VENTOLIN HFA- albuterol sulfate aerosol, metered

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

ALBUTEROL SULFATE (UNII: 021SEF3731) (ALBUTEROL - UNII:QF8SVZ843E)

Dostopno od:

REMEDYREPACK INC.

Pot uporabe:

RESPIRATORY (INHALATION)

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

VENTOLIN HFA is indicated for the treatment or prevention of bronchospasm in adult and pediatric patients aged 4 years and older with reversible obstructive airway disease. VENTOLIN HFA is indicated for the prevention of exercise-induced bronchospasm in adult and pediatric patients aged 4 years and older. VENTOLIN HFA is contraindicated in patients with a history of hypersensitivity to any of the ingredients [see Warnings and Precautions ( 5.6), Description ( 11)] . Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to asthma medications during pregnancy. For more information, contact the MotherToBaby Pregnancy Studies conducted by the Organization of Teratology Information Specialists at 1‑877-311-8972 or visit https://mothertobaby.org/ongoing-study/asthma/. Risk Summary There are no randomized clinical studies of use of albuterol sulfate during pregnancy. Available data from epidemiological studies and postmarketing case reports of pregnancy outcomes following inhaled albuterol use do not consistently demonstrate a risk of major birth defects or miscarriage. There are, however, clinical considerations in pregnant women with asthma. (See Clinical Considerations.) Administration of VENTOLIN HFA to mice and rabbits during the period of organogenesis revealed evidence of adverse developmental outcomes (cleft palate in mice, delayed ossification in rabbits) at less than the maximum recommended human daily inhaled dose (MRHDID). (See Data.) The estimated background risk of major birth defects and miscarriage for the indicated population(s) is unknown. In the U.S. general population, the estimated risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-Associated Maternal and/or Embryofetal Risk: In women with poorly or moderately controlled asthma, there is an increased risk of several perinatal adverse outcomes such as preeclampsia in the mother and prematurity, low birth weight, and small for gestational age in the neonate. Pregnant women with asthma should be closely monitored and medication adjusted as necessary to maintain optimal asthma control. Labor or Delivery: Because of the potential for beta-agonist interference with uterine contractility, use of VENTOLIN HFA during labor should be restricted to those patients in whom the benefits clearly outweigh the risk. VENTOLIN HFA has not been approved for the management of pre-term labor. Serious adverse reactions, including pulmonary edema, have been reported during or following treatment of premature labor with beta 2 -agonists, including albuterol. Data Human Data: While available studies cannot definitively establish the absence of risk, published data from epidemiological studies and case reports have not consistently demonstrated an association with use of VENTOLIN HFA during pregnancy and major birth defects, specific birth defects, or miscarriage. The available studies have methodologic limitations, including inconsistent comparator groups, definitions of outcomes, and assessment of disease impact. Animal Data: In a study in pregnant mice, subcutaneously administered albuterol sulfate produced cleft palate formation in 5 of 111 (4.5%) fetuses at an exposure less than the MRHDID for adults (on a mg/m 2 basis at a maternal dose of 0.25 mg/kg) and in 10 of 108 (9.3%) fetuses at approximately 9 times the MRHDID (on a mg/m 2 basis at a maternal dose of 2.5 mg/kg). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with isoproterenol, another beta 2 -agonist. In a study in pregnant rabbits, orally administered albuterol sulfate produced cranioschisis in 7 of 19 fetuses (37%) at approximately 750 times the MRHDID (on a mg/m 2 basis at a maternal dose of 50 mg/kg). In a study in pregnant rabbits, an albuterol/HFA-134a formulation administered by inhalation produced enlargement of the frontal portion of the fetal fontanelles at approximately one third of the MRHDID on a mg/m 2 basis. A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus. Risk Summary There are no available data on the presence of albuterol or the components of VENTOLIN HFA in human milk, the effects on the breastfed child, or the effects on milk production. However, plasma levels of albuterol after inhaled therapeutic doses are low in humans, and if present in breast milk, are likely to be correspondingly low [see Clinical Pharmacology (12.3)] . The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VENTOLIN HFA and any potential adverse effects on the breastfed child from VENTOLIN HFA or from the underlying maternal condition. The safety and effectiveness of VENTOLIN HFA for treatment or prevention of bronchospasm and for prevention of exercised-induced bronchospasm in pediatric patients aged 4 years and older have been established. Use of VENTOLIN HFA for this indication is supported by evidence from adequate and well-controlled studies of two 12-week clinical trials in subjects aged 12 years and older with asthma and one 2-week clinical trial in subjects aged 4 to 11 years with asthma [see Adverse Reactions (6.1), Clinical Studies (14.1)]. The safety and effectiveness of VENTOLIN HFA in pediatric patients younger than 4 years have not been established. Three trials have been conducted to evaluate the safety and efficacy of VENTOLIN HFA in subjects younger than 4 years and the findings are described below. Two 4-week randomized, double-blind, placebo-controlled trials were conducted in 163 pediatric subjects aged from birth to 48 months with symptoms of bronchospasm associated with obstructive airway disease (presenting symptoms included: wheeze, cough, dyspnea, or chest tightness). VENTOLIN HFA or placebo HFA was delivered with either an AeroChamber Plus Valved Holding Chamber or an Optichamber Valved Holding Chamber with mask 3 times daily. In one trial, VENTOLIN HFA 90 mcg (n = 26), VENTOLIN HFA 180 mcg (n = 25), and placebo HFA (n = 26) were administered to children aged between 24 and 48 months. In the second trial, VENTOLIN HFA 90 mcg (n = 29), VENTOLIN HFA 180 mcg (n = 29), and placebo HFA (n = 28) were administered to children aged between birth and 24 months. Over the 4-week treatment period, there were no treatment differences in asthma symptom scores between the groups receiving VENTOLIN HFA 90 mcg, VENTOLIN HFA 180 mcg, and placebo in either trial. In a third trial, VENTOLIN HFA was evaluated in 87 pediatric subjects younger than 24 months for the treatment of acute wheezing. VENTOLIN HFA was delivered with an AeroChamber Plus Valved Holding Chamber in this trial. There were no significant differences in asthma symptom scores and mean change from baseline in an asthma symptom score between VENTOLIN HFA 180 mcg and VENTOLIN HFA 360 mcg. In vitro dose characterization studies were performed to evaluate the delivery of VENTOLIN HFA via holding chambers with attached masks. The studies were conducted with 2 different holding chambers with masks (small and medium size). The in vitro study data when simulating patient breathing suggest that the dose of VENTOLIN HFA presented for inhalation via a valved holding chamber with mask will be comparable to the dose delivered in adults without a spacer and mask per kilogram of body weight (Table 2). However, clinical trials in children younger than 4 years described above suggest that either the optimal dose of VENTOLIN HFA has not been defined in this age group or VENTOLIN HFA is not effective in this age group. The safety and effectiveness of VENTOLIN HFA administered with or without a spacer device in children younger than 4 years have not been demonstrated. Age Mask Flow Rate (L/min) Holding Time (seconds) Mean Medication Delivery through AeroChamber Plus (mcg/actuation) Body Weight 50 th Percentile (kg) a Medication Delivered per Actuation (mcg/kg) b 6 to 12 Months Small 4.9 18.2 7.5-9.9 1.8-2.4 2 19.8 2.0-2.6 5 13.8 1.4-1.8 10 15.4 1.6-2.1 2 to 5 Years Small 8.0 17.8 12.3-18.0 1.0-1.4 2 16.0 0.9-1.3 5 16.3 0.9-1.3 10 18.3 1.0-1.5 2 to 5 Years Medium 8.0 21.1 12.3-18.0 1.2-1.7 2 15.3 0.8-1.2 5 18.3 1.0-1.5 10 18.2 1.0-1.5 >5 Years Medium 12.0 26.8 18.0 1.5 2 20.9 1.2 5 19.6 1.1 10 20.3 1.1 Clinical trials of VENTOLIN HFA did not include sufficient numbers of subjects aged 65 years and older to determine whether older subjects respond differently than younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Povzetek izdelek:

VENTOLIN HFA is supplied in the following boxes of 1 as a pressurized aluminum canister fitted with a counter and supplied with a blue plastic actuator with a blue cap: Each inhaler is packaged with a Patient Information leaflet. The blue actuator supplied with VENTOLIN HFA should not be used with any other product canisters, and actuators from other products should not be used with a VENTOLIN HFA canister. Counter VENTOLIN HFA has a counter attached to the canister. The counter starts at 204 or 064 and counts down each time a spray is released. The correct amount of medication in each actuation cannot be assured after the counter reads 000, even though the canister is not completely empty and will continue to operate. The inhaler should be discarded when the counter reads 000. Contents Under Pressure Do not puncture. Do not use or store near heat or open flame. Exposure to temperatures above 120°F may cause bursting. Never throw canister into fire or incinerator. NDC: 70518-1237-00 PACKAGING: 1 in 1 CARTON, 60 in 1 INHALER TYPE 2 Storage Store at room temperature between 68°F and 77°F (20°C and 25°C); excursions permitted from 59°F to 86°F (15°C to 30°C) [See USP Controlled Room Temperature]. Store the inhaler with the mouthpiece down. For best results, the inhaler should be at room temperature before use. Repackaged and Distributed By: Remedy Repack, Inc. 625 Kolter Dr. Suite #4 Indiana, PA 1-724-465-8762

Status dovoljenje:

New Drug Application

Lastnosti izdelka

VENTOLIN HFA- ALBUTEROL SULFATE AEROSOL, METERED
REMEDYREPACK INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
VENTOLIN HFA SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR VENTOLIN HFA.
VENTOLIN HFA (ALBUTEROL SULFATE INHALATION AEROSOL), FOR ORAL
INHALATION USE
INITIAL U.S. APPROVAL: 1981
INDICATIONS AND USAGE
VENTOLIN HFA is a beta
-adrenergic agonist indicated for:
Treatment or prevention of bronchospasm in adult and pediatric
patients aged 4 years and older with
reversible obstructive airway disease. ( 1.1)
Prevention of exercise-induced bronchospasm in adult and pediatric
patients aged 4 years and older. (
1.2)
DOSAGE AND ADMINISTRATION
For oral inhalation only. ( 2)
Treatment or prevention of bronchospasm in adult and pediatric
patients aged 4 years and older: 2
inhalations by oral inhalation every 4 to 6 hours. For some patients,
1 inhalation every 4 hours may be
sufficient. ( 2.1)
Prevention of exercise-induced bronchospasm in adult and pediatric
patients aged 4 years and older: 2
inhalations by oral inhalation 15 to 30 minutes before exercise. (
2.2)
Priming information: Prime VENTOLIN HFA before using for the first
time, when the inhaler has not been
used for more than 2 weeks, or when the inhaler has been dropped. To
prime VENTOLIN HFA, release 4
sprays into the air away from the face, shaking well before each
spray. ( 2.3)
Cleaning information: At least once a week, wash the actuator with
warm water and let it air-dry
completely. ( 2.3)
DOSAGE FORMS AND STRENGTHS
Inhalation aerosol: 108 mcg albuterol sulfate (90 mcg albuterol base)
per actuation. ( 3)
CONTRAINDICATIONS
Hypersensitivity to any ingredient. ( 4)
WARNINGS AND PRECAUTIONS
Life-threatening paradoxical bronchospasm may occur. Discontinue
VENTOLIN HFA immediately and
institute alternative therapy. ( 5.1)
Need for more doses of VENTOLIN HFA than usual may be a sign of
deterioration of asthma and
requires reevaluation of treatment. ( 5.2)
VENTOLIN HFA is not a s