Doctors-on-tour.ca

24 life JANUARY 12, 2010 CanadianHealthcareNetwork.ca THE MEDICAL POST
In harmony with nature in the Amazon
An ecological y responsible vacation in Ecuador has great outdoor adventures that support native groups The desTrucTion of the
der, in the southern Ecuadorian in your bathroom for shower- our planet with an abundance of trinkets were everywhere.
The Journey to Kapawi
isolated, is accessed only by air, three-step drainage process, species of plants and 540 differ- initial funding, management Ecolodge entertainment
wanted to visit before all of this landing strip in the middle of we recently joined the Doctors- boarded a motorized canoe for 205753_PI_7.875x10.75:205699_PI_CME 11/3/09 9:13 AM Page 3 cisions that were made. In a 20-minute ride up a lazy river beautiful lagoon to minimize on fetal development as they were lethal to the does). In rats, significant decreases in pup birth weight and Less Common Clinical Trial Adverse Drug Reactions (<1%): Other (potentially important) adverse events
weight gain were observed at doses ≥1.6 mg/kg/day, and delays in developmental milestones and dose- that have been reported in controlled or open-label trials with an incidence of greater than 0.5%, regardless dependent increases in the incidence of dilation of the renal pelvis were observed at doses ≥8 mg/kg/day.
of causality: Cardiac disorders: tachycardia. Ear and labyrinth disorders: vertigo. Gastrointestinal disorders: The no observed effect dose for developmental toxicity in rats is 0.3 mg/kg/day, about one-tenth the MRHD abdominal pain, dyspepsia, nausea. General disorders and administration site conditions: chest pain, edema peripheral. Infections and infestations: gastroenteritis. Metabolism and nutrition disorders: Olmetec PLUS® – No teratogenic effects were observed when 1.6:1 combinations of olmesartan medoxomil
hypercholesterolemia, hyperlipidemia, hyperuricaemia. Musculoskeletal and connective tissue disorders: and HCTZ were administered to pregnant mice at oral doses up to 1625 mg/kg/day (122 times the MRHD on arthralgia, arthritis, myalgia. Renal and urinary disorders: albuminuria. Respiratory, thoracic and mediastinal a mg/m2 basis) or pregnant rats at oral doses up to 1625 mg/kg/day (280 times the MRHD on a mg/m2 basis).
disorders: cough. Skin and subcutaneous tissue disorders: rash. Facial edema was reported in 5 patients In rats, however, fetal body weights at 1625 mg/kg/day (a toxic, sometimes lethal dose in the dams) were receiving olmesartan medoxomil. Angioedema has been reported with other angiotensin II antagonists.
significantly lower than control. The no observed effect dose for developmental toxicity in rats, Abnormal Hematologic and Clinical Chemistry Findings: In controlled clinical trials, clinically important
162.5 mg/kg/day, is about 28 times, on a mg/m2 basis, the MRHD of Olmetec PLUS® (40 mg olmesartan changes in standard laboratory parameters were rarely associated with administration of olmesartan DRUG INTERACTIONS
Hemoglobin and Hematocrit: Small decreases in hemoglobin and hematocrit (mean decreases of Drug-Drug Interactions:
approximately 0.3 g/dL and 0.3 volume percent, respectively) were observed.
Diuretics:
Liver Function Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently. Patients on diuretics, and especially those in whom diuretic therapy was recently instituted, may occasionally Placebo (n=555)
Total olmesartan
experience an excessive reduction in blood pressure after initiation of therapy with olmesartan. The possibility medoxomil (n=2450)
of symptomatic hypotension with the use of olmesartan can be minimized by discontinuing the diuretic prior ¥GT increased
to initiation of treatment. No drug interaction of clinical significance has been identified with thiazide CPK increased
ALT increased
Pravastatin:
and AUC of pravastatin by approximately 25% and 21%, respectively. Since AST increased
there is a high degree of variability in the bioavailability of pravastatin, this finding is not considered to be Post-Market Adverse Drug Reactions: Other adverse events reported rarely in post-marketing use include:
asthenia, angioedema, vomiting, hyperkalemia, rhabdomyolysis, renal failure acute, blood creatinine Warfarin:
increased, alopecia, pruritus, urticaria, palpitations, syncope, and blood uric acid increased.
There was no effect on either the pharmacokinetics or pharmacodynamics of warfarin when co-administered with olmesartan medoxomil in healthy volunteers. Table 2: Adverse Eventsa Occurring >1% in Placebo-controlled Cohort
Digoxin:
No pharmacokinetics or pharmacodynamics effects were reported when olmesartan medoxomil was co- administered with digoxin in healthy volunteers. olmesartan
olmesartan
System Organ Class (SOC)
medoxomil
medoxomil
Antacids:
The bioavailability of olmesartan was not significantly altered when co-administered with antacids Cytochrome P450 Enzyme System:
MedDRA preferred term
Unlike some other ARB, olmesartan medoxomil is not metabolized by cytochrome P450 enzymes. Interactions with drugs that inhibit, induce or are metabolized by these enzymes are not expected. Ear and labyrinth disorders
Hydrochlorothiazide:
When administered concurrently the following drugs may interact with thiazide diuretics; Agents Increasing Gastrointestinal disorders
Serum Potassium: Concomitant use of potassium-sparing diuretics (e.g., spironolactone, triamterene, amiloride), potassium supplements, or salt substitutes containing potassium may lead to increase in serum potassium. Since olmesartan decreases the production of aldosterone, potassium-sparing diuretics or potassium supplements should be given only for documented hypokalemia and with frequent monitoring of serum potassium when olmesartan medoxomil therapy is initiated. Potassium-containing salt substitutes should also be used with caution. Concomitant thiazide diuretic use may attenuate any effect that olmesartan may have on serum potassium. Alcohol, Barbiturates, or Narcotics: Potentiation of orthostatic hypotension may occur. Antidiabetic Drugs (oral agents and insulin): Due to the potential for hyperglycemia in patients on General disorders and administration site conditions
thiazides, dosage adjustment of the antidiabetic drug may be required. Cholestyramine and Colestipol Resins: Absorption of HCTZ is impaired in the presence of anionic exchange resins. Single doses of either cholestyramine or colestipol resins bind the HCTZ and reduce its absorption from the gastrointestinal tract by up to 85 and 43 percent, respectively. Corticosteroids, ACTH: Intensified electrolyte depletion, particularly Immune system disorders
hypokalemia may occur. Non-steroidal Anti-inflammatory Drugs (NSAIDs): The administration of a non- steroidal anti-inflammatory agent can reduce the diuretic, natiuretic and antihypertensive effects of loop, Infections and infestations
potassium-sparing and thiazide diuretics. Therefore, when Olmetec PLUS® and NSAID agents are used concomitantly, the patients should be observed closely to determine if the desired effect of the diuretic is obtained. Other Antihypertensive Drugs: Diuretic additive effect or potentiation of antihypertensive effect may occur. Pressor Amines (e.g., Norepinephrine): In the presence of diuretics, possible decreased response to pressor amines may occur but the effect is not sufficient to preclude their use. Skeletal Muscle Relaxants, Non depolarizing (e.g., Turbocurarine): Thiazide drugs may increase responsiveness to the muscle relaxant. Drug-Food Interactions: Olmetec® and Olmetec PLUS® may be administered with or without food.
Drug-Herb Interactions: Interactions with herbal products have not been established.
Injury, poisoning and procedural complications
Drug-Laboratory Interactions: Interactions with laboratory tests have not been established.
ADVERSE REACTIONS
Treatment with Olmetec® and Olmetec PLUS® was well tolerated, with an incidence of events similar to Metabolism and nutrition disorders
placebo. Events generally were mild, transient, and had no relationship to the dose. Table 1: Adverse Events Occurring >1% in Placebo-controlled Monotherapy Studiesa
Arriving in Ecuador
Total olmesartan
System Organ Class (SOC)
medoxomil
Musculoskeletal and connective tissue disorders
(n=2540)
MedDRA preferred term
Gastrointestinal disorders
Nervous system disorders
General disorders and
administration site conditions
Renal and urinary disorders
Infections and infestations
Respiratory, thoracic and mediastinal disorders
Vascular disorders
Injury, poisoning and
procedural complications
a Adverse events reported in >1% of patients in the Total Olmesartan Medoxomil + HCTZ treatment group.
Other adverse events that have been reported with an incidence of greater than 1.0%, whether or not Metabolism and nutrition
attributed to treatment, in the more than 1200 hypertensive patients treated with olmesartan medoxomil - disorders
hydrochlorothiazide in controlled or open-label trials: Gastrointestinal disorders: abdominal pain, dyspepsia, diarrhea. General disorders and administration site conditions: chest pain, edema peripheral. Infections and infestations: gastroenteritis. Investigations: alanine aminotransferase increased, aspartate aminotransferase increased, creatine phosphokinase increased, Musculoskeletal and
gamma-glutamyltransferase increased. Musculoskeletal and connective tissue disorders: arthritis, arthralgia, connective tissue disorders
back pain, myalgia. Nervous system disorders: vertigo. Renal and urinary disorders: hematuria. Respiratory, thoracic and mediastinal disorders: cough. Skin and subcutaneous tissue disorders: rash.
Nervous system disorders
Less Common Clinical Trial Adverse Drug Reactions (<1%): Facial edema was reported in 2/1243 patients
receiving olmesartan medoxomil - hydrochlorothiazide. Angioedema has been reported with angiotensin II Abnormal Hematologic and Clinical Chemistry Findings: In controlled clinical trials, clinically important
Renal and urinary disorders
changes in standard laboratory parameters were rarely associated with administration of olmesartan a Body systems in which patients in either treatment group experienced events and in which at least one event Liver Functions Tests: Elevations of liver enzymes and/or serum bilirubin were observed infrequently.
was reported in >1% of patients in either treatment group.

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