Foracort forte

Contraindications

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What is the most important information I should know about Foracort Forte?

While taking Foracort Forte, tell your doctor if you have changes in the shape or location of body fat (especially in your arms, legs, face, neck, breasts, and waist), high blood pressure, (severe headache, fast or uneven heart rate, blurred vision), or a general ill feeling with headache, tiredness, nausea, and vomiting.

Grapefruit and grapefruit juice may interact with Foracort Forte and cause increased levels of the medication in your blood. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Foracort Forte.

Undesirable effects

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What are the possible side effects of Foracort Forte?

The following adverse reactions were reported in patients treated with Foracort Forte (Foracort Forte).

The incidence of common adverse events is based upon double-blind, placebo-controlled US clinical trials in which 1116 adult and pediatric patients age 6-70 years (472 females and 644 males) were treated with Foracort Forte (Foracort Forte) (200 to 800 mcg twice daily for 12 to 20 weeks) or placebo.

The following table shows the incidence of adverse events in patients previously receiving bronchodilators and/or inhaled corticosteroids in US controlled clinical trials. This population included 232 male and 62 female pediatric patients (age 6 to 17 years) and 332 male and 331 female adult patients (age 18 years and greater).

Adverse Events with ≥ 3% Incidence reported by Patients on Foracort Forte (Foracort Forte)

The table above includes all events (whether considered drug-related or non-drug-related by the investigators) that occurred at a rate of ≥3% in any one Foracort Forte (Foracort Forte) group and were more common than in the placebo group. In considering these data, the increased average duration of exposure for Foracort Forte (Foracort Forte) patients should be taken into account.

The following other adverse events occurred in these clinical trials using Foracort Forte (Foracort Forte) with an incidence of 1 to 3% and were more common on Foracort Forte (Foracort Forte) than on placebo.

Body As A Whole:neck pain

Cardiovascular: syncope

Digestive: abdominal pain, dry mouth, vomiting

Metabolic and Nutritional: weight gain

Musculoskeletal: fracture, myalgia

Nervous: hypertonia, migraine

Platelet, Bleeding and Clotting: ecchymosis

Psychiatric: insomnia

Resistance Mechanisms: infection

Special Senses: taste perversion

In a 20-week trial in adult asthmatics who previously required oral corticosteroids, the effects of Foracort Forte (Foracort Forte) 400 mcg twice daily (N=53) and 800 mcg twice daily (N=53) were compared with placebo (N=53) on the frequency of reported adverse events. Adverse events, whether considered drug-related or non-drug-related by the investigators, reported in more than five patients in the Foracort Forte (Foracort Forte) group and which occurred more frequently with Foracort Forte (Foracort Forte) than placebo are shown below (% Foracort Forte (Foracort Forte) and % placebo). In considering these data, the increased average duration of exposure for Foracort Forte (Foracort Forte) patients (78 days for Foracort Forte (Foracort Forte) vs. 41 days for placebo) should be taken into account.

The adverse event profile of once-daily administration of Foracort Forte (Foracort Forte) 200 mcg and 400 mcg, and placebo, was evaluated in 309 adult asthmatic patients in an 18-week study. The study population included both patients previously treated with inhaled corticosteroids, and patients not previously receiving corticosteroid therapy. There was no clinically relevant difference in the pattern of adverse events following once-daily administration of Foracort Forte (Foracort Forte) when compared with twice-daily dosing.

Pediatric Studies: In a 12-week placebo-controlled trial in 404 pediatric patients 6 to 18 years of age previously maintained on inhaled corticosteroids, the frequency of adverse events for each age category (6 to 12 years, 13 to 18 years) was comparable for Foracort Forte (Foracort Forte) (at 100, 200 and 400 mcg twice daily) and placebo. There were no clinically relevant differences in the pattern or severity of adverse events in children compared with those reported in adults.

Adverse Event Reports From Other Sources: Rare adverse events reported in the published literature or from worldwide marketing experience with any formulation of inhaled Foracort Forte include: immediate and delayed hypersensitivity reactions including rash, contact dermatitis, urticaria, angioedema and bronchospasm; symptoms of hypocorticism and hypercorticism; glaucoma, cataracts; psychiatric symptoms including depression, aggressive reactions, irritability, anxiety and psychosis.

Therapeutic indications

Foracort Forte (Foracort Forte) is indicated for the maintenance treatment of asthma as prophylactic therapy in adult and pediatric patients six years of age or older. It is also indicated for patients requiring oral corticosteroid therapy for asthma. Many of those patients may be able to reduce or eliminate their requirement for oral corticosteroids over time.

Foracort Forte (Foracort Forte) is NOT indicated for the relief of acute bronchospasm.

Foracort Forte is used to help prevent the symptoms of asthma. When used regularly every day, inhaled Foracort Forte decreases the number and severity of asthma attacks. However, it will not relieve an asthma attack that has already started.

Foracort Forte is a corticosteroid or steroid (cortisone-like medicine). It works by preventing inflammation (swelling) in the lungs, which makes the asthma attack less severe. Inhaled Foracort Forte may be used with other asthma medicines such as bronchodilators, which are also used to open up narrowed breathing passages in the lungs.

Foracort Forte is available only with your doctor's prescription.

Name of the medicinal product

Qualitative and quantitative composition

Turbuhaler: One metered dose contains Budesonide 100 micrograms or 200 micrograms.

Respules: Each single-dose unit of 2 ml contains 0.5 mg or 1 mg Foracort Forte.

Respules: The active ingredient, Foracort Forte, is a non-halogenated glucocorticoid structurally related to 16-α- hydroxyprednisolone. The chemical name is 16α, 17α -22R, S-propylmethylenedioxy-pregna-1, 4-diene-11ß, 21-diol-3, 20-dione; MW 430.5.

Foracort Forte is a white to off-white powder, freely soluble in chloroform, sparingly soluble in ethanol and practically insoluble in water and heptane. Foracort Forte melts with decomposition between 224°C and 231.5°C.

Foracort Forte RESPULES nebulising suspension for inhalation is a white to off-white suspension in plastic single dose units. Foracort Forte RESPULES contain Foracort Forte 0.5 mg/2 mL or 1.0 mg/2 mL as the active ingredient plus disodium edetate, sodium chloride, polysorbate 80 (E 433) citric acid - anhydrous (E 330), sodium citrate (E 331) and water for injections.

Excipients/Inactive Ingredients: Turbuhaler: Foracort Forte contains no excipients.

Respules: Disodium edetate, sodium chloride, polysorbate 80 (E 433) citric acid anhydrous (E 330), sodium citrate (E 331) and water for injections.

Special warnings and precautions for use

Use Foracort Forte as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Foracort Forte. Talk to your pharmacist if you have questions about this information.
• Foracort Forte is for rectal use only. Do not take Foracort Forte by mouth.
• Before using Foracort Forte, use the bathroom to empty your bowels.
• If you need more lubricant for the applicator, you may use petrolatum or petroleum jelly.
• Warm Foracort Forte before use by holding the can in your hands and shaking it for 10 to 15 seconds.
• You can use Foracort Forte while standing, lying down, or sitting.
• If you are using Foracort Forte in the evening, use right before bedtime. After using Foracort Forte, try to avoid emptying your bowels until the next morning.
• Foracort Forte is flammable. Avoid fire, flame, and smoking while you use Foracort Forte and right after using it.
• Use Foracort Forte on a regular schedule to get the most benefit from it.
• Do not eat grapefruit or drink grapefruit juice while you use Foracort Forte.
• If you miss a dose of Foracort Forte, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Foracort Forte.

This medication is used to treat certain bowel conditions (such as Crohn's disease, ulcerative colitis). While Foracort Forte does not cure these conditions, it may decrease symptoms such as pain and diarrhea. Foracort Forte is an anti-inflammatory drug (corticosteroid hormone). It works by decreasing the body's natural defense response (immune response).

Read the Patient Information Leaflet provided by your pharmacist before you start using Foracort Forte and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food as directed by your doctor, usually once daily in the morning. Take this medication by mouth with a full glass of water (8 ounces/240 milliliters) unless your doctor directs you otherwise. Swallow this medication whole. Do not crush or chew. Doing so can release all of the drug at once, increasing the risk of side effects. If you are using the extended-release tablets, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage and length of treatment are based on your medical condition, response to treatment, and age.

Avoid eating grapefruit or drinking grapefruit juice while being treated with this medication unless your doctor instructs you otherwise. Grapefruit may increase the amount of certain medications in your body. Consult your doctor or pharmacist for more details.

If you are regularly taking a different corticosteroid by mouth (such as prednisone), you should not stop taking it unless directed by your doctor. Some conditions (such as asthma, allergies) may become worse when the drug is suddenly stopped. You may have withdrawal symptoms if the drug is suddenly stopped. To prevent withdrawal symptoms (such as weakness, weight loss, nausea, muscle pain, headache, tiredness, dizziness), your doctor may direct you to slowly lower the dose of your old medication when you are taking Foracort Forte. Consult your doctor or pharmacist for more details, and report any withdrawal reactions right away. See also Precautions section.

Use this medication regularly and exactly as prescribed in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not increase your dose, take it more frequently, or use it for a longer time than prescribed because this may increase your risk of serious side effects.

Do not stop taking this medication without consulting your doctor. Some conditions may become worse when this drug is suddenly stopped. Your dose may need to be gradually decreased.

Inform your doctor if your condition persists or worsens.

Dosage (Posology) and method of administration

Foracort Forte (Foracort Forte) should be administered by the orally inhaled route in asthmatic patients age 6 years and older. Individual patients will experience a variable onset and degree of symptom relief. Generally, Foracort Forte (Foracort Forte) has a relatively rapid onset of action for an inhaled corticosteroid. Improvement in asthma control following inhaled administration of Foracort Forte (Foracort Forte) can occur within 24 hours of initiation of treatment, although maximum benefit may not be achieved for 1 to 2 weeks, or longer. The safety and efficacy of Foracort Forte (Foracort Forte) when administered in excess of recommended doses have not been established.

The recommended starting dose and the highest recommended dose of Foracort Forte (Foracort Forte), based on prior asthma therapy, are listed in the following table.

*In patients with mild to moderate asthma who are well controlled on inhaled corticosteroids, dosing with Foracort Forte (Foracort Forte) 200 mcg or 400 mcg once daily may be considered. Foracort Forte (Foracort Forte) can be administered once daily either in the morning or in the evening.

If the once-daily treatment with Foracort Forte (Foracort Forte) does not provide adequate control of asthma symptoms, the total daily dose should be increased and/or administered as a divided dose.

Initially, Foracort Forte (Foracort Forte) should be used concurrently with the patient's usual maintenance dose of systemic corticosteroid. After approximately one week, gradual withdrawal of the systemic corticosteroid is started by reducing the daily or alternate daily dose. The next reduction is made after an interval of one or two weeks, depending on the response of the patient. Generally, these decrements should not exceed 2.5 mg of prednisone or its equivalent. A slow rate of withdrawal is strongly recommended. During reduction of oral corticosteroids, patients should be carefully monitored for asthma instability, including objective measures of airway function, and for adrenal insufficiency. During withdrawal, some patients may experience symptoms of systemic corticosteroid withdrawal, eg, joint and/or muscular pain, lassitude, and depression, despite maintenance or even improvement in pulmonary function. Such patients should be encouraged to continue with Foracort Forte (Foracort Forte) but should be monitored for objective signs of adrenal insufficiency. If evidence of adrenal insufficiency occurs, the systemic corticosteroid doses should be increased temporarily and thereafter withdrawal should continue more slowly. During periods of stress or a severe asthma attack, transfer patients may require supplementary treatment with systemic corticosteroids.

NOTE: In all patients it is desirable to titrate to the lowest effective dose once asthma stability is achieved.

Illustrated Patient's Instructions for Use accompany each package of Foracort Forte (Foracort Forte).

Patients should be instructed to prime Foracort Forte (Foracort Forte) prior to its initial use, and instructed to inhale deeply and forcefully each time the unit is used. Rinsing the mouth after inhalation is also recommended.

Foracort Forte (Foracort Forte) consists of a number of assembled plastic details, the main parts being the dosing mechanism, the storage unit for drug substance and the mouthpiece. The inhaler is protected by a white outer tubular cover screwed onto the inhaler. The body of the inhaler is white and the turning grip is brown. The following wording is printed on the grip in raised lettering, “Foracort Forte™ 200 mcg”. The TURBUHALER inhaler cannot be refilled and should be discarded when empty.

Foracort Forte (Foracort Forte) is available as 200 mcg/dose, 200 doses (NDC 0186-0915-42) and has a target fill weight of 104 mg.

When there are 20 doses remaining in Foracort Forte (Foracort Forte), a red mark will appear in the indicator window. If the unit is used beyond the point at which the red mark appears at the bottom of the window, the correct amount of medication may not be obtained. The unit should be discarded.

Store with the cover tightened in a dry place at controlled room temperature 20-25°C (68-77°F). Keep out of the reach of children.

All trademarks are the property of the AstraZeneca group of companies. ©AstraZeneca 2001, 2006. Manufactured for: AstraZeneca LP, Wilmington, DE 19850 By: AstraZeneca AB, Sodertalje, Sweden 33020-00. Rev. 10/06. FDA Rev date: 8/20/2007

Interaction with other medicinal products and other forms of interaction

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What other drugs will affect Foracort Forte?

Foracort Forte:

Oral ketoconazole 200 mg once daily increased the plasma concentrations of oral Foracort Forte (3 mg) on average 6-fold when administered simultaneously. When ketoconazole was administered 12 hrs after Foracort Forte, the concentration increased on average of 3-fold. Information on this interaction is lacking for nasal Foracort Forte, but greatly increased plasma levels are expected too. Since there is an absence of data to permit dosage recommendations for nasal administration, the combination should be avoided. If this is not possible, the interval between administration of ketoconazole and Foracort Forte should be as long as possible. A reduction of the Foracort Forte dose must also be considered. Other potent inhibitors of CYP3A4 probably also cause a marked increase in the plasma levels of Foracort Forte.

Rhinocort Turbuhaler: Foracort Forte has not been observed to interact with any drug used for the treatment of rhinitis.

The metabolism, of Foracort Forte is primarily mediated by CYP3A4. Inhibitors of this enzyme, eg, ketoconazole and itraconazole, may therefore increase systemic exposure to Foracort Forte several times.

Oral ketoconazole 200 mg once daily increased the plasma concentrations of oral Foracort Forte (3 mg in a single dose) on average 6-fold when administered simultaneously. When oral ketoconazole was administered 12 hrs after Foracort Forte, the concentration increased on average 3-fold. There is no information about this interaction for nasal Foracort Forte, but also in such cases greatly increased plasma levels are expected. Since there are no data that support a dosage recommendation to be given in cases of nasal administration the combination must be avoided. If this is not possible, the time interval between treatments must be as long as possible and a reduction of the Foracort Forte dose may also be considered. Other potent inhibitors of CYP3A4 also probably cause a marked increase in the plasma levels of Foracort Forte.

Elevated plasma concentrations and increased effects of corticosteroids have been observed in women who were also treated with oestrogens and contraceptive steroids, but no effect has been observed with Foracort Forte and concomitant intake of combined low dose contraceptive pills.

As adrenal function may be inhibited, an ACTH stimulation test for diagnosis of pituitary failure may show an incorrect result (low value).