Ramipril and Hydrochlorothiazide tablet: Difference between revisions

Jump to navigation Jump to search
Newer edit →
VisualWikitext
Ahmed Zaghw (talk | contribs)
nocaptcha
4,404 edits
Created page with "{{DrugProjectFormSinglePage |genericName=generic name |aOrAn=a |drugClass=Adrenergic receptor agonist |indication=a list of indications, separated by commas. |hasBlackBoxWarni..."
 
Ahmed Zaghw (talk | contribs)
nocaptcha
4,404 edits
No edit summary
Line 126: Line 126:


(Description)
(Description)
|clinicalTrials=======Central Nervous System======
|clinicalTrials====Ramipril===
(to be filled)


: (list/description of adverse reactions)
===Hydrochlorothiazide===


======Cardiovascular======
=====General=====
* [[Chest pain]], weakness, fever, viral infection.


: (list/description of adverse reactions)
=====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.


======Respiratory======
=====Dermatologic=====
* [[Pruritus]], [[rash]].


: (list/description of adverse reactions)
=====Endocrine/Metabolic=====
* Sexual dysfunction, change in libido, breast mass.


======Gastrointestinal======
=====Gastrointestinal=====
* Nausea/vomiting, [[diarrhea]], [[dyspepsia]]/heartburn, abdominal pain, [[gastritis]]/ esophagitis.


: (list/description of adverse reactions)
=====Immunologic=====
* [[Angioedema]] (see WARNINGS: Head and Neck [[Angioedema]] and Intestinal Angioedema).


======Hypersensitive Reactions======
=====Musculoskeletal=====
*[[Myalgia]]/muscle cramps.


: (list/description of adverse reactions)
=====Neurologic/Psychiatric=====
* [[Somnolence]], [[depression]], numbness/paresthesia.


======Miscellaneous======
=====Respiratory=====
* Sinus congestion, [[pharyngitis]], [[rhinitis]].


: (list/description of adverse reactions)
=====Special Senses=====
* [[Tinnitus]].


=====Condition 2=====
=====Urogenital=====
* Urinary tract infection, urinary frequency, dysuria.


======Central Nervous System======
=====Laboratory Test Abnormalities=====
* Serum electrolytes, uric acid, glucose, magnesium, cholesterol, triglycerides, and calcium (see PRECAUTIONS). [[Neutropenia]].


: (list/description of adverse reactions)
* 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======
=====Cardiovascular=====
* [[Angina]], myocardial infarction, cerebrovascular accident, [[hypertensive crisis]], [[hypotension]], claudication.


: (list/description of adverse reactions)
=====Dermatologic=====
* [[Urticaria]], [[photosensitivity]].


======Respiratory======
=====Endocrine/Metabolic=====
* [[Gout]].


: (list/description of adverse reactions)
=====Gastrointestinal=====
* [[Pancreatitis]], [[hepatitis]], [[dysphagia]], abdominal distention, flatulence, appetite/weight change, dry mouth.


======Gastrointestinal======
=====Hematologic=====
* Lymphadenopathy.


: (list/description of adverse reactions)
=====Musculoskeletal=====
* [[Arthralgia]].


======Hypersensitive Reactions======
=====Neurologic/Psychiatric=====
* Memory disturbance, [[tremor]], confusion, mood change, sleep disturbance.


: (list/description of adverse reactions)
=====Respiratory=====
* Bronchospasm, laryngitis/hoarseness, [[epistaxis]], and (in two patients) a symptom-complex of cough, bronchospasm, and eosinophilia.


======Miscellaneous======
=====Special Senses=====
* Vision disturbance, taste disturbance, eye irritation.


: (list/description of adverse reactions)
=====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)
|postmarketing=(Description)
|drugInteractions=* Drug 1
|drugInteractions=* Drug 1

Revision as of 19:04, 24 April 2014

Ramipril and Hydrochlorothiazide tablet
Black Box Warning
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1];

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Black Box Warning

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)

Overview

Ramipril and Hydrochlorothiazide tablet is a Adrenergic receptor agonist that is FDA approved for the {{{indicationType}}} of a list of indications, separated by commas.. There is a Black Box Warning for this drug as shown here. Common adverse reactions include a list of adverse reactions, separated by commas..

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition 1
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)
Condition 2
  • Developed by: (Organisation)
  • Class of Recommendation: (Class) (Link)
  • Strength of Evidence: (Category A/B/C) (Link)
  • Dosing Information/Recommendation
  • (Dosage)

Non–Guideline-Supported Use

Condition 1
  • Dosing Information
  • (Dosage)
Condition 2
  • Dosing Information
  • (Dosage)
Condition 3
  • Dosing Information
  • (Dosage)

Contraindications

  • Condition 1
  • Condition 2
  • Condition 3
  • Condition 4
  • Condition 5

Warnings

Warning Title
See full prescribing information for complete Boxed Warning.
Condition Name: (Content)
Conidition 1

(Description)

Conidition 2

(Description)

Conidition 3

(Description)

Adverse Reactions

Clinical Trials Experience

Ramipril

(to be filled)

Hydrochlorothiazide

General
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
Endocrine/Metabolic
  • Sexual dysfunction, change in libido, breast mass.
Gastrointestinal
Immunologic
Musculoskeletal
Neurologic/Psychiatric
Respiratory
Special Senses
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
Dermatologic
Endocrine/Metabolic
Gastrointestinal
Hematologic
  • Lymphadenopathy.
Musculoskeletal
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
Gastrointestinal
Hematologic
Immunologic
Metabolic
Musculoskeletal
  • Muscle spasm.
Neurologic
  • Vertigo, lightheadedness, transient blurred vision, headache, paresthesia, xanthopsia, weakness, and restlessness.

Postmarketing Experience

(Description)

Drug Interactions

  • Drug 1
  • Drug 2
  • Drug 3
  • Drug 4
  • Drug 5
Drug 1

(Description)

Drug 2

(Description)

Drug 3

(Description)

Drug 4

(Description)

Drug 5

(Description)

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): (Description)
Pregnancy Category (AUS): (Description)

Labor and Delivery

(Description)

Nursing Mothers

(Description)

Pediatric Use

(Description)

Geriatic Use

(Description)

Gender

(Description)

Race

(Description)

Renal Impairment

(Description)

Hepatic Impairment

(Description)

Females of Reproductive Potential and Males

(Description)

Immunocompromised Patients

(Description)

Others

(Description)

Administration and Monitoring

Administration

(Oral/Intravenous/etc)

Monitoring

Condition 1

(Description regarding monitoring, from Warnings section)

Condition 2

(Description regarding monitoring, from Warnings section)

Condition 3

(Description regarding monitoring, from Warnings section)

IV Compatibility

Solution

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Y-Site

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Admixture

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Syringe

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

TPN/TNA

Compatible

  • Solution 1
  • Solution 2
  • Solution 3

Not Tested

  • Solution 1
  • Solution 2
  • Solution 3

Variable

  • Solution 1
  • Solution 2
  • Solution 3

Incompatible

  • Solution 1
  • Solution 2
  • Solution 3

Overdosage

Acute Overdose

Signs and Symptoms

(Description)

Management

(Description)

Chronic Overdose

Signs and Symptoms

(Description)

Management

(Description)

Pharmacology

Ramipril and Hydrochlorothiazide tablet
Systematic (IUPAC) name
?
Identifiers
CAS number ?
ATC code ?
PubChem ?
Chemical data
Formula ?
Mol. mass ?
Pharmacokinetic data
Bioavailability ?
Metabolism ?
Half life ?
Excretion ?
Therapeutic considerations
Pregnancy cat.

?

Legal status
Routes ?

Mechanism of Action

(Description)

Structure

(Description with picture)

Pharmacodynamics

(Description)

Pharmacokinetics

(Description)

Nonclinical Toxicology

(Description)

Clinical Studies

Condition 1

(Description)

Condition 2

(Description)

Condition 3

(Description)

How Supplied

(Description)

Storage

There is limited information regarding Ramipril and Hydrochlorothiazide tablet Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Ramipril and Hydrochlorothiazide tablet |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ramipril and Hydrochlorothiazide tablet |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

(Patient Counseling Information)

Precautions with Alcohol

Alcohol-Ramipril and Hydrochlorothiazide tablet interaction has not been established. Talk to your doctor regarding the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Ramipril and Hydrochlorothiazide tablet Brand Names in the drug label.

Look-Alike Drug Names

  • (Paired Confused Name 1a) — (Paired Confused Name 1b)
  • (Paired Confused Name 2a) — (Paired Confused Name 2b)
  • (Paired Confused Name 3a) — (Paired Confused Name 3b)

Drug Shortage Status

Drug Shortage

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

Retrieved from "https://www.wikidoc.org/index.php?title=Ramipril_and_Hydrochlorothiazide_tablet&oldid=966961"