Budate-100 Transcap(30cap)

Class: Corticosteroid Action Exerts potent anti-inflammatory effect on nasal passages. Indications Intranasal: Management of seasonal and perennial allergic rhinitis symptoms in adults and children (Rhinocort, Rhinocort Aqua); management of nonallergic perennial rhinitis in adults (Rhinocort only). Oral inhalation: For the maintenance treatment of asthma as prophylactic therapy in adults and children and for patients requiring oral corticosteroid therapy for asthma (inhaler). Inhalation suspension: Maintenance treatment of asthma and prophylactic therapy in children 12 mo to 8 yr. Oral capsule: Crohn disease. Contraindications Untreated localized infections involving the nasal mucosa; relief of acute bronchospasm; primary treatment of status asthmaticus or other acute episodes of asthma when intensive measures are required; hypersensitivity to the drug or drug compound of the product. Not recommended for treatment of nonallergic rhinitis because of lack of data. Route/Dosage Turbuhaler (Rhinocort) Adults and Children at least 6 yr: Intranasal Initial dose: 256 mcg/day, given as 2 sprays in each nostril in the morning and evening or 4 sprays in each nostril in the morning. Maintenance: Smallest amount necessary to control symptoms (max, 4 spray/nostril daily). Rhinocort Aqua Adult and Children at least 12 yr: Spray Start with 64 mcg/day administered as 1 spray in each nostril once daily. Maintenance : Titrate to minimum effective dose (max, 256 mcg/day administered as 4 sprays in each nostril once daily). Adult and Children 6 to under 12 yr: Spray Start with 64 mcg/day administered as 1 spray in each nostril once daily. Maintenance : Titrate to minimum effective dose (max, 128 mcg/day administered as 2 sprays in each nostril once daily). Aerosol Adults: Oral inhaler 200 to 400 mcg bid. Children at least 6 yr: Oral inhaler 200 mcg bid. Respules Children 12 mo to 8 yr: Inhalation suspension Administer by inhaled route via jet nebulizer connected to air compressor. Children receiving bronchodilators alone: 0.5 mg/day administered once or bid in divided doses (max, 0.5 mg/day). Children receiving inhaled corticosteroids: 0.5 mg/day administered once or bid in divided doses (max, 1 mg/day). Children receiving oral corticosteroids: 1 mg/day administered as 0.5 mg bid or 1 mg once daily (max, 1 mg/day). Oral Capsules Adults: PO 9 mg once daily in the morning for up to 8 wk (Crohn disease). Interactions Grapefruit juice, ketoconazole: May increase budesonide plasma levels, increasing the pharmacologic and adverse effects. Lab Test Interferences None well documented. Adverse Reactions CARDIOVASCULAR: Hypertension, palpitations, tachycardia (oral). CNS: Headache, dizziness, fatigue, hyperkinesias, paresthesia, tremor, agitation, increased appetite, confusion, insomnia, nervousness, sleep disorder, somnolence (oral). DERMATOLOGIC: Acne, alopecia, dermatitis, eczema, skin disorder, increased sweating (oral). EENT: Nasal irritation/bleeding; burning; stinging; sneezing; pharyngitis; glossitis, ear infection, vertigo, eye abnormality, abnormal vision (oral). GI: Dry mouth; indigestion; nausea, dyspepsia, abdominal pain, flatulence, vomiting, anus disorder, aggravated Crohn disease, enteritis, epigastric pain, GI fistula, hemorrhoids, intestinal obstruction, tongue edema, tooth disorder (oral). GU: Intermenstrual bleeding, menstrual disorder, dysuria, micturition frequency, nocturia, hematuria, pyuria (oral). HEMATOLOGIC: Leukocytosis, anemia, increased erythrocyte sedimentation rate (oral). HYPERSENSITIVITY: Immediate or delayed reactions including urticaria; angioedema; rash; bronchospasm; face and tongue edema; pruritus; wheezing; dyspnea. METABOLIC: Hypokalemia, weight increase (oral). RESPIRATORY: Increased cough; respiratory tract infection, bronchitis, dyspnea (oral). OTHER: Symptoms of hypercorticism, back pain, pain, asthenia, increased C-reactive protein, chest pain, dependent edema, face edema, flu-like symptoms, malaise, aggravated arthritis, cramps, myalgia, moniliasis, flushing (oral). Precautions Pregnancy: Category B. Lactation: Undetermined. Use caution because other corticosteroids are excreted in human milk. CHILDREN: Not recommended for children under 6 yr; safety and efficacy not established in children for Entocort EC. Oral corticosteroids may suppress growth in children and adolescents, particularly with higher doses over extended periods. Elderly: Select dose with caution, reflecting greater frequency of decreased hepatic, renal, or cardiac function and comorbidity. Fungal infections: Antifungal treatment or discontinuation of corticosteroid therapy may be necessary. Hypersensitivity: Immediate hypersensitivity reactions have occurred. Immunology: Patients receiving immunosuppressant agents are more susceptible to infections than healthy adults. If a patient is exposed to measles or chickenpox, appropriate prophylaxis and treatment may be indicated. Ketoconazole: May increase plasma levels when used concomitantly. Use with caution. Systemic effects: Use cautiously in patients taking daily or alternate-day steroid therapy; may increase likelihood of hypothalamic-pituitary-adrenal (HPA) suppression. Exceeding recommended dose may cause systemic effects. PATIENT CARE CONSIDERATIONS Administration/Storage Intranasal Shake well before using. Before nasal inhalation, instruct patient to blow gently to clear nasal passages. A topical decongestant may be used 5 to 10 min before administration to ensure adequate penetration. Nasal lavage with saline also may help remove secretions. Clean outer portion of nose with a damp tissue. Wash hands with soap and water. Insert nozzle into patient's nostril. Use your finger to keep other nostril closed. Instruct patient to inhale while you activate medication. Repeat with other nostril. Must be used within 6 mo after opening the aluminum pouch. Store at room temperature in a low humidity environment with the valve downward. Cold temperatures reduce effectiveness. Do not puncture or incinerate container. Storing container over 120°F (50°C) may cause canister to burst. Transfer patients receiving concomitant systemic steroids to steroid inhalant. Subsequent management may be more difficult because of slow HPA function recovery that may last up to 12 mo. Do not abruptly stop treatment with inhaled drug. These agents may be effective and may permit replacement or significant reduction in corticosteroid dosage. Stabilize patient's asthma before treatment is started. Initially, use inhaled corticosteroids concurrently with usual maintainance dose of systemic steroid. After approximately 1 wk, start gradual withdrawal of systemic steroid by reducing the daily or alternate dose. Make the next reduction after 1 to 2 wk, depending on response. Store at room temperature (68° to 77°F) with valve up. Assessment/Interventions Obtain patient history. If change is made from systemic (oral) to inhaled or intranasal corticosteroids, observe patient carefully for signs of steroid withdrawal (eg, nausea, fatigue, dizziness, hypotension, depression, joint and muscle pain). Notify health care provider if these signs occur. Deaths caused by adrenal insufficiency have occurred during and after transfer to aerosol corticosteroids. Have epinephrine 1:1000 available for immediate or delayed hypersensitivity reaction. Inhaler Improvement in asthma control following inhaled administration of this medicine can occur within 24 hr of initiation of treatment, although maximum benefit may not be seen for at least 1 to 2 wk. OVERDOSAGE: SIGNS & SYMPTOMS Hypercorticoidism, adrenal suppression Patient/Family Education Review administration technique. Have patient demonstrate technique. Before nasal inhalation, instruct patient to blow gently to clear nasal passages. A topical decongestant may be used 15 min before administration to ensure adequate penetration. Open and lock nasal adapter into place. Hold inhaler upright. Shake well. Insert inhaler into 1 nostril; close other nostril by pressing on nose with finger. Begin to inhale through nostril; breathe and actuate dose by pressing on the canister. Repeat procedure for other nostril. Teach patient to clean plastic parts by removing from aerosol canister and soaking in warm water with a mild detergent. Allow parts to dry before replacing. Stress importance of using the medication as prescribed. Instruct patient not to exceed prescribed dose. Warn patient to call the health care provider if signs of nasal, oral, or pharyngeal infections develop. If patient is being converted from oral to nasal steroids, review signs and symptoms of adrenal insufficiency, which may occur days or weeks after conversion is complete. Instruct patient to use caution if sores or injuries occur in nasal passages. Drug may prevent or slow proper healing. Inform patient to report any fungal infections of the nose or throat to health care provider. Explain that effects of drug are not immediate. Benefit requires daily use as instructed and usually occurs after several days. Full relief may take 1 to 2 wk. Caution patient not to continue therapy after 3 wk if there is no improvement. Instruct patient that this medicine is to be used for preventative therapy only; it should not be used to abort an acute asthmatic attack. Instruct patient whose systemic corticosteroids have been reduced or withdrawn to carry a warning card indicating need for supplemental systemic steroids in event of stress or severe asthmatic attack unresponsive to bronchodilators. Use this medicine at regularly scheduled intervals, even if the patient has no current symptoms. Warn patient taking immunosuppressant doses of corticosteroids to avoid exposure to chickenpox or measles. Advise patient to seek immediate medical advice if exposed. A patient receiving bronchodilators (eg, isoproterenol, metaproterenol, albuterol) by inhalation should use the bronchodilators several minutes before the corticosteroid inhalant to enhance penetration of the steroid. Advise patient to contact health care provider if sore throat develops. Instruct patient in the following proper use of the inhaler. Hold inhaler upright and twist the cover off; twist the brown grip fully to the right as far as it will go, then twist it back. There will be a click. Exhale, then place the mouthpiece between lips and inhale deeply and forcefully. Rinse the mouth with water or mouthwash after each use to help reduce dry mouth and hoarseness and reduce risk of oral candidiasis. Advise patient to contact health care provider if symptoms do not improve, if condition worsens, or if sneezing or nasal irritation occurs. Advise patient not to take OTC medications without consulting a health care provider. Advise patient to swallow capsules (eg, Entocort EC); do not chew or break capsules. Instruct patient to avoid consumption of grapefruit juice for the duration of Entocort EC therapy.