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Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Generic Amlodipine Besylate Tablets is used to treat high
blood pressure (hypertension) by itself or together with
other medicines.
Lowering high blood pressure helps prevent strokes, heart
attacks, and kidney problems. Amlodipine is also used to
relieve chronic stable angina (chest pain) in adults.
Generic Amlodipine could help to increase the ability to
exercise and decrease the frequency of angina attacks.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Chemical Structure - Amlodipine Besylate
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
The active ingredient contained in
Generic Amlodipine tablets is Amlodipine
Besylate (Amlodipine Besilate).
Each uncoated Generic Amlodipine tablet
contains Amlodipine Besylate equivalent to
Amlodipine 2.5 mg, 5 mg or 10 mg.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Uses of Generic Amlodipine 2.5mg, 5mg and 10mg tablets:
Generic Amlodipine Besylate tablets is used for the first-line treatment of
hypertension and can be used as the sole agent to control blood pressure
in the majority of patients.
Amlodipine Besilate tablets are indicated for the first-line treatment of
myocardial ischaemia, whether due to fixed obstruction (stable angina)
and/or vasospasm/vasoconstriction (Prinzmetal’s or variant angina) of
coronary vasculature.
Generic Amlodipine could be used where the clinical presentation suggests a
possible vasospastic/vasoconstrictive component but where
vasospasm/vasoconstriction has not been confirmed.
Generic Amlodipine may be used alone as monotherapy, or in combination
with other antianginal drugs in patients with angina that is refractory to
nitrates and/or beta-blockers.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Uses of Generic Amlodipine 2.5mg, 5mg and 10mg tablets:
Amlodipine Besylate is a calcium channel blocker. It affects
the movement of calcium into the cells of the heart and blood
vessels. This relaxes the blood vessels and lowers blood
pressure.
A lower blood pressure will increase the supply of blood and
oxygen to the heart.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Stamlo Tablets
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Stamlo Tablets
Manufactured By: Dr. Reddy's Laboratories Limited, India
Strengths Available: 2.5 mg, 5 mg and 10 mg Tablets.
More details on Stamlo Tablets
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Amlopres Tablets
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Amlopres Tablets
Manufactured By: Cipla Limited, India
Strengths Available: 2.5 mg, 5 mg and 10 mg Tablets.
More details on Amlopres Tablets
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Recommended Dosage
For most adult patients, the starting dose of Generic
Amlodipine Besylate Tablets for the treatment of
Hypertension is 5 mg once daily, with a maximum dose of
10 mg once daily.
Small, fragile or elderly individuals or patients with hepatic
insufficiency may be started on 2.5 mg once daily and this
dose may be used when adding Amlodipine Besilate to
other anti-hypertensive therapy. The starting dose for
pediatric patients is 2.5 mg to 5 mg once daily.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Recommended Adult Dosage
Chronic Stable or Vasospastic Angina: The starting
dose of Amlodipine Besilate is 5 mg to 10 mg with a
lower dose (2.5 mg) in the elderly and in patients with
hepatic insufficiency.
The recommended dose range for patients with Coronary
Artery Disease (CAD) is 5mg to 10 mg once daily. During
clinical studies, the majority of patients required 10 mg.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Contraindications
➔
Generic Amlodipine tablets are contraindicated in patients with a
known hypersensitivity to Amlodipine Besylate, other dihydropyridines or
any component of the tablet.
➔
Amlodipine is transferred into human breast milk, therefore Generic
Amlodipine is contraindicated during breast-feeding.
➔
Generic Amlodipine Besylate Tablets are also contraindicated in patients
with severe hypotension, shock including cardiogenic shock, obstruction
of the outflow tract of the left ventricle (e.g. high grade aortic stenosis)
and haemodynamically unstable heart failure after acute myocardial
infarction
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Storage Instructions
Generic Amlodipine Besylate Tablets have to be
stored at controlled room temperature i.e. from
20°C to 25°C (68°F to 77°F) with excursions
permitted between 15° to 30°C (59° to 86°F).
Keep this as well as all other medicines away
from children and pets.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Warnings
Symptomatic hypotension is possible, particularly in
patients with severe aortic stenosis. However, acute
hypotension is unlikely.
Worsening angina and acute myocardial infarction
can develop after starting or increasing the dose of
Generic Amlodipine tablets particularly in patients
with severe obstructive coronary artery disease.
Titrate slowly in patients with severe hepatic
impairment.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Warnings
No studies on the effects on the ability to drive and
use machines have been performed.
Patients who experience dizziness as an adverse
reaction should avoid driving vehicles or using
machines.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Warnings
What medications must not be taken with Amlodipine Tablets?
The FDA recommends limiting the dosage of Simvastatin to 20 mg daily
while also taking Generic Amlodipine Besylate Tablets.
Medicines that inhibit an enzyme called CYP3A4 can increase the
concentration of Amlodipine in the blood. These medications include
Diltiazem, Ketoconazole, Itraconazole, And Ritonavir. The FDA
recommends that doctors monitor people who are taking both CYP3A4
inhibitors and Amlodipine for symptoms of edema and low blood
pressure.
In patients who have had a kidney transplant, taking Amlodipine and
Cyclosporine together Could increase the levels of Cyclosporine in the
body.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Possible Side Effects
Most common Amlodipine Besylate tablets side
effects are headache and edema which occurred in a
dose related manner. Other side effects not dose
related but reported with an incidence of more than
1.0% are headache, fatigue, nausea, abdominal pain,
and somnolence.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Possible Side Effects
The following events occurred in less than 1% but more than 0.1% of patients in
controlled clinical trials or under conditions of open trials or marketing
experience:
Cardiovascular: arrhythmia (including ventricular tachycardia and atrial
fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia,
vasculitis.
Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral,
paresthesia, tremor, vertigo.
Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence,
pancreatitis, vomiting, gingival hyperplasia.
General: allergic reaction, asthenia1,back pain, hot flushes, malaise, pain, rigors,
weight gain, weight decrease.
Musculoskeletal System: arthralgia, arthrosis, muscle cramps, myalgia.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Possible Side Effects
The following events occurred in less than 1% but more than 0.1% of patients in
controlled clinical trials or under conditions of open trials or marketing
experience:
Psychiatric: sexual dysfunction (male and female), insomnia, nervousness,
depression, abnormal dreams, anxiety, depersonalization.
Respiratory System: dyspnea, epistaxis.
Skin and Appendages: angioedema, erythema multiforme, pruritus, rash, rash
erythematous, rash maculopapular.
Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus.
Urinary System: micturition frequency, micturition disorder, nocturia.
Autonomic Nervous System: dry mouth, sweating increased.
Metabolic and Nutritional: hyperglycemia, thirst.
Hemopoietic: leukopenia, purpura, thrombocytopenia.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Amlodipine Besylate Tablets Overdosage
Amlodipine Besylate tablets overdosage might be
expected to cause excessive peripheral vasodilation with
marked hypotension and possibly a reflex tachycardia.
In humans, experience with intentional overdosage of
Amlodipine Besylate (Amlodipine Besilate) is limited.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Treatment of Amlodipine Besylate Tablets Overdosage
If massive Amlodipine tablets overdose should occur, active cardiac and
respiratory monitoring should be instituted. Frequent blood pressure
measurements are necessary.
Should hypotension occur, cardiovascular support including elevation of
the extremities and the judicious administration of fluids should be started.
If hypotension remains unresponsive to these conservative measures,
administration of vasopressors (such as phenylephrine) should be
considered with attention to circulating volume and urine output.
Intravenous calcium gluconate may help to reverse the effects of calcium
entry blockade. As Amlodipine is highly protein bound, hemodialysis is not
likely to be of benefit.
Treat Hypertension with Generic Amlodipine Tablets
© The Swiss Pharmacy
Generic Amlodipine Tablets During Pregnancy
Amlodipine Besylate has been classified by the US FDA as Pregnancy
Category C. There are no adequate and well-controlled studies in pregnant
women. Amlodipine should be used during pregnancy only if the potential
benefit justifies the risk to the fetus.
During animal reproduction studies, there was no evidence of adverse
developmental effects when pregnant rats and rabbits were treated orally
with Amlodipine Besilate during organogenesis at doses up to 10 mg
Amlodipine/kg/day (approximately 8 and 23-times the maximum
recommended human dose (MRHD), respectively).
However for rats, litter size was significantly decreased (by about 50%)
and the number of intrauterine deaths was significantly increased.

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Treat Hypertension with Generic Amlodipine Besylate Tablets

  • 1. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy
  • 2. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Generic Amlodipine Besylate Tablets is used to treat high blood pressure (hypertension) by itself or together with other medicines. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Amlodipine is also used to relieve chronic stable angina (chest pain) in adults. Generic Amlodipine could help to increase the ability to exercise and decrease the frequency of angina attacks.
  • 3. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Chemical Structure - Amlodipine Besylate
  • 4. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy The active ingredient contained in Generic Amlodipine tablets is Amlodipine Besylate (Amlodipine Besilate). Each uncoated Generic Amlodipine tablet contains Amlodipine Besylate equivalent to Amlodipine 2.5 mg, 5 mg or 10 mg.
  • 5. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Uses of Generic Amlodipine 2.5mg, 5mg and 10mg tablets: Generic Amlodipine Besylate tablets is used for the first-line treatment of hypertension and can be used as the sole agent to control blood pressure in the majority of patients. Amlodipine Besilate tablets are indicated for the first-line treatment of myocardial ischaemia, whether due to fixed obstruction (stable angina) and/or vasospasm/vasoconstriction (Prinzmetal’s or variant angina) of coronary vasculature. Generic Amlodipine could be used where the clinical presentation suggests a possible vasospastic/vasoconstrictive component but where vasospasm/vasoconstriction has not been confirmed. Generic Amlodipine may be used alone as monotherapy, or in combination with other antianginal drugs in patients with angina that is refractory to nitrates and/or beta-blockers.
  • 6. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Uses of Generic Amlodipine 2.5mg, 5mg and 10mg tablets: Amlodipine Besylate is a calcium channel blocker. It affects the movement of calcium into the cells of the heart and blood vessels. This relaxes the blood vessels and lowers blood pressure. A lower blood pressure will increase the supply of blood and oxygen to the heart.
  • 7. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Stamlo Tablets
  • 8. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Stamlo Tablets Manufactured By: Dr. Reddy's Laboratories Limited, India Strengths Available: 2.5 mg, 5 mg and 10 mg Tablets. More details on Stamlo Tablets
  • 9. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Amlopres Tablets
  • 10. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Amlopres Tablets Manufactured By: Cipla Limited, India Strengths Available: 2.5 mg, 5 mg and 10 mg Tablets. More details on Amlopres Tablets
  • 11. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Recommended Dosage For most adult patients, the starting dose of Generic Amlodipine Besylate Tablets for the treatment of Hypertension is 5 mg once daily, with a maximum dose of 10 mg once daily. Small, fragile or elderly individuals or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding Amlodipine Besilate to other anti-hypertensive therapy. The starting dose for pediatric patients is 2.5 mg to 5 mg once daily.
  • 12. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Recommended Adult Dosage Chronic Stable or Vasospastic Angina: The starting dose of Amlodipine Besilate is 5 mg to 10 mg with a lower dose (2.5 mg) in the elderly and in patients with hepatic insufficiency. The recommended dose range for patients with Coronary Artery Disease (CAD) is 5mg to 10 mg once daily. During clinical studies, the majority of patients required 10 mg.
  • 13. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Contraindications ➔ Generic Amlodipine tablets are contraindicated in patients with a known hypersensitivity to Amlodipine Besylate, other dihydropyridines or any component of the tablet. ➔ Amlodipine is transferred into human breast milk, therefore Generic Amlodipine is contraindicated during breast-feeding. ➔ Generic Amlodipine Besylate Tablets are also contraindicated in patients with severe hypotension, shock including cardiogenic shock, obstruction of the outflow tract of the left ventricle (e.g. high grade aortic stenosis) and haemodynamically unstable heart failure after acute myocardial infarction
  • 14. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Storage Instructions Generic Amlodipine Besylate Tablets have to be stored at controlled room temperature i.e. from 20°C to 25°C (68°F to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F). Keep this as well as all other medicines away from children and pets.
  • 15. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Warnings Symptomatic hypotension is possible, particularly in patients with severe aortic stenosis. However, acute hypotension is unlikely. Worsening angina and acute myocardial infarction can develop after starting or increasing the dose of Generic Amlodipine tablets particularly in patients with severe obstructive coronary artery disease. Titrate slowly in patients with severe hepatic impairment.
  • 16. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Warnings No studies on the effects on the ability to drive and use machines have been performed. Patients who experience dizziness as an adverse reaction should avoid driving vehicles or using machines.
  • 17. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Warnings What medications must not be taken with Amlodipine Tablets? The FDA recommends limiting the dosage of Simvastatin to 20 mg daily while also taking Generic Amlodipine Besylate Tablets. Medicines that inhibit an enzyme called CYP3A4 can increase the concentration of Amlodipine in the blood. These medications include Diltiazem, Ketoconazole, Itraconazole, And Ritonavir. The FDA recommends that doctors monitor people who are taking both CYP3A4 inhibitors and Amlodipine for symptoms of edema and low blood pressure. In patients who have had a kidney transplant, taking Amlodipine and Cyclosporine together Could increase the levels of Cyclosporine in the body.
  • 18. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Possible Side Effects Most common Amlodipine Besylate tablets side effects are headache and edema which occurred in a dose related manner. Other side effects not dose related but reported with an incidence of more than 1.0% are headache, fatigue, nausea, abdominal pain, and somnolence.
  • 19. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Possible Side Effects The following events occurred in less than 1% but more than 0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience: Cardiovascular: arrhythmia (including ventricular tachycardia and atrial fibrillation), bradycardia, chest pain, peripheral ischemia, syncope, tachycardia, vasculitis. Central and Peripheral Nervous System: hypoesthesia, neuropathy peripheral, paresthesia, tremor, vertigo. Gastrointestinal: anorexia, constipation, dysphagia, diarrhea, flatulence, pancreatitis, vomiting, gingival hyperplasia. General: allergic reaction, asthenia1,back pain, hot flushes, malaise, pain, rigors, weight gain, weight decrease. Musculoskeletal System: arthralgia, arthrosis, muscle cramps, myalgia.
  • 20. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Possible Side Effects The following events occurred in less than 1% but more than 0.1% of patients in controlled clinical trials or under conditions of open trials or marketing experience: Psychiatric: sexual dysfunction (male and female), insomnia, nervousness, depression, abnormal dreams, anxiety, depersonalization. Respiratory System: dyspnea, epistaxis. Skin and Appendages: angioedema, erythema multiforme, pruritus, rash, rash erythematous, rash maculopapular. Special Senses: abnormal vision, conjunctivitis, diplopia, eye pain, tinnitus. Urinary System: micturition frequency, micturition disorder, nocturia. Autonomic Nervous System: dry mouth, sweating increased. Metabolic and Nutritional: hyperglycemia, thirst. Hemopoietic: leukopenia, purpura, thrombocytopenia.
  • 21. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Amlodipine Besylate Tablets Overdosage Amlodipine Besylate tablets overdosage might be expected to cause excessive peripheral vasodilation with marked hypotension and possibly a reflex tachycardia. In humans, experience with intentional overdosage of Amlodipine Besylate (Amlodipine Besilate) is limited.
  • 22. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Treatment of Amlodipine Besylate Tablets Overdosage If massive Amlodipine tablets overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are necessary. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be started. If hypotension remains unresponsive to these conservative measures, administration of vasopressors (such as phenylephrine) should be considered with attention to circulating volume and urine output. Intravenous calcium gluconate may help to reverse the effects of calcium entry blockade. As Amlodipine is highly protein bound, hemodialysis is not likely to be of benefit.
  • 23. Treat Hypertension with Generic Amlodipine Tablets © The Swiss Pharmacy Generic Amlodipine Tablets During Pregnancy Amlodipine Besylate has been classified by the US FDA as Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Amlodipine should be used during pregnancy only if the potential benefit justifies the risk to the fetus. During animal reproduction studies, there was no evidence of adverse developmental effects when pregnant rats and rabbits were treated orally with Amlodipine Besilate during organogenesis at doses up to 10 mg Amlodipine/kg/day (approximately 8 and 23-times the maximum recommended human dose (MRHD), respectively). However for rats, litter size was significantly decreased (by about 50%) and the number of intrauterine deaths was significantly increased.