Bronkovent

Bromhexine (Bronkovent) hydrochloride SYRUP indicated for cough associated with wheeziness (bronchospasm) and tenacious phlegm (sputum).

Guaifenesin (Bronkovent) and hydrocodone is used to treat cough and reduce chest congestion caused by the common cold, flu, or allergies.

Salbutamol (Bronkovent)® (desogestrel and ethinyl estradiol) Tablets are indicated for the prevention of pregnancy in women who elect to use this product as a method of contraception.

Oral contraceptives are highly effective. Table 1 lists the typical unintended pregnancy rates for users of combination oral contraceptives and other methods of contraception. The efficacy of these contraceptive methods, except sterilization, the IUD, and implants, depends upon the reliability with which they are used. Correct and consistent use of these methods can result in lower failure rates.

Guaifenesin (Bronkovent) is used to reduce chest congestion caused by the common cold, flu, or chronic bronchitis.

Guaifenesin (Bronkovent) helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.

There are many brands and forms of Guaifenesin (Bronkovent) available. Not all brands are listed on this leaflet.

Guaifenesin (Bronkovent) may also be used for purposes not listed in this medication guide.

Unless otherwise prescribed, the following doses are recommended:

Tablet: Adults and Children >12 years: 8 mg (1 tab) thrice daily; 6-12 years: 4 mg (½ tab) thrice daily; 2-6 years: 4 mg (½ tab) twice daily.

Oral Solution:

Inhalation Solution (with aerosol apparatus): It is generally recommended to warm inhalation solution to body temperature before inhalation. Patients with bronchial asthma may be advised to commencing inhalation after they have taken their regular bronchospasmolytic therapy.

Adults: 4 mL. Children >12 years: 2 mL; 6-12 years: 1 mL; 2-6 years: 10 drops; <2 years: 5 drops. All doses to be taken twice daily.

The solution may be diluted 1:1 in physiological saline solution. In order to avoid precipitation, the solution should be inhaled immediately after mixing. The combined administration of inhalation and oral application intensifies the effect, and is especially suited for the commencement of treatment in cases where the full effect is to be reached quickly.

Syrup: Adults and Children >12 years: 5 ml (1 tsp) thrice daily.

At commencement of treatment, it may be necessary to increase the total daily dose up to 48 mg in adults.

The syrup is sugar-free and therefore suitable for diabetics and small children.

Ampoule: Severe cases, before and after surgical intervention: 1 amp SC, IM or IV (duration of injection: 2-3 min) 2-3 times daily.

Capsule: Adults: 1 cap 3 times daily.

It is recommended for the initial phase of treatment usually lasting not more than a week.

Patients being treated with Bromhexine (Bronkovent) should be notified of an expected increase in the flow of secretions.

ORGANIDIN® NR (Guaifenesin (Bronkovent))

Tablets — Adults and children 12 years of age and older: One to 2 tablets (200 mg to 400 mg) every four hours, not to exceed 2400 mg (12 tablets) in 24 hours.

PATIENTS SHOULD BE ADVISED TO KEEP THESE AND ALL DRUGS OUT OF THE REACH OF CHILDREN AND TO SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY IN CASE OF ACCIDENTAL OVERDOSE.

How supplied

ORGANIDIN® NR (Guaifenesin (Bronkovent))

Tablets — Each round, scored, rose-colored tablet contains 200 mg Guaifenesin (Bronkovent) USP—available in bottles of 100 (NDC 0037-4312-01)

Storage

Store at controlled room temperature 20°-25°C (68°-77°F). Protect tablets from moisture. Keep bottle tightly closed.

To report SUSPECTED ADVERSE REACTIONS, contact Meda Pharmaceuticals Inc. at 1-800-526-3840 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Meda Pharmaceuticals Inc. Somerset, New Jersey 08873-4120. Rev. 11/09

The usual starting dosage for patients 2 to 12 years of age is 1.25 mg or 0.63 mg of Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) administered 3 or 4 times daily, as needed, by nebulization. More frequent administration is not recommended.

To administer 1.25 mg or 0.63 mg of albuterol, use the entire contents of one unit-dose vial (3 mL of 1.25 mg or 0.63 mg inhalation solution) by nebulization. Adjust nebulizer flow rate to deliver Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) over 5 to 15 minutes.

The use of Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) can be continued as medically indicated to control recurring bouts of bronchospasm. During this time most patients gain optimum benefit from regular use of the inhalation solution.

Patients 6 to 12 years of age with more severe asthma (baseline FEV less than 60% predicted), weight > 40 kg, or patients 11 to 12 years of age may achieve a better initial response with the 1.25 mg dose.

Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) has not been studied in the setting of acute attacks of bronchospasm. A 2.5 mg dose of albuterol provided by a higher concentration product (2.5 mg albuterol per 3 mL) may be more appropriate for treating acute exacerbations, particularly in children 6 years old and above.

If a previously effective dosage regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of seriously worsening asthma which would require reassessment of therapy.

The drug compatibility (physical and chemical), clinical efficacy and safety of Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) solution, when mixed with other drugs in a nebulizer have not been established.

The safety and efficacy of Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) have been established in clinical trials when administered using the Pari LC Plus™ nebulizer and Pari PRONEB™ compressor. The safety and efficacy of Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) when administered with other nebulizer systems have not been established.

Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) should be administered via jet nebulizer connected to an air compressor with adequate air flow, equipped with a mouthpiece or suitable face mask.

How supplied

Salbutamol (Bronkovent) (albuterol sulfate) Inhalation Solution is supplied as a 3 mL, clear, colorless, sterile, preservative-free, aqueous solution in two different strengths, 0.63 mg and 1.25 mg, of albuterol (equivalent to 0.75 mg of albuterol sulfate or 1.5 mg of albuterol sulfate per 3 mL) in unit-dose low-density polyethylene (LDPE) vials. Each unit-dose LDPE vial is protected in a foil pouch, and each foil pouch contains 5 unit-dose LDPE vials. Each strength of Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) (albuterol sulfate) Inhalation Solution is available in a shelf carton containing multiple foil pouches.

Salbutamol (Bronkovent)® (albuterol sulfate) Inhalation Solution, 0.63 mg (potency expressed as albuterol) contains 0.75 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-692-03 5 foil pouches, each containing 5 vials, total 25 vials per carton

Salbutamol (Bronkovent)® (albuterol sulfate) Inhalation Solution, 1.25 mg (potency expressed as albuterol) contains 1.50 mg albuterol sulfate per 3 mL in unit-dose vials and is available in the following packaging configuration.

NDC 49502-693-03 5 foil pouches, each containing 5 vials, total 25 vials per carton

Storage

Store between 2°C and 25°C (36°F - 77°F). Protect from light and excessive heat.

Store unit-dose vials in protective foil pouch at all times. Once removed from the foil pouch, use vial(s) within one week. Discard the vial if the solution is not colorless.

Keep out of the reach of children.

DEY®, Napa, CA 94558. JAN 07

Bromhexine (Bronkovent) hydrochloride SYRUP is contra-indicated in patients with known hypersensitivity to sympathomimetic amines or any of the other ingredients; hypertrophic obstructive cardiomyopathy; and tachyarrhythmia.

Sympathomimetics, such as orciprenaline sulphate, may interact with monoamine oxidase inhibitors (MAOI), and therefore Bromhexine (Bronkovent) hydrochloride SYRUP should not be given to patients receiving such treatment or within 14 days of MAOI treatment termination.

Safety in pregnancy and lactation has not been established.

See also:
What is the most important information I should know about Salbutamol (Bronkovent)?

Oral contraceptives should not be used in women who currently have the following conditions:

• Thrombophlebitis or thromboembolic disorders
• A past history of deep vein thrombophlebitis or thromboembolic disorders
• Cerebral vascular or coronary artery disease (current or history)
• Valvular heart disease with thrombogenic complications
• Severe hypertension
• Diabetes with vascular involvement
• Headaches with focal neurological symptoms
• Major surgery with prolonged immobilization
• Known or suspected carcinoma of the breast (or personal history of breast cancer)
• Carcinoma of the endometrium or other known or suspected estrogen-dependent neoplasia
• Undiagnosed abnormal genital bleeding
• Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
• Hepatic tumors (benign or malignant) or active liver disease
• Known or suspected pregnancy
• Heavy smoking (≥15 cigarettes per day) and over age 35
• Hypersensitivity to any of the components of Salbutamol (Bronkovent)® (desogestrel and ethinyl estradiol) Tablets

Use Guaifenesin (Bronkovent) sustained-release tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Take Guaifenesin (Bronkovent) sustained-release tablets by mouth with or without food.
• Drinking extra fluids while you are taking Guaifenesin (Bronkovent) sustained-release tablets is recommended. Check with your doctor for instructions.
• Swallow Guaifenesin (Bronkovent) sustained-release tablets whole. Do not break, crush, or chew before swallowing.
• If you miss a dose of Guaifenesin (Bronkovent) sustained-release tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Guaifenesin (Bronkovent) sustained-release tablets.

Bromhexine (Bronkovent) is used to treat breathing difficulties caused by excessive mucus secretions in the air passages associated with respiratory tract infections.

Guaifenesin (Bronkovent) is used to treat coughs and congestion caused by the common cold, bronchitis, and other breathing illnesses. This product is usually not used for ongoing cough from smoking or long-term breathing problems (such as chronic bronchitis, emphysema) unless directed by your doctor. Guaifenesin (Bronkovent) is an expectorant. It works by thinning and loosening mucus in the airways, clearing congestion, and making breathing easier.

If you are self-treating with this medication, it is important to read the package instructions carefully before you start using this product to be sure it is right for you.

Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Therefore, do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely.

These products do not cure or shorten the length of the common cold. To decrease the risk for side effects, carefully follow all dosage directions. Do not give other cough-and-cold medication that might contain the same or similar ingredients. Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

How to use 2/G

Take this medication by mouth with or without food, as directed by your doctor, usually every 4 hours. If you are self-treating, follow all directions on the product package. If you are uncertain about any of the information, ask your doctor or pharmacist.

Guaifenesin (Bronkovent) may have a bitter taste. Do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

If you are using the liquid form of this medication, carefully measure the dose using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.

For powder packets, empty the entire contents of the packet onto the tongue and swallow. To prevent a bitter taste, do not chew.

Dosage is based on your age, medical condition, and response to treatment. Do not take more than 6 doses in a day. Do not increase your dose or take this drug more often than directed.

Drink plenty of fluids while taking this medication. Fluids will help to break up mucus and clear congestion.

Tell your doctor if your cough is accompanied by fever, severe sore throat, rash, persistent headache, or if it persists, returns, or worsens after 7 days. These may be signs of a serious medical problem. Seek immediate medical attention if you think you may have a serious medical problem.

Salbutamol (Bronkovent) is used to prevent reversible airways obstruction occurring during asthma, infections of airway passages (bronchitis), lung disorder in which the flow of air to the lungs is blocked (emphysema), and other lung diseases.

A reduction in dose of cardiac glycosides (e.g. digitalis) and quinidine might become necessary in patients suffering from congestive cardiac failure because of the positive inotropic effect of orciprenaline sulphate.

Bromhexine (Bronkovent) hydrochloride SYRUP should not be administered concomitantly with beta-blocking agents, due to orciprenaline’s reversal of anti-hypertensive action.

The concomitant use of other sympathomimetic agents should be carefully controlled to avoid potentiation of effects.

See also:
What other drugs will affect Guaifenesin (Bronkovent)?

In vitro results suggest that methadone undergoes hepatic N-demethylation by cytochrome P450 enzymes, principally CYP3A4, CYP2B6, CYP2C19 and to a lesser extent by CYP2C9 and CYP2D6. Coadministration of methadone with CYP inducers of these enzymes may result in a more rapid metabolism and potential for decreased effects of methadone, whereas administration with CYP inhibitors may reduce metabolism and potentiate methadones effects. Although antiretroviral drugs such as efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir combination are known to inhibit CYPs, they are shown to reduce the plasma levels of methadone, possibly due to their CYP induction activity. Therefore, drugs administered concomitantly with methadone should be evaluated for interaction potential; clinicians are advised to evaluate individual response to drug therapy.

Opioid Antagonists, Mixed Agonist/Antagonists, and Partial Agonists

As with other mu-agonists, patients maintained on methadone may experience withdrawal symptoms when given opioid antagonists, mixed agonist/antagonists, and partial agonists. Examples of such agents are naloxone, naltrexone, pentazocine, nalbuphine, butorphanol, and buprenorphine.

Anti-retroviral Agents

Abacavir, amprenavir, efavirenz, nelfinavir, nevirapine, ritonavir, lopinavir+ritonavir combination - Coadministration of these anti-retroviral agents resulted in increased clearance or decreased plasma levels of methadone. Guaifenesin (Bronkovent)-maintained patients beginning treatment with these antiretroviral drugs should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly.

Didanosine and Stavudine - Experimental evidence demonstrated that methadone decreased the AUC and peak levels for didanosine and stavudine, with a more significant decrease for didanosine. Guaifenesin (Bronkovent) disposition was not substantially altered.

Zidovudine - Experimental evidence demonstrated that methadone increased the area under the concentration-time curve (AUC) of zidovudine which could result in toxic effects.

Cytochrome P450 Inducers

Guaifenesin (Bronkovent)-maintained patients beginning treatment with CYP3A4 inducers should be monitored for evidence of withdrawal effects and methadone dose should be adjusted accordingly. The following drug interactions were reported following coadministration of methadone with inducers of cytochrome P450 enzymes:

Rifampin - In patients well-stabilized on methadone, concomitant administration of rifampin resulted in a marked reduction in serum methadone levels and a concurrent appearance of withdrawal symptoms.

Phenytoin - In a pharmacokinetic study with patients on methadone maintenance therapy, phenytoin administration (250 mg b.i.d. initially for 1 day followed by 300 mg QD for 3 to 4 days) resulted in an approximately 50% reduction in methadone exposure and withdrawal symptoms occurred concurrently. Upon discontinuation of phenytoin, the incidence of withdrawal symptoms decreased and methadone exposure increased to a level comparable to that prior to phenytoin administration.

St. Johns Wort, Phenobarbital, Carbamazepin/strong>Administration of methadone along with other CYP3A4 inducers may result in withdrawal symptoms.

Cytochrome P450 Inhibitors

Since the metabolism of methadone is mediated primarily by CYP3A4 isozyme, coadministration of drugs that inhibit CYP3A4 activity may cause decreased clearance of methadone. The expected clinical results would be increased or prolonged opioid effects. Thus, methadone-treated patients coadministered strong inhibitors of CYP3A4, such as azole antifungal agents (e.g., ketoconazole) and macrolide antibiotics (e.g., erythromycin), with methadone should be carefully monitored and dosage adjustment should be undertaken if warranted. Some selective serotonin reuptake inhibitors (SSRIs) (e.g., sertraline, fluvoxamine) may increase methadone plasma levels upon coadministration with methadone and result in increased opiate effects and/or toxicity.

Voriconazole - Repeat dose administration of oral voriconazole (400mg Q12h for 1 day, then 200mg Q12h for 4 days) increased the Cmax and AUC of (R)-methadone by 31% and 47%, respectively, in subjects receiving a methadone maintenance dose (30 to 100 mg QD). The Cmax and AUC of (S)-methadone increased by 65% and 103%, respectively. Increased plasma concentrations of methadone have been associated with toxicity including QT prolongation. Frequent monitoring for adverse events and toxicity related to methadone is recommended during coadministration. Dose reduction of methadone may be needed.

Others

Monoamine Oxidase (MAO) Inhibitors - Therapeutic doses of meperidine have precipitated severe reactions in patients concurrently receiving monoamine oxidase inhibitors or those who have received such agents within 14 days. Similar reactions thus far have not been reported with methadone. However, if the use of methadone is necessary in such patients, a sensitivity test should be performed in which repeated small, incremental doses of methadone are administered over the course of several hours while the patients condition and vital signs are under careful observation.

Desipramine - Blood levels of desipramine have increased with concurrent methadone administration.

Potentially Arrhythmogenic Agents

Extreme caution is necessary when any drug known to have the potential to prolong the QT interval is prescribed in conjunction with methadone. Pharmacodynamic interactions may occur with concomitant use of methadone and potentially arrhythmogenic agents such as class I and III antiarrhythmics, some neuroleptics and tricyclic antidepressants, and calcium channel blockers.

Caution should also be exercised when prescribing methadone concomitantly with drugs capable of inducing electrolyte disturbances (hypomagnesemia, hypokalemia) that may prolong the QT interval. These drugs include diuretics, laxatives, and, in rare cases, mineralocorticoid hormones.

Interactions with Alcohol and Drugs of Abuse

Guaifenesin (Bronkovent) may be expected to have additive effects when used in conjunction with alcohol, other opioids or CNS depressants, or with illicit drugs that cause central nervous system depression. Deaths have been reported when methadone has been abused in conjunction with benzodiazepines.

Anxiety - Since methadone as used by tolerant patients at a constant maintenance dosage does not act as a tranquilizer, patients who are maintained on this drug will react to life problems and stresses with the same symptoms of anxiety as do other individuals. The physician should not confuse such symptoms with those of narcotic abstinence and should not attempt to treat anxiety by increasing the dose of methadone. The action of methadone in maintenance treatment is limited to the control of narcotic withdrawal symptoms and is ineffective for relief of general anxiety.

Acute Pain - Maintenance patients on a stable dose of methadone who experience physical trauma, postoperative pain or other acute pain cannot be expected to derive analgesia from their existing dose of methadone. Such patients should be administered analgesics, including opioids, in doses that would otherwise be indicated for non-methadone-treated patients with similar painful conditions. Due to the opioid tolerance induced by methadone, when opioids are required for management of acute pain in methadone patients, somewhat higher and/or more frequent doses will often be required than would be the case for non-tolerant patients.

Risk of Relapse in Patients on Guaifenesin (Bronkovent) Maintenance Treatment of Opioid Addiction

Abrupt opioid discontinuation can lead to development of opioid withdrawal symptoms. Presentation of these symptoms have been associated with an increased risk of susceptible patients to relapse to illicit drug use and should be considered when assessing the risks and benefit of methadone use.

Tolerance and Physical Dependence

Tolerance is the need for increasing doses of opioids to maintain a defined effect such as analgesia (in the absence of disease progression or other external factors). Physical dependence is manifested by withdrawal symptoms after abrupt discontinuation of a drug or upon administration of an antagonist. Physical dependence and/or tolerance are not unusual during chronic opioid therapy.

If methadone is abruptly discontinued in a physically dependent patient, an abstinence syndrome may occur. The opioid abstinence or withdrawal syndrome is characterized by some or all of the following: restlessness, lacrimation, rhinorrhea, yawning, perspiration, chills, myalgia, and mydriasis. Other symptoms also may develop, including irritability, anxiety, backache, joint pain, weakness, abdominal cramps, insomnia, nausea, anorexia, vomiting, diarrhea, or increased blood pressure, respiratory rate, or heart rate.

In general, chronically administered methadone should not be abruptly discontinued.

Special-Risk Patients

Guaifenesin (Bronkovent) should be given with caution and the initial dose reduced in certain patients, such as the elderly and debilitated and those with severe impairment of hepatic or renal function, hypothyroidism, Addisons disease, prostatic hypertrophy, or urethral stricture. The usual precautions appropriate to the use of parenteral opioids should be observed and the possibility of respiratory depression should always be kept in mind.

See also:
What other drugs will affect Salbutamol (Bronkovent)?

The concomitant use of Salbutamol (Bronkovent) (albuterol sulfate syrup) and other oral sympathomimetic agents is not recommended since such combined use may lead to deleterious cardiovascular effects. This recommendation does not preclude the judicious use of an aerosol bronchodilator of the adrenergic stimulant type in patients receiving Salbutamol (Bronkovent) (albuterol sulfate syrup). Such concomitant use, however, should be individualized and not given on a routine basis. If regular coadministration is required, then alternative therapy should be considered.

Beta-Blockers

Beta-adrenergic receptor blocking agents not only block the pulmonary effect of beta-agonists, such as Salbutamol (Bronkovent) (albuterol sulfate syrup), but may produce severe bronchospasm in asthmatic patients. Therefore, patients with asthma should not normally be treated with beta-blockers. However, under certain circumstances, eg, as prophylaxis after myocardial infarction, there may be no acceptable alternatives to the use of beta-adrenergic blocking agents in patients with asthma. In this setting, cardioselective beta-blockers could be considered, although they should be administered with caution.

Diuretics

The ECG changes and/or hypokalemia that may result from the administration of nonpotassium-sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by beta-agonists, especially when the recommended dose of the beta-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the coadministration of beta-agonists with nonpotassium-sparing diuretics.

Digoxin

Mean decreases of 16% to 22% in serum digoxin levels were demonstrated after single dose intravenous and oral administration of albuterol, respectively, to normal volunteers who had received digoxin for 10 days. The clinical significance of these findings for patients with obstructive airway disease who are receiving albuterol and digoxin on a chronic basis is unclear. Nevertheless, it would be prudent to carefully evaluate the serum digoxin levels in patients who are currently receiving digoxin and albuterol.

Monoamine Oxidase Inhibitors or Tricyclic Antidepressants

Albuterol should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors or tricyclic antidepressants, or within 2 weeks of discontinuation of such agents, because the action of albuterol on the vascular system may be potentiated.

Bromhexine (Bronkovent)’s pharmacological action may lead to gastric irritation. A transient rise in serum aminotransferase values have been reported due to Bromhexine (Bronkovent).

Orciprenaline sulphate, as a sympathomimetic agent, may precipitate a wide range of adverse effects. Side-effects include fear; anxiety, restlessness, tremor, insomnia, confusion, irritability, weakness and psychotic states. Appetite may be reduced and nausea and vomiting may occur. A rise in blood pressure which may produce cerebral haemorrhage and pulmonary oedema, tachycardia and cardiac arrhythmias, anginal pain, palpitations, and cardiac arrest. Hypotension with dizziness and fainting and flushing may occur. Other effects that may occur include difficulty in micturition and urinary retention; dyspnoea; weakness; headache; disturbances of glucose metabolism; sweating and hypersalivation. Muscle cramps or twitching or unpleasant taste may occur.

See also:
What are the possible side effects of Salbutamol (Bronkovent)?

Clinical Trial Experience: Adverse events reported in > 1% of patients receiving Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) and more frequently than in patients receiving placebo in a four-week double-blind study are listed in the following table.

Table 1: Adverse Events with an Incidence of > 1% of Patients Receiving Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) and Greater than Placebo (expressed as % of treatment group)

There was one case of ST segment depression in the 1.25 mg Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) treatment group.

No clinically relevant laboratory abnormalities related to Salbutamol (Bronkovent) (albuterol sulfate inhalation solution) administration were seen in this study.

Postmarketing Experience

Metabolic acidosis has been reported after the use of albuterol sulfate inhalation solution. Because this reaction is reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate its frequency or establish a causal relationship to drug exposure..

Each tablet also contains lactose, maize or potato starch, gelatine and magnesium stearate as excipients.

The oral/inhalation solution also contains tartaric acid and methyl parahydroxybenzoate as excipients.

The syrup also contains tartaric acid, benzoic acid, sodium carboxymethylcellulose, glycerol, sorbitol solution, pharma flavor and ethanol as excipients.

Each capsule also contains lactose, cornstarch and magnesium stearate as excipients.

Bromhexine (Bronkovent) HCl is N-cyclohexyl-N-methyl-(2-amino-3,5-dibromobenzyl)amine hydrochloride.

A synthetic opioid that is used as the hydrochloride. It is an opioid analgesic that is primarily a mu-opioid agonist. It has actions and uses similar to those of morphine. It also has a depressant action on the cough center and may be given to control intractable cough associated with terminal lung cancer. Guaifenesin (Bronkovent) is also used as part of the treatment of dependence on opioid drugs, although prolonged use of methadone itself may result in dependence. (From Martindale, The Extra Pharmacopoeia, 30th ed, p1082-3)

Each 200 mcg/dose powder for inhalation solution contains Salbutamol (Bronkovent) sulphate equivalent to Salbutamol (Bronkovent) 200 mcg per metered dose. The dose, which the patient gets through the mouthpiece of the device is Salbutamol (Bronkovent) 180 mcg.

It contains lactose monohydrate (milk protein) as excipient.

The Salbutamol (Bronkovent) multiple dose powder inhaler contains 200 doses of finely powdered Salbutamol (Bronkovent) sulphate mixed in a small quantity of lactose. The amount of drug received by the patient (180 mcg/dose) corresponds to that from Salbutamol (Bronkovent) inhalation aerosol. The dose to be inhaled is released from the container by pressing the device between the thumb and forefinger. This is followed by inhalation through the device. As a result, Salbutamol (Bronkovent) particles are transferred to their target, the lungs. Use of the Salbutamol (Bronkovent) does not require coordination of actuation of the dose and inhalation.