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

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

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

Diclofenac SR Tablet:

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

Diclofenac Dispersible Tablet:

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

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

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

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

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

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

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

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

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

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

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

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

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

Diclofenac SR Tablet:

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

Diclofenac Dispersible Tablet:

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

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

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

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

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

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

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

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

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

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

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

Diclofenac Sodium is a potent nonsteroidal antiinflammatory drug (NSAID) with marked analgesic and antipyretic properties. It also has some uricosuric effects. The action of Diclofenac appeared to be associated with the inhibition of prostaglandin synthesis. Diclofenac may inhibit synthesis of prostaglandins by inhibiting cyclooxygenase, an enzyme that catalyses the formation of prostaglandin precursors from arachidonic acid. Peak plasma concentration is achieved within half an hour following injection. Lidocaine is the most widely used local anaesthetic drug. It acts more rapidly and is more stable than most other local anaesthetics. It is a very useful surface anaesthetic. Like other local anaesthetics, Lidocaine impairs the generation and conduction of nerve impulses by slowing depolarization. The onset of anaesthesia of Lidocaine Hydrochloride is more rapid and the duration is 1-2 hours.

Adult: One ampoule once (or in severe cases, twice) daily by intramuscular injection.

Renal colic: One ampoule once daily intramuscularly. A second dose may be administered after 30 minutes if necessary.

Children: In Juvenile chronic arthritis, 1-3 mg of Diclofenac Sodium per kg body weight daily in divided doses.

Elderly patients: In elderly or debilitated patients, the lowest effective dosage is recommended, commensurate with age and physical status, or as prescribed by the physician.

Side effects to Diclofenac Sodium and Lidocaine injection are usually mild and transient. However if serious side effects occur the injection should be discontinued. Gastrointestinal discomfort, nausea, diarrhea and occasionally bleeding may occur. In very rare instances, injection site disorder may occur. In isolated cases, abscesses and local necrosis may occur. The adverse effects due to Lidocaine mainly involve the CNS, are usually of short duration, and are dose related. The CNS reactions may be manifested by drowsiness, dizziness, disorientation, confusion, lightheadedness etc.

It is contraindicated for those patients who are hypersensitive to Diclofenac. In patients with active or suspected peptic ulcer or gastrointestinal bleeding or for those patients in whom attacks of asthma, urticaria or acute rhinitis are precipitated by Aspirin or other NSAIDs possessing prostaglandin synthetase inhibiting activity Diclofenac is also contraindicated. Because of the presence of Lidocaine, this injection is also contraindicated for those patients who are hypersensitive to local anaesthetics of the amide type, although the incidence is very rare. In patients with Adams-Stokes syndrome or with severe degrees of SA, AV, or intraventricular heart block in the absence of an artificial pacemaker, and for those patients who are hypersensitive to any of the excipients used in the formulation (Sodium Metabisulphite, Disodium Edetate, Benzyl Alcohol, Sodium Hydroxide, Propylene Glycol), this injection is also contraindicated.

Renal: Patients with severe hepatic, cardiac or renal insufficiency or the elderly should be kept under close observation, since the use of NSAIDs may result in deterioration of renal function. The lowest effective dose should be used and renal function should be monitored.

Hepatic: If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Diclofenac should be discontinued. All patients who are receiving long term treatment with NSAIDs should be monitored as a precautionary measure (e.g., renal, hepatic function and blood counts).

Lithium and Digoxin: Diclofenac may increase plasma concentrations of Lithium and Digoxin.

Anticoagulants: There are isolated reports of an increased risk of haemorrhage with the combined use of Diclofenac and anticoagulant therapy, although clinical investigations do not appear to indicate any influence on anticoagulant effect.

Antidiabetic agents: Clinical studies have shown that Diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect.

Cyclosporin: Cases of nephrotoxicity have been reported in patients receiving Cyclosporin and Diclofenac concomitantly.

Methotrexate: Cases of serious toxicity have been reported when Methotrexate and NSAIDs are given within 24 hours of each other.

Quinolone antimicrobials: Convulsions may occur due to an interaction between quinolones and NSAIDs. Therefore, caution should be exercised when considering concomitant therapy of NSAIDs and quinolones.

Other NSAIDs and steroids: Co-administration of Diclofenac with other systemic NSAIDs and steroids may increase the frequency of unwanted effects. With Aspirin, the plasma levels of each are lowered, although no clinical significance is known.

Diuretics: Various NSAIDs are liable to inhibit the activity of diuretics. Concomitant treatment with potassium-sparing diuretics may be associated with increased serum potassium levels. So, serum potassium should be monitored.

It should not be prescribed during pregnancy unless there are compelling reasons for doing so. The lowest effective dosage should be used. These types of drugs are not recommended during the last trimester of pregnancy. Very small quantities of Diclofenac may be detected in breast milk, but no undesirable effects on the infant are to be expected.

Store at temparature not exceeding 30°C in a dry place. Protected from light.

This combination is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.

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

It is a combination product containing Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties and Misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E 1 analog. The mechanism of action of Diclofenac Sodium, like other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. NSAIDs inhibit prostaglandin synthesis. A deficiency of prostaglandins within the gastric and duodenal may lead to diminish bicarbonate and mucosal secretion and may contribute to mucosal damage caused by NSAIDs. Misoprostol can increase bicarbonate and mucous production & prevents gastric and duodenal ulcers.

Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.

Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.

The most common reported side effects are abdominal pain, diarrhea and other GI symptoms. Diarrhea and abdominal pain developed early in the course of therapy and were usually self-limited (resolved after 2 to 7 days). Rare instances of profound diarrhea leading to  severe dehydration have been reported in patients receiving Misoprostol.

This is contraindicated in patients with hypersensitivity to Diclofenac, Misoprostol or to other prostaglandins. This should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.

Patients with an underlying condition such as inflammatory bowel disease or those in whom dehydration should be monitored carefully if Diclofenac Sodium plus Misoprostol is prescribed.

Aspirin: Concomitant administration with aspirin is not recommended because Diclofenac Sodium is displaced from its binding sites by aspirin, resulting in lower plasma concentrations, peak plasma levels and AUC values.

Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium. Antihypertensives: NSAIDs can inhibit the activity of antihypertensives, including ACE inhibitors.

Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious bleeding greater than users of either drug alone.

Oral hypoglycaemics: Diclofenac Sodium does not alter glucose metabolism in healthy people nor it alters the effects of oral hypoglycaemics. Diclofenac Sodium may alter diabetic patient’s response to insulin or oral hypoglycaemics.

Antacids: Antacids reduce the bioavailability of Misoprostol. Antacids may also delay absorption of Diclofenac Sodium.

Diuretics: The Diclofenac Sodium component like other NSAIDs, can inhibit the activity of diuretics. Concomitant therapy with potassium-sparing diuretics may be associated with increased serum potassium levels.

Because of the abortifacient property of the Misoprostol component, this is contraindicated in women who are pregnant. Diclofenac Sodium has been found in the milk of nursing mothers. Diclofenac Sodium plus Misoprostol is not recommended for use by nursing mothers.

Paediatric use: Safety and effectiveness of Diclofenac Sodium and Misoprostol combination in paediatric patients have not been established.

Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly person cannot be ruled out. As with any NSAID, the elderly are likely to tolerate adverse events less well than younger patients.

Misoprostol: Convulsions, sedation, tremor, dyspnoea, diarrhoea, abdominal pain, fever, palpitations, hypotension, bradycardia. Management: Supportive treatment.

Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely

Store in a cool and dry place below 25º C. Protect from light.

This combination is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.

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

It is a combination product containing Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties and Misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E 1 analog. The mechanism of action of Diclofenac Sodium, like other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. NSAIDs inhibit prostaglandin synthesis. A deficiency of prostaglandins within the gastric and duodenal may lead to diminish bicarbonate and mucosal secretion and may contribute to mucosal damage caused by NSAIDs. Misoprostol can increase bicarbonate and mucous production & prevents gastric and duodenal ulcers.

Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.

Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.

The most common reported side effects are abdominal pain, diarrhea and other GI symptoms. Diarrhea and abdominal pain developed early in the course of therapy and were usually self-limited (resolved after 2 to 7 days). Rare instances of profound diarrhea leading to  severe dehydration have been reported in patients receiving Misoprostol.

This is contraindicated in patients with hypersensitivity to Diclofenac, Misoprostol or to other prostaglandins. This should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.

Patients with an underlying condition such as inflammatory bowel disease or those in whom dehydration should be monitored carefully if Diclofenac Sodium plus Misoprostol is prescribed.

Aspirin: Concomitant administration with aspirin is not recommended because Diclofenac Sodium is displaced from its binding sites by aspirin, resulting in lower plasma concentrations, peak plasma levels and AUC values.

Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium. Antihypertensives: NSAIDs can inhibit the activity of antihypertensives, including ACE inhibitors.

Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious bleeding greater than users of either drug alone.

Oral hypoglycaemics: Diclofenac Sodium does not alter glucose metabolism in healthy people nor it alters the effects of oral hypoglycaemics. Diclofenac Sodium may alter diabetic patient’s response to insulin or oral hypoglycaemics.

Antacids: Antacids reduce the bioavailability of Misoprostol. Antacids may also delay absorption of Diclofenac Sodium.

Diuretics: The Diclofenac Sodium component like other NSAIDs, can inhibit the activity of diuretics. Concomitant therapy with potassium-sparing diuretics may be associated with increased serum potassium levels.

Because of the abortifacient property of the Misoprostol component, this is contraindicated in women who are pregnant. Diclofenac Sodium has been found in the milk of nursing mothers. Diclofenac Sodium plus Misoprostol is not recommended for use by nursing mothers.

Paediatric use: Safety and effectiveness of Diclofenac Sodium and Misoprostol combination in paediatric patients have not been established.

Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly person cannot be ruled out. As with any NSAID, the elderly are likely to tolerate adverse events less well than younger patients.

Misoprostol: Convulsions, sedation, tremor, dyspnoea, diarrhoea, abdominal pain, fever, palpitations, hypotension, bradycardia. Management: Supportive treatment.

Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely

Store in a cool and dry place below 25º C. Protect from light.

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

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

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

Diclofenac SR Tablet:

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

Diclofenac Dispersible Tablet:

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

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

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

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

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

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

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

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

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

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

Anti-emetic drugs, Prokinetic drugs

Metoclopramide blocks dopamine receptors and in higher doses, it also blocks serotonin receptors in chemoreceptor trigger zone of the CNS. It enhances the response to acetylcholine of tissue in upper GI tract causing enhanced motility and accelerated gastric emptying w/o stimulating gastric, biliary, or pancreatic secretions. It also increases lower esophageal sphincter tone.

Metoclopramide Spray:

Adults less than 65 years of age: The recommended dosage is 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum of 4 sprays daily) for 2 to 8 weeks, depending on symptomatic response.

Adults 65 years of age and older: Metoclopramide is not recommended in geriatric patients as initial therapy. Geriatric patients receiving an alternative metoclopramide product at a stable dosage of 10 mg four times daily can be switched to Metoclopramide 1 spray (15 mg) in one nostril, 30 minutes before each meal and at bedtime (maximum four times daily) for 2 to 8 weeks, depending on symptomatic response.

Metoclopramide tablet:

Gastroesophageal Reflux: Administer Metoclopramide continuously or intermittently:

• Continuous: Administer 10 to 15 mg, 30 minutes before each meal and at bedtime (maximum of 60 mg per day) for 4 to 12 weeks.
• Intermittent: Single doses up to 20 mg prior to provoking situation.

Acute and Recurrent Diabetic Gastroparesis: Administer 10 mg, 30 minutes before each meal and at bedtime (maximum of 40 mg per day) for 2 to 8 weeks.

Metoclopramide injection:

For the Relief of Symptoms Associated with Diabetic Gastroparesis (Diabetic Gastric Stasis): If only the earliest manifestations of diabetic gastric stasis are present, oral administration of metoclopramide may be initiated. However, if severe symptoms are present, therapy should begin with Metoclopramide Injection (IM or IV). Doses of 10 mg may be administered slowly by the intravenous route over a 1- to 2-minute period. Administration of Metoclopramide Injection (metoclopramide injection, USP) up to 10 days may be required before symptoms subside, at which time oral administration of metoclopramide may be instituted. The physician should make a thorough assessment of the risks and benefits prior to prescribing further metoclopramide treatment.

For the Prevention of Nausea and Vomiting Associated with Emetogenic Cancer Chemotherapy: Intravenous infusions should be made slowly over a period of not less than 15 minutes, 30 minutes before beginning cancer chemotherapy and repeated every 2 hours for two doses, then every 3 hours for three doses. The initial two doses should be 2 mg/kg if highly emetogenic drugs such as cisplatin or dacarbazine are used alone or in combination. For less emetogenic regimens, 1 mg/kg per dose may be adequate.

For the Prevention of Postoperative Nausea and Vomiting: Metoclopramide Injection should be given intramuscularly near the end of surgery. The usual adult dose is 10 mg; however, doses of 20 mg may be used.

Most common adverse reactions (≥5%) are: dysgeusia, headache, and fatigue.

Metoclopramide is contraindicated:

• In patients with a history of tardive dyskinesia (TD) or a dystonic reaction to metoclopramide.
• When stimulation of gastrointestinal motility might be dangerous (e.g., in the presence of gastrointestinal hemorrhage, mechanical obstruction, or perforation).
• In patients with pheochromocytoma or other catecholamine-releasing paragangliomas. Reglan may cause a hypertensive/pheochromocytoma crisis, probably due to release of catecholamines from the tumor.
• In patients with epilepsy. Reglan may increase the frequency and severity of seizures.
• In patients with hypersensitivity to metoclopramide. Reactions have included laryngeal and glossal angioedema and bronchospasm.

Tardive Dyskinesia (TD), Other Extrapyramidal Symptoms (EPS), and Neuroleptic Malignant Syndrome (NMS): Avoid concomitant use of other drugs known to cause TD/EPS/NMS and avoid use in patients with Parkinson’s Disease. If symptoms occur, discontinue Reglan and seek immediate medical attention.  

Depression and suicidal ideation/suicide: Avoid use.

Pregnancy Category B. Reproduction studies performed in rats, mice and rabbits by the IM, IV, subcutaneous (SC), and oral routes at maximum levels ranging from 12 to 250 times the human dose have demonstrated no impairment of fertility or significant harm to the fetus due to metoclopramide. 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.

Nursing Mothers: Metoclopramide is excreted in human milk. Caution should be exercised when metoclopramide is administered to a nursing mother.

Store between 20-25°C. Protect from light.

Broad spectrum penicillins

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

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

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

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

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

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

Amoxicillin is contraindicated in penicillin hypersensitive patients.

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

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

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

Amoxycillin 500 mg Injection:

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

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

Broad spectrum penicillins

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

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

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

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

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

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

Amoxicillin is contraindicated in penicillin hypersensitive patients.

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

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

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

Amoxycillin 500 mg Injection:

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

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

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.

Naproxen is indicated for the relief of sign and symptoms of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis, juvenile arthritis, tendonitis, bursitis & acute gout. It is also indicated for the management of primary dysmenorrhea & pain.

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

Naproxen is a non steroidal anti-inflammatory drug (NSAID) with anti-inflammatory, analgesic & antipyretic properties. It is rapidly absorbed from the gastrointestinal tract and achieves 95% bioavailability.

Naproxen Tablet-

• Rheumatoid arthritis, osteoarthritis and ankylosing spondylitis: The usual dose is 500-1000 mg daily in two divided doses after meals.
• Management of pain, primary dysmenorrhea, acute tendonitis & bursitis: Recommended starting dose is 500 mg followed by 500 mg every 12 hours or 250 mg every 6-8 hours. The initial total daily dose should not exceed 1250 mg and thereafter, the total daily dose should not exceed 1000 mg.
• Acute gout: Recommended starting dose is 750 mg followed by 250 mg every 8 hours until the attack has subsided.

Naproxen Suspension-

• For Juvenile rheumatoid arthritis: The usual dose for children over 2 years is 10 mg/kg/day given as two divided doses at 12-hours intervals. Therapy in children under 2 years of age is not recommended.

Naproxen Gel-

• Is to be applied 2-6 times a day as required and is not recommended for use in children.

Most frequently reported side effects include following:

• Gastrointestinal: Heartburn, abdominal pain, nausea, diarrhea, dyspepsia.
• Central Nervous System: Headache, vertigo, drowsiness.
• Dermatological: Pruritus (itching), purpura.
• Cardiovascular: Edema, palpitation.
• Others: Visual disturbances, hearing disturbances.

Naproxen is contraindicated in patients with known hypersensitivity to Naproxen. It should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. It is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

ACE inhibitors: diminish the antihypertensive effect of ACE inhibitors.
Antacids & Sucralfate: delay the absorption of Naproxen.
Aspirin: increase adverse effects.
Diuretics: reduce the natriuretic effect of Furosemide and Thiazides.
Methotrexate: enhance the toxicity of Methotrexate.
Warfarin: increase the risk of GI bleeding.
Selective Serotonin Reuptake Inhibitors (SSRI): increase the risk of GI bleeding.

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

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

Fourth generation Cephalosporins

Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

Cefepime should be administered intravenously over approximately 30 minutes.

• Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
• Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
• Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
• Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
• Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
• Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.

Note:
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use 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. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.

Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.

Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.

Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.

Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.

Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.

500 mg (IV) vials for intravenous administration:

• Amount of WFI to be added: 5 ml
• Approximate available volume: 5.6 ml

500 mg (IM) vials for intramuscular administration:

• Amount of WFI to be added: 1.3 ml
• Approximate available volume: 1.8 ml 

1 gm (IV) vials for Intravenous administration:

• Amount of WFI to be added: 10 ml
• Approximate available volume: 11.3 ml

1 gm (IM) vials for intramuscular administration:

• Amount of WFI to be added: 2.4 ml
• Approximate available volume: 3.6 ml

2 gm (IV) vials for Intravenous administration:

• Amount of WFI to be added: 10 ml
• Approximate available volume: 12.5 ml 

Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Fourth generation Cephalosporins

Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

Cefepime should be administered intravenously over approximately 30 minutes.

• Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
• Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
• Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
• Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
• Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
• Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.

Note:
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use 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. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.

Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.

Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.

Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.

Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.

Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.

500 mg (IV) vials for intravenous administration:

• Amount of WFI to be added: 5 ml
• Approximate available volume: 5.6 ml

500 mg (IM) vials for intramuscular administration:

• Amount of WFI to be added: 1.3 ml
• Approximate available volume: 1.8 ml 

1 gm (IV) vials for Intravenous administration:

• Amount of WFI to be added: 10 ml
• Approximate available volume: 11.3 ml

1 gm (IM) vials for intramuscular administration:

• Amount of WFI to be added: 2.4 ml
• Approximate available volume: 3.6 ml

2 gm (IV) vials for Intravenous administration:

• Amount of WFI to be added: 10 ml
• Approximate available volume: 12.5 ml 

Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

Fourth generation Cephalosporins

Cephalosporins are bactericidal and have the same mode of action as other beta-lactam antibiotics (such as penicillins). Cephalosporins disrupt the synthesis of the peptidoglycan layer of bacterial cell walls. The peptidoglycan layer is important for cell wall structural integrity, especially in Gram-positive organisms. The final transpeptidation step in the synthesis of the peptidoglycan is facilitated by transpeptidases known as penicillin binding proteins (PBPs).

Cefepime should be administered intravenously over approximately 30 minutes.

• Moderate to Severe Pneumonia due to S. pneumoniae, *P. aeruginosa, K. pneumoniae, or Enterobacter species: 1-2 gm IV 12 hourly for 10 days.
• Empiric therapy for febrile neutropenic patients: 2 gm IV 8 hourly for 7** days.
• Mild to Moderate Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli, K. pneumoniae, or P. mirabilis*: 0.5-1 gm IV/IM*** 12 hourly for 7-10 days.
• Severe Uncomplicated or Complicated Urinary Tract Infections, including pyelonephritis, due to E. coli or K. pneumoniae*: 2 gm IV 12 hourly for 10 days.
• Moderate to Severe Uncomplicated Skin and Skin Structure Infections due to S. aureus or S. pyogenes: 2 gm IV 12 hourly for 10 days.
• Complicated Intra-abdominal Infections (used in combination with metronidazole) caused by E. coli, viridans group streptococci, P. aeruginosa, K. pneumoniae, Enterobacter species, or B. fragilis: 2 gm IV 12 hourly for 7-10 days.

Note:
*including cases associated with concurrent bacteremia.
**or until resolution of neutropenia. In patients whose fever resolves but who remain neutropenic for more than 7 days, the need for continued antimicrobial therapy should be re evaluated frequently.
*** IM route of administration is indicated only for mild to moderate, uncomplicated or complicated UTls due to E. coli when the IM route is considered to be a more appropriate route of drug administration.

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

Cefepime is contraindicated in patients who have shown immediate hypersensitivity reactions to cefepime or the cephalosporin class of antibiotics, penicillin, or other betalactum antibiotics.

Renal function should be monitored carefully if high doses of aminoglycosides are to be administered with Cefepime because of the increased potential of nephrotoxicity and ototoxicity of aminoglycoside antibiotics. Nephrotoxicity has been reported following concomitant administration of other cephalosporins with potent diuretics such as furosemide.

Pregnancy Category B. There are, however, no adequate and well-controlled studies of cefepime use 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. Cefepime is excreted in human breast milk in very low concentrations (0.5 pg/ml). Caution should be exercised when cefepime is administered to a nursing woman.

Pediatric Use (2 months up to 16 years): The maximum dose for pediatric patients should not exceed the recommended adult dose. The usual recommended dosage in pediatric patients up to 40 kg in weight for uncomplicated and complicated urinary tract infections (including pyelonephritis), uncomplicated skin and skin structure infections, and pneumonia is 50 mg/kg/dose, administered every 12 hours (50 mg/kg/dose, every 8 hours for febrile neutropenic patients), for durations as given above.

Geriatric Use: Serious adverse events have occurred in geriatric patients with renal insufficiency given unadjusted doses of cefepime, including life-threatening or fatal occurrences of the following: encephalopathy, myoclonus, and seizures. This drug is known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, care should be taken in dose selection, and renal function should be monitored.

Impaired Hepatic Function: No adjustment is necessary for patients with impaired hepatic function.

Impaired Renal Function: In patients with impaired renal function (creatinine clearance<60 ml/min), the dose of Cefepime should be adjusted to compensate for the slower rate of renal elimination.

Patients who receive an overdose should be carefully observed and given supportive treatment. In the presence of renal insufficiency, hemodialysis, not peritoneal dialysis, is recommended to aid the removal of cefepime from the body. Accidental overdosing has occurred when large doses were given to patients with impaired renal function. Symptoms of overdose include encephalopathy (disturbance of consciousness including confusion, hallucinations, stupor, and coma), myoclonus, seizures, and neuromuscular excitability.

For IV the resulting solution should be injected directly into the vein over a period of three to five minutes or injected into the tubing of an administration set while the patient is receiving a compatible IV fluid.

Intravenous: Cefepime is compatible with Sterile Water for Injection. It is also compatible at concentrations between 1 mg/ml and 40 mg/ml with the following IV infusion fluids: 0.9% Sodium Chloride Injection, 5% and 10% Dextrose Injection, M/6 Sodium Lactate Injection, 5% Dextrose and 0.9% Sodium Chloride Injection, Lactated Ringers and 5% Dextrose Injection.

Intramuscular: Cefepime is compatible with the following diluent such as: Sterile Water for Injection, 0.9% Sodium Chloride Injection, 5% Dextrose Injection, Sterile Bacteriostatic Water for Injection with Parabens or Benzyl Alcohol or 0.5% or 1% Lidocaine Hydrochloride.

500 mg (IV) vials for intravenous administration:

• Amount of WFI to be added: 5 ml
• Approximate available volume: 5.6 ml

500 mg (IM) vials for intramuscular administration:

• Amount of WFI to be added: 1.3 ml
• Approximate available volume: 1.8 ml 

1 gm (IV) vials for Intravenous administration:

• Amount of WFI to be added: 10 ml
• Approximate available volume: 11.3 ml

1 gm (IM) vials for intramuscular administration:

• Amount of WFI to be added: 2.4 ml
• Approximate available volume: 3.6 ml

2 gm (IV) vials for Intravenous administration:

• Amount of WFI to be added: 10 ml
• Approximate available volume: 12.5 ml 

Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician.

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

First generation Cephalosporins

Cephradine is a semisynthetic broad spectrum bactericidal antibiotic, it is active against infections caused by both gram-positive and gram-negative microorganisms. Both penicillinase producing and nonproducing staphylococci are sensitive to Cephradine. The main site of action of Cephradine is the cell wall of bacteria. Cell wall of sensitive organism contains peptidoglycan. Cephradine inhibits cross-linking process and as a result cell wall with many pores are formed, thus lysis of bacteria occur due to external osmotic pressure.

For oral administration-
Adults:

• Urinary tract infections: 500mg four times daily or 1g twice daily. Infections which are severe or chronic may necessitate the administration of higher doses. Where complications arise including prostatitis and epididymitis continued intensive treatment is required.
• Respiratory tract infections: 250 to 500mg four times daily or 500mg to 1g twice daily, dependent on the site and severity of the infection.
• Skin and soft tissue infections: 250 to 500mg four times daily or 500mg to 1g twice daily, again dependent on the site and severity of the infection.

Children:

• Total daily dose of 25 to 50mg/kg given in two or four equally divided doses.
• Otitis media: Total daily dose of 75 to 100mg/kg given in divided doses 6 to 12 hourly.
• Maximum daily dosage: 4 gm

Elderly: The normal adult dose is appropriate. Patients with impaired renal or hepatic function should be monitored during treatment.

For injectable administration-

• Adult: The usual dose is 2-4 gm daily in four equally divided doses up to 8 gm daily. For prophylaxis a single preoperative dose of 1-2 gm intramuscularly or intravenously is given.
• Children: The dose is 50-100 mg/kg daily in four equally divided doses, up to 300 mg/kg daily in severe infection.

Limited essentially to gastro-intestinal disturbances and on occasions to hypersensitivity phenomena. The latter are more likely to occur in individuals, who have previously demonstrated hypersensitivity and thos with a history of allergy, asthma, hay fever or urticaria. Skin reactions have occasionally been reported. Rare- Glossitis, heartburn, dizziness, tightness in the chest, nausea, vomiting, diarrhoea, abdominal pain, vaginitis, candida overgrowth. Skin and hypersensitivity reactions include urticaria, skin rashes, joint pains, oedema.

• Blood and lymphatic system disorders- Unknown: blood disorders (including thrombocytopenia, leucopenia, agranulocytosis, aplastic anaemia and haemolytic anaemia)
• Immune system disorders- Unknown: Fever, serum sickness like reactions, anaphylaxis
• Psychiatric disorders- Unknown: Confusion, sleep disturbances
• Nervous system disorders- Unknown: hyperactivity, hypertonia, dizziness, nervousness; Rarely: Headache
• Hepatobiliary disorders- Frequency unknown: Liver, enzyme disturbances, transient hepatitis, cholestatic jaundice
• Renal and urinary disorders- Unknown: Reversible interstitial nephritis
• Investigations- Unknown: Elevation of blood urea nitrogen, serum creatinine, alanine aminotransferase, aspartate aminotransferase, total bilirubin, alkaline phosphatase.

Cephradine should not be used in patients with known or suspected hypersensitivity to cephalosporins.

The concomitant use of nephrotoxic drugs such as aminoglycosides with Cefradine may increase the risk of kidney damage. Diuretics (e.g. frusemide, ethacrynic acid) and probenecid enhanced the possibility of renal toxicity.

Although animal studies have not demonstrated any teratogenicity, safety in pregnancy has not been established. Cephradine is excreted in breast milk and should be used with caution in lactating mothers. Since the medicine may cause dizziness, patients should be cautioned about operating hazardous machinery, including automobiles.

Renal Impairment: The following doses are recommended (based on 500 mg every 6 hours) for patients not on haemodialysis:

• CrCl: >20 ml/min: 500 mg every 6 hours
• CrCl: 5-20 ml/min: 250 mg every 6 hours
• CrCl: <5 ml/min: 250 mg every 50-70 hours.

Recommendations for patients on chronic, intermittent haemodialysis:

• 250 mg at the start of haemodialysis
• 250 mg 6 to 12 hours after the start
• 250 mg 36 to 48 hours after the start
• 250 mg at the start of the next haemodialysis session if more than 30 hours have elapsed since the last dose.

Additional Information for all patients Regardless of patient age or weight, higher doses of up to 1 gm four times daily may be required for infections which are chronic or severe. Treatment should continue for at least 2 to 3 days after symptoms have resolved or bacteria have been eradicated. To reduce the possibility of rheumatic fever or glomerulonephritis resulting from infections with haemolytic streptococci, treatment should be continued for at least 10 days. Throughout treatment of chronic urinary tract infections and for several months thereafter, regular bacteriological and clinical monitoring is required.

Doses below those recommended above should not be prescribed. Paediatric dosages should not exceed those specified for adults, regardless of severity of infection. It may be necessary to continue Cephradine therapy for several weeks in persistent infections. Patients may be transferred from intramuscular/intravenous Cephradine therapy to oral treatment at the same dosage level.

The symptoms of Sefrad overdose are non-specific and are generally nausea, vomiting, diarrhoea and gastric upsets. Treatment is mainly supportive although gastric lavage will be necessary if a large amount has been ingested.

Cephradine Suspension should be freshly prepared. Reconstituted Suspension should be used within 7 days if kept at room temperature or within 14 days, if kept in a refrigerator. Cephradine Injection solutions should be used within 2 hours when kept at room temperature. When stored at 5°C, solutions retain potency for 12 hours. Reconstituted solutions may vary in colour from light to straw yellow; however, this does not affect the potency. Do not use later than the date of expiry. Keep all medicines out of the reach of children. To be dispensed only on the prescription of a registered physician

Nitrofurantoin is specifically indicated for the treatment & prophylaxis of urinary tract infections caused by susceptible strains of Escherichia coli, Enterococci, Staphylococcus aureus, Staphylococcus saprophyticus and certain susceptible strains of Klebsiella and Enterobacter species.

Systemic Urinary Anti- infective

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. Nitrofurantoin inactivates or alters bacterial ribosomal proteins and other macromolecules. Nitrofurantoin has been shown to be active against the following bacteria: Gram-Positive Aerobes Staphylococcus saprophyticus, Coagulase-negative staphylococci (including Staphylococcus epidermidis), Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Group D streptococci, Viridans group streptococci. Gram-Negative Aerobes- Escherichia coli, Citrobacter amalonaticus, Citrobacter diversus, Citrobacter freundii, Klebsiella oxytoca, Klebsiella ozaenae.

Nitrofurantoin tablet (In adults):

• Uncomplicated urinary tract infections: 50-100 mg four times a day- the lower dosage level is recommended. Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained.
• For long-term suppressive therapy: In adults, a reduction of dosage to 50-100 mg at bedtime may be adequate.

Nitrofurantoin capsule (In adults):

• Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for 7 days.
• Long term suppression: 50-100 mg once a day.
• Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

Nitrofurantoin SR capsule:

• Adults and Children over 12 years: One 100 mg capsule every 12 hours for seven days.
• Genito-urinary surgical prophylaxis: One capsule twice daily on day of procedure and for next 3 days.

Nitrofurantoin suspension: Children: 5-7 mg/kg/day in four divided doses (contraindicated under one month of age). The average dose of Nintoin suspension for pediatric patients are as follows-

• 7 to 11 kg: ½ (2.5 ml) teaspoonfuls 4 times daily.
• 12 to 21 kg: 1 (5 ml) teaspoonfuls 4 times daily.
• 22 to 30 kg: 1½ (7.5 ml) teaspoonfuls 4 times daily.
• 31 to 41 kg: 2 (10 ml) teaspoonfuls 4 times daily.

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. For long-term suppressive therapy in children, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate.

Nitrofurantoin should be taken with food.

The most frequent clinical adverse events are nausea, headache, and flatulence. Other less occurred adverse events are diarrhea, dyspepsia, abdominal pain, constipation, emesis, dizziness and drowsiness.

Anuria, oliguria or significant impairment of renal function are contraindications. This drug is contraindicated in pregnant patients at 38-42 weeks, during labor and delivery. Nitrofurantoin is also contraindicated in those patients with known hypersensitivity to Nitrofurantoin.

If acute, sub-acute or chronic pulmonary reactions occur, Nitrofurantoin should be discontinued. Antacid preparations containing magnesium trisilicate should not be taken while taking Nitrofurantoin.

Antacids containing Magnesium Trisilicate, when administered concomitantly with Nitrofurantoin, reduce both the rate and extent of absorption of Uricosuric drugs, such as Probenecid and Sulfinpyrazone, can inhibit renal tubular secretion of Nitrofurantoin.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from Nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Occasional incidents of acute overdosage of Nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended.

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

Nitrofurantoin is specifically indicated for the treatment & prophylaxis of urinary tract infections caused by susceptible strains of Escherichia coli, Enterococci, Staphylococcus aureus, Staphylococcus saprophyticus and certain susceptible strains of Klebsiella and Enterobacter species.

Systemic Urinary Anti- infective

Nitrofurantoin is an antibacterial agent specific for urinary tract infections. Nitrofurantoin is highly soluble in urine, to which it may impart a brown color. Nitrofurantoin inactivates or alters bacterial ribosomal proteins and other macromolecules. Nitrofurantoin has been shown to be active against the following bacteria: Gram-Positive Aerobes Staphylococcus saprophyticus, Coagulase-negative staphylococci (including Staphylococcus epidermidis), Enterococcus faecalis, Staphylococcus aureus, Streptococcus agalactiae, Group D streptococci, Viridans group streptococci. Gram-Negative Aerobes- Escherichia coli, Citrobacter amalonaticus, Citrobacter diversus, Citrobacter freundii, Klebsiella oxytoca, Klebsiella ozaenae.

Nitrofurantoin tablet (In adults):

• Uncomplicated urinary tract infections: 50-100 mg four times a day- the lower dosage level is recommended. Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained.
• For long-term suppressive therapy: In adults, a reduction of dosage to 50-100 mg at bedtime may be adequate.

Nitrofurantoin capsule (In adults):

• Acute Uncomplicated Urinary Tract Infections (UTIs): 50 mg four times daily for 7 days.
• Long term suppression: 50-100 mg once a day.
• Prophylaxis: 50 mg four times daily for the duration of procedure and for three days thereafter.

Nitrofurantoin SR capsule:

• Adults and Children over 12 years: One 100 mg capsule every 12 hours for seven days.
• Genito-urinary surgical prophylaxis: One capsule twice daily on day of procedure and for next 3 days.

Nitrofurantoin suspension: Children: 5-7 mg/kg/day in four divided doses (contraindicated under one month of age). The average dose of Nintoin suspension for pediatric patients are as follows-

• 7 to 11 kg: ½ (2.5 ml) teaspoonfuls 4 times daily.
• 12 to 21 kg: 1 (5 ml) teaspoonfuls 4 times daily.
• 22 to 30 kg: 1½ (7.5 ml) teaspoonfuls 4 times daily.
• 31 to 41 kg: 2 (10 ml) teaspoonfuls 4 times daily.

Therapy should be continued for one week or for at least 3 days after sterility of the urine is obtained. For long-term suppressive therapy in children, doses as low as 1 mg/kg per 24 hours, given in a single dose or in two divided doses, may be adequate.

Nitrofurantoin should be taken with food.

The most frequent clinical adverse events are nausea, headache, and flatulence. Other less occurred adverse events are diarrhea, dyspepsia, abdominal pain, constipation, emesis, dizziness and drowsiness.

Anuria, oliguria or significant impairment of renal function are contraindications. This drug is contraindicated in pregnant patients at 38-42 weeks, during labor and delivery. Nitrofurantoin is also contraindicated in those patients with known hypersensitivity to Nitrofurantoin.

If acute, sub-acute or chronic pulmonary reactions occur, Nitrofurantoin should be discontinued. Antacid preparations containing magnesium trisilicate should not be taken while taking Nitrofurantoin.

Antacids containing Magnesium Trisilicate, when administered concomitantly with Nitrofurantoin, reduce both the rate and extent of absorption of Uricosuric drugs, such as Probenecid and Sulfinpyrazone, can inhibit renal tubular secretion of Nitrofurantoin.

Pregnancy Category B. There are no adequate and well-controlled studies in pregnant women. This drug should be used during pregnancy only if clearly needed. Nitrofurantoin has been detected in human breast milk in trace amounts. Because of the potential for serious adverse reactions from Nitrofurantoin in nursing infants under one month of age, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Occasional incidents of acute overdosage of Nitrofurantoin have not resulted in any specific symptoms other than vomiting. Induction of emesis is recommended.

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