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Risperidone tablet is indicated for the treatment of-

• Acute and chronic psychoses
• Mania
• Schizophrenia

Atypical neuroleptic drugs

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT₂ and dopaminergic D₂ receptors. Risperidone binds also to alpha₁ adrenergic receptors and with lower affinity, to H₁ histamine and alpha₂ adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D₂ antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1-2 divided doses on 1^st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
• Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
• Child under 15 years not recommended.

Mania:

• Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Risperidone is contraindicated in patients with a known hypersensitivity to the product.

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.

Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.

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

Risperidone tablet is indicated for the treatment of-

• Acute and chronic psychoses
• Mania
• Schizophrenia

Atypical neuroleptic drugs

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT₂ and dopaminergic D₂ receptors. Risperidone binds also to alpha₁ adrenergic receptors and with lower affinity, to H₁ histamine and alpha₂ adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D₂ antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1-2 divided doses on 1^st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
• Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
• Child under 15 years not recommended.

Mania:

• Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Risperidone is contraindicated in patients with a known hypersensitivity to the product.

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.

Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.

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

Central Depolarizing muscle relaxants, Centrally acting Skeletal Muscle Relaxants

Tolperisone Hydrochloride is a centrally acting muscle relaxant, which acts on the central nervous system and used mainly for the treatment of elevated muscle tone and tension as well as for certain circulation problems in the extremities.

The recommended dose is as follows:

• Adult: 50-150 mg three times daily according to the individual requirement and tolerance of the patient.
• Children (from 3 months to 6 years): 5 mg/kg/day in three divided doses.
• Children (from 6 to 14 years): 2-4 mg/kg/day in three divided doses. or, as directed by the registered physician.

Possible side-effects include sometimes muscular weakness, headache, nausea, vomiting and rarely hypersensitivity reactions (itching, redness of the skin, skin rash) may occur.

It is contraindicated in patients with a history of hypersensitivity to any component of the product, myasthenia gravis and nursing mother.

In case of children, the prescribed dose and duration of treatment should closely be observed.

Concomitant use of methocarbamol with Tolperisone Hydrochloride has been reported to cause disturbance of visual accommodation.

Tolperisone Hydrochloride should be used in pregnancy according to the physician's advice. It should not be used during breast feeding.

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

Bisphosphonate preparations

Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronat inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption.

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures: The recommended dose is Risedronate Sodium 5 mg once daily or Risedronate Sodium 35 mg once weekly on the same day each week or Risedronate Sodium 150 mg once monthly. 

Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis: The recommended dose is Risedronate Sodium 5 mg once daily. 

To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months): Systemic corticosteroid treatment at doses 7.5 mg/day prednisone or equivalent. The recommended dose is Risedronate Sodium 5 mg once daily. 

Treatment of osteoporosis in men at high risk of fractures: The recommended dose is Risedronate Sodium 35 mg once weekly. The tablet should be taken on the same day each week.

The absorption of Risedronate Sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate tablets at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instances that before breakfast dosing is not practical, Risedronate 5 mg tablet can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Risedronate Sodium tablet is taken on an empty stomach-Between meals:

Risedronate Sodium tablet should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). In the evening:

Risedronate Sodium tablet should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. If a dose is missed: Risedronate 5 mg tablet: If an occasional dose is missed, Risedronate 5 mg tablet can be taken before breakfast, between meals, or in the evening according to the instructions above.

Risedronate 35 mg tablet: Patients should be instructed that if a dose is missed, just take one Risedronate 35 mg tablet on the morning after remember. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.

Risedronate 150 mg tablet: Patient should be instructed that if a dose is missed and the next month’s schedule dose is more than 7 days away, then should take the missed tablet in the morning after the day it is remembered. Patients should then return to taking one tablet once a month normally taken.The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate tablet is to be taken while in an upright position with a glass of plain water (120 ml or more). Patients should not lie down for 30 minutes after taking the tablet. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.

Serious side effects:

• chest pain;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• new or worsening heartburn;
• severe joint, bone, or muscle pain; or
• jaw pain, numbness, or swelling.

Less serious side effects:

• mild heartburn or stomach upset;
• diarrhea, gas,or constipation;
• mild joint or back pain;
• headache.

Risedronate Sodium tablet is contraindicated in patients with known hypersensitivity to Risedronate Sodium and in patients with hypocalcaemia, severe renal impairment (creatinine clearance lower than 30 ml/min), during pregnancy and lactation.

Take special care with Risedronate if you:

• Have low blood calcium (hypocalcemia)
• Cannot sit or stand up for 30 minutes
• Have kidneys that work poorly
• Have an allergy to Risedronate Sodium

Before taking Risedronate talk to doctor if you:

• Are pregnant or may become pregnant. We do not know if Risedronate Sodium can harm your unborn child.
• Are breast-feeding or plan to breast-feed. We do not know if Risedronate Sodium can passthrough your milk and if it can harm your baby.
• Have kidney problems Risedronate Sodium may not be right for you.
• Risedronate sodium is not intended for use in children.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking Risedronate sodium and seek medical advice immediately. If you have stopped treatment due to hypersensitivity reactions you should not re-start therapy with Risedronate sodium.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription specially aspirin or other NSAIDs. Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Risedronate Sodium. If you use these other medicines, do not take them for at least 30 minutes after taking a Risedronate Sodium tablet.

Pregnancy: Risedronate Sodium is meant for use only in postmenopausal women. Therefore, Risedronate Sodium should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.

Breast-feeding: Risedronate Sodium is meant for use only in postmenopausal women. Therefore, breast-feeding women should not take this medicine. If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.

Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (60 years of age or older) compared to younger subjects. This has also been shown in the very elderly, 75 years old and above postmenopausal population. 

Renal impairment: No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of Risedronate Sodium is contra-indicated in patients with severe renal impairment (Creatinine clearance lower than 30ml/min).

Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

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

Bisphosphonate preparations

Risedronate has an affinity for hydroxyapatite crystals in bone and acts as an antiresorptive agent. At the cellular level, Risedronat inhibits osteoclasts. The osteoclasts adhere normally to the bone surface, but show evidence of reduced active resorption.

Treatment of postmenopausal osteoporosis, to reduce the risk of vertebral fractures. Treatment of established postmenopausal osteoporosis, to reduce the risk of hip fractures: The recommended dose is Risedronate Sodium 5 mg once daily or Risedronate Sodium 35 mg once weekly on the same day each week or Risedronate Sodium 150 mg once monthly. 

Prevention of osteoporosis in postmenopausal women with increased risk of osteoporosis: The recommended dose is Risedronate Sodium 5 mg once daily. 

To maintain or increase bone mass in postmenopausal women undergoing long-term (more than 3 months): Systemic corticosteroid treatment at doses 7.5 mg/day prednisone or equivalent. The recommended dose is Risedronate Sodium 5 mg once daily. 

Treatment of osteoporosis in men at high risk of fractures: The recommended dose is Risedronate Sodium 35 mg once weekly. The tablet should be taken on the same day each week.

The absorption of Risedronate Sodium is affected by food, thus to ensure adequate absorption patients should take Risedronate tablets at least 30 minutes before the first food, other medicinal product or drink (other than plain water) of the day. In the particular instances that before breakfast dosing is not practical, Risedronate 5 mg tablet can be taken between meals or in the evening at the same time everyday, with strict adherence to the following instructions, to ensure Risedronate Sodium tablet is taken on an empty stomach-Between meals:

Risedronate Sodium tablet should be taken at least 2 hours before and at least 2 hours after any food, medicinal product or drink (other than plain water). In the evening:

Risedronate Sodium tablet should be taken at least 2 hours after the last food, medicinal product or drink (other than plain water) of the day. If a dose is missed: Risedronate 5 mg tablet: If an occasional dose is missed, Risedronate 5 mg tablet can be taken before breakfast, between meals, or in the evening according to the instructions above.

Risedronate 35 mg tablet: Patients should be instructed that if a dose is missed, just take one Risedronate 35 mg tablet on the morning after remember. Patients should then return to taking one tablet once a week on the day the tablet is normally taken. Two tablets should not be taken on the same day.

Risedronate 150 mg tablet: Patient should be instructed that if a dose is missed and the next month’s schedule dose is more than 7 days away, then should take the missed tablet in the morning after the day it is remembered. Patients should then return to taking one tablet once a month normally taken.The tablet must be swallowed whole and not sucked or chewed. To aid delivery of the tablet to the stomach Risedronate tablet is to be taken while in an upright position with a glass of plain water (120 ml or more). Patients should not lie down for 30 minutes after taking the tablet. Supplemental calcium and vitamin D should be considered if the dietary intake is inadequate.

Serious side effects:

• chest pain;
• difficulty or pain when swallowing;
• pain or burning under the ribs or in the back;
• new or worsening heartburn;
• severe joint, bone, or muscle pain; or
• jaw pain, numbness, or swelling.

Less serious side effects:

• mild heartburn or stomach upset;
• diarrhea, gas,or constipation;
• mild joint or back pain;
• headache.

Risedronate Sodium tablet is contraindicated in patients with known hypersensitivity to Risedronate Sodium and in patients with hypocalcaemia, severe renal impairment (creatinine clearance lower than 30 ml/min), during pregnancy and lactation.

Take special care with Risedronate if you:

• Have low blood calcium (hypocalcemia)
• Cannot sit or stand up for 30 minutes
• Have kidneys that work poorly
• Have an allergy to Risedronate Sodium

Before taking Risedronate talk to doctor if you:

• Are pregnant or may become pregnant. We do not know if Risedronate Sodium can harm your unborn child.
• Are breast-feeding or plan to breast-feed. We do not know if Risedronate Sodium can passthrough your milk and if it can harm your baby.
• Have kidney problems Risedronate Sodium may not be right for you.
• Risedronate sodium is not intended for use in children.

During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), you must stop taking Risedronate sodium and seek medical advice immediately. If you have stopped treatment due to hypersensitivity reactions you should not re-start therapy with Risedronate sodium.

Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription specially aspirin or other NSAIDs. Antacids, supplements, or medicines that contain aluminum, calcium, magnesium, or other minerals can interfere with how your body absorbs Risedronate Sodium. If you use these other medicines, do not take them for at least 30 minutes after taking a Risedronate Sodium tablet.

Pregnancy: Risedronate Sodium is meant for use only in postmenopausal women. Therefore, Risedronate Sodium should not be taken during pregnancy. If you take it by accident during pregnancy, stop taking it straight away and talk to your doctor.

Breast-feeding: Risedronate Sodium is meant for use only in postmenopausal women. Therefore, breast-feeding women should not take this medicine. If you take it by accident during breast-feeding, stop taking it straight away and talk to your doctor.

Elderly: No dosage adjustment is necessary since bioavailability, distribution and elimination were similar in elderly (60 years of age or older) compared to younger subjects. This has also been shown in the very elderly, 75 years old and above postmenopausal population. 

Renal impairment: No dosage adjustment is required for those patients with mild to moderate renal impairment. The use of Risedronate Sodium is contra-indicated in patients with severe renal impairment (Creatinine clearance lower than 30ml/min).

Seek emergency medical attention if you think you have used too much of this medicine. Drink a full glass of milk right away. Do not make yourself vomit and do not lie down.

Overdose symptoms may include nausea, heartburn, stomach pain, diarrhea, muscle cramps, numbness or tingling, tight muscles in your face, seizure (convulsions), irritability, and unusual thoughts or behavior.

Store in a cool and dry place. Protect from light & moisture. 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.

Risperidone injection is an atypical antipsychotic indicated:

• For the treatment of schizophrenia.
• As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder.

Atypical neuroleptic drugs

The mechanism of action of risperidone in schizophrenia is unclear. The drug’s therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major active metabolite, 9-hydroxyrisperidone (paliperidone). Antagonism at receptors other than D2 and 5HT 2 may explain some of the other effects of risperidone

For patients who have never taken oral Risperidone, tolerability should be established with oral Risperidone prior to initiating treatment with Risperidone.

Administer by deep intramuscular (IM) deltoid or gluteal injection. Each injection should be administered by a health care professional using the appropriate enclosed safety needle (1-inch for deltoid administration alternating injections between the two arms and 2-inch for gluteal administration alternating injections between the two buttocks). Do not administer intravenously.

25 mg intramuscular (IM) every 2 weeks. Patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg every 2 weeks.

Oral Risperidone (or another antipsychotic medication) should be given with the first injection of Risperidone, and continued for 3 weeks (and then discontinued) to ensure adequate thera peutic plasma concentrations from Risperidone

Upward dose adjustment of Risperidone should not be made more frequently than every 4 weeks. Clinical effects of each upward dose adjustment should not be anticipated earlier than 3 weeks after injection.

Avoid inadvertent administration into a blood vessel.

Known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperidone

Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Risperidone

Lactation: Advise breastfeeding women using Risperidone to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs

Renal or Hepatic Impairment: dose appropriately with oral Risperidone prior to initiating treatment with Risperidone. A lower starting dose of Risperidone of 12.5 mg may be appropriate in some patients.

Pediatric Use: safety and effectiveness not established in patients less than 18 years of age.

Elderly: dosing for otherwise healthy elderly patients is the same as for healthy nonelderly. Elderly may be more predisposed to orthostatic effects than nonelderly.

The entire dose pack should be stored in the refrigerator (2°-8°C) and protected from light. Keep out of reach of children.

Risperidone injection is an atypical antipsychotic indicated:

• For the treatment of schizophrenia.
• As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder.

Atypical neuroleptic drugs

The mechanism of action of risperidone in schizophrenia is unclear. The drug’s therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major active metabolite, 9-hydroxyrisperidone (paliperidone). Antagonism at receptors other than D2 and 5HT 2 may explain some of the other effects of risperidone

For patients who have never taken oral Risperidone, tolerability should be established with oral Risperidone prior to initiating treatment with Risperidone.

Administer by deep intramuscular (IM) deltoid or gluteal injection. Each injection should be administered by a health care professional using the appropriate enclosed safety needle (1-inch for deltoid administration alternating injections between the two arms and 2-inch for gluteal administration alternating injections between the two buttocks). Do not administer intravenously.

25 mg intramuscular (IM) every 2 weeks. Patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg every 2 weeks.

Oral Risperidone (or another antipsychotic medication) should be given with the first injection of Risperidone, and continued for 3 weeks (and then discontinued) to ensure adequate thera peutic plasma concentrations from Risperidone

Upward dose adjustment of Risperidone should not be made more frequently than every 4 weeks. Clinical effects of each upward dose adjustment should not be anticipated earlier than 3 weeks after injection.

Avoid inadvertent administration into a blood vessel.

Known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperidone

Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Risperidone

Lactation: Advise breastfeeding women using Risperidone to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs

Renal or Hepatic Impairment: dose appropriately with oral Risperidone prior to initiating treatment with Risperidone. A lower starting dose of Risperidone of 12.5 mg may be appropriate in some patients.

Pediatric Use: safety and effectiveness not established in patients less than 18 years of age.

Elderly: dosing for otherwise healthy elderly patients is the same as for healthy nonelderly. Elderly may be more predisposed to orthostatic effects than nonelderly.

The entire dose pack should be stored in the refrigerator (2°-8°C) and protected from light. Keep out of reach of children.

Risperidone injection is an atypical antipsychotic indicated:

• For the treatment of schizophrenia.
• As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of Bipolar I Disorder.

Atypical neuroleptic drugs

The mechanism of action of risperidone in schizophrenia is unclear. The drug’s therapeutic activity in schizophrenia could be mediated through a combination of dopamine Type 2 (D2) and serotonin Type 2 (5HT2) receptor antagonism. The clinical effect from risperidone results from the combined concentrations of risperidone and its major active metabolite, 9-hydroxyrisperidone (paliperidone). Antagonism at receptors other than D2 and 5HT 2 may explain some of the other effects of risperidone

For patients who have never taken oral Risperidone, tolerability should be established with oral Risperidone prior to initiating treatment with Risperidone.

Administer by deep intramuscular (IM) deltoid or gluteal injection. Each injection should be administered by a health care professional using the appropriate enclosed safety needle (1-inch for deltoid administration alternating injections between the two arms and 2-inch for gluteal administration alternating injections between the two buttocks). Do not administer intravenously.

25 mg intramuscular (IM) every 2 weeks. Patients not responding to 25 mg may benefit from a higher dose of 37.5 mg or 50 mg. The maximum dose should not exceed 50 mg every 2 weeks.

Oral Risperidone (or another antipsychotic medication) should be given with the first injection of Risperidone, and continued for 3 weeks (and then discontinued) to ensure adequate thera peutic plasma concentrations from Risperidone

Upward dose adjustment of Risperidone should not be made more frequently than every 4 weeks. Clinical effects of each upward dose adjustment should not be anticipated earlier than 3 weeks after injection.

Avoid inadvertent administration into a blood vessel.

Known hypersensitivity to risperidone, paliperidone, or to any excipients in Risperidone

Pregnancy: Advise patients to notify their healthcare provider if they become pregnant or intend to become pregnant during treatment with Risperidone

Lactation: Advise breastfeeding women using Risperidone to monitor infants for somnolence, failure to thrive, jitteriness, and extrapyramidal symptoms (tremors and abnormal muscle movements) and to seek medical care if they notice these signs

Renal or Hepatic Impairment: dose appropriately with oral Risperidone prior to initiating treatment with Risperidone. A lower starting dose of Risperidone of 12.5 mg may be appropriate in some patients.

Pediatric Use: safety and effectiveness not established in patients less than 18 years of age.

Elderly: dosing for otherwise healthy elderly patients is the same as for healthy nonelderly. Elderly may be more predisposed to orthostatic effects than nonelderly.

The entire dose pack should be stored in the refrigerator (2°-8°C) and protected from light. Keep out of reach of children.

Risperidone tablet is indicated for the treatment of-

• Acute and chronic psychoses
• Mania
• Schizophrenia

Atypical neuroleptic drugs

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT₂ and dopaminergic D₂ receptors. Risperidone binds also to alpha₁ adrenergic receptors and with lower affinity, to H₁ histamine and alpha₂ adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D₂ antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1-2 divided doses on 1^st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
• Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
• Child under 15 years not recommended.

Mania:

• Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Risperidone is contraindicated in patients with a known hypersensitivity to the product.

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.

Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.

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

Risperidone tablet is indicated for the treatment of-

• Acute and chronic psychoses
• Mania
• Schizophrenia

Atypical neuroleptic drugs

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT₂ and dopaminergic D₂ receptors. Risperidone binds also to alpha₁ adrenergic receptors and with lower affinity, to H₁ histamine and alpha₂ adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D₂ antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1-2 divided doses on 1^st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
• Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
• Child under 15 years not recommended.

Mania:

• Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Risperidone is contraindicated in patients with a known hypersensitivity to the product.

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.

Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.

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

Risperidone tablet is indicated for the treatment of-

• Acute and chronic psychoses
• Mania
• Schizophrenia

Atypical neuroleptic drugs

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT₂ and dopaminergic D₂ receptors. Risperidone binds also to alpha₁ adrenergic receptors and with lower affinity, to H₁ histamine and alpha₂ adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D₂ antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1-2 divided doses on 1^st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
• Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
• Child under 15 years not recommended.

Mania:

• Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Risperidone is contraindicated in patients with a known hypersensitivity to the product.

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.

Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.

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

Risperidone tablet is indicated for the treatment of-

• Acute and chronic psychoses
• Mania
• Schizophrenia

Atypical neuroleptic drugs

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT₂ and dopaminergic D₂ receptors. Risperidone binds also to alpha₁ adrenergic receptors and with lower affinity, to H₁ histamine and alpha₂ adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D₂ antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1-2 divided doses on 1^st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
• Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
• Child under 15 years not recommended.

Mania:

• Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Risperidone is contraindicated in patients with a known hypersensitivity to the product.

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.

Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.

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

Risperidone tablet is indicated for the treatment of-

• Acute and chronic psychoses
• Mania
• Schizophrenia

Atypical neuroleptic drugs

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT₂ and dopaminergic D₂ receptors. Risperidone binds also to alpha₁ adrenergic receptors and with lower affinity, to H₁ histamine and alpha₂ adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D₂ antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1-2 divided doses on 1^st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
• Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
• Child under 15 years not recommended.

Mania:

• Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Risperidone is contraindicated in patients with a known hypersensitivity to the product.

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.

Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.

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

Risperidone tablet is indicated for the treatment of-

• Acute and chronic psychoses
• Mania
• Schizophrenia

Atypical neuroleptic drugs

Risperidone is a selective monoaminergic antagonist having a high affinity for serotoninergic 5-HT₂ and dopaminergic D₂ receptors. Risperidone binds also to alpha₁ adrenergic receptors and with lower affinity, to H₁ histamine and alpha₂ adrenergic receptors. Risperidone has no affinity for 8 cholinergic receptors. Risperidone, as a potent D₂ antagonist, improves the positive symptoms of schizophrenia but causes less depression of motor activity. Balanced central serotonin and dopamine antagonism may reduce extrapyramidal side effect liability and extend the therapeutic activity to the negative and affective symptoms of schizophrenia.

Psychoses:

• 2 mg in 1-2 divided doses on 1^st day then 4 mg in 1-2 divided doses on second day (Slower titration appropriate in some patients);
• Usual dose range 4-6 mg daily; doses above 10 mg daily only if benefit considered to outweigh risk (max. 16 mg daily).
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.
• Child under 15 years not recommended.

Mania:

• Initially, 2 mg once daily increased if necessary in step of 1 mg daily; usual dose range 1-6 mg daily;
• Elderly (or in hepatic or renal impairment) initially 1 mg daily in two divided doses increased in steps of 1-2 mg twice daily.

Schizophrenia:

• Risperidone should be generally administered at 1 mg BID initially, with increases in increments of 1 mg BID on the second and third day, as tolerated, to a target dose of 3 mg BID by the third day.
• Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week. When dosage adjustments are necessary, small dose increments/decrements of 1-2 mg are recommended.

Insomnia, agitation, anxiety, headache, less commonly drowsiness, impaired concentration, fatigue, blurred vision, constipation, nausea and vomiting, dyspepsia, abdominal pain, hyperprolactinaemia, urine incontinence, tachycardia, hypertension, edema, rash, rhinitis, cerebrovascular accident, neurtropenia and thrombocytopenia have been reported.

Risperidone is contraindicated in patients with a known hypersensitivity to the product.

Special precaution should be taken in case of preexisting cardiovascular diseases, discontinue use if signs and symptoms of tardive dyskinesia occur, renal and hepatic impairment, elderly epilepsy, Parkinson's disease and in pregnancy.

Risperidone May antagonize the effects of levodopa and dopamine agonists. Chronic administration with Carbamazepine reduces plasma clearance of Risperidone. Chronic administration with Clozapine may decrease the clearance of Risperidone. Risperidone may enhance the effects of certain antihypertensives.

Although, in experimental animals, Risperidone did not show direct reproductive toxicity, some indirect, prolactin- and CNS-mediated effects were observed, No teratogenicity effect of Risperidone was noted in any study. The safety of Risperidone for use during human pregnancy has not been established. In animal studies, Risperidone and 9-hydroxyrisperidone are excreted in the milk. It has been demonstrated that Risperidone and 9-hydroxyrisperidone are also excreted in human breast milk. Therefore, women receiving Risperidone should not breastfeed.

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

Third generation Cephalosporins

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

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

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

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

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

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

Preparation of Solutions for Intramuscular / Intravenous Injections:

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

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

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

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

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

No drug interactions have been reported.

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

Preparation of Solutions for Intramuscular / Intravenous Injections:

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

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

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

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

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

No drug interactions have been reported.

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

Preparation of Solutions for Intramuscular / Intravenous Injections:

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

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

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

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

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

No drug interactions have been reported.

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

Preparation of Solutions for Intramuscular / Intravenous Injections:

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

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

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

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

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

No drug interactions have been reported.

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

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

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

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

Third generation Cephalosporins

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

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

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

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

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

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

Preparation of Solutions for Intramuscular / Intravenous Injections:

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

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

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

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

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

No drug interactions have been reported.

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

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

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

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