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This is indicated for the treatment and prevention of zinc and vitamin B deficiencies.

Specific mineral & vitamin combined preparations

Zinc is vital for many biological functions such as immunity enhancement, wound healing, digestion, reproduction, physical growth and mental development. Zinc supports normal growth and development during pregnancy, childhood, and adolescence. Zinc also has some antioxidant properties. Zinc is used to treat ADHD (Attention Deficit Hyper-activity Disorder) in children. In adult, due to zinc deficiency loss of appetite, poor sense of taste and smell, tendency towards depression, white marks on fingernails, frequent infections, low fertility, prostate problems, mental problems, poor wound healing, a poor immune system, diarrhoea, mental lethargy, rough skin and weight loss may occur.

B-Vitamins are needed to release energy from food. They play an important role in ensuring healthy brain and nerve function, healthy red blood cells formation in children & adults. They are specially needed for healthy growth and development of children. B-Vitamin deficiencies in adult cause profound fatigue and various types of neurologic manifestations, which may include weakness, poor balance, confusion, irritability, memory loss, nervousness, tingling of the limbs and loss of coordination. Additional symptoms of vitamin B deficiency are sleep disturbances, nausea, poor appetite, frequent infections, and skin lesions.

Syrup-

• Adults: 10 ml (2 teaspoonful) 2 to 3 times daily or as recommended by the physician.
• Children: 10 ml (2 teaspoonful) 1 to 3 times daily or as recommended by the physician.
• Infants: 5 ml (1 teaspoonful) 1 to 2 times daily or as recommended by the physician.

Tablet-

• Adults & Children over 30 kg: 1 to 2 tablets 2 to 3 times daily or as recommended by the physician.

This is generally well tolerated. However, a few side effects like nausea, vomiting, diarrhoea & stomach upset may occur. Side effects have been reported with specific vitamins but generally at levels substantially higher than recommended doses.

Vitamin B Complex & Zinc is contraindicated in patients with a known hypersensitivity to any of the ingredients of this product.

In acute renal failure, zinc accumulation may occur, so dosage adjustment is needed. This is not intended for the treatment of severe specific deficiencies.

Concomitant intake of tetracyclines and zinc may decrease the Gl absorption and serum levels of tetracyclines. Similarly concomitant administration of zinc and fluroquinolones may decrease the Gl absorption and serum  levels of some fluroquinolones. Coadministration of Niacin and HMG-CoA reductase inhibitors (eg. lovastatin) may result mayopathy and rhabdomyolysis. Pyridoxine reduces levodopa's effectiveness by increasing its peripheral metabolism. Co-administration of pyridoxine with phenytoin may decrease serum levels of phenytoin.

This is recommended in pregnancy and lactation.

In case of overdosage, initially epigastric pain, diarrhoea and vomiting can occur. In that case, one should seek emergency medical attention. Initially, an emetic should be given and then gastric lavage and general supportive measures should be employed.

Store in a cool & dry place, protected from light. Keep all medicines out of reach of children.

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.

Epilepsy-

• Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
• Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
• Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.

Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.

Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.

The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.

Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.

Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

Do not store above 30°C. Keep away from light and out of the reach of children.

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.

Epilepsy-

• Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
• Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
• Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.

Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.

Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.

The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.

Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.

Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

Do not store above 30°C. Keep away from light and out of the reach of children.

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.

Epilepsy-

• Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
• Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
• Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.

Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.

Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.

The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.

Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.

Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

Do not store above 30°C. Keep away from light and out of the reach of children.

Primary anti-epileptic drugs

Sodium Valproate, the active ingredient of this preparation is endowed with anti-epileptic activity against a variety of seizures. The mechanism by which Sodium Valproate exerts its anti-epileptic effects has not been established. However, it has been suggested that its activity is related to increase brain levels of gamma-aminobutyric acid (GABA).

Sodium Valproate tablets may be given once or twice daily. Sodium Valproate syrup should be given in divided doses.

Epilepsy-

• Adults: Initially 600 mg daily given in 2 divided doses, preferably after food, increasing by 200 mg/day at 3-day intervals to a maximum of 2.5 g daily in divided doses until control of seizure is achieved. Usual maintenance dose is 1-2 g daily (20-30 mg/kg daily)
• Children (up to 20 kg): Initially 20 mg/kg daily in divided doses, may be increased provided plasma concentrations monitored (above 40 mg/kg daily also monitor clinical chemistry and hematological parameters).
• Children (over 20 kg): Initially 400 mg daily in divided doses increased until control (usually in the range of 20-30 mg/kg daily) Maximum 35 mg/kg daily.

Febrile convulsion: 20-30 mg/kg/day in 3 divided doses.

Bipolar disorder: Initially 20-30 mg/kg/day in 2-3 divided doses; adjust dosage in 3-5 days. Maintenance dosage is 1000-2000 mg/day.

Prophylaxis of migraine: 300 mg twice daily, although some may require 1000 mg daily.

The most common side effects are anorexia, nausea and vomiting. However, these side effects are minimized with the use of enteric coated tablets. Effects on the CNS include sedation, ataxia and tremor. These symptoms occur infrequently and usually respond to a decrease in doses. Rash, alopecia and stimulation of appetite have been observed occasionally. Sodium Vaiproate has several effects on hepatic function of which elevation of liver enzymes in plasma is observed in up to 40% of patients and often occurs asymptomatically during the first few months of therapy. Rarely a fulminate hepatitis that may be fatal may develop. Children below 2 years of age with other medical conditions and those being treated with multiple antiepileptic agents are specially prone to suffer from hepatic injury, acute pancreatitis and hyperammonemia have also been frequently associated with the use of Sodium Valproate.

Sodium Valproate is contraindicated to patients who have known hypersensitivity to the drug and liver dysfunction. Use of Sodium Valproate is restricted during pregnancy and in women of childbearing potential.

Liver functions should be monitored before therapy and during first 6 months especially in patients most at risk, No undue potential for bleeding before starting and before major surgery must be ensured, Care should be taken in renal impairment, pregnancy, breast-feeding and systemic lupus erythematosus. Sodium Valproate is partially eliminated in the urine as a ketone metabolite, which may lead to a false interpretation of the urine ketone test. Sudden withdrawal of therapy should be avoided. Sodium Valproate should not be used during pregnancy and in women of childbearing potential.

Sodium Vaiproate appears to act as a non specific inhibitor of drug metabolism. Drugs to which it interacts most significantly are Phenobarbital, Phenytoin, Warfarin, Aspirin etc.

Sodium Vaiproate crosses the placenta and in humans, exposure to valproate in the first trimester has been associated with neural tube defects such as anencephaly and spina bifida in newborn. Pregnant women treated with Sodium Vaiproate should be offered to estimate serum a-fetoprotein. Sodium Valproate is excreted in breast miik. However, breast-feeding by a mother taking Sodium Valproate probably causes no risk to the child.

Do not store above 30°C. Keep away from light and out of the reach of children.

Specific mineral preparations

Zinc sulphate monohydrate is an essential trace element and is involved in a number of body enzyme systems. The body needs zinc for normal growth and health. Zinc is also vital for sexual maturation and reproduction, dark vision adaptation, olfactory and gustatory activity, insulin storage & release and for a variety of host immune defenses. Zinc deficiency may lead to impaired immune function, delayed wound healing, a decrease in sense of taste and smell, a reduced ability to fight infections, poor night vision, increased risk of abortion, alopecia, mental lethargy, skin changes and poor development of reproductive organs.

Child under 10 kg: 5 ml (1 teaspoonful) 2 times daily after food.
Child between 10-30 kg: 10 ml (2 teaspoonfuls) 1-3 times daily after food.
Adults and child over 30 kg: 20 ml (4 teaspoonfuls) 1-3 times daily after food.

This drug is most effective if they are taken at least 1 hour before or 2 hour after meals. However, if causes stomach upset, this may be taken with a meal.

For dispersible tablet-

• Place the tablet in a teaspoon
• Add adequate amount of water
• Let the tablet dissolve completely
• Give the entire spoonful solution

Zinc may cause nausea, vomiting, diarrhoea, stomach upset, heartburn and gastritis.

It is contraindicated in those who are hypersensitive to any component of the ingredient of this preparation.

In acute renal failure, zinc accumulation may occur in body; so dose adjustment is needed.

Concomitant intake of a tetracycline and zinc may decrease the absorption of both the tetracycline and zinc. Similarly concomitant administration of zinc and quinolone drug may also decrease the absorption of both. Concomitant intake of penicillamine and zinc may decrese absorption of zinc.

The safety of this product in human pregnancy has not been established. Zinc crosses the placenta and is present in breast milk.

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

Effective in aches including headache and pain for muscular stiffness, Rheumatic pains, Gout, Bruising, Sprains and Fibrositis.

Herbal and Nutraceuticals

Mentha piperita- It contains peppermint oil- menthol (35-45%), menthone (15-20%) and menthyl acetate (3-5%). It has analgesic, antibacterial and insecticidal effects. Moreover, Mentha piperita has the cooling effect on the skin and is equally effective as acetaminophen in relieving headaches.

Cinnamomum camphora- It contains essential oil- sesquiterpenes camphorenone and campherenol. It has antispasmodic, bronchial secretolytic and hyperemic effect. It acts beneficialy in gout, rheumatic pains, neuralgia. It can be safely applied externally in all cases of inflammation, bruises and sprains.

Gaultheria procumbens- It contains volatile oil- methyl salicylate (96-98%) and has rubefacient effect that administered in the treatment of rheumatoid arthritis and related condition.

Capsicum annum- It contains capsaicinoids- capsaicin (32-38%), dihydro-capsaicin (18-52%) and volatile oil (0.1%). It has analgesic, powerful local irritant and rubefacient effects. The most important active ingredient of capsaicinoids is capsaicin, which relieves pain by depleting neuropathies. It enriches blood, lessens inflammation and pain.

Apply topically to the affected area 2 to 3 times daily. Or as directed by the physician.

Not yet known.

There is no absolute contraindication.

No data available.

No restriction is known yet.

Keep all medicines out of the reach of children. Store in a cool and dry place, protected from light.

Doxophylline is used to treat in following indications:

• Bronchial asthma
• Bronchospasm
• Chronic obstructive pulmonary disease (COPD)
• Pulmonary disease with spastic bronchial component.

Bronchodilator, Methyl xanthine derivatives

Doxophylline is a novel bronchodilator. It structurally differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phosphodiesterase 4 thereby relaxes bronchial smooth muscle. However, differently from Theophylline, Doxophylline appears to have decreased affinities toward adenosine A1 and A2 receptors, which may account for the better safety profile of the drug. Doxophylline is reported to inhibit platelet activating factor (PAF) and generation of leukotriene production.

Elderly: 200 mg tablet two or three times daily.

Adults: 400 mg tablet two or three times daily or as prescribed by the physician.

Children:

• >12 years of age: 10 ml syrup or 200 mg tablet two or three times daily.
• 6-12 years of age: 6-9 mg/kg body weight two times daily, i.e. if body weight is 10 kg, 3 ml (60 mg) two times daily or as prescribed by the physician.

If required daily dose of Doxophylline is 400 mg then Doxophylline SR tablet to be taken once daily or as prescribed by the physician

Doxophylline rarely causes serious side effects, however possible side effects are similar for taking excess amount of caffeine. These include: nausea, vomiting, headache, upset stomach and heartburn.

Doxophylline is contraindicated in acute myocardial infarction. It is also contraindicated in patients with hypotension, in lactating women & patients who have shown hypersensitivity to its components.

The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, in patients with congestive heart failure and in those patients taking certain other drugs like erythromycin, troleandomycin, lincomycin, allopurinol, cimetidine, propanolol and anti-flu vaccine. In these cases, a lower dose of Doxophylline may be needed. Phenytoin, other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half-life. In these cases higher doses of Doxophylline may be needed.

Doxophylline should not be administered together with other xanthine derivatives. Toxic synergism with ephedrine has been documented for xanthines. Like other xanthines, concomitant therapy with troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, ranitidine, propranolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels. No evidence of a relationship between Doxophylline serum concentrations and toxic events have been reported.

Animal reproduction studies indicate that, Doxophylline does not cause fetal harm when administered to pregnant animals or can not affect reproduction capacity. However, since there is limited experience in human during pregnancy, xanthines should be given to pregnant women only if clearly needed. Doxophylline is contraindicated in nursing mothers.

In case of overdose severe cardiac arrhythmias and tonic-clonic seizure may occur. These effects may represent the first signs of intoxication. The appearance of side effects may require discontinuation of the treatment which, if necessary, at the physician’s discretion, may be resumed at lower doses after all signs and symptoms of toxicity have subsided.

As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.

Keep in a dry place away from light and heat. Keep out of the reach of children. Doxophylline should be used only on prescription of specialist physician.

Clozapine is indicated in-

• Schizophrenia in patients unresponsive to, or intolerant of, conventional antipsychotic drugs.
• Psychosis in Parkinson's disease.

Atypical neuroleptic drugs

Clozapine is classified as an 'atypical' antipsychotic drug because of its profile of binding to dopamine receptors and its effects on various dopamine-mediated behaviors differ from those exhibited by other typical antipsychotic drug products. In particular, although Clozapine does interfere with the binding of dopamine at D1, D2, D3 and D5 receptors, and has a high affinity for the D4 receptor. This evidence, consistent with the view that Clozapine is preferentially more active at limbic than at striatal dopamine receptors. This may explain the relative freedom of Clozapine from extrapyramidal side effects. Clozapine also acts as an antagonist at adrenergic, cholinergic, histaminergic and serotonergic receptors.

Schizophrenia: Adult over 16 years, 12.5 mg once or twice (elderly 12.5 mg once) on first day then 25-50 mg (elderly 25-37.5 mg) on second day then increased gradually (if well tolerated) in steps of 25-50 mg daily (elderly max. increment 25 mg daily) over 14-21 days up to 300 mg daily in divided doses (larger dose at night, up to 200 mg daily may be taken as a single dose at bedtime); if necessary may be further increased in steps of 50-100 mg once (preferably) or twice weekly; usual dose 200-450 mg daily (max. 900 mg daily)

Psychosis in Parkinson's disease: Adult over 16 years, 12.5 mg at bedtime then increased according to response in steps of 12.5 mg up to twice weekly; usual dose range 25-37.5 mg at bedtime, usual maximum 50 mg daily; exceptionally, dose may be increased further in steps of 12.5 mg weekly to maximum 100 mg daily in 1-2 divided doses.

Common side effects are constipation, dizziness or lightheadedness (mild), drowsiness, headache (mild), increased watering of mouth, nausea or vomiting, unusual weight gain. Less common side effects include abdominal discomfort or heartburn, dryness of mouth.

Severe cardiac disorders (e.g. myocarditis); renal impairment (avoid if creatinine clearance less than 10 ml/minute); history of neutropenia or agranulocytosis; bone-marrow disorders; paralytic ileus; alcoholic and toxic psychoses; history of circulatory collapse; drug intoxication; coma or severe CNS depression; uncontrolled epilepsy; breast-feeding.

Medication should not be stopped abruptly; should be tapered off over 1-2 weeks. If conditions warrant abrupt discontinuation (leukopenia, myocarditis, cardiomyopathy), monitor patient for psychosis and cholinergic rebound (headache, nausea, vomiting, diarrhea). Elderly patients are more susceptible to adverse effects  (including agranulocytosis, cardiovascular, anticholinergic, and tardive dyskinesia). Significant risk of agranulocytosis, potentially life-threatening. WBC testing should occur weekly for the first 6 months of therapy; thereafter, if acceptable WBC counts are maintained (WBC 3000/mm3, ANC 1500/mm3) then WBC counts can be monitored every other week. WBCs must be monitored weekly for the first 4 weeks after therapy discontinuation. Use with caution in patients receiving other marrow suppressive agents. Eosinophilia has been reported to occur with Clozapine and may require temporary or permanent interruption of therapy.

Cognitive and/or motor impairment (sedation) is common with Clozapine, resulting in impaired performance of tasks requiring alertness (eg, operating machinery or driving). Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold. Has been associated with benign, self-limiting fever (<100.4°F, usually within first 3 weeks). However, dozapine may also be associated with severe febrile reactions, including neuroleptic malignant syndrome (NMS). Clozapine's potential for extrapyramidal symptoms appear to be extremely low.

May cause anticholinergic effects; should be used with caution in patients with urinary retention, benign prostatic hyperplasia, narrow-angle glaucoma, xerostomia, visual problems, constipation, or history of bowel obstruction. May cause hyperglycemia; in some cases may be extreme and associated with ketoacidosis, hyperosmolar coma, or death. Use with caution in patients with diabetes or other disorders of glucose regulation; monitor for worsening of glucose control. Use with caution in patients with hepatic disease or impairment; hepatitis has been reported as a consequence of therapy.

May cause orthostatic hypotension and tachycardia; should be used with caution in patients at risk of hypotension or in patients where transient hypotensive episodes would be poorly tolerated (cardiovascular disease or cerebrovascular disease). Concurrent use of psychotropics and benzodiazepines may increase the risk of severe cardiopulmonary reactions.

Myocarditis, pericarditis, pericardial effusion, cardiomyopathy, and CHF have also been associated with clozapine. Fatalities due to myocarditis have been reported; highest risk in the first month of therapy, however, later cases also reported. Myocarditis or cardiomyopathy should be considered in patients who present with signs/symptoms of heart failure (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea, peripheral edema), chest pain, palpitations, new electrocardiographic abnormalities (arrhythmias, ST-T wave abnormalities), or unexplained fever. Patients with tachycardia during the first month of therapy should be closely monitored for other signs of myocarditis. Discontinue clozapine if myocarditis is suspected; do not rechallenge in patients with clozapine-related myocarditis. The reported rate of cardiomyopathy in clozapine treated patients is similar to that in the general population. The majority of patients were over 50 years of age and were taking clozapine for >6 months. Clozapine should be discontinued in patients with confirmed cardiomyopathy unless benefit clearly outweighs risk. Rare cases of thromboembolism, including pulmonary embolism and stroke resulting in fatalities, have been associated with clozapine.

Myelosuppression may be aggravated with concomitant use of myelosuppressants. Clozapine may interact with other CNS active drugs or alcohol. Orthostatic hypotension may occur with benzodiazepine usage or other psychotropics. Since Clozapine is highly bound to proteins. It may be displaced by other drugs, which are also highly protein bound. Conversely, Clozapine may also displace protein bound drugs (e.g. warfarin, digoxin). Cimetidine may decrease plasma Clozapine levels.

Although concomitant administration of Carbamazepine and Clozapine is not recommended, it should be noted that discontinuation of concomitant Carbamazepine may result in an increase in plasma Clozapine levels. A reduced Clozapine dosage should be used when it is combined with drugs like fluvoxamine, paroxetine and sertraline. The action of hypotensive drugs may be potentiated. Other anticholinergic drug action may also be increased. Administration of adrenaline should generally be avoided due to possibility of reversal of adrenaline effect due to alpha adrenergic blockade by Clozapine. Concomitant use of Clozapine with other drugs metabolized by cytochrome P450 2D6 (such as phenothiazines, antidepressants, propafenone, flecainide and encainide) or those that inhibit this enzyme such as quinidine; require lower doses of either Clozapine or the other drugs.

There are no adequate studies of Clozapine in pregnant women. Studies in animals suggest no important effects on the fetus. Clozapine can be used in pregnancy if the physician feels that it is necessary. Animal studies suggest that Clozapine is secreted in breast milk. Therefore, women taking Clozapine should not nurse their infants.

The most commonly reported signs and symptoms associated with Clozapine overdose are: altered states of consciousness, including drowsiness, delirium and coma; tachycardia; hypotension; respiratory depression or failure; hypersalivation. Aspiration pneumonia and cardiac arrhythmias have also been reported. Seizures have occurred in a minority of reported cases. Fatal overdoses have been reported with Clozapine, generally at doses above 2500 mg. There have also been reports of patients recovering from overdoses well in excess of 4 gm.

Management of Overdose: Should be established and maintained an airway; should be ensured adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdosage. Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. Additional surveillance should be continued for several days because of the risk of delayed effects. Avoid epinephrine and derivatives when treating hypotension, and quinidine and procainamide when treating cardiac arrhythmia. There are no specific antidotes for Clozapine. Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. ln managing overdosage, the physician should consider the possibility of multiple drug involvement.

Do not store above 30°C. Keep away from light and out of the reach of children.

Clozapine is indicated in-

• Schizophrenia in patients unresponsive to, or intolerant of, conventional antipsychotic drugs.
• Psychosis in Parkinson's disease.

Atypical neuroleptic drugs

Clozapine is classified as an 'atypical' antipsychotic drug because of its profile of binding to dopamine receptors and its effects on various dopamine-mediated behaviors differ from those exhibited by other typical antipsychotic drug products. In particular, although Clozapine does interfere with the binding of dopamine at D1, D2, D3 and D5 receptors, and has a high affinity for the D4 receptor. This evidence, consistent with the view that Clozapine is preferentially more active at limbic than at striatal dopamine receptors. This may explain the relative freedom of Clozapine from extrapyramidal side effects. Clozapine also acts as an antagonist at adrenergic, cholinergic, histaminergic and serotonergic receptors.

Schizophrenia: Adult over 16 years, 12.5 mg once or twice (elderly 12.5 mg once) on first day then 25-50 mg (elderly 25-37.5 mg) on second day then increased gradually (if well tolerated) in steps of 25-50 mg daily (elderly max. increment 25 mg daily) over 14-21 days up to 300 mg daily in divided doses (larger dose at night, up to 200 mg daily may be taken as a single dose at bedtime); if necessary may be further increased in steps of 50-100 mg once (preferably) or twice weekly; usual dose 200-450 mg daily (max. 900 mg daily)

Psychosis in Parkinson's disease: Adult over 16 years, 12.5 mg at bedtime then increased according to response in steps of 12.5 mg up to twice weekly; usual dose range 25-37.5 mg at bedtime, usual maximum 50 mg daily; exceptionally, dose may be increased further in steps of 12.5 mg weekly to maximum 100 mg daily in 1-2 divided doses.

Common side effects are constipation, dizziness or lightheadedness (mild), drowsiness, headache (mild), increased watering of mouth, nausea or vomiting, unusual weight gain. Less common side effects include abdominal discomfort or heartburn, dryness of mouth.

Severe cardiac disorders (e.g. myocarditis); renal impairment (avoid if creatinine clearance less than 10 ml/minute); history of neutropenia or agranulocytosis; bone-marrow disorders; paralytic ileus; alcoholic and toxic psychoses; history of circulatory collapse; drug intoxication; coma or severe CNS depression; uncontrolled epilepsy; breast-feeding.

Medication should not be stopped abruptly; should be tapered off over 1-2 weeks. If conditions warrant abrupt discontinuation (leukopenia, myocarditis, cardiomyopathy), monitor patient for psychosis and cholinergic rebound (headache, nausea, vomiting, diarrhea). Elderly patients are more susceptible to adverse effects  (including agranulocytosis, cardiovascular, anticholinergic, and tardive dyskinesia). Significant risk of agranulocytosis, potentially life-threatening. WBC testing should occur weekly for the first 6 months of therapy; thereafter, if acceptable WBC counts are maintained (WBC 3000/mm3, ANC 1500/mm3) then WBC counts can be monitored every other week. WBCs must be monitored weekly for the first 4 weeks after therapy discontinuation. Use with caution in patients receiving other marrow suppressive agents. Eosinophilia has been reported to occur with Clozapine and may require temporary or permanent interruption of therapy.

Cognitive and/or motor impairment (sedation) is common with Clozapine, resulting in impaired performance of tasks requiring alertness (eg, operating machinery or driving). Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold. Has been associated with benign, self-limiting fever (<100.4°F, usually within first 3 weeks). However, dozapine may also be associated with severe febrile reactions, including neuroleptic malignant syndrome (NMS). Clozapine's potential for extrapyramidal symptoms appear to be extremely low.

May cause anticholinergic effects; should be used with caution in patients with urinary retention, benign prostatic hyperplasia, narrow-angle glaucoma, xerostomia, visual problems, constipation, or history of bowel obstruction. May cause hyperglycemia; in some cases may be extreme and associated with ketoacidosis, hyperosmolar coma, or death. Use with caution in patients with diabetes or other disorders of glucose regulation; monitor for worsening of glucose control. Use with caution in patients with hepatic disease or impairment; hepatitis has been reported as a consequence of therapy.

May cause orthostatic hypotension and tachycardia; should be used with caution in patients at risk of hypotension or in patients where transient hypotensive episodes would be poorly tolerated (cardiovascular disease or cerebrovascular disease). Concurrent use of psychotropics and benzodiazepines may increase the risk of severe cardiopulmonary reactions.

Myocarditis, pericarditis, pericardial effusion, cardiomyopathy, and CHF have also been associated with clozapine. Fatalities due to myocarditis have been reported; highest risk in the first month of therapy, however, later cases also reported. Myocarditis or cardiomyopathy should be considered in patients who present with signs/symptoms of heart failure (dyspnea, fatigue, orthopnea, paroxysmal nocturnal dyspnea, peripheral edema), chest pain, palpitations, new electrocardiographic abnormalities (arrhythmias, ST-T wave abnormalities), or unexplained fever. Patients with tachycardia during the first month of therapy should be closely monitored for other signs of myocarditis. Discontinue clozapine if myocarditis is suspected; do not rechallenge in patients with clozapine-related myocarditis. The reported rate of cardiomyopathy in clozapine treated patients is similar to that in the general population. The majority of patients were over 50 years of age and were taking clozapine for >6 months. Clozapine should be discontinued in patients with confirmed cardiomyopathy unless benefit clearly outweighs risk. Rare cases of thromboembolism, including pulmonary embolism and stroke resulting in fatalities, have been associated with clozapine.

Myelosuppression may be aggravated with concomitant use of myelosuppressants. Clozapine may interact with other CNS active drugs or alcohol. Orthostatic hypotension may occur with benzodiazepine usage or other psychotropics. Since Clozapine is highly bound to proteins. It may be displaced by other drugs, which are also highly protein bound. Conversely, Clozapine may also displace protein bound drugs (e.g. warfarin, digoxin). Cimetidine may decrease plasma Clozapine levels.

Although concomitant administration of Carbamazepine and Clozapine is not recommended, it should be noted that discontinuation of concomitant Carbamazepine may result in an increase in plasma Clozapine levels. A reduced Clozapine dosage should be used when it is combined with drugs like fluvoxamine, paroxetine and sertraline. The action of hypotensive drugs may be potentiated. Other anticholinergic drug action may also be increased. Administration of adrenaline should generally be avoided due to possibility of reversal of adrenaline effect due to alpha adrenergic blockade by Clozapine. Concomitant use of Clozapine with other drugs metabolized by cytochrome P450 2D6 (such as phenothiazines, antidepressants, propafenone, flecainide and encainide) or those that inhibit this enzyme such as quinidine; require lower doses of either Clozapine or the other drugs.

There are no adequate studies of Clozapine in pregnant women. Studies in animals suggest no important effects on the fetus. Clozapine can be used in pregnancy if the physician feels that it is necessary. Animal studies suggest that Clozapine is secreted in breast milk. Therefore, women taking Clozapine should not nurse their infants.

The most commonly reported signs and symptoms associated with Clozapine overdose are: altered states of consciousness, including drowsiness, delirium and coma; tachycardia; hypotension; respiratory depression or failure; hypersalivation. Aspiration pneumonia and cardiac arrhythmias have also been reported. Seizures have occurred in a minority of reported cases. Fatal overdoses have been reported with Clozapine, generally at doses above 2500 mg. There have also been reports of patients recovering from overdoses well in excess of 4 gm.

Management of Overdose: Should be established and maintained an airway; should be ensured adequate oxygenation and ventilation. Activated charcoal, which may be used with sorbitol, may be as or more effective than emesis or lavage, and should be considered in treating overdosage. Cardiac and vital signs monitoring is recommended along with general symptomatic and supportive measures. Additional surveillance should be continued for several days because of the risk of delayed effects. Avoid epinephrine and derivatives when treating hypotension, and quinidine and procainamide when treating cardiac arrhythmia. There are no specific antidotes for Clozapine. Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit. ln managing overdosage, the physician should consider the possibility of multiple drug involvement.

Do not store above 30°C. Keep away from light and out of the reach of children.

Ribavirin is indicated for the treatment of chronic hepatitis C (CHC) virus infection in combination with other antiviral drugs in patients with compensated liver disease not previously treated with interferon alpha and in adult CHC patients coinfected with HIV. Ribavirin should not be used alone.

Hepatic viral infections (Hepatitis C)

Ribavirin is a synthetic nucleoside which has inhibitory action against respiratory syncytial virus, influenza virus and herpes simplex virus. The mechanism of action is not clear. It may act at several sites including cellular enzymes to interfere with viral nucleic acid synthesis. The mono- and triphosphate derivatives are known to be responsible for the antiviral action of the compound.

The recommended duration of treatment for patients previously untreated with interferon is 24 to 48 weeks. After 24 weeks of treatment virologic response should be assessed. Treatment discontinuation should be considered in any patient who has not achieved an HCV RNA below the limit of detection of the assay by 24 weeks. There are no safety and efficacy data on treatment for longer than 48 weeks in the previously untreated patient population. In patients who relapse following interferon therapy, the recommended duration of treatment is 24 weeks. There are no safety and efficacy data on treatment for longer than 24 weeks in the relapse patient populations.

Ribavirin + Interferon: Genotype Ribavirin Daily Interferon alpha-2a Duration or interferon alpha-2b.

• All <75 kg: (400+600) mg 3 MIU 3 times weekly 48 weeks Genotypes subcutaneously (Genotype1&4)
• >75 kg: (600+600) mg 24 weeks (Genotype2&3)

Ribavirin + Peg-Interferon: Genotype Ribavirin Daily Peg-Interferon alpha-2a Duration or Peg-interferon alpha-2b:

• 1 & 4 < 75 kg: (400+600) mg 180 gm once weekly 48 weeks
• > 75 kg: (600+600) mg subcutaneously 2 & 3 (400+400) mg 24 weeks

Ribavirin may be administered without regard to food, but should be administered in a consistent manner. Drink plenty of water while being treated with this medication; drinking water will decrease the risk of serious side effects.

The most common adverse reactions in adults receiving combination therapy are psychiatric and central nervous system effects, severe ocular disorder, dental and periodontal disorders & growth inhibition in children and adolescents that may be irreversible in some patients. The most common adverse reactions in pediatric subjects were similar to those seen in adults.

Women who are pregnant. Ribavirin may cause fetal harm when administered to a pregnant woman. Ribavirin is contraindicated in women who are or may become pregnant. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Patients with hemoglobinopathies (e.g., thalassemia major or sickle-cell anemia). In combination with didanosine. Reports of fatal hepatic failure, as well as peripheral neuropathy, pancreatitis and symptomatic hyperlactatemia/lactic acidosis have been reported in clinical trials.

Birth defects and fetal death with ribavirin: Do not use in pregnancy and for 6 months after treatment. Patients must have a negative pregnancy test prior to therapy, use at least 2 forms of contraception and undergo monthly pregnancy tests. For a male patient, it is very important for his female partner to avoid becoming pregnant during treatment and during the 7 months after treatment and do not have sex with a pregnant women.

Nucleoside reverse transcriptase inhibitors or reduce dose or discontinue interferon, ribavirin or both with worsening toxicities

Azathioprine: Concomitant use of azathioprine with ribavirin has been reported to induce severe pancytopenia and may increase the risk of azathioprine-related myelotoxicity.

Pregnancy Category X. Ribavirin produced significant embryocidal and/or teratogenic effects in all animal species in which adequate studies have been conducted. Malformations of the skull, palate, eye, jaw, limbs, skeleton and gastrointestinal tract were noted. The incidence and severity of teratogenic effects increased with escalation of the drug dose. Survival of fetuses and offspring was reduced.

Nursing Mothers: It is not known whether Ribavirin is excreted in human milk. Because many drugs are excreted in human milk and to avoid any potential for serious adverse reactions in nursing infants from ribavirin, a decision should be made either to discontinue nursing or therapy with Ribavirin, based on the importance of the therapy to the mother.

Pediatric Use: Safety and effectiveness of Ribavirin in combination with Peginterferon has not been established in pediatric patients below the age of 3 years.

Geriatric Use: The risk of toxic reactions to this drug may be greater in patients with impaired renal function. The dose of Ribavirin should be reduced in patients with creatinine clearance less than or equal to 50 ml/min; and the dose of Interferon should be reduced in patients with creatinine clearance less than 30 ml/min.

Keep out of the reach of children. Keep in a cool & dry place. Protect from light.

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.

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.

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.

Empagliflozin is indicated in:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume. 

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia. 

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control. 

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Empagliflozin is indicated in:

• As an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.
• To reduce the risk of cardiovascular death in adult patients with type 2 diabetes mellitus and established cardiovascular disease.

Sodium-glucose Cotransporter-2 (SGLT2) Inhibitors

Empagliflozin is a sodium glucose co-transporter-2 (SGLT-2) inhibitor. SGLT2 co-transporters are responsible for reabsorption of glucose from the glomerular filtrate in the kidney. The glucuretic effect resulting from SGLT2 inhibition reduces renal absorption and lowers the renal threshold for glucose, resulting in increased glucose excretion. Additionally, it contributes to reduced hyperglycaemia, assists weight loss, and reduces blood pressure.

The recommended dose of Empagliflozin is 10 mg once daily, taken in the morning, with or without food. In patients tolerating Empagliflozin, the dose may be increased to 25 mg once daily. In patients with volume depletion, correcting this condition prior to initiation of Empagliflozin is recommended.

The most common adverse reactions associated with Empagliflozin are urinary tract infections and female genital mycotic infections. Others common side effects includes dehydration, hypotension, weakness, dizziness and increased thirstiness.

Empagliflozin is contraindicated in patients with history of serious hypersensitivity reaction to Empagliflozin or any of its ingredients, severe renal impairment, end-stage renal disease, or dialysis.

Assessment of renal function is recommended prior to initiation of Empagliflozin and periodically thereafter. Empagliflozin should not initiated in patients with an eGFR less than 45 ml/min/1.73 m². No dose adjustment is needed in patients with an eGFR greater than or equal to 45 ml/min/1.73 m².

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume. 

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia. 

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors as SGLT2 inhibitors increase urinary glucose excretion and will lead to positive urine glucose tests. Use alternative methods to monitor glycemic control. 

Interference with 1,5-anhydroglucitol (1,5-AG) Assay: Monitoring glycemic control with 1,5-AG assay is not recommended as measurements of 1,5-AG are unreliable in assessing glycemic control in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

There are no adequate and well-controlled studies of Empagliflozin in pregnant women. Empagliflozin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known if Empagliflozin is excreted in human milk. It is not recommended when breastfeeding.

In the event of an overdose with Empagliflozin the usual supportive measures (e.g., remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Empagliflozin by hemodialysis has not been studied.

Keep in a cool & dry place (below 30° C), protected from light & moisture. Keep out of the reach of children.

Combination Oral hypoglycemic preparations

Empagliflozin is an inhibitor of Sodium-Glucose Co-Transporter 2 (SGLT2). SGLT2 is the predominant transporter, responsible for reabsorption of glucose from the kidney back into the circulation. By inhibiting SGLT2, Empagliflozin reduces renal reabsorption of filtered glucose and lowers the renal threshold for glucose and thereby increases urinary glucose excretion.

Metformin Hydrochloride is a biguanide type oral antihyperglycemic drug, used in the management of type 2 diabetes. It lowers both basal and postprandial plasma glucose. It does not produce hypoglycemia. Metformin Hydrochloride decreases hepatic glucose production, decreases intestinal absorption of glucose and improves insulin sensitivity by an increase in peripheral glucose uptake and utilization.

The dosage should be individualized based on effectiveness and tolerability. Take this combination twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal side effects due to Metformin Hydrochloride. Maximum recommended daily dose of Metformin Hydrochloride is 2000 mg and Empagliflozin is 25 mg.

Recommended individualized starting dose:

• In patients on Metformin Hydrochloride, switch to this combination containing Empagliflozin 5 mg with a similar total daily dose of Metformin Hydrochloride.
• In patients on Empagliflozin, switch to this combination containing Metformin Hydrochloride 500 mg with a similar total daily dose of Empagliflozin.
• In patients already treated with Empagliflozin and Metformin Hydrochloride separately switch to this combination containing the same total daily doses of each component.
• In patients with volume depletion not previously treated with Empagliflozin, correct this condition before initiating this combination.

Renal impaired patient: Assess renal function before initiating this combination. In patients with an eGFR below 45 mL/min/1.73 m² is contraindicated.

Pediatric patients under 18 years of age: Safety and effectiveness in pediatric patients under 18 years of age have not been established.

Most common adverse reactions associated with Empagliflozin (5% or greater incidence) were urinary tract infection and female genital mycotic infections. Most common adverse reactions associated with Metformin (>5%) are diarrhea, nausea/vomiting, flatulence, abdominal discomfort, indigestion, asthenia, and headache. The following important adverse reactions are given below:

• Very common: Hypoglycemia (when used with sulphonylurea or insulin), Gastrointestinal symptoms
• Common: Vaginal moniliasis, vulvovaginitis, balanitis and other genital infection. Urinary tract infection (including pyelonephritis and urosepsis), thirst, taste disturbance, pruritus (generalised), rash, Increased urination, serum lipids increased
• Uncommon: Volume depletion, urticaria, dysuria, blood creatinine increased/Glomerular filtration rate decreased, Haematocrit increased
• Rare: Diabetic ketoacidosis.

Lactic Acidosis: Postmarketing cases of Metformin Hydrochloride-associated lactic acidosis. If lactic acidosis is suspected, general supportive measures should be instituted promptly in a hospital setting, along with immediate discontinuation of this combination.

Hypotension: Before initiating this combination assess and correct volume status in patients with renal impairment, the elderly, in patients with low systolic blood pressure, and in patients on diuretics. Monitor for signs and symptoms of hypotension after initiating therapy and increase monitoring in clinical situations where volume contraction is expected.

Ketoacidosis: Before initiating this combination assess patients who present with signs and symptoms of metabolic acidosis for ketoacidosis, regardless of blood glucose level. If suspected, discontinue this combination, evaluate and treat promptly.

Acute kidney injury & impairment in renal function: Consider temporarily discontinuing this combination in settings of reduced oral intake or fluid losses. If acute kidney injury occurs, discontinue this combination promptly and institute treatment.

Urosepsis, Pyelonephritis, Fournier’s gangrene & Genital mycotic infections: Treatment with SGLT2 inhibitors increases the risk for urinary tract infections. Evaluate patients for signs and symptoms of urinary tract infections and treat promptly, if indicated.

Hypoglycemia: Consider lowering the dose of insulin secretagogue or insulin to reduce the risk of hypoglycemia when initiating this combination.

Vitamin B12 Deficiency: Metformin Hydrochloride may lower vitamin B12 levels. Monitor hematologic parameters annually.

Increased LDL-C: Monitor and treat as appropriate.

Macrovascular Outcomes: There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with this combination.

Diuretics: Co-administration of Empagliflozin with diuretics resulted in increased urine volume and frequency of voids, which might enhance the potential for volume depletion.

Insulin or Insulin Secretagogues: Co-administration of Empagliflozin with insulin or insulin secretagogues increases the risk for hypoglycemia.

Positive Urine Glucose Test: Monitoring glycemic control with urine glucose tests is not recommended in patients taking SGLT2 inhibitors. Use alternative methods to monitor glycemic control.

Drugs that Reduce Metformin Clearance: Drugs that reduce Metformin clearance (such as ranolazine, vandetanib, dolutegravir, and cimetidine) may increase the accumulation of Metformin.

Carbonic Anhydrase Inhibitors: Carbonic anhydrase inhibitors may increase risk of lactic acidosis.

Drugs Affecting Glycemic Control: Thiazides and other diuretics, corticosteroids, phenothiazines, thyroid products, estrogens, oral contraceptives, phenytoin, nicotinic acid, sympathomimetics, calcium channel blocking drugs, and isoniazid produce hoperglycemia. When such drugs are administered to a patient receiving Empagliflozin and Metformin combination, the patient should be closely observed to maintain adequate glycemic control. When such drugs are withdrawn from a patient receiving Empagliflozin and Metformin combination, the patient should be observed closely for hypoglycemia.

Alcohol: Alcohol can potentiate the effect of Metformin on lactate metabolism. Warn patients against excessive alcohol intake.

Advise females of the potential risk to a fetus especially during the second and third trimesters. This is not recommended when breastfeeding.

In controlled clinical studies single doses of up to 800 mg Empagliflozin (equivalent to 32-times the highest recommended daily dose) in healthy volunteers and multiple daily doses of up to 100 mg Empagliflozin (equivalent to 4-times the highest recommended daily dose) in patients with type 2 diabetes did not show any toxicity. Hypoglycaemia has not been seen with Metformin doses of up to 85 g, although lactic acidosis has occurred in such circumstances. Lactic acidosis is a medical emergency and must be treated in hospital. In the event of an overdose, treatment should be initiated as appropriate to the patient's clinical status. The most effective method to remove lactate and Metformin is haemodialysis. The removal of Empagliflozin by haemodialysis has not been studied

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

This preparation temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• Non-productive cough due to minor throat or bronchial irritation
• Runny Nose
• Sneezing
• Itching of the nose or throat
• Itchy & watery eyes
• Nasal congestion

Combined cough suppressants

This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. Phenylephrine is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, sinusitis & bronchitis. This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe. Triprolidine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness. By antagonizing another natural substance acetylcholine, it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose.

Adults & Children over 12 years: 1 teaspoonful (5 ml) 4 times a day every 4 hours interval.

6-12 years: 1/2 teaspoonful 4 times a day every 4 hours interval.

Use in children and adolescents: A physician's advice should be obtained before administering this combination to children less than 6 years.

It may cause drowsiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type.

It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment

This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication.

There are no specific data on use of this combination during pregnancy & lactation.

In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations and convulsion.

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

This kit is indicated for the treatment and prevention of Osteoporosis. It increases Bone Mineral Density (BMD) and reduces the incidence of vertebral fractures.

Bisphosphonate preparations

Ibandronic Acid (Ibandronate Sodium Monohydrate) is a nitrogen- containing bisphosphonate that inhibits osteoclast-mediated bone resorption. The action of Ibandronate on bone tissue is based on its affinity for hydroxyapatite, which is part of the mineral matrix of bone. Ibandronate inhibits osteoclast activity and reduces bone resorption and turnover. In postmenopausal women, it reduces the elevated rate of bone turnover, leading to, on average, a net gain in bone mass.

The combination of Coral Calcium and Colecalciferol is composed of Calcium Carbonate with small amounts of Magnesium and other Trace minerals. Coral Calcium ensures better absorption than Calcium of other Calcium Carbonate origin due to its chemical structure that is very similar to the composition of human bone Calcium Carbonate. Vitamin-D aids in the absorption of Calcium from GI tract and helps to maintain Calcium balance in the body.

One tablet of Ibandronic Acid 150 mg once monthly on the same date of each month is recommended. To maximize clinical benefit of Ibandronic acid, two tablets of Calcium 500 mg and Vitamin D3 200 IU per day are usually recommended in divided dosage or as directed by the physician.

Day 1: Take the Ibandronic Acid tablet on an empty stomach at least 60 minutes before the first food or drink (other than water) of the day or before taking any oral medication or supplementation including Calcium, Antacid and/or Vitamins

• Swallow tablet whole with a glass of plain water while standing or sitting in an upright position
• Avoid lying down for 60 minutes
• Do not chew or suck the tablet

Day 2-31: One tablet of Calcium and Vitamin D should be taken at the morning and at the evening after meal

• Tablets should be taken in order as directed on the blister strip for ease of dose tracking.

Pediatric patient: Safety and effectiveness in pediatric patients have not been established.

Ibandronic Acid: Common side effects include Hypertension, Dyspepsia, Nausea, Diarrhea, Abdominal Pain, Arthralgia, Back Pain, Localized Osteoarthritis, Myalgia, Muscle Cramp, Influenza, Nasopharyngitis, Bronchitis, Urinary Tract Infection, Upper Respiratory Tract Infection, Headache, Dizziness, Skin rash, Insomnia etc.

Calcium & Vitamin D3: Most common side effects are flatulence, diarrhea, constipation, upper GI discomfort etc. Hypercalciuria and hypercalcemia due to prolong use has rarely been reported.

Ibandronic Acid is contraindicated in conditions like: abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia. Inability to stand or sit upright for at least 60 minutes, Hypocalcemia, known hypersensitivity to Ibandronic Acid.

Calcium & Vitamin D3: Hypersensitivity to any of the component of this preparation. It is also contraindicated in case of hypercalcemia, hyperparathyroidism, hypercalciuria, nephrolithiasis, severe renal insufficiencies, concomitant Digoxin therapy (requires careful monitoring of serum calcium level), renal calculi and Zollinger Ellison syndrome.

Ibandronic Acid:

• Upper Gastrointestinal Adverse Reactions: Ibandronic acid like other bisphosphonates administered orally may cause local irritation of the upper gastrointestinal mucosa. Because of these possible irritant effects, caution should be used when Ibandronic acid is given to patients with active upper gastrointestinal problems (such as known Barrett’s esophagus, dysphagia, other esophageal diseases, gastritis, duodenitis or ulcers).
• Hypocalcaemia and Mineral Metabolism: Treat hypocalcemia and other disturbances of bone and mineral metabolism before starting therapy.
• Musculoskeletal Pain: Severe and occasionally incapacitating bone, joint, and/or muscle pain has been reported in patients taking Ibandronic acid and other bisphosphonates.
• Jaw Osteonecrosis: Osteonecrosis, primarily in the jaw, has been reported in patients treated with bisphosphonates. Most cases have been in cancer patients undergoing dental procedures, but some have occurred in patients with postmenopausal osteoporosis or other diagnoses.

Calcium and Vitamin-D: In mild hypercalciuria reduction of dose is sufficient to return to normal serum Calcium concentration. Plasma and serum Calcium level should be monitored in mild to moderate renal impairment patients and also in case of long term use. Patients with renal stone or with such previous history should be recommended to increase their fluid intake.

Ibandronic Acid: Products containing calcium and other multivalent cations (such as aluminum, magnesium, iron), including milk, food, and antacids are likely to interfere with absorption of Ibandronate. It is also found to interact with H2 blockers such as Ranitidine in several clinical trials..

Calcium (Coral) and Vitamin-D: Oral Calcium can reduce the absorption of tetracycline & fluoride preparations and minimum 3 hours’ time should be allowed between ingestion of these medications. Thiazide diuretics reduce the renal excretion of Calcium. Phenytoin, barbiturates, glucocorticoids may induce metabolism of Vitamin D. Concomitant intake of certain foods like spinach, cereals, milk and its derivatives may reduce the intestinal uptake of Calcium.

Pregnancy category C. There are no adequate and well-controlled studies in pregnant women. This kit should be used during pregnancy only if the potential benefit justifies the potential risk to the mother and fetus.

Nursing mother: It is not known whether this kit is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this kit is administered to a nursing woman.

No specific information is available on the treatment of over dosage of Ibandronic acid. However, based on knowledge of this class of compounds, oral over dosage may result in hypocalcemia, hypophosphatemia, and upper gastrointestinal adverse events.

Do not store above 30°C. Keep away from light and out of the reach of children.