Lopressor HCT

Lopressor HCT is a prescription medication used to treat high blood pressure.

Lopressor HCT is a single product containing 2 medications: metoprolol and hydrochlorothiazide. Metoprolol belongs to a group of drugs called beta blockers, which work by relaxing blood vessels and slowing heart rate. This improves blood flow and decreases overall blood pressure. Hydrochlorothiazide belongs to a group of drugs called thiazide diuretics, which work by stopping reabsorption of salt into your body. This prevents fluid from building up in the body.

This medication comes in tablet form and can be given once or twice daily with or immediately following meals. 

Common side effects of Lopressor HCT include slow heart rate and headache. Lopressor HCT can also cause dizziness, drowsiness, and blurred vision. Do not drive or operate heavy machinery until you know how Lopressor HCT affects you. 

• Novartis Pharmaceuticals Corporation

• Validus Pharmaceuticals, Inc.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Lopressor HCT falls into category C. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child. 

Appropriate studies have not been performed on the relationship of age to the effects of metoprolol and hydrochlorothiazide combination in the pediatric population. Safety and efficacy have not been established.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Chest pain or discomfort
• convulsions
• decreased urine
• dry mouth
• increased thirst
• lightheadedness, dizziness, or fainting
• loss of appetite
• mood changes
• muscle pain or cramps
• nausea or vomiting
• numbness or tingling in the hands, feet, or lips
• slow or irregular heartbeat
• unusual tiredness or weakness

• Ankle, knee, or great toe joint pain
• decreased ability to exercise
• difficult or labored breathing
• joint stiffness or swelling
• lower back or side pain
• swelling of the face, fingers, feet, or lower legs
• tightness in the chest

Get emergency help immediately if any of the following symptoms of overdose occur:

• Blurred vision
• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings
• chemical imbalance in the blood
• cold, clammy skin
• coma
• confusion
• cough
• dilated neck veins
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• drowsiness
• extreme fatigue
• fast or pounding heartbeat or pulse
• frequent urination
• headache
• increased volume of pale, dilute urine
• irregular breathing
• irritability
• noisy breathing
• not able to pass urine
• pain or aching in the lower legs
• pain or weakness in the hands or feet
• seizures
• sweating
• trembling
• unconsciousness
• very drowsy or sleepy
• weak pulse
• weakness and heaviness of the legs
• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Chills
• diarrhea
• feeling of constant movement of self or surroundings
• fever
• general feeling of discomfort or illness
• muscle aches
• nightmares
• runny nose
• sensation of spinning
• shivering
• sleepiness
• sore throat
• trouble sleeping
• unusual drowsiness, dullness, or feeling of sluggishness

• Continuing ringing or buzzing or other unexplained noise in the ears
• decreased interest in sexual intercourse
• difficulty having a bowel movement (stool)
• earache
• hearing loss
• inability to have or keep an erection
• loss in sexual ability, desire, drive, or performance
• pinpoint red or purple spots on the skin
• weight loss

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Dizziness.
• Headache.
• Loose stools (diarrhea).
• Feeling sleepy.
• Flu-like signs.
• Feeling tired or weak.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about Lopressor HCT, please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Lopressor HCT. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using Lopressor HCT.

Review Date: October 4, 2017

Lopressor

Cardiac Failure: Sympathetic stimulation is a vital component supporting circulatory function in congestive heart failure, and beta blockade carries the potential hazard of further depressing myocardial contractility and precipitating more severe failure. In hypertensive patients who have congestive heart failure controlled by digitalis and diuretics, Lopressor should be administered cautiously.

In Patients Without a History of Cardiac Failure: Continued depression of the myocardium with beta-blocking agents over a period of time can, in some cases, lead to cardiac failure. At the first sign or symptom of impending cardiac failure, patients should be fully digitalized and/or given a diuretic. The response should be observed closely. If cardiac failure continues, despite adequate digitalization and diuretic therapy, Lopressor should be withdrawn.

Bronchospastic Diseases: PATIENTS WITH BRONCHOSPASTIC DISEASES SHOULD, IN GENERAL, NOT RECEIVE BETA BLOCKERS, including Lopressor HCT. Because of its relative beta1 selectivity, however, Lopressor may be used with caution in patients with bronchospastic disease who do not respond to, or cannot tolerate, other antihypertensive treatment. Since beta1 selectivity is not absolute, a beta2-stimulating agent should be administered concomitantly, and the lowest possible dose of Lopressor should be used. In these circumstances it would be prudent initially to administer Lopressor in smaller doses three times daily, instead of larger doses two times daily, to avoid the higher plasma levels associated with the longer dosing interval (see DOSAGE AND ADMINISTRATION).

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

Diabetes and Hypoglycemia: Lopressor should be used with caution in diabetic patients if a beta-blocking agent is required. Beta blockers, including Lopressor HCT, may mask tachycardia occurring with hypoglycemia, but other manifestations such as dizziness and sweating may not be significantly affected. Selective beta blockers do not potentiate insulin-induced hypoglycemia and, unlike nonselective beta blockers, do not delay recovery of blood glucose to normal levels.

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. Administration of beta blockers alone in the setting of pheochromocytoma has been associated with a paradoxical increase in blood pressure due to the attenuation of beta-mediated vasodilatation in skeletal muscle.

Thyrotoxicosis: Beta-adrenergic blockade may mask certain clinical signs (e.g., tachycardia) or hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta blockade, which might precipitate a thyroid storm.

Hydrochlorothiazide

Thiazides should be used with caution in patients with severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.

Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte imbalance may precipitate hepatic coma.

Thiazides may add to or potentiate the action of other antihypertensive drugs. Potentiation occurs with ganglionic or peripheral adrenergic blocking drugs.

Sensitivity reactions are more likely to occur in patients with a history of allergy or bronchial asthma.

The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.

Acute Myopia and Secondary Angle-Closure Glaucoma: Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.

Dosage should be determined by individual titration (see INDICATIONS AND USAGE).

Hydrochlorothiazide is usually given at a dosage of 12.5 to 50 mg per day. The usual initial dosage of Lopressor is 100 mg daily in single or divided doses. Dosage may be increased gradually until optimum blood pressure control is achieved. The effective dosage range is 100 to 450 mg per day. While once-daily dosing is effective and can maintain a reduction in blood pressure throughout the day, lower doses (especially 100 mg) may not maintain a full effect at the end of the 24-hour period, and larger or more frequent daily doses may be required. This can be evaluated by measuring blood pressure near the end of the dosing interval to determine whether satisfactory control is being maintained throughout the day. Beta1 selectivity diminishes as dosage of Lopressor is increased.

The following dosage schedule may be used to administer from 100 to 200 mg of Lopressor per day and from 25 to 50 mg of hydrochlorothiazide per day:

Dosing regimens that exceed 50 mg of hydrochlorothiazide per day are not recommended. When necessary, another antihypertensive agent may be added gradually, beginning with 50% of the usual recommended starting dose to avoid an excessive fall in blood pressure.

Tablets 50/25 - capsule-shaped, white and mottled-blue, scored (imprinted Geigy on one side and 35 twice on the scored side), 50 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide
    Bottles of 100..........................................NDC 30698-460-01

Tablets 100/25 - capsule-shaped, white and mottled-pink, scored (imprinted Geigy on one side and 53 twice on the scored side), 100 mg of metoprolol tartrate and 25 mg of hydrochlorothiazide
    Bottles of 100..........................................NDC 30698-461-01

Tablets 100/50 - capsule- shaped, white and mottled-yellow, scored (imprinted Geigy on one side and 73 twice on the scored side), 100 mg of metoprolol tartrate and 50 mg of hydrochlorothiazide
    Bottles of 100..........................................NDC 30698-462-01

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Protect from moisture.

Dispense in tight, light-resistant container (USP).

To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-9VALIDUS (1-866-982-5438) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

Distributed by:
Validus Pharmaceuticals LLC
Parsippany, New Jersey 07054
info@validuspharma.com
www.validuspharma.com
1-866-9VALIDUS

© 2012 Validus Pharmaceuticals LLC

October 2012

463000-01

PRINCIPAL DISPLAY PANEL - 50/25 mg Tablet

NDC 30698-460-01

Lopressor HCT®
metoprolol tartrate USP 50 mg
hydrochlorothiazide USP 25 mg

50/25 mg
100 Tablets

Rx Only