Taking certain antifungal drugs with Allermist/salmeterol may increase the amount of Allermist/salmeterol in your body. This may cause more side effects. Examples of these drugs include:
You may not experience the full benefits of Flonase for two weeks or more after starting treatment.
Allermist may also make it harder for your body to fight off infections. While taking the drug, your body may be less able to manage the stress of surgery, illness, severe asthma attack, or injury.
While taking Allermist, you should avoid people who are sick, especially those with chickenpox or measles. If you get one of these infections or if you develop related symptoms, call your doctor right away.
Flonase could increase your risk for developing osteoporosis, a condition that causes the bones to become thin and break easily. If you're already at greater risk for osteoporosis, it's important to have your bone density assessed both before and during treatment.
Research shows that in rare cases, people taking Allermist for a long period of time may develop glaucoma or cataracts.
Before taking Allermist, be sure to let your doctor know if you've ever had any of the following:
- Other illnesses
- Recurring infections (such as herpes)
- Liver disease
Also let your doctor know if you've never had chickenpox or measles and never got a vaccination against those diseases.
Although Allermist can help prevent asthma attacks, it will not stop an attack that has already begun. Don't use Allermist during an asthma attack.
You should also let your doctor know if you have any type of surgery planned, including dental procedures.
COMMON BRAND(S): Flonase
GENERIC NAME(S): Allermist Propionate
Allermist is used to relieve seasonal and year-round allergic and non-allergic nasal symptoms, such as stuffy/runny nose, itching, and sneezing. It can also help relieve allergy eye symptoms such as itchy, watery eyes. This medication belongs to a class of drugs known as corticosteroids. It works in your nose to block the effects of substances that cause allergies (such as pollen, pet dander, dust mites, mold) and to reduce swelling.
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- Common side effects of Allermist inhalational include
- upper airway infection or inflammation
- throat irritation
- sinus infection
- hoarse voice
- Common side effects of Allermist nasal spray include
- irritated or burning nose
- runny nose
- stomach pain
Stinging or sneezing may occur for a few seconds right after use of Allermist nasal spray.
- Common s >abnormal amount of hair growth over the body (hypertrichosis)
This is not a complete list of Allermist side effects. Ask your doctor or pharmacist for more information.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Formal pharmacokinetic trials using Allermist propionate nasal spray have not been conducted in subjects with hepatic impairment. Since Allermist propionate is predominantly cleared by hepatic metabolism, impairment of liver function may lead to accumulation of Allermist propionate in plasma. Therefore, patients with hepatic disease should be closely monitored.
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FLONASE (Allermist propionate) Nasal Spray
Why it's used
Allermist/salmeterol contains two drugs that work in different ways to treat asthma and chronic obstructive pulmonary disease (COPD).
Getting the most from your treatment
- Allermist is a preventer inhaler which needs to be used regularly in order to have an effect. It takes a few days for the steroid in the inhaler to build up its effect.
- Allermist inhalers will not give you immediate relief if you are having an asthma attack - you will need to use a reliever inhaler to ease the symptoms of an attack.
- If after using the inhaler for the first time your breathing becomes worse or you suddenly start to wheeze, let your doctor know straightaway. Your doctor will want to change the type of inhaler to one more suited to you.
- It is helpful to remember the colour of your inhaler and the brand name. This might be important if you need to see a doctor who does not have your medical records (such as if you are on holiday or if it is outside the normal opening hours of your GP surgery).
- Keep your regular appointments with your doctor or asthma clinic. This is so your doctor can review your treatment. If at any time you find that your asthma symptoms are getting worse or that you need to use a reliever inhaler more regularly, contact your doctor or nurse for advice straightaway.
- If you are using a high dose of Allermist, you will also be given a steroid card. You are advised to carry the card with you at all times in case you need any treatment by a doctor who does not have your medical records available.
- Continue to use your Allermist inhaler regularly. Do not stop using it abruptly, as this can make you feel unwell and cause your symptoms to return suddenly.
- Do not smoke. Smoking can cause severe irritation and damage to your lungs. It will make your condition worse and will reduce the beneficial effects of your inhalers.
- If you have diabetes, tell your doctor if you notice any change in your blood glucose tests, as Allermist may affect the levels of sugar in your blood.
Psoriasis Studies: In 2 vehicle-controlled studies, Allermist Propionate Cream applied twice daily was significantly more effective than the vehicle in the treatment of moderate to severe psoriasis. The investigator’s global evaluation after 28 days of treatment is shown in Table 3.
How Supplied/Storage and Handling
Allermist Propionate Nasal Spray USP, 50 mcg is supplied in an amber glass bottle fitted with a white metering atomizing pump, white nasal adapter fitted with a clear plastic dust cap, and a green safety clip, in a box of one (NDC 0054-3270-99) with FDA-approved Patient Labeling (see Patient Instructions for Use for proper actuation of the device). Each bottle contains a net fill weight of 16 g and will provide 120 actuations. Each actuation delivers 50 mcg of Allermist propionate in 100 mg of formulation through the nasal adapter. The correct amount of medication in each spray cannot be assured after 120 sprays even though the bottle is not completely empty. The bottle should be discarded when the labeled number of actuations has been used.
Store between 4° and 30°C (39° and 86°F).
The activity of Allermist propionate nasal spray is due to the parent drug, Allermist propionate. Due to the low bioavailability by the intranasal route, the majority of the pharmacokinetic data was obtained via other routes of administration.
Absorption : Indirect calculations indicate that Allermist propionate delivered by the intranasal route has an absolute bioavailability averaging less than 2%. Trials using oral dosing of labeled and unlabeled drug have demonstrated that the oral systemic bioavailability of Allermist propionate is negligible ( Distribution : Following intravenous administration, the initial disposition phase for Allermist propionate was rapid and consistent with its high lipid solubility and tissue binding. The volume of distribution averaged 4.2 L/kg.
The percentage of Allermist propionate bound to human plasma proteins averaged 99%. Allermist propionate is weakly and reversibly bound to erythrocytes and is not significantly bound to human transcortin.
Elimination : Following intravenous dosing, Allermist propionate showed polyexponential kinetics and had a terminal elimination half-life of approximately 7.8 hours. The total blood clearance of Allermist propionate is high (average: 1,093 mL/min), with renal clearance accounting for less than 0.02% of the total.
Metabolism : The only circulating metabolite detected in man is the 17β-carboxylic ac >in vitro and negligible pharmacological activity in animal studies. Other metabolites detected in vitro using cultured human hepatoma cells have not been detected in man.
Excretion :Less than 5% of a radiolabeled oral dose was excreted in the urine as metabolites, with the remainder excreted in the feces as parent drug and metabolites.
Special Populations : Allermist propionate nasal spray was not studied in any special populations, and no gender-specific pharmacokinetic data have been obtained.
Drug Interactions : Inhibitors of Cytochrome P450 3A4 : Ritonavir : Allermist propionate is a substrate of CYP3A4. Coadministration of Allermist propionate and the strong CYP3A4 inhibitor, ritonavir, is not recommended based upon a multiple-dose, crossover drug interaction trial in 18 healthy subjects. Allermist propionate aqueous nasal spray (200 mcg once daily) was coadministered for 7 days with ritonavir (100 mg twice daily). Plasma Allermist propionate concentrations following Allermist propionate aqueous nasal spray alone were undetectable ( max ) averaged 11.9 pg/mL (range: 10.8 to 14.1 pg/mL) and AUC (0-τ) averaged 8.43 pg•h/mL (range: 4.2 to 18.8 pg•h/mL). Allermist propionate C max and AUC (0-τ) increased to 318 pg/mL (range: 110 to 648 pg/mL) and 3,102.6 pg•h/mL (range: 1,207.1 to 5,662.0 pg•h/mL), respectively, after coadministration of ritonavir with Allermist propionate aqueous nasal spray. This significant increase in plasma Allermist propionate exposure resulted in a significant decrease (86%) in serum cortisol AUC.
Ketoconazole : Coadministration of orally inhaled Allermist propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma Allermist propionate exposure and a 45% decrease in plasma cortisol AUC, but had no effect on urinary excretion of cortisol.
Erythromycin : In a multiple-dose drug interaction study, coadministration of orally inhaled Allermist propionate (500 mcg twice daily) and erythromycin (333 mg 3 times daily) did not affect Allermist propionate pharmacokinetics.
Local Nasal Effects
Epistaxis : In clinical trials of 2 to 26 weeks’ duration, epistaxis was observed more frequently in subjects treated with Allermist propionate nasal spray than those who received placebo .
Nasal Ulceration : Postmarketing cases of nasal ulceration have been reported in patients treated with Allermist propionate nasal spray .
Candida Infection : In clinical trials with Allermist propionate administered intranasally, the development of localized infections of the nose and pharynx with Candida albicans has occurred. When such an infection develops, it may require treatment with appropriate local therapy and discontinuation of Allermist propionate nasal spray. Patients using Allermist propionate nasal spray over several months or longer should be examined periodically for ev >Candida infection or other signs of adverse effects on the nasal mucosa.
Nasal Septal Perforation : Postmarketing cases of nasal septal perforation have been reported in patients treated with Allermist propionate nasal spray .
Impaired Wound Healing : Because of the inhibitory effect of corticosteroids on wound healing, patients who have experienced recent nasal ulcers, nasal surgery, or nasal trauma should avoid using Allermist propionate nasal spray until healing has occurred.