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White soft paraffin, Liquid paraffin & Wool alcohol combination eye ointment is indicated in dry eye condition particularly useful at night as it remains in the eye longer than drops. It is used as adjunctive therapy to lubricate and protect the eye in conditions such as exposure keratitis, decreased corneal sensitivity, recurrent corneal erosions, keratitis sicca, and ophthalmic surgery.

Emollients & combined preparations

White soft paraffin, Liquid paraffin & Wool alcohol combination eye ointment produce a transparent, lubricating and moistening film on the surface of the eyeball. White soft paraffin, Liquid paraffin & Wool alcohol eye ointment provides soothing relief from the symptoms of dry eyes such as soreness, irritation or a gritty sensation. These may be caused by inadequate production of tears to keep the eye moist or by things such as certain medical conditions or treatment. The ointment also helps to protect the eyeball and can thus be useful for people who suffer from recurrent corneal epithelial erosion.

Apply a ribbon of ointment (1-1.5 cm) into the affected eye(s) prior to going to sleep or as directed by doctor.

Stinging/redness in the eye, widened pupils or blurred vision may occur.

Hypersensivity to any components of the medication

Ophthalmic use only. If patients experience headache, eye pain, vision changes, irritation of the eyes, persistent redness or if the condition worsens or persists for more than 72 hours discontinue use and consult with doctor.

Pregnancy: There is no data from the use of White paraffin, Liquid paraffin & Wool alcohol combination eye ointment in pregnant women. However, all three components are pharmacologically inert, non-irritating and nontoxic.

Lactation: It is unknown that White paraffin, Liquid paraffin & Wool alcohol eye ointment are excreted in human milk.

Store in a cool and dry place, away from light. Keep out of reach of children. Do not touch the tip to surfaces since this may contaminate the product. Do not use the medicine after one month of first opening.

Benzodiazepine sedatives

Bromazepam is a powerful psychotropic agent. In lower dosage, it selectively reduces tension and anxiety. In higher dosage, it shows sedative and muscle-relaxant properties. Bromazepam binds to the GABA-A receptor producing a conformational change and potentiating its inhibitory effects. Other neurotransmitters are not influenced.

Standard dosage: Average dosage for outpatient therapy is 1.5-3 mg up to three times daily. Treatment of outpatients should begin with low doses, gradually increasing to the optimum level.

In severe cases, especially in hospital: 6-12 mg 2 or 3 times daily. The overall treatment generally should not be more than 8-12 weeks. In certain cases extension beyond the maximum treatment period may be necessary; if so, it should be taken with re-evaluation of the patient's status with special expertise.

Elderly and debilitated patients: Elderly patients and those with impaired hepatic functions require lower doses.

Children: Bromazepam is usually not indicated in children, but if the physician feels bromazepam treatment is appropriate, then the dose should be adjusted to their low bodyweight (about 0.1-0.3 mg/kg bodyweight)

Bromazepam tablets are for oral administration

Common side-effects include fatigue, drowsiness, muscle weakness, numbed muscle, reduced alertness, confusion, headache, ataxia etc. These phenomena occur predominantly at the start of therapy and usually disappear with prolonged administration. Anterograde amnesia may occur using therapeutic doses.

Bromazepam is contraindicated in patients with known hypersensitivity to bromazepam, severe respiratory insufficiency, severe hepatic insufficiency or sleep apnea syndrome.

The use of benzodiazepines and benzodiazepine like agents may lead to the development of physical and psychological dependence upon these products. This dependence depends on the dose and duration of treatment; it is also greater in predisposed patients with a history of alcohol. Once physical dependence has developed, termination of the treatment will be accompanied by withdrawal symptoms. These may consist of headache, muscle pain, extreme anxiety, tension, confusion and irritability. Since the risk of withdrawal phenomena and rebound phenomena is greater after abrupt discontinuation of the treatment, it is recommended that the dosage be decreased gradually. Bromazepam is not recommended for the primary treatment of sleeplessness caused by psychotic illness. Caution should be exercised while driving cars or using machineries.

If bromazepam is combined with other centrally active drugs, its sedative effects may be enhanced. These drugs are antidepressants, hypnotics, narcotics, antipsychotics, sedatives, antiepileptic drugs, sedative antihistamines and anesthetics. Co-administration of cimetidine may prolong the eliminiation half-life of bromazepam. Concomitant intake of bromazepam with alcohol should be avoided, because the sedative effect of bromazepam may be intensified by alcohol.

The safety of bromazepam during pregnancy has not been established. As bromazepam is excreted in breast milk, use should be avoided during lactation.

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

Nikethamide Injection is used for the treatment, control, prevention, & improvement of the following diseases, conditions and symptoms: Central nervous system stimulant, Barbiturate overdose

Respiratory stimulants: analeptics

Nikethamide was formerly used as a respiratory stimulant but its use for this indication is no longer recommended as the effective doses are close to those causing toxic effects (especially convulsions).

1500 mg as single dose. Frequency: as recommended.

The following is a list of possible side-effects that may occur from all constituting ingredients of Nikethamide Injection: Skin irritation, Eye irritation, Respiratory irritation.

Porphyria, epilepsy or other convulsive disorders, cerebral oedema, cerebrovascular accident, head injury, acute severe asthma, physical obstruction of the airway, severe hypertension, ischaemic heart disease, hyperthyroidism, phaeochromocytoma.

Less severe degrees of hypertension or impaired cardiac reserve; liver dysfunction.

Additive pressor effects with sympathomimetics or MAOIs. Increased risk of cardiac arrythmias with some anaesthetics (halothane, enflurane, isoflurane). May mask the effects of neuromuscular blockers. Increased risk of convulsions with bupropion.

Herbal and Nutraceuticals

কালাে জিরা প্রায় ২০০০ বছরেরও বেশি সময় ধরে ওষুধ হিসাবে ব্যবহৃত হয়ে আসছে। এমনকি কিং টুটের সমাধি থেকেও এটি আবিষ্কৃত হয়েছিল। প্রাচীনকাল থেকেই কালাে জিরা মাথা ব্যথা, দাঁত ব্যথা, নাক বন্ধ এবং পেটের ক্রিমি উপশমে ব্যবহৃত হয়ে আসছে। বর্তমানে কালাে জিরা পরিপাকতন্ত্রের বিভিন্ন সমস্যা, যেমন- গ্যাস্ট্রিক, পেট ব্যথা, ডায়রিয়া, আমাশয়, কোষ্ঠকাঠিন্য এবং অশ্বরােগেও ব্যবহৃত হয়। এছাড়াও এটি হাঁপানি, এলার্জি, ব্রংকাইটিস, এমফিসেমা এবং কনজেশনের মত বিভিন্ন শ্বসনতন্ত্রের সমস্যায় ব্যবহৃত হয়। রক্তচাপ নিয়ন্ত্রণে, চর্বি কমাতে, ক্যান্সার নিরাময়ে এবং রােগ প্রতিরােধ ক্ষমতা বাড়াতেও এর ব্যবহার লক্ষণীয়। মহিলারা মাসিকের সমস্যায় এমনকি দুধের পরিমাণ বাড়াতেও কালােজিরা ব্যবহার করে। কালােজিরা কেমােথেরাপির পার্শ্বপ্রতিক্রিয়া কমাতেও সাহায্য করে। অনেকে বাতের ব্যথা, মাথা ব্যথা এবং ত্বকের নানা সমস্যায় সরাসরি কালােজিরা তেল ব্যবহার করে থাকেন।

প্রাপ্ত বয়স্ক (১৫ বছরের উপরে): ১ টি করে ক্যাপসুল দিনে ২ বার।
শিশু (৫-১৫ বছরের মধ্যে): প্রতিদিন ১ টি করে ক্যাপসুল অথবা চিকিৎসকের পরামর্শ অনুযায়ী সেব্য।

স্বল্পমাত্রায় ওষুধ হিসাবে ব্যবহারে কোন বিরূপ প্রতিক্রিয়া লক্ষ্য করা না গেলেও, অতিমাত্রায় ব্যবহার কতটুকু নিরাপদ সে বিষয়ে যথেষ্ট তথ্য পাওয়া যায় না।

৫ বছরের কম বয়সী শিশুদের ক্ষেত্রে ব্যবহার সমীচিন নয়।

কালােজিরা রক্ত জমাট বাঁধার প্রক্রিয়াকে ব্যহত করে রক্ত ক্ষরণের সম্ভাবনাকে বাড়িয়ে দেয়। তাই এটি ব্লিডিং ডিজঅর্ডারকে আরও বৃদ্ধি করে থাকে। তাছাড়া কালােজিরা অ্যানেস্থেসিয়ার সাথেও সমস্যা সৃষ্টি করে বিধায় এটি যে কোন সার্জারির কমপক্ষে দুই সপ্তাহ আগে থেকে বন্ধ করা উচিৎ।

গর্ভাবস্থায় এর ব্যবহারে কোন নিষেধাজ্ঞা জানা যাযনি। এটি মাতৃদুগ্ধ উৎপাদন এবং নিঃসরণ বৃদ্ধিতেও বহুল ব্যবহৃত।

আলাে থেকে দূরে, শুষ্ক ও ঠাণ্ডা স্থানে রাখুন। সকল ওষুধ শিশুদের নাগালের বাইরে রাখুন।

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

Antacids, Anti-dyspeptic/Carminatives

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

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

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

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

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

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

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

Over dosage with this formulation is a rare case.

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

Drugs for subcutaneous and mycoses, Topical Antifungal preparations

Clotrimazole acts primarily by damaging the permeability barrier in the cell membrane of fungi. Clotrimazole causes inhibition of ergosterol biosynthesis, an essential constituent of fungal cell membranes. If ergosterol synthesis is either completely or partially inhibited, the cell is no longer able to construct an intact and functional cell membrane. Because ergosterol directly promotes the growth of fungal cells in a hormone‐like fashion, rapid onset of the above events leads to dose-dependent inhibition of fungal growth.

Though decreased ergosterol, due to the inhibition of lanosterol 14-demethylase (also known as CYP51) is accepted to be primarily responsible for the antimycotic properties of clotrimazole, this drug also shows other pharmacological effects. These include the inhibition of sarcoplasmic reticulum Ca²⁺ ATPase, depletion of intracellular calcium, and blocking of calcium‐dependent potassium channels and voltage‐dependent calcium channels. The action of clotrimazole on these targets accounts for other effects of this drug that are separate from its antimycotic activities.

Clotrimazole Cream: This should be thinly applied 2-3 times daily to the infected sites and rubbed in. On account of the excellent efficacy, a small amount of cream is usually sufficient for an area about the size of the palm. For the treatment to become a complete success, reliable and sufficiently long-time application of Clotrimazole Cream is important. The duration of treatment varies; it depends among other factors on the extent and localization of the disease.

Recommended duration of treatment-

• Dermatomycoses: 3-4 weeks
• Candida vulvitis and Candida balanitis: 1-2 weeks
• Erythrasma and Pityriasis Versicolor: 3 weeks (approximately)

In fungal infection of the feet, to prevent relapse, treatment should be continued for about 2 weeks beyond the disappearance of all signs of disease. After washing, the feet should be thoroughly dried (particularly spaces between the toes). Clotrimazole Cream is odorless, can be washed off and does not stain clothing.

Clotrimazole topical solution: Apply this sparingly to the affected areas and rub in gently, two or three times daily.

When applied topically, Clotrimazole is well tolerated.With external application, systemic effects are not observed. Local irritation or burning sensation may occur in a very few cases but these symptoms are not considered harmful.

Hypersensitivity to Clotrimazole.

No information is available.

It is recommended that Clotrimazole should be used in pregnancy only when considered necessary by the physician.

Keep below 25°C temperature, away from light & moisture. Keep out of the reach of children.

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

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

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

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

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

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

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

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

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

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

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

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

Third generation Cephalosporins

Ceftriaxone is a 3rd generation broad-spectrum parenteral cephalosporin antibiotic. It has potent bactericidal activity against a wide range of Gram-positive and Gram-negative organisms. Like other cephalosporins and penicillins, Ceftriaxone kills bacteria by interfering with the synthesis of the bacterial cell wall. Ceftriaxone has a high degree of stability in the presence of beta lactamases. A remarkable feature of Ceftriaxone is its relatively long plasma elimination half-life of about 6 to 9 hours, which makes single or once-daily dosage of the drug appropriate for most patients. Ceftriaxone is not metabolized in the body. About 40-65% of a dose of Ceftriaxone is excreted unchanged in the urine; the remainder is excreted in the bile and ultimately found in the feces as unchanged drug and microbiologically inactive compound. The drug is highly protein bound (95%).

Adult: The usual dose is 1 to 2 gm by intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Acute bacterial otitis media, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections, Meningitis: 1 to 2 g IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 4 gm/day
• Uncomplicated gonococcal infections: 250 mg IM as a single dose
• Surgical prophylaxis: 1 g IV as a single dose 30 to 120 minutes before surgery

Infants and Children (01 month or older): The usual dose is 50 to 75 mg/kg intravenous or intramuscular administration once a day (or in equally divided doses twice a day).

• Pneumonia, Bronchitis, Skin and skin structure infection, Urinary tract infections, Bacterial Septicemia, Bone and joint infections: 50 to 75 mg/kg IV or IM once a day (or in equally divided doses twice a day); Maximum dose: 2 gm/day
• Acute bacterial otitis media: 50 mg/kg IM in single dose; Maximum dose: 1 gm/day
• Meningitis: 100 mg/kg IV or IM in single daily dose or (or in equally divided doses twice a day); Maximum dose: 4 gm/day

Duration of therapy: Continue for more than 2 days after signs and symptoms of infection have disappeared. Usual duration is 4 to 14 days; in complicated infections, longer therapy may be required.

Preparation of Solutions for Intramuscular / Intravenous Injections:

• For Intramuscular Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 2 ml Lidocaine HCI 1% injection or 1 g Ceftriaxone in 3.5 ml of Lidocaine HCI 1% injection.
• For Intravenous Injection: 250 mg or 500 mg Ceftriaxone should be dissolved in 5 ml of Water for injection or 1 g Ceftriaxone in 10 ml of Water for injection USP or 2 g Ceftriaxone in 20 ml of Water for injection.

The injection should be administered over 2-4 minutes, by Intramuscular or Intravenous injection or by tubing infusion over a period of 30 minutes at concentration between 10 mg/mL and 40 mg/mL. Before starting treatment through Ceftriaxone injection, patient tolerance test should be checked by administration of a test dose. (The use of freshly reconstituted solution is recommended. However, it maintains potency for at least 6 hours at room temperature or 24 hours at 5°C).

Ceftriaxone is generally well tolerated. A few side effects such as gastro-intestinal effects including diarrhea, nausea and vomiting, stomatitis and glossitis; cutaneous reactions including rash, pruritus, urticaria, edema and erythema multiforme; hematologic reactions including eosinophilia, thrombocytopenia, leucopenia, anemia and neutropenia; hepatic reactions including elevations of SGOT or SGPT, bilirubinemia; CNS reactions including nervousness, confusion, sleep disturbances, headache, hyperactivity, convulsion, hypertonia and dizziness were reported. Local phlebitis occurs rarely following intravenous administration but can be minimized by slow injections over 2-4 minutes.

Ceftriaxone should not be given to patients with a history of hypersensitivity to cephalosporin antibiotics.

As with other cephalosporins, anaphylactic shock cannot be ruled out even if a thorough patient history is taken. Anaphylactic shock requires immediate countermeasures such as intravenous epinephrine followed by a glucocorticoid. In rare cases, shadows suggesting sludge have been detected by sonograms of the gallbladder. This condition was reversible on discontinuation or completion of Ceftriaxone therapy. Even if such findings are associated with pain, conservative, nonsurgical management is recommended. During prolonged treatment the blood picture should be checked at regular intervals.

No drug interactions have been reported.

Its safety in human pregnancy has not been established. Therefore, it should not be used in pregnancy unless absolutely indicated. Low concentrations of Ceftriaxone are excreted in human milk. Caution should be exercised when Ceftriaxone is administered to a lactating mother.

Ceftriaxone must not be given to neonates if the neonates is premature and newborn (up to 28 days of age).

There is no specific antidote. Treatment of overdosage should be symptomatic.

Vial store in a cool, dry place (below 30° C), away 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.

Nilotinib is indicated in advanced renal cell carcinoma (RCC), advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of Nilotinib 200 for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

Targeted Cancer Therapy

Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T- cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). In vitro, Pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR receptors.

Absorption: Pazopanib is absorbed orally with the median time to achieve peak concentrations of 2 to 4 hours after the dose. Daily dosing at 800 mg results in geometric mean AUC and Cmax of 1,037 mcg/mL and 58.1 mcg/mL (equivalent to 132 μM), respectively. There was no consistent increase in AUC or Cmax at Pazopanib doses above 800 mg.

Distribution: Binding of Pazopanib to human plasma protein in vivo was greater than 99% with no concentration dependence over the range of 10 to 100 mcg/mL. In vitro, studies suggest that Pazopanib is a substrate for P-gp and BCRP.

Metabolism: In vitro studies demonstrated that Pazopanib is metabolized by CYP3A4 with a minor contribution from CYP1A2 and CYP2C8.

Elimination: Pazopanib has a mean half-life of 30.9 hours after administration of the recommended dose of 800 mg. Elimination is primarily via feces with renal elimination accounting for less than 4% of the administered dose.

The recommended starting dose of Pazopanib is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Pazopanib should not exceed 800 mg. Tablets should not be crushed due to the potential for an increased rate of absorption which may affect systemic exposure. If a dose is missed, it should not be taken if it is less than 12 hours until the next dose or as directed by the registered physicians.

Pediatric Use: The safety and effectiveness of Pazopanib in pediatric patients have not been established.

Should be taken on an empty stomach. Avoid food at least 2 hr before & at least 1 hr after a dose. Swallow whole, do not chew/crush. Avoid grapefruit products.

Rash, pruritus, hepatotoxicity, headache, fever, fatigue, GI disturbances (nausea, constipation, diarrhoea), alopecia, asthenia, muscle spasms, arthralgia, myalgia, pain (e.g. musculoskeletal or chest pain), oedema, folliculitis, papilloma, insomnia, dizziness, vertigo, anxiety, paraesthesia, hyperhidrosis, dry skin, urticaria, acne, conjunctivitis, dry eye, flushing, dyspnoea, cough, myelosuppression (e.g. thrombocytopenia, neutropenia, and anaemia), thrombotic disorders or haemorrhage, arrhythmias, heart failure, pericarditis, palpitations, HTN, angina, MI; elevated AST/ALT, serum lipase; electrolyte imbalances.

It is contraindicated in patients with known hypersensitivity to Pazopanib or any other components of this product.

Hepatic Toxicity and Hepatic Impairment: In clinical trials with Pazopanib, hepatotoxicity, manifested as increases in serum transaminases (alanine transferase [ALT], aspartate aminotransferase [AST]) and bilirubin, was observed. This hepatotoxicity can be severe and fatal. Patients older than 65 years are at greater risk for hepatotoxicity. Transaminase elevations occur early in the course of treatment (92.5% of all transaminase elevations of any grade occurred in the first 18 weeks).

QT Prolongation and Torsades De Pointes: In the RCC trials of Pazopanib, QT prolongation (greater than or equal to 500 msec) was identified on routine electrocardiogram (ECG) monitoring in 2% (11/558) of patients. Torsades de pointes occurred in less than 1% (2/977) of patients who received Pazopanib in the monotherapy trials. Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medications that may prolong QT interval, and those with relevant pre-existing cardiac disease. When using Pazopanib, baseline and periodic monitoring of ECGs and maintenance of electrolytes (e.g., calcium, magnesium, potassium) within the normal range should be performed.

Hemorrhagic Events: Fatal hemorrhage occurred in 0.9% (5/586) in the RCC trials; there were no reports of fatal hemorrhage in the STS trials. In the randomized RCC trial, 13% (37/290) of patients treated with Pazopanib and 5% (7/145) of patients on placebo experienced at least 1 hemorrhagic event. The most common hemorrhagic events in the patients treated with Pazopanib were hematuria (4%), epistaxis (2%), hemoptysis (2%), and rectal hemorrhage (1%). Nine of 37 patients treated with Pazopanib, who had hemorrhagic events, experienced serious events including pulmonary, gastrointestinal, and genitourinary hemorrhage. One percent (4/290) of patients treated with Pazopanib died from hemorrhage compared with no (0/145) patients on placebo. In the overall safety population in RCC (N = 586), cerebral/intracranial hemorrhage was observed in less than 1% (2/586) of patients treated with Pazopanib.

Arterial Thromboembolic Events: Fatal arterial thromboembolic events were observed in 0.3% (2/586) of patients in the RCC trials and in no patients in the STS trials. In the randomized RCC trial, 2% (5/290) of patients receiving Pazopanib experienced myocardial infarction or ischemia, 0.3% (1/290) had a cerebrovascular accident, and 1% (4/290) had an event of transient ischemic attack. In the randomized STS trial, 2% (4/240) of patients receiving Pazopanib experienced a myocardial infarction or ischemia, 0.4% (1/240) had a cerebrovascular accident, and there were no incidents of transient ischemic attack. No arterial thromboembolic events were reported in patients who received placebo in either trial. Pazopanib should be used with caution in patients who are at increased risk for these events or who have had a history of these events. Pazopanib has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months and should not be used in those patients.

Venous Thromboembolic Events: In RCC and STS trials of Pazopanib, venous thromboembolic events (VTEs), including venous thrombosis and fatal pulmonary embolus (PE), have occurred. In the randomized STS trial, VTEs were reported in 5% of patients treated with Pazopanib compared with 2% with placebo. In the randomized RCC trial, the rate was 1% in both arms. Fatal PE occurred in 1% (2/240) of STS patients receiving Pazopanib and in no patients receiving placebo. There were no fatal pulmonary emboli in the RCC trial. Monitor for signs and symptoms of VTE and PE.

Thrombotic Microangiopathy: Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), has been reported in clinical trials of Pazopanib as monotherapy, in combination with Bevacizumab, and in combination with Topotecan. Pazopanib is not indicated for use in combination with other agents. Six of the 7 TMA cases occurred within 90 days of the initiation of Pazonib-200. Improvement of TMA was observed after treatment was discontinued. Monitor for signs and symptoms of TMA. Permanently discontinue Pazopanib in patients developing TMA. Manage as clinically indicated.

Gastrointestinal Perforation and Fistula: In the RCC and STS trials, gastrointestinal perforation or fistula occurred in 0.9% (5/586) of patients and 1% (4/382) of patients receiving Pazopanib, respectively. Fatal perforations occurred in 0.3% (2/586) of these patients in the RCC trials and in 0.3% (1/382) of these patients in the STS trials. Monitor for signs and symptoms of gastrointestinal perforation or fistula.

Interstitial Lung Disease/Pneumonitis: Interstitial lung disease (ILD)/pneumonitis, which can be fatal, has been reported in association with Pazopanib. In clinical trials, ILD/pneumonitis occurred in 0.1% of patients treated with Pazopanib.. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis and discontinue Pazopanib in patients developing ILD or pneumonitis.

Reversible Posterior Leukoencephalopathy Syndrome: Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been reported in patients receiving Pazopanib and may be fatal. RPLS is a neurological disorder that can present with headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances. Mild to severe hypertension may be present. The diagnosis of RPLS is optimally confirmed by magnetic resonance imaging. Permanently discontinue Pazopanib in patients developing RPLS.

Wound Healing: No formal trials on the effect of Pazopanib on wound healing have been conducted. Since vascular endothelial growth factor receptor (VEGFR) inhibitors such as Pazopanib may impair wound healing, treatment with Pazopanib should be stopped at least 7 days prior to scheduled surgery. The decision to resume Pazopanib after surgery should be based on clinical judgment of adequate wound healing. Pazopanib should be discontinued in patients with wound dehiscence.

Hypothyroidism: Hypothyroidism, confirmed based on a simultaneous rise of TSH and decline of T4, was reported in 7% (19/290) of patients treated with Pazopanib in the randomized RCC trial and in 5% (11/240) of patients treated with Pazopanib in the randomized STS trial. No patients on the placebo arm of either trial had hypothyroidism. In RCC and STS trials of Pazopanib, hypothyroidism was reported as an adverse reaction in 4% (26/586) and 5% (20/382) of patients, respectively. Proactive monitoring of thyroid function tests is recommended.

Tumor Lysis Syndrome: Cases of tumor lysis syndrome (TLS), including fatal cases, have been reported in RCC and STS patients treated with Pazopanib. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis, and treat as clinically indicated.

Infection: Serious infections (with or without neutropenia), including some with fatal outcome, have been reported. Monitor patients for signs and symptoms of infection. Institute appropriate anti-infective therapy promptly and consider interruption or discontinuation of Pazopanib for serious infections. Increased Toxicity with other Cancer Therapy: Pazopanib is not indicated for use in combination with other agents. Clinical trials of Pazopanib in combination with Pemetrexed and Lapatinib were terminated early due to concerns over increased toxicity and mortality. The fatal toxicities observed included pulmonary hemorrhage, gastrointestinal hemorrhage, and sudden death. A safe and effective combination dose has not been established with these regimens.

Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes: In vitro studies suggested that the oxidative metabolism of Pazopanib in human liver microsomes is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8. Therefore, inhibitors and inducers of CYP3A4 may alter the metabolism of Pazopanib.

CYP3A4 Inhibitors: Co-administration of Pazopanib with strong inhibitors of CYP3A4 (e.g., Ketoconazole, Ritonavir, Clarithromycin) increases Pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal potential to inhibit CYP3A4. If co-administration of a strong CYP3A4 inhibitor is warranted, reduce the dose of Pazopanib to 400 mg. Grapefruit or grapefruit juice should be avoided as it inhibits CYP3A4 activity and may also increase plasma concentrations of Pazopanib.

CYP3A4 Inducers: CYP3A4 inducers, such as Rifampin, may decrease plasma Pazopanib concentrations. Consider an alternate concomitant medication with no or minimal enzyme induction potential. Pazopanib should not be used if chronic use of strong CYP3A4 inducers cannot be avoided.

Drugs that Inhibit Transporters: In vitro studies suggested that Pazopanib is a substrate of P- glycoprotein (P gp) and breast cancer resistance protein (BCRP). Therefore, absorption and subsequent elimination of Pazopanib may be influenced by products that affect P-gp and BCRP. Concomitant treatment with strong inhibitors of P-gp or BCRP should be avoided due to the risk of increased exposure to Pazopanib. The selection of alternative concomitant medicinal products with no or minimal potential to inhibit P-gp or BCRP should be considered.

Effects of Pazopanib on CYP Substrates: Results from drug-drug interaction trials conducted in cancer patients suggest that Pazopanib is a weak inhibitor of CYP3A4, CYP2C8, and CYP2D6 in vivo, but had no effect on CYP1A2, CYP2C9, or CYP2C19. Concomitant use of Pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. Co-administration may result in inhibition of the metabolism of these products and create the potential for serious adverse events.

Effect of Concomitant Use of Pazopanib and Simvastatin: Concomitant use of Pazopanib and Simvastatin increases the incidence of ALT elevations. Across monotherapy trials with Pazopanib, ALT greater than 3 x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of Simvastatin. If a patient receiving concomitant Simvastatin develops ALT elevations, follow dosing guidelines for Pazopanib or consider alternatives to Pazopanib. Alternatively, consider discontinuing Simvastatin. Insufficient data are available to assess the risk of concomitant administration of alternative statins and Pazopanib.

Pazopanib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. Pregnant women or women should be advised of the childbearing potential of the risk to a fetus. There is no information regarding the presence of Pazopanib or its metabolites in human milk, or their effects on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Pazopanib, a lactating woman should be advised not to breastfeed during treatment with Pazopanib and for 2 weeks after the final dose.

Females contraception: Females of reproductive potential should be advised to use effective contraception during treatment and for at least 2 weeks after the last dose of Pazopanib.

Males contraception: To avoid potential drug exposure to pregnant partners and female partners of reproductive potential, male patients (including those who have had vasectomies) with female partners of reproductive potential should be advised to use condoms during treatment with Pazopanib and for at least 2 weeks after the last dose.

Pazopanib doses up to 2000 mg have been evaluated in clinical trials. Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg daily and 1000 mg daily, respectively. Treatment of overdose with Nilotinib should consist of general supportive measures. There is no specific antidote for overdosage of Nilotinib. Hemodialysis is not expected to enhance the elimination of Nilotinib because Pazopanib is not significantly renally excreted and is highly bound to plasma proteins.

Store in a cool (not above 30°C) and dry place, away from sunlight. Keep out of reach of children.

Nilotinib is indicated in advanced renal cell carcinoma (RCC), advanced soft tissue sarcoma (STS) who have received prior chemotherapy. The efficacy of Nilotinib 200 for the treatment of patients with adipocytic STS or gastrointestinal stromal tumors has not been demonstrated.

Targeted Cancer Therapy

Pazopanib is a multi-tyrosine kinase inhibitor of vascular endothelial growth factor receptor (VEGFR)-1, VEGFR-2, VEGFR-3, platelet-derived growth factor receptor (PDGFR) and fibroblast growth factor receptor (FGFR)-1 and -3, cytokine receptor (Kit), interleukin-2 receptor-inducible T- cell kinase (Itk), lymphocyte-specific protein tyrosine kinase (Lck), and transmembrane glycoprotein receptor tyrosine kinase (c-Fms). In vitro, Pazopanib inhibited ligand-induced autophosphorylation of VEGFR-2, Kit, and PDGFR receptors.

Absorption: Pazopanib is absorbed orally with the median time to achieve peak concentrations of 2 to 4 hours after the dose. Daily dosing at 800 mg results in geometric mean AUC and Cmax of 1,037 mcg/mL and 58.1 mcg/mL (equivalent to 132 μM), respectively. There was no consistent increase in AUC or Cmax at Pazopanib doses above 800 mg.

Distribution: Binding of Pazopanib to human plasma protein in vivo was greater than 99% with no concentration dependence over the range of 10 to 100 mcg/mL. In vitro, studies suggest that Pazopanib is a substrate for P-gp and BCRP.

Metabolism: In vitro studies demonstrated that Pazopanib is metabolized by CYP3A4 with a minor contribution from CYP1A2 and CYP2C8.

Elimination: Pazopanib has a mean half-life of 30.9 hours after administration of the recommended dose of 800 mg. Elimination is primarily via feces with renal elimination accounting for less than 4% of the administered dose.

The recommended starting dose of Pazopanib is 800 mg orally once daily without food (at least 1 hour before or 2 hours after a meal). The dose of Pazopanib should not exceed 800 mg. Tablets should not be crushed due to the potential for an increased rate of absorption which may affect systemic exposure. If a dose is missed, it should not be taken if it is less than 12 hours until the next dose or as directed by the registered physicians.

Pediatric Use: The safety and effectiveness of Pazopanib in pediatric patients have not been established.

Should be taken on an empty stomach. Avoid food at least 2 hr before & at least 1 hr after a dose. Swallow whole, do not chew/crush. Avoid grapefruit products.

Rash, pruritus, hepatotoxicity, headache, fever, fatigue, GI disturbances (nausea, constipation, diarrhoea), alopecia, asthenia, muscle spasms, arthralgia, myalgia, pain (e.g. musculoskeletal or chest pain), oedema, folliculitis, papilloma, insomnia, dizziness, vertigo, anxiety, paraesthesia, hyperhidrosis, dry skin, urticaria, acne, conjunctivitis, dry eye, flushing, dyspnoea, cough, myelosuppression (e.g. thrombocytopenia, neutropenia, and anaemia), thrombotic disorders or haemorrhage, arrhythmias, heart failure, pericarditis, palpitations, HTN, angina, MI; elevated AST/ALT, serum lipase; electrolyte imbalances.

It is contraindicated in patients with known hypersensitivity to Pazopanib or any other components of this product.

Hepatic Toxicity and Hepatic Impairment: In clinical trials with Pazopanib, hepatotoxicity, manifested as increases in serum transaminases (alanine transferase [ALT], aspartate aminotransferase [AST]) and bilirubin, was observed. This hepatotoxicity can be severe and fatal. Patients older than 65 years are at greater risk for hepatotoxicity. Transaminase elevations occur early in the course of treatment (92.5% of all transaminase elevations of any grade occurred in the first 18 weeks).

QT Prolongation and Torsades De Pointes: In the RCC trials of Pazopanib, QT prolongation (greater than or equal to 500 msec) was identified on routine electrocardiogram (ECG) monitoring in 2% (11/558) of patients. Torsades de pointes occurred in less than 1% (2/977) of patients who received Pazopanib in the monotherapy trials. Pazopanib should be used with caution in patients with a history of QT interval prolongation, in patients taking antiarrhythmics or other medications that may prolong QT interval, and those with relevant pre-existing cardiac disease. When using Pazopanib, baseline and periodic monitoring of ECGs and maintenance of electrolytes (e.g., calcium, magnesium, potassium) within the normal range should be performed.

Hemorrhagic Events: Fatal hemorrhage occurred in 0.9% (5/586) in the RCC trials; there were no reports of fatal hemorrhage in the STS trials. In the randomized RCC trial, 13% (37/290) of patients treated with Pazopanib and 5% (7/145) of patients on placebo experienced at least 1 hemorrhagic event. The most common hemorrhagic events in the patients treated with Pazopanib were hematuria (4%), epistaxis (2%), hemoptysis (2%), and rectal hemorrhage (1%). Nine of 37 patients treated with Pazopanib, who had hemorrhagic events, experienced serious events including pulmonary, gastrointestinal, and genitourinary hemorrhage. One percent (4/290) of patients treated with Pazopanib died from hemorrhage compared with no (0/145) patients on placebo. In the overall safety population in RCC (N = 586), cerebral/intracranial hemorrhage was observed in less than 1% (2/586) of patients treated with Pazopanib.

Arterial Thromboembolic Events: Fatal arterial thromboembolic events were observed in 0.3% (2/586) of patients in the RCC trials and in no patients in the STS trials. In the randomized RCC trial, 2% (5/290) of patients receiving Pazopanib experienced myocardial infarction or ischemia, 0.3% (1/290) had a cerebrovascular accident, and 1% (4/290) had an event of transient ischemic attack. In the randomized STS trial, 2% (4/240) of patients receiving Pazopanib experienced a myocardial infarction or ischemia, 0.4% (1/240) had a cerebrovascular accident, and there were no incidents of transient ischemic attack. No arterial thromboembolic events were reported in patients who received placebo in either trial. Pazopanib should be used with caution in patients who are at increased risk for these events or who have had a history of these events. Pazopanib has not been studied in patients who have had an arterial thromboembolic event within the previous 6 months and should not be used in those patients.

Venous Thromboembolic Events: In RCC and STS trials of Pazopanib, venous thromboembolic events (VTEs), including venous thrombosis and fatal pulmonary embolus (PE), have occurred. In the randomized STS trial, VTEs were reported in 5% of patients treated with Pazopanib compared with 2% with placebo. In the randomized RCC trial, the rate was 1% in both arms. Fatal PE occurred in 1% (2/240) of STS patients receiving Pazopanib and in no patients receiving placebo. There were no fatal pulmonary emboli in the RCC trial. Monitor for signs and symptoms of VTE and PE.

Thrombotic Microangiopathy: Thrombotic microangiopathy (TMA), including thrombotic thrombocytopenic purpura (TTP) and hemolytic uremic syndrome (HUS), has been reported in clinical trials of Pazopanib as monotherapy, in combination with Bevacizumab, and in combination with Topotecan. Pazopanib is not indicated for use in combination with other agents. Six of the 7 TMA cases occurred within 90 days of the initiation of Pazonib-200. Improvement of TMA was observed after treatment was discontinued. Monitor for signs and symptoms of TMA. Permanently discontinue Pazopanib in patients developing TMA. Manage as clinically indicated.

Gastrointestinal Perforation and Fistula: In the RCC and STS trials, gastrointestinal perforation or fistula occurred in 0.9% (5/586) of patients and 1% (4/382) of patients receiving Pazopanib, respectively. Fatal perforations occurred in 0.3% (2/586) of these patients in the RCC trials and in 0.3% (1/382) of these patients in the STS trials. Monitor for signs and symptoms of gastrointestinal perforation or fistula.

Interstitial Lung Disease/Pneumonitis: Interstitial lung disease (ILD)/pneumonitis, which can be fatal, has been reported in association with Pazopanib. In clinical trials, ILD/pneumonitis occurred in 0.1% of patients treated with Pazopanib.. Monitor patients for pulmonary symptoms indicative of ILD/pneumonitis and discontinue Pazopanib in patients developing ILD or pneumonitis.

Reversible Posterior Leukoencephalopathy Syndrome: Reversible Posterior Leukoencephalopathy Syndrome (RPLS) has been reported in patients receiving Pazopanib and may be fatal. RPLS is a neurological disorder that can present with headache, seizure, lethargy, confusion, blindness, and other visual and neurologic disturbances. Mild to severe hypertension may be present. The diagnosis of RPLS is optimally confirmed by magnetic resonance imaging. Permanently discontinue Pazopanib in patients developing RPLS.

Wound Healing: No formal trials on the effect of Pazopanib on wound healing have been conducted. Since vascular endothelial growth factor receptor (VEGFR) inhibitors such as Pazopanib may impair wound healing, treatment with Pazopanib should be stopped at least 7 days prior to scheduled surgery. The decision to resume Pazopanib after surgery should be based on clinical judgment of adequate wound healing. Pazopanib should be discontinued in patients with wound dehiscence.

Hypothyroidism: Hypothyroidism, confirmed based on a simultaneous rise of TSH and decline of T4, was reported in 7% (19/290) of patients treated with Pazopanib in the randomized RCC trial and in 5% (11/240) of patients treated with Pazopanib in the randomized STS trial. No patients on the placebo arm of either trial had hypothyroidism. In RCC and STS trials of Pazopanib, hypothyroidism was reported as an adverse reaction in 4% (26/586) and 5% (20/382) of patients, respectively. Proactive monitoring of thyroid function tests is recommended.

Tumor Lysis Syndrome: Cases of tumor lysis syndrome (TLS), including fatal cases, have been reported in RCC and STS patients treated with Pazopanib. Patients may be at risk of TLS if they have rapidly growing tumors, a high tumor burden, renal dysfunction, or dehydration. Closely monitor patients at risk, consider appropriate prophylaxis, and treat as clinically indicated.

Infection: Serious infections (with or without neutropenia), including some with fatal outcome, have been reported. Monitor patients for signs and symptoms of infection. Institute appropriate anti-infective therapy promptly and consider interruption or discontinuation of Pazopanib for serious infections. Increased Toxicity with other Cancer Therapy: Pazopanib is not indicated for use in combination with other agents. Clinical trials of Pazopanib in combination with Pemetrexed and Lapatinib were terminated early due to concerns over increased toxicity and mortality. The fatal toxicities observed included pulmonary hemorrhage, gastrointestinal hemorrhage, and sudden death. A safe and effective combination dose has not been established with these regimens.

Drugs that Inhibit or Induce Cytochrome P450 3A4 Enzymes: In vitro studies suggested that the oxidative metabolism of Pazopanib in human liver microsomes is mediated primarily by CYP3A4, with minor contributions from CYP1A2 and CYP2C8. Therefore, inhibitors and inducers of CYP3A4 may alter the metabolism of Pazopanib.

CYP3A4 Inhibitors: Co-administration of Pazopanib with strong inhibitors of CYP3A4 (e.g., Ketoconazole, Ritonavir, Clarithromycin) increases Pazopanib concentrations and should be avoided. Consider an alternate concomitant medication with no or minimal potential to inhibit CYP3A4. If co-administration of a strong CYP3A4 inhibitor is warranted, reduce the dose of Pazopanib to 400 mg. Grapefruit or grapefruit juice should be avoided as it inhibits CYP3A4 activity and may also increase plasma concentrations of Pazopanib.

CYP3A4 Inducers: CYP3A4 inducers, such as Rifampin, may decrease plasma Pazopanib concentrations. Consider an alternate concomitant medication with no or minimal enzyme induction potential. Pazopanib should not be used if chronic use of strong CYP3A4 inducers cannot be avoided.

Drugs that Inhibit Transporters: In vitro studies suggested that Pazopanib is a substrate of P- glycoprotein (P gp) and breast cancer resistance protein (BCRP). Therefore, absorption and subsequent elimination of Pazopanib may be influenced by products that affect P-gp and BCRP. Concomitant treatment with strong inhibitors of P-gp or BCRP should be avoided due to the risk of increased exposure to Pazopanib. The selection of alternative concomitant medicinal products with no or minimal potential to inhibit P-gp or BCRP should be considered.

Effects of Pazopanib on CYP Substrates: Results from drug-drug interaction trials conducted in cancer patients suggest that Pazopanib is a weak inhibitor of CYP3A4, CYP2C8, and CYP2D6 in vivo, but had no effect on CYP1A2, CYP2C9, or CYP2C19. Concomitant use of Pazopanib with agents with narrow therapeutic windows that are metabolized by CYP3A4, CYP2D6, or CYP2C8 is not recommended. Co-administration may result in inhibition of the metabolism of these products and create the potential for serious adverse events.

Effect of Concomitant Use of Pazopanib and Simvastatin: Concomitant use of Pazopanib and Simvastatin increases the incidence of ALT elevations. Across monotherapy trials with Pazopanib, ALT greater than 3 x ULN was reported in 126/895 (14%) of patients who did not use statins, compared with 11/41 (27%) of patients who had concomitant use of Simvastatin. If a patient receiving concomitant Simvastatin develops ALT elevations, follow dosing guidelines for Pazopanib or consider alternatives to Pazopanib. Alternatively, consider discontinuing Simvastatin. Insufficient data are available to assess the risk of concomitant administration of alternative statins and Pazopanib.

Pazopanib can cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. Pregnant women or women should be advised of the childbearing potential of the risk to a fetus. There is no information regarding the presence of Pazopanib or its metabolites in human milk, or their effects on the breastfed infant, or on milk production. Because of the potential for serious adverse reactions in breastfed infants from Pazopanib, a lactating woman should be advised not to breastfeed during treatment with Pazopanib and for 2 weeks after the final dose.

Females contraception: Females of reproductive potential should be advised to use effective contraception during treatment and for at least 2 weeks after the last dose of Pazopanib.

Males contraception: To avoid potential drug exposure to pregnant partners and female partners of reproductive potential, male patients (including those who have had vasectomies) with female partners of reproductive potential should be advised to use condoms during treatment with Pazopanib and for at least 2 weeks after the last dose.

Pazopanib doses up to 2000 mg have been evaluated in clinical trials. Dose-limiting toxicity (Grade 3 fatigue) and Grade 3 hypertension were each observed in 1 of 3 patients dosed at 2000 mg daily and 1000 mg daily, respectively. Treatment of overdose with Nilotinib should consist of general supportive measures. There is no specific antidote for overdosage of Nilotinib. Hemodialysis is not expected to enhance the elimination of Nilotinib because Pazopanib is not significantly renally excreted and is highly bound to plasma proteins.

Store in a cool (not above 30°C) and dry place, away from sunlight. Keep out of reach of children.

This is indicated in Bacterial & viral skin infections, wound healing, chronic dermatitis, acne vulgaris

Herbal and Nutraceuticals

Neem seed oil: Triterpenes & tetranortriterpenes (limonoid and protolimonoids of the gedunin group).

Neem bark: A paraffin alcohol-sugiol, oxyphenol nimbiol, nimbosterol nimbolin A ad nimbolin B.

Neem leave: It’s mainly yield the flavanoid quercetin and nimbosterol as well as a number of limonoids. Quercetin, a polyphenolic flavonoid, is known to have antibacterial and antifungal properties.

Neem is used ayurvedic medicine for skin diseases, leprosy, inflammation, infections, fever, and purification of blood. It is also used antiseptic, astringent, anthelmintic. Neem is mentioned in most Ayurvedic formulations for the treatment of skin disorders, because of its detoxifying properties. The growth of acne- causing bacteria such as propionibacterium acnes (P. acnes) and staphylococcus epidermidis is also inhibited by Neem.

1-2 tablets, twice daily or as prescribed by the physician.

There is no significant side effect associated with the use of Neem in the above mentioned therapeutic doses.

There is no absolute contraindication.

Not recommended for use during pregnancy. There is no sufficient information for use in lactation.

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

This is indicated in skin diseases like Acne vulgaris, Eczema, Psoriasis and Boils.

Herbal and Nutraceuticals

2-4 capsules 3 times daily or as prescribed by the physician.

There is no known side effect.

Not yet known.

There is no sufficient information.

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

Meningococcal Conjugate Vaccine is indicated for active immunisation of individuals from the age of 6 weeks against invasive meningococcal diseases caused by Neisseria meningitidis group A, C, W-135, and Y.

Vaccines, Anti-sera & Immunoglobulin

Anti-capsular meningococcal antibodies protect against meningococcal diseases via complement mediated bactericidal activity. Meningococcal Conjugate Vaccine induces the production of bactericidal antibodies against capsular polysaccharides of Neisseria meningitidis group A,C,W-135 and Y when measured by assays using either rSBA or hSBA.

• Infants from 6 weeks to less than 6 months of age: two doses, each of 0.5 ml, should be administered with an interval of 2 months between doses.
• Infants from 6 months of age, children, adolescents and adults: a single 0.5 mL doseshould be administered.
• An additional primary dose of Meningococcal Conjugate Vaccine may be considered appropriate for some individuals.

Immunisation should be carried out by intramuscular injection only. In infants, the recommended injection site is the anterolateral aspect of the thigh. In individuals from 1 year of age, the recommended injection site is the anterolateral aspect of the thigh or the deltoid muscle. For instructions on reconstitution of the medicinal product before administration.

Adverse reactions are Appetite lost, Irritability, Insomnia, Crying, Drowsiness, Headache, Hypoaesthesia, Dizziness, Diarrhoea, Vomiting, Nausea, Pruritus, Rash, Myalgia, Pain in extremity, Fever, Swelling at injection site, Pain at injection site, Redness at injection site, Fatigue, Injection site haematoma, Malaise, Injection site induration, Injection site pruritus, Injection site warmth, Injection site anaesthesia

Hypersensitivity to the active substances or to any of the excipients of this preparation.

Pregnancy: There is limited experience with use of Meningococcal Conjugate Vaccine in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo/foetal development, parturition or post-natal development. Meningococcal Conjugate Vaccine should be used during pregnancy only when clearly needed, and the possible advantages outweigh the potential risks for the foetus.

Breast-feeding: It is unknown whether Meningococcal Conjugate Vaccine is excreted in human milk. Meningococcal Conjugate Vaccine should only be used during breast-feeding when the possible advantages outweigh the potential risks.

No case of overdose has been reported.

Store in a refrigerator (2°C-8°C). Do not freeze. Store in the original package in order to protect from light.

For the improvement of neurological outcome by reducing the incidence and severity of ischemic deficits in patients with subarachnoid hemorrhage from ruptured intracranial berry aneurysms regardless of their post ictus neurological condition.

Calcium-channel blockers

Nimodipine inhibits inflow of Calcium ions into cells by blocking Calcium channels or select voltage-sensitive areas resulting in relaxation of vascular smooth muscle and myocardium during depolarisation. Nimodipine has greater action on the cerebral vessels because of its high lipophilicity.

Adult: Initial dose is 60 mg in every four hours interval for 21 consecutive days, preferably not less than one hour before or two hours after meals. Oral Nimodipine therapy should be commence within 96 hours of the subarachnoid hemorrhage.

Use in Pediatric Patients: While there is no specific information on use of this medication in pediatric patients.

Although side effects from nimodipine are not common, the following can occur: headache, dizziness, flushing (feeling of warmth), heartburn, fast heartbeat, slow heartbeat, upset stomach, stomach pain, constipation, depression etc.

Use within 1 mth of MI or an episode of unstable angina. Concomitant use with potent CYP3A4 inhibitors (e.g. clarithromycin, ritonavir, ketoconazole, nefazodone).

Patients with cerebral oedema or severely raised intracranial pressure. Contents of oral capsules should be given only by mouth or through a feeding tube. It must never be administered IV or by any other parenteral route. Hepatic impairment. Pregnancy and lactation.

Plasma concentration and efficacy may be significantly reduced when administered with strong CYP3A4 inducers (e.g. rifampicin, carbamazepine, phenobarbital, phenytoin). May increase serum levels and toxicity of phenytoin. Increased plasma concentrations with cimetidine or sodium valproate.

Use in Pregnancy: Large doses of nimodipine have been shown to cause birth defects in animals. Human studies have not been done. Before you take nimodipine, tell your doctor if you are pregnant or plan to become pregnant.

Use in Nursing Mothers: Nimodipine may pass into breast milk but has not been reported to cause problems; caution is advised. Consult your doctor for advice.

Symptoms: Excessive peripheral vasodilation, systemic hypotension, tachycardia, bradycardia, GI complaints, nausea.

Management: Symptomatic and supportive treatment. Admin of vasopressor may be necessary if significant hypotension occurs. IV Ca salts have been also used for hypotension.

Store between 15-30° C. Protect from light.