Astepro

Name: Astepro

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How supplied

Dosage Forms And Strengths

ASTEPRO is a nasal spray solution available in two dosage strengths:

  • Each spray of ASTEPRO 0.1% delivers a volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride.
  • Each spray of ASTEPRO 0.15% delivers a volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride.

Storage And Handling

ASTEPRO (azelastine hydrochloride) 0.1% nasal spray is supplied as a 30-mL package delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). Each bottle contains 30 mg (1 mg/mL) of azelastine hydrochloride. After priming [see DOSAGE AND ADMINISTRATION], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 137 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used.

ASTEPRO (azelastine hydrochloride) 0.15% nasal spray is supplied as a 30-mL package (NDC 0037-0243-30) delivering 200 metered sprays in a high-density polyethylene (HDPE) bottle fitted with a metered-dose spray pump unit. The spray pump unit consists of a nasal spray pump fitted with a blue safety clip and a blue plastic dust cover. The net content of the bottle is 30 mL (net weight 30 gm of solution). The 30-mL bottle contains 45 mg (1.5 mg/mL) of azelastine hydrochloride. After priming [see DOSAGE AND ADMINISTRATION], each spray delivers a fine mist containing a mean volume of 0.137 mL solution containing 205.5 mcg of azelastine hydrochloride. The correct amount of medication in each spray cannot be assured before the initial priming and after 200 sprays for the 30-mL bottle have been used, even though the bottle is not completely empty. The bottle should be discarded after 200 sprays have been used.

ASTEPRO should not be used after the expiration date “EXP” printed on the medicine label and carton.

Storage

Store upright at controlled room temperature 20° to 25°C (68° to 77°F). Protect from freezing.

Manufactured by: Meda Pharmaceuticals, Somerset, NJ 08873-4120. Revised: 2/2015

Astepro and Pregnancy

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

This medication falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Astepro Usage

  • Astepro nasal spray is to be sprayed into your nose, usually twice a day. Do not spray it into your eyes or mouth.
    • The Astepro bottle will need to be primed before you use it for the first time. You should see a fine mist after you do six priming sprays. This will indicate it is ready for use. (You will need to prime Astepro nasal spray if you have not used the spray for 3 or more days.)
    • Blow your nose first. Then while spraying the medicine, gently breathe in (inhale). To avoid experiencing a bitter taste after taking Astepro, avoid tilting your head back right after taking Astepro.
    • After using 200 sprays, throw away the bottle.

Other Requirements

  • Store Astepro nasal spray at 20°-25°C (68°-77°F).
  • Do not use Astepro after the expiration date "EXP" on the medicine label and box.
  • Keep this and all medicines out of the reach of children.

 

Uses of Astepro

  • It is used to ease allergy signs.
  • It may be given to you for other reasons. Talk with the doctor.

What are some side effects that I need to call my doctor about right away?

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 or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
  • Shortness of breath.
  • Very bad nose irritation.
  • Bad nosebleeds.
  • Ear pain.

What are some other side effects of Astepro?

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:

  • Feeling sleepy.
  • Headache.
  • Cough.
  • Runny nose.
  • Sneezing.
  • Nose pain or irritation.
  • Burning.
  • Change in taste.
  • Feeling tired or weak.
  • Fever.
  • Nosebleed.
  • Sore throat.
  • Upset stomach or throwing up.
  • Dry mouth.
  • Dizziness.
  • Weight gain.

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-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

How do I store and/or throw out Astepro?

  • Store at room temperature. Do not freeze.
  • Store upright with the cap on.
  • Store in a dry place. Do not store in a bathroom.
  • Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
  • Check with your pharmacist about how to throw out unused drugs.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

In 2-year carcinogenicity studies in rats and mice, azelastine hydrochloride did not show evidence of carcinogenicity at oral doses up to 30 mg/kg and 25 mg/kg, respectively. These doses were approximately 150 and 60 times the maximum recommended human daily intranasal dose [MRHDID] on a mg/m2 basis.

Azelastine hydrochloride showed no genotoxic effects in the Ames test, DNA repair test, mouse lymphoma forward mutation assay, mouse micronucleus test, or chromosomal aberration test in rat bone marrow.

Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses up to 30 mg/kg (approximately 150 times the MRHDID in adults on a mg/m2 basis). At 68.6 mg/kg (approximately 340 times the MRHDID on a mg/m2 basis), the duration of estrous cycles was prolonged and copulatory activity and the number of pregnancies were decreased. The numbers of corpora lutea and implantations were decreased; however, pre-implantation loss was not increased.

How should I use Astepro?

Use Astepro Nasal Spray exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

To use the nasal spray:

  • Blow your nose gently. Keep your head upright and insert the tip of bottle into one nostril. Press your other nostril closed with your finger. Breathe in quickly and gently spray the medicine into your nose. Then use the Astepro Nasal Spray in your other nostril.

  • Do not blow your nose for at least a few minutes after using the nasal spray.

  • If the spray gets in your eyes or mouth or on your skin, rinse with water.

  • If Astepro Nasal Spray has not been used for longer than 3 days, prime it by spraying up to 6 sprays into the air, away from your face, until a fine mist appears.

Avoid getting this medicine in your eyes or mouth.

Do not allow a young child to use Astepro without help from an adult.

Call your doctor if your symptoms do not improve, or if they get worse.

Store Astepro Nasal Spray at room temperature in an upright position, away from moisture and heat. Keep the dust cover on the spray nozzle when not in use. Do not allow this medicine to freeze.

Throw away this medicine after you have used 200 sprays, even if there is still medicine left in the bottle.

What happens if I overdose?

An overdose of Astepro is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

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