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PMS-TERAZOSIN is a brand name for Terazosin, supplied as a tablet. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 4 WARNINGS AND PRECAUTIONS…
Verbatim from this product's HC label. Tap a section to expand.
Adverse Drug Reaction Overview Hypertension The incidence of adverse reactions is derived from clinical trials involving 1986 hypertensive patients on terazosin hydrochloride monotherapy or combination therapy. The most serious adverse reaction encountered with terazosin hydrochloride is syncope occurring in approximately 1% of patients.
6%). 8%). 7% of patients following treatment with terazosin hydrochloride. Clinical Trial Adverse Drug Reactions Because clinical trials are conducted under very specific conditions the adverse reaction rates observed in the clinical trials may not reflect the rates observed in practice and should not be compared to the rates in the clinical trials of another drug.
Adverse drug reaction information from clinical trials is useful for identifying drug-related adverse events and for approximating rates. Most Common Adverse Drug Reactions (>1%) Hypertension Adverse drug reactions occurring more commonly in 1% or more of hypertensive patients on terazosin hydrochloride monotherapy or combination therapy are shown in Table 1.
0%). pms-TERAZOSIN Product Monograph Page 11 of 38 Less Common Clinical Trial Adverse Drug Reactions (<1%) Hypertension The following events were reported in less than 1% of cases. The order of presentation corresponds within each heading to the relative frequency of occurrence.
Body as a Whole:
Back pain, weight gain, allergic reactions, malaise.
Cardiovascular System:
Postural hypotension, angina pectoris, arrhythmias, cerebrovascular accident, heart failure, hypotension (at times severe), migraine.
Digestive System:
Dyspepsia, vomiting, anorexia, gastritis, liver function abnormality, jaundice.
Nervous System:
Incoordination, abnormal dreams, confusion, speech disorder, tremor, vertigo, seizure, depression.
Respiratory System:
Sinusitis, cold symptoms, pharyngitis, asthma, increased cough, laryngeal spasm.
Skin and Appendages:
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Pruritus, rash, photosensitivity.
Special Senses:
Tinnitus, taste perversion.
Urogenital System:
Urinary frequency, dysuria.
Miscellaneous:
Hypokalemia, hypophosphatemia, decreased libido.
Benign Prostatic Hyperplasia Cardiovascular System:
Syncope, tachycardia.
Metabolic and Nutritional Disorders:
Peripheral edema, weight gain.
Nervous System:
Libido decrease. pms-TERAZOSIN Product Monograph Page 12 of 38 Post-Market Adverse Drug Reactions Body as a Whole: Fever, neck pain, and shoulder pain, anaphylaxis has been reported, angioedema has been reported. Hypersensitivity has been reported.
Cardiovascular System:
Vasodilation, atrial fibrillation has been reported.
Digestive System:
Constipation and flatulence.
Nervous System:
Anxiety.
Respiratory System:
Bronchitis, epistaxis and flu symptoms.
Special Senses:
Conjunctivitis.
Urogentital System:
Priapism, urinary tract infection, and urinary incontinence primarily reported in post-menopausal women.
Musculoskeletal System:
Arthralgia, arthritis, joint disorder and myalgia.
Hematopoietic System:
Thrombocytopenia has been reported.
Metabolic/Nutritional Disorders:
Gout. During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha-1 blocker therapy. DRUG INTERACTIONS Drug-Drug Interactions The following table provides a list of potential drug interactions due to pharmacokinetic reasons: Table 2: Potential Drug Interactions Associated with Terazosin Hydrochloride Concomitant Drug Class: Drug Name Ref Effect Clinical Comment Verapamil P/CT Significant increases in AUC, Cmax and Cmin of terazosin hydrochloride in hypertensive patients.
The pharmacokinetics of verapamil were not altered. Symptomatic hypotension, and in some cases tachycardia, were observed when terazosin hydrochloride was administered concomitantly with verapamil. Caution should therefore be exercised when these drugs are administered concomitantly.
See (WARNINGS AND PRECAUTIONS). , sildenafil, vardenafil, and tadalafil P/C Hypotension has been reported during the concomitant use of PDE5 inhibitors and terazosin hydrochloride See […]