amphotericin b lipid complex Intravenous, Injection

am-foe-TER-i-sin B LIP-id KOM-plex

Commonly used brand name(s)

In the U.S.

• Abelcet

Available Dosage Forms:

• Powder for Solution


• Suspension

Therapeutic Class: Antifungal

Chemical Class: Polyene

Uses For amphotericin b lipid complex

Amphotericin B lipid complex is an antifungal medicine. It is used to help the body overcome serious infections caused by fungus.

amphotericin b lipid complex is available only with your doctor's prescription.

Before Using amphotericin b lipid complex

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 amphotericin b lipid complex, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to amphotericin b lipid complex 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

amphotericin b lipid complex has been tested in children and, in effective doses, has not been shown to cause different side effects or problems than it does in adults.

Geriatric

amphotericin b lipid complex has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	B	Animal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

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 amphotericin b lipid complex, 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 amphotericin b lipid complex 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.

• Cyclosporine

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 amphotericin b lipid complex. Make sure you tell your doctor if you have any other medical problems, especially:

• Blood transfusion—Amphotericin B lipid complex may cause side effects affecting the lungs

• Kidney disease—Amphotericin B lipid complex may make your kidney problems worse

Proper Use of amphotericin b lipid complex

Dosing

The dose of amphotericin b lipid complex 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 amphotericin b lipid complex. 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 injection dosage form:
  
  • For treatment of serious infection caused by fungus:
    
    • Adults and children—5 milligrams per kilogram (2.27 mg per pound) of body weight per day, injected slowly into a vein.
    
    
  
  

amphotericin b lipid complex Side Effects

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

• Chills and fever


• headache


• nausea and vomiting

Less common

• Difficulty in breathing


• sore throat and fever


• unusual bleeding or bruising


• unusual tiredness and weakness

Rare

• Increased or decreased urination

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

• Diarrhea


• loss of appetite


• stomach pain

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: amphotericin b lipid complex Intravenous, Injection side effects (in more detail)

The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.

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• Aspergillosis, Aspergilloma
• Aspergillosis, Invasive
• Blastomycosis
• Candida Infections, Systemic
• Coccidioidomycosis
• Cryptococcosis
• Histoplasmosis
• Leishmaniasis

Lotrimin AF Cream

Generic Name: clotrimazole topical (kloe TRIM a zole)

Brand Names: Anti-Fungal Liquid, Desenex AF Prescription Strength, FungiCURE Pump Spray, Lotrimin AF Cream, Lotrimin AF For Her, Lotrimin AF Jock Itch, Lotrimin AF Solution, Lotrimin Jock Itch Powder, MPM Anti-Fungal, Prescription Strength Cruex

What is Lotrimin AF Cream (clotrimazole topical)?

Clotrimazole topical is an antifungal antibiotic that fights infections caused by fungus.

Clotrimazole topical is used to treat skin infections such as athlete's foot, jock itch, ringworm, and yeast infections.

Clotrimazole topical may also be used for purposes not listed in this medication guide.

What is the most important information I should know about Lotrimin AF Cream (clotrimazole topical)?

You should not use clotrimazole topical if you are allergic to it.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared.

Do not use bandages or dressings that do not allow air to circulate to the affected area (occlusive dressings) unless otherwise directed by your doctor. Wear loose-fitting clothing (preferably cotton).

Avoid getting this medication in your eyes, nose, or mouth.

What should I discuss with my healthcare provider before using Lotrimin AF Cream (clotrimazole topical)?

You should not use clotrimazole topical if you are allergic to it. FDA pregnancy category B. Clotrimazole topical is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether clotrimazole topical passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I use Lotrimin AF Cream (clotrimazole topical)?

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.

Wash your hands before and after using this medication, unless you are using it to treat a hand infection.

Clean and dry the affected area. Apply a small amount of the cream (usually twice daily) for 2 to 4 weeks.

Do not take this medication by mouth.

Use this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. If the infection does not clear up in 4 weeks, or if it appears to get worse, see your doctor.

Do not use bandages or dressings that do not allow air circulation over the affected area (occlusive dressings) unless otherwise directed by your doctor. A light cotton-gauze dressing may be used to protect clothing.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

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

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Lotrimin AF Cream (clotrimazole topical)?

Avoid getting this medication in your eyes, nose, or mouth.

Avoid using other medications on the areas you treat with clotrimazole topical unless you doctor tells you to.

Avoid wearing tight-fitting, synthetic clothing that doesn't allow air circulation. Wear clothing made of loose cotton and other natural fibers until the infection is healed.

Lotrimin AF Cream (clotrimazole topical) 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. Stop using clotrimazole topical and call your doctor at once if you have unusual or severe blistering, itching, redness, peeling, dryness, swelling, or irritation of the skin.

Less serious side effects are more likely, and you may have none at all.

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 Lotrimin AF Cream (clotrimazole topical)?

There may be other drugs that can interact with clotrimazole topical. 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.

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• Tinea Corporis
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Where can I get more information?

• Your pharmacist can provide more information about clotrimazole topical.

See also: Lotrimin AF side effects (in more detail)

Vascalpha 5mg Prolonged Release Tablet

1. Name Of The Medicinal Product

VASCALPHA 5 mg PROLONGED RELEASE TABLETS

(FELODIPINE)

2. Qualitative And Quantitative Composition

One prolonged release tablet contains 5mg of felodipine.

Lactose monohydrate 23.95mg

For excipients, see 6.1

3. Pharmaceutical Form

Prolonged release tablet.

Light pink, round, biconvex, film-coated prolonged release tablets with imprint 5.

4. Clinical Particulars

4.1 Therapeutic Indications

Essential hypertension

4.2 Posology And Method Of Administration

Vascalpha (felodipine) prolonged release tablets should usually be administered as follows:

The recommended starting dose is 5 mg felodipine once daily.

If necessary, the dose may be increased to 10 mg felodipine once daily or another antihypertensive agent added. Dose increases should occur at intervals of at least 2 weeks. The usual maintenance dose is 5-10mg once daily.

The maximum daily dose is 10 mg felodipine.

The dose should be adjusted to the individual requirements of the patient.

Elderly

The recommended starting dose should be 2.5mg.

Subsequent dose increases should be undertaken with particular caution.

Impaired hepatic function

In patients with mild to moderate hepatic impairment, the recommended starting dose should be lowered to the minimal therapeutic effective dose of felodipine.

The dose should only be increased after carefully balancing the benefits against the risks (see 5.2 Pharmacokinetic properties). It is contraindicated in patients with severe hepatic impairment.

Impaired renal function

The pharmacokinetics are not significantly affected in patients with mild to moderate impaired renal function. Caution should be taken in patients with severe renal impairment (see section 4.4 Special warnings and precautions for use and section 5.2. Pharmacokinetic properties).

Children

Felodipine is not recommended for use in children due to lack of data on safety and efficacy.

Administration

The prolonged release tablets should be taken in the morning with a sufficient amount of fluid (e.g. a glass of water, but it should NOT be taken with grapefruit juice!) (see 4.5 Interaction with other medicinal products and other forms of interaction).

The prolonged release tablets should be swallowed whole and not chewed or crushed. The tablets may be taken on an empty stomach or with a light meal, however a high fat meal should be avoided (see 5.2 Pharmacokinetic properties).

4.3 Contraindications

Felodipine is contra-indicated in patients with:

- hypersensitivity to felodipine (or other dihydropyridines) or to any of the excipients

- cardiogenic shock

- severe aortic and mitral stenosis

- obstructive hyperthrophic cardiomyopathy

- unstable angina pectoris

- acute myocardial infarction (within 4-8 weeks of a myocardial infarction)

- decompensated heart failure

- severe hepatic impairment

- pregnancy (see section 4.6)

4.4 Special Warnings And Precautions For Use

Felodipine should be used with caution in patients with:

- conduction disorders, compensated heart failure, tachycardia and aortic or mitral valve stenosis.

- mild to moderate hepatic impairment, as the anti-hypertensive effect may be enhanced. Adjustment of the dosage should be considered.

- severe renal impairment (GFR <30ml/min)

- AV block of the second or third degree

If treatment with felodipine is discontinued abruptly, a hypertensive crisis may occur in individual cases.

Felodipine could cause significant hypotension (vasodilation effect) with consecutive tachycardia, leading to myocardial ischaemia in sensitive patients, therefore predisposed patients may suffer from myocardial infarction (see section 5.1 Pharmacodynamic properties).

Dihydropyridines may cause acute hypotension. In some cases there is a risk of hypoperfusion accompanied by reflex tachycardia (paradoxical angor) (see section 5.1 Pharmacodynamic properties).

Patients with rare hereditary problems of galactose intolerance, the lapp lactase deficiency or glucose-galactose malabsorption should not take this medicinal product.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Felodipine is a CYP3A4 substrate. Drugs that induce or inhibit CYP3A4 will have large influence on felodipine concentrations.

The anti-hypertensive effect of felodipine may be enhanced by other anti-hypertensives and tricyclic antidepressants.

The concomitant intake of felodipine and drugs which inhibit the cytochrome P450 isoenzyme 3A4 of the liver (such as cimetidine, azole antifungals [itraconazole or ketoconazole], macrolide antibiotics [erythromycin clarithromycin, telithromycin] or HIV protease inhibitors leads to increased felodipine plasma levels (see section 4.4 Special warnings and precautions for use). Grapefruit juice results in increased peak plasma levels and bioavailability possibly due to interaction with flavanoids in the fruit juice. Therefore grapefruit juice should not be taken together with felodipine.

Cocomitant treatment with drugs such as carbamazepine, phenytoin and barbiturates (e.g. phenobarbital) and rifampicin reduces the plasma levels of felodipine via enzyme induction in the liver (cytochrome P450 System). A similar effect is expected with St John's Wort. Therefore a dose increase of felodipine may be necessary.

Hydrochlorothiazide may enhance the antihypertensive effect of felodipine.

Felodipine can induce an increase of Cmax of ciclosporin. Additionally, ciclosporin may inhibit felodipine metabolism, which may create a potential risk of felodipine toxicity.

Blood levels of digoxin increase during concomitant administration of felodipine. Therefore, decreasing of digoxin dosage should be taken into account when the two drugs are administered concurrently.

4.6 Pregnancy And Lactation

Pregnancy

Felodipine is contra-indicated during the entire duration of pregnancy, as animal experiments have demonstrated foetal damage (see 5.3 Preclinical safety data). Pregnancy must be excluded before starting treatment with felodipine.

Lactation

Felodipine is excreted in breast milk. If the breast-feeding mother is taking therapeutic doses of felodipine, a fully breast-fed infant absorbs only a very low dose of the active substance with the breast milk. There is no experience of the risk this may pose to the newborn, therefore as a precaution breast-feeding should be discontinued during treatment.

4.7 Effects On Ability To Drive And Use Machines

Felodipine can cause dizziness or tiredness. These adverse effects are more likely to occur after initiation of the treatment, after dose increases, or after concomitant ingestion of alcohol. Should they occur, one should refrain from driving and other activities requiring alertness.

4.8 Undesirable Effects

Adverse drug reactions are listed below by system organ class and frequency. Frequencies are defined as: very common (

Nervous system disorders

Very common: Headache (particularly at the beginning of treatment, when the dose is increased or when high doses are administered). Generally, those effects subside on continued treatment.

Uncommon: Paraesthesia, dizziness, fatigue, syncope, restlessness

Ear and labyrinth disorders

Very common: Tinnitus (particularly at the beginning of treatment, when the dose is increased or when high doses are administered). Generally, those effects subside on continued treatment.

Cardiac disorders

Common: Particularly at the beginning of treatment, angina pectoris attacks may occur, or in patients with pre-existing angina pectoris there may be an increase in the frequency, duration and severity of the attacks.

Uncommon: Palpitations, tachycardia, hypotension.

Very rare: Myocardial infarction

Vascular disorders

Rare: Leucocytoclastic vasculitis

Respiratory, thoracic and mediastinal disorders

Uncommon: Dyspnoea

Gastrointestinal disorders

Uncommon: Nausea, vomiting, diarrhoea, constipation.

Hepatobiliary disorders

Very rare: Hepatic function disorders (elevated transaminase levels).

Skin and subcutaneous tissue disorders

Very common: Flushing (particularly at the beginning of treatment, when the dose is increased or when high doses are administered). Generally, those effects subside on continued treatment.

Uncommon: Skin and hypersensitivity reactions such as pruritus, urticaria, exanthema, photosensitisation. Gingival hyperplasia and gingivitis

Very rare: Exfoliative dermatitis

Musculoskeletal and connective tissue disorders

Uncommon: Myalgia, arthralgia, tremors

Renal and urinary disorders

Uncommon: Pollakisuria

Reproductive system and breast disorders

Very rare: Erection disorders, gynaecomastia, menorrhagia.

General disorders and administration site conditions

Common: Peripheral oedema (The degree of ankle swelling is dose related).

Uncommon: Weight gain, sweating

Very rare: Angiooedema, fever

4.9 Overdose

Symptoms of intoxication

Overdose may lead to excessive peripheral vasodilatation with marked hypotension and in rare cases bradycardia.

Management of intoxication

The therapeutic measures should focus on elimination of the active ingredient (e.g. administration of charcoal, bowel irrigation) and monitoring of the vital signs. If severe hypotension occurs, symptomatic treatment should be provided, the patient should be placed supine with the legs elevated. In case of accompanying bradycardia, atropine (0.5 – 1.0 mg) should be given intravenously. Additional intravenous fluids should be cautiously administered under haemodynamic supervision to prevent cardiac overloading. Sympathomimetic drugs with predominant effect on the α₁-adrenoreceptor (such as dobutamine, dopamine, noradrenaline (norepinephrine) or adrenaline (epinephrine)) may also be given. Dosage depends on the efficacy obtained.

Felodipine is only dialysable to a minimal extent (approx. 9%).

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotheraputic group: 1,4-didydropyridine derivative/calcium antagonist

ATC code: C08C A02

Felodipine is a calcium antagonist of the dihydropyridine class of calcium channel blockers. Calcium antagonists interfere with the voltage-dependent L-type (slow) calcium channels in the plasma membranes of smooth muscle cells and reduce the inflow of calcium ions. This results in vasodilatation.

Felodipine has a greater selectivity for vascular smooth muscle than myocardial muscle. Felodipine selectively dilates arterioles with no effects on venous vessels. Felodipine leads to a dose-related lowering of blood pressure via vasodilatation and consequently a reduction of peripheral vascular resistance. It reduces both systolic and diastolic blood pressure. The haemodynamic effect of felodipine is accompanied by reflex (baroreceptor-mediated) tachycardia. In therapeutic doses, felodipine has no direct effect on either cardiac contractility or cardiac conduction. Felodipine reduces renal vascular resistance. The glomerular filtration rate remains unchanged.

Felodipine has a weak natriuretic/diuretic effect and does not provoke fluid retention.

Felodipine can be used as a monotherapy but also concomitantly with beta-blockers, diuretics and ACE inhibitors.

5.2 Pharmacokinetic Properties

Absorption

Felodipine is completely absorbed following oral administration. Peak plasma levels are reached with the prolonged release formulation after 3 – 5 hours and result in even felodipine plasma concentrations within the therapeutic range for 24 hours. Steady state is reached approx. 3 days after starting treatment. Due to an extensive first-pass effect, only approx. 15 % of the administered dose is systemically available.

Distribution

The plasma protein binding of felodipine is> 99 %. The volume of distribution is approximately 10 l/kg at steady state, so that felodipine is indicating large tissue distribution. There is no significant accumulation during long-term treatment.

Metabolism

Felodipine is extensively metabolised in the liver by CYP3A4. All identified metabolites are inactive.

Elimination

No unchanged parent substance is detectable in the urine. The average half-life of felodipine in the terminal phase is 25 hours. The inactive hydrophilic metabolites formed by hepatic biotransformation are mainly eliminated renally (to approx. 70 %), and the remainder is excreted in the faeces. The mean plasma clearance is 1100 ml/l and depends on the hepatic blood flow.

Elderly

Increased plasma concentrations have been measured in elderly patients.

Impaired hepatic function

Increased plasma concentrations of up to 100% have been measured in patients with impaired hepatic function.

Impaired renal function

Renal impairment does not affect the pharmacokinetics of felodipine, although accumulation of inactive metabolites occurs in renal failure.

Effect of food

The rate, but not the extent of absorption is affected by the simultaneous ingestion of fatty food. Cmax was 2 to 2.5 times higher following intake of a high-fat meal compared to a fasting state.

5.3 Preclinical Safety Data

Preclinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, repeated dose toxicity, genotoxicity and carcinogenic potential. In animal studies with respect to the reproduction, adverse effects were found. Effects in rats (prolonged duration of pregnancy and difficult labour) and rabbits (impaired development of distal phalanges, presumably due to decreased uteroplacental perfusion) revealed no evidence of a direct teratogenic effect, but indicate secondary consequences of the pharmacodynamic effect. In monkeys, an abnormal position of the distal phalanges was found. The significance of these observations for humans is unknown.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Tablet core:

Lactose monohydrate, microcrystalline cellulose, hypromellose, povidone K25, propyl gallate (PhEur), colloidal anhydrous silica, magnesium stearate (PhEur)

Tablet coat:

Hypromellose, talcum, propylene glycol, titanium dioxide (E171), iron oxide red (E172), iron oxide yellow (E172).

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

48 months

6.4 Special Precautions For Storage

Do not store above 25°C.

6.5 Nature And Contents Of Container

PVC/PE/PVDC aluminium blister.

Pack sizes: 10, 14, 20, 28, 30, 50, 56, 60, 90, 98, 100, 250, 500 and 1000 prolonged release tablets.

Not all pack sizes may be marketed.

6.6 Special Precautions For Disposal And Other Handling

No special requirements

7. Marketing Authorisation Holder

Actavis UK Limited (Trading style: Actavis)

Whiddon Valley

BARNSTAPLE

N Devon EX32 8NS

8. Marketing Authorisation Number(S)

PL 00142/0541

9. Date Of First Authorisation/Renewal Of The Authorisation

21 July 2003

10. Date Of Revision Of The Text

June 2007

Phenylephrine Tablets

Pronunciation: FEN-il-EF-rin
Generic Name: Phenylephrine
Brand Name: Examples include Contac-D and Sudafed PE

Phenylephrine is used for:

Relieving congestion due to colds, flu, hay fever, and other allergies. It may also be used for other conditions as determined by your doctor.

Phenylephrine is a decongestant. It works by reducing swelling and constricting blood vessels in the nasal passages, allowing you to breathe more easily.

Do NOT use Phenylephrine if:

• you are allergic to any ingredient in Phenylephrine


• you have had an unusual reaction (eg, dizziness, weakness, tremors, irregular heartbeat) to another sympathomimetic medicine (eg, pseudoephedrine)


• you are taking furazolidone or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) in the last 14 days


• you have severe high blood pressure, severe heart blood vessel disease, fast heartbeat, or severe heart problems

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

Before using Phenylephrine:

Some medical conditions may interact with Phenylephrine. 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 a history of glaucoma or increased pressure in the eye, enlarged prostate gland or other prostate problems, heart problems, diabetes, high blood pressure, blood vessel problems, adrenal gland problems, overactive thyroid, seizures, or stroke

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

• Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), furazolidone, indomethacin, methyldopa, or MAOIs (eg, phenelzine) because they may increase the risk of Phenylephrine's side effects


• Tricyclic antidepressants (eg, amitriptyline) because they may decrease Phenylephrine's effectiveness


• Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased


• Bromocriptine because the risk of its side effects may be increased by Phenylephrine


• Guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Phenylephrine

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

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

• Take Phenylephrine by mouth with or without food.


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

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

Important safety information:

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


• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.


• If your symptoms do not get better within 7 days or if you develop a high fever, check with your doctor.


• Phenylephrine has phenylephrine in it. Before you start any new medicine, check the label to see if it has phenylephrine or pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.


• Do not take diet or appetite control medicines while you are taking Phenylephrine.


• If you have trouble sleeping, ask your pharmacist or doctor about the best time to take Phenylephrine.


• Tell your doctor or dentist that you take Phenylephrine before you receive any medical or dental care, emergency care, or surgery.


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


• Use Phenylephrine with caution in the ELDERLY; they may be more sensitive to its effects.


• Caution is advised when using Phenylephrine in CHILDREN; they may be more sensitive to its effects.


• Different brands of Phenylephrine may have different dosing instructions for CHILDREN. Follow the dosing instructions on the package labeling. If your doctor has given you instructions, follow those. If you are unsure of the dose to give a child, check with your doctor or pharmacist.


• Phenylephrine should be used with extreme caution in CHILDREN younger than 2 years old; safety and effectiveness in these children have not been confirmed.


• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Phenylephrine while you are pregnant. Phenylephrine is found in breast milk. Do not breast-feed while taking Phenylephrine.

Possible side effects of Phenylephrine:

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:

Dizziness; headache; nausea; nervousness; restlessness; sleeplessness; stomach irritation.

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); fast or irregular heartbeat; hallucinations; seizures; tremor; trouble urinating.

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.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room right away. Symptoms may include confusion; hallucinations; irregular or unusually slow or rapid heartbeat; rapid breathing; seizures.

Proper storage of Phenylephrine:

Store Phenylephrine at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Phenylephrine out of the reach of children and away from pets.

General information:

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


• Phenylephrine 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 Phenylephrine. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Phenylephrine resources

• Phenylephrine Dosage
• Phenylephrine Use in Pregnancy & Breastfeeding
• Drug Images
• Phenylephrine Drug Interactions
• Phenylephrine Support Group
• 3 Reviews for Phenylephrine - Add your own review/rating

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St. Joseph Aspirin Adult EC

Generic Name: aspirin (oral) (AS pir in)

Brand Names: Arthritis Pain, Aspergum Cherry, Aspergum Orginal, Aspir 81, Aspir-Low, Aspirin Lite Coat, Aspirin Litecoat, Aspirin Low Dose, Aspirin Low Strength, Bayer Aspirin, Bayer Aspirin Regimen, Bayer Aspirin Sugar Free, Bayer Aspirin with Calcium, Bayer Childrens Aspirin, Bayer Low Strength, Bayer Plus, Buffered Aspirin, Bufferin, Bufferin Arthritis Strength, Bufferin Extra Strength, Easprin, Ecotrin, Ecotrin Adult Low Strength, Ecotrin Maximum Strength, Fasprin, Genacote, Halfprin, Litecoat Aspirin, Norwich Aspirin, St. Joseph Aspirin, St. Joseph Aspirin Adult Chewable, St. Joseph Aspirin Adult EC, Stanback Analgesic, Tri-Buffered Aspirin, YSP Aspirin, Zorprin

What is aspirin?

Aspirin is in a group of drugs called salicylates (sa-LIS-il-ates). It works by reducing substances in the body that cause pain, fever, and inflammation.

Aspirin is used to treat mild to moderate pain, and also to reduce fever or inflammation. Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Aspirin may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about aspirin?

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

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children.

Stop using this medication and call your doctor at once if you have any symptoms of bleeding in your stomach or intestines. Symptoms include black, bloody, or tarry stools, and coughing up blood or vomit that looks like coffee grounds.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding.

Aspirin is sometimes used to treat or prevent heart attacks, strokes, and chest pain (angina). Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

What should I discuss with my healthcare provider before taking aspirin?

Aspirin should not be given to a child or teenager who has a fever, especially if the child also has flu symptoms or chicken pox. Aspirin can cause a serious and sometimes fatal condition called Reye's syndrome in children. Do not use this medication if you are allergic to aspirin, or if you have:

• 
  

  a recent history of stomach or intestinal bleeding;

  
  


• 
  

  a bleeding disorder such as hemophilia; or

  
  


• 
  

  an allergy to an NSAID (non-steroidal anti-inflammatory drug) such as Advil, Motrin, Aleve, Orudis, Indocin, Lodine, Voltaren, Toradol, Mobic, Relafen, Feldene, and others.

  
  

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take aspirin:

• 
  

  asthma or seasonal allergies;

  
  


• 
  

  stomach ulcers;

  
  


• liver disease;


• kidney disease;


• 
  

  a bleeding or blood clotting disorder;

  
  


• 
  

  heart disease, high blood pressure, or congestive heart failure;

  
  


• 
  

  gout; or

  
  


• 
  

  nasal polyps.

  
  

If you are taking aspirin to prevent heart attack or stroke, avoid also taking ibuprofen (Advil, Motrin). Ibuprofen may make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form). This medication may be harmful to an unborn baby's heart, and may also reduce birth weight or have other dangerous effects. Tell your doctor if you are pregnant or plan to become pregnant while you are taking aspirin. Aspirin 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 aspirin?

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

Take this medication with a full glass of water. Taking aspirin with food or milk can lessen stomach upset. Enteric-coated aspirin is specially formulated to be gentle on your stomach, but you may take it with food or milk if desired. Do not crush, chew, break, or open an enteric-coated or extended-release pill. Swallow the pill whole. The enteric-coated pill has a special coating to protect your stomach. Breaking the pill could damage this coating. The extended-release tablet is specially made to release medicine slowly in the body. Breaking this pill would cause too much of the drug to be released at one time.

The chewable tablet form of aspirin must be chewed before swallowing.

Keep the orally disintegrating tablet in its package until you are ready to take the medicine. Open the package and peel the back cover from the tablet. Using dry hands, place the tablet into your mouth. It will begin to dissolve right away, without water. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

If you need to have any type of surgery, tell the surgeon ahead of time that you are taking aspirin. You may need to stop using the medicine for a short time.

Do not take this medication if you smell a strong vinegar odor in the aspirin bottle. The medicine may no longer be effective. Store aspirin at room temperature away from moisture and heat.

What happens if I miss a dose?

Since aspirin is often used as needed, you may not be on a dosing schedule. If you are using the medication regularly, take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and wait until your next regularly scheduled dose. Do not use 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 ringing in your ears, headache, nausea, vomiting, dizziness, confusion, hallucinations, rapid breathing, fever, seizure (convulsions), or coma.

What should I avoid while taking aspirin?

Do not use any other over-the-counter medication without first asking your doctor or pharmacist. Aspirin is contained in many medicines available over the counter. If you take certain products together you may accidentally take too much aspirin. Read the label of any other medicine you are using to see if it contains aspirin.

Avoid taking an NSAID (non-steroidal anti-inflammatory drug) while you are taking aspirin. NSAIDs include ibuprofen (Motrin, Advil), diclofenac (Voltaren), diflunisal (Dolobid), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), naproxen (Aleve, Naprosyn), piroxicam (Feldene), and others.

Avoid drinking alcohol while you are taking aspirin. Alcohol may increase your risk of stomach bleeding. Avoid taking ibuprofen (Advil, Motrin) if you are taking aspirin to prevent stroke or heart attack. Ibuprofen can make aspirin less effective in protecting your heart and blood vessels. If you must use both medications, take the ibuprofen at least 8 hours before or 30 minutes after you take the aspirin (non-enteric coated form).

Aspirin side effects

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

• 
  

  black, bloody, or tarry stools;

  
  


• 
  

  coughing up blood or vomit that looks like coffee grounds;

  
  


• 
  

  severe nausea, vomiting, or stomach pain;

  
  


• 
  

  fever lasting longer than 3 days;

  
  


• 
  

  swelling, or pain lasting longer than 10 days; or

  
  


• 
  

  hearing problems, ringing in your ears.

  
  

Less serious side effects may include:

• 
  

  upset stomach, heartburn;

  
  


• 
  

  drowsiness; or

  
  


• 
  

  headache.

  
  

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 aspirin?

Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with aspirin may cause you to bruise or bleed easily.

Before taking aspirin, tell your doctor if you are using any of the following drugs:

• 
  

  a blood thinner such as warfarin (Coumadin); or

  
  


• 
  

  another salicylate such as choline salicylate and/or magnesium salicylate (Magan, Doan's, Bayer Select Backache Pain Formula, Mobidin, Arthropan, Trilisate, Tricosal), or salsalate (Disalcid).

  
  

This list is not complete and there may be other drugs that can interact with aspirin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More St. Joseph Aspirin Adult EC resources

• St. Joseph Aspirin Adult EC Side Effects (in more detail)
• St. Joseph Aspirin Adult EC Use in Pregnancy & Breastfeeding
• St. Joseph Aspirin Adult EC Drug Interactions
• 0 Reviews for St. Joseph Aspirin Adult EC - Add your own review/rating

• Aspirin Monograph (AHFS DI)


• Aspirin Prescribing Information (FDA)


• Aspirin MedFacts Consumer Leaflet (Wolters Kluwer)


• Bayer Low Strength Delayed-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)


• Ecotrin Advanced Consumer (Micromedex) - Includes Dosage Information


• ZORprin Controlled-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

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• Prosthetic Heart Valves
• Prosthetic Heart Valves, Mechanical Valves
• Revascularization Procedures, Prophylaxis
• Thromboembolic Stroke Prophylaxis
• Transient Ischemic Attack

Where can I get more information?

• Your pharmacist can provide more information about aspirin.

See also: St. Joseph Aspirin Adult EC side effects (in more detail)

D-GAM, Solution for Injection 500iu vials

1. Name Of The Medicinal Product

D-GAM ^®, Human Anti-D Immunoglobulin, 500 IU, solution for injection.

2. Qualitative And Quantitative Composition

Each vial contains 500 IU human Anti-D immunoglobulin

One mL contains 250 IU/ml human Anti-D immunoglobulin.

*100 micrograms of human anti-D immunoglobulin correspond to 500 international units (IU).

Human protein content 5 – 50 g/L of which at least 95% is IgG.

For excipients see 6.1.

3. Pharmaceutical Form

A solution for injection.

4. Clinical Particulars

4.1 Therapeutic Indications

Prevention of RhD immunisation in RhD negative women:

i. Pregnancy/delivery of a RhD positive baby.

ii. Abortion/threatened abortion, ectopic pregnancy or hydatidiform mole.

iii. After ante-partum haemorrhage (APH), amniocentesis, chorionic biopsy or obstetric manipulative procedure e.g. external version, or abdominal trauma, which may cause transplacental haemorrhage (TPH).

Treatment of RhD negative patients after transfusions of RhD positive blood or other products containing RhD positive red blood cells (e.g. platelets).

4.2 Posology And Method Of Administration

Posology

a) Post-Natal Dosage:

The recommended dose is 500 IU.

For postnatal use, the product should be administered as soon as possible within 72 hours of delivery.

If a large fetomaternal haemorrhage is suspected, its extent should be determined by a suitable method and additional doses of anti-D should be administered as indicated.

b) Ante-Natal Prophylaxis:

500 IU given at both 28 and 34 weeks of gestation or

a single dose of 1,500 IU at 28 weeks of gestation.

c) Following a Potentially Sensitising Event During Pregnancy:

D-GAM ^® should be administered as soon as possible and no later than 72 hours after the event.

Up to 20 weeks gestation: recommended dose is 250 IU per incident.

After 20 weeks gestation: recommended dose is 500 IU per incident. A test for the size of the FMH should be performed when anti-D is given after 20 weeks and additional doses of anti-D should be administered as indicated.

d) Prevention of Immunisation in RhD Negative Patients Given Blood Components Containing RhD Positive Cells:

Recommended doses: 125 IU per mL of transfused RhD positive red cells; 250 IU per three adult doses of platelets.

Method of administration

For intramuscular use (preferably into the deltoid muscle).

D-GAM ^® vials are for single use only.

In the case of haemorrhagic disorders, where intramuscular injections are contra-indicated, Anti-D immunoglobulin may be administered subcutaneously. Careful manual pressure with a compress should be applied to the site after injection.

If large total doses (>5 mL) are required, it is advisable to administer them in divided doses at different sites.

4.3 Contraindications

Hypersensitivity to any of the components.

4.4 Special Warnings And Precautions For Use

Do not administer this product intravenously (risk of shock).

In the case of post-partum use, the product is intended for maternal administration. It should not be given to the newborn infant.

The product is not intended for use in RhD positive individuals.

Patients should be observed for at least 20 minutes after administration.

If symptoms of allergic or anaphylactic type reactions occur, immediate discontinuation of the administration is required.

True hypersensitivity reactions are rare but allergic type responses to Anti-D immunoglobulin may occur. Patients should be informed of the early signs of hypersensitivity reactions including hives, generalised urticaria, tightness of the chest, wheezing, hypotension and anaphylaxis. The treatment required depends on the nature and severity of the side effect. In case of shock, the current medical standards for shock treatment should be observed.

D-GAM ^® contains a small quantity of IgA. Although anti-D immunoglobulin has been used successfully to treat selected IgA deficient individuals, the attending physician must weigh the benefit against the potential risks of hypersensitivity reactions. Individuals deficient in IgA have a potential for development of IgA antibodies and anaphylactic reactions after administration of blood components containing IgA.

Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded. This also applies to unknown or emerging viruses and other pathogens.

The viral removal/inactivation procedures may be of limited value against non-enveloped viruses such as hepatitis A virus or parvovirus B19.

In the interest of patients, it is recommended that, whenever possible, every time that D-GAM ^® is administered to them, the name and batch number of the product is registered.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Active immunisation with live virus vaccines (e.g. measles, mumps or rubella) should be postponed until 3 months after the administration of Anti-D immunoglobulin, as the efficacy of the live virus vaccine may be impaired. If Anti-D immunoglobulin needs to be administered within 2-4 weeks of a live virus vaccination, then the efficacy of such a vaccination may be impaired.

After injection of immunoglobulin, the transitory rise of the various passively transferred antibodies in the patient's blood may result in misleading positive results in serological testing.

The results of blood typing and antibody testing, including the Coombs' or antiglobulin test, are significantly affected by the administration of anti-D immunoglobulin.

4.6 Pregnancy And Lactation

This medicinal product is used in pregnancy.

4.7 Effects On Ability To Drive And Use Machines

No effects on ability to drive and use machines have been observed.

4.8 Undesirable Effects

Local pain and tenderness can be observed at the injection site; this can be prevented by dividing larger doses over several injection sites.

The following side effects are known to be associated with Anti-D (the incidence has not been quantified): Occasionally fever, malaise, headache, cutaneous reactions and chills occur. In rare cases: nausea, vomiting, hypotension, tachycardia and allergic or anaphylactic type reactions, including dyspnoea and shock, are reported, even when the patient has shown no hypersensitivity to previous administration.

For information on viral safety see 4.4.

4.9 Overdose

No data are available on overdosage. RhD negative patients who are given RhD positive blood or other products containing RhD positive red blood cells and receive anti-D immunoglobulin should be monitored clinically and by biological parameters, because of the risk of haemolytic reaction.

In other RhD negative individuals, overdosage should not lead to more frequent or more severe undesirable effects than the normal dose.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group: immune sera and immunoglobulins: Anti-D (Rh) immunoglobulin. ATC code: J06B B01.

Anti-D immunoglobulin contains specific antibodies (IgG) against the RhD antigen of human erythrocytes.

5.2 Pharmacokinetic Properties

Measurable levels of antibodies are obtained approximately 8 hours after intramuscular injection. Peak serum levels are usually achieved 2 to 4 days later.

The half-life in the circulation of individuals with normal IgG levels is 3 to 5 weeks.

IgG and IgG-complexes are broken down in cells of the reticuloendothelial system.

5.3 Preclinical Safety Data

D-GAM ^® is a preparation of human plasma proteins, so safety testing in animals is not particularly relevant to the safety of use in man. Acute toxicity studies in rat and mouse showed species specific reactions, which bear no relevance to administration in humans.

Repeated dose safety testing is impracticable due to the induction of and interference with antibodies to human protein. Clinical experience provides no sign of tumourigenic and mutagenic effects.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sodium chloride

Glycine

Sodium acetate trihydrate

Sodium hydroxide

6.2 Incompatibilities

This medicinal product must not be mixed with other medicinal products.

6.3 Shelf Life

Stored at 2° - 8°C:	2 years.
Stored at 25°C:	1 week.

6.4 Special Precautions For Storage

D-GAM ^® should be stored in the original container at 2°C to 8°C. Storage for up to one week at ambient temperatures (25°C) in the original container is not detrimental. DO NOT FREEZE.

The condition of date-expired, or incorrectly stored product cannot be guaranteed. Such product may be unsafe, and should not be used.

6.5 Nature And Contents Of Container

Neutral borosilicate glass vial (Type I Ph.Eur.) with overseal consisting of a halobutyl rubber wad (Type I Ph.Eur.), clear lacquered aluminium skirt and flip-off polypropylene cap.

6.6 Special Precautions For Disposal And Other Handling

The product should be brought to room or body temperature before use.

The solution should be clear or slightly opalescent. Do not use solutions which are cloudy or have deposits.

Any unused product or waste material should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Bio Products Laboratory

Dagger Lane

Elstree

Hertfordshire

WD6 3BX

United Kingdom.

8. Marketing Authorisation Number(S)

PL 08801/0048 - 500 IU dose size.

9. Date Of First Authorisation/Renewal Of The Authorisation

31 July 2000

10. Date Of Revision Of The Text

11th August 2011	Version Code: SDS5B
POM

Hiprex Tablets

1. Name Of The Medicinal Product

Hiprex 1 g Tablets

2. Qualitative And Quantitative Composition

Each Hiprex tablet contains methenamine hippurate 1 g.

For excipients see 6.1.

3. Pharmaceutical Form

White, oblong tablet with breakline marked HX on one side and 3M on the other.

4. Clinical Particulars

4.1 Therapeutic Indications

Hiprex is indicated in the prophylaxis and treatment of urinary tract infections:

1. As maintenance therapy after successful initial treatment of acute infections with antibiotics.

2. As long-term therapy in the prevention of recurrent cystitis.

3. To suppress urinary infection in patients with indwelling catheters and to reduce the incidence of catheter blockage.

4. To provide prophylaxis against the introduction of infection into the urinary tract during instrumental procedures.

5. Asymptomatic bacteriuria.

4.2 Posology And Method Of Administration

Adults: 1g twice daily.

In patients with catheters the dosage may be increased to 1g three times daily.

Children under 6 years: Not recommended.

Children: 6-12 years: 500mg twice daily.

Elderly: No special dosage recommendations.

The tablets may be halved, or they can be crushed and taken with a drink of milk or fruit juice if the patient prefers.

4.3 Contraindications

Hepatic dysfunction, renal parenchymal infection, severe dehydration, metabolic acidosis, severe renal failure (creatinine clearance or GFR<10 ml/min.) or gout. Hiprex may be used where mild (20-50 ml/min.) to moderate (10-20 ml/min.) renal insufficiency is present. (If the GFR is not available the serum creatinine concentration can be used as a guide.).

Hiprex should not be administered concurrently with sulphonamides because of the possibility of crystalluria, or with alkalising agents, such as a mixture of potassium citrate.

4.4 Special Warnings And Precautions For Use

None.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Methenamine hippurate should not be given/administered concurrently with sulphonamides because of the possibility of crystalluria, or with alkalising agents such as potassium citrate. Concurrent use with acetazolamide should be avoided as the desired effect of hexamine will be lost.

4.6 Pregnancy And Lactation

There is inadequate evidence of safety of the drug in human pregnancy but it has been in wide use for many years without apparent ill consequence, animal studies having shown no hazard.

Methenamine is excreted in breast milk but the quantities will be insignificant to the infant. Mothers can therefore breast feed their infants.

4.7 Effects On Ability To Drive And Use Machines

None.

4.8 Undesirable Effects

Occasionally rashes, pruritis,gastric irritation, irritation of the bladder, may occur.

All side effects are reversible on the withdrawal of the drug.

4.9 Overdose

Vomiting and haematuria may occur. These can be treated by the use of an anti-emetic and drinking copious quantities of water respectively. Bladder symptoms can be treated by the consumption of copious quantities of water and 2-3 teaspoonfuls of bicarbonate of soda.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Pharmacotherapeutic group G04A A01

Hiprex is a urinary antibacterial agent with a wide antibacterial spectrum covering both gram-positive and gram-negative organisms. Urinary antibacterial activity can be shown within 30 minutes of administration.

The chemical structure of methenamine hippurate is such that a two-fold antibacterial action is obtained:

1. The slow release of the bactericidal formaldehyde, from the methenamine part, in the urine; acid pH is necessary for this reaction to occur. It is obtained and maintained there by the presence of hippuric acid.

2. The bacteriostatic effect of hippuric acid itself on urinary tract pathogens.

5.2 Pharmacokinetic Properties

Methenamine hippurate is readily absorbed from the gastro-intestinal tract and excreted via the kidney.

Plasma concentrations of methenamine hippurate reach maximum 1-2 hours after a single dose and then decline with a half-life of about 4 hours. Methenamine recovered in the urine corresponds to about 80% of the dose given per 12 hours.

5.3 Preclinical Safety Data

Not applicable

6. Pharmaceutical Particulars

6.1 List Of Excipients

Magnesium Stearate

Povidone

Colloidal anhydrous silica

6.2 Incompatibilities

Not applicable.

6.3 Shelf Life

5 years

6.4 Special Precautions For Storage

Do not store above 30°C. Keep bottle tightly closed.

6.5 Nature And Contents Of Container

Glass bottles of 60 tablets

6.6 Special Precautions For Disposal And Other Handling

None

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 15142/0099

9. Date Of First Authorisation/Renewal Of The Authorisation

12 October 1989/13 September 2005

10. Date Of Revision Of The Text

31^st March 2010

Dithrocream

1. Name Of The Medicinal Product

DITHROCREAM™

2. Qualitative And Quantitative Composition

Dithranol 0.1%, 0.25%, 0.5%, 1.0% or 2.0% w/w.

3. Pharmaceutical Form

Yellow aqueous cream.

4. Clinical Particulars

4.1 Therapeutic Indications

For the topical treatment of subacute and chronic psoriasis including psoriasis of the scalp.

4.2 Posology And Method Of Administration

Dithranol therapy customarily involves titrating the concentration applied to skin to suit individual patient's circumstances. Dithrocream is, therefore, available in five strengths. The different packs are colour coded as follows:

0.1%	pale blue
0.25%	red
0.5%	purple
1.0%	brown
2.0%	yellow

For adults and the elderly: It is important to determine each patient's optimal treatment strength, as too high a strength may induce a burning sensation. Where the response to Dithrocream has not previously been established, always commence with Dithrocream 0.1%, continuing for at least one week and then, if necessary, increase to the 0.25% followed by the 0.5%, the 1.0% and finally the 2.0% strength. The aim should be to build up gradually over approximately 4 weeks to the highest tolerated strength to produce the optimum therapeutic effect. This optimum concentration will depend upon such factors as the thickness and location of the psoriatic plaques, as well as the variation between individual patients in their reaction to dithranol.

Dithrocream should be applied sparingly, and only to the affected areas, once every 24 hours, at any convenient time of the day or evening. Rub the cream gently and carefully into the skin until completely absorbed. For use on the scalp, first comb the hair to remove scalar debris and, after suitably parting, rub the cream well into the affected areas. Remove by washing off the skin or scalp, usually no more than one hour after application (Short Contact Therapy). Alternatively, it may be applied at night before retiring and washed off in the morning.

Treatment should be continued until the skin is entirely clear, i.e. when there is nothing to feel with the fingers and the texture is normal. By gradually increasing the strength of cream applied, it should be possible to clear psoriasis patches within 4 to 6 weeks.

For children No additional special precautions necessary. However, use cautiously as described above for adults and the elderly, with regular supervision.

4.3 Contraindications

Not to be used on the face, or for acute or pustular psoriasis.

Not to be used in cases of sensitivity to any of the ingredients.

4.4 Special Warnings And Precautions For Use

Dithrocream 0.5%, Dithrocream 1.0% and Dithrocream 2.0% should only be used for those patients who have failed to respond to lower strengths of dithranol. Dithrocream 1.0% and 2.0% should normally only be applied for 'short contact' periods.

Dithrocream 0.5%, Dithrocream 1.0% and Dithrocream 2.0% should always be used under medical supervision.

It is most important to avoid applying an excessive amount of the cream, which may cause unnecessary soiling and staining of the clothing and/or bed linen. After each period of treatment, a bath/shower should be taken to remove any residual cream. To prevent the possibility of discolouration, particularly where Dithrocream 1.0% or 2.0% has been used, always rinse the bath/shower with hot water immediately after washing/showering and then use a suitable cleanser to remove any deposit on the surface of the bath/shower.

After use on the scalp, a shampoo may be used to remove the Dithrocream residue. Great care must be taken when washing out the shampoo (which may contain some Dithrocream residue), to ensure that it does not get into the eyes or on the face. This is particularly important when the higher strengths of Dithrocream have been used.

Although a feeling of warmth at the application site is normal, if this amounts to a burning sensation, or if the lesions spread, treatment should be stopped at once, and the dosage re-evaluated by a doctor.

Dithrocream is not normally recommended for use on areas of folded skin such as the groin and beneath the breasts. Do not use high strengths on these sites.

Keep away from the eyes and mucous membranes.

Always wash the hands after use.

As long term use of topical corticosteroids is known to destabilise psoriasis, and withdrawal may give rise to a rebound phenomenon, an interval of at least one week should be allowed between the discontinuance of such steroids and the commencement of Dithrocream therapy. A suitably bland emollient may usefully be applied in the intervening period.

The excipients, chlorocresol and cetostearyl alcohol may on rare occasions give rise to allergic or local skin reactions (eg. contact dermatitis) in sensitive people.

Contact with fabrics, plastics and other materials may cause permanent staining and should be avoided.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

Although there is no experimental evidence to support the safety of the drug in pregnancy or during lactation, no adverse effects have been reported.

4.7 Effects On Ability To Drive And Use Machines

None known.

4.8 Undesirable Effects

Some skin irritation and/or a feeling of warmth at the site of application is normally associated with dithranol therapy. Dithrocream applied at too high a strength or left in contact with the skin for too long may induce a burning sensation.

Dithrocream may cause temporary staining of the skin and/or hair.

4.9 Overdose

Dithranol is a cathartic (laxative) and if accidentally swallowed, it should be removed by gastric lavage.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Dithranol has been used in the treatment of sub-acute and chronic psoriasis for over 70 years and, during that time, it has become established as a safe and effective form of therapy. Its precise mode of action is still to be confirmed, although it has been shown to inhibit DNA replication, cellular respiration and key cellular enzymes eg glucose-6-phosphate dehydrogenase.

Because dithranol causes staining and irritation, it is now widely used in short contact therapy where the preparation is washed off the skin after periods of one hour or less. For this purpose, Dithrocream is particularly suitable, as it is convenient to apply and washes off easily in a bath or shower.

5.2 Pharmacokinetic Properties

The traditional formulations of dithranol are based on soft paraffin from which it is effectively released into the skin. In Dithrocream, during manufacture, the oily paraffin phase of the cream is heated until the dithranol entirely dissolves so that, on cooling, it is retained solely within the paraffin phase and does not spread into the aqueous phase. After application of Dithrocream to the skin, the water is lost through absorption and evaporation, leaving the oily phase which then acts in the same way as a dithranol ointment. However, since the cream may be rubbed into the skin more effectively than the ointment, it is convenient to apply and, owing to the presence of the emulsifying components, is easier to wash off.

The availability of the dithranol has now been confirmed in numerous publications detailing the results of clinical trials.

5.3 Preclinical Safety Data

No special information.

6. Pharmaceutical Particulars

6.1 List Of Excipients

White Soft Paraffin; Cetostearyl Alcohol; Salicylic Acid; Ascorbic Acid; Sodium Laurilsulfate; Chlorocresol; Purified Water.

Dithrocream 2.0% also contains Liquid Paraffin.

6.2 Incompatibilities

None known.

6.3 Shelf Life

48 months.

6.4 Special Precautions For Storage

Do not store above 25°C. Replace cap tightly after use.

6.5 Nature And Contents Of Container

All strengths of Dithrocream are supplied in collapsible tubes containing 50 g. These are supplied as original packs (OP).

6.6 Special Precautions For Disposal And Other Handling

Not applicable.

7. Marketing Authorisation Holder

Dermal Laboratories

Tatmore Place, Gosmore

Hitchin, Herts SG4 7QR, UK.

8. Marketing Authorisation Number(S)

Dithrocream 0.1%	00173/0029
Dithrocream 0.25%	00173/0028
Dithrocream 0.5%	00173/0027
Dithrocream 1.0%	00173/0039
Dithrocream 2.0%	00173/0045

9. Date Of First Authorisation/Renewal Of The Authorisation

31 July 2008.

10. Date Of Revision Of The Text

October 2006.

papain-urea topical

Generic Name: papain-urea topical (PA pane yoo REE ah)

Brand names: Accuzyme, AllanEnzyme, Ethezyme 650, Ethezyme 830, Gladase, Kovia, Pap-Urea, ...show all 17 brand names.Panafil (obsolete), Panafil White, Ethezyme, Ziox (obsolete), Gladase-C (obsolete), Allanfil (obsolete), Accuzyme SE, Panafil SE (obsolete), Kovia 6.5, Paptase

The U.S. Food and Drug Administration (FDA) has ordered companies to stop marketing unapproved drug products that contain papain in a topical dosage form. Firms marketing any unapproved topical papain products must stop manufacturing these products by November 24, 2008. Issued 23rd September 2008

What is papain-urea topical?

Papain is a substance from the papaya fruit. Papain breaks down certain proteins.

Urea also breaks down protein.

Papain-urea topical is used to break down dead skin or tissues in wounds such as bed sores, ulcers, burns, surgical wounds, cysts, and carbuncles. This process is sometimes called debridement (de-BREED-ment). The broken-down tissues can then be more easily removed.

Papain-urea topical may also be used for purposes other than those listed in this medication guide.

What is the most important information I should know about papain-urea topical?

Wash your hands before and after applying papain-urea topical.

Clean the wound as directed by your doctor. Use only the type of cleanser your doctor has recommended.

Apply papain-urea topical directly to the wound. Then cover the treated area with bandaging or other dressing recommended by your doctor. Keep the wound covered at all times, because this medication will cause the dead tissues to slough and peel off.

Avoid using hydrogen peroxide to clean your wound before applying papain-urea topical. Hydrogen peroxide can make the papain-urea less effective in breaking down the tissues of your wound.

Do not use other medicated skin products unless your doctor has told you to.

What should I discuss with my healthcare provider before using papain-urea topical?

Do not use this medication if you are allergic to papain or urea.

Before using papain-urea topical, tell your doctor if you are allergic to any drugs, or if you have other medical conditions. You may not be able to papain-urea topical, or you may need a dosage adjustment or special tests during treatment.

It is not known whether papain-urea will be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether papain-urea passes into breast milk. Do not use papain-urea topical without telling your doctor if you are breast-feeding a baby.

How should I use papain-urea topical?

Use this medication exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Wash your hands before and after applying papain-urea topical.

Clean the wound as directed by your doctor. Use only the type of cleanser your doctor has recommended.

Apply papain-urea topical directly to the wound. Then cover the treated area with bandaging or other dressing recommended by your doctor. Keep the wound covered at all times, because this medication will cause the dead tissues to slough and peel off.

Papain-urea topical is usually applied two times each day. Clean the wound and apply a fresh bandage dressing each time you use the medication.

It is important to use papain-urea regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Store papain-urea topical at room temperature away from moisture and heat.

What happens if I miss a dose?

Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if an overdose of papain-urea is suspected or if the medication has been ingested.

Symptoms of an overdose of papain-urea topical are not known.

What should I avoid while using papain-urea topical?

Avoid using hydrogen peroxide to clean your wound before applying papain-urea topical. Hydrogen peroxide can make the papain-urea less effective in breaking down the tissues of your wound.

Do not use other medicated skin products unless your doctor has told you to.

Avoid getting this medication in your eyes, mouth, and nose, or on your lips. If it does get into any of these areas, wash with water.

Papain-urea topical 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.

Less serious side effects may be more likely to occur, such as mild stinging or burning of the skin where the medicine is applied.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Papain-urea topical Dosing Information

Usual Adult Dose for Dermatologic Lesion:

Papain-urea 830,000 units/g-10% topical ointment or foam:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 650,000 units/g-10% topical ointment:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 1,100,000 units/g-10% topical ointment:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 10%-10% topical spray:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, spray 1 to 2 inches from the affected area until the wound is completely covered. Apply dressing of choice.

Papain-urea-chlorophyllin copper complex sodium 10%-10%-0.5%:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, spray 2 to 3 inches from the affected area until the wound is completely covered. Apply dressing of choice. While application 1 to 2 times daily is preferred, longer intervals of up to 2 to 3 days have been reported.

Usual Adult Dose for Burns - External:

Papain-urea 830,000 units/g-10% topical ointment or foam:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 650,000 units/g-10% topical ointment:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 1,100,000 units/g-10% topical ointment:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 10%-10% topical spray:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, spray 1 to 2 inches from the affected area until the wound is completely covered. Apply dressing of choice.

Papain-urea-chlorophyllin copper complex sodium 10%-10%-0.5%:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, spray 2 to 3 inches from the affected area until the wound is completely covered. Apply dressing of choice. While application 1 to 2 times daily is preferred, longer intervals of up to 2 to 3 days have been reported.

Usual Adult Dose for Wound Debridement:

Papain-urea 830,000 units/g-10% topical ointment or foam:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 650,000 units/g-10% topical ointment:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 1,100,000 units/g-10% topical ointment:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, apply ointment directly to lesion and cover with appropriate dressing.

Papain-urea 10%-10% topical spray:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, spray 1 to 2 inches from the affected area until the wound is completely covered. Apply dressing of choice.

Papain-urea-chlorophyllin copper complex sodium 10%-10%-0.5%:
Irrigate and cleanse the lesion with isotonic saline or a mild cleansing solution 1 or 2 times daily. After cleansing, spray 2 to 3 inches from the affected area until the wound is completely covered. Apply dressing of choice. While application 1 to 2 times daily is preferred, longer intervals of up to 2 to 3 days have been reported.

What other drugs will affect papain-urea topical?

There may be other drugs that can affect papain-urea topical. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

More papain-urea topical resources

• Papain-urea topical Side Effects (in more detail)
• Papain-urea topical Use in Pregnancy & Breastfeeding
• Papain-urea topical Drug Interactions
• Papain-urea topical Support Group
• 1 Review for Papain-urea - Add your own review/rating

• Accuzyme Ointment MedFacts Consumer Leaflet (Wolters Kluwer)


• Accuzyme SE Spray Emulsion MedFacts Consumer Leaflet (Wolters Kluwer)


• AllanEnzyme Spray MedFacts Consumer Leaflet (Wolters Kluwer)


• Paptase Foam MedFacts Consumer Leaflet (Wolters Kluwer)

Compare papain-urea topical with other medications

• Burns, External
• Dermatologic Lesion
• Wound Cleansing

Where can I get more information?

• Your pharmacist has information about papain-urea topical written for health professionals that you may read.

See also: papain-urea side effects (in more detail)