Pharmaflex may be available in the countries listed below.
Ingredient matches for Pharmaflex
Metronidazole
Metronidazole is reported as an ingredient of Pharmaflex in the following countries:
- Luxembourg
International Drug Name Search
Wednesday, 28 September 2016
Clear Fc
Clear Fc may be available in the countries listed below.
Ingredient matches for Clear Fc
Cresol
Cresol is reported as an ingredient of Clear Fc in the following countries:
- Japan
Formaldehyde
Formaldehyde solution 35% (a derivative of Formaldehyde) is reported as an ingredient of Clear Fc in the following countries:
- Japan
International Drug Name Search
Budenofalk 3mg Capsules
BUDENOFALK 3mg
Gastro-resistant Capsules
BUDESONIDE
Please read this leaflet carefully before you start to take your medicine.
It contains important information about your medicine. If you have any questions or are not sure about anything, ask your doctor or pharmacist (chemist). Keep this leaflet until you have finished all of your medicine. You may want to read it again.
What is in your medicine?
Budenofalk 3mg comes in capsule form. Each gastro-resistant capsule contains 3mg of an active ingredient called budesonide.
The capsules also contain lactose monohydrate, sucrose, maize starch, triethyl citrate, talc, povidone and coating agents known as Eudragit.
The capsules are made of hard gelatin, purified water and sodium laurilsulfate. They are coloured with titanium dioxide (E171), red iron oxide (E172), black iron oxide (E172) and erythrosine (E127).
Each box of Budenofalk 3mg contains either 10, 50, 90, 100 or 120 pink capsules in blister strips.
Marketing Authorisation Holder and Manufacturer:
Dr Falk Pharma GmbH
D-79041 Freiburg
Germany
Distributed by:
Dr Falk Pharma UK Ltd
Unit K
Bourne End Business Park
Cores End Road
Bourne End
Bucks
SL8 5AS
UK
What your medicine is used for
Your medicine contains a type of steroid which reduces inflammation. It may be used to treat Crohn’s disease, an inflammation which predominantly affects the last part of the small bowel and/or the first part of the large bowel but can affect other parts of the gastrointestinal tract.
Sometimes Crohn’s disease may include symptoms in the skin, eyes and joints. These symptoms are unlikely to respond to this medicine.
Budenofalk may also be used for the symptomatic relief of chronic diarrhoea due to collagenous colitis.
Before taking your medicine
You should not take this medicine if:
- You are allergic to budesonide or any of the ingredients listed above.
- You have a serious liver disease.
If you are pregnant, trying to become pregnant or think you may be pregnant, you should avoid taking this drug unless advised by your doctor.
It is not known if budesonide passes into breast milk, therefore you should not breast feed while on treatment.
If you answer yes to any of the following questions, tell your doctor or pharmacist.
- Do you have, or have you ever had, tuberculosis, high blood pressure, diabetes, brittle bones (osteoporosis), stomach ulcers, glaucoma, cataracts or liver problems?
- If you know or think you may have any sort of infection.
- Has anyone in your family ever had diabetes or glaucoma?
- Are you taking colestyramine, digoxin, water tablets, ketoconazole, ritonavir, itraconazole, clarithromycin, carbamazepine, rifampicin, cimetidine, oestrogens and oral contraceptives or antacids?
- Are you taking any other medication (including any medicines you have bought without a prescription) which your doctor does not know about?
Please try to avoid contact with people who have chicken pox, shingles or measles. This is particularly important if you do not think you have had this illness yourself. If you think you may have been exposed to any of these illnesses, tell your doctor as soon as possible. Please tell your doctor if you are about to go abroad and need a vaccination whilst you are taking this medicine.
The capsules contain lactose and sucrose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this product
How to take your medicine
It is important to take your medicine as directed by your doctor. The label will tell you how much to take and how often. If it does not or you are unsure, ask your doctor or pharmacist.
- The usual dose is one capsule three times a day (morning, midday and evening).
- Take the capsules about 30 minutes before a meal.
- Swallow the capsules whole with a glass of water (avoid taking with grapefruit juice).
- Do not chew the capsules.
This medicine is not recommended for children.
It is important that you do not stop taking your medicine suddenly as it could make you ill. Keep taking your medicine until your doctor tells you to stop, even if you start to feel better. Your doctor will probably want to reduce your dose gradually, first from 3 to 2 capsules daily for one week, (one in the morning and one in the evening) and then only one capsule daily in the last week of treatment (taken in the morning).
Your doctor will not normally want you to take this medicine for more than 8 weeks.
If you go into hospital, or you visit a dentist or another doctor, tell them you are taking Budenofalk 3mg gastro-resistant capsules.
What to do if you forget to take your medicine
If you forget to take your capsules, take a dose as soon as you remember and then continue with the next dose as instructed on the label. Do not take more capsules in a day than you usually do.
What to do if you take too many capsules
If you accidentally take too many capsules, do not worry, but contact your doctor or local hospital casualty department as soon as possible. Take this medicine with you.
After taking your medicine
Like all medicines, Budenofalk 3mg gastro-resistant capsules may occasionally cause unwanted effects in some people. Most of these effects are not serious. This medicine contains a type of steroid, so you might experience unwanted effects typical of steroids. They may include:
- Skin rashes, acne, itchy skin, development of marks and bleeding within the skin, delayed wound healing.
- Tiredness, muscle weakness or pain, brittle bones, wasting of bones and cartilage.
- Roundness of the face, weight gain, fluid retention including leg edema, increased risk of high blood sugar, diabetes mellitus, increased risk of infections, blood clots and high blood pressure.
- Heartburn, stomach complaints such as ulcers, pancreatitis and constipation.
- Cataract, glaucoma.
- Heavy or irregular periods and male hair growth patterns in women, growth retardation in children, impotence.
- Nervous system disorders including headaches, which may or may not be associated with blurred vision or vomiting and mood changes, such as depression, irritability or euphoria.
If you experience these or any other undesirable effects, then tell your doctor or pharmacist as soon as possible.
How to store your medicine
- Do not store above 25°C.
- Do not take this medicine after the expiry date printed on the carton or blister strip.
- If your doctor decides to stop treatment, return any left over capsules to the pharmacist. Only keep them if the doctor tells you to.
PL 08637/0002
PA 573/2/1
Keep this medicine in a safe place. Keep out of reach and sight of children.
REMEMBER: This medicine is for you. Never give it to anyone else. It may harm them, even if their problems seem to be the same as yours.
Leaflet revised: October 2006
Dr Falk Pharma UK Ltd
Unit K
Bourne End Business Park
Cores End Road
Bourne End
Bucks
SL8 5AS
UK
‘Budenofalk’ is a registered trademark, the property of Dr Falk Pharma GmbH
Tuesday, 27 September 2016
Candesar
Candesar may be available in the countries listed below.
Ingredient matches for Candesar
Candesartan
Candesartan is reported as an ingredient of Candesar in the following countries:
- India
Candesartan cilexetil (a derivative of Candesartan) is reported as an ingredient of Candesar in the following countries:
- Myanmar
International Drug Name Search
Xolamol
Xolamol may be available in the countries listed below.
Ingredient matches for Xolamol
Dorzolamide
Dorzolamide hydrochloride (a derivative of Dorzolamide) is reported as an ingredient of Xolamol in the following countries:
- Oman
Timolol
Timolol maleate (a derivative of Timolol) is reported as an ingredient of Xolamol in the following countries:
- Oman
International Drug Name Search
Infanrix IPV
1. Name Of The Medicinal Product
Infanrix-IPV, suspension for injection in pre-filled syringe
Diphtheria, tetanus, pertussis (acellular, component) and poliomyelitis (inactivated) vaccine (adsorbed)
2. Qualitative And Quantitative Composition
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Diphtheria toxoid1 | not less than 30 IU |
Tetanus toxoid1 | not less than 40 IU |
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Pertussis toxoid1 | 25 micrograms |
Filamentous Haemagglutinin1 | 25 micrograms |
Pertactin1 | 8 micrograms |
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3. Pharmaceutical Form
Suspension for injection in pre-filled syringe.
Infanrix-IPV is a turbid white suspension.
4. Clinical Particulars
4.1 Therapeutic Indications
This vaccine is indicated for booster vaccination against diphtheria, tetanus, pertussis, and poliomyelitis diseases in individuals from 16 months to 13 years of age inclusive who have previously received primary immunisation series against these diseases.
The administration of Infanrix-IPV should be based on official recommendations.
4.2 Posology And Method Of Administration
Posology
A single dose of 0.5 ml should be administered.
Infanrix-IPV may be administered to subjects who have previously received whole cell or acellular pertussis-containing vaccines, and oral live attenuated or injected inactivated poliomyelitis vaccines. (See also sections 4.8 and 5.1).
Method of administration
The vaccine is for intramuscular injection, usually into the deltoid muscle. However, the anterolateral thigh may be used in very young subjects if preferred.
Do not administer intravascularly.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients or neomycin, polymyxin or formaldehyde.
Hypersensitivity after previous administration of diphtheria, tetanus, pertussis, or polio vaccines.
Infanrix-IPV is contraindicated if the child has experienced an encephalopathy of unknown aetiology, occurring within 7 days following previous vaccination with pertussis containing vaccine. In these circumstances pertussis vaccination should be discontinued and the vaccination should be continued with diphtheria-tetanus and polio vaccines.
As with other vaccines, administration of Infanrix-IPV should be postponed in subjects suffering from an acute severe febrile illness. The presence of a minor infection is not a contra-indication.
4.4 Special Warnings And Precautions For Use
As with all injectable vaccines, appropriate medical treatment and supervision should always be readily available in case of a rare anaphylactic event following the administration of the vaccine.
Vaccination should be preceded by a review of the medical history (especially with regard to previous vaccination and possible occurrence of undesirable events). A family history of convulsions or a family history of Sudden Infant Death Syndrome (SIDS) does not constitute a contra-indication.
If any of the following events are known to have occurred in temporal relation to receipt of pertussis-containing vaccine, the decision to give further doses of pertussis-containing vaccines should be carefully considered:
- temperature of
- collapse or shock-like state (hypotonic-hyporesponsiveness episode) within 48 hours of vaccination,
- persistent, inconsolable crying lasting
- convulsions with or without fever, occurring within 3 days of vaccination.
There may be circumstances, such as a high incidence of pertussis, when the potential benefits outweigh possible risks.
As for any vaccination, the risk-benefit of immunising with Infanrix-IPV or deferring this vaccination should be weighed carefully in an infant or in a child suffering from a new onset or progression of a severe neurological disorder.
Infanrix-IPV should be administered with caution to subjects with thrombocytopenia or a bleeding disorder since bleeding may occur following an intramuscular administration to these subjects.
HIV infection is not considered as a contra-indication. The expected immunological response may not be obtained after vaccination of immunosuppressed patients.
For children under immunosuppressive treatment (corticosteroid therapy, antimitotic chemotherapy, etc.), it is recommended to postpone vaccination until the end of treatment.
Infanrix-IPV should under no circumstances be administered intravascularly.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Infanrix-IPV has been administered concomitantly with measles-mumps-rubella vaccine or Hib vaccine in clinical trials. The data available do not suggest any clinically relevant interference in the antibody response to each of the individual antigens.
Interaction studies have not been carried out with other vaccines, biological products or therapeutic medications. However, in accordance with commonly accepted immunisation guidelines, since Infanrix-IPV is an inactivated product, there is no theoretical reason why it should not be administered concomitantly with other vaccines or immunoglobulins at separate sites.
As with other vaccines it may be expected that in patients receiving immunosuppressive therapy or patients with immunodeficiency, a protective immune response to one or more antigens in the vaccine may not be achieved.
4.6 Pregnancy And Lactation
It is anticipated that Infanrix-IPV would only rarely be administered to subjects of child-bearing potential. Adequate human data on the use of Infanrix-IPV during pregnancy and lactation are not available and animal studies on reproductive toxicity have not been conducted. Consequently the use of this combined vaccine is not recommended during pregnancy. It is preferable to avoid the use of this vaccine during lactation.
4.7 Effects On Ability To Drive And Use Machines
It is anticipated that Infanrix-IPV would only rarely be administered to subjects who would be driving or using machines. However, somnolence, commonly reported after vaccination, may temporarily affect the ability to drive and use machines.
4.8 Undesirable Effects
• Clinical trials:
The safety profile presented below is based on data from more than 2200 subjects.
As has been observed for DTPa and DTPa-containing combinations, an increase in local reactogenicity and fever was reported after booster vaccination with Infanrix-IPV with respect to the primary course.
Frequencies per dose are defined as follows:
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Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
Blood and lymphatic system disorders
Rare: lymphadenopathy
Nervous system disorders
Very common: somnolence, headache (age range 6-13 years old)
Respiratory, thoracic and mediastinal disorders
Rare: bronchitis1, cough1
Gastrointestinal disorders
Common: diarrhoea, vomiting, nausea
Skin and subcutaneous tissue disorders
Uncommon: dermatitis allergic, rash1
Rare: pruritus, urticaria
Metabolism and nutrition disorders
Very common: appetite lost
General disorders and administration site conditions
Very common: fever
Common: fever>39.5°C, malaise, injection site reactions including induration, asthenia
Psychiatric disorders
Very common: crying abnormal, irritability, restlessness
* Information on extensive swelling of the injected limb (defined as swelling with a diameter> 50 mm, noticeable diffuse swelling or noticeable increase of limb circumference) occurring after Infanrix-IPV was actively solicited in two clinical trials. When Infanrix-IPV was administered as either a fourth dose or a fifth dose of DTPa to children 4-6 years of age, extensive injection site swelling was reported with incidences of 13% and 25% respectively. The most frequent reactions were large, localised swelling (diameter> 50 mm) occurring around the injection site. A smaller percentage of children (3% and 6% respectively) experiences diffuse swelling of the injected limb, sometimes involving adjacent joint. In general, these reactions began within 48 hours of vaccination and spontaneously resolved over an average of 4 days without sequelae.
• Post marketing surveillance:
Blood and lymphatic system disorders
Thrombocytopenia2
Nervous system disorders:
Collapse or shock-like state (hypotonic-hyporesponsiveness episode), convulsions (with or without fever) within 2 to 3 days of vaccination,
Respiratory, thoracic and mediastinal disorders
Apnoea1
Skin and subcutaneous tissue disorders
Angioneurotic oedema1
General disorders and administration site conditions
Injection site vesicles
Immune system disorders
Allergic reactions, including anaphylactic1 and anaphylactoid reactions
1reported with GSK's DTPa containing vaccines
2reported with D and T vaccines
4.9 Overdose
Cases of overdose have been reported during post-marketing surveillance. Adverse events, when reported, are not specific but similar to adverse events reported with normal vaccine administration.
5. Pharmacological Properties
Pharmaco-therapeutic group: Bacterial and viral vaccines combined, ATC code: J07CA02
5.1 Pharmacodynamic Properties
The immune response after booster vaccination with Infanrix-IPV was evaluated in 917 vaccinees. The immune response observed was independent of the number of doses and type of vaccines administered previously (DTPw or DTPa, OPV or IPV) as shown in the tables below.
One month after vaccination of children aged 15 to 26 months, the immune responses were the following:
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* These levels are considered to be protective
One month after vaccination of children aged 4-7 years, the immune responses were the following:
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* These levels are considered to be protective
One month after vaccination of children/adolescents aged 10-13 years, the immune responses were the following:
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* These levels are considered to be protective
After vaccination,
No serological correlate of protection has been defined for the pertussis antigens. The antibody titres to the three pertussis components were in all cases higher than those observed after primary vaccination with the paediatric acellular pertussis combination vaccine (DTPa, Infanrix™), for which efficacy has been demonstrated in a household contact efficacy study. Based on these comparisons, it can therefore be anticipated that Infanrix-IPV would provide protection against pertussis, although the degree and duration of protection afforded by the vaccine are undetermined.
5.2 Pharmacokinetic Properties
Evaluation of pharmacokinetic properties is not required for vaccines.
5.3 Preclinical Safety Data
Non-clinical data reveal no special hazard for humans based on conventional studies of safety, specific toxicity and compatibility of ingredients.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride
Medium 199 (containing principally amino acids, mineral salts, vitamins)
Water for injections
For adjuvants, see section 2.
6.2 Incompatibilities
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
6.3 Shelf Life
3 years.
6.4 Special Precautions For Storage
Store in a refrigerator (2°C - 8°C).
Do not freeze.
Store in the original package, in order to protect from light.
6.5 Nature And Contents Of Container
0.5 ml of suspension for injection in a pre-filled syringe (type I glass) with plunger stopper (butyl) - pack sizes of 1, 10 or 20 with or without needles.
Not all pack sizes may be marketed.
6.6 Special Precautions For Disposal And Other Handling
Upon storage, a white deposit and clear supernatant may be observed. This does not constitute a sign of deterioration.
The syringe should be well shaken in order to obtain a homogeneous turbid white suspension.
The suspension should be inspected visually for any foreign particulate matter and/or abnormal physical appearance. In the event of either being observed, discard the vaccine.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
SmithKline Beecham plc
Trading as:
GlaxoSmithKline UK
Stockley Park West, Uxbridge
Middlesex UB11 1BT
8. Marketing Authorisation Number(S)
PL 10592/0209
9. Date Of First Authorisation/Renewal Of The Authorisation
7 August 2006
10. Date Of Revision Of The Text
12 April 2010
Monday, 26 September 2016
Promeris Duo
Promeris Duo may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Ingredient matches for Promeris Duo
Amitraz
Amitraz is reported as an ingredient of Promeris Duo in the following countries:
- Finland
- France
- South Africa
- Sweden
Metaflumizone
Metaflumizone is reported as an ingredient of Promeris Duo in the following countries:
- Finland
- France
- South Africa
- Sweden
International Drug Name Search
Friday, 23 September 2016
Nalgesic
Nalgesic may be available in the countries listed below.
Ingredient matches for Nalgesic
Piroxicam
Piroxicam is reported as an ingredient of Nalgesic in the following countries:
- Argentina
International Drug Name Search
Thursday, 22 September 2016
Ibugel Forte 10%
1. Name Of The Medicinal Product
IBUGEL™ FORTE 10%
2. Qualitative And Quantitative Composition
Ibuprofen 10.0% w/w.
3. Pharmaceutical Form
Aqueous-alcoholic, non-greasy, fragrance-free, clear or slightly hazy gel.
4. Clinical Particulars
4.1 Therapeutic Indications
For the topical treatment of rheumatic and muscular pain, sprains, strains, backache and neuralgia. Ibugel Forte 10% is also indicated for symptomatic relief of pain due to non-serious arthritic conditions.
4.2 Posology And Method Of Administration
2 to 5 cm gel (50 to 125 mg ibuprofen) is to be applied to the affected area up to three times daily, or as directed by the physician. The gel should be massaged well into the skin until completely absorbed, and hands washed after use unless being treated.
Treatment should not normally continue for more than a few weeks, unless recommended to do so by a doctor.
The same dosage and dosage schedule applies to all age groups, although Ibugel Forte 10% is not normally recommended for use on children under the age of 12 years, unless instructed by the physician.
4.3 Contraindications
Not to be used if allergic to any of the ingredients, or in cases of hypersensitivity to aspirin, ibuprofen or related painkillers (including when taken by mouth), especially where associated with a history of asthma, rhinitis or urticaria. Not to be used on broken or damaged skin.
4.4 Special Warnings And Precautions For Use
To be kept away from the eyes and mucous membranes. Oral NSAIDs, including ibuprofen, can sometimes be associated with renal impairment, aggravation of active peptic ulcers, and can induce allergic bronchial reactions in susceptible asthmatic patients. Although the systemic absorption of topically applied ibuprofen is less than for oral dosage forms, these complications can occur in rare cases. For these reasons, caution should be exercised before prescribing Ibugel Forte 10% for patients with an active peptic ulcer, a history of kidney problems, asthma or intolerance to aspirin or ibuprofen taken orally. Patients should seek medical advice if symptoms worsen or persist.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Non-steroidal anti-inflammatory drugs may interact with blood pressure lowering drugs, and may possibly enhance the effects of anticoagulants, although the chance of either of these occurring with a topically administered preparation is extremely remote. Where aspirin or other NSAID tablets are taken concurrently, it is important to bear in mind that these may increase the incidence of undesirable effects.
4.6 Pregnancy And Lactation
Not to be used during pregnancy or lactation. Although no teratogenic effects have been demonstrated, ibuprofen should be avoided during pregnancy. The onset of labour may be delayed, and the duration of labour increased. Ibuprofen appears in breast milk in very low concentrations, but is unlikely to affect breast fed infants adversely.
4.7 Effects On Ability To Drive And Use Machines
None known.
4.8 Undesirable Effects
Very rarely, susceptible patients may experience the following side effects with ibuprofen, but these are extremely uncommon when ibuprofen is administered topically. If they occur, treatment should be discontinued:-
Hypersensitivity: hypersensitivity reactions have been reported following treatment with ibuprofen. These may consist of (a) non-specific allergic reactions and anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm, or dyspnoea, or (c) assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angioedema and, less commonly, bullous dermatoses (including epidermal necrolysis and erythema multiforme).
Renal: renal impairment can occur in patients with a history of kidney problems.
Gastrointestinal: side effects such as abdominal pain and dyspepsia have been reported.
4.9 Overdose
Not applicable. Any overdose with a topical presentation of ibuprofen is extremely unlikely. Symptoms of severe ibuprofen overdosage (eg following accidental oral ingestion) include headache, vomiting, drowsiness and hypotension. Correction of severe electrolyte abnormalities should be considered.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Ibugel Forte 10% is a topical preparation which has anti-inflammatory and analgesic properties. It contains the active ingredient, ibuprofen, which exerts its effects directly in inflamed tissues underlying the site of application, mainly by inhibiting prostaglandin biosynthesis.
Because it is formulated in an aqueous/alcoholic gel, Ibugel Forte 10% also exerts a soothing and cooling effect when applied to the affected area.
5.2 Pharmacokinetic Properties
Specially formulated for external application, the active ingredient penetrates through the skin rapidly and extensively, achieving high, therapeutically relevant local concentrations in underlying soft tissues, joints and synovial fluid, whilst producing plasma levels that are unlikely to be sufficient to cause any systemic side effects, other than in rare individuals who are hypersensitive to ibuprofen. Furthermore, there do not appear to be any appreciable differences between the oral and topical routes of administration regarding metabolism or excretion of ibuprofen.
5.3 Preclinical Safety Data
Published information on subchronic toxicity studies confirms that topically applied ibuprofen is well tolerated both locally and by the gastro-intestinal tract. Any local erythema is only mild and no signs of mucosal lesions or ulcerogenic effects have been determined in the gastro-intestinal tract.
In the course of assessing mucosal tolerance, topical ibuprofen has been found to cause acute, but reversible, irritant reactions in the eyes and mucous membranes.
6. Pharmaceutical Particulars
6.1 List Of Excipients
IMS; Carbomers; Diethylamine; Purified Water.
6.2 Incompatibilities
None known.
6.3 Shelf Life
36 months.
6.4 Special Precautions For Storage
Do not store above 25°C.
6.5 Nature And Contents Of Container
100 g collapsible aluminium tube, fitted with a screw cap.
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)
00173/0175.
9. Date Of First Authorisation/Renewal Of The Authorisation
22 May 2008.
10. Date Of Revision Of The Text
October 2007.
Wednesday, 21 September 2016
Mini-Pill
Mini-Pill may be available in the countries listed below.
Ingredient matches for Mini-Pill
Norethisterone
Norethisterone is reported as an ingredient of Mini-Pill in the following countries:
- Finland
International Drug Name Search
Maxitrol Eye Drops
1. Name Of The Medicinal Product
MAXITROL EYE DROPS
2. Qualitative And Quantitative Composition
1 ml suspension contains 1 mg dexamethasone, 6000 IU polymyxin B sulphate, 3500 IU neomycin sulphate (as base)
Excipients: 1 ml suspension contains 0.04 mg benzalkonium chloride
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Eye drops, suspension
White sterile suspension for topical ocular administration.
4. Clinical Particulars
4.1 Therapeutic Indications
MAXITROL eye drops, suspension is indicated for the short-term treatment of steroid responsive conditions of the eye when prophylactic antibiotic treatment is also required, after excluding the presence of fungal and viral disease.
4.2 Posology And Method Of Administration
Children and Adults (including the Elderly)
Apply one or two drops to each affected eye up to six times daily or, more frequently if required.
4.3 Contraindications
• Hypersensitivity to the active substances or to any component of the preparation.
• Epithelial herpes simplex keratitis.
• Vaccinia, varicella, or other viral infection of cornea and conjunctiva (except herpes zoster keratitis).
• Fungal disease s of ocular structures.
• Mycobacterial ocular infections.
4.4 Special Warnings And Precautions For Use
• For ocular use only. Not for injection or ingestion.
• As with all antibacterial preparation prolonged use may lead to overgrowth of non-susceptible bacterial strains or fungi. If superinfection occurs, appropriate therapy should be initiated.
• Sensitivity to topically applied aminoglycosides may occur in some patients. Cross-sensitivity to other aminoglycosides may also occur. If signs of serious reactions or hypersensitivity occur, discontinue the use of this product.
• Patients using ophthalmic preparations containing neomycin sulphate should be advised to consult a physician if ocular pain, redness, swelling, or irritation worsens or persists.
• Serious adverse reactions including neurotoxicity, ototoxicity and nephrotoxicity have occurred in patients receiving systemic neomycin or when applied topically to open wounds or damaged skin. Nephrotoxic and neurotoxic reactions have also occurred with systemic polymyxin B. Although these effects have not been reported following topical ocular use of this product, caution is advised when used concomitantly with systemic aminoglycoside or polymyxin B therapy.
• Prolonged use of ophthalmic steroids may result in ocular hypertension and/or glaucoma, with damage to the optic nerve, reduced visual acuity and visual field defects, and posterior subcapsular cataract formation. In patients receiving prolonged ophthalmic corticosteroid therapy, intraocular pressure should be checked routinely and frequently.
• In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical corticosteroids.
• Corticosteroids may reduce resistance to and aid in the establishment of bacterial, viral, or fungal infections and mask the clinical signs of infection, preventing recognition of ineffectiveness of the antibiotic, or may suppress hypersensitivity reactions to MAXITROL eye drops, suspension. Fungal infection should be suspected in patients with persistent corneal ulceration who have been or are receiving these drugs; corticosteroid therapy should be discontinued if fungal infection occurs.
• To avoid the risk of enhancement of herpetic corneal disease, frequent slit lamp examination is essential.
• Contact lens wear is not recommended during treatment of an ocular infection. Therefore patients should be advised not to wear contact lenses during treatment with MAXITROL eye drops, suspension.
• MAXITROL eye drops, suspension contains benzalkonium chloride which may cause eye irritation and is known to discolour soft contact lenses. Patients must be instructed to remove contact lenses prior to application of MAXITROL eye drops, suspension and wait 15 minutes after instillation of the dose before reinsertion.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
No interaction studies have been performed.
Concomitant and/or sequential use of an aminoglycoside (neomycin) and other systemic, oral, or topical drugs that have neurotoxic, ototoxic, or nephrotoxic effects may result in additive toxicity and should be avoided, whenever possible.
If more than one ophthalmic medicinal product is being used, the medicines must be administered at least 5 minutes apart.
4.6 Pregnancy And Lactation
Pregnancy
There are no or limited amount of data from the use of MAXITROL eye drops, suspension in pregnant women. Studies in animals with some active components of MAXITROL eye drops, suspension have shown reproductive toxicity (see section 5.3).
MAXITROL eye drops, suspension is not recommended during pregnancy.
Lactation
It is unknown whether topical ophthalmic dexamethasone, neomycin or polymyxin B are excreted in human milk. Because systemic corticosteroids and aminoglycosides may be distributed into milk, a risk to the suckling child cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to discontinue therapy with MAXITROL eye drops, suspension taking into account the benefit of breast-feeding for the child and the benefit of the product to the woman.
4.7 Effects On Ability To Drive And Use Machines
MAXITROL eye drops, suspension has no or negligible influence on the ability to drive and use machines. As with any other eye drop, temporarily blurred vision or other visual disturbances may affect the ability to drive or use machines. If transient blurred vision occurs upon instillation, the patient must wait until the vision clears before driving or using machinery.
4.8 Undesirable Effects
Tabulated summary of adverse reactions
The following adverse effects are classified according to the following convention: very common (
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Description of selected adverse event
Due to the steroid component, in diseases causing thinning of the cornea or sclera there is a higher risk for perforation especially after long treatments (See Section Special warnings and precautions for use).
Topical ophthalmic steroid use may result in increased intraocular pressure with damage to the optic nerve, reduced visual acuity and visual field defects. Also it may lead to posterior subcapsular cataract formation (See Section Special warnings and precautions for use).
Sensitivity to topically administered aminoglycosides may occur in some patients (See Section Special warnings and precautions for use). Systemic side effects may occur with extensive use.
4.9 Overdose
No case of overdose has been reported.
Signs and symptoms of an overdosage of MAXITROL eye drops, suspension may be similar to adverse reaction effects seen in some patients (punctuate keratitis, erythema, increased lacrimation, oedema and lid itching).
A topical ophthalmic overdose of MAXITROL eye drops, suspension may be flushed from the eye(s) with lukewarm water.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Pharmacotherapeutic group: ophthalmologicals; anti-infectives
ATC code: S01CA01
Mechanism of Action
MAXITROL eye drops, suspension has a dual effect: suppression of inflammation symptoms by the corticosteroidal component dexamethasone, and an anti
Dexamethasone is a synthetic glucorticoid with potent anti-inflammatory activity. Polymyxin B is a cyclic lipopeptide that penetrates the cell wall of gram-negative bacilli to destabilize the cytoplasmic membrane. It is generally less active against gram-positive bacteria. Neomycin is an aminoglycoside antibiotic that primarily exerts its effect on bacterial cells by inhibiting polypeptide assembly and synthesis on the ribosome.
Mechanism of Resistance
Resistance of bacteria to polymyxin B is of chromosomal origin and is uncommon. A modification of the phospholipids of the cytoplasmic membrane appears to play a role.
Resistance to neomycin occurs by several different mechanisms including (1) alterations of the ribosomal subunit within the bacterial cell; (2) interference with the transport of neomycin into the cell, and (3) inactivation by an array of adenylating, phosphorylating, and acetylating enzymes. Genetic information for production of inactivating enzymes may be carried on the bacterial chromosome or on plasmids.
Breakpoints
Each gram of MAXITROL eye drops, suspension contains 6000 IU polymyxin B sulphate and 3500 IU neomycin sulphate. The breakpoints and the in vitro spectrum as mentioned below are based on the dual activity of either polymyxin B or neomycin. The breakpoints listed here are based upon acquired resistance for specific species found in ocular infections and the ratio in International Units of polymyxin B to neomycin in MAXITROL eye drops, suspension:
Resistance breakpoints:>5:2.5 to>40:20 depending upon the bacterial species
Susceptibility
The information listed below provides guidance on the approximate probabilities on the susceptibility of microorganisms to polymyxin B or neomycin in MAXITROL eye drops, suspension. The presentation below lists bacterial species recovered from external ocular infections of the eye.
The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections. As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the combination of polymyxin B or neomycin as in MAXITROL eye drops, suspension in at least some types of infections is questionable.
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Dexamethasone is a moderately powerful corticosteroid having good penetration in ocular tissue. Corticosteroids have an anti
5.2 Pharmacokinetic Properties
Dexamethasone, like other corticosteroids, is absorbed rapidly after oral administration and has a biological half-life of about 190 minutes. Sufficient absorption may occur after topical application to the skin and eye to produce systemic effects. Intraocular penetration of dexamethasone occurs in significant amounts and contributes to the effectiveness of dexamethasone in anterior segment inflammatory disease.
Polymyxin B sulphate is not absorbed from the gastrointestinal tract or through intact skin, although the intact corneal epithelium prevents penetration into the corneal stroma, therapeutic concentrations do enter the stroma after epithelial damage. Good stromal penetration occurs after epithelial abrasion following topical instillation, subconjunctival injection, or corneal bath. No significant polymyxin B penetration into the vitreous is demonstrable after parenteral or local administration of the drug.
Neomycin is poorly absorbed from the gastrointestinal tract and after topical administration an insufficient amount is absorbed to produce systemic effects. Absorption has been reported to occur from wounds and inflamed skin. After absorption neomycin is rapidly excreted by the kidneys in active form.
5.3 Preclinical Safety Data
Mutagenicity and Carcinogenicity
Genotoxicity studies performed with neomycin and polymyxin B, with and without metabolic activation, were negative in bacterial (Ames test) or mammalian cells (chromosomal aberration assay in CHO cells). Dexamethasone was clastogenic in vivo in the mouse micronucleus assay at doses in excess of those obtained following topical application. Conventional long term carcinogenicity studies with MAXITROL or its active constituents have not been performed.
Teratogenicity
Pregnant rats treated daily with high doses of neomycin produced offspring that exhibited significant ototoxicity. The teratogenic dose is far greater (> 10,000-fold) than the clinical daily exposure from MAXITROL. Dexamethasone has been found to be teratogenic in animal models. Dexamethasone induced abnormalities of foetal development including cleft palate, intra-uterine growth retardation and affects on brain growth and development.
Local Tolerance and Systemic Effects
Systemic exposure to dexamethasone is associated with its pharmacological effects as a potent glucocorticoid. Prolonged exposure to the steroid can result in glucocorticoid imbalance. Topical ocular safety studies with dexamethasone in rabbits have shown systemic effects after 1 month of treatment. In rabbits, MAXITROL was shown to have minimal irritation potential after administration to either control or irritated eyes.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Sodium chloride
Polysorbate 20
Benzalkonium chloride
Hydroxypropyl methylcellulose
Hydrochloric acid/sodium hydroxide
Purified water
6.2 Incompatibilities
None known.
6.3 Shelf Life
Unopened 24 months.
Discard 28 days after first opening
6.4 Special Precautions For Storage
Do not store above 25°C. Keep away from direct sunlight. Do not refrigerate. Keep the container tightly closed.
6.5 Nature And Contents Of Container
5 ml & 10 ml DROP-TANIER, natural LDPE bottles and plugs with polystyrene or polypropylene caps.
6.6 Special Precautions For Disposal And Other Handling
Do not touch the tip of the bottle to any surface as this may contaminate the contents.
Any unused product or waste material should be disposed of in accordance with local requirements.
7. Marketing Authorisation Holder
Alcon Laboratories (UK) Ltd
Pentagon Park
Boundary Way
Hemel Hempstead
HP2 7UD
8. Marketing Authorisation Number(S)
PL 0649/5915R
9. Date Of First Authorisation/Renewal Of The Authorisation
24 January 1991
10. Date Of Revision Of The Text
26/07/2010
Enac Hexal
Enac Hexal may be available in the countries listed below.
Ingredient matches for Enac Hexal
Enalapril
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Enac Hexal in the following countries:
- Austria
International Drug Name Search
Amphadase injectable
Generic Name: hyaluronidase (injectable) (HYE al ure ON i dase)
Brand Names: Amphadase, Hylenex, Vitrase
What is hyaluronidase?
Hyaluronidase is a genetically designed protein.
Hyaluronidase is used as an aid in helping your body absorb other injected medications.
Hyaluronidase is also used to help contrast dyes in your body show more clearly on certain types of x-rays or scans.
Hyaluronidase may also be used for purposes not listed in this medication guide.
What is the most important information I should know about hyaluronidase?
Your doctor may perform a skin test to see if you are allergic to hyaluronidase before you receive the medication.
Before receiving hyaluronidase, tell your doctor if you are using any of the following drugs: furosemide (Lasix); phenytoin (Dilantin); a sedative or anxiety medication (such as Valium, Xanax, Tranxene); aspirin or salicylates; cortisone or ACTH (Corticotropin); estrogens; or an antihistamine (such as a cold or allergy medicine).
What should I discuss with my health care provider before receiving hyaluronidase?
You should not receive this medication if you are allergic to it.
Your doctor may perform a skin test to see if you are allergic to hyaluronidase before you receive the medication.
FDA pregnancy category C. It is not known whether hyaluronidase will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether hyaluronidase 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 hyaluronidase?
This medication is injected under the skin.
A healthcare provider will give you this injection.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your hyaluronidase injection.
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 receiving hyaluronidase?
Follow your doctor's instructions about any restrictions on food, beverages, or activity.
Hyaluronidase 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 include pain, itching, redness, or swelling where the medication was injected.
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 hyaluronidase?
Before receiving hyaluronidase, tell your doctor if you are using any of the following drugs:
furosemide (Lasix);
phenytoin (Dilantin);
a sedative or anxiety medication (such as Valium, Xanax, Tranxene);
aspirin or salicylates;
cortisone or ACTH (Corticotropin);
estrogens; or
an antihistamine (such as a cold or allergy medicine).
This list is not complete and other drugs may interact with hyaluronidase. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
More Amphadase resources
- Amphadase Side Effects (in more detail)
- Amphadase Use in Pregnancy & Breastfeeding
- Amphadase Drug Interactions
- Amphadase Support Group
- 0 Reviews for Amphadase - Add your own review/rating
Compare Amphadase with other medications
- Extravasation
- Hypodermoclysis
- Subcutaneous Urography
Where can I get more information?
- Your pharmacist can provide more information about hyaluronidase injection.
See also: Amphadase side effects (in more detail)
Carac
Dosage Form: cream
Carac® Cream, 0.5%
(fluorouracil cream)
FOR TOPICAL DERMATOLOGICAL USE ONLY (NOT FOR OPHTHALMIC, ORAL, OR INTRAVAGINAL USE)
Carac Description
Carac® (fluorouracil cream) Cream, 0.5%, contains fluorouracil for topical dermatologic use. Chemically, fluorouracil is 5-fluoro-2,4(1H, 3H)-pyrimidinedione. The molecular formula is C4H3FN2O2. Fluorouracil has a molecular weight of 130.08.
Carac Cream contains 0.5% fluorouracil, with 0.35% being incorporated into a patented porous microsphere (Microsponge®)1 composed of methyl methacrylate / glycol dimethacrylate crosspolymer and dimethicone. The cream formulation contains the following other inactive ingredients: Carbomer Homopolymer Type C, dimethicone, glycerin, methyl gluceth-20, methyl methacrylate / glycol dimethacrylate crosspolymer, methylparaben, octyl hydroxy stearate, polyethylene glycol 400, polysorbate 80, propylene glycol, propylparaben, purified water, sorbitan monooleate, stearic acid, and trolamine.
- 1
- Microsponge is a registered trademark of Amcol International Corp. or one of its subsidiaries.
Carac - Clinical Pharmacology
There is evidence that the metabolism of fluorouracil in the anabolic pathway blocks the methylation reaction of deoxyuridylic acid to thymidylic acid. In this manner, fluorouracil interferes with the synthesis of deoxyribonucleic acid (DNA) and to a lesser extent inhibits the formation of ribonucleic acid (RNA). Since DNA and RNA are essential for cell division and growth, the effect of fluorouracil may be to create a thymine deficiency that provokes unbalanced growth and death of the cell. The effects of DNA and RNA deprivation are most marked on those cells that grow more rapidly and take up fluorouracil at a more rapid rate. The contribution to efficacy or safety of individual components of the vehicle has not been established.
Pharmacokinetics
A multiple-dose, randomized, open-label, parallel study was performed in 21 patients with actinic keratoses. Twenty patients had pharmacokinetic samples collected: 10 patients treated with Carac and 10 treated with Efudex®2 5% Cream. Patients were treated for a maximum of 28 days with Carac, 1 g once daily in the morning; or Efudex® 5% Cream, 1 g twice daily, in the morning and evening. Steady-state plasma concentrations and the amounts of fluorouracil in urine resulting from the topical application of either product were measured.
Three patients who received Carac and nine patients who received Efudex® 5% Cream had measurable plasma fluorouracil levels; however, only one patient receiving Carac and six patients receiving Efudex® 5% Cream had a sufficient number of data points to calculate mean pharmacokinetic parameters.
| PK Parameter | Carac n=1 | Efudex (Mean ± SD) n=6 |
|---|---|---|
| Cmax | 0.77 ng/mL | 11.49 ± 8.24 ng/mL |
| Tmax | 1.00 hr | 1.03 ± 0.028 hr |
| AUC (0–24) | 2.80 ng∙hr/mL | 22.39 ± 7.89 ng∙hr/mL |
Five of 10 patients receiving Carac and nine of 10 patients receiving Efudex® 5% Cream had measurable urine fluorouracil levels.
| PK Parameter | Carac (Mean ± SD) (Range) n=10 | Efudex (Mean ± SD) (Range) n=10 |
|---|---|---|
| ||
| Cum Ae* | 2.74± 5.22 mcg | 119.83± 94.80 mcg |
| (min-max) | (0–15.02) | (0–329.87) |
| Max excretion rate | 0.19 ± 0.52 mcg/hr | 40.27 ±47.14 mcg/hr |
| (min-max) | (0–1.67) | (0–164.5) |
Both Carac and Efudex® 5% Cream demonstrated low measurable plasma concentrations for fluorouracil when administered under steady-state conditions. Cumulative urinary excretion of fluorouracil was low for Carac and for Efudex®, corresponding to 0.055% and 0.24% of the applied doses, respectively.
- 2
- Efudex is a registered trademark of ICN Pharmaceuticals, Inc.
Clinical Trials
Under the experimental conditions of the topical safety studies, Carac was not observed to cause contact sensitization. However, approximately 95% of subjects in the active arms of the Phase 3 clinical studies experienced facial irritation. Irritation is likely and sensitization is unlikely based on the results of the topical safety and Phase 3 studies.
Two Phase 3 identically designed, multi-center, vehicle-controlled, double-blind studies were conducted to evaluate the clinical safety and efficacy of Carac. Patients with 5 or more actinic keratoses (AKs) on the face or anterior bald scalp were randomly allocated to active or vehicle treatment in a 2:1 ratio. Patients were randomly allocated to treatment durations of 1, 2, or 4 weeks in a 1:1:1 ratio. They applied the study cream once daily to the entire face/anterior bald scalp. Each patient's clinical response was evaluated 4 weeks after the patient's last scheduled application of study cream. No additional post-treatment follow-up efficacy or safety assessments were performed beyond 4 weeks after the last scheduled application. The following graphs show the percentage of patients in whom 100% of treated lesions cleared, and the percentage of patients in whom 75% or more of treated lesions cleared. Treatment with Carac cream for 1, 2, or 4 weeks is compared to treatment with vehicle cream. Outcomes from 1, 2, and 4 weeks of treatment with vehicle cream are pooled because duration of treatment with vehicle had no substantive effect on clearance. Results from the two Phase 3 studies are shown separately. Although all treatment regimens of Carac studied demonstrated efficacy over vehicle for the treatment of actinic keratosis, continuing treatment up to 4 weeks as tolerated results in further lesion reduction and clearing.
Percentage of Subjects with 100% Clearance
Percentage of Subjects with at Least 75% Clearance
Clinical efficacy and safety in the treatment of AKs on the ears and other sun-exposed areas were not evaluated in the studies.
Indications and Usage for Carac
Carac is indicated for the topical treatment of multiple actinic or solar keratoses of the face and anterior scalp.
Contraindications
Fluorouracil may cause fetal harm when administered to a pregnant woman. Fluorouracil is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.
No adequate and well-controlled studies have been conducted in pregnant women with either topical or parenteral forms of fluorouracil. One birth defect (ventricular septal defect) and cases of miscarriage have been reported when fluorouracil was applied to mucous membrane areas. Multiple birth defects have been reported in the fetus of a patient treated with intravenous fluorouracil.
Animal reproduction studies have not been conducted with Carac. Fluorouracil, the active ingredient, has been shown to be teratogenic in mice, rats, and hamsters when administered parenterally at doses greater than or equal to 10, 15 and 33 mg/kg/day, respectively, [4X, 11X and 20X, respectively, the Maximum Recommended Human Dose (MRHD) based on body surface area (BSA)]. Fluorouracil was administered during the period of organogenesis for each species. Embryolethal effects occurred in monkeys at parenteral doses greater than 40 mg/kg/day (65X the MRHD based on BSA) administered during the period of organogenesis.
Carac should not be used in patients with dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. A large percentage of fluorouracil is catabolized by the enzyme dihydropyrimidine dehydrogenase (DPD). DPD enzyme deficiency can result in shunting of fluorouracil to the anabolic pathway, leading to cytotoxic activity and potential toxicities.
Carac is contraindicated in patients with known hypersensitivity to any of its components.
Warnings
The potential for a delayed hypersensitivity reaction to fluorouracil exists. Patch testing to prove hypersensitivity may be inconclusive.
Patients should discontinue therapy with Carac if symptoms of DPD enzyme deficiency develop.
Rarely, unexpected, systemic toxicity (e.g. stomatitis, diarrhea, neutropenia, and neurotoxicity) associated with parenteral administration of fluorouracil has been attributed to deficiency of dihydropyrimidine dehydrogenase "DPD" activity. One case of life threatening systemic toxicity has been reported with the topical use of 5% fluorouracil in a patient with a complete absence of DPD enzyme activity. Symptoms included severe abdominal pain, bloody diarrhea, vomiting, fever, and chills. Physical examination revealed stomatitis, erythematous skin rash, neutropenia, thrombocytopenia, inflammation of the esophagus, stomach, and small bowel. Although this case was observed with 5% fluorouracil cream, it is unknown whether patients with profound DPD enzyme deficiency would develop systemic toxicity with lower concentrations of topically applied fluorouracil.
Applications to mucous membranes should be avoided due to the possibility of local inflammation and ulceration.
Precautions
General
There is a possibility of increased absorption through ulcerated or inflamed skin.
Information for the Patient
Patients using Carac should receive the following information and instructions:
- This medication is to be used as directed.
- This medication should not be used for any disorder other than that for which it was prescribed.
- It is for external use only.
- Avoid contact with the eyes, eyelids, nostrils, and mouth.
- Cleanse affected area and wait 10 minutes before applying Carac.
- Wash hands immediately after applying Carac.
- Avoid prolonged exposure to sunlight or other forms of ultraviolet irradiation during treatment, as the intensity of the reaction may be increased.
- Most patients using Carac get skin reactions where the medicine is used. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling. Irritation at the application site may persist for two or more weeks after therapy is discontinued. Treated areas may be unsightly during and after therapy.
- If you develop abdominal pain, bloody diarrhea, vomiting, fever, or chills while on Carac therapy, stop the medication and contact your physician and/or pharmacist.
- Report any side effects to the physician and/or pharmacist.
Laboratory Tests
To rule out the presence of a frank neoplasm, a biopsy may be considered for those areas failing to respond to treatment or recurring after treatment.
Carcinogenesis, Mutagenesis and Impairment of Fertility
Adequate long-term studies in animals to evaluate carcinogenic potential have not been conducted with fluorouracil. Studies with the active ingredient of Carac, fluorouracil, have shown positive effects in in vitro and in vivo tests for mutagenicity and on impairment of fertility in in vivo animal studies.
Fluorouracil produced morphological transformation of cells in in vitro cell transformation assays. Morphological transformation was also produced in an in vitro assay by a metabolite of fluorouracil, and the transformed cells produced malignant tumors when injected into immunosuppressed syngeneic mice. Fluorouracil has been shown to exert mutagenic activity in yeast cells, Bacillus subtilis, and Drosophila assays. In addition, fluorouracil has produced chromosome damage at concentrations of 1.0 and 2.0 mcg/mL in an in vitro hamster fibroblast assay, was positive in a microwell mouse lymphoma assay, and was positive in in vivo micronucleus assays in rats and mice following intraperitoneal administration. Some patients receiving cumulative doses of 0.24 to 1.0 g of fluorouracil parenterally have shown an increase in numerical and structural chromosome aberrations in peripheral blood lymphocytes.
Fluorouracil has been shown to impair fertility after parenteral administration in rats. Fluorouracil administered at intraperitoneal doses of 125 and 250 mg/kg has been shown to induce chromosomal aberrations and changes in chromosome organization of spermatogonia in rats. In mice, single-dose intravenous and intraperitoneal injections of fluorouracil have been reported to kill differentiated spermatogonia and spermatocytes at a dose of 500 mg/kg and produce abnormalities in spermatids at 50 mg/kg.
Pediatric Use
Actinic keratosis is not a condition seen within the pediatric population, except in association with rare genetic diseases. Carac should not be used in children. The safety and effectiveness of Carac have not been established in patients less than 18 years old.
Geriatric Use
No significant differences in safety and efficacy measures were demonstrated in patients age 65 and older compared to all other patients.
Pregnancy
Teratogenic Effects
Pregnancy Category X
See CONTRAINDICATIONS
Nursing Women
It is not known whether fluorouracil is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from fluorouracil, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Adverse Reactions
The following were adverse events considered to be drug-related and occurring with a frequency of ≥1% with Carac: application site reaction (94.6%), and eye irritation (5.4%). The signs and symptoms of facial irritation (application site reaction) are presented below.
| Clinical Sign or Symptom | Active One Week N=85 | Active Two Week N=87 | Active Four Week N=85 | ALL Active Treatments N=257 | Vehicle Treatments N=127 | |||||
|---|---|---|---|---|---|---|---|---|---|---|
| n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | |
| Erythema | 76 | (89.4) | 82 | (94.3) | 82 | (96.5) | 240 | (93.4) | 76 | (59.8) |
| Dryness | 59 | (69.4) | 76 | (87.4) | 79 | (92.9) | 214 | (83.3) | 60 | (47.2) |
| Burning | 51 | (60.0) | 70 | (80.5) | 71 | (83.5) | 192 | (74.7) | 28 | (22.0) |
| Erosion | 21 | (24.7) | 38 | (43.7) | 54 | (63.5) | 113 | (44.0) | 17 | (13.4) |
| Pain | 26 | (30.6) | 34 | (39.1) | 52 | (61.2) | 112 | (43.6) | 7 | (5.5) |
| Edema | 12 | (14.1) | 28 | (32.2) | 51 | (60.0) | 91 | (35.4) | 6 | (4.7) |
During clinical trials, irritation generally began on day 4 and persisted for the remainder of treatment. Severity of facial irritation at the last treatment visit was slightly below baseline for the vehicle group, mild to moderate for the 1 week active treatment group, and moderate for the 2 and 4 week active treatment groups. Mean severity declined rapidly for each active group after completion of treatment and was below baseline for each group at the week 2 post-treatment follow-up visit.
Thirty-one patients (12% of those treated with Carac in the Phase 3 clinical studies) discontinued study treatment early due to facial irritation. Except for three patients, discontinuation of treatment occurred on or after day 11 of treatment.
Eye irritation adverse events, described as mild to moderate in intensity, were characterized as burning, watering, sensitivity, stinging and itching. These adverse events occurred across all treatment arms in one of the two Phase 3 studies.
| 9721 and 9722 Combined | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event | Active One Week N= 85 | Active Two Week N= 87 | Active Four Week N= 85 | ALL Active Treatments N=257 | Vehicle Treatments N=127 | |||||
| n | (%) | n | (%) | n | (%) | n | (%) | n | (%) | |
| BODY AS A WHOLE | 7 | (8.2) | 6 | (6.9) | 12 | (14.1) | 25 | (9.7) | 15 | (11.8) |
| Headache | 3 | (3.5) | 2 | (2.3) | 3 | (3.5) | 8 | (3.1) | 3 | (2.4) |
| Common Cold | 4 | (4.7) | 0 | 2 | (2.4) | 6 | (2.3) | 3 | (2.4) | |
| Allergy | 0 | 2 | (2.3) | 1 | (1.2) | 3 | (1.2) | 2 | (1.6) | |
| Infection Upper | 0 | 0 | 0 | 0 | 2 | (1.6) | ||||
| Respiratory | ||||||||||
| MUSCULOSKELETAL | 1 | (1.2) | 1 | (1.1) | 1 | (1.2) | 3 | (1.2) | 5 | (3.9) |
| Muscle Soreness | 0 | 0 | 0 | 0 | 2 | (1.6) | ||||
| RESPIRATORY | 5 | (5.9) | 0 | 1 | (1.2) | 6 | (2.3) | 6 | (4.7) | |
| Sinusitis | 4 | (4.7) | 0 | 0 | 4 | (1.6) | 2 | (1.6) | ||
| SKIN & APPENDAGES | 78 | (91.8) | 83 | (95.4) | 82 | (96.5) | 243 | (94.6) | 85 | (66.9) |
| Application Site | 78 | (91.8) | 83 | (95.4) | 82 | (96.5) | 243 | (94.6) | 83 | (65.4) |
| Reaction | ||||||||||
| Irritation Skin | 1 | (1.2) | 0 | 2 | (2.4) | 3 | (1.2) | 0 | ||
| SPECIAL SENSES | 6 | (7.1) | 4 | (4.6) | 6 | (7.1) | 16 | (6.2) | 6 | (4.7) |
| Eye Irritation | 5 | (5.9) | 3 | (3.4) | 6 | (7.1) | 14 | (5.4) | 3 | (2.4) |
Adverse Experiences Reported by Body System
In the Phase 3 studies, no serious adverse event was considered related to study drug. A total of five patients, three in the active treatment groups and two in the vehicle group, experienced at least one serious adverse event. Three patients died as a result of adverse event(s) considered unrelated to study drug (stomach cancer, myocardial infarction and cardiac failure).
Post-treatment clinical laboratory tests other than pregnancy tests were not performed during the Phase 3 clinical studies. Clinical laboratory tests were performed during conduct of a Phase 2 study of 104 patients and 21 patients in a Phase 1 study. No abnormal serum chemistry, hematology, or urinalysis results in these studies were considered clinically significant.
Carac Dosage and Administration
Carac cream should be applied once a day to the skin where actinic keratosis lesions appear, using enough to cover the entire area with a thin film. Carac cream should not be applied near the eyes, nostrils or mouth. Carac cream should be applied ten minutes after thoroughly washing, rinsing, and drying the entire area. Carac cream may be applied using the fingertips. Immediately after application, the hands should be thoroughly washed. Carac should be applied up to 4 weeks as tolerated. Continued treatment up to 4 weeks results in greater lesion reduction. Local irritation is not markedly increased by extending treatment from 2 to 4 weeks, and is generally resolved within 2 weeks of cessation of treatment.
OVERDOSE
Ordinarily, topical overdosage will not cause acute problems. If Carac is accidentally ingested, induce emesis and gastric lavage. Administer symptomatic and supportive care as needed. If contact is made with the eye, flush with copious amounts of water.
How is Carac Supplied
Cream - 30 gram tube NDC 0066-7150-30
Store at Controlled Room Temperature 20 to 25° C
(68 to 77° F) [see USP].
Prescribing Information as of August 2009.
Keep out of the reach of children.
Dermik Laboratories
a business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
© 2009 sanofi-aventis U.S. LLC
PATIENT INFORMATION
Carac® Cream, 0.5%
(fluorouracil cream)
Read this leaflet carefully before you start to use your medicine. Read the information you get every time you get more medicine. There may be new information about the drug. This leaflet does not take the place of talks with your doctor. If you have any questions or are not sure about something, ask your doctor or pharmacist.
What is Carac?
Carac (Care ack) is a cream used by adults to treat skin conditions on the face and front part of the scalp called solar keratosis or actinic keratosis.
Who should not use Carac?
Do not use Carac
- if you are pregnant or might become pregnant. Carac may harm your unborn child.
- if you are nursing a baby. We do not know if Carac can pass to the baby through the milk.
- if you have dihydropyrimidine dehydrogenase (DPD) enzyme deficiency. The active ingredient in Carac, fluorouracil, can cause serious side effects in patients who are DPD enzyme deficient. If you have DPD enzyme deficiency and use medications containing fluorouracil, you may develop serious side effects such as stomach pain, bloody diarrhea, vomiting, fever, or chills.
- if you are allergic to the ingredients in Carac. Ask your doctor or pharmacist about the inactive ingredients.
- if under 18 years of age. Carac should not be used in children
Tell your doctor if you are able to become pregnant. Your doctor may advise you about birth control to avoid pregnancy.
How should I use Carac?
Use Carac once a day as instructed by your doctor. Use it only on your skin. You should use Carac for up to 4 weeks.
- Clean the area where you will apply Carac. Rinse well and dry the area with a towel and wait 10 minutes before applying Carac.
- Put Carac on your face as directed by your physician, using your fingertips. Use enough to cover the affected skin.
- Avoid contact with your eyes, nostrils, and mouth.
- Wash your hands as soon as you finish putting the Carac on your skin.
- A moisturizer/sunscreen may be applied 2 hours after Carac has been applied. Do not use any other skin products including creams, lotions, medications or cosmetics -unless instructed by your doctor.
What should I avoid while using Carac?
Avoid sunlight or other ultraviolet light (such as tanning booths) as much as possible while using Carac. Sunlight may increase your side effects. When exposed to sunlight, wear a hat and use sunscreen.
Do not cover the treated skin with a dressing.
Do not breast feed or become pregnant while using Carac. If you do become pregnant, stop using Carac and tell your doctor right away.
What are the possible side effects of Carac?
Most patients using Carac get skin reactions where the medicine is used. These reactions include redness, dryness, burning, pain, erosion (loss of the upper layer of skin), and swelling. Irritation may continue for two or more weeks after treatment is over. The treated area may become unsightly during therapy.
Some patients get eye irritation. Eye irritation might consist of burning, sensitivity, itching, stinging, and watering. If you are concerned about side effects, talk to your doctor.
A few patients have reported side effects such as stomach pain, diarrhea, vomiting, fever, or chills, possibly due to the lack of a specific enzyme, DPD, in their body. If you experience any of these symptoms, discontinue therapy immediately, and contact your doctor.
Storage information
Keep this medicine at room temperature (68–77° F/ 20–25° C). Throw away unused medicine.
Keep this medicine out of the reach of children.
General advice about prescription medicines
Medicines are sometimes prescribed for conditions that are not described in patient information leaflets. Do not use it for a condition for which it was not prescribed. This medicine is for your use only. Never give it to other people. It may harm them even if their skin problem appears to be the same as yours. Do not use Carac after the expiration date on the tube
Prescribing Information as of August 2009.
Dermik Laboratories
a business of sanofi-aventis U.S. LLC
Bridgewater, NJ 08807
© 2009 sanofi-aventis U.S. LLC
PRINCIPAL DISPLAY PANEL - 30 gram Tube Label
NDC 0066-7150-30
Carac®
fluorouracil cream
CREAM, 0.5%
FOR TOPICAL USE ONLY
One 30g Tube
DERMIK®
sanofi aventis
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA020985 | 10/27/2000 | |
| Labeler - Dermik Laboratories (824676584) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| sanofi-aventis Canada Inc. | 251046934 | ANALYSIS, MANUFACTURE, LABEL, PACK | |
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