Metoz Metolazone Tablets

Metoz 2.5/5

METOLAZONE TABLETS USP

 

DESCRIPTION

Metoz Tablets (Metolazone Tablets USP) for oral administration contain 2.5 or 5mg of Metolazone USP, a diuretic/saluretic/antihypertensive drug of the quinazoline class.

 

COMPOSITION

Each uncoated tablet contains:

Metolazone USP 2.5 or 5mg

 

CLINICAL PHARMACOLOGY

Metoz (Metolazone) is a quinazoline diuretic, with properties generally similar to the thiazide diuretics. Metoz acts primarily to inhibit sodium reabsorption in the distal convoluted tubule and to a lesser extent in the proximal convoluted tubule. Sodium and chloride ions are excreted in approximately equivalent amounts. The increased delivery of sodium to the distal tubular exchange site, results in increased potassium excretion.

Diuresis and saluresis usually begin within one hour and may persist for 24 hours or more. For most patients, adjusting the daily dose can vary the duration of effect. High doses may prolong the effect.

 

INDICATIONS AND USAGE

Metoz is indicated for the treatment of edema accompanying congestive heart failure and renal diseases, including the nephrotic syndrome and states of diminished renal function.

Metoz is also indicated for the treatment of hypertension, alone or in combination with other antihypertensive drugs of a different class.

 

DOSAGE AND ADMINISTRATION

Dosage of Metoz should be individualized according to indication and patient response.

Usual Single Daily Dosage Schedules:

Edema of cardiac failure: Metoz 5 to 20mg once daily.

Edema of renal disease: Metoz 5 to 20mg once daily.

Mild to moderate essential hypertension: Metoz 2.5 to 5mg once daily.

 

CONTRAINDICATIONS

Anuria, hepatic coma or precoma, known allergy or hypersensitivity to metolazone.

 

WARNINGS

Rapid Onset Hyponatremia and/or Hypokalemia: When symptoms appear, the drug should be discontinued and supportive measures should be initiated immediately.

Lithium: Diuretics should not be given concomitantly because they reduce the renal clearance of lithium and increase the risk of toxicity.

Furosemide: Unusually large or prolonged losses of fluids and electrolytes may result when Metoz is administered concomitantly.

 

PRECAUTIONS

Fluid and Electrolytes: All patients should have serum electrolyte measurements done at appropriate intervals and be observed for clinical signs of fluid and/or electrolyte imbalance.

Glucose Tolerance: Metolazone may raise blood glucose concentrations possibly causing hyperglycemia and glycosuria in patients with diabetes or latent diabetes.

Hyperuricemia: Metolazone may cause an increase in serum uric acid and can occasionally precipitate gouty attacks.

 

INFORMATION FOR PATIENTS

Patients should be informed of possible adverse effects, advised to take the medication as directed, and promptly report any possible adverse reactions to the treating physician.

 

Carcinogenesis, Mutagenesis, Impairment of Fertility

Mice and rats administered metolazone 5 days/week for up to 18 and 24 months, respectively, at daily doses of 2, 10, and 50 mg/kg, exhibited no evidence of a tumorigenic effect. Metolazone was not mutagenic in vitro in the in the Ames Test using Salmonella typhimurium strains TA-97, TA-98, TA-100, TA-102, and TA-1535.

Reproductive performance has been evaluated in mice and rats. There is no evidence that metolazone possesses the potential for altering reproductive capacity in mice.

 

Pregnancy

Pregnancy Category B. Reproduction studies performed in mice, rabbits, and rats treated during gestation at doses up to 50 mg/kg/day have revealed no evidence of harm to the fetus due to metolazone. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Metoz Tablets should be used during pregnancy only if clearly needed.

 

Nursing Mothers

Metolazone appears in breast milk. Because of the potential for serious adverse reactions in nursing infants from metolazone, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

 

DRUG INTERACTIONS

Diuretics: Furosemide and probably other loop diuretics given concomitantly with metolazone can cause unusually large or prolonged losses of fluid and electrolytes.

Other Antihypertensives: When Metoz Tablets are used with other antihypertensive drugs, dosage adjustments of the latter may be necessary.

Alcohol, Barbiturates, and Narcotics: The hypotensive effects of these drugs may be potentiated by the volume contraction associated with metolazone therapy.

Digitalis Glycosides: Diuretic-induced hypokalemia can increase the sensitivity of the myocardium to digitalis. Serious arrhythmias can result.

Corticosteroids or ACTH: May increase the risk of hypokalemia and increase salt and water retention.

Salicylates and Other Non-Steroidal Anti-Inflammatory Drugs: May decrease the antihypertensive effects of Metoz Tablets.

 

ADVERSE REACTIONS

Metolazone is usually well tolerated, and most reported adverse reactions have been mild and transient.

The following adverse reactions have been reported: orthostatic hypotension, excessive volume depletion, venous thrombosis, palpitations, syncope, neuropathy, vertigo, paresthesias, drowsiness, fatigue, weakness, restlessness, headache, dermatitis, urticaria, vomiting, nausea, epigastric distress, diarrhea, constipation, anorexia, abdominal bloating.

Very rarely other adverse reactions seen are: Hypokalemia, hyponatremia, hyperuricemia, hypochloremia, hyperglycemia, glycosuria, hypomagnesemia. hypercalcemia etc.

 

OVERDOSAGE

There is no specific antidote available but immediate evacuation of stomach contents is advised. Care should be taken when evacuating the gastric contents to prevent aspiration, especially in the stuporous or comatose patient. Supportive measures should be initiated as required to maintain hydration, electrolyte balance, respiration, and cardiovascular and renal function.

 

PRESENTATION

Metoz 2.5/5 is available in strips of 10 tablets each. Box of 1 x 10’s /3 x 10’s /10 x 10’s.

 

STORAGE

Store at temperature between 15-30°C, in a dry and dark place.

Keep medicines out of the reach of children.

 

Manufactured by

CENTAUR PHARMACEUTICALS PVT LTD.

Plant – I, Plot No. 3, Tivim Industrial Estate,

Karaswada, Mapusa, Goa-403 526. INDIA.

Metoz 2.5- NAFDAC Reg. No. A4-5411

 

Distributed by

AL-TINEZ PHARMACEUTICALS LTD.

18, Jones Street, Ebutte-Metta

Lagos, Nigeria.

Losatrust Losartan Potassium Tablets

LOSATRUST® 25/5O

LOSARTAN POTASSIUM TABLETS

 

DESCRIPTION

Losartan potassium is an orally active, nonpeptide angiotensin II receptor antagonist and a novel antihypertensive agent.

 

COMPOSITION

Each film-coated tablet contains Losartan Potassium USP 25 mg or 50mg.

 

PHARMACOLOGY

Angiotensin II is a potent vasoconstrictor, formed from angiotensin I in a reaction catalyzed by angiotensin converting enzyme [ACE]. It is the primary vasoactive hormone of the renin-angiotensin system [RAS] and an important component in the pathophysiology of hypertension. Angiotensin II also stimulates aldosterone secretion by the adrenal cortex.

Losartan and its principal active metabolite block the vasoconstrictor and aldosterone-secreting effects of angiotensin II by selectively blocking the binding of angiotensin II to the AT1 receptor found in many tissues, (e.g., vascular smooth muscle, adrenal gland).

Both Losartan and its principal active metabolite have a much greater affinity (about 1000-fold) for the AT1 receptor than for the AT2 receptor. In vitro binding studies indicate that Losartan is a reversible, competitive inhibitor of the AT1 receptor. The active metabolite is 10 to 40 times more potent by weight than Losartan and appears to be a reversible, non-competitive inhibitor of the AT1 receptor.

Losartan is an orally active agent that undergoes substantial first-pass metabolism by cytochrome P450 enzymes. It is converted, in part, to an active carboxylic acid metabolite that is responsible for most of the angiotensin II receptor antagonism that follows Losartan treatment.

 

INDICATIONS

LOSATRUST is indicated for the treatment of hypertension. It may be used alone or in combination with other anti hypertensive agents.

 

DOSAGE ANDADMINISTRATION

The usual starting dose of LOSATRUST is 50 mg once daily. A dose of 25 mg may be used in patients with possible depletion of intravascular volume (e.g. patients treated with diuretics) and patients with a history of hepatic impairment. LOSATRUST can be administered once or twice daily with total daily doses ranging from 25 mg to 100mg.

 

CONTRAINDICATIONS

Hypersensitivity to Losartan or any of the components of this product.

 

WARNINGS

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.

 

PRECAUTIONS

Impaired Hepatic Function

Based on pharmacokinetic data, which demonstrate significantly increased plasma concentrations of Losartan in cirrhotic patients, a lower dose should be considered for patients with impaired liver function.

 

Impaired Renal Function

As a consequence of inhibiting the renin-angiotensin-aldosterone system [RAAS], changes in renal function have been reported in susceptible individuals treated with Losartan; in some patients, these changes in renal function were reversible upon discontinuation of therapy. In patients whose renal function may depend on the activity of the RAAS (e.g., patients with severe congestive heart failure), treatment with ACE inhibitors has been associated with oliguria and/or progressive azotemia and (rarely) with acute renal failure and/or death. Similar outcomes have been reported with Losartan.

 

Electrolyte Imbalance

Electrolyte imbalances are common in patients with renal impairment, with or without diabetes, and should be addressed.

 

DRUG INTERACTIONS

No significant interactions have been observed during concomitant administration of Losartan with hydrochlorothiazide, digoxin, warfarin and phenobarbital.

 

PREGNANCY

Drugs acting on the RAS can cause fetal and neonatal morbidity and death when given to pregnant women. When pregnancy is detected, Losartan should be discontinued.

 

NURSING MOTHERS

It is not known whether Losartan is secreted in human milk, but Losartan and its metabolites have been found in the rat milk. Because of the potential for adverse effects on the nursing infant, a decision must be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

 

PAEDIATRIC USE

Safety and effectiveness of Losartan in pediatric patients have not been established.

 

ADVERSE EFFECTS

Losartan is well tolerated. The commonly observed adverse effects include: headache, dizziness, abdominal pain, asthenia/fatigue, occasional increases in liver enzymes, blood urea or serum creatinine. Angioedema has been reported rarely in patients with Losartan. Hyperkalemia has also been reported.

 

OVERDOSAGE

Limited data is available regarding overdosage in humans. Likely manifestations include hypotension and tachycardia; bradycardia could occur due to vagal stimulation. If symptomatic hypotension should occur, supportive therapy should be instituted. Neither Losartan nor its active metabolite can be removed by dialysis.

 

PRESENTATION

LOSATRUST 25/50 is available in Blister pack of 1 x 10, 3 x 10, 10 x 10 & 10 x 1 x 10 tablets.

 

STORAGE

Store at temperature between 15-30°C. In a dry and dark place. Keep medicines out of the reach of children.

 

LOSATRUST 25 NAFDAC Reg. No.: A4-3317

LOSATRUST 50 NAFDAC Reg. No.: A4-2834

 

Distributed by

AL-TINEZ PHARMA LTD.

18, Jones Street, Ebutte-Metta

Lagos, Nigeria.

 

Manufactured by

CENTAUR PHARMACEUTICALS PVT. LTD.

Plant I, Plot No.3, Tivim Industrial Estate,

Karaswada, Mapusa, Goa-403 526. INDIA.

Bristol Atenolol Film Coated Tablets

ATENOLOL 25MG FILM-COATED TABLETS

ATENOLOL 50MG FILM-COATED TABLETS

ATENOLOL 100MG FILM-COATED TABLETS

 

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.

• If you have any further questions, please ask your, doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

 

What is in this leaflet

1. What Atenolol Tablets are and what they are used for

2. What you need, to know before you take Atenolol Tablets

3. How to take Atenolol Tablets

4. Possible side effects

5. How to store Atenolol Tablets

6. Contents of the pack and other information

 

1 What Atenolol Tablets are and what they are used for

This medicine contains an active substance called Atenolol. This belongs to a group of medicines called beta blockers.

Atenolol is used to:

• Treat high blood pressure (hypertension).

• Treat uneven heart beats (arrhythmias).

• Help prevent chest pain (angina).

• Protect the heart in the early treatment after a heart attack (myocardial infarction).

It works by making your heart beat more slowly and with less force.

 

2 What you need to know before you take Atenolol Tablets

Do not take Atenolol tablets if:

• You are allergic to atenolol or any of the other ingredients of this medicine (listed in section 6).

• You have ever had any of the following heart problems:

– heart failure which is not under control (this usually makes you breathless and causes your ankles to swell)

– second- or third-degree heart block (a condition which may be treated by a pacemaker)

– very slow or very uneven heart beats, very low blood pressure or very poor circulation.

• You have a tumour called phaeochromocytoma that is not being treated. This is usually near your kidney and can cause high blood pressure. If you are being treated for phaeochromocytoma, your doctor will give you another medicine, called an alpha-blocker, to take as well as Atenolol.

• You have been told that you have higher than normal levels of acid in your blood (metabolic acidosis).

Do not take atenolol tablets if any of the above apply to you. If you are not sure, talk to your doctor or pharmacist before taking atenolol tablets.

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Atenolol tablets if:

• You have asthma, wheezing or any other similar breathing problems, or you get allergic reactions, for example to Insect stings. If you have ever had
asthma or wheezing, do not take this medicine without first checking with your doctor.

• You have a type of chest pain (angina) called Prinzmetal’s angina.

• You have poor blood circulation or controlled heart failure.

• You have first-degree heart block.

• You have diabetes. Your medicine may change how you respond to having low blood sugar. You may feel your heart beating faster.

• You have thyrotoxicosis (a condition caused by an overactive thyroid gland). Your medicine may hide the symptoms of thyrotoxicosis.

• You have problems with your kidneys. You may need to have some check ups during your treatment.

If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking Atenolol tablets.

 

Other medicines and Atenolol tablets

Tell your doctor or pharmacist if you are taking, or have recently taken or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. This is because Atenolol can affect the way some other medicines work and some medicines can have an effect on Atenolol.

In particular, tell your doctor if you are taking any of the following medicines:

• Clonidine (for high blood pressure or migraine). If you are taking clonidine and Atenolol together, do not stop taking clonidine unless your doctor tells you to do so. If you have to stop taking clonidine, your doctor will give you careful instructions about how to do it.

• Verapamil, Diltiazem and nifedipine (for high blood pressure or chest pain).

• Disopyramide, quinidine or amiodarone (for an uneven heart beat).

• Digoxin (for heart problems).

• Adrenaline, also known as epinephrine (a medicine that stimulates the heart).

• Ibuprofen or indometacin (for pain and inflammation).

• Insulin or medicines that you take by mouth for diabetes.

• Medicines to treat nose or sinus congestion or other cold remedies (including those yop can buy in the pharmacy).

 

Operations

If you go into hospital to have an operation, tell the anaesthetist or medical staff that you are taking Atenolol tablets. This is because you can get low blood pressure (hypotension) if you are given certain anaesthetics while you are taking Atenolol.

 

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

 

Driving and using machines

• Your medicine is not likely to affect you being able to drive or use any tools or machines. However, it is best to wait to see how your medicine affects you before trying these activities.

• If you feel dizzy or tired when taking this medicine, do not drive or use any tools or machines.

 

Atenolol tablets contain Sunset yellow

• Atenolol tablet contain Sunset Yellow Lake (E110). This may cause allergic reactions.

 

3 How to take Atenolol Tablets

Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

• Your doctor will tell you how many tablets to take each day and when to take them. Read the label on the carton to remind you what the doctor said.

• Swallow your Atenolol tablet whole with a drink of water.

• Try to take your tablet at the same time each day.

 

Adults

• High blood pressure (hypertension): the recommended dose is 50 mg to 100 mg a day.

• Chest pain (angina): the recommended dose is 100 mg a day or 50 mg twice, a day.

• Uneven heart beats (arrhythmias): the recommended dose is 50 mg to 100 mg a day.

• The early treatment of a heart attack (myocrdial infarction): the recommended dose is 50 mg to 100 mg a day.

 

Elderly People

If you are an elderly person, your doctor may decide to give you a lower dose, particularly if you have problems with your kidneys.

 

People with severe kidney problems

If you have severe kidney problems your doctor may decide to give you a lower dose.

 

Use in Children

This medicine must not be given to children.

 

If you take more Atenolol Tablets than you should

If you take more Atenolol Tablets than prescribed by your doctor, talk to a doctor or go to a hospital straight away. Take the medicine pack with you so that the tablets can be identified.

 

If you forget to take Atenolol Tablets

If you forget to take a dose, take it as soon as you remember. However, if it is almost time for the next dose, skip the missed dose. Do not take a double dose to make up for a forgotten dose.

 

lf you stop taking Atenolol Tablets

Do not stop taking Atenolol tablets without talking to your doctor. In some cases, you may need to stop taking it gradually.

 

4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

 

Allergic reactions

If you have an allergic reaction, see a doctor straight away. The signs may include raised lumps on your skin (weals), or swelling of your face, lips, mouth, tongue or throat.

 

Other possible side effects

Common (may affect up to 1 in 10 people)

• You may notice that your pulse rate becomes slower while you are taking the tablets. This is normal, but if you are concerned please tell your doctor about it.

• Cold hands and feet.

• Diarrhoea.

• Feeling sick (nausea).

 

Uncommon (may affect up to 1 in 100 people)

• Disturbed sleep.

 

Rare (may affect up to 1 in 1,000 people)

• Heart block (which can cause dizziness, abnormal heart beat, tiredness or fainting).

• Numbness and spasm in your fingers which is followed by warmth and pain (Raynaud’s disease).

• Mood changes.

• Nightmares.

• Feeling confused.

• Changes in personality (psychoses) or hallucinations.

• Headache.

• Dizziness (particularly when standing up).

• Tingling of your hands.

• Being unable to get an erection (impotence).

• Dry mouth.

• Dry eyes.

• Disturbances of vision.

• Thinning of your hair.

• Skin rash.

• Reduced, numbers of platelets in your blood (this may make you bruise more easily).

• Purplish marks on your skin.

• Jaundice (causing yellowing of your skin or the whites of your eyes).

 

Very rare (may affect up to 1 in 10,000 people)

• Changes to some of the cells or other parts of your blood. Your doctor may take blood samples every so often to check whether Atenolol has had any effect on your blood.

 

Not known (frequency cannot be estimated from the available data)

• Lupus-like syndrome (a disease where the immune system produces antibodies that attacks mainly skin and joints).

 

Conditions that may get worse

If you have any of the following conditions, they may get worse when you start to take your medicine. This happens rarely affecting less than 1 in 1,000 people.

• Psoriasis (a skin condition).

• Being short of breath or having swollen ankles (if you have heart failure).

• Asthma or breathing problems.

• Poor circulation.

 

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at “www.mhra.gov.uk/yellowcard.” By reporting side effects, you can help provide more information on the safety of this medicine.

 

 

5 How to store Atenolol Tablets

• Keep this medicine out of the sight and reach of children.

• Do not use your tablets after the expiry date (EXP) which is stated on the carton. The expiry date refers to the last day of that month.

• The medicinal product does not require any special storage conditions.

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away any medicines that you no longer use. These measures will help to protect the environment.

 

6 Contents of the pack and other information

What Atenolol Tablets contains

• The active substance is atenolol. Each tablet contains 25 mg, 50 mg or 100 mg of atenolol.

• The other ingredients are: magnesium carbonate, sodium starch glycolate, sodium lauryl sulfate, Colloidal anhydrous silica , maize starch, magnesium stearate, hypromellose, titanium dioxide (E171), purified talc, polyethylene glycol 6000 and sunset yellow (E110).

 

What Atenolol Tablets look like and contents of the pack

• Atenolol tablets are orange, circular, biconvex, film-coated tablets with ‘T 25’, ‘T 50’ or ‘T 100’ embossed on one side.

• They are available in packs of 14, 28, 56, 84, 100, 250, 500 and 1000 tablets.

• Not all pack sizes may be marketed.

 

Marketing Authorisation Holder and Manufacturer

Name and address

Bristol Laboratories Ltd,

Unit 3, Canalside, Northbridge Road,

Berkhamsted, Hertfordshire,

HP4 1EG, United Kingdom

info@bristol-labs.co.uk

 

Atenolol 25mg Film-coated Tablets; PL 17907/0069

Atenolol 50mg Film-coated Tablets; PL 17907/0070

Atenolol 100mg Film-coated Tablets; PL 17907/0071

 

This leaflet was last revised in March 2016.

To request a copy of this leaflet in Braille, large print or audio format, please contact the licence holder at the address (email) above.