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Merck Sharp & Dohme Limited
Hertford Road, Hoddesdon, Hertfordshire, EN11 9BU
Telephone: +44 (0)1992 467 272
Fax: +44 (0)1992 479 292
Medical Information e-mail: medicalinformationuk@merck.com

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 22/02/2012
SPC CRIXIVAN 200 mg and 400 mg hard capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 22/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   13-Feb-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 (Posology and method of administration):

- The sub-heading of 'adults' has been removed.

- The paragraph and table which recommends the dose of crixivan for children and adolescents has been removed.

- The sub-heading titled 'paediatric population has been updated as follows: 'The safety and efficacy of CRIXIVAN in children under the age of 4　years have not been established (see section

 

5.1 and 5.2). Currently available data in children above the age of 4 years are described in sections　4.8, and 5.1 and 5.2, but no recommendation on a posology can be made for children under the age of 4　years.'    

 - Under the sub-heading 'method of administration' reference to the method of administration for paediatric patients has been removed. Reference to medical management in patients with one or more episode of nephrolithiasis has also been removed.

Section 4.3 (Contraindications): A cross reference to section 6.1 has been added. 

 

 

 

Section 4.4 (Special warnings and precautions for use): Reference to paediatric patients has been removed from this section, primarily under sub-heading'Nephrolithiasisand tubulointerstitial nephritis'.

Section 4.5 (Interaction with other medicinal products and other forms of interaction): Reference to 'interaction studies which have only been preformed in adults and the relevance of the results from this studies in paediatric patients is unknown' has been removed.

Section 4.8 (undesirable effects): Within the sub-heading 'Paediatric population' the recommended dose of 500 mg/m2 every 8 hours' has been removed.

 Section 6.6 (Special precautions for disposal and other handling): This section has been updated as follows: 'The bottles contain desiccant canisters that should remain in the container. Any unused 

 

 

 

medicinal product or waste material should be disposed of in accordance with local requirements'.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 
Updated on 28/07/2011 and displayed until 22/02/2012
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   18-Jul-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Section 4.2:  The order of this section has been restructured. No new information added.  

Section 4.4: Revised to include further information on nephrolithiasis and tubulointerstitial nephritis. Deletion of the paragraph concerning the safety and efficacy of indinavir in patients with significant underlying liver disorders has not been established as this information already appears in the paragraph above. Other minor typographical corrections.  

 Section 4.6: Minor typographical corrections to Pregnancy and lactation headings. New paragraph added on 'Fertility' to state that there are no data available regarding potential effects of CRIXIVAN treatment on male or female fertility.

Section 6.3: The s

helf life for Crixivan 400mg HDPE bottles containing 18 hard capsule has been removed

 

 

 Section 6.5: Reference to CRIXIVAN 400 mg: HDPE bottles with a polypropylene cap and a foil induction cap containing 18 capsules has been removed.

Section 8: Reference to marketing authorization number for Crixivan 400 mg 18 hard capsule has been removed

 

 

 

 
Updated on 23/06/2010 and displayed until 28/07/2011
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   20-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 6.1 Excipients - Removal of silicon dioxide and sodium lauryl sulphate from the capsule shell excipients

 
Updated on 25/01/2010 and displayed until 23/06/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   22-Dec-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


The changes made to the SmPC are as follows:

Section 4.4 Special warnings and precautions - Addition of information related to atazanavir and co-administration with indinavir.

Section 4.5 Interaction with other medicinal products - Addition of information on the interaction between atazanavir and indinavir.

Section 4.8 Undesirable effects - This sections has been re-organised and a tabular format of side effects has been implemented.

Updated on 20/11/2008 and displayed until 25/01/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   29-Oct-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.3: Addition of the statement "Combination of rifampicin with CRIXIVAN with or without concomitant low-dose ritonavir is contraindicated (see section 4.5)."

Section 4.5: Updated information on interaction of rifampicin with indinavir boosted with ritonavir.
Updated on 05/09/2008 and displayed until 20/11/2008
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   30-Jun-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2

New information provided on Crixivan 400mg administered with ritonavir 100mg as an alternative dosing regimen. Statement that Crixivan may be administered with or without food when co-administered with ritonavir has been added.

 

Ketoconazole has been added as one of the concomitant medicinal products when dosage reduction of Crixivan to 600 mg every 8 hours is recommended.

  

Section 4.3

The statement "with or without ritonavir" has been added in the information provided about concurrent administration of Crixivan with other medicines.

 

Additional contraindications with other medicines have been added, when administering indinavir with ritonavir.

 

The following warning has been added:

"Ritonavir should not be given with indinavir to patients with decompensated liver disease as ritonavir is principally metabolised and eliminated by the liver."

 

Section 4.4

Under the sub-section "Medicinal product interactions" the warning that "combination of rosuvastatin and protease inhibitors is not recommended" has been added.

 

 Section 4.5

The warning that boosted indinavir (indinavir with ritonavir) may have additive pharmacokinetic effects on substances that share the CYP3A4 pathway has been added.

 
In addition, that fact that indinavir with or without ritonavir should not be administered concurrently with medicinal products with narrow therapeutic windows and which are substrates of CYP3A4, has been added.

 

Additional contraindication information on concurrent administration of Crixivan (with or without ritonavir) with other medicinal products has been added.

 

Addition of warning that concurrent use of indinavir with rifampicin or herbal preparations containing St John’s wort (hypericum perforatum) is contraindicated.

 

The interactions of indinavir with other medicinal products, has now been included in a table format. Additional or updated information on the interaction and recommendation concerning co-administration have been provided for the following medicinal products: enteric-coated didanosine, amprenavir, itraconazole, ketoconazole, quinidine, carbamazepine, Phenobarbital phenytoin, dihydropyridine, rosuvastatin, atorvastatin, ciclosporin A, vardebafil, tadalafil and dexamethasone.

 

In addition, a new table regarding interactions and dose recommendations with other medicinal products for indinavir boosted with ritonavir has been provided. The table refers to the following medicinal products: amprenavir, efavirenz, rifabutin, rifampicin, atovaquone, erythromycin, itraconazole, ketoconazole, fentanyl, methadone, morphine, digoxin, warfarin, carbamazepine, divalproex, lamotrigine, trazodone, fexofenadine, loratidine, dilitazem, amlodipine, ciclosporin A, tacrolimus, sildenafil, tadalafil, vardenafil, buspirone, midazolam and dexamethasone.

 

Section 5.1

Additional information is provided on three studies showing reduction in HIV viral load when administering indinavir boosted with ritonavir.

 

Section 5.2

Additional information is provided on food effect and pharmacokinetic parameters when administering indinavir boosted with ritonavir.

 

Section 6.1

Titanium dioxide has been removed from the printing ink information for Crixivan 200 mg.

 
Updated on 29/08/2007 and displayed until 05/09/2008
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

 In SPC section 4.8 'renal failure' has been added under the subsection Renal and urinary disorders'.

The SPC contraindications section 4.3 has been updated to state: 'Crixivan should not be administered concurrently with….midazolam administered orally (for caution on parenterally administered midazolam, see section 4.5)…….' .

Section 4.5 contains additional information regarding 'oral' and 'parenteral' midazolam under the subsection 'Midazolam'.
Updated on 21/06/2007 and displayed until 29/08/2007
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In 4.3 Contraindications, amiodarone has been added to the list of medicinal products with narrow therapeutic windows and which are substrates of CYP3A4 that Indinavir should not be used together with.

Updated on 12/02/2007 and displayed until 21/06/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4: A new paragraph subheaded 'Osteonecrosis' has been added.

Section 4.8: Information regarding 'Osteonecrosis' has been added. Also under 'Renal and urinary disorders', the side effects 'pyelonephritis' and 'renal insufficiency' have been added
Updated on 18/01/2007 and displayed until 12/02/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2: The lactose content for individual capsule strengths is stated

Section 4.3: The list of medicines not to be administered concurrently now includes 'simvastatin' and 'lovastatin'.

Section 4.4: The subsection headed 'liver disease' has been updated with a caution regarding 'indinavir/ritonavir'

Section 4.5: The section has been re-arranged under the group headings: Antiretrovirals, Antifungals, Antimycobacterials and Miscellaneous.

Section 4.8: Clinical and post market side effects have been amalgamated to one list, with frequencies according to MedRA.
Updated on 28/01/2005 and displayed until 18/01/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 16/11/2004 and displayed until 28/01/2005
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 19/04/2004 and displayed until 16/11/2004
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 19/04/2004 and displayed until 19/04/2004
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  indinavir sulphate