Drug Interactions between Mudrane and Teczem

MONITOR CLOSELY: Concomitant use of angiotensin converting enzyme (ACE) inhibitors and potassium salts may increase the risk of hyperkalemia. Inhibition of ACE results in decreased aldosterone secretion, which in turn causes potassium retention. In one report, a significant increase in serum potassium level (3.88 +/- 0.41 to 4.84 +/- 0.45 mEq/L) was observed within one or two days following the addition of captopril in five patients who were treated with regimens that included potassium supplements or potassium-sparing diuretics. Three patients had laboratory-diagnosed hyperkalemia, including one patient receiving potassium supplementation who had a 66% increase in serum potassium. Levels remained elevated until potassium supplementation or captopril therapy was reduced or discontinued. In a postmarketing survey of patients who were prescribed enalapril in England between April and December 1985, researchers identified ten cases where enalapril appeared to have contributed to a deterioration in renal function and subsequent death. All ten patients had hyperkalemia, and seven were also receiving moderate to high dosages of potassium-sparing diuretics and/or potassium supplements. Hyperkalemia was felt to be the immediate cause of death in two of them. Risk factors for developing severe or life-threatening hyperkalemia may include renal impairment, diabetes, old age, severe or worsening heart failure, dehydration, and concomitant use of other agents that block the renin-angiotensin-aldosterone system or otherwise increase serum potassium levels.

MANAGEMENT: Caution is advised if ACE inhibitors must be used concurrently with potassium salts, particularly in patients with renal impairment, diabetes, old age, severe or worsening heart failure, dehydration, or concomitant therapy with other agents that increase serum potassium such as nonsteroidal anti-inflammatory drugs, beta-blockers, cyclosporine, heparin, tacrolimus, trimethoprim, and licorice. The combination should generally be avoided in these patients unless absolutely necessary and the benefits outweigh the potential risks. Serum potassium and renal function should be checked prior to initiating therapy and regularly thereafter. Patients should be given counseling on the appropriate levels of potassium and fluid intake, and advised to seek medical attention if they experience signs and symptoms of hyperkalemia such as nausea, vomiting, weakness, listlessness, tingling of the extremities, paralysis, confusion, weak pulse, and a slow or irregular heartbeat.

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MONITOR: Many psychotherapeutic and CNS-active agents (e.g., anxiolytics, sedatives, hypnotics, antidepressants, antipsychotics, opioids, alcohol, muscle relaxants) exhibit hypotensive effects, especially during initiation of therapy and dose escalation. Coadministration with antihypertensives and other hypotensive agents, in particular vasodilators and alpha-blockers, may result in additive effects on blood pressure and orthostasis.

MANAGEMENT: Caution and close monitoring for development of hypotension is advised during coadministration of these agents. Some authorities recommend avoiding alcohol in patients receiving vasodilating antihypertensive drugs. Patients should be advised to avoid rising abruptly from a sitting or recumbent position and to notify their physician if they experience dizziness, lightheadedness, syncope, orthostasis, or tachycardia.

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GENERALLY AVOID: Coadministration with inducers of CYP450 3A4 may significantly decrease the plasma concentrations of diltiazem, which is primarily metabolized by the isoenzyme. In 13 study subjects, administration of diltiazem (240 mg daily for 21 days) with the CYP450 3A4 inducer efavirenz (600 mg daily for 14 days) decreased diltiazem peak plasma concentration (Cmax), systemic exposure (AUC) and trough plasma concentration (Cmin) by a mean of 60%, 69% and 63%, respectively. Rifampin, a potent CYP450 3A4 inducer, has been reported to lower diltiazem plasma concentrations to undetectable levels.

MANAGEMENT: Use of diltiazem with rifampin or any known CYP450 3A4 inducer should be avoided when possible, and alternative therapy considered. Diltiazem dose adjustment should be guided by clinical response if concomitant use with a CYP450 3A4 inducer is necessary.

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MONITOR: Diltiazem may inhibit the CYP450 3A4 hepatic metabolism of theophylline. Significant increases in serum theophylline levels may result. Data are limited.

MANAGEMENT: Clinical monitoring of patient response and tolerance and serum theophylline levels is recommended. Patients should be advised to report any signs of theophylline toxicity including nausea, vomiting, diarrhea, headache, restlessness, insomnia, or irregular heartbeat to their physicians.

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MONITOR: Barbiturates may decrease serum levels and therapeutic effects of the methylxanthines. The mechanism is barbiturate induction of CYP450 3A4 and 1A2 hepatic metabolism of methylxanthines.

MANAGEMENT: Close observation for clinical and laboratory evidence of decreased methylxanthine effect is indicated if these drugs must be used together. Patients should be advised to notify their physician if they experience a worsening of their respiratory symptoms.

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Calcium channel blockers and angiotensin converting enzyme (ACE) inhibitors may have additive hypotensive effects. While these drugs are often safely used together, careful monitoring of the systemic blood pressure is recommended during coadministration, especially during the first one to three weeks of therapy.

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Ephedrine-methylxanthine combinations are used for the treatment of asthma but the efficacy of the combination has been questioned. This combination may lead to increased xanthine side effects. The mechanism is unknown, but may be related to synergistic pharmacologic effects. Patients using this combination should be closely monitored for side effects such as nausea, vomiting, tachycardia, nervousness, or insomnia. If side effects are noted, the dosage of the xanthine may need to be decreased.

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