Micardis


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telmisartan

MicardisApo-Temazepam, Co Temazepam, Dom-Temazepam, Gen-Temazepam, Novo-Temazepam, Nu-Temazepam, PHL-Temazepam, PMS-Temazepam, Ratio-Temazepam, RestorilTemodal, Temodar

Pharmacologic class: Angiotensin II receptor antagonist

Therapeutic class: Antihypertensive

Pregnancy risk category C (first trimester), D (second and third trimesters)

Pregnancy risk category C (first trimester), D (second and third trimesters)

Pharmacologic class: Benzodiazepine

Therapeutic class: Sedative-hypnotic

Controlled substance schedule IV

Pregnancy risk category X

Pharmacologic class: Alkylating agent

Therapeutic class: Antineoplastic

Pregnancy risk category D

FDA Box Warning

Drugs that act directly on the renin-angiotensin system can cause injury to or death of a developing fetus. Discontinue drug as soon as possible when pregnancy is detected.

Action

Inhibits vasoconstricting effects and blocks aldosterone-producing effects of angiotensin II at various receptor sites, including vascular smooth muscle and adrenal glands

Availability

Tablets: 20 mg, 40 mg, 80 mg

Indications and dosages

Hypertension

Adults: 40 mg P.O. daily, titrated up or down within range of 20 to 80 mg daily based on response and tolerance

Cardiovascular risk reduction

Adults: 80 mg P.O. daily in patients unable to take angiotensin-converting enzyme (ACE) inhibitors

Contraindications

• Hypersensitivity to drug or its components

Precautions

Use cautiously in:
• heart failure, impaired renal function secondary to primary renal disease or renal stenosis, obstructive biliary disorders, hepatic impairment, volume or sodium depletion
• patients receiving high-dose diuretics
• concomitant use of ACE inhibitors and angiotensin receptor blockers (avoid use)
• pregnant or breastfeeding patients
• children younger than age 18 (safety not established).

Administration

• Don't remove tablet from blister pack until just before giving.
• Know that drug may be used alone or with other antihypertensives.

Adverse reactions

CNS: dizziness, headache, fatigue

CV: chest pain, peripheral edema, hypertension, intermittent claudication

EENT: sinusitis, pharyngitis

GI: nausea, vomiting, diarrhea, dyspepsia, abdominal pain

GU: urinary tract infection

Musculoskeletal: myalgia, back and leg pain

Respiratory: cough, upper respiratory infection

Skin: ulcer

Other: pain, flu or flulike symptoms, hypersensitivity

Interactions

Drug-drug. Antihypertensives, diuretics: increased risk of hypotension

Ace inhibitors (ramipril): increased ramipril steady-state Cmax and area under the curve (AUC), decreased telmisartan Cmax and AUC

Digoxin: increased digoxin blood level

Lithium: increased serum lithium concentration and toxicity

Nonsteroidal anti-inflammatory drugs, including selective cyclooxygenase-2 inhibitors): deterioration of renal function, including possible acute renal failure in elderly patients, volume-depleted patients (including those on diuretic therapy), or with compromised renal function; attenuated telmisartan antihypertensive effect

Drug-diagnostic tests. Creatinine: slight elevation

Drug-food. Any food: slightly reduced drug bioavailability

Patient monitoring

• Monitor blood pressure frequently and watch for signs and symptoms of hypotension.
• Closely monitor patient with impaired hepatic or renal function. Correct volume deficits as appropriate before therapy starts. Monitor fluid intake and output and creatinine level during therapy.

Patient teaching

• Tell patient to take 1 hour before or 2 hours after meals.
• Caution patient not to remove tablet from blister pack until just before taking.
• Advise patient to report swelling or chest pain.
• Teach patient to measure blood pressure regularly and report significant changes.
• Tell patient to report suspected pregnancy to prescriber. Caution her not to breastfeed.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, and foods mentioned above.


temazepam

Apo-Temazepam, Co Temazepam, Dom-Temazepam, Gen-Temazepam, Novo-Temazepam, Nu-Temazepam, PHL-Temazepam, PMS-Temazepam, Ratio-Temazepam, Restoril


Pharmacologic class: Benzodiazepine

Therapeutic class: Sedative-hypnotic

Controlled substance schedule IV

Pregnancy risk category X

 

Action

Depresses CNS at limbic, thalamic, and hypothalamic levels. Enhances effects of gamma-aminobutyric acid, resulting in sedation, hypnosis, skeletal muscle relaxation, and anticonvulsant and anxiolytic activity.

Availability

Capsules: 7.5 mg, 15 mg, 22.5 mg, 30 mg

Indications and dosages

Insomnia

Adults: 15 mg P.O. at bedtime p.r.n. Range is 7.5 to 30 mg.

Dosage adjustment

• Elderly or debilitated patients

Contraindications

• Hypersensitivity to drug or other benzodiazepines
• Pregnancy

Precautions

Use cautiously in:
• chronic pulmonary insufficiency, hepatic dysfunction, renal disease, psychoses, drug abuse
• history of suicide attempt or drug abuse
• elderly or debilitated patients
• breastfeeding patients
• children younger than age 15.

Administration

• Give at bedtime with or without food.

Adverse reactions

CNS: hangover, headache, dizziness, drowsiness, lethargy, fatigue, paradoxical stimulation, light-headedness, talkativeness, irritability, nervousness, confusion, euphoria, relaxed feeling, tremor, incoordination, impaired memory, nightmares, paresthesia

CV: chest pain, palpitations, tachycardia

EENT: eye irritation, pain, and swelling; photophobia; tinnitus

GI: nausea, vomiting, constipation, diarrhea, heartburn, abdominal pain, dry mouth, anorexia

Musculoskeletal: joint pain

Other: altered taste, body pain, physical or psychological drug dependence, drug tolerance

Interactions

Drug-drug. Antidepressants, antihistamines, opioid analgesics, other sedative-hypnotics: additive CNS depression

Digoxin: increased digoxin blood level, greater risk of toxicity

Probenecid: faster temazepam onset and prolonged effects

Theophylline: antagonism of temazepam's sedative effects

Drug-herbs. Chamomile, hops, kava, skullcap, valerian: increased CNS depression

Drug-behaviors. Alcohol use: additive CNS depression

Smoking: increased drug metabolism

Patient monitoring

• Monitor neurologic status carefully. Check for paradoxical reactions, especially in elderly patient.
• Watch for signs and symptoms of physical and psychological drug dependence. Stay alert for drug hoarding.

Patient teaching

• Advise patient to establish effective bedtime routine, to minimize insomnia.
• Inform patient (and significant other if appropriate) that drug may cause psychological and physical dependence and should be used only as prescribed and needed.
• Caution patient to avoid driving and other hazardous activities on day after taking drug, until he knows how it affects concentration and alertness.
• Instruct patient not to drink alcohol.
• Advise patient not to smoke or use herbs without consulting prescriber.
• Instruct patient to report suspected pregnancy.
• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, herbs, and behaviors mentioned above.


temozolomide

Temodal, Temodar


Pharmacologic class: Alkylating agent

Therapeutic class: Antineoplastic

Pregnancy risk category D

 

Action

Rapidly converts to monomethyl triazeno imidazole carboxamide, an active compound that prevents DNA transcription

Availability

Capsules: 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, 250 mg

Injection (powder for solution, lyophilized): 100 mg

Indications and dosages

Refractory anaplastic astrocytoma

Adults: 150 mg/m2 P.O. or by 90-minute I.V. infusion daily for 5 consecutive days of each 28-day treatment cycle. Adjust dosage as appropriate based on absolute neutrophil count.

Newly diagnosed glioblastoma multiforme with radiotherapy

Adults: 75 mg/m2 P.O. or by 90-minute I.V. infusion for 42 days with focal radiotherapy (RT), followed by initial maintenance dose of 150 mg/m2 P.O. or by 90-minute I.V. infusion daily for days 1 to 5 of a 28-day cycle for six cycles. Four weeks after completing the drug plus RT phase, administer drug for an additional six cycles of maintenance treatment. Dosage in maintenance cycle 1 is 150 mg/m2 P.O. or by 90-minute I.V. infusion daily for 5 days, followed by 23 days without treatment. At start of maintenance cycle 2, dosage may be escalated to 200 mg/m2 based on absolute neutrophil and platelet counts. Continue dosage at 200 mg/m2 daily for first 5 days of each subsequent cycle except if toxicity occurs. If dosage wasn't escalated at maintenance cycle 2, escalation shouldn't be done in subsequent cycles.

Dosage adjustment

• Neutropenia, thrombocytopenia

Contraindications

• Hypersensitivity to drug, its components, or dacarbazine

Precautions

Use cautiously in:
• severe hepatic or renal impairment, active infection, decreased bone marrow reserve, other chronic debilitating illness
• elderly patients
• pregnant or breastfeeding patients
• children (safety not established).

Administration

• Follow facility policy for handling and disposing of chemotherapeutic drugs.
• Give capsules whole daily with a full glass of water, consistently either with or without food.
• Bring powder for injection to room temperature before reconstituting with 41 ml sterile water for injection that results in a 2.5-mg/ml solution. Gently swirl but don't shake vials. Don't further dilute reconstituted solution. Use reconstituted solution within 14 hours, including infusion time. Withdraw prescribed dose and transfer into empty 250-ml infusion bag. Give reconstituted solution only by I.V. infusion using infusion pump over 90 minutes. Flush lines before and after each infusion.
• Know that drug may be given in same I.V. line with normal saline solution for injection only.
• Be aware that dosages in 28-day cycle depend on nadir neutrophil and platelet counts.

Adverse reactions

CNS: fatigue, headache, dysphasia, poor coordination, ataxia, anxiety, depression, dizziness, drowsiness, confusion, amnesia, insomnia, mental status changes, weakness, paresis, hemiparesis, paresthesias, seizures

CV: peripheral edema

EENT: abnormal vision, diplopia, pharyngitis, sinusitis

GI: nausea, vomiting, constipation, diarrhea, abdominal pain, anorexia

GU: urinary incontinence or frequency, urinary tract infection, breast pain (in women)

Hematologic: anemia, leukopenia, thrombocytopenia

Metabolic: adrenal hypercorticism

Musculoskeletal: abnormal gait, back pain, myalgia

Respiratory: cough, upper respiratory infection

Skin: pruritus, rash

Other: fever, viral infection, weight gain

Interactions

Drug-drug. Antineoplastics: additive bone marrow depression

Live-virus vaccines: decreased antibody response to vaccine, greater risk of adverse reactions

Valproic acid: decreased oral clearance of temozolomide

Drug-diagnostic tests. Neutrophils, platelets: decreased counts

Drug-food. Any food: reduced rate and extent of temozolomide absorption

Patient monitoring

Monitor CBC with white cell differential. Stay alert for evidence of bone marrow depression.
• Assess neurologic status carefully.
• Monitor fluid intake and output, and weigh patient regularly.
• Be aware that Pneumocystis jiroveci pneumonia prophylaxis is required during concomitant administration of RT and should be continued in patients who develop lymphocytopenia until recovery from lymphocytopenia (circulating tumor cells Grade 1 or less).

Patient teaching

• Tell patient to take capsules consistently with or without food, and with a full glass of water.
• Instruct patient to swallow capsules whole without opening or chewing them and if capsules are accidentally opened or damaged, to avoid inhalation or contact with the skin or mucous membranes.
• If drug causes nausea or vomiting, advise patient to take it 1 hour before or 2 hours after a meal.
• Inform patient that drug may cause abnormal gait and dizziness.

Instruct patient to immediately report unusual bleeding or bruising.
• Advise patient to avoid live-virus vaccines.
• Caution patient to avoid driving and other hazardous activities until he knows how drug affects concentration, alertness, and vision.
• Instruct patient to report suspected pregnancy. Caution her not to breastfeed.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs and tests mentioned above.

telmisartan

(tel-mi-sar-tan) ,

Micardis

(trade name)

Classification

Therapeutic: antihypertensives
Pharmacologic: angiotensin ii receptor antagonists
Pregnancy Category: D

Indications

Alone or with other agents in the management of hypertension.Reduction of risk of myocardial infarction, stroke, or cardiovascular death in patients ≥55 yr who are at high risk for cardiovascular events and are unable to take ACE inhibitors.

Action

Blocks the vasoconstrictor and aldosterone-secreting effects of angiotensin II at various receptor sites, including vascular smooth muscle and the adrenal glands.

Therapeutic effects

Lowering of BP in hypertensive patients.

Pharmacokinetics

Absorption: 42–58% absorbed following oral administration (bioavailability increased in patients with hepatic impairment).
Distribution: Crosses the placenta.
Protein Binding: 99.5%.
Metabolism and Excretion: Excreted mostly unchanged in feces via biliary excretion.
Half-life: 24 hr.

Time/action profile (antihypertensive effect)

ROUTEONSETPEAKDURATION
POwithin 3 hr*4 wks†24 hr†
*After single dose†Chronic dosing

Contraindications/Precautions

Contraindicated in: Hypersensitivity; Bilateral renal artery stenosis; Concurrent use with aliskiren in patients with diabetes or moderate-to-severe renal impairment (CCr <60 mL/min) Obstetric: Can cause injury or death of fetus – if pregnancy occurs, discontinue immediately. Lactation: Discontinue drug or use formula.
Use Cautiously in: Volume- or salt-depleted patients or patients receiving large doses of diuretics (correct deficits before initiating therapy); genetic implication Black patients (may not be as effective); Impaired renal function caused by primary renal disease or heart failure (may worsen renal function); Obstructive biliary disorders or hepatic impairment; Women of childbearing potential; Pediatric: Safety not established for children <18 yr.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • fatigue
  • headache

Cardiovascular

  • hypotension

Ear, Eye, Nose, Throat

  • sinusitis

Fluid and Electrolyte

  • hyperkalemia

Gastrointestinal

  • abdominal pain
  • diarrhea
  • dyspepsia

Genitourinary

  • impaired renal function

Musculoskeletal

  • back pain
  • myalgia

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Additive hypotensive effects with other antihypertensives.Excessive hypotension may occur with concurrent use of diuretics.↑ risk of hyperkalemia with concurrent use of potassium supplements,potassium-containing salt substitutes, or potassium-sparing diuretics.↑ risk of hyperkalemia, renal dysfunction, hypotension, and syncope with concurrent use of ACE inhibitors or aliskiren ; avoid concurrent use with aliskiren in patients with diabetes or CCr <60 mL/minMay ↑ serum digoxin levels.NSAIDs and selective COX-2 inhibitors may blunt the antihypertensive effect and ↑ the risk of renal dysfunction.↑ risk of renal dysfunction when used with ramipril ; concurrent use not recommended.

Route/Dosage

Hypertension

Oral (Adults) 40 mg once daily (volume-depleted patients should start with 20 mg); may be titrated up to 80 mg/day.

Cardiovascular Risk Reduction

Oral (Adults) 80 mg once daily.

Availability

Tablets: 20 mg, 40 mg, 80 mg
In combination with: hydrochlorothiazide (Micardis HCT); amlodipine (Twynsta); seecombination drugs.

Nursing implications

Nursing assessment

  • Assess BP (lying, sitting, standing) and pulse frequently during initial dose adjustment and periodically during therapy. Notify health care professional of significant changes.
  • Monitor frequency of prescription refills to determine compliance.
  • Assess patients for signs of angioedema (dyspnea, facial swelling).
  • Lab Test Considerations: Monitor renal function. May cause ↑ BUN and serum creatinine.
    • May cause hyperkalemia.

Potential Nursing Diagnoses

Risk for injury (Adverse Reactions)
Noncompliance (Patient/Family Teaching)

Implementation

  • Volume depletion should be corrected, if possible, before initiation of therapy.

Patient/Family Teaching

  • Emphasize the importance of continuing to take as directed, even if feeling well. Take missed doses as soon as remembered if not almost time for next dose; do not double doses. Instruct patient to take medication at the same time each day. Warn patient not to discontinue therapy unless directed by health care professional. Advise patient to read Patient Information prior to starting therapy and with each refill in case of changes.
  • Caution patient to avoid salt substitutes containing potassium or foods containing high levels of potassium or sodium unless directed by health care professional. See.
  • Encourage patient to comply with additional interventions for hypertension (weight reduction, low-sodium diet, discontinuation of smoking, moderation of alcohol consumption, regular exercise, stress management). Medication controls but does not cure hypertension.
  • Instruct patient and family on proper technique for monitoring BP. Advise them to check BP at least weekly and to report significant changes.
  • Caution patient to avoid sudden changes in position to decrease orthostatic hypotension. Use of alcohol, standing for long periods, exercising, and hot weather may increase orthostatic hypotension.
  • May cause dizziness. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications, especially cough, cold, or allergy remedies.
  • Instruct patient to notify health care professional of medication regimen before treatment or surgery.
  • Instruct patient to notify health care professional if swelling of face, eyes, lips, or tongue or if difficulty swallowing or breathing occur.
  • Emphasize the importance of follow-up exams to evaluate effectiveness of medication.
  • Advise women of childbearing age to use contraception and notify health care professional if pregnancy is planned or suspected or if breastfeeding.

Evaluation/Desired Outcomes

  • Decrease in BP without appearance of excessive side effects.
  • Decreased risk of myocardial infarction, stroke, or cardiovascular death.

Micardis®

Telmisartan, see there.
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The label states that the results of both studies "do adequately support Micardis being more effective than placebo would be in this setting, particularly for" the end point of time to cardiovascular death, myocardial infarction, or stroke.
The two companies expect that Micardis will become applicable for the treatment of type 2 diabetic nephropathy.
GBI Research, the leading business intelligence provider, has released its latest research Anti-Hypertensives Market to 2017 - Patent Expiries of Blockbusters such as Diovan, Micardis, Avapro and Atacand to Accelerate Erosion which provides insights into the anti-hypertensives therapeutics market until 2017.
The company sells other well-known drugs such as Micardis (for high blood pressure), Flomax (enlarged prostate), and Zantac (indigestion).
s Micardis hypertension drug was no better than a placebo in preventing recurring strokes, a company-sponsored study found.
Trandolapril Angiotensin II Receptor Antagonists Classification/Drug Trade Names Starting Dosage Candesartan Atacand 16 mg QD Eprosartan Teveten 600 mg QD Irbesartan Avapro 150 mg QD Losartan Cozaar 50 mg QD Telmisartan Micardis 40 mg QD Valsartan Diovan 80 mg QD Classification/Drug Usual Dosage Range Candesartan 8-32 mg/day in single or divided doses Eprosartan 400-800 mg QD Irbesartan 150-300 mg QD Losartan 25-100 mg QD Telmisartan 20-80 mg QD Valsartan 80-320 mg QD Classification/Drug Comments Candesartan Eprosartan Irbesartan Losartan Telmisartan Valsartan Antiadrenergic Agents Classification/Drug Trade Names Starting Dosage Clonidine (*) Catapres, 0.
Mylan) announced the launch of Telmisartan Tablets USP, 20mg, 40mg, and 80mg, the generic version of Boehringer Ingelhem's Micardis Tablets.
Nasdaq: MYL) today announced that it has launched Telmisartan Tablets USP, 20 mg, 40 mg and 80 mg, the generic version of Boehringer Ingelheim's Micardis Tablets.
List of products purchased online Cardiovascular and respiratory: Lipitor (Pfizer), Plavix (sanofi-aventis), Seretide (GSK), Coversyl (Servier), Micardis (Boehringer-Ingelheim), Spiriva (Boehringer-Ingelheim) Mental health: Zyprexa (Lilly), Efexor (Wyeth), Risperdal (J&J) Alzheimer's disease: Aricept (Pfizer), Reminyl (Shire) Men's health: Cialis (Lilly), Levitra (Bayer-Schering), Viagra (Pfizer), Propecia (MSD) Other: Zoton (Wyeth), Reductil (Abbott), Mirapex (Boehringer-Ingelheim)
In addition to cannibalising sales of the originator product - Merck & Co's Cozaar - Covance will gain market share at the expense of Diovan (valsartan), Aprovel (irbesartan) and Micardis (telmisartan).
Table 31: Micardis HCT: sales forecast ($m), 2007-13 90