VENLAFAXINE HYDROCHLORIDE Capsule, Extended Release [A-S Medication Solutions]

Venlafaxine Hydrochloride Extended-Release Capsules USP

(ven'' la fax' een hye'' droe klor' ide)

Read the Medication Guide that comes with before you start taking them and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your healthcare provider about your medical condition or treatment. Talk with your healthcare provider if there is something you do not understand or want to learn more about. venlafaxine hydrochloride extended-release capsules

What is the most important information I should know aboutvenlafaxine hydrochloride extended-release capsules?

and other antidepressant medicines may cause serious side effects, including: Venlafaxine hydrochloride extended-release capsules

1. Suicidal thoughts or actions:

• in some children, teenagers, or young adults Venlafaxine hydrochloride extended-release capsules and other antidepressant medicines may increase suicidal thoughts or actionswithin the first few months of treatment or when the dose is changed.
• Depression or other serious mental illnesses are the most important causes of suicidal thoughts or actions.
• Watch for these changes and call your healthcare provider right away if you notice:

• New or sudden changes in mood, behavior, actions, thoughts, or feelings, especially if severe.
• Pay particular attention to such changes when are started or when the dose is changed. venlafaxine hydrochloride extended-release capsules

      Keep all follow-up visits with your healthcare provider and call between visits if you are worried about symptoms.

      Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency, especially if they are new, worse, or worry you:

• attempts to commit suicide
• acting on dangerous impulses
• acting aggressive or violent
• thoughts about suicide or dying
• new or worse depression
• new or worse anxiety or panic attacks
• feeling agitated, restless, angry or irritable
• trouble sleeping
• an increase in activity or talking more than what is normal for you
• other unusual changes in behavior or mood
• Visual problems

• eye pain
• changes in vision
• swelling or redness in or around the eye

Only some people are at risk for these problems. You may want to undergo an eye examination to see if you are at risk and receive preventative treatment if you are.

: Call your healthcare provider right away if you have any of the following symptoms, or call 911 if an emergency. Venlafaxine hydrochloride extended-release capsules may be associated with these serious side effects

2.   Serotonin Syndrome

: This condition can be life-threatening and may include

• agitation, hallucinations, coma or other changes in mental status
• coordination problems or muscle twitching (overactive reflexes)
• racing heartbeat, high or low blood pressure
• sweating or fever
• nausea, vomiting, or diarrhea
• muscle rigidity

may: 3.   Changes in blood pressure. Venlafaxine hydrochloride extended-release capsules

• increase your blood pressure. Control high blood pressure before starting treatment and monitor blood pressure regularly

4.   Enlarged pupils (mydriasis).

5.   Anxiety and insomnia.

6.   Changes in appetite or weight.

7.   Manic/hypomanic episodes:

• greatly increased energy
• severe trouble sleeping
• racing thoughts
• reckless behavior
• unusually grand ideas
• excessive happiness or irritability
• talking more or faster than usual

8.   Low salt (sodium) levels in the blood.

      Elderly people may be at greater risk for this. Symptoms may include:

• headache
• weakness or feeling unsteady
• confusion, problems concentrating or thinking or memory problems

9.   Seizures or convulsions.

: and other antidepressant medicines may increase your risk of bleeding or bruising, especially if you take the blood thinner warfarin (Coumadin , Jantoven ), a non-steroidal anti-inflammatory drug (NSAIDs, like ibuprofen or naproxen), or aspirin. 10. Abnormal bleedingVenlafaxine hydrochloride extended-release capsules®®

11. Elevated cholesterol.

: may cause rare lung problems. Symptoms include: 12. Lung disease and pneumoniaVenlafaxine hydrochloride extended-release capsules

• worsening shortness of breath
• cough
• chest discomfort

13. Severe allergic reactions:

• trouble breathing
• swelling of the face, tongue, eyes or mouth
• rash, itchy welts (hives) or blisters, alone or with fever or joint pain.

. Stopping too quickly or changing from another antidepressant too quickly may cause serious symptoms including: Do not stop venlafaxine hydrochloride extended-release capsules without first talking to your healthcare providervenlafaxine hydrochloride extended-release capsules

• anxiety, irritability
• feeling tired, restless or problems sleeping
• headache, sweating, dizziness
• electric shock-like sensations, shaking, confusion, nightmares
• vomiting, nausea, diarrhea

What are venlafaxine hydrochloride extended-release capsules?

are a prescription medicine used to treat depression. It is important to talk with your healthcare provider about the risks of treating depression and also the risks of not treating it. You should discuss all treatment choices with your healthcare provider. are also used to treat: Venlafaxine hydrochloride extended-release capsulesVenlafaxine hydrochloride extended-release capsules

• Social Anxiety Disorder (SAD)
• Panic Disorder (PD)

Talk to your healthcare provider if you do not think that your condition is getting better with treatment. venlafaxine hydrochloride extended-release capsules

Who should not take venlafaxine hydrochloride extended-release capsules?

Do not take if you: venlafaxine hydrochloride extended-release capsules

• are allergic to or any of the ingredients in . See the end of this Medication Guide for a complete list of ingredients in . venlafaxine hydrochloridevenlafaxine hydrochloride extended-release capsulesvenlafaxine hydrochloride extended-release capsules
• have uncontrolled angle-closure glaucoma
• take a Monoamine Oxidase Inhibitor (MAOI). Ask your healthcare provider or pharmacist if you are not sure if you take an MAOI, including the antibiotic linezolid.

• Do not take an MAOI within 7 days of stopping unless directed to do so by your physician. venlafaxine hydrochloride extended-release capsules
• Do not start if you stopped taking an MAOI in the last 2 weeks unless directed to do so by your physician. venlafaxine hydrochloride extended-release capsules

People who take venlafaxine hydrochloride extended-release capsules close in time to an MAOI may have serious or even life-threatening side effects. Get medical help right away if you have any of these symptoms:

• high fever
• uncontrolled muscle spasms
• stiff muscles
• rapid changes in heart rate or blood pressure
• confusion
• loss of consciousness (pass out)

What should I tell my healthcare provider before taking venlafaxine hydrochloride extended-release capsules? Ask if you are not sure.

Before starting , tell your healthcare provider if you: venlafaxine hydrochloride extended-release capsules

• Are taking certain drugs such as:
  • Medicines used to treat migraine headaches such as:
    • triptans
    • Medicines used to treat mood, anxiety, psychotic or thought disorders, such as:
      • tricyclic antidepressants
      • lithium
      • SSRIs
      • SNRIs
      • antipsychotic drugs
      • Medicines used to treat pain such as:
      • Medicines used to thin your blood such as:
      • Medicines used to treat heartburn such as:
        • Cimetidine
      • Over-the-counter medicines or supplements such as:
        • Aspirin or other NSAIDs
        • Tryptophan
        • St. John’s Wort
      • have heart problems
      • have diabetes
      • have liver problems
      • have kidney problems
      • have thyroid problems
      • have or had seizures or convulsions
      • have bipolar disorder or mania
      • have low sodium levels in your blood
      • have high blood pressure
      • have high cholesterol
      • have or had bleeding problems
      • are pregnant or plan to become pregnant. It is not known if will harm your unborn baby. Talk to your healthcare provider about the benefits and risks of treating depression during pregnancy venlafaxine hydrochloride extended-release capsules
      • are breast-feeding or plan to breast-feed. Some may pass into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking . venlafaxine hydrochloridevenlafaxine hydrochloride extended-release capsules

including prescription and non-prescription medicines, vitamins, and herbal supplements. and some medicines may interact with each other, may not work as well, or may cause serious side effects. Tell your healthcare provider about all the medicines that you take,Venlafaxine hydrochloride extended-release capsules

Your healthcare provider or pharmacist can tell you if it is safe to take with your other medicines. Do not start or stop any medicine while taking without talking to your healthcare provider first. venlafaxine hydrochloride extended-release capsulesvenlafaxine hydrochloride extended-release capsules

How should I take venlafaxine hydrochloride extended-release capsules?

 

• Take exactly as prescribed. Your healthcare provider may need to change the dose of until it is the right dose for you. venlafaxine hydrochloride extended-release capsulesvenlafaxine hydrochloride extended-release capsules
• are to be taken with food. Venlafaxine hydrochloride extended-release capsules
• If you miss a dose of , take the missed dose as soon as you remember. If it is almost time for the next dose, skip the missed dose and take your next dose at the regular time. Do not take two doses of at the same time. venlafaxine hydrochloride extended-release capsulesvenlafaxine hydrochloride extended-release capsules
• If you take too much , call your healthcare provider or poison control center right away, or get emergency treatment. venlafaxine hydrochloride
• When switching from another antidepressant to your doctor may want to lower the dose of the initial antidepressant first to avoid side effects. venlafaxine hydrochloride extended-release capsules

What should I avoid while taking venlafaxine hydrochloride extended-release capsules?

can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how affect you. Do not drink alcohol while using . Venlafaxine hydrochloride extended-release capsulesvenlafaxine hydrochloride extended-release capsulesvenlafaxine hydrochloride extended-release capsules

What are the possible side effects of venlafaxine hydrochloride extended-release capsules?

may cause serious side effects, including: Venlafaxine hydrochloride extended-release capsules

• See “What is the most important information I should know about ?” venlafaxine hydrochloride extended-release capsules
• Increased cholesterol-have your cholesterol checked regularly
• Newborns whose mothers take in the third trimester may have problems right after birth including: venlafaxine hydrochloride extended-release capsules
• Angle-closure glaucoma

• problems feeding and breathing
• seizures
• shaking, jitteriness or constant crying

Common possible side effects in people who take include venlafaxine hydrochloride extended-release capsules:

• unusual dreams
• sexual problems
• loss of appetite, constipation, diarrhea, nausea or vomiting, or dry mouth
• feeling tired, fatigued or overly sleepy
• change in sleep habits, problems sleeping
• yawning
• tremor or shaking
• dizziness, blurred vision
• sweating
• feeling anxious, nervous or jittery
• headache
• increase in heart rate

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of . For more information, ask your healthcare provider or pharmacist. venlafaxine hydrochloride extended-release capsules

CALL YOUR DOCTOR FOR MEDICAL ADVICE ABOUT SIDE EFFECTS. YOU MAY REPORT SIDE EFFECTS TO THE FDA AT 1-800-FDA-1088.

How should I store venlafaxine hydrochloride extended-release capsules?

• Store at room temperature between 20° to 25°C (68° to 77°F). venlafaxine hydrochloride extended-release capsules
•  Keep in a dry place. venlafaxine hydrochloride extended-release capsules

Keep venlafaxine hydrochloride extended-release capsules and all medicines out of the reach of children.

General information about venlafaxine hydrochloride extended-release capsules

 

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use for a condition for which it was not prescribed. Do not give to other people, even if they have the same condition. They may harm them. venlafaxine hydrochloride extended-release capsulesvenlafaxine hydrochloride extended-release capsules

This Medication Guide summarizes the most important information about If you would like more information, talk with your healthcare provider. You may ask your healthcare provider or pharmacist for information about that is written for healthcare professionals. venlafaxine hydrochloride extended-release capsules.venlafaxine hydrochloride extended-release capsules

For more information about call venlafaxine hydrochloride extended-release capsules1-866-850-2876.

What are the ingredients in venlafaxine hydrochloride extended-release capsules?

Active ingredient: Venlafaxine hydrochloride

Inactive ingredients:

: Ethyl cellulose, hypromellose, sugar spheres, and talc. The empty hard gelatin capsule shells contain iron oxide red, gelatin, titanium dioxide, and sodium lauryl sulphate. In addition, the 37.5 mg empty hard gelatin capsule shells contain iron oxide black. The capsules are printed with edible ink containing black iron oxide and shellac. Extended-Release Capsules

This Medication Guide has been approved by the U.S. Food and Drug Administration for all antidepressants.

Coumadin is a registered trademark of Bristol Myers Squibb. ®

Jantoven is a registered trademark of Upsher-Smith Laboratories Inc. ®

Manufactured for: 2400 Route 130 North Dayton, NJ 08810 Manufactured by: Hyderabad-500 090, India Revised: 04/2016
Aurobindo Pharma USA, Inc.

Aurobindo Pharma Limited

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VENLAFAXINE HYDROCHLORIDE Capsule, Extended Release [A-S Medication Solutions]

MUCINEX (Guaifenesin) Tablet, Extended Release [A-S Medication Solutions]

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MUCINEX (Guaifenesin) Tablet, Extended Release [A-S Medication Solutions]

VERAPAMIL HYDROCHLORIDE Tablet, Film Coated, Extended Release [A-S Medication Solutions]

General

Use in patients with impaired hepatic function:

Since verapamil is highly metabolized by the liver, it should be administered cautiously to patients with impaired hepatic function. Severe liver dysfunction prolongs the elimination half-life of immediate-release verapamil to about 14 to 16 hours; hence, approximately 30% of the dose given to patients with normal liver function should be administered to these patients. Careful monitoring for abnormal prolongation of the PR interval or other signs of excessive pharmacologic effects (see ) should be carried out. OVERDOSAGE

Use in patients with attenuated (decreased) neuromuscular transmission:

It has been reported that verapamil decreases neuromuscular transmission in patients with Duchenne’s muscular dystrophy, and that verapamil prolongs recovery from the neuromuscular blocking agent vecuronium. It may be necessary to decrease the dosage of verapamil when it is administered to patients with attenuated neuromuscular transmission.

Use in patients with impaired renal function:

About 70% of an administered dose of verapamil is excreted as metabolites in the urine. Verapamil is not removed by hemodialysis. Until further data are available, verapamil should be administered cautiously to patients with impaired renal function. These patients should be carefully monitored for abnormal prolongation of the PR interval or other signs of overdosage (see ). OVERDOSAGE

Drug interactions

The use of HMG-CoA reductase inhibitors that are CYP3A4 substrates in combination with verapamil has been associated with reports of myopathy/rhabdomyolysis. HMG-CoA reductase inhibitors:

Co-administration of multiple doses of 10 mg of verapamil with 80 mg simvastatin resulted in exposure to simvastatin 2.5-fold that following simvastatin alone. Limit the dose of simvastatin in patients on verapamil to 10 mg daily. Limit the daily dose of lovastatin to 40 mg. Lower starting and maintenance doses of other CYP3A4 substrates (e.g., atorvastatin) may be required as verapamil may increase the plasma concentration of these drugs.

Concomitant therapy with beta-adrenergic blockers and verapamil may result in additive negative effects on heart rate, atrioventricular conduction, and/or cardiac contractility. The combination of sustained-release verapamil and beta-adrenergic blocking agents has not been studied. However, there have been reports of excessive bradycardia and AV block, including complete heart block, when the combination has been used for the treatment of hypertension. For hypertensive patients, the risks of combined therapy may outweigh the potential benefits. The combination should be used only with caution and close monitoring. Beta-blockers:

Asymptomatic bradycardia (36 beats/min) with a wandering atrial pacemaker has been observed in a patient receiving concomitant timolol (a beta-adrenergic blocker) eyedrops and oral verapamil.

A decrease in metoprolol and propranolol clearance has been observed when either drug is administered concomitantly with verapamil. A variable effect has been seen when verapamil and atenolol were given together.

: Clinical use of verapamil in digitalized patients has shown the combination to be well tolerated if digoxin doses are properly adjusted. However, chronic verapamil treatment can increase serum digoxin levels by 50% to 75% during the first week of therapy, and this can result in digitalis toxicity. In patients with hepatic cirrhosis the influence of verapamil on digoxin kinetics is magnified. Verapamil may reduce total body clearance and extrarenal clearance of digitoxin by 27% and 29%, respectively. Maintenance and digitalization doses should be reduced when verapamil is administered, and the patient should be carefully monitored to avoid over or underdigitalization. Whenever over-digitalization is suspected, the daily dose of digitalis should be reduced or temporarily discontinued. On discontinuation of verapamil hydrochloride use, the patient should be reassessed to avoid under-digitalization. Digitalis

: Verapamil administered concomitantly with oral antihypertensive agents (e.g., vasodilators, angiotensin-converting enzyme inhibitors, diuretics, beta-blockers) will usually have an additive effect on lowering blood pressure. Patients receiving these combinations should be appropriately monitored. Concomitant use of agents that attenuate alpha-adrenergic function with verapamil may result in a reduction in blood pressure that is excessive in some patients. Such an effect was observed in one study following the concomitant administration of verapamil and prazosin. Antihypertensive agents

Antiarrhythmic agents:

Until data on possible interactions between verapamil and disopyramide phosphate are obtained, disopyramide should not be administered within 48 hours before or 24 hours after verapamil administration. Disopyramide:

A study of healthy volunteers showed that the concomitant administration of flecainide and verapamil may have additive effects on myocardial contractility, AV conduction, and repolarization. Concomitant therapy with flecainide and verapamil may result in additive negative inotropic effect and prolongation of atrioventricular conduction. Flecainide:

In a small number of patients with hypertrophic cardiomyopathy (IHSS), concomitant use of verapamil and quinidine resulted in significant hypotension. Until further data are obtained, combined therapy of verapamil and quinidine in patients with hypertrophic cardiomyopathy should probably be avoided. Quinidine:

The electrophysiologic effects of quinidine and verapamil on AV conduction were studied in 8 patients. Verapamil significantly counteracted the effects of quinidine on AV conduction. There has been a report of increased quinidine levels during verapamil therapy.

Other agents:

Verapamil has been found to significantly inhibit ethanol elimination significantly, resulting in elevated blood ethanol concentrations that may prolong the intoxicating effects of alcohol. (See ). Alcohol:CLINICAL PHARMACOLOGY, Pharmacokinetics and metabolism

Verapamil has been given concomitantly with short- and long-acting nitrates without any undesirable drug interactions. The pharmacologic profile of both drugs and the clinical experience suggest beneficial interactions. Nitrates:

The interaction between cimetidine and chronically administered verapamil has not been studied. Variable results on clearance have been obtained in acute studies of healthy volunteers; clearance of verapamil was either reduced or unchanged. Cimetidine:

Increased sensitivity to the effects of lithium (neurotoxicity) has been reported during concomitant verapamil-lithium therapy; lithium levels have been observed sometimes to increase, sometimes to decrease, and sometimes to be unchanged. Patients receiving both drugs must be monitored carefully. Lithium:

Verapamil therapy may increase carbamazepine concentrations during combined therapy. This may produce carbamazepine side effects such as diplopia, headache, ataxia, or dizziness. Carbamazepine:

Therapy with rifampin may markedly reduce oral verapamil bioavailability. Rifampin:

Phenobarbital therapy may increase verapamil clearance. Phenobarbital:

Verapamil therapy may increase serum levels of cyclosporine. Cyclosporine:

Verapamil therapy may inhibit the clearance and increase the plasma levels of theophylline. Theophylline:

Animal experiments have shown that inhalation anesthetics depress cardiovascular activity by decreasing the inward movement of calcium ions. When used concomitantly, inhalation anesthetics and calcium antagonists, such as verapamil, should each be titrated carefully to avoid excessive cardiovascular depression. Inhalation anesthetics:

Clinical data and animal studies suggest that verapamil may potentiate the activity of neuromuscular blocking agents (curare-like and depolarizing). It may be necessary to decrease the dose of verapamil and/or the dose of the neuromuscular blocking agent when the drugs are used concomitantly. Neuromuscular blocking agents:

Clinical data and animal studies suggest that verapamil may potentiate the activity of neuromuscular blocking agents (curare-like and depolarizing). It may be necessary to decrease the dose of verapamil and/or the dose of the neuromuscular blocking agent when the drugs are used concomitantly. Neuromuscular blocking agents:

Hypotension and bradyarrhythmias have been observed in patients receiving concurrent telithromycin, an antibiotic in the ketolide class. Telithromycin:

Sinus bradycardia resulting in hospitalization and pacemaker insertion has been reported in association with the use of clonidine concurrently with verapamil. Monitor heart rate in patients receiving concomitant verapamil and clonidine. Clonidine:

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VERAPAMIL HYDROCHLORIDE Tablet, Film Coated, Extended Release [A-S Medication Solutions]