Tukol X-pecto Miel Multi Symptom Cold
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Questions & Answers
Side Effects & Adverse Reactions
Diltiazem prolongs AV node refractory periods without significantly prolonging sinus node recovery time, except in patients with sick sinus syndrome. This effect may rarely result in abnormally slow heart rates (particularly in patients with sick sinus syndrome) or second- or third-degree AV block (six of 1243 patients for 0.48%). Concomitant use of diltiazem with beta-blockers or digitalis may result in additive effects on cardiac conduction. A patient with Prinzmetal's angina developed periods of asystole (2 to 5 seconds) after a single dose of 60 mg of diltiazem (see ). 1.Cardiac Conduction.ADVERSE REACTIONS
Although diltiazem has a negative inotropic effect in isolated animal tissue preparations, hemodynamic studies in humans with normal ventricular function have not shown a reduction in cardiac index nor consistent negative effects on contractility (dp/dt). Experience with the use of diltiazem alone or in combination with beta-blockers in patients with impaired ventricular function is very limited. Caution should be exercised when using the drug in such patients. 2.Congestive Heart Failure.
Decreases in blood pressure associated with diltiazem therapy may occasionally result in symptomatic hypotension. 3.Hypotension.
In rare instances, significant elevations in enzymes such as alkaline phosphatase, LDH, SGOT, SGPT, and other phenomena consistent with acute hepatic injury have been noted. These reactions have been reversible upon discontinuation of drug therapy. The relationship to diltiazem is uncertain in most cases, but probable in some (see ). 4.Acute Hepatic Injury.PRECAUTIONS
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Diltiazem hydrochloride tablets USP are indicated for the management of chronic stable angina and angina due to coronary artery spasm.
History
There is currently no drug history available for this drug.
Other Information
Diltiazem hydrochloride tablets USP are a calcium ion cellular influx inhibitor (slow channel blocker or calcium antagonist). Chemically, diltiazem hydrochloride, USP is 1,5-Benzothiazepin-4(5 )one,3-(acetyloxy)-5-[2-(dimethylamino)ethyl]-2,3-dihydro-2-(4-methoxyphenyl)-,monohydrochloride,(+)-cis-. The structural formula is: H
C H N O S•HCl M.W. 450.98 222624
Diltiazem hydrochloride, USP is a white to off-white crystalline powder with a bitter taste. It is soluble in water, methanol, and chloroform.
Each tablet for oral administration contains 30 mg, 60 mg, 90 mg, or 120 mg of diltiazem hydrochloride, USP. Each tablet also contains the following inactive ingredients: hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, polysorbate 80, povidone, titanium dioxide and FD&C yellow #6 aluminum lake.
Diltiazem hydrochloride tablets meet USP Dissolution Test 1.
Sources
Tukol X-pecto Miel Multi Symptom Cold Manufacturers
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Genomma Lab Usa, Inc.
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Tukol X-pecto Miel Multi Symptom Cold | Unit Dose Services
Exertional Angina Pectoris Due to Atherosclerotic Coronary Artery Disease or Angina Pectoris at Rest Due to Coronary Artery SpasmDosage must be adjusted to each patient's needs. Starting with 30 mg four times daily, before meals and at bedtime, dosage should be increased gradually (given in divided doses three or four times daily) at 1 to 2 day intervals until optimum response is obtained. Although individual patients may respond to any dosage level, the average optimum dosage range appears to be 180 to 360 mg/day. There are no available data concerning dosage requirements in patients with impaired renal or hepatic function. If the drug must be used in such patients, titration should be carried out with particular caution.
Concomitant Use With Other Cardiovascular Agents may be taken as required to abort acute anginal attacks during diltiazem hydrochloride tablet therapy. Sublingual NTG Diltiazem hydrochloride tablets may be safely coadministered with short- and long-acting nitrates, but there have been no controlled studies to evaluate the antianginal effectiveness of this combination. Prophylactic Nitrate Therapy: (See and .) Beta-blockers.WARNINGSPRECAUTIONS
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