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Proventil HFA
Overview
What is Proventil HFA?
The active component of PROVENTIL HFA (albuterol sulfate)
Inhalation Aerosol is albuteraol sulfate, USP racemic α
[(Butylamino)methyl]-4-hydroxy--xylene-α,α'-diol sulfate (2:1)(salt), a relatively
selective beta-adrenergic bronchodilator having the
following chemical structure:
Albuterol sulfate is the official generic name in the United States. The
World Health Organization recommended name for the drug is salbutamol sulfate.
The molecular weight of albuterol sulfate is 576.7, and the empirical formula is
(CH NO)•HSO. Albuterol sulfate is a white to off-white crystalline solid.
It is soluble in water and slightly soluble in ethanol. PROVENTIL HFA Inhalation
Aerosol is a pressurized metered-dose aerosol unit for oral inhalation. It
contains a microcrystalline suspension of albuterol sulfate in propellant
HFA-134a (1,1,1,2-tetrafluoroethane), ethanol, and oleic acid.
Each actuation delivers 120 mcg albuteraol sulfate, USP from the valve and
108 mcg albuteraol sulfate, USP from the mouthpiece (equivalent to 90 mcg of
albuterol base from the mouthpiece). Each canister provides 200 inhalations. It
is recommended to prime the inhaler before using for the first time and in cases
where the inhaler has not been used for more than 2 weeks by releasing four
“test sprays” into the air, away from the face.
This product does not contain chlorofluorocarbons (CFCs) as the propellant.
What does Proventil HFA look like?
What are the available doses of Proventil HFA?
Sorry No records found.
What should I talk to my health care provider before I take Proventil HFA?
Sorry No records found
How should I use Proventil HFA?
PROVENTIL HFA Inhalation Aerosol is indicated in adults and children 4 years of
age and older for the treatment or prevention of bronchospasm with reversible
obstructive airway disease and for the prevention of exercise-induced
bronchospasm.
For treatment of acute episodes of bronchospasm or prevention of
asthmatic symptoms, the usual dosage for adults and children 4 years of age and
older is two inhalations repeated every 4 to 6 hours. More frequent
administration or a larger number of inhalations is not recommended. In some
patients, one inhalation every 4 hours may be sufficient. Each actuation of
PROVENTIL HFA Inhalation Aerosol delivers 108 mcg of albuterol sulfate
(equivalent to 90 mcg of albuterol base) from the mouthpiece. It is recommended
to prime the inhaler before using for the first time and in cases where the
inhaler has not been used for more than 2 weeks by releasing four “test sprays”
into the air, away from the face.
Exercise Induced Bronchospasm Prevention:
To maintain proper use of this product, it is important that the mouthpiece
be washed and dried thoroughly at least once a week. The inhaler may cease to
deliver medication if not properly cleaned and dried thoroughly. See . Keeping the
plastic mouthpiece clean is very important to prevent medication build-up and
blockage. The inhaler may cease to deliver medication if not properly cleaned
and air dried thoroughly. If the mouthpiece becomes blocked, washing the
mouthpiece will remove the blockage.
If a previously effective dose regimen fails to provide the usual response,
this may be a marker of destabilization of asthma and requires reevaluation of
the patient and the treatment regimen, giving special consideration to the
possible need for anti-inflammatory treatment, eg, corticosteroids.
What interacts with Proventil HFA?
PROVENTIL HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other PROVENTIL HFA components.
What are the warnings of Proventil HFA?
Array
1. Paradoxical Bronchospasm:
2. Deterioration of Asthma:
3. Use of Anti-inflammatory Agents:
4. Cardiovascular Effects:
5. Do Not Exceed Recommended Dose:
6. Immediate Hypersensitivity Reactions:
What are the precautions of Proventil HFA?
General
Large doses of intravenous albuterol have been reported to aggravate
preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists,
albuterol may produce significant hypokalemia in some patients, possibly through
intracellular shunting, which has the potential to produce adverse
cardiovascular effects. The decrease is usually transient, not requiring
supplementation.
Information for Patients
It is recommended to prime the inhaler before using for the first time and in
cases where the inhaler has not been used for more than 2 weeks by releasing
four “test sprays” into the air, away from the face.
KEEPING THE PLASTIC MOUTHPIECE CLEAN IS VERY IMPORTANT TO PREVENT MEDICATION
BUILD-UP AND BLOCKAGE. THE MOUTHPIECE SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS
WATER, AND AIR DRIED THOROUGHLY AT LEASE ONCE A WEEK. INHALER MAY CEASE TO
DELIVER MEDICATION IF NOT PROPERLY CLEANED.
The mouthpiece should be cleaned (with the canister removed) by running warm
water through the top and bottom for 30 seconds at least once a week. The
mouthpiece must be shaken to remove excess water, then air dried thoroughly
(such as overnight). Blockage from medication build-up or improper medication
delivery may result from failure to thoroughly air dry the mouthpiece.
If the mouthpiece should become blocked (little or no medication coming out
of the mouthpiece), the blockage may be removed by washing as described
above.
If it is necessary to use the inhaler before it is completely dry, shake off
excess water, replace canister, test spray twice away from face, and take the
prescribed dose. After such use, the mouthpiece should be rewashed and allowed
to air dry thoroughly.
The action of PROVENTIL HFA Inhalation Aerosol should last up to 4 to 6
hours. PROVENTIL HFA Inhalation Aerosol should not be used more frequently than
recommended. Do not increase the dose or frequency of doses of PROVENTIL HFA
Inhalation Aerosol without consulting your physician. If you find that treatment
with PROVENTIL HFA Inhalation Aerosol becomes less effective for symptomatic
relief, your symptoms become worse, and/or you need to use the product more
frequently than usual, medical attention should be sought immediately. While you
are taking PROVENTIL HFA Inhalation Aerosol, other inhaled drugs and asthma
medications should be taken only as directed by your physician.
Common adverse effects of treatment with inhaled albuterol include
palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are
pregnant or nursing, contact your physician about use of PROVENTIL HFA
Inhalation Aerosol. Effective and safe use of PROVENTIL HFA Inhalation Aerosol
includes an understanding of the way that it should be administered. Use
PROVENTIL HFA Inhalation Aerosol only with the actuator supplied with the
product. Discard the canister after 200 sprays have been used.
In general, the technique for administering PROVENTIL HFA
Inhalation Aerosol to children is similar to that for adults. Children should
use PROVENTIL HFA Inhalation Aerosol under adult supervision, as instructed by
the patient's physician.
1. Beta Blockers:
2. Diuretics:
3. Albuterol-Digoxin:
4. Monoamine Oxidase Inhibitors or Tricyclic
Antidepressants:
In a 2-year study in Sprague-Dawley rats, albuterol sulfate
caused a dose-related increase in the incidence of benign leiomyomas of the
mesovarium at the above dietary doses of 2 mg/kg (approximately 15 times the
maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 6 times the maximum recommended daily
inhalation dose for children on a mg/mbasis). In another
study this effect was blocked by the coadministration of propranolol, a
nonselective beta-adrenergic antagonist. In an 18-month study in CD-1 mice,
albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to
500 mg/kg (approximately 1700 times the maximum recommended daily inhalation
dose for adults on a mg/mbasis ans approximately 800
times the maximum recommended daily inhalation dose for children on a mg/mbasis). In a 22-month study in Golden Hamsters, albuterol
sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg
(approximately 225 times the maximum recommended daily inhalation dose for
adults on a mg/mbasis and approximately 110 times the
maximum recommended daily inhalation dose for children on a mg/mbasis).
Albuterol sulfate was not mutagenic in the Ames test or a mutation test in
yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte
assay or in an AH1 strain mouse micronucleus assay.
Reproduction studies in rats demonstrated no evidence of impaired fertility
at oral doses up to 50 mg/kg (approximately 340 times the maximum recommended
daily inhalation dose for adults on a mg/mbasis).
Albuterol sulfate has been shown to be teratogenic in mice. A
study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate
formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum
recommended daily inhalation dose for adults on a mg/mbasis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg
(approximately 8 times the maximum recommended daily inhalation dose for adults
on a mg/mbasis). The drug did not induce cleft palate
formation at a dose of 0.025 mg/kg (less than the maximum recommended daily
inhalation dose for adults on a mg/mbasis). Cleft palate
also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously
with 2.5 mg/kg of isoproterenol (positive control).
A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of
19 (37%) fetuses when albuterol sulfate was administered orally at 50 mg/kg dose
(approximately 680 times the maximum recommended daily inhalation dose for
adults on a mg/mbasis).
In an inhalation reproduction study in Sprague-Dawley rats, the albuterol
sulfate/HFA-134a formulation did not exhibit any teratogenic effects at 10.5
mg/kg (approximately 70 times the maximum recommended daily inhalation dose for
adults on a mg/mbasis).
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.
There are no adequate and well-controlled studies of PROVENTIL HFA Inhalation
Aerosol or albuterol sulfate in pregnant women. PROVENTIL HFA Inhalation Aerosol
should be used during pregnancy only if the potential benefit justifies the
potential risk to the fetus.
During worldwide marketing experience, various congenital anomalies,
including cleft palate and limb defects, have been reported in the offspring of
patients being treated with albuterol. Some of the mothers were taking multiple
medications during their pregnancies. Because no consistent pattern of defects
can be discerned, a relationship between albuterol use and congenital anomalies
has not been established.
Because of the potential for beta-agonist interference with
uterine contractility, use of PROVENTIL HFA Inhalation Aerosol for relief of
bronchospesm during labor should be restricted to those patients in whom the
benefits clearly outweigh the risk.
Tocolysis:
Plasma levels of albuterol sulfate and HFA-134a after inhaled
therapeutic doses are very low in humans, but it is not known whether the
components of PROVENTIL HFA Inhalation Aerosol are excreated in human milk.
Because of the potential for tumorigenicity shown for albuterol in animal
studies and lack of experience with the use of PROVENTIL HFA Inhalation Aerosol
by nursing mothers, a decision should be made whether to discontinue nursing or
to discontinue the drug, taking into account the importance of the drug to the
mother. Caution should be exercised when albuterol sulfate is administered to a
nursing woman.
The safety and effectiveness of PROVENTIL HFA Inhalation Aerosol
in pediatric patients below the age of 4 years have not been established.
PROVENTIL HFA Inhalation Aerosol has not been studied in a
geriatric population. As with other beta-agonists,
special caution should be observed when using PROVENTIL HFA Inhalation Aerosol
in elderly patients who have concomitant cardiovascular disease that could be
adversely affected by this class of drug.
What are the side effects of Proventil HFA?
Adverse reaction information concerning PROVENTIL HFA Inhalation Aerosol is
derived from a 12-week, double-blind, double-dummy study which compared
PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and
an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists
the incidence of all adverse events (whether considered by the investigator drug
related or unrelated to drug) from this study which occurred at a rate of 3% or
greater in the PROVENTIL HFA Inhalation Aerosol treatment group and more
frequently in the PROVENTIL HFA Inhalation Aerosol treatment group than in the
placebo group. Overall, the incidence and nature of the adverse reactions
reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled
albuterol inhaler were comparable.
* This table includes all adverse events (whether considered by the investigator drug
related or unrelated to drug) which occurred at an incidence rate of at least
3.0% in the PROVENTIL HFA Inhalation Aerosol group and more frequently in the
PROVENTIL HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler
group.
Array
Adverse events reported by less than 3% of the patients receiving PROVENTIL
HFA Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA Inhalation
Aerosol patients thatn placebo patients, which have the potential to be related
to PROVENTIL HFA Inhalation Aerosol include: dysphonia, increased sweating, dry
mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesias, eructation,
flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash.
Palpitation and dizziness have also been observed with PROVENTIL HFA Inhalation
Aerosol.
Adverse events reported in a 4-week pediatric clinical trail comparing
PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler
occurred at a low incidence rate and were similar to those seen in the adult
trials.
In small, cumulative dose studies, tremor, nervousness, and headache appeared
to be dose related.
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal
edema have been reported after the use of inhaled albuterol. In addition,
albuterol, like other sympathomimetic agents, can cause adverse reactions such
as hypertension, angina, vertigo, central nervous system stimulation, insomnia,
headache, and drying or irritation of the oropharynx.
| Body System/Adverse Event (Preferred Term) | PROVENTILHFAInhalationAerosol(N=193) | CFC 11/12PropelledAlbuterolInhaler(N=186) | HFA-134aPlaceboInhaler(N=186) | ||||
| Application Site Disorders | Inhalation Site Sensation | 6 | 9 | 2 | |||
| Inhalation Taste Sensation | 4 | 3 | 3 | ||||
| Body as a Whole | AllergicReaction/Symptoms | 6 | 4 | less than1 | |||
| Central and Peripheral Nervous System | Tremor | 7 | 8 | 2 | |||
| Gastrointestinal System | Nausea Vomiting | 10 7 | 9 2 | 5 3 | |||
| Heart Rate and Rhythm Disorder | Tachycardia | 7 | 2 | less than 1 | |||
| Psychiatric Disorders | Nervousness | 7 | 9 | 3 | |||
| Respiratory System Disorders | Respiratory Disorder(unspecified) Rhinitis Upper Resp Tract Infection | 6 16 21 | 4 22 20 | 5 14 18 | |||
| Urinary System Disorder | Urinary Tract Infection | 3 | 4 | 2 |
What should I look out for while using Proventil HFA?
PROVENTIL HFA Inhalation Aerosol is contraindicated in patients with a history
of hypersensitivity to albuterol or any other PROVENTIL HFA components.
1. Paradoxical Bronchospasm:
2. Deterioration of Asthma:
3. Use of Anti-inflammatory Agents:
4. Cardiovascular Effects:
5. Do Not Exceed Recommended Dose:
6. Immediate Hypersensitivity Reactions:
What might happen if I take too much Proventil HFA?
The expected symptoms with overdosage are those of excessive
beta-adrenergic stimulation and/or occurrence or exaggeration of any of the
symptoms listed under , eg, seizures, angina, hypertension or hypotension,
tachycardia with rates up to 200 beats per minute, arrhythmias, nervousness,
headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise,
and insomnia.
Hypokalemia may also occur. As with all sympathomimetic medications, cardiac
arrest and even death may be associated with abuse of PROVENTIL HFA Inhalation
Aerosol. Treatment consists of discontinuation of PROVENTIL HFA Inhalation
Aerosol together with appropriate symptomatic therapy. The judicious use of a
cardioselective bete-receptor blocker may be considered, bearing in mind that
such medication can produce bronchospasm. There is insufficient evidence to
determine if dialysis is beneficial for overdosage of PROVENTIL HFA Inhalation
Aerosol.
The oral median lethal dose of albuterol sulfate in mice is greater than 2000
mg/kg (approximately 6800 times the maximum recommended daily inhalation dose
for adults on a mg/mbasis and approximately 3200 times
the maximum recommended daily inhalation dose for children on a mg/mbasis). In mature rats, the subcutaneous median lethal dose of
albuterol sulfate is approximately 450 mg/kg (approximately 3000 times the
maximum recommended daily inhalation dose for adults on a mg/mbasis and approximately 1400 times the maximum recommended
daily inhalation dose for children on a mg/mbasis). In
young rats, the subcutaneous median lethal dose is approximately 2000 mg/kg
(approximately 14,000 times the maximum recommended daily inhalation dose for
adults on a mg/mbasis and approximately 64000 times the
maximum recommended daily inhalation dose for children on a mg/mbasis). The inhalation median lethal dose has not been
determined in animals.
How should I store and handle Proventil HFA?
Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].PROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USAPROVENTIL HFA (albuterol sulfate) Inhalation Aerosol is supplied as a pressurized aluminum canister with a yellow plastic actuator and orange dust cap each in boxes of one. Each actuation delivers 120 mcg of albuterol sulfate from the valve and 108 mcg of albuterol sulfate from the mouthpiece (equivalent to 90 mcg of albuterol base). Canisters with a labeled net weight of 6.7 g contain 200 inhalations ().Rx only. Store between 15° and 25°C (59° and 77°F). For best results, canister should be at room temperature before use.SHAKE WELL BEFORE USING.The yellow actuator supplied with PROVENTIL HFA Inhalation Aerosol should not be used with any other product caniter, and actuator from other products should not be used with a PROVENTIL HFA Inhalation Aerosol canister. The correct amount of medication in each canister cannot be assured after 200 actuations, even though the canister is not completely empty. The canister should be discarded when the labeled number of actuations have been used.WARNING: Avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Exposure to temperatures above 120°F may cause bursting. Keep out of reach of children.PROVENTIL HFA Inhalation Aerosol does not contain chlorfluorocarbons (CFCs) as the propellant.Developed and Manufactured by3M Health Care LimitedLoughborough UKor3M Drug Delivery SytemsNorthridge, CA 91324orLaboratoires 3MSante Pithiviers FRforSchering CorporationKenilworth, NJ 07033 USA
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Mechanism of Action
In vitro
in vivo
Activation of beta-adrenergic receptors on airway
smooth muscle leads to the activation of adenylcyclase and to an increase in the
intracellular concentration of cyclic-3',5'-adenosine monophosphate (cyclic
AMP). This increase of cyclic AMP leads to the activation of protein kinase A,
which inhabits the phosphorylation of myosin and lowers intracellular ionic
calcium concentrations, resulting in relaxation. Albuterol relaxes the smooth
muscles of all airways, from the trachea to the terminal bronchioles. Albuterol
acts as a functional antagonist to relax the airway irrespective of the
spasmogen involved, thus protecting against all bronchoconstricor challenges.
Increased cyclic AMP concentrations are also associated with the inhibition of
release of mediators from mast cells in the airway.
Albuterol has been shown in most clinical trials to have more effect on the
respiratory tract, in the form of bronchial smooth muscle relaxation, than
isoproterenol at comparable doses while producing fewer cardiovascular effects.
Controlled clinical studies and other clinical experience have shown that
inhaled albuterol, like other beta-adrenergic agonist drugs, can produce a
significant cardiovascular effect in some patients, as measured by pulse rate,
blood pressure, symptoms, and/or electrocardiographic changes.
Preclinical
Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated
the occurrence of cardiac arrhythmias and sudden death (with histologic evidence
of myocardial necrosis) when β-agonist and methylxanthines were administered
concurrently. The clinical significance of these findings is unknown.
Propellant HFA-134a is devoid of pharmacological activity except at very high
doses in animals (380-1300 times the maximum human exposure based on comparisons
of AUC values), primarily producing ataxia, tremors, dyspnea, or salivation.
These are similar to effects produced by the structurally related
chlorofluorocarbons (CFCs), which have been used extensively in metered dose
inhalers.
In animals and humans, propellant HFA-134a was found to be rapidly absorbed
and rapidly eliminated, with an elimination half-life of 3 to 27 minutes in
animals and 5 to 7 minutes in humans. Time to maximum plasma concentration
(Tmax) and mean residence time are both extremely short leading to a transient
appearance of HFA-134a in the blood with no evidence of accumulation.
Pharmacokinetics
Clinical Trials
Serial FEV measurements (shown below as percent
change from test-day baseline) demonstrated that two inhalations of PROVENTIL
HFA Inhalation Aerosol produced significantly greater improvement in pulmonary
function than placebo and produced outcomes which were clinically comparable to
a CFC 11/12 propelled albuterol inhaler.
The mean time to onset of a 15% increase in FEV was 6
minutes and the mean time to peak effect was 50 to 55 minutes. The mean duration
of effect as measured by a 15% increase in FEV was 3
hours. In some patients, duration of effect was as long as 6 hours.
In another clinical study in adults, two inhalations of PROVENTIL HFA
Inhalation Aerosol taken 30 minutes before exercise prevented exercise-induced
bronchospasm as demonstrated by the maintenance of FEV
within 80% of baseline values in the majority of patients.
In a 4-week, randomized, open-label trial, 63 children, 4 to 11 years of age,
with asthma were evaluated for the bronchodilator efficacy of PROVENTIL HFA
Inhalation Aerosol (33 pediatric patients) in comparison to a CFC 11/12
propelled albuterol inhaler (30 pediatric patients).
Serial FEV measurements as percent change from
test-day baseline demonstrated that two inhalations of PROVENTIL HFA Inhalation
Aerosol produced outcomes which were clinically comparable to a CFC 11/12
propelled albuterol inhaler.
The mean time to onset of a 12% increase in FEV for
PROVENTIL HFA Inhalation Aerosol was 7 minutes and the mean time to peak effect
was approximately 50 minutes. The mean duration of effect as measured by a 12%
increase in FEV was 2.3 hours. In some pediatric
patients, duration of effect was as long as 6 hours.
In another clinical study in pediatric patients, two inhalations of PROVENTIL
HFA Inhalation Aerosol taken 30 minutes before exercise provided comparable
protection against exercise-induced bronchospasm as a CFC 11/12 propelled
albuterol inhaler.
Non-Clinical Toxicology
PROVENTIL HFA Inhalation Aerosol is contraindicated in patients with a history of hypersensitivity to albuterol or any other PROVENTIL HFA components.1. Paradoxical Bronchospasm:
2. Deterioration of Asthma:
3. Use of Anti-inflammatory Agents:
4. Cardiovascular Effects:
5. Do Not Exceed Recommended Dose:
6. Immediate Hypersensitivity Reactions:
The concurrent administration of allopurinol and ampicillin increases substantially the incidence of skin rashes in patients receiving both drugs as compared to patients receiving ampicillin alone. It is not known whether this potentiation of ampicillin rashes is due to allopurinol or the hyperuricemia present in these patients.
General
Large doses of intravenous albuterol have been reported to aggravate preexisting diabetes mellitus and ketoacidosis. As with other beta-agonists, albuterol may produce significant hypokalemia in some patients, possibly through intracellular shunting, which has the potential to produce adverse cardiovascular effects. The decrease is usually transient, not requiring supplementation.
Information for Patients
It is recommended to prime the inhaler before using for the first time and in cases where the inhaler has not been used for more than 2 weeks by releasing four “test sprays” into the air, away from the face.
KEEPING THE PLASTIC MOUTHPIECE CLEAN IS VERY IMPORTANT TO PREVENT MEDICATION BUILD-UP AND BLOCKAGE. THE MOUTHPIECE SHOULD BE WASHED, SHAKEN TO REMOVE EXCESS WATER, AND AIR DRIED THOROUGHLY AT LEASE ONCE A WEEK. INHALER MAY CEASE TO DELIVER MEDICATION IF NOT PROPERLY CLEANED.
The mouthpiece should be cleaned (with the canister removed) by running warm water through the top and bottom for 30 seconds at least once a week. The mouthpiece must be shaken to remove excess water, then air dried thoroughly (such as overnight). Blockage from medication build-up or improper medication delivery may result from failure to thoroughly air dry the mouthpiece.
If the mouthpiece should become blocked (little or no medication coming out of the mouthpiece), the blockage may be removed by washing as described above.
If it is necessary to use the inhaler before it is completely dry, shake off excess water, replace canister, test spray twice away from face, and take the prescribed dose. After such use, the mouthpiece should be rewashed and allowed to air dry thoroughly.
The action of PROVENTIL HFA Inhalation Aerosol should last up to 4 to 6 hours. PROVENTIL HFA Inhalation Aerosol should not be used more frequently than recommended. Do not increase the dose or frequency of doses of PROVENTIL HFA Inhalation Aerosol without consulting your physician. If you find that treatment with PROVENTIL HFA Inhalation Aerosol becomes less effective for symptomatic relief, your symptoms become worse, and/or you need to use the product more frequently than usual, medical attention should be sought immediately. While you are taking PROVENTIL HFA Inhalation Aerosol, other inhaled drugs and asthma medications should be taken only as directed by your physician.
Common adverse effects of treatment with inhaled albuterol include palpitations, chest pain, rapid heart rate, tremor, or nervousness. If you are pregnant or nursing, contact your physician about use of PROVENTIL HFA Inhalation Aerosol. Effective and safe use of PROVENTIL HFA Inhalation Aerosol includes an understanding of the way that it should be administered. Use PROVENTIL HFA Inhalation Aerosol only with the actuator supplied with the product. Discard the canister after 200 sprays have been used.
In general, the technique for administering PROVENTIL HFA Inhalation Aerosol to children is similar to that for adults. Children should use PROVENTIL HFA Inhalation Aerosol under adult supervision, as instructed by the patient's physician.
1. Beta Blockers:
2. Diuretics:
3. Albuterol-Digoxin:
4. Monoamine Oxidase Inhibitors or Tricyclic Antidepressants:
In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a dose-related increase in the incidence of benign leiomyomas of the mesovarium at the above dietary doses of 2 mg/kg (approximately 15 times the maximum recommended daily inhalation dose for adults on a mg/m basis and approximately 6 times the maximum recommended daily inhalation dose for children on a mg/mbasis). In another study this effect was blocked by the coadministration of propranolol, a nonselective beta-adrenergic antagonist. In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 500 mg/kg (approximately 1700 times the maximum recommended daily inhalation dose for adults on a mg/mbasis ans approximately 800 times the maximum recommended daily inhalation dose for children on a mg/mbasis). In a 22-month study in Golden Hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses of up to 50 mg/kg (approximately 225 times the maximum recommended daily inhalation dose for adults on a mg/mbasis and approximately 110 times the maximum recommended daily inhalation dose for children on a mg/mbasis).
Albuterol sulfate was not mutagenic in the Ames test or a mutation test in yeast. Albuterol sulfate was not clastogenic in a human peripheral lymphocyte assay or in an AH1 strain mouse micronucleus assay.
Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses up to 50 mg/kg (approximately 340 times the maximum recommended daily inhalation dose for adults on a mg/mbasis).
Albuterol sulfate has been shown to be teratogenic in mice. A study in CD-1 mice given albuterol sulfate subcutaneously showed cleft palate formation in 5 of 111 (4.5%) fetuses at 0.25 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/mbasis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately 8 times the maximum recommended daily inhalation dose for adults on a mg/mbasis). The drug did not induce cleft palate formation at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/mbasis). Cleft palate also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg of isoproterenol (positive control).
A reproduction study in Stride Dutch rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol sulfate was administered orally at 50 mg/kg dose (approximately 680 times the maximum recommended daily inhalation dose for adults on a mg/mbasis).
In an inhalation reproduction study in Sprague-Dawley rats, the albuterol sulfate/HFA-134a formulation did not exhibit any teratogenic effects at 10.5 mg/kg (approximately 70 times the maximum recommended daily inhalation dose for adults on a mg/mbasis).
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.
There are no adequate and well-controlled studies of PROVENTIL HFA Inhalation Aerosol or albuterol sulfate in pregnant women. PROVENTIL HFA Inhalation Aerosol should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
During worldwide marketing experience, various congenital anomalies, including cleft palate and limb defects, have been reported in the offspring of patients being treated with albuterol. Some of the mothers were taking multiple medications during their pregnancies. Because no consistent pattern of defects can be discerned, a relationship between albuterol use and congenital anomalies has not been established.
Because of the potential for beta-agonist interference with uterine contractility, use of PROVENTIL HFA Inhalation Aerosol for relief of bronchospesm during labor should be restricted to those patients in whom the benefits clearly outweigh the risk.
Tocolysis:
Plasma levels of albuterol sulfate and HFA-134a after inhaled therapeutic doses are very low in humans, but it is not known whether the components of PROVENTIL HFA Inhalation Aerosol are excreated in human milk.
Because of the potential for tumorigenicity shown for albuterol in animal studies and lack of experience with the use of PROVENTIL HFA Inhalation Aerosol by nursing mothers, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother. Caution should be exercised when albuterol sulfate is administered to a nursing woman.
The safety and effectiveness of PROVENTIL HFA Inhalation Aerosol in pediatric patients below the age of 4 years have not been established.
PROVENTIL HFA Inhalation Aerosol has not been studied in a geriatric population. As with other beta-agonists, special caution should be observed when using PROVENTIL HFA Inhalation Aerosol in elderly patients who have concomitant cardiovascular disease that could be adversely affected by this class of drug.
Adverse reaction information concerning PROVENTIL HFA Inhalation Aerosol is derived from a 12-week, double-blind, double-dummy study which compared PROVENTIL HFA Inhalation Aerosol, a CFC 11/12 propelled albuterol inhaler, and an HFA-134a placebo inhaler in 565 asthmatic patients. The following table lists the incidence of all adverse events (whether considered by the investigator drug related or unrelated to drug) from this study which occurred at a rate of 3% or greater in the PROVENTIL HFA Inhalation Aerosol treatment group and more frequently in the PROVENTIL HFA Inhalation Aerosol treatment group than in the placebo group. Overall, the incidence and nature of the adverse reactions reported for PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler were comparable.
* This table includes all adverse events (whether considered by the investigator drug related or unrelated to drug) which occurred at an incidence rate of at least 3.0% in the PROVENTIL HFA Inhalation Aerosol group and more frequently in the PROVENTIL HFA Inhalation Aerosol group than in the HFA-134a placebo inhaler group.
Adverse events reported by less than 3% of the patients receiving PROVENTIL HFA Inhalation Aerosol, and by a greater proportion of PROVENTIL HFA Inhalation Aerosol patients thatn placebo patients, which have the potential to be related to PROVENTIL HFA Inhalation Aerosol include: dysphonia, increased sweating, dry mouth, chest pain, edema, rigors, ataxia, leg cramps, hyperkinesias, eructation, flatulence, tinnitus, diabetes mellitus, anxiety, depression, somnolence, rash. Palpitation and dizziness have also been observed with PROVENTIL HFA Inhalation Aerosol.
Adverse events reported in a 4-week pediatric clinical trail comparing PROVENTIL HFA Inhalation Aerosol and a CFC 11/12 propelled albuterol inhaler occurred at a low incidence rate and were similar to those seen in the adult trials.
In small, cumulative dose studies, tremor, nervousness, and headache appeared to be dose related.
Rare cases of urticaria, angioedema, rash, bronchospasm, and oropharyngeal edema have been reported after the use of inhaled albuterol. In addition, albuterol, like other sympathomimetic agents, can cause adverse reactions such as hypertension, angina, vertigo, central nervous system stimulation, insomnia, headache, and drying or irritation of the oropharynx.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
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Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72Tips
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A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).