| Antihypertensive |
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Losartan Potassium Tablets
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INFORMATION FOR USE OF A MEDICAL PRACTITIONER, HOSPITAL OR LABORATORY |
| LOSARTAN POTASSIUM TABLETS |
| Each film coated tablet contains: Losartan Potassium USP…50 mg |
| IMPORTANT WARNING: When used in pregnancy during the second and third trimesters, drugs that act directly on the renin-angiotensin system can cause injury and even death to the developing fetus. When pregnancy is detected, Losartan Potassium should be discontinued as soon as possible. |
PHARMACOLOGICAL CLASSIFICATION |
Angiotensin II [formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme (ACE, kininase II)], is a potent vasoconstrictor, the primary vasoactive hormone of the renin-angiotensin system and an important component in the pathophysiology of hypertension. It also stimulates aldosterone secretion by the adrenal cortex. Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g., vascular smooth muscle, adrenal gland). There is also an AT2 receptor found in many tissues but it is not known to be associated with cardiovascular homeostasis. Both losartan and its principal active metabolite do not exhibit any partial agonist activity at the AT1 receptor and have much greater affinity (about 1000-fold) for the AT1 receptor than for the AT2 receptor. Following oral administration, losartan is well absorbed (based on absorption of radiolabeled losartan) and undergoes substantial first-pass metabolism; the systemic bioavailability of losartan is approximately 33%. About 14% of an orally-administered dose of losartan is converted to the active metabolite. Mean peak concentrations of losartan and its active metabolite are reached in 1 hour and in 3-4 hours, respectively. While maximum plasma concentrations of losartan and its active metabolite are approximately equal, the AUC of the metabolite is about 4 times as great as that of losartan. A meal slows absorption of losartan and decreases its Cmax but has only minor effects on losartan AUC or on the AUC of the metabolite (about 10% decreased). The terminal half-life of losartan is about 2 hours and of the metabolite is about 6-9 hours.
| Losartan Potassium is indicated for the treatment of hypertension. It may be used alone or in combination with other antihypertensive agents, including diuretics. |
Hypertensive Patients with Left Ventricular Hypertrophy |
| Losartan Potassium is indicated to reduce the risk of stroke in patients with hypertension and left ventricular hypertrophy, but there is evidence that this benefit does not apply to Black patients. |
Nephropathy in Type 2 Diabetic Patients |
| Losartan Potassium is indicated for the treatment of diabetic nephropathy with an elevated serum creatinine and proteinuria (urinary albumin to creatinine ratio ≥300 mg/g) in patients with type 2 diabetes and a history of hypertension. In this population, Losartan Potassium reduces the rate of progression of nephropathy as measured by the occurrence of doubling of serum creatinine or end stage renal disease (need for dialysis or renal transplantation) |
| BEFORE YOU TAKE LOSARTAN POTASSIUM |
Make sure you have told your doctor if you: |
· Are pregnant, trying for a baby or breast-feeding · Suffer from heart failure or heart disease. · Suffer from liver or kidney problems. |
HOW TO TAKE LOSARTAN POTASSIUM |
| You must take your medicine as the doctor tells you. It is important to take Losartan Potassium Tablets at the right time. Your doctor will decide which is the best dose for you, depending on your illness. |
Adult Hypertensive Patients |
The usual starting dose of Losartan Potassium is 50 mg once daily, with 25 mg used in patients with possible depletion of intravascular volume (e.g., patients treated with diuretics) and patients with a history of hepatic impairment |
Pediatric Hypertensive Patients ≥ 6 years of age |
The usual recommended starting dose is 0.7 mg/kg once daily (up to 50 mg total) administered as a tablet or a suspension. Dosage should be adjusted according to blood pressure response. |
| Take the missed dose as soon as you remember it. If it is almost time for your next dose, skip the dose you missed and take your next dose when you are meant to. Otherwise, take it as soon as you remember, and then go back to taking your doses as you would normally. If you are not sure whether to skip the dose, talk to your doctor or pharmacist. Do not take a double dose to make up for the dose that you missed. |
WHAT TO DO IF AN OVERDOSE IS TAKEN |
| In that case do not delay, ask your doctor immediately what to do or contact your nearest hospital emergency department. Do this even if there are no signs of discomfort or poisoning. |
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without prescription, your doctor may wish to alter your dose of Losartan Potassium if you are taking any drug: |
· potassium supplements · salt substitutes containing potassium · water pills (diuretics) |
| · Medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors. |
Like all medicines, Losartan Potassium can cause side effects. |
The most common side effects of Losartan Potassium in people with high blood pressure are: |
· “colds” (upper respiratory infection) · dizziness · stuffy nose · back pain |
The most common side effects of Losartan Potassium in people with type 2 diabetes with diabetic kidney disease are: |
· diarrhea · tiredness · low blood sugar · chest pain · high blood potassium · low blood pressure |
· Keep all medicines out of the reach of children. · Store in a cool, dry place, away from direct heat and light. |
| Disclaimer: Strictly meant for information purpose only. The above information should not be used at one’s own discretion nor should substitute your physician’s advice. |
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