Losartan Potassium description, usages, side effects, indications, overdosage, supplying and lots more!

Menu
Search

Losartan Potassium

REMEDYREPACK INC.


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

BOXED WARNING

USE IN PREGNANCY
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 tablets should be discontinued as soon as possible. See WARNINGS, Fetal/Neonatal Morbidity and Mortality.


LOSARTAN POTASSIUM DESCRIPTION



Losartan Potassium






CLINICAL PHARMACOLOGY

Mechanism of Action



PHARMACOKINETICS

General







Special Populations

Pediatric



****

Geriatric and gender


Race


Renal insufficiency


Hepatic insufficiency


Drug Interactions


PHARMACODYNAMICS AND CLINICAL EFFECTS

Adult Hypertension








Pediatric Hypertension


Reduction in the Risk of Stroke



Losartan Potassium


Losartan Potassium





**


Losartan Potassium



Race


Nephropathy in Type 2 Diabetic Patients





Losartan Potassium










INDICATIONS AND USAGE

INDICATIONS & USAGE

Hypertension


Hypertensive Patients With Left Ventricular Hypertrophy


Nephropathy in Type 2 Diabetic Patients


LOSARTAN POTASSIUM CONTRAINDICATIONS



WARNINGS

Fetal/Neonatal Morbidity and Mortality









HypotensionVolume-Depleted Patients


PRECAUTIONS

General

Hypersensitivity


Impaired Hepatic Function


Impaired Renal Function




Electrolyte Imbalance


INFORMATION FOR PATIENTS

Pregnancy


Potassium Supplements


DRUG INTERACTIONS




Lithium


Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) Including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors)



CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY





PREGNANCY

Teratogenic Effects

Pregnancy categories C (first trimester) and D (second and third trimesters)


NURSING MOTHERS



PEDIATRIC USE



GERIATRIC USE


Race


LOSARTAN POTASSIUM ADVERSE REACTIONS

Hypertension






















**


Pediatric Patients


Hypertensive Patients With Left Ventricular Hypertrophy


Nephropathy in Type 2 Diabetic Patients



Postmarketing Experience











Laboratory Test Findings


Creatinine, Blood Urea Nitrogen


Hemoglobin and Hematocrit


Liver Function Tests


OVERDOSAGE





DOSAGE & ADMINISTRATION

Adult Hypertensive Patients






Pediatric Hypertensive Patients6 Years of Age



Preparation of Suspension (for 200 mL of a 2.5 mg/mL Suspension)



Hypertensive Patients With Left Ventricular Hypertrophy


Nephropathy in Type 2 Diabetic Patients


HOW SUPPLIED















INFORMATION FOR PATIENTS

PATIENT INFORMATION ABOUT LOSARTAN POTASSIUM TABLETS USP







  • ●     alone or with other blood pressure medicines to lower high blood pressure (hypertension).
  • ●     to lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy. Losartan potassium tablets USP may not help Black patients with this problem.
  • ●     to slow the worsening of diabetic kidney disease (nephropathy) in patients with type 2 diabetes who have or had high blood pressure.





  • ●     Do not take losartan potassium tablets USP if you are allergic to any of the ingredients in losartan potassium tablets USP. See the end of this leaflet for a complete list of ingredients in losartan potassium tablets USP.


  • ●     are pregnant or planning to become pregnant. SeeWhat is the most important information I should know about losartan potassium tablets USP?
  • ●     are breast-feeding. It is not known if losartan potassium passes into your breast milk. You should choose either to take losartan potassium tablets USP or breast-feed, but not both.
  • ●     are vomiting a lot or having a lot of diarrhea
  • ●     have liver problems
  • ●     have kidney problems


  • ●     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.

  • ●     Take losartan potassium tablets USP exactly as prescribed by your doctor. Your doctor may change your dose if needed.
  • ●     Losartan potassium tablets USP can be taken with or without food.
  • ●     If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
  • ●     If you take too many losartan potassium tablets USP, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.


  • ●     Injury or death of unborn babies. SeeWhat is the most important information I should know about losartan potassium tablets USP?
  • ●     Allergic reaction. Symptoms of an allergic reaction are swelling of the face, lips, throat or tongue. Get emergency medical help right away and stop taking losartan potassium tablets USP.
  • ●     Low blood pressure (hypotension). Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy. Call your doctor right away.
  • ●     For people who already have kidney problems, you may see a worsening in how well your kidneys work. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain.

  • ●     colds(upper respiratory infection)
  • ●     dizziness
  • ●     stuffy nose
  • ●     back pain

  • ●     diarrhea
  • ●     tiredness
  • ●     low blood sugar
  • ●     chest pain
  • ●     high blood potassium
  • ●     low blood pressure



  • ●     Store losartan potassium tablets USP at 20to 25(68to 77
  • ●     Keep losartan potassium tablets USP in a tightly closed container that protects the medicine from light.
  • ●     Keep losartan potassium tablets USP and all medicines out of the reach of children.














PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION














Losartan Potassium

Losartan Potassium

Losartan Potassium

Losartan Potassium TABLET

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:49349-383(NDC:0093-7364)
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
LOSARTAN POTASSIUM LOSARTAN 25 mg

Inactive Ingredients

Ingredient Name Strength
D&C YELLOW NO. 10
ALUMINUM OXIDE
FD&C BLUE NO. 2
lactose monohydrate
MAGNESIUM STEARATE
cellulose, microcrystalline
polyethylene glycol
POLYVINYL ALCOHOL
STARCH, CORN
talc
titanium dioxide

Product Characteristics

Color Size Imprint Code Shape
green 9 mm 93;7364 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49349-383-02 30 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA076958 2011-07-15


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
Copyright © 2014. drugs-library.com. All rights reserved. Information on drugs-library.com is provided for educational purposes only and is not to be used for medical advice, diagnosis or treatment.
Support info@drugs-library.com.