Veloz may be available in the countries listed below.
Rabeprazole is reported as an ingredient of Veloz in the following countries:
Rabeprazole sodium salt (a derivative of Rabeprazole) is reported as an ingredient of Veloz in the following countries:
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Sufentanil Actavis may be available in the countries listed below.
Sufentanil citrate (a derivative of Sufentanil) is reported as an ingredient of Sufentanil Actavis in the following countries:
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Tramadol HCl PCH may be available in the countries listed below.
Tramadol hydrochloride (a derivative of Tramadol) is reported as an ingredient of Tramadol HCl PCH in the following countries:
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Vasocedine may be available in the countries listed below.
Naphazoline nitrate (a derivative of Naphazoline) is reported as an ingredient of Vasocedine in the following countries:
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Metforal may be available in the countries listed below.
Metformin is reported as an ingredient of Metforal in the following countries:
Metformin hydrochloride (a derivative of Metformin) is reported as an ingredient of Metforal in the following countries:
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Minia may be available in the countries listed below.
Ketotifen fumarate (a derivative of Ketotifen) is reported as an ingredient of Minia in the following countries:
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Estro-Pause may be available in the countries listed below.
Estradiol 17ß-valerate (a derivative of Estradiol) is reported as an ingredient of Estro-Pause in the following countries:
Norethisterone is reported as an ingredient of Estro-Pause in the following countries:
International Drug Name Search
Monurol is a brand name of fosfomycin, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Monurol available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Monurol. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Monurol.
Nandrolona Decanoato may be available in the countries listed below.
Nandrolone 17ß-decanoate (a derivative of Nandrolone) is reported as an ingredient of Nandrolona Decanoato in the following countries:
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Praxis may be available in the countries listed below.
Bicalutamide is reported as an ingredient of Praxis in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
Benzylpenicillin procaine (a derivative of Benzylpenicillin) is reported as an ingredient of Aqua Mast in the following countries:
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Carbamazepina Perugen may be available in the countries listed below.
Carbamazepine is reported as an ingredient of Carbamazepina Perugen in the following countries:
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Clorhidrato de procaina Biocrom may be available in the countries listed below.
Procaine hydrochloride (a derivative of Procaine) is reported as an ingredient of Clorhidrato de procaina Biocrom in the following countries:
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Neurabol Caps. may be available in the countries listed below.
Stanozolol is reported as an ingredient of Neurabol Caps. in the following countries:
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Use of Ritonavir Solution along with certain other medicines (eg, certain antiarrhythmics, certain sleep medicines, ergot medicines) may cause severe and possibly life-threatening side effects. Inform your doctor and pharmacist of all prescription and over-the-counter medicine that you are taking before taking Ritonavir Solution.
Treating HIV in combination with other medicines.
Ritonavir Solution is an HIV protease inhibitor. It works by blocking the growth of HIV.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Ritonavir Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
Some MEDICINES MAY INTERACT with Ritonavir Solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
This may not be a complete list of all interactions that may occur. Ask your health care provider if Ritonavir Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Use Ritonavir Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.
Ask your health care provider any questions you may have about how to use Ritonavir Solution.
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Abnormal skin sensations, especially around the mouth, fingers, and toes; diarrhea; headache; loss of appetite; mild stomach pain; nausea; taste changes; tiredness; vomiting; weakness.
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest or throat; swelling of the mouth, face, lips, or tongue; unusual hoarseness); chest, jaw or arm pain; decreased urination; dizziness or light-headedness; fainting; fast or irregular heartbeat; fever, chills, or sore throat; flushed face; loss of consciousness; mental or mood changes (eg, depression); mouth sores or ulcers; muscle or joint pain; red, swollen, blistered, or peeling skin; seizures; shortness of breath; sudden, severe nausea or vomiting; symptoms of liver problems (eg, dark urine, pale stools, persistent loss of appetite, right-sided stomach pain, yellowing of the skin or eyes); symptoms of pancreatitis (eg, severe stomach or back pain, with or without nausea or vomiting); unusual bruising or bleeding; unusual sweating; unusual tiredness or weakness; vision changes; wheezing.
This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.
See also: Ritonavir side effects (in more detail)
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include burning, numbness, or tingling; decreased urination.
Store Ritonavir Solution at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Do not refrigerate. Keep Ritonavir Solution out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Ritonavir Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.
In the US, Vitrasert (ganciclovir ophthalmic) is a member of the drug class ophthalmic anti-infectives and is used to treat CMV Retinitis.
US matches:
Ganciclovir is reported as an ingredient of Vitrasert in the following countries:
International Drug Name Search
Insulin Human Insulatard ge may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Insulin, Isophane human (a derivative of Insulin, Isophane) is reported as an ingredient of Insulin Human Insulatard ge in the following countries:
International Drug Name Search
Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, SOO doe ee FED rin)
Brand Names: Altarussin PE, Ambifed, Ambifed-G, Biotuss PE, Congestac, D-Feda II, Despec-SR, Dynex, Entex PSE, ExeFen, ExeFen-IR, Guiatex II SR, Levall G, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Mucinex D Max Strength, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin PE, Robitussin Severe Congestion, Ru-Tuss Jr., Sinutab Non Drying, Stamoist E, SudaTex-G, Tenar PSE, Touro LA, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of guaifenesin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and cough caused by allergies or the common cold.
Guaifenesin and pseudoephedrine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
heart disease or high blood pressure;
diabetes; or
a thyroid disorder.
Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.
Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.
Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
dizziness or headache;
feeling restless or excited;
sleep problems (insomnia);
mild nausea, vomiting, or stomach upset;
mild loss of appetite;
warmth, redness, or tingly feeling under your skin; or
skin rash or itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medicines you use, especially:
methyldopa (Aldomet);
blood pressure medications;
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and other drugs may interact with guaifenesin and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Despec-SR side effects (in more detail)
Ajatin may be available in the countries listed below.
Benzododecinium bromide (a derivative of Benzododecinium) is reported as an ingredient of Ajatin in the following countries:
International Drug Name Search
Lactugel may be available in the countries listed below.
Lactulose is reported as an ingredient of Lactugel in the following countries:
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BAN
C01CA08,S01GA06
0000094-07-5
C9-H13-N-O2
167
Sympathomimetic agent
Antihypotensive agent
Benzenemethanol, 4-hydroxy-α-[(methylamino)methyl]-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
Vitamin B12 Fisons may be available in the countries listed below.
Mecobalamin is reported as an ingredient of Vitamin B12 Fisons in the following countries:
International Drug Name Search
Corticina may be available in the countries listed below.
Hydrocortisone 21-(hydrogen succinate) (a derivative of Hydrocortisone) is reported as an ingredient of Corticina in the following countries:
International Drug Name Search
Naftin is a brand name of naftifine topical, approved by the FDA in the following formulation(s):
No. There is currently no therapeutically equivalent version of Naftin available.
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Naftin. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.
See also: About generic drugs.
There are no current U.S. patents associated with Naftin.
Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.
Otospon may be available in the countries listed below.
Ciprofloxacin hydrochloride (a derivative of Ciprofloxacin) is reported as an ingredient of Otospon in the following countries:
Fluocinolone Acetonide is reported as an ingredient of Otospon in the following countries:
International Drug Name Search
Mecetronium Etilsulfate may be available in the countries listed below.
Mecetronium Etilsulfate (BAN) is also known as Mecetronium Ethylsulfate (Rec.INN)
International Drug Name Search
Glossary
| BAN | British Approved Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Pangetan may be available in the countries listed below.
Loperamide hydrochloride (a derivative of Loperamide) is reported as an ingredient of Pangetan in the following countries:
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DuoNeb®
(Ipratropium Bromide 0.5 mg/Albuterol Sulfate 3.0 mg*)
Inhalation Solution
*Equivalent to 2.5 mg albuterol base
The active components in DuoNeb® Inhalation Solution are albuterol sulfate and ipratropium bromide.
Albuterol sulfate, is a salt of racemic albuterol and a relatively selective β2-adrenergic bronchodilator chemically described as α1-[(tert-butylamino)methyl]-4-hydroxy-m-xylene-α, α'-diol sulfate (2:1) (salt). It has a molecular weight of 576.7 and the empirical formula is (C13H21NO3)2•H2SO4. It is a white crystalline powder, soluble in water and slightly soluble in ethanol. The World Health Organization recommended name for albuterol base is salbutamol.
Figure 3. 1-1. Chemical structure of albuterol sulfate.
Ipratropium bromide is an anticholinergic bronchodilator chemically described as 8-azoniabicyclo [3.2.1]-octane, 3-(3-hydroxy-1-oxo-2-phenylpropoxy)-8methyl-8-(1-methylethyl)-, bromide, monohydrate (endo, syn)-, (±)-; a synthetic quaternary ammonium compound, chemically related to atropine. It has a molecular weight of 430.4 and the empirical formula is C20H30BrNO3•H2O. It is a white crystalline substance, freely soluble in water and lower alcohols, and insoluble in lipophilic solvents such as ether, chloroform, and fluorocarbons.
Figure 3. 1-2. Chemical structure of ipratropium bromide.
Each 3 mL vial of DuoNeb contains 3.0 mg (0.1%) of albuterol sulfate (equivalent to 2.5 mg (0.083%) of albuterol base) and 0.5 mg (0.017%) of ipratropium bromide in an isotonic, sterile, aqueous solution containing sodium chloride, hydrochloric acid to adjust to pH 4, and edetate disodium, USP (a chelating agent).
DuoNeb is a clear, colorless solution. It does not require dilution prior to administration by nebulization. For DuoNeb Inhalation Solution, like all other nebulized treatments, the amount delivered to the lungs will depend on patient factors, the jet nebulizer utilized, and compressor performance. Using the Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor system, under in vitro conditions, the mean delivered dose from the mouth piece (% nominal dose) was approximately 46% of albuterol and 42% of ipratropium bromide at a mean flow rate of 3.6 L/min. The mean nebulization time was 15 minutes or less. DuoNeb should be administered from jet nebulizers at adequate flow rates, via face masks or mouthpieces (see DOSAGE AND ADMINISTRATION).
DuoNeb Inhalation Solution is a combination of the β2-adrenergic bronchodilator, albuterol sulfate, and the anticholinergic bronchodilator, ipratropium bromide.
The prime action of β-adrenergic drugs is to stimulate adenyl cyclase, the enzyme that catalyzes the formation of cyclic-3',5'-adenosine monophosphate (cAMP) from adenosine triphosphate (ATP). The cAMP thus formed mediates the cellular responses. In vitro studies and in vivo pharmacologic studies have demonstrated that albuterol has a preferential effect on β2-adrenergic receptors compared with isoproterenol. While it is recognized that β2-adrenergic receptors are the predominant receptors in bronchial smooth muscle, recent data indicated that 10% to 50% of the β-receptors in the human heart may be β2-receptors. The precise function of these receptors, however, is not yet established. Albuterol has been shown in most controlled 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 β-adrenergic agonist drugs, can produce a significant cardiovascular effect in some patients.
Albuterol sulfate is longer acting than isoproterenol in most patients by any route of administration, because it is not a substrate for the cellular uptake processes for catecholamine nor for the metabolism of catechol-O-methyl transferase. Instead the drug is conjugatively metabolized to albuterol 4'-O-sulfate.
Intravenous studies in rats with albuterol sulfate have demonstrated that albuterol crosses the blood-brain barrier and reaches brain concentrations amounting to approximately 5% of plasma concentrations. In structures outside of the blood-brain barrier (pineal and pituitary glands), albuterol concentrations were found to be 100 times those found in whole brain.
Studies in laboratory animals (minipigs, rodents, and dogs) have demonstrated the occurrence of cardiac arrythmias and sudden death (with histological evidence of myocardial necrosis) when beta-agonists and methyl-xanthines are administered concurrently. The clinical significance of these findings is unknown.
Ipratropium bromide is an anticholinergic (parasympatholytic) agent, which blocks the muscarinic receptors of acetylcholine, and, 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 (cGMP), resulting from the interaction of acetylcholine with the muscarinic receptors of bronchial smooth muscle.
The bronchodilation following inhalation of ipratropium is primarily a local, site-specific effect, not a systemic one. Much of an inhaled dose is swallowed as shown by fecal excretion studies. Following nebulization of a 1-mg dose to healthy volunteers, a mean of 4% of the dose was excreted unchanged in the urine.
Ipratropium bromide is minimally (0% to 9% in vitro) bound to plasma albumin and α1-acid glycoproteins. It is partially metabolized to inactive ester hydrolysis products. Following intravenous administration, approximately one-half is excreted unchanged in the urine. The half-life of elimination is about 1.6 hours after intravenous administration. Ipratropium bromide that reaches the systemic circulation is reportedly removed by the kidneys rapidly at a rate that exceeds the glomerular filtration rate. The pharmacokinetics of DuoNeb Inhalation Solution or ipratropium bromide have not been studied in the elderly and in patients with hepatic or renal insufficiency (see PRECAUTIONS).
Autoradiographic studies in rats have shown that ipratropium does not penetrate the blood-brain barrier.
DuoNeb is expected to maximize the response to treatment in patients with chronic obstructive pulmonary disease (COPD) by reducing bronchospasm through two distinctly different mechanisms: sympathomimetic (albuterol sulfate) and anticholinergic/parasympatholytic (ipratropium bromide). Simultaneous administration of both an anticholinergic and a β2-sympathomimetic is designed to produce greater bronchodilation effects than when either drug is utilized alone at its recommended dosage.
In 30-day studies in Sprague-Dawley rats and Beagle dogs, subcutaneous doses of up to 205.5 mcg/kg of ipratropium administered with up to 1000 mcg/kg albuterol in rats and 3.16 mcg/kg ipratropium and 15 mcg/kg albuterol in dogs (less than the maximum recommended daily inhalation dose for adults on a mg/m2 basis) did not cause death or potentiation of the cardiotoxicity induced by albuterol administered alone.
In a double blind, double period, crossover study, 15 male and female subjects were administered single doses of DuoNeb or albuterol sulfate inhalation solution at two times the recommended single doses as two inhalations separated by 15 minutes. The total nebulized dose of albuterol sulfate from both treatments was 6.0 mg and the total dose of ipratropium bromide from DuoNeb was 1.0 mg. Peak albuterol plasma concentrations occurred at 0.8 hours after dosing for both treatments. The mean peak albuterol concentration following administration of albuterol sulfate alone was 4.86 (± 2.65) mg/mL and it was 4.65 (± 2.92) mg/mL for DuoNeb. Mean AUC values for the two treatments were 26.6 (± 15.2) ng∙hr/mL (albuterol sulfate alone) versus 24.2 (± 14.5) ng∙hr/mL (DuoNeb). The mean t1/2 values were 7.2 (± 1.3) hours (albuterol sulfate alone) and 6.7 (± 1.7) hours (DuoNeb). A mean of 8.4 (± 8.9)% of the albuterol dose was excreted unchanged in urine following administration of two vials of DuoNeb which is similar to 8.8 (± 7.3)% that was obtained from albuterol sulfate inhalation solution. There were no statistically significant differences in the pharmacokinetics of albuterol between the two treatments. For ipratropium, a mean of 3.9 (± 5.1)% of the ipratropium bromide dose was excreted unchanged in urine following two vials of DuoNeb Inhalation Solution, which is comparable with previously reported data.
In a 12 week, randomized, double-blind, positive-control, crossover study of albuterol sulfate, ipratropium bromide, and DuoNeb, 863 COPD patients were evaluated for bronchodilator efficacy comparing DuoNeb with albuterol sulfate and ipratropium bromide alone.
DuoNeb demonstrated significantly better changes in FEV1, as measured from baseline to peak response, when compared with either albuterol sulfate or ipratropium bromide. DuoNeb was also shown to have the rapid onset associated with albuterol sulfate, with a mean time to peak FEV1 of 1.5 hours, and the extended duration associated with ipratropium bromide with a duration of 15% response in FEV1 of 4.3 hours.
Figure 3. 1-3. Mean Change in FEV<sub>1</sub> - Measured on Day 14
This study demonstrated that each component of DuoNeb contributed to the improvement in pulmonary function, especially during the first 4 to 5 hours after dosing, and that DuoNeb was significantly more effective than albuterol sulfate or ipratropium bromide alone.
DuoNeb is indicated for the treatment of bronchospasm associated with COPD in patients requiring more than one bronchodilator.
DuoNeb is contraindicated in patients with a history of hypersensitivity to any of its components, or to atropine and its derivatives.
In the clinical study of DuoNeb, paradoxical bronchospasm was not observed. However, paradoxical bronchospasm has been observed with both inhaled ipratropium bromide and albuterol products and can be life-threatening. If this occurs, DuoNeb should be discontinued immediately and alternative therapy instituted.
Fatalities have been reported in association with excessive use of inhaled products containing sympathomimetic amines and with the home use of nebulizers.
DuoNeb, like other beta adrenergic agonists, can produce a clinically significant cardiovascular effect in some patients as measured by pulse rate, blood pressure, and/or symptoms. Although such effects are uncommon for DuoNeb at recommended doses, if they occur, the drug may need to be discontinued. In addition, beta agonists have been reported to produce ECG changes, such as flattening of the T-wave, prolongation of the QTc interval, and ST segment depression. The clinical significance of these findings is unknown. Therefore, DuoNeb, like other sympathomimetic amines, should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension.
Immediate hypersensitivity reactions to albuterol and/or ipratropium bromide may occur after the administration of DuoNeb as demonstrated by rare cases of urticaria, angioedema, rash, pruritus, oropharyngeal edema, bronchospasm, and anaphylaxis.
1. Effects Seen with Sympathomimetic Drugs
As with all products containing sympathomimetic amines, DuoNeb should be used with caution in patients with cardiovascular disorders, especially coronary insufficiency, cardiac arrhythmias, and hypertension; in patients with convulsive disorders, hyperthyroidism, or diabetes mellitus; and in patients who are unusually responsive to sympathomimetic amines. Large doses of intravenous albuterol have been reported to aggravate pre-existing diabetes mellitus and ketoacidosis. Additionally, β-agonists may cause a decrease in serum potassium in some patients, possibly through intracellular shunting. The decrease is usually transient, not requiring supplementation.
Due to the presence of ipratropium bromide in DuoNeb, it should be used with caution in patients with narrow-angle glaucoma, prostatic hypertrophy, or bladder-neck obstruction.
DuoNeb has not been studied in patients with hepatic or renal insufficiency. It should be used with caution in these patient populations.
The action of DuoNeb should last up to 5 hours. DuoNeb should not be used more frequently than recommended. Patients should be instructed not to increase the dose or frequency of DuoNeb without consulting their healthcare provider. If symptoms worsen, patients should be instructed to seek medical consultation.
Patients must avoid exposing their eyes to this product as temporary papillary dilation, blurred vision, eye pain, or precipitation or worsening of narrow-angle glaucoma may occur, and therefore proper nebulizer technique should be assured, particularly if a mask is used.
If a patient becomes pregnant or begins nursing while on DuoNeb, they should contact their healthcare provider about use of DuoNeb.
See the illustrated Patient's Instruction for Use in the product package insert.
Although ipratropium bromide is minimally absorbed into the systemic circulation, there is some potential for an additive interaction with concomitantly used anticholinergic medications. Caution is, therefore, advised in the co-administration of DuoNeb with other drugs having anticholinergic properties.
Caution is advised in the co-administration of DuoNeb and other sympathomimetic agents due to the increased risk of adverse cardiovascular effects.
These agents and albuterol sulfate inhibit the effect of each other. β-receptor blocking agents should be used with caution in patients with hyperreactive airways, and if used, relatively selective β1 selective agents are recommended.
The electrocardiogram (ECG) changes and/or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β-agonists, especially when the recommended dose of the β-agonist is exceeded. Although the clinical significance of these effects is not known, caution is advised in the co-administration of β-agonist-containing drugs, such as DuoNeb, with non-potassium sparing diuretics.
DuoNeb 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 sulfate on the cardiovascular system may be potentiated.
In a 2-year study in Sprague-Dawley rats, albuterol sulfate caused a significant dose-related increase in the incidence of benign leiomyomas of the mesovarium at and above dietary doses of 2 mg/kg (approximately equal to the maximum recommended daily inhalation dose for adults on a mg/m2 basis). In another study, this effect was blocked by the coadministration of propranolol, a non-selective beta-adrenergic antagonist.
In an 18-month study in CD-1 mice, albuterol sulfate showed no evidence of tumorigenicity at dietary doses up to 500 mg/kg (approximately 140 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). In a 22-month study in Golden hamsters, albuterol sulfate showed no evidence of tumorigenicity at dietary doses up to 50 mg/kg (approximately 20 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
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 micronucleous assay.
Reproduction studies in rats demonstrated no evidence of impaired fertility at oral doses of albuterol sulfate up to 50 mg/kg (approximately 25 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
In 2-year studies in Sprague-Dawley rats and CD-1 mice, ipratropium bromide showed no evidence of tumorigenicity at oral doses up to 6 mg/kg (approximately 15 times and 8 times the maximum recommended daily inhalation dose for adults in rats and mice respectively, on a mg/m2 basis).
Ipratropium bromide was not mutagenic in the Ames test and mouse dominant lethal test. Ipratropium bromide was not clastogenic in a mouse micronucleous assay.
A reproduction study in rats demonstrated decreased conception and increased resorptions when ipratropium bromide was administered orally at a dose of 90 mg/kg (approximately 240 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). These effects were not seen with a dose of 50 mg/kg (approximately 140 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
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/m2 basis) and in 10 of 108 (9.3%) fetuses at 2.5 mg/kg (approximately equal to the maximum recommended daily inhalation dose for adults on a mg/m2 basis). The drug did not induce cleft palate formation when administered subcutaneously at a dose of 0.025 mg/kg (less than the maximum recommended daily inhalation dose for adults on a mg/m2 basis). Cleft palate formation also occurred in 22 of 72 (30.5%) fetuses from females treated subcutaneously with 2.5 mg/kg isoproterenol (positive control).
A reproduction study in Stride rabbits revealed cranioschisis in 7 of 19 (37%) fetuses when albuterol was administered orally at a dose of 50 mg/kg (approximately 55 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis).
A study in which pregnant rats were dosed with radiolabeled albuterol sulfate demonstrated that drug-related material is transferred from the maternal circulation to the fetus.
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.
Reproduction studies in CD-1 mice, Sprague-Dawley rats and New Zealand rabbits demonstrated no evidence of teratogenicity at oral doses up to 10, 100, and 125 mg/kg, respectively (approximately 15, 270, and 680 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). Reproduction studies in rats and rabbits demonstrated no evidence of teratogenicity at inhalation doses up to 1.5 and 1.8 mg/kg, respectively (approximately 4 and 10 times the maximum recommended daily inhalation dose for adults on a mg/m2 basis). There are no adequate and well-controlled studies of the use of DuoNeb, albuterol sulfate, or ipratropium bromide in pregnant women. DuoNeb should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Oral albuterol sulfate has been shown to delay preterm labor in some reports. Because of the potential of albuterol to interfere with uterine contractility, use of DuoNeb during labor should be restricted to those patients in whom the benefits clearly outweigh the risks.
It is not known whether the components of DuoNeb are excreted in human milk. Although lipid-insoluble quaternary bases pass into breast milk, it is unlikely that ipratropium bromide would reach the infant to an important extent, especially when taken as a nebulized solution. Because of the potential for tumorigenicity shown for albuterol sulfate in some animals, a decision should be made whether to discontinue nursing or discontinue DuoNeb, taking into account the importance of the drug to the mother.
The safety and effectiveness of DuoNeb in patients below 18 years of age have not been established.
Of the total number of subjects in clinical studies of DuoNeb, 62 percent were 65 and over, while 19 percent were 75 and over. No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out.
Adverse reaction information concerning DuoNeb was derived from the 12-week controlled clinical trial.
| Body System COSTART Term | Albuterol n (%) | Ipratropium n (%) | DuoNeb n (%) |
| NUMBER OF PATIENTS | 761 | 754 | 765 |
| N (%) Patients with AE | 327 (43.0) | 329 (43.6) | 367 (48.0) |
| BODY AS A WHOLE | |||
| Pain | 8 (1.1) | 4 (0.5) | 10 (1.3) |
| Pain chest | 11 (1.4) | 14 (1.9) | 20 (2.6) |
| DIGESTIVE | |||
| Diarrhea | 5 (0.7) | 9 (1.2) | 14 (1.8) |
| Dyspepsia | 7 (0.9) | 8 (1.1) | 10 (1.3) |
| Nausea | 7 (0.9) | 6 (0.8) | 11 (1.4) |
| MUSCULO-SKELETAL | |||
| Cramps leg | 8 (1.1) | 6 (0.8) | 11 (1.4) |
| RESPIRATORY | |||
| Bronchitis | 11 (1.4) | 13 (1.7) | 13 (1.7) |
| Lung Disease | 36 (4.7) | 34 (4.5) | 49 (6.4) |
| Pharyngitis | 27 (3.5) | 27 (3.6) | 34 (4.4) |
| Pneumonia | 7 (0.9) | 8 (1.1) | 10 (1.3) |
| UROGENITAL | |||
| Infection urinary tract | 3 (0.4) | 9 (1.2) | 12 (1.6) |
Additional adverse reactions reported in more than 1% of patients treated with DuoNeb included constipation and voice alterations.
In the clinical trial, there was a 0.3% incidence of possible allergic-type reactions, including skin rash, pruritus, and urticaria.
Additional information derived from the published literature on the use of albuterol sulfate and ipratropium bromide singly or in combination includes precipitation or worsening of narrow-angle glaucoma, acute eye pain, blurred vision, paradoxical bronchospasm, wheezing, exacerbation of COPD symptoms, drowsiness, aching, flushing, upper respiratory tract infection, palpitations, taste perversion, elevated heart rate, sinusitis, back pain, sore throat, and metabolic acidosis. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
The effects of overdosage with DuoNeb are expected to be related primarily to albuterol sulfate, since ipratropium bromide is not well-absorbed systemically after oral or aerosol administration. The expected symptoms with overdosage are those of excessive beta-adrenergic stimulation and/or occurrence or exaggeration of symptoms such as seizures, angina, hypertension or hypotension, tachycardia with rates up to 200 beats per minute, arrhythmia, nervousness, headache, tremor, dry mouth, palpitation, nausea, dizziness, fatigue, malaise, insomnia, and exaggeration of pharmacological effects listed in ADVERSE REACTIONS. Hypokalemia may also occur. As with all sympathomimetic aerosol medications, cardiac arrest and even death may be associated with abuse of DuoNeb. Treatment consists of discontinuation of DuoNeb together with appropriate symptomatic therapy. The judicious use of a cardioselective beta-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 DuoNeb.
The oral median lethal dose of albuterol sulfate in mice is greater than 2000 mg/kg (approximately 540 times the maximum recommended daily inhalation dose of DuoNeb on a mg/m2 basis). The subcutaneous median lethal dose of albuterol sulfate in mature rats and small young rats is approximately 450 and 2000 mg/kg respectively (approximately 240 and 1100 times the maximum recommended daily inhalation dose of DuoNeb on a mg/m2 basis, respectively). The inhalation median lethal dose has not been determined in animals. The oral median lethal dose of ipratropium bromide in mice, rats and dogs is greater than 1000 mg/kg, approximately 1700 mg/kg and approximately 400 mg/kg, respectively (approximately 1400, 4600, and 3600 times the maximum recommended daily inhalation dose in adults on a mg/m2 basis, respectively).
The recommended dose of DuoNeb is one 3 mL vial administered 4 times per day via nebulization with up to 2 additional 3 mL doses allowed per day, if needed. Safety and efficacy of additional doses or increased frequency of administration of DuoNeb beyond these guidelines has not been studied and the safety and efficacy of extra doses of albuterol sulfate or ipratropium bromide in addition to the recommended doses of DuoNeb have not been studied.
The use of DuoNeb can be continued as medically indicated to control recurring bouts of bronchospasm. If a previously effective regimen fails to provide the usual relief, medical advice should be sought immediately, as this is often a sign of worsening COPD, which would require reassessment of therapy.
A Pari-LC-Plus™ nebulizer (with face mask or mouthpiece) connected to a PRONEB™ compressor was used to deliver DuoNeb to each patient in one U.S. clinical study. The safety and efficacy of DuoNeb delivered by other nebulizers and compressors have not been established.
DuoNeb should be administered via jet nebulizer connected to an air compressor with an adequate air flow, equipped with a mouthpiece or suitable face mask.
DuoNeb is supplied as a 3-mL sterile solution for nebulization in sterile low-density polyethylene unit-dose vials. Store in pouch until time of use. Supplied in cartons as listed below.
NDC 49502-672-30 30 vials per carton/5 vials per foil pouch
NDC 49502-672-60 60 vials per carton/5 vials per foil pouch
Store between 2°C and 25°C (36°F and 77°F). Protect from light.
DuoNeb is a registered trademark of Dey Pharma L.P.
Dey®
A Mylan Company
Dey Pharma L.P., Napa, CA 94558
03-485-32
MAR 11
(Ipratropium Bromide 0.5 mg/Albuterol Sulfate 3.0 mg*)
Inhalation Solution
*Equivalent to 2.5 mg albuterol base
Patient's Instructions for Use
Read this patient information completely every time your prescription is filled as information may have changed. Keep these instructions with your medication as you may want to read them again.
DuoNeb should only be used under the direction of a physician. Your physician and pharmacist have more information about DuoNeb and the condition for which it has been prescribed. Contact them if you have additional questions.
Storing your Medicine
Store DuoNeb between 2°C and 25°C (36°F and 77°F). Vials should be protected from light before use, therefore, keep unused vials in the foil pouch or carton. Do not use after the expiration (EXP) date printed on the carton.
Dose
DuoNeb is supplied as a single-dose, ready-to-use vial containing 3 mL of solution. No mixing or dilution is needed. Use one new vial for each nebulizer treatment.
FOLLOW THESE DIRECTIONS FOR USE OF YOUR NEBULIZER/COMPRESSOR OR THE DIRECTIONS GIVEN BY YOUR HEALTHCARE PROVIDER. A TYPICAL EXAMPLE IS SHOWN BELOW.
Instructions for Use
Dey®
A Mylan Company
Dey Pharma L.P., Napa, CA 94558
03-485-32
MAR 11
DuoNeb® (DOO-o-neb)
(Ipratropium Bromide 0.5 mg/Albuterol Sulfate 3.0 mg*) Inhalation Solution
*Equivalent to 2.5 mg albuterol base
Prescription Only.
Read the patient information that comes with DuoNeb® before you start using it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.
What is DuoNeb®?
DuoNeb® is a combination of two medicines called bronchodilators. DuoNeb® contains albuterol sulfate, which is a beta-adrenergic agonist, and ipratropium bromide, which is an anticholinergic. These two medicines work together to help open the airways in your lungs. DuoNeb® is used to help treat airway narrowing (bronchospasm) that happens with chronic obstructive pulmonary disease (COPD) in adult patients who need to use more than one bronchodilator medicine.
Who should not use DuoNeb®?
Do not use DuoNeb® if you:Are allergic to any of the ingredients in DuoNeb or to atropine. The active ingredients are albuterol sulfate and ipratropium bromide. See the end of this leaflet for a complete list of ingredients in DuoNeb®.
DuoNeb® has not been studied in patients younger than 18 years of age.
What should I tell my doctor before I start using DuoNeb®?
Tell your doctor about all of your conditions, including if you:
Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. DuoNeb® and other medicines can interact. This may cause serious side effects. Especially tell your doctor if you take:
Ask your doctor or pharmacist if you are not sure if you take any of these types of medicines. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacists when you get a new medicine.
How should I use DuoNeb®?
What should I avoid while using DuoNeb®?
Do not get DuoNeb® in your eyes. Be careful not to spray DuoNeb® in your eyes while you are using your nebulizer. DuoNeb® can cause the following short-term eye problems:
DuoNeb® can cause a serious eye problem called narrow-angle glaucoma or worsen the narrow-angle glaucoma you already have.
What are the possible side effects with DuoNeb®?
DuoNeb® may cause the following serious side effects:
The most common side effects with DuoNeb® include lung disease, sore throat, chest pain, constipation, diarrhea, bronchitis, urinary tract infection, leg cramps, nausea, upset stomach, voice changes, and pain.
These are not all the side effects with DuoNeb®. For a complete list, ask your doctor or pharmacist.
How should I store DuoNeb®?
General advice about DuoNeb®
Medicines are sometimes prescribed for conditions that are not mentioned in the patient information leaflets. Do not use DuoNeb® for a condition for which it was not prescribed. Do not give DuoNeb® to other people, even if they have the same symptoms you have. It may harm them.
This leaflet summarizes the most important information about DuoNeb®. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about DuoNeb® that is written for healthcare professionals. You can also call the company that makes DuoNeb® toll free at 1-800-395-3376 or visit their website at www.dey.com.
What are the ingredients in DuoNeb®?
Active Ingredients: ipratropium bromide and albuterol sulfate
Inactive Ingredients: sodium chloride, hydrochloric acid, and edetate sodium, USP.
Dey Pharma L.P., Napa, CA 94558; 1-800-395-3376; www.dey.com
© 2004 Printed in U.S.A.
U.S. Pat. No. 6,632,842
M9-356-00 April 2006
PRINCIPAL DISPLAY PANEL - 3 mL
NDC 49502-672-30
DuoNeb®
(ipratropium bromide
and albuterol sulfate)
INHALATION SOLUTION
Sterile Unit-Dose Vials
For Inhalation Only
INGREDIENTS:
Active: 0.5 mg ipratropium bromide and 3.0 mg albuterol sulfate*.
Inactive: Sodium chloride, edetate disodium, and hydrochloric acid (to
adjust to pH 4) and purified water.
STORAGE CONDITIONS: PROTECT FROM LIGHT. STORE IN POUCH
UNTIL TIME OF USE. Store between 2°C and 25°C (36°F and 77°F).
USUAL DOSAGE: See accompanying prescribing information. USE ONLY
AS DIRECTED BY YOUR PHYSICIAN. DO NOT EXCEED
RECOMMENDED DOSAGE.
Rx only.
*Equivalent to 2.5 mg albuterol base.
U.S. Pat. No. 6,632,842
DuoNeb is a registered trademark of Dey Pharma, L.P.
Dey®
A Mylan Company
Napa, CA 94558
©2001
ATTENTION PHARMACIST: Detach "Patient's Instructions
for Use" from package insert and dispense with solution.
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