7 Interactions found for:
Drug Interactions
Moderate
Levothyroxine
+ Ozempic
The following applies to the ingredients: Levothyroxine and Semaglutide (found in Ozempic)
MONITOR: The efficacy of insulin and other antidiabetic agents may be diminished by certain drugs, including atypical antipsychotics, corticosteroids, diuretics, estrogens, gonadotropin-releasing hormone agonists, human growth hormone, phenothiazines, progestins, protease inhibitors, sympathomimetic amines, thyroid hormones, L-asparaginase, alpelisib, copanlisib, danazol, diazoxide, isoniazid, megestrol, omacetaxine, phenytoin, sirolimus, tagraxofusp, temsirolimus, as well as pharmacologic dosages of nicotinic acid and adrenocorticotropic agents. These drugs may interfere with blood glucose control because they can cause hyperglycemia, glucose intolerance, new-onset diabetes mellitus, and/or exacerbation of preexisting diabetes.
MANAGEMENT: Caution is advised when drugs that can interfere with glucose metabolism are prescribed to patients with diabetes. Close clinical monitoring of glycemic control is recommended following initiation or discontinuation of these drugs, and the dosages of concomitant antidiabetic agents adjusted as necessary. Patients should be advised to notify their physician if their blood glucose is consistently high or if they experience symptoms of severe hyperglycemia such as excessive thirst and increases in the volume or frequency of urination. Likewise, patients should be observed for hypoglycemia when these drugs are withdrawn from their therapeutic regimen.
References
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- Pollare T, Lithell H, Berne C "A comparison of the effects of hydrochlorothiazide and captopril on glucose and lipid metabolism in patients with hypertension." N Engl J Med 321 (1989): 868-73
- Carter BL, Small RE, Mandel MD, Starkman MT "Phenytoin-induced hyperglycemia." Am J Hosp Pharm 38 (1981): 1508-12
- Al-Rubeaan K, Ryan EA "Phenytoin-induced insulin insensitivity." Diabet Med 8 (1991): 968-70
- Chaudhuri ML, Catania J "A comparison of the effects of bumetanide (Burinex) and frusemide on carbohydrate metabolism in the elderly." Br J Clin Pract 42 (1988): 427-9
- Goldman JA, Neri A, Ovadia J, Eckerling B, Vries A, de "Effect of chlorothiazide on intravenous glucose tolerance in pregnancy." Am J Obstet Gynecol 105 (1969): 556-60
- Miller NR, Moses H "Transient oculomotor nerve palsy. Association with thiazide-induced glucose intolerance." JAMA 240 (1978): 1887-8
- Kansal PC, Buse J, Buse MG "Thiazide diuretics and control of diabetes mellitus." South Med J 62 (1969): 1372-9
- Andersen OO, Persson I "Carbohydrate metabolism during treatment with chlorthalidone and ethacrynic acid." Br Med J 2 (1968): 798-801
- Curtis J, Horrigan F, Ahearn D, Varney R, Sandler SG "Chlorthalidone-induced hyperosmolar hyperglycemic nonketotic coma." JAMA 220 (1972): 1592-3
- Chowdhury FR, Bleicher SJ "Chlorthalidone--induced hypokalemia and abnormal carbohydrate metabolism." Horm Metab Res 2 (1970): 13-6
- Diamond MT "Hyperglycemic hyperosmolar coma associated with hydrochlorothiazide and pancreatitis." N Y State J Med 72 (1972): 1741-2
- Jones IG, Pickens PT "Diabetes mellitus following oral diuretics." Practitioner 199 (1967): 209-10
- Black DM, Filak AT "Hyperglycemia with non-insulin-dependent diabetes following intraarticular steroid injection." J Fam Pract 28 (1989): 462-3
- Gunnarsson R, Lundgren G, Magnusson G, Ost L, Groth CG "Steroid diabetes--a sign of overtreatment with steroids in the renal graft recipient?" Scand J Urol Nephrol Suppl 54 (1980): 135-8
- Murphy MB, Kohner E, Lewis PJ, Schumer B, Dollery CT "Glucose intolerance in hypertensive patients treated with diuretics: a fourteen-year follow-up." Lancet 2 (1982): 1293-5
- Seltzer HS, Allen EW "Hyperglycemia and inhibition of insulin secretion during administration of diazoxide and trichlormethiazide in man." Diabetes 18 (1969): 19-28
- Jori A, Carrara MC "On the mechanism of the hyperglycaemic effect of chlorpromazine." J Pharm Pharmacol 18 (1966): 623-4
- Erle G, Basso M, Federspil G, Sicolo N, Scandellari C "Effect of chlorpromazine on blood glucose and plasma insulin in man." Eur J Clin Pharmacol 11 (1977): 15-8
- "Product Information. Thorazine (chlorpromazine)." SmithKline Beecham PROD (2002):
- "Product Information. Diabinese (chlorpropamide)." Pfizer U.S. Pharmaceuticals PROD (2002):
- "Product Information. Glucotrol (glipizide)." Pfizer U.S. Pharmaceuticals PROD (2002):
- "Product Information. Diabeta (glyburide)." Hoechst Marion-Roussel Inc, Kansas City, MO.
- "Product Information. Synthroid (levothyroxine)." Abbott Pharmaceutical PROD (2002):
- "Product Information. Carafate (sucralfate)." Hoechst Marion Roussel PROD (2001):
- Stambaugh JE, Tucker DC "Effect of diphenylhydantoin on glucose tolerance in patients with hypoglycemia." Diabetes 23 (1974): 679-83
- Malherbe C, Burrill KC, Levin SR, Karam JH, Forsham PH "Effect of diphenylhydantoin on insulin secretion in man." N Engl J Med 286 (1972): 339-42
- Javier Z, Gershberg H, Hulse M "Ovulatory suppressants, estrogens, and carbohydrate metabolism." Metabolism 17 (1968): 443-56
- Sotaniemi E, Kontturi M, Larmi T "Effect of diethylstilbestrol on blood glucose of prostatic cancer patients." Invest Urol 10 (1973): 438-41
- Bell DS "Insulin resistance. An often unrecognized problem accompanying chronic medical disorders." Postgrad Med 93 (1993): 99-103,
- Berlin I "Prazosin, diuretics, and glucose intolerance." Ann Intern Med 119 (1993): 860
- Rowe P, Mather H "Hyperosmolar non-ketotic diabetes mellitus associated with metolazone." Br Med J 291 (1985): 25-6
- Haiba NA, el-Habashy MA, Said SA, Darwish EA, Abdel-Sayed WS, Nayel SE "Clinical evaluation of two monthly injectable contraceptives and their effects on some metabolic parameters." Contraception 39 (1989): 619-32
- Virutamasen P, Wongsrichanalai C, Tangkeo P, Nitichai Y, Rienprayoon D "Metabolic effects of depot-medroxyprogesterone acetate in long-term users: a cross-sectional study." Int J Gynaecol Obstet 24 (1986): 291-6
- Dimitriadis G, Tegos C, Golfinopoulou L, Roboti C, Raptis S "Furosemide-induced hyperglycaemia - the implication of glycolytic kinases." Horm Metab Res 25 (1993): 557-9
- Goldman JA, Ovadia JL "The effect of estrogen on intravenous glucose tolerance in woman." Am J Obstet Gynecol 103 (1969): 172-8
- Hannaford PC, Kay CR "Oral contraceptives and diabetes mellitus." BMJ 299 (1989): 1315-6
- Spellacy WN, Ellingson AB, Tsibris JC "The effects of two triphasic oral contraceptives on carbohydrate metabolism in women during 1 year of use." Fertil Steril 51 (1989): 71-4
- Ludvik B, Clodi M, Kautzky-Willer A, Capek M, Hartter E, Pacini G, Prager R "Effect of dexamethasone on insulin sensitivity, islet amyloid polypeptide and insulin secretion in humans." Diabetologia 36 (1993): 84-7
- Domenet JG "Diabetogenic effect of oral diuretics." Br Med J 3 (1968): 188
- Coni NK, Gordon PW, Mukherjee AP, Read PR "The effect of frusemide and ethacrynic acid on carbohydrate metabolism." Age Ageing 3 (1974): 85-90
- Schmitz O, Hermansen K, Nielsen OH, Christensen CK, Arnfred J, Hansen HE, Mogensen CE, Orskov H, Beck-Nielsen H "Insulin action in insulin-dependent diabetics after short-term thiazide therapy." Diabetes Care 9 (1986): 631-6
- Blayac JP, Ribes G, Buys D, Puech R, Loubatieres-Mariani MM "Effects of a new benzothiadiazine derivative, LN 5330, on insulin secretion." Arch Int Pharmacodyn Ther 253 (1981): 154-63
- Elmfeldt D, Berglund G, Wedel H, Wilhelmsen L "Incidence and importance of metabolic side-effects during antihypertensive therapy." Acta Med Scand Suppl 672 (1983): 79-83
- Winchester JF, Kellett RJ, Boddy K, Boyle P, Dargie HJ, Mahaffey ME, Ward DM, Kennedy AC "Metolazone and bendroflumethiazide in hypertension: physiologic and metabolic observations." Clin Pharmacol Ther 28 (1980): 611-8
- Petri M, Cumber P, Grimes L, Treby D, Bryant R, Rawlins D, Ising H "The metabolic effects of thiazide therapy in the elderly: a population study." Age Ageing 15 (1986): 151-5
- "Product Information. Glucophage (metformin)." Bristol-Myers Squibb PROD (2001):
- Harper R, Ennis CN, Heaney AP, Sheridan B, Gormley M, Atkinson AB, Johnston GD, Bell PM "A comparison of the effects of low- and conventional-dose thiazide diuretic on insulin action in hypertensive patients with NIDDM." Diabetologia 38 (1995): 853-9
- "Product Information. Precose (acarbose)." Bayer PROD (2001):
- "Product Information. Norvir (ritonavir)." Abbott Pharmaceutical PROD (2001):
- "Product Information. Amaryl (glimepiride)." Hoechst Marion Roussel PROD (2001):
- Charan VD, Desai N, Singh AP, Choudhry VP "Diabetes mellitus and pancreatitis as a complication of L- asparaginase therapy." Indian Pediatr 30 (1993): 809-10
- Seifer DB, Freedman LN, Cavender JR, Baker RA "Insulin-dependent diabetes mellitus associated with danazol." Am J Obstet Gynecol 162 (1990): 474-5
- "Product Information. Crixivan (indinavir)." Merck & Co., Inc PROD (2001):
- Pickkers P, Schachter M, Hughes AD, Feher MD, Sever PS "Thiazide-induced hyperglycaemia: a role for calcium-activated potassium channels?" Diabetologia 39 (1996): 861-4
- "Product Information. Viracept (nelfinavir)." Agouron Pharma Inc PROD (2001):
- Dube MP, Johnson DL, Currier JS, Leedom JM "Protease inhibitor-associated hyperglycaemia." Lancet 350 (1997): 713-4
- "Product Information. Oncaspar (pegaspargase)." Rhone Poulenc Rorer PROD (2001):
- "Product Information. Prandin (repaglinide)." Novo Nordisk Pharmaceuticals Inc PROD (2001):
- "Product Information. Elspar (asparaginase)." Merck & Co., Inc PROD (2001):
- "Product Information. Hyperstat (diazoxide)." Apothecon Inc (2022):
- "Product Information. Megace (megestrol)." Bristol-Myers Squibb PROD (2001):
- Walli R, Demant T "Impaired glucose tolerance and protease inhibitors." Ann Intern Med 129 (1998): 837-8
- "Product Information. Agenerase (amprenavir)." Glaxo Wellcome PROD (2001):
- Mauss S, Wolf E, Jaeger H "Impaired glucose tolerance in HIV-positive patients receiving and those not receiving protease inhibitors." Ann Intern Med 130 (1999): 162-3
- Kaufman MB, Simionatto C "A review of protease inhibitor-induced hyperglycemia." Pharmacotherapy 19 (1999): 114-7
- "Product Information. Tolinase (tolazamide)." Pharmacia and Upjohn PROD (2001):
- "Product Information. Orinase (tolbutamide)." Pharmacia and Upjohn PROD (2001):
- "Product Information. Dymelor (acetohexamide)." Lilly, Eli and Company PROD (2001):
- Wehring H, Alexander B, Perry PJ "Diabetes mellitus associated with clozapine therapy." Pharmacotherapy 20 (2000): 844-7
- Tsiodras S, Mantzoros C, Hammer S, Samore M "Effects of protease inhibitors on hyperglycemia, hyperlipidemia, and lipodystrophy - A 5-year cohort study." Arch Intern Med 160 (2000): 2050-6
- "Product Information. Fortovase (saquinavir)." Roche Laboratories PROD (2001):
- "Product Information. Starlix (nateglinide)." Novartis Pharmaceuticals PROD (2001):
- Hardy H, Esch LD, Morse GD "Glucose disorders associated with HIV and its drug therapy." Ann Pharmacother 35 (2001): 343-51
- Leary WP, Reyes AJ "Drug interactions with diuretics." S Afr Med J 65 (1984): 455-61
- "Product Information. NovoLOG Mix 70/30 (insulin aspart-insulin aspart protamine)." Novo Nordisk Pharmaceuticals Inc (2022):
- "Product Information. Reyataz (atazanavir)." Bristol-Myers Squibb (2003):
- "Product Information. Lexiva (fosamprenavir)." GlaxoSmithKline (2003):
- "Product Information. Apidra (insulin glulisine)." Aventis Pharmaceuticals (2004):
- "Product Information. Prezista (darunavir)." Ortho Biotech Inc (2006):
- "Product Information. Zolinza (vorinostat)." Merck & Co., Inc (2006):
- "Product Information. Torisel (temsirolimus)." Wyeth-Ayerst Laboratories (2007):
- "Product Information. Rexulti (brexpiprazole)." Otsuka American Pharmaceuticals Inc (2015):
- "Product Information. Elzonris (tagraxofusp)." Stemline Therapeutics (2019):
- "Product Information. Piqray (alpelisib)." Novartis Pharmaceuticals (2019):
Drug and Food Interactions
Moderate
Levothyroxine
+ Food
The following applies to the ingredients: Levothyroxine
ADJUST DOSING INTERVAL: Consumption of certain foods as well as the timing of meals relative to dosing may affect the oral absorption of T4 thyroid hormone (i.e., levothyroxine). T4 oral absorption is increased by fasting and decreased by foods such as soybean flour (e.g., infant formula), cotton seed meal, walnuts, dietary fiber, calcium, and calcium fortified juices. Grapefruit or grapefruit products may delay the absorption of T4 thyroid hormone and reduce its bioavailability. The mechanism of this interaction is not fully understood.
MANAGEMENT: Some manufacturers recommend administering oral T4 as a single daily dose, on an empty stomach, one-half to one hour before breakfast. In general, oral preparations containing T4 thyroid hormone should be administered on a consistent schedule with regard to time of day and relation to meals to avoid large fluctuations in serum levels. Foods that may affect T4 absorption should be avoided within several hours of dosing if possible. Consult local guidelines for the administration of T4 in patients receiving enteral feeding.
References
- "Product Information. Synthroid (levothyroxine)." Abbott Pharmaceutical PROD (2002):
- "Product Information. Armour Thyroid (thyroid desiccated)." Forest Pharmaceuticals (2022):
- Wohlt PD, Zheng L, Gunderson S, Balzar SA, Johnson BD, Fish JT "Recommendations for the use of medications with continuous enteral nutrition." Am J Health Syst Pharm 66 (2009): 1438-67
The following applies to the ingredients: Levothyroxine
ADJUST DOSING INTERVAL: Concurrent administration of calcium-containing products may decrease the oral bioavailability of levothyroxine by one-third in some patients. Pharmacologic effects of levothyroxine may be reduced. The exact mechanism of interaction is unknown but may involve nonspecific adsorption of levothyroxine to calcium at acidic pH levels, resulting in an insoluble complex that is poorly absorbed from the gastrointestinal tract. In one study, 20 patients with hypothyroidism who were taking a stable long-term regimen of levothyroxine demonstrated modest but significant decreases in mean free and total thyroxine (T4) levels as well as a corresponding increase in mean thyrotropin (thyroid-stimulating hormone, or TSH) level following the addition of calcium carbonate (1200 mg/day of elemental calcium) for 3 months. Four patients had serum TSH levels that were higher than the normal range. Both T4 and TSH levels returned to near-baseline 2 months after discontinuation of calcium, which further supported the likelihood of an interaction. In addition, there have been case reports suggesting decreased efficacy of levothyroxine during calcium coadministration. It is not known whether this interaction occurs with other thyroid hormone preparations.
MANAGEMENT: Some experts recommend separating the times of administration of levothyroxine and calcium-containing preparations by at least 4 hours. Monitoring of serum TSH levels is recommended. Patients with gastrointestinal or malabsorption disorders may be at a greater risk of developing clinical or subclinical hypothyroidism due to this interaction.
References
- Schneyer CR "Calcium carbonate and reduction of levothyroxine efficacy." JAMA 279 (1998): 750
- Singh N, Singh PN, Hershman JM "Effect of calcium carbonate on the absorption of levothyroxine." JAMA 283 (2000): 2822-5
- Csako G, McGriff NJ, Rotman-Pikielny P, Sarlis NJ, Pucino F "Exaggerated levothyroxine malabsorption due to calcium carbonate supplementation in gastrointestinal disorders." Ann Pharmacother 35 (2001): 1578-83
- Neafsey PJ "Levothyroxine and calcium interaction: timing is everything." Home Healthc Nurse 22 (2004): 338-9
Moderate
Ozempic
+ Food
The following applies to the ingredients: Semaglutide (found in Ozempic)
MONITOR: Glucagon-like peptide-1 (GLP-1) receptor agonists and dual GLP-1 and glucose-dependent insulinotropic polypeptide (GIP) receptor agonists can delay gastric emptying, which may impact the absorption of concomitantly administered oral medications. Mild to moderate decreases in plasma concentrations of coadministered drugs have been demonstrated in pharmacokinetic studies for some GLP-1 receptor agonists (e.g., exenatide, lixisenatide), but not others. According to the prescribing information, liraglutide did not affect the absorption of several orally administered drugs to any clinically significant extent, including acetaminophen, atorvastatin, digoxin, griseofulvin, lisinopril, and an oral contraceptive containing ethinyl estradiol-levonorgestrel. Likewise, no clinically relevant effect on absorption was observed for concomitantly administered oral drugs studied with albiglutide (digoxin, ethinyl estradiol-norethindrone, simvastatin, warfarin), dulaglutide (acetaminophen, atorvastatin, digoxin, ethinyl estradiol-norelgestromin, lisinopril, metformin, metoprolol, sitagliptin, warfarin), or semaglutide (atorvastatin, digoxin, ethinyl estradiol-levonorgestrel, metformin, warfarin). The impact of dual GLP-1 and GIP receptor agonist tirzepatide on gastric emptying was reported to be dose- and time-dependent, with the greatest effect observed after a single 5 mg dose but diminished after subsequent doses. When acetaminophen was administered following a single 5 mg dose of tirzepatide, acetaminophen peak plasma concentration (Cmax) was decreased by 50% and its median time to peak plasma concentration (Tmax) delayed by 1 hour. However, no significant impact on acetaminophen Cmax and Tmax was observed after 4 consecutive weekly doses of tirzepatide (5 mg/5 mg/8 mg/10 mg), and the overall exposure (AUC) of acetaminophen was unaffected. Tirzepatide at lower doses of 0.5 mg and 1.5 mg also had minimal effects on acetaminophen exposure.
MANAGEMENT: Although no specific dosage adjustment of concomitant medications is generally recommended based on available data, potential clinical impact on some oral medications cannot be ruled out, particularly those with a narrow therapeutic index or low bioavailability, those that depend on threshold concentrations for efficacy (e.g., antibiotics), and those that require rapid gastrointestinal absorption (e.g., hypnotics, analgesics). Pharmacologic response to concomitantly administered oral medications should be monitored more closely following initiation, dose adjustment, or discontinuation of a GLP-1 receptor agonist or a dual GLP-1 and GIP receptor agonist.
References
- "Product Information. Byetta (exenatide)." Amylin Pharmaceuticals Inc (2005):
- "Product Information. Victoza (liraglutide)." Novo Nordisk Pharmaceuticals Inc (2010):
- "Product Information. Tanzeum (albiglutide)." GlaxoSmithKline (2014):
- "Product Information. Trulicity (dulaglutide)." Eli Lilly and Company (2014):
- "Product Information. Adlyxin (lixisenatide)." sanofi-aventis (2016):
- "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2022):
- "Product Information. Mounjaro (tirzepatide)." Eli Lilly and Company Ltd (2023):
- "Product Information. Mounjaro (tirzepatide)." Lilly, Eli and Company (2023):
- Eli Lilly Canada Inc. "Product monograph including patient medication information MOUNJARO tirzepatide injection. https://pdf.hres.ca/dpd_pm/00068421.PDF" (2023):
Drug and Pregnancy Interactions
Major
Ozempic
+ Pregnancy
The following applies to the ingredients: Semaglutide (found in Ozempic)
Benefit should outweigh risk
AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned
Risk summary: Available data are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other maternal or fetal outcomes; based on animal data, there may be potential risks to the fetus from exposure during pregnancy. Additionally weight loss offers no benefit to a pregnant patient and may cause fetal harm.
Comments:
-Poorly controlled diabetes during pregnancy is associated with both maternal and fetal risks.
-When pregnancy is recognized for a women on Wegovy, this drug should be discontinued and the patient should be advised of the risk to a fetus.
-Women of childbearing potential should be encouraged to use contraception during therapy; if pregnancy is desired, stop treatment at least 2 months prior to a planned pregnancy due to its long washout period.
-A pregnancy registry has been created to monitor pregnancy outcomes in women exposed to semaglutide (Wegovy) during pregnancy; pregnant women exposed to Wegovy and healthcare providers are encourage to contact Novo Nordisk at 1-800-727-6500.
Studies in pregnant rats have shown embryofoetal mortality, structural abnormalities, and alterations to growth when administered during organogenesis at maternal exposures below the maximum recommended human dose (MRHD). Early pregnancy losses and structural abnormalities were observed in rabbits at doses below the MRHD. In cynomolgus monkeys, early pregnancy losses and structural abnormalities were observed at exposures of 10-fold or higher that of the MRHD. In rabbits and monkeys, these finding coincided with marked maternal body weight loss. Salcaprozate sodium (SNAC), an absorption enhancer in the oral tablet has been shown to cross the placenta and reach fetal tissue in rats. Administration of SNAC to pregnant rats has shown an increase in number of stillbirths and a decrease in pup viability. There are no adequate and well-controlled studies in pregnant women.
Clinical considerations:
-Poorly controlled diabetes during pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, stillbirth and delivery complications and increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity. In the US, the estimated background risk of major birth defects in women with pregestational diabetes with an HbA1c greater than 7 is 6% to 10%; in women with pregestational diabetes and a HbA1c greater than 10, this risk has been reported as 20% to 25%.
-Appropriate weight gain based on pre-pregnancy weight is recommended for all pregnant patients because of the obligatory weight gain that occurs in maternal tissues during pregnancy.
AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
References
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2022):
- "Product Information. Rybelsus (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2021):
- "Product Information. Wegovy (0.25 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc ORIG-1 (2021):
Minor
Levothyroxine
+ Pregnancy
The following applies to the ingredients: Levothyroxine
Use is considered acceptable
AU TGA pregnancy category: A
US FDA pregnancy category: Not Assigned
Risk Summary: No increased rates of major birth defects or miscarriages have been reported with use during pregnancy; untreated hypothyroidism during pregnancy is associated with risks to the mother and fetus
Comments:
-Thyroid replacement therapy should not be discontinued during pregnancy; hypothyroidism diagnosed during pregnancy should be promptly treated.
-Monitor TSH levels and adjust doses as needed.
Animal studies have not been conducted. There is a long history of using this drug in pregnant women and this experience has not shown increased rates of fetal malformations, miscarriages or other adverse maternal or fetal outcomes. Hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, pre-eclampsia, stillbirth and premature delivery. Maternal hypothyroidism may have an adverse effect on fetal neurocognitive development. Pregnant women taking this drug should have their TSH measured during each trimester and dose adjusted as appropriate. Patients will generally return to their pre-pregnancy dose after delivery. There are no controlled data in human pregnancy.
AU TGA pregnancy category A: Drugs which have been taken by a large number of pregnant women and women of childbearing age without any proven increase in the frequency of malformations or other direct or indirect harmful effects on the fetus having been observed.
US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.
References
- "Product Information. Synthroid (levothyroxine)." Abbott Pharmaceutical PROD (2002):
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp" (2006):
- Cerner Multum, Inc. "Australian Product Information." O 0
Drug and Breastfeeding Interactions
Major
Ozempic
+ Breastfeeding
The following applies to the ingredients: Semaglutide (found in Ozempic)
Oral Administration: Not recommended
Subcutaneous Administration: Benefit should outweigh risk
Excreted into human milk: Unknown
Excreted into animal milk: Yes
Comments:
-Oral tablets: Breastfeeding is not recommended with maternal use of the oral tablet due to the possible accumulation of the absorption enhancer (salcaprozate sodium) in breastfed infant; if therapy is necessary, the subcutaneous injection should be used.
-Subcutaneous injection: The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need and any potential adverse effects on the breastfed infant from this drug or from the underlying maternal condition.
-Some authorities advise against semaglutide use during lactation as a risk to the breastfed child cannot be excluded.
Subcutaneous formulation: In lactating rats, this drug was detected in milk at levels 3 to 12-fold lower than maternal plasma. There are no data on the presence of this drug in human milk, the effects on milk production, or the effects on the breastfed infant. It is assumed that because this drug is a peptide molecule and is over 99% protein bound, if excreted, the amount in milk would be low. Additionally, it is believed that if excreted in milk, infant absorption would be unlikely as it would probably be destroyed in the infant's gastrointestinal tract.
Oral Tablet: Salcaprozate sodium (SNAC) is present in the oral formulation as an absorption enhancer. SNAC and/or its metabolites have been found in concentrated quantities in the milk of lactating rats. There are no data in the presence of SNAC in human milk, however, the enzyme needed to clear SNAC (UGT2B7) is lower in infants compared to adults and therefore higher SNAC plasma levels may occur in breastfed infants. The potential for serious adverse reactions due to accumulation of SNAC are unknown.
References
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Cerner Multum, Inc. "Australian Product Information." O 0
- United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
- "Product Information. Ozempic (1 mg dose) (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2022):
- "Product Information. Rybelsus (semaglutide)." Novo Nordisk Pharmaceuticals Inc (2021):
Minor
Levothyroxine
+ Breastfeeding
The following applies to the ingredients: Levothyroxine
Use is considered acceptable
Excreted into human milk: Yes
Comments:
-Levothyroxine (T4) is a normal component of human milk; limited data on exogenous replacement doses during breastfeeding have not shown an adverse effect in nursing infants.
-Levothyroxine dose requirements may be increased in the postpartum period compared to prepregnancy requirements in patients with Hashimoto's thyroiditis.
-The presence of thyroid hormone in breast milk does not appear to interfere with neonatal thyroid screening.
References
- "Product Information. Synthroid (levothyroxine)." Abbott Pharmaceutical PROD (2002):
- Jansson L, Ivarsson S, Larsson I, Ekman R "Tri-iodothyronine and thyroxine in human milk." Acta Paediatr Scand 72 (1983): 703-5
- Moller B, Bjorkhem I, Falk O, Lantto O, Lafsson A "Identification of thyroxine in human breast milk by gas chromatography-mass spectrometry." J Clin Endocrinol Metab 56 (1983): 30-4
- Mizuta H, Amino N, Ichihara K, et al. "Thyroid hormones in human milk and their influence on thyroid function of breast-fed babies." Pediatr Res 17 (1983): 468-71
- Hahn HB, Spiekerman AM, Otto R, Hossalla DE "Thyroid function tests in neonates fed human milk." Am J Dis Child 137 (1983): 220-2
- Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
- Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. http://www.appco.com.au/appguide/default.asp" (2006):
- Cerner Multum, Inc. "Australian Product Information." O 0
- United States National Library of Medicine "Toxnet. Toxicology Data Network. http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT" (2013):
Therapeutic Duplication Warnings
No warnings were found for your selected drugs.Therapeutic duplication warnings are only returned when drugs within the same group exceed the recommended therapeutic duplication maximum.
Switch to: Consumer Interactions
Drug Interaction Classification | |
---|---|
These classifications are only a guideline. The relevance of a particular drug interaction to a specific individual is difficult to determine. Always consult your healthcare provider before starting or stopping any medication. |
|
Major | Highly clinically significant. Avoid combinations; the risk of the interaction outweighs the benefit. |
Moderate | Moderately clinically significant. Usually avoid combinations; use it only under special circumstances. |
Minor | Minimally clinically significant. Minimize risk; assess risk and consider an alternative drug, take steps to circumvent the interaction risk and/or institute a monitoring plan. |
Unknown | No interaction information available. |
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