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Intravenous fluid preparations, Parenteral nutritional preparations

Dose is variable. It depends on the clinical condition, age and body surface area of the patients.

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and hypervolemia. If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Do not take this medicine and tell your doctor if: Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

As the preparation contains Sodium Chloride, it should be administered with caution to patients with congestive heart failure, peripheral or pulmonary oedema, impaired renal function or pre-eclampsia. Serum glucose concentration should also be carefully monitored and concurrent use of insulin may be needed in case of diabetic patients. Infusion of fluid should be immediately discontinued if rigor arises for any reason during the process. Do not use if the solution is cloudy, contains particles, or after expiry date.

FDA pregnancy category C. It is not known whether dextrose 5% in water will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether dextrose 5% in water passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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

Rifampicin and Isoniazid belongs to a group of medicines called antituberculosis agents. It is a fixed combination of two very effective antituberculosis agents which stop the growth of mycobacteria. These mycobacteria cause tuberculosis. Rifampicin and Isoniazid is used for the continuation phase treatment of tuberculosis.

Combined anti- Tubercular Preparations

Rifampicin and isoniazid are active bactericidal anti-TB drugs which are particularly active against the rapidly growing extracellular organisms and also have bactericidal activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. Cross-resistance to rifampicin has only been shown with other rifamycins. It has activity against slow-and intermittently-growing M. tuberculosis. Isoniazid acts against actively growing tubercle bacilli.

Body weight <50 kg: 3 tablet of 150/100 once daily or 1 tablet of 450/300 once daily
Body weight >50 kg: 2 tablet of 300/150 once daily.
Hepatic impairment: Max: 8 mg/kg daily.

Unwanted effects which may occur during continuous daily or intermittent therapy: Rifampicin: Rifampicin may cause reddish discolouration of body fluids and occasionally other body secretions eg, urine, sputum, lacrimal fluid, faeces, saliva and sweat. It may permanently discolour soft contact lenses.

Hepatic Effects: Very common (>10%) is an asymptomatic increase in liver enzymes; severe life-threatening hepatic reactions eg, hepatic failure and acute fulminant hepatitis are uncommon (>0.1% and <1%). In isolated cases (<0.01 %), a fatal outcome was observed.

Renal Effects: Elevations of BUN and serum uric acid, haemolysis, haematuria, interstitial nephritis, renal insufficiency. Gastrointestinal Effects: Nausea, abdominal pains, vomiting or diarrhoea, pseudomembranous colitis.

Central and Peripheral Nervous System Effects: Tiredness, drowsiness, headache, dizziness, ataxia, mental confusion, muscular weakness, visual disturbances. Haematological Changes: Leucopenia, eosinophilia, thrombocytopenia and thrombocytopenic purpura. Effects on Skin and Appendages: Flushing, itching with or without skin rash, urticaria, reddening of the eyes, exudative conjunctivitis or generalised hypersensitivity reactions involving the skin eg, exfoliative dermatitis, Lyell's syndrome and pemphigoid reactions. Endocrine Effects: Disturbances in the menstrual cycle, induction of crisis in Addison patients. Unwanted effects chiefly occurring during intermittent therapy or upon resumption of treatment after temporary interruption

Known or suspected hypersensitivity to rifamycins and/or to INH, and/or to any of the excipients including a history of drug-induced hepatitis; acute liver diseases, regardless of their origin; peripheral neuritis.

Use of isoniazid should be carefully monitored in the following:

• Daily users of alcohol. Daily ingestion of alcohol may be associated with a higher incidence of isoniazid hepatitis.
• Patients with active chronic liver disease or severe renal dysfunction.
• Age >35.
• Concurrent use of any chronically administered medication.
• History of previous discontinuation of isoniazid.
• Existence of peripheral neuropathy or conditions predisposing to neuropathy. Pregnancy.
• Injection drug use.
• Women belonging to minority groups, particularly in the post-partum period.
• HIV seropositive patients.

May reduce effectivity of hormonal contraceptives. Reduced absorption with antacids. May decrease plasma concentrations of antivirals (e.g. atazanavir, darunavir, fosamprenavir), atovaquone with rifampicin. Rifampicin may reduce serum levels of anticonvulsants (e.g. phenytoin), antiarrhythmics (e.g. disopyramide), oral anticoagulants, antifungals (e.g. ketoconazole), barbiturates, ?-blockers, Ca channel blockers (e.g. diltiazem), chloramphenicol, clarithromycin, corticosteroids, ciclosporin, cardiac glycosides, clofibrate, dapsone, diazepam, doxycycline, fluoroquinolones (e.g. ciprofloxacin), haloperidol, oral hypoglycemic agents (sulfonylureas), levothyroxine, methadone, narcotic analgesics, progestins, quinine, tacrolimus, theophylline, TCAs (e.g. amitriptyline, nortriptyline) and zidovudine. Increased risk of hepatotoxicity with halothane.

Isoniazid may inhibit the metabolism of anticonvulsants (e.g. carbamazepine, phenytoin), benzodiazepines (e.g. diazepam), haloperidol, ketoconazole, theophylline, and warfarin. May enhance the CNS effects of meperidine, cycloserine, and disulfiram with isoniazid. Loss of glucose control in patients on oral hypoglycaemics with isoniazid.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

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

Rifampicin and Isoniazid belongs to a group of medicines called antituberculosis agents. It is a fixed combination of two very effective antituberculosis agents which stop the growth of mycobacteria. These mycobacteria cause tuberculosis. Rifampicin and Isoniazid is used for the continuation phase treatment of tuberculosis.

Combined anti- Tubercular Preparations

Rifampicin and isoniazid are active bactericidal anti-TB drugs which are particularly active against the rapidly growing extracellular organisms and also have bactericidal activity intracellularly. Rifampicin inhibits DNA-dependent RNA polymerase activity in susceptible cells. Specifically, it interacts with bacterial RNA polymerase but does not inhibit the mammalian enzyme. Cross-resistance to rifampicin has only been shown with other rifamycins. It has activity against slow-and intermittently-growing M. tuberculosis. Isoniazid acts against actively growing tubercle bacilli.

Body weight <50 kg: 3 tablet of 150/100 once daily or 1 tablet of 450/300 once daily
Body weight >50 kg: 2 tablet of 300/150 once daily.
Hepatic impairment: Max: 8 mg/kg daily.

Unwanted effects which may occur during continuous daily or intermittent therapy: Rifampicin: Rifampicin may cause reddish discolouration of body fluids and occasionally other body secretions eg, urine, sputum, lacrimal fluid, faeces, saliva and sweat. It may permanently discolour soft contact lenses.

Hepatic Effects: Very common (>10%) is an asymptomatic increase in liver enzymes; severe life-threatening hepatic reactions eg, hepatic failure and acute fulminant hepatitis are uncommon (>0.1% and <1%). In isolated cases (<0.01 %), a fatal outcome was observed.

Renal Effects: Elevations of BUN and serum uric acid, haemolysis, haematuria, interstitial nephritis, renal insufficiency. Gastrointestinal Effects: Nausea, abdominal pains, vomiting or diarrhoea, pseudomembranous colitis.

Central and Peripheral Nervous System Effects: Tiredness, drowsiness, headache, dizziness, ataxia, mental confusion, muscular weakness, visual disturbances. Haematological Changes: Leucopenia, eosinophilia, thrombocytopenia and thrombocytopenic purpura. Effects on Skin and Appendages: Flushing, itching with or without skin rash, urticaria, reddening of the eyes, exudative conjunctivitis or generalised hypersensitivity reactions involving the skin eg, exfoliative dermatitis, Lyell's syndrome and pemphigoid reactions. Endocrine Effects: Disturbances in the menstrual cycle, induction of crisis in Addison patients. Unwanted effects chiefly occurring during intermittent therapy or upon resumption of treatment after temporary interruption

Known or suspected hypersensitivity to rifamycins and/or to INH, and/or to any of the excipients including a history of drug-induced hepatitis; acute liver diseases, regardless of their origin; peripheral neuritis.

Use of isoniazid should be carefully monitored in the following:

• Daily users of alcohol. Daily ingestion of alcohol may be associated with a higher incidence of isoniazid hepatitis.
• Patients with active chronic liver disease or severe renal dysfunction.
• Age >35.
• Concurrent use of any chronically administered medication.
• History of previous discontinuation of isoniazid.
• Existence of peripheral neuropathy or conditions predisposing to neuropathy. Pregnancy.
• Injection drug use.
• Women belonging to minority groups, particularly in the post-partum period.
• HIV seropositive patients.

May reduce effectivity of hormonal contraceptives. Reduced absorption with antacids. May decrease plasma concentrations of antivirals (e.g. atazanavir, darunavir, fosamprenavir), atovaquone with rifampicin. Rifampicin may reduce serum levels of anticonvulsants (e.g. phenytoin), antiarrhythmics (e.g. disopyramide), oral anticoagulants, antifungals (e.g. ketoconazole), barbiturates, ?-blockers, Ca channel blockers (e.g. diltiazem), chloramphenicol, clarithromycin, corticosteroids, ciclosporin, cardiac glycosides, clofibrate, dapsone, diazepam, doxycycline, fluoroquinolones (e.g. ciprofloxacin), haloperidol, oral hypoglycemic agents (sulfonylureas), levothyroxine, methadone, narcotic analgesics, progestins, quinine, tacrolimus, theophylline, TCAs (e.g. amitriptyline, nortriptyline) and zidovudine. Increased risk of hepatotoxicity with halothane.

Isoniazid may inhibit the metabolism of anticonvulsants (e.g. carbamazepine, phenytoin), benzodiazepines (e.g. diazepam), haloperidol, ketoconazole, theophylline, and warfarin. May enhance the CNS effects of meperidine, cycloserine, and disulfiram with isoniazid. Loss of glucose control in patients on oral hypoglycaemics with isoniazid.

Pregnancy Category C. Animal reproduction studies have shown an adverse effect on the fetus and there are no adequate and well-controlled studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks

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

This medication is used to relieve the dryness and pain associated with reduced or abnormal tear production.

Drugs for Dry eyes

Carboxymethylcellulose Sodium & Hypromellose both of them are polymer in nature. It is a clear and colorless aqueous solution. This medication lubricates the surface of the eye in the same way as natural tears. It can therefore be used to relieve the dryness and pain associated with reduced or abnormal tear production.

For Adults and Children: Instill 1 or 2 drops in the affected eye(s) as needed.

Common side effects are blurred vision, matting or stickiness of eyelashes.

Known sensitivity or allergy to any ingredient of the formulation.

If you experience eye pain, changes in vision, continued redness or irritation of the eye or if your symptoms continue for more than 3 days or become worse, check with your doctor.

Carboxymethylcellulose Sodium & Hypromellose have not been shown to cause birth defects or other problems during pregnancy and breastfeeding.

This drug does not cause different side effects or problems in children than it does in adults.

Store in a cool, dry place and protected from light, Keep out of the reach of children, Do not use more than 4 weeks after opening.

For topical application in the treatment of acne vulgaris in which comedones, papules and pustules predominate.

Topical retinoid and related preparations

Although the exact mode of action of Tretinoin is unknown, current evidence suggests that topical Tretinoin decreases cohesiveness of follicular epithelial cells with decreased microcomedo formation. Additionally Tretinoin stimulates mitotic activity and increases turnover of follicular epithelial cells, causing extrusion of the comedones, papules and pustules.

This cream should be applied sparingly to the whole affected area once or twice daily. The skin should be thoroughly cleaned and dried before application. Patient should be advised that 6 to 8 weeks of treatment may be required before a therapeutic effect is observed. Moisturizers and cosmetics may be used during treatment with Tretinoin cream but should not be applied to the skin at the same time. Astringent toiletries should be avoided.

Initial external application of Tretinoin generally may cause burning or slight irritation, erythema and peeling at the site of application may also occur. If irritation becomes severe and persists, discontinue application and consult your physicians, if necessary.

Tretinoin is contraindicated to those who are highly sensitive to any of the ingredients. This cream should not be used in patients with a personal or family history of cutaneous epithelioma (skin cancer).

Avoid contact of Tretinoin with lips, mouth, eyes, eyelids, nostrils or another mucous membrane. If contact in these areas occurs, careful washing with water is recommended. Apply the cream to sensitive areas of skin, such as the neck, with caution. Do not use it on broken, eczematous or sun burned skin.

Other topical acne treatments should be used with caution during treatment with Tretinoin. Particular caution should be exercised when using preparation containing a peeling agent for example benzoyl peroxide. It is also possible to apply Tretinoin and benzoyl peroxide alternately. The suggested regimens are either Tretinoin in the morning and benzoyl peroxide in the evening or the preparations should be used on alternate days.

There is an inadequate evidence of the safety of topically applied Tretinoin in human pregnancy. Tretinoin has been associated with teratogenicity in human when administered systemically. So the cream should not be used during pregnancy and lactation.

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

Drugs acting on the Uterus, Prostaglandin analogues

Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Misoprostol acid are diminished when the dose is taken with food and total availability of Misoprostol acid is reduced by use of concomitant antacid. Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 meg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.

Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required.

Prophylaxis of NSAID-induced gastric and duodenal ulcer: 200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician.

Induction of labor: Place 25 mcg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 mcg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 mcg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6. Maternal vital signs, fetal heart rate and contractions should be monitored. Oxytocin can be started 4 hours after last dose of misoprostol. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral misoprostol therapy should be monitored by Physician.

Prevention of postpartum hemorrhage: 600 mcg orally immediately following delivery.

Treatment of postpartum hemorrhage: 600 mcg orally or 1000 mcg per rectally.

Generally, Misoprostol is well tolerated. The most frequent adverse effects associated with Misoprostol therapy involve the GI tract such as diarrhea, abdominal pain, dyspepsia, flatulence, nausea, vomiting, rashes and dizziness. The incidence of diarrhea may be minimized by administering the drug after meal and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.

Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.

In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misoprostol is contraindicated in women who are pregnant, and should not be used in women of child bearing potential unless the patient requires NSAID therapy. Women of child bearing potential should be told that they must not be pregnant when Misoprostol therapy is initiated and they must use an effective contraception method while taking misoprostol.

In case of induction of labor: The pregnancy should have completed 38 weeks gestation by reliable dating, or lung maturity as evidenced by a L/S >2.0 or a positive phosphotidyl glycerol test, or completed 36 weeks gestation with a maternal or fetal medical indication for induction of labor. Induction of labor is contraindicated in acute fetal distress, abruptio placenta, placenta previa or unexplained vaginal bleeding. The fetus should be in vertex presentation.

There is no evidence of clinically significant interaction between Misoprostol and cardiac, pulmonary, CNS drugs and NSAID's. The bioavailability of Misoprostol is decreased with high doses of antacid.

Because of the abortifacient property of the Misoprostol component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, it may be prescribed if the patient:

• has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
• is capable of complying with effective contraceptive measures.
• has received both oral and written warnings of the hazards of Misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
• will begin it only on the second or third day of the next normal menstrual period.

Excretion of the active metabolite (Misoprostol acid) into milk is possible but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.

Use in children: Safety and effectiveness of Misoprostol in children below the age of 18 years have not been established.

The toxic dose of Misoprostol in human has not been determined. Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea and fever. Symptoms should be treated with supportive therapy.

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

Drugs acting on the Uterus, Prostaglandin analogues

Misoprostol is extensively absorbed, and undergoes rapid de-esterification to its free acid, which is responsible for its clinical activity and, unlike the parent compound, is detectable in plasma. Maximum plasma concentrations of Misoprostol acid are diminished when the dose is taken with food and total availability of Misoprostol acid is reduced by use of concomitant antacid. Misoprostol has both antisecretory (inhibiting gastric acid secretion) and (in animals) mucosal protective properties. NSAIDs inhibit prostaglandin synthesis, and a deficiency of prostaglandins within the gastric mucosa may lead to diminishing bicarbonate and mucus secretion and may contribute to the mucosal damage caused by these agents. Misoprostol can increase bicarbonate and mucus production, but in man this has been shown at doses 200 meg and above that are also antisecretory. It is therefore not possible to tell whether the ability of Misoprostol to reduce the risk of gastric ulcer is the result of its antisecretory effect, its mucosal protective effect, or both.

Benign gastric and duodenal ulceration and NSAID associated ulceration: 800 mcg daily (in 2-4 divided doses) with breakfast or main meals and at bedtime; treatment should be continued for at least 4 weeks and may be continued for up to 8 weeks if required.

Prophylaxis of NSAID-induced gastric and duodenal ulcer: 200 mcg 2-4 times daily taken with NSAID. If this dose cannot be tolerated, a dose of 100 mcg can be used. Misoprostol should be taken for the duration of NSAID therapy as prescribed by the physician.

Induction of labor: Place 25 mcg in the posterior fornix of the vagina. Repeat after every 6 hours if necessary until the maximum dosage of 200 mcg total misoprostol is reached. Fetal heart rate and uterus contractions should be monitored. Alternatively, 100 mcg taken orally. If cervical ripening or active labor does not occur, repeated dose of 100-200 mcg of oral misoprostol is given every 4 hourly until labor is established (as evidenced by a Bishop score of 7 or more). Maximum number of dose is 6. Maternal vital signs, fetal heart rate and contractions should be monitored. Oxytocin can be started 4 hours after last dose of misoprostol. Physician should be notified for signs of fetal distress or tetanic uterine contractions. Oral misoprostol therapy should be monitored by Physician.

Prevention of postpartum hemorrhage: 600 mcg orally immediately following delivery.

Treatment of postpartum hemorrhage: 600 mcg orally or 1000 mcg per rectally.

Generally, Misoprostol is well tolerated. The most frequent adverse effects associated with Misoprostol therapy involve the GI tract such as diarrhea, abdominal pain, dyspepsia, flatulence, nausea, vomiting, rashes and dizziness. The incidence of diarrhea may be minimized by administering the drug after meal and at bedtime and by avoiding concomitant administration with a magnesium-containing or other laxative antacid.

Misoprostol is contraindicated to anyone with a history of allergy to prostaglandins and it is also contraindicated in pregnancy.

In case of prevention and treatment of NSAID induced gastric and duodenal ulcer: Misoprostol is contraindicated in women who are pregnant, and should not be used in women of child bearing potential unless the patient requires NSAID therapy. Women of child bearing potential should be told that they must not be pregnant when Misoprostol therapy is initiated and they must use an effective contraception method while taking misoprostol.

In case of induction of labor: The pregnancy should have completed 38 weeks gestation by reliable dating, or lung maturity as evidenced by a L/S >2.0 or a positive phosphotidyl glycerol test, or completed 36 weeks gestation with a maternal or fetal medical indication for induction of labor. Induction of labor is contraindicated in acute fetal distress, abruptio placenta, placenta previa or unexplained vaginal bleeding. The fetus should be in vertex presentation.

There is no evidence of clinically significant interaction between Misoprostol and cardiac, pulmonary, CNS drugs and NSAID's. The bioavailability of Misoprostol is decreased with high doses of antacid.

Because of the abortifacient property of the Misoprostol component, it is contraindicated in women who are pregnant. It should not be used in women of childbearing potential unless the patient requires nonsteroidal anti-inflammatory drug (NSAID) therapy and is at high risk of developing gastric or duodenal ulceration or for developing complications from gastric or duodenal ulcers associated with the use of the NSAID. In such patients, it may be prescribed if the patient:

• has had a negative serum pregnancy test within 2 weeks prior to beginning therapy.
• is capable of complying with effective contraceptive measures.
• has received both oral and written warnings of the hazards of Misoprostol, the risk of possible contraception failure, and the danger to other women of childbearing potential should the drug be taken by mistake.
• will begin it only on the second or third day of the next normal menstrual period.

Excretion of the active metabolite (Misoprostol acid) into milk is possible but has not been studied. Because of the potential for serious adverse reactions in nursing infants, it is not recommended for use by nursing mothers.

Use in children: Safety and effectiveness of Misoprostol in children below the age of 18 years have not been established.

The toxic dose of Misoprostol in human has not been determined. Clinical signs that may indicate an overdose are a sedation, tremor, convulsions, dyspnea, abdominal pain, diarrhea and fever. Symptoms should be treated with supportive therapy.

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

Psyllium Husk is indicated in-

• Constipation
• Raised levels of cholesterol
• Hemorrhoids or piles
• Irritable bowel syndrome (IBS)
• Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Bulk-forming laxatives

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

No significant interaction has been observed with other medicine.

Store in a cool and dry place. Keep out of reach of children.

Psyllium fiber and standardized Senna extract is indicated in-

• Constipation
• Hemorrhoids or piles
• Bowel regulation for bed ridden patient

Bulk-forming laxatives, Herbal and Nutraceuticals

Psyllium Fiber & Senna Extract has documented laxative effect for Psyllium or Ispaghula husk powder (Plantago ovata) and standardized Senna extract (Cassia angustifolia). When one spoonful of powder is mixed with water it forms an orange colored and flavored drink. Psyllium (bulk-forming laxative) contains mucilage and Senna extract (stimulant laxative) contains hydroxyanthracene glycosides (as Sennoside B) that helps to relieve constipation and normalizes bowel action. The additive effect of Psyllium Fiber & Senna Extract is ensured for its combination partners. This special combination preparation accelerates intestinal passage and increases water absorption to increase filling pressure. Psyllium Fiber & Senna Extract helps to reduce pain by easy bowel evacuation with soft stool for patients who are suffering from haemorrhoids (piles), rectal surgery and colon cancer. It has soothing effects on gastric and intestinal mucosa, gastric irritation and ulceration. Psyllium Fiber & Senna Extract helps to maintain serum cholesterol and blood glucose level.

Adults and children over 12 years old: 1-2 spoonful at night with at least 150 ml water or as directed by physician. Intake of additional water will be helpful. This can be taken with fruit juice, milk and warm drink. And should not be taken until ½ to 1 hour after intake of other medications. Continuous use for more than 2 weeks requires medical supervision.

Occasionally allergic reaction may occur. Chronic use may cause loss of electrolytes (potassium) that will reverse upon discontinuation.

Contraindicated for patients with pathological narrowing in gastrointestinal tract, intestinal obstructions, difficult-to-control diabetes mellitus, acutely inflamed intestinal diseases, e.g. Crohn's disease, ulcerative colitis, appendicitis and abdominal pain of unknown origin. Contraindicated for children under 12 years old.

Drink immediately after preparation. Keep tightly closed after each use.

Chronic use may causes potassium deficiency which may increase the effectiveness of cardiac glycosides and may influence the action of antiarrhythmic drugs. Potassium deficiency can be increased by simultaneous application of thiazide diuretics, corticoadrenal steroids. A reduction of dose of insulin may be necessary for insulin dependent diabetic patients. The absorption of concurrently administered drugs can be delayed.

Recommended but special precaution should be taken during first trimester of pregnancy.

Overdose may alter electrolyte and water balance.

Store in a cool and dry place, away from light and moisture. Keep out of reach of children.

Psyllium Husk is indicated in-

• Constipation
• Raised levels of cholesterol
• Hemorrhoids or piles
• Irritable bowel syndrome (IBS)
• Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Bulk-forming laxatives

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

No significant interaction has been observed with other medicine.

Store in a cool and dry place. Keep out of reach of children.

Psyllium Husk is indicated in-

• Constipation
• Raised levels of cholesterol
• Hemorrhoids or piles
• Irritable bowel syndrome (IBS)
• Reduces blood glucose level

Psyllium also provides easy bowel movement with smooth stool. So, it is desirable in patients with anal fissures, colon cancer, post anal & rectal surgery and during pregnancy.

Bulk-forming laxatives

Usual dose: 1 spoonful 1-3 times daily or as per doctor's advice.

Adults and children over 12 years: 1 spoonful with water 2 times daily or as per doctor's advice.

Children 6 to 12 years: ½ to 1 spoonful with water depending on age and size, in the morning and at bedtime or as per doctor's advice.

Children below 6 years: Not recommended except as directed by the physician.

An additional glass of water is helpful after taking this gel.

Common side effects are flatulence, abdominal distension, gastro-intestinal obstruction.

Contraindicated in patients with gastrointestinal tract obstruction or threatening obstruction of the bowel.

No significant interaction has been observed with other medicine.

Store in a cool and dry place. Keep out of reach of children.

This cream is used to temporarily relieve pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy, poison oak, and poison sumac, dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

Local Antipruritic, Topical Antihistamines

Diphenhydramine is an antihistamine and works as a topical anti-allergic and analgesic by blocking the releases of histamine at its sources. Zinc is used as a skin protectant.

Adults & children above 2 years: Apply to the affected area 3 to 4 times daily. Before application of cream, the skin should be clean, cool and dry. Should not have a hot shower or bath before applying. Apply the cream lightly on the skin until the cream disappears. It is important to include all skin surfaces, such as between the fingers and toes, under the nails and on the soles of the feet.

For babies under 2 years: Initially consult with the physician, if it is recommended, apply to the face, neck, ears and scalp as well, only avoiding the area immediately around the eyes and mouth. Leave cream on for at least 8 hours, before washing off. Reapply to any area that may be washed during the 8 hours treatment time (such as after washing the hands).

Contact dermatitis with mild erythematous vesicular lesions and papules has occasionally been reported.

Use of cream is contraindicated in individuals with a known allergy to its components, other pyrethroids or pyrethrins.

For external use only. Flammable, keep away from fire or flame. Do not use on large areas of the body with any other product containing diphenhydramine, even should not be taken by mouth. Consult with the physician before use on chicken pox, on measles. When using this product, avoid contact of eyes.

In the absence of specific studies in pregnant women its use in pregnancy should only follow medical advice. However, teratogenic effects would not be anticipated. Although caution should be exercised in administration of diphenhydramine to nursing mothers, levels in breast milk following topical application are likely to be very low.

Store below 30°C. Protect from light. Do not freeze.

Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs

Sodium Cromoglycate 2% sterile Eye Drops inhibits the release of chemical mediators from sensitised mast cells and is capable of rapid phosphorylation of mast cell protein. The exact mechanism of action of the drug remains to be elucidated but Sodium Cromoglycate appears to modulate the allergic response to antigen antibody interactions in a way which prevents the subsequent formation or release of toxic or inflammatory mediators. Sodium Cromoglycate 2% Eye Drops appears to act mainly through a local effect on the mucous of the eye. Approximately 0.03% of an ophthalmic dose of Sodium Cromoglycate 2% Eye Drops is absorbed systemically. Sodium Cromoglycate 2% Eye Drops prevent, release of mediators of type-I allergic reactions, including histamine and slow reacting substance of anaphylaxis (SRS-A) from sensitised mast cells after the antigen antibody union has taken place. The drug does not inhibit the binding of IgE to mast cells nor the interaction between cell bound IgE and the specific antigen; instead Sodium Cromoglycate suppresses the release of substances (e.g. histamine, SRS-A) in response to this reaction. The drug also inhibits Type-III (late allergic, Arthus) reactions.

The usual dosage of Sodium Cromoglycate 2% Eye Drops in adults and children over 4 years of age or older is 1 or 2 drops in each eye 4-6 times daily at regular intervals. The recommended frequency of administration should not be exceeded. Patients should be advised that the therapeutic effects of Sodium Cromoglycate 2% Eye Drops depend on administration of the drug at regular intervals.

The most frequent adverse effect reported with use of Sodium Cromoglycate 2% Eye Drops is transient ocular stinging or burning upon instillation of the drug.

Sodium Cromoglycate 2% Eye Drops is contraindicated in individuals who have shown hypersensitivity to the drug or any of the ingredients.

Sodium Cromoglycate 2% Eye Drops contains benzalkonium chloride and patients should be advised not to wear soft contact lenses during treatment with Sodium Cromoglycate 2% Eye Drops.

Sodium Cromoglycate has no known drug interactions.

In animal studies, Sodium Cromoglycate has produced adverse effects on the foetus only in high parenteral doses. There was no evidence of impaired fertility in reproduction studies in animals. Healthy infants have been born to women who received Sodium Cromoglycate throughout pregnancy; nevertheless, there is insufficient evidence to establish the safety in pregnancy. It should be used during pregnancy only when clearly needed. Since it is not known if Sodium Cromoglycate is distributed into milk in humans, the drug should be used with caution in nursing women.

Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

Sodium Cromoglycate 2% Eye Drops should be protected from direct sunlight and stored at a temperature less than 30˚C; any unused ophthalmic solution should be discarded 4 weeks after opening the cap of the bottle.

Mast Cell Stabiliser, Ophthalmic Non-Steroid drugs

Sodium Cromoglicate inhibits the degranulation of sensitized mast cells which occurs after exposure to specific antigens. Sodium Cromoglicate acts by inhibiting the release of histamine and various membrane derived mediators of inflammation from mast cells. Sodium Cromoglicate has no vasoconstrictor or antihistaminic activity.

For eyes: For Child and Adult: 1 to 2 drops into each eye 2 to 3 times daily.
For nose: For Child and Adult: 1 drop to each nostril 2 to 3 times daily.

Transient stinging and burning may occur after instillation of this drops. Other symptoms of local irritation have been reported rarely.

This drop is contraindicated in patient with hypersensitivity to Sodium Cromoglicate .

As this drop contains benzalkonium chloride, patients should not wear contact lenses during treatment with this drop.

No evidence of interaction with other drugs has been observed.

Sodium Cromoglicate should be used with caution during pregnancy and only if the expected benefit to the mother is greater than any possible risk to the fetus. There are no known harmful effects when this medicine is used by breastfeeding mothers.

Overdose is unlikely. In the event of accidental ingestion, symptomatic treatment is recommended.

Store at room temperature and protect from light. Any remaining contents should be discarded 4 weeks after opening. Do not touch dropper tip to any surface since this may contaminate the solution.

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.

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.

For temporary relief of pain and itching associated with minor burns, sunburns, minor cuts, scrapes, insect bites, minor skin irritations and rashes

Topical Analgesics

Pramoxine Hydrochloride blocks Na⁺ ion channel in neuronal cell membrane and prevents pain transmission, thereby effecting local anesthetic action. Calamine causing a cooling sensation and provides anti-itching action.

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Consult with a doctor.

Local skin reaction, e.g. anaphylactoid, burning, stinging, contact dermatitis, tenderness, urticaria, skin peeling and skin lesions

This preparation is for topical use only. Avoid contact of this medicine with the eyes, nose, ears and mouth. If the medication gets in these areas, wipe it off and rinse immediately with water. Stop using this medication and tell your doctor if your condition worsens, if symptoms do not improve within 7 days or persist after 7 days of treatment or if symptoms clear up and return in a few days. Do not apply to wound or damage skin and not bandage tightly in the affected area. This medicine may be harmful if swallowed. If swallowed get medical help or contact a poison center immediately

No significant interactions known or found for this cream. Caution always advised with multiple medications.

Pregnancy Category: Undetermined. No safety information is available on the use of this product during pregnancy and lactation. Pregnant and breastfeeding patients should seek advice of health professional before using this cream.

This cream should be stored at room temperature of 20°C - 25°C. Keep out of the reach of children

For temporary relief of pain and itching associated with minor burns, sunburns, minor cuts, scrapes, insect bites, minor skin irritations and rashes

Topical Analgesics

Pramoxine Hydrochloride blocks Na⁺ ion channel in neuronal cell membrane and prevents pain transmission, thereby effecting local anesthetic action. Calamine causing a cooling sensation and provides anti-itching action.

Adults and children 2 years of age and older: Apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age: Consult with a doctor.

Local skin reaction, e.g. anaphylactoid, burning, stinging, contact dermatitis, tenderness, urticaria, skin peeling and skin lesions

This preparation is for topical use only. Avoid contact of this medicine with the eyes, nose, ears and mouth. If the medication gets in these areas, wipe it off and rinse immediately with water. Stop using this medication and tell your doctor if your condition worsens, if symptoms do not improve within 7 days or persist after 7 days of treatment or if symptoms clear up and return in a few days. Do not apply to wound or damage skin and not bandage tightly in the affected area. This medicine may be harmful if swallowed. If swallowed get medical help or contact a poison center immediately

No significant interactions known or found for this cream. Caution always advised with multiple medications.

Pregnancy Category: Undetermined. No safety information is available on the use of this product during pregnancy and lactation. Pregnant and breastfeeding patients should seek advice of health professional before using this cream.

This cream should be stored at room temperature of 20°C - 25°C. Keep out of the reach of children

It is indicated for the treatment and prophylaxis of Iron, Folic Acid and Zinc deficiency especially during pregnancy and lactation.

Iron, Vitamin & Mineral Combined preparation

This timed-release capsule is the combined preparation of Carbonyl Iron, Folic Acid and Zinc Sulphate Monohydrate. It contains Carbonyl Iron with not less than 98% Iron content. Carbinyl Iron, having high bioavailability and low toxicity is safer and more effective choice for iron supplementation.

Adult: One Capsule daily before food or as directed by the physician.

Gastrointestinal irritations such as nausea, anorexia, vomiting, discomfort, constipation and diarrhoea may occur. Patients may complain of dark stool. Carbonyl Iron pellets incorporated into the capsules to reduce the possibility of gastrointestinal irritations. Rarely there may be allergic reactions.

It is contraindicated in patients with known hypersensitivity to any of its component or those with Iron overload.

Special care should be taken in patients with Iron overload states, such as haemochromatosis, haemolytic anaemia or red blood cell aplasia. Failure to response to the treatment requires further investigations to exclude other causes of anaemia. In patients with renal failure there may be the risk of Zinc accumulation.

Carbonyl Iron decreases the absorption of tetracycline antibiotics, quinolone antibiotics, levodopa, levothyroxine, methyldopa and penecillamine. Folic Acid interacts with antiepileptics, so plasma concentrations of phenobarbital, phenytoin and primidone are possibly reduced.

Use of any drug during first trimester of pregnancy should be avoided if possible. Thus administration of Iron during the first trimester requires definite evidence of Iron deficiency. Prophylaxis of Iron deficiency where inadequate diet calls for supplementary Zinc and Folic acid is justified during the remainder of pregnancy.

Symptoms of Carbonyl Iron include decreased energy, nausea, abdominal pain, tarry stool, weak, rapid pulse, fever, coma, seizures.

Store below 30°C. and keep away from light and moisture. Keep all medicines out of the reach of children.