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| DCIT | Denominazione Comune Italiana |
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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)
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Relieving congestion, sneezing, runny nose, nasal or throat itching, and itchy or watery eyes caused by colds, hay fever, or other allergic conditions. It may also be used for other conditions as determined by your doctor.
Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets. 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 Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets. 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 Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets 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 Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets 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 Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets.
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:
Constipation; diarrhea; dizziness; drowsiness; dry mouth, throat, or nose; excitability; headache; loss of appetite; nausea; nervousness; restlessness; trouble sleeping; vomiting.
Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blurred vision; chest pain; decreased coordination; difficulty urinating; fast or irregular heartbeat; fever; hallucinations; ringing in the ears; seizures; severe dizziness or drowsiness; severe nervousness, anxiety, or restlessness; tremors; unusual weakness.
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: Dexchlorpheniramine/Pseudoephedrine 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 bluish-colored skin; difficulty breathing; dilated pupils; fast or irregular heartbeat; fever; flushing; hallucinations; mental or mood changes; seizures; severe drowsiness or dizziness; severe excitability; severe nausea or vomiting; sweating; tremors; trouble breathing.
Store Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Dexchlorpheniramine/Pseudoephedrine Controlled-Release Tablets. 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.
Alfentanil-hameln may be available in the countries listed below.
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Ifa Fonal may be available in the countries listed below.
Diazepam is reported as an ingredient of Ifa Fonal in the following countries:
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Camphor D-Camphor (a derivative of Camphor) is reported as an ingredient of Canfora Alvita in the following countries:
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In some countries, this medicine may only be approved for veterinary use.
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Formoterol fumarate (a derivative of Formoterol) is reported as an ingredient of Eolus in the following countries:
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| SPC | Summary of Product Characteristics (UK) |
Fluoxetine EG may be available in the countries listed below.
Fluoxetine hydrochloride (a derivative of Fluoxetine) is reported as an ingredient of Fluoxetine EG in the following countries:
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Rec.INN
G03DB07
0034184-77-5
C22-H30-O2
326
Progestin
Estra-4,9-dien-3-one, 17-methyl-17-(1-oxopropyl)-, (17ß)-
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| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Inapsine is a brand name of droperidol, approved by the FDA in the following formulation(s):
Yes. The following products are equivalent to Inapsine:
Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Inapsine. 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 Inapsine.
Prometazina Cloridrato QualiFarma may be available in the countries listed below.
Promethazine is reported as an ingredient of Prometazina Cloridrato QualiFarma in the following countries:
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The following drugs and medications are in some way related to, or used in the treatment of Dog Tapeworm. This service should be used as a supplement to, and NOT a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
Aciclobene Pulver may be available in the countries listed below.
Aciclovir sodium salt (a derivative of Aciclovir) is reported as an ingredient of Aciclobene Pulver in the following countries:
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Apresolina may be available in the countries listed below.
Hydralazine hydrochloride (a derivative of Hydralazine) is reported as an ingredient of Apresolina in the following countries:
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Gemcite may be available in the countries listed below.
Gemcitabine hydrochloride (a derivative of Gemcitabine) is reported as an ingredient of Gemcite in the following countries:
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Xylitol is reported as an ingredient of GX Braun Infusionslösung in the following countries:
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Diclofenac sodium salt (a derivative of Diclofenac) is reported as an ingredient of Diclofenaco Llorens in the following countries:
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Asparaginase is reported as an ingredient of Asparaginase medac in the following countries:
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Robaxin (methocarbamol injection, USP) Injectable, a carbamate derivative of guaifenesin, is a central nervous system (CNS) depressant with sedative and musculoskeletal relaxant properties. It is a sterile, pyrogen-free solution intended for intramuscular or intravenous administration.
Each mL contains: methocarbamol, USP 100 mg, polyethylene glycol 300, NF 0.5 mL, Water for Injection, USP q.s. The pH is adjusted, when necessary, with hydrochloric acid and/or sodium hydroxide. The chemical name of methocarbamol is 3‑(2‑methoxyphenoxy)‑1,2-propanediol 1‑carbamate and has the empirical formula of C11H15NO5. Its molecular weight is 241.24. The structural formula is shown below:
Methocarbamol is a white powder, sparingly soluble in water and chloroform, soluble in alcohol (only with heating) and propylene glycol, and insoluble in benzene and n‑hexane.
Robaxin Injectable has a pH between 3.5 and 6.0.
AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE.
The mechanism of action of methocarbamol in humans has not been established, but may be due to general CNS depression. It has no direct action on the contractile mechanism of striated muscle, the motor end plate or the nerve fiber.
In healthy volunteers, the plasma clearance of methocarbamol ranges between 0.20 and 0.80 L/h/kg, the mean plasma elimination half-life ranges between 1 and 2 hours, and the plasma protein binding ranges between 46% and 50%.
Methocarbamol is metabolized via dealkylation and hydroxylation. Conjugation of methocarbamol also is likely. Essentially all methocarbamol metabolites are eliminated in the urine. Small amounts of unchanged methocarbamol also are excreted in the urine.
The mean (±SD) elimination half-life of methocarbamol in elderly healthy volunteers (mean (±SD) age, 69 (±4) years) was slightly prolonged compared to a younger (mean (±SD) age, 53.3 (±8.8) years), healthy population (1.5 (±0.4) hours versus 1.1 (±0.27) hour, respectively). The fraction of bound methocarbamol was slightly decreased in the elderly versus younger volunteers (41 to 43% versus 46 to 50%, respectively).
The clearance of methocarbamol in 8 renally-impaired patients on maintenance hemodialysis was reduced about 40% compared to 17 normal subjects, although the mean (±SD) elimination half-life in these two groups was similar (1.2 (±0.6) versus 1.1 (±0.3) hours, respectively).
In 8 patients with cirrhosis secondary to alcohol abuse, the mean total clearance of methocarbamol was reduced approximately 70% compared to that obtained in 8 age- and weight-matched normal subjects. The mean (±SD) elimination half-life in the cirrhotic patients and the normal subjects was 3.38 (±1.62) hours and 1.11 (±0.27) hours respectively. The percent of methocarbamol bound to plasma proteins was decreased to approximately 40 to 45% compared to 46 to 50% in the normal subjects.
The injectable form of methocarbamol is indicated as an adjunct to rest, physical therapy, and other measures for the relief of discomfort associated with acute, painful musculoskeletal conditions. The mode of action of this drug has not been clearly identified, but may be related to its sedative properties. Methocarbamol does not directly relax tense skeletal muscles in man.
Robaxin Injectable should not be administered to patients with known or suspected renal pathology. This caution is necessary because of the presence of polyethylene glycol 300 in the vehicle.
A much larger amount of polyethylene glycol 300 than is present in recommended doses of Robaxin Injectable is known to have increased pre-existing acidosis and urea retention in patients with renal impairment. Although the amount present in this preparation is well within the limits of safety, caution dictates this contraindication.
Robaxin Injectable is contraindicated in patients hypersensitive to methocarbamol or to any of the injection components.
Since methocarbamol may possess a general CNS depressant effect, patients receiving Robaxin Injectable should be cautioned about combined effects with alcohol and other CNS depressants.
Safe use of Robaxin Injectable has not been established with regard to possible adverse effects upon fetal development. There have been very rare reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Robaxin Injectable should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see PRECAUTIONS, Pregnancy).
Methocarbamol may impair mental and/or physical abilities required for performance of hazardous tasks, such as operating machinery or driving a motor vehicle. Patients should be cautioned about operating machinery, including automobiles, until they are reasonably certain that methocarbamol therapy does not adversely affect their ability to engage in such activities.
The vial stopper contains dry natural rubber that may cause hypersensitivity reactions when handled by or when the product is injected in persons with known or possible latex sensitivity.
As with other agents administered either intravenously or intramuscularly, careful supervision of dose and rate of injection should be observed. Rate of injection should not exceed 3 mL per minute–i.e., one 10 mL vial in approximately three minutes. Since Robaxin Injectable is hypertonic, vascular extravasation must be avoided. A recumbent position will reduce the likelihood of side reactions.
Blood aspirated into the syringe does not mix with the hypertonic solution. This phenomenon occurs with many other intravenous preparations. The blood may be injected with the methocarbamol, or the injection may be stopped when the plunger reaches the blood, whichever the physician prefers.
The total dosage should not exceed 30 mL (three vials) a day for more than three consecutive days except in the treatment of tetanus.
Caution should be observed in using the injectable form in patients with suspected or known seizure disorders.
Patients should be cautioned that methocarbamol may cause drowsiness or dizziness, which may impair their ability to operate motor vehicles or machinery.
Because methocarbamol may possess a general CNS-depressant effect, patients should be cautioned about combined effects with alcohol and other CNS depressants.
See WARNINGS and PRECAUTIONS for interaction with CNS drugs and alcohol.
Methocarbamol may inhibit the effect of pyridostigmine bromide. Therefore, methocarbamol should be used with caution in patients with myasthenia gravis receiving anticholinesterase agents.
Methocarbamol may cause a color interference in certain screening tests for 5‑hydroxyindoleacetic acid (5-HIAA) using nitrosonaphthol reagent and in screening tests for urinary vanillylmandelic acid (VMA) using the Gitlow method.
Long-term studies to evaluate the carcinogenic potential of methocarbamol have not been performed. No studies have been conducted to assess the effect of methocarbamol on mutagenesis or its potential to impair fertility.
Animal reproduction studies have not been conducted with methocarbamol. It is also not known whether methocarbamol can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Robaxin Injectable should be given to a pregnant woman only if clearly needed.
Safe use of Robaxin Injectable has not been established with regard to possible adverse effects upon fetal development. There have been reports of fetal and congenital abnormalities following in utero exposure to methocarbamol. Therefore, Robaxin Injectable should not be used in women who are or may become pregnant and particularly during early pregnancy unless in the judgment of the physician the potential benefits outweigh the possible hazards (see WARNINGS).
Methocarbamol and/or its metabolites are excreted in the milk of dogs; however, it is not known whether methocarbamol or its metabolites are excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Robaxin Injectable is administered to a nursing woman.
Safety and effectiveness of Robaxin Injectable in pediatric patients have not been established except in tetanus. See DOSAGE AND ADMINISTRATION, Special Directions for Use in Tetanus, For Pediatric Patients.
The following adverse reactions have been reported coincident with the administration of methocarbamol. Some events may have been due to an overly rapid rate of intravenous injection.
Anaphylactic reaction, angioneurotic edema, fever, headache
Bradycardia, flushing, hypotension, syncope, thrombophlebitis
In most cases of syncope there was spontaneous recovery. In others, epinephrine, injectable steroids, and/or injectable antihistamines were employed to hasten recovery.
Dyspepsia, jaundice (including cholestatic jaundice), nausea and vomiting
Amnesia, confusion, diplopia, dizziness or light-headedness, drowsiness, insomnia, mild muscular incoordination, nystagmus, sedation, seizures (including grand mal), vertigo
The onset of convulsive seizures during intravenous administration of methocarbamol has been reported in patients with seizure disorders. The psychic trauma of the procedure may have been a contributing factor. Although several observers have reported success in terminating epileptiform seizures with Robaxin Injectable, its administration to patients with epilepsy is not recommended (see PRECAUTIONS, General).
Blurred vision, conjunctivitis, nasal congestion, metallic taste, pruritus, rash, urticaria
Pain and sloughing at the site of injection
Limited information is available on the acute toxicity of methocarbamol. Overdose of methocarbamol is frequently in conjunction with alcohol or other CNS depressants and includes the following symptoms: nausea, drowsiness, blurred vision, hypotension, seizures, and coma. In post-marketing experience deaths have been reported with an overdose of methocarbamol alone or in the presence of other CNS depressants, alcohol or psychotropic drugs.
Management of overdose includes symptomatic and supportive treatment. Supportive measures include maintenance of an adequate airway, monitoring urinary output and vital signs, and administration of intravenous fluids if necessary. The usefulness of hemodialysis in managing overdose is unknown.
For Intravenous and Intramuscular Use Only. Total adult dosage should not exceed 30 mL (3 vials) a day for more than 3 consecutive days except in the treatment of tetanus. If the condition persists, a like course may be repeated after a drug-free interval of 48 hours. Dosage and frequency of injection should be based on the severity of the condition being treated and therapeutic response noted.
For the relief of symptoms of moderate degree, one dose of 1 gram (one 10 mL vial) may be adequate. Ordinarily this injection need not be repeated, as the administration of the oral form will usually sustain the relief initiated by the injection. For the severest cases or in postoperative conditions in which oral administration is not feasible, additional doses of 1 gram may be repeated every 8 hours up to a maximum of 3 g/day for no more than 3 consecutive days.
Robaxin Injectable may be administered undiluted directly into the vein at a maximum rate of three mL per minute. It may also be added to an intravenous drip of Sodium Chloride Injection (Sterile Isotonic Sodium Chloride Solution for Parenteral Use) or five percent Dextrose Injection (Sterile 5 percent Dextrose Solution); one vial given as a single dose should not be diluted to more than 250 mL for I.V. infusion. AFTER MIXING WITH I.V. INFUSION FLUIDS, DO NOT REFRIGERATE. Care should be exercised to avoid vascular extravasation of this hypertonic solution, which may result in thrombophlebitis. It is preferable that the patient be in a recumbent position during and for at least 10 to 15 minutes following the injection.
When the intramuscular route is indicated, not more than five mL (one-half vial) should be injected into each gluteal region. The injections may be repeated at eight hour intervals, if necessary. When satisfactory relief of symptoms is achieved, it can usually be maintained with tablets.
Not Recommended for Subcutaneous Administration.
There is clinical evidence which suggests that methocarbamol may have a beneficial effect in the control of the neuromuscular manifestations of tetanus. It does not, however, replace the usual procedure of debridement, tetanus antitoxin, penicillin, tracheotomy, attention to fluid balance, and supportive care. Robaxin Injectable should be added to the regimen as soon as possible.
Inject one or two vials directly into the tubing of the previously inserted indwelling needle. An additional 10 mL or 20 mL may be added to the infusion bottle so that a total of up to 30 mL (three vials) is given as the initial dose (see PRECAUTIONS). This procedure should be repeated every six hours until conditions allow for the insertion of a nasogastric tube. Crushed methocarbamol tablets suspended in water or saline may then be given through this tube. Total daily oral doses up to 24 grams may be required as judged by patient response.
A minimum initial dose of 15 mg/kg or 500 mg/m2 is recommended. This dosage may be repeated every six hours, if required. The total dose should not exceed 1.8 g/m2 for 3 consecutive days. The maintenance dosage may be given by injection into tubing or by I.V. infusion with an appropriate quantity of fluid. See directions for I.V. use.
Robaxin Injectable (100 mg/mL) supplied in – 10 mL single dose vials in packages of 25 (NDC 60977-150-01).
Store at 20°- 25°C (68°- 77°F), excursions permitted to 15°- 30°C (59°- 86°F).
Robaxin is a registered trademark of Wyeth and used under license.
For Product Inquiry 1 800 ANA DRUG (1-800-262-3784)
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