Toprol XL

Prescription Drug Information: Toprol

Generic Name: Metoprolol

Toprol XL contains the active ingredient metoprolol succinate, which is a selective Beta-1 adrenergic receptor antagonist. Toprol XL is used for the treatment of cardiac indications such as hypertension, angina pectoris and heart failure. Toprol XL is an extended release formulation prescribed for once daily administration.

Indication/Usage: Toprol XL is approved for the treatment of various cardiac indications as follows:

• Hypertension: Toprol XL is primarily indicated for the treatment of hypertension (high blood pressure) as monotherapy or in combination with other antihypertensive drugs.
• Angina pectoris: Toprol XL is indicated as a long-term therapy for angina pectoris. It helps reduce angina attacks and improves exercise tolerance.
• Heart failure: Toprol XL is also indicated in the treatment of stable, symptomatic (NYHA Class II or III) heart failure originated from ischemia, hypertension, or cardiac myopathy.

Toprol XL was studied in patients receiving ACE inhibitors, diuretics and digitalis. In such patients, cardiovascular mortality rates and instances of heart failure hospitalization were decreased.

Dose, Administration and Dosage Forms: Toprol XL is available as extended release tablets in 25 mg, 50 mg, 100 mg, and 200 mg strengths. Extended release tablets are formulated as a multiple unit system containing the active ingredient in a matrix of controlled release pellets. Each of these pellets behaves as an individual drug delivery unit which constantly delivers metoprolol succinate. The recommended dose of Toprol XL for the treatment of hypertension is 100 mg to 450 mg daily in single or divided doses and 100 mg to 400 mg daily in two divided doses for angina pectoris. Toprol XL must be taken before meals or at bedtime. It should be stored between 15 C-30 C in a moisture free environment in a light-resistant container.

Mechanism of Action: Toprol XL contains metoprolol succinate which is a selective ?-1 (cardio selective) adrenergic receptor blocking agent. By blocking these receptors it reduces the contraction force of cardiac muscles leading to suppressed blood pressure. In addition to reducing the force of muscular contractions, Toprol XL also reduces heart rate and oxygen demand in the heart muscles, thereby decreasing incidents of angina pectoris where the oxygen demand in cardiac muscles exceeds the oxygen supply.

Side-effects and Safety Profile: Various mild and transient side-effects reported with Toprol XL clinical trials include: tiredness, decreased heart rates, dizziness, headache, diarrhea, dyspnea, rash, heart failure, depression, and vertigo, etc.

Various post-operative side-effects reported with Toprol XL are bradycardia, hypotension, and stroke.

Toprol XL side-effects reported during post-marketing studies include: agranulocytosis, anxiety, arterial insufficiency, arthralgia, blurred vision, bronchospasm, chest pain, constipation, confused mental state, cold extremities, dry mouth, decreased libido, dry eyes, flatulence, hallucinations, hypotension, heartburn, hepatitis, insomnia, male impotency, musculoskeletal pain, nausea, nightmares, palpitations, peripheral edema, photosensitivity, pruritus, paresthesia, reversible alopecia, short-term memory loss, somnolence, syncope, sweating, taste disturbance, tinnitus, vomiting, worsening of psoriasis, wheezing, etc.

Warnings and Contraindications:

• Toprol XL is contraindicated in patients with known allergies to metoprolol.
• Toprol XL is contraindicated in patients with conditions like severe bradycardia, cardiogenic shock, heart block over first degree, sick sinus syndrome without pacemaker, and decompensated heart failure.
• Ischemic heart disease: Toprol XL must be gradually withdrawn over a period of one to two weeks after chronic treatment especially in patients with ischemic heart disease.
• Heart failure: Worsening of heart failure has been reported with Toprol XL dosage up-titration. In such cases, diuretics doses must be increased until clinical stability is restored. Toprol XL dose may be necessarily decreased or temporarily withdrawn.
• Bronchospastic disease: Patients with a history of bronchospastic diseases must not be prescribed Toprol XL.
• Pheochromocytoma: Toprol XL should be prescribed in pheochromocytoma in combination with an alpha blocker, since Toprol XL monotherapy in pheochromocytoma has been reported to cause a paradoxical increase in blood pressure due to attenuation of beta-mediated vasodilatation in skeletal muscles.
• Toprol XL is classified as a pregnancy category C drug, which means metoprolol has been shown to cause fetal harm in preclinical studies (post-implantation loss and decreased neonatal survival in rats). Toprol XL has not yet been studied in clinical trials; therefore, it should be used in pregnant women only if the potential benefit justifies the potential risk to the fetus.
• Nursing mothers: Metoprolol is reported to be excreted via breast milk; therefore, it must not be prescribed to nursing women as it may harm feeding baby.

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