Alclometasone

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Aclovate® may be confused with Accolate®

U.S. BRAND NAMES — Aclovate®

PHARMACOLOGIC CATEGORY
Corticosteroid, Topical

DOSING: ADULTS — Steroid-responsive dermatoses: Topical: Apply a thin film to the affected area 2-3 times/day. Note: Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

DOSING: PEDIATRIC — Steroid-responsive dermatoses: Topical: Children ≥ 1 year: Apply thin film to affected area 2-3 times/day. Note: Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Do not use for >3 weeks.

(For additional information see "Alclometasone: Pediatric drug information")

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, as dipropionate: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 60 g)

Ointment, as dipropionate: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 45 g, 60 g)

DOSAGE FORMS: CONCISE
Cream: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 60 g)

Ointment: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 45 g, 60 g)

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — For external use only. Do not use on open wounds. Should not be used in the presence of open or weeping lesions. Apply sparingly to occlusive dressings.

USE — Treatment of inflammation of corticosteroid-responsive dermatosis (low to medium potency topical corticosteroid)

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Dermatologic: Acne, allergic dermatitis, hypopigmentation, maceration of the skin, perioral dermatitis, skin atrophy, striae, miliaria, telangiectasia

Endocrine & metabolic: HPA suppression, Cushing's syndrome, growth retardation

Local: Burning, erythema, itching, irritation, dryness, folliculitis, hypertrichosis, papular rash

Miscellaneous: Secondary infection

CONTRAINDICATIONS — Hypersensitivity to alclometasone or any component of the formulation; viral, fungal, or tubercular skin lesions

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypothalamic-pituitary-adrenal (HPA) axis suppression (reversible) particularly in younger children. HPA axis suppression may lead to adrenal crisis. Risk is increased when used over large surface areas, for prolonged periods, or with occlusive dressings. Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation. Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered. Systemic effects: Adverse systemic effects including hyperglycemia, glycosuria, fluid and electrolyte changes, and HPA suppression may occur when used on large surface areas, for prolonged periods, or with an occlusive dressing.

Special populations: Pediatrics: Safety and efficacy have not been established in children <1 year of age. Chronic use of corticosteroids in children may interfere with growth and development. Not for the treatment of diaper dermatitis.

DRUG INTERACTIONS
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Teratogenic effects have been observed in animals administered topical corticosteroids.

PRICING — (data from drugstore.com)
Cream (Aclovate)
0.05% (45): $73.99

Cream (Alclometasone Dipropionate)
0.05% (45): $38.99
0.05% (60): $52.99

Ointment (Aclovate)
0.05% (15): $44.99

Ointment (Alclometasone Dipropionate)
0.05% (15): $16.99
0.05% (60): $35.99

INTERNATIONAL BRAND NAMES — Aclosone (NL); Almeta (JP); Cloderm (ID); Delonal (DE); Demiderm (VE); Legederm (IT); Logoderm (NZ); Lomesone (GR); Miloderme (PT); Modraderm (BE); Modrasone (GB); Perderm (AE, BH, CY, EG, HK, HN, ID, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)

MECHANISM OF ACTION — Stimulates the synthesis of enzymes needed to decrease inflammation, suppress mitotic activity, and cause vasoconstriction

PHARMACODYNAMICS / KINETICS
Absorption: Topical: ~3% absorbed systemically after 8 hours when applied to intact skin

PATIENT INFORMATION — Before applying, gently wash area to reduce risk of infection. Apply a thin film to cleansed area and rub in gently and thoroughly until medication vanishes. Avoid exposure to sunlight; severe sunburn may occur.

Alclometasone

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Aclovate® may be confused with Accolate®

U.S. BRAND NAMES — Aclovate®

PHARMACOLOGIC CATEGORY
Corticosteroid, Topical

DOSING: ADULTS — Steroid-responsive dermatoses: Topical: Apply a thin film to the affected area 2-3 times/day. Note: Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.

DOSING: PEDIATRIC — Steroid-responsive dermatoses: Topical: Children ≥ 1 year: Apply thin film to affected area 2-3 times/day. Note: Therapy should be discontinued when control is achieved; if no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Do not use for >3 weeks.

(For additional information see "Alclometasone: Pediatric drug information")

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Cream, as dipropionate: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 60 g)

Ointment, as dipropionate: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 45 g, 60 g)

DOSAGE FORMS: CONCISE
Cream: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 60 g)

Ointment: 0.05% (15 g, 45 g, 60 g)
Aclovate®: 0.05% (15 g, 45 g, 60 g)

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — For external use only. Do not use on open wounds. Should not be used in the presence of open or weeping lesions. Apply sparingly to occlusive dressings.

USE — Treatment of inflammation of corticosteroid-responsive dermatosis (low to medium potency topical corticosteroid)

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Dermatologic: Acne, allergic dermatitis, hypopigmentation, maceration of the skin, perioral dermatitis, skin atrophy, striae, miliaria, telangiectasia

Endocrine & metabolic: HPA suppression, Cushing's syndrome, growth retardation

Local: Burning, erythema, itching, irritation, dryness, folliculitis, hypertrichosis, papular rash

Miscellaneous: Secondary infection

CONTRAINDICATIONS — Hypersensitivity to alclometasone or any component of the formulation; viral, fungal, or tubercular skin lesions

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Adrenal suppression: Systemic absorption of topical corticosteroids may cause hypothalamic-pituitary-adrenal (HPA) axis suppression (reversible) particularly in younger children. HPA axis suppression may lead to adrenal crisis. Risk is increased when used over large surface areas, for prolonged periods, or with occlusive dressings. Contact dermatitis: Allergic contact dermatitis can occur, it is usually diagnosed by failure to heal rather than clinical exacerbation. Kaposi's sarcoma: Prolonged treatment with corticosteroids has been associated with the development of Kaposi's sarcoma (case reports); if noted, discontinuation of therapy should be considered. Systemic effects: Adverse systemic effects including hyperglycemia, glycosuria, fluid and electrolyte changes, and HPA suppression may occur when used on large surface areas, for prolonged periods, or with an occlusive dressing.

Special populations: Pediatrics: Safety and efficacy have not been established in children <1 year of age. Chronic use of corticosteroids in children may interfere with growth and development. Not for the treatment of diaper dermatitis.

DRUG INTERACTIONS
Corticorelin: Corticosteroids may diminish the therapeutic effect of Corticorelin. Specifically, the plasma ACTH response to corticorelin may be blunted by recent or current corticosteroid therapy. Risk C: Monitor therapy

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Teratogenic effects have been observed in animals administered topical corticosteroids.

PRICING — (data from drugstore.com)
Cream (Aclovate)
0.05% (45): $73.99

Cream (Alclometasone Dipropionate)
0.05% (45): $38.99
0.05% (60): $52.99

Ointment (Aclovate)
0.05% (15): $44.99

Ointment (Alclometasone Dipropionate)
0.05% (15): $16.99
0.05% (60): $35.99

INTERNATIONAL BRAND NAMES — Aclosone (NL); Almeta (JP); Cloderm (ID); Delonal (DE); Demiderm (VE); Legederm (IT); Logoderm (NZ); Lomesone (GR); Miloderme (PT); Modraderm (BE); Modrasone (GB); Perderm (AE, BH, CY, EG, HK, HN, ID, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE)

MECHANISM OF ACTION — Stimulates the synthesis of enzymes needed to decrease inflammation, suppress mitotic activity, and cause vasoconstriction

PHARMACODYNAMICS / KINETICS
Absorption: Topical: ~3% absorbed systemically after 8 hours when applied to intact skin

PATIENT INFORMATION — Before applying, gently wash area to reduce risk of infection. Apply a thin film to cleansed area and rub in gently and thoroughly until medication vanishes. Avoid exposure to sunlight; severe sunburn may occur.

Albuterol

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Albuterol may be confused with Albutein®, atenolol
Proventil® may be confused with Bentyl®, Prilosec® Prinivil®
Salbutamol may be confused with salmeterol
Ventolin® may be confused with phentolamine, Benylin®, Vantin®
Volmax® may be confused with Flomax®

SPECIAL ALERTS
Stolen Medication: Albuterol Inhalation Solution Unit-Dose Vials - Updated September 18th, 2009

For information on affected NDC/lot numbers, please refer to:
Notice to pharmacists concerning theft in Texas (September 10th): http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181772.htm
Dey-issued advisory concerning theft in Florida (September 11th): http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm182091.htm
FDA advisory to consumers (September 17th): http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182846.htm

U.S. BRAND NAMES — AccuNeb®; ProAir® HFA; Proventil® HFA; Ventolin® HFA; VoSpire ER®

PHARMACOLOGIC CATEGORY
Beta2 Agonist

DOSING: ADULTS
Bronchospasm:
Metered-dose inhaler: 2 puffs every 4-6 hours as needed (NIH Guidelines, 2007):
Solution for nebulization: 2.5 mg every 4-8 hours as needed; Quick relief: 1.25-5 mg every 4 to 8 hours as needed (NIH Guidelines, 2007)
Oral: 2-4 mg/dose 3-4 times/day; maximum dose not to exceed 32 mg/day (divided doses)
Extended release: 8 mg every 12 hours; maximum dose not to exceed 32 mg/day (divided doses). A 4 mg dose every 12 hours may be sufficient in some patients, such as adults of low body weight.
I.V. continuous infusion (Ventolin® I.V. solution [not available in U.S.]): Severe bronchospasm and status asthmaticus: Initial: 5 mcg/minute; may increase up to 10-20 mcg/minute at 15- to 30-minute intervals if needed

Exacerbation of asthma (acute, severe) (NIH Guidelines, 2007):
Metered-dose inhaler: 4-8 puffs every 20 minutes for up to 4 hours, then every 1-4 hours as needed
Solution for nebulization: 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg every 1-4 hours as needed, or 10-15 mg/hour by continuous nebulization

Exercise-induced bronchospasm (prevention):Metered-dose inhaler: 2 puffs 5-30 minutes prior to exercise

DOSING: PEDIATRIC

(For additional information see "Albuterol (salbutamol): Pediatric drug information")
Bronchospasm:
Oral, regular release:
Children 2-6 years: 0.1-0.2 mg/kg/dose 3 times/day (maximum: 12 mg/day)
Children 6-12 years: 2 mg/dose 3-4 times/day (maximum 24 mg/day)
Children >12 years: 2-4 mg/dose 3-4 times/day (maximum: 32 mg/day)
Oral, extended release:
Children 6-12 years: 4 mg every 12 hours (maximum: 24 mg/day)
Children >12 years: 8 mg every 12 hours (maximum 32 mg/day)
Metered-dose inhaler (90 mcg/puff): NIH Guidelines, 2007: Quick relief:
Children ≤ 4 years: 1-2 puffs every 4-6 hours as needed
Children 5-11 years: 2 puffs every 4-6 hours as needed
Children ≥ 12 years: 2 puffs every 4-6 hours as needed
Solution for nebulization:
Manufacturer's recommendations:
Children 2-12 years (AccuNeb®): 0.63-1.25 mg every 4-6 hours as needed
Children ≥ 12 years: 2.5 mg every 4-8 hours as needed
NIH Guidelines, 2007: Quick relief:
Children ≤ 4 years: 0.63-2.5 mg every 4-6 hours as needed
Children ≥ 5 years: 1.25-5 mg every 4-8 hours as needed
I.V. (Ventolin® I.V. solution [not available in U.S.]): Dosage not established for children

Exacerbation of asthma (acute, severe) (NIH Guidelines, 2007):
Metered-dose inhaler (90 mcg/puff):
Children <12 years: 4-8 puffs every 20 minutes for 3 doses, then every 1-4 hours as needed
Children ≥ 12 years: 4-8 puffs every 20 minutes for up to 4 hours, then every 1-4 hours as needed
Solution for nebulization:
Children <12 years: 0.15 mg/kg (minimum: 2.5 mg) every 20 minutes for 3 doses, then 0.15-0.3 mg/kg (maximum: 10 mg) every 1-4 hours as needed, or 0.5 mg/kg/hour by continuous nebulization
Children ≥ 12 years: 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg every 1-4 hours as needed, or 10-15 mg/hour by continuous nebulization

Exercise-induced bronchospasm (prevention):Metered-dose inhaler (90 mcg/puff):
Children ≤ 4 years: 1-2 puffs 5 minutes prior to exercise (NIH Guidelines, 2007)
Children >4 years: 2 puffs 5-30 minutes prior to exercise

DOSING: ELDERLY
Inhalation: Refer to adult dosing.

Bronchospasm (treatment): Oral: 2 mg 3-4 times/day; maximum: 8 mg 4 times/day

DOSING: RENAL IMPAIRMENT — Not removed by hemodialysis

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product; [CAN] = Canadian brand name

Aerosol, for oral inhalation: 90 mcg/metered inhalation (17 g) [200 metered inhalations; contains chlorofluorocarbons] [DSC]

Aerosol, for oral inhalation:
ProAir® HFA: 90 mcg/metered inhalation (8.5 g) [200 metered inhalations; chlorofluorocarbon free]
Proventil® HFA: 90 mcg/metered inhalation (6.7 g) [200 metered inhalations; chlorofluorocarbon free]
Ventolin® HFA: 90 mcg/metered inhalation (8 g) [60 metered inhalation; chlorofluorocarbon free]; (18 g) [200 metered inhalations; chlorofluorocarbon free]

Injection, solution, as sulphate:
Ventolin® I.V. [CAN]: 1 mg/1mL (5 mL) [not available in U.S.]

Solution for nebulization [preservative free]: 0.021% (3 mL); 0.042% (3 mL); 0.083% (3 mL); 0.5% (0.5 mL, 20 mL)
AccuNeb®: 0.021% (3 mL); 0.042% (3 mL)

Syrup, oral: 2 mg/5 mL (480 mL)

Tablet, oral: 2 mg, 4 mg

Tablet, extended release, oral: 4 mg, 8 mg
VoSpire ER®: 4 mg, 8 mg

DOSAGE FORMS: CONCISE — [CAN] = Canadian brand name

Aerosol, for oral inhalation:
ProAir® HFA: 90 mcg/metered inhalation (8.5 g)
Proventil® HFA: 90 mcg/metered inhalation (6.7 g)
Ventolin® HFA: 90 mcg/metered inhalation (8 g, 18 g)

Injection, solution, as sulphate:
Ventolin® I.V. [CAN]: 1 mg/1mL (5 mL) [not available in U.S.]

Solution for nebulization [preservative free]: 0.021% (3 mL); 0.042% (3 mL); 0.083% (3 mL); 0.5% (0.5 mL, 20 mL)
AccuNeb®: 0.021% (3 mL); 0.042% (3 mL)

Syrup, oral: 2 mg/5 mL

Tablet, oral: 2 mg, 4 mg

Tablet, extended release, oral: 4 mg, 8 mg
VoSpire ER®: 4 mg, 8 mg

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION
Metered-dose inhaler: Shake well before use; prime prior to first use, and whenever inhaler has not been used for >2 weeks or when it has been dropped, by releasing 3-4 test sprays into the air (away from face). A spacer device or valved holding chamber is recommended for use with metered-dose inhalers.

Solution for nebulization: Concentrated solution should be diluted prior to use. Blow-by administration is not recommended, use a mask device if patient unable to hold mouthpiece in mouth for administration.

Infusion solution (Ventolin® I.V.): Do not inject undiluted. Reduce concentration by at least 50% before infusing. Administer as a continuous infusion via infusion pump. Discard unused portion of infusion within 24 hours of preparation.

Oral: Do not crush or chew extended release tablets.

COMPATIBILITY
Intravenous solution: Stable in water for injection, NS, D5W, and D5NS when mixed in PC bags or glass bottles. Avoid addition of other medications to infusion solution.

Solution for nebulization: Compatible with cromolyn sodium, budesonide inhalation suspension, ipratropium solution for nebulization

USE — Bronchodilator in reversible airway obstruction due to asthma or COPD; prevention of exercise-induced bronchospasm

USE - UNLABELED / INVESTIGATIONAL — As tocolytic agent (injectable form; not available in U.S.)

ADVERSE REACTIONS SIGNIFICANT — Incidence of adverse effects is dependent upon age of patient, dose, and route of administration.

Cardiovascular: Angina, atrial fibrillation, arrhythmias, chest discomfort, chest pain, extrasystoles, flushing, hyper-/hypotension, palpitation, supraventricular tachycardia, tachycardia

Central nervous system: CNS stimulation, dizziness, drowsiness, headache, insomnia, irritability, lightheadedness, migraine, nervousness, nightmares, restlessness, seizure

Dermatologic: Angioedema, rash, urticaria

Endocrine & metabolic: Hyperglycemia, hypokalemia, lactic acidosis

Gastrointestinal: Diarrhea, dry mouth, dyspepsia, gastroenteritis, nausea, unusual taste, vomiting

Genitourinary: Micturition difficulty

Local: Injection: Pain, stinging

Neuromuscular & skeletal: Muscle cramps, musculoskeletal pain, tremor, weakness

Otic: Otitis media, vertigo

Respiratory: Asthma exacerbation, bronchospasm, cough, epistaxis, laryngitis, oropharyngeal drying/irritation, oropharyngeal edema, pharyngitis, rhinitis, upper respiratory inflammation, viral respiratory infection

Miscellaneous: Allergic reaction, anaphylaxis, diaphoresis, lymphadenopathy

Postmarketing and/or case reports: Anxiety, glossitis, hoarseness, myocardial ischemia, pulmonary edema, throat irritation, tongue ulceration

CONTRAINDICATIONS — Hypersensitivity to albuterol, adrenergic amines, or any component of the formulation

Injection formulation (not available in U.S.): Patients with tachyarrhythmias; risk of abortion during first or second trimester

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.

Disease-related concerns: Asthma: Appropriate use: Optimize anti-inflammatory treatment before initiating maintenance treatment with albuterol. Do not use as a component of chronic therapy without an anti-inflammatory agent. Only the mildest forms of asthma (Step 1 and/or exercise-induced) would not require concurrent use based upon asthma guidelines. Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia or hypertension or HF); beta-agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2-agonists may also increase risk of arrhythmias. Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose. Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure. Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity. Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium. Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.

Special populations: Pediatrics: Face masks should be used in children <4 years of age.

Dosage form specific issues: Chlorofluorocarbons: Patient response may vary between inhalers that contain chlorofluorocarbons and those which are chlorofluorocarbon-free.

Other warnings/precautions: Appropriate use: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics. Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed. A spacer device or valved holding chamber is recommended when using a metered-dose inhaler.

DRUG INTERACTIONS
Alpha-/Beta-Blockers: May diminish the therapeutic effect of Beta2-Agonists. Risk D: Consider therapy modification

Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk D: Consider therapy modification

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Risk C: Monitor therapy

Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination

MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

ETHANOL / NUTRITION / HERB INTERACTIONS
Food: Avoid or limit caffeine (may cause CNS stimulation).

Herb/Nutraceutical: Avoid ephedra, yohimbe (may cause CNS stimulation). Avoid St John's wort (may decrease the levels/effects of albuterol).

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Albuterol crosses the placenta; tocolytic effects, fetal tachycardia, fetal hypoglycemia secondary to maternal hyperglycemia with oral or intravenous routes reported. Available evidence suggests safe use as an inhalation during pregnancy, and albuterol is the preferred short-acting beta agonist for use in asthma according to the NHLBI 2007 Guidelines for the Diagnosis and Management of Asthma.

Use of the parenteral formulation (not available in the U.S.) as a tocolytic agent has been associated with myocardial ischemia. Patients with a history of cardiac disease should be referred to a cardiologist for evaluation prior to initiating therapy in premature labor. If therapy is initiated, patients should be carefully monitored for ECG changes as well as for changes in fluid balance and cardiopulmonary function. Maternal pulse rate should not exceed 140 beats per minute during I.V. infusion of salbutamol. Consider discontinuing therapy with the development of signs of pulmonary edema or myocardial ischemia. Cautious use of parenteral salbutamol, as with other beta2-agonists, is also warranted when used during labor and delivery for the relief of bronchospasm.

LACTATION — Excretion in breast milk unknown/use caution

DIETARY CONSIDERATIONS — Oral forms should be administered with water 1 hour before or 2 hours after meals.

PRICING — (data from drugstore.com)
Aerosol solution (ProAir HFA)
108 (90 Base) mcg/ACT (8.5): $41.84

Aerosol solution (Proventil HFA)
108 (90 Base) mcg/ACT (6.7): $52.02

Aerosol solution (Ventolin HFA)
108 (90 Base) mcg/ACT (18): $37.99

Nebulization (AccuNeb)
0.63 mg/3 mL (75): $49.13
1.25 mg/3 mL (75): $50.99

Nebulization (Albuterol Sulfate)
0.63 mg/3 mL (3): $11.99
(2.5 MG/3ML) 0.083% (75): $18.99
(5 MG/ML) 0.5% (20): $15.99

Syrup (Albuterol Sulfate)
2 mg/5 mL (120): $12.99

Tablet, 12-hour (VoSpire ER)
4 mg (30): $56.59
8 mg (60): $204.08

Tablets (Albuterol Sulfate)
2 mg (90): $15.99
4 mg (100): $24.98

MONITORING PARAMETERS — FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium; asthma symptoms; arterial or capillary blood gases (if patients condition warrants)

CANADIAN BRAND NAMES — Airomir; Alti-Salbutamol; Apo-Salvent®; Apo-Salvent® CFC Free; Apo-Salvent® Respirator Solution; Apo-Salvent® Sterules; Gen-Salbutamol; PMS-Salbutamol; ratio-Inspra-Sal; ratio-Salbutamol; Rhoxal-salbutamol; Salbu-2; Salbu-4; Ventolin®; Ventolin® Diskus; Ventolin® HFA; Ventolin® I.V. Infusion; Ventrodisk

INTERNATIONAL BRAND NAMES — Aero-Vent (PH); Aerolin (BR, CN, GR); Aeromol (TH); Airmax (CO); Airomir (AU, FR, HK, LU, PL, SE, TH, UY); Antomol (TH); Asmacaire (PH); Asmadil (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW); Asmalin Pulmoneb (PH); Asmatol (AR); Asmidon (JP); Asmol CFC-Free (AU); Asmovent (MY); Assal (MX); Asthalin (IN); Asthalin HFA (HK); Asthavent (ZA); Asvimol (PH); Avedox-FC (MX); Azmacon (ID); Azmasol (SG); Bajapres (CO); Bronchosal (ID); Bronchosol (TH); Broncovaleas (IT); Bronter (CO); Brusal (MX); Brytolin (PH); Butamol (AU); Buto-Asma (ES, SG, TH); Butotal (CN); Buventol (NO, SG, TW); Buventol Easyhaler (FR, TH); Cybutol (ID); Easyhaler Salbutamol (GB, IE); Epaq Inhaler (AU); Farcolin (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Hivent DS (PH); Huma-Salmol (HU); Inbumed (MX); Libretin (PH); Medolin (SG); Mozal (TW); Provexel NS (PH); Pulmol-S (PE); Respax (NZ); Salamol (PL); Salbetol (IN); Salbron (ID); Salbulin (LU); Salbumed (PH); Salbutalan (MX); Salbutamol (HU, PL); Salbutamol-GW (HU); Salbutan (VE); Salbutin (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Salbutol (KP, PE); Salbutron SR (KP); Salbuven (ID); Salbuvent (PL); Salda (TH); Salden (EC); Salmaplon (IN); Salmundin Retard (DE); Salomol (TW); Sedalin (PH); Solia (TH); Steri-Neb Salamol (PL); Sultanol (AT, DE, JP); Suprasma (ID); Teoden (BR); Unibron (MX); Venalax (PH); Venetlin (JP); Venteze (ZA); Ventilan (PT); Ventilastin Novolizer (DE, FR); Ventodisk (LU, PL); Ventol (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Ventolin (AE, AR, AU, BB, BE, BF, BG, BH, BJ, BM, BS, BZ, CH, CI, CL, CR, CY, CZ, EC, EE, EG, ET, GH, GM, GN, GT, GY, HK, HN, HR, HU, ID, IE, IL, IQ, IR, IT, JM, JO, KE, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, NL, OM, PA, PE, PH, PK, PL, PY, QA, SA, SC, SD, SL, SN, SR, SV, SY, TH, TN, TT, TW, TZ, UG, UY, VE, YE, ZA, ZM, ZW); Ventolin CFC-Free (AU); Ventolin [tabs./sol./sir.] (PL); Ventoline (DK, FI, FR, NO, SE); Volmax (AE, BH, CY, EC, EG, HK, HU, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Zenmolin (AE, BH, CY, EG, HK, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Zibil (MX)

MECHANISM OF ACTION — Relaxes bronchial smooth muscle by action on beta2-receptors with little effect on heart rate

PHARMACODYNAMICS / KINETICS
Onset of action: Peak effect:
Nebulization/oral inhalation: 0.5-2 hours
CFC-propelled albuterol: 10 minutes
Ventolin® HFA: 25 minutes
Oral: 2-3 hours

Duration: Nebulization/oral inhalation: 3-4 hours; Oral: 4-6 hours

Metabolism: Hepatic to an inactive sulfate

Half-life elimination: Inhalation: 3.8 hours; Oral: 3.7-5 hours

Excretion: Urine (30% as unchanged drug)

PATIENT INFORMATION — Do not exceed recommended dosage. Rinse mouth with water following each inhalation to help with dry throat and mouth. Follow specific instructions accompanying inhaler; if more than one inhalation is necessary, wait at least 1 full minute between inhalations. May cause nervousness, restlessness, insomnia; if these effects continue after dosage reduction, notify prescriber. Also report palpitations, tachycardia, chest pain, muscle tremors, dizziness, headache, flushing, or if breathing difficulty persists.

Albuterol

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Albuterol may be confused with Albutein®, atenolol
Proventil® may be confused with Bentyl®, Prilosec® Prinivil®
Salbutamol may be confused with salmeterol
Ventolin® may be confused with phentolamine, Benylin®, Vantin®
Volmax® may be confused with Flomax®

SPECIAL ALERTS
Stolen Medication: Albuterol Inhalation Solution Unit-Dose Vials - Updated September 18th, 2009

For information on affected NDC/lot numbers, please refer to:
Notice to pharmacists concerning theft in Texas (September 10th): http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm181772.htm
Dey-issued advisory concerning theft in Florida (September 11th): http://www.fda.gov/NewsEvents/PublicHealthFocus/ucm182091.htm
FDA advisory to consumers (September 17th): http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm182846.htm

U.S. BRAND NAMES — AccuNeb®; ProAir® HFA; Proventil® HFA; Ventolin® HFA; VoSpire ER®

PHARMACOLOGIC CATEGORY
Beta2 Agonist

DOSING: ADULTS
Bronchospasm:
Metered-dose inhaler: 2 puffs every 4-6 hours as needed (NIH Guidelines, 2007):
Solution for nebulization: 2.5 mg every 4-8 hours as needed; Quick relief: 1.25-5 mg every 4 to 8 hours as needed (NIH Guidelines, 2007)
Oral: 2-4 mg/dose 3-4 times/day; maximum dose not to exceed 32 mg/day (divided doses)
Extended release: 8 mg every 12 hours; maximum dose not to exceed 32 mg/day (divided doses). A 4 mg dose every 12 hours may be sufficient in some patients, such as adults of low body weight.
I.V. continuous infusion (Ventolin® I.V. solution [not available in U.S.]): Severe bronchospasm and status asthmaticus: Initial: 5 mcg/minute; may increase up to 10-20 mcg/minute at 15- to 30-minute intervals if needed

Exacerbation of asthma (acute, severe) (NIH Guidelines, 2007):
Metered-dose inhaler: 4-8 puffs every 20 minutes for up to 4 hours, then every 1-4 hours as needed
Solution for nebulization: 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg every 1-4 hours as needed, or 10-15 mg/hour by continuous nebulization

Exercise-induced bronchospasm (prevention):Metered-dose inhaler: 2 puffs 5-30 minutes prior to exercise

DOSING: PEDIATRIC

(For additional information see "Albuterol (salbutamol): Pediatric drug information")
Bronchospasm:
Oral, regular release:
Children 2-6 years: 0.1-0.2 mg/kg/dose 3 times/day (maximum: 12 mg/day)
Children 6-12 years: 2 mg/dose 3-4 times/day (maximum 24 mg/day)
Children >12 years: 2-4 mg/dose 3-4 times/day (maximum: 32 mg/day)
Oral, extended release:
Children 6-12 years: 4 mg every 12 hours (maximum: 24 mg/day)
Children >12 years: 8 mg every 12 hours (maximum 32 mg/day)
Metered-dose inhaler (90 mcg/puff): NIH Guidelines, 2007: Quick relief:
Children ≤ 4 years: 1-2 puffs every 4-6 hours as needed
Children 5-11 years: 2 puffs every 4-6 hours as needed
Children ≥ 12 years: 2 puffs every 4-6 hours as needed
Solution for nebulization:
Manufacturer's recommendations:
Children 2-12 years (AccuNeb®): 0.63-1.25 mg every 4-6 hours as needed
Children ≥ 12 years: 2.5 mg every 4-8 hours as needed
NIH Guidelines, 2007: Quick relief:
Children ≤ 4 years: 0.63-2.5 mg every 4-6 hours as needed
Children ≥ 5 years: 1.25-5 mg every 4-8 hours as needed
I.V. (Ventolin® I.V. solution [not available in U.S.]): Dosage not established for children

Exacerbation of asthma (acute, severe) (NIH Guidelines, 2007):
Metered-dose inhaler (90 mcg/puff):
Children <12 years: 4-8 puffs every 20 minutes for 3 doses, then every 1-4 hours as needed
Children ≥ 12 years: 4-8 puffs every 20 minutes for up to 4 hours, then every 1-4 hours as needed
Solution for nebulization:
Children <12 years: 0.15 mg/kg (minimum: 2.5 mg) every 20 minutes for 3 doses, then 0.15-0.3 mg/kg (maximum: 10 mg) every 1-4 hours as needed, or 0.5 mg/kg/hour by continuous nebulization
Children ≥ 12 years: 2.5-5 mg every 20 minutes for 3 doses, then 2.5-10 mg every 1-4 hours as needed, or 10-15 mg/hour by continuous nebulization

Exercise-induced bronchospasm (prevention):Metered-dose inhaler (90 mcg/puff):
Children ≤ 4 years: 1-2 puffs 5 minutes prior to exercise (NIH Guidelines, 2007)
Children >4 years: 2 puffs 5-30 minutes prior to exercise

DOSING: ELDERLY
Inhalation: Refer to adult dosing.

Bronchospasm (treatment): Oral: 2 mg 3-4 times/day; maximum: 8 mg 4 times/day

DOSING: RENAL IMPAIRMENT — Not removed by hemodialysis

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product; [CAN] = Canadian brand name

Aerosol, for oral inhalation: 90 mcg/metered inhalation (17 g) [200 metered inhalations; contains chlorofluorocarbons] [DSC]

Aerosol, for oral inhalation:
ProAir® HFA: 90 mcg/metered inhalation (8.5 g) [200 metered inhalations; chlorofluorocarbon free]
Proventil® HFA: 90 mcg/metered inhalation (6.7 g) [200 metered inhalations; chlorofluorocarbon free]
Ventolin® HFA: 90 mcg/metered inhalation (8 g) [60 metered inhalation; chlorofluorocarbon free]; (18 g) [200 metered inhalations; chlorofluorocarbon free]

Injection, solution, as sulphate:
Ventolin® I.V. [CAN]: 1 mg/1mL (5 mL) [not available in U.S.]

Solution for nebulization [preservative free]: 0.021% (3 mL); 0.042% (3 mL); 0.083% (3 mL); 0.5% (0.5 mL, 20 mL)
AccuNeb®: 0.021% (3 mL); 0.042% (3 mL)

Syrup, oral: 2 mg/5 mL (480 mL)

Tablet, oral: 2 mg, 4 mg

Tablet, extended release, oral: 4 mg, 8 mg
VoSpire ER®: 4 mg, 8 mg

DOSAGE FORMS: CONCISE — [CAN] = Canadian brand name

Aerosol, for oral inhalation:
ProAir® HFA: 90 mcg/metered inhalation (8.5 g)
Proventil® HFA: 90 mcg/metered inhalation (6.7 g)
Ventolin® HFA: 90 mcg/metered inhalation (8 g, 18 g)

Injection, solution, as sulphate:
Ventolin® I.V. [CAN]: 1 mg/1mL (5 mL) [not available in U.S.]

Solution for nebulization [preservative free]: 0.021% (3 mL); 0.042% (3 mL); 0.083% (3 mL); 0.5% (0.5 mL, 20 mL)
AccuNeb®: 0.021% (3 mL); 0.042% (3 mL)

Syrup, oral: 2 mg/5 mL

Tablet, oral: 2 mg, 4 mg

Tablet, extended release, oral: 4 mg, 8 mg
VoSpire ER®: 4 mg, 8 mg

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION
Metered-dose inhaler: Shake well before use; prime prior to first use, and whenever inhaler has not been used for >2 weeks or when it has been dropped, by releasing 3-4 test sprays into the air (away from face). A spacer device or valved holding chamber is recommended for use with metered-dose inhalers.

Solution for nebulization: Concentrated solution should be diluted prior to use. Blow-by administration is not recommended, use a mask device if patient unable to hold mouthpiece in mouth for administration.

Infusion solution (Ventolin® I.V.): Do not inject undiluted. Reduce concentration by at least 50% before infusing. Administer as a continuous infusion via infusion pump. Discard unused portion of infusion within 24 hours of preparation.

Oral: Do not crush or chew extended release tablets.

COMPATIBILITY
Intravenous solution: Stable in water for injection, NS, D5W, and D5NS when mixed in PC bags or glass bottles. Avoid addition of other medications to infusion solution.

Solution for nebulization: Compatible with cromolyn sodium, budesonide inhalation suspension, ipratropium solution for nebulization

USE — Bronchodilator in reversible airway obstruction due to asthma or COPD; prevention of exercise-induced bronchospasm

USE - UNLABELED / INVESTIGATIONAL — As tocolytic agent (injectable form; not available in U.S.)

ADVERSE REACTIONS SIGNIFICANT — Incidence of adverse effects is dependent upon age of patient, dose, and route of administration.

Cardiovascular: Angina, atrial fibrillation, arrhythmias, chest discomfort, chest pain, extrasystoles, flushing, hyper-/hypotension, palpitation, supraventricular tachycardia, tachycardia

Central nervous system: CNS stimulation, dizziness, drowsiness, headache, insomnia, irritability, lightheadedness, migraine, nervousness, nightmares, restlessness, seizure

Dermatologic: Angioedema, rash, urticaria

Endocrine & metabolic: Hyperglycemia, hypokalemia, lactic acidosis

Gastrointestinal: Diarrhea, dry mouth, dyspepsia, gastroenteritis, nausea, unusual taste, vomiting

Genitourinary: Micturition difficulty

Local: Injection: Pain, stinging

Neuromuscular & skeletal: Muscle cramps, musculoskeletal pain, tremor, weakness

Otic: Otitis media, vertigo

Respiratory: Asthma exacerbation, bronchospasm, cough, epistaxis, laryngitis, oropharyngeal drying/irritation, oropharyngeal edema, pharyngitis, rhinitis, upper respiratory inflammation, viral respiratory infection

Miscellaneous: Allergic reaction, anaphylaxis, diaphoresis, lymphadenopathy

Postmarketing and/or case reports: Anxiety, glossitis, hoarseness, myocardial ischemia, pulmonary edema, throat irritation, tongue ulceration

CONTRAINDICATIONS — Hypersensitivity to albuterol, adrenergic amines, or any component of the formulation

Injection formulation (not available in U.S.): Patients with tachyarrhythmias; risk of abortion during first or second trimester

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Bronchospasm: Rarely, paradoxical bronchospasm may occur with use of inhaled bronchodilating agents; this should be distinguished from inadequate response. Hypersensitivity reactions: Immediate hypersensitivity reactions (urticaria, angioedema, rash, bronchospasm) have been reported.

Disease-related concerns: Asthma: Appropriate use: Optimize anti-inflammatory treatment before initiating maintenance treatment with albuterol. Do not use as a component of chronic therapy without an anti-inflammatory agent. Only the mildest forms of asthma (Step 1 and/or exercise-induced) would not require concurrent use based upon asthma guidelines. Cardiovascular disease: Use with caution in patients with cardiovascular disease (arrhythmia or hypertension or HF); beta-agonists may cause elevation in blood pressure, heart rate and result in CNS stimulation/excitation. Beta2-agonists may also increase risk of arrhythmias. Diabetes: Use with caution in patients with diabetes mellitus; beta2-agonists may increase serum glucose. Glaucoma: Use with caution in patients with glaucoma; may elevate intraocular pressure. Hyperthyroidism: Use with caution in hyperthyroidism; may stimulate thyroid activity. Hypokalemia: Use with caution in patients with hypokalemia; beta2-agonists may decrease serum potassium. Seizures: Use with caution in patients with seizure disorders; beta-agonists may result in CNS stimulation/excitation.

Special populations: Pediatrics: Face masks should be used in children <4 years of age.

Dosage form specific issues: Chlorofluorocarbons: Patient response may vary between inhalers that contain chlorofluorocarbons and those which are chlorofluorocarbon-free.

Other warnings/precautions: Appropriate use: Do not exceed recommended dose; serious adverse events, including fatalities, have been associated with excessive use of inhaled sympathomimetics. Patient information: Patients must be instructed to seek medical attention in cases where acute symptoms are not relieved or a previous level of response is diminished. The need to increase frequency of use may indicate deterioration of asthma, and treatment must not be delayed. A spacer device or valved holding chamber is recommended when using a metered-dose inhaler.

DRUG INTERACTIONS
Alpha-/Beta-Blockers: May diminish the therapeutic effect of Beta2-Agonists. Risk D: Consider therapy modification

Atomoxetine: May enhance the tachycardic effect of Beta2-Agonists. Risk C: Monitor therapy

Beta-Blockers (Beta1 Selective): May diminish the bronchodilatory effect of Beta2-Agonists. Of particular concern with nonselective beta-blockers or higher doses of the beta1 selective beta-blockers. Risk C: Monitor therapy

Beta-Blockers (Nonselective): May diminish the bronchodilatory effect of Beta2-Agonists. Risk D: Consider therapy modification

Betahistine: May diminish the therapeutic effect of Beta2-Agonists. Risk C: Monitor therapy

Cannabinoids: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapy

Iobenguane I 123: Sympathomimetics may diminish the therapeutic effect of Iobenguane I 123. Risk X: Avoid combination

MAO Inhibitors: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

Sympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapy

Tricyclic Antidepressants: May enhance the adverse/toxic effect of Beta2-Agonists. Risk C: Monitor therapy

ETHANOL / NUTRITION / HERB INTERACTIONS
Food: Avoid or limit caffeine (may cause CNS stimulation).

Herb/Nutraceutical: Avoid ephedra, yohimbe (may cause CNS stimulation). Avoid St John's wort (may decrease the levels/effects of albuterol).

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Albuterol crosses the placenta; tocolytic effects, fetal tachycardia, fetal hypoglycemia secondary to maternal hyperglycemia with oral or intravenous routes reported. Available evidence suggests safe use as an inhalation during pregnancy, and albuterol is the preferred short-acting beta agonist for use in asthma according to the NHLBI 2007 Guidelines for the Diagnosis and Management of Asthma.

Use of the parenteral formulation (not available in the U.S.) as a tocolytic agent has been associated with myocardial ischemia. Patients with a history of cardiac disease should be referred to a cardiologist for evaluation prior to initiating therapy in premature labor. If therapy is initiated, patients should be carefully monitored for ECG changes as well as for changes in fluid balance and cardiopulmonary function. Maternal pulse rate should not exceed 140 beats per minute during I.V. infusion of salbutamol. Consider discontinuing therapy with the development of signs of pulmonary edema or myocardial ischemia. Cautious use of parenteral salbutamol, as with other beta2-agonists, is also warranted when used during labor and delivery for the relief of bronchospasm.

LACTATION — Excretion in breast milk unknown/use caution

DIETARY CONSIDERATIONS — Oral forms should be administered with water 1 hour before or 2 hours after meals.

PRICING — (data from drugstore.com)
Aerosol solution (ProAir HFA)
108 (90 Base) mcg/ACT (8.5): $41.84

Aerosol solution (Proventil HFA)
108 (90 Base) mcg/ACT (6.7): $52.02

Aerosol solution (Ventolin HFA)
108 (90 Base) mcg/ACT (18): $37.99

Nebulization (AccuNeb)
0.63 mg/3 mL (75): $49.13
1.25 mg/3 mL (75): $50.99

Nebulization (Albuterol Sulfate)
0.63 mg/3 mL (3): $11.99
(2.5 MG/3ML) 0.083% (75): $18.99
(5 MG/ML) 0.5% (20): $15.99

Syrup (Albuterol Sulfate)
2 mg/5 mL (120): $12.99

Tablet, 12-hour (VoSpire ER)
4 mg (30): $56.59
8 mg (60): $204.08

Tablets (Albuterol Sulfate)
2 mg (90): $15.99
4 mg (100): $24.98

MONITORING PARAMETERS — FEV1, peak flow, and/or other pulmonary function tests; blood pressure, heart rate; CNS stimulation; serum glucose, serum potassium; asthma symptoms; arterial or capillary blood gases (if patients condition warrants)

CANADIAN BRAND NAMES — Airomir; Alti-Salbutamol; Apo-Salvent®; Apo-Salvent® CFC Free; Apo-Salvent® Respirator Solution; Apo-Salvent® Sterules; Gen-Salbutamol; PMS-Salbutamol; ratio-Inspra-Sal; ratio-Salbutamol; Rhoxal-salbutamol; Salbu-2; Salbu-4; Ventolin®; Ventolin® Diskus; Ventolin® HFA; Ventolin® I.V. Infusion; Ventrodisk

INTERNATIONAL BRAND NAMES — Aero-Vent (PH); Aerolin (BR, CN, GR); Aeromol (TH); Airmax (CO); Airomir (AU, FR, HK, LU, PL, SE, TH, UY); Antomol (TH); Asmacaire (PH); Asmadil (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM, ZW); Asmalin Pulmoneb (PH); Asmatol (AR); Asmidon (JP); Asmol CFC-Free (AU); Asmovent (MY); Assal (MX); Asthalin (IN); Asthalin HFA (HK); Asthavent (ZA); Asvimol (PH); Avedox-FC (MX); Azmacon (ID); Azmasol (SG); Bajapres (CO); Bronchosal (ID); Bronchosol (TH); Broncovaleas (IT); Bronter (CO); Brusal (MX); Brytolin (PH); Butamol (AU); Buto-Asma (ES, SG, TH); Butotal (CN); Buventol (NO, SG, TW); Buventol Easyhaler (FR, TH); Cybutol (ID); Easyhaler Salbutamol (GB, IE); Epaq Inhaler (AU); Farcolin (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Hivent DS (PH); Huma-Salmol (HU); Inbumed (MX); Libretin (PH); Medolin (SG); Mozal (TW); Provexel NS (PH); Pulmol-S (PE); Respax (NZ); Salamol (PL); Salbetol (IN); Salbron (ID); Salbulin (LU); Salbumed (PH); Salbutalan (MX); Salbutamol (HU, PL); Salbutamol-GW (HU); Salbutan (VE); Salbutin (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Salbutol (KP, PE); Salbutron SR (KP); Salbuven (ID); Salbuvent (PL); Salda (TH); Salden (EC); Salmaplon (IN); Salmundin Retard (DE); Salomol (TW); Sedalin (PH); Solia (TH); Steri-Neb Salamol (PL); Sultanol (AT, DE, JP); Suprasma (ID); Teoden (BR); Unibron (MX); Venalax (PH); Venetlin (JP); Venteze (ZA); Ventilan (PT); Ventilastin Novolizer (DE, FR); Ventodisk (LU, PL); Ventol (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Ventolin (AE, AR, AU, BB, BE, BF, BG, BH, BJ, BM, BS, BZ, CH, CI, CL, CR, CY, CZ, EC, EE, EG, ET, GH, GM, GN, GT, GY, HK, HN, HR, HU, ID, IE, IL, IQ, IR, IT, JM, JO, KE, KW, LB, LR, LU, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, NL, OM, PA, PE, PH, PK, PL, PY, QA, SA, SC, SD, SL, SN, SR, SV, SY, TH, TN, TT, TW, TZ, UG, UY, VE, YE, ZA, ZM, ZW); Ventolin CFC-Free (AU); Ventolin [tabs./sol./sir.] (PL); Ventoline (DK, FI, FR, NO, SE); Volmax (AE, BH, CY, EC, EG, HK, HU, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Zenmolin (AE, BH, CY, EG, HK, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Zibil (MX)

MECHANISM OF ACTION — Relaxes bronchial smooth muscle by action on beta2-receptors with little effect on heart rate

PHARMACODYNAMICS / KINETICS
Onset of action: Peak effect:
Nebulization/oral inhalation: 0.5-2 hours
CFC-propelled albuterol: 10 minutes
Ventolin® HFA: 25 minutes
Oral: 2-3 hours

Duration: Nebulization/oral inhalation: 3-4 hours; Oral: 4-6 hours

Metabolism: Hepatic to an inactive sulfate

Half-life elimination: Inhalation: 3.8 hours; Oral: 3.7-5 hours

Excretion: Urine (30% as unchanged drug)

PATIENT INFORMATION — Do not exceed recommended dosage. Rinse mouth with water following each inhalation to help with dry throat and mouth. Follow specific instructions accompanying inhaler; if more than one inhalation is necessary, wait at least 1 full minute between inhalations. May cause nervousness, restlessness, insomnia; if these effects continue after dosage reduction, notify prescriber. Also report palpitations, tachycardia, chest pain, muscle tremors, dizziness, headache, flushing, or if breathing difficulty persists.

Albumin:

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Albutein® may be confused with albuterol
Buminate® may be confused with bumetanide

U.S. BRAND NAMES — Albumarc®; Albuminar®; AlbuRx™ ; Albutein®; Buminate®; Flexbumin; Plasbumin®

PHARMACOLOGIC CATEGORY
Blood Product Derivative
Plasma Volume Expander, Colloid

DOSING: ADULTS
Note: Use 5% solution in hypovolemic patients or intravascularly-depleted patients. Use 25% solution in patients in whom fluid and sodium intake is restricted.

Usual dose: 25 g; initial dose may be repeated in 15-30 minutes if response is inadequate; no more than 250 g should be administered within 48 hours.

Hypoproteinemia: I.V.: 0.5-1 g/kg/dose; repeat every 1-2 days as calculated to replace ongoing losses.

Hypovolemia: 5% albumin: 0.5-1 g/kg/dose; repeat as needed. Note: May be considered after inadequate response to crystalloid therapy and when nonprotein colloids are contraindicated. The volume administered and the speed of infusion should be adapted to individual response.

DOSING: PEDIATRIC

(For additional information see "Albumin: Pediatric drug information")
Note:5% should be used in hypovolemic patients or intravascularly-depleted patients. 25% should be used in patients in whom fluid and sodium intake must be minimized.

Dose depends on condition of patient: Hypovolemia: I.V.: 0.5-1 g/kg/dose (10-20 mL/kg/dose of albumin 5%); maximum dose: 6 g/kg/day

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [preservative free; human]: 5% (250 mL, 500 mL); 25% (50 mL, 100 mL)
Albuminar®: 5% (50 mL, 250 mL, 500 mL) [50 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 1 mEq/L; packaging contains dry natural rubber]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 1 mEq/L; packaging contains dry natural rubber]
AlbuRx™ : 5% (250 mL, 500 mL) [50 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]; 25% (50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]
Albutein®: 5% (250 mL, 500 mL) [50 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]
Buminate®: 5% (250 mL, 500 mL) [50 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L; packaging contains dry natural rubber]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L; packaging contains dry natural rubber]
Flexbumin: 25% (50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]
Human Albumin Grifols®: 25% (50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]
Plasbumin®: 5% (50 mL, 250 mL) [50 mg/mL; contains sodium ~145 mEq/L and potassium ≤ 2 mEq/L]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL; contains sodium ~145 mEq/L and potassium ≤ 2 mEq/L]

DOSAGE FORMS: CONCISE
Injection, solution [preservative free; human]: 5% (250 mL, 500 mL); 25% (50 mL, 100 mL)
Albuminar®: 5% (50 mL, 250 mL, 500 mL) [50 mg/mL]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL]
AlbuRx™ : 5% (250 mL, 500 mL) [50 mg/mL]; 25% (50 mL, 100 mL) [250 mg/mL]
Albutein®: 5% (250 mL, 500 mL) [50 mg/mL]
Buminate®: 5% (250 mL, 500 mL) [50 mg/mL]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL]
Flexbumin: 25% (50 mL, 100 mL) [250 mg/mL]
Human Albumin Grifols®: 25% (50 mL, 100 mL) [250 mg/mL]
Plasbumin®: 5% (50 mL, 250 mL) [50 mg/mL]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL]

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — For I.V. administration only. Use within 4 hours after opening vial; discard unused portion. In emergencies, may administer as rapidly as necessary to improve clinical condition. After initial volume replacement:
5%: Do not exceed 2-4 mL/minute in patients with normal plasma volume; 5-10 mL/minute in patients with hypoproteinemia
25%: Do not exceed 1 mL/minute in patients with normal plasma volume; 2-3 mL/minute in patients with hypoproteinemia

Do not dilute 5% solution. Rapid infusion may cause vascular overload. Albumin 25% may be given undiluted or diluted in normal saline. May give in combination or through the same administration set as saline or carbohydrates. Do not use with ethanol or protein hydrolysates, precipitation may form.

COMPATIBILITY — Stable in dextran 6% in D5W, dextran 6% in NS, D5LR, D5NS, D51/2NS, D51/4NS, D5W, D10W, LR, NS, 1/2NS; incompatible with sterile water.

Y-site administration: Compatible: Diltiazem, lorazepam. Incompatible: Midazolam, vancomycin, verapamil.

Compatibility when admixed: Compatible: TPN. Incompatible: Verapamil.

USE — Plasma volume expansion and maintenance of cardiac output in the treatment of certain types of shock or impending shock; may be useful for burn patients, ARDS, and cardiopulmonary bypass; other uses considered by some investigators (but not proven) are retroperitoneal surgery, peritonitis, and ascites; unless the condition responsible for hypoproteinemia can be corrected, albumin can provide only symptomatic relief or supportive treatment

USE - UNLABELED / INVESTIGATIONAL — In cirrhotics, administered with diuretics to help facilitate diuresis; large volume paracentesis; volume expansion in dehydrated, mildly-hypotensive cirrhotics

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: CHF precipitation, edema, hyper-/hypotension, hypervolemia, tachycardia

Central nervous system: Chills, fever, headache

Dermatologic: Pruritus, rash, urticaria

Gastrointestinal: Nausea, vomiting

Respiratory: Bronchospasm, pulmonary edema

Miscellaneous: Anaphylaxis

CONTRAINDICATIONS — Hypersensitivity to albumin or any component of the formulation; patients with severe anemia or cardiac failure

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Hypervolemia: All patients should be observed for signs of hypervolemia such as pulmonary edema; monitor closely with rapid infusions.

Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment; protein load may exacerbate or precipitate encephalopathy. Renal impairment: Use with caution in patients with renal impairment; protein load may precipitate azotemia.

Special populations: Preterm infants: Avoid 25% concentration in preterm infants due to risk of intraventricular hemorrhage. Sodium restricted patients: Use with caution in those patients for whom sodium restriction is necessary.

Other warnings/precautions: Nutritional supplementation: Is not an appropriate indication for albumin.

DRUG INTERACTIONS — There are no known significant interactions.

PREGNANCY RISK FACTOR — C (show table)

LACTATION — Excretion in breast milk unknown/compatible

DIETARY CONSIDERATIONS
Albumarc®, Albuminar®, Albutein®, Buminate®, Flexbumin: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium 130-160 mEq/L

Plasbumin®: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium ~145 mEq/L

MONITORING PARAMETERS — Blood pressure, pulmonary edema, hematocrit

CANADIAN BRAND NAMES — Plasbumin®-25; Plasbumin®-5

INTERNATIONAL BRAND NAMES — Alba (IN); Albapure (ID, TW); Albotein (IT); Albuman (PE); Albumer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, PH, SC, SD, SL, SN, TH, TN, TZ, UG, ZA, ZM, ZW); Albumex (AU); Albumin 5% (CH); Albumin 5% Human (DE); Albumin Human Salzarm 25% (DE); Albumina Humana (BR); Albuminar (BR, IL); Albuminate (ID); Albuminativ (NO); Alburaas (TH); Albutein 25% (BR, HK); Buminate 25% (HK); Flexbumin (SE); Human Albumin (AT); Human albumin (PL); Human Albumin 25% (DE); Human Albumin 5% (CZ, DE); Human Albumin ZLB (DK); Humanalbumin 5% (AT); Makroalbumina (PL); Octalbin (DK, FI, ID, MX); Plasbumin (ID); Seralbumin (CO, CR, DO, GT, HN, PA, SV); SRK (CH); Taninal (PL); Tanninum albuminatum (PL); Vialebex (FR); Volumin (IN)

MECHANISM OF ACTION — Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space

Albumin:

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Albutein® may be confused with albuterol
Buminate® may be confused with bumetanide

U.S. BRAND NAMES — Albumarc®; Albuminar®; AlbuRx™ ; Albutein®; Buminate®; Flexbumin; Plasbumin®

PHARMACOLOGIC CATEGORY
Blood Product Derivative
Plasma Volume Expander, Colloid

DOSING: ADULTS
Note: Use 5% solution in hypovolemic patients or intravascularly-depleted patients. Use 25% solution in patients in whom fluid and sodium intake is restricted.

Usual dose: 25 g; initial dose may be repeated in 15-30 minutes if response is inadequate; no more than 250 g should be administered within 48 hours.

Hypoproteinemia: I.V.: 0.5-1 g/kg/dose; repeat every 1-2 days as calculated to replace ongoing losses.

Hypovolemia: 5% albumin: 0.5-1 g/kg/dose; repeat as needed. Note: May be considered after inadequate response to crystalloid therapy and when nonprotein colloids are contraindicated. The volume administered and the speed of infusion should be adapted to individual response.

DOSING: PEDIATRIC

(For additional information see "Albumin: Pediatric drug information")
Note:5% should be used in hypovolemic patients or intravascularly-depleted patients. 25% should be used in patients in whom fluid and sodium intake must be minimized.

Dose depends on condition of patient: Hypovolemia: I.V.: 0.5-1 g/kg/dose (10-20 mL/kg/dose of albumin 5%); maximum dose: 6 g/kg/day

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Injection, solution [preservative free; human]: 5% (250 mL, 500 mL); 25% (50 mL, 100 mL)
Albuminar®: 5% (50 mL, 250 mL, 500 mL) [50 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 1 mEq/L; packaging contains dry natural rubber]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 1 mEq/L; packaging contains dry natural rubber]
AlbuRx™ : 5% (250 mL, 500 mL) [50 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]; 25% (50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]
Albutein®: 5% (250 mL, 500 mL) [50 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]
Buminate®: 5% (250 mL, 500 mL) [50 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L; packaging contains dry natural rubber]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L; packaging contains dry natural rubber]
Flexbumin: 25% (50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]
Human Albumin Grifols®: 25% (50 mL, 100 mL) [250 mg/mL; contains sodium 130-160 mEq/L and potassium ≤ 2 mEq/L]
Plasbumin®: 5% (50 mL, 250 mL) [50 mg/mL; contains sodium ~145 mEq/L and potassium ≤ 2 mEq/L]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL; contains sodium ~145 mEq/L and potassium ≤ 2 mEq/L]

DOSAGE FORMS: CONCISE
Injection, solution [preservative free; human]: 5% (250 mL, 500 mL); 25% (50 mL, 100 mL)
Albuminar®: 5% (50 mL, 250 mL, 500 mL) [50 mg/mL]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL]
AlbuRx™ : 5% (250 mL, 500 mL) [50 mg/mL]; 25% (50 mL, 100 mL) [250 mg/mL]
Albutein®: 5% (250 mL, 500 mL) [50 mg/mL]
Buminate®: 5% (250 mL, 500 mL) [50 mg/mL]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL]
Flexbumin: 25% (50 mL, 100 mL) [250 mg/mL]
Human Albumin Grifols®: 25% (50 mL, 100 mL) [250 mg/mL]
Plasbumin®: 5% (50 mL, 250 mL) [50 mg/mL]; 25% (20 mL, 50 mL, 100 mL) [250 mg/mL]

GENERIC EQUIVALENT AVAILABLE — Yes

ADMINISTRATION — For I.V. administration only. Use within 4 hours after opening vial; discard unused portion. In emergencies, may administer as rapidly as necessary to improve clinical condition. After initial volume replacement:
5%: Do not exceed 2-4 mL/minute in patients with normal plasma volume; 5-10 mL/minute in patients with hypoproteinemia
25%: Do not exceed 1 mL/minute in patients with normal plasma volume; 2-3 mL/minute in patients with hypoproteinemia

Do not dilute 5% solution. Rapid infusion may cause vascular overload. Albumin 25% may be given undiluted or diluted in normal saline. May give in combination or through the same administration set as saline or carbohydrates. Do not use with ethanol or protein hydrolysates, precipitation may form.

COMPATIBILITY — Stable in dextran 6% in D5W, dextran 6% in NS, D5LR, D5NS, D51/2NS, D51/4NS, D5W, D10W, LR, NS, 1/2NS; incompatible with sterile water.

Y-site administration: Compatible: Diltiazem, lorazepam. Incompatible: Midazolam, vancomycin, verapamil.

Compatibility when admixed: Compatible: TPN. Incompatible: Verapamil.

USE — Plasma volume expansion and maintenance of cardiac output in the treatment of certain types of shock or impending shock; may be useful for burn patients, ARDS, and cardiopulmonary bypass; other uses considered by some investigators (but not proven) are retroperitoneal surgery, peritonitis, and ascites; unless the condition responsible for hypoproteinemia can be corrected, albumin can provide only symptomatic relief or supportive treatment

USE - UNLABELED / INVESTIGATIONAL — In cirrhotics, administered with diuretics to help facilitate diuresis; large volume paracentesis; volume expansion in dehydrated, mildly-hypotensive cirrhotics

ADVERSE REACTIONS SIGNIFICANT — Frequency not defined.

Cardiovascular: CHF precipitation, edema, hyper-/hypotension, hypervolemia, tachycardia

Central nervous system: Chills, fever, headache

Dermatologic: Pruritus, rash, urticaria

Gastrointestinal: Nausea, vomiting

Respiratory: Bronchospasm, pulmonary edema

Miscellaneous: Anaphylaxis

CONTRAINDICATIONS — Hypersensitivity to albumin or any component of the formulation; patients with severe anemia or cardiac failure

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Hypervolemia: All patients should be observed for signs of hypervolemia such as pulmonary edema; monitor closely with rapid infusions.

Disease-related concerns: Hepatic impairment: Use with caution in patients with hepatic impairment; protein load may exacerbate or precipitate encephalopathy. Renal impairment: Use with caution in patients with renal impairment; protein load may precipitate azotemia.

Special populations: Preterm infants: Avoid 25% concentration in preterm infants due to risk of intraventricular hemorrhage. Sodium restricted patients: Use with caution in those patients for whom sodium restriction is necessary.

Other warnings/precautions: Nutritional supplementation: Is not an appropriate indication for albumin.

DRUG INTERACTIONS — There are no known significant interactions.

PREGNANCY RISK FACTOR — C (show table)

LACTATION — Excretion in breast milk unknown/compatible

DIETARY CONSIDERATIONS
Albumarc®, Albuminar®, Albutein®, Buminate®, Flexbumin: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium 130-160 mEq/L

Plasbumin®: 5% [50 mg/mL] and 25% [250 mg/mL] contain sodium ~145 mEq/L

MONITORING PARAMETERS — Blood pressure, pulmonary edema, hematocrit

CANADIAN BRAND NAMES — Plasbumin®-25; Plasbumin®-5

INTERNATIONAL BRAND NAMES — Alba (IN); Albapure (ID, TW); Albotein (IT); Albuman (PE); Albumer (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, PH, SC, SD, SL, SN, TH, TN, TZ, UG, ZA, ZM, ZW); Albumex (AU); Albumin 5% (CH); Albumin 5% Human (DE); Albumin Human Salzarm 25% (DE); Albumina Humana (BR); Albuminar (BR, IL); Albuminate (ID); Albuminativ (NO); Alburaas (TH); Albutein 25% (BR, HK); Buminate 25% (HK); Flexbumin (SE); Human Albumin (AT); Human albumin (PL); Human Albumin 25% (DE); Human Albumin 5% (CZ, DE); Human Albumin ZLB (DK); Humanalbumin 5% (AT); Makroalbumina (PL); Octalbin (DK, FI, ID, MX); Plasbumin (ID); Seralbumin (CO, CR, DO, GT, HN, PA, SV); SRK (CH); Taninal (PL); Tanninum albuminatum (PL); Vialebex (FR); Volumin (IN)

MECHANISM OF ACTION — Provides increase in intravascular oncotic pressure and causes mobilization of fluids from interstitial into intravascular space

Albendazole

MEDICATION SAFETY ISSUES
Sound-alike/look-alike issues:
Albenza® may be confused with Aplenzin™ , Relenza®

International issues:
Albenza® may be confused with Avanza® which is a brand name for mirtazapine in Australia

U.S. BRAND NAMES — Albenza®

PHARMACOLOGIC CATEGORY
Anthelmintic

DOSING: ADULTS
Neurocysticercosis: Oral:
<60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day) for 8-30 days
≥ 60 kg: 800 mg/day in 2 divided doses for 8-30 days
Note: Give concurrent anticonvulsant and steroid therapy during first week.

Hydatid: Oral:
<60 kg: 15 mg/kg/day in 2 divided doses (maximum: 800 mg/day)
≥ 60 kg: 800 mg/day in 2 divided doses
Note: Administer dose for three 28-day cycles with a 14-day drug-free interval in between. The manufacturer recommends a total of 3 cycles.

Ancylostoma caninum, Ascaris lumbricoides(roundworm), Ancylostoma duodenale (hookworm), and Necator americanus(hookworm) (unlabeled use): Oral: 400 mg as a single dose

Clonorchis sinensis(Chinese liver fluke) (unlabeled use): Oral: 10 mg/kg for 7 days

Cutaneous larva migrans (unlabeled use): Oral: 400 mg once daily for 3 days

Enterobius vermicularis(pinworm) (unlabeled use): Oral: 400 mg as a single dose; may repeat in 2 weeks

Gnathostoma spinigerum (unlabeled use): Oral: 800 mg/day in 2 divided doses for 21 days

Gongylonemiasis (unlabeled use): Oral: 10 mg/kg/day for 3 days

Mansonella perstans(unlabeled use): Oral: 800 mg/day in 2 divided doses for 10 days

Visceral larva migrans (toxocariasis) (unlabeled use): Oral: 800 mg/day in 2 divided doses for 5 days

Cysticercus cellulosae(unlabeled use): Oral: 800 mg/day in 2 divided doses for 8-30 days; may be repeated as necessary

Disseminated microsporidiosis (unlabeled use): Oral: 800 mg/day in 2 divided doses

Echinococcus granulosus(tapeworm) (unlabeled use): Oral: 800 mg/day in 2 divided doses for 1-6 months

Intestinal microsporidiosis (unlabeled use): Oral: 800 mg/day in 2 divided doses for 21 days

Ocular microsporidiosis (unlabeled use): Oral: 800 mg/day in 2 divided doses, in combination with fumagillin

DOSING: PEDIATRIC

(For additional information see "Albendazole: Pediatric drug information")
Neurocysticercosis: Oral: Refer to adult dosing.

Hydatid: Oral: Refer to adult dosing.

Cysticercus cellulosae(unlabeled use): Oral: 15 mg/kg/day (maximum: 800 mg/day) in 2 divided doses for 8-30 days; may be repeated as necessary

Echinococcus granulosus(tapeworm) (unlabeled use): Oral: 15 mg/kg/day (maximum: 800 mg) divided twice daily for 1-6 months

For the following unlabeled uses, refer to adult dosing:
Ancylostoma caninum, Ascaris lumbricoides (roundworm), Ancylostoma duodenale (hookworm), Clonorchis sinensis, (Chinese liver fluke), cutaneous larva migrans, Enterobius vermicularis (pinworm), Gnathostoma spinigerum, gongylonemiasis, Mansonella perstans, Necator americanus (hookworm), visceral larva migrans (toxocariasis)

DOSING: ELDERLY — Refer to adult dosing.

DOSAGE FORMS — Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet:
Albenza®: 200 mg

DOSAGE FORMS: CONCISE
Tablet:
Albenza®: 200 mg

GENERIC EQUIVALENT AVAILABLE — No

ADMINISTRATION — Should be administered with a high-fat meal. Administer anticonvulsant and steroid therapy during first week of neurocysticercosis therapy. If patients have difficulty swallowing, tablets may be crushed or chewed, then swallowed with a drink of water.

USE — Treatment of parenchymal neurocysticercosis caused by Taenia solium and cystic hydatid disease of the liver, lung, and peritoneum caused by Echinococcus granulosus

USE - UNLABELED / INVESTIGATIONAL — Albendazole has activity against Ascaris lumbricoides (roundworm); Ancylostoma caninum; Ancylostoma duodenale and Necator americanus (hookworms); cutaneous larva migrans; Enterobius vermicularis (pinworm); Gnathostoma spinigerum; Gongylonema sp; Mansonella perstans (filariasis); Opisthorchis sinensis (liver fluke); visceral larva migrans (toxocariasis); activity has also been shown against the liver fluke Clonorchis sinensis, Giardia lamblia, Cysticercus cellulosae, and Echinococcus multilocularis. Albendazole has also been used for the treatment of intestinal microsporidiosis (Encephalitozoon intestinalis), disseminated microsporidiosis (E. hellem, E. cuniculi, E. intestinalis, Pleistophora sp, Trachipleistophora sp, Brachiola vesicularum), and ocular microsporidiosis (E. hellem, E. cuniculi, Vittaforma corneae).

ADVERSE REACTIONS SIGNIFICANT
>10%:
Central nervous system: Headache (11% neurocysticercosis; 1% hydatid)
Hepatic: LFTs increased (16% hydatid; <1% neurocysticercosis)

1% to 10%:
Central nervous system: Intracranial pressure increased (up to 2%), dizziness (≤ 1%), fever (≤ 1%), vertigo (≤ 1%), meningeal signs (1%)
Dermatologic: Alopecia (<1% to 2%)
Gastrointestinal: Abdominal pain (up to 6%), nausea/vomiting (4% to 6%)

<1% (Limited to important or life-threatening symptoms): Acute liver failure, acute renal failure, aplastic anemia, agranulocytosis, erythema multiforme, granulocytopenia, hepatitis, hypersensitivity reaction, leukopenia, neutropenia, pancytopenia, rash, Stevens-Johnson syndrome, thrombocytopenia, urticaria

CONTRAINDICATIONS — Hypersensitivity to albendazole, benzimidazoles, or any component of the formulation

WARNINGS / PRECAUTIONS
Concerns related to adverse effects: Bone marrow suppression: Agranulocytosis, aplastic anemia, granulocytopenia, leukopenia, and pancytopenia have occurred leading to fatalities (rare); use with caution in patients with hepatic impairment (more susceptible to hematologic toxicity). Discontinue therapy in all patients who develop clinically significant decreases in blood cell counts. Transaminase elevations: Reversible elevations in hepatic enzymes have been reported. Patients with abnormal LFTs and hepatic echinococcosis are at an increased risk of hepatotoxicity. Discontinue therapy if LFT elevations are >2 times the upper limit of normal; may consider restarting treatment (with frequent monitoring of LFTs) when hepatic enzymes return to pretreatment values.

Disease-related concerns: Neurocysticercosis: Appropriate use: Corticosteroids should be administered before or upon initiation of albendazole therapy to minimize inflammatory reactions and prevent cerebral hypertension. Anticonvulsant therapy should be used concurrently during the first week of therapy to prevent seizures. If retinal lesions exist, weigh risk of further retinal damage due to albendazole-induced changes to the retinal lesion vs benefit of disease treatment.

METABOLISM / TRANSPORT EFFECTS — Substrate (minor) of CYP1A2, 3A4; Inhibits CYP1A2 (weak)

DRUG INTERACTIONS
Aminoquinolines (Antimalarial): May decrease the serum concentration of Anthelmintics. Risk C: Monitor therapy

ETHANOL / NUTRITION / HERB INTERACTIONS — Food: Albendazole serum levels may be increased if taken with a fatty meal (increases the oral bioavailability by up to 5 times).

PREGNANCY RISK FACTOR — C (show table)

PREGNANCY IMPLICATIONS — Albendazole has been shown to be teratogenic in laboratory animals and should not be used during pregnancy, if at all possible. Women should be advised to avoid pregnancy for at least 1 month following therapy. Discontinue if pregnancy occurs during treatment.

LACTATION — Excretion in breast milk unknown/not recommended

DIETARY CONSIDERATIONS — Should be taken with a high-fat meal.

PRICING — (data from drugstore.com)
Tablets (Albenza)
200 mg (12): $26.99

MONITORING PARAMETERS — Monitor fecal specimens for ova and parasites for 3 weeks after treatment; if positive, retreat; LFTs and CBC with differential at start of each 28-day cycle and every 2 weeks during therapy (more frequent monitoring for patients with liver disease); pregnancy test

INTERNATIONAL BRAND NAMES — ABZ (IN); Acure (PK); Albatel (TH); Alben (BR); Albenzol (EC); Albex (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Albezole (IN); Alfuca (TH); Almex (MY); Alminth (IN); Alzental (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SG, SY, YE); Alzol (TH); Bendex-400 (ZA); Benzol (PH); Bruzol (MX); Ceprazol (CN); Champs D-Worm 6 (MY); Ciclopar (CO); Dalben (HR); Digezanol (MX); Emanthal (IN); Eskasole (MX); Eskazole (AT, AU, DE, ES, GB, IL, JP, NL); Fintel (PE); Gascop (MX); Helmiben (UY); Helmidazole (AE, BH, CY, EG, IL, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE); Labenda (TH); Lomsin (MX); Lurdex (MX); Mebenix (BR); Mesin-C (MY); Nemozole (IN); Pantex (PY); Paranthil (ZA); Parhel (CR, DO, GT, HN, NI, PA, SV); Rotopar (EC); Sioban (IN); Valbazen Vet (NO); Vastus (AR); Vemizol (MY); Vermin Plus (MX); Zeben (TH); Zela (TH); Zentab (TH); Zentel (AE, AU, BB, BF, BG, BH, BJ, BM, BR, BS, BZ, CH, CI, CL, CN, CR, CY, CZ, DO, EG, ET, FR, GH, GM, GN, GR, GT, GY, HN, IL, IQ, IR, IT, JM, JO, KE, KP, KW, LB, LR, LY, MA, ML, MR, MU, MW, MX, MY, NE, NG, NI, NL, OM, PA, PE, PH, PL, PR, PT, QA, SA, SC, SD, SL, SN, SR, SV, SY, TH, TN, TT, TZ, UG, VE, YE, ZA, ZM, ZW)

MECHANISM OF ACTION — Active metabolite, albendazole sulfoxide, causes selective degeneration of cytoplasmic microtubules in intestinal and tegmental cells of intestinal helminths and larvae; glycogen is depleted, glucose uptake and cholinesterase secretion are impaired, and desecratory substances accumulate intracellulary. ATP production decreases causing energy depletion, immobilization, and worm death.

PHARMACODYNAMICS / KINETICS
Absorption: Poor; may increase up to 5 times when administered with a fatty meal

Distribution: Well inside hydatid cysts and CSF

Protein binding: 70%

Metabolism: Hepatic; extensive first-pass effect; pathways include rapid sulfoxidation to active metabolite (albendazole sulfoxide [major]), hydrolysis, and oxidation

Half-life elimination: 8-12 hours

Time to peak, serum: 2-5 hours

Excretion: Urine (<1% as active metabolite); feces