LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (Page 4 of 5)

OVERDOSAGE

Losartan Potassium

Significant lethality was observed in mice and rats after oral administration of 1000 mg/kg and 2000 mg/kg, respectively, about 44 and 170 times the maximum recommended human dose on a mg/m2 basis.

Limited data are available in regard to overdosage in humans. The most likely manifestation of overdosage would be hypotension and tachycardia; bradycardia could occur from parasympathetic (vagal) stimulation. If symptomatic hypotension should occur, supportive treatment should be instituted.

Neither losartan nor its active metabolite can be removed by hemodialysis.

Hydrochlorothiazide

The oral LD50 of hydrochlorothiazide is greater than 10 g/kg in both mice and rats. The most common signs and symptoms observed are those caused by electrolyte depletion (hypokalemia, hypochloremia, hyponatremia) and dehydration resulting from excessive diuresis. If digitalis has also been administered, hypokalemia may accentuate cardiac arrhythmias. The degree to which hydrochlorothiazide is removed by hemodialysis has not been established.

DOSAGE AND ADMINISTRATION

Hypertension

Dosing must be individualized. The usual starting dose of losartan is 50 mg once daily, with 25 mg recommended for patients with intravascular volume depletion (e.g., patients treated with diuretics) (see WARNINGS, Hypotension ─ Volume-Depleted Patients) and patients with a history of hepatic impairment (see WARNINGS, Impaired Hepatic Function). Losartan can be administered once or twice daily at total daily doses of 25 to 100 mg. If the antihypertensive effect measured at trough using once-a-day dosing is inadequate, a twice-a-day regimen at the same total daily dose or an increase in dose may give a more satisfactory response.

Hydrochlorothiazide is effective in doses of 12.5 to 50 mg once daily and can be given at doses of 12.5 to 25 mg as Losartan Potassium and Hydrochlorothiazide Tablets.

To minimize dose-independent side effects, it is usually appropriate to begin combination therapy only after a patient has failed to achieve the desired effect with monotherapy.

The side effects (see WARNINGS) of losartan are generally rare and apparently independent of dose; those of hydrochlorothiazide are a mixture of dose-dependent (primarily hypokalemia) and dose-independent phenomena (e.g., pancreatitis), the former much more common than the latter. Therapy with any combination of losartan and hydrochlorothiazide will be associated with both sets of dose-independent side effects.

Replacement Therapy: The combination may be substituted for the titrated components.

Dose Titration by Clinical Effect: A patient whose blood pressure is not adequately controlled with losartan monotherapy (see above) or hydrochlorothiazide alone, may be switched to Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg once daily or one tablet of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg (losartan 100 mg/hydrochlorothiazide 25 mg) once daily. A patient whose blood pressure is not adequately controlled with losartan 100 mg monotherapy (see above) may be switched to Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/12.5 mg once daily. If blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg once daily or one tablet of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.

A patient whose blood pressure is inadequately controlled by 25 mg once daily of hydrochlorothiazide, or is controlled but who experiences hypokalemia with this regimen, may be switched to Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg (losartan 50 mg/hydrochlorothiazide 12.5 mg) once daily, reducing the dose of hydrochlorothiazide without reducing the overall expected antihypertensive response. The clinical response to Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg should be subsequently evaluated, and if blood pressure remains uncontrolled after about 3 weeks of therapy, the dose may be increased to two tablets of Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg once daily or one tablet of Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/25 mg (losartan 100 mg/hydrochlorothiazide 25 mg) once daily.

The usual dose of Losartan Potassium and Hydrochlorothiazide is one tablet of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg once daily. More than two tablets of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg once daily or more than one tablet of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg once daily is not recommended. The maximal antihypertensive effect is attained about 3 weeks after initiation of therapy.

Use in Patients with Renal Impairment: The usual regimens of therapy with Losartan Potassium and Hydrochlorothiazide Tablets may be followed as long as the patient’s creatinine clearance is >30 mL/min. In patients with more severe renal impairment, loop diuretics are preferred to thiazides, so Losartan Potassium and Hydrochlorothiazide Tablets are not recommended.

Patients with Hepatic Impairment: Losartan Potassium and Hydrochlorothiazide Tablets are not recommended for titration in patients with hepatic impairment (see WARNINGS, Impaired Hepatic function) because the appropriate 25 mg starting dose of losartan cannot be given.

Severe Hypertension

The starting dose of Losartan Potassium and Hydrochlorothiazide Tablets for initial treatment of severe hypertension is one tablet of Losartan Potassium and Hydrochlorothiazide 50 mg/12.5 mg once daily (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects). For patients who do not respond adequately to Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg after 2 to 4 weeks of therapy, the dosage may be increased to one tablet of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg once daily. The maximum dose is one tablet of Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg once daily. Losartan Potassium and Hydrochlorothiazide Tablets are not recommended as initial therapy in patients with hepatic impairment (see WARNINGS, Impaired Hepatic Function) because the appropriate 25 mg starting dose of losartan cannot be given. It is also not recommended for use as initial therapy in patients with intravascular volume depletion (e.g., patients treated with diuretics, see WARNINGS, Hypotension ─ Volume-Depleted Patients).

Hypertensive Patients with Left Ventricular Hypertrophy

Treatment should be initiated with losartan potassium tablets 50 mg once daily. Hydrochlorothiazide 12.5 mg should be added or Losartan Potassium and Hydrochlorothiazide Tablets 50 mg/12.5 mg substituted if the blood pressure reduction is inadequate. If additional blood pressure reduction is needed, losartan potassium tablets 100 mg and hydrochlorothiazide 12.5 mg or Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/12.5 mg may be substituted, followed by losartan potassium tablets 100 mg and hydrochlorothiazide 25 mg or Losartan Potassium and Hydrochlorothiazide Tablets 100 mg/25 mg. For further blood pressure reduction other antihypertensives should be added (see CLINICAL PHARMACOLOGY, Pharmacodynamics and Clinical Effects, Losartan Potassium, Reduction in the Risk of Stroke).

Losartan Potassium and Hydrochlorothiazide Tablets may be administered with other antihypertensive agents.

Losartan Potassium and Hydrochlorothiazide Tablets may be administered with or without food.

HOW SUPPLIED

Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg are light yellow colored, oval shaped, biconvex film coated tablets, debossed with “116″ on one side and plain on other side.

Bottles of 30 NDC 13668-116-30

Bottles of 90 NDC 13668-116-90

Bottles of 1000 NDC 13668-116-10

100 Unit Dose Tablets NDC 13668-116-74

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg are white to off white colored, oval shaped, biconvex film coated tablets, debossed with “1117″ on one side and plain on other side.

Bottles of 30 NDC 13668-117-30

Bottles of 90 NDC 13668-117-90

Bottles of 1000 NDC 13668-117-10

100 Unit Dose Tablets NDC 13668-117-74

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg are yellow colored, oval shaped, biconvex film coated tablets, debossed with “1118″ on one side and plain on other side.

Bottles of 30 NDC 13668-118-30

Bottles of 90 NDC 13668-118-90

Bottles of 1000 NDC 13668-118-10

100 Unit Dose Tablets NDC 13668-118-74

Storage

Store at 20° to 25°C (68° to 77°F) (See USP controlled room temperature). Protect from light.

Keep container tightly closed.

Logo Image

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

For:

TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009.

8025591 Revised September 2010

Patient Information

Losartan Potassium and Hydrochlorothiazide Tablets, USP

50 mg/12.5 mg, 100 mg/12.5 mg and 100 mg/25 mg

Rx only

Read the Patient Information that comes with Losartan Potassium and Hydrochlorothiazide Tablets before you start taking it 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 tablets 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.

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.

  • 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).

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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

  • Store Losartan Potassium and Hydrochlorothiazide Tablets 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. It 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, USP and hydrochlorothiazide, USP

Inactive ingredients: colloidal silicon dioxide, hydroxypropyl cellulose, hypromellose, lactose anhydrous, magnesium stearate, microcrystalline cellulose, pregelatinized starch, talc and titanium dioxide. Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg and Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg also contain D and C yellow No. 10 lake.

Logo Image

Manufactured by:

TORRENT PHARMACEUTICALS LTD., Indrad-382 721, Dist. Mehsana, INDIA.

For:

TORRENT PHARMA INC., 5380 Holiday Terrace, Suite 40, Kalamazoo, Michigan 49009.

8025591 Revised September 2010

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