Amlodipine Mylan Uses, Dosage, Side Effects, Precautions & Warnings

Generic drug of Amlor
Therapeutic class: Cardiology and angiology
Active ingredients: Amlodipine

what is Amlodipine Mylan ?

• Amlodipine Mylan is used to treat high blood pressure (hypertension), or a certain type of chest pain called angina, a rare form of which is Prinzmetal’s angina.
• In patients with high blood pressure values, your medicine works by relaxing the blood vessels so that blood passes through them more easily. In patients with angina, Amlodipine Mylan works by improving the blood supply to the heart muscle, which thus receives more oxygen, which prevents the onset of chest pain. Your medicine does not provide immediate relief for chest pain associated with angina.

PRESENTATION (S) AVAILABLE FOR AMLODIPINE MYLAN 10 MG

10 presentations are available for this drug:

• Polypropylene pill box (s) with child-resistant closure of 28 capsule (s)
• polypropylene pillbox (s) with child-resistant closure of 30 capsule (s)
• polypropylene pillbox (s) with child-resistant closure of 60 capsule (s)
• polypropylene pillbox (s) with child-resistant closure of 90 capsule (s)
• polypropylene pillbox (s) with child-resistant closure of 100 capsule (s)
• PVC (ACLAR RX) polytrifluorochloroethylene aluminum blister pack (s) of 28 capsule (s)
• PVC (ACLAR RX) polytrifluorochloroethylene aluminum blister pack (s) of 30 capsule (s)
• PVC (ACLAR RX) polytrifluorochloroethylene aluminum blister (s) of 60 capsule (s)
• PVC (ACLAR RX) polytrifluorochloroethylene aluminum blister (s) of 90 capsule (s)
• PVC (ACLAR RX) polytrifluorochloroethylene aluminum blister pack (s) of 100 capsule (s)

FEATURE	DESCRIPTION
Pharmaceutical class	calcium antagonists
Active substance (s)	amlodipine besilate
General medicine	Yes
Pharmaceutical form	capsule
Route (s) of administration	oral
Social security reimbursement rate	65%
Laboratory (s)	MYLAN SAS
Conditions of issue	available by simple prescription

 

what is Amlodipine Mylan capsule used for and indication?

• Hypertension.
• Chronic stable angina.
• Vasospastic angina (Prinzmetal syndrome).

Amlodipine Mylan  Dosage

Dosage

Adults

• For hypertension and angina, the usual starting dose is 5 mg of Amlodipine Mylan once daily, which may be increased up to a maximum dose of 10 mg depending on the patient’s individual response.
• In hypertensive patients, Amlodipine Mylan has been used in combination with a thiazide diuretic, an alpha blocker, a beta blocker, or an angiotensin converting enzyme inhibitor. In angina, Amlodipine Mylan can be used as monotherapy or in combination with other antianginal drugs in patients with angina refractory to nitrates and / or at adequate doses of beta-blockers.
• No dose adjustment of AMLODIPINE MYLAN is necessary when co-administered with thiazide diuretics, beta blockers and angiotensin converting enzyme inhibitors.

Special populations

Older subjects

• Amlodipine Mylan used in similar doses shows equivalent good tolerability in elderly and younger patients. Normal dosage regimens are recommended in the elderly, but increased dosage should be done with caution ( Pharmacokinetic properties ).

Hepatic insufficiency

• Dosage recommendations have not been established in patients with mild to moderate hepatic impairment therefore the dose should be chosen with caution and should start at the lowest effective dose (  and Pharmacokinetic properties ). The pharmacokinetics of amlodipine have not been studied in severe hepatic impairment. Amlodipine should be started at the lowest dose and increased slowly in patients with severe hepatic impairment.

Renal failure

• Changes in plasma amlodipine concentrations do not correlate with the degree of renal impairment, therefore a usual dosage is recommended. Amlodipine is not dialyzable.

Children and adolescents

Children and adolescents with hypertension from 6 to 17 years old. 

• The recommended oral antihypertensive dose for children aged 6 to 17 years is 2.5 mg once daily as a starting dose, which may be increased up 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
• A 2.5 mg dose of amlodipine is not possible with this medicine.

Children under 6 years old.

• There is no data available.

Administration mode

Capsule for oral administration.

Amlodipine Mylan Contraindications

Do not take Amlodipine Mylan 10 mg hard capsules:

• if you are allergic (hypersensitive) to amlodipine or any of the other ingredients of your medicine listed in section 6, or to other calcium channel blockers. This can be manifested by itching, redness of the skin, or difficulty breathing.
• If you have severe drop in blood pressure (hypotension).
• If you have narrowing of the aortic valve (aortic stenosis) or cardiogenic shock (a condition in which your heart was unable to supply enough blood to the body).
• If you suffer from heart failure after a heart attack.

HOW TO TAKE Amlodipine Mylan?

• Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if in doubt.
• The recommended starting dose of Amlodipine Mylan is 5 mg once daily. This dose can be increased up to 10 mg of Amlodipine Mylan once a day.
• This medicine can be used before or after consuming food and drink. It is best to take this medicine at the same time every day with a glass of water. Do not take Amlodipine Mylan with grapefruit juice.

how does Amlodipine Mylan work?

Pharmacotherapeutic group: selective calcium channel blocker with predominantly vascular effect, ATC code: C08CA01.

Action mechanism

• Amlodipine is an inhibitor of calcium ion influx of the dihydropyridine group (slow channel inhibitor or calcium ion antagonist) and transmembrane influx of calcium ions into heart muscle and vascular smooth muscle.
• The mechanism of the antihypertensive effect of amlodipine is linked to a direct relaxant effect in vascular smooth muscle. The precise mechanism by which amlodipine relieves angina has not been fully determined, but amlodipine reduces the total ischemic burden by the following two actions:

1. • Amlodipine dilates peripheral arterioles and therefore reduces the total peripheral resistance (afterload) against which the heart acts. As long as the heart rate remains stable, this reduction in the work of the heart decreases myocardial energy consumption and oxygen requirements.
   • The mechanism of action of amlodipine also probably involves the dilation of the main coronary arteries and coronary arterioles, in normal and ischemic regions. This dilation increases the delivery of oxygen to the myocardium in patients with coronary artery spasm (Prinzmetal’s angina).

Pharmacodynamic effects

• In hypertensive patients, once daily administration results in clinically significant reductions in blood pressure in both supine and upright position for a 24 hour interval. Due to the slow onset of action, acute hypotension is not associated with administration of amlodipine.
• In patients with angina, administration as a single daily dose of amlodipine increases the total duration of exertion, the time to onset of angina and a 1 mm ST segment depression. , and it decreases both the frequency of angina attacks and the consumption of glyceryl trinitrate tablets.

Clinical efficacy and safety

• Amlodipine has not been associated with adverse metabolic effects or changes in plasma lipids, and is suitable for patients with asthma, diabetes and gout.

Use in patients with coronary artery disease

• The efficacy of amlodipine in preventing clinical events in patients with coronary artery disease was evaluated in an independent, multicenter, randomized, double-blind, placebo-controlled study in 1,997 patients: the study CAMELOT (Comparison of Amlodipine vs Enalapril to Limit Occurrences of Thrombosis, comparison of amlodipine and enalapril in the limitation of episodes of thrombosis). Of these patients, 663 were treated with amlodipine 5-10 mg, 673 were treated with enalapril 10-20 mg, and 655 with placebo, in addition to standard treatment with statins, beta-blockers , diuretics and aspirin for two years. The main efficacy results are shown in Table 1.

Table 1. Incidence of significant clinical endpoints in the CAMELOT study
	Event rate cardiovascular, number (%)			Amlodipine versus placebo
Evaluation criteria	Amlodipine	Placebo	Enalapril	Relative risk (95% CI)	P-value
Primary endpoint
Cardiovascular adverse events	110 (16.6)	151 (23.1)	136 (20.2)	0.69 (0.54-0.88)	0.003

 

Individual components
Coronary revascularization	78 (11.8)	103 (15.7)	95 (14.1)	0.73 (0.54-0.98)	0.03
Hospitalization for angina	51 (7.7)	84 (12.8)	86 (12.8)	0.58 (0.41-0.82)	0.002
Non-fatal IDM	14 (2.1)	19 (2.9)	11 (1.6)	0.73 (0.37-1.46)	0.37
AVC or AIT	6 (0.9)	12 (1.8)	8 (1.2)	0.50 (0.19-1.32)	0.15
Cardiovascular mortality	5 (0.8)	2 (0.3)	5 (0.7)	2.46 (0.48-12.7)	0.27
Hospitalization for CHF	3 (0.5)	5 (0.8)	4 (0.6)	0.59 (0.14-2.47)	0.46
Resuscitation after cardiac arrest	0	4 (0.6)	1 (0.1)	N / A	0.04
Appearance of peripheral vascular disease	5 (0.8)	2 (0.3)	8 (1.2)	2.6 (0.50-13.4)	0.24
Abbreviations: CHF, congestive heart failure; CI, confidence interval; IDM, myocardial infarction; TIA, transient ischemic attacks; Stroke, stroke.

Use in patients with heart failure

• Hemodynamic studies and controlled studies based on stress tests in patients with NYHA class II-IV heart failure showed that amlodipine did not cause clinical deterioration in exercise tolerance, left ventricular ejection fraction and clinical symptomatology.
• A placebo-controlled study (PRAISE) designed to evaluate patients with NYHA Class III-IV heart failure receiving digoxin, diuretics and ACE inhibitors showed that amlodipine did not cause increased risk of mortality or mortality and morbidity combined with heart failure.
• In a long-term, placebo-controlled follow-up study (PRAISE-2) of amlodipine in patients with NYHA Class III and IV heart failure without clinical symptoms or objective findings suggesting or underlying ischemic disease, When treated with stable doses of ACE inhibitors, digitalis and diuretics, amlodipine had no effect on total cardiovascular mortality. In this same population, amlodipine has been associated with increased reports of pulmonary edema.

Treatment to Prevent Heart Attack Trial (ALLHAT)

• The ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial), randomized, double-blind, morbidity and mortality study was performed to compare treatments recent: amlodipine 2.5 to 10 mg / day (calcium channel blocker) or lisinopril 10 to 40 mg / day (ACE inhibitor) as first-line treatment compared to a thiazide diuretic, chlortalidone at a dose of 12, 5 to 25 mg / day in mild to moderate hypertension.
• A total of 33,357 hypertensive patients aged 55 or over were randomized and followed for an average of 4.9 years. Patients had at least one risk factor for additional coronary artery disease, including: history of myocardial infarction or stroke (more than six months prior to inclusion) or documentation of other atherosclerotic cardiovascular disease (a total of 51, 5%), type 2 diabetes (36.1%), HDL cholesterol <35 mg / dl (11.6%), left ventricular hypertrophy diagnosed by electrocardiography or echocardiography (20.9%), current smoking (21.9 %).
• The primary composite endpoint was fatal coronary artery disease or non-fatal myocardial infarction. No significant difference was observed for the primary endpoint between treatment with amlodipine and treatment with chlortalidone: RR: 0.98; 95% CI (0.90 to 1.07); p = 0.65. Among the secondary endpoints, the incidence of heart failure (part of a composite cardiovascular endpoint) was significantly higher in the amlodipine group compared to the chlortalidone group (10.2% versus 7.7% ; RR: 1.38; 95% CI [1.25 to 1.52]; p <0.001). However, no significant difference was observed in mortality from any cause between treatment with amlodipine and treatment with chlortalidone: RR: 0.96; 95% CI [0.89 to 1.02]; p = 0.20.

Use in children (at least six years old)

• In a study of 268 children aged 6 to 17 years with predominantly secondary hypertension, a 2.5 mg dose and a 5.0 mg dose of amlodipine were compared with placebo. Both doses were found to lower systolic blood pressure significantly more than placebo. The difference between the two doses was not statistically significant.
• The long-term effects of amlodipine on growth, puberty and general development have not been studied. The long-term efficacy of amlodipine as a treatment in children to reduce cardiovascular morbidity and mortality in adulthood has not been established.

HOW TO STORE Amlodipine Mylan?

• Keep this medication out of the sight and reach of children.
• Do not use this medicine after the expiry date which is stated on the carton, blisters, pillbox after “EXP”. The expiration date refers to the last day of that month.
• Store the capsules in the original package.
• Do not throw away any medicines via a wastewater treatment plant or with household waste. Ask your pharmacist how to throw away the medicines you no longer use. These measures will help protect the environment.

Amlodipine Mylan Side Effects

Summary of the safety profile

• The most commonly reported adverse reactions during treatment are drowsiness, dizziness, headache, palpitations, flushing, abdominal pain, nausea, ankle edema, edema and fatigue.

List of side effects

• The following side effects have been observed and reported during treatment with amlodipine with the following frequencies: very common (≥ 1/10); common (≥ 1/100 to <1/10); uncommon (≥ 1/1000 to ≤ 1/100); rare (≥ 1 / 10,000 to ≤ 1 / 1,000); very rare (≤1 / 10,000).
• Within each frequency grouping, undesirable effects are presented in order of decreasing severity.

System organ class	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 in mood (including anxiety), depression
	Rare	Confusion
Nervous system disorders	Frequent	Drowsiness, dizziness, headache (especially at the start of treatment)
	Rare	Tremor, dysgeusia, syncope, hypoaesthesia, paraesthesia
	Very rare	Hypertonia, peripheral neuropathy
Eye disorders	Rare	Visual disturbance (including diplopia)
Ear and labyrinth disorders	Rare	Tinnitus
Cardiac disorders	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	Dyspnoea, 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, increased liver enzymes *
Skin and subcutaneous tissue disorders	Rare	Alopecia, purpura, skin discoloration, hyperhidrosis, pruritus, rash, exanthema
	Very rare	Angioedema, erythema multiforme, urticaria, exfoliating dermatitis, Stevens-Johnson syndrome, angioedema, photosensitivity
Musculoskeletal, connective tissue and bone disorders	Frequent	Ankle edema
	Rare	Arthralgia, myalgia, muscle cramp, back pain
Kidney and urinary tract disorders	Rare	Urination disorder, nocturia, increased urinary frequency
Reproductive system and breast disorders	Rare	Impotence, gynecomastia
General disorders and administration site conditions	Frequent	Edema, fatigue
	Rare	Chest pain, asthenia, pain, malaise
Investigations	Rare	Increase in weight, decrease in weight

* Usually suggestive of cholestasis

Exceptional cases of extrapyramidal syndrome have been reported.

Amlodipine Mylan Interactions

Taking other medications

If you are taking or have recently taken any other medicines, including medicines obtained without a prescription, talk to your doctor or pharmacist.

Amlodipine Mylan may affect or be affected by other medicines, such as:

• ketoconazole, itraconazole (antifungal drugs),
• ritonavir, indinavir, nelfinavir (called a protease inhibitor used to treat HIV infection)
• rifampicin, erythromycin, clarithromycin (antibiotics)
• Hypericum perforatum (St. John’s Wort)
• verapamil, diltiazem (heart medicines)
• dantrolene (infusion for severe increases in body temperature)
• simvastatin (a drug that lowers cholesterol levels).

Amlodipine Mylan may lower your blood pressure even more if you are already taking other medicines to treat high blood pressure.

Drive and use machines

• Amlodipine Mylan may affect your ability to drive and use machines.
• If the capsules cause nausea, dizziness or fatigue, or a headache, you should not drive or use machines, and you should contact your doctor immediately.

Warnings and Precautions

The safety and efficacy of amlodipine in hypertensive crisis have not been established.

Patients with heart failure

• Patients with heart failure should be treated with caution. In a long-term placebo-controlled study in patients with severe heart failure (NYHA class III and IV), the reported incidence of pulmonary edema was higher in the amlodipine group compared to the placebo group. (see section Pharmacodynamic properties). Calcium channel blockers including amlodipine should be used with caution in patients with congestive heart failure because they may increase the risk of cardiovascular events and mortality.

Patients with hepatic impairment

• The half-life of amlodipine is increased and its AUC (Area Under the Curve) is greater in patients with hepatic impairment; dosage recommendations have not been established. Therefore, amlodipine should be initiated at the lowest effective dose and with caution, both during initiation of treatment and when increasing the dose. Slow dose escalation and careful monitoring may be necessary in patients with severe hepatic impairment.

Elderly patients

• In the elderly, an increase in the dosage should be carried out with caution .

Patients with renal impairment

• Amlodipine can be used in these patients at normal doses. Changes in amlodipine plasma concentrations do not correlate with the degree of renal impairment. Amlodipine is not dialyzable.
• This medicine contains less than 1 mmol (23 mg) sodium per capsule, i.e. that it is essentially “sodium-free”

PREGNANCY & BREAST-FEEDING & FERTILITY

• The safety of amlodipine in pregnant women has not been established. If you think you may be pregnant, or are planning to become pregnant, you should talk to your doctor before taking Amlodipine Mylan.
• It has not been established whether amlodipine is excreted in human milk. If you are breast-feeding or about to breast-feed you should talk to your doctor before taking Amlodipine Mylan.
• Ask your doctor or pharmacist for advice before taking any medicine.

What happens if I overdose from Amlodipine Mylan?

• Taking too many capsules can lead to a dangerous drop in your blood pressure.
• You may feel dizzy, light-headed, pass out, or feel faint. If the blood pressure drops too severely, shock may occur.
• Your skin may become cold and clammy and you may lose consciousness.
• Talk to your doctor straight away if you take too many Amlodipine Mylan capsules.

What should I do if I miss a dose?

• Do not worry. If you forget to take one capsule, skip the dose completely.
• Take the next dose at the normal pace.
• Do not take a double dose to make up for the dose you forgot to take.

What is  Forms and Composition ?

Capsule.

Composition

Active ingredient	Capsule
Amlodipine	10 mg *

* per unit dose

Active ingredients: Amlodipine

Excipients: Microcrystalline cellulose , Corn starch , Sodium carboxymethyl starch , Magnesium stearate , Capsule shell: Gelatin , Titanium dioxide , black iron oxide , yellow iron oxide

No excipient with known effect ? is not present in the composition of this drug

NOT’s

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general information:

• Includes a general description of the drug, its use, brand names, FAQs, and relevant news and articles

Additional information:

• General explanation about dealing with the medicine: how to take the medicine, the doses and times of it, the start and duration of its effectiveness, the recommended diet during the period of taking the medicine, the method of storage and storage, recommendations in cases for forgetting the dose and instructions to stop taking the drug and take additional doses.

Special warnings:

• For pregnant and breastfeeding women, the elderly, boys and drivers, and use before surgery.

Side effects:

• It treats possible side effects and drug interactions that require attention and its effect on continuous use.
• The information contained in this medicine is based on medical literature, but it is not a substitute for consulting a doctor.