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This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.

Antacids, Anti-dyspeptic/Carminatives

This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.

Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.

Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.

Care should be taken in decreased kidney function, hypophosphataemia and weak people.

It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.

Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Over dosage with this formulation is a rare case.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

This is indicated to relieve symptoms of dyspepsia, heartburn, acid indigestion, sour stomach, gastroesophageal reflux and hiatal hernia. It is also prescribed in hyperacidity associated with peptic ulcers, gastritis and esophagitis. Magaldrate may be given to children if necessary. Also indicated for the relief of flatulence, abdominal distension and windy colic.

Antacids, Anti-dyspeptic/Carminatives

This is a combination of magaldrate and simethicone. Magaldrate (magnesium aluminium compound i.e. Hydroxymagnesium Aluminate), which neutralizes gastric acid extraordinarily quickly without raising the pH above 5-6. It also decreases the activity of pepsin in gastric secretion. Besides this, simethicone, the another component of Marlox Plus, enables the gas buble to coalesce and give relief from flatulence.

Tablet: 1-4 chewable tablets, 20 to 60 minutes after meals and at bedtime, or as directed by the physician.
Suspension: 2-4 teaspoonfuls (10-20 ml) of suspension, 20 to 60 minutes after meals and at bed time, or as directed by the physician.

Gastrointestinal side-effects are uncommon. Occasionally, if excessive amount is consumed, diarrhea, constipation or regurgitation may occur.

Magaldrate is contraindicated in patients with known hypersensitivity to magnesium and aluminium. It is also contraindicated in patients with impaired renal functions.

Care should be taken in decreased kidney function, hypophosphataemia and weak people.

It should not be used in patients taking any form of Tetracycline. The drug may cause reduced bio-availability or slower absorption of a number of drugs including propranolol, isoniazid, prednisolone and naproxen.

Magaldrate may be used in pregnancy if indicated however one should avoid excessive dosage. Magaldrate may pass into breast milk but has not been reported to cause problem in nursing babies.

Over dosage with this formulation is a rare case.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

Sulfonylureas

Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca⁺²  transport across the β-cell membranes and decreases hepatic glucose output.

Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.

Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.

The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).

If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.

If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.

Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.

Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.

Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.

Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.

As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.

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. By reporting side effects, you can help provide more information on the safety of this medicine.

Do not take Gliclazide:

• if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
• if you have insulin-dependent diabetes (type 1)
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
• if you have severe kidney or liver disease
• if you are taking medicines to treat fungal infections
• if you are breastfeeding

Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.

Low blood sugar (Hypoglycaemia) may occur:

• if you take meals irregularly or skip meals altogether,
• if you are fasting
• if you are malnourished
• if you change your diet
• if you increase your physical activity and carbohydrate intake does not match this increase,
• if you drink alcohol, especially in combination with skipped meals,
• if you take other medicines or natural remedies at the same time,
• if you take too high doses of gliclazide,
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
• if your kidney function or liver function is severely decreased.

if you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.

In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).

You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).

If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.

If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.

Gliclazide is not recommended for use in children due to lack of data.

Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
• antibiotics (sulphonamides, clarithromycin)
• medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
• medicines to treat fungal infections (miconazole, fluconazole)
• medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
• medicines to treat depression (monoamine oxidase inhibitors)
• painkiller or antirheumatics (phenylbutazone, ibuprofen)
• medicines containing alcohol

The blood-glucose-lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:

• medicines to treat disorders of the central nervous system (chlorpromazine)
• medicines reducing inflammation (corticosteroids)
• medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
• medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
• St John's Wort- Hypericum perforatum- preparations

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazide especially in elderly patients.

Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).

Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.

Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.

Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:

• have frequent episodes of low blood sugar (hypoglycaemia)
• have few or no warning signals of low blood sugar (hypoglycaemia)

Gliclazide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.

Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. 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.

Digoxin is indicated in:

• Heart failure.
• Atrial fibrillation with an uncontrolled ventricular rate.
• Acute left ventricular failure.
• Chronic left ventricular failure and conjestive heart failure,especially when caused by hypertensive valvular (especially mitral valvular) disease or ischaemic heart disease.

Positive Inotropic drugs

Digoxin is a cardiac glycoside used in the management of particularly atrial fibrillation and in heart failure.The principal actions of digoxin are an increase in the force of myocardial contraction (positive inotropic activity and a reduction in the conductivity of the heart particularly in conduction through the atrioventricular node. Digoxin also has a direct action on vascular smooth muscle and indirect effects mediated primarily by the autonomic nervous system and particularly by an increase in vagal activity.

By oral administration:

• Rapid digitalization: 1-1.5 mg in divided doses over 24 hours
• Less urgent digitalization: 250-500 micrograms daily (higher dose may be divided)
• Maintenance: 62.5-500 micrograms daily (higher dose may be divided) according to renal function and in atrial fibrillation on heart rate response.
• Usual range: 125-250 micrograms daily (lower dose may be divided) according to renal function and in atrial fibrilation on heart rate response.
• Usual range: 125-250 micrograms daily (lower dose may be appropriate in the elderly).

Usually associated with excessive dosage include anorexia, nausea, vomiting, diarrhoea, abdominal pain, visual disturbance, headache, fatigue, drowsiness, confusion, delirium, hallucination, depression, arrhythmia, heart block, intestinal ischaemia, gynaecomastia on long term use, thrombocytopenia reported. Digoxin can be safely used in pregnancy

Potassium-depleting diuretics increase the effects of digitalis. Calcium particularly if administered rapidly by the intravenous route, may produce serious arrhythmia in digitalized patients. Quinidine, verapamil, amiodarone, propafenone, indomethacin, itraconazole, alprazolam, spironolactone, erythromycin, clarithromycin (and possibly other macrolide antibiotics) and tetracycline increase digoxin serum level. Besides antacids, kaolinpectin, sulfasalazine, neomycin, penicillamine, calestipol, metoclopramide, rifampin may interfere with intestinal absorption of digoxin resulting low serum concentrations of the drug.

Digoxin is excreted in breast milk but in concentration below those found in plasma and therefore poses no hazard to the breast-fed infant.

Neonates: Digoxin can be used in neonates.

Children: Digoxin can be used in children.

The elderly: Partly because of reduced renal function and partly because their tissues are more sensitive to the effects of digitalis, the elderly require a lower maintenance dose of digoxin than younger adults.

Store in a cool and dry place.Keep out of the reach of children.

Diloxanide is indicated for intestinal amoebiasis

Amoebicides

Diloxanide is a luminal amoebicide which is hydrolysed in the gut, thus releasing the free diloxanide which acts as an amoebicide. It is given alone in asymptomatic cyst passers. For patients with active amoebic infections, it can be administered with a 5-nitroimidazole e.g. metronidazole or tinidazole.

Adult: The recommended dose is 500 mg 3 times/day for 10 days. May repeat course if needed.

Child: >25 kg: 20 mg/kg daily in 3 divided doses for 10 days, repeated if necessary.

The frequency of these side-effects is unknown flatulence, itching, urticaria, vomiting

Hypersensitivity.

Caution should be exercised in pregnant and breastfeeding women. Avoid excess dosage.

There are no known drug interactions and none well documented.

Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Diloxanide is indicated for intestinal amoebiasis

Amoebicides

Diloxanide is a luminal amoebicide which is hydrolysed in the gut, thus releasing the free diloxanide which acts as an amoebicide. It is given alone in asymptomatic cyst passers. For patients with active amoebic infections, it can be administered with a 5-nitroimidazole e.g. metronidazole or tinidazole.

Adult: The recommended dose is 500 mg 3 times/day for 10 days. May repeat course if needed.

Child: >25 kg: 20 mg/kg daily in 3 divided doses for 10 days, repeated if necessary.

The frequency of these side-effects is unknown flatulence, itching, urticaria, vomiting

Hypersensitivity.

Caution should be exercised in pregnant and breastfeeding women. Avoid excess dosage.

There are no known drug interactions and none well documented.

Pregnancy Category- Not Classified. FDA has not yet classified the drug into a specified pregnancy category.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Alpha adrenoceptor blocking drugs, Beta-adrenoceptor blocking drugs, Beta-blockers

Carvedilol is a cardiovascular drug whose main pharmacological action is non-selective antagonism of β-adrenergic receptors but which also possesses appreciable a-adrenergic antagonistic activity. It also has antiproliferative properties and is a scavenger of reactive free oxidant radicals. It is used in the treatment of hypertension, angina pectoris and congestive heart failure.

In hypertension: initially, 12.5 mg once daily, increased after 2 days to the usual dose of 25 mg once daily; if necessary the dose may be further increased at intervals of at least 2 weeks to maximum 50 mg daily in single or divided doses. In elderly patients, the initial dose of 12.5 mg daily may provide satisfactory control.

In angina pectoris: the recommended dose for initiation of therapy is 12.5 mg twice daily for the first 2 days. Thereafter, the recommended dosage is 25 mg twice daily. For elderly patients, the maximum daily dose is 50 mg daily in divided doses.

In heart failure: initially, 3.125 mg twice daily (with food) may be given, the dose may be increased at intervals of at least 2 weeks to 6.25 mg twice daily, then to 12.5 mg twice daily, then to 25 mg twice daily. The dose may be increased to the highest dose tolerated, maximum 25 mg twice daily in patients less than 85 kg body-weight and 50 mg twice daily in patients over 85 kg.

Postural hypotension, dizziness, headache, fatigue, gastro-intestinal disturbances, bradycardia; occasionally diminished peripheral circulation, peripheral oedema and painful extremities, dry mouth, dry eyes, eye irritation or disturbed vision, impotence, disturbances of micturition, influenza-like symptoms, rarely angina, AV block, exacerbation of intermittent claudication or Raynaud's phenomenon, allergic skin reactions, exacerbation of psoriasis, nasal stuffiness, wheezing, depressed mood, sleep disturbances, paresthesia, heart failure, changes in liver enzymes, thrombocytopenia, leukopenia are also reported.

Carvedilol is contraindicated in patients with decompensated heart failure requiring intravenous inotropic therapy, bronchial asthma or related bronchospastic conditions, second or third-degree AV block, sick sinus syndrome (unless a permanent pacemaker is in place), cardiogenic shock or severe bradycardia.

Take caution in hepatic impairment and in heart failure monitor clinical status for 2-3 hours after initiation and after increasing each dose. Before increasing dose ensure that the renal function and heart failure are not deteriorating

Digoxin: In normal healthy volunteers a single dose of carvedilol taken together with a single dose of digoxin resulted in significantly increased levels of digoxin 24 hours later. Patients with congestive heart failure stabilized on digoxin have been given carvedilol concomitantly without any adverse effects. Increased monitoring of digoxin is recommended when initiating, adjusting, or discontinuing the dose of carvedilol.

Rifampin: Pretreatment with rifampin resulted in a 60% decrease in Cmax and AUC.

Warfarin: Carvedilol did not alter the in vitro plasma protein binding of warfarin.

Clonidine: β-receptor antagonists potentiate the pressor reaction which may follow the sudden withdrawal of treatment with clonidine although, in theory, the a-blocking action of carvedilol should modify the pressure rise.

Carvedilol should not be used during breast-feeding, since no studies have been performed in lactating women and animal studies have shown that carvedilol is excreted in breast milk. Safety and efficacy in children have not been established with carvedilol. Carvedilol should not be used during pregnancy as no studies have been performed in this group. Animal studies have shown that carvedilol crosses the placental barrier. No information is available on the safety and efficacy of Carvedilol use in neonates.

Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Roflumilast is indicated:

• As add-on therapy to bronchodilator treatment.
• For the maintenance treatment of severe Chronic Obstructive Pulmonary Disease (COPD) associated with chronic bronchitis (i.e. patients with a history of chronic cough and sputum) in adult patients with a history of frequent exacerbations.

Roflumilast should not be used as a rescue medication.

Antihistamines anti-allergies & hypo-sensitisation

Roflumilast is a phosphodiesterase-4 (PDE-4) inhibitor which, due to its selective inhibition of the PDE4 isoenzyme, has potential antiinflammatory and antimodulatory effects in the pulmonary system. It is thought that the increased levels of intracellular cyclic AMP are responsible for the therapeutic actions of Roflumilast.

The recommended dosage for patients with COPD is one 500 mcg tablet daily, with or without food.

General disorders: Fatigue.
Metabolism and nutrition disorders: Decreased appetite, Weight decreased.
Musculoskeletal and connective tissue disorders: Back pain, muscle spasms.
Nervous system disorders: Dizziness, Headache, Tremor.
Psychiatric disorders: Anxiety, Depression, Insomnia.

Hypersensitivity to Roflumilast or to any of the excipients. Moderate to severe liver impairment.

Not as emergency treatment for relief of acute brochospasm. Monitor body wt regularly. Severe immunological disease, severe acute infections, cancers (except basal cell carcinoma) or patients on immunosuppressants; CHF (NYHA grades III & IV). History of depression associated with suicidal ideation or behavior. Galactose intolerance, Lapp-lactase deficiency or glucose-galactose malabsorption. Hepatic impairment. Pregnancy & lactation.

A major step in Roflumilast metabolism is the N-oxidation of Roflumilast to Roflumilast N-oxide by CYP3A4 and CYP1A2. Therefore, the use of strong cytochrome P450 enzyme inducers (e.g. rifampicin, phenobarbital, carbamazepine, phenytoin) with Roflumilast is not recommended. The co-administration of Roflumilast with CYP3A4 inhibitors or dual inhibitors that inhibit both CYP3A4 and CYP1A2 simultaneously (e.g., erythromycin, ketoconazole, fluvoxamine, enoxacin, cimetidine) may increase Roflumilast systemic exposure and may result in increased adverse reactions. The co-administration of Roflumilast with oral contraceptives containing gestodene and ethinyl estradiol may increase roflumilast systemic exposure and may result in increased side effects.

Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Roflumilast should not be used during pregnancy & lactation.

Geriatrics ( 65 years of age): There were no overall differences in safety and effectiveness of Roflumilast in the elderly compared to younger patients with COPD. Therefore, no dose adjustment is necessary.

Pediatrics (<18 years of age): Safety and effectiveness of Roflumilast in children and adolescents below 18 years of age have not been established.

Hepatic Impairment: Roflumilast is not recommended for use in patients with moderate or severe liver impairment.

Renal impairment: No dosage adjustment is necessary for patients with renal impairment

No case of overdose has been reported in clinical studies with Roflumilast. However, during the Phase I studies of Roflumilast, at an increased rate after a single oral dose of 2500 mcg and a single dose of 5000 mcg,

The following symptoms were observed: headache, gastrointestinal disorders, dizziness, palpitations, lightheadedness, clamminess and arterial hypotension.

Missed Dose: Patients should be advised that if they forget to take a tablet at the usual time, they should take the tablet as soon as they remember or continue on the next day with the next tablet at the usual time. Patients should not take a double dose to make up for a forgotten dose.

Store below 30° C, keep away from light, moisture. Keep out of the reach of children.

Torasemide is indicated for the management of edema of cardiac, renal and hepatic origin.The management of hypertension, as a sole therapeutic agent or in combination with other classes of antihypertensive agents.

Loop diuretics

Torasemide inhibits the Na⁺/K⁺/2CI^- carrier system (via interference of the chloride binding site) in the lumen of the thick ascending portion of the loop of Henle, resulting in a decrease in reabsorption of sodium and chloride. This results in an increase in the rate of delivery of tubular fluid and electrolytes to the distal sites of hydrogen and potassium ion secretion, while plasma volume contraction increases aldosterone production. The increased delivery and high aldosterone levels promote sodium reabsorption at the distal tubules, and By increasing the delivery of sodium to the distal renal tubule, torasemide indirectly increases potassium excretion via the sodium-potassium exchange mechanism. Torasemide's effects in other segments of the nephron have not been demonstrated. Thus torasemide increases the urinary excretion of sodium, chloride, and water, but it does not significantly alter glomerular filtration rate, renal plasma flow, or acid-base balance. Torasemide's effects as a antihypertensive are due to its diuretic actions. By reducing extracellular and plasma fluid volume, blood pressure is reduced temporarily, and cardiac output also decreases.

Congestive heart failure: The usual initial oral dose is 10 mg or 20 mg once daily. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200 mg have not been adequately studied.

Chronic renal failure: The usual initial oral dose is 20 mg once daily. lf the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 200mg have not been adequately studied.

Hepatic cirrhosis: The usual initial oral dose is 5 mg or 10 mg once daily, administered together with an aldosterone antagonist or a potassium sparing diuretic. If the diuretic response is inadequate, the dose should be titrated upward by approximately doubling until the desired diuretic response is obtained. Single doses higher than 40 mg have not been adequately studied. Chronic use of any diuretic in hepatic disease has not been studied in adequate and well-controlled trials.

Hypertension: The usual initial oral dose is 2.5-5 mg once daily. If the 5 mg dose does not provide adequate reduction of blood pressure within 4 to 6 weeks, the dose may be increased to 10 mg once daily. If the response to 10 mg is insufficient, an additional antihypertensive should be added to the treatment regimen.

Usually torasemide is well tolerated. However, a few side effects like dry mouth, dizziness, tiredness, skin rash, diarrhea, constipation, nausea, vomiting, orthostatic hypotention and muscle cramp may occur. All side effects usually are mild and transient.

Torasemide is contraindicated in patients with known hypersensitivity to torasemide and other sulfonyl ureas. It is also contraindicated in patients who are anuric.

Precautions should be taken while torasemide is administered in the conditions like diabetes, gout, hypotension and liver failure.

Increased risk of severe hypokalaemia with amphotercin B, corticosteroids, carbenoxolone, hypokalaemia-causing medications. Increased risk of lithium toxicity. Increased potential for ototoxicity and nephrotoxicity with nephrotoxic or ototoxic medications e.g. aminoglycosides. High dose salicylates may increase the risk of salicylate toxicity. Increased risk of toxicity with digoxin. Reduced diuretic effect with NSAIDs. Increased risk of hypotension with antihypertensives.

Pregnancy: Adequate and well controlled studies of torasemide have not been carried out in pregnant woman. Because animal reproduction studies are not always predictive of human response, torasemide can be used during pregnancy only if clearly needed.

Nursing Mother: lt is not known whether torasemide is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when torasemide is administered to a nursing mother.

Use in children: Safety and efficacy of torasemide in children have not been established.

There is no human experience of overdoses of torasemide, but the signs and symptoms of overdosage can be anticipated to be those of excessive pharmacological effect: dehydration, hypovolemia, hypotension and hypokalemia. Treatment of overdose should consist of fluid and electrolyte supplement.

Store Torasemide at room temperature less than 30° C and keep in cool and dry place, away from moisture and sunlight. Keep the medicine out of the reach of children.

For mydriasis and cycloplegia for diagnostic procedure, for the treatment of acute and subacute iridocyclitis, chronic iridocyclitis, Adhesions and disruptions of iris and ciliary body, Sclera and iris operations

Mydriatic and Cycloplegic agents

Tropicamide binds to and blocks the receptors in the muscles of the eye (muscarinic receptor M4). Tropicamide acts by blocking the responses of the iris sphincter muscle to the iris and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.

For refraction: Instill one or two drops of 1% solution in the eye(s), repeated in five minutes. If patient is not seen within 20 to 30 minutes, an additional drop may be instilled to prolong mydriatic effect.

For examination of fundus: Instill one or two drops of 0.5% solution 15 to 20 minutes prior to examination. Individuals with heavily pigmented irides may require higher strength or more doses.

Transient stinging, blurred vision, photophobia and superficial punctate keratitis have been reported with the use of tropicamide. Increased intraocular pressure has been reported following the use of mydriatics. Dryness of the mouth, tachycardia, headache, allergic reactions, nausea, vomiting, pallor, central nervous system disturbances and muscle rigidity have been reported with the use of tropicamide.

Contraindicated in persons showing hypersensitivity to any component of this preparation.

The lacrimal sac should be compressed by digital pressure for 2-3 minutes after instillation to avoid excessive systemic absorption.

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine, or ophthalmic cholinesterase inhibitors.

Pregnancy Category C. Tropicamide should be given to a pregnant woman only if clearly needed. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when tropicamide is administered to a nursing woman.

Store at 15° to 25°C . Do not refrigerate or store at high temperatures. Keep container tightly closed.

Preparations for Ophthalmic diagnosis

Tropicamide binds to and blocks the receptors in the muscles of the eye (muscarinic receptor M4). Tropicamide acts by blocking the responses of the iris sphincter muscle to the iris and ciliary muscles to cholinergic stimulation, producing dilation of the pupil and paralysis of the ciliary muscle.

Phenylephrine Hydrochloride is a selective alpha-1 agonist, which causes mydriasis without cycloplegia. It tends to reduce intraocular lesion by vasoconstrictor action.

Uveitis: 1-2 drops bid-qid or as required.

Diagnostic purpose/Pre-operative purpose: Instill 1-2 drops in the eye(s) 15-20 minutes before examination. If examination is not conducted within 20–30 minutes, an additional drop may be placed in the eye(s) to prolong the effect.

Elevated IOP (occasionally), stinging, blurred vision, tachycardia, photophobia, headache, parasympathetic stimulation and allergic reactions. Systemic effects include arrhythmias, hypertension and coronary artery spasm.

This medication is contraindicated in these following cases

• Patients with hypersensitivity to any of the components and narrow angles or narrow angle glaucoma.
• Low birth weight infants and some elderly adults with severe arteriosclerotic cardiovascular or cerebrovascular disease.
• During intraocular operative procedures when the corneal epithelial barrier has been disturbed.

Caution should be taken when administered with, or upto 21days after administration of monoamine oxidase (MAO) inhibitors as exaggerated adrenergic effects may result.

The possibility of psychotic reactions and behavioral disturbances should be considered in patients who are hypersensitive to anticholinergic drugs.

Use with extreme caution in infants.

Tropicamide may interfere with the antihypertensive action of carbachol, pilocarpine or ophthalmic cholinesterase inhibitors.

The safety of this medication during pregnancy or lactation has not been established.

Excessive use in children and in certain susceptible individuals may produce systemic toxic symptoms.

Keep out of the reach of children. Store in a cool, dry place, away from heat and direct light. Do not use more than 4 weeks after opening. 

Diltiazem Hydrochloride sustained release tablet is indicated in the prophylaxis and treatment of angina pectoris. It is used in the management of classical and vasospastic angina pectoris. It has also been used in the treatment of essential hypertension. It is used for prophylaxis of some selected supraventricular tachyarrhythmias.

Calcium-channel blockers

Diltiazem hydrochloride is a calcium channel antagonist. It is a peripheral and coronary vasodilator with some negative inotropic activity. Diltiazem inhibits cardiac conduction particularly at the sino-atrial and atrioventricular nodes. Diltiazem has the following actions:

Antianginal: A direct dilatation of coronary arteries and arterioles proved oxygen supply to myocardial tissues. In addition dilatation of the peripheral vasculature reduces systemic pressure of cardiac "after load" which results in lessened stress and reduced oxygen requirements of the myocardial tissues.

Antiarrhythmic: The inhibited influx of calcium ions in cardiac tissues result in slowed electrophysiological activity through the S-A and A-V nodes without affecting accessory bypass conduction or altering normal atrial action potential or intraventricular conduction.

Antihypertensive: Reduces peripheral vascular resistance as a result of vasodilatation. More than 90% of an oral dose is rapidly absorbed. Protein binding is very high. Peak plasma concentration reaches within 30-60 minutes. It is metabolised in the liver and excreted (60%) through bile.

Mild to moderate hypertension: initially 90 mg or 120 mg twice daily (elderly once daily); up to 360 mg daily may be required (elderly upto 240 mg) daily.

Angina: initially 90 mg or 120 mg twice daily in divided doses may be required (elderly up to 240 mg daily).

Bradycardia, sino-atrial block, atrioventricular block, hypertension, malaise, headache, hot flushes, GIT disturbances, oedema, hepatitis and depression reported.

Diltiazem Hydrochloride sustained release tablet is contraindicated in patients with known hypersensitivity to the drug, sick sinus syndrome, second or third degree AV block, severe hypertension or acute myocardial infarction and rediographically documented pulmonary congestion.

Concomitant prophylactic therapy with short-or long-acting nitrates may be administered safely during diltiazem therapy. Diltiazem recommended caution and careful dosage titration when diltiazem is administered concomitantly with other drugs that can affect cardiac contractility and/ or conduction.

There are no adequate and controlled studies to date with diltiazem in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Because diltiazem is distributed into milk, women receiving the drug should not breastfeed their infants; an alternative method of infant feeding should be used if diltiazem therapy is considered necessary in nursing women.

Keep medicine out of the reach of children. Store in a cool and dry place.

Diltiazem Hydrochloride sustained release tablet is indicated in the prophylaxis and treatment of angina pectoris. It is used in the management of classical and vasospastic angina pectoris. It has also been used in the treatment of essential hypertension. It is used for prophylaxis of some selected supraventricular tachyarrhythmias.

Calcium-channel blockers

Diltiazem hydrochloride is a calcium channel antagonist. It is a peripheral and coronary vasodilator with some negative inotropic activity. Diltiazem inhibits cardiac conduction particularly at the sino-atrial and atrioventricular nodes. Diltiazem has the following actions:

Antianginal: A direct dilatation of coronary arteries and arterioles proved oxygen supply to myocardial tissues. In addition dilatation of the peripheral vasculature reduces systemic pressure of cardiac "after load" which results in lessened stress and reduced oxygen requirements of the myocardial tissues.

Antiarrhythmic: The inhibited influx of calcium ions in cardiac tissues result in slowed electrophysiological activity through the S-A and A-V nodes without affecting accessory bypass conduction or altering normal atrial action potential or intraventricular conduction.

Antihypertensive: Reduces peripheral vascular resistance as a result of vasodilatation. More than 90% of an oral dose is rapidly absorbed. Protein binding is very high. Peak plasma concentration reaches within 30-60 minutes. It is metabolised in the liver and excreted (60%) through bile.

Mild to moderate hypertension: initially 90 mg or 120 mg twice daily (elderly once daily); up to 360 mg daily may be required (elderly upto 240 mg) daily.

Angina: initially 90 mg or 120 mg twice daily in divided doses may be required (elderly up to 240 mg daily).

Bradycardia, sino-atrial block, atrioventricular block, hypertension, malaise, headache, hot flushes, GIT disturbances, oedema, hepatitis and depression reported.

Diltiazem Hydrochloride sustained release tablet is contraindicated in patients with known hypersensitivity to the drug, sick sinus syndrome, second or third degree AV block, severe hypertension or acute myocardial infarction and rediographically documented pulmonary congestion.

Concomitant prophylactic therapy with short-or long-acting nitrates may be administered safely during diltiazem therapy. Diltiazem recommended caution and careful dosage titration when diltiazem is administered concomitantly with other drugs that can affect cardiac contractility and/ or conduction.

There are no adequate and controlled studies to date with diltiazem in pregnant women, and the drug should be used during pregnancy only when the potential benefits justify the possible risk to the fetus. Because diltiazem is distributed into milk, women receiving the drug should not breastfeed their infants; an alternative method of infant feeding should be used if diltiazem therapy is considered necessary in nursing women.

Keep medicine out of the reach of children. Store in a cool and dry place.

Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.

Short-acting selective & β2-adrenoceptor stimulants

Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.

Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.

Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).

Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.

Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.

Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.

Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.

Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.

Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.

Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.

Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.

Short-acting selective & β2-adrenoceptor stimulants

Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.

Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.

Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).

Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.

Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.

Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.

Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.

Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.

Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.

Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.

Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Bambuterol is indicated for Bronchial asthma, chronic bronchitis, emphysema & other lung diseases where bronchospasm is a complicating factor.

Short-acting selective & β2-adrenoceptor stimulants

Bambuterol is an adrenergic β2 receptor agonist which predominantly stimulates β2 receptor, thus producing relaxation of bronchial smooth muscle, inhibition of release of endogenous spasmogens, inhibition of edema caused by endogenous mediators & increased mucocilliary clearance.

Adult or Elderly: The recommended initial dose 10 mg. The dose may be increased to 20 mg after 1-2 weeks depending on the clinical effect.

Children 2-5 years: The recommended normal dose 10 mg (10 ml syrup).

Children 6-12 years: The recommended normal dose 10 mg (10 ml syrup). The dose may be increased to 20 mg.

Common side effects are fatigue, nausea, palpitation, headache, dizziness & tremor.

Bambuterol is contraindicated in hepatic impairment, liver cirrhosis or severely impaired liver function.

Reduce the dose in renal impairment, avoid in cirrhosis and severe hepatic impairment. Caution should be observed in patients with severe cardiovascular disorder, such as ischaemic heart disease, tachyarrhythmias or severe heart failure.

Succinylcholin, MAOIs (monoamine oxidase inhibitors), β2-blockers, corticosteroids, diuretics, muscle relaxants, sympathomimetic xanthine derivatives. Bambuterol may partly or totally inhibit the effect of β-blockers.

Pregnant women: There is no definite evidence of ill consequence during pregnancy. Nevertheless, the drug should not be used during the first trimester of pregnancy, unless the expected benefit is thought to outweigh any possible risk to the fetus.

Lactating mother: It is excreted in breast milk. So, patients taking this drug should not breast-feed.

Impaired renal function (GFR 50 ml/min): The recommended starting dose is 5 mg, which may be increased to 10 mg after one to two weeks, depending on the clinical effect.

Impaired hepatic function: Not recommended because of unpredictable conversion to terbutaline.

Keep away from light, store in a cool and dry place. Keep out of reach of children.

Anti-viral drugs

Remdesivir is a preparation of Remdesivir. It is an adenosine nucleotide prodrug that distributes into cells where it is metabolized to form the pharmacologically active nucleoside triphosphate metabolite. Metabolism of Remdesivir to Remdesivir Triphosphate has been demonstrated in multiple cell types. Remdesivir Triphosphate act as an analogue of adenosine triphosphate (ATP) and competes with the natural ATP substrate for incorporation into nascent RNA chains by the SARS-CoV-2 RNA-dependent RNA polymerase, which results in delayed chain termination during replication of the viral RNA. Remdesivir triphosphate is a weak inhibitor of mammalian DNA and RNA polymerase with low potential for mitochondrial toxicity.

General Information-

• Adult and pediatric patients (>28 days and old) must have an eGFR determined and full-term neonates (≥7 days to ≤28 days old) must have serum creatinine determined before dosing of Remdesivir.
• Hepatic laboratory testing should be performed in all patients prior to starting Remdesivir and daily while receiving Remdesivir.
• Remdesivir should be administered via intravenous infusion only. Do not administer as intramuscular injection.

Adult Patients-

• The recommended dosage in adults requiring invasive mechanical ventilation and/or ECMO is a single loading dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 9 days.
• The recommended dose in adults not requiring invasive mechanical ventilation and/or ECMO is a single dose of Remdesivir 200 mg on day 1 followed by once daily maintenance dose of Remdesivir 100 mg for 4 days. If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
• Remdesivir is to be administered via intravenous infusion in a total volume of up to 250 ml 0.9% saline over 30 to 120 minutes.

Pediatric Patients-

• The recommended pediatric dose for pediatric patients weighing between 3.5 kg <40 kg should be calculated using the mg/kg dose according to the patient’s weight.
• For pediatric patients with body weight between 3.5 kg <40 kg use Remdesivir for injection 100 mg lyophilized powder only. Administer a body weight-based dosing regimen of one loading dose of Remdesivir 5 mg/kg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 2.5 mg/kg IV (infused over 30 to 120 minutes) once daily for 9 days (for pediatric patients requiring invasive mechanical ventilation and/or ECMO, days 2 through 5). If a patient dose not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days)
• For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 9 days will be administered.
• For pediatric patients with body weight ≥40 kg requiring invasive mechanical ventilation and/or ECMO, the adult dosage regimen of one loading dose of Remdesivir 200 mg IV (infused over 30 to 120 minutes) on day 1 followed by Remdesivir 100 mg IV (infused over 30 to 120 minutes) once daily for 4 days (days 2 through 5) will be administered. If a patient does not demonstrate clinical improvement, treatment may be extended for up to 5 additional days (i.e. up to a total of 10 days).

The prepared dilution should not be administered simultaneously with any other medication. The compatibility of Remdesivir injection with IV solutions and medications other than saline is not known. Please administered the diluted solution with the infusion rate described in the below table. Recommended Rate of Infusion- Diluted Remdesivir for Injection Lyophilized Powder in Adults and Pediatric Patients Weighing > 40 kg

Infusion bag 250 ml:

• Infusion Time: 30 min, Rate of Infusion: 8.33 ml/min
• Infusion Time: 60 min, Rate of Infusion: 4.17 ml/min
• Infusion Time: 120 min, Rate of Infusion: 2.08 ml/min

Infusion bag 100 ml:

• Infusion Time: 30 min, Rate of Infusion: 3.33 ml/min
• Infusion Time: 60 min, Rate of Infusion: 1.67 ml/min
• Infusion Time: 120 min, Rate of Infusion: 0.83 ml/min

An adverse reaction associated with Remdesivir in clinical trials in healthy adult subjects was increased liver transaminases.

Remdesivir is contraindicated in patients with known hypersensitivity to Remdesivir.

There are limited clinical data available for Remdesivir. Serious and unexpected adverse events may occur that have not been previously reported with Remdesivir use.

No adequate and well controlled studies of Remdesivir use in pregnant women have been conducted. Remdesivir should be used in pregnancy only if the potential benefit justifies the potential risk for the mother fetus. There is no information regarding the presence of Remdesivir in human milk, the effects on the breastfeed infants, or the effects on milk production. Because of the potential for viral transmission of SARS-CoV-2 negative infants and adverse reactions from the drug in breastfeeding infants, the development and health benefits of breastfeeding should be considered along with the mother's clinical need for Remdesivir and any potential adverse effects on the breastfed child from Remdesivir or from the underlying maternal condition.

Reconstitution instructions:

• Aseptically reconstitute Remdesivir lyophilized powder by addition of 19 ml of sterile water for injection using a suitably sized syringe and needle per vial.
• Discard the vial if a vacuum does not pull the sterile water for injection into the vial.
• Immediately shake the vial for 30 seconds.
• Allow the contents of the vial to settle for 2 to 3 minutes. A clear solution should result.
• If the content of the vial is not completely dissolved, shake the vial again for 30 seconds and allow the contents to settle for 2 to 3 minutes. Repeat this procedure as necessary until the contents of the vial are completely dissolved.
• Following reconstitution, each vial contains 100 mg/20 ml (5 mg/ml).
• Parenteral drug products should be inspected virtually for particulate matter and and discoloration prior to administration, whenever solution and container permit.

Please do not reuse or save unused Remdesivir Lyophilized powder, injection solution or diluted solution for infusion for further use. This product contains no preservatives.

Lyophilized Powder: Please store Remdesivir for injection, 100 mg, vials at temperature not exceeding 30°C in a dry place until required for use. Protect from light & moisture. Do not use after expiration date.

After reconstitution: vials can be stored up to 4 hours at room temperature (20°C-25°C) prior to administration or 24 hours at refrigerated temperature (2°C-8°C). Please dilute within the same day as administration.

Diluted Solution for Infusion: Please store diluted Remdesivir solution for infusion up to 4 hours at room temperature (20°C-25°C) or 24 hours at refrigerated temperature (2°C-8°C).

Indacaterol & Glycopyrronium combination is indicated for the long-term, maintenance treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD).

Combined bronchodilators

Indacaterol Maleate is a selective β2-adrenergic agonist. Its chemical name is (R)-5-[2-(5,6-Diethylindan-2-ylamino)-1-hydroxyethyl]-8 hydroxy-1H-quinolin-2-one maleate. Indacaterol Maleate has a molecular weight of 508.56 and its empirical formula is C24H28N2O3.C4H4O4. Indacaterol Maleate is a white to very slightly grayish or very slightly yellowish powder. Indacaterol Maleate is freely soluble in N methylpyrrolidone and dimethylformamide, slightly soluble in methanol, ethanol, propylene glycol and polyethylene glycol 400, very slightly soluble in water, isopropyl alcohol and practically insoluble in 0.9% sodium chloride in water, ethyl acetate and n-octanol. Glycopyrronium is a long-acting, specific antimuscarinic agent, in clinical medicine often called an anticholinergic. It has a similar affinity to the subtypes of muscarinic receptors M1 to M5. In the airways, inhibition of M3-receptors at the smooth muscle results in relaxation. The high potency and slow receptor dissociation found its clinical correlate in significant and long-acting bronchodilation in patients with COPD.

Indacaterol 110 µg and Glycopyrronium 50 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule once daily with the ConviHaler device.

Indacaterol 27.5 µg & Glycopyrronium 15.6 µg: The recommended dosage of Indacaterol & Glycopyrronium combination DPI is inhalation of the contents of one capsule twice daily with the ConviHaler device.

Inhaled medicines may cause inhalation-induced bronchospasm, dehydration, dry mouth, constipation dizziness, insomnia, skin and subcutaneous tissue disorders & immune system disorders.

Indacaterol and Glycopyrronium combination is as a twice daily maintenance bronchodilator should not be used for the initial treatment of acute episodes of bronchospasm, i.e. rescue therapy. Immediate hypersensitivity reactions may occur after administration of Indacaterol and Glycopyrronium combination inhalation powder. As with other anticholinergic drugs, Glycopyrronium should be used with caution in patients with narrow-angle glaucoma, prostatic hyperplasia or bladder-neck obstruction.

Adrenergic drugs, xanthine derivatives, steroids, or diuretics, non-potassium sparing diuretics, monoamine oxidase inhibitors, tricyclic antidepressants, QTc prolonging drugs, beta-blockers, inhibitors of cytochrome P450 3A4 and P-gp efflux transporter may interact with Indacaterol.

There is a limited amount of data from the use of Indacaterol and Glycopyrronium combination in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity at clinically relevant doses. Indacaterol and Glycopyrronium combination should not be used in pregnant or nursing women unless the expected benefit outweighs any possible risk to the unborn child or the infant.

An overdose of indacaterol is likely to lead to exaggerated effects typical of beta2-adrenergic stimulants, i.e. tachycardia, tremor, palpitations, headache, nausea, vomiting, drowsiness, ventricular arrhythmias, metabolic acidosis, hypokalaemia and hyperglycaemia. High doses of Glycopyrronium may lead to anticholinergic signs and symptoms.

Do not store above 30°C. Keep away from light and out of the reach of children. Protect from freezing. Insert the ConviCap in the ConviHaler just prior to use to protect from deterioration by moisture.