Are you suffering from paresthesia, Tingling, Itching, Numbness? Answer is here…

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Are you suffering from paresthesia, Tingling, Itching, Numbness Duloxetine is a medication mostly used for major depressive disorder, generalized anxiety disorder, fibromyalgia and neuropathic pain.

It is a thiophene derivative and a selective neurotransmitter reuptake inhibitor for serotonin, norepinephrine, and to a lesser degree dopamine. It belongs to a class of heterocyclic antidepressants known as serotonin–norepinephrine reuptake inhibitors (SNRIs) .Image result for duloxetine

Major Depressive Disorder

Approximately 8.4% (319/3779) of the patients who received CYMBALTA in placebo-controlled trials for MDD discontinued treatment due to an adverse reaction, compared with 4.6% (117/2536) of the patients receiving placebo. Nausea (CYMBALTA 1.1%, placebo 0.4%) was the only common adverse reaction reported as a reason for discontinuation and considered to be drug-related (i.e., discontinuation occurring in at least 1% of the CYMBALTA-treated patients and at a rate of at least twice that of placebo).

Generalized Anxiety Disorder

Approximately 13.7% (139/1018) of the patients who received CYMBALTA in placebo-controlled trials for GAD discontinued treatment due to an adverse reaction, compared with 5.0% (38/767) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (CYMBALTA 3.3%, placebo 0.4%), and dizziness (CYMBALTA 1.3%, placebo 0.4%).

Diabetic Peripheral Neuropathic Pain

Approximately 12.9% (117/906) of the patients who received CYMBALTA in placebo-controlled trials for DPNP discontinued treatment due to an adverse reaction, compared with 5.1% (23/448) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (CYMBALTA 3.5%, placebo 0.7%), dizziness (CYMBALTA 1.2%, placebo 0.4%), and somnolence (CYMBALTA 1.1%, placebo 0.0%).

Fibromyalgia

Approximately 17.5% (227/1294) of the patients who received CYMBALTA in 3 to 6 month placebo-controlled trials for FM discontinued treatment due to an adverse reaction, compared with 10.1% (96/955) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (CYMBALTA 2.0%, placebo 0.5%), headache (CYMBALTA 1.2%, placebo 0.3%), somnolence (CYMBALTA 1.1%, placebo 0.0%), and fatigue (CYMBALTA 1.1%, placebo 0.1%).

Chronic Pain due To Osteoarthritis

Approximately 15.7% (79/503) of the patients who received CYMBALTA in 13-week, placebo-controlled trials for chronic pain due to OA discontinued treatment due to an adverse reaction, compared with 7.3% (37/508) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (CYMBALTA 2.2%, placebo 1.0%).

Chronic Low Back Pain

Approximately 16.5% (99/600) of the patients who received CYMBALTA in 13-week, placebo-controlled trials for CLBP discontinued treatment due to an adverse reaction, compared with 6.3% (28/441) for placebo. Common adverse reactions reported as a reason for discontinuation and considered to be drug-related (as defined above) included nausea (CYMBALTA 3.0%, placebo 0.7%), and somnolence (CYMBALTA 1.0%, placebo 0.0%).

Most Common Adult Adverse Reactions

Pooled Trials For All Approved Indications

The most commonly observed adverse reactions in CYMBALTA-treated patients (incidence of at least 5% and at least twice the incidence in placebo patients) were nausea, dry mouth, somnolence, constipation, decreased appetite, and hyperhidrosis.

Diabetic Peripheral Neuropathic Pain

The most commonly observed adverse reactions in CYMBALTA-treated patients (as defined above) were nausea, somnolence, decreased appetite, constipation, hyperhidrosis, and dry mouth.

Fibromyalgia

The most commonly observed adverse reactions in CYMBALTA-treated patients (as defined above) were nausea, dry mouth, constipation, somnolence, decreased appetite, hyperhidrosis, and agitation.

Chronic Pain Due To Osteoarthritis

The most commonly observed adverse reactions in CYMBALTA-treated patients (as defined above) were nausea, fatigue, constipation, dry mouth, insomnia, somnolence, and dizziness.

Chronic Low Back Pain

The most commonly observed adverse reactions in CYMBALTA-treated patients (as defined above) were nausea, dry mouth, insomnia, somnolence, constipation, dizziness, and fatigue.

Adverse Reactions Occurring At An Incidence Of 5% Or More Among CYMBALTA-Treated Patients In Adult Placebo-Controlled Trials

Table 2 gives the incidence of treatment-emergent adverse reactions in placebo-controlled trials for approved indications that occurred in 5% or more of patients treated with CYMBALTA and with an incidence greater than placebo.

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Adverse ReactionPercentage of Patients Reporting Reaction
CYMBALTA
(N=8100)
Placebo
(N=5655)
Nausea238
Headache1412
Dry mouth135
Somnolence103
Fatigue95
Insomnia95
Constipation94
Dizziness95
Diarrhea96
Decreased appetite72
Hyperhidrosis61
Abdominal pain54
a The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.
b Also includes asthenia.
c Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD
studies which did not have a placebo lead-in period or dose titration.
d Also includes initial insomnia, middle insomnia, and early morning awakening.
e Also includes hypersomnia and sedation.
f Also includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, and gastrointestinal pain.

 

Adverse Reactions Occurring At An Incidence Of 2% Or More Among CYMBALTA-Treated Patients In Adult Placebo-Controlled Trials

Pooled MDD And GAD Trials

Table 3 gives the incidence of treatment-emergent adverse reactions in MDD and GAD placebo-controlled trials for approved indications that occurred in 2% or more of patients treated with CYMBALTA and with an incidence greater than placebo.

Treatment-Emergent Adverse Reactions

System Organ Class /
Adverse Reaction
Percentage of Patients Reporting Reaction
CYMBALTA
(N=4797)
Placebo
(N=3303)
Cardiac Disorders
Palpitations21
Eye Disorders
Vision blurred31
Gastrointestinal Disorders
Nausea238
Dry mouth146
Constipation94
Diarrhea96
Abdominal pain54
Vomiting42
General Disorders and Administration Site Conditions
Fatigue95
Metabolism and Nutrition Disorders
Decreased appetite62
Nervous System Disorders
Headache1414
Dizziness95
Somnolence93
Tremor31
Psychiatric Disorders
Insomnia95
Agitation42
Anxiety32
Reproductive System and Breast Disorders
Erectile dysfunction41
Ejaculation delayed21
Libido decreased31
Orgasm abnormal2<1
Respiratory, Thoracic, and Mediastinal Disorders
Yawning2<1
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis62
a The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.
c For GAD, there were no adverse events that were significantly different between treatments in adults ≥65 years that were also not significant in the adults <65 years.
c Events for which there was a significant dose-dependent relationship in fixed-dose studies, excluding three MDD studies which did not have a placebo lead-in period or dose titration.
d Also includes abdominal pain upper, abdominal pain lower, abdominal tenderness, abdominal discomfort, and gastrointestinal pain
e Also includes asthenia
f Also includes hypersomnia and sedation
g Also includes initial insomnia, middle insomnia, and early morning awakening
h Also includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity
i Also includes loss of libido
j Also includes anorgasmia

 

DPNP, FM, OA, And CLBP

Table 4 gives the incidence of treatment-emergent adverse events that occurred in 2% or more of patients treated with CYMBALTA (determined prior to rounding) in the premarketing acute phase of DPNP, FM, OA, and CLBP placebo-controlled trials and with an incidence greater than placebo.

System Organ Class /
Adverse Reaction
Percentage of Patients Reporting Reaction
CYMBALTA
(N=3303)
Placebo
(N=2352)
Gastrointestinal Disorders
Nausea237
Dry Mouth113
Constipation103
Diarrhea95
Abdominal Pain54
Vomiting32
Dyspepsia21
General Disorders and Administration Site Conditions
Fatigue115
Infections and Infestations
Nasopharyngitis44
Upper Respiratory Tract Infection33
Influenza22
Metabolism and Nutrition Disorders
Decreased Appetite81
Musculoskeletal and Connective Tissue
Musculoskeletal Pain33
Muscle Spasms22
Nervous System Disorders
Headache138
Somnolence113
Dizziness95
Paraesthesia22
Tremor2<1
Psychiatric Disorders
Insomnia105
Agitation31
Reproductive System and Breast Disorders
Erectile Dysfunction4<1
Ejaculation Disorder2<1
Respiratory, Thoracic, and Mediastinal Disorders
Cough22
Skin and Subcutaneous Tissue Disorders
Hyperhidrosis61
Vascular Disorders
Flushing31
Blood pressure increased21
a The inclusion of an event in the table is determined based on the percentages before rounding; however, the percentages displayed in the table are rounded to the nearest integer.
b Incidence of 120 mg/day is significantly greater than the incidence for 60 mg/day.
c Also includes abdominal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness and gastrointestinal pain
d Also includes asthenia
e Also includes myalgia and neck pain
f Also includes hypersomnia and sedation
g Also includes hypoaesthesia, hypoaesthesia facial, genital hypoaesthesia and paraesthesia oral
h Also includes initial insomnia, middle insomnia, and early morning awakening.
i Also includes feeling jittery, nervousness, restlessness, tension and psychomotor hyperactivity
j Also includes ejaculation failure
k Also includes hot flush
l Also includes blood pressure diastolic increased, blood pressure systolic increased, diastolic hypertension, essential hypertension, hypertension, hypertensive crisis, labile hypertension, orthostatic hypertension, secondary
hypertension, and systolic hypertension

 

Effects On Male And Female Sexual Function In Adults

Changes in sexual desire, sexual performance and sexual satisfaction often occur as manifestations of psychiatric disorders or diabetes, but they may also be a consequence of pharmacologic treatment. Because adverse sexual reactions are presumed to be voluntarily underreported, the Arizona Sexual Experience Scale (ASEX), a validated measure designed to identify sexual side effects, was used prospectively in 4 MDD placebo-controlled trials. In these trials, as shown in Table 5 below, patients treated with CYMBALTA experienced significantly more sexual dysfunction, as measured by the total score on the ASEX, than did patients treated with placebo. Gender analysis showed that this difference occurred only in males. Males treated with CYMBALTA experienced more difficulty with ability to reach orgasm (ASEX Item 4) than males treated with placebo. Females did not experience more sexual dysfunction on CYMBALTA than on placebo as measured by ASEX total score. Negative numbers signify an improvement from a baseline level of dysfunction, which is commonly seen in depressed patients. Physicians should routinely inquire about possible sexual side effects.

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Table 5: Mean Change in ASEX Scores by Gender in MDD Placebo-Controlled Trials

 

Male PatientsFemale Patients
CYMBALTA
(n=175)
Placebo
(n=83)
CYMBALTA
(n=241)
Placebo
(n=126)
ASEX Total (Items 1-5)0.56b-1.07-1.15-1.07
Item 1 — Sex drive-0.07-0.12-0.32-0.24
Item 2 — Arousal0.01-0.26-0.21-0.18
Item 3 — Ability to achieve erection (men); Lubrication (women)0.03-0.25-0.17-0.18
Item 4 — Ease of reaching orgasm0.40c-0.24-0.09-0.13
Item 5 — Orgasm satisfaction0.09-0.13-0.11-0.17
a n=Number of patients with non-missing change score for ASEX total
b p=0.013 versus placebo
c p<0.001 versus placebo

 

What special precautions should I follow?

Before taking duloxetine,

  • tell your doctor and pharmacist if you are allergic to duloxetine, any other medications, or any of the ingredients in duloxetine delayed-release capsules. Ask your doctor or pharmacist for a list of the ingredients.
  • tell your doctor if you are taking thioridazine or a monoamine oxidase (MAO) inhibitor, such as isocarboxazid (Marplan), linezolid (Zyvox); methylene blue; phenelzine (Nardil), selegiline (Eldepryl, Emsam, Zelapar), and tranylcypromine (Parnate), or if you have stopped taking an MAO inhibitor within the past 14 days. Your doctor will probably tell you not to take duloxetine. If you stop taking duloxetine, you should wait at least 5 days before you start to take an MAO inhibitor.
  • tell your doctor and pharmacist what other prescription and nonprescription medications and vitamins you are taking or plan to take. Be sure to mention any of the following: anticoagulants (‘blood thinners’) such as warfarin (Coumadin, Jantoven); antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Adapin, Sinequan), imipramine (Tofranil), nortriptyline (Aventyl, Pamelor), protriptyline (Vivactil), and trimipramine (Surmontil); antihistamines; aspirin and other nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn); buspirone; cimetidine (Tagamet); diuretics (‘water pills’); fentanyl (Abstral, Actiq, Fentora, Onsolis, others); medications for irregular heartbeat such as amiodarone (Cordarone), flecainide (Tambocor), moricizine (Ethmozine), propafenone (Rythmol), and quinidine (Quinidex); medications for anxiety, high blood pressure, mental illness, pain, and nausea; propranolol (Inderal); medications for migraine headaches such as almotriptan (Axert), eletriptan (Relpax), frovatriptan (Frova), naratriptan (Amerge), rizatriptan (Maxalt), sumatriptan (Imitrex), and zolmitriptan (Zomig); lithium (Eskalith, Lithobid); proton pump inhibitors such as lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), and rabeprazole (Aciphex); quinolone antibiotics such as ciprofloxacin (Cipro) and enoxacin (Penetrex); sedatives; certain selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine (Prozac, Sarafem), fluvoxamine (Luvox) and paroxetine (Paxil); sibutramine (Meridia); sleeping pills; theophylline (Theochron, Theolair); tramadol (Ultram); and tranquilizers. Many other medications may interact with duloxetine, so be sure to tell your doctor about all the medications you are taking, even those that do not appear on this list. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
  • tell your doctor what nutritional supplements and herbal products you are taking, especially products containing St. John’s wort or tryptophan.
  • tell your doctor if you drink or have ever drunk large amounts of alcohol or if you use or have ever used street drugs or have ever overused prescription medications. Also tell your doctor if you have or have ever had a heart attack; high blood pressure; seizures; coronary artery disease (blockage or narrowing of the blood vessels that lead to the heart); or heart, liver, or kidney disease. If you have diabetes, be sure to talk to your doctor about how serious your condition is so your doctor can decide if duloxetine is right for you.
  • tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, or if you plan to become pregnant or are breast-feeding. If you become pregnant while taking duloxetine, call your doctor. Duloxetine may cause problems in newborns following delivery if it is taken during the last months of pregnancy.
  • if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking duloxetine.
  • you should know that duloxetine may make you drowsy, dizzy, or may affect your judgment, thinking or coordination. Do not drive a car or operate machinery until you know how this medication affects you.
  • ask your doctor about the safe use of alcoholic beverages while you are taking duloxetine. Alcohol can increase the risk of serious side effects from duloxetine.
  • you should know that duloxetine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking duloxetine or with an increase in dose. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
  • you should know that duloxetine may cause high blood pressure. You should have your blood pressure checked before starting treatment and regularly while you are taking this medication.
  • you should know that duloxetine may cause angle-closure glaucoma (a condition where the fluid is suddenly blocked and unable to flow out of the eye causing a quick, severe increase in eye pressure which may lead to a loss of vision). Talk to your doctor about having an eye examination before you start taking this medication. If you have nausea, eye pain, changes in vision, such as seeing colored rings around lights, and swelling or redness in or around the eye, call your doctor or get emergency medical treatment right away.
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What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Incidence not known:

  • Abdominal or stomach pain
  • area rash
  • blindness
  • blistering, peeling, or loosening of the skin
  • blurred vision
  • change in consciousness
  • chills
  • clay-colored stools
  • cold sweats
  • confusion
  • convulsions
  • dark urine
  • decreased urine output
  • decreased vision
  • difficulty swallowing
  • dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
  • eye pain
  • fainting
  • fast or irregular heartbeat
  • general tiredness or weakness
  • hives or welts, itching, or skin rash
  • hives, itching, puffiness, or swelling of the eyelids or around the eyes, face, lips, or tongue
  • increased thirst
  • joint or muscle pain
  • large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs
  • light-colored stools
  • loss of consciousness
  • red skin lesions, often with a purple center
  • red, irritated eyes
  • redness of the skin
  • sores, ulcers, or white spots in the mouth or on the lips
  • swelling of the face, ankles, or hands
  • tearing
  • tightness in the chest
  • unpleasant breath odor
  • upper right stomach pain
  • vomiting of blood
  • yellow eyes and skin

If any of the following symptoms of overdose occur while taking duloxetine, get emergency help immediately:

Symptoms of overdose

  • Agitation
  • diarrhea
  • fever
  • loss of bladder control
  • muscle spasm or jerking of all extremities
  • overactive reflexes
  • poor coordination
  • restlessness
  • shivering
  • sleepiness or unusual drowsiness
  • sudden loss of consciousness
  • sweating
  • talking or acting with excitement you cannot control
  • trembling or shaking
  • twitching
  • unusual tiredness or weakness
  • vomiting

Minor Side Effects

Some of the side effects that can occur with duloxetine may not need medical attention. As your body adjusts to the medicine during treatment these side effects may go away. Your health care professional may also be able to tell you about ways to reduce or prevent some of these side effects. If any of the following side effects continue, are bothersome or if you have any questions about them, check with your health care professional:

More common:

  • Body aches or pain
  • cough
  • difficulty having a bowel movement (stool)
  • dry mouth
  • ear congestion
  • frequent urination
  • headache
  • lack or loss of strength
  • loss of appetite
  • loss of voice
  • muscle aches
  • nausea
  • sleepiness or unusual drowsiness
  • sneezing
  • sore throat
  • stuffy or runny nose
  • sweating increased
  • trouble sleeping
  • weight loss
Some side effects can be serious. If you experience any of the following side effects, or those mentioned in the IMPORTANT WARNING or SPECIAL PRECAUTIONs section, call your doctor immediately or get emergency medical treatment
  • unusual bruising or bleeding
  • pain in the upper right part of the stomach
  • swelling of the abdomen
  • itching
  • yellowing of the skin or eyes
  • dark colored urine
  • loss of appetite
  • extreme tiredness or weakness
  • confusion
  • flu-like symptoms
  • fever, sweating, confusion, fast or irregular heartbeat, and severe muscle stiffness
  • fever
  • blisters or peeling skin
  • rash
  • hives
  • difficulty breathing or swallowing
  • swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
  • hoarseness

What should I know about storage and disposal of this medication?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

  • agitation
  • hallucinating (seeing things or hearing voices that do not exist)
  • fast heartbeat
  • fever
  • loss of coordination
  • nausea
  • vomiting
  • diarrhea
  • drowsiness
  • seizures
  • dizziness
  • lightheadedness
  • fainting
  • unresponsiveness
                                                                                    Courtesy by Rx Foundation

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