Fixocard5 mg+50 mg

Fixocard is a fixed-dose combination of a dihydropyridine calcium channel blocker (amlodipine) and a cardioselective beta-1 blocker (atenolol). It is indicated for:

• Hypertension (established use): Fixocard is used in patients with essential hypertension whose blood pressure is not adequately controlled on amlodipine or atenolol monotherapy alone, or in patients already controlled on the individual components at the same doses present in the combination, as a substitution for convenience.
• Not intended as first-line/initial therapy: Fixocard is not recommended for initiating treatment; the individual component doses should first be titrated separately, and this fixed combination used only once appropriate doses for both components have been established.

Fixocard is not approved as a stand-alone treatment for angina, arrhythmia, or post-myocardial infarction care; those indications apply to the individual components (amlodipine, atenolol) used alone at physician-determined doses, not to this fixed-ratio combination.

Each tablet of Amlodipine Besilate + Atenolol contains amlodipine besilate equivalent to amlodipine (commonly 5 mg or 10 mg) combined with atenolol (commonly 25 mg or 50 mg), in fixed-dose combination tablets. Exact strengths vary by manufacturer and market; refer to the specific product label for the exact composition dispensed.

Fixocard combines two complementary antihypertensive mechanisms in a single tablet. Amlodipine besilate is a long-acting dihydropyridine calcium channel blocker that relaxes vascular smooth muscle and lowers peripheral vascular resistance. Atenolol is a cardioselective (beta-1 selective) adrenergic blocker that reduces heart rate, cardiac contractility, and cardiac output, and suppresses renin release.

The combination is formulated for patients whose hypertension requires more than one antihypertensive agent, allowing once-daily dosing with a single tablet after the individual component doses have been established.

Fixocard belongs to the therapeutic class of antihypertensive combination agents, specifically a Calcium Channel Blocker (dihydropyridine) combined with a Cardioselective Beta-1 Adrenergic Blocker.

Amlodipine Besilate + Atenolol exerts its antihypertensive effect through two distinct, complementary mechanisms:

• Amlodipine besilate inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle through L-type calcium channels. This produces peripheral arterial vasodilation, reducing systemic vascular resistance and blood pressure, with minimal direct effect on cardiac contractility at therapeutic doses.
• Atenolol selectively blocks beta-1 adrenergic receptors, predominantly located in the heart, reducing heart rate, myocardial contractility, cardiac output, and renin secretion from the kidney, thereby lowering blood pressure and cardiac workload.

The beta-blocker component of Amlodipine Besilate + Atenolol also blunts the reflex tachycardia that can occur with dihydropyridine calcium channel blockers when used alone, making the combination pharmacologically complementary.

Amlodipine has a long elimination half-life (approximately 30–50 hours), supporting once-daily dosing and a gradual onset/offset of action. Atenolol is predominantly excreted unchanged by the kidneys with a half-life of approximately 6–7 hours, and does not undergo significant hepatic metabolism.

Take Fixocard orally, once daily, at the same time each day, with or without food, swallowed whole with water. Do not discontinue Fixocard suddenly without medical advice.

Fixocard carries the interaction profile of both its components. Clinically significant interactions include:

• Non-dihydropyridine calcium channel blockers (verapamil, diltiazem): Concurrent use with the atenolol component of Fixocard increases the risk of severe bradycardia, AV conduction block, and worsening heart failure; avoid combining unless closely monitored by a specialist.
• Other antihypertensives, nitrates, and alpha-blockers: Additive blood-pressure-lowering and hypotensive effects when combined with Fixocard.
• Clonidine: Beta-blockers such as the atenolol component can intensify the rebound hypertension that occurs if clonidine is stopped abruptly; if both are used, clonidine should be withdrawn gradually well after discontinuing Fixocard.
• Insulin and oral antidiabetic agents: The atenolol component of Fixocard can mask the tachycardia and tremor that normally warn of hypoglycemia; blood glucose should be monitored closely.
• NSAIDs: May reduce the antihypertensive effect of Fixocard and promote fluid retention.
• Strong CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, ritonavir, clarithromycin): Can increase amlodipine plasma levels, increasing the risk of hypotension and edema from Fixocard.
• Strong CYP3A4 inducers (e.g., rifampin): Can reduce amlodipine plasma levels and blunt the antihypertensive effect of Fixocard.
• Simvastatin: The amlodipine component of Fixocard increases simvastatin exposure; simvastatin doses above 20 mg/day should generally be avoided during co-administration.
• Digoxin: Additive risk of bradycardia when combined with Fixocard; heart rate should be monitored.

Side effects of Fixocard reflect both of its components. Reporting frequency varies by individual dose and patient.

Common

• Peripheral (ankle/leg) edema — a well-recognized amlodipine-related effect
• Fatigue, tiredness, or reduced exercise tolerance
• Bradycardia (slow heart rate) and cold extremities — beta-blocker related
• Dizziness, lightheadedness, or headache
• Flushing
• Gastrointestinal upset (nausea, abdominal discomfort)

Less common but clinically important

• Symptomatic hypotension
• Worsening of heart failure symptoms
• Bronchospasm, particularly in patients with reactive airway disease (see Precautions and Warnings)
• Mood changes, sleep disturbance, or vivid dreams (beta-blocker related)
• Erectile dysfunction

Patients should seek prompt medical attention for severe dizziness, fainting, very slow heart rate, difficulty breathing, or swelling suggestive of heart failure while taking Fixocard.

Fixocard is generally not recommended during pregnancy. The atenolol component has been associated with fetal growth restriction (low birth weight), bradycardia, and hypoglycemia in the newborn when used in pregnancy, particularly if started early and continued throughout gestation. Data on the amlodipine component in human pregnancy are limited. Fixocard should be used in pregnancy only if no safer alternative is suitable and the potential benefit is judged by a physician to justify the potential risk to the fetus; women who become pregnant while taking Fixocard should contact their physician promptly to review their treatment.

Both amlodipine and atenolol pass into breast milk, and atenolol may accumulate in breast milk to a clinically relevant degree, with a risk of bradycardia and hypotension in the breastfed infant. Fixocard should be used during breastfeeding only if clearly needed, under medical supervision, with the infant monitored for signs of beta-blockade (poor feeding, lethargy, slow heart rate).

Do not stop Fixocard abruptly. Sudden discontinuation of the beta-blocker (atenolol) component can precipitate rebound hypertension, worsening angina, myocardial infarction, or life-threatening arrhythmias, particularly in patients with underlying coronary artery disease. If discontinuation is needed, the dose should be tapered gradually over one to two weeks under medical supervision.

• Diabetes mellitus: The beta-blocker component of Fixocard can mask the warning signs (tachycardia, tremor) of hypoglycemia; blood glucose should be monitored more closely.
• Asthma/COPD: Atenolol is relatively cardioselective, but this selectivity is not absolute, especially at higher doses; Fixocard should be used with caution and only when clearly necessary in patients with bronchospastic disease, with a short-acting bronchodilator readily available.
• Peripheral vascular disease: The beta-blocker component may worsen symptoms of peripheral arterial insufficiency; use Fixocard with caution and monitor for worsening claudication.
• Heart failure: Use Fixocard with caution in patients with compensated heart failure; it is contraindicated in severe, decompensated heart failure (see Contraindications).
• Peripheral edema: The amlodipine component commonly causes dose-related ankle/leg edema; this should be distinguished from edema due to worsening heart failure.
• Surgery/anesthesia: Inform the treating physician and anesthetist that the patient is taking Fixocard, as continued beta-blockade affects the response to anesthesia and blood loss.
• Renal impairment: Atenolol accumulates in renal impairment; individual component dosing rather than this fixed combination is preferred in such patients (see Dosage and Administration).

Overdose of Fixocard can cause profound hypotension, marked bradycardia, cardiac conduction disturbances (AV block), cardiogenic shock, and, from the amlodipine component, excessive peripheral vasodilation with reflex tachycardia; bronchospasm and hypoglycemia may also occur due to the beta-blocker component.

Suspected overdose of Fixocard is a medical emergency. Seek immediate medical attention or contact emergency services/a poison control center right away. Do not attempt to manage a suspected overdose at home. Treatment is supportive and will be directed by medical professionals, and may include cardiac monitoring, intravenous fluids, and specific agents to reverse severe bradycardia or hypotension as clinically indicated.

Store at room temperature (below 30°C), away from light and moisture. Keep out of reach of children.

• Elderly: Fixocard can generally be used in elderly patients, who may be more sensitive to blood-pressure-lowering and heart-rate-lowering effects; monitor closely, especially at treatment initiation or dose changes.
• Renal impairment: Not generally recommended as a fixed combination in significant renal impairment because the atenolol component requires dose/interval adjustment; individual component titration is preferred (see Dosage and Administration).
• Hepatic impairment: The amlodipine component is hepatically metabolized and may require a lower starting dose; individual component titration is generally preferred over starting with the fixed combination.
• Diabetes: Use Fixocard with caution; the beta-blocker component can mask symptoms of hypoglycemia (see Precautions and Warnings).
• Pregnancy and lactation: See Pregnancy and Lactation section — use only if clearly needed and under close medical supervision.
• Children: See Pediatric Uses.

Fixocard is typically used long-term for chronic management of hypertension, for as long as the treating physician determines it is needed and well tolerated. It should not be stopped or the dose changed without medical advice, and blood pressure and heart rate should be periodically reviewed by the prescribing physician.

Calcium Channel Blocker (Dihydropyridine) + Cardioselective Beta-1 Adrenergic Blocker (fixed-dose antihypertensive combination)

Amlodipine Besilate + Atenolol lowers blood pressure through two complementary mechanisms acting together:

• Amlodipine besilate blocks L-type calcium channels in vascular smooth muscle, reducing calcium influx and causing arterial vasodilation, which lowers peripheral vascular resistance and blood pressure.
• Atenolol selectively blocks cardiac beta-1 adrenergic receptors, reducing heart rate, myocardial contractility, cardiac output, and renin release, further lowering blood pressure and reducing myocardial oxygen demand.

The beta-blocker component also counteracts the mild reflex tachycardia that can occur with dihydropyridine calcium channel blockers used alone, giving Amlodipine Besilate + Atenolol a complementary, additive antihypertensive effect.

Amlodipine component: Category C. Atenolol component: Category D (legacy FDA pregnancy categories).

The safety and efficacy of Fixocard have not been established in children and adolescents. This fixed-dose combination is not recommended for pediatric use; if antihypertensive therapy is needed in a child, a physician should select and individually dose age-appropriate agents rather than this adult combination product.