Valsartan Oral
Generic Name: valsartan oral
Brand Names:
Valsartan
11 DESCRIPTION Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is: Valsartan is an off white to white powder.
Overview
11 DESCRIPTION Valsartan is a nonpeptide, orally active, and specific angiotensin II receptor blocker acting on the AT 1 receptor subtype. Valsartan is chemically described as N -(1-oxopentyl)- N -[[2′-(1 H -tetrazol-5-yl) [1,1′-biphenyl]-4-yl]methyl]-L-valine. Its empirical formula is C 24 H 29 N 5 O 3 , its molecular weight is 435.5, and its structural formula is: Valsartan is an off white to white powder.
Uses
1 INDICATIONS AND USAGE Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension in adults and children six years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV); Valsartan oral solution significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets ( 1.2 ) Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; Valsartan oral solution reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets ( 1.3 ) 1.1 Hypertension Valsartan is indicated for the treatment of hypertension in adults and ch...
Dosage
2 DOSAGE AND ADMINISTRATION Indication Starting Dose Dose Range Target Maintenance Dose as tolerated by patient Hypertension - adults ( 2.1 ) 40 or 80 mg twice daily 40 -160 mg twice daily --- Hypertension—age 6 to16 years ( 2.2 ) 0.65 mg/kg twice daily (up to 40 mg total) 0.65-1.35 mg/kg twice daily (up to 40 mg-160 mg total) --- He art Failure ( 2.3 ) 40 mg twice daily 40 mg-160 mg twice daily 160 mg twice daily Post-Myocardial Infarction ( 2.4 ) 20 mg twice daily 20 mg - 160 mg twice daily 160 mg twice daily 2.1 General Considerations Valsartan oral solution is not therapeutically equivalent to the tablet formulation of Diovan.
Side Effects
6 ADVERSE REACTIONS Hypertension: Most common adverse reactions are headache, dizziness, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
Interactions
7 DRUG INTERACTIONS Potassium-sparing diuretics, potassium supplements or salt substitutes may lead to increases in serum potassium, and in heart failure patients, increases in serum creatinine ( 7 ) NSAIDs increase risk of renal impairment and loss of antihypertensive effect ( 7 ) Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia ( 7 ) Lithium: Increases in serum lithium concentrations and lithium toxicity ( 7 ) 7.1 Agents Increasing Serum Potassium Concomitant use of valsartan with other agents that block the renin-angiotensin system, potassium- sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, salt substitutes containing potassium or other drugs that may increase potassium levels (e.g...
Warnings
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue valsartan oral solution as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue valsartan oral solution as soon as possible. 5 WARNINGS AND PRECAUTIONS Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan oral solution as soon as possible [see Use in Specific Populations (8.1 )]. 4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan oral solution in patients with diabetes [see Drug Interactions (7) ]. Known hypersensitivity ( 4 ) Patients with diabetes on aliskiren ( 4 )
Storage
16 HOW SUPPLIED/STORAGE AND HANDLING Valsartan Oral Solution containing 4 mg/mL valsartan, USP for oral administration. Each mL contains 4 mg valsartan. It is a clear, colorless solution and is supplied as: White HDPE bottles of 120 mL: NDC 72888-184-48 White HDPE bottles of 473 mL: NDC 72888-184-13 Store at 20 °C-25 °C (68 °F-77 °F); excursions permitted to 15 °C -30 °C (59 °F -86 °F) [see USP Co...
Frequently Asked Questions
What is Valsartan Oral used for?▼
1 INDICATIONS AND USAGE Valsartan is an angiotensin II receptor blocker (ARB) indicated for: Hypertension in adults and children six years and older, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions ( 1.1 ) Heart failure (NYHA class II-IV); Valsartan oral solution significantly reduces hospitalization for heart failure in patients who are unable to swallow valsartan tablets ( 1.2 ) Stable left ventricular failure or left ventricular dysfunction following myocardial infarction; Valsartan oral solution reduces cardiovascular mortality in patients who are unable to swallow valsartan tablets ( 1.3 ) 1.1 Hypertension Valsartan is indicated for the treatment of hypertension in adults and ch...
What are the side effects of Valsartan Oral?▼
6 ADVERSE REACTIONS Hypertension: Most common adverse reactions are headache, dizziness, fatigue and abdominal pain ( 6.1 ) Heart Failure: Most common adverse reactions are dizziness, hypotension, diarrhea, arthralgia, back pain, fatigue and hyperkalemia ( 6.1 ) Post-Myocardial Infarction: Most common adverse reactions which caused patients to discontinue therapy are hypotension, cough and increased blood creatinine ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Advagen Pharma Ltd, at 866-488-0312 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
What are the important warnings for Valsartan Oral?▼
WARNING: FETAL TOXICITY When pregnancy is detected, discontinue valsartan oral solution as soon as possible. ( 5.1 ) Drugs that act directly on the renin-angiotensin system can cause injury and death to the developing fetus. ( 5.1 ) WARNING: FETAL TOXICITY See full prescribing information for complete boxed warning. When pregnancy is detected, discontinue valsartan oral solution as soon as possible. 5 WARNINGS AND PRECAUTIONS Observe for signs and symptoms of hypotension ( 5.2 ) Monitor renal function and potassium in susceptible patients ( 5.3 , 5.4 ) 5.1 Fetal Toxicity Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue valsartan oral solution as soon as possible [see Use in Specific Populations (8.1 )]. 4 CONTRAINDICATIONS Do not use in patients with known hypersensitivity to any component. Do not coadminister aliskiren with valsartan oral solution in patients with diabetes [see Drug Interactions (7) ]. Known hypersensitivity ( 4 ) Patients with diabetes on aliskiren ( 4 )
Related Medications
Oyster Shell
oyster shell
PURPOSE osteoporosis Cardiovascular Lung disease Boosting immunity COVID-19
Arsenic Alb
arsenic alb
USES USES: Temporary Relief - Vomitings, Stomach Upsets* * Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
Onion, Bryonia Dioica Root, Hedera Helix Flowering Twig, Hyoscyamus Niger, Phosphorus, Polygala Senega Root, Antimony Potassium Tartrate, And Pulmonaria Officinalis Whole
onion, bryonia dioica root, hedera helix flowering twig, hyoscyamus niger, phosphorus, polygala senega root, antimony potassium tartrate, and pulmonaria officinalis whole
Non-Standardized Food Allergenic Extract [EPC]
For relief of minor chest congestion with mucus. Application of this homeopathic remedy for the designated usage is exclusively based on homeopathic experience. With severe forms of this disease, a clinically proven therapy is indicated.
Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.