O - Clinical Tree

Oatmeal — (Aveeno)

International Brand Names

None identified.

Drug Class	Dermatologics
Indications	Contact dermatitis (e.g., poison ivy/oak)
Mechanism	Forms a moisturizing, colloidal suspension
Dosage With Qualifiers	Contact dermatitis—apply tid or qid prn; may also mix in bathwater and soak Contraindications —hypersensitivity to drug or class Caution —unknown
Maternal Considerations	There is no published experience with topical oatmeal during pregnancy. *Side effects* have not been reported.
Fetal Considerations	There are no adequate reports or well-controlled studies of topical oatmeal in human fetuses. Absorption is likely insignificant.
Breastfeeding Safety	There are no adequate reports or well-controlled studies in nursing women. As a traditional food substance, oatmeal is unlikely to pose a clinically significant risk to the nursing infant.
Drug Interactions	No clinically relevant interactions identified.
References	There are no current relevant references.
Summary	Pregnancy Category: A Lactation Category: S

Octreotide acetate — (Sandostatin)

International Brand Names

Sandostatin (Argentina, Brazil, Canada, Chile, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Paraguay, Peru, South Africa, Uruguay, Venezuela); Sandostatina (Italy, Mexico, Portugal); Sandostatina LAR (Colombia, Mexico); Sandostatine (Belgium, France, Netherlands); Sandostatin LAR (Argentina, Brazil, Canada, Chile, Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Korea, Malaysia, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, Uruguay)

Drug Class	Antidiarrheals; Endocrine agents; Gastrointestinals
Indications	Secretory diarrhea, carcinoid tumor, acromegaly, esophageal varices
Mechanism	Somatostatin-like activities include inhibition of GH, LH, insulin, glucagon, and VIP
Dosage With Qualifiers	Secretory diarrhea—50–100 mcg SC/IV qd to tid; max 1500 mcg/d Carcinoid tumor symptoms—50–100 mcg SC/IV qd to tid; max 1500 mcg/d Carcinoid tumor crisis—50 mcg/h IV × 8–24 h acutely; 250–500 mcg IV × 1, 1–2 h preoperatively for prevention Acromegaly—50 mcg SC/IV tid; max 1500 mcg/d Esophageal varices—begin 25–50 mcg IV × 1 for bleeding, then 25–50 mcg/h Contraindications —hypersensitivity to drug or class Caution —biliary disease, renal dysfunction, diabetes mellitus
Maternal Considerations	There are no adequate reports or well-controlled studies in pregnant women. Octreotide has pharmacologic actions that mimic the natural hormone somatostatin but is more potent. There are multiple case reports of octreotide use during pregnancy without obvious adverse maternal effect, typically for the treatment of acromegaly. Depressed vitamin B ₁₂ levels and abnormal Schilling tests are observed in some patients, and monitoring of vitamin B ₁₂ is recommended. *Side effects* include arrhythmias, edema, cholecystitis, cholelithiasis, ascending cholangitis, N/V, diarrhea, steatorrhea, flushing, hyperglycemia, myalgias, arthralgias, and headache.
Fetal Considerations	There are no adequate reports or well-controlled studies in human fetuses. Octreotide crosses the human placenta and can be detected in the newborn at delivery. It does not affect placental GH production. Several case reports describe pregnancy outcomes in women with symptomatic familial hyperinsulinemic hypoglycemia. In each instance, octreotide use was associated with IUGR. In contrast, fetal growth was normal when blood glucose levels were managed through dietary intervention alone (small frequent meals that were high in fiber and low in carbohydrates). The authors suggest octreotide during pregnancy may pose a risk of fetal growth restriction. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically.
Breastfeeding Safety	There are no adequate reports or well-controlled studies in nursing women. Octreotide enters human breast milk, but the reported concentrations are unlikely to have a clinically significant effect on the nursing infant.
Drug Interactions	May alter nutrient absorption and thus impact the absorption of oral drugs. May decrease blood levels of cyclosporine and lead to transplant rejection. Patients receiving insulin , oral hypoglycemic agents, β-blockers, calcium channel blockers, or agents to control fluid and electrolyte balance may require dose adjustments of these agents. Octreotide increases the availability of bromocriptine, possibly by decreasing the metabolic clearance of compounds known to be metabolized by CYP3A4 via the suppression of growth hormones. Because such an effect cannot be excluded for octreotide, drugs metabolized mainly by CYP3A4 and that have a low therapeutic index (e.g., quinidine, terfenadine ) should be avoided or used cautiously.
References	Blackhurst G, Strachan MW, Collie D, et al. Clin Endocrinol 2002; 57:401-4. Caron P, Buscail L, Beckers A, et al. J Clin Endocrinol Metab 1997; 82:3771-6. Caron P, Gerbeau C, Pradayrol L. N Engl J Med 1995; 333:601-2. Castronovo FP Jr, Stone H, Ulanski J. Nucl Med Commun 2000; 21:695-9. Fassnacht M, Capeller B, Arlt W, et al. Clin Endocrinol (Oxf) 2001; 55:411-5. Geilswijk M, Andersen LL, Frost M, et al. Endocrinol Diabetes Metab Case Rep 2017; 2017. pii: 16-0126. Katagiri S, Moon YS, Yuen BH. Hum Reprod 1997; 12:671-6. Maffei P, Tamagno G, Nardelli GB, et al. Clin Endocrinol (Oxf) 2010; 72:668-677. Mikhail N. Mayo Clin Proc 2002; 77:297-8. Skajaa GO, Mathiesen ER, Iyore E, et al. BMC Res Notes 2014; 7:804.
Summary	Pregnancy Category: B Lactation Category: S (probably) Octreotide is considered safe during pregnancy and lactation if the benefit justifies the potential perinatal risk.

Ofloxacin — (Floxin)

International Brand Names

Akilen (Indonesia); Baccidal (Korea); Bactocin (Mexico); Danoflox (Indonesia); Effexin (Korea); Exocin (Ireland); Exocine (France); Flobacin (Italy); Flodemex (Philippines); Flotavid (Indonesia); Flovid (Hong Kong, Malaysia, Philippines); Floxal (Germany); Floxil (Argentina, Mexico); Floxin (Canada); Floxstat (Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Guatemala, Honduras, Mexico, Nicaragua, Panama); Fugacin (Korea); Inoflox (Malaysia, Philippines, Singapore); Kinflocin (Taiwan); Kinoxacin (Korea); Liflox (Indonesia); Loxinter (Indonesia); Marfloxacin (Hong Kong); Medofloxine (Malaysia); Mergexin (Philippines); Novecin (Israel); Nufafloqo (Indonesia); Obide (Korea); Occidal (Thailand); Ocuflox (Australia, Canada, Korea, Mexico); Ofcin (Malaysia, Singapore, Taiwan); Oflin (India); Oflocee (Thailand); Oflocet (France); Oflocin (Italy); Oflodal (Taiwan); Oflodex (Israel); Oflodura (Germany); O-Flox (Thailand); Oflox (Argentina, Brazil, Chile, Colombia, Ecuador, Israel, Peru, Uruguay, Venezuela); Ofloxin (Thailand); Ofus (Hong Kong); Onexacin (Philippines); Operan (Korea); Orocin (Korea); Otonil (Paraguay); Pharflox (Indonesia); Praxin (Korea); Puiritol (Hong Kong); Qinolon (Philippines); Qipro (Indonesia); Quinolon (Thailand); Quotavil (Hong Kong); Rilox (Indonesia); Sinflo (Taiwan); Tabrin (Greece); Tariflox (Indonesia); Tarivid (China, France, Greece, India, Indonesia, Israel, Italy, Japan, Korea, Malaysia, Poland, Singapore, Slovenia, South Africa, Switzerland, Taiwan, Thailand, Turkey); Tarivid Eye Ear (Hong Kong); Tarivid Otic (Malaysia, Singapore); Telbit (Korea); Tructum (Peru); Uro Tarivid (Israel); Viotisone (Thailand); Zanocin (India)

Drug Class	Antibiotics; Ophthalmics; Quinolones
Indications	Bacterial infection with gram-positive and -negative aerobes, uncomplicated gonorrhea (urethritis, cervicitis, rectal), chlamydial infections, bacterial conjunctivitis, corneal ulcer, otitis externa
Mechanism	Bactericidal—inhibits topoisomerase IV and DNA gyrase
Dosage With Qualifiers	Bacterial infections—200–400 mg PO/IV q12h Uncomplicated gonorrhea—400 mg PO × 1 Bacterial conjunctivitis—1–2 gtt q2–4 h each eye × 2 d, then qid × 5 d Corneal ulcer—1–2 gtt q30 min each eye × 2 d, then q1h × 5 d, then qid × 2 d Otitis externa—10 gtt bid × 10 d NOTE: Renal dosing; available in otic, ophthalmic, and parenteral preparations. Contraindications —hypersensitivity to drug or class Caution —hepatic or renal dysfunction, seizure disorder, CNS abnormalities, diabetes mellitus, dehydration, sun exposure
Maternal Considerations	There are no adequate reports or well-controlled studies in pregnant women. Ofloxacin achieves high tissue penetration. It is not effective prophylaxis following therapeutic abortion; doxycycline is preferred. The FDA has added a black box warning covering the potential for tendon rupture. *Side effects* include vaginitis, photosensitivity, pseudomembranous colitis, seizures, increased ICP, headache, psychosis, N/V, diarrhea, abdominal pain, dyspepsia, dizziness, insomnia, agitation, tendonitis, arthralgias, and elevated LFTs.
Fetal Considerations	There are no adequate reports or well-controlled studies in human fetuses. Less than 4% of maternal ofloxacin crosses the isolated perfused human placenta, though clearance is such that potentially therapeutic levels in AF and sera make it a candidate for fetal therapy. It was believed that in humans, fluoroquinolones were not significantly associated with an increased risk of malformation. However, a study based on first-trimester exposures in Quebec suggests otherwise. Exposure to quinolone ( moxifloxacin and ofloxacin ) was associated with urinary system malformations. Neither ophthalmic nor otic application results in significant systemic drug levels. In general, rodent studies are reassuring, though some rodent models using otic application revealed minor skeletal abnormalities and IUGR. The administration of very high multiples of the MRHD is associated with fetal toxicity.
Breastfeeding Safety	There are no well-controlled studies in nursing women. Ofloxacin achieves an M:P ratio of ≥ 1 but is consistently lower than ciprofloxacin. Serum and milk were obtained from 10 women simultaneously at 2, 4, 6, 9, 12, and 24 h after ofloxacin. The mean breast milk levels were 2.4, 1.9, 1.3, 0.6, 0.3, and 0.05 mcg/mL, respectively. The relative infant dose approximates 3%. Even with 100% oral absorption, breastfeeding mothers who take ofloxacin will expose their infants to lower concentrations than used in the pediatric population.
Drug Interactions	Quinolones form chelates with alkaline earth and transition metal cations. Use of quinolones with antacids containing calcium, magnesium, or aluminum; with sucralfate; with divalent or trivalent cations such as iron; with multivitamins containing zinc; or with didanosine chewable/buffered tablets or the pediatric powder for oral solution may substantially interfere with the absorption of quinolones, resulting in systemic levels considerably lower than desired. These agents should not be taken within 2 h before or after ofloxacin. Cimetidine interferes with the elimination of some quinolones, resulting in significant increases in their t/2 and AUC. The potential interaction between ofloxacin and cimetidine has not been studied. Elevated serum levels of cyclosporine were reported with concomitant use of cyclosporine and some other quinolones. The potential for interaction between ofloxacin and cyclosporine has not been studied. Most quinolones inhibit CYPs, which may lead to a prolonged t/2 for some drugs metabolized by this system (e.g., cyclosporine , theophylline /methylxanthines, warfarin ). The extent of this inhibition varies among different quinolones. Use with NSAIDs may increase the risk of CNS stimulation and convulsive seizures. Probenecid has been reported to affect renal tubular secretion of other quinolones. Its effect on the elimination of ofloxacin has not been studied. Steady-state theophylline levels may increase when used with ofloxacin. Theophylline levels should be closely monitored and the dose adjusted as indicated. Adverse reactions (including seizures) may occur with or without an elevation in the serum theophylline level.
	Some quinolones have been reported to enhance the effects of coumadin or its derivatives. The PT or other suitable coagulation test should be monitored closely. Because disturbances of blood glucose, including hyperglycemia and hypoglycemia, are reported in patients treated with quinolones and an antidiabetic agent, careful monitoring of blood glucose is recommended. May produce false-positive urine screening results for opiates using commercially available immunoassay kits. Confirmation of positive opiate screens by more specific methods is necessary.
References	Giamarellou H, Kolokythas E, Petrikkos G, et al. Am J Med 1989; 87:49S-51S. Loebstein R, Addis A, Ho E, et al. Antimicrob Agents Chemother 1998; 42:1336-9. Muanda FT, Sheehy O, Bérard A. Br J Clin Pharmacol. 2017; 83:2557-71. Nielsen IK, Engdahl, Larsen T. Acta Obstet Gynecol Scand 1993; 72:556-9. Polachek H, Holcberg G, Sapir G, et al. Eur J Obstet Gynecol Reprod Biol 2005; 122:61-5.
Summary	Pregnancy Category: C Lactation Category: S (likely) Ofloxacin should be used during pregnancy if the benefit justifies the potential perinatal risk. Though the fetal risk may not be as great as once thought, there are alternative agents that can be used during pregnancy for almost all indications.

Olanzapine — (Zyprexa)

International Brand Names

Dozic (Colombia); Oleanz (India); Zelta (Colombia); Zyprexa Zydis (New Zealand)

Drug Class	Antipsychotics
Indications	Bipolar disorder, psychosis
Mechanism	Unknown; high affinity for 5-HT _2A/2C and dopamine receptors
Dosage With Qualifiers	Bipolar disorder—begin 5–10 mg qd, increasing 5 mg/d prn; max 20 mg/d Psychosis—begin 5–10 mg qd, increasing 5 mg/d prn; max 20 mg/d NOTE: Available in an orally disintegrating tablet form. Contraindications —hypersensitivity to drug or class Caution —seizure disorder, narrow-angle glaucoma, paralytic ileus, hypotension, hypovolemia, hepatic dysfunction, CV or cerebrovascular disease
Maternal Considerations	Olanzapine is an atypical antipsychotic agent whose clearance is 30% lower in women than in men. However, neither its effectiveness nor its side effects are altered. Patients treated with olanzapine for schizophrenia have less akathisia but more weight gain than patients treated with haloperidol. Compliance, symptoms, extrapyramidal symptoms, and overall quality of life are similar for the two drugs, but costs are significantly greater with olanzapine. Although there are no adequate reports or well-controlled studies in pregnant women, the growing body of clinical experience with olanzapine during pregnancy is reassuring. Clearance does not appear to be altered between the first and third trimesters. *Side effects* include hypotension, tachycardia, menstrual irregularities, hyperprolactinemia, tardive dyskinesia, extrapyramidal symptoms, diabetes mellitus, hyperglycemia, somnolence, weight gain, constipation, dry mouth, dyspepsia, rhinitis, fever, and elevated LFTs.
Fetal Considerations	There are no adequate reports or well-controlled studies in human fetuses. In one study, the mean F:M ratio was variable but overall quite high (72.1% ± 42.0% [SD]); it was only about 33% in a second report. This contrasts with quetiapine (23.8% ± 11%). There were tendencies toward higher rates of low birth weight (30.8%) and NICU admission (30.8%) among neonates exposed to olanzapine. The pregnancy outcomes of women who contacted a teratogen information service after exposure to olanzapine appeared normal. A systematic review of the literature identified that 38 children of 1090 olanzapine -exposed pregnancies were born with malformations, a malformation rate of 3.5%. A retrospective review of the worldwide safety database maintained by Eli Lilly and Company indicated that the frequency of fetal outcomes from identified pregnancies exposed to olanzapine did not differ from rates reported in the general population. As for most psychotropic drugs, monotherapy and the lowest effective quantity given in divided doses to flatten peaks can minimize the risks. Rodent studies are reassuring, revealing no evidence of teratogenicity despite the use of doses higher than those used clinically. Embryo and fetal toxicities were seen with high doses. There was no effect of intrauterine exposure on postnatal learning.
Breastfeeding Safety	There are no adequate reports or well-controlled studies in nursing women. Olanzapine enters human breast milk and has a relative infant dose approximating 0.3%–2.2% of the maternal dose.
Drug Interactions	Given the primary CNS effects of olanzapine, caution should be used when combining it with other centrally acting drugs and ethanol . May enhance the effects of certain antihypertensive agents, but may antagonize the effects of levodopa and dopamine agonists. Drugs that induce CYP1A2 or glucuronyl transferase enzymes, such as omeprazole and rifampin, may increase olanzapine clearance. Inhibitors of CYP1A2 may likewise inhibit olanzapine clearance despite the fact that olanzapine is metabolized by multiple enzyme systems. Activated charcoal (1 g) reduced the C _max and AUC of oral olanzapine by about 60%. As peak olanzapine levels are not typically obtained until about 6 h after dosing, charcoal may be a useful treatment for overdose. Carbamazepine (200 mg bid) causes an approximately 50% increase in olanzapine clearance, likely because carbamazepine is a potent inducer of CYP1A2 activity. Higher daily doses of carbamazepine may cause an even greater increase in olanzapine clearance. Fluvoxamine is an inhibitor of CYP1A2 and decreases the clearance of olanzapine. This results in a 54% increase in the olanzapine C _max in female nonsmokers (may be higher in smokers). The mean increase in olanzapine AUC was 52%. A lower dose of olanzapine should be considered.
References	Aichhorn W, Yazdi K, Kravolec K, et al. J Psychopharmacol 2008; 22:923-4. Ambresin G, Berney P, Schulz P, et al. J Clin Psychopharmacol 2004; 24:93-5. Brunner E, Falk DM, Jones M. BMC Pharmacol Toxicol. 2013; 14:38. Ennis ZN, Damkier P. Basic Clin Pharmacol Toxicol 2015; 116:315-20. Ernst CL, Goldberg JF. J Clin Psychiatry 2002; 63(Suppl 4):42-55. Gardiner SJ, Kristensen JH, Begg EJ, et al. Am J Psychiatry 2003; 160:1428-31. Goldstein DJ, Corbin LA, Fung MC. J Clin Psychpharacol 2000; 20:399-400. Kasper SC, Mattiuz EL, Swanson SP, et al. J Chromatogr B Biomed Sci Appl 1999; 726:203-9. McKenna K, Koren G, Tetelbaum M, et al. J Clin Psychiatry 2005; 66:444-9. Newport DJ, Calamaras MR, DeVane CL, et al. Am J Psychiatry 2007; 164:1214-20. Rosengarten H, Quartermain D. Pharmacol Biochem Behav 2002; 72:575-9. Rosenheck R, Perlick D, Bingham S, et al. JAMA 2003; 290:2693-702. Schenker S, Yang Y, Mattiuz E, et al. Clin Exp Pharmacol Physiol 1999; 26:691-7. Westin AA, Brekke M, Molden E, et al. Clin Pharmacol Ther 2017. [Epub ahead of print]
Summary	Pregnancy Category: C Lactation Category: S (likely) Olanzapine should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

Olmesartan medoxomil — (Benicar)

International Brand Names

Alteis (France); Benicar (Brazil); Olmec (Argentina); Olmetec (England, France, Germany, Hong Kong, Ireland, Israel, Philippines, Singapore); Votum (Germany)

Drug Class	ACEI/A2R-antagonists; Antihypertensives
Indications	Hypertension
Mechanism	Selectively AT-1 receptor antagonist
Dosage With Qualifiers	Hypertension—begin 20–40 mg PO qd if monotherapy, lower if on diuretic; max 40 mg/d Contraindications —hypersensitivity to drug or class, pregnancy Caution —hepatic or renal dysfunction, CHF, renal artery stenosis, ACE angioedema, hyponatremia, volume depletion
Maternal Considerations	The published experience with olmesartan during pregnancy is limited to case reports noting perinatal renal impairment. The lowest effective dose should be used when olmesartan is absolutely required during pregnancy for BP control. *Side effects* include severe hypotension, angioedema, hyperkalemia, dizziness, fatigue, URI symptoms, back pain, diarrhea, and dyspepsia.
Fetal Considerations	There are no adequate reports or well-controlled studies in human fetuses. Olmesartan probably crosses the human placenta. Inhibitors of the renin-angiotensin system as a group cross the human placenta. Adverse fetal effects are reported for the class of drugs across gestation and include cranial hypoplasia, anuria, reversible or irreversible renal failure, death, oligohydramnios, prematurity, IUGR, and PDA. The available case reports suggest this is true for olmesartan . In those rare instances when these inhibitors are necessary, women should be apprised of the potential hazards and serial ultrasound examinations conducted. If oligohydramnios is detected, olmesartan should be discontinued unless lifesaving for the mother, and antenatal surveillance should be initiated. Oligohydramnios may not appear until after irreversible injury. Neonates with in utero exposure should be closely observed for hypotension, oliguria, and hyperkalemia.
Breastfeeding Safety	There is no published experience in nursing women. It is unknown whether olmesartan enters human breast milk, though it is secreted at low concentrations in rat milk.
Drug Interactions	No clinically relevant interactions identified.
References	Celentano C, Prefumo F, diVera E, et al. Pediatr Nephrol 2008; 23:333-4. Georgaki-Angelaki E, Stergiou N, Naoum E. NDT Plus 2009; 2:295-7. Pérez-Iranzo A, Ferreres AN, Bou AJ. BMJ Case Rep 2017; 2017. pii: bcr-2016-218921.
Summary	Pregnancy Category: C (first trimester), D (second and third trimesters) Lactation Category: U Olmesartan and other inhibitors of the renin-angiotensin system should be avoided during pregnancy if possible. Women planning pregnancy should be switched to another class of antihypertensive agent if at all possible prior to conception. When the mother’s disease requires treatment with olmesartan, the lowest doses should be used followed by close monitoring of the fetus.

Olopatadine — (Pataday; Patanol)

International Brand Names

Patanol S (many)

Drug Class	Allergy; Antihistamines, H ₁ ; Ophthalmics
Indications	Allergic conjunctivitis
Mechanism	Selective H ₁ receptor antagonist, inhibits mast cell release of histamine
Dosage With Qualifiers	Allergic conjunctivitis—1–2 gtt each eye bid 6–8 h apart Contraindications —hypersensitivity to drug or class Caution —unknown
Maternal Considerations	There is no published experience with olopatadine during pregnancy. *Side effects* include dry eyes, headache, burning, eyelid edema, keratitis, hyperemia, rhinitis, and sinusitis.
Fetal Considerations	There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether olopatadine crosses the human placenta. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. Very high multiples of the MRHD are associated with fetal toxicity.
Breastfeeding Safety	There is no published experience in nursing women. It is unknown whether olopatadine enters human breast milk, though it has been found in rodent milk. However, considering the dose and route, it is unlikely nursing could result in a clinically significant level in the neonate.
Drug Interactions	No clinically relevant interactions identified.
References	No current relevant references are available.
Summary	Pregnancy Category: C Lactation Category: S (probably) Olopatadine should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

Olsalazine — (Dipentum)

International Brand Names

None identified.

Drug Class	Gastrointestinals; Inflammatory bowel disease agents; Salicylates
Indications	Ulcerative colitis
Mechanism	Unknown; appears to work directly on the gut
Dosage With Qualifiers	Ulcerative colitis—500 mg PO bid Contraindications —hypersensitivity to drug or class, hypersensitivity to salicylates Caution —renal dysfunction
Maternal Considerations	There are no adequate reports or well-controlled studies of olsalazine in pregnant women. Limited published experience consists predominantly of case reports and small series. It appears that olsalazine retains efficacy during pregnancy. *Side effects* include hepatotoxicity, interstitial nephritis, pancreatitis, bone marrow suppression, N/V, dyspepsia, diarrhea, abdominal pain, arthralgias, bloating, anorexia, itching, fatigue, depression, and dizziness.
Fetal Considerations	There are no adequate reports or well-controlled studies in human fetuses. Limited quantities of olsalazine and its metabolites cross the human placenta. Epidemiologic study is reassuring. Rodent studies conducted at multiples of the MRHD revealed IUGR and delayed skeletal and organ maturation.
Breastfeeding Safety	There are no well-controlled studies in nursing women. The relative infant dose is thought to approximate 0.9%. In another study, neither olsalazine nor its main active metabolite was detected in breast milk up to 48 h after ingestion. Oral administration to lactating rats in doses 5–20 × the MRHD reduced growth in the pups.
Drug Interactions	Increased PT has been reported in patients taking concomitant coumadin. Concurrent use with varicella vaccine increases the risk of Reye syndrome.
References	Christensen LA. Dan Med Bull 2000; 47:20-41. Miller LG, Hopkinson JM, Motil KJ, et al. J Clin Pharmacol 1993; 33:703-6. Rahimi R, Nikfan S, Rezaie A, Abdollahi M. Reprod Toxicol 2008; 25:271-5. Tennenbaum R, Marteau P, Elefant, et al. Gastroenterol Clin Biol 1999; 23:464-9.
Summary	Pregnancy Category: C Lactation Category: S (probably) Olsalazine should be used during pregnancy and lactation only if the benefit justifies the potential perinatal risk.

Omeprazole — (Losec; Omid; Prilosec; Roweprazol)

International Brand Names

Acidex (Ecuador); Aleprozil (Mexico); Antra (Germany, Italy, Switzerland); Audazol (Spain); Azoran (Mexico); Baromezole (Korea); Desec (Thailand); Domer (Mexico); Dudencer (Indonesia); Duogas (Thailand); Epirazole (Israel); Gasec (Malaysia); Gastec (Argentina); Gastop (Peru); Gastracid (Germany); Gastroloc (Germany); H-Etom (Colombia); Hovizol (Philippines); Hyposec (Israel); Inhibitron (Mexico); Inhipump (Indonesia); Logastric (Belgium); Lomac (India); Lopraz (Israel); Losec (Argentina, Austria, Belgium, Brazil, Bulgaria, Canada, Chile, China, Costa Rica, Czech Republic, Denmark, Dominican Republic, El Salvador, England, Finland, Greece, Guatemala, Honduras, Hong Kong, Hungary, Indonesia, Ireland, Italy, Korea, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Norway, Panama, Paraguay, Philippines, Poland, Portugal, Spain, Sweden, Taiwan, Thailand, Uruguay, Venezuela); Losec MUPS (Philippines); Madiprazole (Thailand); Maxor (Australia); Medoprazole (South Africa); Medral (Mexico); Meiceral (Thailand); Mepzol (Korea); Miracid (Thailand); Mopral (France, Mexico); Nocid (Thailand); Ocid (India, Singapore); Ogal (Colombia); Olexin (Mexico); Omed (India, Korea, South Africa); Omedar (Israel); Omelon (Taiwan); OMEP (Germany); Omepral (Japan); Omeprazon (Japan); Omepril (Ecuador); Omeq (Korea); Omesec (Malaysia, Singapore); Omez (Thailand); Omezin (Korea); Omezol (Israel, India); Omezole (Singapore, Taiwan); Omezzol (Ecuador); Omisec (Israel); Omizac (Bahrain, India, Republic of Yemen); OMP (China, Korea); Omprazole (Korea); OMZ (Indonesia); Onexal (Colombia); Opal (Peru); Oprax (Peru); Ozoken (Mexico); Parizac (Spain); Penrazole (Singapore); Peptidin (Colombia); Peptilcer (India); Peptizole (Thailand); Pra-Sec (Korea); Prazidec (Mexico); Prazole (Korea); Probitor (Australia, Malaysia); Proceptin (Singapore); Prohibit (Indonesia); Ramezol (Korea); Result (Korea); Risek (Indonesia); Roweprazol (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama); Severon (Thailand); Stomacer (Indonesia); Stomec (Thailand); Stozole (India); Suifac (Mexico); Ulcozol (Brazil, Colombia, Peru); Ulnor (Germany); Ulsek (Philippines); Ulsen (Mexico); Vulcasid (Mexico); Wonmp (Korea); Xoprin (Peru); Zatrol (Chile); Zefxon (Thailand); Zenpro (Malaysia, Singapore); Zimor (Singapore); Zoltum (France)

Drug Class	Antiulcer; Gastrointestinals; Proton pump inhibitors
Indications	GERD, GI ulcer, erosive esophagitis , H. pylori treatment
Mechanism	Inhibits hydrogen-potassium ATPase in the gastric parietal cells
Dosage With Qualifiers	GERD—20–40 mg PO before eating qd × 4–8 w, then 10 mg PO qd; max 80 mg/d GI ulcer (gastric or duodenal)—40 mg PO before eating qd × 4–8 w Erosive esophagitis—20–40 mg PO before eating qd × 4–8 w, max 80 mg/d H. pylori treatment—20 mg PO bid × 10 d if combined with amoxicillin and clarithromycin NOTE: Hepatic dosing. Contraindications —hypersensitivity to drug or class Caution —hepatic dysfunction, long-term use
Maternal Considerations	Omeprazole is effective treatment for a number of hypersecretory disorders, and effective preoperative prophylaxis (20–40 mg PO qd) against aspiration pneumonitis. Although there are no adequate reports or well-controlled studies in pregnant women, omeprazole appears to retain its efficacy during pregnancy. Though it increases human myometrial contractility in isolated muscle strips, there are no reports of an increased prevalence of preterm delivery. Omeprazole is advocated to lower gastric pH prior to cesarean section, but the results of the randomized trials are inconsistent, perhaps reflecting dose and route of delivery. Further, it and similar agents require 20–30 min to take effect. Thus Bicitra (citric acid/sodium citrate solution), perhaps with metoclopramide to enhance lower esophageal sphincter tone, remain the agents of choice for emergent procedures. *Side effects* include headache, diarrhea, hepatic dysfunction, Stevens-Johnson syndrome, and blood dyscrasias.
Fetal Considerations	There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether omeprazole crosses the human placenta. Proton pump inhibitors in general, and omeprazole specifically, are not associated with an increased risk of malformations. In the ewe, the F:M ratio approximates 0.5 and is strongly related to the rate of maternal clearance. Rodent studies are generally reassuring, revealing no evidence of teratogenicity despite the use of doses higher than those used clinically. However, embryo and fetal toxicity are noted in some models when multiples of the MRHD are used.
Breastfeeding Safety	There are no adequate reports or well-controlled studies in nursing women. Omeprazole enters human breast milk, but the relative infant dose approximates 1.1%. Further, omeprazole is acid labile. Virtually all of the omeprazole ingested would probably be destroyed in the stomach. Thus the nursing infant is unlikely to ingest a clinically significant amount.
Drug Interactions	May prolong the elimination of diazepam, coumadin and phenytoin , which are all drugs that are metabolized by oxidation in the liver. There have also been clinical reports of interaction with other drugs metabolized via hepatic CYPs (e.g., benzodiazepines, cyclosporine, disulfiram ). Patients should be monitored to determine if it is necessary to adjust the dose. Because of its profound and long-lasting inhibition of gastric acid secretion, omeprazole may interfere with absorption of drugs where gastric pH is an important determinant of their bioavailability (e.g., ampicillin, iron salts, and ketoconazole ). However, antacids were used in the clinical trials with omeprazole. Use with clarithromycin increases the plasma levels of omeprazole, clarithromycin, and 14-hydroxy-clarithromycin.
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Summary	Pregnancy Category: C Lactation Category: S (probably) Omeprazole should be used during pregnancy only if the benefit justifies the unknown potential perinatal risk.