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Stamotens® 5 & 10


Composition :

  • Stamotens® 5 : Each tablet contains 6.935 mg Amlodipine besylate equivalent to amlodipine 5 mg
  • Stamotens® 10 : Each tablet contains 13.870 mg Amlodipine besylate equivalent to amlodipine 10 mg

Indication :
Amlodipine is indicated for the treatment of primary hypertension and can be used as a single drug to control blood pressure in most patients.
Patients inadequately controlled with a single antihypertensive will benefit with the addition of amlodipine, which has been used in combination with drugs known as thiazide diuretics, β adrenergic antagonists or inhibitors of angiotensin converting enzyme. Amlodipine is indicated for primary therapy of myocardial ischemia, whether due to fixed obstruction (stable angina) and / or vasospasm / vasoconstriction (Prinzmetal's or variant angina) of coronary vessels.
Amlodipine may be used where the patient's clinical condition indicates the possibility of a / the vasospasm / vasoconstriction but vasospasm / vasoconstriction itself has never been confirmed.
Amlodipine can be used alone as monotherapy or in combination with other antianginal drugs in patients with angina that is refractory to drugs known as nitrates and / or beta-blockers with adequate doses.

Dosage and Usage :
For hypertension the initial dose is 5 mg amlodipine once daily which can be increased to a maximum of 10 mg depending on the response of each patient and the severity of the disease. In the elderly or infirm individual or patient with hepatic insufficiency may be started with 2.5 mg once daily and this dose may be used in combination with other antihypertensive therapy. Most hypertensive patients with a dose of 5 mg / day is not necessary to increase the dose. When increased doses, amlodipine may be increased to 7.5 mg / day with a maximum dose of 10 mg / day. Dosage recommendation for chronic stable angina or vasospastic angina is 5-10 mg and a lower dose is recommended for the elderly and patients with hepatic insufficiency. No additional doses of amlodipine on thiazide diuretics, b inhibitors and angiotensin converting enzyme inhibitors.
The use in children: Not available experience of the use of amlodipine in children.
Amlodipine is contraindicated in patients known to be sensitive to dihydropyridine.

Side Effects :
Amlodipine is well tolerated. In clinical trials with a placebo as a control in patients with hypertension or angina, the side effects that often arises is headache, edema, fatigue, drowsiness, nausea, abdominal pain, flushing, palpitations and dizziness. Side effects are rare on the experience after the drug was marketed are itching, redness, shortness of breath, weakness, muscle cramps, indigestion of food, gum hyperplasia and erythema multiforme. As with other calcium antagonists rarely reported side effects and that can not be distinguished from the natural history of the primary disease is myocardial infarction, arrhythmia (including ventricular tachycardia and atrial fibrillation) and chest pain.
Have not found abnormal laboratory test results clinically significant associated Amlodipine.

Warnings and Precautions :
The use in patients with impaired hepatic function: as all segments of the calcium antagonist, amlodipine half-life is prolonged in patients with impaired liver function and dosage recommendations can not be determined. In these patients the drug can be administered with caution.
Usage on impaired renal function: Amlodipine extensively metabolized into inactive metabolites with 10% excreted in the urine intact form. Changes in plasma concentration of amlodipine are not related to the degree of renal impairment, so Amlodipine can be given with the usual dose. Amlodipine can not terdialisa.
Elderly patients: The time required to reach peak plasma levels similar in young and elderly patients. Amlodipine clearance tends to decrease the lead / lead to an increase in the area under the curves and elimination half-life in elderly patients. Amlodipine, the use of a similar dose in patients young and old, well tolerated so Amlodipine can be given to elderly patients with doses commonly used.
Pregnancy and lactation: Security Amlodipine use in pregnant or lactating women have not been proven. Amlodipine does not demonstrate toxicity in animal reproductive system in addition to causing the mice to be slow and prolonged labor during childbirth at a dose 50 times the maximum recommended dosage for humans. Then, use during pregnancy is only recommended when there are no other options and when the disease itself carries greater risk for the mother and fetus.
Effects on ability to drive and use no data engined vehicles.

Drug Interactions :
Amlodipine can be given safely in conjunction with thiazide diuretics group, b blockers, ACE inhibitors, long-acting nitrates, sublingual nitroglycerin, non-steroidal anti-inflammatory, antibiotics and oral hypoglycemic drugs. Special studies stated Award along Amlodipine and do not alter the levels of Digoxin Digoxin Digoxin serum or renal clearance in normal volunteers and administration of cimetidine did not alter the pharmacokinetics along Amlodipine.
Data from in vitro studies in human plasma indicate that amlodipine has no effect on protein binding of the drugs tested (Digoxin, Phenytoin, Warfarin or Indomethacin).

Overdose and Treatment :
In humans, experience a state of overdose is very limited. Gastric lavage may be required in some cases.
The available data indicate that an overdose can cause excessive peripheral vasodilation comprehensive and systemic hypotension real.
Clinically significant hypotension due to an overdose of Amlodipine requires active cardiovascular support including regular monitoring of cardiac and respiratory function, elevation of extremities, and attention to the body's circulatory volume and urine output. If there are no contraindications, vasoconstrictor drugs can be used to maintain vascular tone and blood pressure. Gluconat intravenous administration of calcium may be beneficial to restore the effects of calcium antagonists. Dialysis is not too profitable for Amlodipine has a high protein binding.

Presentation :
Stamotens® 5 : Box, 3 strips @ 10 tablets.
Stamotens® 10 : Box, 3 strips @ 10 tablets.

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