Olmesartan Medoxmil and Hydrochlorothiazide

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Overview

What is Olmesartan Medoxmil and Hydrochlorothiazide?

Olmesartan medoxomil and hydrochlorothiazide tablets are a combination of an angiotensin II receptor antagonist (AT subtype), olmesartan medoxomil, and a thiazide diuretic, hydrochlorothiazide (HCTZ).

Olmesartan medoxomil is 1-Imidazole-5-carboxylic acid, 4-(1-hydroxy-1-methylethyl)-2-propyl-1-[[2'-(1-tetrazol-5-yl) [1,1'-biphenyl]-4-yl]methyl]-, (5-methyl-2-oxo-1,3-dioxol-4-yl) methyl ester.

Its molecular formula is CHNO and its structural formula is:

Olmesartan medoxomil, USP is a white to off-white powder with a molecular weight of 558.6. It is practically insoluble in water and sparingly soluble in methanol.

Hydrochlorothiazide is 6-chloro-3,4-dihydro-2-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is CHClNOS and its structural formula is:

Hydrochlorothiazide, USP is a white, or practically white, crystalline powder with a molecular weight of 297.7. Hydrochlorothiazide is slightly soluble in water but freely soluble in sodium hydroxide solution.

Olmesartan medoxomil and hydrochlorothiazide tablets are available for oral administration in tablets containing 20 mg or 40 mg of olmesartan medoxomil combined with 12.5 mg of hydrochlorothiazide, or 40 mg of olmesartan medoxomil combined with 25 mg of hydrochlorothiazide. Inactive ingredients include: colloidal silicon dioxide, D&C Red No. 30 Aluminum Lake, hypromellose, lactose monohydrate, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polyethylene glycol and sodium lauryl sulfate.

What does Olmesartan Medoxmil and Hydrochlorothiazide look like?

What are the available doses of Olmesartan Medoxmil and Hydrochlorothiazide?

Tablets: (olmesartan medoxomil and hydrochlorothiazide) 20/12.5 mg; 40/12.5 mg; 40/25 mg ()

What should I talk to my health care provider before I take Olmesartan Medoxmil and Hydrochlorothiazide?

How should I use Olmesartan Medoxmil and Hydrochlorothiazide?

Olmesartan medoxomil and hydrochlorothiazide tablets are indicated for the treatment of hypertension, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are not indicated for the initial therapy of hypertension .

Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in controlled trials of antihypertensive drugs from a wide variety of pharmacologic classes including the class to which this drug principally belongs. There are no controlled trials demonstrating risk reduction with olmesartan medoxomil and hydrochlorothiazide tablets.

Control of high blood pressure should be part of comprehensive cardiovascular risk management, including, as appropriate, lipid control, diabetes management, antithrombotic therapy, smoking cessation, exercise, and limited sodium intake. Many patients will require more than one drug to achieve blood pressure goals. For specific advice on goals and management, see published guidelines, such as those of the National High Blood Pressure Education Program’s Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure (JNC).

Numerous antihypertensive drugs, from a variety of pharmacologic classes and with different mechanisms of action, have been shown in randomized controlled trials to reduce cardiovascular morbidity and mortality, and it can be concluded that it is blood pressure reduction, and not some other pharmacologic property of the drugs, that is largely responsible for those benefits. The largest and most consistent cardiovascular outcome benefit has been a reduction in the risk of stroke, but reductions in myocardial infarction and cardiovascular mortality also have been seen regularly.

Elevated systolic or diastolic pressure causes increased cardiovascular risk, and the absolute risk increase per mmHg is greater at higher blood pressures, so that even modest reductions of severe hypertension can provide substantial benefit. Relative risk reduction from blood pressure reduction is similar across populations with varying absolute risk, so the absolute benefit is greater in patients who are at higher risk independent of their hypertension (for example, patients with diabetes or hyperlipidemia), and such patients would be expected to benefit from more aggressive treatment to a lower blood pressure goal.

Some antihypertensive drugs have smaller blood pressure effects (as monotherapy) in black patients, and many antihypertensive drugs have additional approved indications and effects (e.g., on angina, heart failure, or diabetic kidney disease). These considerations may guide selection of therapy.

Olmesartan medoxomil and hydrochlorothiazide tablets may be used alone, or in combination with other antihypertensive drugs.

The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablets is 40/12.5 mg once daily in patients whose blood pressure is not adequately controlled with olmesartan monotherapy. Dose can be titrated up to 40/25 mg if necessary.

The recommended starting dose of olmesartan medoxomil and hydrochlorothiazide tablets is 20/12.5 mg once daily in patients whose blood pressure is not adequately controlled with hydrochlorothiazide monotherapy or who experience dose-limiting adverse reactions with hydrochlorothiazide. Dose can be titrated up to 40/25 mg if necessary.

Patients titrated to the individual components olmesartan and hydrochlorothiazide may instead receive the corresponding dose of olmesartan medoxomil and hydrochlorothiazide tablets.

What interacts with Olmesartan Medoxmil and Hydrochlorothiazide?

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What are the warnings of Olmesartan Medoxmil and Hydrochlorothiazide?

Sorry No Records found

What are the precautions of Olmesartan Medoxmil and Hydrochlorothiazide?

Sorry No Records found

What are the side effects of Olmesartan Medoxmil and Hydrochlorothiazide?

Sorry No records found

What should I look out for while using Olmesartan Medoxmil and Hydrochlorothiazide?

Olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated:

What might happen if I take too much Olmesartan Medoxmil and Hydrochlorothiazide?

Olmesartan Medoxomil:

No lethality was observed in acute toxicity studies in mice and rats given single oral doses up to 2000 mg/kg olmesartan medoxomil. The minimum lethal oral dose of olmesartan medoxomil in dogs was greater than 1500 mg/kg.

Hydrochlorothiazide:

How should I store and handle Olmesartan Medoxmil and Hydrochlorothiazide?

Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Store at 25°C (77°F): excursions permitted to 15–30°C (59–86°F) [see USP Controlled Room Temperature]. Keep out of reach of children. Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.Olmesartan Medoxomil and Hydrochlorothiazide Tablets are available containing 20 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP; 40 mg of olmesartan medoxomil, USP and 12.5 mg of hydrochlorothiazide, USP or 40 mg of olmesartan medoxomil, USP and 25 mg of hydrochlorothiazide, USP.The 20 mg/12.5 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1413-93bottles of 30 tabletsNDC 0378-1413-77bottles of 90 tabletsThe 40 mg/12.5 mg tablets are pink, film-coated, modified capsule shaped, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1422-93bottles of 30 tabletsNDC 0378-1422-77bottles of 90 tabletsThe 40 mg/25 mg tablets are pink, film-coated, round, unscored tablets debossed with on one side of the tablet and on the other side. They are available as follows:NDC 0378-1425-93bottles of 30 tabletsNDC 0378-1425-77bottles of 90 tabletsStorage:Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.

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Clinical Information

Chemical Structure

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Clinical Pharmacology

Non-Clinical Toxicology

Olmesartan medoxomil and hydrochlorothiazide tablets are contraindicated:

Inhibitors of CYP2D6

The concomitant use of tramadol hydrochloride extended-release tablets and CYP2D6 inhibitors such as quinidine, fluoxetine, paroxetine and bupropion may result in an increase in the plasma concentration of tramadol and a decrease in the plasma concentration of M1, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride extended-release tablets is achieved. Since M1 is a more potent μ-opioid agonist, decreased M1 exposure could result in decreased therapeutic effects, and may result in signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol. Increased tramadol exposure can result in increased or prolonged therapeutic effects and increased risk for serious adverse events including seizures and serotonin syndrome.

After stopping a CYP2D6 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease and the M1 plasma concentration will increase which could increase or prolong therapeutic effects but also increase adverse reactions related to opioid toxicity, and may cause potentially fatal respiratory depression .

If concomitant use of a CYP2D6 inhibitor is necessary, follow patients closely for adverse reactions including opioid withdrawal, seizures, and serotonin syndrome.

If a CYP2D6 inhibitor is discontinued, consider lowering tramadol hydrochloride extended-release tablets dosage until stable drug effects are achieved. Follow patients closely for adverse events including respiratory depression and sedation.

Inhibitors of CYP3A4

The concomitant use of tramadol hydrochloride extended-release tablets and CYP3A4 inhibitors such as macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g. ketoconazole), protease inhibitors (e.g., ritonavir) can increase the plasma concentration of tramadol and may result in a greater amount of metabolism via CYP2D6 and greater levels of M1. Follow patients closely for increased risk of serious adverse events including seizures and serotonin syndrome, and adverse reactions related to opioid toxicity including potentially fatal respiratory depression, particularly when an inhibitor is added after a stable dose of tramadol hydrochloride extended-release tablets is achieved.

After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the tramadol plasma concentration will decrease , resulting in decreased opioid efficacy and possibly signs and symptoms of opioid withdrawal in patients who had developed physical dependence to tramadol.

If concomitant use is necessary, consider dosage reduction of tramadol hydrochloride extended-release tablets until stable drug effects are achieved. Follow patients closely for seizures and serotonin syndrome, and signs of respiratory depression and sedation at frequent intervals.

If a CYP3A4 inhibitor is discontinued, consider increasing the tramadol hydrochloride extended-release tablets dosage until stable drug effects are achieved and follow patients for signs and symptoms of opioid withdrawal.

Inducers of CYP3A4

The concomitant use of tramadol hydrochloride extended-release tablets and CYP3A4 inducers such as rifampin, carbamazepine, phenytoin can decrease the plasma concentration of tramadol, , resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to tramadol .

After stopping a CYP3A4 inducer, as the effects of the inducer decline, the tramadol plasma concentration will increase , which could increase or prolong both the therapeutic effects and adverse reactions, and may cause seizures and serotonin syndrome, and potentially fatal respiratory depression .

If concomitant use is necessary, consider increasing the tramadol hydrochloride extended-release tablets dosage until stable drug effects are achieved. Follow patients for signs of opioid withdrawal.

If a CYP3A4 inducer is discontinued, consider tramadol hydrochloride extended-release tablets dosage reduction and monitor for seizures and serotonin syndrome, and signs of sedation and respiratory depression.

Patients taking carbamazepine, a CYP3A4 inducer, may have a significantly reduced analgesic effect of tramadol. Because carbamazepine increases tramadol metabolism and because of the seizure risk associated with tramadol, concomitant administration of tramadol hydrochloride extended-release tablets and carbamazepine is not recommended.

Benzodiazepines and other Central Nervous System (CNS) Depressants

Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants such as alcohol, other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, and other opioids, can increases the risk of respiratory depression, profound sedation, coma, and death.

Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Follow patients closely for signs of respiratory depression and sedation .

Serotonergic Drugs

The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system such as s elective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), monoamine oxidase (MAO) inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue) has resulted in serotonin syndrome.

If concomitant use is warranted, carefully observe the patient, particularly during treatment initiation and dose adjustment. Discontinue tramadol hydrochloride extended-release tablets if serotonin syndrome is suspected.

Monoamine Oxidase Inhibitors (MAOIs)

MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma)

Do not use tramadol hydrochloride extended-release tablets in patients taking MAOIs or within 14 days of stopping such treatment.

Mixed Agonist/Antagonist and Partial Agonist Opioid Analgesics

Mixed agonist/antagonist and partial agonist opioid analgesics

Muscle Relaxants

Tramadol hydrochloride extended-release tablets may enhance the neuromuscular blocking action of skeletal muscle relaxants and produce an increased degree of respiratory depression.

If concomitant use is warranted, monitor patients for signs of respiratory depression that may be greater than otherwise expected and decrease the dosage of tramadol hydrochloride extended-release tablets and/or the muscle relaxant as necessary.

Diuretics

Opioids can reduce the efficacy of diuretics by inducing the release of antidiuretic hormone.

If concomitant use is warranted, follow patients for signs of diminished diuresis and/or effects on blood pressure and increase the dosage of the diuretic as needed.

Anticholinergic Drugs

The concomitant use of anticholinergic drugs may increase risk of urinary retention and/or severe constipation, which may lead to paralytic ileus.

If concomitant use is warranted, follow patients for signs and symptoms of urinary retention or reduced gastric motility when tramadol hydrochloride extended-release tablets are used concomitantly with anticholinergic drugs.

Digoxin

Postmarketing surveillance has revealed rare reports of digoxin toxicity. Follow patients for signs of digoxin toxicity and adjust dosage of digoxin as needed.

Warfarin

Postmarketing surveillance of tramadol has revealed rare reports of alteration of warfarin effect, including elevation of prothrombin times. Monitor the prothrombin time of patients on warfarin for signs of an interaction and adjust the dosage of warfarin as needed.

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The following adverse reactions with olmesartan medoxomil and hydrochlorothiazide tablets are described elsewhere:

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72

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Interactions

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