What is Zestoretic?

Zestoretic contains a combination of hydrochlorothiazide and lisinopril. Hydrochlorothiazide is a thiazide diuretic (water pill) that helps prevent your body from absorbing too much salt, which can cause fluid retention.

Lisinopril is in an ACE inhibitor. ACE stands for angiotensin converting enzyme. Lisinopril lowers blood pressure and also relieves symptoms of fluid retention.

Zestoretic is used to treat hypertension (high blood pressure). Lowering blood pressure may lower your risk of a stroke or heart attack.

Zestoretic may also be used for purposes not listed in this medication guide.

Warnings

Do not use Zestoretic if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away.

You should not use Zestoretic if you have ever had angioedema, if you are unable to urinate, or if you are allergic to sulfa drugs or to any ACE inhibitor. Do not take hydrochlorothiazide and lisinopril within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use Zestoretic together with any medication that contains aliskiren (a blood pressure medicine).

Before taking this medicine

You should not use Zestoretic if you are allergic to hydrochlorothiazide or lisinopril, or if:

• you have hereditary angioedema;
• you are unable to urinate;
• you recently took a heart medicine called sacubitril;
• you have an allergy to sulfa drugs; or
• you have ever had a severe allergic reaction to any ACE inhibitor (benazepril, captopril, enalapril, fosinopril, moexipril, perindopril, quinapril, ramipril, trandolapril).

Do not take Zestoretic within 36 hours before or after taking medicine that contains sacubitril (such as Entresto).

If you have diabetes, do not use hydrochlorothiazide and lisinopril together with any medication that contains aliskiren (a blood pressure medicine).

You may also need to avoid taking Zestoretic with aliskiren if you have kidney disease.

To make sure Zestoretic is safe for you, tell your doctor if you have:

• kidney disease (or if you are on dialysis);
• cirrhosis or other liver disease;
• glaucoma;
• heart disease or congestive heart failure;
• asthma or allergies;
• gout;
• lupus;
• an allergy to sulfa drugs or penicillin; or
• if you are on a low-salt diet.

Do not use if you are pregnant. Stop using the medicine and tell your doctor right away if you become pregnant. Lisinopril can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.

You should not breastfeed while using hydrochlorothiazide and lisinopril.

Zestoretic is not approved for use by anyone younger than 18 years old.

How should I take Zestoretic?

Take Zestoretic exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Call your doctor if you have ongoing vomiting or diarrhea, or if you are sweating more than usual. You can easily become dehydrated while taking this medicine. This can lead to very low blood pressure, electrolyte disorders, or kidney failure.

Your blood pressure will need to be checked often, and you may need occasional blood tests.

If you need surgery, tell your surgeon you currently use this medicine.

Keep using this medicine as directed, even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medication for the rest of your life.

Store at room temperature away from moisture, heat, and light.

Dosing information

Usual Adult Dose for Hypertension:

Initial dose: Hydrochlorothiazide 12.5 mg-Lisinopril 10 to 20 mg orally once a day, depending on the current monotherapy dose

Maximum dose: Hydrochlorothiazide 50 mg-Lisinopril 80 mg per day

Comments:
-May increase dose every 2 to 3 weeks.
-If blood pressure is controlled with monotherapy hydrochlorothiazide 25 mg per day, but significant potassium loss occurs, then similar or greater blood pressure control without electrolyte disturbance may be achieved with hydrochlorothiazide 12.5 mg-lisinopril 10 mg orally once a day.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Hydrochlorothiazide may increase your risk of skin cancer. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors. Your doctor may want you to have skin examinations on a regular basis.

Drinking alcohol can further lower your blood pressure and may increase certain side effects of this medicine.

Do not use potassium supplements or salt substitutes while you are taking this medicine, unless your doctor has told you to.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Follow your doctor’s instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.

Zestoretic side effects

Get emergency medical help if you have signs of an allergic reaction to Zestoretic: hives; severe stomach pain; difficulty breathing; swelling of your face, lips, tongue, or throat. You may be more likely to have an allergic reaction if you are African-American.

Call your doctor at once if you have:

• a light-headed feeling, like you might pass out;
• eye pain, vision problems;
• little or no urination;
• weakness, drowsiness, or feeling restless;
• fever, chills, sore throat, mouth sores, trouble swallowing;
• jaundice (yellowing of the skin or eyes);
• high potassium – nausea, tingly feeling, chest pain, irregular heartbeats, loss of movement;
• low potassium – leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• low sodium – headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady.

Common Zestoretic side effects may include:

• cough;
• headache;
• dizziness; or
• tired feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is zaleplon?

Zaleplon is a sedative that is used to treat insomnia. zaleplon causes relaxation to help you fall asleep and stay asleep.

Zaleplon may also be used for purposes not listed in this medication guide.

Zaleplon side effects

Zaleplon may cause a severe allergic reaction. Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; nausea and vomiting; swelling of your face, lips, tongue, or throat.

Some people using this medicine have engaged in activity while not fully awake and later had no memory of it. This may include walking, driving, or making phone calls. If this happens to you, stop taking zaleplon and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Zaleplon may cause serious side effects. Call your doctor at once if you have:

• anxiety, depression, aggression, agitation;
• memory problems, unusual thoughts or behavior;
• thoughts of hurting yourself; or
• confusion, hallucinations (hearing or seeing things).

Common side effects of zaleplon may include:

• day-time drowsiness, dizziness, “hangover” feeling;
• feeling light-headed;
• problems with coordination; or
• numbness, tingling, or prickly feeling on your skin.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Warnings

Some people using zaleplon have engaged in activity while not fully awake and later had no memory of it. If this happens to you, stop taking zaleplon and call your doctor right away.

Serious injury or death could occur if you walk or drive while you are not fully awake.

Before taking this medicine

You should not use zaleplon if you are allergic to it, or if you have ever taken sleep medicine and engaged in activity you later don’t remember.

Zaleplon is not approved for use by anyone younger than 18 years old.

Tell your doctor if you have ever had:

• liver or kidney disease;
• a breathing disorder;
• depression, mental illness, or suicidal thoughts; or
• drug or alcohol addiction.

You should not take zaleplon if you are pregnant.

You should not breastfeed while using zaleplon.

The sedative effects of zaleplon may be stronger in older adults. Accidental falls are common in elderly patients who take sedatives. Use caution to avoid falling or accidental injury while you are taking zaleplon.

How should I take zaleplon?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Zaleplon may be habit-forming. Misuse can cause addiction, overdose, or death. Keep the medication in a place where others cannot get to it. Selling or giving away zaleplon is against the law.

Zaleplon will make you fall asleep. Never take this medication during your normal waking hours, unless you have several hours to dedicate to sleeping.

Zaleplon is for short-term use only. Do not take zaleplon for longer than 5 weeks without your doctor’s advice.

Call your doctor if your symptoms do not improve after 7 to 10 days of treatment, or if they get worse.

Do not stop using zaleplon suddenly after taking it over several days in a row, or you could have unpleasant withdrawal symptoms. Ask your doctor how to safely stop using this medicine.

Store at room temperature away from moisture, heat, and light. Keep track of your medicine. You should be aware if anyone is using it improperly or without a prescription.

Insomnia symptoms may also return after you stop taking zaleplon, and may be even worse than before. Tell your doctor if you still have worsened insomnia after the first few nights without taking zaleplon.

Zaleplon dosing information

Usual Adult Dose for Insomnia:

10 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 20 mg/day

Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

Usual Geriatric Dose for Insomnia:

5 mg orally once a day, immediately before bedtime OR after the patient has gone to bed and is having trouble falling asleep
-Maximum dose: 10 mg/day

Comments:
-Doses should be individualized.
-Efficacy was established in trials ranging from a single night to 5 weeks.

Use: Short-term treatment of insomnia

What happens if I miss a dose?

Since zaleplon is taken only at bedtime, you will not be on a frequent dosing schedule. Never take this medication if you do not have several hours to sleep before being active again.

Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of zaleplon can be fatal, especially when it is taken together with other medications that can cause drowsiness.

Overdose symptoms may include severe drowsiness, confusion, loss of coordination, severe muscle weakness, weak or shallow breathing, fainting.

What should I avoid while taking zaleplon?

Avoid taking zaleplon during travel, such as to sleep on an airplane. You may be awakened before the effects of the medication have worn off. Amnesia (forgetfulness) is more common if you do not get the equivalent of a full night’s sleep after taking zaleplon.

Do not drink alcohol. Dangerous side effects or death could occur.

Avoid taking zaleplon with food or right after eating a high-fat or heavy meal. This will make it harder for your body to absorb the medicine.

Zaleplon can cause side effects that may impair your thinking or reactions. You may still feel sleepy the morning after taking the medication. Until you know how zaleplon will affect you during waking hours, be careful if you drive, operate machinery, pilot an airplane, or do anything that requires you to be awake and alert.

What other drugs will affect zaleplon?

Using zaleplon with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, other sleep medicine, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may affect zaleplon, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

What is Zavzpret?

Zavzpret (zavegepant) is a calcitonin gene-related peptide (CGRP) receptor antagonist nasal spray used to treat acute migraine in adults. Zavzpret can begin relieving pain as early as 15 minutes, and after 2 hours, Zavzpret is significantly better than a placebo at relieving nausea, sensitivity to light (photophobia) or sensitivity to sound (phonophobia).

Zavzpret is not used for preventing migraines.

How does Zavzpret work?

CGRP is a chemical messenger that has a role in causing pain and other symptoms of migraines. Zavzpret is a small molecule CGRP receptor antagonist that works by blocking the CGRP receptors, which reduces migraine pain and other symptoms of migraine, including nausea and sensitivity to light and sound. 

Who should not take Zavzpret?

You should not take this medicine if you are allergic to the active ingredient, zavegepant, or any of the inactive ingredients.  here is a complete list of ingredients at the bottom of the page.

What should I tell my doctor before using Zavzpret?

Tell your healthcare provider about all of your medical conditions, including if you:

 • have kidney problems.

 • have liver problems. 

Pregnancy and Zavzpret 

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if this medicine will harm your unborn baby. 

Breastfeeding and Zavzpret 

Tell your doctor if you are breastfeeding or plan to breastfeed. It is not known whether this medicine passes into your breast milk. Talk with your healthcare provider about the best way to feed your baby 

How should I take Zavzpret?

• Use this medicine exactly how your healthcare provider tells you to use it.
• Read all the printed instructions your doctor gives you.
• Zavzpret is a nasal spray
• Each dose of this medicine is provided in an individual pack. Use all of the medicine in 1 pack for a complete dose.
• Each Zavzpret only contains 1 time and cannot be reused.
• Do not test or prime the nasal spray before use. 
• Avoid using intranasal decongestants with this medicine.  If you have to use an intranasal decongestant, use it at least 1 hour after using this medicine. 

Dosing information

• The recommended dose is 10 mg given as a single spray in one nostril. 
• Do not use more than 1 spray (10 mg) of Zavzpret nasal spray in a 24-hour period.
•  It is not known if it is safe to use more than 8 sprays (doses) of this medicine in 30 days. 

What are the side effects of Zavzpret?

Common Zavzpret side effects may include:

• unusual taste (dysgeusia)
• feeling sick (nausea)
• nasal discomfort
• vomiting .

Serious Zavzpret side effects include:

Allergic reactions, including hives and swelling of the face, can happen after you use this medicine. Call your healthcare provider or get emergency help right away if you have any of the following symptoms, which may be part of an allergic reaction: 

• swelling of the face, mouth, tongue, or throat 
• trouble breathing

These are not the only possible side effects of this medicine. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800- FDA-1088.

Interactions

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.  

Storage

• Store Zavzpret in the blister package that it comes in.
•  Store at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not freeze.
• Keep this medicine and all medicines out of the reach of children. 

Ingredients

Active ingredients: zavegepant 

Inactive ingredients: dextrose, hydrochloric acid, sodium hydroxide, and succinic acid in water for injection. 

Manufacturer:

Pfizer Labs, Division of Pfizer Inc. New York, NY 10001.