs continue to be widely used during pregnancy but remain inadequately studied. Desipramine is a metabolite of imipramine. Desipramine lowers the threshold for seizures. There are no adequate reports or well-controlled studies of desipramine in pregnant women. There are marked interindividual differences during pregnancy in the metabolism of TCAs. TCAs are effective for the treatment of postpartum depression.
Side effects include stroke, MI, arrhythmias, thrombocytopenia, seizures, urinary retention, and glaucoma.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Imipramine and desipramine appear to cross the placenta in animals and humans. No evidence of teratogenicity is seen in rhesus monkey fetuses exposed to imipramine despite a high incidence of maternal toxicity and abortion. A large body of study on the impact of in utero exposure to desipramine on postnatal neurologic function is inconclusive.
Breastfeeding Safety Desipramine is excreted in small quantities into human breast milk with a relative infant dose less than 1%. It is not detectable in the blood of breastfeeding newborns. No adverse effects are reported in breastfeeding neonates.
Drug Interactions Metabolized by CYP2D6, and the activity of 2D6 is reduced in 7%–10% of whites (“poor metabolizers”). Poor metabolizers have higher than expected plasma concentrations of TCAs when given usual doses. The increase in plasma concentration may be small or quite large (up to an eightfold increase in the AUC).
The drugs that inhibit CYP2D6 include both those that are not metabolized by the enzyme ( quinidine, cimetidine ) and those that are substrates (other antidepressants, phenothiazines, and the class IC antiarrhythmics propafenone and flecainide ).
All SSRIs (e.g., fluoxetine, sertraline, paroxetine ) inhibit CYP2D6 to varying degrees. The extent to which this interaction creates a clinical problem depends on the degree of inhibition and the pharmacokinetics of the SSRI involved. Caution is indicated in co-administration and in switching from one class to the other.
Close supervision and careful adjustment of dosage are required when desipramine is given concomitantly with anticholinergic or sympathomimetic drugs.
Patients should be warned that their response to alcohol may be exaggerated while taking desipramine .
Both the sedative and anticholinergic effects of the major tranquilizers are additive to those of desipramine.
References Gelenberg AJ, Wojcik JD, Lydiard RB, et al. J Clin Psychiatry 1984; 45:54-9.
Sjoqvist F, Bertilsson L. Adv Biochem Psychopharmacol 1984; 39:359-72.
Stancer HC, Reed KL. Am J Psychiatry 1986; 143:1597-600.
Ware MR, DeVane CL. J Clin Psychiatry 1990; 51:482-4.
Wen SW, Walker M. J Obstet Gynaecol Can 2004; 26:887-92.
Wisner KL, Parry BL, Piontek CM. N Engl J Med 2002; 347:194-9.
Yoshida K, Smith B, Craggs M, Kumar RC. J Affect Disord 1997; 43:225-37.
Summary Pregnancy Category: C
Lactation Category: S (probably)

  • TCAs are effective second-line therapies (behind SSRIs) for postpartum depression.

  • Pregnancy is not a reason a priori to discontinue psychotropic drugs.

Desmopressin — (DDAVP Desmopressin; Octim)

International Brand Names

Adiuretin-SD (Bulgaria, Czech Republic, Hungary, Poland); DDAVP (Brazil, Canada, Chile, Italy, South Africa, Taiwan); DDAVP Desmopressin (Portugal); Defirin (Greece); Desmopressin Nasal Solution (Japan); Desmospray (England, Ireland); Desmotab (England, Ireland); D-VOID (India); Minirin (Austria, China, Denmark, Finland, France, Germany, Israel, Korea, Malaysia, Mexico, Norway, Philippines, Sweden, Switzerland, Taiwan, Turkey); Minirin DDAVP (Greece, Hong Kong, Israel, Italy, Thailand); Minrin (Belgium, Netherlands); Minurin (Spain); Nocutil (England, Ireland); Nucotil nasenspray (Germany); Octim (France); Octostim (Finland, Hong Kong, Korea, Netherlands, New Zealand, Norway, Philippines, Sweden, Switzerland); Octostim Nasal Spray (Korea); Presinex (England, Ireland)

Drug Class Antidiuretics; Hormones
Indications Diabetes insipidus, vWD, factor VIII deficiency, nocturnal enuresis
Mechanism Synthetic analog of hormone arginine vasopressin
Dosage With Qualifiers Diabetes insipidus—10–40 mcg NAS qhs; 1–2 mcg SC/IV bid also acceptable (10 mcg = 40 U) vWD—0.3 mcg/kg IV × 1; alternatively, NAS to provide 300 mcg
Factor VIII deficiency—0.3 mcg/kg IV × 1; alternatively, NAS × 1
Nocturnal enuresis—10–40 mcg NAS qhs

  • Contraindications —hypersensitivity to drug or class, CAD, type IIB vWD

  • Caution —hyponatremia, electrolyte imbalance

Maternal Considerations The metabolic clearance rate of AVP increases fourfold during human pregnancy. As opposed to natural hormone, desmopressin (1-deamino-[8- d -arginine]vasopressin) has no uterotonic action in antidiuretic doses. Management of diabetes insipidus of pregnancy depends on the pathophysiology; forms that lack AVP can be treated with desmopressin , whereas forms that involve resistance to AVP require evaluation of the underlying causes. It is also an effective treatment for women who develop transient diabetes insipidus during late pregnancy and/or the immediate puerperium. Desmopressin is the treatment of choice for most patients with type 1 vWD. Types 2 and 3 are typically unresponsive and best treated with either FFP or concentrates containing von Willebrand factor. There is a high risk of delayed postpartum hemorrhage in vWD type 1, especially during the first week. Desmopressin is effective prophylaxis in responsive women. The risk is independent of the factor VIII level during the third trimester and reflects the rapid clearance of the various factor VIII components postpartum. The risk of postpartum hemorrhage is especially high in women with type 2 or 3 vWD. Hemorrhage may occur up to 5 w postpartum. Administer desmopressin at least 30 min prior to a surgical procedure to maintain hemostasis during the procedure and immediately postoperatively. Maternal desmopressin use reduces and stabilizes plasma osmolality and increases AF volume. It has been proposed as a possible treatment of oligohydramnios and, if given intraamniotically, polyhydramnios.
Side effects include hyponatremia, cerebral edema, rhinitis, flushing, abdominal pain, and thrombotic accidents.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. There is no detectable transfer of desmopressin at therapeutic maternal drug concentrations. No adverse fetal effects are reported when desmopressin is used during human pregnancy. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. In sheep, intraamniotic desmopressin inhibits fetal urination without CV effect or change in fetal swallowing.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. A single study found minimal desmopressin in human breast milk after a single nasal spray. The estimated relative infant dose was < 0.1%. Considering the dose and dosing frequency, it seems unlikely a significant quantity would reach the breastfeeding neonate.
Drug Interactions Large doses of desmopressin may enhance the response to other pressor agents, which dictates careful patient monitoring.
References Ananthakrishnan S. Best Pract Res Clin Endocrinol Metab 2016; 30:305-15.
Brewster UC, Hayslett JP. Obstet Gynecol 2005; 105:1173-6.
Burrow GN, Wassenaar W, Robertson GL, Sehl H. Acta Endocrinol (Copenh) 1981; 97:23-5.
Chediak JR, Alban GM, Maxey B. Am J Obstet Gynecol 1986; 155:618-24.
Davison JM, Sheills EA, Philips PR, et al. Am J Physiol 1993; 264:F348-53.
Kouides PA. Best Pract Res Clin Haematol 2001; 14:381-99.
Kullama LK, Nijland MJ, Ervin MG, Ross MG. Am J Obstet Gynecol 1996; 174:78-84.
Lee CA, Abdul-Kadir R. Semin Hematol 2005; 42:42-8.
Nichols WL, Hultin MB, James AH, et al. Haemophilia 2008; 14:171-232.
Ray JG, Boskovic R, Knie B, et al. Clin Biochem 2004; 37:10-3.
Ross MG, Cedars L, Nijland MJ, Ogundipe A. Am J Obstet Gynecol 1996; 174:1608-13.
Siristatidis C, Salamalekis E, Iakovidou H, Creatsas G. J Matern Fetal Neonatal Med 2004; 16:61-3.
Trigg DE, Stergiotou I, Peitsidis P, Kadir RA. Haemophilia 2012; 18:25-33.
Summary Pregnancy Category: B
Lactation Category: S

  • Desmopressin is effective therapy for women with either diabetes insipidus or type 1 vWD during pregnancy, if necessary, or in the puerperium.

Dexamethasone — (Aeroseb-Dex; Corotason; Curson; Decaderm; Decadron; Decarex; Decaspray; Decofluor; Desigdron; Dexone; Dms; Hexadrol; Isopto; Lebedex; Lozusu; Maxidex; Millicorten; Mymethasone; Predni; Taidon)

International Brand Names

Adrecort (Mexico); Alfalyl (Colombia); Alin (Costa Rica, Dominican Republic, El Salvador, Guatemala, Mexico, Nicaragua, Panama); Artrosone (Spain); BiDexol (Thailand); Cetadexon (Indonesia); Corsona (Indonesia); Cortidex (Indonesia); Cortidexason (Germany); Dabu (Japan); Danasone (Indonesia); Decadran (Spain); Decadron (Argentina, Brazil, Canada, Denmark, Ecuador, Finland, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Netherlands, Norway, Paraguay, Poland, Portugal, Russia, Sweden, Switzerland, Taiwan, Thailand); Decdan (India); Decilone (Philippines); Dectancyl (Israel); Deltafluorene (Malaysia); Desalark (Italy); Desigdron (Philippines); Dexacort (Peru); Dexacortal (Sweden); Dexagel (Taiwan); Dexalien (Uruguay); Dexalocal (Dominican Republic, El Salvador, Guatemala, Honduras, Hong Kong, Switzerland); Dexame (Japan); Dexamed (Malaysia, Singapore); Dexametason (Finland); Dexamethason (Hungary); Dexamethasone (Greece, Israel, New Zealand); Dexamonozon (Germany); Dexano (Thailand); Dexa-P (Thailand); Dexasone (Canada, Hong Kong, Thailand); Dexasone S (Japan); Dexmethsone (Australia, Hong Kong); Dexona (Israel, India); Dextrasone (Malaysia); Dibasona (Mexico); Fortecortin (Austria, Bulgaria, Czech Republic, Germany, Russia, Switzerland); Isopto-Dex (Germany); Isopto-Maxidex (Argentina, Finland, Norway, Paraguay, Sweden); Loverine (Japan); Maxidex (Bulgaria); Mexasone (Singapore); Oftan-Dexa (Finland); Oradexon (Belgium, Chile, Czech Republic, Finland, Greece, Hungary, Indonesia, Israel, Netherlands, Peru, Taiwan, Turkey); Pidexon (Indonesia); Predni-F (Germany); Santenson (Japan); Santeson (Philippines); Sawasone (Japan); Spersadex (Norway); Sterasone (Philippines); Thilodexine (Greece); Vexamet (Philippines); Visumetazone (Italy); Wymesone (India)

Drug Class Corticosteroids
Indications Accelerating fetal lung maturity, adrenal insufficiency, inflammatory states, congenital adrenal hyperplasia, allergic reactions, testing for Cushing’s syndrome, cerebral edema, shock
Mechanism Unknown
Dosage With Qualifiers Prevention of RDS in preterm neonates—6 mg IM q12h × 4 doses
Adrenal insufficiency—0.03–0.15 mg/kg PO/IV/IM qd
Inflammatory states—0.75–9 mg PO/IV/IM qd
Inflammatory ocular—1–2 gtt q1–6 h
Congenital adrenal hyperplasia—0.03–0.15 mg/kg/d in 2–4 divided doses
Allergic reactions—0.75–9 mg PO qd
Diagnostic test for Cushing’s disease—2 mg of dexamethasone PO q6h for 48 h; 24-h urine collection required to calculate 17-hydroxycorticosteroid production
Cerebral edema—10 mg IV, then 4 mg IM q6h
Shock—1–6 mg/kg IV q2–6 h prn
Postoperative N/V—4–5 mg IV
NOTE: Also available in a multitude of preparations for dermatologic and ophthalmologic uses; inhalation: 1 puff = 100 mcg; 3 puffs = 3 – 4 puffs/d. Equivalent doses: dexamethasone 0.75 mg = methylprednisolone 4 mg = hydrocortisone 20 mg.

  • Contraindications —hypersensitivity to drug or class, fungal infections, active untreated infections (however, may be used in patients under treatment for tuberculosis meningitis), and lactation

  • Caution —seizure disorder, diabetes, hypertension, osteoporosis, hepatic dysfunction

Maternal Considerations Dexamethasone is used widely during pregnancy for the acceleration of fetal lung maturity. A comparison of PO (8 mg) versus IM (6 mg) dosing reveals similar bioavailability as determined by the AUC and terminal t/2s. Most large studies conclude the risk of maternal infection in women after PPROM is not increased by dexamethasone. It may transiently cause an abnormal glucose tolerance test and worsens diabetes mellitus. Large doses such as those given to hasten the fetal lung maturation are associated with pulmonary edema, especially when combined with a tocolytic agent in the setting of an underlying infection. Dexamethasone does not reduce the maternal perception of fetal movements and short-term variability. It is not contraindicated in women with severe preeclampsia requiring preterm delivery. Women chronically treated must be monitored closely for hypertension or glucose intolerance and treated with stress replacement doses postoperatively and postpartum. Dexamethasone is an effective antiemetic after general anesthesia for pregnancy termination. There are as yet uncorroborated reports that IV dexamethasone helps modify the clinical course of the so-called HELLP syndrome both ante- and postpartum. It may also reduce itching in women with intrahepatic cholestasis of pregnancy.
Side effects include immunosuppression, pancreatitis, fluid retention, CV failure, pseudotumor cerebri, suppression of growth and development in children, myositis, Cushing’s disease, decreased carbohydrate tolerance, osteoporosis, hepatic dysfunction, thromboembolism, insomnia, and anxiety.
Fetal Considerations Antenatal corticosteroid administration is the only therapy conclusively demonstrated to reduce the perinatal morbidity and death associated with preterm delivery. Newborns of treated women have lower incidences of RDS, NEC, and IVH and shorter hospital stays. Therapy for pulmonary maturity should be limited to no more than two courses. The route of administration is apparently important, as neonatal outcome is worse when dexamethasone is given PO compared with IM. Dexamethasone readily crosses the human placenta unmetabolized. Infants of women treated chronically should be carefully observed for signs of hypoadrenalism. Complete fetal heart block has been treated with dexamethasone with positive result. Some studies suggest that, in contrast to betamethasone, dexamethasone does not alter biophysical parameters of the fetus (i.e., fetal breathing) when administered for lung maturation. However, oligohydramnios is more common. Clinical trials (four trials, 549 infants) directly comparing outcomes of betamethasone to dexamethasone confirm that dexamethasone significantly decreases the risk of IVH with betamethasone . When initiated by 6–7 w, dexamethasone can prevent or diminish virilization due to congenital adrenal hyperplasia. It is continued until a definitive diagnosis is established by fetal DNA analysis. One observational study concluded that children subjected to multiple antenatal doses of dexamethasone for enhancement of pulmonary maturity were more likely to develop leukomalacia and neurodevelopmental abnormalities at 2 y old than were those treated with either betamethasone or single doses of dexamethasone. This remains to be confirmed. Some suggest emotional stress during organogenesis can cause congenital malformations by increasing the level of cortisone. Corticosteroids produce oral clefting in some rodents. Some epidemiologic studies have concluded, after controlling for confounding factors, that prenatal exposure to corticosteroids adds a sixfold increase in the risk for cleft lip with or without cleft palate, IUGR, and shortening of the head and mandible. In contrast, the Collaborative Perinatal Project followed women treated during the first trimester. Although the number of exposures was limited, no increase in congenital malformations was detected. There was no increased risk of anomalies after organogenesis. Antenatal dexamethasone for fetal lung maturation is associated with diminished growth (12 g at 24–26 w, 63 g at 27–29 w, 161 g at 30–32 w, and 80 g at 33–34 w gestation) and decreased myelination in several animal models. The long-term impacts of these effects remain to be established. Corticosteroids (e.g., cortisone ) accelerate fetal rat intestinal maturation, perhaps explaining why corticosteroids decrease the incidence of NEC.
Breastfeeding Safety There are no adequate reports or well-controlled studies in breastfeeding women. It is unclear whether maternal treatment increases the concentration of dexamethasone or cortisone in breast milk. Other corticosteroids like prednisone are poorly transferred to human breast milk.
Drug Interactions Aminoglutethimide may diminish the adrenal suppression produced by corticosteroids.
There are case reports of cardiac enlargement, CHF, and hypokalemia when corticosteroids are administered with potassium-depleting agents such as amphotericin B and diuretics.
Macrolide antibiotics can decrease corticosteroid clearance.
Anticholinesterase agents and corticosteroids may produce severe weakness in patients with myasthenia gravis. When possible, anticholinesterase agents should be withdrawn at least 24 h before initiating corticosteroid therapy.
May reduce the response to warfarin.
May decrease serum concentrations of isoniazid.
Cholestyramine may increase corticosteroid clearance.
The activity of both cyclosporine and corticosteroids may be increased when used together. Convulsions have been reported with this concurrent use.
False-negative results have been reported in patients undergoing a dexamethasone suppression test when also treated with indomethacin.
Ephedrine may increase clearance, decreasing blood levels and lessening physiologic activity.
CYP3A4 inducers (e.g., barbiturates, phenytoin, carbamazepine, rifampin ) may enhance corticosteroid metabolism, requiring an upward dose adjustment.
Inhibitors of CYP3A4 (e.g., ketoconazole, erythromycin ) may increase plasma concentrations of corticosteroids.
A moderate inducer of CYP3A4; use with other drugs metabolized by CYP3A4 (e.g., indinavir, erythromycin ) may increase their clearance, resulting in decreased plasma concentration.
Ketoconazole may decrease the metabolism of corticosteroids by up to 60%, leading to an increased risk of corticosteroid side effects. Further, it alone can inhibit adrenal corticosteroid synthesis and cause adrenal insufficiency during corticosteroid withdrawal.
Use of aspirin and other NSAIDs increases the risk of GI side effects.
The clearance of salicylates may be increased with concurrent use of corticosteroids.
Corticosteroids may suppress reactions to skin tests.
Toxic epidermal necrolysis has been reported when dexamethasone is used with thalidomide.
Patients on corticosteroid therapy may have diminished responses to toxoids and live or inactivated vaccines; routine administration should be deferred until after corticosteroid therapy is discontinued.
References Bloom SL, Sheffield JS, McIntire DD, Leveno KJ. Obstet Gynecol 2001; 97:485-90.
Brownfoot FC, Gagliardi DI, Bain E, et al. Cochrane Database Syst Rev 2013; 8:CD006764.
Crowther CA, Harding JE, Middleton PF, et al. BMC Pregnancy Childbirth 2013; 13:104.
Egerman RS, Mercer BM, Doss JL, Sibai BM. Am J Obstet Gynecol 1998; 179:1120-3.
Egerman RS, Pierce WF 4th, Andersen RN, et al. Obstet Gynecol 1997; 89:276-80.
Egerman RS, Walker, RA, Mercer BM, et al. Am J Obstet Gynecol 1998; 179:1234-6.
Elimian A, Garry D, Figueroa R, et al. Obstet Gynecol 2007; 110:26-30.
Fujii Y, Uemura A. Obstet Gynecol 2002; 99:58-62.
Goldenberg RL, Wright LL. Obstet Gynecol 2001; 97:316-7.
Guinn DA, Atkinson MW, Sullivan L, et al. JAMA 2001; 286:1581-7.
Isler CM, Barrilleaux PS, Magann EF, et al. Am J Obstet Gynecol 2001; 184:1332-7.
Lammert F, Marschall HU, Matern S. Curr Treat Options Gastroenterol 2003; 6:123-32.
Moritz K, Butkus A, Hantzis V, et al. Endocrinology 2002; 143:1159-65.
Mushkat Y, Ascher-Landsberg J, Keidar R, et al. Eur J Obstet Gynecol Reprod Biol 2001; 97:50-2.
Nevagi SA, Kaliwal BB. Indian J Exp Biol 2001; 39:1163-5.
New MI. Curr Urol Rep 2001; 2:11-8.
Ritzen EM. Semin Neonatol 2001; 6:357-62.
Roberts D, Dalziel S. Cochrane Database Syst Rev 2006; (3):CD004454.
Spiliotis BE. J Pediatr Endocrinol Metab 2001; 14:1299-302.
Spinillo A, Viazzo F, Colleoni R, et al. Am J Obstet Gynecol 2004; 191:217-24.
Wong JP, Kwek KY, Tan JY, Yeo GS. Aust N Z J Obstet Gynaecol 2001; 41:339-41.
Summary Pregnancy Category: C
Lactation Category: U

  • Dexamethasone is effective for the reduction of neonatal RDS and other complications of prematurity.

  • There is no evidence of increased benefit after 2 courses; there is some evidence of fetal harm.

Dexchlorpheniramine — (Dexchlor; Dex-Cpm; Mylaramine; Polaramine)

International Brand Names

Dapriton (Hong Kong); Delamin (Taiwan); Destramin (Bulgaria); Dexferin (Taiwan); Isomerine Repetabs (Paraguay); Liramin (Venezuela); Nasamine (Thailand); Polamec (Indonesia); Polamine (Malaysia); Polaramin (Denmark, Italy, Japan, Norway, Sweden); Polaramine (Belgium, Brazil, Colombia, France, Hong Kong, Indonesia, Malaysia, Mexico, Netherlands, Puerto Rico, Spain, Switzerland, Taiwan); Polaramine (non-prescription) (Australia); Polaramine Repetabs (France, Greece); Polaramin Prolongat (Finland); Polaramin Prolongatum (Sweden); Polaramin Prolong Depottab (Norway); Polarist (Indonesia); Polaronil (Austria); Polazit (Japan); Rhiniramine (Singapore); Rhiniramine SR (Hong Kong, Singapore); Somin (Malaysia); Tomin (Taiwan); Trenelone (Portugal)

Drug Class Antihistamines, H 1 ; Decongestants
Indications Allergic rhinitis, anaphylaxis
Mechanism Antagonizes central and peripheral H 1 receptors
Dosage With Qualifiers Allergic rhinitis—2–4 mg PO q4–6 h; max 24 mg/24 h
Anaphylaxis—5–20 mg SC/IM q6–12 h prn; max 40 mg/24 h

  • Contraindications—see Chlorpheniramine

  • Caution—see Chlorpheniramine

Maternal Considerations Dexchlorpheniramine is the active metabolite of chlorpheniramine. There are no adequate reports or well-controlled studies in pregnant women, and its safety during pregnancy is not established. However, chlorpheniramine is widely available in OTC preparations and has not been implicated with adverse effects during pregnancy.
Side effects include hypotension, dry mouth, N/V, and constipation.
Fetal Considerations Dexchlorpheniramine has not been incriminated as a human teratogen. (See Chlorpheniramine. )
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. Dexchlorpheniramine is excreted into human milk but the amounts remain to be detailed. There are no reports of adverse effects on the breastfeeding neonate despite widespread availability.
Drug Interactions May cause severe hypotension when given in conjunction with an MAOI.
Sedative effects are potentiated by alcohol and other sedative drugs.
The action of oral anticoagulants may be inhibited by antihistamines.
References See Chlorpheniramine.
Summary Pregnancy Category: B
Lactation Category: S (probably)

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

Dexmedetomidine — (Precedex)

International Brand Names

Precedex (Israel)

Drug Class Adrenergic agonists; α 2 -agonist, central; Analgesics, non-narcotic; Anesthesia, adjunct; Sedatives
Indications Sedation of ventilated patients
Mechanism Selective α 2 -adrenoceptor agonist
Dosage With Qualifiers Sedation—begin 1 mcg/kg IV over 10 min, then 0.2–0.7 mcg/kg/h IV
Anesthetic adjunct—0.5–0.6 mcg/kg IV
Postoperative pain—0.4 mcg/kg IV
NOTE: Avoid abrupt withdrawal.

  • Contraindications —hypersensitivity to drug or class

  • Caution —CV disease, bradycardia, second- or third-degree heart block, sick sinus syndrome, hypotension, transient hypertension, hypovolemia, diabetes mellitus, hepatic or renal dysfunction, adrenal insufficiency, tachycardia, anemia, thirst

Maternal Considerations There are no adequate reports or well-controlled studies of dexmedetomidine in pregnant women. The results of a small prospective, double-blind RCT suggest a combination of dexmedetomidine and remifentanil may lower labor analgesic requirements and limit nausea and vomiting often associated with opioid analgesia. Dexmedetomidine does not cause respiratory or circulatory depression. Dexmedetomidine enhances rat myometrial contractility in vitro .
Side effects include bradycardia, hypotension, atrial fibrillation, pulmonary edema, pleural effusion, bronchospasm, hypokalemia, leukocytosis, adrenal insufficiency, and N/V.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Dexmedetomidine crosses the human placenta, which also binds a large fraction, delaying transfer. Rodent studies are generally reassuring, revealing no evidence of teratogenicity, though embryotoxicity and IUGR occurs in some models. It is a potent neuroprotector that has been explored in perinatal models.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether dexmedetomidine enters human breast milk. Dexmedetomidine is excreted into rodent milk. Considering its indications and duration of treatment, it is unlikely to pose a clinically significant risk to women who choose to breastfeed.
Drug Interactions Administration with anesthetics, sedatives, hypnotics, and opioids is likely to lead to enhanced effects. This effect has been confirmed with sevoflurane, isoflurane, propofol, alfentanil, and midazolam, though no pharmacokinetic interactions have been demonstrated.
References Abdalla W, Ammar MA, Tharwat Al. Saudi J Anaesth 2015;9:433-8.
Ala-Kokko TI, Pienimaki P, Lampela E, et al. Acta Anaesthesiol Scand 1997; 41:313-9.
Hayashi Y, Maze M. Br J Anaesth 1993; 71:108-18.
Karaman S, Evren V, Firat V, Cankayali I. Adv Ther 2006; 23:238-43.
Laudenbach V, Mantz J, Lagercrantz H, et al. Anesthesiology 2002; 96:134-41.
Peden CJ, Prys-Roberts C. Br J Anaesth 1992; 68:123-5.
Summary Pregnancy Category: C
Lactation Category: U

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

Dexmethylphenidate — (Focalin)

International Brand Names

None identified.

Drug Class CNS stimulants
Indications ADD
Mechanism Unknown; stimulates CNS activity
Dosage With Qualifiers ADD—begin 2.5 mg PO bid; increase by 5–10 mg/d qw, max dose 20 mg/d

  • Contraindications —hypersensitivity to drug or class, history of severe anxiety, glaucoma, motor tics, MAOI use within 14 d

  • Caution —CV disease, hypertension, seizure disorder, psychosis, substance abuse, hyperthyroidism

Maternal Considerations There are no published reports of dexmethylphenidate use during pregnancy. Rodent studies have shown a decrease in maternal gestational weight while taking methylphenidate .
Side effects include seizures, dependency, arrhythmia, angina, thrombocytopenia, leukopenia, nervousness, insomnia, abdominal pain, headache, dizziness, palpitations, blurred vision, anorexia, weight loss, dyskinesia, and rash.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Animal studies have established that amphetamines are transferred across the placenta, but it is unknown whether dexmethylphenidate crosses the human placenta. Rodent studies are reassuring, revealing no evidence of teratogenicity, though delayed ossification is seen at the highest dose level. However, there is concern that antenatal exposure may lead to behavioral abnormalities based on rodent and human study of related drugs ( amphetamine and methamphetamine ).
Breastfeeding Safety There is no published experience in nursing women. Dexmethylphenidate appears to enter human breast milk, but at levels that are clinically irrelevant with an estimated relative infant dose of < 0.05%. Methylphenidate reduces serum prolactin, but the effect of methylphenidate on milk production is unknown. Large dosages of methylphenidate might interfere with milk production in women whose lactation is not well established.
Drug Interactions May decrease the effectiveness of drugs used to treat hypertension. As a result, it should be used cautiously with pressor agents.
May inhibit the metabolism of coumarin anticoagulants, anticonvulsants (e.g., phenobarbital, phenytoin, primidone ), and some antidepressants (TCAs [e.g., imipramine, clomipramine, desipramine ] and SSRIs). Downward dose adjustments may be required.
Serious adverse events have been reported when used with clonidine, though no causality has been established.
Should not be used in patients being treated (currently or within the proceeding 2 w) with MAOIs.
References National Toxicology Program. NTP CERHR MON 2005; (16):vii-III1.
Summary Pregnancy Category: C
Lactation Category: S (probably)

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

Dextroamphetamine — (Amphaetex; Das; Dexampex; Dexedrina; Dexedrine; Dextrostat; Ferndex; Oxydess; Spancap No. 1)

International Brand Names

Dexamphetamini Sulfas (Switzerland); Dexedrine (Canada, England, Ireland); Dexedrine Spansule (Canada)

Drug Class Adrenergic agonists; Amphetamines; CNS stimulants
Indications ADHD, narcolepsy, obesity
Mechanism CNS stimulant
Dosage With Qualifiers ADHD—5 mg PO qd/bid; increase up to 5 mg/w prn, max 40 mg qd
Narcolepsy—10–60 mg PO qd; begin 10 mg PO qd and increase 10 mg/w if necessary
Obesity—5–30 mg PO qd 30 min before breakfast

  • Contraindications —hypersensitivity to drug or class, hypertension, glaucoma, hyperthyroidism, Tourette’s syndrome

  • Caution —mild hypertension

Maternal Considerations There are no adequate reports or well-controlled studies of dextroamphetamine in pregnant women. There are case reports of its use for the treatment of narcolepsy during pregnancy. Because amphetamines are used to decrease appetite and maintain adequate body weight, its usage during pregnancy should be discouraged once pregnancy is diagnosed. Mothers dependent on amphetamines have an increased risk of premature delivery and low infant birth weight.
Side effects include arrhythmia, palpitation, insomnia, irritability, dry mouth, diarrhea, tremor, anorexia, and personality changes.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Amphetamines cross the human placenta. One case report describes severe congenital body deformity, tracheoesophageal fistula, and anal atresia in the newborn of a mother who took dextroamphetamine throughout the first trimester. Epidemiologic study reveals that birth weight is unaffected if discontinued prior to 28 w, but it is significantly lower if discontinued later. Mouse transport is also confirmed (approximately 18% after 1 h). Dextroamphetamine is embryotoxic and teratogenic when administered to some but not all rodents. Infants of amphetamine-dependent mothers may experience withdrawal symptoms such as dysphoria, agitation, and lassitude.
Breastfeeding Safety Amphetamines are excreted in human milk and are generally considered incompatible with breastfeeding.
Drug Interactions GI acidifying agents (e.g., guanethidine, reserpine, ascorbic acid, fruit juices) lower absorption of amphetamines.
Urinary acidifying agents (e.g., ammonium chloride, sodium acid phosphate) increase urinary excretion.
Adrenergic blockers are inhibited by amphetamines.
GI alkalinizing agents (e.g., sodium bicarbonate) increase absorption of amphetamines.
Urinary alkalinizing agents (e.g., acetazolamide, some thiazides) decrease urinary excretion.
Desipramine or protriptyline and possibly other TCAs may cause a striking and sustained increase in the concentration of dextroamphetamine in the brain as well as potentiating CV effects.
MAOIs, as well as a metabolite of furazolidone, slow the metabolism of amphetamines, increasing their effect on NE release and causing headaches and other signs of hypertensive crisis. Fatalities are reported.
Chlorpromazine and haloperidol block dopamine and NE reuptake, inhibiting their central effects. They can be used to treat amphetamine poisoning.
Amphetamines may delay intestinal absorption of ethosuximide.
Amphetamines potentiate the analgesic effect of meperidine.
Urinary excretion of amphetamines is increased, and efficacy is reduced, by acidifying agents used in methenamine.
In cases of propoxyphene overdose, amphetamine CNS stimulation is potentiated and fatal convulsions can occur.
Amphetamines inhibit the hypotensive effect of veratrum alkaloids.
References Briggs GG, Samson JH, Crawford DJ. Am J Dis Child 1975; 129:249-50.
Hoover-Stevens S, Kovacevic-Ristanovic R. Clin Neuropharmacol 2000; 23:175-81.
Naeye RL. Pharmacology 1983; 26:117-20.
Shah NS, Yates JD. Arch Int Pharmacodyn Ther 1978; 233:200-8.
Summary Pregnancy Category: C
Lactation Category: NS

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

  • Dextroamphetamine abuse is common and should be monitored accordingly.

  • There are few indications for dextroamphetamine during pregnancy, which would preclude its temporary cessation.

Dextromethorphan — (Aquabid-Dm; Biophen-Dm; Bio-Tuss Dm; Broncot; Dectuss DM; Equi-Tuss Dm; Fenex Dm; Gani-Tuss-Dm Nr; Genophen-Dm Elixir; Guaibid Dm; Guiadrine Dm; Guaifenesin Dm; Guaifenesin w/Dextromethorphan; Humibid DM; Iodur-Dm; Iofen-Dm Nf; Iogan-Dm; Iophen D-C; Iophen-DM; Io Tuss-Dm; Iotuss-Dm; Mucobid Dm; Muco-Fen-Dm; Myodine Dm; Numobid Dx; Oridol Dm; Pancof-HC; Phenergan w/Dextromethorphan; Phen-Tuss DM; Pherazine DM; Promethazine w/DM; Prothazine; Q-Mibid-Dm; RobafenDm; Roganidin-Dm; Sil-O-Tuss Dm; Sudal-DM; Tosmar Dm; Tri-Onex Dm; Tusnel; Tusside; Tussidin Dm; Tussidin Dm Nr; Tussin Dm; Tussi-Organidin DM; Tussi-Organidin DM NR; Tussi-Organidin DM-S NR; Tussi-R-Gen Dm; Tusso-DM)

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