Chlorosan may be available in the countries listed below.
Ingredient matches for Chlorosan
Chloramphenicol
Chloramphenicol is reported as an ingredient of Chlorosan in the following countries:
- Yemen
International Drug Name Search
Thursday, October 27, 2016
Evamyl
Evamyl may be available in the countries listed below.
Ingredient matches for Evamyl
Lormetazepam
Lormetazepam is reported as an ingredient of Evamyl in the following countries:
- Japan
International Drug Name Search
Mydrilate
Mydrilate may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
UK matches:
- Mydrilate 0.5% Eye Drops (SPC)
- Mydrilate 1.0% Eye Drops (SPC)
Ingredient matches for Mydrilate
Cyclopentolate
Cyclopentolate hydrochloride (a derivative of Cyclopentolate) is reported as an ingredient of Mydrilate in the following countries:
- Ireland
- United Kingdom
International Drug Name Search
Glossary
| SPC | Summary of Product Characteristics (UK) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Ipvent
Ipvent may be available in the countries listed below.
Ingredient matches for Ipvent
Ipratropium
Ipratropium Bromide is reported as an ingredient of Ipvent in the following countries:
- South Africa
International Drug Name Search
Warfarin tablets 3mg B. P
1. Name Of The Medicinal Product
Warfarin Tablets 3mg
2. Qualitative And Quantitative Composition
Each tablet contains 3 mg warfarin sodium(as clathrate).
3. Pharmaceutical Form
Round blue uncoated tablet, scored and marked 'W3' on one side with company logo on reverse.
4. Clinical Particulars
4.1 Therapeutic Indications
For prophylaxis against venous thrombosis and pulmonary embolism, and for use in the treatment of these conditions to prevent their extension. For the prophylaxis of systemic embolisation in patients with rheumatic heart disease and atrial fibrillation.
4.2 Posology And Method Of Administration
Warfarin tablets are for oral administration.
An initial daily dose of 10mg on the first two days. Subsequent daily doses should be adjusted according to the results of the prothrombin time or other appropriate coagulation tests. The single daily maintenance requirement is usually between 5mg and 12mg, but can vary between 2mg and 30mg.
The maintenance dose is omitted if the prothrombin time is excessively prolonged.
Use in elderly patients: The elderly are generally more sensitive to the effects of warfarin and often require a smaller dose on a weight for weight basis than younger patients.
Target INR
By referring to the target INR (see below), the dosage of warfarin can be adjusted depending on the deviation of the patient's INR from the target value. An INR within 0.5 INR units of the target is considered to be generally satisfactory.
The following target INR values are based on guidelines from The British Society for Haematology:
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4.3 Contraindications
• Known hypersensitivity to warfarin or to any of the excipients
• Haemorrhagic stroke (see section 4.4 for further details)
• Clinically significant bleeding
• Within 72 hours of major surgery with risk of severe bleeding (for information on other surgery, see section 4.4)
• Within 48 hours postpartum
• Pregnancy (first and third trimesters, see section 4.6)
• Drugs where interactions may lead to a significantly increased risk of bleeding (see section 4.5)
4.4 Special Warnings And Precautions For Use
Most adverse events reported with warfarin are a result of over anticoagulation therefore it is important that the need for therapy is reviewed on a regular basis and therapy discontinued when no longer required.
Patients should be given a patient-held information booklet ('warfarin card') and informed of symptoms for which they should seek medical attention.
Commencement of therapy
Monitoring
When warfarin is started using a standard dosing regimen the INR should be determined daily or on alternate days in the early days of treatment. Once the INR has stabilised in the target range the INR can be determined at longer intervals.
INR should be monitored more frequently in patients at an increased risk of over coagulation e.g. patients with severe hypertension, liver or renal disease.
Patients for whom adherence may be difficult should be monitored more frequently.
Thrombophilia
Patients with protein C deficiency are at risk of developing skin necrosis when starting warfarin treatment. In patients with protein C deficiency, therapy should be introduced without a loading dose of warfarin even if heparin is given. Patients with protein S deficiency may also be at risk and it is advisable to introduce warfarin therapy slowly in these circumstances.
Risk of haemorrhage
The most frequently reported adverse effect of all oral anticoagulants is haemorrhage. Warfarin should be given with caution to patients where there is a risk of serious haemorrhage (e.g. concomitant NSAID use, recent ischaemic stroke, bacterial endocarditis, previous gastrointestinal bleeding).
Risk factors for bleeding include high intensity of anticoagulation (INR>4.0), age
Checking the INR and reducing or omitting doses depending on INR level is essential, following consultation with anticoagulation services if necessary. If the INR is found to be too high, reduce dose or stop warfarin treatment; sometimes it will be necessary to reverse anticoagulation. INR should be checked within 2–3 days to ensure that it is falling.
Any concomitant anti-platelet drugs should be used with caution due to an increased risk of bleeding.
Haemorrhage
Haemorrhage can indicate an overdose of warfarin has been taken. For advice on treatment of haemorrhage see section 4.9.
Unexpected bleeding at therapeutic levels should always be investigated and INR monitored.
Ischaemic stroke
Anticoagulation following an ischaemic stroke increases the risk of secondary haemorrhage into the infarcted brain. In patients with atrial fibrillation long term treatment with warfarin is beneficial, but the risk of early recurrent embolism is low and therefore a break in treatment after ischaemic stroke is justified. Warfarin treatment should be re-started 2–14 days following ischaemic stroke, depending on the size of the infarct and blood pressure. In patients with large embolic strokes, or uncontrolled hypertension, warfarin treatment should be stopped for 14 days.
Surgery
For surgery where there is no risk of severe bleeding, surgery can be performed with an INR of <2.5.
For surgery where there is a risk of severe bleeding, warfarin should be stopped 3 days prior to surgery.
Where it is necessary to continue anticoagulation e.g. risk of life-threatening thromboembolism, the INR should be reduced to <2.5 and heparin therapy should be started.
If surgery is required and warfarin cannot be stopped 3 days beforehand, anticoagulation should be reversed with low-dose vitamin K.
The timing for re-instating warfarin therapy depends on the risk of post-operative haemorrhage. In most instances warfarin treatment can be re-started as soon as the patient has an oral intake.
Dental Surgery
Warfarin need not be stopped before routine dental surgery, eg, tooth extraction.
Active peptic ulceration
Due to a high risk of bleeding, patients with active peptic ulcers should be treated with caution. Such patients should be reviewed regularly and informed of how to recognise bleeding and what to do in the event of bleeding occurring.
Interactions
Many drugs and foods interact with warfarin and affect the prothrombin time (see section 4.5). Any change to medication, including self-medication with OTC products, warrants increased monitoring of the INR. Patients should be instructed to inform their doctor before they start to take any additional medications including over the counter medicines, herbal remedies or vitamin preparations.
Thyroid disorders
The rate of warfarin metabolism depends on thyroid status. Therefore patients with hyper- or hypo-thyroidism should be closely monitored on starting warfarin therapy.
Additional circumstances where changes in dose may be required
The following also may exaggerate the effect of warfarin tablets, and necessitate a reduction of dosage:
• Loss of weight
• Acute illness
• Cessation of smoking
The following may reduce the effect of warfarin tablets, and require the dosage to be increased:
• Weight gain
• Diarrhoea
• Vomiting
Other warnings
Acquired or inherited warfarin resistance should be suspected if larger than usual daily doses of warfarin are required to achieve the desired anticoagulant effect.
Genetic information
Genetic variability particularly in relation to CYP2C9 and VKORC1 can significantly affect dose requirements for warfarin. If a family association with these polymorphisms is known extra care is warranted.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Warfarin has a narrow therapeutic range and care is required with all concomitant therapy. The individual product information for any new concomitant therapy should be consulted for specific guidance on warfarin dose adjustment and therapeutic monitoring. If no information is provided the possibility of an interaction should be considered. Increased monitoring should be considered when commencing any new therapy if there is any doubt as to the extent of interaction.
Pharmacodynamic interactions
Drugs which are contraindicated
Concomitant use of drugs used in the treatment or prophylaxis of thrombosis, or other drugs with adverse effects on haemostasis may increase the pharmacological effect of warfarin, increasing the risk of bleeding.
Fibrinolytic drugs such as streptokinase and alteplase are contraindicated in patients receiving warfarin.
Drugs which should be avoided if possible
The following examples should be avoided, or administered with caution with increased clinical and laboratory monitoring:
• Clopidogrel
• NSAIDs (including aspirin and cox-2 specific NSAIDS)
• Sulfinpyrazone
• Thrombin inhibitors such as bivalirudin, dabigatran
• Dipyridamole
• Unfractionated heparins and heparin derivatives, low molecular weight heparins
• Fondaparinux, rivaroxaban
• Glycoprotein IIb/IIIa receptor antagonists such as eptifibatide, tirofiban and abciximab
• Prostacyclin
• SSRI and SNRI antidepressants
• Other drugs which inhibit haemostasis, clotting or platelet action
Low-dose aspirin with warfarin may have a role in some patients but the risk of gastrointestinal bleeding is increased. Warfarin may initially be given with a heparin in the initial treatment of thrombosis, until the INR is in the correct range.
Metabolic interactions
Warfarin is a mixture of enantiomers which are metabolised by different CYPP450 cytochromes. R-warfarin is metabolised primarily by CYP1A2 and CYP3A4. S-warfarin is metabolised primarily by CYP2C9. The efficacy of warfarin is affected primarily when the metabolism of S-warfarin is altered.
Drugs that compete as substrates for these cytochromes or inhibit their activity may increase warfarin plasma concentrations and INR, potentially increasing the risk of bleeding. When these drugs are co-administered, warfarin dosage may need to be reduced and the level of monitoring increased.
Conversely, drugs which induce these metabolic pathways may decrease warfarin plasma concentrations and INR, potentially leading to reduced efficacy. When these drugs are co-administered, warfarin dosage may need to be increased and the level of monitoring increased.
There are a small subsets of drugs for which interactions are known; however their clinical effect on the INR is variable. In these cases increased monitoring on starting and stopping therapy is advised.
Care should also be taken when stopping or reducing the dose of a metabolic inhibitor or inducer, once patients are stable on this combination (offset effect).
Listed below are drugs which are known to interact with warfarin in a clinically significant way.
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Other drug interactions
Broad spectrum antibiotics may potentiate the effect of warfarin by reducing the gut flora which produce vitamin K. Similarly, orlistat may reduce absorption of vitamin K. Cholestyramine and sucralfate potentially decrease absorption of warfarin.
Increased INR has been reported in patients taking glucosamine and warfarin. This combination is not recommended.
Interactions with herbal products
Herbal preparations containing St John's Wort (Hypericum perforatum) must not be used whilst taking warfarin due to a proven risk of decreased plasma concentrations and reduced clinical effects of warfarin.
Many other herbal products have a theoretical effect on warfarin; however most of these interactions are not proven. Patients should generally avoid taking any herbal medicines or food supplements whilst taking warfarin, and should be told to advise their doctor if they are taking any, as more frequent monitoring is advisable.
Alcohol
Acute ingestion of a large amount of alcohol may inhibit the metabolism of warfarin and increase INR. Conversely, chronic heavy alcohol intake may induce the metabolism of warfarin. Moderate alcohol intake can be permitted.
Interactions with food and food supplements
Individual case reports suggest a possible interaction between warfarin and cranberry juice, in most cases leading to an increase in INR or bleeding event. Patients should be advised to avoid cranberry products. Increased supervision and INR monitoring should be considered for any patient taking warfarin and regular cranberry juice.
Limited evidence suggests that grapefruit juice may cause a modest rise in INR in some patients taking warfarin.
Certain foods such as liver, broccoli, Brussels sprouts and green leafy vegetables contain large amounts of vitamin K. Sudden changes in diet can potentially affect control of anticoagulation. Patients should be informed of the need to seek medical advice before undertaking any major changes in diet.
Many other food supplements have a theoretical effect on warfarin; however most of these interactions are not proven. Patients should generally avoid taking any food supplements whilst taking warfarin, and should be told to advise their doctor if they are taking any, as more frequent monitoring is advisable.
Laboratory tests
Heparins and danaparoid may prolong the prothrombin time, therefore a sufficient time interval should be allowed after administration before performing the test.
4.6 Pregnancy And Lactation
Pregnancy:
Based on human experience warfarin causes congenital malformations and foetal death when administered during pregnancy.
Warfarin is contraindicated in pregnancy in the first and third trimester.
Women of child-bearing age who are taking Warfarin Tablets should use effective contraception during treatment.
Lactation:
Warfarin is excreted in breast milk in small amounts. However, at therapeutic does of warfarin no effects on the breast-feeding child are anticipated. Warfarin can be used during breast-feeding.
4.7 Effects On Ability To Drive And Use Machines
Nil.
4.8 Undesirable Effects
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4.9 Overdose
The benefit of gastric decontamination is uncertain. If the patient presents within 1 hour of ingestion of more than 0.25 mg/kg or more than the patient's therapeutic dose, consider activated charcoal (50 g for adults; 1 g/kg for children)
In cases of life-threatening haemorrhage
Stop warfarin treatment, give prothrombin complex concentrate (factors II, VII, IX, and X) 30–50 units/kg or (if no concentrate available) fresh frozen plasma 15 mL/kg. Discuss with local haematologist or National Poisons Information Service, or both.
Non-life threatening haemorrhage
Where anticoagulation can be suspended, give slow intravenous injection of phytomenadione (vitamin K1) 10–20 mg for adults (250 micrograms/kg for a child)
Where rapid re-anticoagulation is desirable (eg, valve replacements) give prothrombin complex concentrate (factors II, VII, IX, and X) 30–50 units/kg or (if no concentrate available) fresh frozen plasma 15 mL/kg.
Monitor INR to determine when to restart normal therapy. Monitor INR for at least 48 hours post overdose.
For patients on long-term warfarin therapy without major haemorrhage
• INR> 8·0, no bleeding or minor bleeding—stop warfarin, and give phytomenadione (vitamin K1) 0·5–1 mg for adults, 0·015–0·030 mg/kg (15–30 micrograms/kg) for children by slow intravenous injection or 5 mg by mouth (for partial reversal of anticoagulation give smaller oral doses of phytomenadione eg, 0·5–2·5 mg using the intravenous preparation orally); repeat dose of phytomenadione if INR still too high after 24 hours. Large doses of phytomenadione may completely reverse the effects ofwarfarin and make re-establishment of anticoagulation difficult.
• INR 6·0–8·0, no bleeding or minor bleeding—stop warfarin, restart when INR <5·0
• INR < 6·0 but more than 0·5 units above target value—reduce dose or stop warfarin, restart when INR <5·0
For patients NOT on long-term anticoagulants without major haemorrhage
Measure the INR (prothrombin time) at presentation and sequentially every 24–48 hours after ingestion depending on the initial dose and initial INR.
• If the INR remains normal for 24–48 hours and there is no evidence of bleeding, there should be no further monitoring necessary.
• Give vitamin K1 (phytomenadione) if:
a) there is no active bleeding and the patient has ingested more than 0·25 mg/kg;
OR
b) the prothrombin time is already significantly prolonged (INR>4·0).
The adult dose of vitamin K1 is 10–20 mg orally (250 micrograms/kg body weight for a child). Delay oral vitamin K1 at least 4 hours after any activated charcoal has been given. Repeat INR at 24 hours and consider further vitamin K1.
5. Pharmacological Properties
5.1 Pharmacodynamic Properties
Warfarin is a coumarin anticoagulant which depresses the hepatic vitamin K-dependent synthesis of coagulation factors II (Prothrombin), VII, IX and X. It acts indirectly, with no effect on existing clots.
5.2 Pharmacokinetic Properties
Warfarin Sodium is readily absorbed from the gastro-intestinal tract; it can also be absorbed through the skin. It is extensively bound to plasma proteins and its plasma half-life is about 37 hours. It crosses the placenta but does not occur in significant quantities in breast milk. Warfarin is administered as a racemic mixture. The s-isomer is reported to be more potent; the R and S isomers are both metabolised in the liver, though at different rates; the stereo-isomers may also be affected differently by other drugs. The inactive metabolites are excreted in the urine following reabsorption from the bile.
5.3 Preclinical Safety Data
No further relevant information other than that which is included in other sections of the Summary of Product Characteristics.
6. Pharmaceutical Particulars
6.1 List Of Excipients
Lactose, Maize Starch, Sodium Starch Glycollate, Magnesium Stearate, Indigo Carmine Lake ( E132 ), Alumina.
6.2 Incompatibilities
None known
6.3 Shelf Life
Securitainers: 5 years
HDPE containers: 5 years
Blister packs: 3 years
6.4 Special Precautions For Storage
Store below 25°C.
Protect from light and moisture.
6.5 Nature And Contents Of Container
Antigen International Ltd.: Polypropylene securitainers with tamper evident lid.
APS Ltd.: HDPE containers with LDPE lids or child resistant caps.
Pack size : 100 tablets, 500 tablets.
Blister strips of 14 tablets.
Pack size: 28 tablets, 56 tablets.
6.6 Special Precautions For Disposal And Other Handling
Use as directed by the physician.
7. Marketing Authorisation Holder
Antigen International Ltd.,
Roscrea,
Co. Tipperary,
Ireland.
8. Marketing Authorisation Number(S)
PL 02848/0186
9. Date Of First Authorisation/Renewal Of The Authorisation
22 November 1995
10. Date Of Revision Of The Text
16/04/2010
Wednesday, October 26, 2016
Taicezolin
Taicezolin may be available in the countries listed below.
Ingredient matches for Taicezolin
Cefazolin
Cefazolin sodium salt (a derivative of Cefazolin) is reported as an ingredient of Taicezolin in the following countries:
- Japan
International Drug Name Search
Clacef
Clacef may be available in the countries listed below.
Ingredient matches for Clacef
Cefotaxime
Cefotaxime sodium salt (a derivative of Cefotaxime) is reported as an ingredient of Clacef in the following countries:
- Indonesia
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Fluciderm
Fluciderm may be available in the countries listed below.
Ingredient matches for Fluciderm
Fluocinolone
Fluocinolone Acetonide is reported as an ingredient of Fluciderm in the following countries:
- Ethiopia
- Sri Lanka
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Frusene
Frusene may be available in the countries listed below.
UK matches:
- Frusene
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Furosemide
Furosemide is reported as an ingredient of Frusene in the following countries:
- United Kingdom
Triamterene
Triamterene is reported as an ingredient of Frusene in the following countries:
- United Kingdom
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Melperon beta
Melperon beta may be available in the countries listed below.
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Melperone
Melperone hydrochloride (a derivative of Melperone) is reported as an ingredient of Melperon beta in the following countries:
- Germany
International Drug Name Search
Alfacet
Alfacet may be available in the countries listed below.
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Cefaclor
Cefaclor is reported as an ingredient of Alfacet in the following countries:
- Serbia
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Prandil
Prandil may be available in the countries listed below.
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Repaglinide
Repaglinide is reported as an ingredient of Prandil in the following countries:
- Bangladesh
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Felodipin EP
Felodipin EP may be available in the countries listed below.
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Felodipine
Felodipine is reported as an ingredient of Felodipin EP in the following countries:
- Romania
International Drug Name Search
Tuesday, October 25, 2016
Fada Lorazepam
Fada Lorazepam may be available in the countries listed below.
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Lorazepam
Lorazepam is reported as an ingredient of Fada Lorazepam in the following countries:
- Argentina
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Ileveran
Ileveran may be available in the countries listed below.
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Enalapril
Enalapril maleate (a derivative of Enalapril) is reported as an ingredient of Ileveran in the following countries:
- Mexico
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Tronazam
Tronazam may be available in the countries listed below.
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Piperacillin
Piperacillin sodium salt (a derivative of Piperacillin) is reported as an ingredient of Tronazam in the following countries:
- Argentina
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Cortic
Cortic may be available in the countries listed below.
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Hydrocortisone
Hydrocortisone 21-acetate (a derivative of Hydrocortisone) is reported as an ingredient of Cortic in the following countries:
- Australia
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Monday, October 24, 2016
Lamotrigine GSK
Lamotrigine GSK may be available in the countries listed below.
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Lamotrigine
Lamotrigine is reported as an ingredient of Lamotrigine GSK in the following countries:
- Luxembourg
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Espasevit
Espasevit may be available in the countries listed below.
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Ondansetron
Ondansetron is reported as an ingredient of Espasevit in the following countries:
- Peru
Ondansetron hydrochloride (a derivative of Ondansetron) is reported as an ingredient of Espasevit in the following countries:
- Argentina
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Clarithromycin Grünenthal
Clarithromycin Grünenthal may be available in the countries listed below.
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Clarithromycin
Clarithromycin is reported as an ingredient of Clarithromycin Grünenthal in the following countries:
- Poland
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Lozione Vittoria
Lozione Vittoria may be available in the countries listed below.
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Benzalkonium Chloride
Benzalkonium chloride (a derivative of Benzalkonium) is reported as an ingredient of Lozione Vittoria in the following countries:
- Italy
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Sunday, October 23, 2016
Cloxadar
Cloxadar may be available in the countries listed below.
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Cloxacillin
Cloxacillin sodium salt (a derivative of Cloxacillin) is reported as an ingredient of Cloxadar in the following countries:
- Bahrain
- Iraq
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- Lebanon
- Libya
- Nigeria
- Qatar
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- United Arab Emirates
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L-Cetifilm
L-Cetifilm may be available in the countries listed below.
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Levocetirizine
Levocetirizine is reported as an ingredient of L-Cetifilm in the following countries:
- Peru
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Pentothal
In some countries, this medicine may only be approved for veterinary use.
In the US, Pentothal (thiopental systemic) is a member of the drug class general anesthetics and is used to treat Anesthesia, Anesthetic Adjunct, Coma Induction, Psychosis and Seizures.
US matches:
- Pentothal
Ingredient matches for Pentothal
Thiopental
Thiopental Sodium is reported as an ingredient of Pentothal in the following countries:
- Australia
- Belgium
- Canada
- Denmark
- Indonesia
- Israel
- Italy
- Luxembourg
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- Switzerland
- Taiwan
- Thailand
- United States
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Gentacortin
Gentacortin may be available in the countries listed below.
Ingredient matches for Gentacortin
Fluprednidene
Fluprednidene 21-acetate (a derivative of Fluprednidene) is reported as an ingredient of Gentacortin in the following countries:
- Indonesia
Gentamicin
Gentamicin sulfate (a derivative of Gentamicin) is reported as an ingredient of Gentacortin in the following countries:
- Indonesia
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Breacol
Breacol may be available in the countries listed below.
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Guaifenesin
Guaifenesin is reported as an ingredient of Breacol in the following countries:
- Singapore
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Saturday, October 22, 2016
Allobenz
Allobenz may be available in the countries listed below.
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Allopurinol
Allopurinol is reported as an ingredient of Allobenz in the following countries:
- Austria
Benzbromarone
Benzbromarone is reported as an ingredient of Allobenz in the following countries:
- Austria
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Ritrocel
Ritrocel may be available in the countries listed below.
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Methylphenidate
Methylphenidate hydrochloride (a derivative of Methylphenidate) is reported as an ingredient of Ritrocel in the following countries:
- Chile
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Fluorette Novum
Fluorette Novum may be available in the countries listed below.
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Sodium Fluoride
Sodium Fluoride is reported as an ingredient of Fluorette Novum in the following countries:
- Sweden
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Carboplatino Ebewe
Carboplatino Ebewe may be available in the countries listed below.
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Carboplatin
Carboplatin is reported as an ingredient of Carboplatino Ebewe in the following countries:
- Italy
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Friday, October 21, 2016
Ephedrine Aguettant
Ephedrine Aguettant may be available in the countries listed below.
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Ephedrine
Ephedrine is reported as an ingredient of Ephedrine Aguettant in the following countries:
- Tunisia
Ephedrine hydrochloride (a derivative of Ephedrine) is reported as an ingredient of Ephedrine Aguettant in the following countries:
- Malta
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Trimidar-M
Trimidar-M may be available in the countries listed below.
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Sulfamethoxazole
Sulfamethoxazole is reported as an ingredient of Trimidar-M in the following countries:
- Bahrain
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- Libya
- Nigeria
- Oman
- Qatar
- Romania
- Saudi Arabia
- Somalia
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- United Arab Emirates
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Trimethoprim
Trimethoprim is reported as an ingredient of Trimidar-M in the following countries:
- Bahrain
- Iraq
- Jordan
- Kuwait
- Lebanon
- Libya
- Nigeria
- Oman
- Qatar
- Romania
- Saudi Arabia
- Somalia
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- Tunisia
- United Arab Emirates
- Yemen
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Palancon
Palancon may be available in the countries listed below.
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Sofalcone
Sofalcone is reported as an ingredient of Palancon in the following countries:
- Japan
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Wednesday, October 19, 2016
Potassium Aspartate and Magnesium Aspartate
Potassium Aspartate and Magnesium Aspartate may be available in the countries listed below.
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Amino Acids
Potassium Aspartate and Magnesium Aspartate (USAN) is known as Amino Acids in the US.
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Glossary
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Trimétazidine Sandoz
Trimétazidine Sandoz may be available in the countries listed below.
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Trimetazidine
Trimetazidine dihydrochloride (a derivative of Trimetazidine) is reported as an ingredient of Trimétazidine Sandoz in the following countries:
- France
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FDG Scan
FDG Scan may be available in the countries listed below.
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Fludeoxyglucose (18F)
Fludeoxyglucose (18F) is reported as an ingredient of FDG Scan in the following countries:
- Spain
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Tuesday, October 18, 2016
Rolsical
Rolsical may be available in the countries listed below.
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Calcitriol
Calcitriol is reported as an ingredient of Rolsical in the following countries:
- India
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Monday, October 17, 2016
Endol
Endol may be available in the countries listed below.
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Indometacin
Indometacin is reported as an ingredient of Endol in the following countries:
- Turkey
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Citalopram Genericon
Citalopram Genericon may be available in the countries listed below.
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Citalopram
Citalopram hydrobromide (a derivative of Citalopram) is reported as an ingredient of Citalopram Genericon in the following countries:
- Austria
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Papavérine Serb
Papavérine Serb may be available in the countries listed below.
Ingredient matches for Papavérine Serb
Papaverine
Papaverine hydrochloride (a derivative of Papaverine) is reported as an ingredient of Papavérine Serb in the following countries:
- France
International Drug Name Search
Sunday, October 16, 2016
Medifer
Medifer may be available in the countries listed below.
Ingredient matches for Medifer
Ferrous Sulfate
Ferrous Sulfate is reported as an ingredient of Medifer in the following countries:
- Argentina
International Drug Name Search
Menbutone
In some countries, this medicine may only be approved for veterinary use.
Scheme
Rec.INN
CAS registry number (Chemical Abstracts Service)
0003562-99-0
Chemical Formula
C15-H14-O4
Molecular Weight
258
Therapeutic Category
Choleretic
Chemical Name
1-Naphthalenebutanoic acid, 4-methoxy-þ-oxo-
Foreign Names
- Menbutonum (Latin)
- Menbuton (German)
- Menbutone (French)
- Menbutona (Spanish)
Generic Names
- Menbutone (OS: BAN, DCF, DCIT)
- Menbutone Diethanolamine (OS: BANM)
Brand Names
- Actiliver (Menbutone and Sorbitol (veterinary use))
Laboratoires Biové, France - Genabil (veterinary use)
Boehrvet, Germany - Genabilin (veterinary use)
Boehringer Ingelheim Vet, Italy - Genabiline (veterinary use)
Boehringer Ingelheim Santé Animale, France - Genebile (veterinary use)
Boehringer Ingelheim Vetmedica, Ireland - Menbutil (veterinary use)
Gräub, Switzerland - Genabil (veterinary use)
Boehringer Ingelheim vet, Switzerland; Boehringer Ingelheim Vetmedica, Austria
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| DCIT | Denominazione Comune Italiana |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Lishenbao
Lishenbao may be available in the countries listed below.
Ingredient matches for Lishenbao
Urofollitropin
Urofollitropin is reported as an ingredient of Lishenbao in the following countries:
- China
International Drug Name Search
Pharmaseal Scrub Care
Ingredient matches for Pharmaseal Scrub Care
Chlorhexidine
Chlorhexidine digluconate (a derivative of Chlorhexidine) is reported as an ingredient of Pharmaseal Scrub Care in the following countries:
- United States
International Drug Name Search
Lenti
Lenti may be available in the countries listed below.
Ingredient matches for Lenti
Levocarnitine
Levocarnitine is reported as an ingredient of Lenti in the following countries:
- Bangladesh
International Drug Name Search
Friday, October 14, 2016
Maxidauno
Maxidauno may be available in the countries listed below.
Ingredient matches for Maxidauno
Daunorubicin
Daunorubicin hydrochloride (a derivative of Daunorubicin) is reported as an ingredient of Maxidauno in the following countries:
- Argentina
International Drug Name Search
Betamac T
Betamac T may be available in the countries listed below.
Ingredient matches for Betamac T
Sulpiride
Sulpiride is reported as an ingredient of Betamac T in the following countries:
- Japan
International Drug Name Search
Bareon
Bareon may be available in the countries listed below.
Ingredient matches for Bareon
Lomefloxacin
Lomefloxacin hydrochloride (a derivative of Lomefloxacin) is reported as an ingredient of Bareon in the following countries:
- Japan
International Drug Name Search
Thiopental Sandoz
Thiopental Sandoz may be available in the countries listed below.
Ingredient matches for Thiopental Sandoz
Thiopental
Thiopental Sodium is reported as an ingredient of Thiopental Sandoz in the following countries:
- Austria
- Estonia
- Latvia
- Lithuania
International Drug Name Search
Efedrinã
Efedrinã may be available in the countries listed below.
Ingredient matches for Efedrinã
Ephedrine
Ephedrine hydrochloride (a derivative of Ephedrine) is reported as an ingredient of Efedrinã in the following countries:
- Romania
International Drug Name Search
Thursday, October 13, 2016
Brolax
Brolax may be available in the countries listed below.
Ingredient matches for Brolax
Salbutamol
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Brolax in the following countries:
- Bangladesh
International Drug Name Search
Bagomet
Bagomet may be available in the countries listed below.
Ingredient matches for Bagomet
Metformin
Metformin is reported as an ingredient of Bagomet in the following countries:
- Russian Federation
International Drug Name Search
Gokumisin
Gokumisin may be available in the countries listed below.
Ingredient matches for Gokumisin
Ulinastatin
Ulinastatin is reported as an ingredient of Gokumisin in the following countries:
- Japan
International Drug Name Search
Tepilta
Tepilta may be available in the countries listed below.
Ingredient matches for Tepilta
Oxetacaine
Oxetacaine is reported as an ingredient of Tepilta in the following countries:
- Austria
International Drug Name Search
Famo
Famo may be available in the countries listed below.
Ingredient matches for Famo
Famotidine
Famotidine is reported as an ingredient of Famo in the following countries:
- Bangladesh
- Israel
International Drug Name Search
Rye
Rye may be available in the countries listed below.
Ingredient matches for Rye
Bifonazole
Bifonazole is reported as an ingredient of Rye in the following countries:
- Greece
International Drug Name Search
Wednesday, October 12, 2016
Rheohes
Rheohes may be available in the countries listed below.
Ingredient matches for Rheohes
Hetastarch
Hetastarch is reported as an ingredient of Rheohes in the following countries:
- Germany
International Drug Name Search
Forosa
Forosa may be available in the countries listed below.
Ingredient matches for Forosa
Alendronic Acid
Alendronic Acid is reported as an ingredient of Forosa in the following countries:
- Bulgaria
- Croatia (Hrvatska)
- Slovenia
Alendronic Acid sodium trihydrate (a derivative of Alendronic Acid) is reported as an ingredient of Forosa in the following countries:
- Greece
International Drug Name Search
Glimepirid Ivax
Glimepirid Ivax may be available in the countries listed below.
Ingredient matches for Glimepirid Ivax
Glimepiride
Glimepiride is reported as an ingredient of Glimepirid Ivax in the following countries:
- Finland
International Drug Name Search
Pimobendan
In some countries, this medicine may only be approved for veterinary use.
Scheme
Rec.INN
CAS registry number (Chemical Abstracts Service)
0074150-27-9
Chemical Formula
C19-H18-N4-O2
Molecular Weight
334
Therapeutic Categories
Cardiac stimulant, cardiotonic agent
Vasodilator
Chemical Name
4,5-Dihydro-6-[2-(p-methoxyphenyl)-5-benzimidazolyl]-5-methyl-3(2H)-pyridazinone
Foreign Names
- Pimobendanum (Latin)
- Pimobendan (German)
- Pimobendane (French)
- Pimobendan (Spanish)
Generic Names
- Pimobendan (OS: USAN, BAN)
- dl-Pimobendan (IS)
- UD-CG 115 BS (IS: Thomae)
- Pimobendan (PH: BP 2010, Ph. Eur. 6)
- Pimobendanum (PH: Ph. Eur. 6)
Brand Names
- Acardi
Boehringer Ingelheim, Japan - Vetmedin (veterinary use)
Boehringer Ingelheim, Australia; Boehringer Ingelheim, Sweden; Boehringer Ingelheim Animal, Belgium; Boehringer Ingelheim Animal, Netherlands; Boehringer Ingelheim Animal, Portugal; Boehringer Ingelheim Animals, New Zealand; Boehringer Ingelheim International, Luxembourg; Boehringer Ingelheim Santé Animale, France; Boehringer Ingelheim vet, Switzerland; Boehringer Ingelheim vet, Italy; Boehringer Ingelheim vet, Norway; Boehringer Ingelheim Vetmedica, Austria; Boehringer Ingelheim Vetmedica, United Kingdom; Boehringer Ingelheim Vetmedica, Ireland; Boehringer Ingelheim Vetmedica, United States; Boehrvet, Germany; Vetcare, Finland
International Drug Name Search
Glossary
| BAN | British Approved Name |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Adalken
Adalken may be available in the countries listed below.
Ingredient matches for Adalken
Penicillamine
Penicillamine is reported as an ingredient of Adalken in the following countries:
- Mexico
International Drug Name Search
Tinoridine hydrochloride
Tinoridine hydrochloride may be available in the countries listed below.
Ingredient matches for Tinoridine hydrochloride
Tinoridine
Tinoridine hydrochloride (JAN) is also known as Tinoridine (Rec.INN)
International Drug Name Search
Glossary
| JAN | Japanese Accepted Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Proval
Proval may be available in the countries listed below.
Ingredient matches for Proval
Valproic Acid
Valproic Acid semisodium (a derivative of Valproic Acid) is reported as an ingredient of Proval in the following countries:
- Bangladesh
International Drug Name Search
Tuesday, October 11, 2016
Bicaprol
Bicaprol may be available in the countries listed below.
Ingredient matches for Bicaprol
Bicalutamide
Bicalutamide is reported as an ingredient of Bicaprol in the following countries:
- Greece
International Drug Name Search
Monovas
Monovas may be available in the countries listed below.
Ingredient matches for Monovas
Amlodipine
Amlodipine is reported as an ingredient of Monovas in the following countries:
- Turkey
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of Monovas in the following countries:
- Bosnia & Herzegowina
International Drug Name Search
Risperidona Spyfarma
Risperidona Spyfarma may be available in the countries listed below.
Ingredient matches for Risperidona Spyfarma
Risperidone
Risperidone is reported as an ingredient of Risperidona Spyfarma in the following countries:
- Spain
International Drug Name Search
Monday, October 10, 2016
Loratadina Teva
Loratadina Teva may be available in the countries listed below.
Ingredient matches for Loratadina Teva
Loratadine
Loratadine is reported as an ingredient of Loratadina Teva in the following countries:
- Italy
- Spain
International Drug Name Search
Aceglutamide
Scheme
Rec.INN
CAS registry number (Chemical Abstracts Service)
0002490-97-3
Chemical Formula
C7-H12-N2-O4
Molecular Weight
188
Therapeutic Category
Central stimulant
Chemical Name
L-Glutamine, N2-acetyl-
Foreign Names
- Aceglutamidum (Latin)
- Aceglutamid (German)
- Acéglutamide (French)
- Aceglutamida (Spanish)
Generic Names
- Acéglutamide (OS: DCF)
- Aceglutamide Aluminum (OS: USAN)
- Aceglutamide complex with Al(OH)₃ (IS)
- KW-110 (IS)
- Aceglutamide Aluminum (PH: JP XV)
Brand Name
- Glumal
Kyowa Hakko Kirin, Japan
International Drug Name Search
Glossary
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Click for further information on drug naming conventions and International Nonproprietary Names.
Finasterid AbZ
Finasterid AbZ may be available in the countries listed below.
Ingredient matches for Finasterid AbZ
Finasteride
Finasteride is reported as an ingredient of Finasterid AbZ in the following countries:
- Germany
International Drug Name Search
Aceclofenac
UK matches:
- Aceclofenac 100mg Tablets (SPC)
Scheme
Rec.INN
ATC (Anatomical Therapeutic Chemical Classification)
M01AB16,M02AA25
CAS registry number (Chemical Abstracts Service)
0089796-99-6
Chemical Formula
C16-H13-Cl2-N-O4
Molecular Weight
354
Therapeutic Categories
Analgesic, antipyretic and anti-inflammatory agent
Non-steroidal anti-inflammatory drug, NSAID
Chemical Name
Glycolic acid, [o-(2,6-dichloroanilino)phenyl]acetate (ester)
Foreign Names
- Aceclofenacum (Latin)
- Aceclofenac (German)
- Acéclofénac (French)
- Aceclofenaco (Spanish)
Generic Names
- Aceclofenac (OS: BAN)
- Acéclofénac (OS: DCF)
- Aceclofenac (PH: BP 2010, Ph. Eur. 6)
- Acéclofénac (PH: Ph. Eur. 6)
- Aceclofenacum (PH: Ph. Eur. 6)
Brand Names
- Acebel-P (Aceclofenac and Paracetamol)
Blubell, India - Aceclo
Aristo, India - Acecloben
Benham, Bangladesh - Aceclofenac Alter
Alter, Portugal - Aceclofenac Ciclum
Ciclum, Portugal - Acéclofenac EG
EG Labo, France - Aceclofenac Generis
Generis, Portugal - Aceclofenac Help
Help, Greece - Acéclofenac Mylan
Mylan, France - Acéclofenac Qualimed
Qualimed, France - Aceclofenaco Alprofarma
Alprofarma, Spain - Aceclofenaco Alter
Alter, Spain - Aceclofenaco Bexal
Bexal, Spain - Aceclofenaco Cinfa
Cinfa, Spain - Aceclofenaco Cuve
Cuvefarma, Spain - Aceclofenaco Davur
Davur, Spain - Aceclofenaco Goibela
Cinfa, Spain - Aceclofenaco Kern Pharma
Kern, Spain - Aceclofenaco Mabo
Mabo, Spain - Aceclofenaco Merck
Merck Genericos, Spain - Aceclofenaco
Medicalex, Colombia - Aceclonac
Verisfield, Greece - Acecol
Ziska, Bangladesh - Acefenac
General Pharma, Bangladesh - Acenac
Medicon, Bangladesh - Ace-Q-Para (Aceclofenac and Paracetamol)
Q-Check, India - Aclo
Alco, Bangladesh - Aclocen
Centrum, Spain - Aclofen
Globe, Bangladesh - Aflamil
Gedeon Richter, Bulgaria; Gedeon Richter, Romania; Richter Gedeon RT, Slovakia - Aflamin
Gedeon Richter, Hungary - Air Tal
Almirall, Belgium; Almirall, Luxembourg - Airtal Difucreme
Almirall, Spain; Almirall, Portugal - Airtal
Almirall, Burkina Faso; Almirall, Bulgaria; Almirall, Benin; Almirall, Congo; Almirall, Cote D'ivoire; Almirall, Cameroon; Almirall, Spain; Almirall, Gabon; Almirall, Italy; Almirall, Madagascar; Almirall, Mali; Almirall, Mauritius; Almirall, Niger; Almirall, Portugal; Almirall, Senegal; Almirall, Togo; Gedeon Richter, Latvia - Alembicfortafen
Alembic, Vietnam - Apeclo
Apex, Bangladesh - Aros
Globe, Bangladesh - Beofenac
Almirall Hermal, Germany - Berlofen
Elea, Argentina - Biofenac
Almirall, Belgium; Almirall, Greece; Almirall, Luxembourg; Almirall, Netherlands; Biomeks, Turkey; Dr. Fisher, Netherlands; EU-Pharma, Netherlands - Bristaflam
Almirall, Mexico; Bristol-Myers Squibb, Bahrain; Bristol-Myers Squibb, Peru; Elmor, Venezuela - Cartrex
Almirall, France - Ceclofen
Renata, Bangladesh - Celofen
ACI, Bangladesh - Clanza
Korea, Philippines - Clof
Bio-Pharma, Bangladesh - Ecena
Edruc, Bangladesh - Ena
Asiatic Lab, Bangladesh - Falcol Difucrem
Farma Lepori, Spain - Falcol
Farma Lepori, Spain - Filexi
BV Pharma, Vietnam - Flaxinac (Aceclofenac and Paracetamol)
Solitaire, India - Flaxinac-SR
Solitaire, India - Flexi
Square, Bangladesh - Flexibel-AD (Aceclofenac and Diacerein)
Blubell, India - Fractopon
Intermed, Greece - Gerbin
Omega, Spain - Gladio
Abiogen, Italy - Iasan
Uni-Pharma, Greece - Intafenac
Intas, Vietnam - Kafenac
Almirall, Italy - Maclo
Doctor's Chemical Work, Bangladesh - Mervan
Aristopharma, Bangladesh - Movex
Opsonin, Bangladesh - Movon
Ipca, India - Noak
Orion, Bangladesh - Nofenac
Drug International, Bangladesh - Orifen
Silva, Bangladesh - Ostoflex
Somatec, Bangladesh - Painex
Chemist, Bangladesh - Parclo-AP (Aceclofenac and Paracetamol)
Candor, India - Perservin
Ibn Sina, Bangladesh - Preservex
Almirall, United Kingdom - Proflam
Bristol-Myers Squibb, Brazil - Reservix
Incepta, Bangladesh - Rheuma
Mystic, Bangladesh - Sapclo
Shamsul Alamin, Bangladesh - Servex
Novo Healthcare, Bangladesh - Sovipan
Sanofi-Synthelabo, Greece - Speenac
Korea United Pharm, Vietnam - Tonec
U.C. Pharma, Taiwan - Tuffox
Eskayef, Bangladesh - Zerodol
Ipca, Myanmar; Navana, Bangladesh - Zolfin
Beximco, Bangladesh
International Drug Name Search
Glossary
| BAN | British Approved Name |
| DCF | Dénomination Commune Française |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| SPC | Summary of Product Characteristics (UK) |
Click for further information on drug naming conventions and International Nonproprietary Names.
Sunday, October 9, 2016
Glinux 70 / 30
Glinux 70/30 may be available in the countries listed below.
Ingredient matches for Glinux 70/30
Insulin Zinc Suspension (compound)
Insulin Zinc Suspension (compound) human (a derivative of Insulin Zinc Suspension (compound)) is reported as an ingredient of Glinux 70/30 in the following countries:
- Mexico
International Drug Name Search
Amoxicillina Jet
Amoxicillina Jet may be available in the countries listed below.
Ingredient matches for Amoxicillina Jet
Amoxicillin
Amoxicillin trihydrate (a derivative of Amoxicillin) is reported as an ingredient of Amoxicillina Jet in the following countries:
- Italy
International Drug Name Search
TV Amlodipin
TV Amlodipin may be available in the countries listed below.
Ingredient matches for TV Amlodipin
Amlodipine
Amlodipine besilate (a derivative of Amlodipine) is reported as an ingredient of TV Amlodipin in the following countries:
- Vietnam
International Drug Name Search
Paroxetina Alter
Paroxetina Alter may be available in the countries listed below.
Ingredient matches for Paroxetina Alter
Paroxetine
Paroxetine hydrochloride (a derivative of Paroxetine) is reported as an ingredient of Paroxetina Alter in the following countries:
- Portugal
- Spain
International Drug Name Search
Saturday, October 8, 2016
Kaletra 200 mg / 50 mg film-coated tablets (Abbott Laboratories Limited)
1. Name Of The Medicinal Product
Kaletra 200 mg/50 mg film-coated tablets
2. Qualitative And Quantitative Composition
Each film-coated tablet contains 200 mg of lopinavir co-formulated with 50 mg of ritonavir as a pharmacokinetic enhancer.
For a full list of excipients, see section 6.1.
3. Pharmaceutical Form
Film-coated tablet
Yellow embossed with [Abbott logo] and “KA”.
4. Clinical Particulars
4.1 Therapeutic Indications
Kaletra is indicated in combination with other antiretroviral medicinal products for the treatment of HIV-1 infected adults, adolescents and children above the age of 2 years.
The choice of Kaletra to treat protease inhibitor experienced HIV-1 infected patients should be based on individual viral resistance testing and treatment history of patients (see sections 4.4 and 5.1).
4.2 Posology And Method Of Administration
Kaletra should be prescribed by physicians who are experienced in the treatment of HIV infection.
Kaletra tablets must be swallowed whole and not chewed, broken or crushed
Posology
Adult and adolescent use: the standard recommended dosage of Kaletra tablets is 400/100 mg (two 200/50 mg) tablets twice daily taken with or without food. In adult patients, in cases where once daily dosing is considered necessary for the management of the patient, Kaletra tablets may be administered as 800/200 mg (four 200/50 mg tablets) once daily with or without food. The use of a once daily dosing should be limited to those adult patients having only very few protease inhibitor (PI) associated mutations (i.e. less than 3 PI mutations in line with clinical trial results, see section 5.1 for the full description of the population) and should take into account the risk of a lesser sustainability of the virologic suppression (see section 5.1) and higher risk of diarrhoea (see section 4.8) compared to the recommended standard twice daily dosing. An oral solution is available to patients who have difficulty swallowing. Refer to the Summary of Product Characteristics for Kaletra oral solution for dosing instructions.
Paediatric use (2 years of age and above): the adult dose of Kaletra tablets (400/100 mg twice daily) may be used in children 40 kg or greater or with a Body Surface Area (BSA)* greater than 1.4 m2. For children weighing less than 40 kg or with a BSA between 0.5 and 1.4 m2 and able to swallow tablets, please refer to the Kaletra 100 mg/25 mg tablets Summary of Product Characteristics. For children unable to swallow tablets, please refer to the Kaletra oral solution Summary of Product Characteristics. Kaletra dosed once daily has not been evaluated in paediatric patients.
* Body surface area can be calculated with the following equation:
BSA (m2) = √ (Height (cm) X Weight (kg) / 3600)
Children less than 2 years of age: the safety and efficacy of Kaletra in children aged less than 2 years have not yet been established. Currently available data are described in section 5.2 but no recommendation on a posology can be made.
Concomitant Therapy: Efavirenz or nevirapine
The following table contains dosing guidelines for Kaletra tablets based on BSA when used in combination with efavirenz or nevirapine in children.
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* Kaletra tablets must not be chewed, broken or crushed.
Hepatic impairment: In HIV-infected patients with mild to moderate hepatic impairment, an increase of approximately 30% in lopinavir exposure has been observed but is not expected to be of clinical relevance (see section 5.2). No data are available in patients with severe hepatic impairment. Kaletra must not be given to these patients (see section 4.3).
Renal impairment: since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment. Because lopinavir and ritonavir are highly protein bound, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Method of administration
Kaletra tablets are administered orally and must be swallowed whole and not chewed, broken or crushed. Kaletra tablets can be taken with or without food.
4.3 Contraindications
Hypersensitivity to the active substances or to any of the excipients.
Patients with severe hepatic insufficiency.
Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A. Kaletra should not be co-administered with medicinal products that are highly dependent on CYP3A for clearance and for which elevated plasma concentrations are associated with serious and/or life threatening events. These medicinal products include astemizole, terfenadine, oral midazolam (for caution on parenterally administered midazolam, see section 4.5), triazolam, cisapride, pimozide, amiodarone, ergot alkaloids (e.g. ergotamine, dihydroergotamine, ergonovine and methylergonovine) lovastatin, simvastatin, sildenafil used for the treatment of pulmonary arterial hypertension (for the use of sildenafil in patients with erectile dysfunction, see section 4.5) and vardenafil.
Herbal preparations containing St John's wort (Hypericum perforatum) must not be used while taking lopinavir and ritonavir due to the risk of decreased plasma concentrations and reduced clinical effects of lopinavir and ritonavir (see section 4.5).
4.4 Special Warnings And Precautions For Use
Patients with coexisting conditions
Hepatic impairment: the safety and efficacy of Kaletra has not been established in patients with significant underlying liver disorders. Kaletra is contraindicated in patients with severe liver impairment (see section 4.3). Patients with chronic hepatitis B or C and treated with combination antiretroviral therapy are at an increased risk for severe and potentially fatal hepatic adverse reactions. In case of concomitant antiviral therapy for hepatitis B or C, please refer to the relevant product information for these medicinal products.
Patients with pre-existing liver dysfunction including chronic hepatitis have an increased frequency of liver function abnormalities during combination antiretroviral therapy and should be monitored according to standard practice. If there is evidence of worsening liver disease in such patients, interruption or discontinuation of treatment should be considered.
Elevated transaminases with or without elevated bilirubin levels have been reported in HIV-1 mono-infected and in individuals treated for post-exposure prophylaxis as early as 7 days after the initiation of lopinavir/ritonavir in conjunction with other antiretroviral agents. In some cases the hepatic dysfunction was serious.
Appropriate laboratory testing should be conducted prior to initiating therapy with lopinavir/ritonavir and close monitoring should be performed during treatment.
Renal impairment: since the renal clearance of lopinavir and ritonavir is negligible, increased plasma concentrations are not expected in patients with renal impairment. Because lopinavir and ritonavir are highly protein bound, it is unlikely that they will be significantly removed by haemodialysis or peritoneal dialysis.
Haemophilia: there have been reports of increased bleeding, including spontaneous skin haematomas and haemarthrosis in patients with haemophilia type A and B treated with protease inhibitors. In some patients additional factor VIII was given. In more than half of the reported cases, treatment with protease inhibitors was continued or reintroduced if treatment had been discontinued. A causal relationship had been evoked, although the mechanism of action had not been elucidated. Haemophiliac patients should therefore be made aware of the possibility of increased bleeding.
Lipid elevations
Treatment with Kaletra has resulted in increases, sometimes marked, in the concentration of total cholesterol and triglycerides. Triglyceride and cholesterol testing is to be performed prior to initiating Kaletra therapy and at periodic intervals during therapy. Particular caution should be paid to patients with high values at baseline and with history of lipid disorders. Lipid disorders are to be managed as clinically appropriate (see also section 4.5 for additional information on potential interactions with HMG-CoA reductase inhibitors).
Pancreatitis
Cases of pancreatitis have been reported in patients receiving Kaletra, including those who developed hypertriglyceridaemia. In most of these cases patients have had a prior history of pancreatitis and/or concurrent therapy with other medicinal products associated with pancreatitis. Marked triglyceride elevation is a risk factor for development of pancreatitis. Patients with advanced HIV disease may be at risk of elevated triglycerides and pancreatitis
Pancreatitis should be considered if clinical symptoms (nausea, vomiting, abdominal pain) or abnormalities in laboratory values (such as increased serum lipase or amylase values) suggestive of pancreatitis should occur. Patients who exhibit these signs or symptoms should be evaluated and Kaletra therapy should be suspended if a diagnosis of pancreatitis is made (see section 4.8).
Hyperglycaemia
New onset diabetes mellitus, hyperglycaemia or exacerbation of existing diabetes mellitus has been reported in patients receiving protease inhibitors. In some of these the hyperglycaemia was severe and in some cases also associated with ketoacidosis. Many patients had confounding medical conditions some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycaemia.
Fat redistribution and metabolic disorders
Combination antiretroviral therapy has been associated with redistribution of body fat (lipodystrophy) in HIV patients. The long-term consequences of these events are currently unknown. Knowledge about the mechanism is incomplete. A connection between visceral lipomatosis and protease inhibitors (PIs) and lipoatrophy and nucleoside reverse transcriptase inhibitors (NRTIs) has been hypothesised. A higher risk of lipodystrophy has been associated with individual factors such as older age, and with drug related factors such as longer duration of antiretroviral treatment and associated metabolic disturbances. Clinical examination should include evaluation for physical signs of fat redistribution. Consideration should be given to measurement of fasting serum lipids and blood glucose. Lipid disorders should be managed as clinically appropriate (see section 4.8).
Immune Reactivation Syndrome
In HIV-infected patients with severe immune deficiency at the time of institution of combination antiretroviral therapy (CART), an inflammatory reaction to asymtomatic or residual opportunistic pathogens may arise and cause serious clinical conditions, or aggravation of symptoms. Typically, such reactions have been observed within the first few weeks or months of initiation of CART. Relevant examples are cytomegalovirus retinitis, generalised and/or focal mycobacterial infections, and Pneumocystis jiroveci pneumonia. Any inflammatory symptoms should be evaluated and treatment instituted when necessary.
Osteonecrosis
Although the etiology is considered to be multifactorial (including corticosteroid use, alcohol consumption, severe immunosuppression, higher body mass index), cases of osteonecrosis have been reported particularly in patients with advanced HIV-disease and/or long-term exposure to combination antiretroviral therapy (CART). Patients should be advised to seek medical advice if they experience joint aches and pain, joint stiffness or difficulty in movement.
PR interval prolongation
Lopinavir/ritonavir has been shown to cause modest asymptomatic prolongation of the PR interval in some healthy adult subjects. Rare reports of 2nd or 3rd degree atroventricular block in patients with underlying structural heart disease and pre-existing conduction system abnormalities or in patients receiving drugs known to prolong the PR interval (such as verapamil or atazanavir) have been reported in patients receiving lopinavir/ritonavir. Kaletra should be used with caution in such patients (see section 5.1).
Interactions with medicinal products
Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A. Kaletra is likely to increase plasma concentrations of medicinal products that are primarily metabolised by CYP3A. These increases of plasma concentrations of co-administered medicinal products could increase or prolong their therapeutic effect and adverse events (see sections 4.3 and 4.5).
The combination of Kaletra with atorvastatin is not recommended. If the use of atorvastatin is considered strictly necessary, the lowest possible dose of atorvastatin should be administered with careful safety monitoring. Caution must also be exercised and reduced doses should be considered if Kaletra is used concurrently with rosuvastatin. If treatment with a HMG-CoA reductase inhibitor is indicated, pravastatin or fluvastatin is recommended (see section 4.5).
PDE5 inhibitors: particular caution should be used when prescribing sildenafil or tadalafil for the treatment of erectile dysfunction in patients receiving Kaletra. Co-administration of Kaletra with these medicinal products is expected to substantially increase their concentrations and may result in associated adverse events such as hypotension, syncope, visual changes and prolonged erection (see section 4.5). Concomitant use of vardenafil and lopinavir/ritonavir is contraindicated (see section 4.3). Concomitant use of sildenafil prescribed for the treatment of pulmonary arterial hypertension with Kaletra is contraindicated (see section 4.3).
Particular caution must be used when prescribing Kaletra and medicinal products known to induce QT interval prolongation such as: chlorpheniramine, quinidine, erythromycin, clarithromycin. Indeed, Kaletra could increase concentrations of the co-administered medicinal products and this may result in an increase of their associated cardiac adverse reactions. Cardiac events have been reported with Kaletra in preclinical studies; therefore, the potential cardiac effects of Kaletra cannot be currently ruled out (see sections 4.8 and 5.3).
Co-administration of Kaletra with rifampicin is not recommended. Rifampicin in combination with Kaletra causes large decreases in lopinavir concentrations which may in turn significantly decrease the lopinavir therapeutic effect. Adequate exposure to lopinavir/ritonavir may be achieved when a higher dose of Kaletra is used but this is associated with a higher risk of liver and gastrointestinal toxicity. Therefore, this co-administration should be avoided unless judged strictly necessary (see section 4.5).
Concomitant use of Kaletra and fluticasone or other glucocorticoids that are metabolised by CYP3A4 is not recommended unless the potential benefit of treatment outweighs the risk of systemic corticosteroid effects, including Cushing's syndrome and adrenal suppression (see section 4.5).
Other
Kaletra is not a cure for HIV infection or AIDS. It does not reduce the risk of passing HIV to others through sexual contact or blood contamination. Appropriate precautions should be taken. People taking Kaletra may still develop infections or other illnesses associated with HIV disease and AIDS.
4.5 Interaction With Other Medicinal Products And Other Forms Of Interaction
Kaletra contains lopinavir and ritonavir, both of which are inhibitors of the P450 isoform CYP3A in vitro. Co-administration of Kaletra and medicinal products primarily metabolised by CYP3A may result in increased plasma concentrations of the other medicinal product, which could increase or prolong its therapeutic and adverse reactions. Kaletra does not inhibit CYP2D6, CYP2C9, CYP2C19, CYP2E1, CYP2B6 or CYP1A2 at clinically relevant concentrations (see section 4.3).
Kaletra has been shown in vivo to induce its own metabolism and to increase the biotransformation of some medicinal products metabolised by cytochrome P450 enzymes (including CYP2C9 and CYP2C19) and by glucuronidation. This may result in lowered plasma concentrations and potential decrease of efficacy of co-administered medicinal products.
Medicinal products that are contraindicated specifically due to the expected magnitude of interaction and potential for serious adverse events are listed in section 4.3.
All interaction studies, when otherwise not stated, were performed using Kaletra capsules, which gives an approximately 20% lower exposure of lopinavir than the 200/50 mg tablets.
Known and theoretical interactions with selected antiretrovirals and non-antiretroviral medicinal products are listed in the table below.
Interaction table
Interactions between Kaletra and co-administered medicinal products are listed in the table below (increase is indicated as “↑”, decrease as “
Unless otherwise stated, studies detailed below have been performed with the recommended dosage of lopinavir/ritonavir (i.e. 400/100 mg twice daily).
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