Phosphocol P-32

Generic Name: chromic phosphate p 32 (Injection route)

KROME-ik FOS-fate P 32

Commonly used brand name(s)

In the U.S.

• Phosphocol P-32

Available Dosage Forms:

• Suspension

Therapeutic Class: Diagnostic Agent, Radiopharmaceutical Imaging

Uses For Phosphocol P-32

Chromic phosphate P 32 is a radiopharmaceutical. Radiopharmaceuticals are agents used to diagnose certain medical problems or treat certain diseases.

Chromic phosphate P 32 is used to treat cancer or related problems. It is put by catheter into the pleura (sac that contains the lungs) or into the peritoneum (sac that contains the liver, stomach, and intestines) to treat the leaking of fluid inside these areas that is caused by cancer. It may also be given by injection to treat cancer in certain organs such as the ovaries and prostate.

Chromic phosphate P 32 is to be given only by or under the direct supervision of a doctor with specialized training in nuclear medicine.

Before Using Phosphocol P-32

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 use of chromic phosphate P 32 in children with use in other age groups.

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 chromic phosphate P 32 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.

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.

Proper Use of Phosphocol P-32

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.

Phosphocol P-32 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:

Less common or rare

• Abdominal or stomach pain (severe)


• chest pain


• chills and/or fever


• dry cough


• nausea and vomiting (severe)


• sore throat and fever


• troubled breathing


• unusual bleeding or bruising


• unusual tiredness or weakness

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 or stomach cramps


• diarrhea


• feeling of discomfort


• loss of appetite


• nausea and vomiting


• 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: Phosphocol P-32 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 Phosphocol P-32 resources

• Phosphocol P-32 Side Effects (in more detail)
• Phosphocol P-32 Support Group
• 0 Reviews · Be the first to review/rate this drug

Fucidin Cream

1. Name Of The Medicinal Product

Fucidin^® Cream

2. Qualitative And Quantitative Composition

Fucidin^® Cream contains fusidic acid Ph.Eur. 2%.

Excipient: butylhydroxyanisole

Excipient: cetyl alcohol

Excipient: potassium sorbate

For full list of excipients, see section 6.1

3. Pharmaceutical Form

Cream for topical administration

4. Clinical Particulars

4.1 Therapeutic Indications

Indicated either alone or in combination with systemic therapy, in the treatment of primary and secondary skin infections caused by sensitive strains of Staphylococcus aureus, Streptococcus spp and Corynebacterium minutissimum. Primary skin infections that may be expected to respond to treatment with fusidic acid applied topically include: impetigo contagiosa, superficial folliculitis, sycosis barbae, paronychia and erythrasma; also such secondary skin infections as infected eczematoid dermatitis, infected contact dermatitis and infected cuts / abrasions.

4.2 Posology And Method Of Administration

Adults and Children:

Uncovered lesions - apply gently three or four times daily.

Covered lesions - less frequent applications may be adequate.

4.3 Contraindications

Known hypersensitivity to fusidic acid/sodium fusidate or to any of the excipients

Infection caused by non-susceptible organisms, in particular, Pseudomonas aeruginosa.

4.4 Special Warnings And Precautions For Use

Bacterial resistance has been reported to occur with the use of fusidic acid. As with all antibiotics, extended or recurrent use may increase the risk of developing antibiotic resistance.

Extended or recurrent use may increase the risk of developing contact sensitisation.

Fusidic acid does not appear to cause conjunctival irritation in experimental animals. Caution should still be exercised, however, when Fucidin Cream is used near the eyes.

Fucidin^® Cream contains butylhydroxyanisole, cetyl alcohol and potassium sorbate which may cause local skin reactions (e.g. contact dermatitis). Butylhydroxyanisole may also cause irritation to the eyes and mucous membranes.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known

4.6 Pregnancy And Lactation

There is inadequate evidence of safety in human pregnancy. Animal studies and many years of clinical experience have suggested that fusidic acid is devoid of teratogenic effect. There is evidence to suggest that when given systemically, fusidic acid can penetrate the placental barrier. The use of topical Fucidin^® in pregnancy requires that the potential benefits be weighed against the possible hazards to the foetus.

Safety in nursing mothers has not been established. When fusidic acid (as the sodium salt) has been given systemically, levels have been detected in breast milk, but with topical use the possible amount of drug present is unlikely to affect the infant.

4.7 Effects On Ability To Drive And Use Machines

Fucidin^® administered topically has no or negligible influence on the ability to drive and to use machines.

4.8 Undesirable Effects

Based on combined clinical data for Fucidin^® cream and Fucidin^® ointment, less than 5% of patients can be expected to experience an undesirable effect.

The most frequently reported adverse drug reactions are various skin reactions and in particular application site reactions.

Undesirable effects are listed by MedDRA SOC and the individual undesirable effects are listed starting with the most frequently reported.

Very common

Common

Uncommon

Rare

Very rare <1/10,000

Not known (cannot be estimated from the available data)

Immune system disorders

Rare

Hypersensitivity

Eye disorders

Rare

Conjunctivitis

Skin and subcutaneous tissue disorders

Uncommon

Pruritus

Rash including erythematous, maculo-papular and pustular reactions

Contact Dermatitis

Irritation at site of application (including pain, stinging, burning and erythema)

Not known

Urticaria

Angioedema

Eczema

Periorbital oedema

4.9 Overdose

Overdose is unlikely to occur

Unless hypersensitivity to Fusidic acid or any of the excipients exists, accidental ingestion of Fucidin^® cream is unlikely to cause any harm. The total quantity of fusidic acid (30g Fucidin^® cream contains 600mg fusidic acid) will usually not exceed the approved total daily oral dose of fusidic acid containing products except in children aged less than 1 year and weighing ^® cream. The concentration of the excipients is too low to constitute a safety risk.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Fusidic acid is a potent antibacterial agent. Fusidic acid and its salts show fat and water solubility and strong surface activity and exhibit unusual ability to penetrate intact skin. Concentrations of 0.03 - 0.12 mcg fusidic acid per ml inhibit nearly all strains of Staphylococcus aureus. Topical application of fusidic acid is also effective against streptococci, corynebacteria, neisseria and certain clostridia.

5.2 Pharmacokinetic Properties

In Vitro studies show that fusidic acid can penetrate intact human skin. The degree of penetration depends on factors such as the duration of exposure to fusidic acid and the condition of the skin. Fusidic acid is excreted mainly in the bile with little excreted in the urine.

5.3 Preclinical Safety Data

There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Butylated hydroxyanisole, cetanol, glycerol, liquid paraffin, potassium sorbate, polysorbate 60, white soft paraffin, purified water.

6.2 Incompatibilities

Not applicable

6.3 Shelf Life

3 years

6.4 Special Precautions For Storage

None

6.5 Nature And Contents Of Container

Aluminium tubes of 3.5 gram, 5 gram, 10 gram, 15 gram, 25 gram and 30 gram.

6.6 Special Precautions For Disposal And Other Handling

None

7. Marketing Authorisation Holder

LEO Laboratories Limited

Princes Risborough

Bucks

HP27 9RR

8. Marketing Authorisation Number(S)

PL 0043/0065

9. Date Of First Authorisation/Renewal Of The Authorisation

03/03/2009.

10. Date Of Revision Of The Text

5 August 2010

altretamine

al-TRET-a-meen

Oral route(Capsule)

Peripheral blood counts should be monitored at least monthly, prior to the initiation of each course of altretamine, and as clinically indicated. Because of the possibility of altretamine-related neurotoxicity, neurologic examination should be performed regularly during altretamine administration .

Commonly used brand name(s)

In the U.S.

• Hexalen

Available Dosage Forms:

• Capsule

Therapeutic Class: Antineoplastic Agent

Uses For altretamine

Altretamine belongs to the group of medicines called antineoplastics. It is used to treat cancer of the ovaries. It may also be used to treat other kinds of cancer, as determined by your doctor.

Altretamine interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by altretamine, other effects will also occur. Some of these may be serious and must be reported to your doctor. Other effects may not be serious but may cause concern. Some effects may not occur for months or years after the medicine is used.

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

Altretamine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although this use is not included in product labeling, altretamine is used in certain patients with the following medical condition:

• Cancer of the lung

Before Using altretamine

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 altretamine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to altretamine 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 use of altretamine in children with use in other age groups.

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 altretamine in the elderly with use in other age groups, altretamine is not expected to cause different side effects or problems in older people than it does in younger adults.

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 taking altretamine, 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 altretamine 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 altretamine 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


• Brofaromine


• Clorgyline


• Furazolidone


• Influenza Virus Vaccine, Live


• Iproniazid


• Isocarboxazid


• Lazabemide


• Linezolid


• Measles Virus Vaccine, Live


• Moclobemide


• Mumps Virus Vaccine, Live


• Nialamide


• Pargyline


• Phenelzine


• Procarbazine


• Pyridoxine


• Rasagiline


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Selegiline


• Smallpox Vaccine


• Toloxatone


• Tranylcypromine


• 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 altretamine. 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

• Nervous system problems—May be worsened by altretamine

• Infection—Altretamine may decrease your body's ability to fight infection

• Kidney disease—Effects of altretamine may be increased because of slower removal from the body

• Liver disease—Effects may be changed because altretamine is activated and cleared from the body by the liver

Proper Use of altretamine

altretamine often causes nausea and vomiting. However, it is very important that you continue to receive the medicine even if you begin to feel ill. Taking altretamine after meals will lessen stomach upset. Ask your health care professional for other ways to lessen these effects.

Dosing

The dose of altretamine 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 altretamine. 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.

Missed Dose

Call your doctor or pharmacist for instructions.

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 altretamine

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

While you are being treated with altretamine, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Altretamine 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 polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. 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 mouth.

Altretamine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an 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 infections. 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 a safety razor or fingernail or toenail cutters.


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

altretamine 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:

Less common or rare

• Black, tarry stools


• blood in urine or stools


• cough or hoarseness, accompanied by fever or chills


• fever or chills


• lower back or side pain, accompanied by fever or chills


• painful or difficult urination, accompanied by fever or chills


• pinpoint red spots on skin


• unusual bleeding or bruising


• unusual tiredness

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Anxiety


• clumsiness


• confusion


• convulsions (seizures)


• dizziness


• mental depression


• numbness in arms or legs


• weakness

Rare

• Skin rash or itching

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

• Nausea and vomiting

Less common

• Diarrhea


• loss of appetite


• stomach cramps

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: altretamine 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 altretamine resources

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

• altretamine Concise Consumer Information (Cerner Multum)


• Altretamine Professional Patient Advice (Wolters Kluwer)


• Altretamine MedFacts Consumer Leaflet (Wolters Kluwer)


• Altretamine Monograph (AHFS DI)


• Hexalen Prescribing Information (FDA)

Compare altretamine with other medications

• Ovarian Cancer

Dacarbazine 200 mg, powder for solution for injection (Hospira UK Ltd)

DACARBAZINE 200 mg POWDER FOR SOLUTION FOR INJECTION

Read all of this leaflet carefully before you start using this medicine

Keep this leaflet. You may need to read it again.

If you have any further questions ask your doctor.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

In this leaflet:

• 1. What Dacarbazine Powder for Solution for Injection is and what it is used for


• 2. Before you use Dacarbazine Powder for Solution for Injection


• 3. How to use Dacarbazine Powder for Solution for Injection


• 4. Possible side effects


• 5. How to store Dacarbazine Powder for Solution for Injection


• 6. Further information

What Dacarbazine Powder For Solution For Injection Is And What It Is Used For

Dacarbazine Powder for Solution for Injection is an anti-cancer medicine, in the form of a powder for solution for injection. Treatment with an anti-cancer medicine is sometimes called cancer chemotherapy.

Dacarbazine Powder for Solution for Injection may be used for the treatment of some types of cancer, for example: metastatic malignant melanoma (a type of skin cancer that has spread) and Hodgkin’s disease and some types of cancer in soft tissues.

Before You Use Dacarbazine Powder For Solution For Injection

Do not use Dacarbazine Powder for Solution for Injection

• if you have shown signs of hypersensitivity (severe allergy) to dacarbazine on previous occasions


• if you have severe liver or kidney diseases


• in combination with yellow fever vaccine and some other types of vaccines (live attenuated)


• in combination with phenytoin (a medicine used to prevent convulsions).

Taking/using other medicines

Special care should be taken if you are taking other medicinal products which could interact with Dacarbazine:

• ciclosporin or tacrolimus (medicines used after having a transplant)


• fotemustine (a medicine used in cancer treatment)


• medicines which could damage your liver


• warfarin (a medicine used to thin the blood). Your doctor may need to do your blood test (INR) more often

Please tell your doctor if you are taking, or have recently taken, any other medicines, including medicines obtained without a prescription.

Pregnancy and breast feeding

Do not use Dacarbazine:

• if you are pregnant or trying to become pregnant


• if you are breast feeding

Driving and using machines

Dacarbazine may influence the ability to drive or operate machinery because of nausea and vomiting or rare adverse reactions affecting the nervous system.

Important information about one of the ingredients of Dacarbazine Powder for Solution for Injection

This medicine contains less than 1 mmol sodium (23 mg) per vial, i.e. essentially ‘sodium free’.

How To Use Dacarbazine Powder For Solution For Injection

This medicinal product is for intravenous use (injection into a vein).

Your treatment will usually be given to you in hospital.

You will be given Dacarbazine as an infusion (slow injection via a drip) into a vein or a slow intravenous injection(injection into a vein).

Tell your doctor or nurse at once if you notice any pain at the injection site during or shortly after treatment. Pain around the injection site could mean the needle has not been properly inserted into the vein.

The dose of dacarbazine will depend on the illness for which you are being treated. The dose is calculated according to your body surface area (expressed as mg/m²).

Depending on your illness, dosing is typically between 200 and 850 mg/m² of dacarbazine.

As this medicine will be given to you whilst you are in hospital it is unlikely that you will be given too little or too much. However, tell your doctor or pharmacist if you have any concerns.

Possible Side Effects

Like all medicines Dacarbazine Powder for Solution for Injection can have side effects although not everybody gets them.

If any of the following happen, tell your doctor immediately:

• severe allergic reaction - you may experience a sudden itchy rash (hives), swelling of the hands, feet, ankles, face, lips, mouth and throat (which may cause difficulty in swallowing or breathing), and you may feel you are going to faint.

This is a very serious side effect. You may need urgent medical attention. This very serious side effect is rare.

If you experience any of the following tell your doctor as soon as possible:

Common (less than 1 in 10 patients but more than 1 in 100):

• pallor (anaemia)


• loss of appetite


• nausea/vomiting

Uncommon (Less than 1 in 100 patients but more than 1 in 1000):

• confusion


• fits (seizures)


• numbness of the skin or pins and needles sensation in the face (paraesthesia)


• headache


• blurred vision


• facial flushing


• hair loss (alopecia)


• transient rash


• an influenza (‘flu’) type syndrome of fever, muscle pain (myalgia) and generally feeling unwell (malaise) which may start approximately one week after treatment and may last for up to three weeks


• tiredness and weakness (lethargy)

Rare (less than 1 in 1000 patients but more than 1 in 10,000)

• diarrhoea


• bruising


• increased sensitivity of the skin to sunlight (photosensitivity)

Very rare (less than 1 in 10,000)

• redness of the skin/rash


• itching

Blood samples will be taken to check for changes in blood cells levels, which is a common side effect of Dacarbazine treatment. Blood and urine tests will be performed to check for changes in kidney function. Blood tests may be performed to check that your liver is working properly. Kidney and liver problems are uncommon.

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

HOW TO STORE DACARBAZINE 200 mg POWDER FOR SOLUTION FOR INJECTION

Keep out of the reach and sight of children

The vials should be stored at 2 - 8°C with the vials kept in the outer carton (in order to protect from light).

This medicine should not be used after the expiry date printed on the vial label.

Further Information

What Dacarbazine Powder for Solution for Injection contains

The medicine is presented in glass containers called vials containing 200 mg dacarbazine. Each pack contains 1 vial.

• The active substance is dacarbazine


• The other ingredients are citric acid monohydrate, mannitol and sodium hydroxide

What Dacarbazine Powder for Solution for Injection looks like and contents of the pack

The powder is a white or pale yellow solid.

The vial containing the powder is a glass container with a rubber stopper.

Each single-dose vial contains 200 mg of Dacarbazine. When reconstituted each ml of solution contains 10 mg of dacarbazine.

The 200 mg presentation of Dacarabazine is sold in packs containing 1 vial of powder

Marketing Authorisation Holder and Manufacturer

The Marketing authorisation holder and company responsible for batch release in the European Union is

Mayne Pharma Plc

Queensway

Royal Leamington Spa

Warwickshire

CV31 3RW

UK

The Manufacturer is

Mayne Pharma Pty Ltd

Lexia Place

Mulgrave

Victoria 3170

Australia

This leaflet was last approved in

08/2006

Lidex Gel

fluocinonide

Dosage Form: Gel

Rx Only

Lidex Description

Lidex® (fluocinonide) Gel 0.05% is intended for topical administration. The active component is the corticosteroid fluocinonide, which is the 21-acetate ester of fluocinolone acetonide and has the chemical name pregna - 1,4 - diene - 3,20 - dione,21 - (acetyloxy) - 6,9 - difluoro - 11 - hydroxy - 16,17 - [(1 - methylethylidene)bis(oxy)] - ,(6α,11β,16α) - . It has the following chemical structure:

Lidex Gel contains fluocinonide 0.5 mg/g in a specially formulated gel base consisting of carbomer 940, edetate disodium, popyl gallate, propylene glycol, sodium hydroxide and/or hydrochloric acid (to adjust the pH), and water (purified). This clear, colorless, thixotropic vehicle is greaseless, non-staining and completely water miscible.

In this formulation, the active ingredient is totally in solution.

Lidex - Clinical Pharmacology

Topical corticosteroids share anti-inflammatory, anti-pruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION).

Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

Indications and Usage for Lidex

Lidex Gel is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Contraindications

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

Precautions

General

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS—Pediatric Use). If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted.

As with any topical corticosteroid product, prolonged use may produce atrophy of the skin and subcutaneous tissues. When used on intertriginous or flexor areas, or on the face, this may occur even with short-term use.

In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

Patients using topical corticosteroids should receive the following information and instructions:

1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.


2. Patients should be advised not to use this medication for any disorder other than that for which it was prescribed.


3. The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.


4. Patients should report any signs of local adverse reactions, especially under occlusive dressing.


5. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

The following tests may be helpful in evaluating the HPA axis suppression:

      Urinary free cortisol test

      ACTH stimulation test

Carcinogenesis, Mutagenesis, and Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy Category C

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing's syndrome, and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

Administration of topical corticosteroids to children should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Burning	Perioral dermatitis
Itching	Allergic contact dermatitis
Irritation	Maceration of the skin
Dryness	Secondary infection
Folliculitis	Skin atrophy
Hypertrichosis	Striae
Acneiform eruptions	Miliaria
Hypopigmentation

Overdosage

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS).

Lidex Dosage and Administration

Lidex Gel is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition.

Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

How is Lidex Supplied

Lidex® (fluocinonide) Gel 0.05% is supplied in

      15 g Tube - NDC 99207-507-13

      30 g Tube - NDC 99207-507-14

      60 g Tube - NDC 99207-507-17

Store at room temperature 15°–30°C (59°–86°F).

Manufactured for:

MEDICIS, The Dermatology Company®

Scottsdale, AZ 85258

April 2001

IN-5071/S

Lidex  fluocinonide  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 99207-507 Route of Administration TOPICAL DEA Schedule

INGREDIENTS Name (Active Moiety) Type Strength fluocinonide (fluocinonide) Active 0.5 MILLIGRAM  In 1 GRAM carbomer 940 Inactive   edetate disodium Inactive   popyl gallate Inactive   propylene glycol Inactive   sodium hydroxide and/or hydrochloric acid Inactive   water Inactive

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 99207-507-13 15 g (GRAM) In 1 TUBE None 2 99207-507-14 30 g (GRAM) In 1 TUBE None 3 99207-507-17 60 g (GRAM) In 1 TUBE None

Revised: 07/2006MEDICIS

More Lidex resources

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

Compare Lidex with other medications

• Atopic Dermatitis
• Dermatitis
• Psoriasis

Patanol

Generic Name: olopatadine (Ophthalmic route)

oh-loe-PA-ta-deen

Commonly used brand name(s)

In the U.S.

• Pataday


• Patanol

Available Dosage Forms:

• Solution

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Antihistamine

Uses For Patanol

Olopatadine ophthalmic (eye) solution is used to temporarily prevent itching of the eye caused by a condition known as allergic conjunctivitis. It works by acting on certain cells, called mast cells, to prevent them from releasing substances that cause the allergic reaction.

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

Before Using Patanol

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

Studies on this medicine have been done only in adult patients, and there is no specific information comparing use of olopatadine in children up to 3 years of age with use in other age groups.

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 or if they cause different side effects or problems in older people. There is no specific information comparing use of olopatadine in the elderly with use in other age groups.

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

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.

Proper Use of olopatadine

This section provides information on the proper use of a number of products that contain olopatadine. It may not be specific to Patanol. Please read with care.

This medicine should not be used for irritation caused by contact lenses.

If your eye is red, do not wear your contact lens.

If you wear contact lenses: Take out your contact lenses before using olopatadine eye drops. Wait at least 10 minutes after putting the eye drops in before you put your contact lenses back in only if your eye is not red.

To use the eye drops:

• First, wash your hands. Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed for 1 or 2 minutes to allow the medicine to be absorbed by the eye.


• If you think you did not get the drop of medicine into your eye properly, use another drop.


• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed.

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 ophthalmic dosage form (eye drops):
  
  • For treatment of allergic conjunctivitis:
    
    • Adults and children 3 years of age and older—Use one drop (0.1% solution) in each affected eye two times a day, with each dose being at least six to eight hours apart. Or, use one drop (0.2% solution) in each affected eye one time a day.
    
    
    • Children up to 3 years of age—Use and dose must be determined by your doctor.
    
    
  
  

Missed Dose

If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

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 Patanol

If your symptoms do not improve or if your condition becomes worse, check with your doctor.

Patanol 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.

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

• Headache


• runny or stuffy nose


• sore throat

Less common

• Back pain


• burning, dryness, itching, or stinging of the eye


• change in taste


• chills


• diarrhea


• eye irritation or pain


• feeling of something in the eye


• general feeling of discomfort or illness


• increased cough


• loss of appetite


• muscle aches and pains


• nausea


• pain


• redness of eye or inside of eyelid


• shivering


• sweating


• swelling of eyelid


• trouble sleeping


• unusual tiredness or weakness


• vomiting

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: Patanol 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 Patanol resources

• Patanol Side Effects (in more detail)
• Patanol Use in Pregnancy & Breastfeeding
• Patanol Support Group
• 8 Reviews for Patanol - Add your own review/rating

• Patanol Prescribing Information (FDA)


• Patanol Consumer Overview


• Patanol Monograph (AHFS DI)


• Patanol Drops MedFacts Consumer Leaflet (Wolters Kluwer)


• Pataday Prescribing Information (FDA)

Compare Patanol with other medications

• Seasonal Allergic Conjunctivitis

Prenatal 19

Generic Name: prenatal multivitamins (PRE nay tal VYE ta mins)

Brand Names: Advance Care Plus, Bright Beginnings, Cavan Folate, Cavan One, Cavan-Heme OB, Cenogen Ultra, CitraNatal Rx, Co Natal FA, Complete Natal DHA, Complete-RF, CompleteNate, Concept OB, Docosavit, Dualvit OB, Duet, Edge OB, Elite OB 400, Femecal OB, Folbecal, Folcaps Care One, Folivan-OB, Foltabs, Gesticare, Icar Prenatal, Icare Prenatal Rx, Inatal Advance, Infanate DHA, Kolnatal DHA, Lactocal-F, Marnatal-F, Maternity, Maxinate, Mission Prenatal, Multi-Nate 30, Multinatal Plus, Nata 29 Prenatal, Natachew, Natafort, Natelle, Neevo, Nestabs, Nexa Select with DHA, Novanatal, NovaStart, O-Cal Prenatal, OB Complete, OB Natal One, Ob-20, Obtrex DHA, OptiNate, Paire OB Plus DHA, PNV Select, PNV-Total, PR Natal 400, Pre-H-Cal, Precare, PreferaOB, Premesis Rx, PrenaCare, PrenaFirst, PrenaPlus, Prenatabs OBN, Prenatabs Rx, Prenatal 1 Plus 1, Prenatal Elite, Prenatal Multivitamins, Prenatal Plus, Prenatal S, Prenatal-U, Prenate Advanced Formula, Prenate DHA, Prenate Elite, Prenavite FC, PreNexa, PreQue 10, Previte Rx, PrimaCare, Pruet DHA, RE OB Plus DHA, Renate, RightStep, Rovin-NV, Se-Care, Se-Natal One, Se-Plete DHA, Se-Tan DHA, Select-OB, Seton ET, Strongstart, Stuart Prenatal with Beta Carotene, Tandem OB, Taron-BC, Tri Rx, TriAdvance, TriCare, Trimesis Rx, Trinate, Triveen-PRx RNF, UltimateCare Advance, Ultra-Natal, Vemavite PRX 2, VeNatal FA, Verotin-BY, Verotin-GR, Vinacal OR, Vinatal Forte, Vinate Advanced (New Formula), Vinate AZ, Vinate Care, Vinate Good Start, Vinate II (New Formula), Vinate III, Vinate One, Vitafol-OB, VitaNatal OB plus DHA, Vitaphil, Vitaphil Aide, Vitaphil Plus DHA, Vitaspire, Viva DHA, Vol-Nate, Vol-Plus, Vol-Tab Rx, Vynatal F.A., Zatean-CH, Zatean-PN

What are Prenatal 19 (prenatal multivitamins)?

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

Prenatal vitamins are a combination of many different vitamins that are normally found in foods and other natural sources.

Prenatal vitamins are used to provide the additional vitamins needed during pregnancy. Minerals may also be contained in prenatal multivitamins.

Prenatal vitamins may also be used for purposes not listed in this medication guide.

What is the most important information I should know about prenatal vitamins?

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

Never take more than the recommended dose of a multivitamin. Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

What should I discuss with my healthcare provider before taking prenatal vitamins?

Many vitamins can cause serious or life-threatening side effects if taken in large doses. Do not take more of this medication than directed on the label or prescribed by your doctor.

Before taking prenatal vitamins, tell your doctor about all of your medical conditions.

You may need to continue taking prenatal vitamins if you breast-feed your baby. Ask your doctor about taking this medication while breast-feeding.

How should I take prenatal vitamins?

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Never take more than the recommended dose of prenatal vitamins.

Many multivitamin products also contain minerals such as calcium, iron, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Take your prenatal vitamin with a full glass of water.

Swallow the regular tablet or capsule whole. Do not break, chew, crush, or open it.

The chewable tablet must be chewed or allowed to dissolve in your mouth before swallowing. You may also allow the chewable tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products). Drink this mixture right away.

Use prenatal vitamins regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store at room temperature away from moisture and heat. Keep prenatal vitamins in their original container. Storing vitamins in a glass container can ruin the medication.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects and can also harm your unborn baby. Certain minerals contained in a prenatal multivitamin may also cause serious overdose symptoms or harm to the baby if you take too much.

Overdose symptoms may include stomach pain, vomiting, diarrhea, constipation, loss of appetite, hair loss, peeling skin, tingly feeling in or around your mouth, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine, pale skin, and easy bruising or bleeding.

What should I avoid while taking prenatal vitamins?

Avoid taking any other multivitamin product within 2 hours before or after you take your prenatal vitamins. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Avoid the regular use of salt substitutes in your diet if your multivitamin contains potassium. If you are on a low-salt diet, ask your doctor before taking a vitamin or mineral supplement.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the prenatal vitamin.

Prenatal vitamins 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.

When taken as directed, prenatal vitamins are not expected to cause serious side effects. Less serious side effects may include:

• 
  

  upset stomach;

  
  


• 
  

  headache; or

  
  


• 
  

  unusual or unpleasant taste in your mouth.

  
  

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 prenatal vitamins?

Vitamin and mineral supplements can interact with certain medications, or affect how medications work in your body. Before taking a prenatal vitamin, tell your doctor if you also use:

• 
  

  diuretics (water pills);

  
  


• 
  

  heart or blood pressure medications;

  
  


• 
  

  tretinoin (Vesanoid);

  
  


• 
  

  isotretinoin (Accutane, Amnesteen, Clavaris, Sotret);

  
  


• 
  

  trimethoprim and sulfamethoxazole (Cotrim, Bactrim, Gantanol, Gantrisin, Septra, TMP/SMX); or

  
  


• 
  

  an NSAID (non-steroidal anti-inflammatory drug) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Cataflam, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others.

  
  

This list is not complete and other drugs may interact with prenatal vitamins. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

More Prenatal 19 resources

• Prenatal 19 Use in Pregnancy & Breastfeeding
• Prenatal 19 Drug Interactions
• Prenatal 19 Support Group
• 0 Reviews for Prenatal9 - Add your own review/rating

• Cal-Nate MedFacts Consumer Leaflet (Wolters Kluwer)


• CareNatal DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal 90 DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• CitraNatal Assure Prescribing Information (FDA)


• CitraNatal Harmony Prescribing Information (FDA)


• Concept DHA Prescribing Information (FDA)


• Docosavit Prescribing Information (FDA)


• Duet DHA with Ferrazone MedFacts Consumer Leaflet (Wolters Kluwer)


• Folbecal MedFacts Consumer Leaflet (Wolters Kluwer)


• Folcal DHA Prescribing Information (FDA)


• Folcaps Care One Prescribing Information (FDA)


• Gesticare DHA Prescribing Information (FDA)


• Gesticare DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• Inatal Advance Prescribing Information (FDA)


• Inatal Ultra Prescribing Information (FDA)


• Multi-Nate DHA Prescribing Information (FDA)


• Multi-Nate DHA Extra Prescribing Information (FDA)


• MultiNatal Plus MedFacts Consumer Leaflet (Wolters Kluwer)


• Natelle One Prescribing Information (FDA)


• Neevo Caplets MedFacts Consumer Leaflet (Wolters Kluwer)


• Neevo DHA MedFacts Consumer Leaflet (Wolters Kluwer)


• OB Complete 400 MedFacts Consumer Leaflet (Wolters Kluwer)


• Paire OB Plus DHA Prescribing Information (FDA)


• PreNexa MedFacts Consumer Leaflet (Wolters Kluwer)


• PreNexa Prescribing Information (FDA)


• PreferaOB Prescribing Information (FDA)


• Prenatal Plus Prescribing Information (FDA)


• Prenatal Plus Iron Prescribing Information (FDA)


• Prenate Elite Prescribing Information (FDA)


• Prenate Elite MedFacts Consumer Leaflet (Wolters Kluwer)


• Prenate Elite tablets


• Prenate Essential Prescribing Information (FDA)


• PrimaCare Advantage MedFacts Consumer Leaflet (Wolters Kluwer)


• PrimaCare ONE capsules


• PrimaCare One MedFacts Consumer Leaflet (Wolters Kluwer)


• Renate DHA Prescribing Information (FDA)


• Se-Natal 19 Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Se-Natal 19 Prescribing Information (FDA)


• Tandem DHA Prescribing Information (FDA)


• Tandem OB Prescribing Information (FDA)


• TriAdvance Prescribing Information (FDA)


• Triveen-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Triveen-PRx RNF Prescribing Information (FDA)


• UltimateCare ONE NF Prescribing Information (FDA)


• Ultra NatalCare MedFacts Consumer Leaflet (Wolters Kluwer)


• Vinate AZ Prescribing Information (FDA)


• Vitafol-One MedFacts Consumer Leaflet (Wolters Kluwer)


• Zatean-CH Prescribing Information (FDA)

Compare Prenatal 19 with other medications

• Vitamin/Mineral Supplementation during Pregnancy/Lactation

Where can I get more information?

• Your pharmacist can provide more information about prenatal vitamins.

Sterile Water Irrigation

Directions for Use of Flexible Plastic Irrigation Containers

If desired, warm in overwrap to near body temperature in a water bath or oven heated to not more than 45°C.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

DIRECTIONS FOR USE

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired.

Use Aseptic Technique.

1. Suspend container using hanger hole.


2. Remove plastic protector from outlet port at bottom of container.


3. Attach irrigation set. Refer to complete directions accompanying set.

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C): brief exposure up to 40°C does not adversely affect the product.

Baxter Healthcare Corporation

Deerfield, Il 60015 USA

Printed in USA

©Copyright 1980, 1984, 1989, Baxter Healthcare Corporation. All rights reserved.

7-19-4-268

Rev. July 1997

PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

Sterile Water for Irrigation USP Container Label

NOT FOR INJECTION

5000 mL

2B7119

NDC 0338-0003-49

STERILE WATER

For Irrigation USP

FOR IRRIGATION ONLY PREPARED BY DISTILLATION

NO ANTIMICROBIAL AGENT OR OTHER SUBSTANCE HAS

BEEN ADDED pH 5.5 (5.0 to 7.0) OSMOLARITY

0 mOsmol/L (CALC) STERILE NONPYROGENIC

SINGLE DOSE CONTAINER

DO NOT USE UNLESS SOLUTION IS CLEAR

DISCARD UNUSED PORTION

CAUTIONS THIS SOLUTION IS NOT ISOTONIC AND IS

HEMOLYTIC SQUEEZE AND INSPECT INNER BAG

WHICH MAINTAINS PRODUCT STERILITY DISCARD IF

LEAKS ARE FOUND RX ONLY STORE UNIT IN

MOISTURE BARRIER OVERWRAP AT ROOM

TEMPERATURE (25°C) UNTIL READY TO USE AVOID

EXCESSIVE HEAT SEE INSERT

Sterile Water

H2O

For Irrigation USP

UROMATIC CONTAINER PL 146 PLASTIC

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

BAXTER UROMATIC AND

PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

FOR PRODUCT INFORMATION

1-800-933-0303

Sterile Water for Irrigation USP Carton Label

STERILE WATER FOR IRRIGATION, USP

UROMATIC CONT

2-5000ML

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

PRIMARY BAR CODE

(01) 50303380003490

LOT XXXXX

EXP XXXXX

2B7119

STERILE WATER  water  irrigant

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 0338-0003 Route of Administration IRRIGATION DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength WATER (WATER) WATER 1 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0338-0003-44 1000 mL In 1 BAG None 2 0338-0003-46 2000 mL In 1 BAG None 3 0338-0003-47 3000 mL In 1 BAG None 4 0338-0003-49 5000 mL In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA017866	05/30/1980

Labeler - BAXTER HEALTHCARE CORPORATION (005083209)

Establishment
Name	Address	ID/FEI	Operations
BAXTER HEALTHCARE CORPORATION		059140764	MANUFACTURE

Revised: 12/2009BAXTER HEALTHCARE CORPORATION

More Sterile Water Irrigation resources

• Sterile Water Irrigation Support Group
• 0 Reviews · Be the first to review/rate this drug

isoniazid/pyrazinamide/rifampin

Generic Name: isoniazid, pyrazinamide, and rifampin (EYE soe NYE a zid, PIR a ZIN a mide, and rif AM pin)

Brand Names: Rifater

What is isoniazid, pyrazinamide, and rifampin?

Isoniazid, pyrazinamide, and rifampin are antibiotics. They prevent tuberculous bacteria from multiplying in your body.

The combination of isoniazid, pyrazinamide, and rifampin is used to treat tuberculosis (TB).

Isoniazid, pyrazinamide, and rifampin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about isoniazid, pyrazinamide, and rifampin?

Take this medication for the full prescribed length of time. Your symptoms may get better before your infection is completely cleared. Isoniazid, pyrazinamide, and rifampin will not treat a viral infection such as the common cold or flu. Avoid drinking alcohol while taking isoniazid, pyrazinamide, and rifampin. Alcohol may increase your risk of liver damage. Isoniazid, pyrazinamide, and rifampin can make birth control pills less effective. Ask your doctor about using a different method of birth control while taking isoniazid, pyrazinamide, and rifampin. Avoid foods that are high in tyramine, listed in the "What should I avoid while taking isoniazid, pyrazinamide, and rifampin?" section of this leaflet. Tyramine can interact with this medication and cause unpleasant side effects.

What should I discuss with my healthcare provider before taking isoniazid, pyrazinamide, and rifampin?

You should not use this medication if you are allergic to isoniazid, pyrazinamide, or rifampin (Rifamate, Rifadin, Rimactane), or if you have:

• 
  

  severe liver disease;

  
  


• 
  

  active gout; or

  
  


• 
  

  if you have ever had drug fever, chills, and arthritis caused by taking this medication.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use isoniazid, pyrazinamide, and rifampin:

• kidney disease;


• liver disease;


• 
  

  HIV;

  
  


• 
  

  porphyria;

  
  


• 
  

  gout;

  
  


• 
  

  diabetes; or

  
  


• 
  

  if you drink alcohol daily.

  
  

FDA pregnancy category C. It is not known whether isoniazid, pyrazinamide, and rifampin is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Isoniazid, pyrazinamide, and rifampin can make birth control pills less effective. Ask your doctor about using a different method of birth control to prevent pregnancy while taking isoniazid, pyrazinamide, and rifampin. Isoniazid, pyrazinamide, and rifampin 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.

How should I take isoniazid, pyrazinamide, and rifampin?

Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take this medicine with a full glass (8 ounces) of water. Take isoniazid, pyrazinamide, and rifampin on an empty stomach, at least 1 hour before or 2 hours after a meal. Take this medication for the full prescribed length of time. Your symptoms may get better before your infection is completely cleared. Isoniazid, pyrazinamide, and rifampin will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your liver function will need to be checked with blood tests on a regular basis. You may also need routine eye exams during treatment. Do not miss any follow-up visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are taking isoniazid, pyrazinamide, and rifampin.

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

See also: Isoniazid/pyrazinamide/rifampin dosage (in more detail)

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. 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 nausea, vomiting, slurred speech, hallucinations, and seizure.

What should I avoid while taking isoniazid, pyrazinamide, and rifampin?

Avoid drinking alcohol while taking isoniazid, pyrazinamide, and rifampin. Alcohol may increase your risk of liver damage.

If you take an antacid, avoid taking it within 1 hour after you have taken isoniazid, pyrazinamide, and rifampin. Antacids can make it harder for your body to absorb rifampin.

Antibiotic medicines can cause diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or has blood in it, stop taking this medication and call your doctor. Do not use any medicine to stop the diarrhea unless your doctor has told you to.

Certain foods can interact with isoniazid, pyrazinamide, and rifampin, causing unpleasant side effects. Avoid foods that are high in tyramine, including:

• 
  

  avocados, bananas, figs, raisins, and sauerkraut;

  
  


• 
  

  beef or chicken liver, fish, meats prepared with tenderizer, bologna, pepperoni, salami, summer sausage, game meat, meat extracts, caviar, dried fish, herring, and shrimp paste;

  
  


• 
  

  beer (alcoholic and nonalcoholic), red wine (especially Chianti), sherry, vermouth, and other distilled spirits;

  
  


• 
  

  caffeine (including coffee, tea, cola); and

  
  


• 
  

  cheeses, including American, blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, mozzarella, parmesan, romano, roquefort, stilton, and Swiss;

  
  


• 
  

  chocolate;

  
  


• 
  

  ginseng;

  
  


• 
  

  sour cream and yogurt;

  
  


• 
  

  soy sauce, miso soup, bean curd, fava beans; or

  
  


• 
  

  yeast extracts.

  
  

Do not wear soft contact lenses while taking isoniazid, pyrazinamide, and rifampin. This medicine may turn certain body fluids a red color (including tears, saliva, urine, and sweat). While this is a harmless side effect, it may permanently stain contact lenses.

Isoniazid, pyrazinamide, and rifampin side effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat. Isoniazid, pyrazinamide, and rifampin can cause severe liver symptoms. Stop taking this medication and call your doctor at once if you have any of these liver symptoms:

• 
  

  low fever;

  
  


• 
  

  nausea, stomach pain, loss of appetite;

  
  


• 
  

  dark urine, clay-colored stools; or

  
  


• 
  

  jaundice (yellowing of the skin or eyes).

  
  

Call your doctor at once if you have any other serious side effects such as:

• 
  

  fever, chills, body aches, flu symptoms, weakness, sores in your mouth and throat;

  
  


• 
  

  pale skin, easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;

  
  


• 
  

  feeling short of breath, feeling like you might pass out;

  
  


• 
  

  cough, chest pain or tightness;

  
  


• 
  

  diarrhea that is watery or bloody;

  
  


• 
  

  vision problems;

  
  


• 
  

  urinating less than usual or not at all; or

  
  


• 
  

  drowsiness, mood changes, increased thirst, swelling, weight gain.

  
  

Less serious side effects may include:

• 
  

  mild stomach pain, heartburn, diarrhea;

  
  


• 
  

  mild rash or itching;

  
  


• 
  

  muscle or joint pain;

  
  


• 
  

  drowsiness, dizziness, spinning sensation;

  
  


• 
  

  ringing in your ears; or

  
  


• 
  

  numbness or tingling in your legs.

  
  

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.

Isoniazid/pyrazinamide/rifampin Dosing Information

Usual Adult Dose for Tuberculosis -- Active:

44 kg or less: 4 tablets (200 mg isoniazid, 1200 mg pyrazinamide, and 480 mg rifampin total dose) orally once a day
45 to 54 kg: 5 tablets (250 mg isoniazid, 1500 mg pyrazinamide, and 600 mg rifampin total dose) orally once a day
55 kg or more: 6 tablets (300 mg isoniazid, 1800 mg pyrazinamide, and 720 mg rifampin total dose) orally once a day

Usual Pediatric Dose for Tuberculosis -- Active:

14 years or younger: The ratio of isoniazid, pyrazinamide, and rifampin in the combination tablet may not be appropriate; for example, isoniazid mg/kg doses are typically higher in pediatric patients than adults.

15 years or older:
44 kg or less: 4 tablets (200 mg isoniazid, 1200 mg pyrazinamide, and 480 mg rifampin total dose) orally once a day
45 to 54 kg: 5 tablets (250 mg isoniazid, 1500 mg pyrazinamide, and 600 mg rifampin total dose) orally once a day
55 kg or more: 6 tablets (300 mg isoniazid, 1800 mg pyrazinamide, and 720 mg rifampin total dose) orally once a day

What other drugs will affect isoniazid, pyrazinamide, and rifampin?

Many drugs can interact with isoniazid, pyrazinamide, and rifampin. Below is just a partial list. Tell your doctor if you are using:

• 
  

  cyclosporine (Gengraf, Neoral, Sandimmune);

  
  


• 
  

  haloperidol (Haldol);

  
  


• 
  

  nortriptyline (Pamelor),

  
  


• 
  

  probenecid (Benemid);

  
  


• 
  

  theophylline (Elixophyllin, Theo-24, Uniphyl);

  
  


• 
  

  an antibiotic such as ciprofloxacin (Cipro), clarithromycin (Biaxin), dapsone, erythromycin (E.E.S., Erythrocin, Ery-Tab), and others;

  
  


• 
  

  antifungal medication such as fluconazole (Diflucan), itraconazole (Sporanox), ketoconazole (Nizoral);

  
  


• 
  

  a barbiturate such as butabarbital (Butisol), secobarbital (Seconal), pentobarbital (Nembutal), or phenobarbital (Solfoton);

  
  


• 
  

  birth control pills or hormone replacement therapy;

  
  


• 
  

  a blood thinner such as warfarin (Coumadin);

  
  


• 
  

  diabetes medications you take by mouth;

  
  


• 
  

  heart or blood pressure medication such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), digoxin (Lanoxin), diltiazem (Cartia, Cardizem), metoprolol (Toprol), propranolol (Inderal), nifedipine (Procardia), verapamil (Covera, Isoptin, Verelan), and others;

  
  


• 
  

  heart rhythm medication such as disopyramide (Norpace), mexiletine (Mexitil), quinidine (Quinaglute, Quinidex, Quin-Release);

  
  


• 
  

  narcotic medications such as buprenorphine (Buprenex, Subutex), fentanyl (Actiq, Duragesic, Fentora), methadone (Dolophine, Methadose);

  
  


• 
  

  a sedative such as diazepam (Valium);

  
  


• 
  

  seizure medication such as carbamazepine (Carbatrol, Tegretol), phenytoin (Dilantin), primidone (Mysoline), valproic acid (Depakene);

  
  


• 
  

  a steroid such as prednisolone; or

  
  


• 
  

  a sulfa drug (Cotrim, Bactrim, Septra, SMX-TMP, and others).

  
  

There are many other medicines that can interact with isoniazid, pyrazinamide, and rifampin. 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. Keep a list of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.

More isoniazid/pyrazinamide/rifampin resources

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

• Isoniazid/Pyrazinamide/Rifampin MedFacts Consumer Leaflet (Wolters Kluwer)


• Rifater Prescribing Information (FDA)


• Rifater Advanced Consumer (Micromedex) - Includes Dosage Information

Compare isoniazid/pyrazinamide/rifampin with other medications

• Tuberculosis, Active

Where can I get more information?

• Your pharmacist can provide more information about isoniazid, pyrazinamide, and rifampin.

See also: isoniazid/pyrazinamide/rifampin side effects (in more detail)