DESCRIPTION
Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg, combine an angiotensin II receptor (type AT
1) antagonist and a diuretic, hydrochlorothiazide.
Losartan potassium, a non-peptide molecule, is chemically described as 2-butyl-4-chloro-1-[
p-(
o-1
H-tetrazol-5-ylphenyl)benzyl]imidazole-5-methanol monopotassium salt. Its molecular formula is C
22H
22ClKN
6O, and its structural formula is:
Losartan potassium USP is a white to off-white powder with a molecular weight of 461.01. It is freely soluble in water, soluble in alcohols, and slightly soluble in common organic solvents, such as acetonitrile and methyl ethyl ketone.
Oxidation of the 5-hydroxymethyl group on the imidazole ring results in the active metabolite of losartan.
Hydrochlorothiazide is 6-chloro-3,4-dihydro-2
H-1,2,4-benzothiadiazine-7-sulfonamide 1,1-dioxide. Its molecular formula is C
7H
8ClN
3O
4S
2 and its structural formula is:
Hydrochlorothiazide USP is a white or practically white, practically odorless, crystalline powder with a molecular weight of 297.74, which is slightly soluble in water, but freely soluble in sodium hydroxide solution.
Losartan potassium and hydrochlorothiazide is available for oral administration in three tablet combinations of losartan and hydrochlorothiazide. Losartan potassium and hydrochlorothiazide tablets USP, 50 mg/12.5 mg contain 50 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/12.5 mg contain 100 mg of losartan potassium USP and 12.5 mg of hydrochlorothiazide USP. Losartan potassium and hydrochlorothiazide tablets USP, 100 mg/25 mg contain 100 mg of losartan potassium USP and 25 mg of hydrochlorothiazide USP. Inactive ingredients are colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake.
Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg contains 4.24 mg (0.108 mEq) of potassium, losartan potassium and hydrochlorothiazide 100 mg/12.5 mg contains 8.48 mg (0.217 mEq) of potassium, and losartan potassium and hydrochlorothiazide 100 mg/25 mg contains 8.48 mg (0.217 mEq) of potassium.
WARNINGS
Fetal/Neonatal Morbidity and Mortality
Drugs that act directly on the renin-angiotensin system can cause fetal and neonatal morbidity and death when administered to pregnant women. Several dozen cases have been reported in the world literature in patients who were taking angiotensin converting enzyme inhibitors. When pregnancy is detected, losartan potassium and hydrochlorothiazide should be discontinued as soon as possible.
The use of drugs that act directly on the renin-angiotensin system during the second and third trimesters of pregnancy has been associated with fetal and neonatal injury, including hypotension, neonatal skull hypoplasia, anuria, reversible or irreversible renal failure, and death. Oligohydramnios has also been reported, presumably resulting from decreased fetal renal function; oligohydramnios in this setting has been associated with fetal limb contractures, craniofacial deformation, and hypoplastic lung development. Prematurity, intrauterine growth retardation, and patent ductus arteriosus have also been reported, although it is not clear whether these occurrences were due to exposure to the drug.
These adverse effects do not appear to have resulted from intrauterine drug exposure that has been limited to the first trimester.
Mothers whose embryos and fetuses are exposed to an angiotensin II receptor antagonist only during the first trimester should be so informed. Nonetheless, when patients become pregnant, physicians should have the patient discontinue the use of losartan potassium and hydrochlorothiazide as soon as possible.
Rarely (probably less often than once in every thousand pregnancies), no alternative to an angiotensin II receptor antagonist will be found. In these rare cases, the mothers should be apprised of the potential hazards to their fetuses, and serial ultrasound examinations should be performed to assess the intra-amniotic environment.
If oligohydramnios is observed, losartan potassium and hydrochlorothiazide should be discontinued unless it is considered life-saving for the mother. Contraction stress testing (CST), a non-stress test (NST), or biophysical profiling (BPP) may be appropriate, depending upon the week of pregnancy. Patients and physicians should be aware, however, that oligohydramnios may not appear until after the fetus has sustained irreversible injury.
Infants with histories of
in utero exposure to an angiotensin II receptor antagonist should be closely observed for hypotension, oliguria, and hyperkalemia. If oliguria occurs, attention should be directed toward support of blood pressure and renal perfusion. Exchange transfusion or dialysis may be required as means of reversing hypotension and/or substituting for disordered renal function.
There was no evidence of teratogenicity in rats or rabbits treated with a maximum losartan potassium dose of 10 mg/kg/day in combination with 2.5 mg/kg/day of hydrochlorothiazide. At these dosages, respective exposures (AUCs) of losartan, its active metabolite, and hydrochlorothiazide in rabbits were approximately 5, 1.5, and 1 times those achieved in humans with 100 mg losartan in combination with 25 mg hydrochlorothiazide. AUC values for losartan, its active metabolite and hydrochlorothiazide, extrapolated from data obtained with losartan administered to rats at a dose of 50 mg/kg/day in combination with 12.5 mg/kg/day of hydrochlorothiazide, were approximately 6, 2, and 2 times greater than those achieved in humans with 100 mg of losartan in combination with 25 mg of hydrochlorothiazide. Fetal toxicity in rats, as evidenced by a slight increase in supernumerary ribs, was observed when females were treated prior to and throughout gestation with 10 mg/kg/day losartan in combination with 2.5 mg/kg/day hydrochlorothiazide. As also observed in studies with losartan alone, adverse fetal and neonatal effects, including decreased body weight, renal toxicity, and mortality, occurred when pregnant rats were treated during late gestation and/or lactation with 50 mg/kg/day losartan in combination with 12.5 mg/kg/day hydrochlorothiazide. Respective AUCs for losartan, its active metabolite and hydrochlorothiazide at these dosages in rats were approximately 35, 10 and 10 times greater than those achieved in humans with the administration of 100 mg of losartan in combination with 25 mg hydrochlorothiazide. When hydrochlorothiazide was administered without losartan to pregnant mice and rats during their respective periods of major organogenesis, at doses up to 3000 and 1000 mg/kg/day, respectively, there was no evidence of harm to the fetus.
Thiazides cross the placental barrier and appear in cord blood. There is a risk of fetal or neonatal jaundice, thrombocytopenia, and possibly other adverse reactions that have occurred in adults.
Hypotension - Volume-Depleted Patients
In patients who are intravascularly volume-depleted (e.g., those treated with diuretics), symptomatic hypotension may occur after initiation of therapy with losartan potassium and hydrochlorothiazide. This condition should be corrected prior to administration of losartan potassium and hydrochlorothiazide (see
DOSAGE AND ADMINISTRATION).
Impaired Hepatic Function
Losartan Potassium and Hydrochlorothiazide
Losartan potassium and hydrochlorothiazide is not recommended for patients with hepatic impairment who require titration with losartan. The lower starting dose of losartan recommended for use in patients with hepatic impairment cannot be given using losartan potassium and hydrochlorothiazide.
Hydrochlorothiazide
Thiazides should be used with caution in patients with impaired hepatic function or progressive liver disease, since minor alterations of fluid and electrolyte balance may precipitate hepatic coma.
Hypersensitivity Reaction
Hypersensitivity reactions to hydrochlorothiazide may occur in patients with or without a history of allergy or bronchial asthma, but are more likely in patients with such a history.
Systemic Lupus Erythematosus
Thiazide diuretics have been reported to cause exacerbation or activation of systemic lupus erythematosus.
Lithium Interaction
Lithium generally should not be given with thiazides (see
PRECAUTIONS, Drug Interactions, Hydrochlorothiazide, Lithium).
Acute Myopia and Secondary Angle-Closure Glaucoma
Hydrochlorothiazide, a sulfonamide, can cause an idiosyncratic reaction, resulting in acute transient myopia and acute angle-closure glaucoma. Symptoms include acute onset of decreased visual acuity or ocular pain and typically occur within hours to weeks of drug initiation. Untreated acute angle-closure glaucoma can lead to permanent vision loss. The primary treatment is to discontinue hydrochlorothiazide as rapidly as possible. Prompt medical or surgical treatments may need to be considered if the intraocular pressure remains uncontrolled. Risk factors for developing acute angle-closure glaucoma may include a history of sulfonamide or penicillin allergy.
ADVERSE REACTIONS
Losartan potassium and hydrochlorothiazide has been evaluated for safety in 858 patients treated for essential hypertension and 3889 patients treated for hypertension and left ventricular hypertrophy. In clinical trials with losartan potassium and hydrochlorothiazide, no adverse experiences peculiar to this combination have been observed. Adverse experiences have been limited to those that were reported previously with losartan potassium and/or hydrochlorothiazide. The overall incidence of adverse experiences reported with the combination was comparable to placebo.
In general, treatment with losartan potassium and hydrochlorothiazide was well tolerated. For the most part, adverse experiences 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 experiences 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, the following adverse experiences reported with losartan and hydrochlorothiazide occurred in ≥1 percent of patients, and more often on drug than placebo, regardless of drug relationship:
| Losartan Potassium and Hydrochlorothiazide (n=858)
| Placebo (n=173)
|
Body as a Whole
|
|
|
Abdominal pain
| 1.2
| 0.6
|
Edema/swelling
| 1.3
| 1.2
|
Cardiovascular
|
|
|
Palpitation
| 1.4
| 0
|
Musculoskeletal
|
|
|
Back pain
| 2.1
| 0.6
|
Nervous/Psychiatric
|
|
|
Dizziness
| 5.7
| 2.9
|
Respiratory
|
|
|
Cough
| 2.6
| 2.3
|
Sinusitis
| 1.2
| 0.6
|
Upper respiratory infection
| 6.1
| 4.6
|
Skin
|
|
|
Rash
| 1.4
| 0
|
The following adverse events were also reported at a rate of 1% or greater, but were as, or more, common in the placebo group in studies of essential hypertension: asthenia/fatigue, diarrhea, nausea, headache, bronchitis, pharyngitis.
Adverse events occurred at about the same rates in men and women. Adverse events were somewhat more frequent in the elderly compared to non-elderly patients and somewhat more frequent in Blacks compared to non-Blacks for both the losartan and hydrochlorothiazide and the control groups.
A patient with known hypersensitivity to aspirin and penicillin, when treated with losartan potassium, was withdrawn from study due to swelling of the lips and eyelids and facial rash, reported as angioedema, which returned to normal 5 days after therapy was discontinued.
Superficial peeling of palms and hemolysis were reported in one subject treated with losartan potassium.
Losartan Potassium
Other adverse experiences that have been reported with losartan, without regard to causality, are listed below:
Body as a Whole: chest pain, facial edema, fever, orthostatic effects, syncope
Cardiovascular: angina pectoris, arrhythmias including atrial fibrillation, sinus bradycardia, tachycardia, ventricular tachycardia and ventricular fibrillation, CVA, hypotension, myocardial infarction, second degree AV block
Digestive: anorexia, constipation, dental pain, dry mouth, dyspepsia, flatulence, gastritis, vomiting
General disorders and administration site conditions: malaise
Hematologic: anemia
Metabolic: gout
Musculoskeletal: arm pain, arthralgia, arthritis, fibromyalgia, hip pain, joint swelling, knee pain, leg pain, muscle cramps, muscle weakness, musculoskeletal pain, myalgia, shoulder pain, stiffness
Nervous System/Psychiatric: anxiety, anxiety disorder, ataxia, confusion, depression, dream abnormality, hypoesthesia, insomnia, libido decreased, memory impairment, migraine, nervousness, panic disorder, paresthesia, peripheral neuropathy, sleep disorder, somnolence, tremor, vertigo
Respiratory: dyspnea, epistaxis, nasal congestion, pharyngeal discomfort, respiratory congestion, rhinitis, sinus disorder
Skin: alopecia, dermatitis, dry skin, ecchymosis, erythema, flushing, photosensitivity, pruritus, sweating, urticaria
Special Senses: blurred vision, burning/stinging in the eye, conjunctivitis, decrease in visual acuity, taste perversion, tinnitus
Urogenital: impotence, nocturia, urinary frequency, urinary tract infection.
Hydrochlorothiazide
Other adverse experiences that have been reported with hydrochlorothiazide, without regard to causality, are listed below:
Body as a Whole: weakness
Digestive: pancreatitis, jaundice (intrahepatic cholestatic jaundice), sialadenitis, cramping, gastric irritation
Hematologic: aplastic anemia, agranulocytosis, leukopenia, hemolytic anemia, thrombocytopenia
Hypersensitivity: purpura, photosensitivity, urticaria, necrotizing angiitis (vasculitis and cutaneous vasculitis), fever, respiratory distress including pneumonitis and pulmonary edema
Metabolic: hyperglycemia, glycosuria, hyperuricemia
Musculoskeletal: muscle spasm
Nervous System/Psychiatric: restlessness
Renal: renal failure, renal dysfunction, interstitial nephritis
Skin: erythema multiforme including Stevens-Johnson syndrome, exfoliative dermatitis including toxic epidermal necrolysis
Special Senses: transient blurred vision, xanthopsia.
Persistent dry cough (with an incidence of a few percent) 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 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 50 mg, lisinopril 20 mg, or either placebo (one study, n=97) or 25 mg hydrochlorothiazide (n=135). The double-blind treatment period lasted up to 8 weeks. The incidence of cough is shown below.
|
Study 1*
| HCTZ
| Losartan
| Lisinopril
|
Cough
| 25%
| 17%
| 69%
|
Study 2†
| Placebo
| Losartan
| Lisinopril
|
Cough
| 35%
| 29%
| 62%
|
These studies demonstrate that the incidence of cough associated with losartan therapy, in a population that all had cough associated with ACE-inhibitor therapy, is similar to that associated with hydrochlorothiazide or placebo therapy.
Cases of cough, including positive re-challenges, have been reported with the use of losartan in post-marketing experience.
Severe Hypertension
In a clinical study in patients with severe hypertension (SiDBP ≥110 mmHg), the overall pattern of adverse events reported through six weeks of follow-up was similar in patients treated with losartan potassium and hydrochlorothiazide as initial therapy and in patients treated with losartan as initial therapy. There were no reported cases of syncope in either treatment group. There were 2 (0.6%) and 0 (0%) cases of hypotension reported in the group treated with losartan potassium and hydrochlorothiazide and the group treated with losartan, respectively. There were 3 (0.8%) and 2 (1.2%) cases of increased serum creatinine (>0.5 mg/dL) in the group treated with losartan potassium and hydrochlorothiazide and the group treated with losartan, respectively, during the same time period (see
CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Severe Hypertension).
Post-Marketing Experience
The following additional adverse reactions have been reported in post-marketing experience:
Digestive: Hepatitis has been reported rarely in patients treated with losartan.
Hemic: 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; some of these patients previously experienced angioedema with other drugs including ACE inhibitors. Vasculitis, including Henoch-Schönlein purpura, has been reported with losartan. Anaphylactic reactions have been reported.
Metabolic and Nutrition: Hyperkalemia, hyponatremia have been reported with losartan.
Musculoskeletal: Rare cases of rhabdomyolysis have been reported in patients receiving angiotensin II receptor blockers.
Respiratory: Dry cough (see above) has been reported with losartan.
Skin: Erythroderma has been reported with losartan.
Laboratory Test Findings
In controlled clinical trials, clinically important changes in standard laboratory parameters were rarely associated with administration of losartan potassium and hydrochlorothiazide.
Creatinine, Blood Urea Nitrogen
Minor increases in blood urea nitrogen (BUN) or serum creatinine were observed in 0.6 and 0.8 percent, respectively, of patients with essential hypertension treated with losartan potassium and hydrochlorothiazide alone. No patient discontinued taking losartan potassium and hydrochlorothiazide due to increased BUN. One patient discontinued taking losartan potassium and hydrochlorothiazide due to a minor increase in serum creatinine.
Hemoglobin and Hematocrit
Small decreases in hemoglobin and hematocrit (mean decreases of approximately 0.14 grams percent and 0.72 volume percent, respectively) occurred frequently in patients treated with losartan potassium and hydrochlorothiazide alone, but were rarely of clinical importance. No patients were discontinued due to anemia.
Liver Function Tests
Occasional elevations of liver enzymes and/or serum bilirubin have occurred. In patients with essential hypertension treated with losartan potassium and hydrochlorothiazide alone, no patients were discontinued due to these laboratory adverse experiences.
HOW SUPPLIED
Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘48’ on the other side.
Bottles of 30 NDC 16714-226-01
Bottles of 90 NDC 16714-226-02
Bottles of 1000 NDC 16714-226-04
Cartons of 100 (10 x 10)Unit-dose Tablets NDC 16714-226-06
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg are white, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘F’ on one side and ‘74’ on the other side.
Bottles of 30 NDC 16714-224-01
Bottles of 90 NDC 16714-224-02
Bottles of 1000 NDC 16714-224-03
Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg are yellow colored, oval shaped, beveled edge, biconvex film-coated tablets debossed with ‘E’ on one side and ‘49’ on the other side.
Bottles of 30 NDC 16714-225-01
Bottles of 90 NDC 16714-225-02
Bottles of 1000 NDC 16714-225-04
Cartons of 100 (10 x 10) Unit-dose Tablets NDC 16714-225-06
Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Keep container tightly closed. Protect from light.
Manufactured for: Northstar Rx LLC
Memphis, TN 38141
Toll Free: 1-800-206-7821
Manufactured by: Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
AP-509302, INDIA
M.L.No.: 22/MN/AP/2009/F/G
Revised: 05/2012
Patient Information
Losartan Potassium and Hydrochlorothiazide Tablets, USP
Rx only
Read the Patient Information that comes with losartan potassium and hydrochlorothiazide tablets before you start taking them and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your condition and treatment.
What is the most important information I should know about losartan potassium and hydrochlorothiazide tablets?
Do not take losartan potassium and hydrochlorothiazide tablets if you are pregnant or plan to become pregnant. Losartan potassium and hydrochlorothiazide tablets can harm your unborn baby causing injury and even death. Stop taking losartan potassium and hydrochlorothiazide tablets if you become pregnant and call your doctor right away. If you plan to become pregnant, talk to your doctor about other treatment options before taking losartan potassium and hydrochlorothiazide tablets.
What are losartan potassium and hydrochlorothiazide tablets?
Losartan potassium and hydrochlorothiazide tablets contain 2 prescription medicines, an angiotensin receptor blocker (ARB) and a diuretic (water pill). It is used to:
- lower high blood pressure (hypertension). Losartan potassium and hydrochlorothiazide tablets are not usually the first medicine used to treat high blood pressure.
- lower the chance of stroke in patients with high blood pressure and a heart problem called left ventricular hypertrophy (LVH). Losartan potassium and hydrochlorothiazide tablets may not help Black patients with this problem.
Losartan potassium and hydrochlorothiazide tablets have not been studied in children less than 18 years old.
High Blood Pressure (hypertension) Blood pressure is the force in your blood vessels when your heart beats and when your heart rests. You have high blood pressure when the force is too much. The losartan ingredient in losartan potassium and hydrochlorothiazide tablets can help your blood vessels relax so your blood pressure is lower. The hydrochlorothiazide ingredient in losartan potassium and hydrochlorothiazide tablets work by making your kidneys pass more water and salt.
Left Ventricular Hypertrophy (LVH) is an enlargement of the walls of the left chamber of the heart (the heart’s main pumping chamber). LVH can happen from several things. High blood pressure is the most common cause of LVH.
Who should not take losartan potassium and hydrochlorothiazide tablets?
Do not take losartan potassium and hydrochlorothiazide tablets if you:
- are allergic to any ingredients in losartan potassium and hydrochlorothiazide tablets. See a complete list of ingredients in losartan potassium and hydrochlorothiazide tablets at the end of this leaflet.
- are allergic to any sulfonamide-containing (“sulfa”) medicines. Ask your doctor if you are not sure what sulfonamide-containing (“sulfa”) medicines are.
- are not passing urine.
What should I tell my doctor before taking losartan potassium and hydrochlorothiazide tablets?
Tell your doctor about all your medical conditions including if you:
-
are pregnant or planning to become pregnant. See “What is the most important information I should know about losartan potassium and hydrochlorothiazide tablets?”
- are breast-feeding or plan to breast-feed. Losartan potassium and hydrochlorothiazide can pass into your milk and may harm your baby. You and your doctor should decide if you will take losartan potassium and hydrochlorothiazide tablets or breast-feed. You should not do both.
- have been vomiting (throwing up), having diarrhea, sweating a lot, or not drinking enough fluids. These could cause you to have low blood pressure.
- have liver problems
- have kidney problems
- have systemic lupus erythematosus (Lupus; SLE)
- have diabetes
- have asthma
- have gout
- have any allergies
Tell your doctor about all of the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.
Losartan potassium and hydrochlorothiazide tablets and certain other medicines may interact with each other. Especially tell your doctor if you are taking:
- potassium supplements
- salt substitutes containing potassium
- water pills (diuretics)
- lithium (a medicine used to treat a certain kind of depression)
- medicines used to treat pain and arthritis, called non-steroidal anti-inflammatory drugs (NSAIDs), including COX-2 inhibitors
- Other medicines to reduce blood pressure.
Know the medicines you take. Keep a list of your medicines and show it to your doctor and pharmacist when you get a new medicine.
How should I take losartan potassium and hydrochlorothiazide tablets?
- Take losartan potassium and hydrochlorothiazide tablets exactly as prescribed by your doctor. Your doctor may change your dose if needed.
- Losartan potassium and hydrochlorothiazide tablets can be taken with or without food.
- If you miss a dose, take it as soon as you remember. If it is close to your next dose, do not take the missed dose. Just take the next dose at your regular time.
- If you take too much losartan potassium and hydrochlorothiazide tablets, call your doctor or Poison Control Center, or go to the nearest hospital emergency room right away.
- Your doctor may do blood tests from time to time while you are taking losartan potassium and hydrochlorothiazide tablets.
What are the possible side effects of losartan potassium and hydrochlorothiazide tablets?
Losartan potassium and hydrochlorothiazide tablets may cause the following side effects that may be serious:
-
injury or death of unborn babies. See “What is the most important information I should know about losartan potassium and hydrochlorothiazide tablets?”
-
allergic reaction. Symptoms of an allergic reaction are swelling of the face, lips, throat or tongue. Get emergency medical help right away and stop taking losartan potassium and hydrochlorothiazide tablets.
-
low blood pressure (hypotension). Low blood pressure may cause you to feel faint or dizzy. Lie down if you feel faint or dizzy. Call your doctor right away.
-
a new or worsening condition called systemic lupus erythematosus (Lupus; SLE)
-
if you have kidney problems, you may see a worsening in how well your kidneys work. Call your doctor if you get swelling in your feet, ankles, or hands, or unexplained weight gain.
-
If you have liver problems, you may see a worsening in how well your liver works. Call your doctor if you get nausea, pain in the right upper stomach area (abdomen), yellow eyes or skin (which can be itchy).
-
Eye problems. One of the medicines in losartan potassium and hydrochlorothiazide tablets can cause eye problems that, if left untreated, may lead to vision loss. Symptoms of eye problems can happen within hours to weeks of starting losartan potassium and hydrochlorothiazide tablets. Tell your doctor right away if you have:
- decrease in vision
- eye pain
The most common side effects of losartan potassium and hydrochlorothiazide tablets in people with high blood pressure are:
- “colds” (upper respiratory infection)
- dizziness
- stuffy nose
- back pain
- fast or irregular heartbeat (palpitations)
- rash
Tell your doctor if you get any side effect that bothers you or that won't go away. This is
not a complete list of side effects. For a complete list, ask your doctor or pharmacist.
How should I store losartan potassium and hydrochlorothiazide tablets?
- Store losartan potassium and hydrochlorothiazide tablets at room temperature at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.]
- Keep losartan potassium and hydrochlorothiazide tablets in a tightly closed container, and keep losartan potassium and hydrochlorothiazide tablets out of the light.
-
Keep losartan potassium and hydrochlorothiazide tablets and all medicines out of the reach of children.
General information about losartan potassium and hydrochlorothiazide tablets
Medicines are sometimes prescribed for conditions that are not mentioned in patient information leaflets. Do not use losartan potassium and hydrochlorothiazide tablets for a condition for which it was not prescribed. Do not give losartan potassium and hydrochlorothiazide tablets to other people, even if they have the same symptoms that you have. They may harm them.
This leaflet summarizes the most important information about losartan potassium and hydrochlorothiazide tablets. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information that is written for health professionals.
What are the ingredients in losartan potassium and hydrochlorothiazide tablets?
Active ingredients: losartan potassium, hydrochlorothiazide
Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, pregelatinised starch, and titanium dioxide. Losartan potassium and hydrochlorothiazide 50 mg/12.5 mg and losartan potassium and hydrochlorothiazide 100 mg/25 mg also contain D&C yellow No. 10 aluminum lake.
Manufactured for: Northstar Rx LLC
Memphis, TN 38141
Toll Free: 1-800-206-7821
Manufactured by: Aurobindo Pharma Limited
Unit-VII (SEZ)
Mahaboob Nagar (Dt)
AP-509302, INDIA
M.L.No.: 22/MN/AP/2009/F/G
Revised: 05/2012