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Acetazolamide is indicated in open angle glaucoma, secondary glaucoma and as an adjuvant in the treatment of edema and epilepsy.

Carbonic anhydrase inhibitor

Acetazolamide is a carbonic anhydrase inhibitor. This enzyme catalyzes the reversible reaction involving the hydration of carbon-di-oxide and the dehydration of carbonic acid. In the eye, this inhibitory action of Acetazolamide decreases the secretion of aqueous humor and results in a drop in intraocular pressure, a reaction considered desirable in case of glaucoma. Inhibition of carbonic anhydrase in the central nervous system appears to retard abnormal paroxysmal and excessive discharge from central nervous system neurons. So, Acetazolamide is also used as an adjuvant in the treatment of epilepsy.

Adults : Initially 250 mg (1 tablet) 4 times daily. Dose should be adjusted later with individual need.

Children : ½ to 2 tablets in divided doses.

In intraocular pressure: 1 tablet 6 hourly. In acute condition, dose should be started with 2 tablets followed by 1 tablet 6 hourly or as directed by the physician

Common side effects are headache, drowsiness, dizziness, fatigue, anorexia, polyurea, insomnia, gastrointestinal upset.

Acetazolamide is contraindicated in cases of marked kidney and liver diseases or dysfunction, in situations in which sodium and or potassium blood serum levels decreased. Acetazolamide is also contraindicated in patients with chronic noncongestive angle closure glaucoma

There are no adequate and well controlled studies in pregnant women and neonates. So, Acetazolamide should be used with care in those physiological conditions.

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

Broad spectrum penicillins

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

• Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
• Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
• Pneumonia: Recommended dose is 500-1000 mg three times daily.
• Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
• Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
• Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
• In renal impairment: it may be necessary to reduce the total daily dosage.

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

Amoxicillin is contraindicated in penicillin hypersensitive patients.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.

Amoxycillin 500 mg Injection:

• Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
• Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

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

Broad spectrum penicillins

Amoxicillin is a broad spectrum penicillin. It is effective against a wide range of Gram-positive and Gram-negative bacteria. It acts through the inhibition of biosynthesis of cell wall. Amoxicillin is stable in the presence of gastric acid and is rapidly absorbed after oral administration. After an oral dose, peak plasma concentration of Amoxicillin is reached within 1 to 2 hours. Amoxicillin is widely distributed at varying concentration in body tissues and fluids.

Adult: 250 mg three times daily, increasing up to 500 mg three times daily for severe infections.

Children (up to 10 years of age) : 125 mg three times daily, increasing up to 250 mg three times daily for severe infections.

• Severe or recurrent purulent respiratory infection: 3 gm every 12 hours.
• Otitis media: Recommended dose is 1 g three times daily for adult and 40 mg/kg body weight daily in 3 divided doses for children (max. 3 g daily).
• Pneumonia: Recommended dose is 500-1000 mg three times daily.
• Dental abscess: Recommended dose is 3 gm, repeated after 10-12 hours.
• Urinary tract infections: Recommended dose is 3 gm, repeated after 10-12 hours.
• Gonorrhoea: Single dose of 2-3 gm with Probenecid 1 gm is recommended (Probenecid is contraindicated in children under 2 years).
• In renal impairment: it may be necessary to reduce the total daily dosage.

Reconstituted suspension can be administered by adding the required amount of suspension to milk, fruit juice, water. These preparations should then be taken immediately.

Side effects are mild and transient in nature. This may include diarrhoea, indigestion or occasionally rash. Pseudo-membranous colitis has been reported rarely.

Amoxicillin is contraindicated in penicillin hypersensitive patients.

The possibility of superinfections with mycotic or bacterial pathogens should be kept in mind during therapy. If superinfections occur, Amoxicillin should be discontinued and appropriate therapy should be instituted.

Concurrent use of Amoxicillin and Probenecid may result in increased and prolonged blood levels of Amoxicillin. Amoxicillin may affect the gut flora, leading to lower estrogen reabsorption and reduced efficacy of combined oral estrogen/progesterone contraceptives.

US FDA pregnancy category of Amoxicillin is B. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Amoxicillin has been shown to be excreted in human milk. So, caution should be exercised when Amoxicillin is administered to a lactating mother.

Amoxycillin 500 mg Injection:

• Intramuscular: Add 2.5 ml water for injection to Amoxycillin 500 mg injection vial.
• Intravenous: Dissolve Amoxycillin 500 mg injection in 10 ml water for injection.

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

Memantine is indicated for the treatment of all froms of dementia of the Alzheimer's type. Memantine may also be indicated in other types of dementia.

Persistent activation of N-methyl-D-aspartate (NMDA) receptors in Central Nervous System by the excitatory amino acid glutamate has been hypothesized to contribute to the symptomatology of Alzheimer's disease. Memantine is postulated to exert its therapeutic effect through its action as a low to moderate affinity as an uncompetitive (open-channel) NMDA receptor antagonist which binds preferentially to the NMDA receptor-operated cation channels.

Memantine is well absorbed after oral administration and has linear pharmacokinetics over the therapeutic dose range. It is excreted predominantly unchanged in the urine and has a terminal elimination half-life of about 60-80 hours. Following oral administration, Memantine is highly absorbed with peak concentrtions reached in about 3-7 hours. Food has no effect on the absorption of Memantine. The mean volume of distribution of Memantine is 9-11 L/kg and the plasma protein binding is low (45%). emantine undergoes partial hepatic metabolism. About 48% of administered drug is excreted unchanged in urine; the remainder is converted primarily to three polar metabolites which possess minimal NMDA receptor antagonistic activity: the N-glucuronide conjugate, 6-hydroxy Memantine and 1-nitroso-deaminated Memantine. A total of 74% of the administered dose is excreted as the sum of the parent drug and the N-glucuronide conjugate. The hepatic microsomal CYP-450 enzyme system does not play a significant role in the metabolism of Memantine.

The recommended maintenance dose of Memantine for adults and older patients is 20 mg every day. In order to lower the risk of side effects, the dose should be achieved by upward titration with 5 mg per week over 3 weeks, achieving the maintenance dose of 20 mg/day from the start of week 4 according to the following dosage guideline:

Week 1 (Everyday): Morning- 5 mg (1 tablet), Night- No dose
Week 2 (Everyday): Morning- 5 mg (1 tablet), Night- 5 mg (1 tablet)
Week 3 (Everyday): Morning- 10 mg (2 tablets), Night- 5 mg (1 tablet)
Week 4 and onwards (Everyday): Morning- 10 mg (2 tablets), Night- 10 mg (2 tablets)

Missed Dose: If any dose is missed, just wait and take the next dose at the usual time. Do not double the dose to compensate for the missed dose.

In case renal impairment: In patients with moderate renal impairment (creatinine clearance 30-49 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes). If tolerated well after at least 7 days of treatment, the dose could be increased up to 20 mg/day according to standard titration scheme. In patients with severe renal impairment (creatinine clearance 5-29 ml/min) daily dose should be 10 mg (1 ml solution, equivalent to two downward strokes) per day.

In case of hepatic impairment: In patients with mild or moderate hepatic impaired function, no dosage adjustment is needed. Administration of memantine is not recommended in patients with severe hepatic impairment.

Children under 18 years: Memantine is not recommended for use in children below 18 years due to lack of data on safety and efficacy.

Most frequent side effects (frequency of 2% or less) include hallucination, confusion, dizziness, headache and fatigue. Occasional side effects include anxiety, hypertonus (heightened muscle tension), vomiting, bladder infections and increased sexual drive. If there is a history of epileptic seizures, there is a slight chance that Memantine may increase the probability of an attack.

Memantine Hydrochloride is contraindicated in patients with known hypersensitivity to Memantine Hydrochloride or to any excipients used in the formulation.

Caregivers should be instructed in the recommended administration (twice per day for doses above 5 mg) and dose escalation (minimum interval of one week between dose increases). If the patients suffer from kidney dysfunction, the kidney function should be monitored at regular basis.

Seizures: Memantine has not been systematically evaluated in patients with a seizure disorder. One clinical trial shows that seizures occurred in 0.2% of patients treated with Memantine and 0.5% of patients treated with placebo.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Study shows that no risk of carcinogenesis, mutagenesis and impairment of fertility are caused after Memantine use.

Operating Vehicles or Machinery: Taking Memantine may alter the reaction time significantly; therefore safe driving and safe operation of machinery may no longer be possible.

Due to the pharmacological effects and mechanism of action of memantine suggests that the effects of L-dopa, dopaminergic agonists, and anticholinergics may be enhanced by concomitant treatment with NMDA-antagonists such as memantine. The effects of barbiturates and neuroleptics may be reduced. Concomitant administration of mematine with the antispasmodic agents, dantrolene or baclofen, can modify their effects and a dosage adjustment may be necessary. Memantine should not be used with amantadine, ketamine, dextromethorphan, phenytoin, cimetidine, ranitidine, procainamide, quinidine, quinidine, quinine & nicotine.

Pregnancy Category B. Yet there are no adequate and well controlled studies of Memantine in pregnant women. Memantine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. It is not known whether Memantine is excreted in human breast milk. Because many drugs are excreted in human milk, caution should be exercised when Memantine is administered to a nursing mother.

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

Drugs affecting the immune response

Tacrolimus is a macroiide immunomodulator produced by fungus, Streptomyces tsukubaensis. It has been demonstrated that Tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This leads to a general decrease in the entire inflammatory cascade.

Use in adults: Apply a thin layer of Tacrolimus ointment onto the affected skin areas twice daily and rub in gently and completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic dermatitis. The safety of Tacrolim ointment under occlusion which may promote systemic exposure has not been evaluated. Tacrolimus ointment should not be used with occlusive dressings.

Use in Children:

• Tacrolimus 0.03% ointment can be used in pediatric patients 2 years of age and older.
• Tacrolimus 0.1% ointment can be used in children 16 years of age and older.

Use in Elderly Patients: Patients >65 years old received Tacrolimus ointment in phase 3 studies. The adverse event profile for these patients was consistent with that for other adult patients.

Topically applied Tacrolimus ointment have very few and rare type of side-effects including skin burning, pruritus, flu-like symptoms, allergic reactions, skin erythema, skin infections, headache, etc.

Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to Tacrolimus or any other component of the preparation.

Cautions should be exercised while treatment with Tacrolimus ointment in patients with atopic dermatitis predisposed to superficial skin infections. The safety of Tacrolimus ointment has not been established in patients with generalized erythroderma.

Formal topical drug interaction studies with Tacrolimus ointment have not been conducted. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Pregnancy Category C. There are no adequate and well-controlled studies of topically administered Tacrolimus in pregnant women. Although systemic absorption of Tacrolimus following topical applications of Tacrolimus ointment is minimal relative to systemic administration, it is known that Tacrolimus is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Tacrolimus ointment is not for oral use. Accidental oral ingestion of Tacrolimus ointment may lead to adverse effects associated with systemic administration of Tacrolimus. If oral ingestion occurs, medical advice should be sought.

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

Drugs affecting the immune response

Tacrolimus is a macroiide immunomodulator produced by fungus, Streptomyces tsukubaensis. It has been demonstrated that Tacrolimus inhibits T-lymphocyte activation by first binding to an intracellular protein, FKBP-12. A complex of Tacrolimus-FKBP-12, calcium, calmodulin, and calcineurin is then formed and the phosphatase activity of calcineurin is inhibited. This leads to a general decrease in the entire inflammatory cascade.

Use in adults: Apply a thin layer of Tacrolimus ointment onto the affected skin areas twice daily and rub in gently and completely. Treatment should be continued for one week after clearing of signs and symptoms of atopic dermatitis. The safety of Tacrolim ointment under occlusion which may promote systemic exposure has not been evaluated. Tacrolimus ointment should not be used with occlusive dressings.

Use in Children:

• Tacrolimus 0.03% ointment can be used in pediatric patients 2 years of age and older.
• Tacrolimus 0.1% ointment can be used in children 16 years of age and older.

Use in Elderly Patients: Patients >65 years old received Tacrolimus ointment in phase 3 studies. The adverse event profile for these patients was consistent with that for other adult patients.

Topically applied Tacrolimus ointment have very few and rare type of side-effects including skin burning, pruritus, flu-like symptoms, allergic reactions, skin erythema, skin infections, headache, etc.

Tacrolimus ointment is contraindicated in patients with a history of hypersensitivity to Tacrolimus or any other component of the preparation.

Cautions should be exercised while treatment with Tacrolimus ointment in patients with atopic dermatitis predisposed to superficial skin infections. The safety of Tacrolimus ointment has not been established in patients with generalized erythroderma.

Formal topical drug interaction studies with Tacrolimus ointment have not been conducted. The concomitant administration of known CYP3A4 inhibitors in patients with widespread and/or erythrodermic disease should be done with caution. Some examples of such drugs are erythromycin, itraconazole, ketoconazole, fluconazole, calcium channel blockers and cimetidine.

Pregnancy Category C. There are no adequate and well-controlled studies of topically administered Tacrolimus in pregnant women. Although systemic absorption of Tacrolimus following topical applications of Tacrolimus ointment is minimal relative to systemic administration, it is known that Tacrolimus is excreted in human milk. Because of the potential for serious adverse reactions in nursing infants from Tacrolimus, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Tacrolimus ointment is not for oral use. Accidental oral ingestion of Tacrolimus ointment may lead to adverse effects associated with systemic administration of Tacrolimus. If oral ingestion occurs, medical advice should be sought.

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

Drugs for Megaloblastic Anemia

Mecobalamin is the neurologically active form of vitamin B12 and occurs as a water-soluble vitamin in the body. It is a cofactor in the enzyme methionine synthase, which functions to transfer methyl groups for the regeneration of methionine from homocysteine. In anaemia, it increases erythrocyte production by promoting nucleic acid synthesis in the bone marrow and by promoting maturation and division of erythrocytes.

Tablet: The usual adult dosage is 500 mcg tablet three times daily. The dosage should be adjusted according to the age of patient and the severity of symptoms. 

Injection:

• Peripheral neuropathies: The usual adult dosage is  500 mcg Mecobalamin administered intramuscularly or intravenously three times a week.The dosage should be adjusted according to the age of patient and the severity of symptoms. 
• Megaloblastic anemia: The usual adult dosage is  500 mcg Mecobalamin administered intramuscularly or intravenously three times a week. After about two months of administration, dosage should be changed to one ampoule equivalent to 500 mcg of Mecobalamin every one to three months as maintenance therapy

Generally Mecobalamin is well tolerated. However, a few side effects like GI discomfort (including anorexia, nausea or diarrhea) & rash may be seen after administration of Mecobalamin.

Hypersensitivity to any component of this product.

The medicine should not be used for months if there is no response at all after its use for a certain period of time.

Decreased GI tract absorption with neomycin, aminosalicylic acid, H2-blockers and colchicine. Reduced serum concentrations with oral contraceptives. Reduced effects in anaemia with parenteral chloramphenicol.

Not recommended during pregnancy & lactation.

Use in children: Not recommended.

Oral: Store at room temperature. Protect from moisture and light.
Parenteral: Store at room temperature. Do not expose to direct light.

Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Dilofenac Sodium is a potent non-steroidal anti-inflammatory drug (NSAID) with pronounced anti-rheumatic, anti-inflammatory, analgesic and antipyretic properties. It has also some uricosuric effect. Diclofenac exerts its effect by inhibiting prostaglandin biosynthesis which plays a major role in causing inflammation, pain and fever. Diclofenac is rapidly and completely absorbed from the gastro-intestinal tract when taken with or after meal. Peak plasma concentrations are reached within an average of 2 hours after ingestion of it. At therapeutic concentrations, it is 99.7% bound to plasma proteins. Diclofenac is metabolized in the liver and undergoes first pass metabolism.

Diclofenac FC Tablet: Adults: 75-150 mg daily in 2 to 3 divided doses, preferably after food. Dose should be reduced in long term use.

Diclofenac SR Tablet:

• Adult: 1 tablet daily, taken whole with liquid, preferably at meal times. If necessary, the daily dose can be increased to 150 mg by supplementation with conventional tablets.
• Children: 1-3 mg of diclofenac/kg body wt. daily in divided doses.
• Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, although the pharmacokinetics of diclofenac sodium is not impaired to any clinically relevant extent in elderly patients.

Diclofenac Dispersible Tablet:

• Adults: The recommended daily dosage is 2-3 tablets and the maximum daily dose is 150 mg. In milder cases, 2 tablets of Diclofenac DT per day are sufficient. Diclofenac DT should preferably be taken before meals.
• Children: Diclofenac is not recommended in children for other indications except juvenile rheumatoid arthritis where the recommended dose is 1-3 mg/kg body weight. Diclofenac DT is to be dropped into a half-glass of water and the liquid is to be stirred to aid dispersion before swallowing. There is no information on the use of Diclofenac DT for more than 03 months.

Diclofenac TR Capsule: One capsule daily. Diclofenac TR should be taken preferably after mealtimes.

Diclofenac Suppository: For adults: 50 mg suppository 2-3 times daily. Maximum daily dose is 150 mg.

Diclofenac injection: For adults the usual dose is 1 ampoule daily. In serious cases this dose may be increased up to 2 ampoules daily.

Diclofenac Gel: For external use only. Depending on the size of area to be treated, 2-4 g of Diclofenac gel should be applied to the skin 3-4 times daily. To the affected area gel should be rubbed in lightly. This gel may also be given in addition to further treatment with other dosage forms of Diclofenac.

Diclofenac Sodium is generally well tolerated. Adverse effects are mild, rare and transient. At the starting of the treatment, however, patients may be sometimes complaining of epigastric pain, eructation, nausea and diarrhea or dizziness or headache. These effects are usually mild in nature. Peripheral edema and skin reactions, such as rash and eczema have also been encountered. Diclofenac Sodium Gel may cause local irritation and reddening of the skin and skin rash.

Contraindicated to the patients hypersensitive to any ingredient of the products. Peptic ulcer, hypersensitivity to Diclofenac like other non-steroid anti-inflammatory agents, Diclofenac is also contra-indicated in asthmatic patient in whom attack with asthma, urticaria or acute rhinitis are precipitated by acetylsalicylic acid or by other drugs with prostaglandin synthetase inhibitor. This Gel should not be used under occlusive airtight dressings.

In rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients under treatment with Diclofenac. In patients with advanced age should be kept under close observation. Diclofenac Sodium Gel should not be allowed to come in contact with the eyes or mucus membranes, after application the hands should be washed properly and not to be taken by mouth.

During pregnancy, Diclofenac should be employed only for compelling reasons. The lowest effective dose should be used. These types of drugs are not recommended during the first trimester of pregnancy. In view of insufficient clinical data, Diclofenac Sodium Gel is not recommended during pregnancy. A very insignificant quantity of Diclofenac may be detected in breast milk but no undesirable effects on the infant to be expected.

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

Antacids

This is the combination of Sodium Alginate and Potassium Bicarbonate. Sodium Alginate is a naturally occurring substance. It reacts with the acid in the stomach to form a gel. Potassium Bicarbonate also reacts with the acid in the stomach to form bubbles of carbon dioxide. These bubbles are trapped by the gel formed by Sodium Alginate and they allow the gel to float like a raft on top of the stomach contents. The raft prevents acid in the stomach from flowing back into the esophagus. This relieves the symptoms of reflux such as heartburn. The mode of action of this is physical and does not depend on absorption into the systemic circulation. The raft lasts for up to 4 hours on top of the stomach contents and is then broken down in the digestive system and excreted in the feces.

Tablet:

• Adults and children over 12 years: 1-2 tablets 3-4 times daily, after meals and before bedtime.
• Children 6-12 years: ½-1 tablet 3-4 times daily, after meals and before bedtime.

Suspension:

• Adults and children 12 years and above: 5-10 ml (1-2 teaspoonfuls) 3-4 times daily, after meals and before bedtime.
• Children 2-12 years: 2.5-5ml (½-1 teaspoonful) 3-4 times daily, after meals and before bedtime.

Use in children: This is not recommended under 2 years of age.
Elderly: No dose modifications are necessary for this age group.
Hepatic Impairment: No dose modifications are necessary.
Renal Insufficiency: Caution if a highly restricted salt diet is necessary.

In addition to the desired effect of the drug, some side effects may appear such as: nausea, constipation, diarrhea or headache. In these cases consult a physician In case too big dosage has been taken, there might appear a sensation of swelling. In this case it is advisable to consult a physician.

Sodium alginate and potassium bicarbonate is contraindicated in patients with known hypersensitivity to these.

Sodium Alginate and Potassium Bicarbonate should be prescribed with caution in patients with renal impairment and congestive cardiac failure. Care needs to be taken in treating patients with hypercalcemia, nephrocalcinosis and recurrent calcium-containing renal calculi. There is a possibility of reduced efficacy in patients with very low levels of gastric acid. If symptoms do not improve after seven days, the clinical situation should be reviewed.

A time interval of 2 hours should be considered between this intake and the administration of other medicinal products, especially tetracyclines, fluoroquinolones, iron salts, thyroid hormones, chloroquine, bisphosphonates, and estramustine.

This combination (Sodium Alginate and Potassium Bicarbonate) can be used during pregnancy, if clinically needed. No known effect on breast-fed infants. This combination can be used during breastfeeding.

Overdosage with this formulation is a rare case. In case of overdose please consult with a registered physician.

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

This solution is used in Haemodialysis.

Haemodialysis solutions

Calcium chloride is used to prevent or treat negative calcium balance. It also regulates action potential excitation threshold to facilitate nerve and muscle performance.

Potassium chloride is a major cation of the intracellular fluid. It plays an active role in the conduction of nerve impulses in the heart, brain and skeletal muscle; contraction of cardiac skeletal and smooth muscles; maintenance of normal renal function, acid-base balance, carbohydrate metabolism and gastric secretion.

Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives.

Magnessium Chloride acts as cofactor in numerous enzymatic reactions involving protein synthesis and carbohydrate metabolism; depresses CNS, blocks peripheral neuromuscular transmission, produces anticonvulsant effects.

Recommended dose: 5 liters concentrate per dialysis or as required.

Fluid and electrolyte imbalance, hypovolemia, hypotension or muscle cramping may occur.

Known hypersensitivity to any of the ingredients of this preparation.

It is used for hemodialysis purposes only. Do not use solution A or B alone. Discard container in case visible solid particles inside.

There are no known drug interactions and none well documented.

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

Bicarbonate Component [HCO3 Hemodialysis Solution] solution is indicated in renal failure, Chronic renal failure and Haemodialysis. Bicarbonate serves a crucial biochemical role in the physiological pH buffering system.

Haemodialysis solutions

Sodium chloride is the major extracellular cation. It is important in electrolyte and fluid balance, osmotic pressure control and water distribution as it restores sodium ions. It is used as a source of electrolytes and water for hydration, treatment of metabolic acidosis, priming solution in haemodialysis and treatment of hyperosmolar diabetes. It is also used as diluents for infusion of compatible drug additives. Sodium bicarbonate raises blood and urinary pH by dissociation to provide bicarbonate ions, which neutralises the hydrogen ion concentration. It also neutralises gastric acid via production of carbon dioxide.

Acidic component & Bicarbonate Component should be used in the dilution ratio of-

• Acidic component: 1.00 Volume
• Bicarbonate Component: 1.83 Volume
• Purified Water: 34.00 Volume

Known hypersensitivity to any of the ingredients of this preparation.

Sodium bicarbonate: Increases toxicity of amphetamines, ephedrine, pseudoephedrine, flecainide, quinidine and quinine. Decreases effects of lithium, chlorpropamide and salicylates due to increased clearance. May affect the absorption of certain drugs due to raised intra-gastric pH. Sodium chloride: May affect serum concentrations of lithium.

Keep out of reach of children. Not for Injection. Store below 30°C.

Dipeptidyl Peptidase-4 (DPP-4) inhibitor

Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.

Linagliptin 5 mg once daily. If added to metformin, the dose of metformin should be maintained and linagliptin administered concomitantly. When used in combination with a sulfonylurea, a lower dose of the sulphonylurea may be considered to reduce the risk of hypoglycaemia.

Patients with renal impairment: No dose adjustment required. Linagliptin can be taken with or without a meal at any time of the day.

There may be hypoglycaemia, nasopharyngitis, cough and pancreatitis in combination with metformin and sulfonylurea.

Hypersensitivity to the active substance or to any of the excipients.

Hypersensitivity to the active substance or to any of the excipients.

Linagliptin is a weak competitive and a weak to moderate mechanism-based inhibitor of CYP isozyme CYP3A4, but does not inhibit other CYP isozymes. The risk for clinically meaningful interactions by other medicinal products on linagliptin is low and in clinical studies linagliptin had no clinically relevant effect on the pharmacokinetics of metformin, glyburide, simvastatin, warfarin, digoxin or oral contraceptives.

Pregnancy category B. There are no adequate and well controlled studies in pregnant women. So, Linagliptin tablets should be used during pregnancy only if clearly needed. It is not known whether Linagliptin passes into breast milk or not.

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

This is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both Linagliptin and Metformin Hydrochloride is appropriate

Combination Oral hypoglycemic preparations

Linagliptin is indicated to improve glycemic control in patients with type 2 diabetes mellitus. Linagliptin is an inhibitor of DPP-4 (dipeptidyl peptidase-4), an enzyme that degrades the incretin hormones GLP-1 (glucagon like peptide-1) and GIP (glucose dependent insulinotropic polypeptide). Thus, Linagliptin increases the concentrations of active incretin hormones, stimulating the release of insulin from pancreatic beta (β) cells in a glucose-dependent manner and decreasing the secretion of glucagon from pancreatic alpha (α) cells in the circulation.

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

Linagliptin & Metformin immediate release tablet: The dosage of Linagliptin & Metformin should be individualized on the basis of both effectiveness and tolerability. Maximum recommended dose of 2.5 mg Linagliptin and 1000 mg Metformin Hydrochloride twice daily with meals. Dose escalation should be gradual to reduce the gastrointestinal (GI) side effects associated with Metformin Hydrochloride use.

Recommended starting dose: In patients currently not treated with Metformin Hydrochloride, initiate treatment with 2.5 mg Linagliptin and 500 mg Metformin Hydrochloride twice daily.

In patients already treated with Metformin Hydrochloride, start with 2.5 mg Linagliptin and the current dose of Metformin Hydrochloride twice daily.

Patients already treated with Linagliptin and Metformin Hydrochloride, individual components may be switched to this combination containing the same doses of each component.


Linagliptin & Metformin extend release tablet: The dosage of this combination should be individualized on the basis of both effectiveness and tolerability, while not exceeding the maximum recommended total daily dose of Linagliptin 5 mg and Metformin Hydrochloride 2000 mg. this combination should be given once daily with a meal.

Recommended starting dose: In patients currently not treated with metformin, initiate this combination treatment with 5 mg Linagliptin/1000 mg Metformin Hydrochloride extended-release once daily with a meal.

In patients already treated with Metformin, start this combination with 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.

In patients already treated with Linagliptin & Metformin immediate release tablet, switch to extend release tablet containing 5 mg of Linagliptin total daily dose and a similar total daily dose of Metformin once daily with a meal.

5 mg Linagliptin & 1000 mg Metformin Hydrochloride extended-release tablet should be taken as a single tablet once daily. Patients using 2.5 mg Linagliptin & 1000 mg Metformin extended release tablets should take two tablets together once daily.

Most common side effects are nasopharyngitis and diarrhea. Hypoglycemia is more common in patients treated with this combination and sulfonylureas.

Although Linagliptin undergoes minimal renal excretion, Metformin Hydrochloride is known to be substantially excreted by the kidney. The risk of Metformin Hydrochloride accumulation and lactic acidosis increases with the degree of renal impairment. Therefore, this combination is contraindicated in patients with renal impairment. It is also contraindicated in acute or chronic metabolic acidosis (diabetic ketoacidosis) and in hypersensitivity to Linagliptin or Metformin Hydrochloride.

In a patient with lactic acidosis who is taking Metformin, the drug should be discontinued immediately and supportive therapy promptly instituted. There have been postmarketing reports of acute pancreatitis. If pancreatitis is suspected, promptly discontinue Linagliptin & Metformin. Temporarily discontinue Linagliptin & Metformin in patients undergoing radiologic studies with intravascular administration of iodinated contrast materials or any surgical procedures necessitating restricted intake of food and fluids. Metformin may lower Vitamin B12 levels; so hematologic parameters shoud be monitored annually.

Cationic drugs (amiloride, digoxin, morphine, ranitidine, trimethoprim etc.): May reduce metformin elimination.

P-glycoprotien/CYP3A4 inducer (i.e. rifampin): The efficacy of this medicine may be reduced when administered in combination.

There are no adequate and well-controlled studies in pregnant women with this combination or its individual component; so it should be used during pregnancy only if clearly needed. Caution should also be excercised when it is administered to a lactating mother.

In the event of an overdose with this combination the usual supportive measures (i.e. remove unabsorbed material from the gastrointestinal tract, perform clinical monitoring, and institute supportive treatment) should be employed. Removal of Linagliptin by hemodialysis or peritoneal dialysis is unlikely but Metformin Hydrochloride is dialyzable.

During controlled clinical trials in healthy subjects, with single doses of up to 600 mg of Linagliptin (equivalent to 120 times the recommended daily dose), there were no dose-related clinical adverse drug reactions.

Overdose of Metformin Hydrochloride has occurred in case of ingestion of amounts greater than 50 grams. Hypoglycemia was reported in approximately 10% of cases, but no causal association with Metformin Hydrochloride has been established. Lactic acidosis has been reported in approximately 32% of Metformin Hydrochloride overdose cases.

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

Eye Anti-Infectives & Antiseptics, Tetracycline group of drugs, Topical antibiotics for Acne

Oxytetracycline inhibits cell growth by inhibiting translation. It binds to the 30S ribosomal subunit and prevents the amino-acyl tRNA from binding to the A site of the ribosome. The binding is reversible in nature. Oxytetracycline is lipophilic and can easily pass through the cell membrane or passively diffuses through porin channels in the bacterial membrane.

Adults: 250-500 mg every 6 hours. Food, milk and some dairy products interfere with the absorption of Tetracyclines. So Tetracyclines should be given one hour before or two hours after meals.

Side effects of Oxytetracycline, which have been reported in some patients, are anorexia, nausea, vomiting, diarrhoea, glossitis, skin rashes and urticaria.

Oxytetracycline should not be used with patients who are hypersensitive to Tetracyclines. It should not be used in children under 12 years of age. It is contraindicated in pregnant women because of tooth staining in the fetus and possible growth retardation effects.

Oxytetracycline should be used with caution in renal impairment.

Antacids containing Aluminium, Calcium, Magnesium, Zinc or Iron salts may impair the absorption of Oxytetracycline. In long term therapy, Tetracyclines depress plasma prothrombin activity and reduced doses of concomitant anticoagulants may be necessary. A few cases of pregnancy or breakthrough bleeding have been attributed to the concurrent use of Tetracyclines or Oxytetracyclines with oral contraceptives.

Results of animal studies indicate that tetracyclines cross the placenta, are found in fetal tissues and can have toxic effects on the developing fetus. Evidence of embryotoxicity has also been noted in animals treated early in pregnancy. Tetracyclines are present in the milk of lactating women who are taking a drug in this class.

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

Atypical neuroleptic drugs

The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.

Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.

Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.

Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.

The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.

Quetiapine is contra-indicated in patients who are hypersensitive to it.

Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.

Atypical neuroleptic drugs

The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.

Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.

Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.

Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.

The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.

Quetiapine is contra-indicated in patients who are hypersensitive to it.

Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.

Atypical neuroleptic drugs

The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.

Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.

Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.

Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.

The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.

Quetiapine is contra-indicated in patients who are hypersensitive to it.

Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.

Atypical neuroleptic drugs

The mechanism of action of Quetiapine, as with other drugs having efficacy in the treatment of schizophrenia and acute manic episodes associated with bipolar disorder, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine type 2 (D2 ) and serotonin type 2 (5HT2) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of Quetiapine. Quetiapine's antagonism of histamine H1 receptors may explain the somnolence observed with this drug. Quetiapine's antagonism of adrenergic α1 receptors may explain the orthostatic hypotension observed with this drug.

Acute and chronic psychoses, including schizophrenia: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). From Day 4 onwards, the dose should be titrated to the usual effective dose range of 300-450 mg/day. However, this may be adjusted, depending on the clinical response and tolerability of the individual patient, within the range 150 to 750 mg/day.

Manic episodes associated with bipolar disorder: Quetiapine should be administered twice daily, with or without food. The total daily dose for the first four days of therapy is 100 mg (Day 1), 200 mg (Day 2), 300 mg (Day 3) and 400 mg (Day 4). Further dosage adjustments up to 800mg/day by Day 6 should be in increments of no greater than 200 mg/day. The dose may be adjusted depending on clinical response & tolerability of the individual patient, within the range of 200 to 800 mg/day. The usual effective dose is in the range of 400 to 800mg/day.

Depressive episodes associated with bipolar disorder: Quetiapine should be administered once daily at bedtime, with or without food. The usual dose is 300 mg/day. The daily dose for the first four days of therapy is 50 mg (Day 1), 100 mg (Day 2), 200 mg (Day 3) and 300 mg (Day 4). Quetiapine can be titrated to 400 mg on Day 5 and up to 600mg by Day 8. Antidepressant efficacy was demonstrated with Quetiapine at 300mg and 600 mg, however no additional benefit was seen in the 600mg group during short term treatment.

Maintenance treatment of bipolar I disorder in combination with mood stabilizers: Patients who have responded to Quetiapine in combination therapy with a mood stabiliser for acute treatment of bipolar disorder should continue on Quetiapine therapy at the same dose. Quetiapine dose can be re-adjusted depending on clinical response and tolerability of the individual patient. Efficacy was demonstrated with Quetiapine (administered twice daily totalling 400mg to 800mg a day) as combination therapy with a mood stabilizer.

The most commonly reported Adverse Drug Reactions (ADRs) with Quetiapine are somnolence, dizziness, dry mouth, withdrawal (discontinuation) symptoms, elevations in serum triglyceride levels, elevations in total cholesterol (predominantly LDL cholesterol), decreases in HDL cholesterol, weight gain, decreased haemoglobin and extrapyramidal symptoms.

Quetiapine is contra-indicated in patients who are hypersensitive to it.

Caution should be exercised when Quetiapine is used concomitantly with medicines known to cause electrolyte imbalance or to increase QT interval. Co-administration of Quetiapine and thioridazine or carbamazepine caused increases in the clearance of Quetiapine. Co-administration of Quetiapine with another microsomal enzyme inducer, phenytoin, also caused increases in the clearance of Quetiapine.

The safety and efficacy of Quetiapine during human pregnancy have not been established. Therefore, Quetiapine should only be used during pregnancy if the benefits justify the potential risks and the administered dose and duration of treatment should be as low and as short as possible. The degree to which Quetiapine is excreted into human milk is unknown. Women who are breast-feeding should therefore be advised to avoid breast-feeding while taking Quetiapine.

Elderly: As with other antipsychotics, Quetiapine should be used with caution in the elderly, especially during the initial dosing period. The rate of dose titration may need to be slower, and the daily therapeutic dose lower, than that used in younger patients, depending on the clinical response and tolerability of the individual patient. The mean plasma clearance of Quetiapine was reduced by 30% to 50% in elderly subjects when compared with younger patients.

Children and Adolescents: Quetiapine is not indicated for use in children and adolescents below 18 years of age.

In clinical trials, survival has been reported in acute overdoses of up to 30 grams of Quetiapine. There is no specific antidote to Quetiapine. In cases of severe intoxication, the possibility of multiple drug involvement should be considered, and intensive care procedures are recommended, including establishing and maintaining a patent airway, ensuring adequate oxygenation and ventilation, and monitoring and support of the cardiovascular system. In cases of Quetiapine overdose, refractory hypotension should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (adrenaline and dopamine should be avoided, since beta stimulation may worsen hypotension in the setting of Quetiapine-induced alpha blockade). Close medical supervision and monitoring should be continued until the patient recovers.

Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the blister pack and the carton. The expiry date refers to the last day of that month. Store in a cool and dry place away from light.

Triamcinolone & Combined preparations

Adults: This cream should be applied sparingly to the skin lesion no more than 2 times daily, preferably once in the morning and once in the evening. This cream should not be applied with an occlusive dressing, or to large areas of skin on the body. The duration of treatment with this cream should continue until the inflammatory symptoms subside but not longer than 2 weeks; after 2 weeks of therapy with this cream, continue therapy as needed with a preparation containing econazole or econazole nitrate alone.

Pediatric Use: Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing's syndrome than mature patients because of a larger skin surface area to body weight. Caution should be exercised.

Rarely, transient local mild irritation, itching & redness may occur immediately after application. Econazole has the minimal allergenic effect and is well tolerated, even by delicate skin. Adrenal suppression on long term continuous topical steroid therapy may occur, particularly in infants or children, or when occlusive dressings are applied. It should be noted that an infant's napkin may act as an occlusive dressing.

This Cream is contraindicated-

• In individuals who have shown hypersensitivity to any of its ingredients.
• Like any other dermatological preparation containing corticosteroids, this Cream is contraindicated in specific skin conditions such as tuberculous, varicella, herpes simplex or other viral infections of the skin, or fresh vaccination sites.
• Decubitus ulcers: Viral, bacterial or fungal skin infections (e.g. tuberculosis of the skin, syphilis of the skin, herpes simplex, herpes zoster, chickenpox).
• Rosacea and rosacea-like dermatitis.

• For external use only. This Cream is not for ophthalmic or oral use.
• If a reaction suggesting hypersensitivity or chemical irritation should occur, use of the medication should be discontinued.
• Corticosteroids applied to the skin can be absorbed in sufficient amounts to produce systemic effects, including adrenal suppression. Systemic absorption may be increased by various factors such as application over a large skin surface area, application to damaged skin, application under occlusive skin dressings and prolonged duration of therapy.
• Topical corticosteroids are associated with skin thinning and atrophy, striae, telangiectasis and purpura.
• Topical corticosteroids may lead to increased risk of dermatological superinfection or opportunistic infection.

Children: Increased caution is required when treating children. Compared to adults, the nature of a child's skin and the larger skin surface area relative to body weight may lead to an increased absorption of the corticosteroid via the child's skin. This cream should be used in children only for short periods of time (less than 2 weeks) and on small areas (less than 10% of body surface area).

Visual disturbance may be associated with systemic and topical corticosteroid use. If a patient presents with symptoms such as blurred vision or other visual disturbances, the patient should be considered for referral to an ophthalmologist for evaluation of possible causes which may include cataract, glaucoma or rare diseases such as central serous chorioretinopathy (CSCR).

Econazole: compound metabolized by CYP3A4/2C9 oral anticoagulants (warfarin & acenocoumarol).

Triamcinolone: lowering of plasma salicylates levels. Increased risk of Gl bleeding and ulceration with NSAIDs. Antagonised blood glucose-lowering effects of the antidiabetics. Increased risk of Hyperkalemia with amphotericin B, beta-blockers, potassium-depleting diuretics, theophylline. Increased clearance of the triamcinolone with ciclosporin, carbamazepine, phenytoin, barbiturate, rifampicin.

Pregnancy: Not the Econazole but the Triamcinolone Acetonide crosses the placenta and topical administration of corticosteroids during pregnancy can cause abnormalities of foetal development. The relevance of this finding to human beings has not been established. However, topical steroids in large amounts or for prolonged periods
should not be used in pregnancy.

Lactation: Negligible amount of econazole and to some extent Triamcinolone may be excreted in small amounts in breast milk. So this cream should not be prescribed to the lactating mother or if prescribed lactation should be withheld during treatment.

This Cream is for cutaneous application only. Corticosteroids applied to the skin, including triamcinolone, can be absorbed in sufficient amounts to produce systemic effects. In the event of accidental ingestion, treat symptomatically. If this cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.

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

Vitamin B1, B6 & B12 is indicated for the treatment of vitamin B1, B6 & B12 deficiency syndrome. It is also indicated for the supportive treatment of neuritis & non-inflammatory diseases of the nerves, e.g.- Diabetic neuropathy, Peripheral neuralgin, Lumbago, Myalgia, Optic neuritis, Sciatica, Facial neuralgia, Intercostal neuralgia, Spinal pain.

Specific combined vitamin preparations

Vitamin B1 converts carbohydrates, fatty acids and amino acids into energy, promotes healthy nerves, improves mood, strengthens the heart. Vitamin B6 forms RBCs, helps cells to make proteins, manufactures neurotransmitters e.g. serotonin and releases stored forms of energy, helps to prevent CVS diseases and stroke, helps to lift depression and eases insomnia. Vitamin B12 is essential for cell replication and important for RBC production, prevents anemia, helps to prevent depression, reduces nerve pain, numbness, tingling and lowers the risk of heart diseases.

The vitamin ingredients are absorbed well in per oral reception. It is widely distributed to most tissues and appears in breast milk. Within the cell, thiamine is mostly present as diphosphate. Thiamine is not stored to any appreciable extent in the body and amounts in excess of the body’s requirements are excreted in the urine as unchanged thiamine or as metabolites. Pyridoxine, pyridoxal and pyridoxamine are readily absorbed from the GIT following oral administration and are converted to the active forms of pyridoxal phosphate an pyridoxamine phosphate. They are stored mainly in liver where there is oxidation to 4-pyridoxic acid and other inactive metabolites, which are excreted in urine. As the dose increases, proportionally greater amounts are excreted unchanged in the urine.

Tablet: 1-3 Tablets per day or as advised by the physician.

Injection:

• In severe (acute) cases: 1 injection daily until the acute symptoms subside or taken as advised by the physician.
• In mild cases: 1 injection 2-3 times per week. Ampoules are preferably injected intramuscularly.

Use in children: There is no information on the use of this drug in children.

Generally well tolerated but allergic reactions may be observed in few cases.

Vitamin B1, Vitamin B6 and Vitamin B12 is contraindicated in patients on levodopa therapy, and in patients with hypersensitivity to any of the ingredients of the preparation.

Cyanocobalamin should not be given in patients with subacute degeneration of the spinal cord. Cyanocobalamin is not suitable form of vitamin B12 for the treatment of optic neuropathies associated with raised plasma concentrations of cyanocobalamin.

No drug interaction has been reported yet.

Oral tablet form is recommended but due to the presence of benzyl alcohol, injection is not recommended during pregnancy & lactation.

No overdosage symptoms are to be expected in the recommended dosage. If there is known overdose then treatment is symptomatic & supportive.

Keep out of reach of children. Store in a cool (below 25°C temperature) and dry place, protected from light.