Cipridanol may be available in the countries listed below.
Methylprednisolone is reported as an ingredient of Cipridanol in the following countries:
Methylprednisolone 21-(sodium succinate) (a derivative of Methylprednisolone) is reported as an ingredient of Cipridanol in the following countries:
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Trasicor may be available in the countries listed below.
UK matches:
Oxprenolol hydrochloride (a derivative of Oxprenolol) is reported as an ingredient of Trasicor in the following countries:
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Glossary
| SPC | Summary of Product Characteristics (UK) |
Kwas foliowy may be available in the countries listed below.
Folic Acid is reported as an ingredient of Kwas foliowy in the following countries:
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PAS may be available in the countries listed below.
Aminosalicylic Acid is reported as an ingredient of PAS in the following countries:
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Pertacilon may be available in the countries listed below.
Captopril is reported as an ingredient of Pertacilon in the following countries:
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Sultolin may be available in the countries listed below.
Salbutamol is reported as an ingredient of Sultolin in the following countries:
Salbutamol sulfate (a derivative of Salbutamol) is reported as an ingredient of Sultolin in the following countries:
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Azathioprine EG may be available in the countries listed below.
Azathioprine is reported as an ingredient of Azathioprine EG in the following countries:
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Tadasil may be available in the countries listed below.
Cisapride is reported as an ingredient of Tadasil in the following countries:
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Generic Name: guaifenesin and pseudoephedrine (gwye FEN e sin, SOO doe ee FED rin)
Brand Names: Altarussin PE, Ambifed, Ambifed-G, Biotuss PE, Congestac, D-Feda II, Despec-SR, Dynex, Entex PSE, ExeFen, ExeFen-IR, Guiatex II SR, Levall G, Maxifed, Maxifed-G, Medent LD, Medent-LDI, Mucinex D, Mucinex D Max Strength, Nasabid SR, Nasatab LA, Nomuc-PE, Poly-Vent, Poly-Vent IR, Poly-Vent, Jr., Pseudatex, Pseudo GG, Pseudo GG TR, Pseudo Max, Q-Tussin PE, Respaire-120 SR, Respaire-30, Respaire-60 SR, Robitussin PE, Robitussin Severe Congestion, Ru-Tuss Jr., Sinutab Non Drying, Stamoist E, SudaTex-G, Tenar PSE, Touro LA, Touro LA-LD, Triaminic Softchews Chest Congestion, We Mist II LA, We Mist LA
Guaifenesin is an expectorant. It helps loosen congestion in your chest and throat, making it easier to cough out through your mouth.
Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can cause nasal congestion (stuffy nose).
The combination of guaifenesin and pseudoephedrine is used to treat stuffy nose, sinus congestion, and cough caused by allergies or the common cold.
Guaifenesin and pseudoephedrine may also be used for purposes not listed in this medication guide.
Ask a doctor or pharmacist if it is safe for you to take this medicine if you have:
heart disease or high blood pressure;
diabetes; or
a thyroid disorder.
Artificially sweetened liquid cough or cold medicine may contain phenylalanine. If you have phenylketonuria (PKU), check the medication label to see if the product contains phenylalanine.
Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. Cough and cold medicine is usually taken only for a short time until your symptoms clear up.
Measure liquid medicine with a special dose-measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.
If you need surgery, tell the surgeon ahead of time if you have taken a cough or cold medicine within the past few days.
Since cough or cold medicine is taken when needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
Overdose symptoms may include nausea, vomiting, dizziness, and feeling restless or nervous.
Avoid taking this medication if you also take diet pills, caffeine pills, or other stimulants (such as ADHD medications). Taking a stimulant together with a decongestant can increase your risk of unpleasant side effects.
fast, pounding, or uneven heartbeat;
severe dizziness, anxiety, or nervousness;
easy bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms; or
increased blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure).
Less serious side effects may include:
dizziness or headache;
feeling restless or excited;
sleep problems (insomnia);
mild nausea, vomiting, or stomach upset;
mild loss of appetite;
warmth, redness, or tingly feeling under your skin; or
skin rash or itching.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Tell your doctor about all other medicines you use, especially:
methyldopa (Aldomet);
blood pressure medications;
a beta-blocker such as atenolol (Tenormin, Tenoretic), carvedilol (Coreg), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), sotalol (Betapace), and others; or
an antidepressant such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.
This list is not complete and other drugs may interact with guaifenesin and pseudoephedrine. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.
See also: Robitussin PE side effects (in more detail)
Acetylsalicylic Acid is reported as an ingredient of Aspirin Adult in the following countries:
International Drug Name Search
Tensiohess may be available in the countries listed below.
Losartan is reported as an ingredient of Tensiohess in the following countries:
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Betoptic S® Ophthalmic Suspension 0.25% is indicated for the treatment of elevated intraocular pressure in patients with chronic open-angle glaucoma or ocular hypertension.
Instill one drop of Betoptic S® Ophthalmic Suspension 0.25% in the affected eye(s) twice daily. It may be used alone or in combination with other intraocular pressure lowering medications.
Bottle filled with 2.5, 5, 10, and 15 mL of 0.25% sterile ophthalmic suspension
Betoptic S® Suspension is contraindicated in patients with:
• sinus bradycardia
• greater than a first degree atrioventricular block
• cardiogenic shock
• patients with overt cardiac failure
• hypersensitivity to any component of this product.
As with many topically applied ophthalmic drugs, this drug is absorbed systemically. The same adverse reactions found with systemic administration of beta-adrenergic receptor inhibitors may occur with topical administration. For example, severe respiratory reactions and cardiac reactions, including death due to bronchospasm in patients with asthma, and death due to cardiac failure, have been reported with topical application of beta-adrenergic receptor inhibitors.
Betoptic S® Suspension has been shown to have a minor effect on heart rate and blood pressure in clinical studies. Caution should be used in treating patients with a history of cardiac failure or heart block. Treatment with Betoptic S® should be discontinued at the first signs of cardiac failure.
Beta-adrenergic receptor inhibitors should be administered with caution in patients subject to hypoglycemia or to diabetic patients (especially those with labile diabetes) who are receiving insulin or oral hypoglycemic agents.
Beta-adrenergic receptor inhibitors may mask the signs and symptoms of acute hypoglycemia.
Beta-adrenergic receptor inhibitors may mask certain clinical signs (e.g., tachycardia) of hyperthyroidism. Patients suspected of developing thyrotoxicosis should be managed carefully to avoid abrupt withdrawal of beta-adrenergic receptor inhibitors, which might precipitate a thyroid storm.
Beta-adrenergic receptor inhibitors have been reported to potentiate muscle weakness consistent with certain myasthenic symptoms (e.g., diplopia, ptosis and generalized weakness).
The necessity or desirability of withdrawal of beta-adrenergic receptor inhibitors prior to major surgery is controversial. Beta-adrenergic receptor inhibitors impair the ability of the heart to respond to beta-adrenergically mediated reflex stimuli. This may augment the risk of general anesthesia in surgical procedures. Some patients receiving beta-adrenergic receptor inhibitors have experienced protracted, severe hypotension during anesthesia. Difficulty in restarting and maintaining the heartbeat has also been reported. In patients undergoing elective surgery, consider gradual withdrawal of beta-adrenergic receptor inhibitors. If necessary during surgery, the effects of beta-adrenergic receptor inhibitors may be reversed by sufficient doses of adrenergic agonists.
Caution should be exercised in the treatment of glaucoma patients with excessive restriction of pulmonary function. There have been reports of asthmatic attacks and pulmonary distress during betaxolol treatment. Although re-challenges of some such patients with ophthalmic betaxolol has not adversely affected pulmonary function test results, the possibility of adverse pulmonary effects in patients sensitive to beta-adrenergic receptor inhibitors cannot be ruled out.
While taking beta-adrenergic receptor inhibitors, patients with a history of atopy or a history of severe anaphylactic reaction to a variety of allergens may be more reactive to repeated accidental, diagnostic, or therapeutic challenge with such allergens. Such patients may be unresponsive to the usual doses of epinephrine used to treat anaphylactic reactions.
In patients with angle-closure glaucoma, the immediate treatment objective is to reopen the angle. This may require constricting the pupil. Betaxolol has little or no effect on the pupil and should not be used alone in the treatment of angle-closure glaucoma.
Because of potential effects of beta-adrenergic receptor inhibitors on blood pressure and pulse, these inhibitors should be used with caution in patients with cerebrovascular insufficiency. If signs or symptoms suggesting reduced cerebral blood flow develop following initiation of therapy with Betoptic S®, alternative therapy should be considered.
Bacterial keratitis may occur with use of multiple dose containers of topical ophthalmic products when these containers are inadvertently contaminated by patients who, in most cases, had a concurrent corneal disease or a disruption of the ocular epithelial surface. Instruct patients on appropriate instillation techniques. [see Patient Counseling Information (17)].
Choroidal detachment after filtration procedures has been reported with the administration of aqueous suppressant therapy.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
In clinical trials, the most frequent adverse reaction associated with the use of Betoptic S® Ophthalmic Suspension 0.25% has been transient ocular discomfort. The following other adverse reactions have been reported in small numbers of patients:
Ocular: blurred vision, corneal punctuate keratitis, foreign body sensation, photophobia, tearing, itching, dryness of eyes, erythema, inflammation, discharge, ocular pain, decreased visual acuity and crusty lashes.
Systemic adverse reactions include:
Cardiovascular: Bradycardia, heart block and congestive failure.
Pulmonary: Pulmonary distress characterized by dyspnea, bronchospasm, thickened bronchial secretions, asthma and respiratory failure.
Central Nervous System: Insomnia, dizziness, vertigo, headaches, depression, lethargy, and increase in signs and symptoms of myasthenia gravis.
Other: Hives, toxic epidermal necrolysis, hair loss and glossitis. Perversions of taste and smell have been reported.
In a 3-month, double-masked, active-controlled, multicenter study in pediatric patients, the adverse reaction profile of Betoptic S® Ophthalmic Suspension 0.25% was comparable to that seen in adult patients.
Additional medical events reported with other formulations of betaxolol include allergic reactions, decreased corneal sensitivity, corneal punctuate staining which may appear in dendritic formations, edema and anisocoria.
Patients who are receiving a beta-adrenergic receptor inhibitor orally and BETOPTIC S® Ophthalmic Suspension 0.25% should be observed for a potential additive effect either on the intraocular pressure or on the known systemic effects of beta blockade.
Close observation of the patient is recommended when a beta–adrenergic receptor inhibitor is administered to patients receivingcatecholamine-depleting drugs such as reserpine, because of possible additive effects and the production of hypotension and/or bradycardia which may result in vertigo, syncope, or postural hypotension.
Betaxolol is an adrenergic receptor inhibitor; therefore, caution should be exercised in patients using concomitant adrenergic psychotropic drugs.
Teratogenic effects
Pregnancy Category C: Reproduction, teratology, and peri- and postnatal studies have been conducted with orally administered betaxolol HCl in rats and rabbits. There was evidence of drug related postimplantation loss in rabbits and rats at dose levels above 12 mg/kg and 128 mg/kg, respectively. Betaxolol HCl was not shown to be teratogenic, however, and there were no other adverse effects on reproduction at subtoxic dose levels. There are no adequate and well-controlled studies in pregnant women.
Betoptic S® Ophthalmic Suspension 0.25% should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
It is not known whether betaxolol HCl is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BETOPTIC S® Ophthalmic Suspension 0.25% is administered to nursing women.
Safety and IOP-lowering effect of Betoptic S® Ophthalmic Suspension 0.25% has been demonstrated in pediatric patients in a 3-month, multicenter, double-masked, active-controlled trial.
No overall differences in safety or effectiveness have been observed between elderly and younger patients.
No information is available on overdosage in humans. The oral LD50 of the drug ranged from 350-920 mg/kg in mice and 860-1050 mg/kg in rats. The symptoms which might be expected with an overdose of a systemically administered beta-1-adrenergic receptor inhibitor are bradycardia, hypotension and acute cardiac failure.
A topical overdose of Betoptic S® Ophthalmic Suspension 0.25% may be flushed from the eye(s) with warm tap water.
Betoptic S® Ophthalmic Suspension 0.25% contains betaxolol hydrochloride, a cardioselective beta-adrenergic receptor inhibitor, in a sterile resin suspension formulation. Betaxolol hydrochloride is a white, crystalline powder, with a molecular weight of 343.89. The chemical structure is presented below.
Empirical Formula:
C18H29NO3•HCl
Chemical Name:
(±)-1-[p-[2-(cyclopropylmethoxy) ethyl]phenoxy]-3-(isopropylamino)-2-propanol hydrochloride.
Each mL of Betoptic S® Ophthalmic Suspension 0.25% contains: Active: betaxolol HCl 2.8 mg equivalent to 2.5 mg of betaxolol base. Preservative: benzalkonium chloride 0.01%. Inactives: mannitol, poly(styrene-divinyl benzene) sulfonic acid, carbomer 934P, edetate disodium, hydrochloric acid or sodium hydroxide (to adjust pH) and purified water.
Betoptic S® Ophthalmic Suspension 0.25% has pH of approximately 7.6 and an osmolality of approximately 290 mOsmol/kg.
Betaxolol HCl, a cardioselective (beta-1-adrenergic) receptor inhibitor, does not have significant membrane-stabilizing (local anesthetic) activity and is devoid of intrinsic sympathomimetic action. Orally administered beta-adrenergic receptor inhibitors reduce cardiac output in healthy subjects and patients with heart disease. In patients with severe impairment of myocardial function, beta-adrenergic receptor antagonists may inhibit the sympathetic stimulatory effect necessary to maintain adequate cardiac function.
When instilled in the eye, Betoptic S® Ophthalmic Suspension 0.25% has the action of reducing elevated intraocular pressure, whether or not accompanied by glaucoma. Ophthalmic betaxolol has minimal effect on pulmonary and cardiovascular parameters.
Elevated IOP presents a major risk factor in glaucomatous field loss. The higher the level of IOP, the greater the likelihood of optic nerve damage and visual field loss. Betaxolol has the action of reducing elevated as well as normal intraocular pressure and the mechanism of ocular hypotensive action appears to be a reduction of aqueous production as demonstrated by tonography and aqueous fluorophotometry.
The onset of action with betaxolol can generally be noted within 30 minutes and the maximum effect can usually be detected 2 hours after topical administration. A single dose provides a 12-hour reduction in intraocular pressure. In some patients, the intraocular pressure lowering responses to BETOPTIC S® may require a few weeks to stabilize. As with any new medication, careful monitoring of patients is advised.
Ophthalmic betaxolol solution at 1% (one drop in each eye) was compared to placebo in a crossover study challenging nine patients with reactive airway disease. Betaxolol HCl had no significant effect on pulmonary function as measured by Forced Expiratory Volume in 1 second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC and was not significantly different from placebo. The action of isoproterenol, a beta stimulant, administered at the end of the study was not inhibited by ophthalmic betaxolol.
No evidence of cardiovascular beta adrenergic-blockade during exercise was observed with betaxolol in a double-masked, crossover study in 24 normal subjects comparing ophthalmic betaxolol and placebo for effects on blood pressure and heart rate.
Lifetime studies with betaxolol HCl have been completed in mice at oral doses of 6, 20 or 60 mg/kg/day and in rats at 3, 12 or 48 mg/kg/day; betaxolol HCl demonstrated no carcinogenic effect. Higher dose levels were not tested.
In a variety of in vitro and in vivo bacterial and mammalian cell assays, betaxolol HCl was nonmutagenic.
In controlled, double-masked studies, the magnitude and duration of the ocular hypotensive effect of Betoptic S® Ophthalmic Suspension 0.25% and BETOPTIC® Ophthalmic Solution 0.5% were clinically equivalent. BETOPTIC S® Suspension was significantly more comfortable than BETOPTIC® Solution.
Betoptic S® Ophthalmic Suspension 0.25% is supplied as follows: 2.5, 5, 10 and 15 mL in plastic ophthalmic DROP-TAINER® dispensers. Tamper evidence is provided with a shrink band around the closure and neck area of the DROP-TAINER® package.
5 mL: NDC0065-0246-05
10 mL: NDC0065-0246-10
15 mL: NDC0065-0246-15
Storage and Handling
Store upright at 2° - 25°C (36° - 77°F).
Shake well before using.
How to Use The DROP-TAINER® Bottle
The DROP-TAINER® bottle is designed to assure the delivery of a precise dose of medication. Before using your DROP-TAINER® bottle, read the complete instructions carefully.
1. If you use other topically applied ophthalmic medications, they should be administered at least 10 minutes before BETOPTIC S®.
2. Wash hands before each use.
3. Before using the medication for the first time, be sure the Safety Seal on the bottle isunbroken.
4. Tear off the Safety Seal to break the seal.
5. Before each use, shake well and remove the screw cap.
6. Invert the bottle and hold the bottle between your thumb and middle finger, with the tips of the fingers pointing towards you.
7. Tilt your head back and position the bottle above the affected eye. DO NOT TOUCH THE EYE WITH THE TIP OF THE DROPPER.
8. With the opposite hand, place a finger under the eye. Gently pull down until a “V” pocket is made between your eye and lower lid.
9. With the hand holding the bottle, place your index finger on the bottom of the bottle. Push the bottom of the bottle to dispense one drop of medication. DO NOT SQUEEZE THE SIDES OF THE BOTTLE.
10. Repeat 6, 7, 8 and 9 with other eye if instructed to do so.
11. Replace screw cap by turning until firmly touching the bottle.
Patients should be instructed to avoid allowing the tip of the dispensing container to contact the eye(s) or surrounding structures. Patients should also be instructed that ocular solutions, if handled improperly, could become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye(s) and subsequent loss of vision may result from using contaminated solutions.
Patients should be advised that if they have ocular surgery or develop an intercurrent ocular condition (e.g., trauma or infection), they should immediately seek their physician’s advice concerning the continued use of the present multidose container.
Patients requiring concomitant topical ophthalmic medications should be instructed to administer these at least 10 minutes before instilling BETOPTIC S® Suspension.
© 2003, 2007, 2008, 2009 Alcon, Inc.
Alcon Laboratories, Inc.
Fort Worth, Texas76134
9002808-0109
NDC 0065-0246-05
Alcon®
Betoptic S®
(betaxolol HCl ophthalmic suspension)
0.25% as base
5 mL Sterile
| Betoptic S betaxolol hydrochloride suspension | ||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| NDA | NDA019845 | 01/15/1996 | |
| Labeler - Alcon Laboratories, Inc. (008018525) |
| Registrant - Alcon Laboratories, Inc. (008018525) |
| Establishment | |||
| Name | Address | ID/FEI | Operations |
| Alcon Laboratories, Inc. | 008018525 | MANUFACTURE | |
Fexofenadine Mylan may be available in the countries listed below.
Fexofenadine hydrochloride (a derivative of Fexofenadine) is reported as an ingredient of Fexofenadine Mylan in the following countries:
International Drug Name Search
Flecaïnide-acetaat A may be available in the countries listed below.
Flecainide acetate (a derivative of Flecainide) is reported as an ingredient of Flecaïnide-acetaat A in the following countries:
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Rupemet may be available in the countries listed below.
Metoclopramide is reported as an ingredient of Rupemet in the following countries:
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Levodopa Carbidopa Hexal may be available in the countries listed below.
Carbidopa is reported as an ingredient of Levodopa Carbidopa Hexal in the following countries:
Levodopa is reported as an ingredient of Levodopa Carbidopa Hexal in the following countries:
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Rec.INN
M05BA07
0105462-24-6
C7-H11-N-O7-P2
283
Calcium regulator
Phosphonic acid, [1-hydroxy-2-(3-pyridinyl)ethylidene]bis-
International Drug Name Search
Glossary
| BAN | British Approved Name |
| BANM | British Approved Name (Modified) |
| DCF | Dénomination Commune Française |
| IS | Inofficial Synonym |
| OS | Official Synonym |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Bethacil may be available in the countries listed below.
Ampicillin sodium salt (a derivative of Ampicillin) is reported as an ingredient of Bethacil in the following countries:
Sulbactam sodium salt (a derivative of Sulbactam) is reported as an ingredient of Bethacil in the following countries:
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Citramar may be available in the countries listed below.
Calcium Citrate is reported as an ingredient of Citramar in the following countries:
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Glimepirid LPH may be available in the countries listed below.
Glimepiride is reported as an ingredient of Glimepirid LPH in the following countries:
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Kinitron may be available in the countries listed below.
Formoterol fumarate (a derivative of Formoterol) is reported as an ingredient of Kinitron in the following countries:
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Tamsulosin Winthrop may be available in the countries listed below.
Tamsulosin hydrochloride (a derivative of Tamsulosin) is reported as an ingredient of Tamsulosin Winthrop in the following countries:
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Rec.INN
C03DA02
0002181-04-6
C22-H29-K-O4
396
Potassium-sparing diuretic agent, aldosterone antagonist
Pregna-4,6-diene-21-carboxylic acid, 17-hydroxy-3-oxo-, monopotassium salt, (17α)-
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Glossary
| DCIT | Denominazione Comune Italiana |
| IS | Inofficial Synonym |
| JAN | Japanese Accepted Name |
| OS | Official Synonym |
| PH | Pharmacopoeia Name |
| Rec.INN | Recommended International Nonproprietary Name (World Health Organization) |
| USAN | United States Adopted Name |
Curaverm may be available in the countries listed below.
In some countries, this medicine may only be approved for veterinary use.
Fenbendazole is reported as an ingredient of Curaverm in the following countries:
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Menamin SR may be available in the countries listed below.
Ketoprofen is reported as an ingredient of Menamin SR in the following countries:
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Antidepressants increase the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of Desyrel or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed 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. Desyrel is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS: Pediatric Use).
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.
Desyrel (trazodone hydrochloride) is an antidepressant chemically unrelated to tricyclic, tetracyclic, or other known antidepressant agents. Trazodone hydrochloride is a triazolopyridine derivative designated as 2-[3-[4-(3-chlorophenyl)-1-piperazinyl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one hydrochloride. It is a white, odorless, crystalline powder which is freely soluble in water. Its molecular weight is 408.3. The empirical formula is C19H22ClN5O • HCl and the structural formula is represented as follows:
Desyrel is supplied for oral administration in 50 mg tablet.
Desyrel Tablets, 50 mg, contain the following inactive ingredients: colloidal silicon dioxide, anhydrous lactose, magnesium stearate, microcrystalline cellulose, and sodium starch glycolate
The mechanism of Desyrel’s antidepressant action in man is not fully understood. In animals, Desyrel selectively inhibits serotonin uptake by brain synaptosomes and potentiates the behavioral changes induced by the serotonin precursor, 5-hydroxytryptophan. Cardiac conduction effects of Desyrel in the anesthetized dog are qualitatively dissimilar and quantitatively less pronounced than those seen with tricyclic antidepressants. Desyrel is not a monoamine oxidase inhibitor and, unlike amphetamine-type drugs, does not stimulate the central nervous system.
In humans, Desyrel is well absorbed after oral administration without selective localization in any tissue. When Desyrel is taken shortly after ingestion of food, there may be an increase in the amount of drug absorbed, a decrease in maximum concentration and a lengthening in the time to maximum concentration. Peak plasma levels occur approximately one hour after dosing when Desyrel is taken on an empty stomach or two hours after dosing when taken with food.
In vitro studies in human liver microsomes show that trazodone is metabolized to an active metabolite, m-chlorophenylpiperazine (mCPP) by cytochrome P450 3A4 (CYP3A4). Other metabolic pathways that may be involved in metabolism of trazodone have not been well characterized.
In some patients, Desyrel may accumulate in the plasma.
See also PRECAUTIONS: Drug Interactions. In vitro drug metabolism studies reveal that trazodone is a substrate of the cytochrome P450 3A4 (CYP3A4) enzyme and trazodone metabolism can be inhibited by the CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir. The effect of short-term administration of ritonavir (200 mg twice daily, 4 doses) on the pharmacokinetics of a single dose of trazodone (50 mg) has been studied in 10 healthy subjects. The Cmax of trazodone increased by 34%, the AUC increased 2.4-fold, the half-life increased by 2.2-fold, and the clearance decreased by 52%. Adverse effects including nausea, hypotension, and syncope were observed when ritonavir and trazodone were co-administered.
Carbamazepine induces CYP3A4. Following co-administration of carbamazepine 400 mg/day with trazodone 100 mg to 300 mg daily, carbamazepine reduced plasma concentrations of trazodone (as well as mCPP) by 76% and 60%, respectively, compared to pre-carbamazepine values.
For those patients who responded to Desyrel, one-third of the inpatients and one-half of the outpatients had a significant therapeutic response by the end of the first week of treatment. Three-fourths of all responders demonstrated a significant therapeutic effect by the end of the second week. One-fourth of responders required 2 to 4 weeks for a significant therapeutic response.
Desyrel is indicated for the treatment of depression. The efficacy of Desyrel has been demonstrated in both inpatient and outpatient settings and for depressed patients with and without prominent anxiety. The depressive illness of patients studied corresponds to the Major Depressive Episode criteria of the American Psychiatric Association’s Diagnostic and Statistical Manual, III.1
Major Depressive Episode implies a prominent and relatively persistent (nearly every day for at least two weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least four of the following eight symptoms: change in appetite, change in sleep, psychomotor agitation or retardation, loss of interest in usual activities or decrease in sexual drive, increased fatigability, feelings of guilt or worthlessness, slowed thinking or impaired concentration, and suicidal ideation or attempts.
Desyrel is contraindicated in patients hypersensitive to Desyrel.
Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. There has been a long-standing concern that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients. Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders.
Pooled analyses of short-term placebo-controlled trials of 9 antidepressant drugs (SSRIs and others) in children and adolescents with MDD, OCD, or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal behavior or thinking (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. There was considerable variation in risk among drugs, but a tendency toward an increase for almost all drugs studied. The risk of suicidality was most consistently observed in the MDD trials, but there were signals of risk arising from some trials in other psychiatric indications (obsessive compulsive disorder and social anxiety disorder) as well. No suicides occurred in any of these trials. It is unknown whether the suicidality risk in pediatric patients extends to longer-term use, ie, beyond several months. It is also unknown whether the suicidality risk extends to adults.
All pediatric patients being treated with antidepressants for any indication should be observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. Such observation would generally include at least weekly face-to-face contact with patients or their family members or caregivers during the first 4 weeks of treatment, then every other week visits for the next 4 weeks, then at 12 weeks, and as clinically indicated beyond 12 weeks. Additional contact by telephone may be appropriate between face-to-face visits.
Adults with MDD or co-morbid depression in the setting of other psychiatric illness being treated with antidepressants should be observed similarly for clinical worsening and suicidality, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases.
The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.
Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.
Families and caregivers of pediatric patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to health care providers. Such monitoring should include daily observation by families and caregivers. Prescriptions for Desyrel should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose. Families and caregivers of adults being treated for depression should be similarly advised.
A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that Desyrel is not approved for use in treating bipolar depression.
TRAZODONE HAS BEEN ASSOCIATED WITH THE OCCURRENCE OF PRIAPISM. IN MANY OF THE CASES REPORTED, SURGICAL INTERVENTION WAS REQUIRED AND, IN A SOME OF THESE CASES, PERMANENT IMPAIRMENT OF ERECTILE FUNCTION OR IMPOTENCE RESULTED. MALE PATIENTS WITH PROLONGED OR INAPPROPRIATE ERECTIONS SHOULD IMMEDIATELY DISCONTINUE THE DRUG AND CONSULT THEIR PHYSICIAN.
The detumescence of priapism and drug-induced penile erections has been accomplished by both pharmacologic, eg, the intracavernosal injection of alpha-adrenergic stimulants such as epinephrine and norepinephrine, as well as surgical procedures.2-7 Any pharmacologic or surgical procedure utilized in the treatment of priapism should be performed under the supervision of a urologist or a physician familiar with the procedure and should not be initiated without urologic consultation if the priapism has persisted for more than 24 hours.
Desyrel (trazodone hydrochloride) is not recommended for use during the initial recovery phase of myocardial infarction.
Caution should be used when administering Desyrel to patients with cardiac disease, and such patients should be closely monitored, since antidepressant drugs (including Desyrel) have been associated with the occurrence of cardiac arrhythmias. Recent clinical studies in patients with pre-existing cardiac disease indicate that Desyrel may be arrhythmogenic in some patients in that population. Arrhythmias identified include isolated PVCs, ventricular couplets, and in two patients, short episodes (3–4 beats) of ventricular tachycardia.
The possibility of suicide in seriously depressed patients is inherent in the illness and may persist until significant remission occurs. Therefore, prescriptions should be written for the smallest number of tablets consistent with good patient management.
Hypotension, including orthostatic hypotension and syncope, has been reported to occur in patients receiving Desyrel. Concomitant administration of antihypertensive therapy with Desyrel may require a reduction in the dose of the antihypertensive drug.
Little is known about the interaction between Desyrel and general anesthetics; therefore, prior to elective surgery, Desyrel should be discontinued for as long as clinically feasible.
As with all antidepressants, the use of Desyrel should be based on the consideration of the physician that the expected benefits of therapy outweigh potential risk factors.
Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with Desyrel and should counsel them in its appropriate use. A patient Medication Guide About Using Antidepressants in Children and Teenagers is available for Desyrel. The prescriber or health professional should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents. Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. The complete text of the Medication Guide is reprinted at the end of this document.
Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking Desyrel.
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down. Families and caregivers of patients should be advised to observe for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.
Because priapism has been reported to occur in patients receiving Desyrel, patients with prolonged or inappropriate penile erection should immediately discontinue the drug and consult with the physician (see WARNINGS).
Antidepressants may impair the mental and/or physical ability required for the performance of potentially hazardous tasks, such as operating an automobile or machinery; the patient should be cautioned accordingly.
Desyrel may enhance the response to alcohol, barbiturates, and other CNS depressants.
Desyrel should be given shortly after a meal or light snack. Within any individual patient, total drug absorption may be up to 20% higher when the drug is taken with food rather than on an empty stomach. The risk of dizziness/lightheadedness may increase under fasting conditions.
Occasional low white blood cell and neutrophil counts have been noted in patients receiving Desyrel. These were not considered clinically significant and did not necessitate discontinuation of the drug; however, the drug should be discontinued in any patient whose white blood cell count or absolute neutrophil count falls below normal levels. White blood cell and differential counts are recommended for patients who develop fever and sore throat (or other signs of infection) during therapy.
In vitro drug metabolism studies suggest that there is a potential for drug interactions when trazodone is given with CYP3A4 inhibitors. Ritonavir, a potent CYP3A4 inhibitor, increased the Cmax, AUC, and elimination half-life, and decreased clearance of trazodone after administration of ritonavir twice daily for 2 days. Adverse effects including nausea, hypotension, and syncope were observed when ritonavir and trazodone were co-administered. It is likely that ketoconazole, indinavir, and other CYP3A4 inhibitors such as itraconazole or nefazodone may lead to substantial increases in trazodone plasma concentrations, with the potential for adverse effects. If trazodone is used with a potent CYP3A4 inhibitor, a lower dose of trazodone should be considered.
Carbamazepine reduced plasma concentrations of trazodone when co-administered. Patients should be closely monitored to see if there is a need for an increased dose of trazodone when taking both drugs.
Increased serum digoxin or phenytoin levels have been reported to occur in patients receiving Desyrel concurrently with either of those two drugs.
It is not known whether interactions will occur between monoamine oxidase (MAO) inhibitors and Desyrel. Due to the absence of clinical experience, if MAO inhibitors are discontinued shortly before or are to be given concomitantly with Desyrel, therapy should be initiated cautiously with gradual increase in dosage until optimum response is achieved.
Concurrent administration with electroshock therapy should be avoided because of the absence of experience in this area.
There have been reports of increased and decreased prothrombin time occurring in warfarinized patients who take Desyrel.
No drug- or dose-related occurrence of carcinogenesis was evident in rats receiving Desyrel in daily oral doses up to 300 mg/kg for 18 months.
Desyrel has been shown to cause increased fetal resorption and other adverse effects on the fetus in two studies using the rat when given at dose levels approximately 30 to 50 times the proposed maximum human dose. There was also an increase in congenital anomalies in one of three rabbit studies at approximately 15 to 50 times the maximum human dose. There are no adequate and well-controlled studies in pregnant women. Desyrel should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Desyrel and/or its metabolites have been found in the milk of lactating rats, suggesting that the drug may be secreted in human milk. Caution should be exercised when Desyrel is administered to a nursing woman.
Safety and effectiveness in the pediatric population have not been established (see BOXED WARNING and WARNINGS: Clinical Worsening and Suicide Risk).
Anyone considering the use of Desyrel in a child or adolescent must balance the potential risks with the clinical need.
Because the frequency of adverse drug effects is affected by diverse factors (eg, drug dose, method of detection, physician judgment, disease under treatment, etc.) a single meaningful estimate of adverse event incidence is difficult to obtain. This problem is illustrated by the variation in adverse event incidence observed and reported from the inpatients and outpatients treated with Desyrel. It is impossible to determine precisely what accounts for the differences observed.
The table below is presented solely to indicate the relative frequency of adverse events reported in representative controlled clinical studies conducted to evaluate the safety and efficacy of Desyrel® (trazodone hydrochloride).
The figures cited cannot be used to predict precisely the incidence of untoward events in the course of usual medical practice where patient characteristics and other factors often differ from those which prevailed in the clinical trials. These incidence figures, also, cannot be compared with those obtained from other clinical studies involving related drug products and placebo as each group of drug trials is conducted under a different set of conditions.
| Treatment-Emergent Symptom Incidence | ||||
| Inpts. | Outpts. | |||
| D | P | D | P | |
| * Incidence less than 1% | ||||
| D = Desyrel P = PLACEBO | ||||
| Number of Patients | 142 | 95 | 157 | 158 |
| % of Patients Reporting | ||||
| Allergic | ||||
| Skin Condition/Edema | 2.8 | 1.1 | 7.0 | 1.3 |
| Autonomic | ||||
| Blurred Vision | 6.3 | 4.2 | 14.7 | 3.8 |
| Constipation | 7.0 | 4.2 | 7.6 | 5.7 |
| Dry Mouth | 14.8 | 8.4 | 33.8 | 20.3 |
| Cardiovascular | ||||
| Hypertension | 2.1 | 1.1 | 1.3 | * |
| Hypotension | 7.0 | 1.1 | 3.8 | 0.0 |
| Shortness of Breath | * | 1.1 | 1.3 | 0.0 |
| Syncope | 2.8 | 2.1 | 4.5 | 1.3 |
| Tachycardia/Palpitations | 0.0 | 0.0 | 7.0 | 7.0 |
| CNS | ||||
| Anger/Hostility | 3.5 | 6.3 | 1.3 | 2.5 |
| Confusion | 4.9 | 0.0 | 5.7 | 7.6 |
| Decreased Concentration | 2.8 | 2.1 | 1.3 | 0.0 |
| Disorientation | 2.1 | 0.0 | * | 0.0 |
| Dizziness/Lightheadedness | 19.7 | 5.3 | 28.0 | 15.2 |
| Drowsiness | 23.9 | 6.3 | 40.8 | 19.6 |
| Excitement | 1.4 | 1.1 | 5.1 | 5.7 |
| Fatigue | 11.3 | 4.2 | 5.7 | 2.5 |
| Headache | 9.9 | 5.3 | 19.8 | 15.8 |
| Insomnia | 9.9 | 10.5 | 6.4 | 12.0 |
| Impaired Memory | 1.4 | 0.0 | * | * |
| Nervousness | 14.8 | 10.5 | 6.4 | 8.2 |
| Gastrointestinal | ||||
| Abdominal/Gastric Disorder | 3.5 | 4.2 | 5.7 | 4.4 |
| Bad Taste in Mouth | 1.4 | 0.0 | 0.0 | 0.0 |
| Diarrhea | 0.0 | 1.1 | 4.5 | 1.9 |
| Nausea/Vomiting | 9.9 | 1.1 | 12.7 | 9.5 |
| Musculoskeletal | ||||
| Musculoskeletal Aches/Pains | 5.6 | 3.2 | 5.1 | 2.5 |
| Neurological | ||||
| Incoordination | 4.9 | 0.0 | 1.9 | 0.0 |
| Paresthesia | 1.4 | 0.0 | 0.0 | * |
| Tremors | 2.8 | 1.1 | 5.1 | 3.8 |
| Sexual Function | ||||
| Decreased Libido | * | 1.1 | 1.3 | * |
| Other | ||||
| Decreased Appetite | 3.5 | 5.3 | 0.0 | * |
| Eyes Red/Tired/Itching | 2.8 | 0.0 | 0.0 | 0.0 |
| Head Full-Heavy | 2.8 | 0.0 | 0.0 | 0.0 |
| Malaise | 2.8 | 0.0 | 0.0 | 0.0 |
| Nasal/Sinus Congestion | 2.8 | 0.0 | 5.7 | 3.2 |
| Nightmares/Vivid Dreams | * | 1.1 | 5.1 | 5.7 |
| Sweating/Clamminess | 1.4 | 1.1 | * | * |
| Tinnitus | 1.4 | 0.0 | 0.0 | * |
| Weight Gain | 1.4 | 0.0 | 4.5 | 1.9 |
| Weight Loss | * | 3.2 | 5.7 | 2.5 |
Occasional sinus bradycardia has occurred in long-term studies.
In addition to the relatively common (ie, greater than 1%) untoward events enumerated above, the following adverse events have been reported to occur in association with the use of Desyrel® (trazodone hydrochloride) in the controlled clinical studies: akathisia, allergic reaction, anemia, chest pain, delayed urine flow, early menses, flatulence, hallucinations/delusions, hematuria, hypersalivation, hypomania, impaired speech, impotence, increased appetite, increased libido, increased urinary frequency, missed periods, muscle twitches, numbness, and retrograde ejaculation.
Although the following adverse reactions have been reported in Desyrel users, the causal association has neither been confirmed nor refuted.
Voluntary reports received since market introduction include the following: abnormal dreams, agitation, alopecia, anxiety, aphasia, apnea, ataxia, breast enlargement or engorgement, cardiospasm, cerebrovascular accident, chills, cholestatis, clitorism, congestive heart failure, diplopia, edema, extrapyramidal symptoms, grand mal seizures, hallucinations, hemolytic anemia, hirsutism, hyperbilirubinemia, increased amylase, increased salivation, insomnia, leukocytosis, leukonychia, jaundice, lactation, liver enzyme alterations, methemoglobinemia, nausea/vomiting (most frequently), paresthesia, paranoid reaction, priapism (See WARNINGS and PRECAUTIONS:Information for Patients; some patients have required surgical intervention), pruritus, psoriasis, psychosis, rash, stupor, inappropriate ADH syndrome, tardive dyskinesia, unexplained death, urinary incontinence, urinary retention, urticaria, vasodilation, vertigo and weakness.
Cardiovascular system effects which have been reported include the following: conduction block, orthostatic hypotension and syncope, palpitations, bradycardia, atrial fibrillation, myocardial infarction, cardiac arrest, arrhythmia, and ventricular ectopic activity, including ventricular tachycardia (see WARNINGS).
The oral LD50 of the drug is 610 mg/kg in mice, 486 mg/kg in rats, and 560 mg/kg in rabbits.
Death from overdose has occurred in patients ingesting Desyrel (trazodone hydrochloride) and other drugs concurrently (namely, alcohol; alcohol + chloral hydrate + diazepam; amobarbital; chlordiazepoxide; or meprobamate).
The most severe reactions reported to have occurred with overdose of Desyrel alone have been priapism, respiratory arrest, seizures, and EKG changes. The reactions reported most frequently have been drowsiness and vomiting. Overdosage may cause an increase in incidence or severity of any of the reported adverse reactions (see ADVERSE REACTIONS).
There is no specific antidote for Desyrel. Treatment should be symptomatic and supportive in the case of hypotension or excessive sedation. Any patient suspected of having taken an overdose should have the stomach emptied by gastric lavage. Forced diuresis may be useful in facilitating elimination of the drug.
The dosage should be initiated at a low level and increased gradually, noting the clinical response and any evidence of intolerance. Occurrence of drowsiness may require the administration of a major portion of the daily dose at bedtime or a reduction of dosage. Desyrel should be taken shortly after a meal or light snack. Symptomatic relief may be seen during the first week, with optimal antidepressant effects typically evident within two weeks. Twenty-five percent of those who respond to Desyrel require more than two weeks (up to four weeks) of drug administration.
An initial dose of 150 mg/day in divided doses is suggested. The dose may be increased by 50 mg/day every three to four days. The maximum dose for outpatients usually should not exceed 400 mg/day in divided doses. Inpatients (ie, more severely depressed patients) may be given up to but not in excess of 600 mg/day in divided doses.
Dosage during prolonged maintenance therapy should be kept at the lowest effective level. Once an adequate response has been achieved, dosage may be gradually reduced, with subsequent adjustment depending on therapeutic response.
Although there has been no systematic evaluation of the efficacy of Desyrel beyond six weeks, it is generally recommended that a course of antidepressant drug treatment should be continued for several months.
Desyrel® (trazodone hydrochloride)
The 50 mg tablets are white, round, scored tablets debossed with PLIVA;433. They are available as follows:
NDC 68387-165-60
bottles of 60 tablets
Store at room temperature. Protect from temperatures above 104°F (40°C).
Dispense in tight, light-resistant container (USP).
Desyrel® (Trazodone Hydrochloride) TABLETS
Medication Guide
About Using Antidepressants in Children and Teenagers
What is the most important information I should know if my child is being prescribed an antidepressant?
Parents or guardians need to think about 4 important things when their child is prescribed an antidepressant:
1. There is a Risk of Suicidal Thoughts or Actions
Children and teenagers sometimes think about suicide, and many report trying to kill themselves.
Antidepressants increase suicidal thoughts and actions in some children and teenagers. But suicidal thoughts and actions can also be caused by depression, a serious medical condition that is commonly treated with antidepressants. Thinking about killing yourself or trying to kill yourself is called suicidality or being suicidal.
A large study combined the results of 24 different studies of children and teenagers with depression or other illnesses. In these studies, patients took either a placebo (sugar pill) or an antidepressant for 1 to 4 months. No one committed suicide in these studies, but some patients became suicidal. On sugar pills, 2 out of every 100 became suicidal. On the antidepressants, 4 out of every 100 patients became suicidal.
For some children and teenagers, the risk of suicidal actions may be especially high. These include patients with
If any of these are present, make sure you tell your healthcare provider before your child takes an antidepressant.
2. How to Try to Prevent Suicidal Thoughts and Actions
To try to prevent suicidal thought and actions in your child, pay close attention to changes in her or his moods or actions, especially if the changes occur suddenly. Other important people in your child’s life can help by paying attention as well (eg, your child, brothers and sisters, teachers, and other important people). The changes to look out for are listed in Section 3, on what to watch for.
Whenever an antidepressant is started or its dose is changed, pay close attention to your child.
After starting an antidepressant, your child should generally see his or her healthcare provider:
You should call your child’s healthcare provider between visits if needed.
3. You Should Watch For Certain Signs if Your Child is Taking an Antidepressant
Contact your child’s healthcare provider right away if your child exhibits any of the following signs for the first time, or if they seem worse, or worry you, your child, or your child’s teacher:
Never let your child stop taking an antidepressant without first talking to his or healthcare provider. Stopping an antidepressant suddenly can cause other symptoms.
4. There are Benefits and Risks When Using Antidepressants
Antidepressants are used to treat depression and other illnesses. Depression and other illnesses can lead to suicide. In some children and teenagers, treatment with an antidepressant increases suicidal thinking or actions. It is important to discuss all the risks of treating depression and also the risks of not treating it. You and your child should discuss all treatment choices with your healthcare provider, not just the use of antidepressants.
Other side effects can occur with antidepressants (see section below).
Of all antidepressants, only fluoxetine (Prozac®) has been FDA approved to treat pediatric depression.
For obsessive compulsive disorder in children and teenagers, FDA has approved only fluoxetine (Prozac®), sertraline (Zoloft®), fluvoxamine, and clomipramine (Anafranil®).
Your healthcare provider may suggest other antidepressants based on the past experience of your child or other family members.
Is this all I need to know if my child is being prescribed an antidepressant?
No. This is a warning about the risk for suicidality. Other side effects can occur with antidepressants. Be sure to ask your healthcare provider to explain all the side effects of the particular drug he or she is prescribing. Also ask about drugs to avoid when taking an antidepressant. Ask your healthcare provider or pharmacist where to find more information.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Prozac® is a registered trademark of Eli Lilly and Company
Zoloft® is a registered trademark of Pfizer Pharmaceuticals
Anafranil® is a registered trademark of Mallinckrodt Inc.
This Medication Guide has been approved by the U. S. Food and Drug Administration for all antidepressants.
Manufactured for:
Keltman Pharmaceuticals Inc.
1 Lakeland Square, Suite A
Flowood, Ms 39232
R4
Package Label - Principal Display Panel – 60-count Bottle, 50 mg Tablets
NDC 68387-165-60
Rx Only
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