Losartan + Hidroclorotiazida Labesfal Side effects

• Side effects of Losartan + Hidroclorotiazida Labesfal in details
• Losartan + Hidroclorotiazida Labesfal contraindications
• Losartan + Hidroclorotiazida Labesfal reviews

What are the possible side effects of Losartan + Hidroclorotiazida Labesfal?

Get emergency medical help if you have any signs of an allergic reaction to Losartan + Hidroclorotiazida Labesfal: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

In rare cases, Losartan + Hidroclorotiazida Labesfal 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.

Call your doctor at once if you have:

• eye pain, vision problems;

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

• swelling, rapid weight gain, little or no urinating;

• drowsiness, confusion, mood changes, increased thirst, loss of appetite, nausea and vomiting;

• fast or pounding heartbeats;

• pale skin, easy bruising or bleeding;

• jaundice (yellowing of the skin or eyes); or

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

Common Losartan + Hidroclorotiazida Labesfal side effects may include:

• stomach pain;

• back pain;

• dizziness, tired feeling;

• skin rash;

• runny or stuffy nose, sore throat; or

• dry cough.

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 Losartan + Hidroclorotiazida Labesfal in details

Clinical Trials Experience

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

Losartan (Losartan + Hidroclorotiazida Labesfal) potassium-Hydrochlorothiazide (Losartan (Losartan + Hidroclorotiazida Labesfal) + Hidroclorotiazida Labesfal) has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. Most adverse reactions have been mild and transient in nature and have not required discontinuation of therapy. In controlled clinical trials, discontinuation of therapy due to clinical adverse events was required in only 2.8% and 2.3% of patients treated with the combination and placebo, respectively.

In these double-blind controlled clinical trials, adverse reactions occurring in greater than 2% of subjects treated with Losartan (Losartan + Hidroclorotiazida Labesfal)-Hydrochlorothiazide (Losartan (Losartan + Hidroclorotiazida Labesfal) + Hidroclorotiazida Labesfal) and at a greater rate than placebo were: back pain (2.1% vs 0.6%), dizziness (5.7% vs 2.9%), and upper respiratory infection (6.1% vs 4.6%).

The following additional adverse reactions have been reported in clinical trials with Losartan + Hidroclorotiazida Labesfal and/or the individual components:

Blood and the lymphatic system disorders: Anemia, aplastic anemia, hemolytic anemia, leukopenia, agranulocytosis.

Metabolism and nutrition disorders: Anorexia, hyperglycemia, hyperuricemia, electrolyte imbalance including hyponatremia and hypokalemia.

Psychiatric disorders: Insomnia, restlessness.

Nervous system disorders: Dysgeusia, headache, migraine, paraesthesias.

Eye disorders: Xanthopsia, transient blurred vision.

Cardiac disorders: Palpitation, tachycardia.

Vascular disorders: Dose-related orthostatic effects, necrotizing angiitis (vasculitis, cutaneous vasculitis).

Respiratory, thoracic and mediastinal disorders: Nasal congestion, pharyngitis, sinus disorder, respiratory distress (including pneumonitis and pulmonary edema).

Gastrointestinal disorders: Dyspepsia, abdominal pain, gastric irritation, cramping, diarrhea, constipation, nausea, vomiting, pancreatitis, sialoadenitis.

Hepato-biliary disorders: Jaundice (intrahepatic cholestatic jaundice).

Skin and subcutaneous tissue disorders: Rash, pruritus, purpura, toxic epidermal necrolysis, urticaria, photosensitivity, cutaneous lupus erythematosus.

Musculoskeletal and connective tissue disorders: Muscle cramps, muscle spasm, myalgia, arthralgia.

Renal and urinary disorders: Glycosuria, renal dysfunction, interstitial nephritis, renal failure.

Reproductive system and breast disorders: Erectile dysfunction/impotence.

General disorders and administration site conditions: Chest pain, edema/swelling, malaise, fever, weakness.

Investigations: Liver function abnormalities.

Cough

Persistent dry cough has been associated with ACE-inhibitor use and in practice can be a cause of discontinuation of ACE-inhibitor therapy. Two prospective, parallel-group, double-blind, randomized, controlled trials were conducted to assess the effects of Losartan (Losartan + Hidroclorotiazida Labesfal) on the incidence of cough in hypertensive patients who had experienced cough while receiving ACE-inhibitor therapy. Patients who had typical ACE-inhibitor cough when challenged with lisinopril, whose cough disappeared on placebo, were randomized to Losartan (Losartan + Hidroclorotiazida Labesfal) 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg Hydrochlorothiazide (Losartan (Losartan + Hidroclorotiazida Labesfal) + Hidroclorotiazida Labesfal) (n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown in Table 1 below.

Table 1:

* Demographics = (89% Caucasian, 64% female) † Demographics = (90% Caucasian, 51% female)
Study 1*	HCTZ	Losartan (Losartan + Hidroclorotiazida Labesfal)	Lisinopril
Cough	25%	17%	69%
Study 2†	Placebo	Losartan (Losartan + Hidroclorotiazida Labesfal)	Lisinopril
Cough	35%	29%	62%

These studies demonstrate that the incidence of cough associated with Losartan (Losartan + Hidroclorotiazida Labesfal) therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with Hydrochlorothiazide (Losartan (Losartan + Hidroclorotiazida Labesfal) + Hidroclorotiazida Labesfal) or placebo therapy.

Cases of cough, including positive re-challenges, have been reported with the use of Losartan (Losartan + Hidroclorotiazida Labesfal) in postmarketing experience.

Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Losartan + Hidroclorotiazida Labesfal. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to estimate their frequency reliably or to establish a causal relationship to drug exposure.

Digestive: Hepatitis has been reported rarely in patients treated with Losartan (Losartan + Hidroclorotiazida Labesfal).

Hematologic: Thrombocytopenia.

Hypersensitivity: Angioedema, including swelling of the larynx and glottis, causing airway obstruction and/or swelling of the face, lips, pharynx, and/or tongue has been reported rarely in patients treated with Losartan (Losartan + Hidroclorotiazida Labesfal); some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported with Losartan (Losartan + Hidroclorotiazida Labesfal). Anaphylactic reactions have been reported.

Musculoskeletal: rhabdomyolysis

Skin: Erythroderma

What is the most important information I should know about Losartan + Hidroclorotiazida Labesfal?

• Losartan + Hidroclorotiazida Labesfal may cause drowsiness, dizziness, or light-headedness. These effects may be worse if you take it with alcohol or certain medicines. Use Losartan + Hidroclorotiazida Labesfal with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Losartan + Hidroclorotiazida Labesfal 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.
• Report any light-headedness or fainting to your doctor immediately. Your risk of light-headedness or fainting may be increased if you experience diarrhea, vomiting, excessive sweating, if you do not drink enough fluids, or if you are on a low-salt (sodium) diet.
• It may take 2 to 4 weeks to get the full benefit from Losartan + Hidroclorotiazida Labesfal. Do not stop using Losartan + Hidroclorotiazida Labesfal or change your dose of Losartan + Hidroclorotiazida Labesfal without checking with your doctor.
• 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.
• Losartan + Hidroclorotiazida Labesfal contains a sulfonamide called Hydrochlorothiazide (Losartan (Losartan + Hidroclorotiazida Labesfal) + Hidroclorotiazida Labesfal), which can cause certain eye problems (myopia, angle-closure glaucoma). Your risk may be increased if you are allergic to sulfonamide medicines (eg, sulfamethoxazole) or penicillin antibiotics (eg, amoxicillin). Untreated angle-closure glaucoma can lead to permanent vision loss. If these eye problems occur, symptoms usually occur within hours to weeks of starting Losartan + Hidroclorotiazida Labesfal. Contact your doctor right away if you experience symptoms such as vision changes (eg, decreased vision clearness) or eye pain.
• Losartan + Hidroclorotiazida Labesfal may cause you to become sunburned more easily. Avoid the sun, sunlamps, or tanning booths until you know how you react to Losartan + Hidroclorotiazida Labesfal. Use a sunscreen or wear protective clothing if you must be outside for more than a short time.
• Tell your doctor or dentist that you take Losartan + Hidroclorotiazida Labesfal before you receive any medical or dental care, emergency care, or surgery.
• 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.
• Your doctor may have also prescribed a potassium supplement for you. If so, follow the dosing carefully. Do not start taking additional potassium on your own or change your diet to include more potassium without first checking with your doctor.
• Check with your doctor before you use a salt substitute or a product that has potassium in it.
• Diabetes patients - Losartan + Hidroclorotiazida Labesfal may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Losartan + Hidroclorotiazida Labesfal may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.
• Losartan + Hidroclorotiazida Labesfal may not be effective in reducing the risk of stroke in black patients who have high blood pressure and a certain heart problem (enlarged ventricle).
• Losartan + Hidroclorotiazida Labesfal may interfere with certain lab tests, including parathyroid function tests. Be sure your doctor and lab personnel know you are taking Losartan + Hidroclorotiazida Labesfal.
• Lab tests, including kidney function, blood pressure, and blood electrolytes, may be performed while you use Losartan + Hidroclorotiazida Labesfal. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Losartan + Hidroclorotiazida Labesfal with caution in the ELDERLY; they may be more sensitive to its effects.
• Losartan + Hidroclorotiazida Labesfal should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: Losartan + Hidroclorotiazida Labesfal 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. Losartan + Hidroclorotiazida Labesfal is found in breast milk. Do not breast-feed while taking Losartan + Hidroclorotiazida Labesfal.

Losartan + Hidroclorotiazida Labesfal contraindications

Hypersensitivity to Losartan (Losartan + Hidroclorotiazida Labesfal), sulphonamide-derived substances (as Hydrochlorothiazide (Losartan (Losartan + Hidroclorotiazida Labesfal) + Hidroclorotiazida Labesfal)) or to any of the excipients of Losartan + Hidroclorotiazida Labesfal.

Therapy resistant hypokalemia or hypercalcemia; severe hepatic impairment; cholestasis and biliary obstructive disorders; refractory hyponatremia; symptomatic hyperuricemia/gout; 2nd and 3rd trimester of pregnancy; lactation; severe renal impairment (ie, creatinine clearance <30 mL/min); anuria.

Excipient: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take Losartan + Hidroclorotiazida Labesfal.

Use in lactation: It is not known whether Losartan (Losartan + Hidroclorotiazida Labesfal) is excreted in human milk. However, Losartan (Losartan + Hidroclorotiazida Labesfal) is excreted in the milk of lactating rats. Because no information is available regarding the use of Losartan (Losartan + Hidroclorotiazida Labesfal) during breastfeeding, Losartan (Losartan + Hidroclorotiazida Labesfal) is not recommended and alternative treatments with better established safety profiles during breastfeeding are preferable, especially while nursing a newborn or preterm infant.

Thiazides pass into human milk and may inhibit lactation. Because of the potential for adverse effects on the nursing infant, Losartan (Losartan + Hidroclorotiazida Labesfal)/HCTZ is contraindicated during breastfeeding.

References

1. DailyMed. "AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL: 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. DailyMed. "LOSARTAN POTASSIUM: 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).
3. DTP/NCI. "losartan: 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).

Reviews

The results of a survey conducted on ndrugs.com for Losartan + Hidroclorotiazida Labesfal 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 Losartan + Hidroclorotiazida Labesfal. 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