Medicinal Products

AMLODIPINE PHR LAB 10 mg

Generic drug of Amlor
Therapeutic class: Cardiology and angiology
active ingredients: Amlodipine
laboratory: Teva Sante

capsule
Box of 30
All forms

Indication

Hypertension

Chronic stable angina

Vasospastic angina (Prinzmetal syndrome)

Dosage AMLODIPINE PHR LAB 10 mg Capsule Box of 30

Dosage

adults

For hypertension and angina, the usual starting dose is 5 mg AMLODIPINE PHR LAB once daily, which can be increased to a maximum dose of 10 mg depending on the patient's individual response.

In hypertensive patients, amlodipine has been used in combination with a thiazide diuretic, an alpha blocker, a beta-blocker, or an angiotensin converting enzyme inhibitor. In angina, amlodipine can be used alone or in combination with other antianginal agents in patients with nitrate-refractory angina and / or adequate doses of beta-blockers.

No dose adjustment of AMLODIPINE PHR LAB is required for the concomitant administration of thiazide diuretics, beta-blockers and angiotensin converting enzyme inhibitors.

Special populations

Elderly

Amlodipine used at similar doses shows good equivalent tolerance in elderly patients and younger patients. Normal dosing regimens are recommended for elderly patients, but dosage increases should be made with caution (see Warnings and Precautions and Pharmacokinetic Properties sections).

Hepatic insufficiency

Dose recommendations have not been established in patients with mild to moderate hepatic impairment therefore the dose should be selected with caution and should start at the lowest effective dose (see sections Warnings and Precautions for Use). and pharmacokinetic properties ). The pharmacokinetic properties of amlodipine have not been studied in patients with severe hepatic impairment. Amlodipine should be started at the lowest dose and slowly increased in patients with severe hepatic impairment.

Renal failure

Changes in plasma concentrations of amlodipine are not correlated with the degree of renal impairment, so a usual dosage is recommended. Amlodipine is not dialysable.

Children and adolescents

Hypertensive children and adolescents from 6 to 17 years old.

The recommended oral antihypertensive dosage in children aged 6 to 17 years is 2.5 mg once daily as the initial dose, which can be increased to 5 mg once daily if the desired blood pressure is not reached after four weeks. Doses greater than 5 mg once daily have not been studied in pediatric patients (see sections Pharmacodynamic properties and Pharmacokinetic properties ).

A dosage of 2.5 mg amlodipine is not possible with this drug.

Children under 6 years old.

There is no data available.

Administration mode

Capsule for oral administration.

Against indications

Amlodipine is contraindicated in patients with:

· Hypersensitivity to dihydropyridine derivatives, amlodipine or any of the excipients.

· Severe hypotension.

· Shock (including cardiogenic shock)

· Obstruction of the left ventricular outflow tract (eg, high degree of aortic stenosis).

· Hemodynamically unstable heart failure after acute myocardial infarction.

Adverse effects Amlodipine Phr Lab

Summary of the security profile

The most common side effects reported during treatment are drowsiness, dizziness, headache, palpitations, flushing, abdominal pain, nausea, swollen ants, edema, and fatigue.

List of undesirable effects

The following adverse reactions have been observed and reported during treatment with amlodipine at the following frequencies: very common (≥ 1/10); frequent (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to ≤ 1/100); rare (≥ 1/10 000 to ≤ 1/1 000); very rare (≤1 / 10, 000).

In each frequency group, the adverse effects are presented in order of decreasing severity.

Class of organ systems

Frequency

Side effects

Blood and lymphatic system disorders

Very rare

Leukocytopenia, thrombocytopenia,

Immune system disorders

Very rare

Allergic reaction

Metabolism and nutrition disorders

Very rare

hyperglycemia

Psychiatric disorders

Rare

Insomnia, change of mood (including anxiety), depression

Rare

Confusion

Nervous system disorders

Frequent

Drowsiness, dizziness, headache (especially at the beginning of treatment)

Rare

Tremor, dysgeusia, syncope, hypoaesthesia, paresthesia

Very rare

Hypertonia, peripheral neuropathy

Eye disorders

Rare

Visual disorder (including, diplopia)

Affections of the ear and labyrinth

Rare

tinnitus

Heart conditions

Frequent

palpitations

Very rare

Myocardial infarction, arrhythmia (including bradycardia, ventricular tachycardia, and atrial fibrillation)

Vascular disorders

Frequent

Flushing

Rare

hypotension

Very rare

vasculitis

Respiratory, thoracic and mediastinal disorders

Rare

Dyspnea, rhinitis

Very rare

Cough

Gastrointestinal disorders

Frequent

Abdominal pain, nausea

Rare

Vomiting, dyspepsia, transit disorders (including diarrhea and constipation), dry mouth

Very rare

Pancreatitis, gastritis, gingival hyperplasia

Hepatobiliary disorders

Very rare

Hepatitis, jaundice, elevated liver enzymes *

Skin and subcutaneous tissue disorders

Rare

Alopecia, purpura, change of skin color, hyperhidrosis, pruritus, rash, exanthema

Very rare

Angioedema, erythema multiforme, urticaria, exfoliating dermatitis, Stevens-Johnson syndrome, angioedema, photosensitivity

Musculoskeletal, Connective Tissue and Bone Disorders

Frequent

Edema of the ankles

Rare

Arthralgia, myalgia, muscle cramp, back pain

Renal and urinary disorders

Rare

Micturition disorder, nocturia, increased urinary frequency

Disorders of reproductive organs and breast

Rare

Impotence, gynecomastia

General disorders and administration site conditions

Frequent

Edema, tiredness

Rare

Chest pain, asthenia, pain, discomfort

investigations

Rare

Increased weight, decreased weight

* Generally suggestive of cholestasis

Exceptional cases of extrapyramidal syndrome have been reported.

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