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INTRODUCTION
AMLODAC T is a combination of Amlodipine and Telmisartan which belongs to a group of medicines called Antihypertensives. It is used to treat high blood pressure. High blood pressure (also known as hypertension) is a medical condition in which the force of the blood exerted against the walls of the artery remains very high, and as a result it may lead to severe damage to the blood vessels of several organs, thus causing heart attack, heart or kidney failure, stroke, or even blindness.
Amlodipine is a Calcium channel blocker and Telmisartan is an Angiotensin-II antagonist. Collectively, they act together and reduces blood pressure by relaxing the blood vessels supplying the heart, thus making it easier for your heart to pump blood around your body.
Before taking AMLODAC T inform your doctor if you have diabetes, low blood pressure, heart diseases and liver or kidney problems. AMLODAC T is generally not recommended for use in pregnant women and in children (below 18 years). Consult your doctor before taking. Avoid grapefruit juice while taking AMLODAC T as it may cause unwanted interactions. The common side effects of AMLODAC T are dizziness, swelling in the ankle, tiredness, headache or upset stomach.
USES OF AMLODAC T
- Treats High Blood Pressure (Hypertension)
HOW AMLODAC T WORKS
AMLODAC T effectively reduces blood pressure, where amlodipine acts by reducing the contractility of the heart muscles and telmisartan acts by blocking the actions of a peptide called Angiotensin – II, which is responsible for increasing blood pressure. Collectively, they relax the blood vessels supplying the heart, thus making it easier for your heart to pump blood around your body.
DIRECTIONS FOR USE
Take AMLODAC T with or without food. Swallow it as a whole and do not crush or chew the medicine. Do not stop taking AMLODAC T unless advised by your doctor.
SIDE EFFECTS OF AMLODAC T
COMMON
- dizziness
- sleepiness
- ankle swelling (oedema)
- headache
- tiredness, weakness
- palpitations
- indigestion
- nausea
- diarrhea
- constipation
- double vision, visual disturbances
- muscle cramps
- flushing of the face or neck
UNCOMMON
- urinary tract infections
- upper respiratory tract infections (sore throat, common cold, inflamed sinus)
- anemia
- fainting
- hair loss
- vertigo (spinning sensation)
- slow heartbeat
- orthostatic hypotension (dizziness while standing up from sitting or lying position)
- increased sweating
- chest pain
- shortness of breath
- mood changes
- trembling
- ringing in ears
- numbness or tingling sensation in hands or legs
- dry mouth
- cough
- weight loss or gain
- back pain
- impotence (inability to achieve erection)
- altered taste
RARE
- confusion
- drowsiness
- fast heartbeat (tachycardia)
- rapid swelling of the skin and mucosa
- sepsis (high fever and severe illness)
- signs of low blood sugar (sweating, shakiness, increased hunger, fast heartbeat)
- eczema, redness of skin, rash
- tendon pain
- low platelet count (easy bruising or bleeding)
Stop taking AMLODAC T and contact your doctor immediately if you experience any of the following side effects:
- severe skin reactions such as Stevens-Johnson syndrome, toxic epidermal necrolysis (skin rash, itching, blistering reddening of skin all over the body, peeling and swelling of the skin, swelling of mucous membrane)
- heart attack or irregular heartbeat
- signs of inflamed pancreas (severe stomach and back pain, usually felling unwell)
- sepsis (infection of blood due to severe infection occurs due to body’s extreme inflammatory response)
- severe allergic reactions (such as swelling of the face, lips, tongue, and/or throat which can lead to difficulty in breathing or swallowing)
HOW TO MANAGE SIDE EFFECTS
Headache:
Rest and drink plenty of fluids. Apply a wet or cold cloth to forehead and rest in a quiet, comfortable, dark room.
Constipation:
Take fiber rich foods in your diet such as fresh fruits, vegetables and whole grain cereals, and drink plenty of fluids. Exercise more regularly and stay active.
Nausea:
Try to take this medicine with, or just after, a meal or snack and stick to simple meals and do not eat oil rich or spicy food.
WARNING & PRECAUTIONS
PREGNANCY
AMLODAC T is not recommended in early pregnancy and must not be taken after the third month of pregnancy, as it may cause serious harm to your baby. Consult your doctor for advice.
BREASTFEEDING
AMLODAC T may pass into breast milk in small amounts, hence it should be used with caution during breastfeeding. Consult your doctor for advice.
DRIVING AND USING MACHINES
Do not drive or operate any tools or machines if you experience dizziness, fainting or spinning sensation while taking AMLODAC T.
ALCOHOL
Avoid consumption of alcohol while taking AMLODAC T as it may make you feel dizzy.
KIDNEY
AMLODAC T should be used with caution in patients with kidney disease (renal artery stenosis). Consult your doctor for advice.
LIVER
AMLODAC T should be used with caution if you have liver disease (biliary obstruction). Consult your doctor for advice.
ALLERGY
Tell your doctor if you are allergic to Amlodipine or Telmisartan or any other ingredients of AMLODAC T.
HEART DISEASE
AMLODAC T is not recommended for use in patients with recent heart attack, aortic stenosis, cardiogenic shock, heart failure and should be used with caution in patient’s having unstable angina. Consult your doctor for advice.
OTHERS
Inform your physician before taking AMLODAC T if you have or had,
- diabetes
- raised aldosterone levels
- low blood pressure (due to dehydration or salt deficiency in the body)
- elevated potassium levels in blood
Use in pediatrics:
AMLODAC T is not recommended for use in children and adolescents less than 18 years of age. Consult your doctor for advice
Use in geriatrics:
AMLODAC T should be used with caution in elderly patients particularly at higher doses. Consult your doctor for advice.
INTERACTIONS
A. Drug-Drug interactions:
Before taking AMLODAC T, inform your doctor if you are taking:
- enalapril, lisinopril, ramipril (treats high blood pressure or heart failure)
- aliskiren (used to high blood pressure)
- lithium (used to treat mental illness such as depression)
- potassium-sparing diuretics (used to retain potassium levels in blood)
- acetylsalicylic acid or ibuprofen (treats pain and inflammation)
- cyclosporin (used to suppress overactive immune response)
- rifampicin, erythromycin, clarithromycin (used to treat bacterial infections)
- dantrolene infusion (used to treat body temperature abnormalities)
- sirolimus, temsirolimus and everolimus (used to alter the way your immune system works)
- ritonavir, nelfinavir, indinavir (used to treat HIV/AIDS)
- ketoconazole, itraconazole (used to treat fungal infection)
- diltiazem, verapamil (used to treat heart problems)
- diuretics such as hydrochlorothiazide, chlorthalidone (used to treat edema or high blood pressure)
- digoxin (treats heart conditions)
- simvastatin (lowers high cholesterol levels)
- baclofen (used to treat muscle spasm)
- amifostine (used to treat cancer)
- neuroleptics or antidepressants (used to treat depression or psychiatric disorders)
- heparin, (treats blood clot)
- st. john’s wort (herbal medicine)
B. Drug-Food interactions:
Do not eat grapefruit or drink grapefruit juice while taking AMLODAC T as it increases the level of this medicine in the blood resulting in lower blood pressure than desired. Consult your doctor before taking it.
Overdosage:
If you or anyone else accidentally take too much of AMLODAC T, consult your doctor immediately. Overdosage can cause severe low blood pressure such as fainting, dizziness, weakness and increase in heartrate.
SYNOPSIS
| Drug | : | Amlodipine, Telmisartan |
| Pharmacological Category | : | Calcium channel blockers, Angiotensin-II receptor blockers |
| Therapeutic Indication | : | High blood pressure |
| Dosage Forms | : | Tablet |
MORE INFORMATION
- Keep AMLODAC T out of reach of children
- Store AMLODAC T at room temperature
FAQs ABOUT AMLODAC T
What will happen if I stop taking AMLODAC T?
You should not stop taking AMLODAC T without talking to your doctor first as it may increase the blood pressure.
Is it safe to take AMLODAC T for a long time?
Yes, it is safe to take AMLODAC T for long time, if advised by your doctor. Your doctor will determine the dose and duration of treatment depending upon the condition and response to the treatment in managing your blood pressure.
What happens if I forget to take AMLODAC T?
If you miss a dose taking AMLODAC T, take it as soon as you remember and do not double the dose.
How can I effectively control my blood pressure while taking AMLODAC T?
Your doctor may generally advice you to do regular physical exercises, lifestyle changes and dietary changes, especially salt restricted diet. Reducing stress will effectively help in controlling blood pressure rather than taking AMLODAC T alone.
Can I take AMLODAC T before driving?
Do not take AMLODAC T before driving as it can cause side effects such as dizziness, sleepiness, vertigo, or tiredness. If this is a matter of concern, consult your doctor for alternative medicines.
REFERENCES
1. KD Tripathi MD. Antihypertensive drugs. Essentials of Medical Pharmacology 7th ed. New Delhi, May 2013. Page – 561.
2. Jaswant Goyal, Zafer Yab Khan, Prerna Upadhyaya, Barkha Goyal and Shipra Jain. Comparative Study of High Dose Monotherapy of Amlodipine or Telmisartan, and Their Low Dose Combination in Mild to Moderate Hypertension. June 20, 2014. [Accessed on 23rd March 2022] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4129356/
3. Telmisartan/Amlodipine Alembic. [Accessed on 23rd March 2022] https://mri.cts-mrp.eu/Human/Downloads/EE_H_0301_003_FinalPL.pdf
4. Actavis Ltd. Electronic Medicines Compendium (EMC). [Revised in July 2021] [Accessed on 23rd March 2022] https://www.medicines.org.uk/emc/files/pil.12400.pdf
5. Dr. Reddy’s Laboratories (UK) Ltd. Electronic Medicines Compendium (EMC). [Revised in August 2018] [Accessed on 23rd March 2022] https://www.medicines.org.uk/emc/files/pil.3478.pdf
6. Sanofi India Limited. Windlas Biotech Private Limited. [Revised on July, 2019] [Accessed on 23rd March 2022] https://www.sanofi.in/-/media/Project/One-Sanofi-Web/Websites/Asia-Pacific/Sanofi-IN/Home/science-and-innovation/for-healthcare-professionals/product-information/Telsite-am-PI-June-2018.pdf?la
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- Kidney Function Test
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