Hydrochlorothiazide; lisinopril is classified as FDA pregnancy risk category D. Once pregnancy is detected, every effort should be made to discontinue hydrochlorothiazide; lisinopril therapy. Women of child-bearing age should be made aware of the potential risk and hydrochlorothiazide; lisinopril should only be given after careful counseling and consideration of individual risks and benefits. When used during the second and third trimesters, drugs that affect the renin-angiotensin system (., ACE inhibitors, angiotensin II receptor antagonists) reduce fetal renal function and increase fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Other potential neonatal adverse effects include skull hypoplasia, anuria, and hypotension. Based on the results from one large study, first trimester use of thiazide and related diuretics may increase the risk for congenital defects. In addition to malformations, other fetal risks associated with thiazide use during pregnancy include hypoglycemia, thrombocytopenia, hyponatremia, hypokalemia, and death from maternal complications. An observational study based on Tennessee Medicaid data reported that the risk of congenital malformations is significantly increased during first-trimester exposure to ACE inhibitors. However, a much larger observational study (n = 465,754) found that the risk of birth defects was similar in infants exposed to ACE inhibitors during the first trimester, in infants exposed to other antihypertensives during the first trimester, and in those whose mothers were hypertensive but were not treated. Infants born to mothers with hypertension, either treated or untreated, had a higher risk of birth defects than those born to mothers without hypertension. The authors concluded that the presence of hypertension likely contributed to the development of birth defects rather than the use of medications. In rare cases when another antihypertensive agent cannot be used to treat a pregnant patient, serial ultrasound examinations should be performed to assess the intraamniotic environment. If oligohydramnios is observed, discontinue hydrochlorothiazide; lisinopril unless it is considered life-saving for the mother. It should be noted that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe newborns with histories of in utero exposure to hydrochlorothiazide; lisinopril for hypotension, oliguria, and hyperkalemia. If oliguria or hypotension occurs, blood pressure and renal perfusion support may be required, as well as exchange transfusion or dialysis to reverse hypotension and/or support decreased renal function. Lisinopril crosses the placenta and has been removed from neonatal circulation by peritoneal dialysis with some clinical benefit, and theoretically may be removed by exchange transfusion, although there is no experience with the latter procedure.
-Take orally 2 times a week; may take with or without food
-Since hyperprolactinemia with amenorrhea/galactorrhea and infertility may be associated with pituitary tumors, a complete evaluation of the pituitary should be done prior to initiating treatment.
-Use for postpartum lactation inhibition or suppression is not recommended due to potential risk of hypertension, stroke, and seizures.
-The durability of efficacy beyond 24 months has not been established.
-Perform a cardiovascular evaluation including echocardiogram to assess for valvular disease prior to initiating treatment; routine echocardiographic monitoring should be performed every 6 to 12 months during treatment or more often as clinically indicated.
-Monitor for fibrotic disorders/reactions; consider clinical and diagnostic tests such as erythrocyte sedimentation rate, chest-x-ray, and serum creatinine at baseline and periodically throughout treatment.
Patient advice :
-Patients should be instructed to notify their health care provider if they develop shortness of breath, persistent cough, difficulty breathing while lying down, or swelling in extremities.
-Patients should not drive a car or operate machinery or other potentially dangerous activities until it is determined how this drug affects their mental and/or motor performance.
-Patients should be instructed to report episodes of sudden onset of sleep and new or worsening compulsive behaviors and/or unusual urges.
-Patients should speak to their physician or health care provider if they become pregnant, intend to become pregnant, or are breastfeeding.
Ropinirole ( INN ; trade names Requip , Repreve , Ronirol , Adartrel ) is a dopamine agonist of the non- ergoline class of medications. It is manufactured by GlaxoSmithKline (GSK), Cipla , Dr. Reddy's Laboratories and Sun Pharmaceutical . It is used in the treatment of Parkinson's disease and restless legs syndrome (RLS). Ropinirole is one of three medications approved by the FDA to treat RLS, the other two being pramipexole (Mirapex) and gabapentin enacarbil (Horizant). The discovery of the drug's utility in RLS has been used as an example of successful drug repurposing .