Predxal Side effects

• Side effects of Predxal in details
• Predxal contraindications
• Predxal reviews

What are the possible side effects of Predxal?

Get emergency medical help if you have any of these signs of an allergic reaction to Predxal: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Predxal can cause a condition that results in the breakdown of skeletal muscle tissue, leading to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, and dark colored urine.

Also call your doctor at once if you have:

• a light-headed feeling, like you might pass out;

• little or no urinating;

• swelling, rapid weight gain; or

• high potassium (slow heart rate, weak pulse, muscle weakness, tingly feeling).

Common Predxal side effects may include:

• stuffy nose, sinus pain;

• back pain; or

• diarrhea.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Side effects of Predxal in details

The following adverse reaction is described elsewhere in labeling:

Renal dysfunction upon use with ramipril

  Clinical Trials Experience

Because clinical studies are conducted under widely varying conditions, adverse reactions rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Hypertension

Predxal has been evaluated for safety in more than 3700 patients, including 1900 treated for over 6 months and more than 1300 for over one year. Adverse experiences have generally been mild and transient in nature and have infrequently required discontinuation of therapy.

In placebo-controlled trials involving 1041 patients treated with various doses of Predxal (20 to 160 mg) monotherapy for up to 12 weeks, the overall incidence of adverse events was similar to that in patients treated with placebo.

Adverse events occurring at an incidence of ≥1% in patients treated with Predxal and at a greater rate than in patients treated with placebo, irrespective of their causal association, are presented in Table 1.

Table 1 Adverse Events Occurring at an Incidence of ≥1% in Patients Treated with Predxal and at a Greater Rate Than Patients Treated with Placebo

	Predxal n=1455 %	Placebo n=380 %
Upper respiratory tract infection	7	6
Back pain	3	1
Sinusitis	3	2
Diarrhea	3	2
Pharyngitis	1	0

In addition to the adverse events in the table, the following events occurred at a rate of ≥1% but were at least as frequent in the placebo group: influenza-like symptoms, dyspepsia, myalgia, urinary tract infection, abdominal pain, headache, dizziness, pain, fatigue, coughing, hypertension, chest pain, nausea, and peripheral edema. Discontinuation of therapy because of adverse events was required in 2.8% of 1455 patients treated with Predxal tablets and 6.1% of 380 placebo patients in placebo-controlled clinical trials.

The incidence of adverse events was not dose-related and did not correlate with gender, age, or race of patients.

The incidence of cough occurring with Predxal in 6 placebo-controlled trials was identical to that noted for placebo-treated patients (1.6%).

In addition to those listed above, adverse events that occurred in more than 0.3% of 3500 patients treated with Predxal monotherapy in controlled or open trials are listed below. It cannot be determined whether these events were causally related to Predxal tablets:

Autonomic Nervous System: impotence, increased sweating, flushing; Body as a Whole: allergy, fever, leg pain, malaise; Cardiovascular: palpitation, dependent edema, angina pectoris, tachycardia, leg edema, abnormal ECG; CNS: insomnia, somnolence, migraine, vertigo, paresthesia, involuntary muscle contractions, hypoesthesia; Gastrointestinal: flatulence, constipation, gastritis, vomiting, dry mouth, hemorrhoids, gastroenteritis, enteritis, gastroesophageal reflux, toothache, non-specific gastrointestinal disorders; Metabolic: gout, hypercholesterolemia, diabetes mellitus; Musculoskeletal: arthritis, arthralgia, leg cramps; Psychiatric: anxiety, depression, nervousness; Resistance Mechanism: infection, fungal infection, abscess, otitis media; Respiratory: asthma, bronchitis, rhinitis, dyspnea, epistaxis; Skin: dermatitis, rash, eczema, pruritus; Urinary: micturition frequency, cystitis; Vascular: cerebrovascular disorder; and Special Senses: abnormal vision, conjunctivitis, tinnitus, earache.

During initial clinical studies, a single case of angioedema was reported (among a total of 3781 patients treated).

Clinical Laboratory Findings

In placebo-controlled clinical trials, clinically relevant changes in standard laboratory test parameters were rarely associated with administration of Predxal tablets.

Hemoglobin: A greater than 2 g/dL decrease in hemoglobin was observed in 0.8% Predxal patients compared with 0.3% placebo patients. No patients discontinued therapy because of anemia.

Creatinine: A 0.5 mg/dL rise or greater in creatinine was observed in 0.4% Predxal patients compared with 0.3% placebo patients. One Predxal-treated patient discontinued therapy because of increases in creatinine and blood urea nitrogen.

Liver Enzymes: Occasional elevations of liver chemistries occurred in patients treated with Predxal; all marked elevations occurred at a higher frequency with placebo. No Predxal-treated patients discontinued therapy because of abnormal hepatic function.

Cardiovascular Risk Reduction

Because common adverse reactions were well characterized in studies of Predxal in hypertension, only adverse events leading to discontinuation and serious adverse events were recorded in subsequent studies of Predxal for cardiovascular risk reduction. In TRANSCEND (N=5926, 4 years and 8 months of follow-up), discontinuations for adverse events were 8.4% on Predxal and 7.6% on placebo. The only serious adverse events at least 1% more common on Predxal than placebo were intermittent claudication (7% vs 6%) and skin ulcer (3% vs 2%).

  Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Predxal. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate reliably their frequency or establish a causal relationship to drug exposure. Decisions to include these reactions in labeling are typically based on one or more of the following factors: (1) seriousness of the reaction, (2) frequency of reporting, or (3) strength of causal connection to Predxal.

The most frequent spontaneously reported events include: headache, dizziness, asthenia, coughing, nausea, fatigue, weakness, edema, face edema, lower limb edema, angioneurotic edema, urticaria, hypersensitivity, sweating increased, erythema, chest pain, atrial fibrillation, congestive heart failure, myocardial infarction, blood pressure increased, hypertension aggravated, hypotension (including postural hypotension), hyperkalemia, syncope, dyspepsia, diarrhea, pain, urinary tract infection, erectile dysfunction, back pain, abdominal pain, muscle cramps (including leg cramps), myalgia, bradycardia, eosinophilia, thrombocytopenia, uric acid increased, abnormal hepatic function/liver disorder, renal impairment including acute renal failure, anemia, increased CPK, anaphylactic reaction, tendon pain (including tendonitis, tenosynovitis), drug eruption (toxic skin eruption mostly reported as toxicoderma, rash, and urticaria), hypoglycemia (in diabetic patients), and angioedema (with fatal outcome).

Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers, including Predxal.

What is the most important information I should know about Predxal?

• Predxal may cause dizziness, light-headedness, or fainting. These effects may be worse if you take it with alcohol or certain medicines. Use Predxal with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Predxal may cause dizziness, light-headedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.
• Do not change your dose of Predxal without checking with your doctor.
• Predxal may cause a serious side effect called angioedema. Contact your doctor at once if you develop swelling of the hands, face, lips, eyes, throat, or tongue; difficulty swallowing or breathing; or hoarseness.
• Predxal may not work as well in black patients. Discuss any questions or concerns with your doctor.
• Dehydration, excessive sweating, vomiting, or diarrhea may increase the risk of low blood pressure. Contact your health care provider at once if any of these occur.
• Check with your doctor before you use a salt substitute or a product that has potassium in it.
• Tell your doctor or dentist that you take Predxal before you receive any medical or dental care, emergency care, or surgery.
• Patients who take medicine for high blood pressure often feel tired or run down for a few weeks after starting treatment. Be sure to take your medicine even if you may not feel "normal." Tell your doctor if you develop any new symptoms.
• If you have high blood pressure, do not use nonprescription products that contain stimulants. These products may include diet pills or cold medicines. Contact your doctor if you have any questions or concerns.
• Lab tests, including blood pressure, blood electrolyte levels, and kidney and liver function, may be performed while you use Predxal. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Predxal should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Predxal may cause birth defects or fetal death if you take it while you are pregnant. If you think you may be pregnant, contact your doctor right away. It is not known if Predxal is found in breast milk. Do not breast-feed while taking Predxal.

Predxal contraindications

Hypersensitivity to Predxal or to any of the excipients of Predxal.

Biliary obstructive disorders and severe hepatic impairment.

The concomitant use with aliskiren is contraindicated in patients with diabetes mellitus or renal impairment (GFR <60 mL/min/1.73 m²).

In case of rare hereditary conditions that may be incompatible with an excipient of Predxal, the use of Predxal is contraindicated.

Use in pregnancy: The use of angiotensin II receptor antagonists is not recommended during the 1st trimester of pregnancy and should not be initiated during pregnancy.

Nonclinical studies with Predxal do not indicate teratogenic effect, but have shown fetotoxicity.

Angiotensin II receptor antagonist exposure during the 2nd and 3rd trimester is known to induce human fetotoxicity (decreased renal function, oligohydramnios, skull ossification retardation) and neonatal toxicity (renal failure, hypotension, hyperkalemia).

Unless continued and angiotensin II receptor antagonist therapy is considered essential, patients planning pregnancy should be changed to alternative antihypertensive treatments which have an established safety profile for use in pregnancy. When pregnancy is diagnosed, treatment with angiotensin II receptor antagonist should be stopped immediately and if appropriate, alternative therapy should be started.

Should exposure to angiotensin II receptor antagonists have occurred from the 2nd trimester of pregnancy, ultrasound check of renal function and skull is recommended.

Infants whose mothers have taken angiotensin II receptor antagonist should be closely observed for hypotension.

Use in lactation: Predxal is contraindicated during lactation since it is not known whether it is excreted in human milk.

Animal studies have shown excretion of Predxal in breast milk.

References

1. DailyMed. "AMLODIPINE BESYLATE; TELMISARTAN: 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).
2. DTP/NCI. "Telmisartan: The NCI Development Therapeutics Program (DTP) provides services and resources to the academic and private-sector research communities worldwide to facilitate the discovery and development of new cancer therapeutic agents.". https://dtp.cancer.gov/dtpstandard/s... (accessed September 17, 2018).
3. European Chemicals Agency - ECHA. "2-(4-{[4-methyl-6-(1-methyl-1H-1,3-benzodiazol-2-yl)-2-propyl-1H-1,3-benzodiazol-1-yl]methyl}phenyl)benzoic acid: The information provided here is aggregated from the "Notified classification and labelling" from ECHA's C&L Inventory. ". https://echa.europa.eu/information-o... (accessed September 17, 2018).

Reviews

The results of a survey conducted on ndrugs.com for Predxal are given in detail below. The results of the survey conducted are based on the impressions and views of the website users and consumers taking Predxal. We implore you to kindly base your medical condition or therapeutic choices on the result or test conducted by a physician or licensed medical practitioners.

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Information checked by Dr. Sachin Kumar, MD Pharmacology