Glipizide Shin Poong may be available in the countries listed below.
Glipizide is reported as an ingredient of Glipizide Shin Poong in the following countries:
International Drug Name Search
Generic Name: salicylic acid topical (SAL i SIL ik AS id TOP ik al)
Brand Names: Compound W, DermalZone, Dermarest Psoriasis Skin Treatment, Dr Scholl's Callus Removers, Dr Scholl's Clear Away Wart Remover, Dr Scholl's Corn Removers, Duofilm, Freezone Corn Remover, Hydrisalic, Keralyt, Mediplast, Oxy Face Scrub, Propa P.H., Salac, Salex, Scalpicin Scalp Relief, Sebucare, Stri-Dex, Wart-Off Treatment
Salicylic acid is a keratolytic (peeling agent). Salicylic acid causes shedding of the outer layer of skin.
Salicylic acid topical is used in the treatment of acne, dandruff, corns, and warts.
Salicylic acid topical may also be used for purposes other than those listed here.
Before using salicylic topical, talk to your doctor if you
have diabetes;
have poor circulation; or
are treating a child.
You may not be able to use salicylic acid topical, or you may require a dosage adjustment or special monitoring during treatment.
Use salicylic acid topical exactly as directed by your healthcare provider or as directed on the package. If you do not understand these instructions, ask your pharmacist, nurse, or doctor to explain them to you.
Gently clean and dry the affected area. For the treatment of warts and calluses, gentle removal of loose skin with a soft brush, wash cloth, or emery board may be recommended before application of the medication.
Apply a thin film of the medication to the affected area(s) as directed.
Use the soap and shampoo as directed on the package.
Apply the salicylic acid topical adhesive pads as directed on the package.
Talk to your doctor if you experience excessive burning, dryness, or irritation of the skin, or changes in the color of the skin.
Use the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and use only the next regularly scheduled dose.
Do not apply a double dose of the medication.
Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.
Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.
an allergic reaction (shortness of breath; closing of the throat; swelling of the lips, face, or tongue; or hives); or
severe skin irritation.
Other, less serious side effects are more likely to occur. Continue to use salicylic acid topical and talk to your doctor if you experience skin burning; stinging; itching; dryness; redness; peeling; or irritation.
Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.
Do not use other topical preparations on the treated area unless otherwise directed by your healthcare provider. They may interfere with treatment or increase skin irritation.
Avoid the use of abrasive, harsh, or drying soaps and cleansers such as alcoholic cleansers, tinctures, astringents, abrasives, or other peeling agents while using salicylic acid topical.
Drugs other than those listed here may also interact with salicylic acid topical. Talk to your doctor and pharmacist before taking or using any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.
Temporarily relieving cough due to the common cold. It is used along with a steam vaporizer. It may also be used for other conditions as determined by your doctor.
Camphor Liquid is a cough suppressant. It works by helping steam to moisten breathing passages.
Contact your doctor or health care provider right away if any of these apply to you.
Some medical conditions may interact with Camphor Liquid. 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 Camphor Liquid. However, no specific interactions with Camphor Liquid are known at this time.
Ask your health care provider if Camphor Liquid 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 Camphor Liquid 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 Camphor Liquid.
All medicines may cause side effects, but many people have no, or minor, side effects. No COMMON side effects have been reported with Camphor Liquid. Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).
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: Camphor 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.
Store Camphor Liquid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat. Keep Camphor Liquid out of the reach of children and away from pets.
This information is a summary only. It does not contain all information about Camphor Liquid. 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.
Class: Antineoplastic Agents
VA Class: AN300
Chemical Name: 2-Chloro-2′-deoxyadenosine
Molecular Formula: C10H12ClN5O3
CAS Number: 4291-63-8
Brands: Leustatin
Administer only under supervision of qualified clinicians experienced in therapy with antineoplastic agents.1
Risk of severe bone marrow suppression; 1 generally reversible and dose dependent. 1 (See Hematologic Effects under Cautions.)
Severe, irreversible neurologic effects (e.g., paraparesis/quadriparesis) reported following administration of high dosages (4–9 times current recommended dosage for hairy cell leukemia).1 33 Neurotoxicity appears to be dose related and occurs rarely at recommended dosages.1 (See Neurotoxicity under Cautions.)
Acute, renal toxicity reported following administration of high dosages (4–9 times current recommended dosage for hairy cell leukemia), especially in conjunction with other nephrotoxic drugs.1 33 (See Renal Effects under Cautions.)
Antimetabolite antineoplastic agent; synthetic purine nucleoside.1 2 3 4 5 6 7 9
Used alone as first-line therapy for active hairy cell leukemia (leukemic reticuloendotheliosis), defined as disease involving clinically important anemia, neutropenia, thrombocytopenia, or other disease-related symptoms.1 30 31
Considered first-line therapy because of apparent greater efficacy compared with interferon alfa.20 29 30 31 32 41
Used as an alternative agent for the treatment of chronic lymphocytic leukemia†.30
Used as an alternative agent for the treatment of low-grade non-Hodgkin’s lymphoma†.30
Used as an alternative agent for treatment of cutaneous T-cell lymphoma†.30
Consult specialized references for procedures for proper handling and disposal of antineoplastics.1
Administer by IV infusion.1 9 21 42 45 46
For solution compatibility information, see Compatibility under Stability.
Administer by continuous IV infusion as a single course of therapy over 7 consecutive days or as 7 single daily doses infused IV continuously over 24 hours for a total of 7 consecutive days.1
Handle cautiously; use of latex gloves and protective gowns is recommended during preparation and administration.a If skin or mucosal contact occurs, immediately wash affected area(s) thoroughly.a
Cladribine for injection concentrate must be diluted prior to administration.1
Use strict aseptic technique since drug product contains no preservative or bacteriostatic agent.1
Continuous 7-day infusion: Must be diluted in bacteriostatic 0.9% sodium chloride injection containing benzyl alcohol as preservative prior to administration, to provide a total solution volume of 100 mL.1 Pass calculated dose of cladribine for injection concentrate, followed by calculated amount of diluent, through a sterile 0.22-mcm disposable hydrophilic syringe filter and into the infusion reservoir.1
Single daily infusions: Must be diluted in a polyvinyl chloride infusion bag containing 500 mL of 0.9% sodium chloride injection prior to administration.1 Dextrose 5% injection should not be used due to accelerated cladribine degradation.1
Infuse IV over 7 consecutive 24-hour periods as a repeated single daily dose or as a continuous 7-day infusion of the total dose.1
Deviations from recommended dosage regimen not advised.1 If patient fails to respond to the initial course of therapy, additional courses unlikely to provide any benefit.1
Continuous 7-day infusion: 0.63 mg/kg by continuous IV infusion over 7 consecutive days.1
Single daily infusions: 0.09 mg/kg daily by repeated 24-hour IV infusions for 7 consecutive days.1
No specific dosage recommendations at this time;1 however, use with caution.1 20
No specific dosage recommendations at this time;1 however, use with caution.1 20 (See Cautions.)
Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.a
Known hypersensitivity to cladribine or any ingredient in the formulation.1
Risk of severe and usually reversible myelosuppression (e.g., neutropenia, anemia, thrombocytopenia),1 5 22 24 especially at high doses or in patients with preexisting pancytopenia.32 Myelotoxicity may be cumulative with multiple cycles of therapy.20 Caution in patients with preexisting myelosuppression, and if drug administered before, after, or in conjunction with other myelosuppressive agents.1
Myelosuppression occurs frequently during the first month after initiation of therapy; transfusions (i.e., RBC, platelet) may be required.1
Mean platelet count, ANC, and hemoglobin concentration decline during first 2 weeks after initiation of therapy; normalization of mean counts generally occurs by day 12, week 5, and week 8, respectively.1
Monitor hematologic function carefully to detect development of anemia, neutropenia, and thrombocytopenia and for early detection of any potential sequelae (e.g., infection, bleeding).1 (See Adequate Patient Evaluation and Monitoring under Cautions.)
Prolonged depression of CD4+ and T4+ cell counts reported.1 24
Potentially severe and irreversible neurologic effects (e.g., delayed, progressive paraparesis/quadriparesis) consistent with demyelinating disease. Manifestations usually appear 35–84 days after initiation of therapy.1
Neurotoxicity appears to be dose related, usually occurring with dosages higher than those recommended for hairy cell leukemia, in conjunction with cyclophosphamide and total body irradiation.1 33
Dose-related axonal peripheral polyneuropathy reported in patients not receiving cyclophosphamide or total body irradiation.1
Acute renal insufficiency (e.g., acidosis, anuria, elevated Scr) reported; generally has required dialysis and has been reversible in some cases.1 33
Renal dysfunction appears to be dose related, usually occurring with dosages higher than those recommended for hairy cell leukemia, in conjunction with cyclophosphamide and total body irradiation.1 33 Similar nephrotoxicity not reported in patients receiving currently recommended dosage.1
Risk of serious, sometimes fatal, infectious complications (e.g., septicemia, pneumonia), especially during the first month after initiation of therapy.1 21 22 24 25 26
Carefully weigh risks and benefits of therapy in patients with active infections.1
Potentially severe fever (temperature ≥40°C) occurs commonly during the first month after initiation of therapy;1 5 21 22 24 usually associated with neutropenia.1 Careful monitoring recommended.1 (See Hematologic Effects and also see Adequate Patient Evaluation and Monitoring under Cautions.)
Fever generally related to the release of pyrogens from tumor cells;5 32 <33% of the febrile events associated with documented infection.1 5 21 22 24
May cause fetal harm;1 teratogenicity and embryotoxicity demonstrated in animals.1
Avoid pregnancy during therapy.1 If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.1
Toxic drug with a low therapeutic index; therapeutic response is not likely to occur without some evidence of toxicity.1 Administer only under constant supervision by clinicians experienced in therapy with cytotoxic agents.1
Perform peripheral blood cell counts, particularly during the first 4–8 weeks after initiation of therapy.1
Perform bone marrow aspiration and biopsy after peripheral blood counts have returned to within normal limits, to confirm response to therapy.1
Evaluate febrile episodes with appropriate laboratory and radiologic studies and initiate anti-infectives as clinically indicated.1
Monitor renal and hepatic function periodically, especially in those with underlying renal or hepatic dysfunction.1
Tumor lysis syndrome reported rarely in patients with other hematologic malignancies with large tumor burdens.1 Not reported in patients with hairy cell leukemia receiving empiric therapy with allopurinol.5 22
Category D.a
Not known whether cladribine is distributed into milk.1 Discontinue nursing or the drug.1
Safety and efficacy not established in children.1
Cladribine IV infusion solutions diluted with bacteriostatic sodium chloride injection containing benzyl alcohol should not be used in neonates.1 Benzyl alcohol as a preservative has been associated with toxicity in neonates, although a causal relationship has not been established.1 12 13 14 15 16 17
Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.1 Select dosage with caution because of age-related decreases in hepatic, renal, and/or cardiac function and potential for concomitant disease and drug therapy.1 (See Geriatric Patients under Dosage and Administration.)
Use with caution;1 20 monitor hepatic function periodically.1 33 40
Use with caution;1 20 monitor renal function periodically.1 33 40
Neutropenia, fever, infection, fatigue, nausea, rash, headache, injection site reactions.1
Possible increased myelosuppression; use concomitantly with caution.1
Potential for increased risk of acute nephrotoxicity; monitor renal function periodically.33 40
Distributed into CSF; CSF concentrations are about 25% of concurrent serum concentrations.a
Approximately 20%.a
18% of administered dose excreted in urine.a
4.2–9.2 hours.a
2–8°C; protect from light.a
Following dilution, refrigerate at 2–8°C for no more than 8 hours before administration.a
For information on systemic interactions resulting from concomitant use, see Interactions.
Compatible |
|---|
Sodium chloride 0.9% |
Compatible |
|---|
Aminophylline |
Bumetanide |
Buprenorphine HCl |
Butorphanol tartrate |
Calcium gluconate |
Carboplatin |
Chlorpromazine HCl |
Cimetidine HCl |
Cisplatin |
Cyclophosphamide |
Cytarabine |
Dexamethasone sodium phosphate |
Diphenhydramine HCl |
Dobutamine HCl |
Dopamine HCl |
Doxorubicin HCl |
Droperidol |
Enalaprilat |
Etoposide |
Famotidine |
Furosemide |
Gallium nitrate |
Granisetron HCl |
Haloperidol lactate |
Heparin sodium |
Hydrocortisone sodium phosphate |
Hydrocortisone sodium succinate |
Hydromorphone HCl |
Hydroxyzine HCl |
Idarubicin HCl |
Leucovorin calcium |
Lorazepam |
Mannitol |
Meperidine HCl |
Mesna |
Methylprednisolone sodium succinate |
Metoclopramide HCl |
Mitoxantrone HCl |
Morphine sulfate |
Nalbuphine HCl |
Ondansetron HCl |
Paclitaxel |
Potassium chloride |
Prochlorperazine edisylate |
Promethazine HCl |
Ranitidine HCl |
Sodium bicarbonate |
Teniposide |
Vincristine sulfate |
Exact mechanism(s) of antileukemic action not fully elucidated.1 3 6 7 8
Converted intracellularly by deoxycytidine kinase to cladribine triphosphate which accumulates and incorporates into DNA.1 2 7
High intracellular concentrations of cladribine triphosphate inhibit ribonucleotide reductase, causing an imbalance in triphosphorylated deoxynucleotide (dNTP) pools and subsequent DNA strand breaks, inhibition of DNA synthesis and repair, nicotinamide adenine dinucleotide (NAD) and ATP depletion, and cell death.1 3 6 8
Cytotoxic effects extend to resting and proliferating lymphocytes and monocytes.1 2 4 7 20
Importance of immediately informing clinician if fever or bleeding occurs.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of women informing clinicians immediately if they are or plan to become pregnant or plan to breast-feed;a necessity for clinicians to advise women to avoid pregnancy during therapy and advise pregnant women of risk to the fetus.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | For injection concentrate, for IV infusion only | 1 mg/mL* | Cladribine for Injection Concentrate | Abraxis, Bedford |
Leustatin (with sodium chloride) | Centocor Ortho Biotech |
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 December 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
1. Ortho Biotech. Leustatin (cladribine) injection for intravenous infusion only prescribing information. Raritan, NJ; 2002 Oct.
2. Carson DA, Wasson DB, Taetle R et al. Specific toxicity of 2-chlorodeoxyadenosine toward resting and proliferating human lymphocytes. Blood. 1983; 62:737-43. [PubMed 6136305]
3. Griffig J, Koob R, Blakley RL. Mechanisms of inhibition of DNA synthesis by 2-chlorodeoxyadenosine in human lymphoblastic cells. Cancer Res. 1989; 49:6923-8. [PubMed 2573423]
4. Carson DA, Wasson DB, Beutler E. Antileukemic and immunosuppressive activity of 2-chloro-2′-deoxyadenosine. Proc Natl Acad Sci USA. 1984; 81:2232-6. [PubMed 6585795]
5. Piro LD, Carrera CJ, Carson DA et al. Lasting remissions in hairy-cell leukemia induced by a single infusion of 2-chlorodeoxyadenosine. N Engl J Med. 1990; 322: 1117-21. [IDIS 265561] [PubMed 1969613]
6. Hirota Y, Yoshioka A, Tanaka S et al. Imbalance of deoxyribonucleoside triphosphates, DNA double-strand breaks, and cell death caused by 2-chlorodeoxyadenosine in mouse FM3A cells. Cancer Res. 1989; 49:915-9. [PubMed 2563234]
7. Riscoe MK, Brouns MC, Fitchen JH. Purine metabolism as a target for leukemia chemotherapy. Blood Rev. 1989; 3:162-73. [PubMed 2676034]
8. Seto S, Carrera CJ, Wasson DB et al. Biochemical basis for deoxyadenosine and 2-chlorodeoxyadenosine toxicity to resting human lymphocytes. Adv Exp Med Biol. 1986; 195(Part B):577-82. [PubMed 2876594]
9. Cheson BD, Sorensen JM, Vena DA et al. Treatment of hairy cell leukemia with 2-chlorodeoxyadenosine via the Group C protocol mechanism of the National Cancer Institute: a report of 979 patients. J Clin Oncol. 1998; 16:3007-15. [IDIS 414248] [PubMed 9738569]
10. 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 March 31, 1993. Rockville, MD; 1993 Apr.
11. US Food and Drug Administration. Leustatin approved for hairy cell leukemia. Rockville, MD: 1993 Mar 2. Press release.
12. American Academy of Pediatrics Committee on Fetus and Newborn and Committee on Drugs. Benzyl alcohol: toxic agent in neonatal units. Pediatrics. 1983; 72:356-8. [IDIS 175725] [PubMed 6889041]
13. Anon. Benzyl alcohol may be toxic to newborns. FDA Drug Bull. 1982; 12:10-1. [PubMed 7188569]
14. Anon. Neonatal deaths associated with use of benzyl alcohol—United States. MMWR Morb Mortal Wkly Rep. 1982; 31:290-1. [IDIS 150868] [PubMed 6810084]
15. Gershanik J, Boecler B, Ensley H et al. The gasping syndrome and benzyl alcohol poisoning. N Engl J Med. 1982; 307:1384-8. [IDIS 160823] [PubMed 7133084]
16. Menon PA, Thach BT, Smith CH et al. Benzyl alcohol toxicity in a neonatal intensive care unit: incidence, symptomatology, and mortality. Am J Perinatol. 1984; 1:288-92. [PubMed 6440575]
17. Anderson CW, Ng KJ, Andresen B et al. Benzyl alcohol poisoning in a premature newborn infant. Am J Obstet Gynecol. 1984; 148:344-6. [IDIS 181207] [PubMed 6695984]
18. Saven A, Piro LD. Treatment of hairy cell leukemia. Blood. 1992; 79:1111-20. [IDIS 293082] [PubMed 1371410]
19. Cheson BD. The purine analogs—a therapeutic beauty contest. J Clin Oncol. 1992; 10:352-5. [PubMed 1346799]
20. Bryson HM, Sorkin EM. Cladribine. A review of its pharmacodynamic and pharmacokinetic properties and therapeutic potential in haematological malignancies. Drugs. 1993; 46:872-94. [PubMed 7507037]
21. Saven A, Burian C, Koziol JA et al. Long-term follow-up of patients with hairy cell leukemia after cladribine treatment. Blood. 1998; 92:1918-26. [IDIS 415018] [PubMed 9731048]
22. Tallman MS, Hakimian D, Variakojis D et al. A single cycle of 2-chlorodeoxyadenosine results in complete remission in the majority of patients with hairy cell leukemia. Blood. 1992; 80:2203-9. [IDIS 304962] [PubMed 1358262]
23. Saven A, Piro LD. Complete remissions in hairy cell leukemia with 2-chlorodeoxyadenosine after failure with 2′-deoxycoformycin. Ann Intern Med. 1993; 119:278-83. [IDIS 318583] [PubMed 8101069]
24. Estey EH, Kurzrock R, Kantarjian HM et al. Treatment of hairy cell leukemia with 2-chlorodeoxyadenosine (2-CdA). Blood. 1992; 79:882-7. [IDIS 291938] [PubMed 1346577]
25. Juliusson G, Liliemark J. Rapid recovery from cytopenia in hairy cell leukemia after treatment with 2-chloro-2′-deoxyadenosine (CDA): relation to opportunistic infections. Blood. 1992; 79:888-94. [IDIS 291939] [PubMed 1346578]
26. Jaiyesimi IA, Kantarjian HM, Estey EH. Advances in therapy for hairy cell leukemia: a review. Cancer. 1993; 72:5-16. [IDIS 316257] [PubMed 7685243]
27. Spielberger RT, Golomb HM. Hairy cell leukemia 1992. Leukemia. 1992; 6(Suppl 4):142-6. [PubMed 1279327]
28. Golomb HM, Ratain MJ, Mick R et al. The treatment of hairy cell leukemia: an update. Leukemia. 1992; 6(Suppl 2):24-7. [PubMed 1349662]
29. Baltz JK, Montello MJ. Cladribine for the treatment of hematologic malignancies. Clin Pharm. 1993; 12:805-13. [IDIS 321039] [PubMed 7903917]
30. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. [PubMed 15529105]
31. Hairy cell leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2005 Apr 5.
32. Beutler E. Cladribine (2-chlorodeoxyadenosine). Lancet. 1993; 340:952-6.
33. Beutler E, Piro LD, Saven A et al. 2-Chlorodeoxyadenosine (2-CdA): a potent chemotherapeutic and immunosuppressive nucleoside. Leuk Lymphoma. 1991; 5:1-8.
34. Dann EJ, Gillis S, Polliack A et al. Brief report: tumor lysis syndrome following treatment with 2-chlorodeoxyadenosine for refractory chronic lymphocytic leukemia. N Engl J Med. 1993; 329:1547-8. [IDIS 322265] [PubMed 8105383]
35. Betticher DC, Fey MF, Rabaglio M et al. Cladribine and severe myelotoxicity. Lancet. 1993; 342:1369. [IDIS 322590] [PubMed 7901666]
36. Dimopoulos MA, Kantarjian H, Estey E et al. Treatment of Waldenstrom macroglobulinemia with 2-chlorodeoxyadenosine. Ann Intern Med. 1993; 118:195-8. [IDIS 308703] [PubMed 8093333]
37. Saven A, Carrera CJ, Carson DA et al. 2-Chlorodeoxyadenosine: an active agent in the treatment of cutaneous T cell lymphoma. Blood. 1992; 80:587-92. [IDIS 299980] [PubMed 1353380]
38. Delannoy A, Hanique G, Ferrant A. 2-Chlorodeoxyadenosine for patients with B-cell chronic lymphocytic leukemia resistant to fludarabine. N Engl J Med. 1993; 328:812. [IDIS 310610] [PubMed 8094888]
39. Santana VM, Mirro J Jr, Harwood FC et al. A Phase I trial of 2-chlorodeoxyadenosine in pediatric patients with acute leukemia. J Clin Oncol. 1991; 9:416-22. [PubMed 1671875]
40. Ortho Biotech, Raritan, NJ: personal communication.
41. Saven A, Piro L. Newer purine analogues for the treatment of hairy-cell leukemia. N Engl J Med. 1994; 330:691-7. [IDIS 326313] [PubMed 7906385]
42. Hoffman MA, Janson D, Rose E et al. Treatment of hairy-cell leukemia with cladribine: response, toxicity, and long-term follow-up. J Clin Oncol. 1997; 15:1138-42. [IDIS 383240] [PubMed 9060556]
43. Au WY, Klasa RJ, Gallagher R et al. Second malignancies in patients with hairy cell leukemia in British Columbia: a 20-year experience. Blood. 1998; 92:1160-4. [IDIS 412557] [PubMed 9694703]
44. Kurzrock R, Strom SS, Estey E et al. Second cancer risk in hairy cell leukemia: analysis of 350 patients. J Clin Oncol. 1997; 15:1803-10. [IDIS 387779] [PubMed 9164188]
45. Goodman GR, Burian C, Koziol JA et al. Extended follow-up of patients with hairy cell leukemia after treatment with cladribine. J Clin Oncol. 2003; 21:891-6. [IDIS 500957] [PubMed 12610190]
46. Chadha P, Rademaker AW, Mendiratta P et al. Treatment of hairy cell leukemia with 2-chlorodeoxyadenosine (2-CdA): long-term follow-up of the Northwestern University experience. Blood. 2005; 106:241-6. [IDIS 537243] [PubMed 15761021]
47. Juliusson G, Heldal D, Hippe E et al. Subcutaneous injections of 2-chlorodeoxyadenosine for symptomatic hairy cell leukemia. J Clin Oncol. 1995; 13:989-95. [IDIS 344875] [PubMed 7707128]
a. Ortho Biotech. Leustatin (cladribine) injection for intravenous infusion only prescribing information. Raritan, NJ; 2006 Jan.
HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:413-7.
Cleanse & Treat
(benzoyl peroxide pad and salicylic acid pad)
Rx Only
Cleanse & Treat contains two separate and distinct non-woven pads enclosed in a heat-sealed foil pack compartmentalized from one another within the foil pack by filmstock. One non-woven pad bears a preparation consisting of 5% benzoyl peroxide and the following inactive ingredients: ammonium lauryl sulfate, carbomer, disodium cocoamphodiacetate, DMDM hydantoin, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium chloride, sodium hydroxide. The other non-woven pad bears a preparation consisting of 2% salicylic acid and the following inactive ingredients: ammonium lauryl sulfate, cellulose gum, disodium ricinoleamido MEA-sulfosuccinate, DMDM hydantoin, propylene glycol monoricinoleate, purified water, sodium citrate dihydrate.
Benzoyl peroxide is an oxidizing agent that possesses antibacterial properties and is classified as a keratolytic. It has an empirical formula of C14H10O4 with a molecular weight of 242.23. Benzoyl peroxide has the following molecular structure:
Salicylic acid is the 2 hydroxy derivative of benzoic aid. It has an empirical formula of C7H6O3 with a molecular weight of 138.12. Salicylic acid has the following molecular structure:
The exact method of action of benzoyl peroxide in acne vulgaris is not known, however, its antibacterial activity against Propionibacterium acnes, together with its mild keratolytic effect, is believed to be its significant mode of action.
Pediatric Use - Cleanse & Treat should not be used by children under 12 years of age.
Information for Patients - Patients should avoid unnecessary sun exposure and use a sunscreen when in sunlight. Contact with hair, fabrics, or any colored materials may result in bleaching or discoloration. Patients should avoid concomitant use of other drugs that may contribute to elevated serum salicylate levels where the potential for toxicity exists. Symptoms of salicylate toxicity may include nausea, vomiting, dizziness, loss of hearing, tinnitus, lethargy, hyperpnea and diarrhea. In the event of salicylate toxicity, the use of Cleanse & Treat should be discontinued, fluids should be administered to promote urinary excretion and medical assistance should be obtained immediately.
Carcinogenesis, Mutagenesis, Impairment of Fertility - Data from some studies using a strain of mice highly susceptible to eveloping cancer suggest that benzoyl peroxide acts as a tumor promoter. The clinical significance of these findings to humans is not known. Benzoyl peroxide has not been found to be mutagenic in the Ames Salmonella Test and there are no published data suggesting that it impairs fertility. No data are available concerning potential carcinogenic or reproductive effects of salicylic acid. It has not been found to be mutagenic in the Ames Salmonella Test and there are no published data suggesting that it impairs fertility.
Pregnancy (Category C) - Animal reproduction studies have not been performed with benzoyl peroxide and it is not known whether benzoyl peroxide can cause fetal harm when administered to a pregnant woman. Nevertheless, benzoyl peroxide should be used by a pregnant woman only if necessary. Salicylic acid has been shown to be teratogenic in rats and monkeys. It is difficult to extrapolate from oral doses of acetylsalicylic acid used in these studies to topical administration as the oral dose to monkeys may represent 10 times or more the maximum daily human dose of salicylic acid when applied topically as directed with Cleanse &Treat. There are no adequate and well-controlled studies in pregnant women. Nevertheless, salicylic acid should be used by a pregnant woman only if necessary.
Cleanse & Treat is indicated for the topical treatment of acne vulgaris.
Cleanse & Treat is contraindicated in patients with a history of hypersensitivity to any of its ingredients.
Allergic contact dermatitis and/or dryness have been reported with topical benzoyl peroxide and salicylic acid, both when used separately and in combination with one another.
If excessive scaling, erythema or edema occurs, patients should discontinue use of Cleanse & Treat and consult with their physician.
Unless otherwise directed by a prescribing physician, patients should apply one salicylic acid pad and one benzoyl peroxide pad to affected areas twice per day. Cleanse & Treat is a leave-on acne treatment, intended for use without water or additional cleansers unless otherwise directed by your physician.
Each Cleanse & Treat packette consists of one 0.8 g. 5% benzoyl peroxide pad and one 0.5 g. 2% salicylic acid pad, with each pad separated from one another by filmstock and both pads enclosed together in an individual heat-sealed foil pack bearing the NDC Number 23710-052-02.
Store at 15°-25° C (59°-77° F)
Cleanse & Treat covered by US Patents: 5,254,109; 5,417,674; and 5,562,642.
Quinnova Pharmaceuticals, Inc., Newtown, PA 18940, (877) 660-6263, www.QUINNOVA.com.
Prescribing Information as of April 2008.
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| UNAPPROVED DRUG OTHER | 01/01/2009 | ||
| Labeler - Quinnova Pharmaceuticals, Inc. (607183766) |
Augmentin BD may be available in the countries listed below.
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Augmentin BD in the following countries:
Clavulanic Acid potassium (a derivative of Clavulanic Acid) is reported as an ingredient of Augmentin BD in the following countries:
International Drug Name Search
Generic Name: acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine (a SEET a MIN o fen, DEX troe meth OR fan, dox IL a meen, SOO doe e FED rin)
Brand Names: Alka-Seltzer Plus Night Time Cold Liquigel, All-Nite Multi-Symptom Cold/Flu Relief, Multi-Symptom Nighttime, NyCair, Nyquil Cold Medicine, NyQuil D, Nyquil Liquicap, Robitussin Night Cold, Theraflu Nighttime Severe Cold (pseudoephedrine)
Acetaminophen is a pain reliever and fever reducer.
Doxylamine is an antihistamine that reduces the effects of the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.
Dextromethorphan is a cough suppressant. It affects the cough reflex in the brain that triggers coughing.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine is used to treat headache, fever, body aches, cough, runny nose, sneezing, itching, and watery eyes caused by allergies, the common cold, or the flu.
Acetaminophen, dextromethorphan, doxylamine, 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:
liver disease, cirrhosis, a history of alcoholism, or if you drink more than 3 alcoholic beverages per day;
a blockage in your digestive tract (stomach or intestines);
kidney disease;
cough with mucus, or cough caused by emphysema or chronic bronchitis;
enlarged prostate or urination problems; or
if you take potassium (Cytra, Epiklor, K-Lyte, K-Phos, Kaon, Klor-Con, Polycitra, Urocit-K).
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. This 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.
Do not take for longer than 7 days in a row. Stop taking the medicine and call your doctor if you still have a fever after 3 days of use, you still have pain after 7 days (or 5 days if treating a child), if your symptoms get worse, or if you have a skin rash, ongoing headache, or any redness or swelling.
Since this 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.
The first signs of an acetaminophen overdose include loss of appetite, nausea, vomiting, stomach pain, sweating, and confusion or weakness. Later symptoms may include pain in your upper stomach, dark urine, and yellowing of your skin or the whites of your eyes.
Overdose symptoms may also include severe forms of some of the side effects listed in this medication guide.
chest pain, rapid pulse;
fast, slow, or uneven heart rate;
severe dizziness or anxiety, feeling like you might pass out;
severe headache;
mood changes, confusion, hallucinations, severe nervousness;
tremor, seizure (convulsions);
fever, easy bruising or bleeding, unusual weakness;
urinating less than usual or not at all;
nausea, pain in your upper stomach, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of your skin or eyes); or
dangerously high blood pressure (severe headache, blurred vision, buzzing in your ears, anxiety, chest pain, uneven heartbeats, seizure).
Less serious side effects may include:
dizziness, drowsiness, mild headache;
dry mouth, nose, or throat;
constipation, diarrhea, mild nausea, upset stomach;
blurred vision;
feeling restless or irritable; or
sleep problems (insomnia).
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.
Ask a doctor or pharmacist if it is safe for you to use acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine if you are also using any of the following drugs:
leflunomide (Arava);
topiramate (Topamax);
zonisamide (Zonegran);
an antibiotic, antifungal medicine, sulfa drug, or tuberculosis medicine;
an antidepressant;
birth control pills or hormone replacement therapy;
bladder or urinary medications;
blood pressure medication;
a bronchodilator;
cancer medicine;
cholesterol-lowering medications such as Lipitor, Niaspan, Zocor, Vytorin, and others;
gout or arthritis medications (including gold injections);
HIV/AIDS medication;
medication for nausea and vomiting, stomach ulcers, or irritable bowel syndrome;
medicines to treat psychiatric disorders;
an NSAID such as Advil, Aleve, Arthrotec, Cataflam, Celebrex, Indocin, Motrin, Naprosyn, Treximet, Voltaren, others; or
seizure medication.
This list is not complete and there may be other drugs that can affect acetaminophen, dextromethorphan, doxylamine, and pseudoephedrine . Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
