Idamycin PFS

Generic Name: Idarubicin Hydrochloride
Class: Antineoplastic Agents
VA Class: AN200
Chemical Name: (7S - cis) - 9 - Acetyl - 7 - [(3 - amino - 2,3,6 - trideoxy - α - l - lyxo - hexopyranosyl)oxy] - 7,8,9,10 - tetrahydro - 6,9,11 - trihydroxyhydrochloride - 5,12 - naphthacenedione
Molecular Formula: C₂₆H₂₇NO₉HCl
CAS Number: 57852-57-0

• 
  

  Severe local tissue necrosis if extravasation occurs.¹ Do not administer IM or sub-Q.¹ Administer slowly into the tubing of a freely flowing IV infusion.¹ (See Administration under Dosage and Administration.)

  
  


• 
  

  Possible cardiotoxicity and potentially fatal CHF.¹ Risk of cardiotoxicity is greater in patients who have preexisting cardiac disease or who have received prior therapy with anthracyclines or other cardiotoxic agents.¹ (See Cardiac Effects under Cautions.)

  
  


• 
  

  Severe myelosuppression may occur.¹ (See Hematologic Effects under Cautions.)

  
  


• 
  

  Administer only under supervision of qualified clinicians experienced in use of cytotoxic therapy.¹ Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.¹ (See Adequate Patient Evaluation and Monitoring under Cautions.)

  
  


• 
  

  Dosage reduction should be considered in patients with hepatic or renal impairment. (See Special Populations under Dosage and Administration.)

  
  

Introduction

Antineoplastic agent;¹ semisynthetic anthracycline; structurally and pharmacologically related to daunorubicin.¹

Uses for Idamycin PFS

Acute Myeloid Leukemia

Used in combination with other antineoplastic agents for the treatment of acute myeloid (myelogenous, nonlymphocytic) leukemia (AML), including French-American-British classifications M1 through M7.^{1 7 10 16 21}

Regimen consisting of cytarabine with either daunorubicin or idarubicin is a regimen of choice for remission induction in AML.^{7 10}

Used in combination with cytarabine for the treatment of recurrent or refractory AML.^{7 13 14}

Idamycin PFS Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastic drugs.

  
  


• 
  

  Monitor serum creatinine and bilirubin concentrations prior to initiating and during idarubicin therapy.¹

  
  

Administration

IV Administration

Administer by slow IV injection into the tubing of a freely flowing IV infusion of 0.9% sodium chloride or 5% dextrose injection.¹ Attach tubing to a butterfly needle or other suitable device and preferably insert into a large vein.¹

Must not administer IM or sub-Q.¹

Avoid extravasation.¹ Extremely irritating to tissues.¹ Stinging or burning sensation during IV administration may be a symptom, but extravasation may occur without these symptoms and even when blood returns well during initial aspiration of the infusion needle.¹ If signs or symptoms of extravasation occur (i.e., pain, erythema, edema, vesication), immediately discontinue administration and restart in another vein;¹ apply intermittent ice packs (immediately for 30 minutes, then 30 minutes 4 times daily for 3 days) over the affected area and elevate the involved extremity.¹ Examine affected area frequently and promptly consult specialist in plastic surgery.¹ In case of ulceration or severe persistent pain at the site of extravasation, consider early wide excision of the affected area.¹ (See Local Effects under Cautions.)

Prepare and handle cautiously to avoid skin reactions.¹ Use of goggles, gloves, and protective gowns recommended during preparation and administration.¹ If skin contact occurs, thoroughly wash affected areas with soap and water; if eye contact occurs, standard irrigation techniques should be used immediately.¹

Rate of Administration

Administer slowly (i.e., over 10–15 minutes) into a freely flowing IV infusion of 0.9% sodium chloride or 5% dextrose injection.¹

Dosage

Available as idarubicin hydrochloride; dosage expressed in terms of the salt.¹

Adults

Acute Myeloid Leukemia

Induction Therapy

IV

12 mg/m² daily for 3 days in combination with cytarabine 100 mg/m² daily by continuous IV infusion for 7 days.¹

Alternatively, 12 mg/m² daily for 3 days in combination with cytarabine (25-mg/m² IV loading dose followed by 200 mg/m² daily) by continuous IV infusion for 5 days.^{1 3}

A second induction course may be administered in the event of an incomplete antileukemic response after the first course.¹

Consolidation Therapy

IV

Patients who have complete remission of disease following 1 or 2 courses of induction therapy generally receive consolidation chemotherapy.^{7 21} The optimal regimen has not been established, but in clinical studies, consolidation chemotherapy typically consists of a cytarabine-based regimen similar to that used in induction therapy administered over a short-term period.^{1 7}

Dosage Modification for Toxicity

IV

In patients who experience severe mucositis with the first course of induction therapy, delay administration of a second course until the mucositis resolves and reduce dosage by 25%.^{1 22}

Special Populations

Hepatic Impairment

Consider dosage reduction; monitor hepatic function.¹ Administration not recommended in patients with serum bilirubin concentration >5 mg/dL.¹ (See Hepatic Impairment under Cautions.)

In one clinical study, patients with serum bilirubin concentration of 2.6–5 mg/dL received 50% of the recommended dosage.¹

Renal Impairment

Consider dosage reduction; monitor renal function.¹ (See Renal Impairment under Cautions.)

Cautions for Idamycin PFS

Contraindications

Serum bilirubin concentration >5 mg/dL.¹

Warnings/Precautions

Warnings

Adequate Patient Evaluation and Monitoring

Administer only under the supervision of qualified clinicians experienced in the use of cytotoxic agents for leukemia therapy.¹ Close observation of the patient and careful laboratory monitoring are required; appropriate diagnostic and treatment facilities must be readily available in case the patient develops severe hemorrhagic conditions, infection, or other drug toxicity.¹

Prior to and during therapy, assess hepatic and renal function; carefully assess hematopoietic and cardiac function during therapy.¹

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenic and embryotoxic in animals.¹ Avoid pregnancy during therapy.¹ If used during pregnancy or patient becomes pregnant, apprise of potential fetal hazard.¹

Major Toxicities

Hematologic Effects

Severe and potentially fatal myelosuppression occurs following adminstration of therapeutic dosages.¹ Careful hematologic monitoring required; perform CBCs at frequent intervals during therapy.¹

Use generally not recommended in patients with preexisting bone marrow suppression caused by previous drug or radiation therapy unless the potential benefit outweighs the risk.¹

Cardiac Effects

Risk of anthracycline-associated cardiotoxicity manifested by potentially fatal CHF, acute life-threatening arrhythmias (e.g., atrial fibrillation), MI, chest pain, asymptomatic decreases in left ventricular ejection fraction, or other cardiomyopathies.¹

Cardiac insufficiency and arrhythmias generally reversible; usually occur in setting of sepsis, anemia, and aggressive IV fluid administration.¹

Increased risk of cardiotoxicity in patients >60 years of age, patients with preexisting cardiac disease, or those who have received prior therapy with anthracyclines or other cardiotoxic agents.¹ Possible increased risk in patients with concomitant or previous radiation therapy to the mediastinal-pericardial area or in patients with anemia, bone marrow suppression, infections, or leukemic pericarditis and/or myocarditis.¹

Risk of anthracycline-induced cardiotoxicity increases with increasing dose; a cumulative dose of idarubicin beyond which the incidence of cardiotoxicity rapidly increases has not been determined.²

Monitor cardiac function carefully, particularly in those patients at increased risk for cardiotoxicity.¹ Anthracyline-induced cardiomyopathy usually is associated with a decrease in left ventricular ejection fraction from pretreatment baseline values.¹ Institute appropriate therapeutic measures for the management of CHF and/or arrhythmias as clinically indicated.¹

General Precautions

Hyperuricemia

Hyperuricemia may result from the rapid lysis of leukemic cells.¹ Appropriate measures should be taken to prevent the occurrence of hyperuricemia.¹

GI Effects

Nausea and/or vomiting, abdominal pain and/or diarrhea, and mucositis reported frequently, but were severe in <5% of patients.¹ Delay subsequent administration and reduce dosage if severe mucositis occurs.¹ (See Dosage Modification for Toxicity under Dosage and Administration.)

Hepatic Effects

Changes in liver function test results reported; usually transient and tended to occur in patients with sepsis who were receiving potentially hepatotoxic anti-infective agents.¹

Renal Effects

Changes in renal function test results reported; usually transient and tended to occur in patients with sepsis who were receiving potentially nephrotoxic anti-infective agents.¹

Local Effects

Extravasation produces severe tissue necrosis.¹ If signs or symptoms of extravasation occur (i.e., pain, erythema, edema, vesication), immediately discontinue administration and restart in another vein.¹ (See Administration under Dosage and Administration.)

Urticaria, hives, and erythematous streaking reported.¹

Specific Populations

Pregnancy

Category D.¹

Lactation

Not known whether idarubicin is distributed into milk.¹ Discontinue nursing because of potential risk to nursing infants.¹

Pediatric Use

Safety and efficacy not established.¹

Geriatric Use

Increased risk of cardiovascular toxicity including CHF, serious arrhythmias, chest pain, MI, and asymptomatic declines in left ventricular ejection fraction in patients >60 years of age.¹

Hepatic Impairment

Pharmacokinetics have not been fully evaluated.¹ However, possible decreased metabolism and increased systemic exposure in patients with moderate or severe hepatic dysfunction.¹ Consider dosage adjustment.¹ Use not recommended in patients with serum bilirubin concentration >5 mg/dL.¹ (See Contraindications under Cautions.)

Renal Impairment

Pharmacokinetics have not been fully evaluated.¹ However, disposition of idarubicin may be altered; consider dosage adjustment.¹

Common Adverse Effects

Infection, nausea, vomiting, hair loss, abdominal cramps/diarrhea, hemorrhage, mucositis, mental status changes, fever, headache.¹

Interactions for Idamycin PFS

No formal drug interaction studies to date.¹

Specific Drugs

Drug	Interaction	Comments
Antifungals	Concurrent therapy may result in decreased hepatic and/or renal function1	Usually transient and occurring in patients with sepsis1
Hepatotoxic agents	Concurrent therapy may result in decreased hepatic function1	Usually transient and occurring in patients with sepsis1
Nephrotoxic agents	Concurrent therapy may result in decreased renal function1	Usually transient and occurring in patients with sepsis1

Idamycin PFS Pharmacokinetics

Distribution

Extent

Rapidly and widely distributed into tissues following IV administration.¹ Concentrations in nucleated blood and bone marrow cells exceed plasma concentrations by more than 100 times.¹

Following IV administration in pediatric patients, idarubicin and idarubicinol were detected in CSF.^{1 20}

Not known whether idarubicin is distributed into milk.¹

Plasma Protein Binding

Idarubicin: Approximately 97%.¹

Idarubicinol: Approximately 94%.¹

Elimination

Metabolism

Metabolized principally to an active metabolite, idarubicinol, via aldoketoreductase.¹ Undergoes extensive extrahepatic metabolism.¹

Elimination Route

Excreted principally in feces via biliary excretion and to a lesser extent in urine.¹

Half-life

Idarubicin: Terminal half-life is approximately 15 hours.¹

Idarubicinol: Terminal half-life is approximately 72 hours.¹

Stability

Storage

Parenteral

Injection

2–8°C; protect from light.¹

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Solution Compatibility^HID

Do not mix with other drugs (unless specific compatibility data are available).¹ Precipitation occurs when mixed with heparin; prolonged contact with any alkaline solution will cause degradation of idrarubicin.¹

Compatible

Dextrose 3.3% in sodium chloride 0.3%

Dextrose 5% in sodium chloride 0.9%

Dextrose 5% in water

Ringer’s injection, lactated

Sodium chloride 0.9%

Drug Compatibility

Y-Site CompatibilityHID

Compatible

Amifostine

Amikacin sulfate

Aztreonam

Cimetidine HCl

Cladribine

Cyclophosphamide

Cytarabine

Diphenhydramine HCl

Droperidol

Erythromycin lactobionate

Etoposide phosphate

Filgrastim

Gemcitabine HCl

Granisetron HCl

Imipenem–cilastatin sodium

Magnesium sulfate

Mannitol

Melphalan HCl

Metoclopramide HCl

Potassium chloride

Ranitidine HCl

Sargramostim

Thiotepa

Vinorelbine tartrate

Incompatible

Acyclovir sodium

Allopurinol sodium

Ampicillin sodium–sulbactam sodium

Cefazolin sodium

Cefepime HCl

Ceftazidime

Clindamycin phosphate

Dexamethasone sodium phosphate

Etoposide

Furosemide

Gentamicin sulfate

Heparin sodium

Hydrocortisone sodium succinate

Lorazepam

Meperidine HCl

Methotrexate sodium

Piperacillin sodium–tazobactam sodium

Sodium bicarbonate

Teniposide

Vancomycin HCl

Vincristine sulfate

ActionsActions

• 
  

  A DNA-reactive agent, although the exact mechanism(s) of action has not been fully elucidated.¹

  
  


• 
  

  Intercalates into DNA and/or inhibits topoisomerase II, resulting in disruption of nucleic acid synthesis.^{1 2}

  
  


• 
  

  Compared with other anthracyclines, is more lipophilic, and consequently undergoes more rapid cellular uptake.¹

  
  

Advice to Patients

• 
  

  Importance of recognizing and reporting adverse effects, including GI, and myelosuppresive (and related precautions), infectious complications, CHF symptoms, and injection site pain.¹

  
  


• 
  

  Risk of myocardial toxicity.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 their clinician if they are or plan to become pregnant or plan to breast-feed; necessity for clinicians to advise women to avoid pregnancy during therapy and advise pregnant women of risk to the fetus.¹

  
  


• 
  

  Importance of advising patients of other important precautionary information.¹ (See Cautions.)

  
  

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Idarubicin Hydrochloride

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	Injection, for IV infusion	1 mg/mL	Idamycin PFS	Pfizer
			Idarubicin Hydrochloride Injection	Sicor

Disclaimer

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 July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

Only references cited for selected revisions after 1984 are available electronically.

1. Pharmacia. Idamycin PFS (idarubicin hydrochloride) injection prescribing information. Kalamazoo, MI; 2003 May.

2. Hollingshead LM, Faulds D. Idarubicin: a review of its pharmacodynamic and pharmacokinetic properties, and therapeutic potential in the chemotherapy of cancer. Drugs. 1991; 42:690-719. [PubMed 1723369]

3. Berman E, Heller G, Santorsa J et al. Results of a randomized trial comparing idarubicin and cytosine arabinoside with daunorubicin and cytosine arabinoside in adult patients with newly diagnosed acute myelogenous leukemia. Blood. 1991; 77:1666-74. [IDIS 280706] [PubMed 2015395]

4. Vogler WR, Velez-Garcia E, Weiner RS et al. A phase III trial comparing idarubicin and daunorubicin in combination with cytarabine in acute myelogenous leukemia: a Southeastern Cancer Study Group study. J Clin Oncol. 1992; 10:1103-11. [PubMed 1607916]

5. Wiernik PH, Banks PLC, Case Jr DC et al. Cytarabine plus idarubicin or daunorubicin as induction and consolidation therapy for previously untreated adult patients with acute myeloid leukemia. Blood. 1992; 79:313-9. [IDIS 290353] [PubMed 1730080]

6. Berman E, Wiernik P, Vogler R et al. Long-term follow-up of three randomized trials comparing idarubicin and daunorubicin as induction therapies for patients with untreated acute myeloid leukemia. Cancer. 1997; 80(Suppl 11):2181-5. [IDIS 397676] [PubMed 9395031]

7. Adult acute myeloid leukemia. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2003 Jun 5.

8. Scheinberg DA, Maslak P, Weiss M. Acute leukemias. In: DeVita VT Jr, Hellman S, Rosenberg SA eds. Cancer: principles and practice of oncology. 5th ed. Philadelphia: Lippincott Williams & Wilkins; 2001:2404-33.

9. Mandelli F, Petti MC, Ardia A et al. A randomised clinical trial comparing idarubicin and cytarabine to daunorubicin and cytarabine in the treatment of acute non-lymphoid leukaemia: a multicentric study from the Italian Co-operative Group GIMEMA. Eur J Cancer. 1991; 27:750-5. [PubMed 1829918]

10. Anon. Drugs of choice for cancer chemotherapy. Med Lett Drugs Ther. 2000; 42:83-92. [PubMed 10994034]

11. AML Collaborative Group. A systematic collaborative overview of randomized trials comparing idarubicin with daunorubicin (or other anthracyclines) as induction therapy for acute myeloid leukemia. Br J Haematol. 1998; 103:100-9. [PubMed 9792296]

12. Rowe JM, Neuberg D, Friedenberg W, et al. A phase III study of daunorubicin vs idarubicin vs mitoxantrone for older adult patients (>55 yrs) with acute myelogenous leukemia (AML): a study of the Eastern Cooperative Oncology Group (E3993). Blood 1998; 92(Suppl 1):313a. Abstract 1284.

13. Lambertenghi-Deliliers G, Maiolo AT, Annaloro C et al. Idarubicin in sequential combination with cytosine arabinoside in the treatment of relapsed and refractory patients with acute non-lymphoblastic leukemia. Eur J Cancer Clin Oncol. 1987; 23:1041-5. [PubMed 3478198]

14. Harousseau JL, Reiffers J, Hurteloup P et al. Treatment of relapsed acute myeloid leukemia with idarubicin and intermediate-dose cytarabine. J Clin Oncol. 1989; 7:45-9. [PubMed 2642539]

15. Anderlini P, Benjamin RS, Wong FC et al. Idarubicin cardiotoxicity: a retrospective study in acute myeloid leukemia and myelodysplasia. J Clin Oncol. 1995; 13:2827-34. [IDIS 355450] [PubMed 7595745]

16. Anon. Idarubicin. Med Lett Drugs Ther. 1991; 33:84-5. [PubMed 1875860]

17. Childhood acute myeloid leukemia/other myeloid malignancies. From: PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2003 Jun 18.

18. Food and Drug Administration. Labeling and prescription drug advertising; content and format for labeling for human prescription drugs. 21 CFR Parts 201 and 202. Final Rule. [Docket No. 75N-0066] Fed Regist. 1979; 44:7434-67.

19. Department of Health and Human Services, Food and Drug Administration. Subpart B--Labeling requirements for prescription drugs and/or insulin. (21 CFR Ch. 1 (4-1-87 Ed.)). 1987:18-24.

20. Reid JM, Pendergrass TW, Krailo MD et al. Plasma pharmacokinetics and cerebrospinal fluid concentrations of idarubicin and idarubicinol in pediatric leukemia patients: a Childrens Cancer Study Group report. Cancer Res. 1990; 50:6525-8. [IDIS 272658] [PubMed 2208112]

21. Reviewers’ comments (personal observations).

22. Pfizer. Kalamazoo, MI: Personal communication.

HID. Trissel LA. Handbook on injectable drugs. 14th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2007:919-22.

More Idamycin PFS resources

• Idamycin PFS Side Effects (in more detail)
• Idamycin PFS Use in Pregnancy & Breastfeeding
• Idamycin PFS Drug Interactions
• Idamycin PFS Support Group
• 0 Reviews for Idamycin PFS - Add your own review/rating

• Idamycin PFS Prescribing Information (FDA)


• Idamycin PFS MedFacts Consumer Leaflet (Wolters Kluwer)


• Idamycin PFS Concise Consumer Information (Cerner Multum)


• Idamycin PFS Advanced Consumer (Micromedex) - Includes Dosage Information


• Idamycin Concise Consumer Information (Cerner Multum)


• Idamycin Prescribing Information (FDA)


• Idarubicin Prescribing Information (FDA)


• Idarubicin Professional Patient Advice (Wolters Kluwer)

Compare Idamycin PFS with other medications

• Leukemia
• Leukocytoclastic Vasculitis
• Solid Tumors

Lodrane Liquid

Generic Name: brompheniramine and pseudoephedrine (BROM fen EER a meen and SOO doe ed FED rin)

Brand Names: Andehist NR Syrup, Bidhist-D, Bromaline, Bromhist Pediatric Drops, Bromhist-NR, BroveX PD, BroveX PSE, Brovex SR, Di-Bromm, Histex SR, J-TanD PD, Lodrane 12D, Lodrane 24D, Lodrane D, Lodrane Liquid, LoHist-12D, LoHist-PD, Q-Tapp, Sildec, Touro Allergy, Ultrabrom, Ultrabrom PD

What is Lodrane Liquid (brompheniramine and pseudoephedrine)?

Brompheniramine is an antihistamine that reduces the natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).

The combination of brompheniramine and pseudoephedrine is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and the common cold.

Brompheniramine and pseudoephedrine may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about Lodrane Liquid (brompheniramine and pseudoephedrine)?

There are many brands and forms of this medicine available and not all brands are listed on this leaflet.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant. Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body. Brompheniramine and pseudoephedrine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

What should I discuss with my healthcare provider before taking Lodrane Liquid (brompheniramine and pseudoephedrine)?

Do not use a cough or cold medicine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take cough or cold medicine before the MAO inhibitor has cleared from your body.

Ask a doctor or pharmacist if it is safe for you to take brompheniramine and pseudoephedrine if you have:

• kidney disease;


• 
  

  diabetes;

  
  


• 
  

  glaucoma;

  
  


• 
  

  heart disease or high blood pressure;

  
  


• 
  

  diabetes;

  
  


• 
  

  a thyroid disorder;

  
  


• 
  

  an enlarged prostate; or

  
  


• 
  

  problems with urination.

  
  

This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Brompheniramine and pseudoephedrine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Artificially-sweetened liquid forms of cold medicine may contain phenylalanine. This would be important to know if you have phenylketonuria (PKU). Check the ingredients and warnings on the medication label if you are concerned about phenylalanine.

How should I take Lodrane Liquid (brompheniramine and pseudoephedrine)?

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended. Cold medicine is usually taken only for a short time until your symptoms clear up.

Do not give this medication to a child younger than 2 years old. Always ask a doctor before giving a cough or cold medicine to a child. Death can occur from the misuse of cough and cold medicines in very young children. Take this medicine with a full glass of water. Do not crush, chew, or break an extended-release tablet. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time.

Measure the liquid form of this medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

Talk with your doctor if your symptoms do not improve after 7 days of treatment, or if you have a fever with a headache, cough, or skin rash.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

This medication can cause you to have unusual results with allergy skin tests. Tell any doctor who treats you that you are taking an antihistamine.

Store the medication at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold or allergy medicine is usually taken only as 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. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include feeling restless or nervous, nausea, vomiting, stomach pain, dizziness, drowsiness, dry mouth, warmth or tingly feeling, or seizure (convulsions).

What should I avoid while taking Lodrane Liquid (brompheniramine and pseudoephedrine)?

This medication can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert. Avoid drinking alcohol. It can increase some of the side effects of this medication.

Avoid taking diet pills, caffeine pills, or other stimulants (such as ADHD medications) without your doctor's advice. Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.

Do not use any other over-the-counter cold, allergy, or sleep medication without first asking your doctor or pharmacist. If you take certain products together you may accidentally take too much of a certain drug. Read the label of any other medicine you are using to see if it contains an antihistamine or decongestant.

Lodrane Liquid (brompheniramine and pseudoephedrine) side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop using this medication and call your doctor at once if you have any of these serious side effects:

• 
  

  fast, pounding, or uneven heartbeat;

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  severe dizziness, anxiety, restless feeling, or nervousness;

  
  


• 
  

  increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

  
  


• 
  

  confusion, hallucinations, unusual thoughts or behavior;

  
  


• 
  

  easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or

  
  


• 
  

  urinating less than usual or not at all.

  
  

Less serious side effects may include:

• 
  

  blurred vision;

  
  


• 
  

  dry mouth;

  
  


• 
  

  nausea, stomach pain, constipation;

  
  


• 
  

  mild loss of appetite, stomach upset;

  
  


• 
  

  warmth, tingling, or redness under your skin;

  
  


• 
  

  sleep problems (insomnia);

  
  


• 
  

  restless or excitability (especially in children);

  
  


• 
  

  skin rash or itching;

  
  


• 
  

  dizziness, drowsiness;

  
  


• 
  

  problems with memory or concentration; or

  
  


• 
  

  ringing in your ears.

  
  

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.

What other drugs will affect Lodrane Liquid (brompheniramine and pseudoephedrine)?

Sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by brompheniramine. Tell your doctor if you regularly use any of these medicines, or any other cold or allergy medications..

Tell your doctor about all other medications you use, especially:

• 
  

  medicines to treat high blood pressure;

  
  


• 
  

  a diuretic (water pill);

  
  


• 
  

  medication to treat irritable bowel syndrome;

  
  


• 
  

  bladder or urinary medications such as oxybutynin (Ditropan, Oxytrol) or tolterodine (Detrol);

  
  


• 
  

  aspirin or salicylates (such as Disalcid, Doan's Pills, Dolobid, Salflex, Tricosal, and others);

  
  


• 
  

  a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

  
  


• 
  

  antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

  
  

This list is not complete and there may be other drugs that can interact with brompheniramine 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.

More Lodrane Liquid resources

• Lodrane Liquid Side Effects (in more detail)
• Lodrane Liquid Use in Pregnancy & Breastfeeding
• Lodrane Liquid Drug Interactions
• Lodrane Liquid Support Group
• 0 Reviews for Lodrane - Add your own review/rating

• Bidhist-D Sustained-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Bromfenex Controlled-Release and Sustained-Release Capsules MedFacts Consumer Leaflet (Wolters Kluwer)


• Lodrane D MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Lodrane Liquid with other medications

• Hay Fever
• Nasal Congestion

Where can I get more information?

• Your pharmacist can provide more information about brompheniramine and pseudoephedrine.

See also: Lodrane side effects (in more detail)

Vioform Topical

Generic Name: clioquinol (Topical route)

klye-oh-KWIN-ol

Commonly used brand name(s)

In Canada

• Vioform

Available Dosage Forms:

• Cream

Therapeutic Class: Antifungal

Uses For Vioform

Clioquinol belongs to the family of medicines called anti-infectives. Clioquinol topical preparations are used to treat skin infections.

Clioquinol is available without a prescription.

Before Using Vioform

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:

Allergies

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.

Pediatric

Clioquinol is not recommended in children younger than 2 years of age. Although there is no specific information comparing use of this medicine in children 2 years of age and older with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of this medicine in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.

Breast Feeding

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.

Interactions with Medicines

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. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

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.

Other Medical Problems

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:

• Kidney disease or


• Liver disease—Caution is advised with clioquinol use in patients with liver or kidney disease

Proper Use of Vioform

Before applying this medicine, wash the affected area with soap and water, and dry thoroughly.

Do not use this medicine in or around the eyes. If accidental contact occurs, flush eyes with water.

Do not bandage or apply an occlusive dressing (airtight covering, such as kitchen plastic wrap) over this medicine, since it may increase the infection and may cause unwanted drug absorption into the body. If you have any questions about this, check with your doctor.

To use the ointment form of this medicine:

• Apply a thin layer of ointment to the affected area and rub in gently. The ointment is recommended for use on dry, crusted lesions.

To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your symptoms have disappeared. Do not miss any doses.

Dosing

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.

• For topical dosage form (ointment):
  
  • For bacterial or fungus infections:
    
    • Adults and children 2 years of age and older—Apply to the affected area(s) of the skin two or three times a day.
    
    
    • Children younger than 2 years of age—Use is not recommended.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, apply 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.

Storage

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.

Precautions While Using Vioform

This medicine should not be used for more than 1 week. If your skin problem does not improve in 1 week, or if it becomes worse, check with your doctor.

Clioquinol should not be used to treat large areas of the skin or large open skin lesions. If you have any questions about this, check with your doctor.

This medicine may turn yellow in color when exposed to air. It may stain clothing, skin, hair, and nails yellow. Avoid getting this medicine on your clothing since bleaching may not remove the stain.

Before you have any medical tests, tell the doctor in charge that you are using this medicine. The results of some tests may be affected by this medicine.

Vioform Side Effects

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 immediately if any of the following side effects occur:

Rare

• Burning, itching, rash, redness, swelling, or other sign of skin irritation not present before use of this medicine or becoming worse during treatment

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: Vioform Topical 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.

More Vioform Topical resources

• Vioform Topical Side Effects (in more detail)
• Vioform Topical Drug Interactions
• Vioform Topical Support Group
• 0 Reviews for Vioform Topical - Add your own review/rating

Compare Vioform Topical with other medications

• Tinea Cruris
• Tinea Pedis

Covonia Herbal Mucus Cough Syrup

1. Name Of The Medicinal Product

Allens Pine and Honey Balsam

Covonia Herbal Mucus Cough Syrup

2. Qualitative And Quantitative Composition

Ipecacuanha liquid extract 0.0076ml/5ml

Liquorice liquid extract 0.l25m1/5ml

Squill oxymel 0.78ml/5ml

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Syrup

4. Clinical Particulars

4.1 Therapeutic Indications

A traditional herbal remedy used for relief of the symptoms of coughs, colds and bronchitis.

4.2 Posology And Method Of Administration

Oral

Recommended doses and dosage schedule

Adults and children over 12 years: l0ml

Elderly: dose as for adults, unless otherwise directed.

The dose may be repeated after 4 hours if required.

4.3 Contraindications

Squill should not be administered to patients with impaired renal function, and is inadvisable in patients with cardiac disorders. Sensitivity to colophony containing products e.g. some lipsticks and eyeshadows etc.

Children under 12 years of age

4.4 Special Warnings And Precautions For Use

Shake the bottle.

Keep all medicines away from children.

Do not give to children under 12 years.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Administration with carbenoxolone or diuretics may cause increased toxicity of squill if hypokalaemia occurs.

4.6 Pregnancy And Lactation

All drugs should be avoided if possible during the first trimester. Insufficient evidence is available to indicate safety of this product during pregnancy or lactation.

4.7 Effects On Ability To Drive And Use Machines

No effects known.

4.8 Undesirable Effects

Adverse effects of squill include nausea and vomiting, which may also be caused by ipecacuanha which has an irritant effect on the gastrointestinal tract. Emetine is known to accumulate in muscle and may interfere with muscle fibre contactility of heart muscle.

Liquorice may cause reversible sodium retention and potassium loss leading to hypertension, water retention and electrolyte imbalance.

4.9 Overdose

The symptoms of overdose of squill and ipecacuanha include nausea and vomiting. Treatment of overdose would depend upon the symptoms, cardiac irregularities, which may be caused by squill, may be treated by emesis or aspiration and lavage. In cases of severe cardiac arrhythmias, potassium and/or anti-arrhythmic agents may be given. Prolonged vomiting may be a symptom of overdose of ipecacuanha alkaloids, which may be controlled by intramuscular injection of 25 -50mg of chlorpromazine or of a comparable dose of a related phenothiazine; fluid and electrolyte imbalance should also be corrected.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Squill is used for its reflex expectorant action. Liquorice acts as a demulcent and expectorant. Ipecacuanha, in small doses, has a reflex expectorant action useful for the treatment of the symptoms of acute and chronic bronchitis, and in coughs

5.2 Pharmacokinetic Properties

Several procedures have been reported for the determination of ipecacuanha alkaloids but the classical acid-based titrimetric method would still appear to be the recommended one.

5.3 Preclinical Safety Data

None

6. Pharmaceutical Particulars

6.1 List Of Excipients

Pumilio Pine Oil

Anise oil

Capsicum tincture

Chloroform

Ethanol (96%)

Diethyl ether (peroxide free)

Arrowroot

Menthol

Peppermint oil

Syrup

Treacle black

Purified water

6.2 Incompatibilities

None known

6.3 Shelf Life

150m1: 36 months unopened.

6.4 Special Precautions For Storage

Store below 25°C.

6.5 Nature And Contents Of Container

150ml bottle-amber glass with a child resistant tamper evident 28mm cap with a Melinex/Aluminium/EPE liner.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

Thornton & Ross Ltd.,

Linthwaite Laboratories,

Huddersfield,

HD7 5QH

8. Marketing Authorisation Number(S)

PL 00240/5209R

9. Date Of First Authorisation/Renewal Of The Authorisation

02/03/2009

10. Date Of Revision Of The Text

03/02/2011

Mycostatin Suspension

Pronunciation: nye-STAT-in
Generic Name: Nystatin
Brand Name: Mycostatin

Mycostatin Suspension is used for:

Treatment of fungal infections of the mouth. It may also be used for other conditions as determined by your doctor.

Mycostatin Suspension is an antifungal. It works by weakening cell membranes of the sensitive fungus. This allows the cell contents to leak out and results in death of the fungus.

Do NOT use Mycostatin Suspension if:

• you are allergic to any ingredient in Mycostatin Suspension

Contact your doctor or health care provider right away if any of these apply to you.

Before using Mycostatin Suspension:

Some medical conditions may interact with Mycostatin Suspension. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding


• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement


• if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Mycostatin Suspension. However, no specific interactions with Mycostatin Suspension are known at this time.

Ask your health care provider if Mycostatin Suspension 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.

How to use Mycostatin Suspension:

Use Mycostatin Suspension as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Shake well before each use.


• Use a measuring device marked for medicine dosing. Ask your pharmacist for help if you are unsure of how to measure your dose.


• If the mouth is affected, place half the dose in each side of the mouth. Swish the medicine around the entire mouth. Retain the dose in your mouth as long as possible before swallowing, unless directed otherwise by your doctor.


• Mycostatin Suspension works best if it is taken at the same time every day.


• To clear up your infection completely, take Mycostatin Suspension for the full course of treatment. Keep taking it even if you feel better in a few days.


• If you miss a dose of Mycostatin Suspension, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Mycostatin Suspension.

Important safety information:

• Practice good oral hygiene, including proper care of dentures, while you are taking Mycostatin Suspension.


• Be sure to use Mycostatin Suspension for the full course of treatment. If you do not, the medicine may not clear up your infection completely. The fungus could also become less sensitive to this or other medicines. This could make the infection harder to treat in the future.


• Diabetes patients - Mycostatin Suspension may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Mycostatin Suspension while you are pregnant. It is not known if Mycostatin Suspension is found in breast milk. If you are or will be breast-feeding while you use Mycostatin Suspension, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Mycostatin Suspension:

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:

Diarrhea; nausea; stomach irritation; upset stomach; vomiting.

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: Mycostatin side effects (in more detail)

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include diarrhea; high blood pressure; nausea; serious irregular heartbeat; vomiting; wheezing.

Proper storage of Mycostatin Suspension:

Store Mycostatin Suspension at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed, light-resistant container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Mycostatin Suspension out of the reach of children and away from pets.

General information:

• If you have any questions about Mycostatin Suspension, please talk with your doctor, pharmacist, or other health care provider.


• Mycostatin Suspension is to be used only by the patient for whom it is prescribed. Do not share it with other people.


• If your symptoms do not improve or if they become worse, check with your doctor.


• Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Mycostatin Suspension. 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.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Mycostatin resources

• Mycostatin Side Effects (in more detail)
• Mycostatin Use in Pregnancy & Breastfeeding
• Drug Images
• Mycostatin Drug Interactions
• Mycostatin Support Group
• 0 Reviews for Mycostatin - Add your own review/rating

Compare Mycostatin with other medications

• Gastrointestinal Candidiasis
• Oral Thrush

Boots Slim Aid

1. Name Of The Medicinal Product

Potter's Boldex

Femmeherb slim aid

Tesco Slim aid

Boots slim aid

2. Qualitative And Quantitative Composition

Each tablet contains: -

27 mg of extract (as dry extract) from Peumus boldus Molina (5:1) (equivalent to 135 mg of Boldo)

Extraction solvent: Methanol 70% V/V

10 mg of Juglans cinerea L. (Butternut Bark)

30 mg of Taraxacum officinale Wiggers (Dandelion Root)

45 mg of extract (as dry extract) from Fucus vesiculosus L. (5:1) (equivalent to 225 mg of Fucus)

Extraction solvent: Ethanol 21% m/m

Excipients:

Each tablet contains 90 mg of Dextrose Monohydrate and is coated with sucrose. See Section 4.4 for further information

For full list of excipients see Section 6.1.

3. Pharmaceutical Form

Oral Tablets

A pinky orange round biconvex sugar-coated tablet.

4. Clinical Particulars

4.1 Therapeutic Indications

A herbal remedy traditionally used as an aid to slimming as part of a calorie controlled diet.

4.2 Posology And Method Of Administration

For oral administration.

Adults: Take one or two tablets three times a day.

Elderly: Take one tablet three or four times a day.

The use in children and adolescents under 18 years of age is not recommended (see section 4.4 'Special warnings and precautions for use'). Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency should not take this medicine.

If the symptoms persist more than two weeks during the use of the medicinal product, a doctor or qualified healthcare practitioner should be consulted.

To ensure an increase in the amount of urine, adequate fluid intake is required during treatment.

4.3 Contraindications

Hypersensitivity to the active substances, including plants of the Asteraceae (Compositae) family, or any of the excipients.

Patients with:

• obstruction of the bile duct or intestinal tract

• cholangitis

• liver disease

• gallstones acute gallbladder inflammation and any other biliary disorders

• active peptic ulcer

4.4 Special Warnings And Precautions For Use

To be used in conjunction with a calorie controlled diet

Do not exceed the stated dose.

The use in children and adolescents under 18 years of age is not recommended because data are insufficient and medical advice should be sought.

Patients with renal failure and/or diabetes, and/or heart failure should avoid taking the product because of possible complications due to hyperkalaemia.

If complaints or symptoms such as fever, dysuria, spasms or blood in the urine occur during the use of the medicinal product, a doctor or a qualified healthcare practitioner should be consulted.

Keep all medicines out of the sight and reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

The safety of this product during pregnancy and lactation has not been established

In view of the preclinical safety data (see section 5.3), the use of this product during pregnancy and lactation should be avoided.

4.7 Effects On Ability To Drive And Use Machines

No studies on the effect on the ability to drive and use machines have been conducted.

4.8 Undesirable Effects

Hypersensitivity reactions have been reported including reports of anaphylaxis with products containing Boldo. The frequency of occurrence of these reactions is not known.

Epigastric pain and hyperacidity may occur. The frequency of occurrence of these side-effects is not known..

If other adverse reactions not mentioned above occur, a doctor or a qualified healthcare practitioner should be consulted.

4.9 Overdose

No cases of overdose have been reported. Give fluids for diuresis.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

ATC Code:- CO3BX

There are no preclinical data of relevance to the prescriber, which are additional to those already included in other sections of the SPC.

5.2 Pharmacokinetic Properties

No relevant pharmacokinetic data are available.

5.3 Preclinical Safety Data

Tests on reproductive toxicity have been performed with a dry ethanolic extract of boldo leaf and boldine administered orally to pregnant rats. Results showed anatomical alterations in the fetus and a few cases of abortion at high doses.

Tests on reproductive toxicity, genotoxicity and carcinogenicity have not been performed.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Dextrose Monohydrate

Dicalcium Phosphate

Talc (E553(b))

Magnesium Stearate (E572)

Croscarmellose

Shellac (E904)

Sucrose

Kaolin Light (E559)

Titanium Dioxide (E171)_

Red Iron Oxide 17266 (E172)

Yellow Iron Oxide 17268 (E172)

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

Three years.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage instructions

6.5 Nature And Contents Of Container

Polyethylene pot with polyethylene push-in closure: 90, 100 and 120 tablets.

Taped polyethylene bag in a cardboard carton, tape-sealed: 500 and 1000 tablets.

Polypropylene pot with HD polyethylene or polypropylene closure; 84, 100, 120 and 180 tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

There are no special precautions for disposal.

7. Marketing Authorisation Holder

Potters Ltd

1 Botanic Court

Martland Park

WIGAN

WN5 0JZ

8. Marketing Authorisation Number(S)

PL 00250/5200R

9. Date Of First Authorisation/Renewal Of The Authorisation

25/02/1991 / 30/01/2002

10. Date Of Revision Of The Text

Adulfen Lysine

Adulfen Lysine may be available in the countries listed below.

Ingredient matches for Adulfen Lysine

Ibuprofen

Ibuprofen lysine (a derivative of Ibuprofen) is reported as an ingredient of Adulfen Lysine in the following countries:

• Belgium


• Luxembourg

International Drug Name Search