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This preparation temporarily relieves these symptoms due to common cold, hay fever (allergic rhinitis) or other upper respiratory allergies:

• Non-productive cough due to minor throat or bronchial irritation
• Runny Nose
• Sneezing
• Itching of the nose or throat
• Itchy & watery eyes
• Nasal congestion

Combined cough suppressants

This preparation is a mixture of antitussive, decongestant and antihistamine agent. Dextromethorphan is a safe, effective, non-narcotic antitussive agent which has a central action on the cough centre in the medulla. Although structurally related to Morphine, it has no analgesic and habit forming properties and in general it has little sedative activity. Phenylephrine is a decongestant that shrinks blood vessels in the nasal passage. Phenylephrine is used for the temporary relief of stuffy nose, sinus, and ear symptoms caused by the common cold, flu, allergies, sinusitis & bronchitis. This medication works by decreasing swelling in the nose and ears, thereby lessening discomfort and making it easier to breathe. Triprolidine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, watery eyes, itchy eyes/nose/throat/skin, cough, runny nose, and sneezing. It is a potent competitive histamine H1-receptor antagonist of the pyrrolidine class with mild central nervous system depressant properties which may cause drowsiness. By antagonizing another natural substance acetylcholine, it helps dry up some body fluids to relieve symptoms such as watery eyes and runny nose.

Adults & Children over 12 years: 1 teaspoonful (5 ml) 4 times a day every 4 hours interval.

6-12 years: 1/2 teaspoonful 4 times a day every 4 hours interval.

Use in children and adolescents: A physician's advice should be obtained before administering this combination to children less than 6 years.

It may cause drowsiness and constipation. Other side effects that may occur include GIT discomfort. No apparent evidence of physical dependence of the morphine type.

It should be avoided in patients with liver disease or asthmatic patients and is contraindicated in patients taking monoamine oxidase inhibitors or within 2 weeks from stopping such treatment

This preparation may cause drowsiness. If affected, do not drive motor vehicle or operate machinery. Avoid alcoholic drink while on this medication. Use with caution in patients with epilepsy, prostatic hypertrophy, glaucoma, hepatic disease, hypertension, heart disease, diabetes, hyperthyroidism. If symptoms do not improve within one week or accompanied with high fever, consult a physician before continuing use.

Taking certain MAO inhibitors with this medication may cause a serious (possibly fatal) drug interaction. Avoid taking isocarboxazid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, or tranylcypromine during treatment with this medication. Most MAO inhibitors should also not be taken for two weeks before treatment with this medication.

There are no specific data on use of this combination during pregnancy & lactation.

In cases of over dosage, hospital admission is strongly advised. Over dosage may produce respiratory depression, paranoid psychosis, delusions, hallucinations and convulsion.

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

Non-sedating antihistamines

Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.

Pediatric drops:

• Child 6-11 months of age: 2 ml drops once daily.
• Child 1-2 years of age: 2.5 ml drops once daily.

Syrup:

• Child 6-11 months of age: 2 ml once daily.
• Child 1-5 years of age: 2.5 ml once daily.
• Child 6-11 years of age: 5 ml once daily.
• Adults & >12 years of age: 10 ml once daily.

Tablet:

• Adults and children 12 years of age and over: 1 tablet daily

Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.

Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.

In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.

No clinically relevant drug interactions have been reported.

Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.

Recommended in the use in children & adolescents.

No clinically relevant adverse effects have been reported.

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

Non-sedating antihistamines

Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.

Pediatric drops:

• Child 6-11 months of age: 2 ml drops once daily.
• Child 1-2 years of age: 2.5 ml drops once daily.

Syrup:

• Child 6-11 months of age: 2 ml once daily.
• Child 1-5 years of age: 2.5 ml once daily.
• Child 6-11 years of age: 5 ml once daily.
• Adults & >12 years of age: 10 ml once daily.

Tablet:

• Adults and children 12 years of age and over: 1 tablet daily

Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.

Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.

In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.

No clinically relevant drug interactions have been reported.

Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.

Recommended in the use in children & adolescents.

No clinically relevant adverse effects have been reported.

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

Non-sedating antihistamines

Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.

Pediatric drops:

• Child 6-11 months of age: 2 ml drops once daily.
• Child 1-2 years of age: 2.5 ml drops once daily.

Syrup:

• Child 6-11 months of age: 2 ml once daily.
• Child 1-5 years of age: 2.5 ml once daily.
• Child 6-11 years of age: 5 ml once daily.
• Adults & >12 years of age: 10 ml once daily.

Tablet:

• Adults and children 12 years of age and over: 1 tablet daily

Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.

Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.

In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.

No clinically relevant drug interactions have been reported.

Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.

Recommended in the use in children & adolescents.

No clinically relevant adverse effects have been reported.

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

Non-sedating antihistamines

Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.

Pediatric drops:

• Child 6-11 months of age: 2 ml drops once daily.
• Child 1-2 years of age: 2.5 ml drops once daily.

Syrup:

• Child 6-11 months of age: 2 ml once daily.
• Child 1-5 years of age: 2.5 ml once daily.
• Child 6-11 years of age: 5 ml once daily.
• Adults & >12 years of age: 10 ml once daily.

Tablet:

• Adults and children 12 years of age and over: 1 tablet daily

Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.

Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.

In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.

No clinically relevant drug interactions have been reported.

Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.

Recommended in the use in children & adolescents.

No clinically relevant adverse effects have been reported.

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

Non-sedating antihistamines

Desloratadine, the major active metabolite of Loratadine, is a non-sedating; long acting tricyclic histamine antagonist with selective H1-receptor histamine antagonist activity. Desloratadine also inhibits histamine release from human mast cell.

Pediatric drops:

• Child 6-11 months of age: 2 ml drops once daily.
• Child 1-2 years of age: 2.5 ml drops once daily.

Syrup:

• Child 6-11 months of age: 2 ml once daily.
• Child 1-5 years of age: 2.5 ml once daily.
• Child 6-11 years of age: 5 ml once daily.
• Adults & >12 years of age: 10 ml once daily.

Tablet:

• Adults and children 12 years of age and over: 1 tablet daily

Less common side effects may include headache, nausea, fatigue, dizziness, pharyngitis, dyspepsia and myalgia.

Desloratadine is contraindicated in patients having hypersensitivity to this medication or to any of its ingredients or Loratadine.

In adult patients with liver or renal impairment: A starting dose of one 5 mg tablet every other day is recommended based on pharmacokinetic data. If the patient has medical or familial history of seizures.

No clinically relevant drug interactions have been reported.

Pregnancy Category C. The safe use of Desloratadine during pregnancy has not been established. Therefore, Desloratadine is not to be used during pregnancy unless clearly indicated. Desloratadine passes into breast milk, therefore a decision should be made whether to discontinue nursing or to discontinue Desloratadine taking into account the importance of the drug to the mother.

Recommended in the use in children & adolescents.

No clinically relevant adverse effects have been reported.

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

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

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

Serotonin-norepinephrine reuptake inhibitor (SNRI)

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

Major Depressive Disorder (MDD)-

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

Generalized Anxiety Disorder (GAD)-

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

Diabetic Peripheral Neuropathic Pain (DPNP)-

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

Fibromyalgia-

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

Chronic Musculoskeletal Pain-

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Serotonin-norepinephrine reuptake inhibitor (SNRI)

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

Major Depressive Disorder (MDD)-

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

Generalized Anxiety Disorder (GAD)-

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

Diabetic Peripheral Neuropathic Pain (DPNP)-

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

Fibromyalgia-

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

Chronic Musculoskeletal Pain-

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

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

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

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

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

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

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

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

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

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

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

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

Trihexyphenidyl Hydrochloride is indicated as an adjunct treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic & idiopathic). Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as dibenzoxazepines, phenothiazines, thioxanthenes & butyrophenones.

Antiparkinson drugs

Trihexyphenidyl is a non-selective muscarinic acetylcholine receptor antagonist but binds with higher affinity to the M1 subtype. In vivo studies have shown that trihexyphenidyl demonstrates higher affinity for central muscarinic receptors located in the cerebral cortex and lower affinity for those located peripherally. Other studies suggest that trihexyphenidyl may modify nicotinic acetylcholine receptor neurotransmission, leading indirectly to enhanced dopamine release in the striatum. Although the anticholinergic has proven to be useful in the treatment of symptoms associated with Parkinson’s disease or other movement disorders, its mechanism of action has yet to be fully elucidated.

Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether Trihexyphenidyl may best be given before or after meals should be determined by the way the patient reacts.

Idiopathic Parkinsonism: 1 mg of Trihexyphenidyl may be administered the first day. The dose may then be increased by 2mg increments at intervals of three to five days.

Drug-Induced Parkinsonism: Commence therapy with a single 1 mg dose increase the total daily dosage to 5-15 mg range if the extrapyramidal manifestations are not controlled.

Concomitant Use with Levodopa: When Trihexyphenidyl is used concomitantly with levodopa, the usual dose is 3-6 mg daily.

Minor side effects such as dryness of the mouth, blurring of vision, dizziness, mild nausea or nervousness. Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Potential side effects are constipation, drowsiness, urinary hesitancy or retention, pupil dilation, increased intraocular tension, vomiting and headache.

Contraindicated in patients with hypersensitivity to Trihexyphenidyl HCI or to any of the tablet or elixir ingredients. Trihexyphenidyl is also contraindicated in patients with narrow angle glaucoma. Blindness after long-term use due to narrow angle glaucoma has been reported.

Patients with cardiac, liver, or kidney disorders, or with hypertensioon, should closely be monitored. Since Trihexyphenidyl HCI has parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy. Trihexyphenidyl is not recommended for use in patients with tardive dyskinesia unless they have concomitant Parkinson’s disease. Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided.

Cannabinoids, barbiturates, opiates, and alcohol may have additive effects with Trihexyphenidyl, and thus, an abuse potential exists. Concurrent use of alcohol or other CNS depressants with Trihexyphenidyl may cause increased sedative effects. It may be contraindicated in patients taking monoamine oxidase inhibitors & tricycllic antidepressants.

Pregnancy Category C. It is not known whether the drug is excreted in human milk and therefore Trihexyphenidyl should only be used if the expected benefit to the mother outweighs the potential risk to the infant.

Overdosage with Trihexyphenidyl produces typical central symptoms of atropine intoxication (the central anticholinergic syndrome). Signs & symptoms are: dilated and sluggish pupils, warm, dry skin, facial flushing, decreased secretions of mouth, pharynx, nose and bronchi, foul smelling breath, tachycardia etc. Neuropsychiatric signs such as delirium, disorientation, anxiety, hallucinations etc. The condition can progress to stupor, coma, paralysis, cardiac, respiratory arrest and death.

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

Trihexyphenidyl Hydrochloride is indicated as an adjunct treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic & idiopathic). Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as dibenzoxazepines, phenothiazines, thioxanthenes & butyrophenones.

Antiparkinson drugs

Trihexyphenidyl is a non-selective muscarinic acetylcholine receptor antagonist but binds with higher affinity to the M1 subtype. In vivo studies have shown that trihexyphenidyl demonstrates higher affinity for central muscarinic receptors located in the cerebral cortex and lower affinity for those located peripherally. Other studies suggest that trihexyphenidyl may modify nicotinic acetylcholine receptor neurotransmission, leading indirectly to enhanced dopamine release in the striatum. Although the anticholinergic has proven to be useful in the treatment of symptoms associated with Parkinson’s disease or other movement disorders, its mechanism of action has yet to be fully elucidated.

Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether Trihexyphenidyl may best be given before or after meals should be determined by the way the patient reacts.

Idiopathic Parkinsonism: 1 mg of Trihexyphenidyl may be administered the first day. The dose may then be increased by 2mg increments at intervals of three to five days.

Drug-Induced Parkinsonism: Commence therapy with a single 1 mg dose increase the total daily dosage to 5-15 mg range if the extrapyramidal manifestations are not controlled.

Concomitant Use with Levodopa: When Trihexyphenidyl is used concomitantly with levodopa, the usual dose is 3-6 mg daily.

Minor side effects such as dryness of the mouth, blurring of vision, dizziness, mild nausea or nervousness. Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Potential side effects are constipation, drowsiness, urinary hesitancy or retention, pupil dilation, increased intraocular tension, vomiting and headache.

Contraindicated in patients with hypersensitivity to Trihexyphenidyl HCI or to any of the tablet or elixir ingredients. Trihexyphenidyl is also contraindicated in patients with narrow angle glaucoma. Blindness after long-term use due to narrow angle glaucoma has been reported.

Patients with cardiac, liver, or kidney disorders, or with hypertensioon, should closely be monitored. Since Trihexyphenidyl HCI has parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy. Trihexyphenidyl is not recommended for use in patients with tardive dyskinesia unless they have concomitant Parkinson’s disease. Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided.

Cannabinoids, barbiturates, opiates, and alcohol may have additive effects with Trihexyphenidyl, and thus, an abuse potential exists. Concurrent use of alcohol or other CNS depressants with Trihexyphenidyl may cause increased sedative effects. It may be contraindicated in patients taking monoamine oxidase inhibitors & tricycllic antidepressants.

Pregnancy Category C. It is not known whether the drug is excreted in human milk and therefore Trihexyphenidyl should only be used if the expected benefit to the mother outweighs the potential risk to the infant.

Overdosage with Trihexyphenidyl produces typical central symptoms of atropine intoxication (the central anticholinergic syndrome). Signs & symptoms are: dilated and sluggish pupils, warm, dry skin, facial flushing, decreased secretions of mouth, pharynx, nose and bronchi, foul smelling breath, tachycardia etc. Neuropsychiatric signs such as delirium, disorientation, anxiety, hallucinations etc. The condition can progress to stupor, coma, paralysis, cardiac, respiratory arrest and death.

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

Trihexyphenidyl Hydrochloride is indicated as an adjunct treatment of all forms of parkinsonism (postencephalitic, arteriosclerotic & idiopathic). Additionally, it is indicated for the control of extrapyramidal disorders caused by central nervous system drugs such as dibenzoxazepines, phenothiazines, thioxanthenes & butyrophenones.

Antiparkinson drugs

Trihexyphenidyl is a non-selective muscarinic acetylcholine receptor antagonist but binds with higher affinity to the M1 subtype. In vivo studies have shown that trihexyphenidyl demonstrates higher affinity for central muscarinic receptors located in the cerebral cortex and lower affinity for those located peripherally. Other studies suggest that trihexyphenidyl may modify nicotinic acetylcholine receptor neurotransmission, leading indirectly to enhanced dopamine release in the striatum. Although the anticholinergic has proven to be useful in the treatment of symptoms associated with Parkinson’s disease or other movement disorders, its mechanism of action has yet to be fully elucidated.

Dosage should be individualized. The initial dose should be low and then increased gradually, especially in patients over 60 years of age. Whether Trihexyphenidyl may best be given before or after meals should be determined by the way the patient reacts.

Idiopathic Parkinsonism: 1 mg of Trihexyphenidyl may be administered the first day. The dose may then be increased by 2mg increments at intervals of three to five days.

Drug-Induced Parkinsonism: Commence therapy with a single 1 mg dose increase the total daily dosage to 5-15 mg range if the extrapyramidal manifestations are not controlled.

Concomitant Use with Levodopa: When Trihexyphenidyl is used concomitantly with levodopa, the usual dose is 3-6 mg daily.

Minor side effects such as dryness of the mouth, blurring of vision, dizziness, mild nausea or nervousness. Patients with arteriosclerosis or with a history of idiosyncrasy to other drugs may exhibit reactions of mental confusion, agitation, disturbed behavior, or nausea and vomiting. Potential side effects are constipation, drowsiness, urinary hesitancy or retention, pupil dilation, increased intraocular tension, vomiting and headache.

Contraindicated in patients with hypersensitivity to Trihexyphenidyl HCI or to any of the tablet or elixir ingredients. Trihexyphenidyl is also contraindicated in patients with narrow angle glaucoma. Blindness after long-term use due to narrow angle glaucoma has been reported.

Patients with cardiac, liver, or kidney disorders, or with hypertensioon, should closely be monitored. Since Trihexyphenidyl HCI has parasympatholytic activity, it should be used with caution in patients with glaucoma, obstructive disease of the gastrointestinal or genitourinary tracts, and in elderly males with possible prostatic hypertrophy. Trihexyphenidyl is not recommended for use in patients with tardive dyskinesia unless they have concomitant Parkinson’s disease. Abrupt withdrawal of treatment for parkinsonism may result in acute exacerbation of parkinsonism symptoms; therefore, abrupt withdrawal should be avoided.

Cannabinoids, barbiturates, opiates, and alcohol may have additive effects with Trihexyphenidyl, and thus, an abuse potential exists. Concurrent use of alcohol or other CNS depressants with Trihexyphenidyl may cause increased sedative effects. It may be contraindicated in patients taking monoamine oxidase inhibitors & tricycllic antidepressants.

Pregnancy Category C. It is not known whether the drug is excreted in human milk and therefore Trihexyphenidyl should only be used if the expected benefit to the mother outweighs the potential risk to the infant.

Overdosage with Trihexyphenidyl produces typical central symptoms of atropine intoxication (the central anticholinergic syndrome). Signs & symptoms are: dilated and sluggish pupils, warm, dry skin, facial flushing, decreased secretions of mouth, pharynx, nose and bronchi, foul smelling breath, tachycardia etc. Neuropsychiatric signs such as delirium, disorientation, anxiety, hallucinations etc. The condition can progress to stupor, coma, paralysis, cardiac, respiratory arrest and death.

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

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.

Other Anti-anginal & Anti-ischaemic drugs

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

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

Symptomatic treatment of chronic stable angina pectoris in coronary artery disease patients with normal sinus rhythm. Ivabradine is indicated:

• In patients unable to tolerate or with a contra-indication to the use of beta-blockers or
• In combination with beta-blockers in patients inadequately controlled with an optimal beta-blocker dose and whose heart rate is > 60 bpm.

Other Anti-anginal & Anti-ischaemic drugs

Ivabradine is a pure heart rate lowering agent. It acts by selective and specific inhibition of the cardiac pacemaker I f current that controls the spontaneous diastolic depolarization in the sinus node and regulates heart rate. By decreasing heart rate, Ivabradine decreases the cardiac workload and therefore oxygen consumption. Concomitantly, Ivabradine prolongs diastole allowing increased perfusion of coronary arteries and increased oxygen supply to the heart. The cardiac effects are specific to the sinus node with no effect on intra-atrial, atrioventricular or intraventricular conduction times, nor on myocardial contractility or ventricular repolarization.

Adult: The usual recommended starting dose of Ivabradine is 5 mg twice daily which may be increased after 3-4 weeks of treatment to 7.5 mg twice daily, depending on therapeutic response. Usual dose is 1 tablet in the morning and 1 tablet in the evening during meals. If the heart rate decreases persistently below 50 bpm at rest or if symptoms related to bradycardia, the dose must be adjusted downwards to 2.5 mg twice daily (one half of the 5 mg tablet twice daily). Treatment must be discontinued if heart rate remains below 50 bpm or symptoms of bradycardia persist.

Elderly: Consider a lower starting dose (2.5 mg twice daily i.e. one half 5 mg tablet twice daily).

Visual symptoms, blurred vision, bradycardia, 1st degree AV block, ventricular extrasystoles, headaches, and dizziness.

History of hypersensitivity to Ivabradine or any of the excipients, resting heart rate below 60 bpm before treatment, cardiogenic shock, acute myocardial infarction, severe hypotension (<90/50 mmHg), severe hepatic insufficiency, sick sinus syndrome, sino-atrial block, heart failure, pacemaker dependent, unstable angina, 3^rd degree AV block, combination with strong cytochrome P-450 3A4 inhibitors (such as azole antifungals, macrolide antibiotics, HIV protease inhibitors).

Mild to moderate hypotension, atrial fibrillation, patients with congenital QT syndrome or treated with QT wave prolonging medicinal products, Moderate hepatic insufficiency, severe renal insufficiency.

QT wave prolonging medicinal products is not recommended. Cardiovascular QT wave prolonging medicinal products (e.g. quinidine, disopyramide, bepridil, sotalol, ibutilide, amiodarone). Non cardiovascular QT wave prolonging medicinal products (e.g. pimozide, ziprasidone, sertindole, mefloquine, halofantrine, pentamidine, cisapride, intravenous erythromycin). The concomitant use of cardiovascular and non cardiovascular QT wave prolonging medicinal products with ivabradine should be avoided since QT wave prolongation may be exacerbated by heart rate reduction. If the combination appears necessary, close cardiac monitoring is needed.

Studies in rats have shown no effect on fertility in males and females. There are no or limited amount of data from the use of ivabradine in pregnant women. Therefore, ivabradine is contra indicated during pregnancy. Animal studies indicate that ivabradine is excreted in milk. Therefore, ivabradine is contra-indicated during breast-feeding.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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

Glucocorticoids

Prednisolone is a synthetic adrenocortical drug with predominantly glucocorticoid properties. Prednisolone directly inhibits the action of the Phospholipase A2 enzyme which is responsible for the production of different inflammatory mediators like Leukotrienes, SRS-A, Prostaglandins etc. Prednisolone is rapidly and well absorbed from the Gl tract following oral administration. Prednisolone is 70- 90% protein-bound in the plasma and it is eliminated from the plasma with a half-life of 2 to 4 hours. It is metabolized mainly in the liver and excreted in the urine.

Adult-
Nephrotic Syndrome:

• Initial: 2 mg/kg/day (maximum 80 mg/day) in divided doses 3 to 4 times/day until urine is protein free for 3 consecutive days (maximum: 28 days); followed by 1 to 1.5 mg/kg/dose given every other day for 4 weeks.
• Maintenance dose: 0.5 to 1 mg/kg/ dose given every other day for 3 to 6 months.

Anti-inflammatory: 5 to 60 mg per day in divided doses 1 to 4 times/day.

Acute Asthma: 40-60 mg/day PO in single daily dose or divided q12 hr for 3-10 days.

Allergic Conditions:

• Day 1: 10 mg PO before breakfast, 5 mg after lunch and after dinner, and 10 mg at bedtime.
• Day 2: 5 mg PO before breakfast, after lunch, and after dinner and 10 mg at bedtime.
• Day 3: 5 mg PO before breakfast, after lunch, after dinner, and at bedtime.
• Day 4: 5 mg PO before breakfast, after lunch, and at bedtime.
• Day 5: 5 mg PO before breakfast and at bedtime.
• Day 6: 5 mg PO before breakfast.

Pediatric-
Asthma:

• 1 year: Acute: 10 mg orally every 12 hours. Maintenance: 10 mg orally every other day.
• 1 to 4 years: Acute: 20 mg orally every 12 hours. Maintenance: 20 mg orally every other day.
• 5 to 12 years: Acute: 30 mg orally every 12 hours. Maintenance: 30 mg orally every other day.
• 12 years: Acute: 40 mg orally every 12 hours. Maintenance: 40 mg orally every other day.

Anti-inflammatory: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Immunosuppression: 0.05 to 2 mg/kg/day divided 1 to 4 times/day.

Common side effects include increased appetite, indigestion, nervousness or restlessness. Less frequent or rare side effects are darkening or lightening of skin color, dizziness or lightheadedness, flushing of face or cheeks, hiccups, increased sweating, the sensation of spinning.

Systemic infections unless specific anti-infective therapy is employed. Hypersensitivity to any ingredient. Ocular herpes simplex because of possible perforation.

Precaution has to be taken in diabetes, hypertension, Psychological disturbances, osteoporosis, post-menopausal women, pregnancy and in chronic nephritis. Long-term use of Prednisolone can cause Cushing's habitus, hyperglycemia, muscular weakness, increased susceptibility to infection, delayed wound healing, and psychiatric disturbances.

The efficacy of prednisolone is reduced by Aminoglutethimide, Antacids, Barbiturates, Carbamazepine, Griseofulvin, Mitotane, Phenylbutazone, Phenytoin, Primidone and Rifampin. Prednisolone reduces the amount of potassium in the blood. Digitalis can cause Cardiac arrhythmias if hypokalemia occurs. Immunization should be done very carefully.

This medicine is not recommended for use during pregnancy unless considered essential by your doctor. It should only be used if the expected benefit to the mother is greater than any possible risk to the foetus. Corticosteroids appear in breast milk and could suppress growth, interfere with endogenous corticosteroid production or cause other unwanted effects.

Adverse effects related to prednisone normally develop only after prolonged use of doses in excess of the normal physiological requirement. Treatment is symptomatic and where possible the prednisone dose should be reduced gradually.

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