Pevalon may be available in the countries listed below.
Phenobarbital sodium salt (a derivative of Phenobarbital) is reported as an ingredient of Pevalon in the following countries:
International Drug Name Search
Moxday may be available in the countries listed below.
Moxifloxacin is reported as an ingredient of Moxday in the following countries:
International Drug Name Search
Carbocistéine Biogaran Sans Sucre may be available in the countries listed below.
Carbocisteine is reported as an ingredient of Carbocistéine Biogaran Sans Sucre in the following countries:
International Drug Name Search
Acido Acetilsalicilico Angenerico may be available in the countries listed below.
Acetylsalicylic Acid is reported as an ingredient of Acido Acetilsalicilico Angenerico in the following countries:
International Drug Name Search
Mesalazyna may be available in the countries listed below.
Mesalazine is reported as an ingredient of Mesalazyna in the following countries:
International Drug Name Search
Deltaderm may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Miconazole nitrate (a derivative of Miconazole) is reported as an ingredient of Deltaderm in the following countries:
International Drug Name Search
Antiplat may be available in the countries listed below.
Cilostazol is reported as an ingredient of Antiplat in the following countries:
International Drug Name Search
Divascan may be available in the countries listed below.
Iprazochrome is reported as an ingredient of Divascan in the following countries:
International Drug Name Search
Azithromycine Arrow may be available in the countries listed below.
Azithromycin monohydrate (a derivative of Azithromycin) is reported as an ingredient of Azithromycine Arrow in the following countries:
International Drug Name Search
Pseudoéphédrine may be available in the countries listed below.
Pseudoéphédrine (DCF) is known as Pseudoephedrine in the US.
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
Class: Mucolytic Agents
ATC Class: R05CB13
VA Class: RE900
Chemical Name: Deoxyribonuclease
CAS Number: 9003-98-9
Brands: Pulmozyme
Mucolytic agent; biosynthetic (recombinant DNA origin) form of human deoxyribonuclease I (DNase I).1 2 33
Adjunctive therapy in patients with cystic fibrosis to reduce mucus viscosity and enable the clearance of airway secretions to improve pulmonary function (designated an orphan drug by FDA for this use).1 4 5 8 9 10 11 12 13 14 15 16 17 18 27 36
Reduces the frequency of respiratory infections requiring parenteral anti-infective therapy in patients with forced vital capacity (FVC) ≥40%.1 4 5 8 9 10 11 12 14 15 16 17 18 27 36
Administer by oral inhalation via nebulization once daily.1
Administer using a recommended nebulizer system; safety and efficacy of dornase alfa inhalation solution administered by a nebulizer system other than those listed below not established.1 1
Use in patients unable to inhale or exhale orally throughout the entire nebulization period.1
Nebulizer | Compressor |
|---|---|
Hudson T Up-draft II with | Pulmo-Aide |
Marquest Acorn II with | Pulmo-Aide |
PARI LC Jet+ with | PARI PRONEB |
PARI BABY with | PARI PRONEB |
Durable Sidestream with | Porta-Neb |
Durable Sidestream with | MOBILAIRE |
Oral inhalation solution should not be diluted nor mixed with any other drugs in the nebulizer.1
Empty the entire contents of the single-use ampul of solution into the nebulizer cup; attach the cup to the inhalation apparatus according to the manufacturer’s instructions.1 32
Place the mouthpiece of the nebulizer in the mouth and turn on the compressor.32 Breathe calmly and evenly through the mouth until the nebulizer stops producing a mist (duration of treatment for full dose is approximately 10–15 minutes).32
Clean the nebulizer after use according to the manufacturer's instructions.b
Oral inhalation solution contains no preservatives; once the single-use ampul is opened, use the entire contents or discard the remainder.1
Each single-use ampul delivers 2.5 mg (2.5 mL of undiluted solution) to the nebulizer cup.1 35
Children ≥5 years of age: 2.5 mg once daily.1 Some patients (e.g., those with FVC >85%) may benefit from 2.5 mg twice daily.1 35
2.5 mg once daily.1 Some patients (e.g., ≥21 years of age, those with FVC >85%) may benefit from 2.5 mg twice daily.1 35
In clinical studies, dosages >2.5 mg twice daily did not provide additional improvement in pulmonary function (e.g., FEV1).1 10
Safety and efficacy of daily administration for >12 months of continuous therapy not established.1
In clinical studies, dosages >2.5 mg twice daily did not provide additional improvement in pulmonary function (e.g., FEV1).1 10
Safety and efficacy of daily administration for >12 months of continuous therapy not established.1
No special population dosage recommendations at this time.a
Known hypersensitivity to dornase alfa, Chinese hamster ovary cell-derived products, or any ingredient in the formulation.a
Adjunct to and not a replacement for standard therapies (e.g., chest physical therapy, anti-infectives, bronchodilators, oral enzyme supplements, vitamins, oral and/or inhaled corticosteroids, analgesics); continue such therapies during enzyme therapy.1 31
Category B.a
Not known whether dornase alfa is distributed into milk; caution if used in nursing women.a
Limited experience in patients <5 years of age; use only in those in whom there is a potential for benefit in pulmonary function or in risk of respiratory tract infection.1
Increased incidence of cough, rhinitis, and rash in children <5 years of age compared with children ≥5 years of age.1
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.a
Pharyngitis, chest pain, voice alteration (e.g., hoarseness), rash, conjunctivitis.a
No formal drug interaction studies to date; however, the manufacturer states that concomitant administration of dornase alfa and other standard therapies for cystic fibrosis is safe and effective.a
Following oral inhalation, serum DNase concentrations were not increased above normal endogenous levels.a
Following oral inhalation, mean sputum DNase concentrations measurable within 15 minutes.a Improvement in pulmonary function (FEV1) evident within 8 days.a
Not known whether dornase alfa crosses the placenta or is distributed into milk.a
2–8°C; protect from light and excessive heat.a b Store ampuls in protective foil pouch to protect from light until used.a Discard if left at room temperature for ≥24 hours.b
Selectively cleaves extracellular DNA (e.g., in purulent pulmonary secretions);1 2 5 33 does not appear to affect sputum in the absence of an inflammatory response to infection (i.e., in those with nonpurulent sputum)2 5 8 35 nor does it affect pulmonary function in healthy individuals.8
Reduces sputum viscosity and viscoelasticity.1 2 3 15 20
Mechanism of action not fully elucidated;6 7 appears to improve the transportability of purulent mucus via ciliary activity and cough.3 19
Reduces airflow obstruction, improves pulmonary function (increased forced vital capacity and forced expiratory volume at 1 second [FEV1]), and improves mucociliary clearance in patients with cystic fibrosis.1 5 8 9 10 11 12 14 27 29
Importance of providing patient a copy of manufacturer's patient information.b
Importance of adequate understanding of proper storage, preparation, and inhalation techniques, including use of the nebulization delivery system.b
Importance of thoroughly washing hands with soap and water before handling drug and nebulizer to avoid microbial contamination.b
Importance of adhering to daily dosing schedule and concomitant therapies, including not exceeding the recommended dose or frequency of use unless otherwise instructed by a clinician.b
Importance of not diluting or mixing with other drugs in the nebulizer.1
Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing patients of other important precautionary information.a (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Oral Inhalation | Solution, for nebulization | 1 mg/mL (2.5 mg) | Pulmozyme | Genentech |
This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.
Pulmozyme 1MG/ML Solution (GENENTECH): 75/$2151.77 or 150/$4200.17
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions April 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
1. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution prescribing information. South San Francisco, CA; 2001 Jan.
2. Shak S, Capon DJ, Hellmiss R et al. Recombinant human DNase I reduces the viscosity of cystic fibrosis sputum. Proc Natl Acad Sci USA. 1990; 87:9188-92. [PubMed 2251263]
3. Zahm JM, de Bentzmann S, Deneuville E et al. Recombinant human DNase I improves the transport of cystic fibrosis respiratory mucus ex vivo. Pediatr Pulmonol. 1993; Suppl 9:250.
4. Collins FS. Cystic fibrosis: molecular biology and therapeutic implications. Science. 1992; 256:774-9. [PubMed 1375392]
5. Hubbard RC, McElvaney NG, Birrer P et al. A preliminary study of aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med. 1992; 326:812-5. [IDIS 293048] [PubMed 1538726]
6. Rubin BK. Aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med. 1992; 327:571. [IDIS 300805] [PubMed 1635583]
7. Hubbard RC, Shak S, Crystal RG. Aerosolized recombinant human deoxyribonuclease I in the treatment of cystic fibrosis. N Engl J Med. 1992; 327:571.
8. Aitken ML, Burke W, McDonald G et al. Recombinant human DNase inhalation in normal subjects and patients with cystic fibrosis: a phase 1 study. JAMA. 1992; 267:1947-51. [IDIS 294316] [PubMed 1548827]
9. Fuchs HJ, Borowitz D, Christiansen D et al. Aerosolized recombinant human DNase reduces pulmonary exacerbations and improves pulmonary function in patients with cystic fibrosis. Presented at the 36th Annual Conference on Chest Disease, Intermountain Thoracic Society. Snowbird, UT: 1993 Jan 26.
10. Ramsey BW, Astley SJ, Aitken ML et al. Efficacy and safety of short-term administration of aerosolized recombinant human deoxyribonuclease in patients with cystic fibrosis. Am Rev Respir Dis. 1993; 148:145-51. [IDIS 316737] [PubMed 8317790]
11. Ranasinha C, Assoufi B, Shak S et al. Efficacy and safety of short-term administration of aerosolised recombinant human DNase I in adults with stable stage cystic fibrosis. Lancet. 1993; 342:199-202. [IDIS 318293] [PubMed 8100928]
12. Ramsey B for the Pulmozyme (rhDNase) Study Group. A summary of the results of the phase III multicenter clinical trial: aerosol administration of recombinant human DNase reduces the risk of respiratory tract infections and improves pulmonary function in patients with cystic fibrosis. Pediatr Pulmonol. 1993; Suppl 9:152-3.
13. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414), to August 31, 1993. Rockville, MD; 1993 September.
14. Quan MP. Manufacturer letter regarding product information on Pulmozyme (dornase alfa). South San Francisco, CA: Genentech, Inc; 1993 Aug 6.
15. Boucher RC. Drug therapy in the 1990s: what can we expect for cystic fibrosis? Drugs. 1992; 43:431-9.
16. Wallace CS, Hall M, Kuhn RJ. Pharmacologic management of cystic fibrosis. Clin Pharm. 1993; 12:657-74. [IDIS 319124] [PubMed 8306566]
17. Fiel SB. Clinical management of pulmonary disease in cystic fibrosis. Lancet. 1993; 341:1070-4. [IDIS 313065] [PubMed 8096969]
18. Gibaldi M. Understanding and treating some genetic diseases. Ann Pharmacother. 1992; 26:1589-94. [IDIS 306629] [PubMed 1482818]
19. Rubin BK, Ramirez OE, Baharav AL. The physical and transport properties of CF sputum after treatment with rhDNase. Pediatr Pulmonol. 1993; Suppl 9:251.
20. Shak S, King M. Effects of rhDNase on cystic fibrosis sputum viscoelasticity in vitro. Pediatr Pulmonol. 1993; Suppl 9:251.
21. Mucolytics. In: Goodman LS, Gilman A, Gilman AG et al, eds. Goodman and Gilman’s the pharmacological basis of therapeutics. 5th ed. New York: Macmillan Publishing Company; 1975:955-6.
22. Lieberman J. Dornase aerosol effect on sputum viscosity in cases of cystic fibrosis. JAMA. 1968; 205:114-5. [PubMed 5694890]
23. Lieberman J. The appropriate use of mucolytic agents. Am J Med. 1970; 49:1-4. [PubMed 4246985]
24. Puckett WH Jr. The pharmacist and inhalation therapy. Am J Hosp Pharm. 1972; 29:556-63. [PubMed 5052020]
25. Raskin P. Bronchospasm after inhalation of pancreatic dornase. Am Rev Respir Dis. 1968; 98:697-8. [PubMed 4877872]
26. Morice AH. Which DNase in cystic fibrosis? Lancet. 1993; 342:624-5. Letter.
27. Shah PL, Scott S, Geddes D et al. A preliminary report on using aerosolised recombinant human DNase I in the treatment of patients with stable stage cystic fibrosis for six months. Pediatr Pulmonol. 1993; Suppl 9:247.
28. Wilmott R, DNase Multicenter Study Group, Genentech Staff. A phase II, double-blind, multicenter study of the safety and efficacy of aerosolized recombinant human DNase I (rhDNase) in hospitalized patients with CF experiencing acute pulmonary exacerbations. Pediatr Pulmonol. 1993; Suppl 9:154.
29. Laube BL, Auci RM, Shields DE et al. A randomized, placebo-controlled trial of the effect of recombinant human DNase I (rhDNase) on the deposition homogeneity and mucociliary clearance of radioaerosol in patients with cystic fibrosis. Pediatr Pulmonol. 1993; Suppl 9:155-6.
30. Shah PL, Scott SF, Hodson ME. Report on a multicentre study using aerosolised recombinant human DNase I in the treatment of cystic fibrosis patients with severe pulmonary disease. Pediatr Pulmonol. 1993; Suppl 9:157.
31. Magnuson DE. Dear hospital pharmacist letter regarding the use of Pulmozyme in the management of patients with cystic fibrosis. South San Francisco, CA: Genentech, Inc; 1994 Jan 5.
32. Genentech, Inc. Patient information booklet: your guide to Pulmozyme (dornase alfa) therapy for cystic fibrosis (CF). South San Francisco, CA; 1994.
33. Webb EC, preparer. Enzyme nomenclature 1992: recommendations of the Nomenclature Committee of the International Union of Biochemistry and Molecular Biology on the nomenclature and classification of enzymes. San Diego, CA: Academic Press, Inc; 1992:339. ECC 3.1.21.1.
34. Armstrong JB, White JC. Liquefaction of viscous purulent exudates by deoxyribonuclease. Lancet. 1950; 1:739-42.
35. Genentech, South San Francisco, CA: Personal communication.
36. Genentech, Inc. Pulmozyme (dornase alfa) recombinant inhalation solution prescribing information. South San Francisco, CA; 1996 Nov.
37. McCoy K, Hamilton S, Johnson C. Effects of 12-week administration of dornase alfa in patients with advanced cystic fibrosis lung disease. Chest. 1996; 110:889-95. [IDIS 373898] [PubMed 8874241]
38. Kanga JF. Dornase alfa therapy in cystic fibrosis: who should get it? Chest. 1996; 110:871-2. Editorial.
a. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution prescribing information. South San Francisco, CA; 2005 Apr.
b. Genentech, Inc. Pulmozyme (dornase alfa) inhalation solution information for the patient/parent. South San Francisco, CA; 2001 Jan.
Generic Name: dirithromycin (Oral route)
dye-rith-roe-MYE-sin
In the U.S.
Available Dosage Forms:
Therapeutic Class: Antibiotic
Chemical Class: Macrolide
Dirithromycin is used to treat bacterial infections in many different parts of the body. It works by killing bacteria or preventing their growth. However, this medicine will not work for colds, flu, or other virus infections.
Dirithromycin was available only with your doctor's prescription.
Dirithromycin is no longer available in the United States.
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Studies on this medicine have been only in adult patients, and there is no specific information comparing use of dirithromycin in children with use in other age groups.
This medicine has been tested in a limited number of elderly patients and has not been shown to cause different side effects or problems in older people than it does in younger adults.
| Pregnancy Category | Explanation | |
|---|---|---|
| All Trimesters | C | Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women. |
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are taking this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.
Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
This section provides information on the proper use of a number of products that contain dirithromycin. It may not be specific to Dynabac D5-Pak. Please read with care.
Dirithromycin should be taken with food or within 1 hour after eating.
To help clear up your infection completely, keep taking dirithromycin for the full time of treatment, even if you begin to feel better after a few days. If you stop taking this medicine too soon, your symptoms may return.
Do not cut, crush, or chew dirithromycin tablets.
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.
The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.
Keep out of the reach of children.
Do not keep outdated medicine or medicine no longer needed.
If your symptoms do not improve within a few days, or if they become worse, check with your doctor.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor as soon as possible if any of the following side effects occur:
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
See also: Dynabac D5-Pak side effects (in more detail)
The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.
The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.
