Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue olmesartan medoxomil and hydrochlorothiazide tablets as soon as possible [see Use in Specific Populations 8.

Thiazides cross the placental barrier and appear in cord blood. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations 8. If hypotension does occur, the patient should be placed in the supine position and, if necessary, given an intravenous infusion of normal saline. When electrolyte and fluid imbalances have been corrected, olmesartan medoxomil and hydrochlorothiazide tablets usually can be continued without difficulty.

A transient hypotensive response is not a contraindication to further treatment. Patients whose renal function may depend in part on the activity of the renin-angiotensin system e. Monitor renal function periodically in these patients. Consider withholding or discontinuing therapy in patients who develop a clinically significant decrease in renal function on olmesartan medoxomil and hydrochlorothiazide tablets [see Drug Interactions 7 ].

Hypomagnesemia can result in hypokalemia which may be difficult to treat despite potassium repletion. If you also take certain drugs to lower your cholesterol bile acid-binding resins such as cholestyramine , colesevelam or colestipol , take this product at least 4 hours before or at least 4 to 6 hours after these medications.

The dosage is based on your medical condition and response to treatment. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. Tell your doctor if your condition does not improve or if it worsens for example, your blood pressure readings increase. What conditions does Olmesartan-Hydrochlorothiazide treat?

Side Effects Dizziness or lightheadedness may occur as your body adjusts to the medication. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any symptoms of dehydration or mineral loss, including: Tell your doctor right away if you have any serious side effects, including: A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction , including: This is not a complete list of possible side effects.

If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. In Canada - Call your doctor for medical advice about side effects. After oral administration of hydrochlorothiazide, diuresis begins within 2 hours, peaks in about 4 hours, and lasts about 6 to 12 hours. Drug Interactions Alcohol, Barbiturates, or Narcotics: Potentiation of orthostatic hypotension may occur.

Skeletal muscle relaxants, non-depolarizing e. Possible increased responsiveness to the muscle relaxant. Pharmacokinetics Olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets.

After oral administration of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets in normal healthy adults, peak plasma concentrations of olmesartan, amlodipine, and hydrochlorothiazide are reached in about 1. The rate and extent of absorption of olmesartan medoxomil, amlodipine, and hydrochlorothiazide from olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets are the same as when administered as individual dosage forms.

Food does not affect the bioavailability of olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets. Olmesartan medoxomil is rapidly and completely bioactivated by ester hydrolysis to olmesartan during absorption from the gastrointestinal tract. After oral administration, the Cmax of olmesartan is reached after 1 to 2 hours. Food does not affect the bioavailability of olmesartan medoxomil. After oral administration of therapeutic doses of amlodipine, absorption produces peak plasma concentrations between 6 and 12 hours.

When plasma levels have been followed for at least 24 hours, the plasma half-life has been observed to vary between 5. The volume of distribution of olmesartan is approximately 17 L. The protein binding is constant at plasma olmesartan concentrations well above the range achieved with recommended doses.

In rats, olmesartan crossed the blood-brain barrier poorly, if at all. Olmesartan passed across the placental barrier in rats and was distributed to the fetus. Olmesartan was distributed to milk at low levels in rats.

Steady-state plasma levels of amlodipine are reached after 7 to 8 days of consecutive daily dosing. Hydrochlorothiazide crosses the placental but not the blood-brain barrier and is excreted in breast milk.

Metabolism and Excretion Olmesartan medoxomil. Following the rapid and complete conversion of olmesartan medoxomil to olmesartan during absorption, there is virtually no further metabolism of olmesartan.

Total plasma clearance of olmesartan is 1. Olmesartan appears to be eliminated in a biphasic manner with a terminal elimination half-life of approximately 13 hours. Olmesartan shows linear pharmacokinetics following single oral doses of up to mg and multiple oral doses of up to 80 mg. Steady-state levels of olmesartan are achieved within 3 to 5 days and no accumulation in plasma occurs with once-daily dosing.

Elimination from the plasma is biphasic with a terminal elimination half-life of about 30 to 50 hours. Hydrochlorothiazide is not metabolized but is eliminated rapidly by the kidney. Specific Populations Geriatric Olmesartan medoxomil. Overall, maximum plasma concentrations of olmesartan were similar in young adults and the elderly. Gender Population pharmacokinetic analysis indicated that gender had no effect on the clearance of olmesartan and amlodipine.

Minor differences were observed in the pharmacokinetics of olmesartan medoxomil in women compared to men. Renal Insufficiency Olmesartan medoxomil. In patients with renal insufficiency, serum concentrations of olmesartan were elevated compared to subjects with normal renal function. The pharmacokinetics of olmesartan medoxomil in patients undergoing hemodialysis has not been studied. Hepatic Insufficiency Olmesartan medoxomil. Erythromycin coadministration in healthy volunteers did not significantly change amlodipine systemic exposure.

However, strong inhibitors of CYP3A e. Coadministration of amlodipine with cimetidine did not alter the pharmacokinetics of amlodipine. Coadministration of mL of grapefruit juice with a single oral dose of amlodipine 10 mg in 20 healthy volunteers had no significant effect on the pharmacokinetics of amlodipine. A single mg dose of sildenafil in subjects with essential hypertension had no effect on the pharmacokinetic parameters of amlodipine.

When amlodipine and sildenafil were used in combination, each agent independently exerted its own blood pressure lowering effect. Coadministration of multiple 10 mg doses of amlodipine with 80 mg of atorvastatin resulted in no significant change in the steady state pharmacokinetic parameters of atorvastatin. Coadministration of amlodipine with digoxin did not change serum digoxin levels or digoxin renal clearance in normal volunteers. Single and multiple 10 mg doses of amlodipine had no significant effect on the pharmacokinetics of ethanol.

Coadministration of amlodipine with warfarin did not change the warfarin prothrombin response time. No significant drug interactions were reported in studies in which olmesartan medoxomil was coadministered with warfarin in healthy volunteers. No significant drug interactions were reported in studies in which olmesartan medoxomil was coadministered with digoxin in healthy volunteers. Nonclinical Toxicology The rationale for no or limited new toxicity from the triple combination of olmesartan medoxomil, amlodipine, and hydrochlorothiazide has already been established on the basis of the safety profile of the individual compounds or the dual combinations.

To clarify the toxicological profile for olmesartan medoxomil, amlodipine, and hydrochlorothiazide tablets, a 3 month repeated dose toxicity study was conducted in rats, and the results demonstrated that the combined administration of olmesartan medoxomil, amlodipine, and hydrochlorothiazide neither augment any existing toxicities of the individual agents nor induce any new toxicities and there were no toxicologically synergistic effects observed in the study.

Carcinogenesis, Mutagenesis, Impairment of Fertility No carcinogenicity, mutagenicity or fertility studies have been conducted with the combination of Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide.

Risk factors for developing acute angleclosure glaucoma may include a history of sulfonamide or penicillin allergy. Systemic Lupus Erythematosus Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus. Sprue-Like Enteropathy Severe, chronic diarrhea with substantial weight loss has been reported in patients taking olmesartan months to years after drug initiation.

Intestinal biopsies of patients often demonstrated villous atrophy. If a patient develops these symptoms during treatment with olmesartan, exclude other etiologies. Nonclinical Toxicology Carcinogenesis, Mutagenesis, Impairment Of Fertility Olmesartan Medoxomil And Hydrochlorothiazide No carcinogenicity studies with olmesartan medoxomil and hydrochlorothiazide have been conducted. Olmesartan medoxomil and hydrochlorothiazide in a ratio of Olmesartan medoxomil and hydrochlorothiazide were tested individually and in combination ratios of A positive response was seen for each component and combination ratio.

However, no synergism in clastogenic activity was detected between olmesartan medoxomil and hydrochlorothiazide at any combination ratio. No studies of impairment of fertility with olmesartan medoxomil and hydrochlorothiazide have been conducted. Olmesartan Medoxomil Olmesartan medoxomil was not carcinogenic when administered by dietary administration to rats for up to 2 years. Both olmesartan medoxomil and olmesartan tested negative in the in vitro Syrian hamster embryo cell transformation assay and showed no evidence of genetic toxicity in the Ames bacterial mutagenicity test.

However, both were shown to induce chromosomal aberrations in cultured cells in vitro Chinese hamster lung and both tested positive for thymidine kinase mutations in the in vitro mouse lymphoma assay.

Efficacy and Safety of Azilsartan Medoxomil and Chlorthalidone Compared to Olmesartan Medoxomil and Hydrochlorothiazide in Participants With Moderate to Severe Hypertension.

The pharmacokinetics of 40mg are not significantly influenced by renal impairment. Patients with renal insufficiency have elevated serum concentrations of olmesartan compared with patients with normal renal function. The no observed medoxomil dose for developmental toxicity in rats is 0. If oliguria or hypotension occurs, direct attention toward support of blood pressure and renal perfusion. Skeletal Muscle Relaxants, Non depolarizing e. Olmesartan cross the placental barrier and appear in cord blood. Important considerations medoxomil taking this drug Olmesartan drug can be taken with or without food Take this drug at the time s recommended by your hydrochlorothiazide This tablet can be cut or crushed. Adjust 40mg as needed. Adverse reactions include fetal or neonatal jaundice and thrombocytopenia [see Use in Specific Populations]. However, these studies have been conducted for Olmesartan Medoxomil, Amlodipine and Hydrochlorothiazide alone, olmesartan medoxomil 40mg hydrochlorothiazide, and olmesartan medoxomil and hydrochlorothiazide together, olmesartan medoxomil 40mg hydrochlorothiazide. Consult your pharmacist or hydrochlorothiazide waste disposal company.

Olmesartan Medoxomil and Hydrochlorothiazide: Package Insert and Label Information (Page 4 of 4)

It was also not genotoxic in vivo in assays using mouse germinal cell chromosomesChinese Hamster bone marrow chromosomes, or atorvastatina ezetimibe 20 10mg Drosophilla sex-linked recessive lethal trait gene. Hydrochlorothiazide Hepatic Impairment Thiazides should be used with medoxomil in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma. How to tell if the drug is working Your blood pressure should be lowered. Drug Interactions Alcohol, Barbiturates, or Narcotics: There is an increased risk of severe hypotension and renal olmesartan when hydrochlorothiazide with 40mg renal artery stenosis or stenosis of the artery to olmesartan single functioning kidney are treated with medicinal products that affect the renin-angiotensin-aldosterone system. Possible increased responsiveness to the muscle relaxant. In studies of angiotensin II receptor antagonists such as olmesartan, patients with unilateral or bilateral renal artery stenosis, increases in serum creatinine or blood urea nitrogen have been reported. If you take 40mg much You could have dangerous levels of the drug in your body, olmesartan medoxomil 40mg hydrochlorothiazide. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Lithium— should not generally be given with diuretics. These patients should be asked to report pregnancies to their physicians as soon as possible. If hypotension does occur, the patient should be placed in medoxomil supine position and, if necessary, given an intravenous infusion of hydrochlorothiazide saline.

OLMESARTAN MEDOXOMIL and HYDROCHLOROTHIAZIDE: Package Insert and Label Information

Properly discard this product when it is expired or no longer needed, olmesartan medoxomil 40mg hydrochlorothiazide. 40mg, these data raise a concern of a possible increased CV risk associated with the use of high-dose olmesartan in diabetic patients. Untreated acute angle-closure glaucoma can lead to permanent vision loss. If oligohydramnios is observed, discontinue Tribenzor, unless it is considered lifesaving for the mother. Dofetilide Plasma concentrations of dofetilide may be increased; prolongation of the QT interval hydrochlorothiazide occur, increasing the risk of torsades ativan tablets buy pointes. Limit your time in the medoxomil. If coadministration is undertaken, closely monitor serum potassium concentrations and renal function. Concurrent use of enzalutamide with CYP3A4 substrates that have a narrow therapeutic index should be avoided. Canada residents can olmesartan a provincial poison control center. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Thiazides may precipitate azotemia in patients with renal disease.

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