ALZOR CCB Olmesartan Medoxomil / Amlodipine Besilate 40mg / 10mg Film-Coated Tablet 30's
RXDRUG-DR-XY38017
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Features
Brand
Alzor CCB
Full Details
Dosage Strength
40 mg / 10 mg
Drug Ingredients
- Amlodipine
- Olmesartan
Drug Packaging
Film-Coated Tablet 30's
Generic Name
Olmesartan Medoxomil / Amlodipine Besilate
Dosage Form
Film-Coated Tablet
Registration Number
DR-XY38017
Drug Classification
Prescription Drug (RX)
Description
Indications/Uses
Olmesartan medoxomil plus Amlodipine besilate is indicated for the treatment of hypertension, alone or with other antihypertensive agents. This fixed combination drug is indicated as initial therapy in patients likely to need multiple anti-hypertensive agents to achieve their blood pressure goals. Initial therapy is not recommended in patients ≥75 years of age or in hepatically impaired patients.
Dosage/Direction for Use
General Considerations: The side effects of Olmesartan medoxomil are generally rare and apparently independent of dose.
Those of Amlodipine are generally dose-dependent (mostly edema).
Maximum antihypertensive effects are attained within 2 weeks after a change in dose.
Olmesartan medoxomil plus Amlodipine besilate may be taken with or without food.
Olmesartan medoxomil plus Amlodipine besilate may be administered with other antihypertensive agents.
Dosage may be increased after 2 weeks. The maximum recommended dose of Olmesartan medoxomil plus Amlodipine besilate is 40/10 mg.
Replacement Therapy: Olmesartan medoxomil plus Amlodipine besilate may be substituted for its individually titrated components.
When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.
Add-on Therapy for Patients with Hypertension Not Adequately Controlled on Amlodipine or Olmesartan Medoxomil Alone: Olmesartan medoxomil plus Amlodipine besilate may be used as add-on therapy for patients not adequately controlled on Amlodipine or Olmesartan medoxomil.
Those of Amlodipine are generally dose-dependent (mostly edema).
Maximum antihypertensive effects are attained within 2 weeks after a change in dose.
Olmesartan medoxomil plus Amlodipine besilate may be taken with or without food.
Olmesartan medoxomil plus Amlodipine besilate may be administered with other antihypertensive agents.
Dosage may be increased after 2 weeks. The maximum recommended dose of Olmesartan medoxomil plus Amlodipine besilate is 40/10 mg.
Replacement Therapy: Olmesartan medoxomil plus Amlodipine besilate may be substituted for its individually titrated components.
When substituting for individual components, the dose of one or both of the components can be increased if blood pressure control has not been satisfactory.
Add-on Therapy for Patients with Hypertension Not Adequately Controlled on Amlodipine or Olmesartan Medoxomil Alone: Olmesartan medoxomil plus Amlodipine besilate may be used as add-on therapy for patients not adequately controlled on Amlodipine or Olmesartan medoxomil.
Overdosage
There is no information on overdosage with Olmesartan medoxomil plus Amlodipine besilate in humans.
Amlodipine: 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 is limited.
If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. 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.
Olmesartan medoxomil: Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension should occur, supportive treatment should be initiated. The dialyzability of Olmesartan is unknown.
Amlodipine: 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 is limited.
If massive overdose should occur, active cardiac and respiratory monitoring should be instituted. Frequent blood pressure measurements are essential. Should hypotension occur, cardiovascular support including elevation of the extremities and the judicious administration of fluids should be initiated. 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.
Olmesartan medoxomil: Limited data are available related to overdosage in humans. The most likely manifestations of overdosage would be hypotension and tachycardia; bradycardia could be encountered if parasympathetic (vagal) stimulation occurs. If symptomatic hypotension should occur, supportive treatment should be initiated. The dialyzability of Olmesartan is unknown.
Administration
May be taken with or without food.
Special Precautions
Fetal/Neonatal Morbidity and Mortality: Olmesartan medoxomil: Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. When pregnancy is detected, Olmesartan medoxomil plus Amlodipine besilate should be discontinued as soon as possible.
During the second and third trimesters of pregnancy, these drugs have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug.
These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of Amlodipine or Olmesartan medoxomil as soon as possible.
During the second and third trimesters of pregnancy, these drugs have been associated with fetal injury that includes hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug.
These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester. Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of Amlodipine or Olmesartan medoxomil as soon as possible.
Use In Pregnancy & Lactation
Pregnancy: Olmesartan medoxomil: Pregnancy Categories C (first trimester) and D (second and third trimesters). (See Precautions.)
Amlodipine: No evidence of teratogenicity or other embryo/fetal toxicity. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether the Amlodipine or Olmesartan medoxomil components of Olmesartan medoxomil plus Amlodipine besilate tablet are excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Amlodipine: No evidence of teratogenicity or other embryo/fetal toxicity. Amlodipine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers: It is not known whether the Amlodipine or Olmesartan medoxomil components of Olmesartan medoxomil plus Amlodipine besilate tablet are excreted in human milk, but Olmesartan is secreted at low concentration in the milk of lactating rats. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
Edema is a known, dose-dependent adverse effect of Amlodipine but not of Olmesartan medoxomil.
Adverse reaction includes hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.
Amlodipine: The most common side effects were headache, edema, gynecomastia, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis).
Olmesartan medoxomil: The overall frequency of adverse events was not dose-related. Events were generally mild, transient, and without relationship to the dose of Olmesartan medoxomil. These are: Body as a Whole: dizziness, asthenia, angioedema.
Gastrointestinal: vomiting.
Musculoskeletal: rhabdomyolysis.
Urogenital System: acute renal failure.
Skin and Appendages: alopecia, pruritus, urticaria.
Adverse reaction includes hypotension, orthostatic hypotension, rash, pruritus, palpitation, urinary frequency, and nocturia.
Amlodipine: The most common side effects were headache, edema, gynecomastia, jaundice and hepatic enzyme elevations (mostly consistent with cholestasis or hepatitis).
Olmesartan medoxomil: The overall frequency of adverse events was not dose-related. Events were generally mild, transient, and without relationship to the dose of Olmesartan medoxomil. These are: Body as a Whole: dizziness, asthenia, angioedema.
Gastrointestinal: vomiting.
Musculoskeletal: rhabdomyolysis.
Urogenital System: acute renal failure.
Skin and Appendages: alopecia, pruritus, urticaria.
Storage
Store at temperatures not exceeding 30°C.
Action
Pharmacodynamics: Amlodipine: Following administration of therapeutic doses to patients with hypertension, Amlodipine produces vasodilation resulting in a reduction of supine and standing blood pressures. These decreases in blood pressure are not accompanied by a significant change in heart rate or plasma catecholamine levels with chronic dosing.
With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The magnitude of reduction in blood pressure with Amlodipine is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (diastolic pressure 105 -114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90-104 mmHg).
In hypertensive patients with normal renal function, therapeutic doses of Amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria.
Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or man.
Olmesartan medoxomil: Olmesartan medoxomil doses of 2.5 mg to 40 mg inhibit the pressor effects of angiotensin I infusion. The duration of the inhibitory effect was related to dose, with doses of Olmesartan medoxomil >40 mg giving >90% inhibition at 24 hours.
With chronic once daily oral administration, antihypertensive effectiveness is maintained for at least 24 hours. Plasma concentrations correlate with effect in both young and elderly patients. The magnitude of reduction in blood pressure with Amlodipine is also correlated with the height of pretreatment elevation; thus, individuals with moderate hypertension (diastolic pressure 105 -114 mmHg) had about a 50% greater response than patients with mild hypertension (diastolic pressure 90-104 mmHg).
In hypertensive patients with normal renal function, therapeutic doses of Amlodipine resulted in a decrease in renal vascular resistance and an increase in glomerular filtration rate and effective renal plasma flow without change in filtration fraction or proteinuria.
Amlodipine does not change sinoatrial nodal function or atrioventricular conduction in intact animals or man.
Olmesartan medoxomil: Olmesartan medoxomil doses of 2.5 mg to 40 mg inhibit the pressor effects of angiotensin I infusion. The duration of the inhibitory effect was related to dose, with doses of Olmesartan medoxomil >40 mg giving >90% inhibition at 24 hours.
MedsGo Class
Angiotensin II Antagonists / Calcium Antagonists
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