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Samantha Allen June 14, 2011 Treatment of Hypertension in the Breastfeeding Mother Objectives: Define criteria for diagnosis of hypertension in breastfeeding women Identify appropriate resources for determining compatibility of a pharmacologic treatment agent with breastfeeding Define characteristics of pharmacologic agents likely not to concentrate in breast milk Identify appropriate pharmacological interventions to treat hypertension in a breastfeeding mother List pharmacologic agents incompatible with breastfeeding Patient Review: HA is a 35 y/o Somalian female who presented to the clinic on May 9, 2011 for a follow-up of new onset Stage II Hypertension. She was first noted to be hypertensive in office on April 27, 2011 with a blood pressure reading of 162/116 mmHg. At a follow-up visit on May 2, 2011, she was again hypertensive with a blood pressure reading of 148/102 mmHg. She was then started on a regimen of hydrochlorothiazide 12.5 mg by mouth once daily with instructions to follow-up with in 1 week to assess the need for an additional medication. All information was obtained through a phone translator. Chief Complaint Headaches and pressure in back of neck PMH Hypertension (Diagnosed 5/2/11), Eight Normal Vaginal Deliveries (Last 7/2010), 1 miscarriage (Date unknown), Sciatica *Note: This is NOT post-partum hypertension Allergies NKDA Family History Negative for diabetes, hypertension, or early death Father still living Social History Negative for tobacco or alcohol use Currently Sexually Active Current Medications Hydrochlorothiazide 12.5 mg PO daily Acetaminophen 500 mg PO q6hr PRN Ferrous Sulfate 325 mg PO daily Docusate 100 mg PO daily Medroxyprogesterone 150 mg IM q84 days Review of Systems Positive: Headaches Negative: Vision changes, chest pain, SOB, heart palpitations, changes or problems with urinary output. Physical Exam Findings Vitals 5/9/11: BP: Temp: TempSrc: Resp: Weight: 150/110 96.2 °F (35.7 °C) Oral 18 140 lb 9.6 oz (63.776 kg) Historical BP Readings: 05/02/11- 148/102 mmHg (LAS RC) 04/27/11- 162/116 mmHg and 150/110 mmHg (LAS RC) 02/02/11- 110/70 mmHg (RAS RC) 11/09/10- 120/80 mmHg (RAS RC) 08/26/10- 140/100 mmHg (Post-Partum) 07/17/10- 122/82 mmHg 06/24/10- 126/93 mmHg (Pregnant) Tests Performed EKG: 5/2/11 – Evidence LVH Discussion of Hypertension in Breastfeeding Mothers: Background Chronic hypertension complicates approximately 3% of pregnancies and is the most common reason patients require long-term pharmacologic treatment for hypertension while breastfeeding. Some women may require treatment for postpartum hypertension, which occurs in the first few days following delivery, but this treatment usually is required for only a few days to weeks until a patient’s blood pressure normalizes and can then be discontinued. Pathophysiology Postpartum hypertension generally occurs within the first 5 days postpartum and will usually normalize within several days to weeks. This is likely attributed to a period of time postpartum of physiological volume expansion and fluid mobilization. The cause of chronic hypertension in breastfeeding mothers is most commonly primary hypertension, also known as essential hypertension. The cause of essential hypertension is largely unknown and may be multifactorial, with genetics playing an important role. Some proposed factors behind primary hypertension include alterations in sodium balance, nitric oxide release, and excretion of aldosterone, angiotension, or certain adrenal steroids. Several mechanisms that are utilized to treat essential hypertension may also be responsible for the development of essential hypertension, including the effects of the renin-angiotensinaldosterone system (RAAS), vasodepressor mechanisms, neuronal mechanisms, peripheral autoregulation, and alterations in sodium, calcium, and natriuretic hormones. Patient Presentation/Diagnosis Postpartum hypertension should be treated with antihypertensive agents if blood pressure exceeds 150 mmHg systolic or 100 mmHg diastolic. Chronic hypertension should be treated in accordance with the JNC7 guidelines, substituting medications compatible with breastfeeding when appropriate. The BP classification is as follows: -Normal: SBP≤120 mmHg and DBP≤80 mmHg -Prehypertension: SBP 120-139 mmHg or DBP 80-89 mmHg -Stage I HTN: SBP 140-159 mmHg or DBP 90-99 mmHg -Stage II HTN: SBP 160-179 mmHg or DBP 100-110 mmHg -Stage III HTN: SBP 180-209 mmHg or DBP 110-119 mmHg Goals of Therapy BP <140/90 mmHg (Diabetic patients or CKD patients <130/80 mmHg) Goals of therapy remain the same for breastfeeding mothers as the general population, which are to normalize blood pressure and to reduce the morbidity and mortality related to targetorgan damage, including CV events, heart failure, and kidney disease that result from sustained elevations in blood pressure. Therapeutic Options There are several resources available to determine if medications are compatible with breastfeeding. Below are a few commonly used resources and several articles that may be helpful in determining which medication is appropriate for the breastfeeding mother. In addition, databases such as Lexi-Comp and Micromedex often provide information on the safety of medications in both pregnancy and breastfeeding based on the recommendations of organizations such as the World Health Organization (WHO) and the American Academy of Pediatrics (AAP). Resources: -Gerald G. Briggs. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. 9th ed. Philadelphia: Williams & Wilkins, 2011. -Breastfeeding and Maternal Medication: Recommendations for Drugs in the Eleventh WHO Model List of Essential Drugs. (http://whqlibdoc.who.int/hq/2002/55732.pdf) -Dr. Hale’s Breastfeeding Pharmacology Page. (http://www.infantrisk.com/) - Podymow T, August P. Update on the use of antihypertensive drugs in pregnancy. Hypertension. 2008:51;960-969. - Spencer JP, Gonzalez LS, Barnhart DJ. Medications in the breast-feeding mother. Am Fam Physician. 2001:64(1);119-26. - American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001;108:776-789. Medication Selection and Dosing Guidelines: There are several considerations when choosing a medication for a breastfeeding mother. If possible, drug therapy should be avoided or topical agents that are not systemically absorbed utilized. Medications that are safe for the nursing infant’s age are usually safe for the breastfeeding mother. However, not all medications that are safe in pregnancy are compatible with breastfeeding. Here are some tips in selecting a medication: Ideal Medication Properties Short half-life Highly protein bound Poor oral absorption Small Volume of Distribution Low lipid solubility Lack of charge at physiological pH Well studied Administering once daily medications after the bed-time feeding where the infant will be sleeping the longest will help to minimize exposure. Dosing medications immediately after breastfeeding will also help to minimize exposure to multiple daily doses. First Line Antihypertensives Labetolol Propranolol Hydrochlorothiazide Methyldopa Alternative Agents Nifedipine XL Verapamil SR Hydralazine Captopril/Enalapril Overview Common Antihypertensives: (*=Preferred in class) Medications Compatible with Breastfeeding Beta Blockers *Labetolol, Propranolol, Metoprolol, Timolol, Oxprenolol Medications to Avoid in Breastfeeding Beta Blockers Atenolol, Sotolol, Acebutolol Accumulation in milk can occur Thiazide Diuretics *Hydrochlorothiazide, Chlorthalidone Loop Diuretics Furosemide, Bumetanide Can suppress lactation Not well studied ACE Inhibitors Captopril, Enalapril ACE Inhibitors Lisinopril Not studied Non-dihydropyridine CCB *Verapamil SR, Diltiazem CD Dihydropyridine CCB Nifedipine XL Dihydropyridine CCB Amlodipine Not well studied Direct Vasodilators Hydralazine, Minoxidil Angiotensin II Receptor Blockers Valsartan, Losartan Not studied Sympatholitic Methyldopa Alpha-1 Blockers Doxazosin, Prazosin, Terazosin Found to concentrate in animal milk Aldosterone Receptor Blockers Spironolactone May suppress lactation Monitoring of Therapy Home monitoring of blood pressure may be useful in postpartum hypertension due to the short duration of treatment and recommendation to discontinue therapy once blood pressure has normalized. Chronic hypertension should be monitored similarly to any other patient with essential hypertension according to JNC-7 recommendations. Patients with Stage I HTN should follow-up with their physician monthly until their blood pressure is controlled, then every 3-6 months. Serum potassium and creatinine should also be measured 1-2 times per year. Patients with complicating comorbid conditions or Stage II HTN may require more frequent follow-up. Summary: Initial Assessment & Plan 5/2/11: 1. Stage II HTN BP elevated above goal of <140/90 mmHg. No signs end organ damage. Patient is currently in Stage II HTN with evidence of LVH which warrants dual therapy, normally with an ACEI and a diuretic. Regimen of a thiazide diuretic with consideration to add a beta blocker was chosen due to breastfeeding. *Initiate hydrochlorothiazide 12.5 mg QAM after morning feeding *Monitor fluid intake and milk production *Monitor infant for s/s hypotension (↑ HR, cold limbs, ↑ RR, Pale skin, lack urination) *Return in 1 week for F/U and potential initiation of metoprolol 12.5 mg BID 2. Wellness Patient reports use of acetaminophen for treatment of headaches. Patient tolerating other medications w/o s/s ADR. *Continue acetaminophen 500 mg q6hr PRN *Continue medroxyprogesterone 150 mg IM q84 days Follow-Up Assessment & Plan 5/9/11: 1. HTN BP elevated above goal of <140/90 mmHg. No signs end organ damage. Patient did not take therapy as prescribed before office visit. Reports decrease in milk production with use of hydrochlorothiazide and need to supplement with formula. Change in therapy is warranted. MD comfortable with use of nifedipine XL because she has used it in previous patients who were breastfeeding. *Discontinue hydrochlorothiazide 12.5 mg daily *Initiate nifedipine XL 30 mg PO daily *Monitor s/s ADR (Headache, dizziness, palpitations) *Monitor infant for s/s hypotension (↑ HR, cold limbs, ↑ RR, Pale skin, lack urination) *Return in 2 weeks for F/U Patient was seen again at a future visit with uncontrolled hypertension and complaints of unacceptable side effects of the nifedipine. Follow-up Assessment & Plan 5/23/11: 1. HTN BP elevated above goal of <140/90 mmHg at 164/115 mmHg (RAS RC). No signs end organ damage. Patient stated she took nifedipine before office visit but is experiencing unacceptable side effects of daily headaches and heart palpitations. Change in therapy is warranted. *Discontinue nifedipine XL 30 mg PO daily *Initiate labetolol 100 mg PO BID *Monitor s/s ADR (Nausea, Dizziness, Fatigue, tingling sensation) *Monitor infant for s/s hypotension (↑ HR, cold limbs, ↑ RR, Pale skin, lack urination) *Return in 1 weeks for F/U Patient was seen again on 6/1/11 with controlled HTN at a BP of 130/80 mmHg and w/o complaints of s/s ADR to therapy. She was continued on labetolol 100 mg BID and was to follow-up in 2 weeks. References: Podymow T, August P. Update on the use of antihypertensive drugs in pregnancy. Hypertension. 2008:51;960-969. Spencer JP, Gonzalez LS, Barnhart DJ. Medications in the breast-feeding mother. Am Fam Physician. 2001:64(1);119-26. American Academy of Pediatrics Committee on Drugs. Transfer of drugs and other chemicals into human milk. Pediatrics. 2001;108:776-789. Gerald G. Briggs. Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk. 9th ed. Philadelphia: Williams & Wilkins, 2011. Saseen JJ, Maclaughlin EJ. Hypertension. In: Dipiro JT, Talbert RL, Yee GC et al.,eds. Pharmacothearpy A Pathophysiologic Approach. 7th ed. New York: McGraw-Hill; 2008: 139-169.