Ramipril and Hydrochlorothiazide tablet: Difference between revisions

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{{DrugProjectFormSinglePage
|genericName=generic name
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|indication=a list of indications, separated by commas.
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|fdaLIADAdult======Condition 1=====


* Dosing Information
:* (Dosage)
=====Condition 2=====
* Dosing Information
:* (Dosage)
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|contraindications=* Condition 1
* Condition 2
* Condition 3
* Condition 4
* Condition 5
|warnings====Ramipril====
to be filled later
===Hydrochlorothiazide===
*Thiazides should be used 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.
*[[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.
*In general, lithium should not be given with diuretics
|clinicalTrials====Ramipril===
(to be filled)
===Hydrochlorothiazide===
=====General=====
* [[Chest pain]], weakness, fever, viral infection.
=====Cardiovascular=====
* [[Orthostatic hypotension]] (seen in 1.8% of fosinopril sodium and hydrochlorothiazide patients and 0.3% of placebo patients; no patients discontinued therapy due to orthostatic hypotension), edema, flushing, rhythm disturbance, syncope.
=====Dermatologic=====
* [[Pruritus]], [[rash]].
=====Endocrine/Metabolic=====
* Sexual dysfunction, change in libido, breast mass.
=====Gastrointestinal=====
* Nausea/vomiting, [[diarrhea]], [[dyspepsia]]/heartburn, abdominal pain, [[gastritis]]/ esophagitis.
=====Immunologic=====
* [[Angioedema]] (see WARNINGS: Head and Neck [[Angioedema]] and Intestinal Angioedema).
=====Musculoskeletal=====
*[[Myalgia]]/muscle cramps.
=====Neurologic/Psychiatric=====
* [[Somnolence]], [[depression]], numbness/paresthesia.
=====Respiratory=====
* Sinus congestion, [[pharyngitis]], [[rhinitis]].
=====Special Senses=====
* [[Tinnitus]].
=====Urogenital=====
* Urinary tract infection, urinary frequency, dysuria.
=====Laboratory Test Abnormalities=====
* Serum electrolytes, uric acid, glucose, magnesium, cholesterol, triglycerides, and calcium (see PRECAUTIONS). [[Neutropenia]].
* Antihypertensive monotherapy with fosinopril has been evaluated for safety in more than 1500 patients, of whom approximately 450 patients were treated for a year or more. The observed adverse events included events similar to those seen with fosinopril sodium and hydrochlorothiazide; in addition, the following others have also been reported with fosinopril:
=====Cardiovascular=====
* [[Angina]], myocardial infarction, cerebrovascular accident, [[hypertensive crisis]], [[hypotension]], claudication.
=====Dermatologic=====
* [[Urticaria]], [[photosensitivity]].
=====Endocrine/Metabolic=====
* [[Gout]].
=====Gastrointestinal=====
* [[Pancreatitis]], [[hepatitis]], [[dysphagia]], abdominal distention, flatulence, appetite/weight change, dry mouth.
=====Hematologic=====
* Lymphadenopathy.
=====Musculoskeletal=====
* [[Arthralgia]].
=====Neurologic/Psychiatric=====
* Memory disturbance, [[tremor]], confusion, mood change, sleep disturbance.
=====Respiratory=====
* Bronchospasm, laryngitis/hoarseness, [[epistaxis]], and (in two patients) a symptom-complex of cough, bronchospasm, and eosinophilia.
=====Special Senses=====
* Vision disturbance, taste disturbance, eye irritation.
=====Urogenital=====
* Renal insufficiency.
=====Laboratory Test Abnormalities=====
* Elevations (usually transient and minor) of BUN and creatinine have been observed, but these have not been more frequent than in parallel patients treated with placebo. The hemoglobin in fosinopril-treated patients generally decreases by an average of 0.1 g/dL, but this nonprogressive change has never been symptomatic. Leukopenia and eosinophilia have also been reported.
* Serum levels of liver function tests (transaminases, LDH, alkaline phosphatase and serum bilirubin) have occasionally been found to be elevated, and these elevations have lead to discontinuation of therapy in 0.7% of patients. Other risk factors for liver dysfunction have often been present in these cases; in any event the elevations generally have resolved after discontinuation of therapy with fosinopril.
Other Adverse Events Reported with ACE Inhibitors
Other adverse effects reported with ACE inhibitors include cardiac arrest; pancytopenia, hemolytic anemia; aplastic anemia; thrombocytopenia; bullous pemphigus, exfoliative dermatitis; and a syndrome that may include one or more of arthralgia/arthritis, vasculitis, serositis, myalgia, fever, rash or other dermopathy, positive ANA titer, leukocytosis, eosinophilia, and elevated ESR.
Hydrochlorothiazide has now been extensively prescribed for many years, but there has not been enough systematic collection of data to support an estimate of the frequency of the observed adverse reactions. Within organ-system groups, the reported reactions are listed here in decreasing order of severity, without regard to frequency.
=====Cardiovascular=====
* [[Orthostatic hypotension]] (may be potentiated by alcohol, barbiturates, or narcotics).
=====Gastrointestinal=====
* [[Pancreatitis]], [[jaundice]] (intrahepatic cholestatic), [[sialadenitis]], [[vomiting]], [[diarrhea]], cramping, [[nausea]], gastric irritation, constipation, and anorexia.
=====Hematologic=====
* Aplastic [[anemia]], [[agranulocytosis]], [[leukopenia]], [[thrombocytopenia]], and [[hemolytic anemia]].
=====Immunologic=====
* Necrotizing angiitis, [[Stevens-Johnson syndrome]], respiratory distress (including [[pneumonitis]] and pulmonary edema), anaphylactic reactions, [[purpura]],[[urticaria]], [[rash]], and [[photosensitivity]].
=====Metabolic=====
* [[Hyperglycemia]], glycosuria, and hyperuricemia.
=====Musculoskeletal=====
* Muscle spasm.
=====Neurologic=====
* [[Vertigo]], lightheadedness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, and restlessness.
|postmarketing=(Description)
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* Drug 2
* Drug 3
* Drug 4
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=====Drug 1=====
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=====Drug 2=====
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=====Drug 3=====
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=====Drug 4=====
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=====Condition 3=====
(Description regarding monitoring, from ''Warnings'' section)
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|overdose====Acute Overdose===
====Signs and Symptoms====
(Description)
====Management====
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===Chronic Overdose===
====Signs and Symptoms====
(Description)
====Management====
(Description)
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Latest revision as of 14:30, 25 April 2014