Furosemide Tablets

• It is used to get rid of extra fluid.
• It is used to treat high blood pressure.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of fluid and electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, very bad dizziness or passing out, fast heartbeat, more thirst, seizures, feeling very tired or weak, not hungry, unable to pass urine or change in the amount of urine produced, dry mouth, dry eyes, or very bad upset stomach or throwing up.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• Signs of a pancreas problem (pancreatitis) like very bad stomach pain, very bad back pain, or very bad upset stomach or throwing up.
• Very bad dizziness or passing out.
• A burning, numbness, or tingling feeling that is not normal.
• Not able to pass urine or change in how much urine is passed.
• Feeling very tired or weak.
• Any unexplained bruising or bleeding.
• Fever or chills.
• Sore throat.
• Hearing problems like lowered hearing and loss of hearing have happened with this medicine. Sometimes this may go away but sometimes it may not. Call your doctor right away if you have ringing in the ears or any change in your hearing.

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:

• Hard stools (constipation).
• Loose stools (diarrhea).
• Dizziness.
• Upset stomach or throwing up.
• Headache.

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.

• Store at room temperature.
• Protect from light.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Edema

FUROSEMIDE TABLET is indicated in adults and pediatric patients for the treatment of edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome. FUROSEMIDE TABLET is particularly useful when an agent with greater diuretic potential is desired.

Hypertension

Oral FUROSEMIDE TABLET may be used in adults for the treatment of hypertension alone or in combination with other antihypertensive agents. Hypertensive patients who cannot be adequately controlled with thiazides will probably also not be adequately controlled with Furosemide Tablets alone.

Adverse reactions are categorized below by organ system and listed by decreasing severity.

Gastrointestinal System Reactions

• hepatic encephalopathy in patients with hepatocellular insufficiency
• pancreatitis
• jaundice (intrahepatic cholestatic jaundice)
• increased liver enzymes
• anorexia
• oral and gastric irritation
• cramping
• diarrhea
• constipation
• nausea
• vomiting

Systemic Hypersensitivity Reactions

• Severe anaphylactic or anaphylactoid reactions (e.g. with shock)
• systemic vasculitis
• interstitial nephritis
• necrotizing angiitis

Central Nervous System Reactions

• tinnitus and hearing loss
• paresthesias
• vertigo
• dizziness
• headache
• blurred vision
• xanthopsia

Hematologic Reactions

• aplastic anemia
• thrombocytopenia
• agranulocytosis
• hemolytic anemia
• leukopenia
• anemia
• eosinophilia

Dermatologic-Hypersensitivity Reactions

• toxic epidermal necrolysis
• Stevens-Johnson Syndrome
• erythema multiforme
• drug rash with eosinophilia and systemic symptoms
• acute generalized exanthematous pustulosis
• exfoliative dermatitis
• bullous pemphigoid
• purpura
• photosensitivity
• rash
• pruritus
• urticaria

Cardiovascular Reaction

• Orthostatic hypotension may occur and be aggravated by alcohol, barbiturates or narcotics.
• Increase in cholesterol and triglyceride serum levels

Other Reactions

• hyperglycemia
• glycosuria
• hyperuricemia
• muscle spasm
• weakness
• restlessness
• urinary bladder spasm
• thrombophlebitis
• fever

Whenever adverse reactions are moderate or severe, FUROSEMIDE TABLET dosage should be reduced or therapy withdrawn.

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088 OR LEADING PHARMA, LLC AT 1-844-740-7500

Edema

Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.

Adults--The usual initial dose of FUROSEMIDE TABLET is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (eg, at 8 am and 2 pm). The dose of FUROSEMIDE TABLET may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.

Edema may be most efficiently and safely mobilized by giving FUROSEMIDE TABLET on 2 to 4 consecutive days each week.

When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable. (See PRECAUTIONS: Laboratory Tests.)

Geriatric patients--In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).

Pediatric patients--The usual initial dose of oral FUROSEMIDE TABLET in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.

Hypertension

Therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.

Adults-- The usual initial dose of Furosemide Tablets for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when FUROSEMIDE TABLET is used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when FUROSEMIDE TABLET is added to the regimen. As the blood pressure falls under the potentiating effect of FUROSEMIDE TABLET, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

Geriatric patients-- In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).

Furosemide Tablets 20 mg are supplied as white to off-white, round, flat face beveled edge, compressed tablets, debossed "EP" and "116" on one side and plain on the other.

Furosemide Tablets 40 mg are supplied as white, round, scored tablets.  The 40 mg tablets are imprinted with "EP 117" on one side and "40" on the other.

Note: Dispense in well-closed, light-resistant containers. Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.

Store at 25° C (77° F); excursions permitted to 15 to 30° C (59 to 86° F). [See USP Controlled Room Temperature.]

Repackaged by

Aidarex Pharmaceuticals, LLC

Corona, CA 92880

Mfd. by:Leading Pharma, LLC

Fairfield, NJ 07004