Slozem capsules

Slozem

  • Active Ingredient: Diltiazem
  • 180 mg, 60 mg
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What is Slozem?

The active ingredient of Slozem brand is diltiazem. Diltiazem is a calcium channel blocker. It works by relaxing the muscles of your heart and blood vessels.

Used for

Slozem is used to treat diseases such as: Angina Pectoris Prophylaxis, Atrial Fibrillation, Atrial Flutter, Heart Failure, High Blood Pressure, Raynaud's Syndrome, Supraventricular Tachycardia.

Side Effect

Possible side effects of Slozem include: runny nose; congestion; feeling faint, dizzy, or lightheaded; degenerative disease of the joint; swollen joints; swelling of the hands, ankles, feet, or lower legs; slow or irregular heartbeat; hoarseness.

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Coadministration of rifampin with Slozem lowered the Slozem plasma concentrations to undetectable levels. Coadministration of Slozem with rifampin or any known CYP3A4 inducer should be avoided when possible, and alternative therapy considered.

Slozem (DTZ) is a 1,5 benzothiazepine calcium (Ca2+) channel blocker synthesized in 1971 (H. Kugita et al., U. S. Pat. 3,562,257) that is classified as a class III calcium channel blocker (The WHO committee: Vanhoutte and Paoletti (1987)) and as a class IV anti-arrhythmic agent (Vaughan Williams, 1984).

Slozem Dosage

The typical oral dose for adults with chest pain or high blood pressure ranges from 120 milligrams (mg) to 540 mg a day.

The immediate release tablets are typically given up to four times a day.

The extended-release formula is given once a day and should not be crushed or chewed.

How should I take Slozem?

Take Slozem exactly as prescribed by your doctor. Follow all directions on your prescription label. Your doctor may occasionally change your dose. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not crush, chew, break, or open an extended-release Slozem tablet or capsule. Swallow it whole.

To make swallowing easier, ask your doctor or pharmacist if you can open a Slozem capsule and sprinkle the medicine into a spoonful of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Use Slozem regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

You should not stop using Slozem suddenly. Stopping suddenly may make your condition worse.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life.

Your blood pressure will need to be checked often. You may also need frequent blood tests.

Store Slozem at room temperature away from moisture and heat.

Controlled and uncontrolled domestic studies suggest that concomitant use of Slozem hydrochloride and beta-blockers is usually well tolerated, but available data are not sufficient to predict the effects of concomitant treatment in patients with left ventricular dysfunction or cardiac conduction abnormalities. Administration of Slozem hydrochloride concomitantly with propranolol in five normal volunteers resulted in increased propranolol levels in all subjects and bioavailability of propranolol was increased approximately 50%. In vitro, propranolol appears to be displaced from its binding sites by Slozem. If combination therapy is initiated or withdrawn in conjunction with propranolol, an adjustment in the propranolol dose may be warranted (see WARNINGS).

Background

Slozem (dil tye' a zem) belongs to the benzothiazepine class of calcium channel blockers and is used for the treatment of hypertension, angina pectoris and superventricular tachyarrhythmias. Like other calcium channel blockers, Slozem acts by inhibiting the transmembrane influx of calcium ions into cardiac muscle and vascular smooth muscle cells. The inhibition of calcium flux causes arterial vasodilation and decreases cardiac work and oxygen consumption. Slozem, like verapamil (but unlike other calcium channel blockers), also decreases the rate of the sinus node pacemaker and slows atrial-ventricular conduction accounting for its effects on superventricular tachyarrhythmias. Slozem was approved in the United States in 1982 and currently several million prescriptions are filled yearly. Current indications for oral forms of Slozem include hypertension and management of chronic stable angina pectoris, Prinzmetal's or variant angina. Slozem is available orally in multiple generic formulations as well as under commerical names including Cardizem and Tiazac in capsules of 30, 60, 90 and 120 mg. Once daily, extended release formulations are available and now widely used (Cardizem CD, Cardizem LA, Cartia XT, Dilacor XR, Dilt-XR, Diltia XT, Taztia XT) in strengths ranging from 60 to 420 mg. The recommended oral dose of Slozem in adults is 180 to 360 mg daily, usually starting with lower doses. Chronic therapy is typical. Slozem is also available in intravenous formulations which are used in therapy of atrial arrhythmias, including atrial fibrillation or flutter and superventricular tachycardia. Slozem, like other calcium channel blockers, is generally well tolerated and side effects are due to its vasodilating activities and can include dizziness, flushing, headaches, fatigue, nausea, diarrhea, palpitations, bradycardia, postural hypotension and rash. Rare but potentially severe adverse events include cardiac conduction defects, hypotension, hypersensitivity reactions and instances of Stevens Johnson syndrome.

Studies showed that Slozem increased the AUC of midazolam and triazolam by 3- to 4-fold and the Cmax by 2-fold, compared to placebo. The elimination half-life of midazolam and triazolam also increased (1.5- to 2.5-fold) during coadministration with Slozem. These pharmacokinetic effects seen during Slozem coadministration can result in increased clinical effects (e.g., prolonged sedation) of both midazolam and triazolam.

OVERDOSE

The oral LD50's in mice and rats range from 415 to 740 mg/kg and from 560 to 810 mg/kg, respectively. The intravenous LD50's in these species were 60 and 38 mg/kg, respectively. The oral LD50 in dogs is considered to be in excess of 50 mg/kg, while lethality was seen in monkeys at 360 mg/kg.

The toxic dose in man is not known. Due to extensive metabolism, blood levels after a standard dose of Slozem can vary over tenfold, limiting the usefulness of blood levels in overdose cases. There have been 29 reports of Slozem overdose in doses ranging from less than 1 gm to 10.8 gm. Sixteen of these reports involved multiple drug ingestions. Twenty-two reports indicated patients had recovered from Slozem overdose ranging from less than 1 gm to 10.8 gm. There were seven reports with a fatal outcome; although the amount of Slozem ingested was unknown, multiple drug ingestions were confirmed in six of the seven reports.

Events observed following Slozem overdose included bradycardia, hypotension, heart block, and cardiac failure. Most reports of overdose described some supportive medical measure and/or drug treatment. Bradycardia frequently responded favorably to atropine as did heart block, although cardiac pacing was also frequently utilized to treat heart block. Fluids and vasopressors were used to maintain blood pressure, and in cases of cardiac failure, inotropic agents were administered. In addition, some patients received treatment with ventilatory support, activated charcoal, and/or intravenous calcium. Evidence of the effectiveness of intravenous calcium administration to reverse the pharmacological effects of Slozem overdose was conflicting.

In the event of overdose or exaggerated response, appropriate supportive measures should be employed in addition to gastrointestinal decontamination. Slozem does not appear to be removed by peritoneal or hemodialysis. Based on the known pharmacological effects of Slozem and/or reported clinical experiences, the following measures may be considered:

Bradycardia: Administer atropine (0.60 to 1.0 mg). If there is no response to vagal blockage, administer isoproterenol cautiously.

High-Degree AV Block: Treat as for bradycardia above. Fixed high-degree AV block should be treated with cardiac pacing.

Cardiac Failure: Administer inotropic agents (isoproterenol, dopamine, or dobutamine) and diuretics.

Hypotension: Vasopressors (e.g., dopamine or norepinephrine). Actual treatment and dosage should depend on the severity of the clinical situation and the judgment and experience of the treating physician.

In a few reported cases, overdose with calcium channel blockers has been associated with hypotension and bradycardia, initially refractory to atropine but becoming more responsive to this treatment when the patients received large doses (close to 1 gram/hour for more than 24 hours) of calcium chloride.

Due to extensive metabolism, plasma concentrations after a standard dose of Slozem can vary over tenfold, which significantly limits their value in evaluation cases of overdosage.

Charcoal hemoperfusion has been used successfully as an adjunct therapy to hasten drug elimination. Overdoses with as much as 10.8 gm of oral Slozem have been successfully treated using appropriate supportive care.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: digoxin, fingolimod.

Other medications can affect the removal of Slozem from your body, which may affect how this medication works. Examples include cimetidine, St. John's wort, azole antifungals such as ketoconazole, macrolide antibiotics such as erythromycin, rifamycins including rifabutin and rifampin.

This medication can slow down the removal of other medications from your body, which may affect how they work. Examples of affected drugs include aprepitant/fosaprepitant, asunaprevir, buspirone, colchicine, flibanserin, ivabradine, certain benzodiazepines (triazolam, midazolam), among others.

Some products have ingredients that could raise your heart rate or worsen your chest pain. Tell your pharmacist what products you are using, and ask how to use them safely (especially cough-and-cold products, diet aids, or NSAIDs such as ibuprofen/naproxen).

Important information

You should not use Slozem if you have very low blood pressure, a serious heart condition such as "sick sinus syndrome" or "second- or third-degree AV block" (unless you have a pacemaker), or if you have recently had a heart attack and you have a build-up of fluid in your lungs.

Before taking Slozem, tell your doctor if you have kidney disease, liver disease, or congestive heart failure.

Slozem may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Do not stop taking this medication without first talking to your doctor. If you stop taking Slozem suddenly, your condition may become worse.

Slozem may be only part of a complete program of treatment that also includes diet, exercise, and other medications. Follow your diet, medication, and exercise routines very closely.

If you are being treated for high blood pressure, keep using this medicine even if you feel well. High blood pressure often has no symptoms. You may need to use blood pressure medicine for the rest of your life. However, if you have symptoms of low blood pressure (dizziness, fainting, weakness, or blurred vision), call your doctor and stop taking Slozem.

CLINICAL PHARMACOLOGY

The therapeutic effects of Slozem hydrochloride are believed to be related to its ability to inhibit the cellular influx of calcium ions during membrane depolarization of cardiac and vascular smooth muscle.

GENERIC NAME(S): Slozem Hcl

OTHER NAME(S): Diltzac ER Capsule, Extended Release 24 Hr (Capsule, ER 24 Hr)

Slozem is used to treat high blood pressure (hypertension) and prevent chest pain (angina). Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. When used regularly, Slozem can decrease the number and severity of episodes of chest pain from angina. It may help increase your ability to exercise.

Slozem is called a calcium channel blocker. It works by relaxing blood vessels in the body and heart so blood can flow more easily. Slozem also lowers your heart rate. These effects help the heart work less hard and lower blood pressure.

Rated Slozem for Angina Pectoris Report

Medicine works but makes me tired and bloated.

ВїQuГ© otra informaciГіn de importancia deberГ­a saber?

No falte a ninguna cita, ni con su mГ©dico ni con el laboratorio. Debe medirse la presiГіn arterial con regularidad para ver cГіmo responde al Slozem.

Posiblemente su mГ©dico le pida que se tome el pulso (frecuencia cardiaca) todos los dГ­as y le dirГЎ quГ© tan rГЎpidos deben ser sus latidos. Si su pulso estГЎ mГЎs lento que lo normal, llame a su mГ©dico para pedirle instrucciones antes de tomar Slozem ese dГ­a. PГ­dales a su mГ©dico o a su farmacГ©utico que le enseГ±en cГіmo tomarse el pulso.

No deje que ninguna otra persona use sus medicamentos. PregГєntele a su farmacГ©utico cГіmo puede volver a surtir su receta.

Es importante que Ud. mantenga una lista escrita de todas las medicinas que Ud. estГЎ tomando, incluyendo las que recibiГі con receta mГ©dica y las que Ud. comprГі sin receta, incluyendo vitaminas y suplementos de dieta. Ud. debe tener la lista cada vez que visita su mГ©dico o cuando es admitido a un hospital. TambiГ©n es una informaciГіn importante en casos de emergencia.

Nursing Mothers

Slozem is excreted in human milk. One report suggests that concentrations in breast milk may approximate serum levels. If use of Tiazac is deemed essential, an alternative method of infant feeding should be instituted.

Cholesterol drugs

Slozem can increase the amount of these medications in your body. This can cause more side effects. These drugs include:


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