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Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Long-acting selective β-adrenoceptor stimulants

Indacaterol capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indacaterol capsules are only for oral inhalation and should only be used with the device.

The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.

Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.

No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.

The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported of hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis and dizziness.

All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.

Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.

Indacaterol shows interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of Indacaterol. The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β2-agonists. Indacaterol, as with other β2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. β-adrenergic receptor antagonists (beta-blockers) and Indacaterol may interfere with the effect of each other when administered concurrently.

Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. Indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.

The expected signs and symptoms associated with over dosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an over dose of Indacaterol powder.

Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.

Indacaterol is indicated for the treatment of airflow obstruction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and/or emphysema.

Long-acting selective β-adrenoceptor stimulants

Indacaterol capsules must not be swallowed as the intended effects on the lungs will not be obtained. The contents of Indacaterol capsules are only for oral inhalation and should only be used with the device.

The recommended dosage of Indacaterol is the once-daily inhalation of the contents of one 75 mcg, 150 mcg, 300 mcg Indacaterol capsule using the device.

Indacaterol should be administered once daily every day at the same time of the day by the orally inhaled route only. If a dose is missed, the next dose should be taken as soon as it is remembered. Do not use Indacaterol more than one time every 24 hours.

No dosage adjustment is required for geriatric patients, patients with mild and moderate hepatic impairment, or renally impaired patients. No data are available for subjects with severe hepatic impairment. Indacaterol is not indicated for use in the pediatric population. Safety and efficacy have not been established.

The most commonly reported adverse effects were cough, nasopharyngitis, headache, nausea, oropharyngeal pain. Some other also reported of hypersensitivity reactions, paradoxical bronchospasm, tachycardia, pruritis and dizziness.

All LABA are contraindicated in patients with asthma without use of a long-term asthma control medication. Indacaterol powder is not indicated for the treatment of asthma. Indacaterol is contraindicated in patients with a history of hypersensitivity to Indacaterol or to any of the ingredients.

Rarely, serious (sometimes fatal) breathing problems have happened to people with asthma using a long-acting inhaled beta agonist (salmeterol). Since Indacaterol is similar to salmeterol, it might cause these serious breathing problems. Indacaterol has not been shown to be safe or effective to treat asthma and is not approved for this use.

Indacaterol shows interaction with Adrenergic Drugs, Xanthine Derivatives, Steroids, or Diuretics. Concomitant treatment with xanthine derivatives, steroids, or diuretics may potentiate any hypokalemic effect of Indacaterol. The ECG changes or hypokalemia that may result from the administration of non-potassium sparing diuretics (such as loop or thiazide diuretics) can be acutely worsened by β2-agonists. Indacaterol, as with other β2-agonists, should be administered with extreme caution to patients being treated with monoamine oxidase inhibitors, tricyclic antidepressants, or other drugs known to prolong the QTc interval. β-adrenergic receptor antagonists (beta-blockers) and Indacaterol may interfere with the effect of each other when administered concurrently.

Pregnancy Category C. There are no adequate and well-controlled studies with Indacaterol powder in pregnant women. Indacaterol powder should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known that the active component of Indacaterol powder, Indacaterol is excreted in human milk. Because many drugs are excreted in human milk and because Indacaterol has been detected in the milk of lactating rats, caution should be exercised when Indacaterol powder is administered to nursing women.

The expected signs and symptoms associated with over dosage of Indacaterol powder are those of excessive beta-adrenergic stimulation and occurrence or exaggeration of any of the signs and symptoms, e.g., angina, hypertension or hypotension, tachycardia, with rates up to 200 bpm, arrhythmias, nervousness, headache, tremor, dry mouth, palpitation, muscle cramps, nausea, dizziness, fatigue, malaise, hypokalemia, hyperglycemia, metabolic acidosis and insomnia. As with all inhaled sympathomimetic medications, cardiac arrest and even death may be associated with an over dose of Indacaterol powder.

Indacaterol capsules must always be stored in the blister, and only removed immediately before use. Keep in a cool & dry place. Keep out of the reach of children.

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

Combined bronchodilators

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

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

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

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

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

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

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

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

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

Oxcarbazepine is indicated for:

Adults: Monotherapy or adjunctive therapy in the treatment of partial seizures

Pediatrics:

• Monotherapy in the treatment of partial seizures in children 4-16 years
• Adjunctive therapy in the treatment of partial seizures in children 2–16 years

Adjunct anti-epileptic drugs

The pharmacological activity of Oxcarbazepine is primarily exerted through the metabolite derivative (the monohydroxy derivative, MHD) of Oxcarbazepine. The mechanism of action of Oxcarbazepine and MHD is thought to be mainly based on blockade of voltage-sensitive sodium channels, thus resulting in stabilization of hyper excited neural membranes, inhibition of repetitive neuronal firing and diminishment of propagation of synaptic impulses.

Adults: initiate with a dose of 600 mg/day, given twice-a-day

• Adjunctive Therapy: Maximum increment of 600 mg/day at approximately weekly intervals. The recommended daily dose is 1200 mg/day
• Conversion to Monotherapy: withdrawal concomitant over 3 to 6 weeks;reach maximum dose of Oxcarbazepine in 2 to 4 weeks with increments of 600 mg/day at weekly intervals to a recommended daily dose of 2400 mg/day
• Initiation of Monotherapy: Increments of 300 mg/day every third day to a dose of 1200 mg/day.
• Creatinine Clearance <30 mL/min: Initiate at one half the usual starting dose and increase slowly

Pediatrics: initiation with 8 to 10 mg/kg/day, given twice-a-day. For patients aged 2 to <4 years and under 20 kg, a starting dose of 16 to 20 mg/kg/day may be considered. Recommended daily dose is dependent upon patient weight.

• Adjunctive Patients (Aged 2–16 Years): For patients aged 4 to 16 years, target maintenance dose should be achieved over 2 weeks. For patients aged 2 to <4 years, maximum maintenance dose should be achieved over 2 to 4 weeks and should not to exceed 60 mg/kg/day
• Conversion to Monotherapy for Patients (Aged 4-16 Years): Maximum increment of 10 mg/kg/day at weekly intervals, concomitant antiepileptic drugs can be completely withdrawn over 3 to 6 weeks
• Initiation of Monotherapy for Patients (Aged 4–16 Years): Increments of 5 mg/kg/day every third day

The most commonly reported adverse reactions are somnolence, headache, dizziness, diplopia, nausea; vomiting and fatigue. Very rarely clinically significant hyponatraemia can develop during Oxazep use. Class I (immediate) hypersensitivity reactions including rash, pruritus, urticaria, angioedema and reports of anaphylaxis have been received.

It is contraindicated to patients with hypersensitivity to the active substance or to any of the excipients.

Alcohol: Caution should be exercised if alcohol is taken in combination with Oxazep therapy, due to a possible additive sedative effect.

Withdrawal: As with all antiepileptic medicinal products, Oxazep should be withdrawn gradually to minimise the potential of increased seizure frequency.

Oxcarbazepine and its metabolite inhibit the enzyme CYP2C19 and therefore, interactions could arise when co-administering high doses of Oxazep with medicinal products that are metabolised by CYP2C19 (e.g. phenobarbital, phenytoin). Concurrent use of Oxazep with hormonal contraceptives may render few contraceptives ineffective (e.g. Ethinylestradiol and Levonorgestrel preparations). Co-administration of Oxazep lowers AUC of felodipine and Verapamil decreases bioavailability of MHD.

Pregnancy: Data on a limited number of pregnancies indicate that Oxcarbazepine may cause serious birth defects (e.g. cleft palate) when administered during pregnancy. In the newborn child. Bleeding disorders in the newborn caused by antiepileptic agents have been reported. As a precaution, vitamin K1 should be administered as a preventive measure in the last few weeks of pregnancy and to the newborn. Oxcarbazepine and its active metabolite (MHD) cross the placenta. Neonatal and maternal plasma MHD concentrations were similar in one case.

Lactation: Oxcarbazepine and its active metabolite (MHD) are excreted in human breast milk. Therefore, Oxazep should not be used during breast-feeding.

Oxaliplatin, used in combination with infusional 5-fluorouracil/leucovorin, is indicated for:

• Adjuvant treatment of stage III colon cancer in patients who have undergone complete resection of the primary tumor.
• Treatment of advanced colorectal cancer.

Cytotoxic Chemotherapy

Oxaliplatin, a platinum-containing complex similar to cisplatin, is an alkylating agent. After intracellular hydrolysis, the platinum compound binds to DNA forming cross-links which inhibit DNA replication and transcription, resulting in cell death.

Intravenous (Adult)-

Adjuvant therapy in stage III colon cancer: In combination with fluorouracil/ leucovorin: 85 mg/m² every 2 wk for 12 cycles. Dose to be given by IV infusion over 2-6 hr, dissolved in 250-500 ml of glucose 5%, every 2 wk; given for 12 cycles. After recovery from toxicity, reduce dose to 75 mg/m². Administer before fluoropyrimidines.

Advanced colorectal cancer: In combination with fluorouracil/ leucovorin: 85 mg/m² every 2 wk until disease progression or unacceptable toxicity. Dose to be given by IV infusion over 2-6 hr, dissolved in 250-500 ml of glucose 5%, . After recovery from toxicity, reduce dose to 65 mg/m². Administer before fluoropyrimidines.

Fatigue, fever, pain, headache, insomnia, nausea, diarrheoa, vomiting, abdominal pain, constipation, anorexia, stomatitis, anemia, thrombocytopenia, leukopenia, aspartate and alanine transaminases increased, total bilirubin increased, peripheral neuropathy, back pain, dyspnoea, cough, oedema, chest pain, peripheral oedema, flushing , thromboembolism, dizziness, rash, alopecia , hand-foot syndrome dehydration, hypokalaemia, dyspepsia, taste perversion, flatulence, mucositis, gastroesophageal reflux, dysphagia, dysuria, neutropenia, inj site reaction, rigors, arthralgia, abnormal lacrimation, serum creatinine increased, rhinitis, epistaxis, pharyngitis, pharyngolaryngeal dysesthesia, allergic reactions, hiccup.

Pregnancy. Peripheral neuropathy with functional impairment. Severe renal impairment.

Should be administered under the supervision of an experienced cancer chemotherapy physician. Use appropriate precautions for handling and disposal. Monitor neurological status and dose should be reduced if symptoms are prolonged or severe. Monitor blood counts during treatment and courses should not be repeated until blood counts have recovered. Caution in elderly, moderate degrees of renal impairment. Avoid using aluminum-containing needles or IV admin sets that may come into contact with oxaliplatin as aluminum has been reported to cause degradation of platinum compounds. Lactation.

May decrease plasma levels of digoxin. May increase risk of toxicity with nephrotoxic drugs. When administered as sequential infusions, taxane derivatives (docetaxel, paclitaxel) should be administered before oxaliplatin to limit myelosuppression and enhance efficacy.

Category D: There is positive evidence of human foetal risk, but the benefits from use in pregnant women may be acceptable despite the risk (e.g., if the drug is needed in a life-threatening situation or for a serious disease for which safer drugs cannot be used or are ineffective).

Renal Impairment: Dose adjustment may be needed

Extensions of known adverse reaction (e.g. thrombocytopenia, myelosuppression, nausea, vomiting, neurotoxicity, respiratory symptoms). Treatment is supportive.

Reconstitute with 10 ml (for 50 mg vial) or 20 ml (for 100 mg vial) water for inj or 5% dextrose inj. Reconstituted solution must be further diluted with 250-500 ml of 5% dextrose inj before admin.

Store intact vials at 15-30°C; do not freeze. Reconstituted solution: May store at 2-8°C for up to 24 hr. Diluted solutions: Stable up to 6 hr at 20-25°C or up to 24 hr under refrigeration at 2-8°C.

Hydroxychloroquine Sulphate is indicated in-

• Acute and chronic rheumatoid arthritis
• Systemic Lupus Erythematosus (SLE)
• Malaria

Anti-malarial drugs, Disease-modifying antirheumatic drugs (DMARDs), Drugs used for Rheumatoid Arthritis

Hydroxychloroquine Sulphate synthetically produced version of quinine. It acts as an immunosuppressant by inhibiting production of rheumatoid and acute phase reactants. It also accumulates in white blood cells, stabilizing lysosomal membranes and inhibiting the activity of many enzymes, including collagenase and the proteases that cause cartilage breakdown. It also acts by disrupting cell walls of infected red blood cells and kills the developing parasites.

Hydroxychloroquine Sulphate tablets are for oral administration and are taken with food to avoid stomach upset.

Acute and chronic rheumatoid arthritis: 400 to 600 mg daily. When good response is obtained (usually 4 to 8 weeks), dose can be reduced to 50%.

Systemic Lupus Erythematosus (SLE): 400 mg once or twice daily for several weeks or months depending on response of the patients. Maintenance dose is 200 to 400 mg daily.

Malaria: In adults, an initial dose of 800 mg followed by 400 mg in 6-8 hours and 400 mg on each of two consecutive days. For children a total dose representing 25 mg/kg is administered in 3 days as follows.

• First dose: 10 mg base/kg (but not exceeding a single dose of 620 mg base).
• Second dose: 5 mg base/kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.
• Third dose: 5 mg base/kg 18 hours after second dose.
• Fourth dose: 5 mg base/kg 24 hours after third dose.

Generally Hydroxychloroquine Sulphate is well tolerated. However, few side effects like nausea, vomiting, stomach upset, loss of appetite, diarrhea, tiredness, weakness or headache and visual problem may occur the first several days.

Children are especially sensitive to the 4-aminoquinoline compounds. Patients should be strongly warned to keep these drugs out of the reach of children. Opthalmologic examination requires in every 12 months.

During pregnancy, this drug should be used only if clearly needed. Since small amounts of this medication are found in breast milk consult your doctor before medication.

Symptoms of overdose consist of headache, drowsiness, visual disturbances, cardiovascular collapse, and convulsions, followed by sudden and early respiratory and cardiac arrest. Gastric lavage until the stomach is completely emptied.

Store below 30° C.

Hydroxychloroquine Sulphate is indicated in-

• Acute and chronic rheumatoid arthritis
• Systemic Lupus Erythematosus (SLE)
• Malaria

Anti-malarial drugs, Disease-modifying antirheumatic drugs (DMARDs), Drugs used for Rheumatoid Arthritis

Hydroxychloroquine Sulphate synthetically produced version of quinine. It acts as an immunosuppressant by inhibiting production of rheumatoid and acute phase reactants. It also accumulates in white blood cells, stabilizing lysosomal membranes and inhibiting the activity of many enzymes, including collagenase and the proteases that cause cartilage breakdown. It also acts by disrupting cell walls of infected red blood cells and kills the developing parasites.

Hydroxychloroquine Sulphate tablets are for oral administration and are taken with food to avoid stomach upset.

Acute and chronic rheumatoid arthritis: 400 to 600 mg daily. When good response is obtained (usually 4 to 8 weeks), dose can be reduced to 50%.

Systemic Lupus Erythematosus (SLE): 400 mg once or twice daily for several weeks or months depending on response of the patients. Maintenance dose is 200 to 400 mg daily.

Malaria: In adults, an initial dose of 800 mg followed by 400 mg in 6-8 hours and 400 mg on each of two consecutive days. For children a total dose representing 25 mg/kg is administered in 3 days as follows.

• First dose: 10 mg base/kg (but not exceeding a single dose of 620 mg base).
• Second dose: 5 mg base/kg (but not exceeding a single dose of 310 mg base) 6 hours after first dose.
• Third dose: 5 mg base/kg 18 hours after second dose.
• Fourth dose: 5 mg base/kg 24 hours after third dose.

Generally Hydroxychloroquine Sulphate is well tolerated. However, few side effects like nausea, vomiting, stomach upset, loss of appetite, diarrhea, tiredness, weakness or headache and visual problem may occur the first several days.

Children are especially sensitive to the 4-aminoquinoline compounds. Patients should be strongly warned to keep these drugs out of the reach of children. Opthalmologic examination requires in every 12 months.

During pregnancy, this drug should be used only if clearly needed. Since small amounts of this medication are found in breast milk consult your doctor before medication.

Symptoms of overdose consist of headache, drowsiness, visual disturbances, cardiovascular collapse, and convulsions, followed by sudden and early respiratory and cardiac arrest. Gastric lavage until the stomach is completely emptied.

Store below 30° C.

Anti-oxidant Multivitamin preparations

Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.

Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.

vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.

This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.

β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.

Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.

Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.

Carocet is contraindicated in patients with hypersensitivity to any of its components.

There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.

Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.

β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.

Should be stored in a dry place below 30˚C.

Anti-oxidant Multivitamin preparations

Beta carotene of this tablet is converted to vitamin A (Retinol) when required. Retinol has several biochemical functions e.g. on retina, growth, tissue differentiation, immunological response. It has also some anti-cancer activity.

Vitamin C is the most powerful reducing agent known to be present in living tissues. Vitamin C deficiency produces scurvy. It is a cofactor in numerous biological processes. Vitamin C and molecular oxygen are essential for the conversion of proline to hydroxyproline, dopamine to noradrenaline . Vitamin C is also essential for the synthesis of adrenal steroid hormones. Vitamin C is important in the defense against infection and studies shown that vitamin C is important for the normal functioning of T-lymphocyte and leukocyte. Ascorbic acid has some antiinflammatory activity and protects cells against oxidation of essential molecules. In high doses, (1-2 g daily) ascorbic acid increases iron absorption.

vitamin E seems to be as a defense against oxidative stress and lipid peroxidation. In most cell membranes there is one molecule of tocopherol for every 1000 lipid molecules. Tocopherol mops up peroxide radicals and then needs a supply of reduced hydrogen to restore the steady-state situation. This is usually supplied by ascorbic acid or reduced glutathione.

This tablet is administered orally. The adult dose of this combination of antioxidant vitamin tablet is 1 tablet daily or as prescribed by the physician.

β carotene is comparatively safe even at high and prolonged exposure. Individuals who routinely ingest large amounts of carotenoids can develop hypercarotenosis, which is characterised by a yellowish colouration of the skin and a very high concentration of carotenoids in the plasma. This benign condition, although resembling jaundice, gradually disappears upon correcting the excessive intake of carotenoids.

Vitamin C is generally a safe drug for human use in normal doses. Larger doses may lead to gastrointestinal tract upset and renal stone formation.

Vitamin E is considered safe even in large doses. Doses over 800 mg may cause diarrhoea, abdominal pain or cramps, fatigue and reduced resistance to bacterial infection and transiently raised blood pressure.

Carocet is contraindicated in patients with hypersensitivity to any of its components.

There are some evidences that β carotene may cause harm to heavy smokers and alcoholics. Therefore, caution should be exercised in these cases. Vitamin C should be given with caution to patients with hyperoxaluria. Vitamin E should be used with caution in patients taking anticoagulant drugs, because vitamin E may enhance the anticoagulant activity of these drugs.

Cholestyramine, Colestipol, Neomycin cause decreased absorption of β carotene. Circulating vitamin C levels have been shown to be reduced during prolonged administration of oral contraceptives containing Oestrogen, Tetracycline and Aspirin. The decrease in vitamin C level may be due to drug induced impaired absorption or increased utilization of the vitamin for drug metabolism. Vitamin E may enhance the anticoagulant activity of anticoagulant drugs. High doses of vitamin E can impair intestinal absorption of vitamins A and K.

β carotene, vitamin C and vitamin E have no teratogenic effects in humans. However, like any other drugs caution should be taken in prescribing to pregnant women.

Should be stored in a dry place below 30˚C.

Oxiconazole topical preparation is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Oxiconazole Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur.

Topical Antifungal preparations

This topical preparation contains the antifungal active compound Oxiconazole Nitrate. For topical dermatological use only. Oxiconazole Nitrate is an imidazole derivative whose antifungal activity is derived primarily from the inhibition of ergosterol biosynthesis, which is critical for cellular membrane integrity. It has in vitro activity against a wide range of pathogenic fungi. Oxiconazole has been shown to be active against most strains of the following organisms both in vitro and in clinical infections at indicated body sites: Epidermophyton floccosum, Trichophyton mentagrophytes, Trichophyton rubrum, Malassezia furfur. Oxiconazole exhibits satisfactory in vitro minimum inhibitory concentrations (MICs) against most strains of the following organisms: Microsporum audouini, Microsporum canis, Microsporum gypseum, Trichophyton tonsurans,Trichophyton violaceum.

This topical preparation should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oxiconazole Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence.

Pruritus, burning, irritation and allergic contact dermatitis, folliculitis, erythema, and papules, fissure, maceration, rash, stinging and nodules.

Oxiconazole topical preparation is contraindicated in individuals who have shown previous hypersensitivity to Oxiconazole

Oxiconazole topical preparation is not for ophthalmic or intravaginal use.

Potential drug interactions between Oxiconazole and other drugs have not been systematically evaluated.

Pregnancy category B. Because Oxiconazole Nitrate is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.

Store in a cool and dry place,protected from light. Do not freeze.

Oxiconazole topical preparation is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum. Oxiconazole Cream is indicated for the topical treatment of tinea (pityriasis) versicolor due to Malassezia furfur.

Topical Antifungal preparations

This topical preparation contains the antifungal active compound Oxiconazole Nitrate. For topical dermatological use only. Oxiconazole Nitrate is an imidazole derivative whose antifungal activity is derived primarily from the inhibition of ergosterol biosynthesis, which is critical for cellular membrane integrity. It has in vitro activity against a wide range of pathogenic fungi. Oxiconazole has been shown to be active against most strains of the following organisms both in vitro and in clinical infections at indicated body sites: Epidermophyton floccosum, Trichophyton mentagrophytes, Trichophyton rubrum, Malassezia furfur. Oxiconazole exhibits satisfactory in vitro minimum inhibitory concentrations (MICs) against most strains of the following organisms: Microsporum audouini, Microsporum canis, Microsporum gypseum, Trichophyton tonsurans,Trichophyton violaceum.

This topical preparation should be applied to affected and immediately surrounding areas once to twice daily in patients with tinea pedis, tinea corporis, or tinea cruris. Oxiconazole Cream should be applied once daily in the treatment of tinea (pityriasis) versicolor. Tinea corporis, tinea cruris, and tinea (pityriasis) versicolor should be treated for 2 weeks and tinea pedis for 1 month to reduce the possibility of recurrence.

Pruritus, burning, irritation and allergic contact dermatitis, folliculitis, erythema, and papules, fissure, maceration, rash, stinging and nodules.

Oxiconazole topical preparation is contraindicated in individuals who have shown previous hypersensitivity to Oxiconazole

Oxiconazole topical preparation is not for ophthalmic or intravaginal use.

Potential drug interactions between Oxiconazole and other drugs have not been systematically evaluated.

Pregnancy category B. Because Oxiconazole Nitrate is excreted in human milk, caution should be exercised when the drug is administered to a nursing woman.

Store in a cool and dry place,protected from light. Do not freeze.

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.

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.

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

Ciprofloxacin is a synthetic fluoroquinolone. It has bactericidal activity against a wide range of gram-positive and gram-negative organisms. It inhibits bacterial DNA synthesis by binding with the bacterial enzyme-DNA gyrase and topoisomerase IV which are responsible for DNA supercoiling.

Tablet: Adult:

• Respiratory Tract Infections: 500 to 750 mg twice daily (7 to 14 days)
• Urinary tract infections: 250 to 750 mg twice daily (3 to 10 days)
• Pelvic Inflammatory Diseases: 500 to 750 mg twice daily (14 days)
• Infectious Diarrhea (Shigella dysenteriae, Vibrio cholera): 500 mg twice daily (1 to 5 days)
• Typhoid fever: 500 mg twice daily (7 days)
• Intra-abdominal infections: 500 to 750 mg twice daily (5 to 14 days)
• Prostatitis: 500 to 750 mg twice daily (2 to 6 weeks)
• Skin and Soft Tissue Infections: 500 to 750 mg twice daily (7 to 14 days)
• Bone and Joint Infections: 500 to 750 mg twice daily (max. 3 months)
• Gonorrhea: 500 mg as a single dose
• Neutropenic patients with fever due to bacterial infection: 500 to 750 mg twice daily co-administered with appropriate antibacterials.
• Meningitis: 500 mg as a single dose.
• Surgical prophylaxis: 500 mg as a single dose, 60 minutes before the procedure.

Suspension: Pediatric: 10-20 mg/kg (max. 750 mg) twice daily (10 to 21 days). The duration of therapy depends on the type and severity of the infection.

Extended-release tablet: In uncomplicated urinary tract infection (acute cystitis), the recommended dose of extended-release tablet is 1000 mg tablet once daily for three days.

For IV infusion:

• Urinary Tract Infection: Mild to Moderate: 200 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 12 hourly for 7-14 days
• Lower Respiratory Tract infection: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Nosocomial Pneumonia: Mild/Moderate/Severe: 400 mg 8 hourly for 10-14 days
• Skin and Skin Structure: Mild to Moderate: 400 mg 12 hourly for 7-14 days; Severe or Complicated: 400 mg 8 hourly for 7-14 days
• Bone and Joint Infection: Mild to Moderate: 400 mg 12 hourly for more than 4-6 weeks; Severe/Complicated: 400 mg 8 hourly for more than 4-6weeks
• Intraabdominal (Acute abdomen): Complicated: 400 mg 12 hourly for 7-14 days
• Acute Sinusitis: Mild/Moderate: 400 mg 12 hourly for 10 days
• Chronic Bacterial Prostatitis: Mild/Moderate: 400 mg 12 hourly for 28 Days.

Instruction for the use of Ciprofloxacin IV infusion-

• Check the bag for minute leaks by squeezing the inner bag firmly. If leaks are found, or if seal is not intact, discard the solution.
• Do not use if the solution is cloudy or a precipitate is present.
• Do not use flexible bags in series connections.
• Close flow control clamp of administration set.
• Remove cover from port at bottom of bag.
• Insert piercing pin of administration set into port with a twisting motion until the pin is firmly seated.
• Suspend bag from hanger.
• Squeeze and release drip chamber to establish proper fluid level in chamber during infusion of Ciprofloxacin IV infusion.
• Open flow control clamp to expel air from set.Close clamp.
• Regulate rate of administration with flow control clamp

Duration of treatment: The duration of treatment depends upon the severity of infection, clinical response and bacteriological findings. For acute infections the usual treatment period is 5 to 10 days. Generally treatment should be continued for 3 days after the signs and symptoms of the infection have been disappeared.

Side effects include- nausea and other gastrointestinal disturbances, headache, dizziness, joint pain and skin rashes.

It is contraindicated in patients who have known hypersensitivity to Ciprofloxacin or other quinolones.

Patients receiving Ciprofloxacin should be instructed to drink fluids liberally. It should be used with caution in patients with suspected or known CNS disorders such as epilepsy or other factors which predispose to seizures and convulsion. Avoid in patients with known QT prolongation, hypokalemia.

Concurrent administration of Ciprofloxacin should be avoided with Magnesium or Aluminum containing antacids or sucralfate or with other products containing Calcium, Iron or Zinc. These products may be taken two hours after or six hours before Ciprofloxacin. Ciprofloxacin should not be taken concurrently with milk or other dairy products, since absorption of Ciprofloxacin may be significantly reduced. Dietary calcium is a part of a meal, however, does not significantly affect the absorption of Ciprofloxacin.

There are no adequate and well-controlled studies in pregnant women. Ciprofloxacin should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus and mother. Ciprofloxacin is excreted in human milk. Due to the potential risk of articular damage, Ciprofloxacin should not be used during lactation.

Although effective in clinical trials, Ciprofloxacin is not a drug of first choice in pediatric population.

Overdose following Ciprofloxacin administration may lead to seizures, hallucinations, confusion, abdominal discomfort, renal and hepatic impairment as well as crystalluria, haematuria, & reversible renal toxicity.

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

Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.

Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations

Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.

Oxymetazoline nasal spray-

• Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
• Elderly: There is no need for dosage reduction in the elderly for nasal administration.
• Children below 6 years of age: It is not suitable for children below 6 years of age.

Oxymetazoline nasal drop-

• Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
• Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.

It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.

Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.

The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.

Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.

Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.

Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.

Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations

Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.

Oxymetazoline nasal spray-

• Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
• Elderly: There is no need for dosage reduction in the elderly for nasal administration.
• Children below 6 years of age: It is not suitable for children below 6 years of age.

Oxymetazoline nasal drop-

• Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
• Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.

It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.

Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.

The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.

Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.

Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.

Oxymetazoline Hydrochlorid is indicated for the treatment of nasal congestion associated with acute or chronic rhinitis, common cold, sinusitis, upper respiratory allergies, epistaxis and hay fever. It is also used as nasal decongestant in otitis media.

Nasal Anti-histamine preparations, Nasal Decongestants & Other Nasal Preparations

Oxymetazoline Hydrochloride is an imidazoline derivative sympathomimetic amine. It is a direct agonist at α-adrenoceptors but has no action on β- adrenoceptors. It is used as a topical agent on the nasal mucosa, produces a rapid and long acting vasoconstriction of the arterioles, thus reducing the blood flow and diminishing swelling of the mucosa. This results in improved potency of the airway and better drainage of the nasal sinus.

Oxymetazoline nasal spray-

• Adults and children (6 years of age and older): 2 or 3 sprays in each nostril twice daily for 3-5 days.
• Elderly: There is no need for dosage reduction in the elderly for nasal administration.
• Children below 6 years of age: It is not suitable for children below 6 years of age.

Oxymetazoline nasal drop-

• Adults & children 6 years of age: 2-3 drops of 0.05% Nasal Drops in each nostril twice daily in the morning and evening.
• Children 2-5 years of age: 2-3 drops of 0.025% Nasal Drops in each nostril twice daily in the morning and evening

How to use the Nasal Spray-

• Shake the bottle gently and remove the dust cover.
• Hold the spray with your forefinger and middle finger on either side of the nozzle and your thumb underneath the bottle. Press down until a fine spray appears. If using for the first time or if you have not used it for a week or more, press the nasal applicator several times until a fine moist comes out from the container.
• Gently blow the nose to clear the nostrils.
• Close one nostril and carefully insert the nasal applicator into the open nostril. Tilt your head forward slightly and keep the spray upright. Breathe in through your nose and while breathing in, press the white-collar of nasal applicator firmly down once to release a spray.
• Breathe out through your mouth.
• Repeat the above steps in the same/ other nostril for consecutive doses.

Cleaning: The nasal spray should be cleaned at least once a week. The procedures are as follows-

• Remove the dust cover.
• Gently pull off the nasal applicator.
• Wash the applicator and dust cover in warm water.
• Shake off the excess water and leave to dry in a normal place. Avoid to apply additional heat.
• Gently push the applicator back on the top of the bottle and re-fix the dust cover.

Occasionally it may cause local irritation and dryness of the mouth and throat. Temporarily discomfort such as burning, stinging, sneezing or increase in nasal discharge may occur.

It is contraindicated in patients with cardiovascular disease, hyperthyroidism, prostatic enlargement, angle closure glaucoma and hypersensitivity to any of its ingredients.

Keep away from the eyes. The spray should not be used for longer than seven days without medical advice. Frequent or prolonged use may cause nasal congestion to recur or worsen.

Oxymetazoline Hydrochloride Nasal preparation should not be given to patients being treated with MAO inhibitors or within 14 days of ceasing such treatment.

The safety of Oxymetazoline Hydrochloride Nasal Spray during pregnancy and lactation has not been established, but is not thought to constitute a hazard during those periods.

Overdose may give rise to local irritation and rebound congestion. Treatment need only be symptomatic.

Keep below 30° C temperature in a dry place, protect from light. Do not refrigerate or freeze. Keep out of the reach of children.

Used to temporarily numb the front surface of the eye so that the eye pressure can be measured or a foreign body removed.

Ocular perioperative drugs

Oxybuprocaine is a local anaesthetic. It may be less irritating than tetracaine, and the onset and duration of action are similar to tetracaine. Oxybuprocaine binds to sodium channel and reversibly stabilizes the neuronal membrane which decreases its permeability to sodium ions. Depolarization of the neuronal membrane is inhibited thereby blocking the initiation and conduction of nerve impulses.

Use as a 0.4% solution in short ophthalmic procedures. Instil 1 drop into the conjunctival sac to allow tonometry after 60 sec; a further drop after a 90 sec interval produces sufficiReduce systemic absorption by compressing the lacrimal sac at the medial canthus for a minute during and following instillation. Heart block; epilepsy, impaired cardiac conduction, myasthenia gravis; not to be applied to inflamed, infected tissues or damaged mucosa. Protect anaesthetised eye from dust and bacterial contamination; cornea may be damaged by prolonged application. Do not drive until normal vision restored.ent anaesthesia for the fitting of contact lenses; 3 drops at 90 sec intervals produces sufficient anaesthesia after 5 min for a foreign body to be removed from the corneal epithelium or for incision of a meibomian cyst through the conjunctiva.

Hypersensitivity reactions; transient stinging and blurring of vision; excitation of CNS; muscle twitching and tremors; convulsions.

Reduce systemic absorption by compressing the lacrimal sac at the medial canthus for a minute during and following instillation. Heart block; epilepsy, impaired cardiac conduction, myasthenia gravis; not to be applied to inflamed, infected tissues or damaged mucosa. Protect anaesthetised eye from dust and bacterial contamination; cornea may be damaged by prolonged application. Do not drive until normal vision restored.

Pregnancy Category C. Either studies in animals have revealed adverse effects on the foetus (teratogenic or embryocidal or other) and there are no controlled studies in women or studies in women and animals are not available. Drugs should be given only if the potential benefit justifies the potential risk to the foetus.

Ursodeoxycholic Acid is indicated for the treatment of

• Cholestasis (Jaundice)
• Viral Hepatitis
• Alcoholic Fatty Liver
• Primary Billiary Cirrhosis (PBC)
• Primary Sclerosing Cholangitis (PSC)
• Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis (NASH).

Anti-gallstones drugs: Bile Acids

Ursodeoxycholic Acid is a naturally occurring bile acid used to treat different hepatobilliary disorders. The activity of Ursodeoxycholic Acid is achieved through a decrease in secretion of cholesterol in bile. Ursodeoxycholic Acid achieves this through a few mechanisms: it reduces cholesterol absorption, suppresses liver cholesterol synthesis and it does not inhibit bile acid synthesis.

Therefore, alters bile composition from supersaturated to unsaturated. Ursodeoxycholic Acid also promotes the formation of liquid cholesterol crystal complexes which enhance removal of the cholesterol from the gallbladder into the intestine to be expelled. Ursodeoxycholic Acid improves cholestatic liver diseases by-

• Protecting cholangiocytes against cytotoxicity of hydrophobic bile acids
• Stimulating hepatobilliary secretion
• Protecting hepatocytes against bile acid-induced apoptosis

Ursodeoxycholic Acid is completely absorbed in the upper intestine. Time to peak serum concentration varies from 30 to 150 minutes. The rate of absorption ranges from 60-80%. After absorption Ursodeoxycholic Acid enters the portal vein and undergoes extraction from portal blood by liver where it is conjugated with amino acid & that may be either glycine or taurine and then secreted into the hepatic bile ducts. Small quantities of Ursodeoxycholic Acid appear in the circulation and very small amounts are excreted into urine. The biologic half life of Ursodeoxycholic Acid ranges from 3.5-5.8 days.

Dissolution of Gall stones: 8-12 mg/kg/day either as single night time dose or in divided doses.

Primary Billiary Cirrhosis: 10-15 mg/kg/day in 2-4 divided doses.

Acute Viral Hepatitis: 600 mg/day.

Alcoholic Fatty Liver: 300 mg/day.

Primary Sclerosing Cholangitis: 25-30 mg/kg/day.

Dissolution of Gallstones and Non-Alcoholic Steato Hepatitis: 13-15 mg/kg/day.

Commonly reported side effects are nausea, vomiting, diarrhoea, gallstone opacilication, pruritus.

Non-functioning gall-bladder calcified and pigmented gallstones, inflammatory bowel disease.

It should be used cautiously in those with liver disease.

Ursodeoxycholic Acid should not be used with drugs, such as oestrogenic hormones, that increase bile cholesterol. Concomitant administration with bile-acid binding drugs including antacids, charcoal and cholestyramine should be avoided, since this may reduce the effectiveness of therapy with Ursodeoxycholic acid.

Pregnancy category B. No evidence of harm has been reported in pregnancy. It has been effectively used for the treatment of cholestasis of pregnancy during the last trimester without any side effects. Problems have not been documented in humans regarding breast feeding.

Store below 25° C. Protected from light and moisture. Keep the medicine out of the reach of children.