PRINIVIL Tablet (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Merck Sharp & Dohme Corp.

Για την προβολή της πλήρους καταχώρησης απαιτείται συνδρομή σε ισχύ.
Αποκτήστε πρόσβαση σε όλες τις πληροφορίες και τα εργαλεία του Galinos.gr δωρεάν για έναν μήνα απλά κάνοντας εγγραφή.
Δωρεάν εγγραφή

BOXED WARNING SECTION

WARNING: FETAL TOXICITY When pregnancy is detected, discontinue PRINIVIL as soon as possible [see Warnings and Precautions (5.1)]./b> Drugs that act directly on the renin-angiotensin ...

1. Indications and Usage

1.1 Hypertension PRINIVIL is indicated for the treatment of hypertension in adult patients and pediatric patients 6 years of age and older to lower blood pressure. Lowering blood pressure lowers the risk ...

2. Dosage and Administration

2.1 Hypertension Initial therapy in adults: The recommended initial dose is 10 mg once a day. Adjust dosage according to blood pressure response. The usual dosage range is 20 to 40 mg per day administered ...

3. Dosage Forms and Strengths

Tablets PRINIVIL, 5 mg, are white, oval-shaped compressed tablets with code MSD 19 on one side and scored on the other side. Tablets PRINIVIL, 10 mg, are light yellow, oval-shaped compressed tablets with ...

4. Contraindications

PRINIVIL is contraindicated in patients with: a history of angioedema or hypersensitivity related to previous treatment with an angiotensin converting enzyme inhibitor hereditary or idiopathic angioedema. ...

5. Warnings and Precautions

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 ...

6.1. Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of ...

6.2. Postmarketing Experience

The following adverse reactions have been identified during post-approval use of lisinopril that are not included in other sections of labeling. Because these reactions are reported voluntarily from a ...

7. Drug Interactions

7.1 Diuretics Initiation of PRINIVIL in patients on diuretics may result in excessive reduction of blood pressure. The possibility of hypotensive effects with PRINIVIL can be minimized by either decreasing ...

8. Use in Specific Populations

8.6 Race ACE inhibitors, including PRINIVIL, have an effect on blood pressure that is less in Black patients than in non-Blacks.

8.1. Pregnancy

Risk Summary Prinivil can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal ...

8.2. Lactation

Risk Summary No data are available regarding the presence of lisinopril in human milk or the effects of lisinopril on the breastfed infant or on milk production. Lisinopril is present in rat milk. Because ...

8.4. Pediatric Use

Antihypertensive effects and safety of PRINIVIL have been established in pediatric patients aged 6 to 16 years [see Dosage and Administration (2.1) and Clinical Studies (14.1)]. No relevant differences ...

8.5. Geriatric Use

No dosage adjustment with PRINIVIL is necessary in elderly patients. In a clinical study of PRINIVIL in patients with myocardial infarctions (GISSI-3 Trial) 4,413 (47%) were 65 and over, while 1,656 (18%) ...

8.7. Renal Impairment

Dose adjustment of PRINIVIL is required in patients undergoing hemodialysis or whose creatinine clearance is ≤30 mL/min. No dose adjustment of PRINIVIL is required in patients with creatinine clearance ...

10. Overdosage

Following a single oral dose of 20 g/kg, no lethality occurred in rats and death occurred in one of 20 mice receiving the same dose. The most likely manifestation of overdosage would be hypotension, for ...

11. Description

PRINIVIL contains lisinopril, a synthetic peptide derivative, and an oral, long-acting angiotensin converting enzyme inhibitor. Lisinopril is chemically described as (S)1[N2 ...

12.1. Mechanism of Action

Lisinopril inhibits angiotensin converting enzyme (ACE) in human subjects and animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance, angiotensin ...

12.2. Pharmacodynamics

Hypertension Adult Patients Administration of PRINIVIL to patients with hypertension results in a reduction of supine and standing blood pressure to about the same extent with no compensatory tachycardia. ...

12.3. Pharmacokinetics

Adult Patients Following oral administration of PRINIVIL, peak serum concentrations of lisinopril occur within about 7 hours, although there was a trend to a small delay in time taken to reach peak serum ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

There was no evidence of a tumorigenic effect when lisinopril was administered for 105 weeks to male and female rats at doses up to 90 mg per kg per day or for 92 weeks to male and female mice at doses ...

14. Clinical Studies

14.1 Hypertension Adult Patients Two dose-response studies utilizing a once daily regimen were conducted in 438 mild to moderate hypertensive patients not on a diuretic. Blood pressure was measured 24 ...

16.1. How Supplied

PRINIVIL is supplied as oval-shaped, compressed tablets scored on one side.   Color Printing Unit of use Bottle/90 5 mg White MSD 19 NDC 0006-0019-54 10 mg Light yellow MSD 106 ...

16.2. Storage and Handling

Store at controlled room temperature, 15-30°C (59-86°F), and protect from moisture. Dispense in a tight container, if product package is subdivided.

17. Patient Counseling Information

NOTE: This information is intended to aid in the safe and effective use of this medication. It is not a disclosure of all possible adverse or intended effects. Pregnancy Tell female patients of childbearing ...