What is Predxal?
Predxal is used alone or together with other medicines to treat high blood pressure (hypertension). High blood pressure adds to the workload of the heart and arteries. If it continues for a long time, the heart and arteries may not function properly. This can damage the blood vessels of the brain, heart, and kidneys, resulting in a stroke, heart failure, or kidney failure. Lowering blood pressure can reduce the risk of strokes and heart attacks.
Predxal is also used to lower the risk of heart attacks or stroke in patients 55 years of age and older who have diabetes or heart problems.
Predxal is an angiotensin II receptor blocker (ARB). It works by blocking a substance in the body that causes blood vessels to tighten. As a result, Predxal relaxes the blood vessels. This lowers blood pressure and increases the supply of blood and oxygen to the heart.
Predxal is available only with your doctor's prescription.
Predxal indications
Hypertension: Treatment of essential hypertension.
Cardiovascular Risk Reduction: Predxal is indicated for reduction of the risk of myocardial infarction, stroke, or death from cardiovascular causes in patients 55 years of age or older at high risk of developing major cardiovascular events who are unable to take ACE inhibitors.
High risk of cardiovascular events can be evidenced by history of coronary artery disease, peripheral arterial disease, stroke, transient ischemic attack, or high-risk diabetes (insulin-dependent or non-insulin dependent) with evidence of end-organ damage. Predxal can be used in additional to other needed treatment (such as antihypertensive, antiplatelet or lipid-lowering therapy).
Studies of Predxal in this setting do not exclude that it may not preserve a meaningful fraction of the effect of the ACE inhibitor to which it was compared. Consider using the ACE inhibitor first, and, if it is stopped for cough only, consider re-trying the ACE inhibitor after the cough resolves.
Use of Predxal with an ACE inhibitor is not recommended.
How should I use Predxal?
Use Predxal as directed by your doctor. Check the label on the medicine for exact dosing instructions.
- An extra patient leaflet is available with Predxal. Talk to your pharmacist if you have questions about this information.
- Take Predxal by mouth with or without food.
- Do not remove the tablet from the blister seal until you are ready to take your dose.
- Take Predxal on a regular schedule to get the most benefit from it. Taking Predxal at the same time each day will help you remember to take it.
- Continue to take Predxal even if you feel well. Do not miss any doses.
- If you miss a dose of Predxal, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
Ask your health care provider any questions you may have about how to use Predxal.
Uses of Predxal in details
Predxal belongs to a class of medicines known as angiotensin II receptor blockers. It is used to treat high blood pressure, prevention and treatment of heart attack (myocardial Infarction) and heart failure; when heart is unable to pump sufficient blood. It is also used for kidney failure in patients with diabetes.
Predxal description
Predxal is an angiotensin II receptor antagonist (ARB) used in the management of hypertension. Generally, angiotensin II receptor blockers (ARBs) such as Predxal bind to the angiotensin II type 1 (AT1) receptors with high affinity, causing inhibition of the action of angiotensin II on vascular smooth muscle, ultimately leading to a reduction in arterial blood pressure. Recent studies suggest that Predxal may also have PPAR-gamma agonistic properties that could potentially confer beneficial metabolic effects.
Predxal dosage
Predxal Dosage
Generic name: Predxal 20mg
Dosage form: tablet
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
2.1 Hypertension
Dosage must be individualized. The usual starting dose of Predxal tablets is 40 mg once a day. Blood pressure response is dose-related over the range of 20 to 80 mg.
Most of the antihypertensive effect is apparent within 2 weeks and maximal reduction is generally attained after 4 weeks. When additional blood pressure reduction beyond that achieved with 80 mg Predxal is required, a diuretic may be added.
No initial dosage adjustment is necessary for elderly patients or patients with renal impairment, including those on hemodialysis. Patients on dialysis may develop orthostatic hypotension; their blood pressure should be closely monitored.
Predxal tablets may be administered with other antihypertensive agents.
Predxal tablets may be administered with or without food.
2.2 Cardiovascular Risk Reduction
The recommended dose of Predxal tablets is 80 mg once a day and can be administered with or without food. It is not known whether doses lower than 80 mg of Predxal are effective in reducing the risk of cardiovascular morbidity and mortality.
When initiating Predxal therapy for cardiovascular risk reduction, monitoring of blood pressure is recommended, and if appropriate, adjustment of medications that lower blood pressure may be necessary.
More about Predxal (Predxal)
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Consumer resources
- Predxal
- Predxal (Advanced Reading)
Professional resources
- Predxal (AHFS Monograph)
- Predxal (FDA)
Other formulations
- Predxal HCT
Related treatment guides
- Cardiovascular Risk Reduction
- High Blood Pressure
- Prevention of Cardiovascular Disease
Predxal interactions
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What other drugs will affect Predxal?
Aliskiren: Do not co-administer aliskiren with Predxal in patients with diabetes. Avoid use of aliskiren with Predxal in patients with renal impairment (GFR < 60 mL/min).
Digoxin: When Predxal was co-administered with digoxin, median increases in digoxin peak plasma concentration (49%) and in trough concentration (20%) were observed. Therefore, monitor digoxin levels when initiating, adjusting, and discontinuing Predxal for the purpose of keeping the digoxin level within the therapeutic range.
Lithium: Reversible increases in serum lithium concentrations and toxicity have been reported during concomitant administration of lithium with angiotensin II receptor antagonists including Predxal. Therefore, monitor serum lithium levels during concomitant use.
Non-Steroidal Anti-Inflammatory Agents including Selective Cyclooxygenase-2 Inhibitors (COX-2 Inhibitors): In patients who are elderly, volume-depleted (including those on diuretic therapy), or with compromised renal function, co-administration of NSAIDs, including selective COX-2 inhibitors, with angiotensin II receptor antagonists, including Predxal, may result in deterioration of renal function, including possible acute renal failure. These effects are usually reversible. Monitor renal function periodically in patients receiving Predxal and NSAID therapy.
The antihypertensive effect of angiotensin II receptor antagonists, including Predxal may be attenuated by NSAIDs including selective COX-2 inhibitors.
Ramipril and Ramiprilat: Co-administration of Predxal 80 mg once daily and ramipril 10 mg once daily to healthy subjects increases steady-state Cmax and AUC of ramipril 2.3-and 2.1-fold, respectively, and Cmax and AUC of ramiprilat 2.4-and 1.5-fold, respectively. In contrast, Cmax and AUC of Predxal decrease by 31% and 16%, respectively. When co-administering Predxal and ramipril, the response may be greater because of the possibly additive pharmacodynamic effects of the combined drugs, and also because of the increased exposure to ramipril and ramiprilat in the presence of Predxal. Concomitant use of Predxal and ramipril is not recommended.
Other Drugs: Co-administration of Predxal did not result in a clinically significant interaction with acetaminophen, amlodipine, glyburide, simvastatin, hydrochlorothiazide, warfarin, or ibuprofen. Predxal is not metabolized by the cytochrome P450 system and had no effects in vitro on cytochrome P450 enzymes, except for some inhibition of CYP2C19. Predxal is not expected to interact with drugs that inhibit cytochrome P450 enzymes; it is also not expected to interact with drugs metabolized by cytochrome P450 enzymes, except for possible inhibition of the metabolism of drugs metabolized by CYP2C19.
Predxal side effects
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What are the possible side effects of Predxal?
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.
Predxal contraindications
See also:
What is the most important information I should know about Predxal?
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.
Active ingredient matches for Predxal:
Telmisartan in Mexico.
| Unit description / dosage (Manufacturer) | Price, USD |
| Tablet; Oral; Astemizole; Telmisartan 40 mg | |
| Tablet; Oral; Astemizole; Telmisartan 80 mg | |
| Predxal 50 mg x 1 Box | |
List of Predxal substitutes (brand and generic names): | |
| Polsart (Poland) | |
| PREVTEL | |
| PREVTEL 40MG TABLET 1 strip / 10 tablets each (Prevento Pharma) | $ 1.08 |
| Pritor (Bosnia & Herzegowina, Croatia (Hrvatska), Denmark, France, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Netherlands, Philippines, Poland, Portugal, Romania, Slovakia, Slovenia, South Africa, South Korea, Spain, Turkey, Venezuela) | |
| Tablet; Oral; Telmisartan 20 mg (GlaxoSmithKline) | |
| Tablet; Oral; Telmisartan 40 mg (GlaxoSmithKline) | |
| Tablet; Oral; Telmisartan 80 mg (GlaxoSmithKline) | |
| Pritor 40 mg x 28's (GlaxoSmithKline) | $ 14.70 |
| Pritor 80 mg x 28's (GlaxoSmithKline) | $ 25.42 |
| Pritor tab 40 mg 28's (GlaxoSmithKline) | $ 14.70 |
| Pritor tab 80 mg 28's (GlaxoSmithKline) | $ 25.42 |
| Pritor Tablet 20 mg (GlaxoSmithKline) | |
| Pritor Tablet 40 mg (GlaxoSmithKline) | |
| Pritor Tablet 80 mg (GlaxoSmithKline) | |
| Pritor 40 mg (Hungary) | |
| Pritor 80 mg (Hungary) | |
| Pritoral (Chile) | |
| Tablet; Oral; Telmisartan 20 mg (Gsk) | |
| Tablet; Oral; Telmisartan 40 mg (Gsk) | |
| Tablet; Oral; Telmisartan 80 mg (Gsk) | |
| Pu Mei Te (China) | |
| Qsar (Chile) | |
| Qu Ya (China) | |
| Qualtan (Turkey) | |
| RELMISART | |
| RELMISART 40MG TABLET 1 strip / 10 tablets each (La Renon Healthcare Pvt Ltd) | $ 0.72 |
| RELMISART 80MG TABLET 1 strip / 10 tablets each (La Renon Healthcare Pvt Ltd) | $ 1.20 |
| Relmisart 80mg Tablet (La Renon Healthcare Pvt Ltd) | $ 0.12 |
| ROZTEL (India) | |
| 40 mg x 10's (Rouzel) | |
| 80 mg x 10's (Rouzel) | |
| Roztel 40mg TAB / 10 (Rouzel) | |
| Roztel 80mg TAB / 10 (Rouzel) | |
| ROZTEL tab 40 mg x 10's (Rouzel) | |
| ROZTEL tab 80 mg x 10's (Rouzel) | |
| Roztel 40mg TAB / 10 (Rouzel) | |
| Roztel 80mg TAB / 10 (Rouzel) | |
| RPTEL 40MG TABLET | |
| RPTEL 40MG TABLET 1 strip / 10 tablets each (RPG Life Sciences Ltd) | $ 1.09 |
| Rulle (Mexico) | |
| SAFETELMI (Georgia) | |
| 20 mg x 10's (MSN Laboratories Ltd) | $ 0.41 |
| 40 mg x 10's (MSN Laboratories Ltd) | $ 0.78 |
| Safetelmi 20 mg Tablet (MSN Laboratories Ltd) | $ 0.04 |
| Safetelmi 40 mg Tablet (MSN Laboratories Ltd) | $ 0.08 |
| Safetelmi 20mg TAB / 10 (MSN Laboratories Ltd) | $ 0.41 |
| Safetelmi 40mg TAB / 10 (MSN Laboratories Ltd) | $ 0.78 |
| SAFETELMI 20 MG TABLET 1 strip / 10 tablets each (MSN Laboratories Ltd) | $ 0.43 |
| SAFETELMI 40 MG TABLET 1 strip / 10 tablets each (MSN Laboratories Ltd) | $ 0.77 |
See 1791 substitutes for Predxal | |
References
- 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).
- PubChem. "Telmisartan". https://pubchem.ncbi.nlm.nih.gov/com... (accessed September 17, 2018).
- DrugBank. "Telmisartan". http://www.drugbank.ca/drugs/DB00966 (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.User reports
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Information checked by Dr. Sachin Kumar, MD Pharmacology
