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Full Prescribing Info
Amlodipine besylate.
Each Lofral 5- and 10-mg tablet contains: Amlodipine 5 and 10 mg corresponding to amlodipine besylate 6.94 mg and 13.89 mg, respectively and other excipients.
Essential hypertension, prophylaxis against attacks in stable angina pectoris and Prinzmetal's or variant angina.
Dosage/Direction for Use
Recommended dose: Initially, 5 mg once daily. Depending on the individual patient's response, increase to 10 mg once daily.
In case of overdose, gastric lavage may be useful, dialysis is not expected to be of any benefit.
In case of relevant hypotension, immediate support of the cardiovascular system and if not contraindicated.
IV calcium gluconate is useful for reversing the effect of calcium antagonists.
Hypersensitivity to dihydropyridines or to any excipients of Lofral.
Special Precautions
Severe chronic obstructive pulmonary disease and pulmonary hypertension. Careful monitoring of the patient with acute myocardial infarction and in the 30 days following infarction.
Normal doses in patients with renal failure and caution in cases of hepatic insufficiency.
Use in pregnancy & lactation: Only recommended if no safer alternative is available and if the disease itself poses a greater risk for mother and infant.
Use in children: Caution to patients <18 years.
Use in the elderly: A lower initial dose may be necessary in older patients.
Use In Pregnancy & Lactation
Only recommended if no safer alternative is available and if the disease itself poses a greater risk for mother and infant.
Adverse Reactions
Very common: Edema.
Occasionally: Dizziness, headache and tiredness, muscle cramps, nausea, somnolence, abdominal pain, palpitation and reddening of the face.
Rare: Angioedema.
As with other calcium antagonists, in rare cases at the start of treatment or when increasing the dose: Myocardial infarction, arrhythmia (including ventricular tachycardia and atrial fibrillation) and chest pain.
Drug Interactions
Theophylline and ergotamine.
ATC Classification
C08CA01 - amlodipine ; Belongs to the class of dihydropyridine derivative selective calcium-channel blockers with mainly vascular effects. Used in the treatment of cardiovascular diseases.
Tab 5 mg x 30's. 10 mg x 30's.
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