Striverdi Respimat

What is Striverdi Respimat used for?

Striverdi Respimat is a prescription medicine that is used to treat COPD (chronic obstructive pulmonary disease).

This medicine is not to be used to treat intense flare-ups of shortness of breath. Use a rescue inhaler.

Description

The active moiety olodaterol is a selective beta2-adrenergic bronchodilator. The drug substance, olodaterol hydrochloride, is chemically described as 2H-1,4-Benzoxazin-3H(4H)-one, 6-hydroxy-8-[(1R)-1-hydroxy-2-[[2-(4-methoxyphenyl)-1,1-dimethylethyl]-amino]ethyl]-, monohydrochloride. Olodaterol hydrochloride is a white to off-white powder that is sparingly-slightly soluble in water and slightly soluble in ethanol. The molecular weight is 422.9 g/mole (salt): 386.5 g/mole (base), and the molecular formula is C21H26N2O5 × HCl as a hydrochloride. The conversion factor from salt to free base is 1.094.

The structural formula is:

The drug product, STRIVERDI RESPIMAT, is composed of a sterile, aqueous solution of olodaterol hydrochloride filled into a 4.5 mL plastic container crimped into an aluminum cylinder (STRIVERDI RESPIMAT cartridge) for use with the STRIVERDI RESPIMAT inhaler.

Excipients include water for injection, benzalkonium chloride, edetate disodium, and anhydrous citric acid. The STRIVERDI RESPIMAT cartridge is only intended for use with the STRIVERDI RESPIMAT inhaler. The STRIVERDI RESPIMAT inhaler is a hand held, pocket sized oral inhalation device that uses mechanical energy to generate a slow-moving aerosol cloud of medication from a metered volume of the drug solution. The STRIVERDI RESPIMAT inhaler has a yellow-colored cap.

When used with the STRIVERDI RESPIMAT inhaler, each cartridge containing a minimum of 4 grams of a sterile aqueous solution delivers the labeled number of metered actuations after preparation for use. Each dose (1 dose equals 2 actuations) from the STRIVERDI RESPIMAT inhaler delivers 5 mcg olodaterol in 22.1 mcL of solution from the mouthpiece. As with all inhaled drugs, the actual amount of drug delivered to the lung may depend on patient factors, such as the coordination between the actuation of the inhaler and inspiration through the delivery system. The duration of inspiration should be at least as long as the spray duration (1.5 seconds).

Prior to first use, the STRIVERDI RESPIMAT cartridge is inserted into the STRIVERDI RESPIMAT inhaler and the unit is primed. When using for the first time, patients are to actuate the inhaler toward the ground until an aerosol cloud is visible and then repeat the process three more times. The unit is then considered primed and ready for use. If not used for more than 3 days, patients are to actuate the inhaler once to prepare the inhaler for use. If not used for more than 21 days, patients are to actuate the inhaler until an aerosol cloud is visible and then repeat the process three more times to prepare the inhaler for use.

 Mechanism of Action

Olodaterol is a long-acting beta2-adrenergic agonist (LABA). The compound exerts its pharmacological effects by binding and activation of beta2-adrenoceptors after topical administration by inhalation. Activation of these receptors in the airways results in a stimulation of intracellular adenyl cyclase, an enzyme that mediates the synthesis of cyclic-3′, 5′ adenosine monophosphate (cAMP). Elevated levels of cAMP induce bronchodilation by relaxation of airway smooth muscle cells. In vitro studies have shown that olodaterol has 241-fold greater agonist activity at beta2-adrenoceptors compared to beta1-adrenoceptors and 2,299-fold greater agonist activity compared to beta3-adrenoceptors. The clinical significance of these findings is unknown.

Beta-adrenoceptors are divided into three subtypes: beta1-adrenoceptors predominantly expressed on cardiac smooth muscle, beta2-adrenoceptors predominantly expressed on airway smooth muscle, and beta3-adrenoceptors predominantly expressed on adipose tissue. Beta2-agonists cause bronchodilation. Although the beta2-adrenoceptor is the predominant adrenergic receptor in the airway smooth muscle, it is also present on the surface of a variety of other cells, including lung epithelial and endothelial cells and in the heart. The precise function of beta2-receptors in the heart is not known, but their presence raises the possibility that even highly selective beta2-agonists may have cardiac effects.

Before taking Striverdi Respimat, tell your doctor:

• If you are allergic to Striverdi Respimat; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have asthma.
• If you are using another drug like this one. If you are not sure, ask your doctor or pharmacist.
• If the patient is a child. Do not give Striverdi Respimat to a child.

This is not a list of all drugs or health problems that interact with this medicine.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take Striverdi Respimat with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Striverdi Respimat?

• Tell all of your health care providers that you take Striverdi Respimat. This includes your doctors, nurses, pharmacists, and dentists.
• If you have high blood sugar (diabetes), Striverdi Respimat may sometimes raise blood sugar. Talk with your doctor about how to keep your blood sugar under control.
• Call your doctor right away if your breathing problems get worse, if your rescue inhaler does not work as well, or if you need to use your rescue inhaler more often.
• Do not take more of Striverdi Respimat or use it more often than you have been told. Deaths have happened when too much of this type of drug has been taken. Talk with your doctor.
• Drugs like this one may raise the chance of asthma-related deaths in people with asthma who do not also use an inhaled steroid. It appears that this effect does not apply to people with COPD. If you have questions, talk with the doctor.
• This medicine is not approved to treat asthma. Talk with your doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is Striverdi Respimat best taken?

Use Striverdi Respimat as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• For breathing in only by an inhaler into the lungs.
• Keep out of your eyes.
• Keep using Striverdi Respimat as you have been told by your doctor or other health care provider, even if you feel well.
• Use Striverdi Respimat at the same time of day.
• Before first use, put the cartridge into the inhaler.
• Prepare the inhaler before first use. Spray towards the ground until mist is seen. Once the mist is seen, spray 3 more times. If it has been more than 3 days since it has been used, spray once at the ground. If not used in more than 21 days, you will need to prepare the inhaler again. Spray until mist is seen then spray 3 more times.
• Put the cap back on after you are done using your dose.
• Follow how to clean carefully.
• After all sprays have been used, the inhaler will lock.
• If you are using more than 1 inhaled drug, ask the doctor which drug to use first.
• Use new inhaler with each refill.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it on the same day you missed the dose.
• If you do not think about the missed dose until the next day, skip the missed dose and go back to your normal time.
• Do not use more than 1 time a day.

What are the side effects of Striverdi Respimat that I need to call my doctor about immediately?

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, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• 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 low potassium levels like muscle pain or weakness, muscle cramps, or a heartbeat that does not feel normal.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Signs of a urinary tract infection (UTI) like blood in the urine, burning or pain when passing urine, feeling the need to pass urine often or right away, fever, lower stomach pain, or pelvic pain.
• Chest pain or pressure.
• Fast or abnormal heartbeat.
• Very nervous and excitable.
• Shakiness.
• This medicine can cause very bad breathing problems right after you take a dose. Sometimes, this may be life-threatening. If you have trouble breathing, breathing that is worse, wheezing, or coughing after using Striverdi Respimat, use a rescue inhaler and get medical help right away.

What are some other side effects of Striverdi Respimat?

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:

• Nose or throat irritation.
• Signs of a common cold.
• Dizziness.
• Diarrhea.
• Back pain.
• Joint pain.

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 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Striverdi Respimat?

• Store at room temperature. Do not freeze.
• Store in a dry place. Do not store in a bathroom.
• After putting together, throw away the inhaler 3 months after first use or when the inhaler locks.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Label

PRINCIPAL DISPLAY PANEL – 2.5 MCG CARTON

• NDC 0597-0192-61
  Striverdi® Respimat®
  (olodaterol inhalation spray)
• 2.5 mcg/actuation*
• FOR ORAL INHALATION ONLY
• Rx only
• 4 Grams
  60 Metered Inhalations
  (Two inhalations equal one dose)
• Boehringer
  Ingelheim

SRC: NLM .