What happens if I overdose Nebistar H?
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local, or emergency room immediately. Symptoms may include severe dizziness; symptoms of blood electrolyte problems (eg, confusion; irregular heartbeat; mental or mood changes; muscle pain, weakness, or cramping; seizures; sluggishness); symptoms of dehydration (eg, dry mouth or eyes; decreased urination; fast heartbeat; unusual thirst, tiredness, or weakness).
Proper storage of Nebistar H capsules:
Store Nebistar H capsules 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. Keep Nebistar H capsules out of the reach of children and away from pets.
Overdose of Nebistar H in details
Losartan Potassium: Significantly, 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 losartan potassium nor its active metabolites can be removed by hemodialysis.
Nebistar H: The oral lethal dose50 (LD50) of Nebistar H is >10 g/kg in both mice and rats. The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which Nebistar H is removed by hemodialysis has not been established.
What should I avoid while taking Nebistar H?
Drinking alcohol can increase certain side effects of Nebistar H.
Avoid becoming overheated or dehydrated during exercise and in hot weather. Follow your doctor's instructions about the type and amount of liquids you should drink. In some cases, drinking too much liquid can be as unsafe as not drinking enough.
Nebistar H warnings
Use with caution in severe renal disease. In patients with renal disease, thiazides may precipitate azotemia. Cumulative effects of the drug may develop in patients with impaired renal function.
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Thiazides may add to or potentiate the action of other antihypertensive drugs.
Sensitivity reactions may occur in patients with or without a history of allergy or bronchial asthma.
The possibility of exacerbation or activation of systemic lupus erythematosus has been reported.
Lithium generally should not be given with diuretics.
Acute Myopia and Secondary Angle-Closure Glaucoma
Nebistar H, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation., Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue Nebistar H as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
What should I discuss with my healthcare provider before taking Nebistar H?
Some medical conditions may interact with Nebistar H solution. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
- if you are pregnant, planning to become pregnant, or are breast-feeding
- if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
- if you have allergies to medicines, foods, or other substances
- if you have gout, liver problems, lupus, kidney problems, diabetes, asthma, parathyroid problems, or high blood cholesterol or lipid levels
- if you have low blood sodium, chloride, potassium, or magnesium levels; or high blood calcium levels
Some MEDICINES MAY INTERACT with Nebistar H solution. Tell your health care provider if you are taking any other medicines, especially any of the following:
- Cholestyramine, colestipol, or nonsteroidal anti-inflammatory medicines (NSAIDs) (eg, ibuprofen) because they decrease the effectiveness of Nebistar H solution
- Barbiturates (eg, phenobarbital), corticosteroids (eg, prednisone), narcotic pain medicines (eg, codeine, morphine, fentanyl), or medicines for high blood pressure because side effects of Nebistar H solution may be increased
- Diazoxide or nondepolarizing muscle relaxants (eg, tubocurarine) because side effects may be increased by Nebistar H solution
- Lithium because risk of toxicity may be increased by Nebistar H solution
- Digoxin, dofetilide, or ketanserin because risk of irregular heartbeat may be increased by Nebistar H solution
- Diabetes medicines (eg, glipizide, metformin), insulin, or pressor amines (eg, norepinephrine) because the effectiveness may be decreased by Nebistar H solution
This may not be a complete list of all interactions that may occur. Ask your health care provider if Nebistar H solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.
Nebistar H precautions
Electrolyte and Fluid Balance Status
In published studies, clinically significant hypokalemia has been consistently less common in patients who received 12.5 mg of Nebistar H than in patients who received higher doses. Nevertheless, periodic determination of serum electrolytes should be performed in patients who may be at risk for the development of hypokalemia. Patients should be observed for signs of fluid or electrolyte disturbances, i.e. hyponatremia, hypochloremic alkalosis, and hypokalemia and hypomagnesemia.
Warning signs or symptoms of fluid and electrolyte imbalance include dryness of mouth, thirst, weakness, lethargy, drowsiness, restlessness, muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, and gastrointestinal disturbances such as nausea and vomiting.
Hypokalemia may develop, especially with brisk diuresis when severe cirrhosis is present, during concomitant use of corticosteroid or adrenocorticotropic hormone (ACTH) or after prolonged therapy. Interference with adequate oral electrolyte intake will also contribute to hypokalemia. Hypokalemia and hypomagnesemia can provoke ventricular arrhythmias or sensitize or exaggerate the response of the heart to the toxic effects of digitalis. Hypokalemia may be avoided or treated by potassium supplementation or increased intake of potassium rich foods.
Dilutional hyponatremia is life-threatening and may occur in edematous patients in hot weather; appropriate therapy is water restriction rather than salt administration, except in rare instances when the hyponatremia is life-threatening. In actual salt depletion, appropriate replacement is the therapy of choice.
Hyperuricemia
Hyperuricemia or acute gout may be precipitated in certain patients receiving thiazide diuretics.
Impaired Hepatic Function
Thiazides should be used with caution in patients with impaired hepatic function. They can precipitate hepatic coma in patients with severe liver disease.
Parathyroid Disease
Calcium excretion is decreased by thiazides, and pathologic changes in the parathyroid glands, with hypercalcemia and hypophosphatemia, have been observed in a few patients on prolonged thiazide therapy.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Two-year feeding studies in mice and rats conducted under the auspices of the National Toxicology Program (NTP) uncovered no evidence of a carcinogenic potential of Nebistar H in female mice (at doses of up to approximately 600 mg/kg/ day) or in male and female rats (at doses of approximately 100 mg/kg/day). The NTP, however, found equivocal evidence for hepatocarcinogenicity in male mice. Nebistar H was not genotoxic in vitro in the Ames mutagenicity assay of Salmonella typhimurium strains TA 98, TA 100, TA 1535, TA 1537, and TA 1538 and in the Chinese Hamster Ovary (CHO) test for chromosomal aberrations, or in vivo in assays using mouse germinal cell chromosomes, Chinese hamster bone marrow chromosomes, and the Drosophila sex-linked recessive lethal trait gene. Positive test results were obtained only in the in vitro CHO Sister Chromatid Exchange (clastogenicity) and in the Mouse Lymphoma Cell (mutagenicity) assays, using concentrations of Nebistar H from 43 to 1300 mcg/mL, and in the Aspergillus nidulans non-disjunction assay at an unspecified concentration.
Nebistar H had no adverse effects on the fertility of mice and rats of either sex in studies wherein these species were exposed, via their diet, to doses of up to 100 and 4 mg/kg, respectively, prior to conception and throughout gestation.
Pregnancy
Teratogenic Effects
Pregnancy Category B: Studies in which Nebistar H was orally administered to pregnant mice and rats during their respective periods of major organogenesis at doses up to 3000 and 1000 mg Nebistar H/kg, respectively, provided no evidence of harm to the fetus.
There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.
Nonteratogenic Effects
Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Nursing Mothers
Thiazides are excreted in breast milk. Because of the potential for serious adverse reactions in nursing infants, a decision should be made whether to discontinue nursing or to discontinue Nebistar H, taking into account the importance of the drug to the mother.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Elderly Use
A greater blood pressure reduction and an increase in side effects may be observed in the elderly (i.e. > 65 years) with Nebistar H. Starting treatment with the lowest available dose of Nebistar H (12.5 mg) is therefore recommended. If further titration is required, 12.5 mg increments should be utilized.
What happens if I miss a dose of Nebistar 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).
- DrugBank. "hydrochlorothiazide". http://www.drugbank.ca/drugs/DB00999 (accessed September 17, 2018).
- MeSH. "Diuretics". https://www.ncbi.nlm.nih.gov/mesh/68... (accessed September 17, 2018).
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Information checked by Dr. Sachin Kumar, MD Pharmacology
