Find Medicines

Amlodipine and Valsartan combination is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension.

Combined antihypertensive preparations

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of Angiotensin II by selectively blocking the binding of Angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for Angiotensin II synthesis. Amlodipine and Valsartan have been shown to be effective in lowering blood pressure. Both Amlodipine and Valsartan lower blood pressure by reducing peripheral resistance, but calcium influx blockade and reduction of Angiotensin II vasoconstriction are complementary mechanisms.

Treatment of hypertension: Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg - 10 mg while Valsartan is effective in doses of 80 mg-320 mg. In clinical trials with Amlodipine and Valsartan, using amlodipine doses of 5 mg-10 mg and Valsartan doses of 160 mg-320 mg, the antihypertensive effects increased with increasing doses. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 10/320 mg once daily as needed to control blood pressure. This combination may be administered with or without food. This combination may be administered with other antihypertensive agents. A patient whose blood pressure is not adequately controlled with Amlodipine alone or with Valsartan alone may be switched to this combination therapy.

Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.

Renal Impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

Hepatic Impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.

Generally been mild and transient in nature. The most common side effects include peripheral edema, nasal congestion, sore throat and discomfort when swallowing, upper respiratory tract infection, dizziness etc.

This combination product is contraindicated in patients who are hypersensitive to any components of this product.

Avoid fetal or neonatal exposure, assess for hypotension, warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina, titrate slowly in patients with impaired hepatic or severely impaired renal function.

No drug interaction studies have been conducted with Amlodipine and Valsartan combination, although studies have been conducted with the individual components.

Pregnancy Category D. It is not known whether Amlodipine or Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in paediatric patients have not been established.

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

Amlodipine and Valsartan combination is indicated for the treatment of hypertension. This fixed combination drug is not indicated for the initial therapy of hypertension.

Combined antihypertensive preparations

Amlodipine is a dihydropyridine calcium channel blocker that inhibits the transmembrane influx of calcium ions into vascular smooth muscle and cardiac muscle. Valsartan blocks the vasoconstrictor and aldosterone-secreting effects of Angiotensin II by selectively blocking the binding of Angiotensin II to the AT1 receptor in many tissues, such as vascular smooth muscle and the adrenal gland. Its action is therefore independent of the pathways for Angiotensin II synthesis. Amlodipine and Valsartan have been shown to be effective in lowering blood pressure. Both Amlodipine and Valsartan lower blood pressure by reducing peripheral resistance, but calcium influx blockade and reduction of Angiotensin II vasoconstriction are complementary mechanisms.

Treatment of hypertension: Amlodipine is an effective treatment of hypertension in once daily doses of 2.5 mg - 10 mg while Valsartan is effective in doses of 80 mg-320 mg. In clinical trials with Amlodipine and Valsartan, using amlodipine doses of 5 mg-10 mg and Valsartan doses of 160 mg-320 mg, the antihypertensive effects increased with increasing doses. The majority of the antihypertensive effect is attained within 2 weeks after initiation of therapy or a change in dose. The dosage can be increased after 1 to 2 weeks of therapy to a maximum of 10/320 mg once daily as needed to control blood pressure. This combination may be administered with or without food. This combination may be administered with other antihypertensive agents. A patient whose blood pressure is not adequately controlled with Amlodipine alone or with Valsartan alone may be switched to this combination therapy.

Elderly patients: Because of decreased clearance of Amlodipine, therapy should usually be initiated at 2.5 mg.

Renal Impairment: No initial dosage adjustment is required for patients with mild or moderate renal impairment. Titrate slowly in patients with severe renal impairment.

Hepatic Impairment: No initial dosage adjustment is required for patients with mild or moderate liver insufficiency. Titrate slowly in patients with hepatic impairment.

Generally been mild and transient in nature. The most common side effects include peripheral edema, nasal congestion, sore throat and discomfort when swallowing, upper respiratory tract infection, dizziness etc.

This combination product is contraindicated in patients who are hypersensitive to any components of this product.

Avoid fetal or neonatal exposure, assess for hypotension, warn patients with severe obstructive coronary artery disease about the risk of myocardial infarction or increased angina, titrate slowly in patients with impaired hepatic or severely impaired renal function.

No drug interaction studies have been conducted with Amlodipine and Valsartan combination, although studies have been conducted with the individual components.

Pregnancy Category D. It is not known whether Amlodipine or Valsartan is excreted in human milk. Because of the potential for adverse effects on the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.

Safety and effectiveness in paediatric patients have not been established.

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

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

Second generation Cephalosporins

Cefuroxime is a bactericidal second generation cephalosporin antibiotic which is active against a wide range of Gram-positive and Gram-negative susceptible organisms including many beta-lactamase producing strains. Cefuroxime inhibits bacterial cell wall synthesis by interfering with the transpeptidation process.

Clavulanic acid is a naturally derived beta lactamase inhibitor produced by Streptomyces clavuligerus. It has similar structure to beta lactam antibiotics which binds irreversibly to beta-lactamase enzymes and inactivates them. Clavulanic acid gives protection of Cefuroxime from degradation by beta lactamase enzymes and provides a solution for the treatment of bacterial infections caused by beta lactam resistant bacteria.

Adolescents and adults (13 years and older)-

• Pharyngitis/tonsillitis: 250 mg b.i.d. for 5-10 days
• Acute bacterial maxillary sinusitis: 250 mg b.i.d. for 10 days
• Acute bacterial exacerbation of chronic bronchitis: 250-500 mg b.i.d. for 10 days
• Secondary bacterial infections of acute bronchitis: 250-500 mg b.i.d. for 5-10 days 
• Uncomplicated skin and skin structure infections: 250-500 mg b.i.d. for 10 days
• Uncomplicated urinary tract infections: 250 mg b.i.d. for 7-10 days
• Uncomplicated Gonorrhoea: 1000 mg b.i.d. Single dose
• Community acquired pneumonia: 250-500 mg b.i.d. for 5-10 days
• MDR Typhoid Fever: 500 mg b.i.d. for 10-14 days
• Early Lyme disease: 500 mg b.i.d. for 20 days

Paediatric Patients (3 months to 12 years)-

• Pharyngitis/Tonsillitis: 20 mg/kg/day b.i.d for 5-10 days
• Acute otitis media: 30 mg/kg/day b.i.d for 10 days
• Acute bacterial maxillary sinusitis: 30 mg/kg/day b.i.d for 10 days
• Impetigo: 30 mg/kg/day b.i.d for 10 days

Cefuroxime-Clavulanic Acid tablet may be taken without regard of food.

Generally Cefuroxime-Clavulanic Acid is well tolerated. However, a few side effects like nausea, vomiting, diarrhea, abdominal discomfort or pain may occur. As with other broad-spectrum antibiotics, prolonged administration of Cefuroxime and Clavulanic acid combination may result in overgrowth of nonsusceptible microorganisms. Rarely (<0.2%) renal dysfunction, anaphylaxis, angioedema, pruritis, rash and serum sickness like urticaria may appear.

Cefuroxime-Clavulanic Acid is contraindicated in patients with known allergy to cephalosporin & in patients with Pseudomembranous Colitis.

Cefuroxime should be given with care to patients receiving concurrent treatment with potent diuretics & who has history of colitis.

Concomitant administration of probenecid with Cefuroxime-Clavulanic Acid increases the area under the serum concentration versus time curve by 50%. Drug that reduces gastric acidity may result in a lower bioavailability of Cefuroxime and tend to cancel the effect of postprandial absorption.

While all antibiotics should be avoided in the first trimester if possible. However, Cefuroxime-Clavulanic Acid can be safely used in later pregnancy to treat urinary and other infections. Cefuroxime-Clavulanic Acid is excreted into the breast milk in small quantities. However, the possibility of sensitizing the infant should be kept in mind.

Store in a cool, dry place (below 30^o C), away from light and moisture. Keep out of the reach of children.

Antiparkinson drugs

If 100/10 mg tablet is used: Dosage may be initiated with one tablet three or four times a day. Titration upward may be required in some patients to achieve optimum dosage of carbidopa. The dosage may be increased by one tablet every day or every other day until a total of eight tablets (two tablets q.d.s.) is reached.

For patients starting with 250/25 mg tablet: The initial dose is one half taken once or twice daily. However, this may not provide the optimal amount of Carbidopa needed by many patients. If necessary, add one-half every day or every other day until optimal response is reached. The suggested starting dosage for most patients taking more than 1500 mg of Levodopa a day is one tablet of 250/25 mg three or four times a day.

Maintenance dose: Therapy should be individualized and adjusted according to the desired therapeutic response. When more levodopa is requried, 250/25 mg tablet should be substituted at a dosage of one tablet three or four times a day. If necessary, the dosage of 250/25 mg tablet may be increased by half to one tablet every other day to a maximum of eight tablets a day. Experience with a total daily dosage greater than 200 mg Carbidopa is limited.

Adverse effects that occur frequently in patients receiving Carbidopa-Levodopa are those due to the central neuropharmacologic activity of dopamine. These reactions usually can be diminished by dosage reduction. The most common adverse effects are dyskinesias including choreiform, dystonic, and other involuntary movements and nausea.

• Body as a whole: syncope, chest pain, anorexia.
• Cardiovascular: palpitation, orthostatic effects including hypotensive episodes, hypertension, phlebitis.
• Gastrointestinal: vomiting, gastrointestinal bleeding, development of duodenal ulcer, diarrhoea, dark saliva.
• Haemotologic: leukopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.
• Hypersensitivity: angioedema, urticaria, pruritus, Henoch-Schonlein purpura.
• Nervous System: dizziness, somnolence, paresthesia, delusions, hallucinations and paranoid ideation, depression with or without development of suicidal tendencies, dementia, dream abnormalities, agitation, confusion, increased libido.
• Respiratory: dyspnea.
• Skin: alopecia, rash, dark sweat.
• Urogenital: dark urine.

Carbidopa-Levodopa tablet is contraindicated in patients with hypersensitivity to Carbidopa and Levodopa, and in patients with narrow-angle glaucoma. Since Levodopa may activate a malignant melanoma, Carbidopa-Levodopa should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.

Carbidopa-Levodopa is not recommended for the treatment of medicine-induced extrapyramidal reactions. Carbidopa Levodopa may be given to patients already taking Levodopa alone; however, the Levodopa must be discontinued at least 12 hours before Carbidopa-Levodopa started. Dyskinesias may occur in patients previously treated with Levodopa alone because Carbidopa permits more Levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Carbidopa-Levodopa should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or a history of peptic ulcer disease or of convulsions.

Care should be exercised to patients with a history of myocardial infarction who have atriai, nodal, or ventricular arrhythmia. In such patients, cardiac function should be monitored with particular care during the period of initial dosage administration and titration. Patients with chronic wide-angle glaucoma may be treated cautiously with Carbidopa-Levodopa, provided the intraocular pressure is weli controlled and the patient monitored carefully for changes in intraocular pressure during therapy.

Symptomatic postural hypotension has occurred when Carbidopa-Levodopa is added to the treatment of a patient receiving antihypertensive medicines. Therefore, when therapy with CarbidopaLevodopa is started, dosage adjustment of the antihypertensive medicine may be required. There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and Carbidopa-Levodopa. Studies demonstrate a decrease in the bioavailability of Carbidopa and/or Levodopa when it is ingested with ferrous sulphate or ferrous gluconate. Dopamine-2 receptor antagonists (e.g., phenothiazines, butyrophenones and risperidone) and isoniazid may reduce the therapeutic effects of Levodopa. In addition, the beneficial effects of Levodopa in Parkinson's disease have been reported to be reversed by phenytoin and papaverine. Patients taking these medicines with Carbidopa-Levodopa should be carefully observed for loss of therapeutic response. Concomitant therapy with selegiline and Carbidopa-Levodopa may be associated with severe orthostatic hypotension not attributable to Carbidopa-Levodopa alone.

Although the effects of CarbidopaLevodopa on human pregnancy are unknown both Levodopa and combinations of Carbidopa and Levodopa have caused visceral and skeletal malformations in rabbits. Therefore, use of CarbidopaLevodopa in women of childbearing potential requires that the anticipated benefits of the medicine be weighed against possible hazards should pregnancy occur. It is not known whether Carbidopa is excreted in human milk. Because many medicines are excreted in human milk and because of the potential for serious adverse reactions in infants, a decision should be made whether to discontinue nursing or to discontinue the use of Carbidopa-Levodopa, taking into account the importance of the medicine to the mother.

Use in children: Safety and effectiveness of Carbidopa-Levodopa in infants and children have not been established, and its use in patients below the age of 18 years is not recommended.

Store in a cool and dry place, protected from light.

Idiopathic Parkinson's disease, in particular to reduce off-period in patients who previously have been treated with levodopa/decarboxylase inhibitors, or with levodopa alone and who have experienced motor fluctuations.

Antiparkinson drugs

Patients currently treated with conventional levodopa/decarboxylase inhibitor combinations: Dosage with Levodopa-Carbidopa prolonged-release tablet should be substituted initially at an amount that provides no more than approximately 10% more levodopa per day when higher dosages are given (more than 900 mg per day). The dosing interval between doses should be prolonged by 30 to 50% at intervals ranging from 4 to 12 hours. It is recommended to give the smaller dose, if divided doses are not equal, at the end of the day. The dose needs to be titrated further depending on clinical response, as indicated below under 'Titration'. Dosages that provide up to 30% more levodopa per day may be necessary. A guide for substitution of Levodopa Carbidopa prolonged-release tablet treatment for conventional levodopa/decarboxylase inhibitor combinations is shown in the table below:

Guideline for conversion from conventional Levodopa/Carbidopa tablet to Levodopa-Carbidopa prolonged-release tablet:

Conventional tablet: Daily Dosage of Levodopa 300-400 mg

• Controlled Release tablet: Daily Dosage of Levodopa 400 mg. Dosage Regimen: 1 tablet 2x daily.

Conventional tablet: Daily Dosage of Levodopa 500-600 mg

• Controlled Release tablet: Daily Dosage of Levodopa 600 mg. Dosage Regimen: 1 tablet 3x daily.

Conventional tablet: Daily Dosage of Levodopa 700-800 mg

• Controlled Release tablet: Daily Dosage of Levodopa 800 mg. Dosage Regimen: 4 tablets in 3 or 4 divided doses.

Conventional tablet: Daily Dosage of Levodopa 900-1000 mg

• Controlled Release tablet: Daily Dosage of Levodopa 1000 mg. Dosage Regimen: 5 tablets in 3 or more divided doses.

Conventional tablet: Daily Dosage of Levodopa 1100-1200 mg

• Controlled Release tablet: Daily Dosage of Levodopa 1200 mg. Dosage Regimen: 6 tablets in 3 or more divided doses.

Conventional tablet: Daily Dosage of Levodopa 1300-1400 mg

• Controlled Release tablet: Daily Dosage of Levodopa 1400 mg. Dosage Regimen: 7 tablets in 3 or more divided doses.

Conventional tablet: Daily Dosage of Levodopa 1500-1600 mg

• Controlled Release tablet: Daily Dosage of Levodopa 1600 mg. Dosage Regimen: 8 tablets in 3 or more divided doses.

Patients currently treated with levodopa alone: Levodopa must be discontinued at least eight hours before therapy with this CR tablet is started. In patients with mild to moderate disease, the initial recommended dose is one tablet of this CR tablet twice daily.

Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is one tablet of this CR tablet twice daily. Initial dosages should not exceed 600 mg per day of levodopa, nor be given at intervals of less than six hours.

Titration: Following initiation of therapy, doses and dosing intervals may be increased or decreased, depending upon therapeutic response. Most patients have been adequately treated with two to eight tablets per day of this CR tablet administered as divided doses at intervals ranging from four to twelve hours during the waking day. Higher doses (up to 12 tablets) and shorter intervals (less than four hours) have been used, but are not usually recommended. When doses of this CR tablet are given at intervals of less than four hours, or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day. In some patients the onset of effect of the first morning dose may be delayed for up to one hour compared with the response usually obtained from the first morning dose of conventional levodopa-carbidopa tablet. An interval of at least three days between dosage adjustments is recommended.

Maintenance: Because Parkinson’s disease is progressive, periodic clinical evaluations are recommended and adjustment of the dosage regimen of this CR tablet may be required.

Addition of other antiparkinson medication: Anticholinergic agents, dopamine agonists and amantadine can be given with this CR tablet. Dosage adjustment of this CR tablet may be necessary when these agents are added to an existing treatment regimen for this CR tablet.

Interruption of therapy: Patients should be observed carefully if abrupt reduction or discontinuation of this CR tablet is required, especially if the patient is receiving antipsychotics.

The side-effect reported most frequently was dyskinesia (a form of abnormal involuntary movements). A greater incidence of dyskinesias was seen with Levodopa-Carbidopa prolonged-release tablet than with Levodopa-Carbidopa tablet. Other side-effects: nausea, hallucinations, confusion, dizziness, chorea, dry mouth, dream abnormalities, dystonia, insomnia, depression, asthenia, vomiting, anorexia, chest pain, palpitation, constipation, diarrhoea, dyspepsia, gastro-intestinal pain, dark saliva, angioedema, urticaria, pruritus, weight loss, neuroleptic malignant syndrome, agitation, anxiety, decreased mental acuity, paraesthesia, disorientation, fatigue, headache, extrapyramidal and movement disorders, falling, gait abnormalities, muscle cramps, on-off phenomenon, increased libido, psychotic episodes, dyspnoea, flushing, alopecia, rash, dark sweat, blurred vision, dark urine, cardiac irregularities, hypertension, phlebitis, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, gastro-intestinal bleeding, flatulence, burning sensation of tongue, development of duodenal ulcer, leucopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.

Levodopa-Carbidopa prolonged-release tablet should not be given when administration of a sympathomimetic amine is contraindicated. Non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with Levodopa-Carbidopa prolonged release tablet. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Levodopa-Carbidopa prolonged release tablet. Levodopa-Carbidopa prolonged release tablet may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g. selegiline hydrochloride). Levodopa-Carbidopa prolonged release tablet is contraindicated in patients with known hypersensitivity to any component of this medication, and in patients with narrow-angle glaucoma. Because levodopa may activate a malignant melanoma, Levodopa-Carbidopa prolonged release tablet should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.

When patients are receiving levodopa monotherapy, levodopa must be discontinued at least eight hours before therapy with Levodopa-Carbidopa prolonged-release tablet is started (at least 12 hours if slow-release levodopa has been administered). Dyskinesias may occur in patients previously treated with levodopa alone because carbidopa permits more levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction. Levodopa-Carbidopa prolonged-release tablet is not recommended for the treatment of drug-induced extrapyramidal reactions or for the treatment of Huntingdon’s chorea. Based on the pharmacokinetic profile of Levodopa-Carbidopa prolonged-release tablet the onset of effect in patients with early morning dyskinesias may be slower than with conventional Levodopa-Carbidopa tablet. The incidence of dyskinesias is slightly higher during treatment with Levodopa-Carbidopa prolonged-release tablet than with conventional Levodopa-Carbidopa tablet (16.5% vs 12.2%) in advanced patients with motor fluctuations. Levodopa-Carbidopa prolonged-release tablet should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or with a history of peptic ulcer disease or of convulsions. Care should be exercised in administering Levodopa-Carbidopa prolonged-release tablet to patients with a history of recent myocardial infarction who have residual atrial, nodal, or ventricular arrhythmia. In such patients, cardiac function should be monitored with particular care during the period of initial dosage administration and titration. Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered. 

As with levodopa, Levodopa-Carbidopa prolonged-release tablet may cause involuntary movements and mental disturbances. Patients with a history of severe involuntary movements or psychotic episodes when treated with levodopa alone or levodopa/decarboxylase inhibitor combination should be observed carefully when Levodopa-Carbidopa prolonged-release tablet is substituted. These reactions are thought to be due to increased brain dopamine following administration of levodopa and use of Levodopa-Carbidopa prolonged-release tablet may cause recurrence. Dosage reduction may be required. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Levodopa-Carbidopa tablet. Review of treatment is recommended if such symptoms develop.

Caution should be exercised when the following drugs are administered concomitantly with Levodopa-Carbidopa prolonged-release tablet.

Antihypertensive agents: Symptomatic postural hypotension has occurred when levodopa/decarboxylase inhibitor combinations were added to the treatment of patients receiving some antihypertensive drugs. Therefore when therapy with Levodopa-Carbidopa prolonged-release tablet is started, dosage adjustment of the antihypertensive drug may be required.

Antidepressants: There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa-levodopa preparations.

Anticholinergics: Anticholinergics may affect the absorption and thus the patient’s response.

Iron: Studies demonstrate a decrease in the bioavailability of carbidopa and/or levodopa when it is ingested with ferrous sulphate or ferrous gluconate.

Other drugs: Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones and risperidone) and isoniazid may reduce the therapeutic effects of levodopa. The beneficial effects of levodopa in Parkinson’s disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with Levodopa-Carbidopa prolonged-release tablet should be observed carefully for loss of therapeutic response. Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone. Since levodopa competes with certain amino acids, the absorption of levodopa may be impaired in some patients on a high protein diet. The effect of simultaneous administration of antacids with Levodopa-Carbidopa prolonged-release tablet on the bioavailability of levodopa has not been studied.

There are insufficient data to evaluate the possible harmfulness of this substance when used in human pregnancy. It is not known whether carbidopa is excreted in human milk. In a study of one nursing mother with Parkinson's disease, excretion of levodopa in breast milk was reported. Levodopa-Carbidopa prolonged-release tablet should not be given during pregnancy and to nursing mothers.

Use in Children: Safety and effectiveness of Levodopa-Carbidopa prolonged-release tablet in infants and children have not been established, and its use in patients below the age of 18 is not recommended.

Store in a cool and dry place, protected from light.

Idiopathic Parkinson's disease, in particular to reduce off-period in patients who previously have been treated with levodopa/decarboxylase inhibitors, or with levodopa alone and who have experienced motor fluctuations.

Antiparkinson drugs

Patients currently treated with conventional levodopa/decarboxylase inhibitor combinations: Dosage with Levodopa-Carbidopa prolonged-release tablet should be substituted initially at an amount that provides no more than approximately 10% more levodopa per day when higher dosages are given (more than 900 mg per day). The dosing interval between doses should be prolonged by 30 to 50% at intervals ranging from 4 to 12 hours. It is recommended to give the smaller dose, if divided doses are not equal, at the end of the day. The dose needs to be titrated further depending on clinical response, as indicated below under 'Titration'. Dosages that provide up to 30% more levodopa per day may be necessary. A guide for substitution of Levodopa Carbidopa prolonged-release tablet treatment for conventional levodopa/decarboxylase inhibitor combinations is shown in the table below:

Guideline for conversion from conventional Levodopa/Carbidopa tablet to Levodopa-Carbidopa prolonged-release tablet:

Conventional tablet: Daily Dosage of Levodopa 300-400 mg

• Controlled Release tablet: Daily Dosage of Levodopa 400 mg. Dosage Regimen: 1 tablet 2x daily.

Conventional tablet: Daily Dosage of Levodopa 500-600 mg

• Controlled Release tablet: Daily Dosage of Levodopa 600 mg. Dosage Regimen: 1 tablet 3x daily.

Conventional tablet: Daily Dosage of Levodopa 700-800 mg

• Controlled Release tablet: Daily Dosage of Levodopa 800 mg. Dosage Regimen: 4 tablets in 3 or 4 divided doses.

Conventional tablet: Daily Dosage of Levodopa 900-1000 mg

• Controlled Release tablet: Daily Dosage of Levodopa 1000 mg. Dosage Regimen: 5 tablets in 3 or more divided doses.

Conventional tablet: Daily Dosage of Levodopa 1100-1200 mg

• Controlled Release tablet: Daily Dosage of Levodopa 1200 mg. Dosage Regimen: 6 tablets in 3 or more divided doses.

Conventional tablet: Daily Dosage of Levodopa 1300-1400 mg

• Controlled Release tablet: Daily Dosage of Levodopa 1400 mg. Dosage Regimen: 7 tablets in 3 or more divided doses.

Conventional tablet: Daily Dosage of Levodopa 1500-1600 mg

• Controlled Release tablet: Daily Dosage of Levodopa 1600 mg. Dosage Regimen: 8 tablets in 3 or more divided doses.

Patients currently treated with levodopa alone: Levodopa must be discontinued at least eight hours before therapy with this CR tablet is started. In patients with mild to moderate disease, the initial recommended dose is one tablet of this CR tablet twice daily.

Patients not receiving levodopa: In patients with mild to moderate disease, the initial recommended dose is one tablet of this CR tablet twice daily. Initial dosages should not exceed 600 mg per day of levodopa, nor be given at intervals of less than six hours.

Titration: Following initiation of therapy, doses and dosing intervals may be increased or decreased, depending upon therapeutic response. Most patients have been adequately treated with two to eight tablets per day of this CR tablet administered as divided doses at intervals ranging from four to twelve hours during the waking day. Higher doses (up to 12 tablets) and shorter intervals (less than four hours) have been used, but are not usually recommended. When doses of this CR tablet are given at intervals of less than four hours, or if the divided doses are not equal, it is recommended that the smaller doses be given at the end of the day. In some patients the onset of effect of the first morning dose may be delayed for up to one hour compared with the response usually obtained from the first morning dose of conventional levodopa-carbidopa tablet. An interval of at least three days between dosage adjustments is recommended.

Maintenance: Because Parkinson’s disease is progressive, periodic clinical evaluations are recommended and adjustment of the dosage regimen of this CR tablet may be required.

Addition of other antiparkinson medication: Anticholinergic agents, dopamine agonists and amantadine can be given with this CR tablet. Dosage adjustment of this CR tablet may be necessary when these agents are added to an existing treatment regimen for this CR tablet.

Interruption of therapy: Patients should be observed carefully if abrupt reduction or discontinuation of this CR tablet is required, especially if the patient is receiving antipsychotics.

The side-effect reported most frequently was dyskinesia (a form of abnormal involuntary movements). A greater incidence of dyskinesias was seen with Levodopa-Carbidopa prolonged-release tablet than with Levodopa-Carbidopa tablet. Other side-effects: nausea, hallucinations, confusion, dizziness, chorea, dry mouth, dream abnormalities, dystonia, insomnia, depression, asthenia, vomiting, anorexia, chest pain, palpitation, constipation, diarrhoea, dyspepsia, gastro-intestinal pain, dark saliva, angioedema, urticaria, pruritus, weight loss, neuroleptic malignant syndrome, agitation, anxiety, decreased mental acuity, paraesthesia, disorientation, fatigue, headache, extrapyramidal and movement disorders, falling, gait abnormalities, muscle cramps, on-off phenomenon, increased libido, psychotic episodes, dyspnoea, flushing, alopecia, rash, dark sweat, blurred vision, dark urine, cardiac irregularities, hypertension, phlebitis, bitter taste, sialorrhoea, dysphagia, bruxism, hiccups, gastro-intestinal bleeding, flatulence, burning sensation of tongue, development of duodenal ulcer, leucopenia, haemolytic and non-haemolytic anaemia, thrombocytopenia, agranulocytosis.

Levodopa-Carbidopa prolonged-release tablet should not be given when administration of a sympathomimetic amine is contraindicated. Non-selective monoamine oxidase (MAO) inhibitors are contraindicated for use with Levodopa-Carbidopa prolonged release tablet. These inhibitors must be discontinued at least two weeks prior to initiating therapy with Levodopa-Carbidopa prolonged release tablet. Levodopa-Carbidopa prolonged release tablet may be administered concomitantly with the manufacturer's recommended dose of an MAO inhibitor with selectivity for MAO type B (e.g. selegiline hydrochloride). Levodopa-Carbidopa prolonged release tablet is contraindicated in patients with known hypersensitivity to any component of this medication, and in patients with narrow-angle glaucoma. Because levodopa may activate a malignant melanoma, Levodopa-Carbidopa prolonged release tablet should not be used in patients with suspicious undiagnosed skin lesions or a history of melanoma.

When patients are receiving levodopa monotherapy, levodopa must be discontinued at least eight hours before therapy with Levodopa-Carbidopa prolonged-release tablet is started (at least 12 hours if slow-release levodopa has been administered). Dyskinesias may occur in patients previously treated with levodopa alone because carbidopa permits more levodopa to reach the brain and, thus, more dopamine to be formed. The occurrence of dyskinesias may require dosage reduction. Levodopa-Carbidopa prolonged-release tablet is not recommended for the treatment of drug-induced extrapyramidal reactions or for the treatment of Huntingdon’s chorea. Based on the pharmacokinetic profile of Levodopa-Carbidopa prolonged-release tablet the onset of effect in patients with early morning dyskinesias may be slower than with conventional Levodopa-Carbidopa tablet. The incidence of dyskinesias is slightly higher during treatment with Levodopa-Carbidopa prolonged-release tablet than with conventional Levodopa-Carbidopa tablet (16.5% vs 12.2%) in advanced patients with motor fluctuations. Levodopa-Carbidopa prolonged-release tablet should be administered cautiously to patients with severe cardiovascular or pulmonary disease, bronchial asthma, renal, hepatic or endocrine disease, or with a history of peptic ulcer disease or of convulsions. Care should be exercised in administering Levodopa-Carbidopa prolonged-release tablet to patients with a history of recent myocardial infarction who have residual atrial, nodal, or ventricular arrhythmia. In such patients, cardiac function should be monitored with particular care during the period of initial dosage administration and titration. Levodopa has been associated with somnolence and episodes of sudden sleep onset. Sudden onset of sleep during daily activities, in some cases without awareness or warning signs, has been reported very rarely. Patients must be informed of this and advised to exercise caution while driving or operating machines during treatment with levodopa. Patients who have experienced somnolence and/or an episode of sudden sleep onset must refrain from driving or operating machines. Furthermore a reduction of dosage or termination of therapy may be considered. 

As with levodopa, Levodopa-Carbidopa prolonged-release tablet may cause involuntary movements and mental disturbances. Patients with a history of severe involuntary movements or psychotic episodes when treated with levodopa alone or levodopa/decarboxylase inhibitor combination should be observed carefully when Levodopa-Carbidopa prolonged-release tablet is substituted. These reactions are thought to be due to increased brain dopamine following administration of levodopa and use of Levodopa-Carbidopa prolonged-release tablet may cause recurrence. Dosage reduction may be required. All patients should be observed carefully for the development of depression with concomitant suicidal tendencies. Patients with past or current psychoses should be treated with caution. Impulse control disorders: Patients should be regularly monitored for the development of impulse control disorders. Patients and carers should be made aware that behavioural symptoms of impulse control disorders including pathological gambling, increased libido, hypersexuality, compulsive spending or buying, binge eating and compulsive eating can occur in patients treated with dopamine agonists and/or other dopaminergic treatments containing levodopa including Levodopa-Carbidopa tablet. Review of treatment is recommended if such symptoms develop.

Caution should be exercised when the following drugs are administered concomitantly with Levodopa-Carbidopa prolonged-release tablet.

Antihypertensive agents: Symptomatic postural hypotension has occurred when levodopa/decarboxylase inhibitor combinations were added to the treatment of patients receiving some antihypertensive drugs. Therefore when therapy with Levodopa-Carbidopa prolonged-release tablet is started, dosage adjustment of the antihypertensive drug may be required.

Antidepressants: There have been rare reports of adverse reactions, including hypertension and dyskinesia, resulting from the concomitant use of tricyclic antidepressants and carbidopa-levodopa preparations.

Anticholinergics: Anticholinergics may affect the absorption and thus the patient’s response.

Iron: Studies demonstrate a decrease in the bioavailability of carbidopa and/or levodopa when it is ingested with ferrous sulphate or ferrous gluconate.

Other drugs: Dopamine D2 receptor antagonists (e.g. phenothiazines, butyrophenones and risperidone) and isoniazid may reduce the therapeutic effects of levodopa. The beneficial effects of levodopa in Parkinson’s disease have been reported to be reversed by phenytoin and papaverine. Patients taking these drugs with Levodopa-Carbidopa prolonged-release tablet should be observed carefully for loss of therapeutic response. Concomitant therapy with selegiline and carbidopa-levodopa may be associated with severe orthostatic hypotension not attributable to carbidopa-levodopa alone. Since levodopa competes with certain amino acids, the absorption of levodopa may be impaired in some patients on a high protein diet. The effect of simultaneous administration of antacids with Levodopa-Carbidopa prolonged-release tablet on the bioavailability of levodopa has not been studied.

There are insufficient data to evaluate the possible harmfulness of this substance when used in human pregnancy. It is not known whether carbidopa is excreted in human milk. In a study of one nursing mother with Parkinson's disease, excretion of levodopa in breast milk was reported. Levodopa-Carbidopa prolonged-release tablet should not be given during pregnancy and to nursing mothers.

Use in Children: Safety and effectiveness of Levodopa-Carbidopa prolonged-release tablet in infants and children have not been established, and its use in patients below the age of 18 is not recommended.

Store in a cool and dry place, protected from light.

It is indicated for Co-enzyme Q10 deficiency and mitochondrial disorders. It is also used in congestive heart failure, myocardial infarction, high blood pressure (hypertension) in combination with other medications, preventing migraine headache, parkinson's disease, improving the immune system, infertility in men and muscular dystrophy.

Herbal and Nutraceuticals, Supplements & adjuvant therapy

Co-enzyme Q10 is a vitamin-like substance found throughout the body especially in the heart, liver, kidney and pancreas. It is required for the proper function of many organs and chemical reactions in the body. It helps to provide energy to cells. It has antioxidant activity.

For Co-enzyme Q10 deficiency: 150 mg daily.
For mitochondrial disorders: 150-160 mg, or 2 mg/kg/day.
For heart failure in adults: 100 mg per day divided into 2 or 3 doses.
For recent myocardial infarction: 120 mg daily in 2 divided doses.
For high blood pressure: 120-200 mg per day divided into 2 doses.
For isolated systolic hypertension: 60 mg twice daily.
For preventing migraine headache: 100 mg three times daily.
For Parkinson's disease: 300 mg, 600 mg, 1200 mg and 2400 mg per day in 3-4 divided doses.
For infertility in men: 200-300 mg per day.
For muscular dystrophy: 100 mg per day.

Dividing the total daily dose by taking smaller amounts two or three times a day instead of a large amount all at once can help to reduce side effects.

Co-enzyme Q10 is safe for most adults. It can cause some mild side effects including stomach upset, loss of appetite, nausea, vomiting, and diarrhea. It can cause allergic skin rashes in some people.

Co-enzyme Q10 is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients scheduled for surgery in the next two weeks.

Co-enzyme Q10 may lower blood sugar levels, so caution should be taken in patients with diabetes or hypoglycemia. Co-enzyme Q10 may decrease blood pressure so caution is advised in patients with low blood pressure or taking blood pressure medications.

Antihypertensive drugs: May cause blood pressure to go too low.
Anticancer drugs: May decrease the effectiveness of some anticancer drugs.
Warfarin: May decrease the effectiveness of warfarin.

Co-enzyme Q10 should not be used in pregnancy and breast-feeding.

Keep in a dry place away from light and heat. Keep out of the reach of children.

It is indicated for Co-enzyme Q10 deficiency and mitochondrial disorders. It is also used in congestive heart failure, myocardial infarction, high blood pressure (hypertension) in combination with other medications, preventing migraine headache, parkinson's disease, improving the immune system, infertility in men and muscular dystrophy.

Herbal and Nutraceuticals, Supplements & adjuvant therapy

Co-enzyme Q10 is a vitamin-like substance found throughout the body especially in the heart, liver, kidney and pancreas. It is required for the proper function of many organs and chemical reactions in the body. It helps to provide energy to cells. It has antioxidant activity.

For Co-enzyme Q10 deficiency: 150 mg daily.
For mitochondrial disorders: 150-160 mg, or 2 mg/kg/day.
For heart failure in adults: 100 mg per day divided into 2 or 3 doses.
For recent myocardial infarction: 120 mg daily in 2 divided doses.
For high blood pressure: 120-200 mg per day divided into 2 doses.
For isolated systolic hypertension: 60 mg twice daily.
For preventing migraine headache: 100 mg three times daily.
For Parkinson's disease: 300 mg, 600 mg, 1200 mg and 2400 mg per day in 3-4 divided doses.
For infertility in men: 200-300 mg per day.
For muscular dystrophy: 100 mg per day.

Dividing the total daily dose by taking smaller amounts two or three times a day instead of a large amount all at once can help to reduce side effects.

Co-enzyme Q10 is safe for most adults. It can cause some mild side effects including stomach upset, loss of appetite, nausea, vomiting, and diarrhea. It can cause allergic skin rashes in some people.

Co-enzyme Q10 is contraindicated in patients who have hypersensitivity to the active substance or to any of the excipients. It is also contraindicated in patients scheduled for surgery in the next two weeks.

Co-enzyme Q10 may lower blood sugar levels, so caution should be taken in patients with diabetes or hypoglycemia. Co-enzyme Q10 may decrease blood pressure so caution is advised in patients with low blood pressure or taking blood pressure medications.

Antihypertensive drugs: May cause blood pressure to go too low.
Anticancer drugs: May decrease the effectiveness of some anticancer drugs.
Warfarin: May decrease the effectiveness of warfarin.

Co-enzyme Q10 should not be used in pregnancy and breast-feeding.

Keep in a dry place away from light and heat. Keep out of the reach of children.

Anti-malarial drugs

This preparation contains a fixed ratio of 1:6 parts of Artemether and Lumefantrine respectively. Artemether is a derivative of naturally occurring substance Artemisinin. Lumefantrine is a synthetic racemic fluorine mixture belonging to the aryl amino alcohol family like other anti-malarials (e.g. Quinine, mafloquine, halofantrine). Both components act in the food vacuoles of malarial parasites, where they are thought to interfere with the conversion of haem, a toxic intermediate formed during haemoglobin breakdown, to the non-toxic haemozin (a malaria pigment). Lumefantrine is thought to interfere with the polymerization process, while Artemether generates reactive metabolites as a result of interaction between the peroxide bridge and haem iron. Both Artemether and Lumefantrine have a secondary action involving inhibition of nucleic acid - protein synthesis within the malarial parasites. This tablet did not induce resistance. This tablet is active against blood stages of Plasmodium vivax, but it is not active against hypnozoites. Therefore, sequential treatment with premaquine should be used to achieve hypnozoite eradication.

Patients with acute malaria are frequently averse to food. The dose should be taken with high fat food or drinks such as milk. In the event of vomiting within 1 hour of administration a repeat dose should be taken.

Adults and children weighing 35 kg and above: A standard 3 days treatment schedule with a total of 6 doses is recommended dosage is 4 tablets as a single dose at the time of initial diagnosis, again 4 tablets after eight hours, and then 4 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 24 tablets).

5 to <15 kg body weight: 1 tablet at the time of initial diagnosis, 1 tablet again after 8 hours and then 1 tablet twice daily (morning and evening) on each of the following two days (Total course comprises of 6 tablets).

15 to <25 kg body weight: 2 tablets as a single dose at the time of initial diagnosis , 2 tablets again after 8 hours and then 2 tablets twice daily (morning and evening) on each of the following two days (Total course comprises 12 tablets).

25 to <35 kg body weight: 3 tablets as a single dose at the time of initial diagnosis, 3 tablets again after 8 hours and then 3 tablets twice daily (morning and evening) on each of the following two days (Total courses comprises 18 tablets).

It is generally very well tolerated by children and adults, with most adverse effects are of mild to moderate severity and duration. Hypersensitivity, headache, dizziness, sleep disorder, somnolence, involuntary muscle contractions, paraesthesia, hypoesthesia, abnormal gait, ataxia, palpitation, cough, abdominal pain, anorexia, diarrhoea, vomiting, nausea, pruritus, rash, arthralgia, myalgia, asthenia, fatigue.

Hypersensitivity to any of the ingredients or excipients; Patients with severe malaria according to WHO definition; First trimester of pregnancy; Patients with a family history of congenital prolongation of the QTc interval or sudden death or with any other clinical condition known to prolong the QTc interval such as patients with a history of symptomatic cardiac arrythmias with clinically relevant bradycardia or with severe cardiac disease; Patients with known disturbance of electrolyte balance e.g. hypokalaemia or hypomagnesemia; Patients taking any drug which is metabolized by the cytochrome enzyme CYP2D6 (e.g. flecainide, metoprolol, imipramine, amitriptyline, clomipramine).

This has not been evaluated for prophylaxis and is therefore not indicated. This is also not evaluated for the treatment of cerebral malaria or other severe manifestations of severe malaria including pulmonary oedema or renal failure.

No such result is available.

Use in pregnancy & lactation is contraindicated; especially in the first trimester of pregnancy. Breast feeding women should not take this preparation. Due to the long elimination half-life of Lumefantrine (4-6 days), it is recommended that breast feeding should not resume before day 28 unless potential benefits to the mother and child outweigh the risk of treatment.

In cases of suspected over dosage, symptomatic and supportive therapy should be given as appropriate. ECG and blood potassium level should be monitored.

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

Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions which do not respond satisfactorily to less potent steroids

Other Topical corticosteroids

Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.

Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.

Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.

The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.

It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.

In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.

Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.

There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.

In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.

Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.

Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.

Clobetasol Propionate is indicated for adults, elderly and children over 1 year in following dermatoses.

• Psoriasis (excluding widespread plaque psoriasis)
• Recalcitrant dermatoses
• Lichen planus
• Discoid lupus erythematosus
• Other skin conditions which do not respond satisfactorily to less potent steroids

Other Topical corticosteroids

Clobetasol Propionate is a very potent topical corticosteroid. It has anti-inflammatory, antipruritic and vasoconstrictive properties. It shows anti-inflammatory activity via multiple mechanisms to inhibit late phase allergic reactions. It decreases the density of mast cells, chemotaxis and activation of eosinophils. It also reduces cytokine production and inhibits the metabolism of arachidonic acid.

Adults, elderly and children over 1 year: Apply a thin layer of Clobetasol Propionate Cream or Ointment to the affected skin areas twice daily and rub in gently and completely. Repeated short courses of Clobetasol Propionate may be used to control exacerbations. In more resistant lesions, especially where there is hyperkeratosis, the effect of Clobetasol can be enhanced, if necessary, by occluding the treatment area with polythene film. Overnight occlusion only is usually adequate to bring about a satisfactory response. Clobetasol Propionate is super-high potency topical corticosteroids; therefore, treatment should be limited to 2 consecutive weeks. The maximum weekly dose should not be exceeded 50 gm/week. In case of children, courses should be limited if possible to five days and reviewed weekly.

Route of administration: Cutaneous. Creams are especially appropriate for moist or weeping surfaces. Ointments are especially appropriate for dry, lichenified or scaly lesions.

The most reported side effects are burning and stinging sensation. Less frequent adverse reactions are itching, skin atrophy, cracking and fissuring of the skin. Cushing syndrome has been reported in infants and adults as a result of prolonged use of topical Clobetasol Propionate formulations.

It is contraindicated in patient with hypersensitivity to any component of the preparation. It should not be used in rosacea, acne vulgaris, perioral dermatitis, perianal and genital pruritus, pruritus without inflammation, untreated cutaneous infections.

In case of using occlusive dressings, the skin should be cleansed before a fresh dressing is applied. Topical corticosteroids should be used with caution in psoriasis as rebound relapses, and development of local or systemic toxicity due to impaired barrier function of the skin may occur. If used on the face, treatment should be limited to 5 days. When Clobetasol Propionate used on eyelids, care should be taken to avoid the eyes as cataract and glaucoma might result from repeated exposure.

Co-administered drugs that can inhibit CYP3A4 (eg ritonavir, itraconazole) have been shown to inhibit the metabolism of corticosteroids leading to increased systemic exposure.

There are limited data from the use of Clobetasol Propionate cream in pregnant women. Topical administration of corticosteroids to pregnant animals can cause abnormalities of foetal development. The relevance of this finding to humans has not been established. However, the administration of Clobetasol Propionate Cream during pregnancy and lactation should only be considered if the expected benefit to the mother outweighs the possible risks of treatment.

It is unknown whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Clobetasol Propionate Cream is administered to a nursing woman.

In infants and children under 12 years of age, long-term continuous topical corticosteroid therapy should be avoided where possible, as adrenal suppression can occur. Children are more susceptible to the use of topical corticosteroids which develops atrophic changes.

Acute overdosage is very unlikely to occur, however, in the case of chronic over-dosage or misuse the features of hypercortisolism may occur and in this situation topical steroid should be discontinued.

Keep below 30°C temperature, protected from light and moisture. Do not freeze. Keep out of the reach of children.

Specific combined vitamin preparations

Cod Liver Oil is one of the most effective providers of Omega-3 Fatty Acids, and an excellent source of Vitamin A and Vitamin D. It contains Eicosapentaenoic Acid (EPA: 18%) & Docosahexaenoic Acid (DHA: 12%) which are been clinically proven to have positive effects on heart, bone, brain, health. They also help to nourish skin, hair, and nails.

Capsule-

• Adults and children over 6 years: Take 1-2 capsule(s) 3 times a day with meals, or as professionally prescribed.
• Children under 6 years: Only as professionally prescribed.
• Pregnant and lactating women: Take 1 capsule 3 times a day with meals.

Emulsion-

• Infant: ½ tsf daily.
• Child (1-4 year): 1 tsf daily
• Child over 4 years: 1.5 tsf daily

Prolonged usage of large amounts can lead to hypervitaminosis symptoms of which include dry mouth, rough skin, painful joints swelling, fatigue, anorexia, loss of weight, vomiting and other gastrointestinal disturbances. These may disappear on discontinuation of supplementation.

Hypervitaminosis of Vitamin A, D or E and hypersensitivity to any of the ingredients in this preparation.

The product has to be protected from light. Liver storage should be adequate before discontinuation of the therapy. Patients with chronic renal failure should be suggested Cod Liver Oil with caution.

The absorption of Cod Liver Oil may be reduced by taking barbiturates or anti-convulsants.

Safety of amounts exceeding 6,000 Units of Vitamin A daily during pregnancy has not been established yet. The recommended daily allowance (RDA) of vitamin A is 5,000
Units for nursing mothers.

When taken in large amounts, Cod Liver Oil can lead to complications including increased risk for hemorrhagic stroke and internal bleeding.

Store in a cool and dry place protected from light and moisture.

Specific combined vitamin preparations

Cod Liver Oil is one of the most effective providers of Omega-3 Fatty Acids, and an excellent source of Vitamin A and Vitamin D. It contains Eicosapentaenoic Acid (EPA: 18%) & Docosahexaenoic Acid (DHA: 12%) which are been clinically proven to have positive effects on heart, bone, brain, health. They also help to nourish skin, hair, and nails.

Capsule-

• Adults and children over 6 years: Take 1-2 capsule(s) 3 times a day with meals, or as professionally prescribed.
• Children under 6 years: Only as professionally prescribed.
• Pregnant and lactating women: Take 1 capsule 3 times a day with meals.

Emulsion-

• Infant: ½ tsf daily.
• Child (1-4 year): 1 tsf daily
• Child over 4 years: 1.5 tsf daily

Prolonged usage of large amounts can lead to hypervitaminosis symptoms of which include dry mouth, rough skin, painful joints swelling, fatigue, anorexia, loss of weight, vomiting and other gastrointestinal disturbances. These may disappear on discontinuation of supplementation.

Hypervitaminosis of Vitamin A, D or E and hypersensitivity to any of the ingredients in this preparation.

The product has to be protected from light. Liver storage should be adequate before discontinuation of the therapy. Patients with chronic renal failure should be suggested Cod Liver Oil with caution.

The absorption of Cod Liver Oil may be reduced by taking barbiturates or anti-convulsants.

Safety of amounts exceeding 6,000 Units of Vitamin A daily during pregnancy has not been established yet. The recommended daily allowance (RDA) of vitamin A is 5,000
Units for nursing mothers.

When taken in large amounts, Cod Liver Oil can lead to complications including increased risk for hemorrhagic stroke and internal bleeding.

Store in a cool and dry place protected from light and moisture.

Specific combined vitamin preparations

This preparation contains 8 essential vitamins with Cod Liver Oil. This provides extra protection for the children. It ensures for getting enough vitamins for children that help them to be grown up strong & stay healthy. Cod Liver Oil contains Vitamin A, Vitamin D, EPA & DHA. Vitamin A is essential for the immune system, bone growth, night vision, cellular growth, testicular and ovarian function, Vitamin D is essential for the absorption and utilization of calcium, which is also required for skeletal growth. EPA and DHA; omega-3 fatty acids, which are converted in the body to produce prostaglandins that affect a wide variety of physiological processes due to their modulating effect on the action of hormones. Omega-3 fatty acids relieve the symptoms of osteoarthritis, rheumatoid arthritis which also enhances immune function and promotes healthy blood circulation. It is thought that EPA and DHA may reduce the risk of coronary heart disease. DHA seems essential for normal brain development in unborn babies.

1-12 Months: 2.5 ml (½ teaspoon) daily
1-4 Years: 5 ml (1 teaspoon) daily
4 years up: 7.5 ml (1½ teaspoon) daily
Adult: 10 ml (2 teaspoons) daily.

This syrup can be taken with water or milk.

Generally well tolerated. However, a few allergic reactions may be seen.

This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

This medicine may accumulate in the body. So, should not be taken in overdose.

Some drug interaction may occur with- Erythromycin, Conjugated estrogens, Sodium bicarbonate, Chloramphenicol etc.

Should be taken on physician's advice.

Keep in cool and dry place and away from light. Keep away from children

Specific combined vitamin preparations

Cod Liver Oil is one of the most effective providers of Omega-3 Fatty Acids, and an excellent source of Vitamin A and Vitamin D. It contains Eicosapentaenoic Acid (EPA: 18%) & Docosahexaenoic Acid (DHA: 12%) which are been clinically proven to have positive effects on heart, bone, brain, health. They also help to nourish skin, hair, and nails.

Capsule-

• Adults and children over 6 years: Take 1-2 capsule(s) 3 times a day with meals, or as professionally prescribed.
• Children under 6 years: Only as professionally prescribed.
• Pregnant and lactating women: Take 1 capsule 3 times a day with meals.

Emulsion-

• Infant: ½ tsf daily.
• Child (1-4 year): 1 tsf daily
• Child over 4 years: 1.5 tsf daily

Prolonged usage of large amounts can lead to hypervitaminosis symptoms of which include dry mouth, rough skin, painful joints swelling, fatigue, anorexia, loss of weight, vomiting and other gastrointestinal disturbances. These may disappear on discontinuation of supplementation.

Hypervitaminosis of Vitamin A, D or E and hypersensitivity to any of the ingredients in this preparation.

The product has to be protected from light. Liver storage should be adequate before discontinuation of the therapy. Patients with chronic renal failure should be suggested Cod Liver Oil with caution.

The absorption of Cod Liver Oil may be reduced by taking barbiturates or anti-convulsants.

Safety of amounts exceeding 6,000 Units of Vitamin A daily during pregnancy has not been established yet. The recommended daily allowance (RDA) of vitamin A is 5,000
Units for nursing mothers.

When taken in large amounts, Cod Liver Oil can lead to complications including increased risk for hemorrhagic stroke and internal bleeding.

Store in a cool and dry place protected from light and moisture.

Anti-histamine & decongestant

Loratadine is a non-sedative histamine H1-receptor antagonist with anti-allergic properties. Loratadine is a long acting tricyclic anti-histamine with selective peripheral H1-receptor antagonistic activity and no central sedative or anti-cholinergic effect.

Pseudoephedrine is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. This is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. It has nasal and bronchial decongestant activity. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Adults and children over 12 years:

• 5/120 tablet: One tablet twice daily (every 12 hours)
• 10/240 tablet: One tablet once daily and to be taken in the morning instead of night.

Patients with renal insufficiency (GFR<30 ml/min) should be given a lower initial dose (one 5/120 tablet per day, or one 10/240 tablet every alternate day) because they have reduced clearance of Loratadine and Pseudoephedrine.

Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use 10/240 tablet.

Paediatric use: Safety and effectiveness in children below the age of 12 years have not been established.

Use in patients approximately 60 years of age and older: The safety and efficacy of this tablet in patients greater than 60 years old have not been investigated in placebo-controlled clinical trials. The elderly is more likely to have adverse reactions to sympathomimetic amines.

Loratadine & Pseudoephedrine tablet should be administered when both the antihistaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine Sulfate are desired in patients 12 years of age and older.

In general it is well tolerated. Clinical trial suggests a very low of adverse effects commonly reported is dry mouth, somnolence, insomnia, pharyngitis, dizziness, coughing, fatigue, nausea, nervousness, anorexia, dysmenorrheal and headache. Other less common side effects may include; increased sweating, thirst, back pain, chest pain, malaise, palpitations, hypertension, tachycardia, abdominal distension, altered taste, flatulence, myalgia, dry throat, agitation, micturation frequency etc.

This tablet is contraindicated in patients who are hypersensitive to any component of this product.

This tablet should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency should be given a lower initial dose because they have reduced clearance of Loratadine and Pseudoephedrine. As because the doses of this fixed combination product cannot be individually titrated and hepatic insufficiency results in a reduced clearance of Loratadine to a much greater extent than Pseudoephedrine.

This tablet should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or with accompanying hypotension may be produced by sympathomimetic amines.

This tablet is contraindicated in patients taking monoamino oxidase (MAO) inhibitors and for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, reserpine and veaturm alkaloids may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when Pseudoephedrine is used concomitantly with digitalis. Concomitantly administration of Erythromycin, Ketoconazole and Cimetidine increases plasma concentration of both Loratadine and Decarboethoxyloratadine. But there were no clinically relevant changes in the safety profile of Loratadine.

Pregnancy category B: no evidence of risk in human is reported. It is not known if this combination product is excreted in human milk. However, both Loratadine and Pseudoephedrine when administered alone passed into breast milk, so it should not be administered to lactating mothers.

In the event of overdosage, general symptomatic and supportive measure should be instituted promptly and maintained for as long as necessary. Treatment of overdose would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed with normal saline.

Store at a cool and dry place, away from light. Keep out of the reach of children.

Anti-histamine & decongestant

Loratadine is a non-sedative histamine H1-receptor antagonist with anti-allergic properties. Loratadine is a long acting tricyclic anti-histamine with selective peripheral H1-receptor antagonistic activity and no central sedative or anti-cholinergic effect.

Pseudoephedrine is an orally active sympathomimetic amine and exerts a decongestant action on the nasal mucosa. This is recognized as an effective agent for the relief of nasal congestion due to allergic rhinitis. It has nasal and bronchial decongestant activity. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Adults and children over 12 years:

• 5/120 tablet: One tablet twice daily (every 12 hours)
• 10/240 tablet: One tablet once daily and to be taken in the morning instead of night.

Patients with renal insufficiency (GFR<30 ml/min) should be given a lower initial dose (one 5/120 tablet per day, or one 10/240 tablet every alternate day) because they have reduced clearance of Loratadine and Pseudoephedrine.

Patients who have a history of difficulty in swallowing tablets or who have known upper gastrointestinal narrowing or abnormal esophageal peristalsis should not use 10/240 tablet.

Paediatric use: Safety and effectiveness in children below the age of 12 years have not been established.

Use in patients approximately 60 years of age and older: The safety and efficacy of this tablet in patients greater than 60 years old have not been investigated in placebo-controlled clinical trials. The elderly is more likely to have adverse reactions to sympathomimetic amines.

Loratadine & Pseudoephedrine tablet should be administered when both the antihistaminic properties of Loratadine and the nasal decongestant activity of Pseudoephedrine Sulfate are desired in patients 12 years of age and older.

In general it is well tolerated. Clinical trial suggests a very low of adverse effects commonly reported is dry mouth, somnolence, insomnia, pharyngitis, dizziness, coughing, fatigue, nausea, nervousness, anorexia, dysmenorrheal and headache. Other less common side effects may include; increased sweating, thirst, back pain, chest pain, malaise, palpitations, hypertension, tachycardia, abdominal distension, altered taste, flatulence, myalgia, dry throat, agitation, micturation frequency etc.

This tablet is contraindicated in patients who are hypersensitive to any component of this product.

This tablet should generally be avoided in patients with hepatic insufficiency. Patients with renal insufficiency should be given a lower initial dose because they have reduced clearance of Loratadine and Pseudoephedrine. As because the doses of this fixed combination product cannot be individually titrated and hepatic insufficiency results in a reduced clearance of Loratadine to a much greater extent than Pseudoephedrine.

This tablet should be used with caution in patients with hypertension, diabetes mellitus, ischemic heart disease, increased intraocular pressure, hyperthyroidism, renal impairment, or with accompanying hypotension may be produced by sympathomimetic amines.

This tablet is contraindicated in patients taking monoamino oxidase (MAO) inhibitors and for 2 weeks after stopping use of an MAO inhibitor. The antihypertensive effects of beta-adrenergic blocking agents, methyldopa, reserpine and veaturm alkaloids may be reduced by sympathomimetics. Increased ectopic pacemaker activity can occur when Pseudoephedrine is used concomitantly with digitalis. Concomitantly administration of Erythromycin, Ketoconazole and Cimetidine increases plasma concentration of both Loratadine and Decarboethoxyloratadine. But there were no clinically relevant changes in the safety profile of Loratadine.

Pregnancy category B: no evidence of risk in human is reported. It is not known if this combination product is excreted in human milk. However, both Loratadine and Pseudoephedrine when administered alone passed into breast milk, so it should not be administered to lactating mothers.

In the event of overdosage, general symptomatic and supportive measure should be instituted promptly and maintained for as long as necessary. Treatment of overdose would reasonably consist of emesis (ipecac syrup), except in patients with impaired consciousness, followed by the administration of activated charcoal to absorb any remaining drug. If vomiting is unsuccessful or contraindicated, gastric lavage should be performed with normal saline.

Store at a cool and dry place, away from light. Keep out of the reach of children.

This is indicated for the symptomatic relief of upper respiratory tract disorders accompanied by productive cough which benefits from the administration of a nasal decongestant, a histamine H1 receptor antagonist and an expectorant combination.

Combined cough expectorants

Pseudoephedrine is a decongestant as well as a bronchodilator for the upper respiratory tract, which gives symptomatic relief of nasal congestion. Pseudoephedrine is both an α-and β-adrenergic receptor agonist. It causes vasoconstriction via direct stimulation of α-adrenergic receptors of the respiratory mucosa. It also directly stimulates β-adrenergic receptors causing bronchial relaxation, increased heart rate and contractility.

Like ephedrine, pseudoephedrine releasing norepinephrine from its storage sites, an indirect effect. This is its main and direct mechanism of action. The displaced noradrenaline is released into the neuronal synapse where it is free to activate the postsynaptic adrenergic receptors.

Guaifenesin reduces the viscosity of tenacious sputum and is used as an expectorant. It increases the hydration of respiratory tract, thereby increasing the volume and reducing the viscosity of bronchial secretions.

Triprolidine is an antihistamine; it is used for the symptomatic relief of hypersensitivity reactions including rhinitis, conjunctivitis and urticaria.

Adult and Children over 12 years: 10 ml (2 teaspoonful) three times a day.
Children 6-12 years: 5 ml (1 teaspoonful) three times a day.
Children 2-5 years: 2.5 ml (1/2 teaspoonful) three times a day.

A physician’s advice is preferred before administering this preparation to children aged less than 2 years.

CNS depression or excitation, drowsiness (reported most frequently), sleep disturbances, hallucinations (rarely reported), skin rashes with or without irritation, tachycardia, dryness of mouth, nose and throat have occasionally been reported.

This is contraindicated in the cases of known hypersensitivity to any of its constituents, cardiovascular disease including hypertension, lower respiratory symptoms including asthma, monoamine oxidase inhibitor (MAOI) therapy.

As with any other antihistamine therapy, Pseudoephedrine, guaiphenasine & triprolidine may cause drowsiness. If affected, patients should be advised not to drive or operate machinery. Concomitant administration of alcohol or other centrally acting sedatives should be avoided. Although Pseudoephedrine has no pressor effects in normotensive patients but Pseudoephedrine, guaiphenasine & triprolidine should be used with caution to patients suffering from mild to moderate hypertension. Moreover, caution should also be exercised in the following disease conditions - hypertension and heart disease, diabetes, hyperthyroidism, elevated intra-ocular pressure, prostatic enlargement, severe renal and hepatic impairment. This preparation should not be used for persistent or chronic cough, which occurs with smoking, asthma or emphysema or where excessive secretions accompany cough, unless directed by a physician.

Concomitant use of Pseudoephedrine, guaiphenasine & triprolidine with sympathomimetic agents such as decongestants, tricyclic antidepressants, appetite suppressants and amphetamine-like psychostimulants or with monoamine oxidase inhibitors which interfere with the catabolism of sympathomimetic amines may occasionally cause a rise in blood pressure. Because of its pseudoephedrine content, Pseudoephedrine, guaiphenasine & triprolidine partially reverse the hypotensive action of drugs which interfere with sympathetic activity including guanethidine, methyldopa, alpha-adrenergic blocking agents.

Although pseudoephedrine, triprolidine and guaiphenesin have been in widespread use of many years without apparent ill consequence, there are no specific data on their use during pregnancy. Caution should therefore be exercised by balancing the potential benefits of treatment of the mother against any possible hazards to the developing fetus.

The effects of acute toxicity from Pseudoephedrine, guaiphenasine & triprolidine may include drowsiness, irritability, restlessness, lethargy, dizziness, gastrointestinal discomfort, respiratory depression, convulsion, tremor, tachycardia and hypertension. Incase of overdose, necessary measures should be taken to maintain and support respiration and control convulsion. Gastric lavage may be undertaken if indicated. Catheterization of bladder may be necessary.

Store below 25° C. Protect from light. Do not refrigerate.