Gleptoferron

In some countries, this medicine may only be approved for veterinary use.

Scheme

Rec.INN

CAS registry number (Chemical Abstracts Service)

0057680-55-4

Chemical Formula

(FeOOH)m[HO-(C6-H10-O5)x-C7-H13-O7]n

Therapeutic Category

Antianemic agent

Chemical Names

(Dextran)(glucoheptonic acid)hydroxyoxoiron (WHO)

Macromolecular complex of iron(III) hydroxyde and dextranglucoheptonic acid (BAN)

Foreign Names

• Gleptoferronum (Latin)
• Gleptoferron (German)
• Gleptoferron (French)
• Gleptoferron (Spanish)

Generic Names

• Gleptoferron (OS: BAN, USAN)
• Eisen(III)-hydroxid-Dextran-Heptonsäure-Komplex (IS)
• Eisen-hydroxid-Dextran-Glucoheptonsäure-Komplex (IS)
• Heptomer (IS: Fisons)

Brand Names

• Gleptosil (veterinary use)
  Alstoe, Netherlands; Alstoe, Norway; Alstoe, United States; Arovet, Switzerland; Ceva, Germany; Ceva, France; Izo, Italy; Pharmaxim, Sweden; Pharmaxim vet, Finland; Vetlima, Portugal; Alstoe LtdGB, Ireland



• Imposil (veterinary use)
  Alstoe, Netherlands; Izo, Italy



• Ursoferran (veterinary use)
  Gräub, Switzerland; Serumber, Germany

International Drug Name Search

Glossary

BAN	British Approved Name
IS	Inofficial Synonym
OS	Official Synonym
Rec.INN	Recommended International Nonproprietary Name (World Health Organization)
USAN	United States Adopted Name
WHO	World Health Organization

Click for further information on drug naming conventions and International Nonproprietary Names.

Enflurano

Enflurano may be available in the countries listed below.

Ingredient matches for Enflurano

Enflurane

Enflurano (DCIT) is known as Enflurane in the US.

International Drug Name Search

Glossary

DCIT	Denominazione Comune Italiana

Click for further information on drug naming conventions and International Nonproprietary Names.

Fada Omeprazol

Fada Omeprazol may be available in the countries listed below.

Ingredient matches for Fada Omeprazol

Omeprazole

Omeprazole is reported as an ingredient of Fada Omeprazol in the following countries:

• Argentina

International Drug Name Search

Viclor

Viclor may be available in the countries listed below.

Ingredient matches for Viclor

Paracetamol

Paracetamol is reported as an ingredient of Viclor in the following countries:

• Argentina

International Drug Name Search

Kriptonal

Kriptonal may be available in the countries listed below.

Ingredient matches for Kriptonal

Bromocriptine

Bromocriptine is reported as an ingredient of Kriptonal in the following countries:

• Chile

International Drug Name Search

Quinax

Quinax may be available in the countries listed below.

Ingredient matches for Quinax

Azapentacene

Azapentacene is reported as an ingredient of Quinax in the following countries:

• Bosnia & Herzegowina


• Bulgaria


• Georgia


• Hong Kong


• Poland


• Romania


• Serbia


• Singapore


• Taiwan

International Drug Name Search

Diagesic

Diagesic may be available in the countries listed below.

Ingredient matches for Diagesic

Diclofenac

Diclofenac potassium salt (a derivative of Diclofenac) is reported as an ingredient of Diagesic in the following countries:

• Venezuela

International Drug Name Search

Lumigan 0.3mg / ml eye drops, solution

1. Name Of The Medicinal Product

LUMIGAN 0.3 mg/ml eye drops, solution

2. Qualitative And Quantitative Composition

One ml of solution contains 0.3 mg bimatoprost.

Excipient:

One ml of solution contains 0.05 mg benzalkonium chloride.

For a full list of excipients, see section 6.1.

3. Pharmaceutical Form

Eye drops, solution.

Colourless to slightly yellow solution.

4. Clinical Particulars

4.1 Therapeutic Indications

Reduction of elevated intraocular pressure in chronic open-angle glaucoma and ocular hypertension in adults (as monotherapy or as adjunctive therapy to beta-blockers).

4.2 Posology And Method Of Administration

The recommended dose is one drop in the affected eye(s) once daily, administered in the evening. The dose should not exceed once daily as more frequent administration may lessen the intraocular pressure lowering effect.

If more than one topical ophthalmic medicinal product is being used, each one should be administered at least 5 minutes apart.

Use in children and adolescents (under the age of 18):

LUMIGAN is not recommended for use in children below 18 years, due to a lack of data on safety and efficacy.

Use in hepatic and renal impairment:

LUMIGAN has not been studied in patients with renal or moderate to severe hepatic impairment and should therefore be used with caution in such patients. In patients with a history of mild liver disease or abnormal alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin at baseline, bimatoprost 0.3 mg/ml eye drops, solution had no adverse effect on liver function over 24 months.

4.3 Contraindications

Hypersensitivity to the active substance or to any of the excipients.

4.4 Special Warnings And Precautions For Use

Before treatment is initiated, patients should be informed of the possibility of eyelash growth, darkening of the eyelid skin and increased iris pigmentation since these have been observed during treatment with LUMIGAN. Some of these changes may be permanent, and may lead to differences in appearance between the eyes when only one eye is treated. The change in iris pigmentation occurs slowly and may not be noticeable for several months or years. At 12 months, the incidence was 1.5% and did not increase following 3 years treatment (see section 4.8). Periorbital tissue pigmentation has been reported to be reversible in some patients.

LUMIGAN has not been studied in patients with compromised respiratory function and should therefore be used with caution in such patients. In clinical studies, in those patients with a history of a compromised respiratory function, no significant untoward respiratory effects have been seen.

LUMIGAN has not been studied in patients with heart block more severe than first degree or uncontrolled congestive heart failure. There have been a limited number of spontaneous reports of bradycardia or hypotension with bimatoprost 0.3 mg/ml eye drops, solution. LUMIGAN should be used with caution in patients predisposed to low heart rate or low blood pressure

LUMIGAN has not been studied in patients with inflammatory ocular conditions, neovascular, inflammatory, angle-closure glaucoma, congenital glaucoma or narrow-angle glaucoma.

Cystoid macular oedema has been uncommonly reported (

There have been rare spontaneous reports of reactivation of previous corneal infiltrates or ocular infections with bimatoprost 0.3 mg/ml eye drops, solution. LUMIGAN should be used with caution in patients with a prior history of significant ocular viral infections (e.g. herpes simplex) or uveitis/iritis.

Bimatoprost 0.3 mg/ml eye drops, solution contains the preservative benzalkonium chloride, which may be absorbed by soft contact lenses. Eye irritation and discolouration of the soft contact lenses may also occur because of the presence of benzalkonium chloride. Contact lenses should be removed prior to instillation and may be reinserted 15 minutes following administration.

Benzalkonium chloride, which is commonly used as a preservative in ophthalmic products, has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since LUMIGAN contains benzalkonium chloride, monitoring is required with frequent or prolonged use in dry eye patients or where the cornea is compromised.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

No interaction studies have been performed.

No interactions are anticipated in humans, since systemic concentrations of bimatoprost are extremely low (less than 0.2 ng/ml) following ocular dosing with bimatoprost 0.3 mg/ml eye drops, solution. Bimatoprost is biotransformed by any of multiple enzymes and pathways, and no effects on hepatic drug metabolising enzymes were observed in preclinical studies.

In clinical studies, LUMIGAN was used concomitantly with a number of different ophthalmic beta

Concomitant use of LUMIGAN and antiglaucomatous agents other than topical beta-blockers has not been evaluated during adjunctive glaucoma therapy.

4.6 Pregnancy And Lactation

Pregnancy

There are no adequate data from the use of bimatoprost in pregnant women. Animal studies have shown reproductive toxicity at high maternotoxic doses (see section 5.3).

LUMIGAN should not be used during pregnancy unless clearly necessary.

Lactation

It is unknown whether bimatoprost is excreted in human breast milk. Animal studies have shown excretion of bimatoprost in breast milk. A risk to the suckling child cannot be excluded. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with LUMIGAN should be made, taking into account the benefit of breast-feeding to the child and the benefit of LUMIGAN therapy to the woman.

4.7 Effects On Ability To Drive And Use Machines

LUMIGAN has negligible influence on the ability to drive and use machines. As with any ocular treatment, if transient blurred vision occurs at instillation, the patient should wait until the vision clears before driving or using machines.

4.8 Undesirable Effects

In clinical studies, over 1800 patients have been treated with LUMIGAN 0.3 mg/ml eye drops, solution. On combining the data from phase III monotherapy and adjunctive LUMIGAN 0.3 mg/ml eye drops, solution usage, the most frequently reported treatment-related adverse events were: growth of eyelashes in up to 45% in the first year with the incidence of new reports decreasing to 7% at 2 years and 2% at 3 years, conjunctival hyperaemia (mostly trace to mild and thought to be of a non-inflammatory nature) in up to 44% in the first year with the incidence of new reports decreasing to 13% at 2 years and 12% at 3 years and ocular pruritus in up to 14% of patients in the first year with the incidence of new reports decreasing to 3% at 2 years and 0% at 3 years. Less than 9% of patients discontinued due to any adverse event in the first year with the incidence of additional patient discontinuations being 3% at both 2 and 3 years.

The following adverse reactions were reported during clinical trials with LUMIGAN 0.3 mg/ml eye drops, solution. Most were ocular, mild to moderate, and none was serious:

Very common (

System Organ class	Frequency	Undesirable effect
Nervous system disorders	common	headache
	uncommon	dizziness
Eye disorders	very common	conjunctival hyperaemia, ocular pruritus, growth of eyelashes
	common	superficial punctate keratitis, corneal erosion, ocular burning, ocular irritation, allergic conjunctivitis, blepharitis, worsening of visual acuity, asthenopia, conjunctival oedema, foreign body sensation, ocular dryness, eye pain, photophobia, tearing, eye discharge, visual disturbance, increased iris pigmentation, eyelash darkening.
	uncommon	retinal haemorrhage, uveitis, cystoid macular oedema, iritis, blepharospasm, eyelid retraction
	not known	enophthalmos
Vascular disorders	common	hypertension
Gastrointestinal disorders	uncommon	nausea
Skin and subcutaneous tissue disorders	common	eyelid erythema, eyelid pruritus, pigmentation of periocular skin
	uncommon	eyelid oedema, hirsutism.
General disorders and administration site conditions	uncommon	asthenia
Investigations	common	liver function test abnormal

4.9 Overdose

No case of overdose has been reported, and is unlikely to occur after ocular administration.

If overdose occurs, treatment should be symptomatic and supportive. If LUMIGAN is accidentally ingested, the following information may be useful: in two-week oral rat and mouse studies, doses up to 100 mg/kg/day did not produce any toxicity. This dose expressed as mg/m² is at least 70

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: Ophthalmologicals, prostaglandin analogues, ATC code: S01EE03.

The mechanism of action by which bimatoprost reduces intraocular pressure in humans is by increasing aqueous humour outflow through the trabecular meshwork and enhancing uveoscleral outflow. Reduction of the intraocular pressure starts approximately 4 hours after the first administration and maximum effect is reached within approximately 8 to 12 hours. The duration of effect is maintained for at least 24 hours.

Bimatoprost is a potent ocular hypotensive agent. It is a synthetic prostamide, structurally related to prostaglandin F_2α (PGF_2α), that does not act through any known prostaglandin receptors. Bimatoprost selectively mimics the effects of newly discovered biosynthesised substances called prostamides. The prostamide receptor, however, has not yet been structurally identified.

During 12 months' monotherapy treatment with LUMIGAN 0.3 mg/ml in adults, versus timolol, mean change from baseline in morning (08:00) intraocular pressure ranged from

In a 6-month clinical study with LUMIGAN 0.3 mg/ml, versus latanoprost, a statistically superior reduction in morning mean IOP (ranging from -7.6 to -8.2 mmHg for bimatoprost versus –6.0 to

Compared to treatment with beta-blocker alone, adjunctive therapy with beta-blocker and LUMIGAN 0.3 mg/ml lowered mean morning (08:00) intraocular pressure by

Limited experience is available in patients with open-angle glaucoma with pseudoexfoliative and pigmentary glaucoma, and chronic angle-closure glaucoma with patent iridotomy.

No clinically relevant effects on heart rate and blood pressure have been observed in clinical trials.

5.2 Pharmacokinetic Properties

Bimatoprost penetrates the human cornea and sclera well in vitro. After ocular administration in adults, the systemic exposure of bimatoprost is very low with no accumulation over time. After once daily ocular administration of one drop of LUMIGAN 0.3 mg/ml to both eyes for two weeks, blood concentrations peaked within 10 minutes after dosing and declined to below the lower limit of detection (0.025 ng/ml) within 1.5 hours after dosing. Mean C_max and AUC _0-24hrs values were similar on days 7 and 14 at approximately 0.08 ng/ml and 0.09 ng•hr/ml respectively, indicating that a steady bimatoprost concentration was reached during the first week of ocular dosing.

Bimatoprost is moderately distributed into body tissues and the systemic volume of distribution in humans at steady-state was 0.67 l/kg. In human blood, bimatoprost resides mainly in the plasma. The plasma protein binding of bimatoprost is approximately 88%.

Bimatoprost is the major circulating species in the blood once it reaches the systemic circulation following ocular dosing. Bimatoprost then undergoes oxidation, N-deethylation and glucuronidation to form a diverse variety of metabolites.

Bimatoprost is eliminated primarily by renal excretion, up to 67% of an intravenous dose administered to healthy adult volunteers was excreted in the urine, 25% of the dose was excreted via the faeces. The elimination half-life, determined after intravenous administration, was approximately 45 minutes; the total blood clearance was 1.5 l/hr/kg.

Characteristics in elderly patients:

After twice daily dosing of LUMIGAN 0.3 mg/ml, the mean AUC_0-24hr value of 0.0634 ng•hr/ml bimatoprost in the elderly (subjects 65 years or older) were significantly higher than 0.0218 ng•hr/ml in young healthy adults. However, this finding is not clinically relevant as systemic exposure for both elderly and young subjects remained very low from ocular dosing. There was no accumulation of bimatoprost in the blood over time and the safety profile was similar in elderly and young patients.

5.3 Preclinical Safety Data

Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use.

Monkeys administered ocular bimatoprost concentrations of

Bimatoprost was not mutagenic or carcinogenic in a series of in vitro and in vivo studies.

Bimatoprost did not impair fertility in rats up to doses of 0.6 mg/kg/day (at least 103

6. Pharmaceutical Particulars

6.1 List Of Excipients

Benzalkonium chloride

Sodium chloride

Sodium phosphate dibasic heptahydrate

Citric acid monohydrate

Hydrochloric acid or sodium hydroxide (to adjust pH)

Purified water

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

2 years.

4 weeks after first opening.

6.4 Special Precautions For Storage

This medicinal product does not require any special storage conditions.

6.5 Nature And Contents Of Container

White opaque low density polyethylene bottles with polystyrene screw cap. Each bottle has a fill volume of 3 ml.

The following pack sizes are available: cartons containing 1 or 3 bottles of 3 ml solution. Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements.

7. Marketing Authorisation Holder

Allergan Pharmaceuticals Ireland

Castlebar Road

Westport

Co. Mayo

Ireland

8. Marketing Authorisation Number(S)

EU/1/02/205/001-002

9. Date Of First Authorisation/Renewal Of The Authorisation

8 March 2002 / 20 February 2007

10. Date Of Revision Of The Text

7 January 2010

Detailed information on this product is available on the website of the European Medicines Agency (EMEA): http://www.emea.europa.eu

Daunoxome

Generic Name: daunorubicin citrate liposome (Intravenous route)

daw-noe-ROO-bi-sin SIT-rate LYE-poh-some

Intravenous route(Solution)

Cardiac function should be monitored regularly because of the potential risk for cardiac toxicity and congestive heart failure. Cardiac monitoring is advised especially in those patients who have received prior anthracyclines or who have pre-existing cardiac disease or who have had prior radiotherapy encompassing the heart. Severe myelosuppression may occur and dosage should be reduced in patients with impaired hepatic function. A triad of back pain, flushing, and chest tightness has been reported with administration. This triad generally occurs during the first five minutes of the infusion, subsides with interruption of the infusion, and generally does not recur if the infusion is then resumed at a slower rate .

Commonly used brand name(s)

In the U.S.

• Daunoxome

Available Dosage Forms:

• Solution

Therapeutic Class: Antineoplastic Agent

Chemical Class: Anthracycline

Uses For Daunoxome

Liposomal daunorubicin belongs to the general group of medicines known as antineoplastics. It is used to treat advanced acquired immunodeficiency syndrome (AIDS)–associated Kaposi's sarcoma (KS), a kind of skin cancer.

Liposomal daunorubicin seems to interfere with the growth of cancer cells, which eventually are destroyed. Since the growth of normal body cells also may be affected by liposomal daunorubicin, other effects will occur. Some of these may be serious and must be reported to your doctor. Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with liposomal daunorubicin, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Liposomal daunorubicin is to be administered only by or under the immediate supervision of your doctor.

Before Using Daunoxome

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

There is no specific information comparing the use of liposomal daunorubicin in children with use in any other age group. Safety and efficacy of liposomal daunorubicin in children have not been established.

Geriatric

There is no specific information comparing the use of liposomal daunorubicin in the elderly with use in any other age group. Safety and efficacy of liposomal daunorubicin in the elderly have not been established.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	D	Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Adenovirus Vaccine Type 4, Live


• Adenovirus Vaccine Type 7, Live


• Bacillus of Calmette and Guerin Vaccine, Live


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Trastuzumab


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

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:

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)—Risk of severe disease affecting other parts of the body

• Gout (history of) or


• Kidney stones—Liposomal daunorubicin may increase uric acid in the body, which can cause gout or kidney stones

• Heart disease—Risk of heart problems caused by liposomal daunorubicin may be increased

• Infection—Liposomal daunorubicin can decrease your body's ability to fight infection

• Kidney disease or


• Liver disease—Effects of liposomal daunorubicin may be increased because of slower removal from the body

Proper Use of Daunoxome

Liposomal daunorubicin is sometimes given together with certain other medicines. If you are using a combination of medicines, it is important that you receive each one at the proper time. If you are taking some of these medicines by mouth, ask your health care professional to help you plan a way to take them at the right times.

While you are receiving liposomal daunorubicin, your doctor may want you to drink extra fluids so that you will pass more urine. This will help prevent kidney problems and keep your kidneys working well.

This medicine often causes nausea and vomiting. However, it is very important that you continue to receive it even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

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.

Precautions While Using Daunoxome

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with liposomal daunorubicin, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Liposomal daunorubicin may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral poliovirus vaccine since there is a chance they could pass the poliovirus on to you. Also, avoid persons who have taken oral poliovirus vaccine. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and the mouth.

Liposomal daunorubicin can temporarily lower the number of white blood cells in your blood, increasing the chance of getting infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take, especially when your blood count is low, to reduce the risk of infection or bleeding:

• If you can, avoid people with infection. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin.


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury can occur.

Daunoxome 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 as soon as possible if any of the following side effects occur:

More common

• Cough or hoarseness


• fever or chills


• lower back or side pain


• painful or difficult urination


• shortness of breath


• sore throat


• troubled breathing


• weakness or numbness in arms or legs

Less common

• Black, tarry stools


• blood in urine or stools


• bloody vomit


• chest pain


• coughing up blood


• fainting


• fast heartbeat


• irregular heartbeat


• pinpoint red spots on skin


• producing large amounts of pale, dilute urine


• sores in mouth and on lips


• swelling of abdomen, face, fingers, hands, feet, or lower legs


• unusual bleeding or bruising


• unusual nighttime urination


• unusual tiredness or weakness


• weight gain

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Abdominal pain


• back pain


• chest tightness


• diarrhea


• feeling unusually cold


• flushing


• headache


• nausea and vomiting


• shivering


• skin rash or itching

Less common

• Bleeding after defecation


• bleeding gums


• constipation


• difficulty swallowing


• dizziness


• dry mouth


• dry, irritated, itching, or red eyes


• extreme feeling of sleepiness


• eye pain


• frequent urge to defecate


• pain in joints or muscles


• pain at site of injection


• painful, red, hot, or irritated hair follicles


• red, hot, or irritated skin at site of injection


• ringing sound in ears


• sleeplessness


• swelling or lump under skin at site of injection


• tooth pain


• uncomfortable swelling around anus


• uncontrollable movement of body

Symptoms of overdose

• Black, tarry stools


• blood in urine or stools


• cough or hoarseness


• fever or chills


• lower back or side pain


• painful or difficult urination


• pinpoint red spots on skin


• sore throat


• sores in mouth and on lips


• unusual bleeding or bruising

Liposomal daunorubicin causes the urine to turn reddish in color, which may stain clothes. This is not blood. It is to be expected and only lasts for 1 or 2 days after each dose is given.

This medicine often causes a temporary and total loss of hair. After treatment with liposomal daunorubicin has ended, normal hair growth should return.

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: Daunoxome 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.

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More Daunoxome resources

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

• Daunoxome Concise Consumer Information (Cerner Multum)


• DaunoXome Prescribing Information (FDA)


• DaunoXome MedFacts Consumer Leaflet (Wolters Kluwer)

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Dactinomycin

Class: Antineoplastic Agents
VA Class: AN200
CAS Number: 50-76-0
Brands: Cosmegen

• 
  

  Powder and solution are highly toxic (e.g., corrosive, carcinogenic, mutagenic, teratogenic).¹⁰⁰ (See Toxicity and Adequate Patient Monitoring under Cautions.)

  
  


• 
  

  Handle and administer with care; avoid inhalation of dust or vapors and contact with skin or mucous membranes, especially the eyes.¹⁰⁰ (See IV Administration under Dosage and Administration.)

  
  


• 
  

  Avoid exposure during pregnancy.¹⁰⁰ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

  
  


• 
  

  Highly corrosive to soft tissue; severe damage to soft tissues if extravasation occurs.¹⁰⁰ Contracture of the arms has been reported.¹⁰⁰ (See Local Effects under Cautions.)

  
  


• 
  

  Administer only under the supervision of a qualified clinician experienced in the use of cancer chemotherapeutic agents.¹⁰⁰

  
  

Introduction

Antineoplastic agent; an actinomycin antibiotic produced by Streptomyces parvullus.¹⁰⁰

Uses for Dactinomycin

Wilms’ Tumor

In children with Wilms’ tumor, used in combination regimens (e.g., with vincristine with or without doxorubicin) as an adjunct to surgery with or without radiation therapy.^{100 101 103} The best combination or sequential therapy to achieve maximum response and duration of survival has not been established and comparative efficacy is continually being evaluated.^{100 103}

Generally should not be administered concomitantly with radiation therapy in the treatment of Wilms’ tumor.^{100 103} (See Toxicity Potentiation with Concomitant Radiation Therapy under Cautions.)

Rhabdomyosarcoma

Component of various chemotherapeutic regimens as an adjunct to surgery with or without radiation therapy; however, the best combination or sequential therapy to achieve maximum response and duration of survival has not been established and comparative efficacy is continually being evaluated.^{100 101 103 104}

Ewing’s Sarcoma

Has been used in combination chemotherapy for treatment of Ewing’s sarcoma;¹⁰⁰ however, other regimens currently are preferred.^{101 105}

Trophoblastic Neoplasms

Treatment (alone or as a component of various chemotherapeutic regimens) of trophoblastic neoplasms (choriocarcinoma, chorioadenoma destruens) in women.^{100 101 106}

Dactinomycin alone is generally reserved for patients whose tumors develop resistance or do not respond to methotrexate or in patients with impaired hepatic or renal function with increased risk of methotrexate toxicity.¹⁰⁶

Combination therapy with methotrexate and cyclophosphamide (MAC regimen) has been used for treatment of metastatic gestational trophoblastic tumors that are refractory to single-drug therapy.^{101 106}

Combination therapy with etoposide, methotrexate, cyclophosphamide, and vincristine (EMA-CO) is commonly used in patients with poor-prognosis metastatic gestational trophoblastic tumors.^{101 106}

Testicular Cancer

Used in combination with vinblastine, bleomycin, cyclophosphamide, and cisplatin (VAB-6) for the treatment of advanced nonseminomatous testicular carcinoma.^{100 107} The best combination or sequential therapy has not been established and comparative efficacy is continually being evaluated.¹⁰⁷

Solid Tumors

Used alone or in combination with other chemotherapeutic agents by regional isolation perfusion as an adjunct to surgery or as palliative therapy alone in the treatment of locally recurrent or locoregional solid tumors (sarcomas, carcinomas, and adenocarcinomas).¹⁰⁰

Ovarian Germ Cell Tumors

Component of alternative chemotherapeutic regimens for ovarian germ cell tumors†.^{101 102}

Dactinomycin Dosage and Administration

General

• 
  

  Consult specialized references for procedures for proper handling and disposal of antineoplastics.¹⁰⁰

  
  

Administration

IV Administration

For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV infusion (preferred) or IV injection.¹⁰⁰ May also be adminstered by regional isolation perfusion.¹⁰⁰

Do not administer IM, sub-Q, or orally.¹⁰⁰

Avoid extravasation; extremely irritating to tissues.¹⁰⁰ Pain and burning or stinging sensation during IV administration may be a symptom, but extravasation may occur without these symptoms and even when blood returns well on aspiration of the infusion needle.¹⁰⁰ If manifestations of extravasation occur, immediately stop administration and restart at another site; apply ice intermittently to affected area for 15 minutes 4 times daily for 3 days. ¹⁰⁰ Because of the progressive nature of extravasation reactions, close observation and plastic surgery consultation recommended.¹⁰⁰ Blistering, ulceration, and/or persistent pain are indications for wide excision surgery, followed by split-thickness skin grafting.¹⁰⁰ (See Local Effects under Cautions.)

Prepare and handle cautiously (by trained nonpregnant personnel); use protective equipment (e.g., latex gloves, protective eyewear) and wash hands after removal of latex gloves.¹⁰⁰ Avoid exposure by inhalation or by direct contact of the skin or mucous membranes.¹⁰⁰ If drug powder or solution comes in contact with skin or mucosa, immediately irrigate affected area with water for ≥15 minutes; flush affected eye(s) with water or saline for ≥15 minutes and obtain prompt ophthalmologic consultation.¹⁰⁰ Remove contaminated clothing and shoes; destroy clothing and and thoroughly clean shoes before reuse.¹⁰⁰ (See Toxicity and Adequate Patient Monitoring under Cautions.)

Administer desired dose directly into any suitable vein or preferably into tubing or sidearm of a freely flowing IV infusion to reduce the risk of severe local reactions.¹⁰⁰ (See Local Effects under Cautions.)

Following injection, flush vein with the running IV solution for 2–5 minutes and/or inject 5–10 mL of IV solution into sidearm to flush any remaining drug from the tubing.^a

For direct IV injection, withdraw dose from the vial with one sterile needle and use another sterile needle for injection into vein.¹⁰⁰

Do not use an inline cellulose ester membrane filter during administration.^a

Reconstitution

Use strict aseptic technique since drug product contains no preservative.¹⁰⁰

Reconstitute vial containing 500 mcg of dactinomycin powder with 1.1 mL of sterile water for injection without preservatives, to provide a solution containing 500 mcg/mL.¹⁰⁰

Do not use diluents with preservatives (benzyl alcohol or parabens) which may cause precipitation.¹⁰⁰

Dilution

Reconstituted solution may be added to IV infusions of 0.5% dextrose or 0.9% sodium chloride injection.¹⁰⁰

Rate of Administration

For direct IV injection, administer desired dose over a few minutes directly into any suitable vein.^a

Regional Isolation Perfusion

Techniques for administration by regional isolation perfusion may vary; consult specialized references.¹⁰⁰

Administration Risks

Possible systemic and local adverse effects associated with drug that escapes into systemic circulation (e.g., myelosuppression, increased susceptibility to infection, impaired wound healing, ulceration of GI mucosa, absorption of toxic products accompanying extensive tumor destruction, edema of extremity, soft tissue damage, venous thrombosis).¹⁰⁰ (See Major Toxicities under Cautions.)

Dosage

Calculate dosage carefully before administration of each dose.¹⁰⁰

Base dosage on the clinical and hematologic response, patient tolerance, and other chemotherapy or irradiation being used.¹⁰⁰

Base dosage on body surface area in obese or edematous patients.¹⁰⁰

Consult published protocols for dosages in combination regimens and method and sequence of administration.¹⁰⁰

Pediatric Patients

Wilms’ Tumor

IV

Children >6 months of age: 15 mcg/kg daily for 5 days administered in various combinations and schedules with other chemotherapeutic agents.¹⁰⁰

Rhabdomyosarcoma

IV

Children >6 months of age: 15 mcg/kg daily for 5 days administered in various combinations and schedules with other chemotherapeutic agents.¹⁰⁰

Ewing’s Sarcoma

IV

Children >6 months of age: 15 mcg/kg daily for 5 days administered in various combinations and schedules with other chemotherapeutic agents.¹⁰⁰

Adults

Trophoblastic Neoplasms

Monotherapy

IV

12 mcg/kg daily for 5 days.¹⁰⁰

Combination Therapy

IV

500 mcg on days 1 and 2 as part of a combination regimen with etoposide, methotrexate, folinic acid, vincristine, cyclophosphamide, and cisplatin.^{100 110}

Testicular Cancer

IV

1000 mcg/m² on day 1 as part of a combination regimen with cyclophosphamide, bleomycin, vinblastine, and cisplatin.¹⁰⁰

Solid Tumors

IV (Regional Isolation Perfusion)

Dosage by regional isolation perfusion may vary; consult specialized references.¹⁰⁰

Pelvis or lower extremity: Usual dose is 50 mcg/kg.¹⁰⁰

Upper extremity: Usual dose is 35 mcg/kg.¹⁰⁰

Consider dosage reduction in obese patients or those who have received prior chemotherapy or irradiation.¹⁰⁰

Prescribing Limits

Pediatric Patients

IV

Maximum 15 mcg/kg daily or 400–600 mcg/m² IV daily for 5 days for each 2-week course of therapy.¹⁰⁰

Adults

IV

Maximum 15 mcg/kg daily or 400–600 mcg/m² IV daily for 5 days for each 2-week course.¹⁰⁰

Special Populations

Hepatic Impairment

No specific dosage recommendations at this time.¹⁰⁰

Renal Impairment

No specific dosage recommendations at this time.¹⁰⁰

Geriatric Patients

Start at lower end of dosage range because of age-related decreases in hepatic, renal, or cardiac function and concomitant disease and drug therapy.¹⁰⁰

Cautions for Dactinomycin

Contraindications

• 
  

  Current or recent infection with chickenpox or herpes zoster.¹⁰⁰ (See Immunosuppression under Cautions.)

  
  


• 
  

  Known hypersensitivity to dactinomycin or any ingredient in the formulation.¹⁰⁰

  
  

Warnings/Precautions

Warnings

Carcinogenic Effects

Secondary malignancies (e.g., leukemias) reported in patients receiving dactinomycin in combination with radiation therapy.¹⁰⁰ Long-term observation for occurrence of secondary malignancy is necessary in patients receiving combined modality treatment for cancer.¹⁰⁰

Fetal/Neonatal Morbidity and Mortality

May cause fetal harm; teratogenicity and embryotoxicity demonstrated in animals.¹⁰⁰ Avoid pregnancy during therapy.¹⁰⁰ If used during pregnancy or if patient becomes pregnant, apprise of potential fetal hazard.¹⁰⁰

Immunosuppression

Do not administer at or near the time of infection with chickenpox or herpes zoster.¹⁰⁰ Risk of severe and possibly fatal generalized disease.¹⁰⁰

Concurrent administration of live virus vaccines not recommended.¹⁰⁰

Sensitivity Reactions

Hypersensitivity Reactions

Possible serious hypersensitivity reactions, including anaphylaxis. ¹⁰⁰

Major Toxicities

Hematologic Effects

Risk of dose-limiting myelosuppression, manifested primarily by leukopenia and thrombocytopenia; anemia, pancytopenia, reticulopenia, agranulocytosis, and aplastic anemia also may occur.^{100 a}

Leukocyte and platelet nadirs generally occur 14–21 days following completion of a course of therapy.^a Leukocyte and platelet counts usually return to normal levels within 21–25 days.¹⁰⁰

Monitor hematologic function frequently.¹⁰⁰ If severe myelosuppression develops, discontinue therapy until blood counts return to an acceptable level;¹⁰⁰ administer supportive therapy, anti-infectives for complicating infections, and blood product transfusions as indicated.^a

Use with extreme caution in patients with impaired bone marrow function.^a

GI Effects

Nausea and vomiting; generally occur within hours of administration and last up to 24 hours.^{100 a} Antiemetics may be effective in preventing or treating nausea and vomiting.^{100 a}

Risk of stomatitis or diarrhea; if stomatitis or diarrhea develops, discontinue therapy until symptoms resolve. ¹⁰⁰

Hepatic Effects

Potentially fatal hepatic failure and hepatic veno-occlusive disease reported.¹⁰⁰ Veno-occlusive disease may be associated with intravascular clotting disorder and multiorgan failure and may be fatal, particularly in children <4 years of age.¹⁰⁰

Abnormal liver function tests, ascites, hepatomegaly, and hepatitis reported.¹⁰⁰

Local Effects

Extravasation may produce severe local tissue damage, necrosis, cellulitis, phlebitis, and inflammation; contracture of the arms reported.^{100 a} Follow precautions to avoid extravasation.¹⁰⁰ (See IV Administration under Dosage and Administration.)

Epidermolysis, erythema, and edema, sometimes severe, reported with regional limb perfusion.¹⁰⁰

General Precautions

Toxicity and Adequate Patient Monitoring

Highly toxic drug with a low therapeutic index; therapeutic response is not likely to occur without some evidence of toxicity.^{100 a} Handle and administer cautiously; administer only under the supervision of qualified clinician experienced in the use of cancer chemotherapy agents.¹⁰⁰ (See IV Administration under Dosage and Administration.)

Closely observe patient and frequently assess bone marrow, hepatic, and renal function.¹⁰⁰

Toxicity Potentiation with Concomitant Radiation Therapy

Appears to potentiate effects of radiation therapy.¹⁰⁰ Severe reactions possible if high doses of both dactinomycin and radiation are used or if patient is especially sensitive to such combination therapy.¹⁰⁰

Increased incidence of GI toxicity (e.g., severe oropharyngeal mucositis) and myelosuppression reported.¹⁰⁰

Erythema at the site of irradiation may occur early in normal skin and buccal and pharyngeal mucosa and may be followed rapidly by hyperpigmentation and/or edema, desquamation, vesiculation, and rarely necrosis.^{100 a}

Possible reactivation of radiation effects (e.g., erythema) in previously irradiated tissues.¹⁰⁰

Hepatomegaly, elevated serum AST concentrations, and ascites reported in the first 2 months after radiation therapy in patients with right-sided Wilms’ tumor; administer dactinomycin with particular caution in the first 2 months after radiation therapy.^{100 a} Do not administer concomitantly with radiation therapy for treatment of Wilms’ tumor unless benefit outweighs risk.^{100 103}

Specific Populations

Pregnancy

Category D.¹⁰⁰ (See Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Not known whether dactinomycin is distributed into human milk.¹⁰⁰ Discontinue nursing or the drug.¹⁰⁰

Pediatric Use

Increased incidence of adverse effects in infants; use only in infants older than 6–12 months of age.¹⁰⁰

Increased incidence of fatal veno-occlusive disease in children <4 years of age.¹⁰⁰ (See Hepatic Effects under Cautions.)

Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults; consider the greater frequency of decreased hepatic, renal, and/or cardiac function and of concomitant disease and drug therapy observed in the elderly.¹⁰⁰

Possible increased incidence of myelosuppression compared with younger adults.¹⁰⁰

Common Adverse Effects

With IV therapy, myelosuppression, nausea, vomiting, anorexia, abdominal pain, diarrhea, GI ulceration, dysphagia, stomatitis, alopecia, rash, malaise, fatigue, lethargy, liver function test abnormalities, hepatitis, growth retardation, fever, infection, myalgia.¹⁰⁰

With regional isolation perfusion, edema of involved extremity, regional soft tissue damage, myelosuppression, infection, impaired wound healing.¹⁰⁰

Interactions for Dactinomycin

No formal drug interaction studies to date.¹⁰⁰

Specific Drugs, Therapies, and Laboratory Tests

Drug	Interaction	Comments
Antibacterial drug concentration bioassay	Possible intereferance with bioassay100
Antineoplastic agents	Possible potentiation of toxicity100	Reduced dactinomycin dosage may be necessary if other chemotherapy is used concomitantly with or prior to dactinomycin100
Radiation therapy	Possible potentiation of GI and hematologic toxicity and radiation effects100	Severe reactions possible; reduced dactinomycin dosage may be necessary if radiation therapy is used concomitantly with or prior to dactinomycin100
Vaccines, live	Potentially hazaradous in immunosuppresed patients, including those undergoing cytotoxic chemotherapy100	Concomitant administration not recommended100

Dactinomycin Pharmacokinetics

Absorption

Bioavailability

Poorly absorbed from the GI tract.^a

Distribution

Extent

Rapidly distributed into tissues, with highest concentrations in bone marrow and nucleated cells (i.e., granulocytes, lymphocytes).^{a 100} Does not cross the blood-brain barrier.^{100 a}

Appears to cross placenta; not known whether distributed into milk.^{a 100}

Elimination

Metabolism

Minimally metabolized.¹⁰⁰

Elimination Route

Excreted in urine and feces; excreted in urine primarily as unchanged drug.^{a 100}

Half-life

Biphasic; terminal half-life is approximately 36 hours.^{100 a}

Stability

Storage

Parenteral

Powder for Injection

25°C (may be exposed to 15–30°C).¹⁰⁰ Protect from light and humidity; discard any unused portion.¹⁰⁰

Compatibility

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

Parenteral

Manufacturer states that dactinomycin should not be mixed with diluents containing preservatives (benzyl alcohol or parabens); precipitation reported.¹⁰⁰

Solution Compatibility^HID

Compatible
Dextrose 5% in water

Drug Compatibility

Y-Site CompatibilityHID

Compatible
Allopurinol sodium
Amifostine
Aztreonam
Cefepime HCl
Etoposide phosphate
Fludarabine phosphate
Gemcitabine HCl
Granisetron HCl
Melphalan HCl
Ondansetron HCl
Sargramostim
Teniposide
Thiotepa
Vinorelbine tartrate
Incompatible
Filgrastim

ActionsActions

• 
  

  Mechanism(s) of antineoplastic action not fully understood; appears to inhibit DNA-dependent RNA synthesis by forming a complex with DNA by intercalating with guanine residues and impairing the template activity of DNA.^{100 a}

  
  


• 
  

  Also inhibits protein and DNA synthesis, but less extensively and at higher concentrations of dactinomycin than are needed to inhibit RNA synthesis.^a

  
  


• 
  

  Cytotoxicity precludes use as an anti-infective agent.^{a 100}

  
  

Advice to Patients

• 
  

  Risk of alopecia, nausea, vomiting, myelosuppression, and hepatotoxicity.¹⁰⁰

  
  


• 
  

  Importance of patients informing clinicians immediately if any stinging or burning occurs at IV injection site during administration.¹⁰⁰

  
  


• 
  

  Importance of women informing clinicians immediately 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.¹⁰⁰

  
  


• 
  

  Importance of patients informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.¹⁰⁰

  
  


• 
  

  Importance of informing patients of other important precautionary information.¹⁰⁰ (See Cautions.)

  
  

Preparations

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

Dactinomycin

Routes	Dosage Forms	Strengths	Brand Names	Manufacturer
Parenteral	For injection	500 mcg	Cosmegen (with mannitol 20 mg)	Merck

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 April 01, 2007. 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.

References

100. Merck & Co., Inc. Cosmegen for injection (dactinomycin for injection) prescribing information. Whitehouse Station, NJ; 2005 Jun.

101. Anon. Drugs of choice for cancer. Treat Guidel Med Lett. 2003; 1:41-52. [PubMed 15529105]

102. Ovarian germ cell tumor. From: CancerNet/PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2001 Sep.

103. Wilms’ tumor. From: CancerNet/PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2001 Oct.

104. Childhood rhabdomyosarcoma. From: CancerNet/PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2001 Oct.

105. Ewing’s family of tumors including primitive neuroectodermal tumor (PNET). From: CancerNet/PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2001 Oct.

106. Gestational trophoblastic tumor. From: CancerNet/PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2001 Jun.

107. Testicular cancer. From: CancerNet/PDQ. Physician data query (database). Bethesda, MD: National Cancer Institute; 2001 Aug.

108. 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; 44:37434-67.

109. 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.

110. Newlands ES, Bagshawe KD, Begent RH et al. Results with the EMA/CO (etoposide, methotrexate, actinomycin D, cyclophosphamide, vincristine) regimen in high risk gestational trophoblastic tumours, 1979 to 1989. Br J Obstet Gynaecol. 1991; 98:550-7. [PubMed 1651757]

a. AHFS drug information 2006. McEvoy GK, ed. Dactinomycin. Bethesda, MD: American Society of Health-System Pharmacists; 2006:1009-11.

HID. Trissel LA. Handbook on injectable drugs. 12th ed. Bethesda, MD: American Society of Health-System Pharmacists; 2003:400-402.

More Dactinomycin resources

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

• Dactinomycin Professional Patient Advice (Wolters Kluwer)


• Dactinomycin MedFacts Consumer Leaflet (Wolters Kluwer)


• Cosmegen Prescribing Information (FDA)


• dactinomycin Concise Consumer Information (Cerner Multum)


• dactinomycin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Compare Dactinomycin with other medications

• Cancer
• Ewing's Sarcoma
• Osteoarthritis
• Osteosarcoma
• Ovarian Cancer
• Rhabdomyosarcoma
• Testicular Cancer
• Trophoblastic Disease
• Wilms' Tumor

Dificid

Pronunciation: fye-DAX-oh-MYE-sin
Generic Name: Fidaxomicin
Brand Name: Dificid

Dificid is used for:

Treating diarrhea caused by a certain bacteria (Clostridium difficile).

Dificid is a macrolide antibiotic. It works by killing sensitive bacteria.

Do NOT use Dificid if:

• you are allergic to any ingredient in Dificid

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

Before using Dificid:

Some medical conditions may interact with Dificid. 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


• if you have another infection

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

Ask your health care provider if Dificid 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 Dificid:

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

• Take Dificid by mouth with or without food.


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


• If you miss a dose of Dificid, 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 Dificid.

Important safety information:

• Do NOT take Dificid for longer than prescribed without checking with your doctor.


• Dificid only works against infections caused by a certain bacteria (Clostridium difficile); it does not treat viral infections (eg, the common cold).


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


• Long-term or repeated use of Dificid may cause a second infection. Tell your doctor if signs of a second infection occur. Your medicine may need to be changed to treat this.


• Dificid should be used with extreme caution in CHILDREN younger than 18 years; safety and effectiveness in these children have not been confirmed.


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

Possible side effects of Dificid:

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:

Nausea; stomach pain; 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); fever, chills, or persistent sore throat; severe or persistent constipation or stomach pain; symptoms of stomach or bowel bleeding (eg, black, tarry stools; vomit that looks like coffee grounds); unusual tiredness or weakness.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

See also: Dificid 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.

Proper storage of Dificid:

Store Dificid at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dificid out of the reach of children and away from pets.

General information:

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


• Dificid 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 Dificid. 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 Dificid resources

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

• Dificid Prescribing Information (FDA)


• Dificid Advanced Consumer (Micromedex) - Includes Dosage Information


• Dificid Consumer Overview


• Fidaxomicin Professional Patient Advice (Wolters Kluwer)

Compare Dificid with other medications

• Clostridial Infection

Metotrexato Lederle

Metotrexato Lederle may be available in the countries listed below.

Ingredient matches for Metotrexato Lederle

Methotrexate

Methotrexate sodium salt (a derivative of Methotrexate) is reported as an ingredient of Metotrexato Lederle in the following countries:

• Iceland

International Drug Name Search

Formotil Genepharm

Formotil Genepharm may be available in the countries listed below.

Ingredient matches for Formotil Genepharm

Formoterol

Formoterol fumarate (a derivative of Formoterol) is reported as an ingredient of Formotil Genepharm in the following countries:

• Greece

International Drug Name Search

Diuril Sodium

Generic Name: chlorothiazide (Intravenous route)

klor-oh-THYE-a-zide

Commonly used brand name(s)

In the U.S.

• Diuril Sodium

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Cardiovascular Agent

Pharmacologic Class: Diuretic

Chemical Class: Thiazide

Uses For Diuril Sodium

Chlorothiazide is used to treat fluid retention (edema) that is caused by congestive heart failure, severe liver disease (cirrhosis), kidney disease, or from treatment with a steroid or hormone medicine.

Chlorothiazide is a thiazide diuretic. It reduces the amount of water in the body by increasing the flow of urine, which helps reduce fluid retention (edema).

This medicine is available only with your doctor's prescription.

Before Using Diuril Sodium

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

Appropriate studies have not been performed on the relationship of age to the effects of chlorothiazide in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of chlorothiazide in the elderly. However, elderly patients are more likely to have age-related liver, kidney, or heart problems, which may require an adjustment in the dose for patients receiving chlorothiazide.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding

Studies suggest that this medication may alter milk production or composition. If an alternative to this medication is not prescribed, you should monitor the infant for side effects and adequate milk intake.

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. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Acetyldigoxin


• Arsenic Trioxide


• Bepridil


• Deslanoside


• Digitalis


• Digitoxin


• Digoxin


• Dofetilide


• Flecainide


• Ketanserin


• Lithium


• Metildigoxin

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Alacepril


• Apazone


• Aspirin


• Benazepril


• Bromfenac


• Calcium


• Captopril


• Celecoxib


• Cilazapril


• Delapril


• Diclofenac


• Diflunisal


• Enalaprilat


• Enalapril Maleate


• Etodolac


• Fenoprofen


• Flurbiprofen


• Fosinopril


• Ginkgo


• Gossypol


• Ibuprofen


• Ibuprofen Lysine


• Imidapril


• Indomethacin


• Ketoprofen


• Ketorolac


• Licorice


• Lisinopril


• Magnesium Salicylate


• Meclofenamate


• Mefenamic Acid


• Meloxicam


• Moexipril


• Nabumetone


• Naproxen


• Nepafenac


• Oxaprozin


• Pentopril


• Perindopril


• Piroxicam


• Quinapril


• Ramipril


• Salicylic Acid


• Salsalate


• Spirapril


• Sulindac


• Temocapril


• Tolmetin


• Trandolapril


• Zofenopril

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:

• Anuria (not able to form urine)—Should not be used in patients with this condition.

• Asthma or


• Diabetes or


• Gout or


• Hypercalcemia (high calcium in the blood) or


• Hyperuricemia (high uric acid in the blood) or


• Hypochloremia (low chloride in the blood) or


• Hypokalemia (low potassium in the blood) or


• Hypomagnesemia (low magnesium in the blood) or


• Hyponatremia (low sodium in the blood) or


• Hypophosphatemia (low phosphorus in the blood) or


• Liver disease or


• Systemic lupus erythematosus—Use with caution. This medicine may make these conditions worse.

• Kidney disease—Use with caution. The effects of the medicine may be increased because of slower removal of the medicine from the body.

Proper Use of Diuril Sodium

A nurse or other trained health professional will give you this medicine. This medicine is given through a needle placed in one of your veins.

Precautions While Using Diuril Sodium

Your doctor will only give you a few doses of this medicine until your condition improves, and then you will be switched to an oral medicine that works the same way. If you have any concerns about this, talk to your doctor.

Diuril Sodium 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 or nurse immediately if any of the following side effects occur:

Incidence not known

• Abdominal or stomach pain


• back, leg, or stomach pains


• black, tarry stools


• bleeding gums


• blisters on skin


• blood in urine or stools


• bloody or cloudy urine


• blue lips and fingernails


• blurred vision


• burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings


• chest pain


• chills


• clay-colored stools


• cold sweats


• confusion


• constipation


• cough or hoarseness


• coughing that sometimes produces a pink frothy sputum


• coughing up blood


• darkened urine


• decrease in urine output or decrease in urine-concentrating ability


• decreased frequency or amount of urine


• diarrhea


• difficult, fast, or noisy breathing, sometimes with wheezing


• difficulty swallowing


• dizziness, faintness, or lightheadedness when getting up from a lying or sitting position suddenly


• dry mouth


• fast heartbeat


• feeling of constant movement of self or surroundings


• fever


• flushed, dry skin


• fruit-like breath odor


• general feeling of discomfort or illness


• general feeling of tiredness or weakness


• headache


• hives


• increased blood pressure


• increased hunger


• increased sensitivity of skin to sunlight


• increased sweating


• increased thirst


• increased urination


• indigestion


• itching


• joint pain, stiffness, or swelling


• loss of appetite


• lower back or side pain


• muscle cramps or pain


• nausea


• nosebleeds


• numbness, tingling, pain, or weakness in hands or feet


• pain in joints or muscles


• painful or difficult urination


• pains in stomach, side, or abdomen, possibly radiating to the back


• pale skin


• pinpoint red spots on skin


• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue


• redness or other discoloration of skin


• redness, soreness, or itching skin


• seizures


• sensation of spinning


• severe sunburn


• shortness of breath


• skin rash


• sores, ulcers, or white spots on lips or in mouth


• sores, welting, or blisters


• sugar in the urine


• sweating


• swelling in legs and ankles


• swelling of face, fingers, or lower legs


• swollen or painful glands


• tenderness of salivary glands


• thickening of bronchial secretions


• tightness in chest


• trembling


• troubled breathing


• unexplained weight loss


• unpleasant breath odor


• unusual bleeding or bruising


• unusual tiredness or weakness


• unusual weight loss


• vomiting of blood


• weight gain


• yellow eyes or skin

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

Incidence not known

• Blistering, peeling, or loosening of skin


• cracks in the skin


• cramping


• decreased interest in sexual intercourse


• difficulty having a bowel movement (stool)


• hair loss, thinning of hair


• inability to have or keep an erection


• loss in sexual ability, desire, drive, or performance


• loss of heat from the body


• muscle spasm


• pinpoint red or purple spots on skin


• red, irritated eyes


• red, swollen skin


• restlessness


• scaly skin


• weakness

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: Diuril Sodium side effects (in more detail)

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More Diuril Sodium resources

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

• Chlorothiazide Prescribing Information (FDA)


• Chlorothiazide Professional Patient Advice (Wolters Kluwer)


• chlorothiazide Concise Consumer Information (Cerner Multum)


• Chlorothiazide MedFacts Consumer Leaflet (Wolters Kluwer)


• Chlorothiazide Monograph (AHFS DI)


• Diuril Prescribing Information (FDA)

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