Saturday, 14 April 2012

Indapamide Sandoz




Indapamide Sandoz may be available in the countries listed below.


Ingredient matches for Indapamide Sandoz



Indapamide

Indapamide is reported as an ingredient of Indapamide Sandoz in the following countries:


  • Italy

  • Netherlands

International Drug Name Search

Thursday, 12 April 2012

ciclopirox Topical


sye-kloe-PIR-ox


Commonly used brand name(s)

In the U.S.


  • CNL8

  • Loprox

  • Loprox TS

  • Penlac

Available Dosage Forms:


  • Lotion

  • Gel/Jelly

  • Cream

  • Suspension

  • Shampoo

  • Solution

  • Powder

Therapeutic Class: Antifungal


Uses For ciclopirox


Ciclopirox is used to treat infections caused by fungus. It works by killing the fungus or preventing its growth.


Ciclopirox cream, gel, or lotion are applied to the skin to treat:


  • ringworm of the body (tinea corporis);

  • ringworm of the foot (tinea pedis; athlete's foot);

  • ringworm of the groin (tinea cruris; jock itch);

  • “sun fungus” (tinea versicolor; pityriasis versicolor); and

  • certain other fungus infections, such as Candida (Monilia) infections.

Ciclopirox gel or shampoo may also be applied to the scalp to treat seborrheic dermatitis.


Ciclopirox topical solution (nail lacquer) is applied to the nails to treat ringworm of the nails (tinea unguium).


Ciclopirox is available only with your doctor's prescription.


Before Using ciclopirox


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 ciclopirox, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to ciclopirox 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 ciclopirox have been done only in adult patients, and there is no specific information comparing use of ciclopirox in children under the age of 10 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 ciclopirox in the elderly with use in other age groups, ciclopirox is not expected to cause different side effects or problems in older people than it does in younger adults.


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.


Proper Use of ciclopirox


For patients using the cream, gel, or lotion form of ciclopirox:


  • Keep ciclopirox away from the eyes.

  • Apply enough ciclopirox to cover the affected and surrounding skin or scalp areas and rub in gently.

For patients using the shampoo form of ciclopirox:


  • Keep ciclopirox away from the eyes.

  • Apply shampoo to wet hair. Lather and leave on hair and scalp for 3 minutes. A timer may be used. Rinse off.

For patients using the topical solution form of ciclopirox:


  • Keep ciclopirox away from the eyes and mucous membranes

  • ciclopirox comes with a patient instruction sheet. Read this sheet carefully and follow the directions. If you have any questions on how to use ciclopirox, be sure to ask your health care professional.

  • In addition to daily application of ciclopirox, you will need to trim your nails as directed, and visit your healthcare professional at regular intervals to have the unattached infected nails removed.

  • Do not use nail polish or other nail cosmetic products on the treated nails.

  • Do not use near heat or open flame.

When ciclopirox is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over the medicine. To do so may irritate the skin. Do not apply an airtight covering over ciclopirox unless you have been directed to do so by your doctor.


To help clear up your infection completely, it is very important that you keep using ciclopirox for the full time of treatment , even if your symptoms begin to clear up after a few days. Since fungus infections may be very slow to clear up, you may have to continue using ciclopirox every day for several weeks or more. If you stop using ciclopirox too soon, your symptoms may return. Do not miss any doses .


Dosing


The dose of ciclopirox 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 ciclopirox. 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 topical cream and lotion dosage forms:
    • Fungus infections (treatment):
      • Adults and children 10 years of age and over—Apply two times a day, morning and evening.

      • Children up to 10 years of age—Use and dose must be determined by your doctor.



    For topical gel dosage form:
    • Fungus infections (treatment) or seborrheic dermatitis (treatment):
      • Adults and children 16 years of age and over—Apply two times a day, morning and evening.

      • Children up to 16 years of age—Use and dose must be determined by your doctor.



    For shampoo dosage form:
    • Seborrheic dermatitis (treatment):
      • Adults and children 16 years of age and over—Apply 1 teaspoon (or up to 2 teaspoons for long hair) two times a week for four weeks with at least three days between each application.

      • Children up to 16 years of age—Use and dose must be determined by your doctor.



    For topical solution dosage form:
    • Fungus infections (treatment):
      • Adults —Apply once daily, preferably at bedtime or eight hours before washing.

      • Children up to 18 years of age—Use and dose must be determined by your doctor.



Missed Dose


If you miss a dose of ciclopirox, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using ciclopirox


If your skin problem does not improve within 2 to 4 weeks, or if it becomes worse, check with your doctor.


Inform your doctor right away if the area where you applied the medicine shows signs of increased irritation (e.g., redness, itching, burning, blistering, swelling, or oozing) because it could be an allergic reaction.


Nail problems treated with the topical solution form of ciclopirox may take up to 6 months to start improving.


To help clear up your infection completely and to help make sure it does not return, good health habits are also required. The following measures will help reduce chafing and irritation and will also help keep the area cool and dry.


  • For patients using ciclopirox for ringworm of the groin (tinea cruris):
    • Avoid wearing underwear that is tight-fitting or made from synthetic materials (for example, rayon or nylon). Instead, wear loose-fitting, cotton underwear.

    • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder (for example, tolnaftate) on the skin. It is best to use the powder between applications of ciclopirox.


  • For patients using ciclopirox for ringworm of the foot (tinea pedis):
    • Carefully dry the feet, especially between the toes, after bathing.

    • Avoid wearing socks made from wool or synthetic materials (for example, rayon or nylon). Instead, wear clean, cotton socks and change them daily or more often if the feet sweat freely.

    • Wear sandals or well-ventilated shoes (for example, shoes with holes on top or on the side).

    • Use a bland, absorbent powder (for example, talcum powder) or an antifungal powder (for example, tolnaftate) between the toes, on the feet, and in socks and shoes freely once or twice a day. It is best to use the powder between applications of ciclopirox.


If you have any questions about these measures, check with your health care professional.


ciclopirox 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 - with ciclopirox shampoo
  • Fainting

  • fast, pounding, or irregular heartbeat or pulse

  • palpitations

Rare
  • Burning, itching, redness, swelling, or other signs of irritation not present before use of ciclopirox

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:


Less common - with ciclopirox shampoo
  • Dandruff

  • headache

  • itching skin or scalp

  • oily skin

  • rash

  • skin disorder

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: ciclopirox Topical 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 ciclopirox Topical resources


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


  • ciclopirox topical Concise Consumer Information (Cerner Multum)

  • Ciclodan Prescribing Information (FDA)

  • Loprox Prescribing Information (FDA)

  • Loprox Cream MedFacts Consumer Leaflet (Wolters Kluwer)



Compare ciclopirox Topical with other medications


  • Cutaneous Candidiasis
  • Onychomycosis, Fingernail
  • Onychomycosis, Toenail
  • Seborrheic Dermatitis
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor

Tuesday, 10 April 2012

Triple Care EPC Topical


Generic Name: miconazole (Topical route)

mye-KON-a-zole

Commonly used brand name(s)

In the U.S.


  • Aloe Vesta 2-N-1 Antifungal

  • Aloe Vesta Antifungal

  • Baza Antifungal

  • Carrington Antifungal

  • Derma Gran AF

  • DiabetAid Antifungal Foot Bath

  • Fungoid

  • Lotrimin AF

  • Micatin

  • Micro-Guard

  • Mitrazol

  • Monistat 1

  • Monistat Derm

  • Neosporin AF

  • QC Miconazole Nitrate

  • Secura Antifungal

  • Soothe & Cool Inzo Antifungal

  • Tetterine

  • Therasoft Antifungal

  • Triple Care Antifungal

  • Triple Care EPC

  • Zeasorb-AF

Available Dosage Forms:


  • Lotion

  • Tablet, Effervescent

  • Cream

  • Ointment

  • Powder

  • Kit

  • Gel/Jelly

  • Tincture

  • Spray

Therapeutic Class: Antifungal


Chemical Class: Imidazole


Uses For Triple Care EPC


Miconazole belongs to the group of medicines called antifungals. Topical miconazole is used to treat some types of fungus infections.


Some of these preparations may be available without a prescription.


Before Using Triple Care EPC


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 this medicine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to this medicine 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


Although there is no specific information comparing use of topical miconazole in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.


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 topical miconazole in the elderly with use in other age groups, this medicine is not expected to cause different side effects or problems in older people than it does in younger adults.


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.


Proper Use of miconazole

This section provides information on the proper use of a number of products that contain miconazole. It may not be specific to Triple Care EPC. Please read with care.


Keep this medicine away from the eyes.


Apply enough miconazole to cover the affected area, and rub in gently.


To use the aerosol powder form of miconazole:


  • Shake well before using.

  • From a distance of 6 to 10 inches, spray the powder on the affected areas. If it is used on the feet, spray it between the toes, on the feet, and in the socks and shoes.

  • Do not inhale the powder.

  • Do not use near heat, near open flame, or while smoking.

To use the aerosol solution form of miconazole:


  • Shake well before using.

  • From a distance of 4 to 6 inches, spray the solution on the affected areas. If it is used on the feet, spray it between the toes and on the feet.

  • Do not inhale the vapors from the spray.

  • Do not use near heat, near open flame, or while smoking.

To use the powder form of miconazole:


  • If the powder is used on the feet, sprinkle it between the toes, on the feet, and in the socks and shoes.

When miconazole is used to treat certain types of fungus infections of the skin, an occlusive dressing (airtight covering, such as kitchen plastic wrap) should not be applied over this medicine. To do so may cause irritation of the skin. Do not apply an occlusive dressing over this medicine unless you have been directed to do so by your doctor.


To help clear up your infection completely, keep using this medicine for the full time of treatment, even if your condition has improved. Do not miss any doses.


Dosing


The dose of this medicine 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 this medicine. 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 aerosol powder, aerosol solution, cream , and powder dosage forms:
    • For fungus infections:
      • Adults and children—Apply to the affected area(s) of the skin two times a day, morning and evening.



  • For cream and lotion dosage forms:
    • For sun fungus:
      • Adults and children—Apply to the affected area(s) of the skin once a day.



Missed Dose


If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.


Storage


Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.


Store the canister at room temperature, away from heat and direct light. Do not freeze. Do not keep this medicine inside a car where it could be exposed to extreme heat or cold. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Precautions While Using Triple Care EPC


If your skin problem does not improve within 4 weeks, or if it becomes worse, check with your health care professional.


Triple Care EPC 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:


  • Blistering, burning, redness, skin rash, or other sign of skin irritation not present before use of this medicine

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.



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 Triple Care EPC Topical resources


  • Triple Care EPC Topical Use in Pregnancy & Breastfeeding
  • Triple Care EPC Topical Drug Interactions
  • Triple Care EPC Topical Support Group
  • 8 Reviews for Triple Care EPC Topical - Add your own review/rating


Compare Triple Care EPC Topical with other medications


  • Cutaneous Candidiasis
  • Oral Thrush
  • Tinea Corporis
  • Tinea Cruris
  • Tinea Pedis
  • Tinea Versicolor
  • Vaginal Yeast Infection

Monday, 9 April 2012

Gabapentin



Class: Anticonvulsants, Miscellaneous
VA Class: CN400
Chemical Name: 1-(Aminomethyl)-cyclohexaneacetic acid
Molecular Formula: C9H17NO2
CAS Number: 60142-96-3
Brands: Neurontin


Special Alerts:


[UPDATE 05/05/2009] FDA notified healthcare professionals that it approved updated labeling for antiepileptic drugs used to treat epilepsy, psychiatric disorders, and other conditions (e.g., migraine and neuropathic pain syndromes). FDA also required development of a medication guide, to be issued to patients each time the product is dispensed. Since issuing safety alerts on December 16, 2008 and January 31, 2008, FDA has been working with the manufacturers of drugs in this class to better understand the suicidality risk. Eleven antiepileptic drugs were included in a pooled analysis of placebo-controlled clinical studies in which these drugs were used to treat epilepsy as well as psychiatric disorders and other conditions. The increased risk of suicidal thoughts or behavior was generally consistent among the eleven drugs, with varying mechanisms of action and across a range of indications. This observation suggests that the risk applies to all antiepileptic drugs used for any indication.


The drugs included in the analyses include (some of these drugs are also available in generic form):



  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)




  • Felbamate (marketed as Felbatol)




  • Gabapentin (marketed as Neurontin)




  • Lamotrigine (marketed as Lamictal)




  • Levetiracetam (marketed as Keppra)




  • Oxcarbazepine (marketed as Trileptal)




  • Pregabalin (marketed as Lyrica)




  • Tiagabine (marketed as Gabitril)




  • Topiramate (marketed as Topamax)




  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)




  • Zonisamide (marketed as Zonegran)



For more information visit the FDA website at: and .


[UPDATE 12/16/2008] The FDA has completed its analysis of reports of suicidality (suicidal behavior or ideation [thoughts]) from placebo-controlled clinical trials of drugs used to treat epilepsy, psychiatric disorders, and other conditions. Based on the outcome of this review, FDA is requiring that all manufacturers of drugs in this class include a Warning in their labeling and develop a Medication Guide to be provided to patients prescribed these drugs to inform them of the risks of suicidal thoughts or actions.


For more information visit the FDA website at: and .


[Posted 01/31/2008] FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA’s analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.


Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.


The drugs included in the analyses include (some of these drugs are also available in generic form):



  • Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)




  • Felbamate (marketed as Felbatol)




  • Gabapentin (marketed as Neurontin)




  • Lamotrigine (marketed as Lamictal)




  • Levetiracetam (marketed as Keppra)




  • Oxcarbazepine (marketed as Trileptal)




  • Pregabalin (marketed as Lyrica)




  • Tiagabine (marketed as Gabitril)




  • Topiramate (marketed as Topamax)




  • Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)




  • Zonisamide (marketed as Zonegran)



Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly. For more information visit the FDA website at: and .


REMS:


FDA approved a REMS for gabapentin to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page () or the ASHP REMS Resource Center ().



Introduction

Anticonvulsant; structurally related to the inhibitory CNS neurotransmitter GABA.1 4 6 7 8 9


Uses for Gabapentin


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Seizure Disorders


Management (in combination with other anticonvulsants) of partial seizures with or without secondary generalization in adults and children >12 years of age.1 2 8 9


Management (in combination with other anticonvulsants) of partial seizures in children 3–12 years of age.1


Neuropathic Pain


Management of postherpetic neuralgia in adults.1 20 21 22 23 24 38 39 40


Treatment of pain associated with diabetic neuropathy.20 21 22 23 24 25 40 41 42 43 44 45 40% of patients who receive gabapentin for pain associated with diabetic neuropathy obtain good pain relief.40


Some evidence of benefit for the relief of chronic neurogenic pain in a variety of conditions including trigeminal neuralgia,20 21 46 47 pain and control of paroxysmal symptoms of multiple sclerosis,20 21 48 49 complex regional pain syndromes,20 52 53 HIV-related peripheral neuropathy,20 21 50 and neuropathic pain associated with cancer.20 21 51 Also has been used in the treatment of restless legs syndrome.26 27 28 Additional study needed to further elucidate precise role in the management of these conditions.


Vasomotor Symptoms


Has been used for the management of vasomotor symptoms (e.g., hot flashes) in women with breast cancer.30


Has been used for the management of vasomotor symptoms (e.g., hot flashes) associated with menopause.31 34 54


Gabapentin Dosage and Administration


General


Seizure Disorders



  • Monitoring of plasma gabapentin concentrations is not necessary to optimize therapy.1 Because addition of gabapentin to existing anticonvulsant therapy does not appreciably alter steady-state plasma concentrations of concomitantly administered anticonvulsants, additional monitoring of plasma concentrations of anticonvulsants generally is not necessary.1 (See Specific Drugs under Interactions.)




  • Discontinuance of gabapentin and/or addition of an alternative anticonvulsant drug to therapy should be done gradually over ≥1 week.1



Administration


Oral Administration


Administer orally without regard to meals.1


If Neurontin film-coated scored tablets containing 600 or 800 mg of gabapentin are to be used in patients requiring a 300- or 400-mg dose, divide the tablet in half to allow administration of the appropriate dose.1 Instruct patients to take one-half tablet and to use the remaining half-tablet for the next dose.1 Half-tablets that are not used within several days should be discarded.1


Seizure Disorders

Administer orally 3 times daily.1 The interval between doses in this schedule should not exceed 12 hours.1


Dosage


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Pediatric Patients


Seizure Disorders

Partial Seizures

Oral

Children 3–12 years of age: Initially, 10–15 mg/kg daily in 3 divided doses.1 Maintenance dosage of 40 mg/kg daily in 3 divided doses for children 3 or 4 years of age and 25–35 mg/kg daily in 3 divided doses for children 5–12 years of age.1


Children >12 years of age: Initially, 300 mg 3 times daily.1 Maintenance dosage of 900 mg to 1.8 g daily in 3 divided doses.1


Adults


Seizure Disorders

Partial Seizures

Oral

Initially, 300 mg 3 times daily.1 Maintenance dosage of 900 mg to 1.8 g daily in 3 divided doses.1


Neuropathic Pain

Postherpetic Neuralgia

Oral

300 mg on the first day, 300 mg twice daily on the second day, and 300 mg 3 times daily on the third day.1 Increase dosage as needed for relief of pain up to a total daily dosage of 1.8 g in 3 divided doses.1 No evidence of additional benefit with dosages >1.8 g daily.1


Diabetic Neuropathy

Oral

Dosages of 900 mg to 3.6 g daily have been used; however, pain relief generally observed in patients receiving dosages >1.8 g daily.24 25


Vasomotor Symptoms

Oral

300 mg 3 times daily has been effective; higher dosages may provide additional benefit.30 31 37


Prescribing Limits


Pediatric Patients


Children 3–12 years of age: Dosages up to 50 mg/kg daily in divided doses have been tolerated as adjunctive therapy in the management of partial seizures.1


Children >12 years of age: Dosage of 3.6 g daily has been tolerated as adjunctive therapy in the management of partial seizures.1


Adults


Dosage of 3.6 g daily has been tolerated as adjunctive therapy in the management of partial seizures.1


Special Populations


Renal Impairment


Not studied in children <12 years of age with renal impairment.1


In adults and children ≥12 years of age, base dosage on measured or estimated Clcr:1 16


aIn patients with Clcr <15 mL/min, reduce dosage proportionally (e.g., a patient with a Clcr of 7.5 mL/min should receive one-half the dosage that a patient with a Clcr of 15 mL/min should receive).


bGive maintenance doses based on Clcr, with supplemental doses (125–350 mg) given after each 4-hour hemodialysis session.1





















Dosage for Adults and Children ≤12 Years of Age with Renal Impairment

Clcr (mL/min)



Total Daily Dosage (mg/day)



Dosage Regimen



≥60



900–3600



300 –1200 mg 3 times daily



30–59



400–1400



200 –700 mg twice daily



15–29



200–700



200 –700 mg once daily



15a



100–300



100 –300 mg once daily



ESRD patients undergoing hemodialysis





125–350 mgb


Geriatric Patients


Select dosage carefully, usually initiating therapy at the low end of the dosage range.1 Adjust dosage based on Clcr.1


Cautions for Gabapentin


Contraindications



  • Known hypersensitivity to gabapentin or any ingredient in the formulation.1



Warnings/Precautions


Warnings


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Cognitive/Neuropsychiatric Effects

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.


Emotional lability (primarily behavioral problems), hostility (including aggressive behaviors), thought disorders (including concentration and school performance changes), and hyperkinesia (primarily restlessness and hyperactivity) associated with use in children 3–12 years of age with epilepsy.1


Withdrawal Seizures

Abrupt withdrawal may result in increased seizure frequency; withdraw gabapentin gradually and reduce dosage slowly over ≥1 week.1


Status Epilepticus

Not established whether incidence of status epilepticus (1.5% in controlled and uncontrolled trials of gabapentin) is higher or lower than would be expected in patients with epilepsy not treated with the drug.1


Tumorigenic Potential

Unexpectedly high incidence of pancreatic acinar adenocarcinomas in male but not female rats.1 Clinical relevance unknown.1


Sudden, Unexplained Deaths in Epilepsy

Higher incidence of sudden and unexplained deaths than would be expected in a healthy (nonepileptic) population; however, incidence is within range of estimates for patients with epilepsy or refractory epilepsy.1


Specific Populations


Pregnancy

Category C.1


Lactation

Distributed into milk; use only if potential benefits outweigh the risks.1


Pediatric Use

Safety and efficacy as adjunctive therapy in the management of partial seizures not established in children <3 years of age.1


Safety and efficacy for the management of postherpetic neuralgia not established in children.1


Geriatric Use

Insufficient experience with gabapentin for the management of partial seizures in patients ≥65 years of age to determine whether they respond differently than younger adults.1 Select dosage carefully.1 (See Geriatric Patients under Dosage and Administration.)


Appeared to be more effective for the management of postherpetic neuralgia in patients >75 years of age than in younger patients; apparent difference in efficacy may be related to decreased renal function in older patients.1


Adverse effects in older patients with postherpetic neuralgia generally similar to those in younger adults; however, the incidence of peripheral edema and ataxia appears to increase with age.1


Geriatric patients may have decreased hepatic, renal, or cardiac function, with increased risk of adverse effects.1 16 Use with caution; renal function monitoring may be useful.1


Renal Impairment

Clearance decreased; adjust dosage in adults and children ≥12 years of age with renal impairment.1 (See Renal Impairment under Dosage and Administration.)


Use in children <12 years of age with renal impairment has not been studied.1


Common Adverse Effects


Children 3–12 years of age receiving gabapentin as adjunctive therapy for partial seizures: viral infection, fever, nausea and/or vomiting, somnolence, hostility.1


Adults and children >12 years of age receiving gabapentin as adjunctive therapy for partial seizures with or without secondary generalization: somnolence, dizziness, ataxia, fatigue, nystagmus.1


Adults receiving gabapentin for management of postherpetic neuralgia: dizziness, somnolence, peripheral edema.1


Interactions for Gabapentin


Not metabolized by CYP isoenzymes.1 Does not inhibit CYP isoenzymes 1A2, 2C9, 2C19, 2D6, 2E1, or 3A4 in vitro; causes slight inhibition of CYP2A6 at high concentrations.1


Specific Drugs






























Drug



Interaction



Comments



Antacids



Reduced bioavailability of gabapentin1



Administer gabapentin at least 2 hours after antacid1



Anticonvulsants



Plasma concentrations of carbamazepine, phenytoin, valproic acid, phenobarbital, and diazepam in existing treatment regimens not affected by gabapentin;1 3 12 13 14 pharmacokinetics of gabapentin not affected by these drugs1 6 12 15



Cimetidine



Possible decrease in gabapentin clearance 1



Not likely to be clinically important1



Hydrocodone



Possible dose-dependent decrease in plasma concentrations of hydrocodone; possible increase in plasma concentrations of gabapentin1



Morphine



Increase in plasma concentrations of gabapentin1



Decrease in dosage of morphine or gabapentin may be required in patients with symptoms of CNS depression (e.g., somnolence)1



Naproxen



Increased bioavailability of gabapentin at subtherapeutic dosages of both drugs1



Extent of interaction at usual therapeutic dosages is unknown1



Oral Contraceptives



Possible increase in peak plasma concentrations of norethindrone1



Not likely to be clinically important1



Probenecid



No pharmacokinetic interaction observed1


Gabapentin Pharmacokinetics


Absorption


Bioavailability


Bioavailability of 60–27% for doses ranging from 900 mg to 4.8 g daily.1 Bioavailability is not dose proportional.1


Food


Food increases extent of absorption and peak plasma concentration by 14%.1


Distribution


Extent


Readily crosses the blood-brain barrier and concentrates in brain tissue.29 Distributed into breast milk.1 Not known whether gabapentin crosses the placenta.1


Plasma Protein Binding


<3%.1


Elimination


Metabolism


Not appreciably metabolized.1


Elimination Route


Excreted renally as unchanged drug.1


Half-life


5–7 hours.1


Special Populations


In children <5 years of age, clearance normalized for weight is higher than in adults and children ≥5 years of age.1


In patients with renal impairment, plasma clearance is decreased and half-life is prolonged.1 In patients with Clcr <30 mL/minute, half-life of 52 hours reported.1 In anuric patients, half-life reported to be 132 hours on nondialysis days and 3.8 hours during hemodialysis.1


Stability


Storage


Oral


Capsules and Tablets

25°C (may be exposed to 15–30°C).1


Oral Solution

2–8°C.1


Actions



  • Mechanism of anticonvulsant action is unknown.1 4 5 7 8 9 Does not bind to GABA receptors,1 4 5 6 7 17 affect GABA reuptake or metabolism, 1 6 7 17 or act as a precursor of GABA or other substances active at GABA receptors.1 17




  • Mechanism of analgesic action is unknown.1 20 21 22 23 Prevents allodynia (pain-related behavior in response to normally innocuous stimuli) and hyperalgesia (exaggerated response to painful stimuli) in several animal models of neuropathic pain.1 20 Decreases pain-related responses after peripheral inflammation in animals; however, has not altered immediate pain-related behaviors.1 Clinical relevance of these findings is not known.1



Advice to Patients


Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.



  • Importance of taking gabapentin exactly as prescribed.1 Importance of not abruptly discontinuing therapy.1




  • Potential for drug to impair mental alertness or physical coordination; avoid driving or operating machinery until effects on individual are known.1




  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1




  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs.1




  • Importance of informing patients of other important precautionary information. (See Cautions.)1



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
























































































Gabapentin

Routes



Dosage Forms



Strengths



Brand Names



Manufacturer



Oral



Capsules



100 mg*



Gabapentin Capsules



Actavis, Apotex, Mutual, Ranbaxy, Sandoz, Teva



Neurontin



Pfizer



300 mg*



Gabapentin Capsules



Actavis, Apotex, Mutual, Ranbaxy, Sandoz, Teva



Neurontin



Pfizer



400 mg*



Gabapentin Capsules



Actavis, Apotex, Mutual, Ranbaxy, Sandoz, Teva



Neurontin



Pfizer



Solution



250 mg/5 mL



Neurontin



Pfizer



Tablets



100 mg*



Gabapentin Tablets



Greenstone, Ranbaxy, Teva



300 mg*



Gabapentin Tablets



Greenstone, Ranbaxy, Teva



400 mg*



Gabapentin Tablets



Greenstone, Ranbaxy, Teva



600 mg



Gabapentin Tablets



Teva



800 mg



Gabapentin Tablets



Teva



Tablets, film-coated



600 mg



Gabapentin Tablets



Actavis



Neurontin



Pfizer



800 mg



Gabapentin Tablets



Actavis



Neurontin



Pfizer


Comparative Pricing


This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 10/2011. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.


Gabapentin 100MG Capsules (AMNEAL PHARMACEUTICALS): 90/$43.99 or 270/$115.97


Gabapentin 250MG/5ML Solution (HI-TECH): 470/$139.99 or 1410/$399.96


Gabapentin 300MG Capsules (AMNEAL PHARMACEUTICALS): 90/$18.99 or 270/$170.96


Gabapentin 400MG Capsules (AMNEAL PHARMACEUTICALS): 90/$74.99 or 270/$209.98


Gabapentin 600MG Tablets (GLENMARK PHARMACEUTICALS): 90/$97.99 or 270/$248.97


Gabapentin 800MG Tablets (GLENMARK PHARMACEUTICALS): 90/$99.99 or 100/$107.97


Neurontin 100MG Capsules (PFIZER U.S.): 100/$93.99 or 300/$269.97


Neurontin 250MG/5ML Solution (PFIZER U.S.): 470/$172.99 or 1410/$475.97


Neurontin 300MG Capsules (PFIZER U.S.): 30/$69.99 or 90/$199.96


Neurontin 400MG Capsules (PFIZER U.S.): 30/$83.99 or 90/$245.97


Neurontin 600MG Tablets (PFIZER U.S.): 90/$396.98 or 100/$435.99


Neurontin 800MG Tablets (PFIZER U.S.): 90/$481.00 or 270/$1,399.96



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 October 27, 2011. 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



1. Parke-Davis. Neurontin (gabapentin) capsules prescribing information. New York, NY; 2005 Dec.



2. Anon. Parke-Davis’ Neurontin recommended for approval as “add on” therapy for refractory seizures in epilepsy; gabapentin monotherapy trials under way. F-D-C Rep. 1992 Dec:7-8.



3. Anon. Warner Lambert’s Neurontin approved for adjunctive therapy in epilepsy patients Dec 30; “1P” drug does not interact with other anticonvulsants. F-D-C Rep. 1994 Jan:11.



4. Ramsay ER. Advances in the pharmacotherapy of epilepsy. Epilepsia. 1993; 34(Suppl 5):S9-16. [PubMed 8339715]



5. MacDonald RL, Kelly KM. Antiepileptic drug mechanisms of action. Epilepsia. 1993; 34(Suppl 5):S1-8. [IDIS 319353] [PubMed 7687957]



6. Goa KL, Sorkin EM. Gabapentin: a review of its pharmacological properties and clinical potential in epilepsy. Drugs. 1993; 46:409-27. [PubMed 7693432]



7. Graves NM, Leppik IE. Antiepileptic medications in development. DICP Ann Pharmacother. 1991; 25:978-86. [IDIS 285278] [PubMed 1949977]



8. UK Gabapentin Study Group. Gabapentin in partial epilepsy. Lancet. 1990; 335:1114-7. [IDIS 266256] [PubMed 1971862]



9. US Gabapentin Study Group. Gabapentin as add-on therapy in refractory partial epilepsy: a double blind, placebo-controlled, parallel-group study. Neurology. 1993; 43:2292-8. (IDIS 321974) [IDIS 321974] [PubMed 8232945]



10. Suman-Chauhan N, Webdale L, Hill DR et al. Characterisation of [3H] gabapentin binding to a novel site in rat brain: homogenate binding studies. Eur J Pharmacol. 1993; 244:293-301.



11. Hill DR, Suman-Chauhan N, Woodruff GN. Localization of [3H] gabapentin to a novel site in rat brain: autoradiogaphic studies. Eur J Pharmacol. 1993; 244: 303-9. [PubMed 8384571]



12. Anhut H, Leppik I, Schmidt B et al. Drug interaction study of the new anticonvulsant gabapentin with phenytoin in epileptic patients. Naunyn- Schmiedeberg Arch Pharmacol. 1988; 337(Suppl):R127. Abstract No. 507.



13. Graves NM, Leppik IE, Wagner ML et al. Effect of gabapentin on carbamazepine levels. Epilepsia. 1990; 31:644. Abstract.



14. Uthman BM, Hammond EJ, Wilder BJ. Absence of gabapentin and valproate interaction: an evoked potential and pharmacokinetic study. Epilepsia. 1990; 31:645. Abstract.



15. Hooper WD, Kavanagh MC, Herkes GK et al. Lack of a pharmacokinetic interaction between phenobarbitone and gabapentin. Br J Clin Pharmacol. 1991; 31:171-4. [IDIS 277831] [PubMed 2049232]



16. Parke-Davis, Morris Plains, NJ: Personal communication.



17. Taylor CP. Mechanism of action of new anti-epileptic drugs. In: Chadwick D, ed. New trends in epilepsy management: the role of gabapentin. London: Royal Society of Medicine Services Ltd; 1993:13-40.



18. Appleton R, Fichtner K, LaMoreaux L et al. Gabapentin as add-on therapy in children with refractory partial seizures: a 12-week, multicentre, double-blind, placebo-controlled study. Epilepsia. 1999; 40:1147-54. [IDIS 432135] [PubMed 10448830]



19. Pfizer, Morris Plains, NJ: Personal communication.



20. Rose MA, Kam PCA. Gabapentin: pharmacology and its use in pain management. Anaesthesia. 2002; 57:451-62. [IDIS 483415] [PubMed 11966555]



21. Tremont-Lukats IW, Megeff C, Backonja MM. Anticonvulsants for neuropathic pain syndromes. Drugs. 2000; 60:1029-1052. [PubMed 11129121]



22. Ross EL. The evolving role of antiepileptic drugs in treating neuropathic pain. Neurology. 2000; 55(supp 1):S41-S46. [IDIS 453200] [PubMed 11001361]



23. Wiffen P, Collins S, McQuay H et al. Anticonvulsant drugs for acute and chronic pain (Cochrane Review). In: The Cochrane Library, Issue 3. Oxford, United Kingdom: update software 2002.



24. Backonja MM. Use of anticonvulsants for treatment of neuropathic pain. Neurology. 2002; 59(suppl 2):S14-S17.



25. Backonja M, Beydoun A, Edwards KR et al. Gabapentin for the symptomatic treatment of painful neuropathy in patients with diabetes mellitus. JAMA. 1998; 280:1831-6. [IDIS 418038] [PubMed 9846777]



26. Garcia-Borreguero D, Larrosa O, de la Llave Y, et al. Treatment of restless legs syndrome with gabapentin. Neurology. 2002;59:1573-79.



27. Happe S, Klosch G, Saletu, et al. Treatment of restless legs syndrome (RLS) with gabapentin. Neurology. 2001;57:1717-19.



28. Thorp MK, Morris DC, Bagby SP. A crossover study of gabapentin in treatment of restless legs syndrome among hemodialysis patients. Am J of Kidney Diseases. 2001;38:104-8.



29. Luer MS, Hamani C, Dujovny M et al. Saturable transport of gabapentin at the blood-brain barrier. Neurol Res. 1999; 21:559-62. [PubMed 10491815]



30. Pandya KJ, Morrow GR, Roscoe JA et al. Gabapentin for hot flashes in 420 women with breast cancer: a randomised double-blind placebo-controlled trial. Lancet. 2005;366:818-24.



31. Guttuso T, Kurlan R, McDermott MP, Kieburtz K. Gabapentin’s effects on hot flashes in postmenopausal women: a randomized controlled trial. Obstet Gynecol. 2003;101:337-45.



32. Jeffery SM, Pepe JJ, Popovich LM et al. Gabapentin for hot flashes in prostate cancer. Ann Pharmacother. 2002; 36:433-6. [IDIS 477342] [PubMed 11895055]



33. Stearns V. Management of hot flashes in breast cancer survivors and men with prostate cancer. Curr Oncol Rep. 2004; 6:285-90. [PubMed 15161582]



34. Fugate SE, Church CO. Nonestrogen treatment modalities for vasomotor symptoms associated with menopause. Ann Pharmacother. 2004; 38:1482-99. [IDIS 528920] [PubMed 15292498]



35. Loprinzi CL, Kugler JW, Sloan JA et al. Venlafaxine in management of hot flashes in survivors of breast cancer: a randomized controlled trial. Lancet. 2000; 356:2059-63. [IDIS 459837] [PubMed 11145492]



36. Reviewers’ comments (personal observations).



37. North American Menopause Society. Treatment of menopause-associated vasomotor symptoms: position statement of the North American Menopause Society. Menopause. 2004; 11:11-33. [PubMed 14716179]



38. Rice AS, Maton S, . Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain. 2001; 94:215-24. [PubMed 11690735]



39. Rowbotham M, Harden N, Stacey B et al. Gabapentin for the treatment of postherpetic neuralgia: a randomized controlled trial. JAMA. 1998; 280:1837-42. [PubMed 9846778]



40. Wiffen PJ, McQuay HJ, Edwards JE et al. Gabapentin for acute and chronic pain. Cochrane Database Syst Rev. 2005; 3:CD005452. [PubMed 16034978]



41. Gorson KC, Schott C, Herman R, Ropper AH. Gabapentin in the treatment of painful diabetic neuropathy: a placebo controlled, double blind, crossover trial. J Neurol Neurosurg Psychiatry. 1999; 66 :251-2. (Letter) [PubMed 10071116]



42. Pérez HE, Sánchez GF. Gabapentin therapy for diabetic neuropathic pain. Am J Med. 2000; 108; 689. (Letter)



43. Simpson DA. Gabapentin and venlafaxine for the treatment of painful diabetic neuropathy. J Clin Neuromusc Dis. 2001; 3:53-62.



44. Dallocchio C, Buffa C, Mazzarello P et al. Gabapentin vs. amitriptyline in painful diabetic neuropathy: an open-label pilot study. J Pain Symptom Manage. 2000; 20:280-5. [PubMed 11027910]



45. Morello CM, Leckband SG, Stoner CP et al. Randomized double-blind study comparing the efficacy of gabapentin with amitriptyline on diabetic peripheral neuropathy pain. Arch Intern Med. 1999; 159:1931-7. [PubMed 10493324]



46. Khan OA. Gabapentin relieves trigeminal neuralgia in multiple sclerosis patients. Neurology. 1998; 51:611-4. [PubMed 9710050]



47. Cheshire WP. Defining the role for gabapentin in the treatment of trigeminal neuralgia: a retrospective study. J Pain. 2002; 3:137-42. [PubMed 14622800]



48. Solaro C, Lunardi GL, Capello E et al. An open-label trial of gabapentin treatment of paroxysmal symptoms in multiple sclerosis patients. Neurology. 1998; 51:609-11. [PubMed 9710049]



49. Yetimalar Y, Gürgör N, Basoglu M. Clinical efficacy of gabapentin for paroxysmal symptoms in multiple sclerosis. Acta Neurol Scand. 2004; 109; 430-1. (Letter) [PubMed 15147470]



50. Hahn K, Arendt G, Braun JS et al. A placebo-controlled trial of gabapentin for painful HIV-associated sensory neuropathies. J Neurol. 2004; 251:1260-6. [PubMed 15503108]



51. Caraceni A, Zecca E, Bonezzi C et al. Gabapentin for neuropathic cancer pain: a randomized controlled trial from the Gabapentin Cancer Pain Study Group. J Clin Oncol. 2004; 22:2909-17. [PubMed 15254060]



52. Serpell MG, . Gabapentin in neuropathic pain syndromes: a randomised, double-blind, placebo-controlled trial. Pain. 2002; 99:557-66. [PubMed 12406532]



53. van der Vusse AC, Stomp-van den Berg SG, Kessels AH, Weber WE. Randomised controlled trial of gabapentin in complex regional pain syndrome type 1. BMC Neurology. 2004. From Bio Med Central website (.)



54. Reddy SY, Warner H, Guttuso T et al. Gabapentin, estrogen, and placebo for treating hot flushes: a randomized controlled trial. Obstet Gynecol. 2006; 108:41-8. [PubMed 16816054]



More Gabapentin resources


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


  • Gabapentin Professional Patient Advice (Wolters Kluwer)

  • Gabapentin Prescribing Information (FDA)

  • Gabapentin MedFacts Consumer Leaflet (Wolters Kluwer)

  • gabapentin Advanced Consumer (Micromedex) - Includes Dosage Information

  • Gralise Consumer Overview

  • Gralise MedFacts Consumer Leaflet (Wolters Kluwer)

  • Gralise Prescribing Information (FDA)

  • Horizant Extended-Release Tablets MedFacts Consumer Leaflet (Wolters Kluwer)

  • Horizant Prescribing Information (FDA)

  • Horizant Consumer Overview

  • Neurontin Prescribing Information (FDA)

  • Neurontin MedFacts Consumer Leaflet (Wolters Kluwer)

  • Neurontin Consumer Overview



Compare Gabapentin with other medications


  • Alcohol Withdrawal
  • Anxiety
  • Benign Essential Tremor
  • Bipolar Disorder
  • Burning Mouth Syndrome
  • Diabetic Nerve Damage
  • Epilepsy
  • Erythromelalgia
  • Fibromyalgia
  • Hiccups
  • Hot Flashes
  • Hyperhidrosis
  • Insomnia
  • Migraine
  • Nausea/Vomiting, Chemotherapy Induced
  • Pain
  • Periodic Limb Movement Disorder
  • Peripheral Neuropathy
  • Persisting Pain, Shingles
  • Postmenopausal Symptoms
  • Pruritus
  • Reflex Sympathetic Dystrophy Syndrome
  • Restless Legs Syndrome
  • Spondylolisthesis
  • Syringomyelia
  • Trigeminal Neuralgia
  • Vulvodynia

Friday, 6 April 2012

pegademase bovine Intramuscular


peg-AD-e-mase BOE-vine


Commonly used brand name(s)

In the U.S.


  • Adagen

Available Dosage Forms:


  • Solution

Therapeutic Class: Immune Stimulant


Pharmacologic Class: Enzyme


Uses For pegademase bovine


Pegademase contains an enzyme called adenosine deaminase (ADA). It is used to treat children who do not have a properly developed immune system because of a lack of ADA in the body.


Pegademase is to be given only by or under the supervision of your doctor.


Before Using pegademase bovine


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 pegademase bovine, the following should be considered:


Allergies


Tell your doctor if you have ever had any unusual or allergic reaction to pegademase bovine 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


Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of pegademase in children.


Geriatric


No information is available on the relationship of age to the effects of pegademase in geriatric patients.


Pregnancy








Pregnancy CategoryExplanation
All TrimestersCAnimal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

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. When you are taking pegademase bovine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.


Using pegademase bovine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.


  • Pentostatin

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 pegademase bovine. Make sure you tell your doctor if you have any other medical problems, especially:


  • Bleeding problems (e.g., thrombocytopenia) or

  • Infections—Use with caution. May make these conditions worse.

  • Thrombocytopenia, severe—Should not be used in patients with this condition.

Proper Use of pegademase bovine


A nurse or other trained health professional will give you or your child pegademase bovine. pegademase bovine is given as a shot into one of your or your child's muscles.


You may be taught how to give pegademase bovine at home. Make sure you understand all instructions before giving yourself or your child an injection. Do not use more medicine or use it more often than your doctor tells you to.


Dosing


The dose of pegademase bovine 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 pegademase bovine. 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 injection dosage form:
    • For treatment of lack of ADA:
      • Children—Dose is based on body weight and must be determined by your doctor. The usual dose is 10 to 20 Units per kilogram (kg) (4.55 to 9.09 Units per pound) of body weight, injected into a muscle once a week. If you are receiving pegademase at home, follow your doctor's orders or the directions on the label. If you have any questions about the proper dose of pegademase, ask your doctor.



Missed Dose


If you miss a dose of pegademase bovine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.


Storage


Store in the refrigerator. Do not freeze.


Keep out of the reach of children.


Do not keep outdated medicine or medicine no longer needed.


Ask your healthcare professional how you should dispose of any medicine you do not use.


Throw away used needles in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.


Precautions While Using pegademase bovine


It is very important that your doctor check you or your child's progress at regular visits to make sure that pegademase bovine is working properly. Blood tests may be needed to check for unwanted effects.


It is very important that you or your child should continue to receive treatment with pegademase. Treatment must be continued for life. Do not stop treatment with pegademase without checking with your doctor. If regular treatment is not continued, the immune system will break down and serious infections may occur.


pegademase bovine 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 immediately if any of the following side effects occur:


Incidence not known
  • Back, leg, or stomach pains

  • bleeding gums

  • chills

  • dark urine

  • difficulty breathing

  • dizziness

  • fever

  • general body swelling

  • headache

  • loss of appetite

  • nausea or vomiting

  • nosebleeds

  • pain, warmth, or burning in the fingers, toes, and legs

  • pale skin

  • problems with vision or hearing

  • sore throat

  • unusual tiredness or weakness

  • yellowing of the eyes or skin

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:


Incidence not known
  • Hives or welts

  • itching

  • redness of skin

  • redness or pain at the site of injection

  • skin rash

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: pegademase bovine Intramuscular side effects (in more detail)



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Thursday, 5 April 2012

Indapamide



Pronunciation: in-DAP-a-mide
Generic Name: Indapamide
Brand Name: Lozol


Indapamide is used for:

Treating high blood pressure alone or along with other medicines. It is also used to treat salt and water retention (swelling) associated with congestive heart failure.


Indapamide is a diuretic. It works by causing the kidneys to eliminate large amounts of water and salts.


Do NOT use Indapamide if:


  • you are allergic to any ingredient in Indapamide or to a sulfonamide medicine (eg, sulfamethoxazole)

  • you are unable to urinate

  • you are taking ketanserin

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



Before using Indapamide:


Some medical conditions may interact with Indapamide. 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 heart problems (eg, irregular heartbeat, heart failure), liver problems (eg, cirrhosis), kidney disease, gout, lupus, problems urinating, or swelling

  • if you have severe or persistent vomiting, or low blood levels of sodium or potassium, or if you are on a low-salt (sodium) diet

  • if you have had a certain neurosurgical procedure (sympathectomy)

  • if you are receiving fluids through a vein (parenteral fluids)

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


  • Nonsteroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen) because they may decrease Indapamide's effectiveness

  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril) because the risk of kidney problems may be increased

  • Diazoxide because the risk of high blood glucose levels, high uric acid levels, or low blood pressure may be increased

  • Adrenocorticotropin hormone (ACTH) or corticosteroids (eg, prednisone) because they may increase the risk of Indapamide's side effects

  • Amantadine, antineoplastic agents (eg, cyclophosphamide), digitalis glycosides (eg, digoxin), ketanserin, lithium, or other blood pressure medicines because the risk of their side effects may be increased by Indapamide

This may not be a complete list of all interactions that may occur. Ask your health care provider if Indapamide 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 Indapamide:


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


  • Take Indapamide by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.

  • Indapamide may increase the amount of urine or cause you to urinate more often when you first start taking it. To keep this from disturbing your sleep, try to take your dose before 6 pm.

  • If you miss a dose of Indapamide and you are taking 1 dose daily, take the missed dose if you remember the same day. Skip the missed dose if you do not remember until the next day. Do not take 2 doses at once.

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



Important safety information:


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

  • Indapamide may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

  • Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.

  • Your doctor may check your blood electrolytes while you take Indapamide to check for a fluid or electrolyte imbalance. Tell your doctor right away if you experience decreased urination; dry mouth; fainting; fast or irregular heartbeat; increased thirst; muscle pain, weakness, or cramping; restlessness; severe dizziness or drowsiness; stomach problems; or unusual tiredness or weakness.

  • Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.

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

  • Tell your doctor or dentist that you take Indapamide before you receive any medical or dental care, emergency care, or surgery.

  • Diabetes patients - Indapamide may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.

  • Indapamide may interfere with certain lab tests. Be sure your doctor and lab personnel know you are taking Indapamide.

  • Lab tests, including blood electrolyte, glucose, and uric acid levels, and kidney function, may be performed while you use Indapamide. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.

  • Use Indapamide with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium or potassium.

  • Indapamide should be used with extreme caution in CHILDREN; safety and effectiveness in 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 Indapamide while you are pregnant. It is not known if Indapamide is found in breast milk. Do not breast-feed while taking Indapamide.


Possible side effects of Indapamide:


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:



Back pain; constipation; diarrhea; dizziness or lightheadedness when siting up or standing; drowsiness; headache; nausea; nervousness; runny nose; 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); blurred vision; chest pain; dark urine; decreased urination or urination problems; dry mouth; fainting; fast heartbeat; fatigue; fever, chills, cough, or sore throat; increased thirst; loss of appetite; numbness of the hands or feet; pale stools; red, swollen, blistered, or peeling skin; severe or persistent dizziness, drowsiness, or lightheadedness; severe stomach pain; swelling of the hands, ankles, or feet; symptoms of low blood potassium (eg, irregular heartbeat; muscle pain, weakness, or cramping); symptoms of low blood sodium (eg, confusion, mental or mood changes, seizures, sluggishness); unusual bruising or bleeding; unusual tiredness or 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: Indapamide 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 nausea; vomiting; weakness.


Proper storage of Indapamide:

Store Indapamide at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Indapamide out of the reach of children and away from pets.


General information:


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

  • Indapamide 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 Indapamide. 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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  • indapamide Advanced Consumer (Micromedex) - Includes Dosage Information

  • Lozol Prescribing Information (FDA)



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