Drug Ingredient Information
LOSARTAN-25MG+CHLORTHALIDONE-6.25MG
LOSARTAN
| Information for
patients
|
| Drug Information |
Losartan belongs to a group of medicines known as angiotensin-II receptor antagonists. Angiotensin-II is a substance produced in the body which binds to receptors in blood vessels, causing them to tighten. This results in an increase in blood pressure. Losartan prevents the binding of angiotensin-II to these receptors, causing the blood vessels to relax which in turn lowers the blood pressure. Losartan slows the decrease of kidney function in patients with high blood pressure and type 2 diabetes.
Losartan potassium is used
to treat patients with high blood pressure (hypertension) in adults and in children and adolescents 6-18 years of age.
to protect the kidney in hypertensive type 2 diabetic patients with laboratory evidence of impaired renal function and proteinuria = 0.5 g per day (a condition in which urine contains an abnormal amount of protein).
to treat patients with chronic heart failure when therapy with specific medicines called angiotensin-converting-enzyme inhibitors (ACE inhibitors, medicine used to lower high blood pressure) is not considered suitable by your doctor. If your heart failure has been stabilised with an ACE inhibitor you should not be switched to losartan.
in patients with high blood pressure and a thickening of the left ventricle, LOSARTAN POTASSIUM has been shown to decrease the risk of stroke (“LIFE indication”). |
| Drug Alert |
| Alert |
if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
if your liver function is severely impaired,
if you are more than 3 months pregnant. |
| Before Consuming
the Medicine
|
| Avoid Drug |
if you are allergic (hypersensitive) to losartan or to any of its other ingredients,
if your liver function is severely impaired,
if you are more than 3 months pregnant. |
| Drug Special Care |
if you have had a history of angiooedema (swelling of the face, lips, throat, and/or tongue).
if you suffer from excessive vomiting or diarrhoea leading to an extreme loss of fluid and/or salt in your body,
if you receive diuretics (medicines that increase the amount of water that you pass out through your kidneys) or are under dietary salt restriction leading to an extreme loss of fluid and salt in your body.
if you are known to have narrowing or blockage of the blood vessels leading to your kidneys or
if you have received a kidney transplant recently,
if your liver function is impaired.
if you suffer from heart failure with or without renal impairment or concomitant severe life threatening cardiac arrhythmias. Special caution is necessary when you are treated with a ß-blocker concomitantly,
if you have problems with your heart valves or heart muscle,
if you suffer from coronary heart disease (caused by a reduced blood flow in the blood vessels of the heart) or from cerebrovascular disease (caused by a reduced blood circulation in the brain),
if you suffer from primary hyperaldosteronism (a syndrome associated with increased secretion of the hormone aldosterone by the adrenal gland, caused by an abnormality within the gland). |
| Drug Drug Interactions |
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines,including medicines obtained without a prescription or herbal medicines and natural products.Take particular care if you are taking the following medicines while under treatment with Losartan potassium
other blood pressure lowering medicines as they may additionally reduce your blood pressure.?Blood pressure may also be lowered by one of the following drugs/ class of drugs: tricyclic?antidepressants, antipsychotics, baclofen, amifostine,
medicines which retain potassium or may increase potassium levels (e.g. potassium supplements, potassium-containing salt substitutes or potassium-sparing medicines such as certain diuretics [amiloride, triamterene, spironolactone] or heparin),
non-steroidal anti-inflammatory drugs such as indometacin, including COX-2-inhibitors (medicines that reduce inflammation, and can be used to help relieve pain) as they may reduce the blood pressure lowering effect of losartan.
If your kidney function is impaired, the concomitant use of these medicines may lead to a worsening of the kidney function.
Lithium containing medicines should not be taken in combination with losartan without close supervision by your doctor. Special precautionary measures (e.g. blood tests) may be appropriate. |
| Drug Pregnancy Interaction |
You must tell your doctor if you think you are (or might become) pregnant. Your doctor will normally advise you to stop taking Losartan potassium before you become pregnant or as soon as you know you are pregnantand will advise you to take another medicine instead of Losartan potassium. Losartan potassium is not recommended in early pregnancy, and must not be taken when more than 3 months pregnant, as it may cause serious harm to your baby if used after the third month of pregnancy. |
| Drug Breast feeding Interaction |
Tell your doctor if you are breast feeding or about to start breast feeding. Losartan potassium is not recommended for mothers who are breast feeding, and your doctor may choose another treatment for you if you wish to breast feed. Especially if your baby is a newborn, or born prematurely. Ask your doctor or pharmacist for advice before taking any medicine. |
| Drug Machinery Interaction |
No studies on the effects on the ability to drive and use machines have been performed.Losartan potassium is unlikely to affect your ability to drive or use machines. However, as with many other medicines used to treat high blood pressure, losartan may cause dizziness or drowsiness in some people. If you experience dizziness or drowsiness, you should consult your doctor before attempting such activities. |
| Drug More Information |
Losartan potassium has been studied in children. For more information,, talk to your doctor. |
| How to take the
Medicine
|
| Consumption Info |
Losartan potassium may be taken with or without food. |
| Drug quanitty |
The doctor may advise a lower dose, especially when starting treatment in certain patients such as those treated with diuretics in high doses, in patients with liver impairment, or in patients over the age of 75 years. The use of losartan is not recommended in patients with severe hepatic impairment.
Adult patients with high blood pressure
Treatment usually starts with 50 mg losartan (one tablet Losartan potassium 50 mg) once a day. The maximal blood pressure lowering effect should be reached 3-6 weeks after beginning treatment. In some patients the dose may later be increased to losartan (two Losartan potassium 50 mg) once daily. If you have the impression that the effect of losartan is too strong or too weak, please talk to your doctor or pharmacist.
Use in children and adolescents (6 to 18 years old)
The recommended starting dose in patients who weigh between 20 and 50 kg is 0.7 mg of losartan per kg of body weight administered once a day (up to 25 mg of Losartan potassium). The doctor may increase the dose if blood pressure is not controlled.
Adult patients with high blood pressure and type 2 diabetes
Treatment usually starts with 50 mg losartan (one tablet Losartan potassium 50 mg) once a day. The dose may later be increased to losartan (two Losartan potassium 50 mg) once daily depending on your blood pressure response. Losartan may be administered with other blood pressure lowering medicines (e.g. diuretics, calcium channel blockers, alpha- or beta-blockers, and centrally acting agents) as well as with insulin and other commonly used medicines that decrease the level of glucose in the blood (e.g. sulfonylureas, glitazones and glucosidase inhibitors).
Adult Patients with heart failure
Treatment usually starts with 12.5 mg losartan (one tablet Losartan potassium 12.5 mg) once a day. Generally, the dose should be increased weekly step-by-step (i.e., 12.5 mg daily during the first week, 25 mg daily during the second week, 50 mg daily during the third week, daily during the fourth week, 150 mg daily during the fifth week) up to the maintenance dose as determined by your physician. A maximum dose of 150 mg losartan (for example, three of Losartan potassium 50 mg or one tablet each of Losartan potassium and Losartan potassium 50 mg) once daily may be used. In the treatment of heart failure, losartan is usually combined with a diuretic (medicine that increases the amount of water that you pass out through your kidneys) and/or digitalis (medicine that helps to make the heart stronger and more efficient) and/or a beta-blocker. |
| Drug Dose |
The should be swallowed with a glass of water. You should try to take your daily dose at about the same time each day. It is important that you continue to take Losartan potassium until your doctor tells you otherwise. |
| Excess Drug Consumption |
If you accidentally take too many, contact your doctor immediately. Symptoms of overdose are low blood pressure, increased heartbeat, possibly decreased heartbeat. |
| Forgot Drug Consumption |
If you accidentally miss a daily dose, just take the next dose as normal. Do not take a double dose to make up for a forgotten tablet. If you have any further questions on the use of this product, ask your doctor or pharmacist. |
| Stop Drug Consumption |
Do not stop the drug untill your doctor says you to do so. |
| Possible Side
Effects
|
| General Information |
dizziness,
low blood pressure,
debility,
fatigue,
too little sugar in the blood (hypoglycaemia),
too much potassium in the blood (hyperkalaemia),
changes in kidney function including kidney failure,
reduced number of red blood cells (anaemia),
increase in blood urea, serum creatinine and serum potassium in patients with heart failure |
| Common Drug Side Effects |
somnolence,
headache,
sleep disorders,
feeling of increased heart rate (palpitations),
severe chest pain (angina pectoris),
low blood pressure (especially after excessive loss of water from the body within blood vessels e.g. in patients with severe heart failure or under treatment with high dose diuretics),
dose-related orthostatic effects such as lowering of blood pressure appearing when rising from a lying or sitting position,
shortness of breath (dyspnoea),
abdominal pain,
obstipation,
diarrhoea,
nausea,
vomiting,
hives (urticaria),
itching (pruritus),
rash,
localised swelling (oedema),
cough.
hypersensitivity,
angiooedema,
inflammation of blood vessels (vasculitis including Henoch-Schonlein purpura),
numbness or tingling sensation (paraesthesia),
fainting (syncope),
very rapid and irregular heartbeat (atrial fibrillation)
brain attack (stroke),
inflammation of the liver (hepatitis),
elevated blood alanine aminotransferase (ALT) levels, usually resolved upon discontinuation of treatment. |
| Rare Drug Side Effects |
reduced number of thrombocytes,
migraine,
liver function abnormalities,
muscle and joint pain,
flu-like symptoms,
back pain and urinary tract infection,
increased sensitivity to the sun (photosensitivity),
unexplained muscle pain with dark (tea-coloured) urine (rhabdomyolysis),
impotence,
inflammation of the pancreas (pancreatitis),
low levels of sodium in the blood (hyponatraemia),
depression,
generally feeling unwell (malaise),
ringing, buzzing, roaring, or clicking in the ears (tinnitus). |
| Very Rare Drug Side Effects |
no data available |
| Drug Side Effects Symptoms |
no data available |
| How to Store the
Medicine
|
| How to Store the Medicine |
Keep out of the reach and sight of children.Do not use Losartan potassium after the expiry date which is stated on the carton or the bottle label. The expiry date refers to the last day of that month.
Blisters
Store Losartan potassium in the original package in order to protect from light and moisture. Do not open the blister pack until you are ready to take the medicine.
Bottles
Store Losartan potassium in the original container in order to protect from light. Do not store above 25OC.Keep the bottle tightly closed in order to protect from moisture.Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment |
CHLORTHALIDONE
| Information for
patients
|
| Drug Information |
This medication is used to treat high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks, and kidney problems. Chlorthalidone is a "water pill" (diuretic) that causes your body to get rid of extra salt and water. This increases the amount of urine you make.
This medication also reduces extra fluid in the body (edema) caused by conditions such as congestive heart failure, liver disease, and kidney disease. Getting rid of extra water helps to reduce fluid in the lungs so that you can breathe easier. It also helps to decrease swelling of the arms, legs, and stomach/abdomen.
OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to treat a condition known as "water diabetes" (diabetes insipidus) and to help prevent calcium kidney stones. |
| Drug Alert |
| Alert |
no data available |
| Before Consuming
the Medicine
|
| Avoid Drug |
Anuria. Known hypersensitivity to chlorthalidone or other sulfonamide-derived drugs. |
| Drug Special Care |
Before taking chlorthalidone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease (inability to make urine).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, untreated salt/mineral imbalance (e.g., imbalance of sodium, potassium, calcium, magnesium), loss of too much body water (dehydration), high levels of fats in the blood (high cholesterol/triglycerides), gout, lupus, certain recent nerve surgery (sympathectomy).
If you have diabetes, chlorthalidone may affect your blood sugar levels. Check your blood sugar levels regularly as directed and share the results with your doctor. Tell your doctor immediately if you have symptoms of high blood sugar such as increased thirst/urination. Your doctor may need to adjust your anti-diabetic medication or diet.
This drug may reduce the potassium levels in your blood. Ask your doctor about increasing the amount of potassium in your diet (e.g., bananas, orange juice) or about using a salt substitute containing potassium. A potassium supplement may be prescribed by your doctor.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
Before having surgery, tell your doctor or dentist that you are taking this medication.
This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely. Limit alcoholic beverages.
To reduce the risk of dizziness and lightheadedness, get up slowly when rising from a sitting or lying position. Significant loss of body water from too much sweating, vomiting, or diarrhea can also lower your blood pressure and worsen dizziness. Drink plenty of fluids to prevent these effects and dehydration. If you are on restricted fluid intake, consult your doctor for further instructions. Contact your doctor if you are unable to drink fluids or if you have persistent diarrhea/vomiting.
Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be more sensitive to the effects of this drug, especially dizziness.
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor.
This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. |
| Drug Drug Interactions |
See also the How to Use section.
Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop, or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: cisapride, dofetilide.
If you are currently using any of these medications, tell your doctor or pharmacist before starting chlorthalidone.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: corticosteroids (e.g., prednisone), diazoxide, digoxin, lithium, nonsteroidal anti-inflammatory drugs (e.g., ibuprofen, indomethacin), drugs that can increase dizziness (e.g., phenobarbital, narcotic pain relievers such as codeine).
Check the labels on all your medicines (e.g., cough-and-cold products, diet aids, nonsteroidal anti-inflammatory drugs-NSAIDs for pain/fever reduction) because they may contain ingredients that could increase your blood pressure (e.g., pseudoephedrine, phenylephrine) or reduce the effect of this medication (e.g., ibuprofen, naproxen). Ask your pharmacist about the safe use of those products.
Low-dose aspirin, as prescribed by your doctor for specific medical reasons such as heart attack or stroke prevention (usually at dosages of 81-325 milligrams per day) should be continued. Consult your doctor or pharmacist for more details.
This product can affect the results of certain lab tests. Make sure laboratory personnel and all your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist. |
| Drug Pregnancy Interaction |
This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. |
| Drug Breast feeding Interaction |
This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding. |
| Drug Machinery Interaction |
This drug may make you dizzy or cause blurred vision. Do not drive, use machinery, or do any activity that requires alertness or clear vision until you are sure you can perform such activities safely |
| Drug More Information |
no data available |
| How to take the
Medicine
|
| Consumption Info |
no data available |
| Drug quanitty |
Hypertension
Therapy in most patients should be initiated with a single daily dose of 15 mg. If the response is insufficient after a suitable trial, the dosage may be increased to 30 mg and then to a single daily dose of 45-50 mg. If additional control is required,the addition of a second antihypertensive drug is recommended. Increases in serum uric acid and decreases in serum potassium are dose-related over the 15-50 mg/day range and beyond.
Edema
INITIATION: Adults, initially 30 to 60 mg daily or 60 mg on alternate days. Some patients may require 90 to 120 mg at these intervals or up to 120 mg daily.Dosages above this level, however, do not usually produce a greater response.
MAINTENANCE: Maintenance doses may often be lower than initial doses and should be adjusted according to the individual patient. Effectiveness is well sustained during continued use. |
| Drug Dose |
Take this medication by mouth with or without food, usually once daily or as directed by your doctor. It is best to avoid taking this medication within 4 hours of your bedtime to avoid having to get up to urinate. Consult your doctor or pharmacist if you have questions about your dosing schedule.
The dosage is based on your medical condition and response to therapy.
Use this medication regularly in order to get the most benefit from it. To help you remember, take it at the same time each day or as prescribed. Do not increase your dose, skip doses, or stop taking this medication unless directed by your doctor. It is important to continue taking this medication even if you feel well. Most people with high blood pressure do not feel sick. For the treatment of high blood pressure, it may take up to several weeks before the full benefit of this drug takes effect.
Cholestyramine and colestipol can decrease the absorption of this medication by your body. If you are taking either of these drugs, separate them from chlorthalidone by at least 4 hours.
Inform your doctor if your condition does not improve or if it worsens (e.g., swelling increases, your routine blood pressure readings increase). |
| Excess Drug Consumption |
Dail 1066. OR Contact doctor immediately |
| Forgot Drug Consumption |
Contact Your doctor |
| Stop Drug Consumption |
Do not stop the drug untill your doctor says you to do so. |
| Possible Side
Effects
|
| General Information |
no data available |
| Common Drug Side Effects |
Dizziness, lightheadedness, headache, blurred vision, loss of appetite, stomach upset, diarrhea, or constipation may occur as your body adjusts to the medication. You may also experience decreased sexual ability or increased sensitivity to the sun. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
This medication may cause a loss of too much body water (dehydration) and salt/minerals. Tell your doctor immediately if you have any of these unlikely but serious symptoms of dehydration or mineral loss: very dry mouth, thirst, muscle cramps, weakness, fast/irregular heartbeat, nausea, vomiting, severe dizziness, unusual drowsiness, unusual decrease in the amount of urine, fainting, confusion, seizures.
Tell your doctor immediately if any of these unlikely but serious side effects occur: numbness/tingling of the arms/legs, joint pain (e.g., big toe pain).
Tell your doctor immediately if any of these rare but very serious side effects occur: signs of infection (e.g., fever, persistent sore throat), easy bruising/bleeding, stomach/abdominal pain, persistent nausea/vomiting, unusual/persistent tiredness, yellowing eyes/skin, dark urine, unusual change in the amount of urine (not including the normal increase in urine when you first start this drug).
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345. |
| Rare Drug Side Effects |
no data available |
| Very Rare Drug Side Effects |
no data available |
| Drug Side Effects Symptoms |
no data available |
| How to Store the
Medicine
|
| How to Store the Medicine |
Store in a cool and dry place. |
|
Substitute Drugs
|
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