Furosemide (Page 3 of 4)

Adverse Reactions to Furosemide

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

Gastrointestinal System Reactions

  1. hepatic encephalopathy in patients with hepatocellular insufficiency
  2. pancreatitis
  3. jaundice (intrahepatic cholestatic jaundice)
  4. increased liver enzymes
  5. anorexia
  6. oral and gastric irritation
  7. cramping
  8. diarrhea
  9. constipation
  10. nausea
  11. vomiting

Systemic Hypersensitivity Reactions

  1. severe anaphylactic or anaphylactoid reactions (e.g. with shock)
  2. systemic vasculitis
  3. interstitial nephritis
  4. necrotizing angiitis

Central Nervous System Reactions

  1. tinnitus and hearing loss
  2. paresthesias
  3. vertigo
  4. dizziness
  5. headache
  6. blurred vision
  7. xanthopsia

Hematologic Reactions

  1. aplastic anemia
  2. thrombocytopenia
  3. agranulocytosis
  4. hemolytic anemia
  5. leukopenia
  6. anemia
  7. eosinophilia

Dermatologic-Hypersensitivity Reactions

  1. toxic epidermal necrolysis
  2. Stevens-Johnson Syndrome
  3. erythema multiforme
  4. drug rash with eosinophilia and systemic symptoms
  5. acute generalized exanthematous pustulosis
  6. exfoliative dermatitis
  7. bullous pemphigoid
  8. purpura
  9. photosensitivity
  10. rash
  11. pruritis
  12. urticaria

Cardiovascular Reaction

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

Other Reactions

  1. hyperglycemia
  2. glycosuria
  3. hyperuricemia
  4. muscle spasm
  5. weakness
  6. restlessness
  7. urinary bladder spasm
  8. thrombophlebitis
  9. fever

Whenever adverse reactions are moderate or severe, furosemide dosage should be reduced or therapy withdrawn.

OVERDOSAGE

The principal signs and symptoms of overdose with furosemide are dehydration, blood volume reduction, hypotension, electrolyte imbalance, hypokalemia and hypochloremic alkalosis, and are extensions of its diuretic action.

The acute toxicity of furosemide has been determined in mice, rats and dogs. In all three, the oral LD50 exceeded 1000 mg/kg body weight, while the intravenous LD50 ranged from 300 to 680 mg/kg. The acute intragastric toxicity in neonatal rats is 7 to 10 times that of adult rats.

The concentration of furosemide in biological fluids associated with toxicity or death is not known.

Treatment of overdosage is supportive and consists of replacement of excessive fluid and electrolyte losses. Serum electrolytes, carbon dioxide level and blood pressure should be determined frequently. Adequate drainage must be assured in patients with urinary bladder outlet obstruction (such as prostatic hypertrophy).

Hemodialysis does not accelerate furosemide elimination.

DOSAGE AND ADMINISTRATION

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 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 (e.g., at 8 am and 2 pm). The dose of furosemide 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 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 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 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 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 is added to the regimen. As the blood pressure falls under the potentiating effect of furosemide, 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).

HOW SUPPLIED

Repackaged by A-S Medication Solutions — Libertyville, IL
See REPACKAGING INFORMATION for available configurations.

A-S Medication Solutions
(click image for full-size original)

Furosemide tablets, USP, for oral administration, are available as:

20 mg: round, white, scored tablets, debossed GG 21 on one side and plain on the reverse side, and supplied as:

NDC 0781-1818-01 bottles of 100

NDC 0781-1818-05 bottles of 500

NDC 0781-1818-10 bottles of 1000

40 mg: round, white, scored tablets, debossed GG 201 on one side and plain on the reverse side, and supplied as:

NDC 0781-1966-60 bottles of 60

NDC 0781-1966-01 bottles of 100

NDC 0781-1966-05 bottles of 500

NDC 0781-1966-10 bottles of 1000

80 mg: round, white, scored tablets, debossed GG 80 on one side and plain on the reverse side, and supplied as:

NDC 0781-1446-01 bottles of 100

NDC 0781-1446-05 bottles of 500

Exposure to light might cause a slight discoloration. Discolored tablets should not be dispensed.

Store at 20°-25°C (68°-77°F) (see USP Controlled Room Temperature).

Dispense in a tight, light-resistant container.

05-2012M

1275

Sandoz Inc.

Princeton, NJ 08540

REPACKAGING INFORMATION

Please reference the HOW SUPPLIED section listed above for a description of individual tablets or capsules. This drug product has been received by A-S Medication Solutions — Libertyville, IL in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from A-S Medication Solutions are listed below:

NDC#Count Strength
50090-0150-010080 mg
50090-0150-13080 mg
50090-0152-03020 mg
50090-0152-110020 mg
50090-0152-720020 mg
50090-0152-89020 mg
50090-0154-03040 mg
50090-0154-110040 mg
50090-0154-21540 mg
50090-0154-36040 mg
50090-0154-99040 mg

Repackaged by:

A-S Medication Solutions
(click image for full-size original)

Libertyville, IL 60048

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