Legal Class of Nifedipine

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There are conflicting data on the use of nifedipine in proteinuria associated with diabetic nephropathy. A significant increase in urinary albumin excretion was reported in 7 normotensive patients with diabetic nephropathy treated with nifedipine 20 mg PO slow-release twice daily and observed for 6 weeks. A significant increase in urinary albumin excretion was also reported in a crossover study of 14 non-insulin-dependent diabetics in a 20-week study. The median dose of the study was 45 +/- 8 mg of long-acting nifedipine once daily. Conversely, in another study, 27 diabetics with persistent microalbuminuria received nifedipine 20 to 80 mg PO once daily for 12 months. These data showed a decrease in urinary albumin excretion (EAU) during treatment, but UAE increased to levels above baseline after treatment discontinuation. 0.2 to 0.5 mg/kg/dose (max. 10 mg/dose) PO every 4 to 6 hours as needed. To avoid an abrupt and unexpected drop in blood pressure, some authors recommend initial doses below 0.2 mg/kg and avoid use in patients with CNS lesions. Mean doses of 0.22 to 0.23 mg/kg (range: 0.04 to 0.69 mg/kg) were reported in retrospective studies (n = 299 paediatric patients 0.1 to 18.9 years of age).

NOTE: According to the FDA and manufacturers, immediate-release dosage forms of nifedipine should not be used to treat hypertension and only to treat patients with stable chronic angina or vasospastic angina. The immediate-release formulation of nifedipine has been associated with serious side effects when used to treat adult patients with hypertension, hypertensive emergency, hypertensive urgency or coexisting myocardial infarction. Although the use of immediate-release nifedipine for the treatment of acute hypertensive episodes is still relatively common in paediatric patients, there is considerable controversy and caution is advised. Due to the relaxing effect of nifedipine on the smooth muscles of peripheral blood vessels, nifedipine is also associated with edema (see below). Additional water retention can lead to weight gain, but this usually resolves with discontinuation of the medication or dose adjustments. Nifedipine sublingually administration has previously been used in hypertensive emergencies. Previously, it was often prescribed as needed to patients taking MAO inhibitors for real or perceived hypertensive seizures. [9] This proved dangerous and was abandoned. Sublingual administration of nifedipine promotes an antihypertensive effect via peripheral vasodilation. It can cause an uncontrollable decrease in blood pressure, reflex tachycardia and theft in some vascular beds.

There have been several reports in the medical literature of serious side effects with sublingual nifedipine, including cerebral ischemia/infarction, myocardial infarction, complete heart block, and death. As a result, in 1985, the FDA reviewed all data on the safety and efficacy of sublingual nifedipine for the treatment of hypertensive emergencies and concluded that the practice should be abandoned as it was neither safe nor effective. [10] [11] An exception to the avoidance of this practice is the use of nifedipine to treat hypertension associated with autonomic dysreflexia in spinal cord injuries. [12] Avoid grapefruit products, certain supplements such as St. John`s wort, and medications that interact with nifedipine. It is known that an overdose of nifedipine causes severe heart failure and should not be taken with medications that could increase this risk. Nifedipine reduces peripheral resistance and may worsen hypotension. Nifedipine must not be used in patients with systolic blood pressure below 90 mm Hg (i.e. severe hypotension). Nifedipine should be used with caution in patients with mild to moderate hypotension. Blood pressure should be carefully monitored in all patients receiving nifedipine.

Weight gain is not a serious side effect associated with nifedipine. However, there are two mechanisms by which individuals can gain or lose weight while taking this medication. Nifedipine has been linked to weight loss in obese animals, which is thought to be linked to nifedipine`s beneficial effect on lipid metabolism and systolic blood pressure. In patients with hepatic impairment, dose reduction and close monitoring of blood pressure are recommended. Although no specific guidelines are available, the half-life and AUC of nifedipine are significantly increased in cirrhotic patients. Nifedipine is indicated for the treatment of stable chronic angina (exertion-associated angina) without evidence of vasospasm in patients who remain symptomatic despite sufficient doses of beta-blockers and/or organic nitrates or who cannot tolerate these agents. In stable chronic angina (exercise-associated angina), nifedipine has been shown to be effective in reducing angina frequency and increasing exercise tolerance in controlled trials of up to eight weeks duration, but confirmation of sustained efficacy and assessment of long-term safety in these patients is incomplete. Controlled studies in a small number of patients suggest that concomitant use of nifedipine and beta-blockers may be beneficial in patients with stable chronic angina, but the available information is insufficient to predict with certainty the effects of concomitant therapy, particularly in patients with impaired left ventricular function or abnormal cardiac conduction. When introducing such concomitant therapy, care should be taken to closely monitor blood pressure, since severe hypotension may occur due to the combined effects of drugs.

Do not stop this medicine without consulting a doctor. You should not stop taking blood pressure medications, including nifedipine, unless you have decided with your doctor that it is the right decision. The use of immediate-release nifedipine dosage forms in geriatric patients (aged 71 years and older) for the treatment of hypertension has been associated with an almost 4-fold higher risk of all-cause mortality compared to other antihypertensive drugs (beta-blockers, ACE inhibitors or non-dihydropyridine calcium channel blockers). Nifedipine plasma concentrations are significantly increased in elderly patients. This patient population may be at higher risk of drug accumulation and toxicity; Start dosing carefully. Small pharmacokinetic studies have shown an increase in half-life, Cmax and AUC in older populations. In healthy subjects, nifedipine clearance after intravenous administration was reduced by 33% in older subjects compared to younger subjects. These changes are not due to changes in kidney function. According to the Beers criteria, immediate-release nifedipine is considered a potentially inappropriate drug (PIM) in geriatric patients; Avoid use because of the risk of hypotension and the risk of triggering myocardial ischemia.

The federal Household Omnibus Reconciliation Act (OBRA) regulates the use of medications by residents of long-term care facilities; Antihypertensive treatments must be individualized to achieve the desired result while minimizing side effects.