Microsoft word - 241001-refrigerated meds _part a_.doc

Detail-Document #241001
−This Detail-Document accompanies the related article published in− PHARMACIST'S LETTER / PRESCRIBER'S LETTER October 2008 Volume 24 Number 241001 Stability of Refrigerated and Frozen Drugs —Chart modified November 2008—
(Based on U.S. product labeling and relevant studies)
Failure to follow storage recommendations of pharmaceutical products can result in subpotent products and potentially, therapeutic failure.1-3 In addition, hundreds of thousand of medications are discarded each year because of improper storage conditions resulting in millions of dollars wasted.1,2 This can occur for a variety of reasons including improper shipping, failure to refrigerate or freeze a product upon receipt or after use, and in the event of a power failure. It is important to recognize when pharmaceutical products have not been stored according to the manufacturer's specifications and take appropriate action. Depending on the product, lot number and expiration date, time of exposure to temperatures outside of the recommended range and actual temperature of exposure, some medications may be deemed suitable for administration while others should be discarded. The following chart provides general guidelines for the room temperature stability of common medications and vaccines which are stored in the refrigerator or freezer. However, if a pharmaceutical product has not been stored according to the recommended conditions, it is important to contact the manufacturer and provide the specifics (lot number, expiration date, exposure temperature, length of time) to determine if the product is viable. Continue to the end of this chart for helpful tips on what to do during a power failure or when there is a potential for flooding. • For a listing of Anti-infective Suspensions and their stability after reconstitution, see Detail-Document #231107
• For a listing of Insulin Products and their storage/stability information, see Detail-Document #220910
Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Adalimumab (Humira) Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Abbott Laboratories 800-633-9110 Alprostadil injection Refrigerate 40 mcg strength at 36º to 46º F After dispensing 40 mcg strength: (Caverject solution) (2º to 8ºC) until dispensed. Three months at or below 25°C (77°F). 800-438-1935 (Store the 5, 10, and 20 mcg strengths at or below 77°F [25°C]). Alprostadil urethral Refrigerate at 36º to 46º F (2º to 8ºC). suppository (Muse) Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 2 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Refrigerate at 36º to 46ºF (2º to 8ºC) 24 hours (reconstituted solution at (Amphocin, others) before reconstitution (lyophilized concentration of 5 mg/mL, diluted with 800-438-1935 Sterile Water for Injection). After reconstitution, refrigerated solution (5 mg/mL concentration, diluted with Sterile Water for Injection) stable for one week. Azithromycin ophthalmic Refrigerate at 36º to 46º F (2º to 8ºC). Once the bottle is opened, store at 2° to Inspire Pharmaceuticals (Azasite) 25°C (36° to 77°F) for up to 14 days. Discard after 14 days. Becaplermin (Regranex) Refrigerate at 36º to 46ºF (2º to 8ºC). Do Contact manufacturer.*** Johnson and Johnson Wound Off-label§ information indicates that unopened bottles left out of refrigerator are stable (up to 86ºF or 30ºC) for up to six days or less, one time only.14 Refrigerate at 36º to 46ºF (2º to 8ºC). Do peroxide/clindamycin (Duac) Calcitonin nasal Refrigerate unopened bottle at 36º to 46º F After opening, store bottle in use in an Upsher-Smith Laboratories (Fortical) upright position for up to 30 days at 68o to 77°F (20o to 25°C). Excursions permitted to 59°F to 86°F (15° to 30°C). Off-label§ information indicates that unopened bottles left out of refrigerator (up to 77oF or 25oC) in the pharmacy for seven days or less can be safely dispensed to the patient.4 Contact manufacturer.*** Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 3 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Calcitonin injectable Refrigerate unopened bottle at 36º to 46º F Contact manufacturer.*** (Miacalcin) Calcitonin nasal Refrigerate unopened bottle at 36º to 46º F Opened bottle may be stored at 59oF to Novartis (Miacalcin) 86oF (15o to 30oC) in upright position Chlorambucil (Leukeran) Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** Off-label§ information indicates stable when maintained at up to 86oF (30oC) for up to one week.5 Darbepoetin alfa (Aranesp) Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Desmopressin (DDAVP Refrigerate at 36º to 46º F (2º to 8ºC). Up to three weeks. Rhinal Tube) Dinoprostone cervical gel Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** (Prepidil) Off-label§ information indicates stable when maintained for 24 hours.6 Dornase alfa (Pulmozyme) Refrigerate at 36º to 46º F (2º to 8ºC). Up to 24 hours. Contact manufacturer.*** Off-label§ information indicates stable when maintained for up to 48 cumulative hours at a temperature up to 86oF (30oC).7 Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 4 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Dronabinol (Marinol) Refrigerate at 36º to 46º F (2º to 8ºC) or Contact manufacturer.*** Solvay Pharmaceuticals store in a cool environment between 46°F Off-label§ information indicates stable to 59°F (8°C to 15°C). when maintained at room temperature 77oF (25oC) for 24 months.8 Epoetin alfa (Epogen) Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Amgen 800-772-6436 Epoetin alfa (Procrit) Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Off-label§ information indicates the following stability data when maintained at room temperature up to 86ºF (30ºC): Single-dose vial – 14 days.15 Unopened multi-dose vial – seven days.15 Estradiol/norethindrone Prior to dispensing, refrigerate at 36º to After dispensing, store at room acetate transdermal system 46ºF (2º to 8ºC). temperature below 77°F (25ºC) for up (CombiPatch) Etonogestrel/ethinyl Refrigerate at 36º to 46ºF (2º to 8ºC). After dispensing, store at 77°F (25°C) estradiol vaginal ring for up to four months; excursions (NuvaRing) permitted to 59° to 86°F (15° to 30°C). Estramustine (Emcyt) Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Pfizer 800-438-1935 Etanercept injection Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Immunex Corporation However, one reference suggests:1 Vial – seven days.1 Prefilled syringe – four days.1,16 Etoposide capsules Prior to dispensing, refrigerate at 36º to Contact manufacturer.*** Bristol-Myers Squibb (VePesid) 46º F (2º to 8ºC). Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 5 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Exenatide (Byetta) Prior to first use, refrigerate at 36º to 46º F After first use, store at a room Amylin Pharmaceuticals (2º to 8ºC). Do not freeze. temperature not to exceed 77°F (25°C). Discard after 30 days. Filgrastim (Neupogen) Refrigerate at 36º to 46º F (2º to 8ºC). Stable at room temperature for up to Formoterol (Foradil) Prior to dispensing, refrigerate at 36º to Store at room temperature 68° to 77°F Schering Corporation 46º F (2º to 8ºC). (20° to 25°C). Off-label§ information indicates stable when maintained at room temperature for up to 6 months.9 Gabapentin oral suspension Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** (Neurontin) Off-label§ information indicates oral solution stable for seven days at temps up to 86oF (30oC).6 Glatiramer acetate injection Refrigerate at 36º to 46º F (2º to 8ºC). One month at room temperature of 59o Teva Neuroscience (Copaxone) to 86oF (15o to 30oC). Interferon alfacon-1 Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Three Rivers Pharm. (Infergen) Interferon beta-1a (Avonex) Refrigerate unreconstituted vial of Lyophilized powder vial – 30 days. lyophilized powder at 36º to 46ºF (2º to Prefilled syringes – seven days. Interferon beta-1a (Rebif) Refrigerate at 36º to 46º F (2º to 8ºC). Pfizer 800-438-1935 More. . Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 6 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Interferon gamma-1b Refrigerate at 36º to 46ºF (2º to 8ºC) Unopened vial should not be left at (Actimmune) immediately upon receipt to ensure room temperature for a total time optimal retention of physical and exceeding 12 hours prior to use. Vials biochemical integrity. Do not freeze. stored at room temperature should not be returned to the refrigerator. Latanoprost (Xalatan) Prior to dispensing and opening, store During shipment, unopened bottle unopened bottles in refrigerator at 36°F to stable at up to 104oF (40oC) for no 46°F (2°C to 8°C). more than eight days. After first use, store at a room temperature not to exceed 77°F (25°C) for up to 6 weeks. Off-label§ information indicates unopened bottle stable when maintained at continuous room temperature 77oF (25oC) for 12 months.6 Contact manufacturer.*** Liotrix (Thyrolar ) Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** Forest Pharmaceuticals 1-800-678-1605, ext. 66297 Lopinavir/ritonavir solution Refrigerate at 36º to 46ºF (2º to 8ºC) until Abbott Laboratories (Kaletra) dispensed. Stable until expiration date if stored in refrigerator. Lorazepam intensol oral Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** Roxane Laboratories Off-label§ information indicates stable when maintained at continuous room temperature 77oF (25oC) for 30 days.10 Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 7 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Melphalan tablets (Alkeran) Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** Octreotide (Sandostatin) Refrigerate at 36º to 46º F (2º to 8ºC). At room temperature (70°F to 86°F, 20°C to 30°C), stable for 14 days, when protected from light. Octreotide injectable Refrigerate at 36º to 46º F (2º to 8ºC). Drug kit can remain at room temperature for 30 to 60 minutes prior (Sandostatin LAR) to preparation. However, must be used immediately after preparation. Papain/urea topical Refrigerate at 36º to 46ºF (2º to 8ºC) or in Contact manufacturer.*** (Ethezyme) cool (46o to 59oF) place (8° to 15°C). Off-label§ information indicates stable when maintained up to 77oF (25oC) for Peginterferon alfa-2a Refrigerate at 36º to 46º F (2º to 8ºC). Roche Laboratories (Pegasys) Peginterferon alfa-2b PegIntron vials - Store at room Contact manufacturer.*** Schering Corporation (PegIntron) temperature (77ºF [25ºC]; excursion permitted to 59ºF to 86ºF [15ºC to 30ºC]). Off-label§ information indicates the After reconstitution, the solution should PegIntron Redipen (unreconstituted be used immediately, but may be stored lyophilized powder) is stable when up to 24 hours at 36° to 46°F (2° to 8°C). maintained up to 86oF (30oC) for one day. However, there is no data to PegIntron Redipen - Refrigerate at 36º to address the re-refrigeration of the 46º F (2º to 8ºC). After reconstitution, the product after maintained in an un- solution should be used immediately, but refrigerated state.9 may be stored up to 24 hours at 36° to 46°F (2° to 8°C). Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 8 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Pramlintide injection Refrigerate at 36º to 46ºF (2º to 8ºC). Amylin Pharmaceuticals Promethazine suppositories Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** G & W Laboratories (Promethegan) Proparacaine ophthalmic Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** Ritonavir capsules (Norvir) Refrigerate at 36º to 46ºF (2º to 8ºC) until Abbott Laboratories dispensed. Stable until expiration date if stored in refrigerator. Sinecatechins (Veregen) Prior to dispensing to the patient, After dispensing, can be stored at room Doak Dermatologics refrigerate at 36º to 46ºF (2º to 8ºC). Sirolimus solution Refrigerate at 36º to 46ºF (2º to 8ºC). Wyeth Pharmaceuticals (Rapamune) Teriparatide (Forteo) Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** Minimize time out of refrigerator during Tobramycin for oral Refrigerate at 36º to 46º F (2º to 8ºC). Opened or unopened pouches may be inhalation (Tobi) stored at room temperature (up to 77ºF or 25ºC) for up to 28 days. Trifluridine (Viroptic) Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** King Pharmaceuticals Off-label§ information indicates stable when maintained up to 77ºF (25ºC) for two weeks. However, due to slight changes in pH (no change in potency), ocular stinging or discomfort may occur.17 Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 9 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)

Vaccines

Diphtheria, tetanus toxoids
Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** (DT) (pediatric)

Tetanus, diphtheria toxoids
(Td) (adult) (Decavac)

Diphtheria, tetanus toxoids,
Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** acellular pertussis vaccine (DTaP) (pediatric)
(Tripedia, Daptacel)

Diphtheria, tetanus toxoids,
Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** acellular pertussis vaccine Off-label§ information indicates stable (DTaP) (pediatric)
when maintained above 46oF to 77oF (above 8oC to 25oC) for 72 hours (Infanrix).12 Diphtheria, tetanus toxoids, Contact manufacturer.*** acellular pertussis vaccine, Off-label§ information indicates stable hepatitis B vaccine, when maintained above 46oF to 77oF inactivated polio vaccine (above 8oC to 25oC) for 72 hours (Pediarix).12 Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 10 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Tetanus toxoid, reduced, Refrigerate at 36º to 46ºF (2º to 8ºC) Contact manufacturer.*** diphtheria toxoids, acellular Off-label§ information indicates stable pertussis vaccine (Tdap) when maintained above 46ºF to 77ºF (adult) (Boostrix)
(above 8ºC to 25ºC) for 72 hours (Boostrix).12 Diphtheria and Tetanus Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Toxoids and Acellular Pertussis Adsorbed,
Inactivated Poliovirus and
Haemophilus b Conjugate
(Tetanus Toxoid
Conjugate) Vaccine
(pediatric) (Pentacel)
Haemophilus influenzae
Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** type B conjugate vaccine (Hib) (PedvaxHIB) Haemophilus influenzae Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** type B conjugate vaccine (Hib) (ActHIB) Haemophilus influenzae Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** type B conjugate (Hib) and hepatitis B vaccines (Comvax) Hepatitis A vaccine Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** (Havrix) Off-label§ information indicates stable when maintained above 46oF to 77oF (above 8oC to 25oC) for 72 hours.12 Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 11 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Hepatitis A vaccine (Vaqta) Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** Hepatitis A and Hepatitis B Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** vaccine (Twinrix) Off-label information indicates stable when maintained above 46oF to 77oF (above 8oC to 25oC) for 72 hours (Twinrix).12 Hepatitis B vaccine Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** (Engerix-B) Off-label§ information indicates stable when maintained above 46oF to 77oF (above 8oC to 25oC) for 72 hours.12 Hepatitis B vaccine Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** (Recombivax HB) Human papillomavirus Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** (Types 6, 11, 16, 18) vaccine (Gardasil) Inactivated polio vaccine Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** (IPV) (IPOL) Influenza virus vaccine, Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** types A and B (Afluria) Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 12 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Influenza virus vaccine, Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** types A and B (FluLaval) Influenza virus vaccine, Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** types A and B (Fluarix) Influenza virus vaccine, Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** types A and B (Fluvirin) Influenza virus vaccine, Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** types A and B (Fluzone) Influenza attenuated Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** influenza vaccine, live Off-label§ information indicates stable (LAIV) (FluMist) when maintained above 46oF to 77oF (above 8oC to 25oC) for 8 hours.13 Measles, mumps. rubella Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** vaccine (MMR) (M-M-R II) Diluent may be stored in the refrigerator or at room temperature. Do not freeze diluent. Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 13 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Measles, mumps. rubella Store in freezer at an average temperature Contact manufacturer.*** (MMR) and varicella of 5°F (–15°C) or colder for up to 18 vaccines (ProQuad) months. Can be stored in a refrigerator at 36º to 46ºF (2º to 8ºC) for up to 72 hours before reconstitution. Diluent may be stored in the refrigerator or at room temperature. Do not freeze diluent. Meningococcal conjugate, Refrigerate at 35º to 46ºF (2º to 8ºC). Contact manufacturer.*** groups A, C, Y and W-135 vaccine (MCV) (Menactra (Menomune single-dose vial should be [also contains diphtheria used within 30 minutes of reconstitution) toxoid], Menomune) Pneumococcal conjugate Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** vaccine (Prevnar) Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** polysaccharide vaccine (Pneumovax 23) Rotavirus vaccine (Rotarix) Refrigerate at 36º to 46ºF (2º to 8ºC). After reconstitution, can be stored at room temperature up to 77°F (25°C) Diluent may be stored at room Rotavirus vaccine Refrigerate at 36º to 46ºF (2º to 8ºC). Contact manufacturer.*** (RotaTeq) Administer as soon as possible after removal from refrigerator. Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 14 of 17) Generic name (Brand
Recommended Storage**
Stability at Room Temperature**
Manufacturer Contact
FOR SPECIFIC INFORMATION,
Information (Quality
CONTACT MANUFACTURER
Control)
Varicella (chickenpox) Store in freezer at 5º F (-15º C) or colder. May be stored at refrigerator vaccine (Varivax) temperatures, 36º to 46º F (2º to 8ºC) Diluent may be stored in the refrigerator for up to 72 hours prior to or at room temperature. Do not freeze reconstitution. Vaccine stored in refrigerator must be used within 72 hours of removal from freezer. Other storage conditions are determined on a case-by-case basis. Contact manufacturer.*** Typhoid vaccine, live oral Refrigerate at 36º to 46º F (2º to 8ºC). Contact manufacturer.*** Berna Biotech, Ltd. (Vivotif) Zoster (shingles) vaccine Store in freezer at 5º F (-15º C) or colder. Contact manufacturer.*** (Zostavax) Diluent may be stored in the refrigerator or at room temperature. Do not freeze diluent. * This table includes commonly used medications and vaccines. For those products not listed, consult the product information or
pharmaceutical manufacturer for stability information at room temperature.

** Data based on information provided by prescribing information, unless otherwise indicated. The following PIs were used for this chart:
Humira (January 2003), Caverject (October 2003), Muse (August 2003), Amphocin (October 2006), Azasite (December 2007), Regranex (May 2008),
Duac (August 2002), Fortical (February 2004), Miacalcin injection (November 2002), Miacalcin nasal spray (June 2006), Leukeran (November
2006), Aranesp (August 2008), DDAVP Rhinal Tube (October 2007), Prepidil (July 2008), Pulmozyme (2008), Marinol (March 2008), Epogen
(August 2008), Procrit (August 2008), CombiPatch (January 2005), NuvaRing (December 2007), Emcyt (June 2007), Enbrel (June 2008), VePesid
(July 2006), Byetta (June 2008), Neupogen (September 2007), Foradil (June 2006), Neurontin oral solution (January 2007), Copaxone (November
2007), Infergen (July 2006), Avonex (November 2006), Rebif (April 2008), Actimmune (January 2007), Xalatan (November 2006), Thyrolar (April
2005), Kaletra (November 2007), Lorazepam Intensol oral concentrate (June 2007), Alkeran (November 2004), Sandostatin (September 2005),
Sandostatin LAR (March 2008), Ethezyme (March 2006), Pegasys (January 2008), PegIntron (April 2008), Symlin (July 2008), Promethegan
suppositories (June 2000), Proparacaine ophthalmic solution (July 2005), Norvir capsules (August 2008), Veregen (December 2007), Rapamune
Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 15 of 17) (January 2008), Forteo (February 2008), Tobi (December 2007), Viroptic (October 2001), Diphtheria and Tetanus Toxoids, adsorbed (December
2005), Decavac (March 2004), Tripedia (March 2001), Daptacel (March 2008), Pentacel (June 2008), Infanrix (July 2003), Pediarix (March 2007),
Boostrix (December 2005), PedvaxHIB (January 2001), ActHib (December 2005), Comvax (September 1996), Havrix (March 2008), Vaqta (May
2007), Twinrix (March 2007), Engerix-B (January 2007), Recombivax (May 2007), Gardasil (September 2008), IPOL (December 2005), Afluria (July
2008), FluLaval (July 2008), Fluarix (August 2008), Fluvirin (August 2008), Fluzone (August 2008), FluMist (July 2008), M-M-R II (May 2008),
ProQuad (February 2008), Menactra (October 2007), Menomune (December 2005), Prevnar (December 2007), Pneumovax 23 (August 2008),
RotaTeq (April 2008), Rotarix (April 2008), Varivax (November 2006), Vivotif (August 2006), Zostavax (July 2007).
*** Room temperature stability determined on a case-by-case basis. Contact manufacturer and provide lot number and expiration date,
length of time exposed to room temperature, maximum exposure temperature.

§ Off-label information is not reviewed or approved by the FDA.

Users of this document are cautioned to use their own professional judgment and consult any other necessary or appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched the information with input from experts, government agencies, and national organizations. Information and Internet links in this article were current as of the date of publication. Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 16 of 17) Safeguarding Pharmaceutical Products During Power Outages or Flooding In the event of a power outage, there are a
2. Welte MS. Vaccines ruined by poor refrigeration. number of steps to take to minimize damage to pharmaceutical products. If the power goes out, the time of the power outage should be noted. During ml. (Accessed December 5, 2007). the power outage, refrigerator and freezer doors 3. Food and Drug Administration. Impact of severe should not be opened. For products which are stored in the freezer, if the power outage continues http://www.fda.gov/cber/weatherimpact.htm. (Accessed September 2, 2008). for more than 24 hours, the products should be 4. Personal communication. Bethany Z. Dimaculangan, removed from the freezer and packed in dry ice. When the power is restored, the temperature in Laboratories. Maple Grove, MN 55369. September the refrigerator and freezer should be recorded, and 5. Personal communication. Jacquelyn Collins. Medical monitored until the temperature has returned to the Information. GlaxoSmithKline. Philadelphia, PA desired temperature. This allows the calculation of 19101. September 12, 2008. the duration of time the product was stored at a 6. Personal communication. Prachi Parmar, R.Ph. temperature outside of the product labeling and may Medical Information. Pfizer. New York, NY 100017. enable calculations to be made by the product September 12, 2008. 7. Personal communication. Deborah Bialy. Corporate manufacturer, in consultation with FDA as Quality Product Support. Genentech. South San necessary, about the continued potency of the Francisco, CA 94080. September 12, 2008. involved products.3 8. Personal communication. Leah Bernstein, Ph.D. When a flood is anticipated, if possible,
Pharmaceuticals. Marletta, GA 30062. September pharmaceutical products should be moved out of areas which could accumulate flood water. If 9. Personal communication. Maleeha Ansari, Pharm.D. possible, elevate products stored on warehouse Global Medical Information. Schering Corporation. floors off the ground (e.g., on pallets). For those Kenilworth, NJ 07033. September 15, 2008. items on shelves, securely anchor the shelves to Information Department. BI Roxane. Columbus, OH keep products dry. For refrigerated products, raise 43216. September 15, 2008. refrigerators onto platforms, if possible. 3 11. Personal communication. Michelle Kraus, Pharm.D., If flooding occurs, any product which was not Medical Communications. KV Pharmaceutical. St. sealed in airtight, waterproof bags should be Louis, MO 63043. September 15, 2008. 12. Personal communication. Jessie Li, Pharm.D. considered contaminated and should be discarded.3 Vaccine and Anti-infectives Team. GlaxoSmithKline. Philadelphia, PA 19101. September 12, 2008. 13. Personal communication. Gregory M. Susla, Users of this document are cautioned to use their own Pharm.D., FCCM. MedImmune. Gaithersburg, MD professional judgment and consult any other necessary or 20878. September 11, 2008. appropriate sources prior to making clinical judgments based on the content of this document. Our editors have researched Customer Communications Center. Centocor Ortho the information with input from experts, government agencies, Biotech. Raritan, NJ 08869. September 23, 2008. and national organizations. Information and Internet links in 15. Personal communication. Diane Butner RN this article were current as of the date of publication. Scientific Affairs. Ortho-McNeil Janssen. Raritan, Project Leader in preparation of this Detail-
NJ 08869. September 23, 2008. Document: Neeta Bahal O'Mara, Pharm.D., BCPS
Mississauga, Ontario L5N 0A4. 866-502-6436. September 19, 2008. 17. Personal communication. Donna Clark. Information 1. Cohen V, Jellinek SP, Teperikidis L, et al. Room- Specialist II. Professional Information Services. temperature stability of medications labeled for Pharmaceuticals. refrigeration. Am J Health Syst Pharm 2007;64:1711- September 23, 2008.
Cite this Detail-Document as follows: Stability of refrigerated and frozen drugs. Pharmacist's Letter/Prescriber's
Letter 2008;24(10):241001.

Copyright 2008 by Therapeutic Research Center – Posted with permission CR09312 Pharmacist's Letter / Prescriber's Letter P.O. Box 8190, Stockton, CA 95208 Phone: 209-472-2240 Fax: 209-472-2249 (Detail-Document #241001: Page 17 of 17) Evidence and Advice You Can Trust… 3120 West March Lane, P.O. Box 8190, Stockton, CA 95208 TEL (209) 472-2240 FAX (209) 472-2249 Copyright  2008 by Therapeutic Research Center – Posted with permission CR09312 Subscribers to Pharmacist's Letter and Prescriber's Letter can get Detail-Documents, like this one, on any topic covered in any issue by going to www.pharmacistsletter.com or www.prescribersletter.com

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