What happens if I overdose Zortan H?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include fainting; fast or slow heartbeat; light-headedness; severe dizziness.
Proper storage of Zortan H:
Store Zortan H at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. If your pharmacist prepares a suspension of Zortan H, store as directed by your pharmacist. Keep Zortan H out of the reach of children and away from pets.
Overdose of Zortan H in details
Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m2 basis.
Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.
Neither Zortan H nor its active metabolite can be removed by hemodialysis.
What should I avoid while taking Zortan H?
Drinking alcohol can further lower your blood pressure and may increase certain side effects of Zortan H.
Do not use potassium supplements or salt substitutes while you are taking Zortan H, unless your doctor has told you to.
Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.
Zortan H warnings
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For Zortan H, the following should be considered:
Pediatric
Studies on Zortan H have been done only in adult patients, and there is no specific information comparing use of Zortan H in children younger than 6 years of age with use in other age groups.
Geriatric
Zortan H has been tested in a limited number of patients 65 years of age or older and has not been shown to cause different side effects or problems in older people than it does in younger adults.
Pregnancy
Pregnancy Category D:
Studies in pregnant women have demonstrated a risk to the fetus. However, the benefits of therapy in a life threatening situation or a serious disease, may outweigh the potential risk.
Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Check with your doctor immediately if you think that you may be pregnant. Zortan H may cause birth defects or other problems in the baby if taken during pregnancy.
It is important that your doctor check your progress at regular visits to make sure that Zortan H is working properly and to check for unwanted effects.
Do not take other medicines unless they have been discussed with your doctor. This especially includes over-the-counter (nonprescription) medicines for appetite control, asthma, colds, cough, hay fever, or sinus problems, since they may tend to increase your blood pressure.
Dizziness or lightheadedness may occur after the first dose of Zortan H, especially if you have been taking a diuretic (water pill). Make sure you know how you react to Zortan H before you drive, use machines, or do anything else that could be dangerous if you are dizzy.
Check with your doctor right away if you become sick while taking Zortan H, especially with severe or continuing nausea and vomiting or diarrhea. These conditions may cause you to lose too much water and lead to low blood pressure.
Dizziness, lightheadedness, or fainting may also occur if you exercise or if the weather is hot. Heavy sweating can cause loss of too much water and result in low blood pressure. Use extra care during exercise or hot weather.
Avoid alcoholic beverages until you have discussed their use with your doctor. Alcohol may make the low blood pressure effect worse and/or increase the possibility of dizziness or fainting.
What should I discuss with my healthcare provider before taking Zortan H?
You should not use Zortan H if you are allergic to Zortan H.
If you have diabetes, do not use Zortan H together with any medication that contains aliskiren (Amturnide, Tekturna, Tekamlo).
You may also need to avoid taking Zortan H with aliskiren if you have kidney disease.
Do not use if you are pregnant. If you become pregnant, stop taking this medicine and tell your doctor right away. Zortan H can cause injury or death to the unborn baby if you take the medicine during your second or third trimester.
To make sure Zortan H is safe for you, tell your doctor if you have:
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kidney disease;
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liver disease;
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congestive heart failure;
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an electrolyte imbalance (such as high levels of potassium in your blood);
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if you are on a low-salt diet; or
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if you are dehydrated.
It is not known whether Zortan H passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.
Zortan H is not approved for use by anyone younger than 6 years old.
Zortan H precautions
Fetal Toxicity: Use of drugs that act on the renin-angiotensin system during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. Resulting oligohydramnios can be associated with fetal lung hypoplasia and skeletal deformations. Potential neonatal adverse effects include skull hypoplasia, anuria, hypotension, renal failure, and death. When pregnancy is detected, discontinue Zortan H as soon as possible.
Hypersensitivity: Angioedema.
Hypotension and Electrolyte/Fluid Imbalance: In patients who are intravascularly volume-depleted (e.g., those treated with high-dose diuretics), symptomatic hypotension may occur. These conditions should be corrected prior to administration of Zortan H, or a lower starting dose should be used.
Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed. In a clinical study conducted in type 2 diabetic patients with proteinuria, the incidence of hyperkalemia was higher in the group treated with Zortan H as compared to the placebo group; however, few patients discontinued therapy due to hyperkalemia.
Liver Function Impairment: Based on pharmacokinetic data which demonstrate significantly increased plasma concentrations of Zortan H in cirrhotic patients, a lower dose should be considered for patients with a history of hepatic impairment.
Renal Function Impairment: As a consequence of inhibiting the renin-angiotensin system, changes in renal function including renal failure have been reported in susceptible individuals; these changes in renal function may be reversible upon discontinuation of therapy.
Other drugs that affect the renin-angiotensin system may increase blood urea and serum creatinine in patients with bilateral renal artery stenosis or stenosis of the artery to a solitary kidney. Similar effects have been reported with Zortan H; these changes in renal function may be reversible upon discontinuation of therapy.
Race: Based on the LIFE (Zortan H Intervention For Endpoint reduction in hypertension) study, the benefits of Zortan H on cardiovascular morbidity and mortality compared to atenolol do not apply to Black patients with hypertension and left ventricular hypertrophy although both treatment regimens effectively lowered blood pressure in Black patients. In the overall LIFE study population (n=9193), treatment with Zortan H resulted in a 13.0% risk reduction (p=0.021) as compared to atenolol for patients reaching the primary composite endpoint of the combined incidence of cardiovascular death, stroke, and myocardial infarction. In this study, Zortan H decreased the risk of cardiovascular morbidity and mortality compared to atenolol in non-Black, hypertensive patients with left ventricular hypertrophy (n=8660) as measured by the primary endpoint of the combined incidence of cardiovascular death, stroke, and myocardial infarction (p=0.003). In this study, however, Black patients treated with atenolol were at lower risk of experiencing the primary composite endpoint compared with Black patients treated with Zortan H (p=0.03). In the subgroup of Black patients (n=533; 6% of the LIFE study patients), there were 29 primary endpoints among 263 patients on atenolol (11%, 25.9 per 1000 patient-years) and 46 primary endpoints among 270 patients (17%, 41.8 per 1000 patient-years) on Zortan H.
Use in Children: Neonates with a history of in utero exposure to Zortan H: If oliguria or hypotension occur, direct attention toward support of blood pressure and renal perfusion. Exchange transfusions or dialysis may be required as a means of reversing hypotension and/or substituting for disordered renal function.
Antihypertensive effects of Zortan H have been established in hypertensive pediatric patients aged >1 month to 16 years. Use of Zortan H in these age groups is supported by evidence from adequate and well-controlled studies of Zortan H in pediatric and adult patients as well as by literature in pediatric patients.
The pharmacokinetics of Zortan H have been investigated in 50 hypertensive pediatric patients >1 month to <16 years of age following once daily oral administration of approximately 0.54 to 0.77 mg/kg of Zortan H (mean doses). The active metabolite is formed from Zortan H in all age groups. Pharmacokinetics of Zortan H and its active metabolite are generally similar across the studied age groups and consistent with pharmacokinetic historic data in adults.
In a clinical study involving 177 hypertensive pediatric patients 6 to 16 years of age, patients who weighed ≥20 kg to <50 kg received either 2.5, 25 or 50 mg of Zortan H daily and patients who weighed ≥50 kg received either 5, 50 or 100 mg of Zortan H daily. Zortan H administration once daily lowered trough blood pressure in a dose-dependent manner. The dose response to Zortan H was observed across all subgroups (e.g., age, Tanner stage, gender, race). However, the lowest doses studied, 2.5 mg and 5 mg, corresponding to an average daily dose of 0.07 mg/kg, did not appear to offer consistent antihypertensive efficacy. In this study, Zortan H was generally well tolerated.
For patients who can swallow tablets, the recommended dose is 25 mg once daily in patients ≥20 to <50 kg. The dose can be increased to a maximum of 50 mg once daily. In patients >50 kg, the starting dose is 50 mg once daily. The dose can be increased to a maximum of 100 mg once daily.
In pediatric patients who are intravascularly volume depleted, these conditions should be corrected prior to administration of Zortan H.
The adverse experience profile for pediatric patients appears to be similar to that seen in adult patients.
Zortan H is not recommended in pediatric patients with glomerular filtration rate <30 mL/min/1.73 m2, in pediatric patients with hepatic impairment, or in neonates as no data are available.
Use in
Elderly: In clinical studies there was no age-related difference in the efficacy or safety profile of Zortan H.
What happens if I miss a dose of Zortan H?
Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.
References
- DailyMed. "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DailyMed. "LOSARTAN POTASSIUM: DailyMed provides trustworthy information about marketed drugs in the United States. DailyMed is the official provider of FDA label information (package inserts).". https://dailymed.nlm.nih.gov/dailyme... (accessed September 17, 2018).
- DrugBank. "hydrochlorothiazide". http://www.drugbank.ca/drugs/DB00999 (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
