Amlodipine and valsartan
Scored, Film coated, Oral, Tablets (amlodipine/valsartan): 5/80 mg, 5/160 mg, 10/160 mg
Indication & Usage
Synomix is the combination tablet of amlodipine, a dihydropyridine calcium channel blocker (DHP CCB), and valsartan, an angiotensin II receptor blocker (ARB). Synomix is indicated for the treatment of hypertension, to lower blood pressure:
- In patients not adequately controlled on monotherapy
- As initial therapy in patients likely to need multiple drugs to achieve their blood pressure goals
Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions.
Dosage & Administration
- Majority of effect attained within 2 weeks
- May be administered with other antihypertensive agents
- May be used as add-on therapy for patients not controlled on monotherapy
- Patients who experience dose-limiting adverse reactions on monotherapy may be switched to Amlodipine and valsartan containing a lower dose of that component
- May be substituted for titrated components
- When used as initial therapy: Initiate with 5/160 mg, then titrate upwards as necessary to a maximum of 10/320 mg once daily
In placebo-controlled clinical trials, discontinuation due to side effects occurred in 1.8% of patients in the Synomix-treated patients and 2.1% in the placebo-treated group. The most common reasons for discontinuation of therapy with Synomix were peripheral edema and vertigo. The adverse experiences that occurred in clinical trials (≥2% of patients) at a higher incidence than placebo included peripheral edema, nasopharyngitis, upper respiratory tract infection, and dizziness.
Known hypersensitivity to any component;
Do not coadminister aliskiren with Synomix in patients with diabetes
- If simvastatin is coadministered with amlodipine, do not exceed doses greater than 20 mg daily of simvastatin
- NSAID use may lead to increased risk of renal impairment and loss of anti-hypertensive effect
- Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia
- Lithium: Increases in serum lithium concentrations and lithium toxicity
Warning & Precaution
- Hypotension: Correct volume depletion prior to initiation
- Increased angina and/or myocardial infarction
- Monitor renal function and potassium in susceptible patients
Pregnancy & Lactation
Pregnancy Category D
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 Synomix as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimesters of pregnancy. Most epidemiologic studies examining fetal abnormalities after exposure to antihypertensive use in the first trimester have not distinguished drugs affecting the renin angiotensin system from other antihypertensive agents. Appropriate management of maternal hypertension during pregnancy is important to optimize outcomes for both mother and fetus.
In the unusual case that there is no appropriate alternative to therapy with drugs affecting the renin-angiotensin system for a particular patient, apprise the mother of the potential risk to the fetus. Perform serial ultrasound examinations to assess the intra-amniotic environment. If oligohydramnios is observed, discontinue Synomix, unless it is considered lifesaving for the mother. Fetal testing may be appropriate, based on the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury. Closely observe infants with histories of in utero exposure to Synomix for hypotension, oliguria, and hyperkalemia.
It is not known whether amlodipine is excreted in human milk. In the absence of this information, it is recommended that nursing be discontinued while amlodipine is administered.
It is not known whether valsartan is excreted in human milk. Valsartan was excreted into the milk of lactating rats; however, animal breast milk drug levels may not accurately reflect human breast milk levels. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from Synomix, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Keep out of the reach of children.
Store below 30°C and protect from light and moisture.
Carton containing 3 Blister strips of 10 tablets each.
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