Composition: Amlodipine tablets are formulated as white tablets equivalent to 2.5 mg, 5 mg, and 10 mg for oral administration. Each amlodipine tablet contains the active ingredient - amlodipine besylate and inactive ingredients - dibasic calcium phosphate anhydrous, microcrystalline cellulose, magnesium stearate and sodium starch glycolate.
Amlodipine is a drug given to reduce the hypertension (high blood pressure) which belongs to the pharmacologically complex drug class - Calcium Channel-Blockers (CCBs).
Amlodipine is a long-acting, dihydropyridine CCB that can be indicated for hypertension and angina. Various studies have demonstrated its effectiveness in angina pectoris too.
Amlodipine tablet is a commonly prescribed medicine in patients with high blood pressure (hypertension) to prevent the complications of high BP such as heart attack or stroke, metabolic syndrome, kidney damage, aneurysm rupture, ventricular hypertrophy, vision loss, vascular dementia, and also it is often prescribed alone or with one or two medicine.
Guidelines for taking amlodipine tablet:
Amlodipine tablet reduces blood pressure by a variety of mechanisms, which are explained below:
A diagnosis of hypertension is based on the mean of two or more properly measured seated blood pressure measurements taken on two or more occasions. Most patients with hypertension have a recommended blood pressure goal of less than 130/80 mm Hg.
Following below are Indications for Amlodipine tablet:
Amlodipine can be safely be given to children adults as well as to geriatrics (elderly public above 60 year of age).
In Adult Patients
Hypertension:
Angina:
In Elderly Patients
In case of the elderly, low dose can be initiated and gradually increased to the optimum in case of non-responsive patients. Lower doses are preferred as the elderly have probable cases of hepatic, renal, or cardiac impairment associated. These patients also experience issues in elimination of amlodipine from the body. The doses are as follows:
In Paediatric Patients
Although rare, the current incidence of paediatric hypertension is seen about 1 in 25 youth within ages of 12-19. Paediatric hypertension is more common in youth with obesity. The dosing for paediatric hypertension given for the children within the ages of 6-17.
Patients with hepatic impairment:
In patients with mild to moderate hepatic impairment, the doctor could take extra caution, as dosage recommendations have not been yet established. Nevertheless, the physician could start at the low end of the dosing range. In case of severe hepatic impairment, initiation of treatment with low doses of amlodipine could be expected, which may be increased slowly.
Patients with renal impairment:
Changes in amlodipine plasma concentrations are not correlated with degree of renal impairment, therefore the normal dosage is recommended. Amlodipine is not dialysable.
Plasma concentrations of amlodipine aren't correlated with renal impairment, so the doctor could prescribe a normal dose. The patient must inform the doctor in case of any dialysis, as amlodipine tablet is not dialysable.
Pregnancy
Amlodipine's safety during pregnancy has not been established, but demonstrated toxicity in animal studies with high doses. Amlodipine crosses the placenta. Concentration in the newborn blood is below the limit of quantification. CCB may be used to treat hypertension in pregnant woman. Agents other than amlodipine are commonly used. Females with pre-existing hypertension can continue using the drug during the pregnancy unless there is any other contraindication for the same.
Breastfeeding
Amlodipine is present in the breast milk. About 3-7% (max 15%) of amlodipine is excreted through human breast milk. Breastfeeding is usually avoided if the infant dose due to breast milk is >25%. Studies done assessing the breast mild concentration have shown no side effects in newborn.
Since the effect of amlodipine tablet on infants is unknown, the physician either decides:
by taking into the account of the benefits of breastfeeding to the child and the benefits of amlodipine therapy to the mother.
Fertility
Reversible biochemical changes in the spermatozoon head were seen with amlodipine administration. The potential effect of amlodipine on fertility was insufficient. Nevertheless, the physician prescribes amlodipine only after balancing the risk benefit ratio.
The physicians do not prescribe amlodipine to patients who are:
Amlodipine can cause various side effects. The most common are:
Apart the common side effects mentioned above, there are other side effects which are obtained by spontaneous reporting by either healthcare personnel or the patient themselves. A detailed list can be found below.
Organs and systems
Nervous system:
Amlodipine can cause Asthenia, dizziness, fatigue and drowsiness. There are also reports of abnormal dreams, anxiety, depression, tremor and vertigo with use of amlodipine.
Fluid balance:
Peripheral oedema - usually limited to the lower legs.
Hematologic:
Thrombocytopenia (low blood platelet count). Patients can be presented with epistaxis (nosebleed) and gingivitis (gum bleeding).
Liver:
Hepatitis has been attributed to amlodipine sometimes. Geriatric (people over 60 years of age) cases demonstrated the development of jaundice along with increased levels of aspartate transaminase, alanine transaminase, and bilirubin when amlodipine was taken for 1 month. Stopping amlodipine normalized symptoms and laboratory values.
Skin:
Erythematous (skin redness) and maculopapular rashes (rash with both flat and raised parts), skin discoloration, urticaria (a rash of round, red welts on the skin that itch intensely), dryness, alopecia (hair loss), dermatitis (skin inflammation), erythema multiforme (immune-mediated reaction causing raised, red rash), and lichen planus (inflammation of the skin and mucous membranes).
Nails:
Longitudinal melanonychia (increased melanin deposition causing black longitudinal streaking in the nail plate).
Yes. Amlodipine is safe when the administration was done at the prescribed dosage and frequency. A study conducted in 2012 demonstrated the efficacy and safety of amlodipine in hypertension patients. Amlodipine was shown to be safe and effective in one-third of patients, with a higher proportion of patients achieving normalised blood pressure. Over the course of the study, a total of only 7.2% of patients experienced side effects related to the study drug.
No. The administration of amlodipine does not affect the viscosity of the blood in anyway.
Amlodipine works on the basis of increasing the area in the arteries through which the volume of blood although remains same the pressure exerted onto its walls are reduced, thus decreasing hypertension. Lowered blood pressure can help prevent heart attack, stroke, and kidney disease etc.
No. The patients must not deviate from the doctor’s prescription and abrupt stopping is not recommended especially in the case of regular usage of this medicine at least for several weeks. Abrupt cessation of drugs without medical intervention can have devastating effects on the body. Similarly, abrupt stopping of amlodipine can cause various effects such as chest pain or reversal of high blood pressure to worse.
Yes. One of the rare side effects of amlodipine is an increased frequency in urination which occurs in less than 1% of the population taking amlodipine for reducing hypertension. Also, nocturia (increased urination during the night) and disorders relating to urination can also occur in 1% population.
Amlodipine can be prescribed at any time by the doctor. It is important to stick to a particular time to take the medicine.
A large recent trial called TIME study compared the outcomes of patients taking antihypertensives in the morning vs evening and it was found that the timing of the drugs did not have any impact on cardiovascular outcomes among the study participants.
While both telmisartan and amlodipine are prescribed to reduce hypertension, the mechanisms of action of both the drugs vary greatly which is why they are indicated in different groups of patients. Various factors such as associated comorbidities, age of the patient and grade of hypertension etc can influence the prescribing pattern of the physician.
Each of the medications has its own set of effects other than decreasing blood pressure. Telmisartan can decrease proteinuria (protein loss in the urine), slow down the worsening of kidney disease if started early in the kidney disease and has beneficial effects on the heart. It has important side effects like hyperkalaemia (high potassium) levels because of which sometimes the drug may have to be stopped.
Amlodipine on the other hand may worsen the proteinuria in patients with proteinuria with kidney disease and can cause side effects which are different from telmisartan. We at present cannot label which is better because both are approved for hypertension and are useful in different sets of patients with varied effects. The doctor will decide the appropriateness of the medication to be used in each patient.
Arteries are the blood vessels which carry blood to different parts of the body. Arteries end in organs and tissues as arterioles and finally into capillaries.
Amlodipine is a calcium channel blocker which reduces hypertension by dilating the arteries. As the area of the blood vessel increases, the pressure exerted by the blood reduces. The underside of this affect results in an increase in capillary pressure as dilated arteries brings large amounts of blood to capillaries.
This leads to the loss of fluids from capillaries into interstitial spaces (space that lies between blood vessels and cells providing the fluid and structural environment surrounding those cells) and causes edema (swelling) in the legs.
Fixed drug combinations of antihypertensive agents have proven to be efficacious in the treatment of hypertension. The physician weighs the pros and cons before prescribing fixed drug combinations. Various factors such as associated comorbidities age of the patient and grade of hypertension etc can influence the prescribing pattern of the physician.
The Indian study in 2013 concluded that fixed drug combinations of amlodipine and metoprolol are effective, safe, and improved treatment compliance apart from being cost-effective in the management of mild to moderate essential hypertension.
Yes, bananas can be taken during the therapy of amlodipine. Research did not indicate any interaction between bananas and amlodipine consumption. Bananas are rich in potassium and caution must be maintained during the therapy of angiotensin-converting enzyme inhibitors, and angiotensin receptor blockers as the combination of the fruit with the drugs bring hyperkalaemia resulting in arrhythmia (irregular, fast or fluttering heartbeat).
On the other hand, large amounts of grapefruit or grapefruit juice are not recommended during the therapy of amlodipine as it results in an increased concentration of amlodipine as well as its prolongation in the body. Prolongation of amlodipine can increase the intensity of side effects.
In case of any increased side effects, the physician must be contacted at once.
Yes. One of the rare side effects of amlodipine, when given for reducing hypertension, is weight gain. Also, weight loss can also occur.
The other systemic side effects include allergic reaction, asthenia (abnormal physical weakness or lack of energy), back pain, hot flushes, malaise (generalised discomfort), pain, rigors (sudden feeling of cold with shivering accompanied by a rise in temperature, often with copious sweating, especially at the onset or height of a fever).
All these aforementioned side effects are seen in about only 1% of patients taking amlodipine.
It takes about 6-12 hours after the administration of amlodipine to work in reducing hypertension.
At least 30-50 hours is necessary for at half of the administered amlodipine dose to get eliminated.
Through this, it is calculated that it takes at least five half-lives for the body to completely eliminate the amlodipine. After the last dose of amlodipine, the medication will remain in the body for around 10 days.
Yes, amlodipine can be taken but care must be taken as alcohol consumption can enhance amlodipine in reducing the blood pressure more than the necessary parameter resulting in dizziness or headache.
Nevertheless, it must be understood that high‐dose alcohol has a biphasic effect on blood pressure. A Cochrane study from 2020 demonstrated that a reduction of blood pressure is seen with high‐dose alcohol up to 12 hours after consumption. Once more than 13 hours have passed, increased blood pressure is seen.
It must be understood that an increase in heart rate is seen at all times up to 24 hours with high‐dose alcohol intake.
There is conflicting evidence regarding the effect of amlodipine on blood sugar levels. There are few case reports where amlodipine was associated with high blood sugar values and reversal of blood sugar values to normal levels after discontinuing the drug. Some other studies have shown that amlodipine does not have an effect on sugar levels in the blood.
Yes, physicians can prescribe a combination of telmisartan and amlodipine if necessary. The synergy of both drugs can rapidly help in controlling hyperthyroidism. An Indian study demonstrated that a combination of both telmisartan and amlodipine at low doses provided a better therapeutic approach when compared with individually separated high-dose monotherapy.
Yes, simvastatin and amlodipine can be administered together in a therapeutic regimen. Nevertheless, it must be understood that the physician does not increase the dose of simvastatin more than 20 mg when co-administered with amlodipine as it can result in the occurrence of myopathy (muscle weakness due to dysfunction of muscle fibre).
Yes. Amlodipine safe for chronic kidney disease (CKD) patients. The anti-hypertensive usage of amlodipine can successfully control hypertension thus decreasing the course of renal disease and lowering the risk of cardiovascular disease.
Apart from controlling blood pressure, amlodipine also improves patient outcomes. Extensive clinical experience with its usage as monotherapy and/or in combination with other antihypertensives in a variety of situations has proved its exceptional features in efficiently controlling hypertension in patients with chronic kidney disease while causing minimal side effects.
When compared to other treatments, amlodipine has a significant reduction in the risk of cardiovascular outcomes, particularly stroke, and in patients with renal impairment. With its prolonged half-life, amlodipine provides effective blood pressure control during a 24-hour period.
Coffee intake can cause mild increase in blood pressure for up to 3 hours after intake. There is no concluding evidence that coffee intake increases hypertension risk and that of worsened cardiovascular outcomes. Regular blood pressure monitoring is required to adjust the medication dose to reach the target blood pressure.
Yes, to protect the stomach, amlodipine can be taken with food or a glass of milk but never with grapefruit or grapefruit juice as it can increase the prolongation of amlodipine in the body thus increasing the chances of increased side effects.
Amlodipine must be taken precisely as prescribed by the doctor which means crushing, chopping, or dissolving amlodipine must be refrained from. Doing so could nullify the impact resulting in possible harmful effects.
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