DRUGS & SUPPLEMENTS
Salbutrop usesSalbutrop consists of Albuterol Sulfate, Ipratropium Bromide.
Salbutrop is a beta adrenoagonists with a predominant effect on beta2-adrenergic receptors (localized, particularly in the bronchi, myometrium, blood vessels).
This medication prevents and reduces or eliminates bronchospasm, reduces the resistance in the airways, increases the vital capacity. It prevents the release of histamine, slow reacting substance from mast cells and factors chemotaxis of neutrophils. Compared with other drugs of this group has a less pronounced positive chrono-and inotropic effect on myocardium. It widen of coronary arteries, practically does not reduce blood pressure. Has tocolytic effect, lowering the tone and the contractile activity of the myometrium.
When using an aerosol there is a rapid absorption of albuterol (salbutamol) in the blood, but its concentration in plasma when used in recommended doses are very low or below detection limit.
After oral administration Salbutrop (Albuterol Sulfate) is well absorbed from the gastrointestinal tract. Plasma protein binding is 10%. Metabolised with "first pass" through the liver and possibly in the wall of the intestine, the main metabolite - inactive sulfate conjugate. Salbutrop (Albuterol Sulfate) is not metabolised in the lungs, thus its ultimate metabolism and excretion following inhalation depends on the method of application, which defines the relationship between inhaled Salbutrop (Albuterol Sulfate) and unintentionally swallowed.
T1/2 from plasma is 2-7 hours. albuterol (salbutamol) is rapidly excreted in the urine as metabolites and unchanged substance, in small amounts excreted in the feces.
Why is Salbutrop prescribed?
The prevention and relief of bronchospasm in all forms of bronchial asthma. Reversible airway obstruction in chronic bronchitis and emphysema, bronchial obstruction in children.
Threatening preterm labor with uterine contractions; birth to 37-38 weeks of pregnancy; isthmic-cervical insufficiency, decrease in fetal heart rate, depending on uterine contractions during opening of the cervix and expulsion. As a preventive measure during surgery on the pregnant uterus (the imposition of a circular suture with the lack of internal os of the uterus).
Dosage and administration
Salbutrop for oral use as a means of extending the broncho adults and children over 12 years - 2.4 mg 3-4 times / day; if necessary, the dose may be increased to 8 mg 4 times / day. Children aged 6-12 years - 2 mg 3-4 times / day; children 2-6 years - 1-2 mg 3 times / day.
Salbutrop (Albuterol Sulfate) for inhalation use dose depends on the applied dosage form, frequency of use depends on the testimony and the clinical situation.
As a tocolytic agent used as IV infusion in dose of 1-2 mg.
Salbutrop (Albuterol Sulfate) side effects, adverse reactions
Cardiovascular system: a transient expansion of peripheral blood vessels, a moderate tachycardia.
Central nervous system: headache, dizziness, nausea, vomiting.
Allergic reactions: in a few cases - angioedema, allergic reactions in the form of skin rashes, urticaria, hypotension, collapse.
Other: Tremor of hands, inner trembling, tension, rarely - paradoxical bronchoconstriction, muscle cramps.
The threat of miscarriage in I and II trimesters of pregnancy, premature placental abruption, bleeding or toxemia in the III trimester of pregnancy, infancy to 2 years; hypersensitivity to Salbutrop.
Using during pregnancy and breastfeeding
Category of the fetus by FDA - C.
Salbutrop (Albuterol Sulfate) is contraindicated in threatened miscarriage in I and II trimesters of pregnancy, premature detachment of the placenta, bleeding, or toxicosis in the III trimester of pregnancy. If necessary, the use of Salbutrop (Albuterol Sulfate) during pregnancy should be related to the expected benefits of treatment for the mother and the potential risk to the fetus. Currently is insufficient data on the safety of Salbutrop (Albuterol Sulfate) in early pregnancy. Salbutrop (Albuterol Sulfate) is excreted in breast milk, so if you need to use during lactation should also assess the potential benefits of treatment for the mother and the potential risk to the child.
With caution used Salbutrop when tachyarrhythmia and other cardiac arrhythmias, arterial hypertension, myocarditis, heart defects, aortic stenosis, diabetes, thyrotoxicosis, glaucoma, acute heart failure (with careful medical supervision).
Increase doses or frequency of receiving albuterol (salbutamol) should be under the supervision of a doctor. Reducing the interval may be only in exceptional cases and should be strictly justified.
In the application of Salbutrop (Albuterol Sulfate) there was a risk of hypokalemia, so the period of treatment in patients with severe asthma should monitor the flow levels of potassium in the blood. The risk of hypokalemia increases with hypoxia.
To increase the effectiveness of therapy the patient should be trained in the proper use of inhalers and the beginning of treatment to use an inhaler under the supervision of medical personnel. Receiving high doses of Salbutrop (Albuterol Sulfate) in patients with acute asthma leads to the fact that each subsequent attack of breathlessness becomes more intense the previous syndrome (rebound). In severe asthma interval between inhalations should be at least 20 minutes. In the absence of the minimal effect of inhalation or the appearance of pronounced tremor, tachycardia, cardiac arrhythmias continued uncontrolled use of the inhaler is contraindicated, and should appeal to the doctor. The risk of complications increases as in the long duration of treatment, and at a sharp lifting of the drug.
Salbutrop drug interactions
With simultaneous use of albuterol (salbutamol) with not cardioselective beta-blockers may suppress mutual therapeutic effects; with theophylline - increases the risk of tachycardia and arrhythmia, in particular, supraventricular extrasystoles.
With simultaneous use of Salbutrop (Albuterol Sulfate) and xanthine derivatives, SCS or diuretics increases the risk of hypokalemia.
Salbutrop in case of emergency / overdose
Symptoms: tachycardia (heart rate to 200 bpm), ventricular flutter, reducing blood pressure, increased cardiac output, hypoxemia, acidosis, hypokalemia, hyperglycemia, muscle tremors, headache, agitation, hallucinations, convulsions.
Treatment: removal of preparation and holding of symptomatic therapy of beta-blockers (selective) in patients with bronchial asthma requires extreme caution because of the risk of severe bronchospasm reaction.
Salbutrop (Ipratropium Bromide) Inhalation Solution, 0.02%
The active ingredient, Salbutrop (Ipratropium Bromide) monohydrate, USP, is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]- octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8-methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (+)-; a synthetic quaternary ammonium compound, chemically related to atropine.
Salbutrop (Ipratropium Bromide) Monohydrate C20H30BrNO3-H2O Mol. Wt. 430.4
Salbutrop (Ipratropium Bromide) is a white crystalline substance, freely soluble in water and lower alcohols. It is a quaternary ammonium compound and thus exists in an ionized state in aqueous solutions. It is relatively insoluble in non-polar media.
Salbutrop (Ipratropium Bromide) Inhalation Solution is administered by oral inhalation with the aid of a nebulizer. It contains Salbutrop (Ipratropium Bromide), USP 0.02% (anhydrous basis) in a sterile, preservative-free, isotonic saline solution, pH-adjusted to 3.4 (3 to 4) with hydrochloric acid.
Salbutrop (Ipratropium Bromide) is an anticholinergic (parasympatholytic) agent that, based on animal studies, appears to inhibit vagally mediated reflexes by antagonizing the action of acetylcholine, the transmitter agent released from the vagus nerve.
Anticholinergics prevent the increases in intracellular concentration of cyclic guanosine monophosphate (cyclic GMP) that are caused by interaction of acetylcholine with the muscarinic receptor on bronchial smooth muscle.
The bronchodilation following inhalation of Salbutrop (Ipratropium Bromide) is primarily a local, site-specific effect, not a systemic one. Much of an administered dose is swallowed but not absorbed, as shown by fecal excretion studies. Following nebulization of a 2 mg dose, a mean 7% of the dose was absorbed into the systemic circulation either from the surface of the lung or from the gastrointestinal tract. The half-life of elimination is about 1.6 hours after intravenous administration. Salbutrop (Ipratropium Bromide) is minimally (0 to 9% in vitro) bound to plasma albumin and a1-acid glycoproteins. It is partially metabolized. Autoradiographic studies in rats have shown that Salbutrop (Ipratropium Bromide) does not penetrate the blood-brain barrier. Salbutrop (Ipratropium Bromide) has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in those patient populations.
In controlled 12-week studies in patients with bronchospasm associated with chronic obstructive pulmonary disease (chronic bronchitis and emphysema) significant improvements in pulmonary function (FEV1 increases of 15% or more) occurred within 15 to 30 minutes, reached a peak in 1 to 2 hours, and persisted for periods of 4 to 5 hours in the majority of patients, with about 25% to 38% of the patients demonstrating increases of 15% or more for at least 7 to 8 hours. Continued effectiveness of Salbutrop (Ipratropium Bromide) inhalation solution was demonstrated throughout the 12-week period. In addition, significant increases in forced vital capacity (FVC) have been demonstrated. However, Salbutrop (Ipratropium Bromide) did not consistently produce significant improvement in subjective symptom scores nor in quality of life scores over the 12-week duration of study.
Additional controlled 12-week studies were conducted to evaluate the safety and effectiveness of Salbutrop (Ipratropium Bromide) inhalation solution administered concomitantly with the beta adrenergic bronchodilator solutions metaproterenol and albuterol compared with the administration of each of the beta agonists alone. Combined therapy produced significant additional improvement in FEV1 and FVC. On combined therapy, the median duration of 15% improvement in FEV1 was 5 to 7 hours, compared with 3 to 4 hours in patients receiving a beta agonist alone.
INDICATIONS AND USAGE
Salbutrop (Ipratropium Bromide) Inhalation Solution administered either alone or with other bronchodilators, especially beta adrenergics, is indicated as a bronchodilator for maintenance treatment of bronchospasm associated with chronic obstructive pulmonary disease, including chronic bronchitis and emphysema.
Salbutrop (Ipratropium Bromide) is contraindicated in known or suspected cases of hypersensitivity to Salbutrop (Ipratropium Bromide), or to atropine and its derivatives.
The use of Salbutrop (Ipratropium Bromide) inhalation solution as a single agent for the relief of bronchospasm in acute COPD exacerbation has not been adequately studied. Drugs with faster onset of action may be preferable as initial therapy in this situation. Combination of Salbutrop (Ipratropium Bromide) and beta agonists has not been shown to be more effective than either drug alone in reversing the bronchospasm associated with acute COPD exacerbation.
Immediate hypersensitivity reactions may occur after administration of Salbutrop (Ipratropium Bromide), as demonstrated by rare cases of urticaria, angioedema, rash, bronchospasm and oropharyngeal edema.
Salbutrop should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy or bladder-neck obstruction.
Information for Patients
Patients should be advised that temporary blurring of vision, precipitation or worsening of narrow-angle glaucoma or eye pain may result if the solution comes into direct contact with the eyes. Use of a nebulizer with mouthpiece rather than face mask may be preferable, to reduce the likelihood of the nebulizer solution reaching the eyes. Patients should be advised that Salbutrop (Ipratropium Bromide) inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Salbutrop (Ipratropium Bromide) Inhalation Solution when mixed with other drugs in a nebulizer have not been established. Patients should be reminded that Salbutrop (Ipratropium Bromide) inhalation solution should be used consistently as prescribed throughout the course of therapy.
Salbutrop has been shown to be a safe and effective bronchodilator when used in conjunction with beta adrenergic bronchodilators. Salbutrop (Ipratropium Bromide) has also been used with other pulmonary medications, including methylxanthines and corticosteroids, without adverse drug interactions.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year oral carcinogenicity studies in rats and mice have revealed no carcinogenic potential at dietary doses up to 6 mg/kg/day of Salbutrop (Ipratropium Bromide).
Results of various mutagenicity studies (Ames test, mouse dominant lethal test, mouse micronucleus test and chromosome aberration of bone marrow in Chinese hamsters) were negative.
Fertility of male or female rats at oral doses up to 50 mg/kg/day was unaffected by Salbutrop (Ipratropium Bromide) administration. At doses above 90 mg/kg increased resorption and decreased conception rates were observed.
Pregnancy TERATOGENIC EFFECTS
Pregnancy Category B
Oral reproduction studies performed in mice, rats and rabbits at doses of 10, 100, and 125 mg/kg respectively, and inhalation reproduction studies in rats and rabbits at doses of 1.5 and 1.8 mg/kg respectively, have demonstrated no evidence of teratogenic effects as a result of Salbutrop (Ipratropium Bromide). However, no adequate or well-controlled studies have been conducted in pregnant women. Because animal reproduction studies are not always predictive of human response, Salbutrop (Ipratropium Bromide) should be used during pregnancy only if clearly needed.
It is not known whether Salbutrop (Ipratropium Bromide) is excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that Salbutrop (Ipratropium Bromide) would reach the infant to a significant extent, especially when taken by inhalation since Salbutrop (Ipratropium Bromide) is not well absorbed systemically after inhalation or oral administration. However, because many drugs are excreted in human milk, caution should be exercised when Salbutrop (Ipratropium Bromide) is administered to a nursing woman.
Safety and effectiveness in the pediatric population below the age of 12 have not been established.
Adverse reaction information concerning Salbutrop (Ipratropium Bromide) inhalation solution is derived from 12-week active-controlled clinical trials. Additional information is derived from foreign post-marketing experience and the published literature.
All adverse events, regardless of drug relationship, reported by three percent or more patients in the 12-week controlled clinical trials appear in the table below.
Additional adverse reactions reported in less than three percent of the patients treated with Salbutrop (Ipratropium Bromide) include tachycardia, palpitations, eye pain, urinary retention, urinary tract infection and urticaria. Cases of precipitation or worsening of narrow-angle glaucoma, mydriasis and acute eye pain have been reported.
Lower respiratory adverse reactions (bronchitis, dyspnea and bronchospasm) were the most common events leading to discontinuation of Salbutrop (Ipratropium Bromide) therapy in the 12-week trials. Headache, mouth dryness and aggravation of COPD symptoms are more common when the total daily dose of Salbutrop (Ipratropium Bromide) equals or exceeds 2,000 mcg.
Allergic-type reactions such as skin-rash, angioedema of tongue, lips and face, urticaria, laryngospasm and anaphylactic reaction have been reported. Many of the patients had a history of allergies to other drugs and/or foods.
Acute systemic overdosage by inhalation solution is unlikely since Salbutrop (Ipratropium Bromide) is not well absorbed after inhalation at up to four-fold the recommended dose, or after oral administration at up to forty-fold the recommended dose. The oral LD50 of Salbutrop (Ipratropium Bromide) ranged between 1001 and 2010 mg/kg in mice; between 1667 and 4000 mg/kg in rats; and between 400 and 1300 mg/kg in dogs.
DOSAGE AND ADMINISTRATION
The usual dosage of Salbutrop (Ipratropium Bromide) inhalation solution is 500 mcg (1 Unit-Dose Vial) administered three to four times a day by oral nebulization, with doses 6 to 8 hours apart. Salbutrop (Ipratropium Bromide) inhalation solution unit-dose vials contain 500 mcg Salbutrop (Ipratropium Bromide), USP anhydrous in 2.5 mL normal saline. Salbutrop (Ipratropium Bromide) inhalation solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour. Drug stability and safety of Salbutrop (Ipratropium Bromide) Inhalation Solution when mixed with other drugs in a nebulizer have not been established.
Salbutrop (Ipratropium Bromide) Inhalation Solution Unit Dose Vial is supplied as a 0.02% clear, colorless solution containing 2.5 mL.
NDC 0591-3798-83, 25 vials in a foil pouch
NDC 0591-3798-30, 30 vials in a foil pouch
NDC 0591-3798-60, 60 vials, two foil pouches of 30 each
Each vial is made from a low density polyethylene (LDPE) resin.
Vials are supplied in a foil pouch.
Store between 59°F (15°C) and 86°F (30°C).
Protect from light.
Store unused vials in the foil pouch.
ATTENTION PHARMACIST: Detach “Patient’s Instructions for Use” from Package Insert and dispense with solution.
Watson Pharma, Inc.
Corona, CA 92880 USA
The Ritedose Corporation
1 Technology Circle
Columbia, SC 29203
Patient’s Instructions for Use
Salbutrop (Ipratropium Bromide)
INHALATION SOLUTION 0.02%
Read complete instructions carefully before using.
Note: Use only as directed by your physician. More frequent administration or higher doses are not recommended. Ipratropium Bromide Inhalation Solution can be mixed in the nebulizer with albuterol or metaproterenol if used within one hour but not with other drugs. Drug stability and safety of Salbutrop (Ipratropium Bromide) Inhalation Solution when mixed with other drugs in the nebulizer have not been established.
Store between 59°F (15°C) and 86°F (30°C). Protect from light. Store unused vials in the foil pouch.
Watson Pharma, Inc.
Corona, CA 92880 USA
The Ritedose Corporation
1 Technology Circle
Columbia, SC 29203
Twist open the top of one unit dose vial and squeeze the contents into the nebulizer reservoir. Connect the nebulizer reservoir to the mouth piece or face mask Sit in a comfortable, upright position; place the mouthpiece in your mout
Salbutrop pharmaceutical active ingredients containing related brand and generic drugs:
Active ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.
Salbutrop available forms, composition, doses:
Form of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.
Salbutrop destination | category:
Destination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.
Salbutrop Anatomical Therapeutic Chemical codes:
A medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.
Salbutrop pharmaceutical companies:
Pharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Salbutrop?
Depending on the reaction of the Salbutrop after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Salbutrop not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Salbutrop addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Salbutrop, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Salbutrop consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
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The information was verified by Dr. Arunabha Ray, MD Pharmacology