Sample PLR Content Marketing Louisiana: Zoloft

Generic Name: sertraline (Oral route)

SER-tra-leen hye-droe-KLOR-ide

Oral route(Solution;Tablet)

Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults with major depressive disorder (MDD) and other psychiatric disorders in short-term studies. Short term studies did not show an increase in the risk of suicidality with antidepressants compared with placebo in adults beyond age 24, and there was a reduction in risk with antidepressants compared with placebo in adults aged 65 and older. This risk must be balanced with the clinical need. Monitor patients closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Sertraline hydrochloride is not approved for use in pediatric patients except for patients with obsessive compulsive disorder (OCD) .

Commonly used brand name(s)

In the U.S.

Zoloft

Available Dosage Forms:

Tablet

Solution

Capsule

Therapeutic Class: Antidepressant

Pharmacologic Class: Sertraline

Uses For Zoloft

Sertraline is used to treat mental depression, obsessive-compulsive disorder (OCD), panic disorder, premenstrual dysphoric disorder (PMDD), posttraumatic stress disorder (PTSD), and social anxiety disorder (SAD).

Sertraline belongs to a group of medicines known as selective serotonin reuptake inhibitors (SSRIs). These medicines are thought to work by increasing the activity of the chemical called serotonin in the brain.

This medicine is available only with your doctor's prescription.

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems. Although these uses are not included in product labeling, sertraline is used in certain patients with the following medical conditions:

Premature ejaculation.

Before Using Zoloft

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

Appropriate studies have not been performed on the relationship of age to the effects of sertraline in the pediatric population. Safety and efficacy have not been established.

Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of sertraline for the treatment of obsessive-compulsive disorder in children. However, safety and efficacy have not been established in children younger than 6 years of age.

Geriatric

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of sertraline in the elderly. However, elderly patients may be more sensitive to the effects of this medicine than younger adults, and are more likely to have hyponatremia (low sodium in the blood), which may require caution and an adjustment in the dose for patients receiving sertraline.

Pregnancy

	Pregnancy Category	Explanation
All Trimesters	C	Animal 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

Studies in women suggest that this medication poses minimal risk to the infant when used during 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 this medicine, 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 this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Clorgyline

Furazolidone

Iproniazid

Isocarboxazid

Levomethadyl

Linezolid

Methylene Blue

Moclobemide

Nialamide

Pargyline

Phenelzine

Pimozide

Procarbazine

Selegiline

Toloxatone

Tranylcypromine

Using this medicine 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.

Abciximab

Aceclofenac

Acemetacin

Acenocoumarol

Alclofenac

Almotriptan

Amitriptyline

Amoxapine

Ancrod

Anisindione

Antithrombin III Human

Apazone

Ardeparin

Aspirin

Astemizole

Benoxaprofen

Bivalirudin

Bromfenac

Bufexamac

Carprofen

Certoparin

Cilostazol

Citalopram

Clometacin

Clomipramine

Clonixin

Clopidogrel

Dalteparin

Danaparoid

Defibrotide

Dermatan Sulfate

Desipramine

Desirudin

Desvenlafaxine

Dexfenfluramine

Dexketoprofen

Dextromethorphan

Diclofenac

Dicumarol

Diflunisal

Dipyridamole

Dipyrone

Dothiepin

Doxepin

Droperidol

Droxicam

Duloxetine

Eletriptan

Enoxaparin

Eptifibatide

Erythromycin

Escitalopram

Etodolac

Etofenamate

Felbinac

Fenbufen

Fenfluramine

Fenoprofen

Fentanyl

Fentiazac

Flecainide

Floctafenine

Flufenamic Acid

Fluoxetine

Flurbiprofen

Fluvoxamine

Fondaparinux

Frovatriptan

Heparin

Ibuprofen

Imipramine

Indomethacin

Indoprofen

Isoxicam

Ketoprofen

Ketorolac

Lofepramine

Lornoxicam

Magnesium Salicylate

Meclofenamate

Mefenamic Acid

Meloxicam

Milnacipran

Nabumetone

Nadroparin

Naproxen

Naratriptan

Nepafenac

Niflumic Acid

Nimesulide

Nortriptyline

Oxaprozin

Oxycodone

Oxyphenbutazone

Parnaparin

Paroxetine

Pentosan Polysulfate Sodium

Phenindione

Phenprocoumon

Phenylbutazone

Pirazolac

Piroxicam

Pirprofen

Prasugrel

Propyphenazone

Proquazone

Protriptyline

Rasagiline

Reviparin

Rizatriptan

Salicylic Acid

Salsalate

Sertraline

Sibutramine

St John's Wort

Sulindac

Sumatriptan

Suprofen

Tamoxifen

Tapentadol

Tenidap

Tenoxicam

Terfenadine

Tiaprofenic Acid

Ticlopidine

Tinzaparin

Tirofiban

Tolmetin

Tramadol

Trimipramine

Tryptophan

Vilazodone

Warfarin

Zolmitriptan

Zomepirac

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Alprazolam

Bupropion

Carbamazepine

Cimetidine

Clozapine

Darunavir

Efavirenz

Fluphenazine

Fosphenytoin

Ginkgo

Lamotrigine

Lithium

Metoclopramide

Phenytoin

Propafenone

Propranolol

Rifampin

Zolpidem

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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following may cause an increased risk of certain side effects but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

Grapefruit Juice

Proper Use of Zoloft

Take this medicine only as directed by your doctor, to benefit your condition as much as possible. Do not take more of it, do not take it more often, and do not take it for a longer time than your doctor ordered.

This medicine should come with a Medication Guide. It is very important that you read and understand this information. Be sure to ask your doctor about anything you do not understand.

Sertraline tablets may be taken with or without food on a full or empty stomach. This medicine should be taken once a day in the morning or at night. If your doctor tells you to take it a certain way, follow your doctor's instructions. .

If you are taking the oral liquid form of this medicine, use the dropper to get your dose and mix it with 1/2 cup (4 ounces) of water, ginger ale, lemon-lime soda, lemonade, or orange juice. Do not mix this medicine with any other liquid. Drink it right away after mixing. Do not mix the medicine with the liquid until you are ready to take your dose. It is okay if the mixture looks hazy.

You may have to take sertraline for 4 weeks or longer before you begin to feel better. Your doctor should check your progress at regular visits during this time. Also, if you are taking this medicine for depression, you may need to keep taking it for 6 months or longer to help prevent the return of the depression.

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 oral dosage forms (solution or tablets):
- For mental depression:
  - Adults—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For obsessive-compulsive disorder:
  - Adults and teenagers—At first, 50 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg per day.
  - Children 6 to 12 years of age—At first, 25 mg once a day, taken either in the morning or evening. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg per day.
  - Children younger than 6 years of age—Use and dose must be determined by your doctor.
- For panic disorder, posttraumatic stress disorder, or social anxiety disorder:
  - Adults—At first, 25 milligrams (mg) once a day, taken either in the morning or evening. Your doctor may gradually increase your dose as needed. However, the dose is usually not more than 200 mg per day.
  - Children—Use and dose must be determined by your doctor.
- For premenstrual dysphoric disorder:
  - Adults—At first, 50 milligrams (mg) once a day throughout your menstrual cycle or just during the premenstrual time. Your doctor may increase your dose as needed. However, the dose is usually not more than 150 mg per day throughout your menstrual cycle or 100 mg per day if you are only taking it during your premenstrual time.
  - Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, 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 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.

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

Precautions While Using Zoloft

It is very important that your doctor check your or your child's progress at regular visits. This is to allow for changes in your dose and to help reduce any side effects.

Do not use this medicine if you have used an MAO inhibitor (MAOI) such as isocarboxazid (Marplan®), phenelzine (Nardil®), selegiline (Eldepryl®), or tranylcypromine (Parnate®) within the past 14 days. You should not use pimozide (Orap®) while you are taking this medicine. Do not use the oral liquid form of sertraline if you are also using disulfiram (Antabuse®). Using these medicines together can cause serious problems.

For some children, teenagers, and young adults, this medicine can increase thoughts of suicide. Tell your doctor or your child's doctor right away if you or your child start to feel more depressed and have thoughts about hurting yourselves. Report any unusual thoughts or behaviors that trouble you or your child, especially if they are new or get worse quickly. Make sure the doctor knows if you or your child have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you or your child have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. Let the doctor know if you, your child, or anyone in your family has bipolar disorder (manic-depressive) or has tried to commit suicide.

Make sure your doctor knows about all the other medicines you or your child are using. Sertraline may cause serious conditions called serotonin syndrome and neuroleptic malignant syndrome (NMS)-like reactions when taken with some medicines. Do not use sertraline with linezolid (Zyvox®), lithium, tryptophan, St. John's wort, or some pain or migraine medicines (e.g., tramadol [Ultram®], rizatriptan [Maxalt®], sumatriptan [Imitrex®], or zolmitriptan [Zomig®]). Check with your doctor first before taking any other medicines.

Sertraline may increase your risk for bleeding problems. Make sure your doctor knows if you or your child are also using other medicines that thin the blood, such as aspirin, pain or arthritis medicines, sometimes called “NSAIDs” (e.g., celecoxib, ibuprofen, naproxen, rofecoxib, valdecoxib, Advil®, Aleve®, Celebrex®, Motrin®, or Vioxx®), or warfarin (Coumadin®).

This medicine may cause hyponatremia (low sodium in the blood). This is more common in elderly patients, those who are taking diuretic medicines for high blood pressure, or those who have decreased amounts of fluid in the body due to severe diarrhea or vomiting. Stop taking this medicine and check with your doctor right away if you or your child have headache, trouble concentrating, memory problems, confusion, weakness, or unsteadiness.

This medicine may affect blood sugar levels, which is especially important if you or your child has diabetes. If you or your child notice a change in the results of your blood or urine sugar tests or if you have any questions, check with your doctor.

Sertraline has not been shown to add to the effects of alcohol. However, use of alcohol is not recommended in patients who are taking sertraline. .

This medicine may cause some people to become drowsy, to have trouble thinking, or to have problems with movement. Make sure you know how you react to this medicine before you drive, use machines, or do anything else that could be dangerous if you are not alert or well-coordinated.

The dropper dispenser contains dry natural rubber (a derivative of latex), which may cause allergic reactions in people who are sensitive to latex. Tell your doctor if you or your child has a latex allergy before you start using this medicine.

Do not stop taking this medicine without checking first with your doctor. Your doctor may want you to gradually reduce the amount you are taking before stopping it completely. This is to decrease the chance of having side effects such as agitation, anxiety, dizziness, a feeling of constant movement of self or surroundings, headache, increased sweating, nausea, trembling or shaking, trouble with sleeping or walking, or unusual tiredness when you stop the medicine.

Before you have any medical tests, tell the medical doctor in charge that you or your child are taking this medicine. The results of some tests may be affected by this medicine.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Zoloft 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:

More common

Decreased sexual desire or ability

failure to discharge semen (in men)

Less common or rare

Aggressive reaction

breast tenderness or enlargement

confusion

convulsions

diarrhea

drowsiness

dryness of the mouth

fast talking and excited feelings or actions that are out of control

fast, pounding, irregular, or slow heartbeat

fever

inability to sit still

increase in body movements

increased sweating

increased thirst

lack of energy

loss of bladder control

mood or behavior changes

muscle spasm or jerking of all extremities

nosebleeds

overactive reflexes

racing heartbeat

red or purple spots on the skin

restlessness

shivering

skin rash, hives, or itching

sudden loss of consciousness

unusual or sudden body or facial movements or postures

unusual secretion of milk (in females)

Incidence not known

Abdominal or stomach pain

bleeding gums

blindness

blistering, peeling, or loosening of the skin

bloating

blood in the urine

bloody, black, or tarry stools

blue-yellow color blindness

blurred vision

chest pain or discomfort

chills

clay-colored stools

coma

cough or hoarseness

darkened urine

decreased urine output

decreased vision

depressed mood

difficulty with breathing

difficulty with speaking

difficulty with swallowing

drooling

dry skin and hair

eye pain

fainting

feeling cold

feeling of discomfort

feeling that others are watching you or controlling your behavior

feeling that others can hear your thoughts

feeling, seeing, or hearing things that are not there

fixed position of the eye

general feeling of discomfort, illness, tiredness, or weakness

hair loss

high fever

high or low blood pressure

hoarseness or husky voice

hostility

increased clotting times

indigestion

inflammation of the joints

irritability

joint or muscle pain

large, hive-like swelling on the face, eyelids, lips, tongue, throat, hands, legs, feet, or sex organs

lethargy

light-colored stools

lightheadedness

loss of appetite

loss of balance control

loss of bladder control

lower back or side pain

muscle aches

muscle cramps and stiffness

muscle trembling, jerking, or stiffness

muscle twitching

painful or difficult urination

pains in the stomach, side, or abdomen, possibly radiating to the back

pale skin

puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue

rapid weight gain

rash

red skin lesions often with a purple center

red, irritated eyes

redness, soreness, or itching skin

right upper abdominal or stomach pain and fullness

severe mood or mental changes

severe muscle stiffness

shortness of breath

shuffling walk

sore throat

sores, ulcers, or white spots in the mouth or on the lips

sores, welting, or blisters

stiffness of the limbs

stupor

sweating

swelling of the face, ankles, or hands

swollen lymph glands

swollen or painful glands

talking or acting with excitement you cannot control

tightness in the chest

troubled breathing

twisting movements of the body

twitching

uncontrolled movements, especially of the face, neck, and back

unexplained bleeding or bruising

unpleasant breath odor

unusual behavior

unusual tiredness or weakness

vomiting of blood

weight gain

wheezing

yellow eyes and skin

Get emergency help immediately if any of the following symptoms of overdose occur:

Symptoms of overdose - May be more severe than side effects occurring at regular doses or several may occur together.

Actions that are out of control

agitation

anxiety

change in consciousness

confusion as to time or place or person

constipation

darkened urine

decreased awareness or responsiveness

dizziness or fainting

drowsiness

headache

holding false beliefs that cannot be changed by fact

loss of consciousness

nausea

pounding in the ears

severe sleepiness

shakiness in the legs, arms, hands, or feet

sweating

trembling or shaking of the hands or feet

unusual excitement or restlessness

unusual tiredness or weakness

unusually fast heartbeat

unusually large pupils

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

More common

Acid or sour stomach

belching

decreased appetite or weight loss

diarrhea or loose stools

heartburn

sleepiness or unusual drowsiness

stomach or abdominal cramps, gas, or pain

trouble with sleeping

Less common

Agitation, anxiety, or nervousness

bladder pain

burning, crawling, itching, numbness, prickling, "pins and needles", or tingling feelings

changes in vision

cloudy urine

constipation

difficult, burning, or painful urination

flushing or redness of the skin, with feeling of warmth or heat

frequent urge to urinate

increased appetite

pain or tenderness around the eyes and cheekbones

stuffy or runny nose

Incidence not known

Flushed, dry skin

fruit-like breath odor

increased hunger

increased urination

redness or other discoloration of the skin

severe sunburn

swelling of the breasts (in women)

unexplained weight loss

unusual secretion of milk (in women)

After you stop using this medicine, it may still produce some side effects that need attention. During this period of time, check with your doctor immediately if you notice the following side effects:

Abnormal dreams

electric shock sensations

failure to discharge semen (in men)

feeling of constant movement of self or surroundings

trouble with walking

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: Zoloft side effects (in more detail)

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More Zoloft resources

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

Zoloft Prescribing Information (FDA)

Zoloft Consumer Overview

Zoloft Monograph (AHFS DI)

Zoloft MedFacts Consumer Leaflet (Wolters Kluwer)

Sertraline Prescribing Information (FDA)

Compare Zoloft with other medications

Depression
Obsessive Compulsive Disorder
Panic Disorder
Post Traumatic Stress Disorder
Postpartum Depression
Premenstrual Dysphoric Disorder
Social Anxiety Disorder

Sample PLR Content Marketing Louisiana

Thursday, October 13, 2016

Zoloft