Friday, September 30, 2016

Sufentanil-ratiopharm




Sufentanil-ratiopharm may be available in the countries listed below.


Ingredient matches for Sufentanil-ratiopharm



Sufentanil

Sufentanil citrate (a derivative of Sufentanil) is reported as an ingredient of Sufentanil-ratiopharm in the following countries:


  • Germany

International Drug Name Search

Apo-Nizatidine




Apo-Nizatidine may be available in the countries listed below.


Ingredient matches for Apo-Nizatidine



Nizatidine

Nizatidine is reported as an ingredient of Apo-Nizatidine in the following countries:


  • Canada

  • Guyana

International Drug Name Search

Atock




Atock may be available in the countries listed below.


Ingredient matches for Atock



Formoterol

Formoterol fumarate dihydrate (a derivative of Formoterol) is reported as an ingredient of Atock in the following countries:


  • China

  • Japan

  • Taiwan

International Drug Name Search

Thursday, September 29, 2016

Mucinex Maximum Strength




Generic Name: guaifenesin

Dosage Form: tablet, extended release
MAXIMUM STRENGTH

Mucinex ®

Drug Facts



Active ingredient (in each extended-release bi-layer tablet)


Guaifenesin 1200 mg



Purpose


Expectorant



Uses


helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive



Warnings



Do not use


  • for children under 12 years of age


Ask a doctor before use if you have


  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

  • cough accompanied by too much phlegm (mucus)


Stop use and ask a doctor if


  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious illness.


If pregnant or breast-feeding, ask a health professional before use.



Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.



Directions


  • do not crush, chew, or break tablet

  • take with a full glass of water

  • this product can be administered without regard for the timing of meals

  • adults and children 12 years of age and over: 1 tablet every 12 hours. Do not exceed 2 tablets in 24 hours.

  • children under 12 years of age: do not use


Other information


  • tamper evident: do not use if carton is open or if printed seal on blister is broken or missing

  • store between 20-25°C (68-77°F)


Inactive ingredients


carbomer 934P, NF; FD&C blue #1 aluminum lake; hypromellose, USP; magnesium stearate, NF; microcrystalline cellulose, NF; sodium starch glycolate, NF



Questions?


1-866-MUCINEX (1-866-682-4639) You may also report side effects to this phone number.



Dist. by: Reckitt Benckiser Inc.

Parsippany, NJ 07054-0224



PRINCIPAL DISPLAY PANEL - 1200 mg Tablet Carton


MAXIMUM STRENGTH


NDC 63824-023-36


Mucinex®

1200 mg guaifenesin extended-release bi-layer tablets


EXPECTORANT


12

HOUR



Thins And Loosens Mucus


Relieves Chest Congestion

28 EXTENDED-RELEASE BI-LAYER TABLETS










MUCINEX  MAXIMUM STRENGTH
guaifenesin  tablet, extended release










Product Information
Product TypeHUMAN OTC DRUGNDC Product Code (Source)63824-023
Route of AdministrationORALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Guaifenesin (Guaifenesin)Guaifenesin1200 mg





Inactive Ingredients
Ingredient NameStrength
No Inactive Ingredients Found


















Product Characteristics
ColorWHITE (blue and white)Scoreno score
ShapeOVALSize22mm
FlavorImprint CodeMucinex;1200
Contains      














































Packaging
#NDCPackage DescriptionMultilevel Packaging
163824-023-141 BOTTLE In 1 CARTONcontains a BOTTLE
114 TABLET In 1 BOTTLEThis package is contained within the CARTON (63824-023-14)
263824-023-364 BLISTER PACK In 1 CARTONcontains a BLISTER PACK
27 TABLET In 1 BLISTER PACKThis package is contained within the CARTON (63824-023-36)
363824-023-281 BOTTLE In 1 CARTONcontains a BOTTLE
328 TABLET In 1 BOTTLEThis package is contained within the CARTON (63824-023-28)
463824-023-431 BOTTLE In 1 BLISTER PACKcontains a BOTTLE
442 TABLET In 1 BOTTLEThis package is contained within the BLISTER PACK (63824-023-43)
563824-023-451 BOTTLE In 1 BLISTER PACKcontains a BOTTLE
544 TABLET In 1 BOTTLEThis package is contained within the BLISTER PACK (63824-023-45)










Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02128208/11/2009


Labeler - Reckitt Benckiser, Inc. (094405024)
Revised: 12/2009Reckitt Benckiser, Inc.




More Mucinex Maximum Strength resources


  • Mucinex Maximum Strength Side Effects (in more detail)
  • Mucinex Maximum Strength Use in Pregnancy & Breastfeeding
  • Drug Images
  • Mucinex Maximum Strength Support Group
  • 51 Reviews for Mucinex Maximum Strength - Add your own review/rating


Compare Mucinex Maximum Strength with other medications


  • Bronchitis
  • Cough
  • Fibromyalgia

Dextromethorphan/Guaifenesin Extended-Release Tablets


Pronunciation: DEX-troe-meth-OR-fan/gwye-FEN-e-sin
Generic Name: Dextromethorphan/Guaifenesin
Brand Name: Examples include Guaifenex DM and Bidex-A


Dextromethorphan/Guaifenesin Extended-Release Tablets are used for:

Temporarily relieving cough due to the common cold, upper respiratory tract infections, sinus inflammation, sore throat, or bronchitis.


Dextromethorphan/Guaifenesin Extended-Release Tablets are a combination of an expectorant (guaifenesin) and a cough suppressant (dextromethorphan). It works by loosening mucus and lung secretions in the chest and making coughs more productive.


Do NOT use Dextromethorphan/Guaifenesin Extended-Release Tablets if:


  • you are allergic to any ingredient in Dextromethorphan/Guaifenesin Extended-Release Tablets

  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, selegiline) within the last 14 days

  • you are taking a selective serotonin reuptake inhibitor (SSRI) (eg, fluoxetine)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Dextromethorphan/Guaifenesin Extended-Release Tablets:


Some medical conditions may interact with Dextromethorphan/Guaifenesin Extended-Release Tablets. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have chronic cough, chronic bronchitis or any breathing problems, such as asthma, emphysema, or chronic obstructive pulmonary disease (COPD)

  • if you have been very ill or weakened, or you are confined to a bed or chair

Some MEDICINES MAY INTERACT with Dextromethorphan/Guaifenesin Extended-Release Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • MAOIs (eg, selegiline) and SSRIs (eg, fluoxetine) because the risk of serious side effects may be increased by Dextromethorphan/Guaifenesin Extended-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Dextromethorphan/Guaifenesin Extended-Release Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Dextromethorphan/Guaifenesin Extended-Release Tablets:


Use Dextromethorphan/Guaifenesin Extended-Release Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Dextromethorphan/Guaifenesin Extended-Release Tablets by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Swallow Dextromethorphan/Guaifenesin Extended-Release Tablets whole. Do not break, crush, or chew before swallowing. Some brands of Dextromethorphan/Guaifenesin Extended-Release Tablets may be broken in half before taking. If you have difficulty swallowing the whole tablet, ask your pharmacist if your brand of medicine may be broken in half.

  • Drinking extra fluids while you are taking Dextromethorphan/Guaifenesin Extended-Release Tablets are recommended. Check with your doctor for instructions.

  • If you miss a dose of Dextromethorphan/Guaifenesin Extended-Release Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Ask your health care provider any questions you may have about how to use Dextromethorphan/Guaifenesin Extended-Release Tablets.



Important safety information:


  • Dextromethorphan/Guaifenesin Extended-Release Tablets may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Dextromethorphan/Guaifenesin Extended-Release Tablets with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Dextromethorphan/Guaifenesin Extended-Release Tablets without first checking with your doctor; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.

  • If your cough lasts for more than 1 week or comes back, or if you also have a fever, rash, or persistent headache, contact your health care provider. A persistent cough could be a sign of a serious condition.

  • Dextromethorphan/Guaifenesin Extended-Release Tablets has dextromethorphan in it. Before you start any new medicine, check the label to see if it has dextromethorphan in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Dextromethorphan/Guaifenesin Extended-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Dextromethorphan/Guaifenesin Extended-Release Tablets.

  • Use Dextromethorphan/Guaifenesin Extended-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects.

  • Dextromethorphan/Guaifenesin Extended-Release Tablets should not be used in CHILDREN younger than 6 years old; safety and effectiveness in these children have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Dextromethorphan/Guaifenesin Extended-Release Tablets while you are pregnant. It is not known if Dextromethorphan/Guaifenesin Extended-Release Tablets are found in breast milk. Do not breast-feed while taking Dextromethorphan/Guaifenesin Extended-Release Tablets.


Possible side effects of Dextromethorphan/Guaifenesin Extended-Release Tablets:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Dizziness; drowsiness; stomach upset.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Dextromethorphan/Guaifenesin side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include confusion; excitement; hallucinations; slowed breathing.


Proper storage of Dextromethorphan/Guaifenesin Extended-Release Tablets:

Store Dextromethorphan/Guaifenesin Extended-Release Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Dextromethorphan/Guaifenesin Extended-Release Tablets out of the reach of children and away from pets.


General information:


  • If you have any questions about Dextromethorphan/Guaifenesin Extended-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.

  • Dextromethorphan/Guaifenesin Extended-Release Tablets are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Dextromethorphan/Guaifenesin Extended-Release Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Dextromethorphan/Guaifenesin resources


  • Dextromethorphan/Guaifenesin Side Effects (in more detail)
  • Dextromethorphan/Guaifenesin Use in Pregnancy & Breastfeeding
  • Drug Images
  • Dextromethorphan/Guaifenesin Drug Interactions
  • Dextromethorphan/Guaifenesin Support Group
  • 2 Reviews for Dextromethorphan/Guaifenesin - Add your own review/rating


Compare Dextromethorphan/Guaifenesin with other medications


  • Cough
  • Expectoration

Humalog KwikPen


See also: Generic Humalog, Generic Humalog Pen


Humalog KwikPen is a brand name of insulin lispro, approved by the FDA in the following formulation(s):


HUMALOG KWIKPEN (insulin lispro recombinant - injectable; injection)



  • Manufacturer: LILLY

    Approval date: September 6, 2007

    Strength(s): 100 UNITS/ML [RLD]

Has a generic version of Humalog KwikPen been approved?


No. There is currently no therapeutically equivalent version of Humalog KwikPen available.


Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Humalog KwikPen. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: About generic drugs.




Related Patents

There are no current U.S. patents associated with Humalog KwikPen.

See also...

  • Humalog KwikPen Consumer Information (Cerner Multum)
  • Insulin Lispro Cartridges Consumer Information (Wolters Kluwer)
  • Insulin Lispro Vials Consumer Information (Wolters Kluwer)
  • Insulin lispro Consumer Information (Cerner Multum)
  • Lispro-PFC Advanced Consumer Information (Micromedex)
  • Insulin lispro Subcutaneous Advanced Consumer Information (Micromedex)
  • Insulin lispro, recombinant Subcutaneous Advanced Consumer Information (Micromedex)
  • Insulin Lispro AHFS DI Monographs (ASHP)

Zeptol




Zeptol may be available in the countries listed below.


Ingredient matches for Zeptol



Carbamazepine

Carbamazepine is reported as an ingredient of Zeptol in the following countries:


  • Bangladesh

  • Myanmar

  • Russian Federation

International Drug Name Search

Wednesday, September 28, 2016

Cefdox




Cefdox may be available in the countries listed below.


Ingredient matches for Cefdox



Cefpodoxime

Cefpodoxime proxetil (a derivative of Cefpodoxime) is reported as an ingredient of Cefdox in the following countries:


  • Bangladesh

International Drug Name Search

Debrox Solution


Pronunciation: CAR-bah-mide per-ox-ide
Generic Name: Carbamide Peroxide
Brand Name: Examples include Auro and Debrox


Debrox Solution is used for:

Softening, loosening, and removing excessive earwax.


Debrox Solution is a form of peroxide. It works by softening and removing earwax.


Do NOT use Debrox Solution if:


  • you are allergic to any ingredient in Debrox Solution

  • you have ear drainage or discharge, ear pain, irritation, rash in the ear, ear injury, hole in the eardrum, broken eardrum, or recent ear surgery

  • you are dizzy

Contact your doctor or health care provider right away if any of these apply to you.



Before using Debrox Solution:


Some medical conditions may interact with Debrox Solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

Some MEDICINES MAY INTERACT with Debrox Solution. Because little, if any, of Debrox Solution is absorbed into the blood, the risk of it interacting with another medicine is low.


This may not be a complete list of all interactions that may occur. Ask your health care provider if Debrox Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Debrox Solution:


Use Debrox Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Debrox Solution is for use in the ear only. Avoid contact with other mucous membranes and eyes.

  • To use ear drops, lie down or tilt your head so that the affected ear faces up. For adults, gently pull the earlobe up and back to straighten the ear canal. For children, gently pull the earlobe down and back to straighten the ear canal. Drop the medicine into the ear canal. Keep the ear facing up for several minutes so the medicine can run to the bottom of the ear canal. A clean cotton plug may be gently inserted into the ear canal to prevent medicine from leaking out. To prevent germs from contaminating the medicine, do not touch the applicator to any surface, including the ear. Keep the container tightly closed.

  • Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe.

  • Use twice daily for 4 days if necessary, or as directed by your doctor. Do not use Debrox Solution for more than 4 days without talking to your doctor.

  • If you miss a dose of Debrox Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Debrox Solution.



Important safety information:


  • If excessive earwax remains after use of Debrox Solution, contact your doctor.

  • Debrox Solution is not recommended for use in CHILDREN younger than 12 years of age except under the advice of a doctor.

  • PREGNANCY and BREAST-FEEDING: It is unknown if Debrox Solution can cause harm to the fetus. If you become pregnant while taking Debrox Solution, discuss with your doctor the benefits and risks of using Debrox Solution during pregnancy. It is unknown if Debrox Solution is excreted in breast milk. If you are or will be breast-feeding while you are using Debrox Solution, check with your doctor or pharmacist to discuss the risks to your baby.


Possible side effects of Debrox Solution:


All medicines may cause side effects, but many people have no, or minor, side effects. When used in small doses, no COMMON side effects have been reported with this product. Seek medical attention right away if any of these SEVERE side effects occur:



Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue).



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Debrox side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.


Proper storage of Debrox Solution:

Store Debrox Solution at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Debrox Solution out of the reach of children and away from pets.


General information:


  • If you have any questions about Debrox Solution, please talk with your doctor, pharmacist, or other health care provider.

  • Debrox Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Debrox Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

More Debrox resources


  • Debrox Side Effects (in more detail)
  • Debrox Use in Pregnancy & Breastfeeding
  • Debrox Support Group
  • 1 Review for Debrox - Add your own review/rating


Compare Debrox with other medications


  • Ear Wax Impaction

Dantrium


Generic Name: Dantrolene Sodium
Class: Direct-acting Skeletal Muscle Relaxants
VA Class: MS200
CAS Number: 24868-20-0


  • Hepatic Effects of Oral Dantrolene


  • Risk of developing potentially fatal, hepatic injury (e.g., hepatitis); should not be used for unlabeled indications.109




  • Females, patients >35 years of age, and those receiving other drugs (especially estrogens) concomitantly are at greatest risk.109




  • Risk of symptomatic hepatitis (fatal and nonfatal) may be dose dependent; incidence much higher at dosages ≥800 mg daily than at dosages ≤400 mg daily.109 Even intermittent, short courses at higher dosages associated with increased risk.109 Use lowest possible effective dose.109




  • Overt hepatitis most frequently observed between 3rd and 12th month of therapy.109




  • Frequently monitor hepatic function.109 (See Hepatic Effects under Cautions.)




  • If benefits are not evident within 45 days, discontinue therapy.109




Introduction

Skeletal muscle relaxant.108 109


Uses for Dantrium


Spasticity


Oral management of spasticity resulting from upper motor neuron disorders (e.g., multiple sclerosis, cerebral palsy, spinal cord injury, stroke syndrome).109


Ineffective in the treatment of amyotrophic lateral sclerosis (ALS).a


Not indicated for the treatment of muscle spasms resulting from rheumatic disorders or musculoskeletal trauma.109 a


Malignant Hyperthermia Crisis


IV treatment of fulminant hypermetabolism of skeletal muscle that is characteristic of malignant hyperthermia crisis;108 should be used with and not as a substitute for supportive measures.a


Preoperative and postoperative prevention or attenuation of malignant hyperthermia in susceptible individuals; used orally or IV (when oral therapy is not practical or feasible).108 109


Neuroleptic Malignant Syndrome


Has been used for the treatment of neuroleptic malignant syndrome; fatalities reported despite therapy with the drug.108 109


Dantrium Dosage and Administration


General


  • Spasticity


  • Establish therapeutic goal before initiating therapy.109 Use lowest possible effective dosage.109 Discontinue drug if beneficial effects are not attained within 45 days.109 (See Boxed Warning.)




  • Subjective impressions of improvement may sometimes be confirmed by withdrawal of the drug for 2–4 days.109



  • Malignant Hyperthermia Crisis


  • Immediately discontinue all anesthetic agents and institute IV dantrolene as soon as malignant hyperthermia crisis is recognized.108




  • Monitor vital signs; employ the usual precautions associated with surgery in susceptible patients, since malignant hyperthermia may only be attenuated rather than prevented.108



Administration


Administer orally or by continuous IV infusion or rapid IV injection.108 109


Oral Administration


Administer orally 1–4 times daily.109


Extemporaneous Suspension

To prepare oral suspension containing 25 mg of dantrolene sodium per 5 mL, empty 5 100-mg capsules in 50 mL of Syrup NF, then add a solution containing 150 mg of citric acid in 10 mL of water followed by a sufficient volume of Syrup NF to make 100 mL.c Mix thoroughly before use.c


IV Administration


For solution compatibility information, see Compatibility under Stability.


For IV infusion, transfer reconstituted solution from the appropriate number of vials to plastic infusion bag.109 Do not use large glass containers; precipitate formation observed with some glass containers.108


Avoid extravasation (injection has high pH).108


Reconstitution

Add 60 mL of sterile water for injection (without bacteriostatic agent) to vial containing 20 mg of dantrolene sodium.108 Shake vial until solution is clear.108


Although reconstituted solutions are stable for 6 hours,108 infusions preferably should be prepared immediately before use.a


Rate of Administration

Preoperative prophylaxis: Infuse IV over approximately 1 hour beginning about 1.25 hours before anticipated anesthesia.108


Treatment of malignant hyperthermia syndrome: Rapid IV injection.108


Dosage


Available as dantrolene sodium; dosage expressed in terms of the salt.108 109


Pediatric Patients


Spasticity

Oral

Children ≥5 years of age: 0.5 mg/kg once daily for 7 days, followed by 0.5 mg/kg 3 times daily for 7 days, then 1 mg/kg 3 times daily for 7 days, and then 2 mg/kg 3 times daily, if necessary.109 Some patients may require doses 4 times daily.109


If no additional benefit is observed at the next higher dosage, decrease dosage to the previous (lower) dosage.109


Malignant Hyperthermia Crisis

Preoperative Prophylaxis

Oral

4–8 mg/kg daily in 3 or 4 divided doses for 1–2 days prior to surgery; give the last dose approximately 3–4 hours before surgery with small amount of water.109


IV

2.5 mg/kg infused over approximately 1 hour beginning about 1.25 hours before anticipated anesthesia; may give additional individualized doses intraoperatively, if necessary.108


Treatment

IV

Initially, 1 mg/kg or more by rapid IV injection.108 Repeat dose as necessary until physiologic and metabolic abnormalities subside or a maximum total dosage of 10 mg/kg is reached.108


Average total dosage: 2.5 mg/kg.a


Repeat regimen if physiologic and metabolic abnormalities reappear.108


Post-crisis Follow-up

Oral

4–8 mg/kg daily in 4 divided doses for up to 3 days after the crisis.109


IV

Initially, 1 mg/kg or more as clinically indicated.108 Individualize subsequent doses.108


Adults


Spasticity

Oral

Initially, 25 mg once daily for 7 days, followed by 25 mg 3 times daily for 7 days, then 50 mg 3 times daily for 7 days, and then 100 mg 3 times daily, if necessary.109 Some patients may require doses 4 times daily.109


If no additional benefit is observed at the next higher dosage, decrease dosage to the previous (lower) dosage.109


Malignant Hyperthermia Crisis

Preoperative Prophylaxis

Oral

4–8 mg/kg daily in 3 or 4 divided doses for 1–2 days prior to surgery; give the last dose approximately 3–4 hours before surgery with small amount of water.109


IV

2.5 mg/kg infused over approximately 1 hour beginning about 1.25 hours before anticipated anesthesia; may give additional individualized doses intraoperatively, if necessary.108


Treatment

IV

Initially, 1 mg/kg or more by rapid IV injection.108 Repeat dose as necessary until physiologic and metabolic abnormalities subside or a maximum total dosage of 10 mg/kg is reached.108


Average total dosage: 2.5 mg/kg.a


Repeat regimen if physiologic and metabolic abnormalities reappear.108


Post-crisis Follow-up

Oral

4–8 mg/kg daily in 4 divided doses for up to 3 days after the crisis.109


IV

Initially, 1 mg/kg or more as clinically indicated.108 Individualize subsequent doses.108


Prescribing Limits


Pediatric Patients


Spasticity

Oral

Maximum 100 mg 4 times daily.109


Malignant Hyperthermia Crisis

Treatment

IV

Maximum 10 mg/kg.108


Adults


Spasticity

Oral

Maximum 100 mg 4 times daily.109


Malignant Hyperthermia Crisis

Treatment

IV

Maximum 10 mg/kg.108


Cautions for Dantrium


Contraindications



  • Oral dantrolene contraindicated in patients with active hepatic disease (e.g., hepatitis, cirrhosis).109




  • Also contraindicated in patients who must utilize spasticity to maintain upright posture and balance in moving or to obtain or maintain increased body function.109




  • No contraindications to IV dantrolene for prophylaxis or management of malignant hyperthermia crisis.108



Warnings/Precautions


Warnings


Hepatic Effects

Fatal and nonfatal hepatic disorders of idiosyncratic or hypersensitivity type possible with oral dantrolene.108 109 (See Boxed Warning.)


Obtain serum AST, ALT, alkaline phosphatase, and total bilirubin concentrations prior to and periodically during therapy or whenever symptoms of hepatitis occur.109


If liver function test abnormalities occur alone, consider discontinuing therapy; continue or reinstitute the drug only if major benefits occurred during dantrolene therapy.109


If symptoms of hepatitis are accompanied by liver function test abnormalities or jaundice, discontinue dantrolene.109


Following discontinuance for clinical and/or laboratory evidence of hepatotoxicity, reinstitute dantrolene only in patients who clearly need the drug and only after symptoms and laboratory abnormalities of hepatotoxicity have resolved.109 Hospitalize patient to reinitiate therapy with very small doses; gradually increase dosage with frequent monitoring of liver function; discontinue drug immediately if signs of liver abnormality recur.109


Risks Associated with Long-term, Chronic Use

Long-term safety in humans yet to be established.109


Nephropathy, benign and malignant mammary and testicular tumors, hepatic lymphangiomas, and hepatic angiosarcomas reported following long-term use in animals; assess risk/benefits of chronic administration.109


Sensitivity Reactions


Photosensitivity

Possible photosensitivity reactions; limit exposure to sunlight.109


General Precautions


CNS Depression

Performance of activities requiring mental alertness may be impaired.108 109


Concurrent use of other CNS depressants may potentiate CNS depression.108 109 (See Specific Drugs under Interactions.)


Mannitol Content

If mannitol is used for the prevention or treatment of late renal complications of malignant hyperthermia, consider mannitol in the IV dantrolene formulation (3 g of mannitol per 20-mg vial) as part of the total amount administered.108


Concomitant Illnesses

Use with caution in patients with severe cardiac impairment secondary to myocardial disease or with impaired pulmonary function (particularly obstructive pulmonary disease).109


Specific Populations


Pregnancy

Category C.108 109


Readily crosses the placenta.108 (See Distribution under Pharmacokinetics.)


Lactation

Distributed into milk;b use of oral dantrolene not recommended.109


Pediatric Use

Long-term safety of oral dantrolene not established in children <5 years of age.109


Weigh possible risks against potential benefits before initiating long-term oral therapy; adverse effects may become evident only after many years.109


Geriatric Use

Insufficient experience in patients ≥65 years of age to determine whether geriatric patients respond differently than younger adults.108


Titrate dosage carefully.108


Hepatic Impairment

Use with caution in patients with a history of hepatic impairment.109


Common Adverse Effects


Muscle weakness, drowsiness, dizziness, lightheadedness, diarrhea, nausea, malaise, fatigue.a 109


Interactions for Dantrium


Metabolized in the liver, but the precise enzymes responsible are unknown.108


Drugs Affecting Hepatic Microsomal Enzymes


Pharmacokinetic interaction with CYP enzyme inducers theoretically possible.108


Specific Drugs




































Drug



Interaction



Comment



Calcium-channel blockers (e.g., verapamil)



Cardiovascular collapse reported rarely108



Concomitant use during malignant hyperthermia crisis not recommended108



Clofibrate



Decreased binding of dantrolene to plasma proteins108



CNS depressants



Possible additive CNS effects (e.g., dizziness)108 109



Use with caution108 109



Diazepam



Additive sedative effect; dantrolene metabolism and protein binding unaffacted108



Use with cautiona



Estrogens



Possible increased frequency of hepatotoxicity in women >35 years of age109



Potential for interaction not clearly established; use with caution109



Phenobarbital



Pharmacokinetic interaction unlikely; dantrolene metabolism unaffected108



Phenytoin



No change in binding of dantrolene to plasma proteins108



Tolbutamide



Increased binding of dantrolene to plasma proteins108



Vecuronium



Potentiation of vecuronium-induced neuromuscular blockade108



Warfarin



Decreased binding of dantrolene to plasma proteins108


Dantrium Pharmacokinetics


Absorption


Bioavailability


Absorption following oral administration is incomplete and slow but consistent.109


Distribution


Extent


Readily crosses the placenta, with maternal and fetal whole blood concentrations approximately equal at delivery; neonatal concentrations then fall approximately 50% per day for 2 days before declining sharply.108


Plasma Protein Binding


Substantially bound to plasma proteins (mostly albumin); binding is readily reversible.108


Elimination


Metabolism


Specific metabolic pathways not established.108 May undergo hydrolysis and subsequent oxidation forming nitrophenylfuroic acid.108


Elimination Route


Specific pathways not established.108


Half-life


Approximately 4–8 hours following IV administration.108


Approximately 9 hours following oral administration in adults.109


Stability


Storage


Oral


Capsules

<40°C.109


Parenteral


Powder for Injection

15–30°C.108 Avoid prolonged exposure to light.108


Store reconstituted solutions at 15–30°C for up to 6 hours.108 Protect from light.108


Compatibility


For information on systemic interactions resulting from concomitant use, see Interactions.


Parenteral


Solution Compatibility108





Incompatible



Dextrose 5% in water



Sodium chloride 0.9%


ActionsActions



  • Causes skeletal muscle relaxation through a direct effect on skeletal muscle, probably by interfering with release of calcium from the sarcoplasmic reticulum.108 109




  • Interference with calcium release from the sarcoplasmic reticulum may prevent the increase in myoplasmic calcium that activates acute catabolism of skeletal muscle cells in patients with anesthesia-induced malignant hyperthermia.108




  • Has little or no effect on the contraction of cardiac or intestinal smooth muscle, except possibly at concentrations higher than those required for effects on skeletal muscle contraction.a



Advice to Patients



  • Risk of hepatoxicity with oral dantrolene.108 109




  • Risk of dizziness and muscle weakness; use caution when driving or operating machinery.108 109 Do not drive or operate machinery within 48 hours of receiving IV dantrolene.109




  • Risk of choking and difficulty swallowing; exercise caution during meals.108




  • Risk of photosensitivity reactions; limit exposure to sunlight.109




  • Importance of women informing their clinician if they are or plan to become pregnant or plan to breast-feed.108 109




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, alcohol consumption, and any concomitant illnesses.108 109




  • Importance of informing patients of other important precautionary information.108 109 (See Cautions.)



Preparations


Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.


* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name











































Dantrolene Sodium

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



25 mg*



Dantrium



Procter & Gamble



Dantrolene Sodium Capsules



Amide, Global



50 mg*



Dantrium



Procter & Gamble



Dantrolene Sodium Capsules



Amide, Global



100 mg*



Dantrium



Procter & Gamble



Dantrolene Sodium Capsules



Amide, Global



Parenteral



For injection



20 mg



Dantrium Intravenous (with mannitol 3 g)



Procter & Gamble


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 03/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Dantrium 100MG Capsules (JHP PHARMACEUTICALS): 45/$99.99 or 135/$291.99


Dantrium 25MG Capsules (JHP PHARMACEUTICALS): 45/$58.98 or 135/$164.96


Dantrium 50MG Capsules (JHP PHARMACEUTICALS): 45/$81.99 or 135/$234.97


Dantrolene Sodium 100MG Capsules (GLOBAL PHARMACEUTICAL CORP): 45/$76.99 or 135/$219.97


Dantrolene Sodium 25MG Capsules (GLOBAL PHARMACEUTICAL CORP): 30/$34.99 or 90/$81.97


Dantrolene Sodium 50MG Capsules (GLOBAL PHARMACEUTICAL CORP): 45/$63.99 or 135/$175.97



Disclaimer

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.


The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions July 2007. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.


† Use is not currently included in the labeling approved by the US Food and Drug Administration.




References


Only references cited for selected revisions after 1984 are available electronically.



100. Coons DJ, Hillman FJ, Marshall RW. Treatment of neuroleptic malignant syndrome with dantrolene sodium: a case report. Am J Psychiatry. 1982; 139:944-5. [IDIS 154797] [PubMed 6124135]



101. Goekoop JG, Carbaat PAT. Treatment of neuroleptic malignant syndrome with dantrolene. Lancet. 1982; 2:49-50.



102. May DC, Morris SW, Stewart RM et al. Neuroleptic malignant syndrome: response to dantrolene sodium. Ann Intern Med. 1983; 98:183-4. [IDIS 164929] [PubMed 6824251]



103. Daoudal P, Delacour JL. Treatment of neuroleptic malignant syndrome with dantrolene. Lancet. 1982; 2:217. [PubMed 6123917]



104. Granato JE, Stern BJ, Ringel A et al. Neuroleptic malignant syndrome: successful treatment with dantrolene and bromocriptine. Ann Neurol. 1983; 14:89-90. [IDIS 173103] [PubMed 6614876]



105. Goulon M, de Rohan-Chabot P, Elkharrat D et al. Beneficial effects of dantrolene in the treatment of neuroleptic malignant syndrome: a report of the two cases. Neurology. 1983; 33:516-8. [IDIS 169146] [PubMed 6682201]



106. Rappaport PL. Extemporaneous dosage preparations for pediatrics. Can J Hosp Pharm. 1983; 36:66-70,74. [PubMed 10262678]



107. Kaplan RF, Feinglass NG, Webster W et al. Phenelzine overdose treated with dantrolene sodium. JAMA. 1986; 255:642-4. [IDIS 210184] [PubMed 3944965]



108. Procter & Gamble Pharmaceuticals. Dantrium IV (dantrolene sodium) for injection prescribing information. Cincinnati, OH; 2001 May.



109. Procter & Gamble Pharmaceuticals. Dantrium (dantrolene sodium) capsules prescribing information. Cincinnati, OH; 1997 Feb.



110. Rubin AS, Zablocki AD. Hyperkalemia, verapamil, and dantrolene. Anesthesiology. 1987; 66:246-9. [IDIS 227329] [PubMed 3813090]



111. Dantrolene (Dantrium) interactions: verapamil (e.g., Calan). In: Hansten PD, Horn JR. Hansten and Horn’s drug interactions, analysis and managements. St. Louis, MO. Facts and Comparisons; 2002:450a.



a. AHFS drug information 2003. McEvoy GK, ed. Dantrolene. Bethesda, MD: American Society of Health-System Pharmacists; 2003:1321-5.



b. Briggs GG, Freeman RK, Yaffe SJ. Drugs in Pregnancy and lactation. 6th ed. Baltimore, MD: Williams & Wilkins; 2002:364-6.



c. Nahata MC, Hipple TF. Pediatric drug formulations. 4th ed. Cincinnati, Ohio: Harvey Whitney Books Company; 2000: 35.



More Dantrium resources


  • Dantrium Side Effects (in more detail)
  • Dantrium Use in Pregnancy & Breastfeeding
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  • Dantrium Support Group
  • 2 Reviews for Dantrium - Add your own review/rating


  • Dantrium Prescribing Information (FDA)

  • Dantrium MedFacts Consumer Leaflet (Wolters Kluwer)

  • Dantrium Concise Consumer Information (Cerner Multum)

  • Dantrium Advanced Consumer (Micromedex) - Includes Dosage Information

  • Dantrolene Prescribing Information (FDA)

  • Dantrium Intravenous Prescribing Information (FDA)

  • Dantrium Intravenous Advanced Consumer (Micromedex) - Includes Dosage Information



Compare Dantrium with other medications


  • Malignant Hyperthermia
  • Spasticity

dapiprazole Ophthalmic


da-PIP-ra-zole


Commonly used brand name(s)

In the U.S.


  • Rev-Eyes

Available Dosage Forms:


  • Powder for Solution

Therapeutic Class: Ophthalmologic Agent


Pharmacologic Class: Alpha-Adrenergic Blocker


Uses For dapiprazole


Dapiprazole is used in the eye to reduce the size of the pupil after certain kinds of eye examinations.


Some eye examinations are best done when your pupil (the black center of the colored part of your eye) is very large, so the doctor can see into your eye better. dapiprazole helps to reduce the size of your pupil back to its normal size after the eye examination.


Before Using dapiprazole


In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For dapiprazole, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to dapiprazole or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.


Pediatric


Studies on dapiprazole have been done only in adult patients, and there is no specific information comparing use of dapiprazole in children with use in other age groups.


Geriatric


Many medicines have not been studied specifically in older people. Therefore, it may not be known whether they work exactly the same way they do in younger adults. Although there is no specific information comparing use of dapiprazole in the elderly with use in other age groups, dapiprazole is not expected to cause different side effects or problems in older people than it does in younger adults.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersBAnimal studies have revealed no evidence of harm to the fetus, however, there are no adequate studies in pregnant women OR animal studies have shown an adverse effect, but adequate studies in pregnant women have failed to demonstrate a risk to the fetus.

Breast Feeding


There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.


Interactions with Medicines


Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.


Interactions with Food/Tobacco/Alcohol


Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.


Other Medical Problems


The presence of other medical problems may affect the use of dapiprazole. Make sure you tell your doctor if you have any other medical problems, especially:


  • Eye problems, other—Use of dapiprazole may make the condition worse

Proper Use of dapiprazole


Dosing


The dose of dapiprazole will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of dapiprazole. If your dose is different, do not change it unless your doctor tells you to do so.


The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.


  • For ophthalmic solution (eye drops) dosage form:
    • For reduction of size of pupil of eye:
      • Adults—One drop, then one drop in five minutes, following eye examination.

      • Children—Use and dose must be determined by your doctor.



Precautions While Using dapiprazole


Even after using dapiprazole, you may have blurred vision or other vision problems. If any of these occur, do not drive, use machines, or do anything else that could be dangerous if you are not able to see well.


dapiprazole may cause your eyes to become more sensitive to light than they are normally. Wearing sunglasses and avoiding too much exposure to bright light may help lessen the discomfort.


dapiprazole Side Effects


Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.


Check with your doctor as soon as possible if any of the following side effects occur:


Less common
  • Irritation (severe) or swelling of the clear part of the eye

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:


More common
  • Burning of eye when medicine is applied

  • redness of the white part of the eye

Less common
  • Blurring of vision

  • browache

  • drooping of upper eyelid

  • dryness of eye

  • headache

  • increased sensitivity of eye to light

  • itching of eye

  • redness of eyelid

  • swelling of eyelid

  • swelling of the membrane covering the white part of the eye

  • tearing of eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.


Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

See also: dapiprazole Ophthalmic side effects (in more detail)



The information contained in the Thomson Reuters Micromedex products as delivered by Drugs.com is intended as an educational aid only. It is not intended as medical advice for individual conditions or treatment. It is not a substitute for a medical exam, nor does it replace the need for services provided by medical professionals. Talk to your doctor, nurse or pharmacist before taking any prescription or over the counter drugs (including any herbal medicines or supplements) or following any treatment or regimen. Only your doctor, nurse, or pharmacist can provide you with advice on what is safe and effective for you.


The use of the Thomson Reuters Healthcare products is at your sole risk. These products are provided "AS IS" and "as available" for use, without warranties of any kind, either express or implied. Thomson Reuters Healthcare and Drugs.com make no representation or warranty as to the accuracy, reliability, timeliness, usefulness or completeness of any of the information contained in the products. Additionally, THOMSON REUTERS HEALTHCARE MAKES NO REPRESENTATION OR WARRANTIES AS TO THE OPINIONS OR OTHER SERVICE OR DATA YOU MAY ACCESS, DOWNLOAD OR USE AS A RESULT OF USE OF THE THOMSON REUTERS HEALTHCARE PRODUCTS. ALL IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE OR USE ARE HEREBY EXCLUDED. Thomson Reuters Healthcare does not assume any responsibility or risk for your use of the Thomson Reuters Healthcare products.


More dapiprazole Ophthalmic resources


  • Dapiprazole Ophthalmic Side Effects (in more detail)
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  • 0 Reviews · Be the first to review/rate this drug


  • Rev-Eyes MedFacts Consumer Leaflet (Wolters Kluwer)


Tuesday, September 27, 2016

Deconamine SR Controlled-Release Capsules


Pronunciation: klor-fen-IHR-ah-meen/sue-do-eh-FED-rin
Generic Name: Chlorpheniramine/Pseudoephedrine
Brand Name: Generic only. No brands available.


Deconamine SR Controlled-Release Capsules are used for:

Relieving symptoms of sinus congestion, sinus pressure, runny nose, and sneezing due to colds, upper respiratory infections, and allergies. It may also be used for other conditions as determined by your doctor.


Deconamine SR Controlled-Release Capsules are an antihistamine and decongestant combination. The antihistamine works by blocking the action of histamine, which helps reduce symptoms such as watery eyes and sneezing. The decongestant promotes sinus and nasal drainage, relieving congestion and pressure.


Do NOT use Deconamine SR Controlled-Release Capsules if:


  • you are allergic to any ingredient in Deconamine SR Controlled-Release Capsules

  • you have severe high blood pressure, severe heart blood vessel disease, rapid heartbeat, or severe heart problems

  • you take sodium oxybate (GHB) or if you have taken furazolidone or a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days

Contact your doctor or health care provider right away if any of these apply to you.



Before using Deconamine SR Controlled-Release Capsules:


Some medical conditions may interact with Deconamine SR Controlled-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have a fast, slow, or irregular heartbeat

  • if you have a history of asthma, lung problems (eg, emphysema), adrenal gland problems (eg, adrenal gland tumor), heart problems, high blood pressure, diabetes, heart blood vessel problems, stroke, glaucoma, a blockage of your stomach or intestines, ulcers, a blockage of your bladder, trouble urinating, an enlarged prostate, seizures, or an overactive thyroid

Some MEDICINES MAY INTERACT with Deconamine SR Controlled-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Beta-blockers (eg, propranolol), catechol-O-methyltransferase (COMT) inhibitors (eg, tolcapone), furazolidone, indomethacin, MAOIs (eg, phenelzine), sodium oxybate (GHB), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Deconamine SR Controlled-Release Capsules's side effects

  • Digoxin or droxidopa because the risk of irregular heartbeat or heart attack may be increased

  • Bromocriptine or hydantoins (eg, phenytoin) because the risk of their side effects may be increased by Deconamine SR Controlled-Release Capsules

  • Guanethidine, guanadrel, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by Deconamine SR Controlled-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Deconamine SR Controlled-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Deconamine SR Controlled-Release Capsules:


Use Deconamine SR Controlled-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Take Deconamine SR Controlled-Release Capsules by mouth with or without food.

  • Swallow Deconamine SR Controlled-Release Capsules whole. Do not break, crush, or chew before swallowing.

  • If you miss a dose of Deconamine SR Controlled-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Deconamine SR Controlled-Release Capsules.



Important safety information:


  • Deconamine SR Controlled-Release Capsules may cause dizziness, drowsiness, or blurred vision. These effects may be worse if you take it with alcohol or certain medicines. Use Deconamine SR Controlled-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

  • Do not take diet or appetite control medicines while you are taking Deconamine SR Controlled-Release Capsules without checking with you doctor.

  • Deconamine SR Controlled-Release Capsules has pseudoephedrine in it. Before you start any new medicine, check the label to see if it has pseudoephedrine in it too. If it does or if you are not sure, check with your doctor or pharmacist.

  • Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.

  • If your symptoms do not get better within 5 to 7 days or if they get worse, check with your doctor.

  • Deconamine SR Controlled-Release Capsules may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Deconamine SR Controlled-Release Capsules. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.

  • Deconamine SR Controlled-Release Capsules may interfere with skin allergy tests. If you are scheduled for a skin test, talk to your doctor. You may need to stop taking Deconamine SR Controlled-Release Capsules for a few days before the tests.

  • Tell your doctor or dentist that you take Deconamine SR Controlled-Release Capsules before you receive any medical or dental care, emergency care, or surgery.

  • Use Deconamine SR Controlled-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects.

  • Caution is advised when using Deconamine SR Controlled-Release Capsules in CHILDREN; they may be more sensitive to its effects.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Deconamine SR Controlled-Release Capsules while you are pregnant. It is not known if Deconamine SR Controlled-Release Capsules are found in breast milk. Do not breast-feed while taking Deconamine SR Controlled-Release Capsules.


Possible side effects of Deconamine SR Controlled-Release Capsules:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; diarrhea; dizziness; drowsiness; excitability; headache; loss of appetite; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); difficulty urinating or inability to urinate; fast or irregular heartbeat; hallucinations; seizures; severe dizziness, lightheadedness, or headache; tremor; vision changes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Deconamine SR side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; hallucinations; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; unusually fast, slow, or irregular heartbeat; vomiting.


Proper storage of Deconamine SR Controlled-Release Capsules:

Store Deconamine SR Controlled-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Deconamine SR Controlled-Release Capsules out of the reach of children and away from pets.


General information:


  • If you have any questions about Deconamine SR Controlled-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.

  • Deconamine SR Controlled-Release Capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

  • Check with your pharmacist about how to dispose of unused medicine.

This information is a summary only. It does not contain all information about Deconamine SR Controlled-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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  • Hay Fever
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Darvon Compound-65


Generic Name: Aspirin/Caffeine/Propoxyphene (AS-pir-in/ka-FEEN/proe-POX-ih-feen)
Brand Name: Darvon Compound-65

Darvon Compound-65 should not be used by people who are suicidal or who easily become addicted to medicines, alcohol, or other substances. Do not take more of Darvon Compound-65 than the dose your doctor prescribed. Taking excessive doses of Darvon Compound-65 by itself, with other medicines, or with alcohol may cause serious side effects and could be fatal. Limit the amount of alcohol you drink while you are taking Darvon Compound-65. Tell your doctor if you have a history of any substance abuse, mood or mental disorders, suicidal thoughts or attempts, or if you take any medicines that cause drowsiness such as tranquilizers, sleep medicines, muscle relaxers, or antidepressants.





Darvon Compound-65 is used for:

Relieving mild to moderate pain with or without fever.


Darvon Compound-65 is a combination narcotic analgesic, caffeine, and salicylate. The narcotic analgesic works in the brain to decrease pain. The salicylate and caffeine help to increase the pain relief.


Do NOT use Darvon Compound-65 if:


  • you are allergic to any ingredient in Darvon Compound-65

  • you have had a severe allergic reaction (eg, severe rash, hives, difficulty breathing, dizziness) to a salicylate (eg, salsalate) or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, naproxen, celecoxib)

  • you have hemophilia, severe bleeding, or decreased blood platelet levels (thrombocytopenia)

  • you have severe diarrhea caused by antibiotic use (pseudomembranous colitis) or poisoning

  • the patient is a child with the flu, chickenpox, or Von Willebrand disease

  • you are taking heparin or sodium oxybate (GHB)

Contact your doctor or health care provider right away if any of these apply to you.



Before using Darvon Compound-65:


Some medical conditions may interact with Darvon Compound-65. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:


  • if you are pregnant, planning to become pregnant, or are breast-feeding

  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement

  • if you have allergies to medicines, foods, or other substances

  • if you have prostate problems, liver problems (eg, hepatitis), or kidney problems

  • if you have a history of alcohol or drug abuse or dependence, depression, anxiety, trouble sleeping, have ever seriously considered suicide, or if you regularly consume alcohol

  • if you have had a head injury; increased pressure, growths, or bleeding in your brain; stroke; or seizures

  • if you have a history of stomach or intestinal problems (eg, inflammation, ulcers, heartburn, stomach pain), urinary problems, bleeding problems, growths in the nose, Kawasaki syndrome, rheumatoid arthritis, low levels of vitamin K in your blood, or you have had abdominal surgery

  • if you have lung or breathing problems (eg, asthma), diabetes, thyroid problems, heart problems, certain blood problems (porphyria), the flu, chickenpox, or hives

Some MEDICINES MAY INTERACT with Darvon Compound-65. Tell your health care provider if you are taking any other medicines, especially any of the following:


  • Anticoagulants (eg, warfarin), clopidogrel, or heparin because side effects, including an increased risk of bleeding, may be increased by Darvon Compound-65

  • Carbamazepine because the risk of severe side effects and toxicity, including nausea, vomiting, loss of coordination, and involuntary eye movements, may occur

  • Quinolone antibiotics (eg, ciprofloxacin) because the actions and side effects of Darvon Compound-65 may be increased

  • Antidepressant medicines (eg, amitriptyline, phenelzine), anticonvulsants (eg, phenobarbital, phenytoin), barbiturate anesthetics (eg, thiopental), antidiabetic medicines (eg, glyburide, insulin, nateglinide), carbonic anhydrase inhibitors (eg, acetazolamide), cimetidine, HIV protease inhibitors (eg, ritonavir), methotrexate, NSAIDs (eg, ibuprofen, celecoxib), terfenadine, theophylline, or valproic acid because side effects may be increased by Darvon Compound-65

  • Naltrexone because the effectiveness of Darvon Compound-65 may be decreased

  • Sodium oxybate (GHB) because side effects, including increased risk of sleep duration and drowsiness leading to unresponsiveness and coma, may be increased by Darvon Compound-65

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), probenecid, or sulfinpyrazone because the effectiveness may be decreased by Darvon Compound-65

This may not be a complete list of all interactions that may occur. Ask your health care provider if Darvon Compound-65 may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.


How to use Darvon Compound-65:


Use Darvon Compound-65 as directed by your doctor. Check the label on the medicine for exact dosing instructions.


  • Darvon Compound-65 may be taken with or without food. If stomach upset occurs, take with food to reduce stomach irritation. Taking it with food may not decrease the risk of stomach or bowel problems (such as bleeding or ulcers) that may occur while taking Darvon Compound-65.

  • Darvon Compound-65 comes with an additional patient leaflet. Read it carefully and reread it each time you get Darvon Compound-65 refilled.

  • Take Darvon Compound-65 with a full glass of water.

  • Do not take more than your prescribed dose or take Darvon Compound-65 for longer than prescribed by your health care provider.

  • If you miss a dose of Darvon Compound-65 and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Darvon Compound-65.



Important safety information:


  • Darvon Compound-65 may cause drowsiness or dizziness. Do not drive, operate machinery, or do anything else that could be dangerous until you know how you react to Darvon Compound-65. Using Darvon Compound-65 alone, with certain other medicines, or with alcohol may lessen your ability to drive or perform other potentially dangerous tasks.

  • If you experience dizziness, drowsiness, nausea, or vomiting, it may help to lie down.

  • Use of alcohol with Darvon Compound-65 may cause serious side effects. Limit your intake of alcohol while taking Darvon Compound-65. If you drink alcohol every day, do not take Darvon Compound-65 without talking to your health care provider first. The combination of Darvon Compound-65 and alcohol may cause liver damage.

  • Make sure your health care provider knows if you are taking tranquilizers, sleep aids, antidepressant medicines, antihistamines, or any other medicines that may make you sleepy. The combination of these products with Darvon Compound-65 may lead to serious side effects, including death.

  • Darvon Compound-65 may cause stomach bleeding. Alcohol use combined with Darvon Compound-65 may increase your risk for stomach bleeding.

  • Darvon Compound-65 may reduce the number of clot-forming cells (platelets) in your blood. To prevent bleeding, avoid situations in which bruising or injury may occur. Report any unusual bleeding, bruising, blood in stools, or dark, tarry stools to your doctor.

  • Before you have any medical or dental treatments, emergency care, or surgery, tell the doctor or dentist that you are using Darvon Compound-65.

  • Darvon Compound-65 may be habit-forming. Do not take more than the dose prescribed by your doctor or take Darvon Compound-65 for a longer period of time than prescribed by your doctor.

  • Diabetes patients - Darvon Compound-65 may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

  • Darvon Compound-65 contains aspirin, which has been linked to Reye syndrome. Do not give Darvon Compound-65 to children or teenagers during or after chickenpox, flu, or other viral infections without checking with your doctor or pharmacist.

  • Darvon Compound-65 contains aspirin. Before you begin taking any new prescription or nonprescription medicine, read the ingredients to see if it also contains aspirin or an NSAID (eg, ibuprofen). If it does or if you are uncertain, contact your doctor or pharmacist.

  • Darvon Compound-65 contains caffeine. Avoid large amounts of caffeine-containing foods and beverages, such as coffee, tea, cocoa, cola drinks, and chocolate, while you are taking Darvon Compound-65.

  • Use Darvon Compound-65 with caution in the ELDERLY because they may be more sensitive to its effects.

  • Use Darvon Compound-65 with extreme caution in CHILDREN. Use of Darvon Compound-65 is not recommended in CHILDREN younger than 12 years of age. Safety and effectiveness in this age group have not been confirmed.

  • PREGNANCY and BREAST-FEEDING: If you become pregnant, discuss with your doctor the benefits and risks of using Darvon Compound-65 during pregnancy. Avoid using Darvon Compound-65 during the last 3 months of pregnancy due to the potential for fetal harm or complications during delivery. Darvon Compound-65 is excreted in breast milk. If you are or will be breast-feeding while you are using Darvon Compound-65, check with your doctor or pharmacist to discuss the risks to your baby.

When used for long periods of time or at high doses, Darvon Compound-65 may not work as well and may require higher doses to obtain the same effect as when originally taken. This is known as TOLERANCE. Talk with your doctor if Darvon Compound-65 stops working well. Do not take more than prescribed.


Darvon Compound-65 can cause DEPENDENCE if taken in higher doses than recommended by your health care provider or over a long period of time. Take Darvon Compound-65 exactly as prescribed by your health care provider. If you suddenly stop taking Darvon Compound-65, you may experience WITHDRAWAL symptoms including anxiety; diarrhea; fever, runny nose, or sneezing; goosebumps and abnormal skin sensations; nausea; pain; rapid heartbeat; rigid muscles; seeing, hearing, or feeling things that are not there; shivering or tremors; sweating; trouble sleeping; and vomiting.



Possible side effects of Darvon Compound-65:


All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:



Constipation; dizziness; drowsiness; lightheadedness; nausea; vomiting.



Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); anxiety; black or bloody stools; cold or clammy skin; confusion; decreased urination; excessive sweating; hallucinations; hearing loss; loss of appetite; loss of consciousness; mental or mood changes; ringing in the ears; seizures; severe drowsiness or dizziness; severe or persistent stomach pain or heartburn; unusual bruising or bleeding; vision changes; vomit that looks like coffee grounds; weakness; yellowing of the skin or eyes.



This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.


See also: Darvon Compound-65 side effects (in more detail)


If OVERDOSE is suspected:


Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include anxiety; confusion; dilated pupils; fast or irregular heartbeat; increased sweating; muscle pain; ringing in the ears; severe or persistent drowsiness, dizziness, nausea, or vomiting; slow or difficult breathing; weakness.


Proper storage of Darvon Compound-65:

Store Darvon Compound-65 at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Keep Darvon Compound-65 out of the reach of children and away from pets.


General information:


  • If you have any questions about Darvon Compound-65, please talk with your doctor, pharmacist, or other health care provider.

  • Darvon Compound-65 is to be used only by the patient for whom it is prescribed. Do not share it with other people.

  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Darvon Compound-65. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.



Issue Date: February 1, 2012

Database Edition 12.1.1.002

Copyright © 2012 Wolters Kluwer Health, Inc.

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