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4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

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

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

Appetite suppressant drugs/Anti-obesity drugs

Orlistat is a potent, specific and long-acting lipase inhibitor. It exerts its therapeutic activity in the lumen of the stomach and upper small intestine by forming a covalent bond with the active serine site of gastric and pancreatic lipases. The inactivated enzyme is thus rendered unable to hydrolyze dietary fats in the form of triglycerides into absorbable free fatty acids and monoglycerides. As undigested triglycerides can not be absorbed, a caloric deficit arises which has a positive effect on weight control. Systemic absorption of orlistat is therefore not needed for the activity. At the recommended therapeutic dose of 120 mg three times a day, orlistat inhibit dietary fat absorption by approximately 30%.

The recommended dose of Orlistat is one 120 mg capsule to be taken immediately before, during or up to one hour after each main meal. If a meal is missed or contains no fat the dose of Orlistat should be omitted. Doses of Orlistat above 120 mg three times daily have not been shown to provide additional benefits. The effect of Orlistat results in an increase in fecal fat 24-48 hours after dosing. Upon discontinuation of therapy, fecal fat content usually returns to pretreatment levels within 48-72 hours.

The safety & efficacy of Orlistat were investigated in clinical studies lasting up to 4 years. The recommended dose of Orlistat for adolescents is as same as adults.

Special dosage instruction: The tolerability and efficacy of Orlistat have not been studied in elderly patients, or patients with hepatic and/ or renal impairments.

Common: Undesirable effects of Orlistat are largely gastrointestinal in nature. Common gastrointestinal side effects are oily spotting from the rectum, flatulence, fecal urgency, oily or fatty stool, abdominal discomfort etc.

Rare: Influenza, anxiety. headache, fatigue etc may rarely occur in some patients. Rare cases of hypersensitivity have been reported. Main clinical symptoms are pruritus, exanthema, urticaria, angioedema and anaphylaxis.

Orlistat is contraindicated in patients with chronic malabsorption syndrome, in patients with cholestasis and in patients who are hypersensitive to orlistat or to any of the other ingredients of the capsules.

Organic causes of obesity (e.g. hypothyroidism) should be excluded before prescribing Orlistat. Orlistat and cyclosporine should not be coadministered. Cyclosporine should be taken at least 2 hours before or after Orlistat in patients taking both drugs. Cyclosporine level should be measured and frequently monitored.

In clinical trial, the decrease in body weight with Orlistat therapy was less in type II diabetic patients than in non-diabetic patients. Antidiabetic drug treatment should be closely monitored during Orlistat therapy. Because of the improvement in glycemic control, the dose of oral antidiabetics or of insulin may need to be adjusted.

Patients should be advised to adhere to the dietary recommendations. The probability of occurrence of gastrointestinal side effects may increase when Orlistat is taken with a fatty meal. The daily intake of fat should be distributed between three main meals. Patients should be strongly encouraged to take a multivitamin supplement that contains fat soluble vitamins to ensure adequate nutrition because orlistat has been shown to reduce the absorption of some fat soluble vitamins & beta-carotene. In addition, the levels of vitamin D & beta carotene may be low in obese patients compared with non-obese patients.

No interactions with commonly prescribed medications such as alcohol, digoxin, nifedipine, oral contraceptives, phenytoin, pravastatin, warfarin, or metformin, glibenclamide, fibrates, furosemide, captopril, or atenolol have been observed in studies.

Use in pregnancy & lactation: No clinical data are available on pregnancy exposed to Orlistat. As it is not known whether Orlistat is excreted in breast milk. Orlistat should not be used during breastfeeding.

Single doses of 800 mg Orlistat and multiple doses of up to 400 mg three times a day for 15 days have been studied in normal weight and obese subjects without significant adverse findings.

Store in cool & dry place below 30°C, protect from light & moisture. Keep out of reach of children.

4-Quinolone preparations, Anti-diarrhoeal Antimicrobial drugs

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

Tablet: Adult:

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

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

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

For IV infusion:

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

Instruction for the use of Ciprofloxacin IV infusion-

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

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

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

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

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

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

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

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

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

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

Aural Anti-bacterial preparations, Ophthalmic antibacterial drugs

Ciprofloxacin is a synthetic broad-spectrum antimicrobial agent for intravenous administration. The bactericidal action of Ciprofloxacin results from inhibition of the enzymes topoisomerase II (DNA gyrase) and topoisomerase IV, which are required for bacterial DNA replication, transcription, repair, and recombination.

Corneal ulcers: The recommended dosage regimen for the treatment of corneal ulcers is two drops into the affected eye every 15 minutes for the first 6 hours and then two drops into the affected eye every 30 minutes for the remainder of the first day. On the second day, instill 2 drops in the affected eye hourly. On the third through the fourteenth day, place two drops in the affected eye every four hours. Treatment may be continued after 14 days if corneal re-epithelization has not been occurred.

Bacterial conjunctivitis: The recommended dosage regimen for the treatment of bacterial conjunctivitis is one or two drops instilled into the conjunctival sac(s) every two hours while awake for two days and one or two drops every four hours while awake for the next five days.

Ear infections: For all infections, 2-3 drops every 2-3 hours initially, reducing the frequency of the instillation with control of infection. Treatment should be continued at least 7 days.

Local burning or discomfort, itching, foreign body sensation, crystalline precipitates, lid margin crusting, conjunctival hyperemia and a bad taste following administration. Photophobia and nausea may be reported.

Hypersensitivity to quinolone group of antibacterials or any of the components of the formulation.

Prolonged ocular use of Ciprofloxacin may result in overgrowth of non-susceptible organisms, including fungi. Ciprofloxacin should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity reaction.

Specific drug interaction studies have not been observed with ophthalmic Ciprofloxacin.

Do not use unless the potential benefits outweigh the potential risk during pregnancy. It is not known whether excretion in human milk occurs following topical ophthalmic administration. Caution should be exercised in the nursing mothers.

Pediatric use: Safety and effectiveness in children under 1 year of age have not been established.

A topical overdose may be flushed from the eye/s with warm tap water.

Store below 30° C in a cool and dry place protected from light. Keep out of reach of children. Do not touch the dropper tip to surfaces since this may contaminate the solution. Do not use after 30 days of first opening.

Aural steroid & antibiotic combined preparations

Dexamethasone is glucocorticoid. It has an anti-inflammatory and anti-allergic action. It is used topically in the treatment of inflammatory conditions of the anterior segment of the eye. It reduces prostaglandin synthesis by inhibiting the enzyme phospholipase A2. Also, Dexamethasone inhibits the chemotactic infiltration of neutrophils into the site of inflammation.

Ciprofloxacin has in vitro activity against a wide range of gram-negative and gram-positive organisms, possessing the greatest antibacterial activity of all quinolones. The bactericidal action of Ciprofloxacin results from interference with the enzyme DNA gyrase which is needed for the synthesis of bacterial DNA.

For Eye: 1 drop to be instilled into conjunctival sac(s) every four to six hours. During the initial 24 to 48 hours, the dosage may be increased to 1 drop every two hours.

For Ear:

• Acute otitis media in pediatric patients with typanastomy tube: 4 drops instilled into the affected ear 2 times daily for 7 days.
• Acute otitis externa: 4 drops instilled into the affected ear 2 times daily for 7 days.

Frequency should be decreased gradually or warranted in clinical signs. Care should be taken not to discontinue therapy prematurely.

Frequently reported adverse reactions are transient ocular burning or discomfort. Other reported reactions include stinging, redness, itching, photophobia, conjunctivitis/ keratitis, Periocular/ facial edema, foreign body sensation, blurred vision, tearing, dryness, and eye pain. Elevation of IOP with development of glaucoma, and delayed wound healing may rarely occur.

Known hypersensitivity to any ingredient of the product. Herpes simplex and other viral conditions, mycosis, glaucoma, newborn babies, fungal diseases of ocular or auricular structures.

Prolonged use may result in overgrowth of nonsusceptible organisms including fungi; in ocular hypertension and/or glaucoma, with damage to the optic nerve, defects in visual acuity and fields of vision and posterior sub capsular cataract formation. Patients wearing contact lenses must not use the drops during the time the lenses are worn.

Specific drug interaction studies have not been conducted with ophthalmic Ciprofloxacin and Dexamethasone. However, the systemic administration of some quinolones has been shown to elevate plasma concentrations of theophylline, interfere with the metabolism of caffeine, enhance the effects of the oral anticoagulant warfarin and its derivatives and have been associated with transient elevations in serum creatinine in patients receiving cyclosporin concomitantly.

Use in pregnancy: This should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Use in lactation: It is not known whether topical administration of corticosteroids would result in sufficient systemic absorption to produce detectable quantities in human milk. It is also not known whether ciprofloxacin is excreted in human milk following topical administration. Because many drugs are excreted in human milk, caution should be exercised when the combination is administered to a nursing woman.

Use in children: Safety & effectiveness for the use of this eye drops in children below the age of one year have not been established.

Store in a cool and dry place, away from light. Keep out of reach of children. Shake well before each use.

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for-

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia and
• Chronic Musculoskeletal Pain.

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.

Major Depressive Disorder (MDD)-

• Starting Dose: 40 mg/day to 60 mg/day
• Target Dose: Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day
• Maximum Dose: 120 mg/day

Generalized Anxiety Disorder (GAD)-

• Starting Dose: 60 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 120 mg/day

Diabetic Peripheral Neuropathic Pain (DPNP)-

• Starting Dose: 60 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Fibromyalgia-

• Starting Dose: 30 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Chronic Musculoskeletal Pain-

• Starting Dose: 30 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.

The most commonly observed adverse events in Duloxetine hydrochloride treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Duloxetine-treated and placebo-treated patients.

Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.

Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended

Use in the pediatric population: Safety and efficacy in pediatric patients have not been established

There is limited clinical experience with Duloxetine overdose in humans. There is no specific antidote to Duloxetine. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting the absorption of Duloxetine from the gastrointestinal tract.

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

Duloxetine is a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for-

• Major Depressive Disorder (MDD)
• Generalized Anxiety Disorder (GAD)
• Diabetic Peripheral Neuropathic Pain (DPNP)
• Fibromyalgia and
• Chronic Musculoskeletal Pain.

Serotonin-norepinephrine reuptake inhibitor (SNRI)

Duloxetine Hydrochloride is a selective serotonin and norepinephrine reuptake inhibitor (SSNRI) for oral administration. Duloxetine is a less potent inhibitor of dopamine reuptake. Duloxetine has no significant affinity for dopaminergic, adrenergic, cholinergic, histaminergic, opioid, glutamate, and GABA receptors in vitro. Duloxetine does not inhibit monoamine oxidase (MAO). Orally administered Duloxetine hydrochloride is well absorbed. Elimination of Duloxetine is mainly through hepatic metabolism.

Major Depressive Disorder (MDD)-

• Starting Dose: 40 mg/day to 60 mg/day
• Target Dose: Acute: 40 mg/day (20 mg twice daily) to 60 mg/day (once daily or as 30 mg twice daily); Maintenance: 60 mg/day
• Maximum Dose: 120 mg/day

Generalized Anxiety Disorder (GAD)-

• Starting Dose: 60 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 120 mg/day

Diabetic Peripheral Neuropathic Pain (DPNP)-

• Starting Dose: 60 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Fibromyalgia-

• Starting Dose: 30 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Chronic Musculoskeletal Pain-

• Starting Dose: 30 mg/day
• Target Dose: 60 mg/day (once daily)
• Maximum Dose: 60 mg/day

Some patients may benefit from starting at 30 mg once daily. There is no evidence that doses greater than 60 mg/day confers an additional benefit, while some adverse reactions were observed to be dose-dependent. A gradual dose reduction is recommended to avoid discontinuation symptoms.

The most commonly observed adverse events in Duloxetine hydrochloride treated patients were nausea, dizziness, dry mouth, constipation, decreased appetite, fatigue, somnolence, increased sweating, hyperhidrosis and asthenia. It may slightly increase blood pressure. No clinically significant differences were observed for QT, PR, and QRS intervals between Duloxetine-treated and placebo-treated patients.

Duloxetine is contraindicated in patients with a known hypersensitivity to this drug or any of the inactive ingredients. Duloxetine is not approved for use in treating bipolar depression. Duloxetine should not be prescribed to patients with substantial alcohol use or evidence of chronic liver disease. In clinical trials, Duloxetine was associated with an increased risk of mydriasis; therefore, it should be used cautiously in patients with controlled narrow-angle glaucoma.

All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes. Blood pressure should be measured prior to initiating treatment and periodically measured throughout treatment. Patients should be cautioned about the risk of bleeding associated with the concomitant use of Duloxetine and NSAIDs, aspirin, or other drugs that affect coagulation. Duloxetine should be used cautiously in patients with a history of mania. Duloxetine should be prescribed with care in patients with a history of a seizure disorder.

Both CYP1A2 and CYP2D6 isozymes are responsible for Duloxetine metabolism. When Duloxetine was co-administered with fluvoxamine, a potent CYP1A2 inhibitor, the AUC, Cmax and t of Duloxetine was increased. Other drugs that inhibit CYP1A2 metabolism include cimetidine and quinolone antimicrobials such as ciprofloxacin and enoxacin would be expected to have similar effects and these combinations should be avoided. Because CYP2D6 is involved in Duloxetine metabolism, concomitant use of Duloxetine with potent inhibitors of CYP2D6 may result in higher concentrations of Duloxetine.

Pregnancy: Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women; therefore, Duloxetine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Labor and Delivery: The effect of Duloxetine on labor and delivery in humans is unknown. Duloxetine should be used during labor and delivery only if the potential benefit justifies the potential risk to the fetus.

Lactation: It is unknown whether or not Duloxetine and/or it's metabolites are excreted into human milk, but nursing while on Duloxetine is not recommended

Use in the pediatric population: Safety and efficacy in pediatric patients have not been established

There is limited clinical experience with Duloxetine overdose in humans. There is no specific antidote to Duloxetine. In case of acute overdose, treatment should consist of those general measures employed in the management of overdose with any drug. An adequate airway, oxygenation, and ventilation should be assured, and cardiac rhythm and vital signs should be monitored. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion or in symptomatic patients. Activated charcoal may be useful in limiting the absorption of Duloxetine from the gastrointestinal tract.

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

4-Quinolone preparations

Levofloxacin is a synthetic, broad-spectrum, third generation fluoroquinolone antibiotic. Chemically, Levofloxacin is a chiral fluorinated carboxyquinolone. Levofloxacin exerts antibacterial action by inhibiting bacterial topoisomerase IV and DNA gyrase, the enzymes required for DNA replication, transcription repair and recombination. It has in vitro activity against a wide range of gm-ve and gm+ve microorganisms.

The usual dose of Levofloxacin Tablets is 250 mg or 500 mg or 750 mg administered orally every 24 hours. Levofloxacin tablets can be administered without regard to food. Levofloxacin oral solution should be taken 1 hour before, or  2 hours after eating.

Levofloxacin injection should only be administered by intravenous infusion. It is not for intramuscular, intrathecal, intraperitoneal, or subcutaneous administration. The usual dose of Levofloxacin injection is 250 mg or 500 mg administered by slow infusion over 60 minutes every 24 hours or 750 mg administered by slow infusion over 90 minutes every 24 hours. Since the Levofloxacin injections are for single-use only, any unused portion should be discarded. Additives or other medications should not be added to Levofloxacin Injection or infused simultaneously through the same intravenous line.

Adults:

• Acute sinusitis: 500 mg once daily for 10-14 days, or 750 mg once daily for 5 days
• Exacerbation of chronic bronchitis: 500 mg once daily for 7 days, or 750 mg once daily for 3 days (Uncomplicated), 750 mg once daily for 5 days (Complicated)
• Community-acquired pneumonia: 500 mg once daily for 7-14 days, or 750 mg once daily for 5 days
• Uncomplicated urinary-tract infections: 250 mg once daily for 3 days
• Complicated urinary-tract infections and acute pyelonephritis: 250 mg once daily for 7-10 days
• Uncomplicated skin and soft-tissue infections: 500 mg once daily for 7-10 days.
• Complicated skin and soft-tissue infections: 750 mg once daily for 7-14 days.
• Enteric fever: 500 mg once daily for 7-14 days.
• Diarrhea, cholera, shigellosis & enteritis: Mild to moderate case: 500 mg (single dose). Moderate to sever case: 500 mg once daily for 3 days

Children:

• Children 6 months to <5 years: 10 mg/kg every 12 hours.
• Children >5 years: 10 mg/kg every 24 hours

In each case, sequential therapy (intravenous to oral) may be instituted at the discretion of the physician.

Instructions for the Use of Levofloxacin Infusion-

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

Levofloxacin is generally well tolerated. However, a few side-effects can usually be seen. There is a risk of retinal detachment. Other side-effects include: nausea, vomiting, diarrhea, abdominal pain, flatulence and rare occurrence of phototoxicity (0.1%). Side-effects that may be seen very rarely include tremors, depression, anxiety, confusion etc.

Levofloxacin is contraindicated in patients with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents, or any other components of this product.

The following measures should be taken during administration of Levofloxacin:

• Levofloxacin Injection should only be administered by slow intravenous infusion over a period of 60 or 90 minutes depending on the dosage.
• While administrating Levofloxacin, adequate amount of water should be taken to avoid concentrated form of urine.
• Dose adjustment should be exercised during Levofloxacin administration in presence of renal insufficiency.

No quinolone should be co-administered with any solution containing multivalent cations, e.g., magnesium, through the same intravenous line. Antacids, Iron and Adsorbents reduce absorption of Levofloxacin. NSAID may increase the risk of CNS stimulation. Warfarin may increase the risk of bleeding.

Levofloxacin is not recommended for use during pregnancy or nursing, as the effects on the unborn child or nursing infant are unknown.

Levofloxacin exhibits a low potential for acute toxicity. However, in the events of an acute overdosage, the stomach should be emptied. The patients should be kept under observation and appropriate hydration should be maintained.

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

Non-steroidal Anti-inflammatory Drugs (NSAIDs)

Lornoxicam is a non-steroidal anti-inflammatory drug (NSAID) that belongs to the oxicam class. As with other NSAIDS, lornoxicam is a potent inhibitor of the cyclooxgenase enzymes, which are responsible for catalyzing the formation of prostaglandins (act as messenger molecules in the process of inflammation) and thromboxane from arachidonic acid. Unlike some NSAIDS, lornoxicam's inhibition of cyclooxygenase does not lead to an increase in leukotriene formation, meaning that arachidonic acid is not moved to the 5-lipoxygenase cascade, resulting in the minimization of the risk of adverse events.

Like other NSAIDS, lornoxicam's anti-inflammatory and analgesic activity is related to its inhibitory action on prostaglandin and thromboxane synthesis through the inhibition of both COX-1 and COX-2. This leads to the reduction of inflammation, pain, fever, and swelling, which are mediated by prostaglandins. However, the exact mechanism of lornoxicam, like that of the other NSAIDs, has not been fully determined.

For all patients, the appropriate dosing regimen should be based upon individual response to treatment.

Pain: 8-16 mg lornoxicam daily divided into 2 or 3 doses. The Maximum recommended daily dose is 16 mg.

Osteoarthritis and Rheumatoid arthritis: Initial recommended dose is 12 mg lornoxicam daily divided into 2 or 3 doses. The maintenance dose should not exceed 16 mg lornoxicam daily. Lornoxicam film-coated tablets are supplied for oral use and should be taken with a sufficient quantity of liquid.

Children and adolescents: Lornoxicam is not recommended for use in children and adolescents below age 18 due to a lack of data on safety and efficacy.

Elderly: No special dosage modification is required for elderly patients above age 65, but Lornoxicam should be administered with precaution as gastrointestinal adverse effects are less well tolerated in this group.

Renal impairment: For patients with mild to moderate renal impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses.

Hepatic impairment: For patients with moderate hepatic impairment the maximum recommended daily dose is 12 mg divided in 2 or 3 doses.

Renal impairment: Lornoxicam should be administered with precaution in patients with mild (serum creatinine 150-300 µmol/l) to moderate (serum creatinine 300 – 700 µmol/l) renal impairment due to dependency on renal prostaglandins for maintenance of renal blood flow. Treatment with lornoxicam should be discontinued if renal function deteriorates during treatment. Renal functions should be monitored in patients who undergo major surgery, with cardiac failure, receiving treatment with diuretics, receiving concomitant treatment with drugs that are suspected to or known to be able to cause kidney damage.

Patients with blood coagulation disorders: Careful clinical monitoring and laboratory assessment is recommended (e.g. APTT).

Hepatic impairment (e.g. liver cirrhosis): Clinical monitoring and laboratory assessments at regular intervals should be considered in patients with hepatic impairment as accumulation of lornoxicam (increase in AUC) may occur after treatment with daily doses of 12-16 mg. Apart from that, hepatic impairment does not seem to affect pharmacokinetic parameters of lornoxicam as compared to healthy subjects.

Long term treatment (longer than 3 months): Regular laboratory assessments of haematology (haemoglobin), renal functions (creatinine) and liver enzymes are recommended.

Elderly patients above 65 years: Monitoring of renal and hepatic function is recommended. Precaution is advised in elderly postoperative patients.

Lornoxicam is contraindicated on the third trimester of pregnancy and should not be used during pregnancy in the first and second trimesters and delivery, as no clinical data on exposed pregnancies are available. There are no adequate data from the use of lornoxicam in pregnant women. Studies in animals have shown reproductive toxicity. There are no data on the excretion of lornoxicam in human breast milk. Lornoxicam is excreted in milk of lactating rats in relatively high concentrations. Therefore lornoxicam should not be used in breastfeeding women.

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.

Danazol is indicated for the following treatment-

• Endometriosis
• Benign breast disease
• Menorrhagia
• Gynecomastia
• Preoperative thinning of the endometrium before hysteroscopic endometrial ablation.

Drugs affecting (inhibiting) gonadotrophin

As a gonadotropin inhibitor, danazol suppresses the pituitary-ovarian axis possibly by inhibiting the output of pituitary gonadotropins. Danazol also depresses the preovulatory surge in output of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), thereby reducing ovarian estrogen production. Danazol may also directly inhibits ovarian steroidogenesis; bind to androgen, progesterone, and glucocorticoid receptors; bind to sex-hormone-binding globulin and corticosteroid-binding globulin; and increases the metabolic clearance rate of progesterone. Another mechanism of action by which danazol may use to facilitate regression of endometriosis is by decreasing IgG, IgM, and IgA concentrations, as well as phospholipid and IgG isotope autoantibodies. In the treatment of endometriosis, as a consequence of suppression of ovarian function, danazol causes both normal and ectopic endometrial tissues to become inactive and atrophic. This leads to anovulation and associated amenorrhea. In fibrocystic breast disease, the exact mechanism of action of danazol is unknown, but may be related to suppressed estrogenic stimulation as a result of decreased ovarian production of estrogen. A direct effect on steroid receptor sites in breast tissue is also possible. This leads to a disappearance of nodularity, relief of pain and tenderness, and possibly changes in the menstrual pattern. In terms of hereditary angioedema, danazol corrects the underlying biochemical deficiency by increasing serum concentrations of the deficient C1 esterase inhibitor, resulting in increased serum concentrations of the C4 component of the complement system.

Preoperative thinning of the endometrium:

• Adult: 400-800 mg daily, in up to 4 divided doses for 3-6 week.

Benign breast disorders:

• Adult: Initially, 100-400 mg daily in 2 divided doses adjusted according to response and continued for 3-6 month.

Hereditary angioedema:

• Adult: Initially, 200 mg bid-tid reduced thereafter according to patient's response.

Endometriosis:

• Adult: 200-800 mg daily in 2 divided doses adjusted according to response, for 3-6 month or if necessary, up to 9 month.

Menorrhagia:

• Adult: 200 mg once daily. Review treatment 3 month later.

Gynaecomastia:

• Adult: Male adolescents: Initially, 200 mg daily, may increase to 400 mg daily after 2 month if no response occurs; adult men: Initial: 400 mg daily in up to 4 divided doses. Usual treatment duration: 6 month.
• Child: Male adolescents: Initially, 200 mg daily increased to 400 mg after 2 month if no response occurs. Treatment usually up to 6 months.

Oedema, weight gain, sweating, acne, hirsutism, flushing, oily skin or hair, deepening of the voice, clitoral hypertrophy, amenorrhoea, hepatic dysfunction, CNS or GI disturbances, benign intracranial hypertension, reduction in breast size, visual disturbances, elevated LFT values.

Epilepsy, migraine; cardiac, hepatic, renal disorders. Severe hypertension, diabetes, polycythaemia, history of thrombosis; children.

Insulin: Patients taking danazol may show increased insulin resistance. The significance of this is not known but such patients should be carefully monitored.

Estrogens and progestogens: Theoretically danazol may interact with exogenous estrogens and/or progestogens. It has been suggested that danazol acts by binding to estrogen, progesterone or androgen receptors at various levels in the hypothalamic pituitary-ovarian axis. Therefore, women of child bearing age should use effective, non hormonal methods of contraception.

Anticonvulsant therapy: Danazol may affect the plasma concentration of carbamazepin and possibly the patient's response to this agent and to phenytoin. A similar interaction is possible for phenobarbital.

Antihypertensive therapy: Danazol can oppose the action of antihypertensive agents, possibly through effects on fluid retention.

Cyclosporine: Danazol can increase the plasma concentration of cyclosporine.

Migraine therapy: Danazol itself may provoke migraine and it may possibly reduce the effectiveness of medication to prevent the condition.

Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

There have been no incidents of acute overdosage with Danazol and it is unlikely that any immediate serious reaction will be seen from a single excessive dose. In case of the acute overdosage, the drug should be removed by gastric lavage and the patient should be kept under observation.

Store at 15-30°C.

Danazol is indicated for the following treatment-

• Endometriosis
• Benign breast disease
• Menorrhagia
• Gynecomastia
• Preoperative thinning of the endometrium before hysteroscopic endometrial ablation.

Drugs affecting (inhibiting) gonadotrophin

As a gonadotropin inhibitor, danazol suppresses the pituitary-ovarian axis possibly by inhibiting the output of pituitary gonadotropins. Danazol also depresses the preovulatory surge in output of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), thereby reducing ovarian estrogen production. Danazol may also directly inhibits ovarian steroidogenesis; bind to androgen, progesterone, and glucocorticoid receptors; bind to sex-hormone-binding globulin and corticosteroid-binding globulin; and increases the metabolic clearance rate of progesterone. Another mechanism of action by which danazol may use to facilitate regression of endometriosis is by decreasing IgG, IgM, and IgA concentrations, as well as phospholipid and IgG isotope autoantibodies. In the treatment of endometriosis, as a consequence of suppression of ovarian function, danazol causes both normal and ectopic endometrial tissues to become inactive and atrophic. This leads to anovulation and associated amenorrhea. In fibrocystic breast disease, the exact mechanism of action of danazol is unknown, but may be related to suppressed estrogenic stimulation as a result of decreased ovarian production of estrogen. A direct effect on steroid receptor sites in breast tissue is also possible. This leads to a disappearance of nodularity, relief of pain and tenderness, and possibly changes in the menstrual pattern. In terms of hereditary angioedema, danazol corrects the underlying biochemical deficiency by increasing serum concentrations of the deficient C1 esterase inhibitor, resulting in increased serum concentrations of the C4 component of the complement system.

Preoperative thinning of the endometrium:

• Adult: 400-800 mg daily, in up to 4 divided doses for 3-6 week.

Benign breast disorders:

• Adult: Initially, 100-400 mg daily in 2 divided doses adjusted according to response and continued for 3-6 month.

Hereditary angioedema:

• Adult: Initially, 200 mg bid-tid reduced thereafter according to patient's response.

Endometriosis:

• Adult: 200-800 mg daily in 2 divided doses adjusted according to response, for 3-6 month or if necessary, up to 9 month.

Menorrhagia:

• Adult: 200 mg once daily. Review treatment 3 month later.

Gynaecomastia:

• Adult: Male adolescents: Initially, 200 mg daily, may increase to 400 mg daily after 2 month if no response occurs; adult men: Initial: 400 mg daily in up to 4 divided doses. Usual treatment duration: 6 month.
• Child: Male adolescents: Initially, 200 mg daily increased to 400 mg after 2 month if no response occurs. Treatment usually up to 6 months.

Oedema, weight gain, sweating, acne, hirsutism, flushing, oily skin or hair, deepening of the voice, clitoral hypertrophy, amenorrhoea, hepatic dysfunction, CNS or GI disturbances, benign intracranial hypertension, reduction in breast size, visual disturbances, elevated LFT values.

Epilepsy, migraine; cardiac, hepatic, renal disorders. Severe hypertension, diabetes, polycythaemia, history of thrombosis; children.

Insulin: Patients taking danazol may show increased insulin resistance. The significance of this is not known but such patients should be carefully monitored.

Estrogens and progestogens: Theoretically danazol may interact with exogenous estrogens and/or progestogens. It has been suggested that danazol acts by binding to estrogen, progesterone or androgen receptors at various levels in the hypothalamic pituitary-ovarian axis. Therefore, women of child bearing age should use effective, non hormonal methods of contraception.

Anticonvulsant therapy: Danazol may affect the plasma concentration of carbamazepin and possibly the patient's response to this agent and to phenytoin. A similar interaction is possible for phenobarbital.

Antihypertensive therapy: Danazol can oppose the action of antihypertensive agents, possibly through effects on fluid retention.

Cyclosporine: Danazol can increase the plasma concentration of cyclosporine.

Migraine therapy: Danazol itself may provoke migraine and it may possibly reduce the effectiveness of medication to prevent the condition.

Category X: Studies in animals or human beings have demonstrated fetal abnormalities or there is evidence of fetal risk based on human experience or both, and the risk of the use of the drug in pregnant women clearly outweighs any possible benefit. The drug is contraindicated in women who are or may become pregnant.

There have been no incidents of acute overdosage with Danazol and it is unlikely that any immediate serious reaction will be seen from a single excessive dose. In case of the acute overdosage, the drug should be removed by gastric lavage and the patient should be kept under observation.

Store at 15-30°C.

Benzodiazepine hypnotics, Benzodiazepine sedatives

Lorazepam is a short-acting tranquilizer of the benzodiazepine group. It is an agonist at benzodiazepine receptors in the CNS. It exerts a depressant action on the CNS, which may be mediated by potentiating the inhibitory actions of GABA (gamma amino butyric acid) in the CNS. This will result in diminution of the ascending activating systems, particularly the serotonergic and noradrenergic pathway from brain stem or the mid-brain to the cerebral cortex.

Lorazepam is administered orally. For optimal results; dose, frequency of administration and duration of therapy should be individualized according to patient's response.

• The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the largest dosage may vary from 1 to 10 mg/day.
• For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.
• For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
• For insomnia 1 to 2 mg before bedtime and as premedicant 1 to 2 mg the night before surgery and 1 to 2 hour before surgery.

Lorazepam injection can be given intravenously or intramuscularly. Premedication (Adults): 0.05 mg/kg (3.5 mg for average 70 kg person) (For IV 30-45 minutes before & IM 60-90 minutes before); Acute anxiety (Adults): 0.025-0.03 mg/kg (1.75-2.1 mg for an average 70 kg person), Repeat 6 hourly; Status epilepticus (Adults): 4 mg intravenously; Status epilepticus (Children): 2 mg intravenously.

For IM use, undiluted Lorazepam injection should be administered. For IV use, it must be diluted with an equal volume of compatible solutions e.g. Sterile Water for Injection, Sodium Chloride Injection, 5% Dextrose Injection. The rate of injection should not exceed 2 mg per minute.

Adverse reactions are usually observed at the beginning of therapy and generally disappeared on continued medication or upon decreasing the dose. The most frequent adverse reactions of Lorazepam are sedation followed by dizziness, weakness and unsteadiness. Less frequent adverse reactions are disorientation, depression, nausea, change in appetite, headache, sleep disturbance, agitation, dermatological symptoms, eye-function disturbance, together with various gastrointestinal symptoms and autonomic manifestations.

Lorazepam should not be given to patients with a previous sensitivity to benzodiazepines or with acute narrow-angle glaucoma and myasthenia gravis.

In patients with depression accompanying anxiety, a possibility for suicide should be borne in mind. For elderly or debilitated patients, the initial daily dosage should not exceed 2 mg in order to avoid over sedation. The usual precautions for treating patients with impaired renal or hepatic function and with acute and chronic pulmonary insufficiency should be observed. Use of Lorazepam for prolonged period and gastric patients requires caution and there should be frequent monitoring for symptoms of upper gastrointestinal disease. Machineries should be avoided during taking Lorazepam.

Lorazepam may potentiate the central depressant effect when combined with other drugs with central depressant action. Such drugs include alcohol, general anesthetics, tricyclic antidepressants and monoamine oxidase inhibitors.

Safety of Lorazepam in pregnancy has not been established. Because the use of this drug is rarely a matter of urgency, the use of Lorazepam during this period should almost always be avoided.

It is not known whether oral Lorazepam is excreted in human milk like other benzodiazepine tranquilizers. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Overdosage of Lorazepam is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, hypnotic states (stages I to III), coma.

Store between 20-25°C

Benzodiazepine hypnotics, Benzodiazepine sedatives

Lorazepam is a short-acting tranquilizer of the benzodiazepine group. It is an agonist at benzodiazepine receptors in the CNS. It exerts a depressant action on the CNS, which may be mediated by potentiating the inhibitory actions of GABA (gamma amino butyric acid) in the CNS. This will result in diminution of the ascending activating systems, particularly the serotonergic and noradrenergic pathway from brain stem or the mid-brain to the cerebral cortex.

Lorazepam is administered orally. For optimal results; dose, frequency of administration and duration of therapy should be individualized according to patient's response.

• The usual range is 2 to 6 mg/day given in divided doses, the largest dose being taken before bedtime, but the largest dosage may vary from 1 to 10 mg/day.
• For anxiety, most patients require an initial dose of 2 to 3 mg/day given b.i.d. or t.i.d.
• For elderly or debilitated patients, an initial dosage of 1 to 2 mg/day in divided doses is recommended, to be adjusted as needed and tolerated.
• For insomnia 1 to 2 mg before bedtime and as premedicant 1 to 2 mg the night before surgery and 1 to 2 hour before surgery.

Lorazepam injection can be given intravenously or intramuscularly. Premedication (Adults): 0.05 mg/kg (3.5 mg for average 70 kg person) (For IV 30-45 minutes before & IM 60-90 minutes before); Acute anxiety (Adults): 0.025-0.03 mg/kg (1.75-2.1 mg for an average 70 kg person), Repeat 6 hourly; Status epilepticus (Adults): 4 mg intravenously; Status epilepticus (Children): 2 mg intravenously.

For IM use, undiluted Lorazepam injection should be administered. For IV use, it must be diluted with an equal volume of compatible solutions e.g. Sterile Water for Injection, Sodium Chloride Injection, 5% Dextrose Injection. The rate of injection should not exceed 2 mg per minute.

Adverse reactions are usually observed at the beginning of therapy and generally disappeared on continued medication or upon decreasing the dose. The most frequent adverse reactions of Lorazepam are sedation followed by dizziness, weakness and unsteadiness. Less frequent adverse reactions are disorientation, depression, nausea, change in appetite, headache, sleep disturbance, agitation, dermatological symptoms, eye-function disturbance, together with various gastrointestinal symptoms and autonomic manifestations.

Lorazepam should not be given to patients with a previous sensitivity to benzodiazepines or with acute narrow-angle glaucoma and myasthenia gravis.

In patients with depression accompanying anxiety, a possibility for suicide should be borne in mind. For elderly or debilitated patients, the initial daily dosage should not exceed 2 mg in order to avoid over sedation. The usual precautions for treating patients with impaired renal or hepatic function and with acute and chronic pulmonary insufficiency should be observed. Use of Lorazepam for prolonged period and gastric patients requires caution and there should be frequent monitoring for symptoms of upper gastrointestinal disease. Machineries should be avoided during taking Lorazepam.

Lorazepam may potentiate the central depressant effect when combined with other drugs with central depressant action. Such drugs include alcohol, general anesthetics, tricyclic antidepressants and monoamine oxidase inhibitors.

Safety of Lorazepam in pregnancy has not been established. Because the use of this drug is rarely a matter of urgency, the use of Lorazepam during this period should almost always be avoided.

It is not known whether oral Lorazepam is excreted in human milk like other benzodiazepine tranquilizers. As a general rule, nursing should not be undertaken while a patient is on a drug since many drugs are excreted in human milk.

Overdosage of Lorazepam is usually manifested by varying degrees of central nervous system depression ranging from drowsiness to coma. In mild cases, symptoms include drowsiness, mental confusion and lethargy. In more serious cases and especially when other drugs or alcohol were ingested, symptoms may include ataxia, hypotonia, hypotension, hypnotic states (stages I to III), coma.

Store between 20-25°C

Gliclazide is a medicine that reduces blood sugar levels (oral antidiabetic medicine belonging to the sulphonylurea group). Gliclazide is used in a certain form of diabetes (type 2 diabetes Mellitus) in adults, when diet, exercise and weight loss alone do not have an adequate effect on keeping blood sugar at the correct level.

Sulfonylureas

Gliclazide is a second generation sulfonylurea drug that has hypoglycaemic and potentially useful hematological properties. It stimulates the release of insulin from pancreatic β-cells by facilitating Ca⁺²  transport across the β-cell membranes and decreases hepatic glucose output.

Film-coated tablet: The usual initial dose is 40 to 80 mg daily. The dose can be increased up to 320 mg daily in divided doses when needed. The drug should be taken before meal. For children, Gliclazide is not used because it is contraindicated in juvenile-onset diabetes.

Modified release preparation: Always take this medicine exactly as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. The dose is determined by the doctor, depending on your blood and possibly urine sugar levels. Change in external factors (weight reduction, lifestyle, stress) or improvements in the blood sugar control may require changed gliclazide doses.

The recommended daily dose is one to four tablets (maximum 120 mg) in a single intake at breakfast time. This depends on the response to treatment. Gliclazide MR tablet is for oral use. Take your tablet(s) with a glass of water at breakfast time (and preferably at the same time each day). Swallow your whole tablet(s) in one piece. Do not chew or crush. You must always eat a meal after taking your tablet(s).

If a combination therapy of gliclazide with metformin, an alpha-glucosidase inhibitor, a thiazolidinedione, a dipeptidyl peptidase-4 inhibitor a GLP-1 receptor agonist or insulin is initiated your doctor will determine the proper dose of each medicine individually for you. If you notice that your blood sugar levels are high although you are taking the medicine as prescribed, you should contact your doctor or pharmacist.

If you take more Gliclazide tablets than you should: If you take too many tablets, contact your doctor or the nearest hospital Accident & Emergency department immediately. The signs of overdose are those of low blood sugar (hypoglycaemia). The symptoms can be helped by taking sugar (4 to 6 lumps) or sugary drinks straight away, followed by a substantial snack or meal. If the patient is unconscious immediately inform a doctor and call the emergency services. The same should be done if somebody, (for instance a child), has taken the product unintentionally. Unconscious patients must not be given food or drink. It should be ensured that there is always a pre-informed person that can call a doctor in case of emergency.

If you forget to take Gliclazide tablet: It is important to take your medicine every day as regular treatment works better. However, if you forget to take a dose of Gliclazide MR tablet, take the next dose at the usual time. Do not take a double dose to make up for a forgotten dose.

If you stop taking Gliclazide MR tablet: As the treatment for diabetes is usually lifelong, you should discuss with your doctor before stopping this medicinal product. Stopping could cause high blood sugar (hyperglycaemia) which increases the risk of developing complications of diabetes. If you have any further questions on the use of this product, ask your doctor or pharmacist.

Like all medicines, Gliclazide can cause side effects, although not everybody gets them. The most commonly observed side effect is low blood sugar (hypoglycaemia). If left untreated these symptoms could progress to drowsiness, loss of consciousness or possibly coma. If an episode of low blood sugar is severe or prolonged, even if it is temporarily controlled by eating sugar, you should seek immediate medical attention.

Liver disorders: There have been isolated reports of abnormal iiver function, which can cause yellow skin and eyes. If you get this, see your doctor immediately. The symptoms generally disappear if the medicine is stopped. Your doctor will decide whether to stop your treatment.

Skin disorders: Skin reactions such as rash, redness, itching, hives, blisters, angioedema (rapid swelling of tissues such as eyelids, face, lips, mouth, tongue or throat that may result in breathing difficulty) have been reported. Rash may progress to widespread blistering or peeling of the skin. If you develop this, stop taking, seek urgent advice from a doctor and tell him that you are taking this medicine. Exceptionally, signs of severe hypersensitivity reactions have been reported: initially as flu-like symptoms and a rash on the face then an extended rash with a high temperature.

Blood disorders: Decrease in the number of cells in the blood (e.g. platelets, red and white blood cells) which may cause paleness, prolonged bleeding, bruising, sore throat and fever have been reported. These symptoms usually vanish when the treatment is discontinued.

Digestive disorders: Abdominal pain, nausea, vomiting, indigestion, diarrhoea, and constipation. These effects are reduced when Gliclazide is taken with a meal as recommended.

Eye disorders: Your vision may be affected for a short time especially at the start of treatment. This effect is due to changes in blood sugar levels.

As for another sulfonylurea, the following adverse events have been observed: cases of severe changes in the number of blood cells and allergic inflammation of the wall of blood vessels, reduction in blood sodium (hyponatraemia), symptoms of liver impairment (for instance jaundice) which in most cases disappeared after withdrawal of the sulfonylurea, but may lead to life-threatening liver failure in isolated cases.

Reporting of side effects: If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. By reporting side effects, you can help provide more information on the safety of this medicine.

Do not take Gliclazide:

• if you are allergic to gliclazide or to other medicines of the same group (sulfonylurea), or to other related medicines (hypoglycaemic sulfonamides)
• if you have insulin-dependent diabetes (type 1)
• if you have ketone bodies and sugar in your urine (this may mean you have diabetic ketoacidosis), a diabetic pre-coma or coma
• if you have severe kidney or liver disease
• if you are taking medicines to treat fungal infections
• if you are breastfeeding

Talk to your doctor before taking Gliclazide. You should observe the treatment plan prescribed by your doctor to achieve proper blood sugar levels. This means, apart from regular tablet intake, to observe the dietary regimen, have physical exercise and, where necessary, reduce weight During gliclazide treatment regular monitoring of your blood (and possibly urine) sugar level and also your glycated haemoglobin (HbA1c) is necessary. In the first few weeks of treatment, the risk of having reduced blood sugar levels (hypoglycaemia) may be increased. So particularly close medical monitoring is necessary.

Low blood sugar (Hypoglycaemia) may occur:

• if you take meals irregularly or skip meals altogether,
• if you are fasting
• if you are malnourished
• if you change your diet
• if you increase your physical activity and carbohydrate intake does not match this increase,
• if you drink alcohol, especially in combination with skipped meals,
• if you take other medicines or natural remedies at the same time,
• if you take too high doses of gliclazide,
• if you suffer from particular hormone-induced disorders (functional disorders of the thyroid gland, pituitary gland or adrenal cortex),
• if your kidney function or liver function is severely decreased.

if you have low blood sugar you may have the following symptoms: headache, intense hunger, nausea, vomiting, weariness, sleep disorders, restlessness, aggressiveness, poor concentration, reduced alertness and reaction time, depression, confusion, speech or visual disorders, tremor, sensory disturbances, dizziness and helplessness.

The following signs and symptoms may also occur: sweating, clammy skin, anxiety, fast or irregular heartbeat, high blood pressure, sudden strong pain in the chest that may radiate into nearby areas (angina pectoris).

If blood sugar levels continue to drop you may suffer from considerable confusion (delirium), develop convulsions, lose self-control, your breathing may be shallow and your heartbeat slowed down, you may become unconscious.

In most cases the symptoms of low blood sugar vanish very quickly when you consume .some form of sugar, (for instance, glucose tablets, sugar cubes, sweet juice, sweetened tea).

You should therefore always carry some form of sugar with you (glucose tablets, sugar cubes). Remember that artificial sweeteners are not effective. Please contact your doctor or the nearest hospital if taking sugar does not help or if the symptoms recur.

Symptoms of low blood sugar may be absent, less obvious or develop very slowly or you are not aware in time that your blood sugar level has dropped. This may happen if you are an elderly patient taking certain medicines (for instance those acting on the central nervous system and beta-blockers).

If you are in stressful situations (e.g. accidents, surgical operations, fever etc.) your doctor may temporarily switch you to insulin therapy.

Symptoms of high blood sugar (hyperglycaemia) may occur when gliclazide has not yet sufficiently reduced the blood sugar when you have not complied with the treatment plan prescribed by your doctor if you take St. John’s Wort (Hypericum perforatum) preparations or in special stress situations. These may include thirst, frequent urination, dry mouth, dry itchy skin, skin infections and reduced performance.

Blood glucose disturbances (low blood sugar and high bold sugar) can occur when Gliclazide is prescribed at the same time as medicines to a class of antibiotics called fluoroquinolone, especially in elderly patients. In this case, your doctor will remind you of the importance of monitoring your blood glucose.

If you have a family history of or know you have the hereditary condition glucose-6-phosphate dehydrogenase (G6PD) deficiency (abnormality of red blood cells), lowering of the haemoglobin level and breakdown of red blood cells (haemolytic anaemia) can occur. Contact your doctor before taking this medicinal product.

Gliclazide is not recommended for use in children due to lack of data.

Other medicines and Gliclazide: Tell your doctor or pharmacist if you are taking or have recently taken any other medicines.

The blood sugar lowering effect of gliclazide may be strengthened and signs of low blood sugar levels may occur when one of the follow ng medicines is taken:

• other medicines used to treat high blood sugar (oral antidiabetics, GLP-1 receptor agonists or insulin),
• antibiotics (sulphonamides, clarithromycin)
• medicines to treat high blood pressure or heart failure (beta-blockers. ACE-inhibitors such as captopril, or enalapril)
• medicines to treat fungal infections (miconazole, fluconazole)
• medicines to treat ulcers in the stomach or duodenum (H2 receptor antagonists),
• medicines to treat depression (monoamine oxidase inhibitors)
• painkiller or antirheumatics (phenylbutazone, ibuprofen)
• medicines containing alcohol

The blood-glucose-lowering effect of gliclazide may be weakened and raised blood sugar levels may occur when one of the following medicines is taken:

• medicines to treat disorders of the central nervous system (chlorpromazine)
• medicines reducing inflammation (corticosteroids)
• medicines to treat asthma or used during labour (intravenous salbutamol, ritodrine and terbutaline)
• medicines to treat breast disorders, heavy menstrual bleeding and endometriosis (danazol)
• St John's Wort- Hypericum perforatum- preparations

Blood glucose disturbance (low blood sugar and high blood sugar) can occur when a medicine belonging to a class of antibiotics called fluoroquinolones is taken at the same time as gliclazide especially in elderly patients.

Gliclazide may increase the effects of medicines that reduce blood clotting (warfarin).

Consult your doctor before you start taking another medicinal product. If you go into hospital tell the medical staff you are taking gliclazide.

Gliclazide with food and drink: Gliclazide can be taken with food and non-alcoholic drinks. Drinking alcohol is not recommended as it can alter the control of your diabetes in an unpredictable manner.

Driving and using machines: Your ability to concentrate or react may be impaired if your blood sugar is too low (hypoglycaemia), or too high (hyperglycaemia) or if you develop visual problems as a result of such conditions. Bear in mind that you could endanger yourself or others (for instance when driving a car or using machines). Please ask your doctor whether you can drive a car if you:

• have frequent episodes of low blood sugar (hypoglycaemia)
• have few or no warning signals of low blood sugar (hypoglycaemia)

Gliclazide contains lactose. If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

Gliclazide is not recommended for use during pregnancy. If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. You must not take Gliclazide while you are breastfeeding.

Keep out of the reach and sight of children. Do not use this medicine after the expiry date which is stated on the carton and the blister. The expiry date refers to the last day of that month. Store below 30°C. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

Levocetirizine is indicated in the treatment of symptoms associated with allergic conditions such as perennial allergic rhinitis, seasonal allergic rhinitis and chronic idiopathic urticaria.

Non-sedating antihistamines

This preparation contains Levocetirizine Dihydrochloride. Levocetirizine is the active (Levo) isomer of cetirizine. It is a new highly effective and well-tolerated nonsedating antihistamine with potent antiallergic properties. It has a two-fold higher affinity for H1 receptors than cetirizine. Levocetirizine has a rapid and long-acting action, allowing once-a-day administration.

Adult and children 12 years of age and older: The recommended dose is 5 mg once daily.

Children 6 to 11 years of age: The recommended dose is 2.5 mg (1/2 tablet or 1 teaspoon oral solution) once daily.

Children 6 months to 5 years of age: The recommended dose is 1.25 mg (1/2 teaspoon oral solution) once daily.

Generally, levocetirizine is well tolerated. However, a few side effects like headache, dry mouth, fatigue and skin rash have been reported rarely.

Hypersensitivity to levocetirizine, cetirizine or its parent compound hydroxyzine. Patients with severe renal impairment (creatinine clearance: <10 ml/min) should not be administered levocetirizine.

Epileptic patients and patients at risk of convulsions. Renal impairment. Pregnancy and lactation.

Levocetirizine is not known to have any interactions with other drugs.

Pregnancy Catagory B. There are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, levocetirizine should be used during pregnancy only if clearly needed. Since levocetirizine is excreted in breast milk it is not recommended for use by nursing mothers.

Pediatric use: The recommended dose for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in patients 6 months to 17 years of age is based on extrapolation of efficacy from adults 18 years of age and older.

Geriatric use: In clinical studies, each approved indication did not include sufficient numbers of patients aged 65 years and older to determine whether they respond differently than younger patients.

Hepatic impairment: No dosage adjustment is required in patients with solely hepatic impairment.

Renal impairment:

• Mild renal impairment (creatinine clearance: 50-80 ml/min): a dose of 2.5 mg once daily is recommended.
• Moderate renal impairment (creatinine clearance: 30-50 ml/min): a dose of 2.5 mg once every other day is recommended.
• Severe renal impairment (creatinine clearance: 10-30 ml/min): a dose of 2.5 mg twice weekly (administered once every 3-4 days) is recommended.
• End-stage renal disease patients (creatinine clearance: <10 ml/min) and patients undergoing hemodialysis: should not receive Levocetirizine.

No clinically relevant adverse events have been reported in case of overdose. However in the event of overdosage, symptomatic and supportive treatment is recommended.

Store at a temperature not exceeding 30°C in a dry place. Protect from light.

Non-sedating antihistamines

This tablet is a preparation of Loratadine. Loratadine is a non-sedative histamine Hr receptor antagonist with antiallergic properties. Loratadine is a long-acting tricyclic antihistamine with selective peripheral Hi-receptor antagonistic activity and no central sedative or anticholinergic effect. It is rapidly effective and long-lasting, allowing once-a-day administration.

Adults and children over 12 years of age: One Loratadine tablet once daily. It is usually administered in the morning or when symptoms require treatment.

Children 2-12 years: Body weight over 30 kg: one Loratadine tablet once daily, below 30 kg: half Loratadine tablet once daily.

Below 2 years of age: Loratadine tablet is not recommended for use below 2 years of age since safety and efficacy has not been established.

During controlled clinical studies the incidence of adverse events, including sedation and anticholinergic effects observed with 10 mg Loratadine was comparable to that observed with placebo. Studies on the effect of Loratadine on actual driving performance, and on tests of cognitive and psychomotor functioning have shown it to be comparable to placebo.

Loratadine is contraindicated in patients who have shown hypersensitivity or idiosyncrasy to their components.

Caution should be taken in patients with liver impairment or renal insufficiency (eGFR <30 ml/min).

There are no reports of potentially hazardous interactions with other drugs. In contrast to many other histamine H1 receptor antagonists, Loratadine has no potentiating effects when administered concurrently with alcohol, as measured by psychomotor performance studies. Concomitant therapy with drugs that inhibit or are metabolized by hepatic cytochromes P450 3A4 and 2D6 may elevate plasma concentrations of either drug and this mayifesult in adverse effects. Cimetidine inhibits both enzymes while erythromycin or ketoconazole inhibits P450 3A4. These drugs increase loratadine serum concentrations but no adverse effects are reported.

There is no experience of the use of Loratadine in human pregnancy. Therefore its use during pregnancy is not advisable. Loratadine is excreted in breast milk in a very small amount. So nursing mothers are advised not to take the drug.

In adults somnolence, tachycardia and headache have been reported with overdose greater than 10 mg. Extrapyramidal signs and palpitations have been reported in children with overdoses of greater than 10 mg. In the event of overdosage, general symptomatic and supportive measures should be instituted promptly and maintained for as long as necessary. It would seem reasonable to treat patients presenting early after large overdoses with oral activated charcoal. The conscious patients may be induced to vomit or gastric lavage may be performed.

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

Albendazole is indicated in single and mixed infestations of-

• Hookworm (Ancylostoma, Necator)
• Roundworm (Ascaris)
• Threadworm (Enterobius)
• Whipworm (Trichuris)
• Strongyloides
• Tapeworm
• Opisthorchi
• Hydatid.

Anthelmintic

Albendazole is a broad spectrum anthelmintic. Albendazole exhibits vermicidal, ovicidal and larvicidal activities. The drug is thought to exert its anthelmintic effect by blocking glucose uptake in the susceptible helminths, thereby depleting the energy level until it becomes inadequate for survival. Immobilization is followed by the parasite. These events may be a consequence of the binding and subsequent inhibition of parasite tubulin polymerization by Albendazole and its metabolites, although the drug also binds to human tubulin. Albendazole is extensively metabolized, probably in the liver. Albendazole is poorly absorbed from the gastrointestinal tract but rapidly undergoes extensive first-pass metabolism. The principal metabolite albendazole sulphoxide has anthelmintic activity and a plasma half-life of about 8.5 hrs. It is excreted in the urine together with other metabolites.

Adults & children over 2 years:

• 400 mg (1 tablet or 10 ml suspension) as a single dose in cases of Enterobius vermicularis, Trichuris trichiura, Ascaris lumbricoides, Ancylostoma duodenale and Necator americanus.
• In cases of strongyloidiasis or taeniasis, 400 mg (1 tablet or 10 ml suspension) daily should be given for 3 consecutive days. If the patient is not cured on follow-up after three weeks, a second course of treatment is indicated. 

Children of 1-2 years: Recommended dose is a single dose of 200 mg (5 ml suspension).

Children under 1 year: Not recommended.

In Hydatid disease (Echinococcosis):

• Albendazole is given by mouth with meals in a dose of 400 mg twice daily for 28 days for patients weighing over 60 kg.
• A dose of 15 mg/kg body weight daily in two divided doses (to a maximum total daily dose of 800 mg) is used for patients weighing less than 60 kg.
• For cystic echinococcosis, the 28 days course may be repeated after 14 days without treatment, to a total of 3 treatment cycles.
• For alveolar echinococcosis, cycles of 28 days of treatment followed by 14 days without treatment, may need to continue for months or years.
• In giardiasis, 400 mg (1 tablet or 10 ml suspension) once daily for five days is used.

Gastrointestinal disturbances, headache, dizziness, changes in liver enzymes, rarely reversible alopecia; rash, fever, blood disorders including leucopenia and pancytopenia reported; allergic shock if cyst leakage; convulsion and meningism in cerebral disease.

Neonates: Albendazole is not normally used in neonates.

Children: Reduction of the dose from 400 mg to 200 mg may be indicated in children weighing less than 10 kg but there are no grounds for a general reduction in dosage to children.

Pregnant woman: Albendazole should not be given during pregnancy or women thought to be pregnant. No information is available on placental transfer.

Concurrent disease: There is no evidence to suggest that dose should be altered in renal, hepatic or cardiac failure.

Blood counts and liver function tests before treatment and twice during each cycle; breastfeeding; exclude pregnancy before starting treatment. Albendazole should only be used in the treatment of Echinococcosis if there is constant medical supervision with regular monitoring of serum-transaminase concentrations and of leucocyte and platelet counts

No interaction involving Albendazole, either pharmacodynamic or pharmacokinetic, has been reported.

US FDA Pregnancy category of Albendazole is C. So, Albendazole should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

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

It is used as a lubricant to relieve irritation and discomfort due to dryness of the eye or due to exposure to wind or sun.

Carboxymethylcellulose binds to the surface of corneal epithelial cells via its glucopyranose subunits binding to glucose receptors GLUT-1. The residence time of carboxymethylcellulose bound to corneal cells is approximately 2 hours as indicated by a short-term binding assay. Binding of carboxymethylcellulose to the matrix proteins stimulated corneal epithelial cell attachment, migration, and re-epithelialization of corneal wounds.

This eye drop contains Carboxymethylcellulose Sodium similar to normal tears which acts as an ocular lubricant. It provides a lubricating and hydrating protective shield on the ocular surface.

Instill 1 drop in the affected eye(s) 4 times a day or as needed.

Burning, Eye Irritation or Pruritus, Visual disturbance, Ocular discharge were reported with this eye drop.

This eye drop is contraindicated in patients with known hypersensitivity to any ingredient of the product.

Concomitant ocular medication should be administered 15 minutes prior to the instillation of this eye drop.

Not known.

Safe use during pregnancy and lactation has not been established.

Pediatric use: This eye drop should not be used in infants and small children under 3 years.

Geriatric use: No overall differences in safety or effectiveness have been observed between elderly and other adult patients.

The drug is to be used within 30 days after the first opening. Store at temperature not exceeding 30°C in a dry place. Protect from light. The bottle is to be closed strongly immediately after use. Keep away from the reach of children.

Lubiprostone is indicated in:

• Irritable Bowel Syndrome with Constipation (IBS-C).
• Chronic Idiopathic Constipation (CIC) in adults.
• Opioid-Induced Constipation (OIC) in adult patients with chronic, non-cancer pain.

Other laxative preparations

Lubiprostone is a locally-acting chloride-channel activator that increases intestinal secretion. In doing so, it increases intestinal motility, thus aiding the passage of stool and relieve the symptoms associated with chronic idiopathic constipation.

Lubiprostone acts by specifically activating ClC-2 chloride channels, which is a normal constituent of the apical membrane of the human intestine, in a protein kinase A action independent fashion. Activation of ClC-2 chloride channels causes an efflux of chloride ions into the lumen, which in turn leads to an efflux of sodium ions through a paracellular pathway to maintain isoelectric neutrality. As a result, water follows sodium into the lumen in order to maintain isotonic equilibrium, thereby increasing intestinal fluid secretion. By increasing intestinal fluid secretion, lubiprostone increases motility in the intestine, thereby increasing the passage of stool and alleviating symptoms associated with chronic idiopathic constipation. Activation of ClC-2 chloride channels may also stimulate the recovery of muscosal barrier function by restoring tight junction protein complexes in the intestine. Patch clamp cell studies in human cell lines have indicated that the majority of the beneficial biological activity of lubiprostone and its metabolites is observed only on the apical (luminal) portion of the gastrointestinal epithelium.

Irritable Bowel Syndrome with Constipation: The recommended dose is 8 mcg twice daily orally with food and water.

Dosage in patients with hepatic impairment: Dosage adjustment is not required for patients with moderately impaired hepatic function. For patients with severely impaired hepatic function, the recommended starting dose is 8 mcg once daily. If tolerated then dose can be increased to 8 mcg twice 

Chronic Idiopathic Constipation and Opioid-induced Constipation: The recommended dose is 24 mcg twice daily orally with food and water. 

Dosage in patients with hepatic impairment: For patients with moderately impaired hepatic function, the recommended starting dose is 16 mcg twice daily. For patients with severely impaired hepatic function, the recommended starting dose is 8 mcg twice daily.

Diarrhea, full or bloated feeling or pressure in the stomach, nausea, stomach pain, swelling of abdominal or stomach area, Dyspnea

Lubiprostone is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Nausea: Patients taking Lubiprostone may experience nausea. Concomitant administration of food with Lubiprostone may reduce symptoms of nausea.

Diarrhea: Lubistone should not be prescribed to patients that have severe diarrhea.

Bowel Obstruction: In patients with symptoms suggestive of mechanical gastrointestinal obstruction, perform a thorough evaluation to confirm the absence of an obstruction prior to initiating therapy with Lubiprostone.

There is a possibility of a dose-dependent decrease in the efficacy of Lubiprostone in patients using diphenylheptane opioids.

Pregnancy category C. It is not known whether lubiprostone is excreted in human milk. Because lubiprostone increases fluid secretion in the intestine and intestinal motility, human milk-fed infants should be monitored for diarrhea. Caution should be exercised when Lubiprostone is administered to a nursing woman.

Adverse reactions due to overdose may include: nausea, diarrhea, vomiting, dizziness, headache, abdominal pain, flushing/hot flash, retching, dyspnea, pallor, stomach discomfort, anorexia, asthenia , chest discomfort, dry mouth, hyperhidrosis , and syncope.

Store between 15-30° C.