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Haemophilus influenzae vaccine — (ActHIB; HibTITER; OmniHIB; PedvaxHIB; ProHIBIT)

International Brand Names

Act-HIB (Brazil, Canada, Chile, Ecuador, Korea, Paraguay, Peru, Uruguay); HIBest (France, India); HibTITER (Austria, Belgium, Denmark, England, Germany, Ireland, Italy, New Zealand, South Africa, Switzerland); Pedvax HIB (Brazil, Canada)

Drug Class Vaccines
Indications Maternal susceptibility
Mechanism Immunization to capsular polysaccharides
Dosage With Qualifiers Haemophilus influenzae B susceptibility—0.5 mg IM × 1

  • Contraindications —hypersensitivity to drug or class, hypersensitivity to diphtheria vaccine or thimerosal, acute febrile illness

  • Caution —immunosuppression

Maternal Considerations Haemophilus influenzae conjugate vaccine is a combination of capsular polysaccharides purified from HIB; it protects only against the B strain. There are no adequate reports or well-controlled studies in pregnant women. Maternal immunization does not interfere with subsequent neonatal immunization. Haemophilus influenzae conjugate vaccine is not contraindicated in women with HIV.
Side effects include erythema, allergic reaction, and fever.
Fetal Considerations There are no adequate reports or well-controlled studies of H. influenzae conjugate vaccine in human fetuses. The H. influenzae antibodies generated cross the placenta providing passive immunity. In two studies, it effectively produced passive immunity in the newborn after administration to women during the third trimester. Maternal malnutrition may reduce placental transfer. Although animal studies have not been conducted, there is no evidence the vaccine components either cross the placenta or pose a risk to the human fetus.
Breastfeeding Safety There is no published experience with H. influenzae conjugate vaccine in nursing women. It is certainly possible H. influenzae antibodies enter human breast milk. It is unknown whether they convey any protection to the nursing newborn.
Drug Interactions No impairment of antibody response to the individual antigens of H. influenzae conjugate vaccine was demonstrated in children 2–20 mo of age given the vaccine at the same time but at separate sites as DTP plus OPV.
References Baril L, Briles DE, Crozier P, et al. Clin Exp Immunol 2004; 135:474-7.
Calvalcante RS, Kopelman BI, Costa-Carvalho BT. Braz J Infect Dis 2008; 12:47-51.
Nahm MH, Glezen P, Englund J. Vaccine 2003; 21:3393-7.
Salam RA, Das JK, Dojo Soeandy C, et al. Cochrane Database Syst Rev 2015; 6:CD009982.
Yamauchi K, Hotomi M, Billal DS, et al. Vaccine 2006; 24:5294-9.
Summary Pregnancy Category: C
Lactation Category: S (likely)

  • An apparently useful tool for the reduction of neonatal H. influenzae infections in some populations.

Halcinonide topical — (Dermalog; Halog; Halog-E)

International Brand Names

Adcortin (Japan); Berodan (Korea); Cortilate (India); Dermalog Simple Al (Mexico); Halciderm (Costa Rica, El Salvador, England, Guatemala, Honduras, Ireland, Italy, Nicaragua, Panama, Peru, Switzerland); Halciderm Crema Al (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama); Halcimat (Germany); Halog (Austria, Brazil, Canada, Denmark, France, Hong Kong, India, Indonesia, Norway, Venezuela); Volog (Israel, South Africa, Turkey)

Drug Class Corticosteroids, topical; Dermatologics
Indications Steroid-responsive dermatitis
Mechanism Unknown
Dosage With Qualifiers Steroid-responsive dermatitis—apply to affected area bid or tid
NOTE: Available in cream, ointment, and salve, 0.25% and 0.1%.

  • Contraindications —hypersensitivity to drug or class

  • Caution —unknown

Maternal Considerations There is no published experience with halcinonide during pregnancy. Halcinonide reduces scar formation.
Side effects include adrenal suppression, burning, itching, contact dermatitis, folliculitis, dry skin, acne, perioral dermatitis, infection, and skin atrophy.
Fetal Considerations Although there are no adequate reports or well-controlled studies in human fetuses, the quantity of halcinonide absorbed systemically is unlikely to pose a risk to the fetus even if it does cross the placenta. Though some corticosteroids are teratogens in some rodents, there is no substantive evidence they act as teratogens in humans.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether halcinonide enters human breast milk. Some nonfluoridated and fluoridated corticosteroids enter human breast milk with M:P ratios ranging between 0.05 and 0.25.
Drug Interactions No clinically relevant interactions identified.
References There is no published experience in pregnancy or during lactation.
Summary Pregnancy Category: C
Lactation Category: S (likely)

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

Halobetasol topical — (Ultravate)

International Brand Names

Ultravate (Canada)

Drug Class Corticosteroids
Indications Steroid-responsive dermatitis, psoriasis
Mechanism Unknown
Dosage With Qualifiers Steroid-responsive dermatitis—apply qd or bid; max 50 g/w
NOTE: Available in cream or ointment.

  • Contraindications —hypersensitivity to drug or class

  • Caution —unknown

Maternal Considerations There is no published experience with halobetasol during pregnancy. Human and animal studies indicate about 2% of the applied cream dose (3% ointment) enters the circulation within 96 h of topical administration.
Side effects include adrenal suppression, burning, itching, contact dermatitis, folliculitis, dry skin, acne, perioral dermatitis, infection, and skin atrophy.
Fetal Considerations Although there are no adequate reports or well-controlled studies in human fetuses, the quantity of halobetasol absorbed systemically is unlikely to pose a risk to the fetus even if it does cross the placenta. Though some corticosteroids are teratogens in rodents, there is no substantive evidence they act as teratogens in humans. When given systemically to rodents at doses that are multiples of the MRHD, halobetasol is associated with embryotoxicity, cleft palate, and abdominal wall defects.
Breastfeeding Safety There is no published experience in nursing women. It is unknown whether halobetasol enters human breast milk. Considering the dose and route, it is unlikely the milk concentration will reach a clinically relevant level. Some nonfluoridated and fluoridated corticosteroids enter human breast milk with M:P ratios ranging between 0.05 and 0.25.
Drug Interactions No clinically relevant interactions identified.
References There is no published experience in pregnancy or during lactation.
Summary Pregnancy Category: C
Lactation Category: S (likely)

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

Haloperidol — (Einalon; Haldol; Haloperidol Lactate; Pacedol; Pericate; Seranase)

International Brand Namess

Alased (Greece); Aloperidin (Greece); Apo-Haloperidol (Canada, Malaysia); Avant (Taiwan); Binison (Taiwan); Brotopon (Japan); Cereen (South Africa); Cizoren (India); Depidol (India); Dores (Indonesia); Dozic (England); Duraperidol (Germany); Einalon S (Japan); Govotil (Indonesia); Haldol (Austria, Belgium, Brazil, Bulgaria, Chile, Costa Rica, Denmark, Dominican Republic, Ecuador, El Salvador, England, France, Germany, Guatemala, Honduras, Hong Kong, Indonesia, Ireland, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Sweden, Switzerland, Taiwan, Thailand); Halidol (India, Israel); Halojust (Japan); Halomed (Thailand); Halo-P (Thailand); Haloper (Czech Republic, Germany, Russia); Haloperil (Mexico); Haloperin (Finland); Halopidol (Argentina, Colombia); Halopol (Thailand); Halosten (Japan); Haricon (Thailand); Haridol-D (China); Inin (Taiwan); Linton (Japan); Lodomer-2 (Indonesia); Mixidol (Japan); Motivan (Malaysia); Novoperidol (Canada); Peluces (Japan); Perida (Thailand); Peridol (Canada, China, Korea); Peridor (Israel); Selezyme (Japan); Seranace (England, South Africa); Serenace (Bangladesh, Indonesia, Ireland, Korea, Pakistan, South Africa, Thailand); Serenase (Belgium, Denmark, Finland, Italy); Serenelfi (Portugal); Sigaperidol (Germany, Switzerland); Trancodol-5 (India); Trancodol-10 (India)

Drug Class Antipsychotics
Indications Psychosis, Tourette’s syndrome
Mechanism Unknown
Dosage With Qualifiers Psychosis—0.5–5 mg PO bid or tid; max 100 mg/d; or 2.5 mg IV/IM q4–8 h
Acute psychosis—0.5–50 mg IV (slow, at 5 mg/min)
Tourette’s syndrome—begin 0.5–1.5 mg PO tid, increase 2 mg/d prn; typically 9 mg/d
NOTE: Available in a depot form ( haloperidol decanoate ), 50–100 mg IM qmo.

  • Contraindications —hypersensitivity to drug or class, CNS depression, coma, Parkinson’s disease

  • Caution —hepatic dysfunction, seizure disorder, thyrotoxicosis, CV disease

Maternal Considerations There are no adequate reports or well-controlled studies of haloperidol in pregnant women. There is, however, a large body of experience during pregnancy suggesting a wide margin of safety. There is one case report of an overdose at 34 w treated symptomatically without detectable adverse effect. There is another case report of neuroleptic malignant syndrome during pregnancy treated successfully with dantrolene and bromocriptine. Haloperidol has also been used to treat chorea gravidarum. It is similar to olanzapine for the treatment of schizophrenia in terms of compliance, symptoms, extrapyramidal symptoms, and overall quality of life, but haloperidol costs significantly less.
Side effects include arrhythmias, seizures, neuroleptic malignant syndrome, tardive dyskinesia, extrapyramidal effects, dystonia, pneumonia, fever, jaundice, insomnia, drowsiness, anxiety, menstrual irregularities, and galactorrhea.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Haloperidol crosses the human placenta (65% of the maternal dose) and can be recovered from neonatal hair. In a series of 188 women who consulted a drug information service after exposure to haloperidol (plus 27 exposed to a similar agent), there was no increase in birth defects, though the preterm birth rate was double that of the matched controls. Two exposed neonates had a limb abnormality. After one maternal overdose, the fetus had an abnormal biophysical profile for 5 d. There is one report of a neonate with transient nephrogenic diabetes insipidus (DI) believed due to fetal exposure. Haloperidol is teratogenic in some rodents. In hamsters, it produces a variety of spinal abnormalities in a dose-dependent fashion.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. Haloperidol enters human breast milk and achieves a relative infant dose of 0.2%–12%. Though the levels in breast milk may be significant, neonatal symptoms have only rarely been described. Breast engorgement, gynecomastia, and lactation may be side effects associated with the use of haloperidol . Alternative agents include risperidone , olanzapine, and aripiprazole .
Drug Interactions An encephalopathic syndrome (characterized by weakness, lethargy, fever, tremulousness and confusion, extrapyramidal symptoms, leukocytosis, and elevated serum enzymes, BUN, and fasting glucose) followed by irreversible brain damage is reported in a few patients treated with lithium plus haloperidol. A causal relationship between these events and the concomitant administration of lithium and haloperidol has not been established; however, patients receiving such combined therapy should be monitored closely.
Haloperidol is a substrate of CYP2D6 and CYP3A4, and caution is indicated when used with other substrates and inhibitors of these enzymes.
Carbamazepine may increase haloperidol metabolism and efficacy.
CNS depressants may enhance the effects of haloperidol .
References Akar M, Kasapkara ÇS, Özbek MN, et al. Ren Fail 2014; 36:951-2.
Diav-Citrin O, Shechtman S, Ornoy S, et al. J Clin Psychiatry 2005; 66:317-22.
Gill TS, Guram MS, Geber WF. Dev Pharmacol Ther 1982; 4:1-5.
Hansen LM, Megeriaqn G, Donnenfeld AE. Obstet Gynecol 1997; 90:659-61.
Karageyim AY, Kars B, Dansuk R, et al. J Matern Fetal Neonatal Med 2002; 12:353-4.
Newport DJ, Calamanas MR, DeVane CI, et al. Am J Psychiatry 2007; 164:1214-20.
Rosenheck R, Perlick D, Bingham S, et al. JAMA 2003; 290:2693-702.
Russell CS, Lang C, McCambridge M, Calhoun B. Obstet Gynecol 2001; 98:906-8.
Uematsu T, Yamada K, Matsuno H, Nakashima M. Ther Drug Monit 1991; 13:183-7.
Yoshida K, Smith B, Craggs M, Kumar R. Psychol Med 1998; 28:81-91.
Summary Pregnancy Category: C
Lactation Category: S (likely)

  • Haloperidol is the drug of choice for the treatment of acute or chronic psychosis during pregnancy based on clinical experience and in comparison to its alternatives.

Heparin — (Heparin Flush; Heparin Lok-Pak; Heparin Porcine; Hepflush; Liquaemin Sodium; Sodium Heparin)

International Brand Names

Beparine (India); Helberina (Mexico); Hepaflex (Finland, Norway); Hepalean (Canada); Heparin (Austria, Bulgaria, Czech Republic, England, Finland, Germany, Greece, Hungary, Israel, Norway, South Africa, Sweden, Switzerland); Heparina (Spain); Heparina Leo (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Panama); Heparine (Belgium, Netherlands); Heparine Choay (France); Heparine Novo (Belgium, Netherlands); Heparin Injection B.P. (Australia); Heparin Leo (Canada, Denmark, Hong Kong, Indonesia, Malaysia, New Zealand, Philippines, Taiwan); Heparin Novo (South Africa, Taiwan, Thailand); Heparin Sodium B Braun (Indonesia, Malaysia); Heparin Subcutaneous (New Zealand); Inhepar (Mexico); Inviclot (Indonesia); Liquemin (Germany, Italy, Switzerland); Liquemine (Belgium, Brazil, Ecuador, Uruguay, Venezuela); Monoparin (New Zealand); Multiparin (New Zealand); Parinix (Argentina); Thromboliquine (Israel); Thrombophob (Germany); Thromboreduct (Germany); Uniparin (Australia)

Drug Class Anticoagulants
Indications Thromboembolic disease (treatment, prophylaxis), thrombophilias (prophylaxis), APL syndrome
Mechanism Works synergistically with ATIII to block factor Xa activity
Dosage With Qualifiers Thromboembolic disease (treatment)—80 U/kg IV × 1, then 18 U/kg/h IV to achieve an aPTT 1.5–2 × baseline
Thromboembolic disease (prophylaxis)—5000 U SC bid first trimester, 7500 U SC bid second trimester, 10,000 U SC bid third trimester
Thrombophilias (prophylaxis)—depends on type and history
APL syndrome—81 mg PO qd aspirin plus 5000 U SC bid first trimester, 7500 U SC bid second trimester, 10,000 U bid third trimester
NOTE: May need to adjust the dose upward for morbid obesity (> 120 kg).

  • Contraindications —hypersensitivity to drug or class, active bleeding except DIC, vascular damage, conduction anesthesia

  • Caution —recent neuraxial anesthesia, severe hypertension, peptic ulcer disease, history of GI bleeding, renal dysfunction

Maternal Considerations Heparin consists of sulfated, long-chain acidic mucopolysaccharides with MWs ranging from 4000 to 30,000 Da. The various LMWHs are derivatives. Each is considered an anticoagulant of choice during pregnancy, is equally effective, and has a similar risk profile. Unfractionated heparin has the principal advantage of low cost. Despite the long history of clinical use, there are no adequate reports or well-controlled studies in pregnant women. Perhaps the greatest clinical limitation is the dose volume that must be used considering the relatively dilute concentrations available. Therapeutic heparinization is the prophylaxis of choice for women with a mechanical heart valve. Several systematic reviews have concluded that heparin significantly reduces the recurrence of PE and associated morbidities.
Side effects include hemorrhage, osteoporosis, thrombocytopenia, hematoma, irritation at injection site, ulceration, fever, chills, itching, urticaria, and rhinitis.
Fetal Considerations There are no adequate reports or well-controlled studies in human fetuses. Heparin does not cross the placenta and is not associated with an adverse fetal outcome. However, one study suggests that both heparin and LMWH have the potential to reduce trophoblast invasion.
Breastfeeding Safety There is no published experience in nursing women. Although it is unknown whether heparin enters human breast milk, it seems unlikely considering its high molecular weight (12,000–15,000 daltons).
Drug Interactions May prolong the one-stage PT. Wait at least 5 h after the last IV dose or 24 h after the last SC dose before blood is drawn for a PT in women also taking dicumarol or warfarin.
Aspirin, dextran, dipyridamole, hydroxychloroquine, ibuprofen, indomethacin, phenylbutazone, and other drugs that interfere with platelet aggregation (the main hemostatic defense of heparinized patients) may induce bleeding.
Anticoagulation by heparin is enhanced by treatment with ATIII (human) in patients with hereditary ATIII deficiency.
Digitalis, tetracyclines, nicotine, or antihistamines may partially counteract the anticoagulant action of heparin.
Heparin injection should not be mixed with ciprofloxacin, doxorubicin, droperidol, or mitoxantrone because a precipitate may form.
Heparin , preserved with benzyl alcohol, has been associated with serious adverse events.
References Dodd JM, McLeod A, Windrim RC, Kingdom J. Cochrane Database Syst Rev. 2013; 7:CD006780.
Ganapathy R, Whitley GS, Cartwright JE, et al. Hum Reprod 2007; 22:2523-7.
Kim BJ, An SJ, Shim SS, et al. J Reprod Med 2006; 51:649-54.
Rai R, Cohen H, Dave M, Regan L. BMJ 1997; 314:253-7.
Rodger MA, Carrier M, Le Gal G, et al. Blood 2014; 123:822-8.
Shannon MS, Edwards MB, Long F, et al. J Heart Valve Dis 2008; 17:526-32.
Ulander V, Stenqvist P, Kaaja R. Thromb Res 2002; 106:13.
Summary Pregnancy Category: C
Lactation Category: S

  • Heparin, both unfractionated and fractionated, is the anticoagulant of choice during pregnancy. There are pragmatic reasons to choose one versus the other reflecting indication and the gestational age.

Hepatitis A vaccine — (Havrix; Vaqta)

International Brand Names

Avaxim (Canada, Colombia, England, Hong Kong, Ireland, South Africa, Thailand); Avaxim Pediatric (Canada); Epaxal (Canada, New Zealand, Peru); HAVpur (Germany); Havrix (Austria, Canada, Chile, Costa Rica, Czech Republic, Denmark, Dominican Republic, El Salvador, England, Finland, France, Guatemala, Honduras, Hungary, Ireland, Italy, Netherlands, Nicaragua, Norway, Panama, Paraguay, Peru, Poland, Spain, Sweden, Switzerland, Uruguay, Venezuela); Havrix Junior (Australia, Hong Kong, India, Mexico); Havrix 1440 (Australia, Hong Kong, India, Mexico); Vaqta (Australia, Canada, England, Germany, Ireland, Israel, Mexico)

Drug Class Vaccines
Indications Maternal susceptibility
Mechanism Immune response to inactivated virus
Dosage With Qualifiers HAV susceptibility—1 mL IM, repeat 6–8 mo later

  • Contraindications —hypersensitivity to drug or class, febrile illness

  • Caution —immunosuppression

Maternal Considerations HAV is a picornavirus, and the vaccine consists of inactivated virus. There are no adequate reports or well-controlled studies in pregnant women. There are no reported adverse effects on mother or fetus. Women either traveling to areas where HAV is endemic, older than 30 y with chronic liver disease, waiting for or who have received liver transplants, or working with nonhuman primates should be vaccinated. HAV vaccination of chronic HCV carrier women substantially reduces morbidity and mortality rates. The disease course is typically unaltered by pregnancy, though fulminant hepatitis is reported in the third trimester. Immunoglobulin is a safe alternative for short-term protection.
Side effects include anaphylaxis, local reaction, fever, rash, pharyngitis, abdominal pain, arthralgia, elevated CPK, myalgias, lymphadenopathy, hypertonic episode, photophobia, and vertigo.
Fetal Considerations There are no adequate reports or well-controlled studies of hepatitis A vaccine in human fetuses. HAV is rarely transmitted to the fetus and is not a known teratogen. The antibodies produced in response to vaccination are known to cross the placenta and may provide enhanced protection during the neonatal period. Rodent teratogenicity studies have not been conducted.
Breastfeeding Safety There are no adequate reports or well-controlled studies in nursing women. It is unknown whether hepatitis A vaccine enters human breast milk. It is likely the resulting antibodies do enter breast milk, but it is unknown whether they confer any immunity for the nursing newborn. The vaccine is generally considered compatible with breastfeeding.
Drug Interactions Preliminary results suggest that the concomitant administration of a wide variety of other vaccines is unlikely to interfere with the immune response to hepatitis A vaccine. However, it should be given with a different syringe and at a different injection site when given with other vaccines or IgG.
Administer with caution to individuals on anticoagulant therapy.
References Duff B, Duff P. Obstet Gynecol 1998; 91:468-71.
Jacobs RJ, Koff RS, Meyerhoff AS. Am J Gastroenterol 2002; 97:427-34.
Summary Pregnancy Category: C
Lactation Category: S

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

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