New Article Directory Tanzania: May 2012

Thursday 31 May 2012

Streptozocin

Pronunciation: STREP-toe-ZOE-sin
Generic Name: Streptozocin
Brand Name: Zanosar

Streptozocin may cause severe, sometimes fatal kidney problems. The risk may be greater with higher doses. It may also cause liver problems, blood problems, diarrhea, and severe nausea and vomiting. It has also caused tumors and cancer in rodents.

Streptozocin is used for:

Treating a certain type of pancreas cancer. It may also be used for other conditions as determined by your doctor.

Streptozocin is an antineoplastic. It works by stopping or slowing the spread of certain cancer cells.

Do NOT use Streptozocin if:

you are allergic to any ingredient in Streptozocin

you are taking cimetidine

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

Before using Streptozocin:

Some medical conditions may interact with Streptozocin. 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 kidney or liver problems, bone marrow problems, diabetes, an infection, chickenpox, or shingles

if you are taking other cancer medicine or having radiation therapy

if you are taking medicines that may cause kidney problems. Ask your doctor if you are unsure if any of your medicines might harm the kidney.

Some MEDICINES MAY INTERACT with Streptozocin. Tell your health care provider if you are taking any other medicines, especially any of the following:

Cimetidine because it may increase the risk of Streptozocin's side effects

Doxorubicin because the risk of its side effects may be increased by Streptozocin

Medicines that may harm the kidney (eg, aminoglycoside antibiotics [eg, gentamicin], amphotericin B, cyclosporine, nonsteroidal anti-inflammatory drugs [NSAIDs] [eg, ibuprofen], tacrolimus, vancomycin) because the risk of kidney side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Streptozocin 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 Streptozocin:

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

Drinking extra fluids while you are taking Streptozocin is recommended. Check with your doctor for instructions.

Streptozocin is usually given as an injection at your doctor's office, hospital, or clinic.

If Streptozocin accidentally spills on your skin, wash it off immediately with soap and water.

If you miss a dose of Streptozocin, contact your doctor right away.

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

Important safety information:

Streptozocin may cause tiredness or confusion. These effects may be worse if you take it with alcohol or certain medicines. Use Streptozocin with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

Streptozocin may cause severe and sometime fatal kidney problems. The risk may be greater in higher doses. Contact your doctor right away if you experience a change in the amount of urine produced, an inability to urinate, or sudden unexplained weight gain.

Streptozocin may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.

Streptozocin may reduce the number of clot-forming cells (platelets) in your blood. Avoid activities that may cause bruising or injury. Tell your doctor if you have unusual bruising or bleeding. Tell your doctor if you have dark, tarry, or bloody stools.

If nausea, vomiting, or diarrhea occurs, ask your doctor for ways to lessen these effects.

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

Lab tests, including liver function, kidney function, complete blood cell counts, and blood electrolyte levels, may be performed while you use Streptozocin. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

Use Streptozocin with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.

PREGNANCY and BREAST-FEEDING: Streptozocin may cause harm to the fetus. Do not become pregnant while you are using it. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Streptozocin while you are pregnant. It is not known if Streptozocin is found in breast milk. Do not breast-feed while taking Streptozocin.

Possible side effects of Streptozocin:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Diarrhea; nausea; 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); change in the amount of urine produced; confusion; dark urine; depression; fever, chills, or sore throat; inability to urinate; mental or mood changes; pain, redness, or swelling at the injection site; severe nausea or vomiting; sudden unexplained weight gain; unusual bruising or bleeding; unusual weakness; yellowing of the skin or eyes.

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: Streptozocin 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 Streptozocin:

Streptozocin is usually handled and stored by a health care provider. If you are using Streptozocin at home, store Streptozocin as directed by your pharmacist or health care provider. Keep Streptozocin, as well as needles and syringes, out of the reach of children and away from pets.

General information:

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

Streptozocin 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 Streptozocin. 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

More Streptozocin resources

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

Streptozocin Monograph (AHFS DI)

Streptozocin Professional Patient Advice (Wolters Kluwer)

streptozocin Concise Consumer Information (Cerner Multum)

streptozocin Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information

Zanosar Prescribing Information (FDA)

Compare Streptozocin with other medications

Pancreatic Cancer

Tuesday 29 May 2012

Topical antifungals

A drug may be classified by the chemical type of the active ingredient or by the way it is used to treat a particular condition. Each drug can be classified into one or more drug classes.

Topical antifungal agents are applied locally to the skin, on the nail, onto mucus membranes or vaginally, to treat fungal infections. They kill or inactivate fungi and yeast. Topical antifungal agents are available as creams, ointments, shampoos, powders and other forms, which can be applied locally on the area that needs to be treated.

Monday 28 May 2012

Sominex

Generic Name: diphenhydramine (DYE fen HYE dra meen)

Brand Names: Aler-Tab, Allergy, Allermax, Altaryl, Benadryl Allergy, Benadryl DF, Benadryl Dye Free Allergy, Benadryl Ultratab, Children's Allergy, Diphen Cough, Diphenhist, Dytuss, PediaCare Children's Allergy, Q-Dryl, Q-Dryl A/F, Siladryl, Siladryl Allergy, Silphen Cough, Simply Sleep, Sleep-ettes, Sleep-ettes D, Sominex Maximum Strength Caplet, Theraflu Thin Strips Multi Symptom, Triaminic Thin Strips Cough & Runny Nose, Unisom Sleepgels Maximum Strength, Valu-Dryl

What is Sominex (diphenhydramine)?

Diphenhydramine is an antihistamine. Diphenhydramine blocks the effects of the naturally occurring chemical histamine in the body.

Diphenhydramine is used to treat sneezing; runny nose; itching, watery eyes; hives; rashes; itching; and other symptoms of allergies and the common cold.

Diphenhydramine is also used to suppress coughs, to treat motion sickness, to induce sleep, and to treat mild forms of Parkinson's disease.

Diphenhydramine may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about Sominex (diphenhydramine)?

Use caution when driving, operating machinery, or performing other hazardous activities. Diphenhydramine may cause dizziness or drowsiness. If you experience dizziness or drowsiness, avoid these activities. Use alcohol cautiously. Alcohol may increase drowsiness and dizziness while taking diphenhydramine.

What should I discuss with my healthcare provider before taking Sominex (diphenhydramine)?

Do not take diphenhydramine if you have taken a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or tranylcypromine (Parnate) in the last 14 days. A very dangerous drug interaction could occur, leading to serious side effects.

Before taking this medication, tell your doctor if you have

glaucoma or increased pressure in the eye;

a stomach ulcer;

an enlarged prostate, bladder problems or difficulty urinating;

an overactive thyroid (hyperthyroidism);

hypertension or any type of heart problems; or

asthma.

You may not be able to take diphenhydramine, or you may require a lower dose or special monitoring during treatment if you have any of the conditions listed above.

Diphenhydramine is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not take diphenhydramine without first talking to your doctor if you are pregnant. Infants are especially sensitive to the effects of antihistamines, and side effects could occur in a breast-feeding baby. Do not take diphenhydramine without first talking to your doctor if you are nursing a baby. If you are over 60 years of age, you may be more likely to experience side effects from diphenhydramine. You may require a lower dose of this medication.

How should I take Sominex (diphenhydramine)?

Take diphenhydramine exactly as directed on the package or as directed by your doctor. If you do not understand these directions, ask your pharmacist, nurse, or doctor to explain them to you.

Take each dose with a full glass of water.

Diphenhydramine can be taken with or without food.

For motion sickness, a dose is usually taken 30 minutes before motion, then with meals and at bedtime for the duration of exposure.

As a sleep aid, diphenhydramine should be taken approximately 30 minutes before bedtime.

To ensure that you get a correct dose, measure the liquid forms of diphenhydramine with a special dose-measuring spoon or cup, not with a regular tablespoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

Never take more of this medication than is prescribed for you. The maximum amount of diphenhydramine that you should take in any 24-hour period is 300 mg.

Store diphenhydramine at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose of this medication unless otherwise directed by your doctor.

What happens if I overdose?

Seek emergency medical attention if an overdose is suspected.

Symptoms of a diphenhydramine overdose include extreme sleepiness, confusion, weakness, ringing in the ears, blurred vision, large pupils, dry mouth, flushing, fever, shaking, insomnia, hallucinations, and possibly seizures.

What should I avoid while taking Sominex (diphenhydramine)?

Sominex (diphenhydramine) side effects

Stop taking diphenhydramine and seek emergency medical attention if you experience an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives).

Other, less serious side effects may be more likely to occur. Continue to take diphenhydramine and talk to your doctor if you experience

sleepiness, fatigue, or dizziness;

headache;

dry mouth; or

difficulty urinating or an enlarged prostate.

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 Sominex (diphenhydramine)?

Talk to your pharmacist before taking other over-the-counter cough, cold, allergy, or insomnia medications. These products may contain medicines similar to diphenhydramine, which could lead to an antihistamine overdose.

Before taking this medication, tell your doctor if you are taking any of the following medicines:

anxiety or sleep medicines such as alprazolam (Xanax), diazepam (Valium), chlordiazepoxide (Librium), temazepam (Restoril), or triazolam (Halcion);

medications for depression such as amitriptyline (Elavil), doxepin (Sinequan), nortriptyline (Pamelor), fluoxetine (Prozac), sertraline (Zoloft), or paroxetine (Paxil); or

any other medications that make you feel drowsy, sleepy, or relaxed.

Drugs other than those listed here may also interact with diphenhydramine. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines, including vitamins, minerals, and herbal products.

More Sominex resources

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

Sominex MedFacts Consumer Leaflet (Wolters Kluwer)

Banophen MedFacts Consumer Leaflet (Wolters Kluwer)

Ben-Tann Suspension MedFacts Consumer Leaflet (Wolters Kluwer)

Benadryl Consumer Overview

Benadryl Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Benadryl Allergy Chewable Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

Children's Allergy Prescribing Information (FDA)

Diphen Advanced Consumer (Micromedex) - Includes Dosage Information

Diphenhydramine MedFacts Consumer Leaflet (Wolters Kluwer)

Diphenhydramine Prescribing Information (FDA)

Diphenhydramine Hydrochloride Monograph (AHFS DI)

Diphenoxylate Hydrochloride Monograph (AHFS DI)

Dytuss Elixir MedFacts Consumer Leaflet (Wolters Kluwer)

Simply Sleep MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Sominex with other medications

Insomnia

Where can I get more information?

Your pharmacist can provide more information about diphenhydramine.

See also: Sominex side effects (in more detail)

Friday 25 May 2012

Tambocor 10mg / ml Injection

1. Name Of The Medicinal Product

Tambocor™ 10mg/ml Injection

2. Qualitative And Quantitative Composition

Each ampoule contains 15 ml of a solution of flecainide acetate 10 mg/ml.

3. Pharmaceutical Form

Solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Tambocor Injection is indicated when rapid control of the following arrhythmias is the main clinical requirement:

a) Ventricular tachyarrhythmias where these are resistant to other treatment.

b) AV nodal reciprocating tachycardia; arrhythmias associated with Wolff-Parkinson-White Syndrome and similar conditions with accessory pathways.

c) Paroxysmal atrial fibrillation in patients with disabling symptoms when treatment need has been established and in the absence of left ventricular dysfunction (see 4.4, Special warnings and special precautions for use). Arrhythmias of recent onset will respond more readily.

Tambocor Injection is for bolus injection or intravenous infusion.

4.2 Posology And Method Of Administration

a) Bolus injection: Tambocor injection can be given in an emergency or for rapid effect by a slow injection of 2mg/kg over not less than ten minutes, or in divided doses. If preferred, the dose may be diluted with 5% dextrose and given as a mini-infusion.

Continuous ECG monitoring is recommended in all patients receiving the bolus dose. The injection should be stopped when there is control of the arrhythmia.

It is recommended that Tambocor injection should be administered more slowly to patients in sustained ventricular tachycardia, with careful monitoring of the electrocardiogram. Similar caution should apply to patients with a history of cardiac failure, who may become decompensated during the administration. For such patients it is recommended that the initial dose is given over 30 minutes. The maximum recommended bolus dose is 150 mg.

b) Intravenous infusion: When prolonged parenteral administration is required, it is recommended that therapy is initiated by slow injection of 2 mg/kg over 30 minutes and continued by intravenous infusion at the following rates:

First hour: 1.5 mg/kg per hour.

Second and later hours: 0.1 - 0.25 mg/kg per hour.

It is recommended that the infusion duration should not exceed 24 hours. However, where this is considered necessary, or for patients receiving the upper end of the dose range, plasma level monitoring is strongly recommended. The maximum cumulative dose given in the first 24 hours should not exceed 600 mg. In patients with severe renal impairment (creatinine clearance of less than 35 ml/min/1.73 sq.m.), each of the above dosage recommendations should be reduced by half.

Transition to oral dosing should be accomplished as soon as possible by stopping the infusion and administering the first required oral dose.

Oral maintenance is then continued as indicated in the relevant oral dosage instructions.

Children: Tambocor is not recommended in children under 12, as there is insufficient evidence of its use in this age group.

Elderly Patients: The rate of flecainide elimination from plasma may be reduced in elderly people. This should be taken into consideration when making dose adjustments.

4.3 Contraindications

Tambocor is contra-indicated in cardiac failure and in patients with a history of myocardial infarction who have either asymptomatic ventricular ectopics or asymptomatic non-sustained ventricular tachycardia.

It is also contra-indicated in patients with long standing atrial fibrillation in whom there has been no attempt to convert to sinus rhythm, and in patients with haemodynamically significant valvular heart disease.

Unless pacing rescue is available, Tambocor should not be given to patients with sinus node dysfunction, atrial conduction defects, second degree or greater atrio-ventricular block, bundle branch block or distal block.

4.4 Special Warnings And Precautions For Use

Electrolyte disturbances should be corrected before using Tambocor.

Since flecainide elimination from the plasma can be markedly slower in patients with significant hepatic impairment, flecainide should not be used in such patients unless the potential benefits clearly outweigh the risks. Plasma level monitoring is strongly recommended in these circumstances.

Tambocor is known to increase endocardial pacing thresholds - ie to decrease endocardial pacing sensitivity. This effect is reversible and is more marked on the acute pacing threshold than on the chronic.

Tambocor should thus be used with caution in all patients with permanent pacemakers or temporary pacing electrodes, and should not be administered to patients with existing poor thresholds or non-programmable pacemakers unless suitable pacing rescue is available.

Generally, a doubling of either pulse width or voltage is sufficient to regain capture, but it may be difficult to obtain ventricular thresholds less than 1 Volt at initial implantation in the presence of Tambocor.

The minor negative inotropic effect of flecainide may assume importance in patients predisposed to cardiac failure. Difficulty has been experienced in defibrillating some patients. Most of the cases reported had pre-existing heart disease with cardiac enlargement, a history of myocardial infarction, arterio-sclerotic heart disease and cardiac failure.

Tambocor should be avoided in patients with structural organic heart disease or abnormal left ventricular function.

Tambocor should be used with caution in patients with acute onset of atrial fibrillation following cardiac surgery.

In a large scale, placebo-controlled clinical trial in post-myocardial infarction patients with asymptomatic ventricular arrhythmia, oral flecainide was associated with a 2.2 fold higher incidence of mortality or non-fatal cardiac arrest as compared with its matching placebo. In that same study, an even higher incidence of mortality was observed in flecainide-treated patients with more than one myocardial infarction. Comparable placebo-controlled clinical trials have not been done to determine if flecainide is associated with higher risk of mortality in other patient groups.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Flecainide is a class I anti-arrhythmic and interactions are possible with other anti-arrhythmic drugs where additive effects may occur or where drugs interfere with the metabolism of flecainide. The following known categories of drugs may intereact with flecainide:

Cardiac glycosides; Flecainide can cause the plasma digoxin level to rise by about 15%, which is unlikely to be of clinical significance for patients with plasma levels in the therapeutic range. It is recommended that the digoxin plasma level in digitalised patients should be measured not less than six hours after any digoxin dose, before or after administration of flecainide.

Class II anti-arrhythmics; the possibility of additive negative inotropic effects of beta-blockers, and other cardiac depressants such as verapamil, with flecainide should be recognised.

Class III anti-arrhythmics; when flecainide is given in the presence of amiodarone, the usual flecainide dosage should be reduced by 50% and the patient monitored closely for adverse effects. Plasma level monitoring is strongly recommended in these circumstances

Class IV anti-arrhythmics; use of flecainide with other sodium channel blockers is not recommended.

Anti-depressants; fluoxetine increases plasma flecainide concentration; increased risk of arrhythmias with tricyclics; manufacturer of reboxetine advises caution.

Anti-epileptics; limited data in patients receiving known enzyme inducers (phenytoin, phenobarbital, carbamazepine) indicate only a 30% increase in the rate of flecainide elimination.

Anti-psychotics: clozapine - increased risk of arrhythmias

Anti-histamines; increased risk of ventricular arrhythmias with mizolastine and terfenadine (avoid concomitant use)

Anti-malarials: quinine increases plasma concentration of flecainide.

Antivirals: plasma concentration increased by ritonavir, lopinavar and indinavir (increased risk of ventricular arrhythmias) avoid concomitant use

Diuretics: Class effect due to hypokalaemia giving rise to cardiac toxicity.

Ulcer healing drugs: cimetidine inhibits metabolism of flecainide. In healthy subjects receiving cimetidine (1g daily) for one week, plasma flecainide levels increased by about 30% and the half-life increased by about 10%.

Anti-smoking aids: Co-administration of bupropion with drugs that are metabolized by CYP2D6 isoenzyme including flecainide, should be approached with caution and should be initiated at the lower end of the dose range of the concomitant medication. If bupropion is added to the treatment regimen of a patient already receiving flecainide, the need to decrease the dose of the original medication should be considered.

Treatment with Tambocor is compatible with use of oral anti-coagulants.

4.6 Pregnancy And Lactation

There is no evidence as to drug safety in human pregnancy. In New Zealand White rabbits high doses of flecainide caused some foetal abnormalities, but these effects were not seen in Dutch Belted rabbits or rats. The relevance of these findings to humans has not been established. Data have shown that flecainide crosses the placenta to the foetus in patients taking flecainide during pregnancy.

Flecainide is excreted in human milk and appears in concentrations which reflect those in maternal blood. The risk of adverse effects to the nursing infant is very small.

4.7 Effects On Ability To Drive And Use Machines

No effect.

4.8 Undesirable Effects

Body as a Whole: Asthenia, fatigue, fever, oedema

Cardiovascular: Pro-arrhythmic effects occur but are most likely in patients with structural heart disease and/or significant left ventricular impairment.

In patients with atrial flutter the use of Tambocor has been associated with 1:1 AV conduction following initial atrial slowing with resultant ventricular acceleration. This has been seen most commonly following the use of the injection for acute conversion. This effect is usually short lived and abates quickly following cessation of therapy.

The following adverse effects have also been reported.

AV block-second-degree and third degree, bradycardia, cardiac failure/congestive cardiac failure, chest pain, hypotension, myocardial infarction, palpitation, sinus pause or arrest and tachycardia (AT or VT).

Skin and Appendages: A range of allergic skin reactions have been reported including rashes and rare but serious reports of urticaria. There have also been isolated cases of photosensitivity.

Immune System: A small number of cases of increases in anti-nuclear antibodies have been reported, with and without systemic inflammatory involvement.

Haematological: Reductions in red blood cells, white blood cells and platelets have been occasionally reported. These changes are usually mild.

Psychiatric: Rarely, hallucinations, depression, confusion, amnesia, anxiety and insomnia have been reported.

Gastrointestinal: Occasionally nausea and vomiting. The following have been also reported: abdominal pain, anorexia, constipation, diarrhoea, dyspepsia and flatulence (bloating).

Liver and Bilary System: A number of cases of elevated liver enzymes and jaundice have been reported in association with Tambocor treatment. So far this has always been reversible on stopping treatment. Hepatic dysfunction has also been reported.

Neurological: Most commonly giddiness, dizziness and lightheadedness which are usually transient. Rare instances of dyskinesia have been reported, which have improved on withdrawal of flecainide therapy. Rare instances of convulsions, and during long term therapy a few cases of peripheral neuropathy, paraesthesia and ataxia have been reported.There also have been reports of flushing, headache, hypoaesthesia, increased sweating, somnolence, syncope, tinnitus, tremor and vertigo.

Ophthalmological: Visual disturbances, such as double vision and blurring of vision may occur but these are usually transient and disappear upon continuing or reducing the dosage.

Extremely rare cases of corneal deposits have also been reported.

Respiratory: Dyspnoea and rare cases of pneumonitis have been reported.

4.9 Overdose

Overdosage with flecainide is a potentially life threatening medical emergency. No specific antidote is known. There is no known way of rapidly removing flecainide from the system, but forced acid diuresis may theoretically be helpful. Neither dialysis nor haemoperfusion is helpful and injections of anticholinergics are not recommended.

Treatment may include therapy with an inotropic agent, intravenous calcium, giving circulatory assistance (eg balloon pumping), mechanically assisting respiration, or temporarily inserting a transvenous pacemaker if there are severe conduction disturbances or the patient's left ventricular function is otherwise compromised.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Tambocor is a Class 1 anti-arrhythmic (local anaesthetic) agent.

Tambocor slows conduction through the heart, having its greatest effect on His Bundle conduction. It also acts selectively to increase anterograde and particularly retrograde accessory pathway refractoriness. Its actions may be reflected in the ECG by prolongation of the PR interval and widening of the QRS complex. The effect on the JT interval is insignificant.

5.2 Pharmacokinetic Properties

Intravenous administration of 0.5 - 2.0 mg/kg to healthy subjects resulted in plasma concentrations ranging from 70 - 340 mcg/l. Protein binding ranges from 32 to 58%. The volume of distribution in healthy subjects following intravenous infusion of 2 mg/kg averaged 512 litres.

The elimination half life after IV administration to patients was 7 to 19 hours.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium Acetate Ph Eur

Glacial Acetic Acid Ph Eur

Water for injections

6.2 Incompatibilities

None known

6.3 Shelf Life

3 year

6.4 Special Precautions For Storage

Do not store above 30°C. Do not freeze. Protect from light.

6.5 Nature And Contents Of Container

Boxes containing 5 x 15 ml glass ampoules.

6.6 Special Precautions For Disposal And Other Handling

Dilution: When necessary Tambocor injection should be diluted with, or injected into, sterile solutions of 5% dextrose. If chloride containing solutions, such as sodium chloride or Ringer's lactate are used, the injection should be added to a volume of not less than 500 ml, otherwise a precipitate will form.

7. Marketing Authorisation Holder

Meda Pharmaceuticals Ltd.

Skyway House

Parsonage Road

Takeley

Bishop's Stortford

CM22 6PU

United Kingdom

8. Marketing Authorisation Number(S)

PL 15142/0077

9. Date Of First Authorisation/Renewal Of The Authorisation

7^th April 1983 / 6^th March 2003

10. Date Of Revision Of The Text

1^st December 2009

Thursday 24 May 2012

Nystop

nystatin

Dosage Form: powder
Nystop®

Nystatin Topical

Powder USP

For topical use only.

Not for ophthalmic use.

Nystop Description

Nystatin is a polyene antifungal antibiotic obtained from Streptomyces nursei. The molecular formula for Nystatin is C47H75NO17. The molecular weight of Nystatin is 926.1. Structural formula:

Nystatin Topical Powder USP is for dermatologic use.

Nystatin Topical Powder USP contains 100,000 USP nystatin units per gram dispersed in talc.

Nystop - Clinical Pharmacology

Pharmacokinetics

Nystatin is not absorbed from intact skin or mucous membrane.

Microbiology

Nystatin is an antibiotic which is both fungistatic and fungicidal in vitro against a wide variety of yeasts and yeast-like fungi, including Candida albicans, C. parapsilosis, C. tropicalis, C. guilliermondi, C. pseudotropicalis, C. krusei, Torulopsis glabrata, Tricophyton rubrum, T. mentagrophytes.

Nystatin acts by binding to sterols in the cell membrane of susceptible species resulting in a change in membrane permeability and the subsequent leakage of intracellular components. On repeated subculturing with increasing levels of nystatin, Candida albicans does not develop resistance to nystatin. Generally, resistance to nystatin does not develop during therapy. However, other species of Candida (C, tropicalis, C. guillier mondi, C. krusei, and C. stellatoides) become quite resistant on treatment with nystatin and simultaneously become cross resistant to amphotericin as well. This resistance is lost when the antibiotic is removed. Nystatin exhibits no appreciable activity against bacteria, protozoa, or viruses.

Indications and Usage for Nystop

Nystatin Topical Powder is indicated in the treatment of cutaneous or mucocutaneous mycotic infections caused by Candida albicans and other susceptible Candida species.

This preparation is not indicated for systemic, oral, intravaginal or ophthalmic use.

Contraindications

Nystatin Topical Powder is contraindicated in patients with a history of hypersensitivity to any of its components.

Precautions

General

Nystatin Topical Powder should not be used for the treatment of systemic, oral, intravaginal or ophthalmic infections.

If irritation or sensitization develops, treatment should be discontinued and appropriate measures taken as indicated. It is recommended that KOH smears, cultures, or other diagnostic methods be used to confirm the diagnosis of cutaneous or mucocutaneous candidiasis and to rule out infection caused by other pathogens.

INFORMATION FOR THE PATIENT

Patients using this medication should receive the following information and instructions:

The patient should be instructed to use this medication as directed (including the replacement of missed doses). This medication is not for any disorder other than that for which it is prescribed.

Even if symptomatic relief occurs within the first few days of treatment, the patient should be advised not to interrupt or discontinue therapy until the prescribed course of treatment is completed.

If symptoms of irritation develop, the patient should be advised to notify the physician promptly.

Laboratory Tests

If there is a lack of therapeutic response, KOH smears, cultures, or other diagnostic methods should be repeated.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No long-term animal studies have been performed to evaluate the carcinogenic potential of nystatin. No studies have been performed to determine the mutagenicity of nystatin or its effects on male or female fertility.

Pregnancy:

Teratogenic Effects

Category C. Animal reproduction studies have not been conducted with any nystatin topical preparation. It also is not known whether these preparations can cause fetal harm when used by a pregnant woman or can affect reproductive capacity. Nystatin topical preparations should be prescribed for a pregnant woman only if the potential benefit to the mother outweighs the potential risk to the fetus.

Nursing Mothers

It is not known whether nystatin is excreted in human milk. Caution should be exercised when nystatin is prescribed for a nursing woman.

Pediatric Use

Safety and effectiveness have been established in the pediatric population from birth to 16 years. (See DOSAGE AND ADMINISTRATION).

Adverse Reactions

The frequency of adverse events reported in patients using nystatin topical preparations is less than 0.1%. The more common events that were reported include allergic reactions, burning, itching, rash, eczema, and pain on application. (See PRECAUTIONS: General.)

Nystop Dosage and Administration

Very moist lesions are best treated with the topical dusting powder.

Adults and Pediatric Patients (Neonates and Older):

Apply to candidal lesions two or three times daily until healing is complete. For fungal infection of the feet caused by Candida species, the powder should be dusted on the feet, as well as, in all foot wear.

How is Nystop Supplied

Nystop® Nystatin Topical Powder USP is supplied as 100,000 units nystatin per gram in 15 g, 30 g and 60 g plastic squeeze bottles.

(NDC 0574-2008-15)

(NDC 0574-2008-30)

(NDC 0574-2008-02)

STORAGE

Store at controlled room temperature 15°-30°C (59°-86°F); avoid excessive heat (40°C;104°F).

Paddock Laboratories, Inc.

Minneapolis, MN 55427

(10-07)

PRINCIPAL DISPLAY PANEL- 15 grams label

Nystop®

Nystatin Topical Powder, USP

NDC 0574-2008-15

100,000 USP UNITS PER GRAM

Rx ONLY

USUAL DOSAGE: Apply to affected

area 2 or 3 times daily.

STORAGE: Store at controlled room

temperature 15°-30°C (59°-86°F);

avoid excessive heat (40°C; 104°F).

NET WEIGHT 15 GRAMS

Paddock

Laboratories, Inc.

Nystop
nystatin powder

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	NDC Product Code (Source)	0574-2008
Route of Administration	TOPICAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Nystatin (Nystatin)	Nystatin	100000 [USP'U] in 1 g

Inactive Ingredients
Ingredient Name	Strength
Talc

Product Characteristics
Color		Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	NDC	Package Description	Multilevel Packaging
1	0574-2008-15	15 g In 1 BOTTLE, PLASTIC	None
2	0574-2008-30	30 g In 1 BOTTLE, PLASTIC	None
3	0574-2008-02	60 g In 1 BOTTLE, PLASTIC	None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA064118	08/16/1996

Labeler - Paddock Laboratories, Inc. (086116803)

Establishment
Name	Address	ID/FEI	Operations
Paddock Laboratories, Inc.		086116803	MANUFACTURE

Revised: 08/2010Paddock Laboratories, Inc.

More Nystop resources

Nystop Side Effects (in more detail)
Nystop Use in Pregnancy & Breastfeeding
Nystop Support Group
1 Review for Nystop - Add your own review/rating

Nystop Topical Advanced Consumer (Micromedex) - Includes Dosage Information

Nystop Powder MedFacts Consumer Leaflet (Wolters Kluwer)

Nystop Concise Consumer Information (Cerner Multum)

Pediaderm AF Cream MedFacts Consumer Leaflet (Wolters Kluwer)

Compare Nystop with other medications

Cutaneous Candidiasis
Vaginal Yeast Infection

Wednesday 23 May 2012

Krystexxa

Pronunciation: peg-LOE-ti-kase
Generic Name: Pegloticase
Brand Name: Krystexxa

Serious, life threatening allergic reactions may occur in some people who receive Krystexxa. These reactions usually occur within 2 hours after receiving Krystexxa, but can occur at any time during or after you receive Krystexxa. Tell your doctor or nurse immediately if you experience any of the following symptoms: dizziness; fainting; fast or weak heartbeat; nervousness; rash; hives; itching; chest pain or tightness; cough; trouble breathing; wheezing; trouble swallowing; swelling of the mouth, face, lips, tongue, or throat; or unusual hoarseness.

Krystexxa is given in a doctor's office, hospital, or clinic where serious allergic reactions can be treated if one occurs. Your health care provider will watch you for any signs of a serious allergic reaction during and after your treatment with Krystexxa. Your doctor will prescribe other medicines to help decrease the risk of an allergic reaction or infusion-related side effects.

Lab tests, including blood uric acid levels, will be monitored before and while you use Krystexxa. Contact your doctor if you have any questions or concerns about this information.

Krystexxa is used for:

Treating chronic gout in certain patients.

Krystexxa is a uric acid-specific enzyme (uricase). It works by allowing uric acid to be more easily removed from the body by the kidneys.

Do NOT use Krystexxa if:

you are allergic to any ingredient in Krystexxa

you have high blood uric acid levels without symptoms

you have a history of blood problems, such as methemoglobinemia (a bluish discoloration to the skin and mucous membranes) or hemolysis, after receiving Krystexxa

you have a metabolic condition called glucose 6-phosphate dehydrogenase (G6PD) deficiency or favism

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

Before using Krystexxa:

Some medical conditions may interact with Krystexxa. 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 are of African or Mediterranean ancestry

if you have a history of heart problems (eg, congestive heart failure [CHF]) or high blood pressure

Some MEDICINES MAY INTERACT with Krystexxa. Tell your health care provider if you are taking any other medicines. However, no specific interactions with Krystexxa are known at this time.

Ask your health care provider if Krystexxa 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 Krystexxa:

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

Krystexxa comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Krystexxa refilled.

Krystexxa is usually given as an injection at your doctor's office, hospital, or clinic.

You may receive certain other medicines, including an antihistamine (eg, diphenhydramine) and a corticosteroid (eg, prednisone), before each treatment with Krystexxa. This will help to decrease the chance of an allergic reaction to Krystexxa. Discuss any questions with your doctor.

Do not use Krystexxa if it contains particles, is cloudy or discolored, or if the vial is cracked or damaged.

Keep this product, as well as syringes and needles, out of the reach of children and pets. Do not reuse needles, syringes, or other materials. Ask your health care provider how to dispose of these materials after use. Follow all local rules for disposal.

If you miss a dose of Krystexxa, contact your doctor immediately to establish a new dosing schedule. Do not use 2 doses at once.

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

Important safety information:

Patients with a metabolic condition called G6PD deficiency should not use Krystexxa because it can severely damage your red blood cells (hemolysis), leading to anemia. It may also cause a condition that affects the ability of your red blood cells to carry oxygen (methemoglobinemia). If you are of African or Mediterranean descent, you may be at higher risk of G6PD deficiency and should be tested to see if you have this condition before starting Krystexxa. Contact your doctor with any questions or concerns.

Gout flares may increase in the first 3 months after you start taking Krystexxa. Do not stop taking Krystexxa if you develop increased gout flares. Your doctor may prescribe certain other medicines (eg, a nonsteroidal anti-inflammatory drug [NSAID] [eg, ibuprofen], colchicine) to decrease the risk of gout flares. Contact your doctor with any questions or concerns.

Lab tests, including uric acid levels, may be performed while you use Krystexxa. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

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

PREGNANCY and BREAST-FEEDING: It is not known if Krystexxa can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Krystexxa while you are pregnant. It is not known if Krystexxa is found in breast milk. Do not breast-feed while taking Krystexxa.

Possible side effects of Krystexxa:

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:

Bruising; constipation; mild sore throat; nausea; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; chest pain or tightness; trouble breathing; wheezing; swelling of the mouth, face, lips, tongue, or throat; or unusual hoarseness); cough; dizziness; fainting; fast or irregular heartbeat; nervousness; new or worsening joint pain or swelling; persistent sore throat; reddening of the face or feeling warm; severe or persistent nausea or vomiting; shortness of breath; swelling of the stomach, feet, or ankles; trouble swallowing.

See also: Krystexxa 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 Krystexxa:

Krystexxa is usually handled and stored by a health care provider. If you are using Krystexxa at home, store Krystexxa as directed by your pharmacist or health care provider. Keep Krystexxa out of the reach of children and away from pets.

General information:

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

Krystexxa 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 Krystexxa. 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

More Krystexxa resources

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

Krystexxa Prescribing Information (FDA)

Krystexxa Consumer Overview

Krystexxa Monograph (AHFS DI)

Krystexxa Advanced Consumer (Micromedex) - Includes Dosage Information

Pegloticase Professional Patient Advice (Wolters Kluwer)

Compare Krystexxa with other medications

Gout

Adizem-XL capsules

Adizem-XL 120 mg, 180 mg, 200 mg, 240 mg and 300 mg prolonged-release capsules

Diltiazem hydrochloride

Read all of this leaflet carefully before you start taking this medicine.

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

If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

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

In this leaflet:

1. What Adizem-XL capsules are and what they are used for

2. Before you take Adizem-XL capsules

3. How to take Adizem-XL capsules

4. Possible side effects

5. How to store Adizem-XL capsules

6. Further information

What Adizem-XL capsules are and what they are used for

These capsules have been prescribed for you to treat angina (chest pain caused by a reduction of oxygen to the heart muscle) or high blood pressure (hypertension). They contain the active ingredient diltiazem. Diltiazem belongs to a group of medicines called calcium antagonists. Calcium antagonists help more blood to reach the heart and reduce blood pressure. The other ingredients of Adizem-XL capsules are listed in section 6 of this leaflet.

Adizem-XL capsules are designed to work properly over 24 hours. If the capsules are crushed or chewed, the entire 24-hour dose may be absorbed rapidly into your body. This can be dangerous, causing serious problems such as an overdose.

Before you take Adizem-XL capsules

Do not take Adizem-XL capsules if you:

are allergic (hypersensitive) to diltiazem or any of the other ingredients of the capsules (see section 6 ‘Further Information’);

have a slow or irregular heart beat;

have heart failure (which can cause shortness of breath or ankle swelling).

Children should not take these capsules.

Take special care with Adizem-XL capsules

Before treatment with Adizem-XL capsules tell your doctor or pharmacist if you have porphyria (a rare disease of the blood pigments).

Taking other medicines

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. If you take Adizem-XL capsules with some other medicines, the effect of Adizem-XL capsules or the other medicine may be changed.

Tell your doctor or pharmacist if you are taking:

any other medicines for high blood pressure, such as beta blockers (for example atenolol), diuretics (for example bendrofluazide) or ACE inhibitors (examples include captopril and enalapril);

medicines known as alpha blockers, which you may be taking to treat high blood pressure or prostate disorders (for example prazosin);

any medicines which may cause low blood pressure or slow heart beat (for example aldesleukin to treat cancer of the kidneys, or antipsychotics to treat mental and behavioural disorders);

ivabradine to treat angina;

anti-arrhythmic medicines to treat an irregular or rapid heart beat (for example digoxin, amiodarone or beta-blockers);

cilostazol to treat intermittent claudication (a condition that causes leg pain due to a restriction in blood supply to the muscles);

medicines known as statins to reduce cholesterol levels in your blood (examples include simvastatin, atorvastatin or lovastatin);

medicines known as H2 antagonists to treat stomach ulcers, indigestion or heartburn, such as
cimetidine or ranitidine;

carbamazepine or phenytoin to treat seizures, fits or convulsions;

medicines known as benzodiazepines to treat anxiety or help you sleep (examples include
midazolam or triazolam);

medicines known as barbiturates to either treat fits or to help you sleep (examples include
phenobarbital or primidone);

a specific type of antidepressant known as a tricyclic antidepressant (examples include amitriptyline or imipramine);

rifampicin to treat tuberculosis;

ciclosporin, sirolimus or tacrolimus to prevent organ transplant rejection or treat other immune system disorders;

a specific type of medicine known as a protease inhibitor to treat HIV (examples include atazanavir or ritonavir);

dantrolene (a muscle relaxant);

theophylline to treat breathing problems such as asthma.

Also tell your doctor if you have recently been given an anaesthetic.

Taking Adizem-XL capsules with alcohol

Do not take Adizem-XL capsules at the same time as an alcoholic drink.

Pregnancy and breastfeeding

Do not take Adizem-XL capsules if you are pregnant, likely to become pregnant or are breastfeeding.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

The capsules may cause a number of side effects such as dizziness which could affect your ability to drive (see section 4 for a full list of side effects). These are usually most noticeable when you start taking the capsules, or when changing to higher dose. If you are affected you should not drive or operate machinery.

Important information about some of the ingredients of Adizem-XL capsules

These capsules contain soya oil. If you are allergic to peanuts or soya do not take these capsules.

How to take Adizem-XL capsules

Always take Adizem-XL capsules exactly as your doctor has told you. The label on your medicine will tell you how many capsules to take and how often.

The usual starting dose for adults is one 240 mg capsule every 24 hours. However, if you are elderly or have kidney problems then your doctor will probably suggest a lower starting dose of one 120 mg capsule every 24 hours. Your doctor will decide how many capsules you should take.

Children should not take these capsules.

Do not exceed the dose recommended by your doctor. You should check with your doctor or pharmacist if
you are not sure.

Swallow your capsules whole with a glass of water. Do not chew or crush the capsules.

You should take your capsules every 24 hours. For instance, if you take a capsule at 8 o’clock in the morning, you should take your next capsule at 8 o’clock the next morning.

If you take more Adizem-XL capsules than you should or if someone accidentally swallows your capsules

Call your doctor or hospital straight away. People who have taken an overdose may become very unwell, feel faint, have a slow heart beat and lose consciousness. They may need emergency treatment in hospital. When seeking medical attention make sure that you take this leaflet and any remaining capsules with you to show to the doctor.

If you forget to take Adizem-XL capsules

If you remember within 4 hours of the time your capsule was due, take your capsule straight away. Take your next capsule at your normal time. If you are more than 4 hours late, please call your doctor or pharmacist for advice. Do not take a double dose to make up for a forgotten capsule.

If you stop taking Adizem-XL capsules

You should not stop taking these capsules unless your doctor tells you to. If you want to stop taking your capsules, discuss this with your doctor first.

If you have any further questions on the use of Adizem-XL capsules ask your doctor or pharmacist.

Adizem-XL capsules Side Effects

Like all medicines, Adizem-XL capsules can cause side effects, although not everybody gets them.

All medicines can cause allergic reactions, although serious allergic reactions are rare. Tell your doctor immediately if you get swelling of the face or throat.

Common side effects (probably affecting more than 1 in 100 people taking Adizem-XL capsules)

Gastrointestinal disorders (e.g. upset stomach), feeling sick.

Dizziness, headache.

Tiredness.

Swelling of the legs.

Facial flushing (redness of the face).

Low blood pressure.

Uncommon side effects (probably affecting fewer than 1 in 100 people taking Adizem-XL capsules)

A reduction in blood platelets which increases the risk of bleeding or bruising.

Changes in muscle tone and/or abnormalities of movement.

Skin problems such as an increased sensitivity to sunlight, itching, rash, redness, swelling, severe flaking or peeling of the skin.

Inflammation of blood vessels (often with skin rash).

A fast, slow or irregular heart beat.

Bleeding, tender or enlarged gums.

Breast enlargement in men.

Inflammation of the liver.

Uncommonly, Adizem-XL capsules may affect the results of blood tests to check that your liver is working properly.

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

How to store Adizem-XL capsules

Keep out of the reach and sight of children.

Do not use any capsules after the expiry date which is stated on the carton. EXP 08 2010 means that you should not take the capsules after the last day of that month i.e. August 2010.

Do not store your capsules above 25^oC.

Do not take your capsules if they are broken or crushed as this can be dangerous and can cause serious problems such as overdose.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Further information

What Adizem-XL capsules contain

The active ingredient is diltiazem hydrochloride. Each capsule contains 120 mg, 180 mg, 200 mg, 240 mg or 300 mg of diltiazem hydrochloride.

The other ingredients are:

Microcrystalline cellulose

Ethylcellulose

Colloidal anhydrous silica

Polysorbate 80

Dibutyl sebacate

Magnesium stearate

Sodium dodecyl sulphate

Gelatin

Shellac

Soya lecithin

2-ethoxyethanol

Dimeticone

Iron oxide (E172)

Titanium dioxide (E171)

The capsules also contain the following colourants:

120 mg, 180 mg and 240 mg – Erythrosine (E127) and indigo carmine (E132)

300 mg - Erythrosine (E127), indigo carmine (E132) and patent blue V (E131)

What Adizem-XL capsules look like and the contents of the pack

Adizem-XL capsules are marked DCR followed by the strength (e.g. 120, 180 etc.) and are coloured as follows: 120 mg - pale pink/navy blue, 180 mg - dark pink/royal blue, 200 mg - brown, 240 mg - dark red/blue, 300 mg - dark maroon/pale blue.

In each box there are 28 capsules.

Marketing Authorisation Holder and Manufacturer

The capsules are made by

Bard Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

for the marketing authorisation holder

Napp Pharmaceuticals Limited

Cambridge Science Park

Milton Road

Cambridge

CB4 0GW

This leaflet is also available in large print, Braille or as an audio CD. To request a copy, please call the RNIB Medicine Information line (free of charge) on:

0800 198 5000

You will need to give details of the product name and reference number.

These are as follows:

Product name: Adizem-XL prolonged-release capsules

Reference number: 16950/0010

This leaflet was last approved in July 2009

Adizem-XL capsules are protected by UK Patent No. 2258613.

Adizem and the NAPP device (logo) are Registered Trade Marks.

P0077-A UK AW R4V2 10-07-09

Adizem XL P0077-A R4V2 UK AW 10-07-09 (Approved)

Monday 21 May 2012

Nilandron

Generic Name: nilutamide (Oral route)

nye-LOO-ta-mide

Oral route(Tablet)

Interstitial pneumonitis has been reported in 2% of patients in controlled clinical trials exposed to nilutamide. Reports of interstitial changes including pulmonary fibrosis that led to hospitalization and death have been reported rarely post-marketing. Symptoms included exertional dyspnea, cough, chest pain, and fever. A routine chest X-ray should be performed prior to initiating treatment and baseline pulmonary function tests may be considered. Patients should be instructed to report any new or worsening shortness of breath, and if symptoms occur, nilutamide should be discontinued until it can be determined if the symptoms are drug-related .

Commonly used brand name(s)

In the U.S.

Nilandron

Available Dosage Forms:

Tablet

Therapeutic Class: Antiandrogen

Uses For Nilandron

Nilutamide is used with surgery to treat metastatic prostate cancer (cancer that has spread) in men. Nilutamide belongs to the group of medicines called antiandrogens. It works by blocking the effects of testosterone (a male hormone), which helps stop the growth and spread of cancer cells. .

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

Before Using Nilandron

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 nilutamide in the pediatric population. Safety and efficacy have not been established.

Geriatric

No information is available on the relationship of age to the effects of nilutamide in geriatric patients.

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

Using this medicine with any of the following medicines 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.

Fosphenytoin

Phenytoin

Theophylline

Warfarin

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Proper Use of Nilandron

Take this medicine only as directed by your doctor. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered. To do so may increase the chance of side effects.

You should begin taking this medicine on the day of or the day after your surgery. Do not stop taking this medicine without checking with your doctor first.

You may take this medicine with food or on an empty stomach.

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 oral dosage form (tablets):
- For prostate cancer:
  - Adults—300 milligrams (mg) once a day for the first 30 days, then 150 mg once a day.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Precautions While Using Nilandron

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly. Blood tests may be needed to check for unwanted effects.

Check with your doctor right away if you have shortness of breath, difficulty with breathing, or chest pain while you are using this medicine.

Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: clay-colored stools; dark urine; fever; headache; loss of appetite; nausea or vomiting; pain or tenderness in the upper right side of the stomach; unusual tiredness or weakness; or yellow eyes or skin.

Drinking alcoholic beverages while taking nilutamide may cause unwanted effects in some people. Possible effects include feeling dizzy or lightheaded when getting up from a lying or sitting position suddenly; having flu-like symptoms; or flushing of the face. If you notice any of these effects, avoid drinking alcohol while you are taking this medicine.

Be very careful while driving, especially at night or when you drive into or out of tunnels. Nilutamide can temporarily change the way your eyes react to light. You may not be able to see as well as usual for several minutes after going from bright light to darkness. Wearing eyeglasses with tinted lenses may help reduce these effects.

Nilandron 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:

More common

Blood in the urine

blurred vision

chest pain

chills

cough

diarrhea

difficult or labored breathing

dizziness

fever or chills

general feeling of discomfort or illness

headache

joint pain

loss of appetite

muscle aches and pains

nausea

nervousness

pale skin

pounding in the ears

runny nose

shivering

shortness of breath

slow or fast heartbeat

sneezing

sore throat

sweating

tightness in the chest

trouble with sleeping

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

vomiting

wheezing

Less common

Arm, back, or jaw pain

blindness

bloody, black, or tarry stools

change in color vision

decreased urine output

decreased vision

difficulty seeing at night

dilated neck veins

fainting

fast or irregular heartbeat

increased cough

increased sensitivity of the eyes to sunlight

irregular breathing

swelling of the face, fingers, feet, or lower legs

vomiting of blood or material that looks like coffee grounds

weight gain or loss

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

Acid or sour stomach

belching

body hair loss

bone pain

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

changes in vision

decrease in testicle size

decreased interest in sexual intercourse

depression

difficulty having a bowel movement (stool)

dizziness

dry skin

feeling of warmth

heartburn

inability to have or keep an erection

increased urge to urinate during the night

indigestion

loss in sexual ability, desire, drive, or performance

pain

rash

redness of the face, neck, arms and occasionally, upper chest

sleeplessness

stomach discomfort, upset, or pain

sudden sweating

unable to sleep

waking to urinate at night

Less common

Difficulty with moving

dry mouth

general feeling of discomfort or illness

itching

muscle pain or stiffness

pain, swelling, or redness in the joints

passing of gas

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: Nilandron 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 Nilandron resources

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

Nilandron Prescribing Information (FDA)

Nilandron MedFacts Consumer Leaflet (Wolters Kluwer)

Nilandron Concise Consumer Information (Cerner Multum)

Nilandron Monograph (AHFS DI)

Nilutamide Professional Patient Advice (Wolters Kluwer)

Compare Nilandron with other medications

Prostate Cancer

Thursday 31 May 2012

Streptozocin is used for:

Do NOT use Streptozocin if:

Before using Streptozocin:

How to use Streptozocin:

Important safety information:

Possible side effects of Streptozocin:

If OVERDOSE is suspected:

General information:

More Streptozocin resources

Compare Streptozocin with other medications

Tuesday 29 May 2012

See also

Drug List:

Monday 28 May 2012

What is Sominex (diphenhydramine)?

What is the most important information I should know about Sominex (diphenhydramine)?

What should I discuss with my healthcare provider before taking Sominex (diphenhydramine)?

How should I take Sominex (diphenhydramine)?

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while taking Sominex (diphenhydramine)?

Sominex (diphenhydramine) side effects

What other drugs will affect Sominex (diphenhydramine)?

More Sominex resources

Compare Sominex with other medications

Where can I get more information?

Friday 25 May 2012

1. Name Of The Medicinal Product

2. Qualitative And Quantitative Composition

3. Pharmaceutical Form

4. Clinical Particulars

4.1 Therapeutic Indications

4.2 Posology And Method Of Administration

4.3 Contraindications

4.4 Special Warnings And Precautions For Use

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

4.6 Pregnancy And Lactation

4.7 Effects On Ability To Drive And Use Machines

4.8 Undesirable Effects

4.9 Overdose

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

5.2 Pharmacokinetic Properties

5.3 Preclinical Safety Data

6. Pharmaceutical Particulars

6.1 List Of Excipients

6.2 Incompatibilities

6.3 Shelf Life

6.4 Special Precautions For Storage

6.5 Nature And Contents Of Container

6.6 Special Precautions For Disposal And Other Handling

7. Marketing Authorisation Holder

8. Marketing Authorisation Number(S)

9. Date Of First Authorisation/Renewal Of The Authorisation

10. Date Of Revision Of The Text

Thursday 24 May 2012

Nystop Description

Nystop - Clinical Pharmacology

Pharmacokinetics

Microbiology

Indications and Usage for Nystop

Contraindications

Precautions

General

INFORMATION FOR THE PATIENT

Laboratory Tests

Carcinogenesis, Mutagenesis, Impairment of Fertility

Pregnancy:

Nursing Mothers

Pediatric Use

Adverse Reactions

Nystop Dosage and Administration

Adults and Pediatric Patients (Neonates and Older):

How is Nystop Supplied

STORAGE

PRINCIPAL DISPLAY PANEL- 15 grams label

More Nystop resources

Compare Nystop with other medications

Wednesday 23 May 2012