DRUGS & SUPPLEMENTS

Mylan-Triazolam

advertisement
How often in a day do you take medicine? How many times?

Mylan-Triazolam uses


INDICATIONS AND USAGE

Mylan-Triazolam Tablets are indicated for the short-term treatment of insomnia (generally 7 to 10 days). Use for more than 2 to 3 weeks requires complete reevaluation of the patient.

Prescriptions for Mylan-Triazolam should be written for short-term use (7 to 10 days) and it should not be prescribed in quantities exceeding a 1-month supply.

CONTRAINDICATIONS

Mylan-Triazolam Tablets are contraindicated in patients with known hypersensitivity to this drug or other benzodiazepines.

Benzodiazepines may cause fetal damage when administered during pregnancy. An increased risk of congenital malformations associated with the use of diazepam and chlordiazepoxide during the first trimester of pregnancy has been suggested in several studies. Transplacental distribution has resulted in neonatal CNS depression following the ingestion of therapeutic doses of a benzodiazepine hypnotic during the last weeks of pregnancy.

Mylan-Triazolam Tablets are contraindicated in pregnant women. If there is a likelihood of the patient becoming pregnant while receiving Mylan-Triazolam Tablets, she should be warned of the potential risk to the fetus. Patients should be instructed to discontinue the drug prior to becoming pregnant. The possibility that a woman of childbearing potential may be pregnant at the time of institution of therapy should be considered.

Mylan-Triazolam Tablets are contraindicated with ketoconazole, itraconazole, and nefazodone, medications that significantly impair the oxidative metabolism mediated by cytochrome P450 3A (CYP 3A).

WARNINGS

Because sleep disturbances may be the presenting manifestation of a physical and/or psychiatric disorder, symptomatic treatment of insomnia should be initiated only after a careful evaluation of the patient. The failure of insomnia to remit after 7 to 10 days of treatment may indicate the presence of a primary psychiatric and/or medical illness that should be evaluated. Worsening of insomnia or the emergence of new thinking or behavior abnormalities may be the consequence of an unrecognized psychiatric or physical disorder. Such findings have emerged during the course of treatment with sedative-hypnotic drugs. Because some of the important adverse effects of sedative-hypnotics appear to be dose related, it is important to use the smallest possible effective dose, especially in the elderly.

Complex behaviors such as “sleep-driving” (i.e., driving while not fully awake after ingestion of a sedative-hypnotic, with amnesia for the event) have been reported. These events can occur in sedative-hypnotic-naïve as well as in sedative-hypnotic-experienced persons. Although behaviors such as sleep-driving may occur with sedative-hypnotics alone at therapeutic doses, the use of alcohol and other CNS depressants with sedative-hypnotics appears to increase the risk of such behaviors, as does the use of sedative-hypnotics at doses exceeding the maximum recommended dose. Due to the risk to the patient and the community, discontinuation of sedative-hypnotics should be strongly considered for patients who report a “sleep-driving” episode.

Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative-hypnotic. As with sleep-driving, patients usually do not remember these events.

Severe Anaphylactic and Anaphylactoid Reactions

Rare cases of angioedema involving the tongue, glottis or larynx have been reported in patients after taking the first or subsequent doses of sedative-hypnotics, including Mylan-Triazolam. Some patients have had additional symptoms such as dyspnea, throat closing, or nausea and vomiting that suggest anaphylaxis. Some patients have required medical therapy in the emergency department. If angioedema involves the tongue, glottis or larynx, airway obstruction may occur and be fatal. Patients who develop angioedema after treatment with Mylan-Triazolam should not be rechallenged with the drug.

Central Nervous System Manifestations

An increase in daytime anxiety has been reported for Mylan-Triazolam after as few as 10 days of continuous use. In some patients this may be a manifestation of interdose withdrawal. If increased daytime anxiety is observed during treatment, discontinuation of treatment may be advisable.

A variety of abnormal thinking and behavior changes have been reported to occur in association with the use of benzodiazepine hypnotics including Mylan-Triazolam. Some of these changes may be characterized by decreased inhibition, e.g., aggressiveness and extroversion that seem excessive, similar to that seen with alcohol and other CNS depressants (e.g., sedative/hypnotics). Other kinds of behavioral changes have also been reported, for example, bizarre behavior, agitation, hallucinations, depersonalization. In primarily depressed patients, the worsening of depression, including suicidal thinking, has been reported in association with the use of benzodiazepines.

It can rarely be determined with certainty whether a particular instance of the abnormal behaviors listed above is drug induced, spontaneous in origin, or a result of an underlying psychiatric or physical disorder. Nonetheless, the emergence of any new behavioral sign or symptom of concern requires careful and immediate evaluation.

Because of its depressant CNS effects, patients receiving Mylan-Triazolam should be cautioned against engaging in hazardous occupations requiring complete mental alertness such as operating machinery or driving a motor vehicle. For the same reason, patients should be cautioned about the concomitant ingestion of alcohol and other CNS depressant drugs during treatment with Mylan-Triazolam tablets.

As with some, but not all benzodiazepines, anterograde amnesia of varying severity and paradoxical reactions have been reported following therapeutic doses of Mylan-Triazolam. Data from several sources suggest that anterograde amnesia may occur at a higher rate with Mylan-Triazolam than with other benzodiazepine hypnotics.

Mylan-Triazolam Interaction With Drugs That Inhibit Metabolism Via Cytochrome P450 3A

The initial step in Mylan-Triazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A (CYP 3A). Drugs that inhibit this metabolic pathway may have a profound effect on the clearance of Mylan-Triazolam. Consequently, Mylan-Triazolam should be avoided in patients receiving very potent inhibitors of CYP 3A. With drugs inhibiting CYP 3A to a lesser but still significant degree, Mylan-Triazolam should be used only with caution and consideration of appropriate dosage reduction. For some drugs, an interaction with Mylan-Triazolam has been quantified with clinical data; for other drugs, interactions are predicted from in vitro data and/or experience with similar drugs in the same pharmacologic class.

The following are examples of drugs known to inhibit the metabolism of Mylan-Triazolam and/or related benzodiazepines, presumably through inhibition of CYP 3A.

Potent CYP 3A Inhibitors

Potent inhibitors of CYP 3A that should not be used concomitantly with Mylan-Triazolam include ketoconazole, itraconazole, and nefazodone. Although data concerning the effects of azole-type antifungal agents other than ketoconazole and itraconazole on Mylan-Triazolam metabolism are not available, they should be considered potent CYP 3A inhibitors, and their co-administration with Mylan-Triazolam is not recommended.

Drugs Demonstrated to be CYP 3A Inhibitors on the Basis of Clinical Studies Involving Mylan-Triazolam (caution and consideration of dose reduction are recommended during co-administration with Mylan-Triazolam)

Macrolide Antibiotics

Co-administration of erythromycin increased the maximum plasma concentration of Mylan-Triazolam by 46%, decreased clearance by 53%, and increased half-life by 35%; caution and consideration of appropriate Mylan-Triazolam dose reduction are recommended. Similar caution should be observed during co-administration with clarithromycin and other macrolide antibiotics.

Cimetidine

Co-administration of cimetidine increased the maximum plasma concentration of Mylan-Triazolam by 51%, decreased clearance by 55%, and increased half-life by 68%; caution and consideration of appropriate Mylan-Triazolam dose reduction are recommended.

Other Drugs Possibly Affecting Mylan-Triazolam Metabolism

Other drugs possibly affecting Mylan-Triazolam metabolism by inhibition of CYP 3A are discussed in the PRECAUTIONS section.

advertisement

PRECAUTIONS

General

In elderly and/or debilitated patients it is recommended that treatment with Mylan-Triazolam tablets be initiated at 0.125 mg to decrease the possibility of development of oversedation, dizziness, or impaired coordination.

Some side effects reported in association with the use of Mylan-Triazolam appear to be dose related. These include drowsiness, dizziness. light-headedness, and amnesia.

The relationship between dose and what may be more serious behavioral phenomena is less certain. Specifically, some evidence, based on spontaneous marketing reports, suggests that confusion, bizarre or abnormal behavior, agitation, and hallucinations may also be dose related, but this evidence is inconclusive. In accordance with good medical practice it is recommended that therapy be initiated at the lowest effective dose.

Cases of “traveler’s amnesia” have been reported by individuals who have taken Mylan-Triazolam to induce sleep while traveling, such as during an airplane flight. In some of these cases, insufficient time was allowed for the sleep period prior to awakening and before beginning activity. Also, the concomitant use of alcohol may have been a factor in some cases.

Caution should be exercised if Mylan-Triazolam is prescribed to patients with signs or symptoms of depression that could be intensified by hypnotic drugs. Suicidal tendencies may be present in such patients and protective measures may be required. Intentional overdosage is more common in these patients, and the least amount of drug that is feasible should be available to the patient at any one time.

The usual precautions should be observed in patients with impaired renal or hepatic function, chronic pulmonary insufficiency, and sleep apnea. In patients with compromised respiratory function, respiratory depression and apnea have been reported infrequently.

Information for Patients

The Medication Guide for patients is included with this insert. To assure safe and effective use of Mylan-Triazolam, the information and instructions provided in this Medication Guide should be discussed with patients.

“Sleep-Driving” and Other Complex Behaviors

There have been reports of people getting out of bed after taking a sedative-hypnotic and driving their cars while not fully awake, often with no memory of the event. If a patient experiences such an episode, it should be reported to his or her doctor immediately, since “sleep-driving” can be dangerous. This behavior is more likely to occur when sedative-hypnotics are taken with alcohol or other central nervous system depressants. Other complex behaviors (e.g., preparing and eating food, making phone calls, or having sex) have been reported in patients who are not fully awake after taking a sedative hypnotic. As with sleep-driving, patients usually do not remember these events.

Laboratory Tests

Laboratory tests are not ordinarily required in otherwise healthy patients.

Drug Interactions

Both pharmacodynamic and pharmacokinetic interactions have been reported with benzodiazepines. In particular, Mylan-Triazolam produces additive CNS depressant effects when co-administered with other psychotropic medications, anticonvulsants, antihistamines, ethanol, and other drugs which themselves produce CNS depression.

Drugs that Inhibit Mylan-Triazolam Metabolism Via Cytochrome P450 3A

The initial step in Mylan-Triazolam metabolism is hydroxylation catalyzed by cytochrome P450 3A. Drugs which inhibit this metabolic pathway may have a profound effect on the clearance of Mylan-Triazolam. Mylan-Triazolam is contraindicated with ketoconazole, itraconazole, and nefazodone.

Drugs and Other Substances Demonstrated to be CYP 3A Inhibitors of Possible Clinical Significance on the Basis of Clinical Studies Involving Mylan-Triazolam (caution is recommended during co-administration with Mylan-Triazolam)

Isoniazid

Co-administration of isoniazid increased the maximum plasma concentration of Mylan-Triazolam by 20%, decreased clearance by 42%, and increased half-life by 31%.

Oral Contraceptives

Co-administration of oral contraceptives increased maximum plasma concentration by 6%, decreased clearance by 32%, and increased half-life by 16%.

Grapefruit Juice

Co-administration of grapefruit juice increased the maximum plasma concentration of Mylan-Triazolam by 25%, increased the area under the concentration curve by 48%, and increased half-life by 18%.

Drugs Demonstrated to be CYP 3A Inhibitors on the Basis of Clinical Studies Involving Benzodiazepines Metabolized Similarly to Mylan-Triazolam or on the Basis of In Vitro Studies with Mylan-Triazolam or Other Benzodiazepines

Available data from clinical studies of benzodiazepines other than Mylan-Triazolam suggest a possible drug interaction with Mylan-Triazolam for the following: fluvoxamine, diltiazem, and verapamil. Data from in vitro studies of Mylan-Triazolam suggest a possible drug interaction with Mylan-Triazolam for the following: sertraline and paroxetine. Data from in vitro studies of benzodiazepines other than Mylan-Triazolam suggest a possible drug interaction with Mylan-Triazolam for the following: ergotamine, cyclosporine, amiodarone, nicardipine, and nifedipine. Caution is recommended during co-administration of any of these drugs with Mylan-Triazolam.

Drugs that Affect Mylan-Triazolam Pharmacokinetics by Other Mechanisms

Ranitidine

Co-administration of ranitidine increased the maximum plasma concentration of Mylan-Triazolam by 30%, increased the area under the concentration curve by 27%, and increased half-life by 3.3%. Caution is recommended during co-administration with Mylan-Triazolam.

Carcinogenesis, Mutagenesis, Impairment of Fertility

No evidence of carcinogenic potential was observed in mice during a 24-month study with Mylan-Triazolam in doses up to 4,000 times the human dose.

Pregnancy

Teratogenic Effects

Pregnancy Category X

.

Non-Teratogenic Effects

It is to be considered that the child born of a mother who is on benzodiazepines may be at some risk for withdrawal symptoms from the drug, during the postnatal period. Also, neonatal flaccidity has been reported in an infant born of a mother who had been receiving benzodiazepines.

Nursing Mothers

Human studies have not been performed; however, studies in rats have indicated that Mylan-Triazolam and its metabolites are secreted in milk. Therefore, administration of Mylan-Triazolam to nursing mothers is not recommended.

Pediatric Use

Safety and effectiveness of Mylan-Triazolam in individuals below 18 years of age have not been established.

Geriatric Use

The elderly are especially susceptible to the dose related adverse effects of Mylan-Triazolam. They exhibit higher plasma Mylan-Triazolam concentrations due to reduced clearance of the drug as compared with younger subjects at the same dose. To minimize the possibility of development of oversedation, the smallest effective dose should be used.

Tolerance/Withdrawal Phenomena

Some loss of effectiveness or adaptation to the sleep inducing effects of these medications may develop after nightly use for more than a few weeks and there may be a degree of dependence that develops. For the benzodiazepine sleeping pills that are eliminated quickly from the body, a relative deficiency of the drug may occur at some point in the interval between each night’s use. This can lead to (1) increased wakefulness during the last third of the night, and (2) the appearance of increased signs of daytime anxiety or nervousness. These two events have been reported in particular for Mylan-Triazolam.

There can be more severe ‘withdrawal’ effects when a benzodiazepine sleeping pill is stopped. Such effects can occur after discontinuing these drugs following use for only a week or two, but may be more common and more severe after longer periods of continuous use. One type of withdrawal phenomenon is the occurrence of what is known as ‘rebound insomnia’. That is, on the first few nights after the drug is stopped, insomnia is actually worse than before the sleeping pill was given. Other withdrawal phenomena following abrupt stopping of benzodiazepine sleeping pills range from mild unpleasant feelings to a major withdrawal syndrome which may include abdominal and muscle cramps, vomiting, sweating, tremor, and rarely, convulsions.

advertisement

ADVERSE REACTIONS

During placebo-controlled clinical studies in which 1,003 patients received Mylan-Triazolam tablets, the most troublesome side effects were extensions of the pharmacologic activity of Mylan-Triazolam, e.g., drowsiness, dizziness, or light-headedness.

The figures cited below are estimates of untoward clinical event incidence among subjects who participated in the relatively short duration (i.e., 1 to 42 days) placebo-controlled clinical trials of Mylan-Triazolam. The figures 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 in clinical trials. These figures 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.

Comparison of the cited figures, however, can provide the prescriber with some basis of estimating the relative contributions of drug and nondrug factors to the untoward event incidence rate in the population studied. Even this use must be approached cautiously, as a drug may relieve a symptom in one patient while inducing it in others. (For example, an anticholinergic, anxiolytic drug may relieve dry mouth [a sign of anxiety] in some subjects but induce it [an untoward event] in others.)

Mylan-Triazolam Placebo
Number of Patients 1003 997
% Patients Reporting:
Central Nervous System
Drowsiness 14 6.4
Headache 9.7 8.4
Dizziness 7.8 3.1
Nervousness 5.2 4.5
Light-headedness 4.9 0.9
Coordination disorders/ataxia 4.6 0.8
Gastrointestinal
Nausea/vomiting 4.6 3.7

In addition to the relatively common (i.e., 1% or greater) untoward events enumerated above, the following adverse events have been reported less frequently (i.e., 0.9% to 0.5%): euphoria, tachycardia, tiredness, confusional states/memory impairment, cramps/pain, depression, visual disturbances.

Rare (i.e., less than 0.5%) adverse reactions included constipation, taste alterations, diarrhea, dry mouth, dermatitis/allergy, dreaming/nightmares, insomnia, paresthesia, tinnitus, dysesthesia, weakness, congestion, death from hepatic failure in a patient also receiving diuretic drugs.

In addition to these untoward events for which estimates of incidence are available, the following adverse events have been reported in association with the use of Mylan-Triazolam and other benzodiazepines: amnestic symptoms (anterograde amnesia with appropriate or inappropriate behavior), confusional states (disorientation, derealization, depersonalization, and/or clouding of consciousness), dystonia, anorexia, fatigue, sedation, slurred speech, jaundice, pruritus, dysarthria, changes in libido, menstrual irregularities, incontinence, and urinary retention. Other factors may contribute to some of these reactions, e.g., concomitant intake of alcohol or other drugs, sleep deprivation, an abnormal premorbid state, etc.

Other events reported include: paradoxical reactions such as stimulation, mania, an agitational state (restlessness, irritability, and excitation), increased muscle spasticity, sleep disturbances, hallucinations, delusions, aggressiveness, falling, somnambulism, syncope, inappropriate behavior and other adverse behavioral effects. Should these occur, use of the drug should be discontinued.

The following events have also been reported: chest pain, burning tongue/glossitis/stomatitis.

Laboratory analyses were performed on all patients participating in the clinical program for Mylan-Triazolam. The following incidences of abnormalities were observed in patients receiving Mylan-Triazolam and the corresponding placebo group. None of these changes were considered to be of physiological significance.

Mylan-Triazolam Placebo
Number of patients 380 361
% of Patients Reporting Low High Low High
Hematology
Hematocrit * * * *
Hemoglobin * * * *
Total WBC count 1.7 2.1 * 1.3
Neutrophil count 1.5 1.5 3.3 1
Lymphocyte count 2.3 4 3.1 3.8
Monocyte count 3.6 * 4.4 1.5
Eosinophil count 10.2 3.2 9.8 3.4
Basophil count 1.7 2.1 * 1.8
Urinalysis
Albumin - 1.1 - *
Sugar - * - *
RBC/HPF - 2.9 - 2.9
WBC/HPF - 11.7 - 7.9
Blood chemistry
Creatinine 2.4 1.9 3.6 1.5
Bilirubin * 1.5 1 *
SGOT * 5.3 * 4.5
Alkaline phosphatase * 2.2 * 2.6

*Less than 1%

When treatment with Mylan-Triazolam is protracted, periodic blood counts, urinalysis, and blood chemistry analyses are advisable.

Minor changes in EEG patterns, usually low-voltage fast activity, have been observed in patients during therapy with Mylan-Triazolam and are of no known significance.

advertisement

DRUG ABUSE AND DEPENDENCE

Abuse and addiction are separate and distinct from physical dependence and tolerance. Abuse is characterized by misuse of the drug for non-medical purposes, often in combination with other psychoactive substances. Physical dependence is a state of adaptation that is manifested by a specific withdrawal syndrome that can be produced by abrupt cessation, rapid dose reduction, decreasing blood level of the drug and/or administration of an antagonist. Tolerance is a state of adaptation in which exposure to a drug induces changes that result in a diminution of one or more of the drug’s effects over time. Tolerance may occur to both the desired and undesired effects of drugs and may develop at different rates for different effects.

Addiction is a primary, chronic, neurobiological disease with genetic, psychosocial, and environmental factors influencing its development and manifestations. It is characterized by behaviors that include one or more of the following: impaired control over drug use, compulsive use, continued use despite harm, and craving. Drug addiction is a treatable disease, utilizing a multidisciplinary approach, but relapse is common.

Controlled Substance

Mylan-Triazolam is a controlled substance under the Controlled Substance Act, and Mylan-Triazolam tablets have been assigned to Schedule IV.

Abuse, Dependence, and Withdrawal

Withdrawal symptoms, similar in character to those noted with barbiturates and alcohol (convulsions, tremor, abdominal and muscle cramps, vomiting, sweating, dysphoria, perceptual disturbances and insomnia), have occurred following abrupt discontinuance of benzodiazepines, including Mylan-Triazolam. The more severe symptoms are usually associated with higher dosages and longer usage, although patients at therapeutic dosages given for as few as 1 to 2 weeks can also have withdrawal symptoms and in some patients there may be withdrawal symptoms (daytime anxiety, agitation) between nightly doses. Consequently, abrupt discontinuation should be avoided and a gradual dosage tapering schedule is recommended in any patient taking more than the lowest dose for more than a few weeks. The recommendation for tapering is particularly important in any patient with a history of seizure.

The risk of dependence is increased in patients with a history of alcoholism, drug abuse, or in patients with marked personality disorders. Such dependence-prone individuals should be under careful surveillance when receiving Mylan-Triazolam. As with all hypnotics, repeat prescriptions should be limited to those who are under medical supervision.

advertisement

OVERDOSAGE

Because of the potency of Mylan-Triazolam, some manifestations of overdosage may occur at 2 mg, four times the maximum recommended therapeutic dose (0.5 mg).

Manifestations of overdosage with Mylan-Triazolam tablets include somnolence, confusion, impaired coordination, slurred speech, and ultimately, coma. Respiratory depression and apnea have been reported with overdosages of Mylan-Triazolam. Seizures have occasionally been reported after overdosages.

Death has been reported in association with overdoses of Mylan-Triazolam by itself, as it has with other benzodiazepines. In addition, fatalities have been reported in patients who have overdosed with a combination of a single benzodiazepine, including Mylan-Triazolam, and alcohol; benzodiazepine and alcohol levels seen in some of these cases have been lower than those usually associated with reports of fatality with either substance alone.

As in all cases of drug overdosage, respiration, pulse, and blood pressure should be monitored and supported by general measures when necessary. Immediate gastric lavage should be performed. An adequate airway should be maintained. Intravenous fluids may be administered.

Flumazenil, a specific benzodiazepine receptor antagonist, is indicated for the complete or partial reversal of the sedative effects of benzodiazepines and may be used in situations when an overdose with a benzodiazepine is known or suspected. Prior to the administration of flumazenil, necessary measures should be instituted to secure airway, ventilation, and intravenous access. Flumazenil is intended as an adjunct to, not as a substitute for, proper management of benzodiazepine overdose. Patients treated with flumazenil should be monitored for re-sedation, respiratory depression, and other residual benzodiazepine effects for an appropriate period after treatment. The prescriber should be aware of a risk of seizure in association with flumazenil treatment, particularly in long-term benzodiazepine users and in cyclic antidepressant overdose. The complete flumazenil package insert including CONTRAINDICATIONS, WARNINGS, and PRECAUTIONS should be consulted prior to use.

Experiments in animals have indicated that cardiopulmonary collapse can occur with massive intravenous doses of Mylan-Triazolam. This could be reversed with positive mechanical respiration and the intravenous infusion of norepinephrine bitartrate or metaraminol bitartrate. Hemodialysis and forced diuresis are probably of little value. As with the management of intentional overdosage with any drug, the physician should bear in mind that multiple agents may have been ingested by the patient.

The oral LD50 in mice is greater than 1,000 mg/kg and in rats is greater than 5,000 mg/kg.

DOSAGE AND ADMINISTRATION

It is important to individualize the dosage of Mylan-Triazolam tablets for maximum beneficial effect and to help avoid significant adverse effects.

The recommended dose for most adults is 0.25 mg before retiring. A dose of 0.125 mg may be found to be sufficient for some patients (e.g., low body weight). A dose of 0.5 mg should be used only for exceptional patients who do not respond adequately to a trial of a lower dose since the risk of several adverse reactions increases with the size of the dose administered. A dose of 0.5 mg should not be exceeded.

In geriatric and/or debilitated patients the recommended dosage range is 0.125 mg to 0.25 mg. Therapy should be initiated at 0.125 mg in these groups and the 0.25 mg dose should be used only for exceptional patients who do not respond to a trial of the lower dose. A dose of 0.25 mg should not be exceeded in these patients.

As with all medications, the lowest effective dose should be used.

HOW SUPPLIED

Mylan-Triazolam Tablets, USP

0.125 mg white, unscored, oval-shaped tablets.

NDC 0054-4858-51: Bottles of 10 tablets.

NDC 0054-8858-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

0.25 mg blue, scored, oval-shaped tablets (Identified 54 620).

NDC 0054-4859-29: Bottles of 500 tablets.

NDC 0054-4859-51: Bottles of 10 tablets.

NDC 0054-8859-25: Unit dose, 10 tablets per strip, 10 strips per shelf pack, 10 shelf packs per shipper.

Storage

Store at 25°C (77°F); excursions permitted to 15° to 30°C (59° to 86°F). Dispense in a tight container, as defined in the USP/NF.

MEDICATION GUIDE

Read this Medication Guide before you start taking Mylan-Triazolam and each time you get a refill.

There may be new information. This Medication Guide does not take the place of talking

to your doctor about your medical condition or treatment. You and your doctor should talk

about the SEDATIVE-HYPNOTIC when you start taking it and at regular checkups.

What is the most important information I should know about Mylan-Triazolam?

After taking a SEDATIVE-HYPNOTIC, you may get up out of bed while not being fully awake and do an activity that you do not know you are doing. The next morning, you may not remember that you did anything during the night. You have a higher chance for doing these activities if you drink alcohol or take other medicines that make you sleepy with a SEDATIVE-HYPNOTIC. Reported activities include:

- driving a car (“sleep-driving”)

- making and eating food

- talking on the phone

- having sex

- sleep-walking

Important:

1.Take Mylan-Triazolam exactly as prescribed

- Do not take more Mylan-Triazolam than prescribed.

- Take Mylan-Triazolam right before you get in bed, not sooner.

2.Do not take Mylan-Triazolam if you:

- drink alcohol

- take other medicines that can make you sleepy. Talk to your doctor about all of your medicines. Your doctor will tell you if you can take Mylan-Triazolam with your other medicines

- cannot get a full night’s sleep

- are pregnant or considering becoming pregnant

3.Call your doctor right away if you find out that you have done any of the above activities after taking Mylan-Triazolam.

What are SEDATIVE-HYPNOTICS?

SEDATIVE-HYPNOTICs are sleep medicines. SEDATIVE-HYPNOTICs are used in adults for the treatment of the symptom of trouble falling asleep due to insomnia.

Mylan-Triazolam is not indicated for use in children.

Elderly patients are especially susceptible to dose related adverse effects when taking Mylan-Triazolam.


Mylan-Triazolam is a federally controlled substance (C-IV) because it can be abused or lead to dependence. Keep Mylan-Triazolam in a safe place to prevent misuse and abuse. Selling or giving away Mylan-Triazolam may harm others, and is against the law. Tell your doctor if you have ever abused or been dependent on alcohol, prescription medicines or street drugs.


Who should not take Mylan-Triazolam?

Do not take Mylan-Triazolam if you are allergic to anything in it. See the end of this Medication Guide for a complete list of ingredients in Mylan-Triazolam.

SEDATIVE-HYPNOTICS may not be right for you. Before starting SEDATIVE-HYPNOTICS, tell your doctor about all of your health conditions, including if you:

- have a history of depression, mental illness, or suicidal thoughts

- have a history of drug or alcohol abuse or addiction

- have kidney or liver disease

- have a lung disease or breathing problems

- are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all of the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements. Medicines can interact, sometimes causing side effects. Do not take SEDATIVE-HYPNOTICS with other medicines that can make you sleepy.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

Mylan-Triazolam should not be taken with potent inhibitors of CYP 3A including ketoconazole, itraconazole, nefazodone and possibly other azole-type antifungal agents.

How should I take Mylan-Triazolam?

- Take Mylan-Triazolam exactly as prescribed. Do not take more Mylan-Triazolam than prescribed for you.

- Take Mylan-Triazolam right before you get into bed. Or you can take Mylan-Triazolam after you have been in bed and have trouble falling asleep.

- Do not take Mylan-Triazolam with or right after a meal.

- Do not take Mylan-Triazolam unless you are able to get a full night’s sleep before you must be active again.

- Call your healthcare provider if your insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing your sleep problem.

- If you take too much Mylan-Triazolam or overdose, call your doctor or poison control center right away, or get emergency treatment.

What are the possible side effects of SEDATIVE-HYPNOTICS?

Serious side effects of SEDATIVE-HYPNOTICS include:

- getting out of bed while not being fully awake and do an activity that you do not know you are doing. (See “What is the most important information I should know about SEDATIVE-HYPNOTICS?)

- abnormal thoughts and behavior. Symptoms include more outgoing or aggressive behavior than normal, confusion, agitation, hallucinations, worsening of depression, and suicidal thoughts or actions.

- memory loss, including “traveler’s amnesia”

- anxiety

- severe allergic reactions. Symptoms include swelling of the tongue or throat, trouble breathing, and nausea and vomiting. Get emergency medical help if you get these symptoms after taking SEDATIVE-HYPNOTICS.

Call your doctor right away if you have any of the above side effects or any other side effects that worry you while using the SEDATIVE-HYPNOTIC.

Common side effects of Mylan-Triazolam include:

- drowsiness

- headache

- dizziness

- lightheadedness

- “pins and needles” feelings on your skin

- difficulty with coordination

- You may still feel drowsy the next day after taking Mylan-Triazolam. Do not drive or do other dangerous activities (including operating machinery) after taking Mylan-Triazolam until you feel fully awake.

- You may have withdrawal symptoms for 1 to 2 days when you stop taking the SEDATIVE-HYPNOTIC suddenly. Withdrawal symptoms include trouble sleeping, unpleasant feelings, stomach and muscle cramps, vomiting, sweating, shakiness, and seizures.

These are not all the side effects of SEDATIVE-HYPNOTICS. Ask your doctor or pharmacist for more information.

How should I store Mylan-Triazolam?

- Store Mylan-Triazolam at room temperature between 59° and 86° F (15° to 30°C).

- Protect from light.

- Keep Mylan-Triazolam and all medicines out of the reach of children.

- Do not use Mylan-Triazolam after the expiration date on the bottle.

General Information about SEDATIVE-HYPNOTICS

- Medicines are sometimes prescribed for purposes not mentioned in a Medication Guide.

- Do not use the SEDATIVE-HYPNOTIC for a condition for which it was not prescribed.

- Do not give the SEDATIVE-HYPNOTIC to other people, even if they have the same condition. It may harm them and it is against the law.

This Medication Guide summarizes the most important information about Mylan-Triazolam. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about Mylan-Triazolam that was written for healthcare professionals.

If you would like more information, contact 1-800-962-8364.

What are the ingredients in Mylan-Triazolam?

Active Ingredient: Mylan-Triazolam

Inactive Ingredients: 0.125 mg-corn starch, docusate sodium, lactose (anhydrous), magnesium stearate, microcrystalline cellulose; 0.25 mg-corn starch, docusate sodium, FD&C Blue No. 1, lactose (anhydrous), magnesium stearate, microcrystalline cellulose.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

4076601//05 Revised February 2010

© RLI, 2010

Package Label - Mylan-Triazolam Tablets, USP

image of label

Mylan-Triazolam pharmaceutical active ingredients containing related brand and generic drugs:

infoActive ingredient is the part of the drug or medicine which is biologically active. This portion of the drug is responsible for the main action of the drug which is intended to cure or reduce the symptom or disease. The other portions of the drug which are inactive are called excipients; there role is to act as vehicle or binder. In contrast to active ingredient, the inactive ingredient's role is not significant in the cure or treatment of the disease. There can be one or more active ingredients in a drug.


Mylan-Triazolam available forms, composition, doses:

infoForm of the medicine is the form in which the medicine is marketed in the market, for example, a medicine X can be in the form of capsule or the form of chewable tablet or the form of tablet. Sometimes same medicine can be available as injection form. Each medicine cannot be in all forms but can be marketed in 1, 2, or 3 forms which the pharmaceutical company decided based on various background research results.
Composition is the list of ingredients which combinedly form a medicine. Both active ingredients and inactive ingredients form the composition. The active ingredient gives the desired therapeutic effect whereas the inactive ingredient helps in making the medicine stable.
Doses are various strengths of the medicine like 10mg, 20mg, 30mg and so on. Each medicine comes in various doses which is decided by the manufacturer, that is, pharmaceutical company. The dose is decided on the severity of the symptom or disease.


Mylan-Triazolam destination | category:

infoDestination is defined as the organism to which the drug or medicine is targeted. For most of the drugs what we discuss, human is the drug destination.
Drug category can be defined as major classification of the drug. For example, an antihistaminic or an antipyretic or anti anginal or pain killer, anti-inflammatory or so.


Mylan-Triazolam Anatomical Therapeutic Chemical codes:

infoA medicine is classified depending on the organ or system it acts [Anatomical], based on what result it gives on what disease, symptom [Therapeutical], based on chemical composition [Chemical]. It is called as ATC code. The code is based on Active ingredients of the medicine. A medicine can have different codes as sometimes it acts on different organs for different indications. Same way, different brands with same active ingredients and same indications can have same ATC code.


Mylan-Triazolam pharmaceutical companies:

infoPharmaceutical companies are drug manufacturing companies that help in complete development of the drug from the background research to formation, clinical trials, release of the drug into the market and marketing of the drug.
Researchers are the persons who are responsible for the scientific research and is responsible for all the background clinical trials that resulted in the development of the drug.


advertisement

References

  1. Dailymed."TRIAZOLAM TABLET [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  2. Dailymed."TRIAZOLAM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailym... (accessed August 28, 2018).
  3. "triazolam". https://pubchem.ncbi.nlm.nih.gov/co... (accessed August 28, 2018).

Frequently asked Questions

Can i drive or operate heavy machine after consuming Mylan-Triazolam?

Depending on the reaction of the Mylan-Triazolam after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Mylan-Triazolam not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.

Is Mylan-Triazolam addictive or habit forming?

Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.

Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.

advertisement

Review

sDrugs.com conducted a study on Mylan-Triazolam, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Mylan-Triazolam consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.

Visitor reports

One visitor reported age

Visitors%
> 601
100.0%

Visitor reviews


There are no reviews yet. Be the first to write one!


Your name: 
Email: 
Spam protection:  < Type 13 here

The information was verified by Dr. Arunabha Ray, MD Pharmacology

© 2002 - 2018 "sDrugs.com". All Rights Reserved