LISORIL ( TABLET ) ( 2.5 mg )

Oral tablet: You should check with your doctor immediately if any of these side effects occur when taking lisinopril:

More common

• Blurred vision
• cloudy urine
• confusion
• decrease in urine output or decrease in urine-concentrating ability
• dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
• sweating
• unusual tiredness or weakness

Less common

• Abdominal or stomach pain
• body aches or pain
• chest pain
• chills
• common cold
• cough
• diarrhea
• difficulty breathing
• ear congestion
• fever
• headache
• loss of voice
• nasal congestion
• nausea
• runny nose
• sneezing
• sore throat
• vomiting
• Arm, back, or jaw pain
• chest discomfort, tightness, or heaviness
• fast or irregular heartbeat
• general feeling of discomfort or illness
• joint pain
• loss of appetite
• muscle aches and pains
• shivering
• trouble sleeping

AU TGA pregnancy category: D

US FDA pregnancy category: D

Adequate methods of contraception should be encouraged.

Animal and human data have revealed evidence of embryolethality and teratogenicity associated with angiotensin converting enzyme (ACE) inhibitors. When pregnancy is detected, ACE inhibitors should be discontinued as soon as possible. If no alternative to ACE inhibitor therapy is available, patients should be made aware of the risks to their fetuses and the intra-amniotic environment should be evaluated by serial ultrasound examinations.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

A decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. ACE inhibitors have the potential to adversely affect a nursing infant.

Hypertension

Adult

Initial dose: 10 mg orally once a day; 5 mg orally once a day

Maintenance dose: 20 to 40 mg orally once a day

Maximum dose: 80 mg orally once a day

Comments:

• The initial dose is 5 mg orally once a day in patients receiving a diuretic.
• The 80 mg dose is used but does not appear to give greater effect.
• If blood pressure is not controlled with lisinopril alone, a low dose of a diuretic may be added (e.g., hydrochlorothiazide, 12.5 mg). After the addition of a diuretic, it may be possible to reduce the dose of lisinopril.

Congestive Heart Failure

Adult

Initial dose: 2.5 to 5 mg orally once a day

Maintenance dose: Dosage should be increased as tolerated

Maximum dose: 40 mg orally once a day

Comments:

• The diuretic dose may need to be adjusted to help minimize hypovolemia, which may contribute to hypotension. The appearance of hypotension after the initial dose of lisinopril does not preclude subsequent careful dose titration with the drug.

Myocardial Infarction

Adult

Initial dose: 5 mg orally (within 24 hours of the onset of acute myocardial infarction)

Subsequent doses: 5 mg orally after 24 hours, then 10 mg orally after 48 hours.

Maintenance dose: 10 mg orally once a day. Dosing should continue for at least 6 weeks.

Comments:

• Therapy should be initiated at 2.5 mg in patients with a low systolic blood pressure (less than or equal to 120 mm Hg and greater than 100 mmHg) during the first 3 days after the infarct. If prolonged hypotension occurs (systolic blood pressure less than 90 mmHg for more than 1 hour) therapy should be withdrawn.

Diabetic Nephropathy

Adult

Initial dose: 10 to 20 mg orally once a day

Maintenance dose: 20 to 40 mg orally once a day

Dosage may be titrated upward every 3 days

Usual Geriatric Dose for Hypertension

Initial dose: 2.5 to 5 mg orally once a day

Maintenance dose: Dosages should be increased at 2.5 mg to 5 mg per day at 1 to 2 week intervals.

Maximum dose: 40 mg orally once a day

Usual Pediatric Dose for Hypertension

Pediatric patients greater than or equal to 6 years of age:

Initial dose: 0.07 mg/kg orally once a day (Maximum initial dose is 5 mg once a day)

Maintenance dose: Dosage should be adjusted according to blood pressure response at 1 to 2 week intervals.

Maximum dose: Doses above 0.61 mg/kg or greater than 40 mg have not been studied in pediatric patients

Comments:

-This drug is not recommended in pediatric patients less than 6 years old or in pediatric patients with glomerular filtration rate less than 30 mL/min.