Syngab 50mg,100mg,200mg caps

(Pregabalin)

pronounced as(pre gab' a lin)

Why is this medication prescribed?

How should this medicine be used?

Other uses for this medicine

What special precautions should I follow?

What special dietary instructions should I follow?

What should I do if I forget a dose?

What side effects can this medication cause?

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

In case of emergency/overdose

What other information should I know?

Brand names

Why is this medication prescribed?

Pregabalin is used to relieve neuropathic pain (pain from damaged nerves) that can occur in your arms, hands, fingers, legs, feet, or toes if you have diabetes or in the area of your rash if you have had shingles (a painful rash that occurs after infection with herpes zoster). It is also used to treat fibromyalgia (a long-lasting condition that may cause pain, muscle stiffness and tenderness, tiredness, and difficulty falling asleep or staying asleep). Pregabalin is used with other medications to treat certain types of seizures in people with epilepsy. Pregabalin is in a class of medications called anticonvulsants. It works by decreasing the number of pain signals that are sent out by damaged nerves in the body.

How should this medicine be used?

Pregabalin comes as a capsule to take by mouth. It is usually taken with or without food two or three times a day. Take pregabalin at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand.

Your doctor will probably start you on a low dose of pregabalin and may gradually increase your dose during the first week of treatment.

Take pregabalin exactly as directed. Pregabalin may be habit forming. Do not take a larger dose, take it more often, or take it for a longer period of time than prescribed by your doctor.

Pregabalin may help control your symptoms but will not cure your condition. It may take several weeks or longer before you feel the full benefit of pregabalin. Continue to take pregabalin even if you feel well. Do not stop taking pregabalin without talking to your doctor, even if you experience side effects such as unusual changes in behavior or mood. If you suddenly stop taking pregabalin, you may experience withdrawal symptoms, including trouble falling asleep or staying asleep, nausea, diarrhea, headaches, or seizures. Your doctor will probably decrease your dose gradually over at least one week.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pregabalin and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs) or the manufacturer's website to obtain the Medication Guide.

Other uses for this medicineReturn to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?Return to top

Before taking pregabalin,

tell your doctor and pharmacist if you are allergic to pregabalin, any other medications, or any of the ingredients in pregabalin capsules. Ask your pharmacist for a list of the ingredients.

tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: angiotensin converting enzyme (ACE) inhibitors such as benazepril (Lotensin, in Lotrel), captopril (Capoten, in Capozide), enalapril (Vasotec, in Vaseretic, Lexxel), fosinopril (Monopril), lisinopril (Prinivil, Zestril, in Prinzide, Zestoretic), moexipril (Univasc, in Uniretic), perindopril (Aceon), quinapril (Accupril, in Accuretic, Quinaretic), ramipril (Altace), and trandolapril (Mavik, in Tarka); antidepressants; antihistamines; medications for anxiety, including lorazepam (Ativan); medications for mental illness or seizures; certain medications for diabetes such as pioglitazone (Actos, in Duetact) and rosiglitazone (Avandia, in Avandaryl, Avandamet); narcotic pain medications, including oxycodone (OxyContin, in Percocet, others); sedatives; sleeping pills; and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

tell your doctor if you drink or have ever drunk large amounts of alcohol, use or have ever used street drugs, or have overused prescription medications. Also tell your doctor if you have or have ever had swelling of the eyes, face, lips, tongue, or throat; problems with your vision, bleeding problems or a low number of platelets (type of blood cell needed for blood clotting) in your blood, or heart or kidney disease.

tell your doctor if you are pregnant, or if you or your partner plans to become pregnant. Also tell your doctor if you are breast-feeding. If you or your partner becomes pregnant while you are taking pregabalin, call your doctor. Pregabalin has caused decreased fertility in male animals and birth defects in the offspring of male and female animals who were treated with the medication. There is not enough information to tell if pregabalin causes these problems in humans.

if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking pregabalin.

you should know that pregabalin may make you dizzy or drowsy. Do not drive a car operate machinery, or do other dangerous activities until you know how this medication affects you. Ask your doctor when you may do these activities.

do not drink alcohol while taking pregabalin. Alcohol can add to the drowsiness caused by this medication.

you should know that your mental health may change in unexpected ways and you may become suicidal (thinking about harming or killing yourself or planning or trying to do so) while you are taking pregabalin for the treatment of epilepsy, mental illness, or other conditions. A small number of adults and children 5 years of age and older (about 1 in 500 people) who took anticonvulsants such as pregabalin to treat various conditions during clinical studies became suicidal during their treatment. Some of these people developed suicidal thoughts and behavior as early as one week after they started taking the medication. There is a risk that you may experience changes in your mental health if you take an anticonvulsant medication such as pregabalin, but there may also be a risk that you will experience changes in your mental health if your condition is not treated. You and your doctor will decide whether the risks of taking an anticonvulsant medication are greater than the risks of not taking the medication. You, your family, or your caregiver should call your doctor right away if you experience any of the following symptoms: panic attacks; agitation or restlessness; new or worsening irritability, anxiety, or depression; acting on dangerous impulses; difficulty falling or staying asleep; aggressive, angry, or violent behavior; mania (frenzied, abnormally excited mood); talking or thinking about wanting to hurt yourself or end your life; withdrawing from friends and family; preoccupation with death and dying; giving away prized possessions; or any other unusual changes in behavior or mood. Be sure that your family or caregiver knows which symptoms may be serious so they can call the doctor if you are unable to seek treatment on your own.

What special dietary instructions should I follow?Return to top

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

What should I do if I forget a dose?Return to top

If you forget to take a dose and remember a few hours later, 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?Return to top

Pregabalin may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

tiredness

dizziness

headache

dry mouth

nausea

vomiting

constipation

gas

bloating

''high'' or elevated mood

speech problems

difficulty concentrating or paying attention

confusion

difficulty remembering or forgetfulness

anxiety

lack of coordination

loss of balance or unsteadiness

uncontrollable shaking or jerking of a part of the body

muscle twitching

weakness

increased appetite

weight gain

swelling of the arms, hands, feet, ankles, or lower legs

back pain

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately:

blurred vision, double vision, or other changes in eyesight

hives

rash

itching

blisters

swelling of the eyes face, throat, mouth, lips, gums, tongue, head or neck

shortness of breath

wheezing

muscle pain, tenderness, soreness, or weakness, especially if it comes along with fever

chest pain

If you have diabetes, you should know that pregabalin has caused skin sores in animals. Pay extra attention to your skin while taking pregabalin, and tell your doctor if you have any sores, redness, or skin problems.

Pregabalin may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/Safety/MedWatch] or by phone [1-800-332-1088].

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

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). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdoseReturn to top

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.

What other information should I know?Return to top

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to pregabalin.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand namesReturn to top

Lyrica

Complete Pregabalin information from Drugs

Trade Names

Lyrica

- Capsules 25 mg

- Capsules 50 mg

- Capsules 75 mg

- Capsules 100 mg

- Capsules 150 mg

- Capsules 200 mg

- Capsules 225 mg

- Capsules 300 mg

- Oral solution 20 mg/mL

Pharmacology

Mechanism of pregabalin's antinociceptive and antiseizure effects is unknown. Effects may be related to high affinity binding to alpha-2 delta site (an auxiliary subunit of voltage-gated calcium channels) in CNS tissue.

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Pharmacokinetics

Absorption

Well absorbed after oral administration; bioavailability is more than 90%. T max occurs within 1.5 h. Steady state was achieved within 24 to 48 h.

Distribution

Vd is approximately 0.5 L/kg. Substrate for system L transporter, which is responsible for the transport of large amino acids across the blood brain barrier.

Metabolism

Negligible metabolism.

Elimination

The half-life is 6.3 h. Largely eliminated by renal excretion; 90% excreted unchanged in urine. Mean renal Cl is approximately 67 to 80.9 mL/min.

Special Populations

Renal Function Impairment

Cl is nearly proportional to CrCl. Plasma concentrations reduced by approximately 50% following a 4-h hemodialysis treatment.

Elderly

Oral Cl tends to decrease with increasing age. Dose reduction may be required in patients who have age-related renal impairment.

Children

Pharmacokinetics have not been studied.

Gender

Pharmacokinetics do not seem to be affected by gender.

Race

Pharmacokinetics do not seem to be affected by race.

Indications and Usage

Management of neuropathic pain associated with diabetic peripheral neuropathy; adjunctive therapy for adults with partial-onset seizures; management of postherpetic neuralgia; management of fibromyalgia.

Unlabeled Uses

Treatment of generalized anxiety disorder.

Contraindications

Standard considerations.

Dosage and Administration

Neuropathic Pain Associated With Diabetic Peripheral Neuropathy

Adults

PO 50 mg 3 times daily initially, increased to 100 mg 3 times daily within 1 wk based on efficacy and tolerability (max, 300 mg/day).

Partial-Onset Seizures

Adults

PO 75 mg twice daily or 50 mg 3 times daily initially, increased to 150 to 600 mg/day divided 2 or 3 times daily based on efficacy and tolerability (max, 600 mg/day).

Postherpetic Neuralgia

Adults

PO 75 mg twice daily or 50 mg 3 times daily initially, increased to 150 mg twice daily or 100 mg 3 times daily within 1 wk based on efficacy and tolerability. If relief is insufficient after 2 to 4 wk, may increase up to 300 mg twice daily or 200 mg 3 times daily.

Fibromyalgia

Adults

PO 75 mg twice daily initially, increased to 150 mg twice daily within 1 wk based on efficacy and tolerability. Patients not experiencing sufficient benefit may further increase the dosage to 225 mg twice daily (max, 450 mg/day).

Dosage Adjustment for Renal Function Impairment

Adults

CrCl 60 mL/min or greater: total daily dose range of 150 to 600 mg/day administered twice daily or 3 times daily; CrCl 30 to 60 mL/min: total daily dose range of 75 to 300 mg/day administered twice daily or 3 times daily; CrCl 15 to 30 mL/min: total daily dose range of 25 to 150 mg administered once or twice daily; CrCl less than 15 mL/min: total daily dose range of 25 to 75 mg/day administered once daily.

Hemodialysis patients

Maintenance doses based on CrCl as recommended plus a supplemental posthemodialysis dose administered after each 4 h of hemodialysis as follows: if maintenance dose 25 mg once daily, postdialysis dose is 25 or 50 mg; if maintenance dose is 25 to 50 mg once daily, postdialysis dose is 50 or 75 mg; if maintenance dose is 50 to 75 mg once daily, postdialysis dose is 75 or 100 mg; if maintenance dose is 75 mg daily, postdialysis dose is 100 to 150 mg.

General Advice

May be given with or without food.

When discontinuing, taper gradually over a minimum of 1 wk.

Storage/Stability

Store at 59 to 86F. Use the oral solution within 45 days of first opening the bottle.

Drug Interactions

ACE inhibitors (eg, captopril)

Coadministration of these agents may increase the risk of swelling and hives. The patient's health care provider should be contacted immediately, if these signs occur.

CNS depressants (eg, alcohol, lorazepam, oxycodone)

Additive effects on cognitive and gross motor function have been seen. Avoid alcohol.

Thiazolidinediones (eg, pioglitazone)

Both pregabalin and thiazolidinediones may cause weight gain and/or fluid retention, possibly exacerbating or leading to heart failure. Use with caution. Monitor the patient. If an interaction is suspected, it may be necessary to adjust the dose of one or both agents.

Adverse Reactions

CNS

Dizziness (45%); somnolence (28%); ataxia (20%); headache (14%); tremor (11%); abnormal thinking, balance disorder, neuropathy (9%); abnormal gait, fatigue (8%); asthenia, confusion, euphoria, speech disorder (7%); amnesia, disturbances in attention, incoordination (6%); twitching (5%); memory impairment, myoclonus, vertigo (4%); abnormal feeling, hypesthesia (3%); anxiety, depression, disorientation, drunk feeling, lethargy (2%); depersonalization, hypertonia, paresthesia, stupor (at least 1%); nervousness (1%).

EENT

Blurred vision, diplopia (12%); abnormal vision (5%); pharyngolaryngeal pain (3%); eye disorder (2%); conjunctivitis, nystagmus, otitis media, tinnitus (at least 1%).

GI

Dry mouth (15%); constipation (10%); increased appetite (7%); flatulence, vomiting (3%); abdominal distension (2%); abdominal pain, gastroenteritis (at least 1%); diarrhea, nausea (postmarketing).

Genitourinary

Urinary incontinence (2%); anorgasmia, impotence, libido decreased, urinary frequency (at least 1%).

Metabolic-Nutritional

Peripheral edema, weight gain (16%); edema (6%); face edema, fluid retention, hypoglycemia (3%).

Musculoskeletal

Arthralgia (6%); back pain, muscle spasm (4%); leg cramps, myalgia, myasthenia (at least 1%).

Respiratory

Sinusitis (7%); bronchitis, dyspnea (3%).

Miscellaneous

Infection (14%); pain (5%); chest pain (4%); flu syndrome (2%); allergic reaction, ecchymosis, fever, pruritus (at least 1%); angioedema, hypersensitivity (postmarketing).

Precautions

Monitor

Monitor for emergence or worsening of depression, suicidal thoughts or behavior, or any unusual changes in behavior. Monitor for weight gain and/or fluid retention, possibly exacerbating or leading to heart failure. Carefully evaluate patients for a history of drug abuse and observe them for signs of pregabalin misuse or abuse (eg, development of tolerance, dose escalation, drug-seeking behavior).

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established.

Elderly

Because of age-related renal function impairment, dosage adjustment may be needed.

Hypersensitivity

Hypersensitivity reactions (including skin redness, blisters, hives, rash, dyspnea, and wheezing) have been reported shortly after initiation of pregabalin.

Renal Function

Dose reduction recommended.

Hazardous Tasks

May cause dizziness and drowsiness, which may impair the ability to preform tasks such as driving or operating machinery.

Angioedema

Has been reported during initial and long-term treatment.

CHF

Use with caution in patients with New York Heart Association class III or IV cardiac status.

Creatine kinase elevations

Have been reported. Discontinue pregabalin if myopathy is diagnosed or suspected or if markedly elevated creatine kinase levels occur.

Decreased platelet count

Clinically significant decreases in platelets (20% below baseline and less than 150 10 3 /mcL) have been documented.

Dependence

Withdrawal symptoms may occur suggestive of physical dependence.

Discontinuation of therapy

Withdraw gradually (over at least 1 wk) to minimize potential of increased seizure frequency in patients with seizure disorders. Upon abrupt or rapid discontinuation, insomnia, nausea, headache, and diarrhea have been reported.

Ophthalmic effects

Reduction in visual acuity, visual field changes, and funduscopic changes have been reported.

Peripheral edema

Has been reported. Occurs more frequently in patients taking pregabalin and a thiazolidinedione antidiabetic agent.

PR interval prolongation

PR interval prolongation (3 to 6 msec) has been reported; the mean change difference was not associated with an increased risk of PR increase more than 25% from baseline, on-treatment PR more than 200 msec, or increased risk of second- or third-degree AV block.

Suicidal behavior and ideation

May increase the risk of suicidal thoughts or behavior. This was observed as early as 1 week after starting treatment and persisted for the duration of treatment.

Weight gain

Has been reported.

Overdosage

Symptoms

None well documented.

Patient Information

Advise patient or caregiver to read the Medication Guide before starting therapy and to reread with each refill.

Instruct patient with epilepsy to continue to take other medications for seizures unless advised otherwise by health care provider.

Advise patient or caregiver that medication will usually be started at a low dose and then increased as tolerated until max benefit has been obtained.

Instruct patient or caregiver to take exactly as prescribed and not to change the dose or discontinue therapy unless advised by health care provider.

Advise patient to take without regard to meals, but to take with food if stomach upset occurs.

Advise patient or caregiver that if medication needs to be discontinued, it will be slowly withdrawn over a period of 1 wk or more unless safety concerns (eg, rash) require a more rapid withdrawal.

Instruct patient to immediately report unexplained muscle pain, tenderness, or weakness, especially if accompanied by general body discomfort or fever.

Caution patient that drug may cause dizziness or drowsiness and to use caution while driving or performing other tasks requiring mental alertness or coordination until tolerance is determined.

Advise patient that pregabalin may cause visual changes, edema (swelling in feet and/or ankles), and weight gain, and to notify health care provider if any of these occur.

Advise patients that concomitant treatment with pregabalin and a thiazolidinedione antidiabetic agent may lead to an additive effect on edema and weight gain. For patients with preexisting cardiac conditions, this may increase the risk of heart failure.

Caution patient to avoid alcohol, opiates, and other CNS depressants while taking pregabalin because of risk of additive CNS impairment and depressant effects.

Advise patient to take frequent sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.

Instruct patient with seizures to notify health care provider if seizures worsen or if new types of seizures occur.

Advise patient with epilepsy to carry medical identification (eg, card, bracelet) indicating medication usage and epilepsy.

Advise patients that the drug may increase the risk of suicidal thoughts and behavior and to be alert for the emergence or worsening of symptoms of depression.

Advise patients that pregabalin may cause angioedema, with swelling of the face, mouth (lip, gum, and tongue), and neck (larynx and pharynx) that can lead to life-threatening respiratory compromise. Instruct patients to discontinue pregabalin and immediately seek medical care if they experience these symptoms.

Advise patients that pregabalin has been associated with hypersensitivity reactions (eg, blisters, dyspnea, hives, rash, wheezing). Instruct patients to discontinue pregabalin and seek medical care immediately if they experience these symptoms.

Counsel patients, their caregivers, and families that antilepileptic drugs, including pregabalin, may increase the risk of suicidal thoughts and behavior and advise them of the need to be alert for the emergence or worsening of symptoms of depression; any unusual changes in mood or behavior; or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Immediately report behaviors of concern to health care providers.

Instruct patients to notify health care provider if they become pregnant or intend to become pregnant during therapy, and to notify their health care provider if they are breast-feeding or intend to breast-feed during therapy.

Encourage patients to enroll in the NAAED Pregnancy Registry if they become pregnant. This registry is collecting information about the safety of antiepileptic drugs during pregnancy. To enroll, patients can call the toll-free number 1-888-233-2334.

Inform men being treated with pregabalin who plan to father a child of the potential risk of male-mediated teratogenicity.

Instruct patients with diabetes to pay particular attention to skin integrity while being treated with pregabalin.