Generic Name

Beclometasone

Brand Name

Beclotrox^®

Dosage Form

Metered-dose inhaler

Strength

50, 100, 250 mcg/dose

Indication

Beclomethasone dipropionate is an inhaled corticosteroid used as maintenance treatment in the prophylaxis of asthma attacks.

Indicated for oral inhalation use in the maintenance treatment of asthma as prophylactic therapy in patients 5 years of age and older. The aerosol form of beclomethasone diproprionate is not indicated for the relief of acute bronchospasm.

Indicated for intranasal use to relieve the symptoms of seasonal or perennial allergic and nonallergic (vasomotor) rhinitis and prevent the recurrence of nasal polyps following surgical removal.

Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older. Corticosteroid-responsive dermatoses include psoriasis, contact dermatitis (dermatitis venenata), atopic dermatitis (infantile eczema, allergic dermatitis), neurodermatitis (lichen simplex chronicus, lichen planus, eczema, eczematous dermatitis), intertrigo, dyshidroses (pompholyx), seborrheic dermatitis, exfoliative dermatitis, solar dermatitis, stasis dermatitis, and anogenital and senile pruritus.

Recommended Dose:

Adults and children 16 years and older;

Mild asthma: one dose, once a day

Moderate asthma: one dose, twice a day

This medicine is not recommended for children under 16 years.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Route of Elimination

Regardless of the route of administration, beclomethasone dipropionate and its metabolites are predominantly excreted in the feces, with less than 10% of the drug and its metabolites being excreted in the urine.

Half- life

Following intravenous administration, the half-life of beclomethasone dipropionate was 0.5 hours while the half-life of the active metabolite 17-BMP was 2.7 hours. Following oral and intranasal administration, the half-life of 17-BMP was 8.8 and 5.7 hours, respectively.

Clearance

Following intravenous administration, the clearance of beclomethasone dipropionate and 17-BMP were 150 L/h and 120 L/h, respectively.

Toxicity

The oral LD₅₀ in rats is >3750 mg/kg.

The acute toxicity of beclometasone dipropionate is low. The only harmful effect that follows inhalation of large amounts of the drug over a short period of time is suppression of hypothalamic-pituitary-adrenal (HPA) function. Chronic: The excessive use of beclometasone dipropionate over a long period could lead to adrenal suppression.

Pregnancy and Lactation

There is no experience of the use of this product in pregnancy and lactation in humans. It should not be used in pregnancy or lactation unless the expected benefits to the mother are thought to outweigh any potential risks to the fetus or neonate.

There is inadequate evidence of safety of beclometasone dipropionate in human pregnancy. Administration of corticosteroids to pregnant animals can cause abnormalities of fetal development including cleft palate and intra-uterine growth retardation. There may therefore, be a risk of such effects in the human fetus. It should be noted, however, that the fetal changes in animals occur after relatively high systemic exposure. Beclometasone dipropionate is delivered directly to the lungs by the inhaled route and so avoids the high level of exposure that occurs when corticosteroids are given by systemic routes.

No specific studies examining the transfer of beclometasone dipropionate into the milk of lactating animals have been performed. It is reasonable to assume that beclometasone dipropionate is secreted in milk, but at the dosages used for direct inhalation there is low potential for significant levels in breast milk.

There is no experience with or evidence of safety of propellant HFA-134a in human pregnancy or lactation. However, studies of the effect of HFA-134a on reproductive function and embryofetal development in animals have revealed no clinically relevant adverse effects.

Interactions with medicines

Some products that may interact with this drug include: aldesleukin, other drugs that weaken the immune system (such as azathioprine, cyclosporine, cancer chemotherapy), mifepristone.

Precautions

Before using beclomethasone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye disease (such as cataracts, glaucoma), liver disease, thyroid problems, diabetes, stomach/intestinal problems (such as diverticulitis, ulcer), bone loss (osteoporosis), current/past infections (such as tuberculosis, positive tuberculosis test, herpes, fungal), bleeding problems, mental/mood conditions (such as psychosis, anxiety, depression).

If you have switched from a corticosteroid taken by mouth (such as prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses for a long time, it may be more difficult for your body to respond to physical stress. Therefore, before having surgery or emergency treatment, or if you get a serious illness/injury, tell your doctor or dentist that you are using this medication or have used a corticosteroid taken by mouth within the past 12 months. Tell your doctor right away if you develop unusual/extreme tiredness or weight loss. Carry a warning card or medical ID bracelet that says you use (or have used) corticosteroid medications.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

This medication may mask signs of infection. It can make you more likely to get infections or may worsen any current infections. Therefore, wash your hands well to prevent the spread of infection. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.

Beclomethasone may cause vaccines not to work as well. Therefore, do not have any immunizations/vaccinations while using this medication without the consent of your doctor. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

This medication may temporarily slow down a child's growth if used for a long time. However, poorly controlled asthma can also slow down growth. See the doctor regularly so your child's height can be checked.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this medication passes into breast milk. Consult your doctor before breast-feeding.

Side effects

Beclomethasone can affect growth in children. Talk with your doctor if you think your child is not growing at a normal rate while using this medicine.

Call your doctor at once if you have:

· wheezing, choking, or other breathing problems after using this medicine;

· worsening asthma symptoms;

· white patches or sores inside your mouth or on your lips;

· blurred vision, tunnel vision, eye pain, or seeing halos around lights;

· signs of infection--fever, chills, body aches, vomiting;

· signs of low adrenal gland hormones--worsening tiredness, lack of energy, weakness, feeling light-headed, nausea, vomiting; or

· Increased adrenal gland hormones--hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes.

Common side effects may include:

· a yeast infection in the mouth;

· sinus pain, irritation in your nose; or

· Cold symptoms such as stuffy nose, sneezing, sore throat.

Contraindications

The following conditions are contraindicated with this drug. Check with your physician if you have any of the following:

Conditions:

• active tuberculosis
• inactive tuberculosis
• herpes simplex infection of the eye
• a nasal fungal infection due to Candida
• an infection due to a parasite
• decreased function of the adrenal gland
• increased pressure in the eye
• wide-angle glaucoma
• clouding of the lens of the eye called cataracts
• ulcers of the nasal septum
• perforation of the wall that divides the nose
• nosebleed
• injury to the nose
• infection caused by the varicella zoster virus
• measles
• operation on nose

Storage

Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.