What Is The Maximum Daily Dose Of Lisinopril?
In our latest question and answer, the pharmacist discusses the maximuim daily dose of the blood pressure medication lisinopril.
How much lisinopril okay to take? Is there a maximum amount that is allowed daily?
Most drugs, including lisinopril, have a defined 'maximum daily dose' (MDD), which is principally based on the amount that was utilized during clinical trials.
Once a drug is approved by the FDA (Food and Drug Administration), the complete dosage recommendations, along with the maximum daily dose, are published in the drugs 'prescribing information'. For lisinopril, the prescribing information can be found via the FDA website.
You may see the 'MDD' sometimes referred to as the 'MRDD', meaning 'maximum recommended daily dose', which is defined as:
"Maximum recommended daily dose (or maximum recommended therapeutic dose) values were determined from pharmaceutical clinical trials that employed an oral route of exposure and daily treatments, usually for 3-12 months."
One way to think of a 'maximum daily dose' is that it is an estimate of the upper limit beyond which the benefits of a drug don't outweigh the risk of adverse reactions.
It is important to point out that even though the FDA approves drugs based on specific dosage recommendations, higher doses (higher than the MDD) may be prescribed by your doctor if there is a medically justifiable reason for use.
For one example, the listed 'maximum daily dose' of antihitamine Zyrtec (cetirizine) is 10 mg per day. However, there are several studies, such as one published in the Journal of Dermatological Treatment, that report higher doses, up to 20 mg per day, may be more useful for treating cases of hives that don't respond to lower doses or other drugs.
So even if a drug has a listed maximum daily dose, it doesn't mean that higher doses aren't, or can't, be used.
Some drugs don't even have a listed maximum daily dose, such as opioids (e.g. morphine, oxycodone etc...). Doses of these drugs are highly individualized and require careful titration of dosage when tolerance develops. They generally is no 'ceiling' dose.
Lisinopril Maximum Daily Dose
For lisinopril, the prescribing information lists the following for the 'maximum daily dose':
- 80 mg per day for hypertension (high blood pressure).
- 40 mg per day for heart failure.
The prescribing information notes that the usual daily dosage range is between 20 to 40 mg per day, but 80 mg per day has been used. Nevertheless, 80 mg per day of the drug doesn't appear to be more effective than doses of 40 mg per day. Per the prescribing information:
"The usual dosage range is 20 to 40 mg per day administered in a single daily dose. The antihypertensive effect may diminish toward the end of the dosing interval regardless of the administered dose, but most commonly with a dose of 10 mg daily. This can be evaluated by measuring blood pressure just prior to dosing to determine whether satisfactory control is being maintained for 24 hours. If it is not, an increase in dose should be considered. Doses up to 80 mg have been used but do not appear to give greater effect."
Lisinopril has relatively a large margin of safety when it comes to overdosage. The prescribing information states that a single dose of '20 grams per kilogram' was not lethal in rats, and caused death to one mouse in 20.
A 20g/kg dose in a 150-pound human would equal over 1,300 grams (1,300,000 milligrams). That's over 30,000 of the 40 mg tablets!
The main side effect that comes from an overdose of lisinopril is hypotension, or low blood pressure, which the prescribing information states can safely be treated with intravenous normal saline. Additionally, if an overdose occurs, lisinopril can be removed via hemodialysis.
While the overdosage information in the prescribing information lists theoretical doses of lisinopril that are considerably high, it is important to note that any overdose has the potential to cause serious problems.
One overdose case, published in American Journal of Health-System Pharmacy, reported on an individual who had taken 27 lisinopril 10 mg tablets, which resulted in multi-organ dysfunction, including acute kidney injury. The patient was treated appropriately and had the lisinopril removed via hemodialysis.
Always be sure to take your medication as prescribed by your doctor. If you suspect an overdose has occurred in you or someone you know, you can contact the Poison Control Center at 1-800-222-1222. Additionally, if any notable adverse reactions occur, you should seek immediate medical attention.
Answer SummaryThe published maximum daily dose for lisinopril is 80 mg per day for the treatment of high blood pressure and 40 mg per day for the treatment of heart failure. Lisinopril has a large margin for safety, but overdoses have been reported cause low blood pressure, and in severe cases, organ failure.
- Elsevier ClinicalKey: Lisinopril (Accessed 2/03/19)
- DSSTox (FDAMDD) FDA Maximum (Recommended) Daily Dose Database. PubChem
- Lisinopril Prescribing Information
- Zyrtec Prescribing Information
- Double dose of cetirizine hydrochloride is effective for patients with urticaria resistant: a prospective, randomized, non-blinded, comparative clinical study and assessment of quality of life. PubMed
- Apparent lisinopril overdose requiring hemodialysis. PubMed