WHAT ARE THE SIDE EFFECTS OF LOPRESSOR® (METOPROLOL TARTRATE) TABLETS?

Tell your doctor or pharmacist as soon as possible if you do not feel well while taking Lopressor® (metoprolol tartrate) Tablets.

As with all medicines, patients treated with Lopressor can have side effects, although not everyone gets them. Sometimes they are serious but most of the time they are not. You may need medical attention if you experience these side effects.

Do not be alarmed by this list of possible side effects. Lopressor is generally
well tolerated and you may not experience any of them.

You doctor or pharmacist can answer any questions you may have.

Get immediate medical help if you notice any of the following side effects:

  • Blurred vision
  • Chest pain or discomfort
  • Dizziness, faintness or lightheadedness when getting up suddenly from a lying or sitting position
  • Shortness of breath
  • Slow or irregular heartbeat
  • Sweating
  • Unusual tiredness or weakness
  • Unexplained weight gain
  • Mental/mood changes (such as confusion, depression, mood swings)

A very serious allergic reaction to Lopressor is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including rash, itching/swelling (especially of the face, tongue or throat), severe dizziness, or trouble breathing.

The following is a list of side effects that are less common, but should they occur, tell your doctor immediately:

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • Cough
  • Decreased urine output
  • Difficult or labored breathing
  • Difficulty with speaking
  • Dilated neck veins
  • Disturbed color perception
  • Double vision
  • Extreme fatigue
  • Fast, pounding, or racing heartbeat or pulse
  • Halos around lights
  • Severe headache
  • Inability to move the arms, legs, or facial muscles
  • Inability to speak
  • Irregular breathing
  • Loss of vision
  • Night blindness
  • Noisy breathing
  • Over-bright appearance of lights
  • Pain, tension, and weakness upon waking that subsides during periods of rest
  • Paleness or cold feeling in fingers and toes
  • Rapid weight gain
  • Seeing, feeling or hearing things that are not there
  • Short-term memory loss
  • Slow speech
  • Tightness in the chest
  • Tingling of the hands or feet
  • Tingling or pain in the fingers when exposed to cold
  • Troubled breathing
  • Tunnel vision
  • Unusual weight gain or loss
  • Blush color skin of the fingers or toes
  • Chills
  • Clay-colored stools
  • Continuing loss of appetite
  • Continuing or severe abdominal or stomach pain
  • Continuing or severe nausea and vomiting
  • Dark urine
  • Difficuly with moving
  • Fever
  • General tiredness and weakness
  • Hoarseness
  • Increased frequency of urination
  • Itching skin
  • Light-colored stools
  • Lower back or side pain
  • Muscle pain or stiffness
  • Numbness of the fingers or toes
  • Pain, swelling, or redness in the joints
  • Rash
  • Sore throat
  • Sores, ulcers, or white spots on the lips or in the mouth
  • Unpleasant breath odor
  • Unusual bleeding or bruising
  • Upper right abdominal or stomach pain
  • Vomiting of blood
  • Weakness
  • Yellow eyes and skin

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to Validus Pharmaceuticals LLC at 1-866-982-5438.

OVERDOSAGE:

Get emergency medical help immediately if any of the following symptoms of overdose occur while taking Lopressor:

  • Bluish color of the fingernails, lips, skin, palms, or nail beds
  • Change in consciousness
  • Loss of consciousness
  • No blood pressure or pulse
  • Stopping of the heart
  • Unconsciousness
  • Very drowsy or sleepy

Seek emergency medical attention or call the Poison Help Line at 1-800-222-1222.

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IMPORTANT SAFETY INFORMATION

Download Full Prescribing Information

Lopressor® (metoprolol tartrate) 50mg and 100mg Tablets

CONTRAINDICATIONS

Lopressor® (metoprolol tartrate) Tablets are contraindicated in patients with hypertension and angina, particularly in sinus bradycardia, certain types of heart blockages (greater than first degree), cardiogenic shock, and obvious cardiac failure. Hypersensitivity to Lopressor and related derivatives, or to any of the excipients, or to other beta-blockers can occur.

Sick sinus syndrome, which may result in irregular heartbeat, can occur, as can severe peripheral arterial circulatory disorders.

Myocardial Infarction

Lopressor is contraindicated in patients having a heart rate <45 beats per minute; second-and third-degree heart block; significant first-degree heart block (P-R interval >0.24 sec), systolic blood pressure <100mmHg, or moderate-to-severe heart failure.

WARNINGS AND PRECAUTIONS

Heart Failure

Beta-blocker(s), like Lopressor, may precipitate heart failure and cardiogenic shock. If this occurs, it may be necessary to lower the dose of Lopressor or discontinue it.

Ischemic Heart Disease

Do not abruptly discontinue Lopressor therapy in patients with coronary artery disease. Severe exacerbation of angina, myocardial infarction and ventricular arrhythmias have been reported in patients with coronary artery disease following the abrupt discontinuation of therapy with beta-blockers. When discontinuing chronically administered Lopressor, particularly in patients with coronary artery disease, the dosage should be gradually reduced over a period of 1-2 weeks and the patient should be carefully monitored. If angina markedly worsens or acute coronary insufficiency develops, Lopressor administration should be reinstated promptly, at least temporarily, and other measures appropriate for the management of unstable angina should be taken. Patients should be warned against interruption or discontinuation of therapy without the physician’s advice. Because coronary artery disease is common and may be unrecognized, it may be prudent not to discontinue Lopressor therapy abruptly even in patients treated only for hypertension.

Use During Major Surgery

Chronically administered beta-blocking therapy should not be withdrawn prior to major surgery; however, the impaired ability of the heart to respond to reflex adrenergic stimuli may increase the risks of general anesthesia and surgical procedures.

Bradycardia

Bradycardia, including sinus pause, heart block, and cardiac arrest have occurred with the use of Lopressor. Patients with first-degree atrioventricular block, sinus node dysfunction, or conduction disorders may be at increased risk.

Exacerbation of Bronchospastic Disease

Patients with bronchospastic disease should not generally receive beta blockers. However, because of its relative beta1 selectivity, Lopressor may be used in patients with bronchospastic disease who do not respond to, or who cannot tolerate, other antihypertensive treatment.

Diabetes and Hypoglycemia

Beta-blockers may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected.

Pheochromocytoma

If Lopressor is used in the setting of pheochromocytoma, it should be given in combination with an alpha blocker, and only after the alpha blocker has been initiated.

Thyrotoxicosis

Lopressor may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Avoid abrupt withdrawal of beta-blockade, which might precipitate a thyroid storm.

Risk of Anaphylactic Reactions

While taking beta-blockers, patients with a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated challenge, either accidental, diagnostic, or therapeutic. Such patients may be unresponsive to the usual doses of epinephrine used to treat allergic reaction.

Drug Interactions

Catecholamine-depleting drugs (e.g., reserpine) may have an additive effect when given with beta-blocking agents or monoamine oxidase (MAO) inhibitors. Both digitalis glycosides and beta-blockers slow atrioventricular conduction and decrease heart rate. Concomitant use can increase the risk of bradycardia. Concomitant administration of a beta-adrenergic antagonist with a calcium channel blocker may produce an additive reaction in myocardial contractility because of negative chronotropic and inotropic effects. Potent inhibitors of the CYP2D6 enzyme may increase plasma concentration of Lopressor. Concomitant administration of hydralazine may inhibit presystemic metabolism of metoprolol leading to increased concentrations of metoprolol. Lopressor may increase the hypertensive effects of alpha-adrenergic blockers. Concomitant administration with beta-blockers may enhance the vasoconstrictive action of ergot alkaloids. In general, administration of beta-blockers should be withheld before dipyridamole testing, with careful monitoring of heart rate following the dipyridamole injection.

Pregnancy Category C

Upon confirming the diagnosis of pregnancy, women should immediately inform their doctor. The amount of data on the use of Lopressor in pregnant women is limited. Lopressor is excreted in breast milk in very small quantities.

Pediatric and Geriatric use of Lopressor has not been studied.

Adverse Reactions

Hypertension and Angina: Most adverse effects have been mild and transient.

Central Nervous System: Tiredness and dizziness have occurred in about 10% of patients.

Cardiovascular: Shortness of breath and bradycardia has occurred in about 3% of patients.

Respiratory: Wheezing and dyspnea have been reported in about 1% of patients.

Gastrointestinal: Diarrhea has occurred in about 5% of patients.

Hypersensitive Reactions: Pruritis or rash has occurred in about 5% of patients.

Overdosage

Acute Toxicity: Several cases of overdosage have been reported, some leading to death.

Signs and Symptoms: Potential signs and symptoms associated with Lopressor overdose are bradycardia, hypotension, bronchospasm, myocardial infarction, cardiac failure, and death. There is no specific antidote.

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals, LLC at — VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch