Valsartan and hydrochlorothiazide
Scored, Oral, Tablets (valsartan/ hydrochlorothiazide): 80/12.5 mg, 160/12.5 mg
Indication & Usage
Panamix is the combination tablet of valsartan, an angiotensin II receptor blocker (ARB) and hydrochlorothiazide (HCTZ), a diuretic.
Panamix is indicated for the treatment of hypertension, to lower blood pressure:
- In patients not adequately controlled with 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
- Dose once daily. Titrate as needed to a maximum dose of 320/25mg
- May be used as add-on/switch therapy for patients not adequately controlled on any of the components (valsartan or HCTZ)
- May be substituted for titrated components
The most common reasons for discontinuation of therapy with Panamix were headache and dizziness. The only adverse experience that occurred in ≥2% of patients treated with Panamix and at a higher incidence than placebo was nasopharyngitis (2.4% vs. 1.9%).
Anuria; Hypersensitivity to any sulfonamide-derived drugs or any component; Do not coadminister Aliskiren with Panamix in patients with diabetes.
- Antidiabetic drugs: Dosage adjustment of antidiabetic may be required
- Cholestyramine and Colestipol: Reduced absorption of thiazides
- Lithium: Increased risk of lithium toxicity. Monitor serum lithium concentrations during concurrent use.
- Non-Steroidal Anti-Inflammatory Drugs (NSAIDs): May increase risk of renal impairment. Can reduce diuretic, natriuretic and antihypertensive effects of diuretics.
- Dual inhibition of the renin-angiotensin system: Increased risk of renal impairment, hypotension, and hyperkalemia
Warning & Precaution
- Hypotension: Correct volume depletion prior to initiation
- Observe for signs of fluid or electrolyte imbalance
- Monitor renal function and potassium in susceptible patients
- Exacerbation or activation of systemic lupus erythematosus
- Acute angle-closure glaucoma
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 Panamix as soon as possible. These adverse outcomes are usually associated with use of these drugs in the second and third trimester 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 Panamix, 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 Panamix for hypotension, oliguria, and hyperkalemia. HydrochlorothiazideThiazides can cross the placenta, and concentrations reached in the umbilical vein approach those in the maternal plasma. Hydrochlorothiazide, like other diuretics, can cause placental hypoperfusion. It accumulates in the amniotic fluid, with reported concentrations up to 19 times higher than in umbilical vein plasma. Use of thiazides during pregnancy is associated with a risk of fetal or neonatal jaundice or thrombocytopenia. Since they do not prevent or alter the course of EPH (Edema, Proteinuria, and Hypertension) gestosis (pre-eclampsia), these drugs should not be used to treat hypertension in pregnant women. The use of hydrochlorothiazide for other indications (e.g., heart disease) in pregnancy should be avoided.
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. Hydrochlorothiazide is excreted in human breast milk. Because many drugs are excreted into human milk and because of the potential for adverse reactions in nursing infants from Panamix, 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 moisture.
Carton containing 1 HDPE Bottle of 30 tablets each.
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