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Bacitracine Martinet (France)
Drug Class | Antibiotics, miscellaneous; Antiinfectives, ophthalmic; Antiinfectives, topical; Dermatologics; Ophthalmics |
Indications | Gram-positive and -negative bacterial infection |
Mechanism | Bactericidal, cyclic polypeptide that inhibits bacterial cell wall synthesis |
Dosage With Qualifiers | Skin or wound infection—apply cream topically qd to tid NOTE: Use no longer than 1 w; often combined with Neosporin and polymixin B.
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Maternal Considerations | There is no published experience during pregnancy. Bacitracin enhances wound healing in nonpregnant surgical patients and reduces scarring compared to placebo. Side effects include contact dermatitis. |
Fetal Considerations | There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether bacitracin crosses the human placenta. Considering the dose and route, it is unlikely the maternal systemic concentration will reach a clinically relevant level. Rodent teratogenicity studies have not been performed. |
Breastfeeding Safety | There are no adequate reports or well-controlled studies in nursing women. It is unknown whether bacitracin enters human breast milk. However, considering the dose and route, it is unlikely the breastfed neonate would ingest clinically relevant amounts. |
Drug Interactions | No drug interaction studies identified. |
References | Smack DP, Harrington AC, Dunn C, et al. JAMA 1996; 276:972-7. Watcher MA, Wheeland RG. J Dermatol Surg Oncol 1989; 11:1188-95. |
Summary | Pregnancy Category: C Lactation Category: S
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Alpha-Baclofen (New Zealand); Backen (Korea); Baclan (Korea); Baclapone (Korea); Baclo (Australia); Baclofene (France); Baclon (Finland, Taiwan); Baclosal (Israel, Thailand); Bacofen (Korea); Bacron (Korea); Bafen (Thailand); Baklofen (Czech Republic, Denmark, Norway); Baropan (Korea); Bigafen (Korea); Clofen (Australia, Malaysia); Curofen (Korea); Espast (Peru); Lebic (Germany); Lioresal (Argentina, Brazil, Canada, Ecuador, Paraguay, Uruguay, Venezuela); Lioresyl (Chile); Liotec (Canada); Lyflex (England, Ireland); Onelaxant-R (Philippines); Pacifen (New Zealand, Taiwan); Spinax (China, Taiwan); Stelax (Australia)
Drug Class | Muscle relaxants |
Indications | Control of the spasticity secondary to MS and other spinal cord diseases |
Mechanism | GABA B receptor antagonist (central-acting muscle relaxant) |
Dosage With Qualifiers | Muscle spasm—begin 5 mg PO tid; increase by 15 mg qd q3d based on response; max 80 mg/d
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Maternal Considerations | There are no adequate reports or well-controlled studies of baclofen in pregnant women. The published experience is mostly limited to case reports, mostly of intrathecal use in women with MS. For example, one documents successful intrathecal use for the treatment of severe tetanus, and another the long-term treatment of severe spasticity after a C5 fracture. Baclofen was superior to placebo for the relief of abortion-related pain. Side effects include CNS depression, seizures, CV collapse, drowsiness, headache, dizziness, blurred vision and slurred speech, constipation, pruritus, urinary frequency, constipation, and rash. |
Fetal Considerations | There are no adequate reports or well-controlled studies in human fetuses. Baclofen crosses the human placenta. A comparison of 134 pregnant women who had taken baclofen in early pregnancy and 400 pregnant controls showed an increased risk of major malformations. The rates of live birth and spontaneous miscarriage did not differ according to baclofen exposure, but terminations were more frequent (14.9% versus 4.2%). Major malformations occurred in 5 (4.8%) of 104 newborns in the baclofen group versus 4 (1.2%) of 330 newborns in the control group, giving an odds ratio of 4.1 (95% confidence interval: 1.1 to 15.6). Fetuses exposed to baclofen from the second or third trimester until birth were also at risk of neuropsychiatric disorders such as convulsions, sedation, and withdrawal symptoms. Thirty-four neonates, four of whom were exposed to maternal doses of baclofen between 50 mg and 90 mg/d, and some to other psychotropic substances, developed withdrawal symptoms or other adverse effects consistent with drug exposure. There is a single case report of neonatal convulsions at 7 d of age. Rodent studies reveal an increased prevalence of omphalocele, incomplete ossification of the sternum, vertebral arch widening, and neural tube defects when given at 10 × the MRHD. |
Breastfeeding Safety | There are no adequate reports or well-controlled studies in nursing women. Baclofen reduces sucking-induced prolactin release, but milk ejection is unchanged. Only about 0.1% of the maternal dose is excreted into human breast milk. Baclofen is considered compatible with breastfeeding. |
Drug Interactions | Concomitant administration of baclofen and lithium may decrease the effect of baclofen . Baclofen use may increase the effect of opiate analgesics, CNS depressants, alcohol, tricyclic antidepressants, neuromuscular blocking agents (e.g., magnesium sulfate) , and MAO inhibitors. |
References | Committee on Drugs, American Academy of Pediatrics. Pediatrics 1994; 93:137-50. Corli O, Roma G, Bacchini M, et al. Clin Ther 1984; 6:800-7. Dalton CM, Keenan E, Jarrett L, et al. Mult Scler 2008; 14:571-2. Engrand N, Van De Perre P, Vilain G, Benhamou D. Eur J Anaesthesiol 2001; 18:261-3. Eriksson G, Swahn CG. Scand J Clin Lab Invest 1981; 41:185-7. Munoz FC, Marco DG, Perez AV, Camacho M. Ann Pharmacother 2000; 34:956. No authors. Prescrire Int. 2015; 24:214. Ratnayaka DM, Dhaliwal H, Watkin S. BMJ 2001; 323:85. |
Summary | Pregnancy Category: C Lactation Category: S
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Benoquin (Argentina); Colazide (Austria, England); Premid (Denmark)
Drug Class | Gastrointestinals; Salicylates |
Indications | Ulcerative colitis, acute |
Mechanism | Exact mechanism unknown (central-acting muscle relaxant) |
Dosage With Qualifiers | Ulcerative colitis—2.25 g PO tid; max use 8 w
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Maternal Considerations | Balsalazide is a prodrug enzymatically cleaved in the colon to produce mesalamine . Though considered safe to use by some clinicians, there are no adequate reports or well-controlled studies of balsalazide in pregnant women. Side effects include angioedema, bradycardia, bronchospasm, colitis, N/V, diarrhea, abdominal pain, anemia, epistaxis, anxiety, depression, nephritis, arthralgia, alopecia, and dermatitis. |
Fetal Considerations | There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether balsalazide crosses the human placenta. Mesalamine is known to cross the placenta. Infants born of women who use salicylates in early pregnancy may have an increased risk of congenital malformation, notably cardiovascular defects. This could be a drug effect or an effect of active inflammatory bowel disease. Rodent studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. |
Breastfeeding Safety | There is no published experience in nursing women. It is unknown whether balsalazide enters human breast milk. Low concentrations of mesalamine do enter human breast milk, but the breastfed newborn would ingest far less than 10% of the therapeutic dose. |
Drug Interactions | No drug interaction studies were identified. Oral antibiotics could theoretically interfere with the release of mesalamine in the colon. |
References | Källén B. Scand J Gastroenterol. 2014; 49: 442-8. Klotz U. Clin Pharmacokinet 1985; 10:285-302. Schroeder KW. Scand J Gastroenterol Suppl 2002; (236):42-7. Silverman DA, Ford J, Shaw I, Probert CS. Gut. 2005; 54:170-1. |
Summary | Pregnancy Category: B Lactation Category: S (likely)
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Simulect (Argentina, Brazil, Canada, Chile, Colombia, Hong Kong, Israel, Malaysia, Mexico, Peru, Philippines, South Africa, Taiwan, Thailand, Uruguay); Simultec (Venezuela)
Drug Class | Immunosuppressants; Monoclonal antibodies |
Indications | Renal transplant immunoprophylaxis |
Mechanism | IL-2 receptor antagonist |
Dosage With Qualifiers | Kidney transplant—20 mg IV single dose NOTE: Basiliximab should be given only after it is determined the patient will receive a graft; a second dose should be administered with great caution.
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Maternal Considerations | There are only case reports of basiliximab use during pregnancy. Side effects include constipation, diarrhea, nausea, hyperkalemia, hypokalemia, acne, insomnia, angina pectoris, headache, tremor, hypertension, dysuria, UTI, edema, fever, asthenia, and hypercholesterolemia. |
Fetal Considerations | There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether basiliximab crosses the human placenta. Rodent and primate studies are reassuring, revealing no evidence of teratogenicity or IUGR despite the use of doses higher than those used clinically. |
Breastfeeding Safety | There is no published experience in nursing women. It is unknown whether basiliximab enters human breast milk. However, considering the indication and dosing, one-time basiliximab use is unlikely to pose a clinically significant risk to the breastfeeding neonate. |
Drug Interactions | No drug interaction studies or reports were identified. It is considered best to avoid live vaccines. |
References | Danesi R, Del Tacca M. Transplant Proc 2004; 36:705-7. |
Summary | Pregnancy Category: B Lactation Category: U
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Aerobec (Germany, Mexico, South Africa); Afifon (Israel); Alanase (New Zealand); Aldecin (Australia, Belgium, Bulgaria, China, Denmark, Hong Kong, Malaysia, Netherlands, Switzerland, Taiwan); Aldecina (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, Panama, Portugal); Aldecin Hayfever Aqueous Nasal Spray (Australia); Anceron (South Africa); Andion (Denmark); Asmabec Clickhaler (France); Atomase (Malaysia, New Zealand, Singapore); Beceze (Israel); Beclate (India, South Africa); Beclazone (Israel, New Zealand); Beclazone CFC Free (Singapore); Beclo-Asma (Hong Kong, Singapore); Beclo-Asma CFC Free (Singapore); Beclocort Nasel (Poland); Becloforte (Israel, Hong Kong, New Zealand, South Africa); Beclomet (Bulgaria, Germany, Malaysia, Switzerland, Taiwan); Beclometasone (France); Beclomet Easyhaler (Indonesia, Korea, Thailand); Beclomet Nasal Aqua (Indonesia, Thailand); Beclone (France); Beclo-Rhino (France); Beclorhinol (Germany); Beclo Siozwo Nasenspray (Germany); Beclosol Aquoso (Brazil); Becloturmant (Germany); Becodisks (China); Beconase (Austria, Belgium, Bulgaria, Chile, China, Costa Rica, Dominican Republic, Ecuador, El Salvador, England, Finland, France, Guatemala, Honduras, Hong Kong, Hungary, Indonesia, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Portugal, South Africa, Spain, Thailand, Venezuela); Becotide (Bangladesh, Bulgaria, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, India, Indonesia, Ireland, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Pakistan, Panama, Paraguay, Peru, Poland, Slovenia, South Africa, Turkey, Uruguay); Belax (Taiwan); Bemedrex Easyhaler (France); Bronconox (Colombia); Bronconox Forte (Colombia); Clenil (Indonesia, Philippines, Singapore, South Africa, Taiwan); Clenil Forte (Indonesia, Philippines); Decomit (Singapore); Ecobec (France); Filair (Chile); Miflasone (France, New Zealand); Nasobec Aqueous (Korea); Nexxair (France); Nobec (South Africa); Q Var (Argentina, Costa Rica, El Salvador, Guatemala, Honduras, Hong Kong, Malaysia, New Zealand, Nicaragua, Panama, Philippines, Singapore, South Africa); Qvar Autohaler (Australia, France); Qvar Inhaler (Australia); RatioAllerg (Germany); Respocort (Malaysia, New Zealand, Philippines); Rhinocort (Israel); Rinaze (South Africa); Rino-Clenil (England); Rynconox (Colombia); Viarex (Israel); Viarox (Germany, South Africa); Xiten (Peru)
Drug Class | Corticosteroids |
Indications | Treatment of asthma, rhinitis; nasal polyp prophylaxis |
Mechanism | Antiinflammatory mechanism unknown |
Dosage With Qualifiers | Asthma—4–16 inhalations/d Rhinitis—1–2 inhalations in each nostril qd; max 336 mcg/d Nasal polyp prophylaxis—1–2 inhalations in each nostril qd; max 336 mcg/d NOTE: Each metered inhalation delivers 42 mcg of aerosolized drug.
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Maternal Considerations | Asthma is associated with several complications during pregnancy. Inhaled corticosteroids are generally considered the prophylactic medication of choice in pregnant women with persistent asthma, unless well controlled by either cromolyn or nedocromil. Beclomethasone effectiveness requires regular use. It is considered a first-line agent during pregnancy along with budesonide . Side effects include irritation of nasal mucous membranes, urticaria, edema, bronchospasm, headache, and nausea. |
Fetal Considerations | There are no well-controlled studies of beclomethasone in human fetuses. Beclomethasone or a metabolite likely crosses the human placenta, as hypoadrenalism has occurred in newborns of women using beclomethasone . Rodent studies using up to 10 × the MRHD revealed increased frequencies of fetal resorption, cleft palate, delayed ossification, agnathia, and embryocidal effect. |
Breastfeeding Safety | There are no adequate reports or well-controlled studies in nursing women. It is unknown whether beclomethasone enters human breast milk. Other steroids are excreted in low amounts. |
Drug Interactions | No drug interaction studies identified. |
References | Beck SA. Allergy Asthma Proc 2001; 22:1-4. Brown HM, Storey G. Postgrad Med J 1975; 51:59-64. de Aguiar MM, da Silva HJ, Rizzo JA, et al. Allergol Immunopathol (Madr) 2014; 42:493-9. Dombrowski MP, Brown CL, Berry SM. J Matern Fetal Med 1996; 5:310-3. Dombrowski MP, Schatz M, Wise R, et al; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network; National Heart, Lung, and Blood Institute. Am J Obstet Gynecol 2004; 190:737-44. Karinski DA, Balkundi D, Rubin LP, Padbury JF. Neonatal Netw 2000; 19:27-32. Mazzotta P, Loebstein R, Koren G. Drug Saf 1999; 20:361-75. Stenius-Aarniala B, Piirila P, Teramo K. Thorax 1988; 43:12-8. Wendel PJ, Ramin SM, Barnett-Hamm C, et al. Am J Obstet Gynecol 1996; 175:150-4. |
Summary | Pregnancy Category: C Lactation Category: U
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Drug Class | Analgesics, narcotic; Parasympatholytics |
Indications | Adjunctive therapy for irritable bowel syndrome, acute enterocolitis, duodenal ulcer, cesarean section (to decrease secretions), fetal bradycardia |
Mechanism | Anticholinergic; atropine is the active agent |
Dosage With Qualifiers | Donnatal—0.0194 mg/tab, 5 mL/elixir (23% alcohol) Lomotil—0.025 mg/tab, 5 mL Atropine sulfate—0.1 mg/mL NOTE: Individualize the dose; may be combined with opium, ergotamine, phenobarbital, or butabarbital .
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Maternal Considerations | There are no well-controlled studies of belladonna in pregnant women. Side effects include xerostomia, taste change, blurred vision, bradycardia, palpitations, drowsiness, headache, and anaphylaxis. |
Fetal Considerations | There are no adequate reports or well-controlled studies in human fetuses. Belladonna rapidly crosses the placenta, producing a pharmacologic fetal vagotomy with subsequent tachycardia. It also decreases fetal breathing. However, no adverse acute or chronic fetal effects are documented in women taking atropine. No association with malformations has been documented. |
Breastfeeding Safety | No adequate well-controlled studies determined the passage of belladonna in the breast milk; it is generally considered safe for breastfeeding. |
Drug Interactions | Caution is advised in the administration of belladonna-butabarbital to women using anticoagulant agents. Belladonna-butabarbital may decrease the systemic effects of exogenous or endogenous corticosteroids. The concomitant use of other CNS depressants, including sedatives or hypnotics, antihistamines, tranquilizers, or alcohol, may produce additive depressant effects. |
References | Abboud T, Raya J, Sadry S, et al. Anesth Analg 1983; 62:426-30. Freeman JJ, Altieri RH, Baptiste HJ, et al. J Natl Med Assoc 1994; 86:704-8. Hellman LM, Filisti LP. Am J Obstet Gynecol 1965; 91:797-805. |
Summary | Pregnancy Category: C Lactation Category: S
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Benace (India); Boncordin (Argentina); Cibace (South Africa); Cibacen (Austria, Belgium, Denmark, Finland, Germany, Greece, Indonesia, Israel, Italy, Japan, Korea, Netherlands, Philippines, Portugal, Spain, Sweden, Switzerland, Taiwan); Cibacen Cor (Germany); Cibacene (France); Lotensin (Brazil, Bulgaria, Canada, China, Czech Republic, Ecuador, Hungary, Mexico, Peru, Poland, Uruguay, Venezuela)
Drug Class | ACEI/A2R-antagonists; Antihypertensives |
Indications | Hypertension, congestive heart failure |
Mechanism | Angiotensin-converting enzyme inhibitor |
Dosage With Qualifiers | Hypertension—begin 10 mg qd, max 80 mg/d Congestive heart failure—begin 5 mg qd; lower doses when used with a diuretic NOTE: Renal dosing. May be combined with hydrochlorothiazide.
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Maternal Considerations | The published experience during pregnancy consists of case reports. However, this class of agents is associated with severe fetal renal toxicity. Once thought relatively safe in the first trimester, benazepril is now considered contraindicated throughout gestation. Side effects include angioedema, hypotension, renal failure, hyperkalemia, elevated BUN/Cr, pancreatitis, liver toxicity, agranulocytosis, dizziness, headache, dyspepsia, cough, rash, urticaria, fatigue, myalgia, diarrhea, and taste changes. |
Fetal Considerations | Benazepril may cause embryonic, fetal, and neonatal morbidity and death. ACEIs during the second and third trimesters are associated with hypotension, neonatal skull hypoplasia, renal failure, and oligohydramnios. It is not known whether all ACEIs have the similar risks. Benazepril has been associated with oligohydramnios in humans that was reversible with discontinuation. Limited placental transfer is noted in the rat. Other ACEIs readily cross the placenta. |
Breastfeeding Safety | There is no published experience in nursing women. Minimal amounts of benazepril enter the breast milk. |
Drug Interactions | May cause hypotension in women on diuretics, especially if recently started. This risk can be minimized by either discontinuing the diuretic or increasing salt intake prior to initiation. If this is not possible, the starting dose should be reduced. May attenuate potassium loss caused by thiazide diuretics. Potassium-sparing diuretics (e.g., spironolactone, amiloride, triamterene ) or potassium supplements increase the risk of hyperkalemia. Increased serum lithium and symptoms of lithium toxicity are reported in patients receiving ACEIs. Frequent monitoring of the serum lithium level is recommended. ACEI may increase digoxin levels and decrease the bioavailability of antacids. Reduced hypotensive effect with NSAIDs; enhanced hypotensive effect with phenothiazines. |
References | Chisholm CA, Chescheir NC, Kennedy M. Am J Perinatol 1997; 14:511-3. Muller PR, James A. J Perinatol 2002; 22:582-4. Waldmeier F, Schmid K. Arzneimittelforschung 1989; 39:62-7. Yamamoto S, Takemori E, Hasegawa Y, et al. Arzneimittelforschung 1991; 41:913-23. |
Summary | Pregnancy Category: C (first trimester), D (second and third trimesters) Lactation Category: S (likely)
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Aprinox (England); Berkozide (England); Centyl (Denmark, Ireland, Norway, Sweden); Inderetic (Netherlands); Naturine (France); Neo-Naclex (New Zealand); Pluryl (Belgium, Netherlands); Pluryle (Greece, Israel, South Africa); Prestim (Netherlands); Salures (Sweden); Sinesalin (Austria, Germany, Switzerland)
Drug Class | Diuretics; Thiazides |
Indications | Hypertension |
Mechanism | Mechanism unknown; interferes with electrolyte resorption in the distal renal tubule |
Dosage With Qualifiers | Diuretic—5 mg PO qam Hypertension—5–20 mg PO qd Hypertension (Corzide)—1 tab PO qd NOTE: Corzide: each tablet contains 5 mg of bendroflumethiazide plus nadolol (40 or 80 mg).
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Maternal Considerations | There is no published experience with bendroflumethiazide during pregnancy. Thiazide diuretics should be avoided during pregnancy except for the treatment of congestive heart disease. It has been suggested but not shown that diuretics in general may hinder placental perfusion by preventing normal plasma expansion. Thiazide diuretics are diabetogenic in some women. There are several reports of severe electrolyte imbalance in both mothers and newborns. Hemorrhagic pancreatitis has also been reported after thiazide exposure. Side effects include CHF, thrombocytopenia, agranulocytosis, and exfoliative dermatitis. |
Fetal Considerations | There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether bendroflumethiazide crosses the human placenta, though thiazide agents readily cross. Fetal bradycardia associated with fetal hypokalemia has also been reported after maternal thiazide use. Though not associated with congenital defects, neonatal thrombocytopenia and hypoglycemia are reported. |
Breastfeeding Safety | There is no published experience in nursing women. Many thiazide diuretics are excreted into breast milk, but in low concentrations. They are generally considered safe for breastfeeding women. |
Drug Interactions | Alcohol, barbiturates, or narcotics may trigger orthostatic hypotension. Amphotericin B, corticosteroids, or corticotropin (ACTH) may intensify electrolyte imbalance, particularly hypokalemia. May decrease the effects of oral anticoagulants. May decrease calcium excretion. May potentiate the effects of other antihypertensive medications (e.g., ganglionic or peripheral adrenergic blocking agents). Oral hypoglycemic agents and insulin dosages may need to be increased, as thiazides may elevate blood glucose. May increase the risk of digitalis toxicity due to hypokalemia. Cholestyramine and colestipol may delay or decrease absorption of bendroflumethiazide. May enhance lithium toxicity by decreasing lithium renal clearance. Hypotensive effects are enhanced by MAOIs. Nondepolarizing muscle relaxants, preanesthetics, and anesthetics used in surgery may be potentiated. In some patients, the administration of an NSAID can reduce the diuretic, natriuretic, and antihypertensive effect of loop, potassium-sparing, or thiazide diuretics. May decrease the effectiveness of methenamine due to alkalinization of the urine. May have hyperuricemic effects requiring an increase in probenecid or sulfinpyrazone. |
References | Assoli NS. Clin Pharmacol Ther 1960; 1:48-52. Beermann B, Fahraeus L, Groschisky-Grind M, Lindstrom B. Gynecol Obstet Invest 1980; 11:45-8. Finnerty FA, Buchholz JH, Tuckman J. JAMA 1958; 166:1414. Flowers CE, Grizzle JE, Easterling WE, Bonner OB. Am J Obstet Gynecol 1962; 84:919-29. Goldman JA, Neri A, Ovadia J, et al. Am J Obstet Gynecol 1969; 105:556-60. Minkowitz S, Soloway HB, Hall JE, Yermakov V. Obstet Gynecol 1964; 24:337-42. [No authors]. Drug Ther Bull 2001; 39(5):37-40. Pritchard JA, Waley PJ. Am J Obstet Gynecol 1961; 81:1241-4. Rodriguez SU, Leikin SL, Hiller MC. N Engl J Med 1964; 270:881-4. Sibai BM, Grossman RA, Grossman HG. Am J Obstet Gynecol 1984; 150:831-5. |
Summary | Pregnancy Category: C Lactation Category: S
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Anaesthesin (Germany); Auralyt (Mexico); Octicaina (Colombia); Topicaine (Australia)
Drug Class | Anesthetics, local |
Indications | Topical anesthetic, lubricant, relief of pain in acute congestive and serous otitis, acute swimmer’s ear, production of anesthesia of mucous membrane |
Mechanism | Stabilizes the neuronal membrane and alters its permeability to sodium ions |
Dosage With Qualifiers | Topical anesthetic (e.g., episiotomy pain)—apply to affected area as needed Anesthetic lubricant—apply over the intratracheal catheters and pharyngeal and nasal airways with the purpose of attenuating local reflexes Congestive and serous otitis and acute swimmer’s ear—supplied as eardrops Anesthesia of mucous membrane—supplied as topical gel or local spray; max 20 mg NOTE: Combined with antipyrine for otic uses.
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Maternal Considerations | There are no well-controlled studies of benzocaine during pregnancy. It provides relief from perineal pain associated with episiotomy, especially when used with a corticosteroid. Some practitioners use it as an alternative to lidocaine for the symptomatic relief of perineal herpetic lesions. Side effects include contact dermatitis, burning, and pruritus. |
Fetal Considerations | There are no well-controlled studies of benzocaine in human fetuses. It is unknown whether benzocaine crosses the human placenta. Considering the dose and route, it is unlikely the maternal systemic concentration will reach a clinically relevant level. |
Breastfeeding Safety | There is no published experience in nursing women. However, considering the dose and route, it is unlikely the breastfed neonate would ingest clinically relevant amounts. |
Drug Interactions | Administration with hyaluronidase may increase risk of toxic systemic reactions. Administration with St. John’s wort may decrease blood pressure. May reduce the efficacy of sulfonamides. |
References | Goldstein PJ, Lipman M, Luebehusen J. South Med J 1977; 70:806-8. |
Summary | Pregnancy Category: C Lactation Category: U
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Acetoxy (Canada); Acnacyl (Hong Kong, Singapore); Acneclear (Hong Kong); Acne Derm (Israel); Acne Mask (Israel); Acnetick-10 (Colombia); Acnexyl (Thailand); Acnie (Taiwan); Akneroxid (Austria, Germany, Hungary, Netherlands, Switzerland); Aldoacne (Spain); Basiron (Denmark, Finland, Norway, Sweden); Benoxid (Finland); Benoxil (Venezuela); Benoxyl (Brazil, Canada, England, Ireland, Israel, New Zealand, Philippines, Puerto Rico, Venezuela); Benoxyl 5 Lotion (Taiwan); Benoxyl AQ AL (Mexico); Benzac AC (Australia, Dominican Republic, El Salvador, Guatemala, Hong Kong, Israel, Malaysia, Mexico, Peru, Singapore, Venezuela); Benzac-AC 5 (South Africa); Benzac W (Australia, Chile, Greece, Mexico, Peru, Philippines, Puerto Rico); Benzeperox (Germany); Benzihex (Argentina); Benzihex AC (Paraguay, Uruguay); Benzolac (Indonesia); Benzperox (Bulgaria); Boxazin (Chile); Brevoxyl (France, Germany, Singapore, Switzerland, Taiwan); Cutacnyl (Portugal); Eclaran (France); Ecuaderm (Venezuela); Effacne (France); Klinoxid (Germany); Mytolac (Sweden); Oxiderma (Spain); Oxy (Brazil); Oxy 5 (Israel); Oxy-5 (Netherlands); Oxy 10 (Israel); Oxyderm (Canada); Oxy Lotion (Korea); Oxy Sensitive Vanishing Gel (Israel); Oxy Wash (Israel); Panoxyl (Australia, Brazil, Canada, Colombia, England, Finland, France, Germany, Hong Kong, Malaysia, Norway, Philippines, Taiwan, Thailand); PanOxyl (Australia); Panoxyl AQ (Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Hong Kong, Nicaragua, Panama, Taiwan, Thailand); Panoxyl Preps (New Zealand); Panoxyl Wash Lotion (Mexico); Pansulfox (Chile); Pernox Gel (India); Peroxiben (Spain); Persol Gel (India); Pimplex (Indonesia); Scherogel (Austria); Ultra Clearasil (Philippines); Vixiderm (Argentina)
Drug Class | Antiinfectives, topical; Dermatologics; Keratolytics |
Indications | Acne vulgaris |
Mechanism | Drying agent |
Dosage With Qualifiers | Acne vulgaris—apply to affected areas qd or bid NOTE: Also packaged with clindamycin or erythromycin.
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Maternal Considerations | Benzoyl peroxide is for external use only. It has been used for the treatment of acne since the 1930s. There are no well-controlled studies in pregnant women. Side effects include dryness, irritation, and pruritus. |
Fetal Considerations | There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether benzoyl peroxide crosses the human placenta. Rodent teratogen studies have apparently not been conducted. Considering the dose and route, it is unlikely the maternal systemic concentration will reach a clinically relevant level. |
Breastfeeding Safety | There is no published experience in nursing women. It is unknown whether benzoyl peroxide enters human breast milk. |
Drug Interactions | No drug interaction studies identified. |
References | Auffret N. Presse Med 2000; 29:1091-7. Chien AL, Qi J, Rainer B, et al. J Am Board Fam Med 2016; 29:254-62. Ives TJ. Am Pharm 1992; NS32:33-8. Kong YL, Tey HL. Drugs 2013; 73:779-87. Reeves JR. Med Times 1980; 108:82-6. |
Summary | Pregnancy Category: C Lactation Category: U
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Akitan (Finland); Apo-Benzthropine (Canada); Bentrop (Australia); Cogentin (Canada, England, Hong Kong, Ireland, Malaysia, Norway, Portugal, Sweden, Thailand)
Drug Class | Anticholinergics; Antihistamines; Antiparkinson agents; Parasympatholytics |
Indications | Adjunct therapy for parkinsonism or for the treatment of extrapyramidal reactions |
Mechanism | Antagonizes ACh and histamine receptors |
Dosage With Qualifiers | Parkinsonism—begin 0.5–1 mg PO qd, increase by 0.5 mg q5d; max 6 mg PO qd Extrapyramidal reactions—1–4 mg PO qd or bid
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Maternal Considerations | There are no adequate reports or well-controlled studies of benztropine in pregnant women. The published experience is limited to case reports. Side effects include tachycardia, anticholinergic psychosis, dry mouth, constipation, sedation, N/V, flatulence, anorexia, rash, dizziness, headache, nervousness, tinnitus, edema, and blurred vision. |
Fetal Considerations | There are no adequate reports or well-controlled studies in human fetuses. It is unknown whether benztropine crosses the human placenta. Exposure to benztropine during the first trimester might be associated with CV defects. Neonatal paralytic ileus has been reported after benztropine use. |
Breastfeeding Safety | There is no published experience in nursing women. It is unknown whether benztropine enters human breast milk. No adverse neonatal effects are reported with other parasympatholytics such as atropine. |
Drug Interactions | May increase the effects of antipsychotic drugs such as phenothiazines, haloperidol, and TCAs. |
References | Committee on Drugs, American Academy of Pediatrics. Pediatrics 1994; 93:137-50. Falterman CG, Richardson CJ. J Pediatr 1980; 97:308-10. Thornburg JE, Moore KE. Res Commun Chem Pathol Pharmacol 1973; 6:313-20. |
Summary | Pregnancy Category: C Lactation Category: U
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