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Thursday, 16 August 2012

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

Monday, 13 August 2012

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.

Thursday, 9 August 2012

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.

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.

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:

Usual Adult Dose for Wound Debridement:

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.

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)

Monday, 6 August 2012

Miscellaneous antidepressants

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.

Saturday, 4 August 2012

Vicks Cough Syrup for Chesty Coughs

1. Name Of The Medicinal Product

Vicks Cough Syrup for Chesty Coughs

2. Qualitative And Quantitative Composition

ACTIVE INGREDIENTS

	%w/v	Specification
Guaifenesin	1.333	Ph. Eur.

3. Pharmaceutical Form

Syrup for oral administration.

4. Clinical Particulars

4.1 Therapeutic Indications

To relieve a cough, loosen mucus, soothe and coat the throat and make the cough more productive.

4.2 Posology And Method Of Administration

Adults and children 12 years and over: 3 x 5ml spoonfuls

Repeat every 4 hours as needed.

No more than 6 doses a day

4.3 Contraindications

Not to be used in children under the age of 6 years

Known hypersensitivity to guaifenesin.

4.4 Special Warnings And Precautions For Use

Do not exceed the stated dose.

Do not administer to children under 2 years except on medical advice.

If symptoms persist, consult your doctor.

Keep out of reach of children.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

None known.

4.6 Pregnancy And Lactation

There is no literature evidence of hazard due to guaifenesin but, as with all medicines, use is not recommended during the first trimester and during breast feeding.

4.7 Effects On Ability To Drive And Use Machines

None expected.

4.8 Undesirable Effects

Gastrointestinal discomfort has been reported.

4.9 Overdose

4.9.1 Symptoms

Symptoms of very large overdose include nausea and vomiting. Any absorbed guaifenesin is, however, rapidly metabolised and excreted in the urine.

4.9.2 Management of an overdose

Treatment is supportive and symptomatic.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Guaifenesin has an expectorant action which increases the output of the respiratory tract fluid by reducing surface tension. The increased flow of less viscid secretions promotes cilary action and facilitates the removal of mucous.

5.2 Pharmacokinetic Properties

Guaifenesin is absorbed from the gastrointestinal tract. It is metabolised and excreted in the urine.

5.3 Preclinical Safety Data

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

6. Pharmaceutical Particulars

6.1 List Of Excipients

Sucrose.

Sodium saccharin.

Propylene glycol.

Ethanol 96%.

Sodium citrate, hydrous.

Citric acid, anhydrous.

Carboxymethylcellulose sodium.

Polyethylene oxide.

Flavour 9512 (David Michael Heat)

Black cherry flavour RF 1195.

Levomenthol.

Menthoxypropanediol (TK10).

Macrogol stearate 40.

Sodium benzoate.

CI 16255 Acid red 18 (E124 Ponceau 4R).

Purified water.

6.2 Incompatibilities

None known.

6.3 Shelf Life

Shelf life (unopened): 3 years

6.4 Special Precautions For Storage

Do not store above 25^oC.

6.5 Nature And Contents Of Container

Amber cylindrical glass bottle (pharmaceutical type III) with a Crab claw seal (polypropylene) child resistant closure:

Bottles containing 15ml, 30ml, 100ml, 120ml, 180ml of product are available

6.6 Special Precautions For Disposal And Other Handling

No specific instructions required.

7. Marketing Authorisation Holder

Procter & Gamble (Health & Beauty Care) Ltd.,

The Heights,

Brooklands,

Weybridge,

Surrey,

KT13 0XP.

8. Marketing Authorisation Number(S)

PL 0129/0078

9. Date Of First Authorisation/Renewal Of The Authorisation

19 June 1996

10. Date Of Revision Of The Text

Oct 2009

Friday, 3 August 2012

Hypovase Tablets

1. Name Of The Medicinal Product

HYPOVASE™ TABLETS

2. Qualitative And Quantitative Composition

500 microgram tablets: prazosin hydrochloride Ph Eur equivalent to 500 micrograms prazosin base, based on potency of 93.1 % base activity.

1 mg tablets: prazosin hydrochloride Ph Eur equivalent to 1 mg prazosin based on a potency of 93.1 % base activity.

3. Pharmaceutical Form

500 microgram tablets: white and round marked “Pfizer” on one side.

1 mg tablets: white and oblong scored on both sides and engraved “M6” on one side.

4. Clinical Particulars

4.1 Therapeutic Indications

Hypertension: Hypovase is indicated in the treatment of all grades of essential (primary) hypertension and of all grades of secondary hypertension of varied aetiology. It can be used as the initial and sole agent or it may be employed in a treatment regimen in conjunction with a diuretic and/or other antihypertensive drug as needed for proper patient response.

Congestive heart failure: Hypovase may be used alone or added to the therapeutic regimen in those patients with congestive heart failure who are resistant or refractory to conventional therapy with diuretics and/or cardiac glycosides.

Raynaud's phenomenon and Raynaud's disease: Hypovase is indicated for the symptomatic treatment of patients with Raynaud's phenomenon and Raynaud's disease.

Benign prostatic hyperplasia: Hypovase is indicated as an adjunct in the symptomatic treatment of urinary obstruction caused by benign prostatic hyperplasia. It may therefore be of value in patients awaiting prostatic surgery.

4.2 Posology And Method Of Administration

Hypovase tablets are for oral administration only.

Hypertension: The dosage range is from 500 micrograms – 20 mg daily. It is recommended that therapy be initiated at the lowest dose, 500 micrograms, twice or three times daily for three to seven days, with the starting dose administered in the evening. This dose should be increased to 1 mg twice or three times daily for a further three to seven days. Thereafter, the daily dose should be increased gradually as determined by the patient's response to the blood pressure lowering effect. Most patients are likely to be maintained on a dosage regimen of Hypovase alone of up to 15 mg daily in divided doses. Maximum recommended daily dosage: 20 mg in divided doses.

Patients receiving other antihypertensive therapy but with inadequate control: The dosage of the other drug should be reduced to a maintenance level and Hypovase initiated at 500 micrograms in the evening, then continuing with 500 micrograms twice or three times daily. Subsequent dosage increases should be made gradually depending upon the patient's response.

There is evidence that adding Hypovase to angiotensin converting enzyme inhibitor, beta-adrenergic antagonist or calcium antagonist therapy may bring about a substantial reduction in blood pressure. Therefore, the low initial dosage regimen is recommended.

Congestive cardiac failure: The recommended starting dose is 500 micrograms two, three or four times daily, increasing to 4 mg in divided doses. Dosage should be adjusted according to the patient's clinical response, based on careful monitoring of cardiopulmonary signs and symptoms, and when indicated, haemodynamic studies. Dosage may be adjusted as often as every two to three days in patients under close medical supervision. In severely ill, decompensated patients, rapid dosage adjustment over one to two days may be indicated and is best done when haemodynamic monitoring is available. In clinical studies the therapeutic dosages ranged from 4 mg to 20 mg daily in divided doses. Adjustment of dosage may be required in the course of Hypovase therapy in some patients to maintain optimal clinical improvement.

Usual daily maintenance dosage: 4 mg to 20 mg in divided doses.

Raynaud's phenomenon and Raynaud's disease: The recommended starting dosage is 500 micrograms twice daily given for a period of three to seven days and should be adjusted according to the patient's clinical response. Usual maintenance dosage is 1 mg or 2 mg twice daily.

Benign prostatic hyperplasia: The recommended dosage is 500 micrograms twice daily for a period of 3 to 7 days, with the initial dose administered in the evening. The dosage should then be adjusted according to clinical response. The usual maintenance dosage is 2 mg twice daily. This dose should not be exceeded unless the patient requires Hypovase as antihypertensive therapy. Patients with benign prostatic hyperplasia receiving hypertensive therapy, should be administered Hypovase only under the supervision of the practitioner responsible for treating the patient's hypertension.

Patients with moderate to severe grades of renal impairment

Evidence to date shows that Hypovase does not further compromise renal function when used in patients with renal impairment. As some patients in this category have responded to small doses of Hypovase, it is recommended that therapy be initiated at 500 micrograms daily and that dosage increases be instituted cautiously.

Patients with hepatic dysfunction: No information is available on the use of Hypovase in this patient group, however, since Hypovase normally undergoes substantial first pass metabolism and subsequent metabolism and excretion by the liver, it is recommended that therapy be initiated at 500 micrograms daily and that dosage increases be instituted cautiously.

Use in children: Hypovase is not recommended for the treatment of children under the age of 12 years since safe conditions for its use have not been established.

Use in the elderly: Since the elderly may be more susceptible to hypotension, therapy should be initiated with the lowest possible dose.

4.3 Contraindications

Hypovase is contraindicated in patients with known sensitivity to Hypovase, other quinazolines, prazosin or any of the excipients.

4.4 Special Warnings And Precautions For Use

In patients with benign prostatic hyperplasia: Hypovase is not recommended for patients with a history of micturition syncope.

Hypovase decreases peripheral vascular resistance and since many patients with this disorder are elderly, careful monitoring of blood pressure during initial administration and during adjustment of dosage is recommended. The possibility of postural hypotension, or rarely, loss of consciousness, as reported in other patient groups should be borne in mind. Close observation is especially recommended. For patients taking medications that are known to lower blood pressure, Hypovase may augment the efficacy of antihypertensive therapy, consequently, close observation is especially recommended for patients taking medications that are known to lower blood pressure. Hypovase should not normally be administered to patients already receiving another alpha-1-antagonist.

In patients with congestive cardiac failure: Hypovase is not recommended in the treatment of congestive cardiac failure due to mechanical obstruction such as aortic valve stenosis, mitral valve stenosis, pulmonary embolism and restrictive pericardial disease. Adequate data are not yet available to establish efficacy in patients with heart failure due to recent myocardial infarction.

When Hypovase is initially administered to patients with congestive cardiac failure who have undergone vigorous diuretic or other vasodilator treatment, particularly in higher than the recommended starting dose, the resultant decrease in left ventricular filling pressure may be associated with a significant fall in cardiac output and systemic blood pressure. In such patients, observance of the recommended starting dose of Hypovase followed by gradual dosage increase is particularly important.

The clinical efficacy of Hypovase in congestive cardiac failure has been reported to diminish after several months of treatment, in a proportion of patients. In these patients there is usually evidence of weight gain or peripheral oedema indicating fluid retention. Since spontaneous deterioration may occur in such severely ill patients, a causal relationship to prazosin therapy has not been established. Thus, as with all patients with congestive cardiac failure, careful adjustment of diuretic dosage according to the patient's clinical condition is required to prevent excessive fluid retention and consequent relief of symptoms.

In those patients without evidence of fluid retention, when clinical improvement has diminished, an increase in the dosage of Hypovase will usually restore clinical efficacy.

In patients with hypertension: A very small percentage of patients may respond in an abrupt and exaggerated manner to the initial dose of Hypovase. Postural hypotension evidenced by dizziness and weakness, or rarely loss of consciousness, has been reported, particularly with the commencement of therapy, but this effect is readily avoided by initiating treatment with a low dose of Hypovase and with small increases in dosage during the first one to two weeks of therapy. The effect when observed is not related to the severity of hypertension, is self-limiting and in most patients does not recur after the initial period of therapy or during subsequent titration steps.

Raynaud's phenomenon and Raynaud's disease: Because Hypovase decreases peripheral vascular resistance, careful monitoring of blood pressure during initial administration and during subsequent dosage increments of Hypovase is suggested. Close observation is especially recommended for patients already taking medications that are known to lower blood pressure.

Use with phosphodiesterase-5 inhibitors (PDE-5 Inhibitors)

Concomitant use of PDE-5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) and prazosin hydrochloride may lead to symptomatic hypotension in some patients. In order to minimise the risk for developing postural hypotension the patient should be stable on the alpha-blocker therapy before initiating use of PDE-5 inhibitors.

Cataract surgery

The 'Intraoperative Floppy Iris Syndrome' (IFIS, a variant of small pupil syndrome) has been observed during cataract surgery in some patients on or previously treated with tamsulosin.

Isolated reports have also been received with other alpha-1 blockers and the possibility of a class effect cannot be excluded. As IFIS may lead to increased procedural complications during the cataract operation current or past use of alpha-1 blockers should be made known to the ophthalmic surgeon in advance of surgery.

4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction

Hypovase has been administered without any adverse drug interaction in clinical experience to date with the following:

Cardiac glycosides: digitalis and digoxin.

Hypoglycaemic agents: insulin, chlorpropamide, phenformin, tolazamide and tolbutamide.

Tranquillizers and sedatives: chlordiazapoxide, diazepam and phenobarbital.

Agents for treatment of gout: allopurinol, colchicine and probenecid.

Anti-arrhythmic agents: procainamide and quinidine.

Analgesic, antipyretic and anti-inflammatory agents: dextropropoxyphene, aspirin, indomethacinand phenylbutazone.

There is evidence that adding Hypovase to beta-adrenergic antagonist or calcium antagonist therapy may produce a substantial reduction in blood pressure. Therefore the low initial dosage regimen is recommended.

PDE-5 Inhibitors: Concomitant use of PDE-5 inhibitors (e.g. sildenafil, tadalafil, vardenafil) and prazosin hydrochloride may lead to symptomatic hypotension in some patients (see section 4.4).

Drug/Laboratory Test Interactions: False positive results may occur in screening tests for phaeochromocytoma urinary vanillylmandelic acid (VMA) and methoxyhydroxyphenyl glycol (MHPG) metabolites of norepinephrine (noradrenaline) in patients who are being treated with Hypovase. Concomitant administration of prazosin hydrochloride with PDE-5 inhibitors may lead to symptomatic hypotension in some patients; See section 4.4.

4.6 Pregnancy And Lactation

Although no teratogenic effects were seen in animal testing, the safety of Hypovase during pregnancy has not yet been established. The use of Hypovase and a beta-blocker for the control of severe hypertension in 44 pregnant women revealed no drug-related foetal abnormalities or adverse effects. Therapy with Hypovase was continued for as long as 14 weeks.

Hypovase has also been used alone or in combination with other hypotensive agents in severe hypertension of pregnancy. No foetal or neonatal abnormalities have been reported with the use of Hypovase.

Studies to date are inadequate to establish the safety of Hypovase in pregnancy, accordingly, it should be used only when, in the opinion of the physician, potential benefit outweighs potential risk. Hypovase has been shown to be excreted in small amounts in human milk. Caution should be exercised when Hypovase is administered to nursing mothers.

4.7 Effects On Ability To Drive And Use Machines

When instituting therapy with any effective antihypertensive agent, the patient should be advised on how to avoid symptoms resulting from postural hypotension and what measures to take should they develop. The patient should be cautioned to avoid situations where injury could result should dizziness or weakness occur during the initiation of Hypovase therapy (i.e. driving or operating machinery).

4.8 Undesirable Effects

The following side-effects have been associated with Hypovase therapy:

MedDRA System Organ Class	Frequency	Undesirable effects
Immune System Disorders	Rare	Allergic reaction
Psychiatric Disorders	Common	Depression, nervousness
	Uncommon	Insomnia
	Rare	Hallucinations
Nervous System Disorders	Common	Dizziness, drowsiness, headache, faintness, syncope
	Uncommon	Paraesthesia
	Rare	Worsening of pre-existing narcolepsy
Eye Disorders	Common	Blurred vision
	Uncommon	Eye pain, reddened sclera
Ear and Labyrinth Disorders	Common	Vertigo
	Uncommon	Tinnitus
Cardiac Disorders	Common	Palpitations
	Uncommon	Angina pectoris, tachycardia,
	Rare	Bradycardia
Vascular Disorders	Rare	Flushing, hypotension, orthostatic hypotension, vasculitis
Respiratory, Thoracic and Mediastinal Disorders	Common	Dyspnoea, nasal congestion
	Uncommon	Epistaxis
Gastrointestinal Disorders	Common	Constipation, diarrhoea, dry mouth, nausea, vomiting
	Uncommon	Abdominal discomfort and/or pain
	Rare	Pancreatitis
Hepato-biliary Disorders	Rare	Liver function abnormalities
Skin and Subcutaneous Tissue Disorders	Common	Rash
	Uncommon	Diaphoresis, pruritis, urticaria
	Rare	Alopecia, lichen planus
Musculoskeletal and Connective Tissue Disorders	Uncommon	Arthralgia
Renal and Urinary Disorders	Common	Urinary frequency
	Rare	Incontinence
Reproductive System and Breast Disorders	Uncommon	Impotence
	Rare	Gynaecomastia, priapism
General Disorders and Administration Site Conditions	Common	Oedema, lack of energy, weakness
	Rare	Fever, pain
Investigations	Rare	Positive ANA titer

The frequency of side-effects observed in patients being managed for left ventricular failure with Hypovase when used in conjunction with cardiac glycosides and diuretics is shown below:

MedDRA System Organ Class	Frequency	Undesirable effects
Nervous System Disorders	Common	Dizziness
	Uncommon	Headache
	Rare	Drowsiness
Eye Disorders	Common	Blurred vision
Cardiac Disorders	Rare	Palpitations
Vascular Disorders	Common	Postural hypotension
Respiratory, Thoracic and Mediastinal Disorders	Rare	Nasal congestion
Gastrointestinal Disorders	Common	Dry mouth, nausea
	Uncommon	Diarrhoea
Reproductive System and Breast Disorders	Common	Impotence
General Disorders and Administration Site Conditions	Rare	Oedema

In most instances these occurrences have been mild to moderate in severity and have resolved with continued therapy or have been tolerated with no decrease in drug dosage.

4.9 Overdose

Should over-dosage lead to hypotension, support of the cardiovascular system is of first importance. Restoration of blood pressure and normalization of heart rate may be accomplished by keeping the patient in the supine position. If this measure is inadequate, shock should first be treated with volume expanders. If necessary, vasopressors including angiotensin should then be used. Renal function should be monitored and supported as needed. Laboratory data indicate Hypovase is not dialysable because it is protein bound.

5. Pharmacological Properties

5.1 Pharmacodynamic Properties

Hypovase causes a decrease in total peripheral vascular resistance through selective inhibition of postsynaptic alpha-1-adrenoreceptors in vascular smooth muscle. The results of forearm plethysmographic studies in humans demonstrate that the resultant peripheral vasodilation is a balanced effect on both resistance vessels (arterioles) and capacitance vessels (veins).

In hypertensive patients, blood pressure is lowered in both the supine and standing positions; this effect is more pronounced on the diastolic blood pressure. Tolerance to the antihypertensive effect has not been observed in long-term clinical use; relatively little tachycardia or change in renin levels has been noted. Rebound elevation of blood pressure does not occur following abrupt cessation of Hypovase therapy.

The therapeutic efficacy of Hypovase in patients with congestive heart failure is ascribed to a reduction in left ventricular filling pressure, reduction in cardiac impedance and an augmentation of cardiac output. The use of Hypovase in congestive heart failure does not provoke a reflex tachycardia and blood pressure reduction is minimal in normotensive patients.

Hypovase has been found to successfully reduce the severity of the signs, symptoms, frequency and duration of attacks, in patients with Raynaud's disease.

In low dosage, antagonism of alpha-1-receptors on prostatic and urethral smooth muscle has been shown to improve the urinary pressure profile in men and to improve symptoms of benign prostatic hypertrophy.

Clinical studies have shown that Hypovase therapy is not associated with adverse changes in the serum lipid profile.

5.2 Pharmacokinetic Properties

Following oral administration in normal volunteers and hypertensive patients plasma concentrations of prazosin reach a peak in one to two hours with a plasma half-life of two to three hours. Pharmacokinetic data in a limited number of patients with congestive heart failure, most of whom showed evidence of hepatic congestion, indicates that peak plasma concentrations are reached in 2.5 hours and plasma half life is approximately 7 hours. Hypovase is highly bound to plasma protein. Studies indicate that Hypovase is extensively metabolised, primarily by demethylation and conjugation, and excreted mainly via bile and faeces.

Renal blood flow and glomerular filtration rate are not impaired by long term oral administration and thus Hypovase can be used with safety in hypertensive patients with impaired renal function.

6. Pharmaceutical Particulars

6.1 List Of Excipients

Calcium phosphate dibasic anhydrous

Maize starch

Microcrystalline cellulose

Magnesium stearate

Sodium lauryl sulphate

6.2 Incompatibilities

None stated.

6.3 Shelf Life

36 months

6.4 Special Precautions For Storage

Store below 30ºC.

6.5 Nature And Contents Of Container

PVC/PVdC/Aluminium blisters.

Hypovase 500 microgram: Original packs of 60 tablets, (in blister strips of 4 x 15 tablets).

PVC/Aluminium blisters.

Hypovase 1 mg: Original packs of 60 tablets, (in blister strips of 4 x 15 tablets).

6.6 Special Precautions For Disposal And Other Handling

No special requirements. Any unused product or waste should be disposed of in accordance with local requirements.

7. Marketing Authorisation Holder

Pfizer Limited

Ramsgate Road

Sandwich

Kent, CT13 9NJ

United Kingdom

8. Marketing Authorisation Number(S)

PL 00057/0149R

PL 00057/0106R

9. Date Of First Authorisation/Renewal Of The Authorisation

5 January 1994 / 22 November 2004

10. Date Of Revision Of The Text

June 2009

11. LEGAL CATEGORY

POM

Ref: HY 9_1 UK