LOTREL Capsule (2020)

Βιβλιογραφική αναφορά

Συγγραφείς

Novartis Pharmaceuticals Corporation

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 Lotrel as soon as possible (5.1). Drugs that act directly on the renin-angiotensin system (RAS) can cause injury and death ...

1. Indications and Usage

1.1 Hypertension Lotrel is indicated for the treatment of hypertension in patients not adequately controlled on monotherapy with either agent.

2. Dosage and Administration

2.1 General Considerations The recommended initial dose is amlodipine 2.5 mg/benazepril 10 mg orally once-daily. Begin therapy with Lotrel only after a patient has either (a) failed to achieve the desired ...

3. Dosage Forms and Strengths

Lotrel (amlodipine/benazepril) capsules are available as follows: 5/10 mg, 5/20 mg, 10/20 mg, and 10/40 mg.

4. Contraindications

Do not coadminister aliskiren with angiotensin receptor blockers (ARBs), angiotensin-converting enzyme (ACE) inhibitors, including Lotrel in patients with diabetes. Lotrel is contraindicated in patients ...

5. Warnings and Precautions

5.1 Fetal Toxicity Lotrel 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 ...

6.1. Clinical Trials Experience

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

6.2. Postmarketing Experience

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. ...

7. Drug Interactions

7.1 Drug/Drug Interactions Amlodipine Simvastatin: Coadministration of simvastatin with amlodipine increases the systemic exposure of simvastatin. Limit the dose of simvastatin in patients on amlodipine ...

8.1. Pregnancy

Risk Summary Lotrel can cause fetal harm when administered to a pregnant woman. Use of drugs that act on the RAS during the second and third trimesters of pregnancy reduces fetal renal function and increases ...

8.2. Lactation

Risk Summary Minimal amounts of unchanged benazepril and of benazeprilat are excreted into the breast milk of lactating women treated with benazepril, so that a newborn child ingesting nothing but breast ...

8.4. Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

8.5. Geriatric Use

In geriatric patients, exposure to amlodipine is increased, thus consider lower initial doses of Lotrel [see Clinical Pharmacology (12.3)]. Of the total number of patients who received Lotrel ...

8.6. Hepatic Impairment

Exposure to amlodipine is increased in patients with hepatic insufficiency, thus consider using lower doses of Lotrel [see Clinical Pharmacology (12.3)].

8.7. Renal Impairment

In patients with severe renal impairment systemic exposure to benazepril is increased. The recommended dose of benazepril in this subgroup is 5 mg which is not an available strength with Lotrel. Lotrel ...

10. Overdosage

Only a few cases of human overdose with amlodipine have been reported. One patient was asymptomatic after a 250 mg ingestion; another, who combined 70 mg of amlodipine with an unknown large quantity of ...

11. Description

Lotrel is a combination of amlodipine besylate and benazepril hydrochloride. Benazepril hydrochloride is a white to off-white crystalline powder, soluble (greater than 100 mg/mL) in water, in ethanol, ...

12.1. Mechanism of Action

Benazepril Benazepril and benazeprilat inhibit ACE in human subjects and in animals. ACE is a peptidyl dipeptidase that catalyzes the conversion of angiotensin I to the vasoconstrictor substance angiotensin ...

12.2. Pharmacodynamics

Benazepril Single and multiple doses of 10 mg or more of benazepril cause inhibition of plasma ACE activity by at least 80% to 90% for at least 24 hours after dosing. For up to 4 hours after a 10 mg dose, ...

12.3. Pharmacokinetics

The rate and extent of absorption of benazepril and amlodipine from Lotrel are the same as when administered as individual tablets. Absorption from the individual tablets is not influenced by the presence ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity and mutagenicity studies have not been conducted with this combination. However, these studies have been conducted with amlodipine and benazepril alone (see below). No adverse effects on ...

14. Clinical Studies

Over 950 patients received Lotrel once-daily in 6 double-blind, placebo-controlled studies. The antihypertensive effect of a single dose persisted for 24 hours, with peak reductions achieved 2 to 8 hours ...

16.1. How Supplied

Lotrel is available as capsules containing amlodipine besylate equivalent to 5 mg, or 10 mg of amlodipine, with 10 mg, 20 mg, or 40 mg of benazepril hydrochloride providing for the following available ...

16.2. Storage and Handling

Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F). [See USP controlled room temperature]. Protect from moisture. Dispense in tight container (USP).

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). Pregnancy Advise female patients of childbearing age about the consequences of exposure to Lotrel during pregnancy. Discuss ...