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Flexibac

Baclofen
Oral Solution 5 mg/5 ml Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView
Baclofen is indicated in-
  • spasticity resulting from multiple sclerosis
  • flexor spasms and concomitant pain, clonus and muscular rigidity
  • skeletal muscle spasm resulting from rheumatic disorders
  • spinal cord injuries and other spinal cord diseases
  • cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years
: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
  • 12 month-2 years: 10-20 mg (10-20 ml)
  • 2 years-6 years: 20-30 mg (20-30 ml)
  • 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
  • Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
  • Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
  • Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
  • Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
  • Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
  • Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
  • Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
  • In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
  • Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
  • Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
  • During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
  • Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
  • Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
  • Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
  • Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
  • The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
  • In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
  • The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
  • Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flexidol

Aceclofenac
Tablet 100 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

DosageView

Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.

Side effectsView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

ContraindicationsView

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

PrecautionsView

Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
  • Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
  • Diuretics: may interact the activity of diuretics.
  • Anticoagulants: may enhance the activity of anticoagulant.
  • Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView

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

Flexifen

Baclofen
Tablet 10 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView
Baclofen is indicated in-
  • spasticity resulting from multiple sclerosis
  • flexor spasms and concomitant pain, clonus and muscular rigidity
  • skeletal muscle spasm resulting from rheumatic disorders
  • spinal cord injuries and other spinal cord diseases
  • cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years
: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
  • 12 month-2 years: 10-20 mg (10-20 ml)
  • 2 years-6 years: 20-30 mg (20-30 ml)
  • 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
  • Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
  • Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
  • Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
  • Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
  • Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
  • Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
  • Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
  • In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
  • Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
  • Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
  • During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
  • Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
  • Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
  • Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
  • Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
  • The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
  • In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
  • The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
  • Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flexifen

Baclofen
Tablet 5 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView
Baclofen is indicated in-
  • spasticity resulting from multiple sclerosis
  • flexor spasms and concomitant pain, clonus and muscular rigidity
  • skeletal muscle spasm resulting from rheumatic disorders
  • spinal cord injuries and other spinal cord diseases
  • cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years
: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
  • 12 month-2 years: 10-20 mg (10-20 ml)
  • 2 years-6 years: 20-30 mg (20-30 ml)
  • 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
  • Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
  • Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
  • Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
  • Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
  • Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
  • Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
  • Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
  • In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
  • Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
  • Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
  • During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
  • Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
  • Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
  • Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
  • Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
  • The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
  • In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
  • The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
  • Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flexifen

Baclofen
Tablet 25 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView
Baclofen is indicated in-
  • spasticity resulting from multiple sclerosis
  • flexor spasms and concomitant pain, clonus and muscular rigidity
  • skeletal muscle spasm resulting from rheumatic disorders
  • spinal cord injuries and other spinal cord diseases
  • cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years
: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
  • 12 month-2 years: 10-20 mg (10-20 ml)
  • 2 years-6 years: 20-30 mg (20-30 ml)
  • 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
  • Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
  • Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
  • Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
  • Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
  • Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
  • Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
  • Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
  • In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
  • Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
  • Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
  • During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
  • Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
  • Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
  • Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
  • Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
  • The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
  • In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
  • The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
  • Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flexilax

Baclofen
Tablet 10 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView
Baclofen is indicated in-
  • spasticity resulting from multiple sclerosis
  • flexor spasms and concomitant pain, clonus and muscular rigidity
  • skeletal muscle spasm resulting from rheumatic disorders
  • spinal cord injuries and other spinal cord diseases
  • cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years
: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
  • 12 month-2 years: 10-20 mg (10-20 ml)
  • 2 years-6 years: 20-30 mg (20-30 ml)
  • 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
  • Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
  • Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
  • Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
  • Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
  • Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
  • Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
  • Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
  • In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
  • Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
  • Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
  • During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
  • Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
  • Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
  • Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
  • Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
  • The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
  • In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
  • The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
  • Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flexilax

Baclofen
Tablet 5 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView
Baclofen is indicated in-
  • spasticity resulting from multiple sclerosis
  • flexor spasms and concomitant pain, clonus and muscular rigidity
  • skeletal muscle spasm resulting from rheumatic disorders
  • spinal cord injuries and other spinal cord diseases
  • cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years
: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
  • 12 month-2 years: 10-20 mg (10-20 ml)
  • 2 years-6 years: 20-30 mg (20-30 ml)
  • 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
  • Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
  • Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
  • Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
  • Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
  • Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
  • Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
  • Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
  • In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
  • Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
  • Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
  • During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
  • Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
  • Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
  • Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
  • Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
  • The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
  • In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
  • The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
  • Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Fleximoov

Methyl Salicylate + Menthol
Cream 15%+10% Allopathic Topical Analgesics

Indications

Trigeminal neuralgia

Indication detailsView
This cream is indicated for the fast relief of minor aches and pains of muscles & joints associated with-
  • Joint Pain
  • Back Pain
  • Arthritic Pain
  • Neck & Shoulder Pain
  • Sprains
  • Strains
Therapeutic classView
Local Antipruritic, Topical Analgesics, Topical anti-inflammatory preparations
PharmacologyView
This cream is a specially formulated Methyl salicylate and Menthol cream. It penetrates into skin to provide fast relief from pain and stiffness of minor arthritis and muscle aches. This cream is fast-acting, strong medicine that penetrates deep down to provide long-lasting and effective relief. Methyl salicylate has been shown that first-pass metabolism exists in the skin and rapidly hydrolyzing salicylate ester to release the active salicylate in both epidermis and dermis. It alleviates pain and inflammation by inhibiting the synthesis of prostaglandins that occur in inflamed tissues. Menthol increases the penetration of drugs when applied on the skin to give a faster onset of action. It dilates the blood vessels causing a sensation of coldness followed by an analgesic effect.
DosageView
Adult and children 2 years of age and older: Apply a thin layer to the affected area and gently massage until this cream disappears. Apply to the affected area not more than 3 to 4 times daily.
Side effectsView
Redness or irritation may occur, especially in persons with sensitive skin. Adverse reactions possibly involved are mild to moderate local irritation, erythema, rash, desquamation, pruritis and relative local reaction at the application site.
ContraindicationsView
Allergy to salicylate or sensitivity to any of the components. Application to broken skin or raw surfaces is contraindicated.
PrecautionsView
For external use only. Use only as directed. Do not use with a heating pad. Keep away from children to avoid accidental ingestion. Do not swallow. If swallowed, get medical help or contact a poison control centre immediately. Do not bandage tightly. Keep away from eyes, mucous membranes, broken or irritated skin. If skin redness or excessive irritation develops, pain lasts for more than 10 days or with arthritis-like conditions in children under 12, do not use and call a physician.
InteractionsView
Methyl Salicylate is systemically absorbed through the skin in measurable amounts and may increase Warfarin action by affecting Vitamin K metabolism or by displacing warfarin from protein-binding sites.
Pregnancy & lactationView
This medication should be used only if clearly needed during pregnancy or while breast-feeding.
Overdose effectsView
Large amount of topical application may cause absorption through the skin and may cause salicylism. Symptoms of salicylism include tinnitus,hearing loss, nausea, vomiting etc.
StorageView
It should be stored in a cool and dry place, away from light, temperature not exceeding 30°C. Keep out of reach of children.

Fleximoov

Methyl Salicylate + Menthol
Cream 30%+8% Allopathic Topical Analgesics

Indications

Trigeminal neuralgia

Indication detailsView
This cream is indicated for the fast relief of minor aches and pains of muscles & joints associated with-
  • Joint Pain
  • Back Pain
  • Arthritic Pain
  • Neck & Shoulder Pain
  • Sprains
  • Strains
Therapeutic classView
Local Antipruritic, Topical Analgesics, Topical anti-inflammatory preparations
PharmacologyView
This cream is a specially formulated Methyl salicylate and Menthol cream. It penetrates into skin to provide fast relief from pain and stiffness of minor arthritis and muscle aches. This cream is fast-acting, strong medicine that penetrates deep down to provide long-lasting and effective relief. Methyl salicylate has been shown that first-pass metabolism exists in the skin and rapidly hydrolyzing salicylate ester to release the active salicylate in both epidermis and dermis. It alleviates pain and inflammation by inhibiting the synthesis of prostaglandins that occur in inflamed tissues. Menthol increases the penetration of drugs when applied on the skin to give a faster onset of action. It dilates the blood vessels causing a sensation of coldness followed by an analgesic effect.
DosageView
Adult and children 2 years of age and older: Apply a thin layer to the affected area and gently massage until this cream disappears. Apply to the affected area not more than 3 to 4 times daily.
Side effectsView
Redness or irritation may occur, especially in persons with sensitive skin. Adverse reactions possibly involved are mild to moderate local irritation, erythema, rash, desquamation, pruritis and relative local reaction at the application site.
ContraindicationsView
Allergy to salicylate or sensitivity to any of the components. Application to broken skin or raw surfaces is contraindicated.
PrecautionsView
For external use only. Use only as directed. Do not use with a heating pad. Keep away from children to avoid accidental ingestion. Do not swallow. If swallowed, get medical help or contact a poison control centre immediately. Do not bandage tightly. Keep away from eyes, mucous membranes, broken or irritated skin. If skin redness or excessive irritation develops, pain lasts for more than 10 days or with arthritis-like conditions in children under 12, do not use and call a physician.
InteractionsView
Methyl Salicylate is systemically absorbed through the skin in measurable amounts and may increase Warfarin action by affecting Vitamin K metabolism or by displacing warfarin from protein-binding sites.
Pregnancy & lactationView
This medication should be used only if clearly needed during pregnancy or while breast-feeding.
Overdose effectsView
Large amount of topical application may cause absorption through the skin and may cause salicylism. Symptoms of salicylism include tinnitus,hearing loss, nausea, vomiting etc.
StorageView
It should be stored in a cool and dry place, away from light, temperature not exceeding 30°C. Keep out of reach of children.

Flexiril

Baclofen
Tablet 5 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView
Baclofen is indicated in-
  • spasticity resulting from multiple sclerosis
  • flexor spasms and concomitant pain, clonus and muscular rigidity
  • skeletal muscle spasm resulting from rheumatic disorders
  • spinal cord injuries and other spinal cord diseases
  • cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years
: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
  • 12 month-2 years: 10-20 mg (10-20 ml)
  • 2 years-6 years: 20-30 mg (20-30 ml)
  • 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
  • Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
  • Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
  • Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
  • Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
  • Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
  • Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
  • Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
  • In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
  • Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
  • Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
  • During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
  • Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
  • Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
  • Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
  • Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
  • The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
  • In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
  • The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
  • Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flexiril

Baclofen
Tablet 10 mg Allopathic Centrally acting Skeletal Muscle Relaxants

Indications

Trigeminal neuralgia

Indication detailsView
Baclofen is indicated in-
  • spasticity resulting from multiple sclerosis
  • flexor spasms and concomitant pain, clonus and muscular rigidity
  • skeletal muscle spasm resulting from rheumatic disorders
  • spinal cord injuries and other spinal cord diseases
  • cerebrovascular accidents or neoplastic or degenerative brain disease
Therapeutic classView
Centrally acting Skeletal Muscle Relaxants
PharmacologyView
Baclofen inhibits both monosynaptic and polysynaptic reflexes at the spinal level by stimulating the GABAB receptors, which inhibits the release of glutamate and aspartate. It may also act at intraspinal sites producing CNS depression. Baclofen also exerts an antinociceptive effect.
DosageView
Adult & children over 10 years: 5 mg 3 times daily, preferably with or after food, gradually increased; max. 100 mg daily.

Children <10 years
: Treatment is usually started with 2.5 mg (2.5 ml) given 4 times daily then raised according to requirement. Daily maintenance dose-
  • 12 month-2 years: 10-20 mg (10-20 ml)
  • 2 years-6 years: 20-30 mg (20-30 ml)
  • 6 years-10 years: 30-60 mg (30-60 ml)
Side effectsView
The most common adverse reactions associated with Baclofen are transient drowsiness, daytime sedation, dizziness, weakness and fatigue.
  • Central Nervous System: Headache (<10%), insomnia (<10%), and rarely, euphoria, excitement, depression, confusion, hallucinations, paraesthesia, nightmares, muscle pain, tinnitus, slurred speech, co-ordination disorder, tremor, rigidity, dystonia, ataxia, blurred vision, nystagmus, strabismus, miosis, mydriasis, diplopia, dysarthria, epileptic seizures, respiratory depression.
  • Cardiovascular: Hypotension (<10%), rare instances of dyspnoea, palpitation, chest pain, syncope.
  • Gastrointestinal: Nausea (approximately 10%), constipation (<10%) and rarely, dry mouth, anorexia, taste disorder, abdominal pain, vomiting, diarrhoea and positive test for occult blood in stool.
  • Genitourinary: Urinary frequency (<10%) and rarely, enuresis, urinary retention, dysuria, impotence, inability to ejaculate, nocturia, haematuria.
  • Other: Instances of rash, pruritus, ankle oedema, excessive perspiration, weight gain, nasal congestion, visual disturbances, hepatic function disorders and paradoxical increase in spasticity. Muscular hypotonia of a degree sufficient to make walking or movement difficult may occur but is usually relieved by readjusting the dosage. For this purpose, the daytime dosage may be reduced and the evening dosage increased.
ContraindicationsView
Baclofen is contraindicated in patients with hypersensitivity to any component of this product.
PrecautionsView
  • Lower doses (approximately 5 mg per day) should be used for patients with impaired renal function or those undergoing chronic haemodialysis.
  • Patients suffering not only from spasticity but also from psychotic disorders, schizophrenia, depressive or manic disorders or confusional states should be treated cautiously and closely monitored as exacerbations of these disorders may occur.
  • In patients with epilepsy and muscle spasticity, Baclofen may be used under appropriate supervision and provided that adequate anticonvulsive therapy is continued. Lowering of the convulsion threshold may occur and seizures have been reported after the cessation of Baclofen therapy or with overdose.
  • Baclofen should be used with caution in patients with or with a history of peptic ulcers, cerebrovascular diseases, or hepatic, renal or respiratory failure.
  • Careful monitoring of respiratory and cardiovascular function is essential especially in patients with cardiopulmonary disease and respiratory muscle weakness.
  • During treatment with Baclofen, neurogenic disturbances affecting emptying of the bladder may improve. However in patients with preexisting sphincter hypertonia, acute retention of urine may occur. Baclofen should be used with caution in these circumstances.
  • Baclofen has not significantly benefited patients with stroke. These patients have also shown poor tolerance to the medicine.
  • Appropriate laboratory tests should be performed periodically in patients with hepatic diseases or diabetes mellitus to ensure that no medicine induced changes in these underlying diseases have occurred.
InteractionsView
  • Increased sedation may occur if Baclofen is taken with agents acting on the central nervous system, alcohol or synthetic opiates. The risk of respiratory depression is also increased.
  • Combined treatment with Baclofen and antihypertensives is likely to increase the fall in blood pressure; therefore the dosage of antihypertensive medication should be adjusted accordingly.
  • The concomitant administration of Baclofen and tricyclic antidepressants may potentiate the pharmacological effects of Baclofen resulting in pronounced muscular hypotonia.
  • In patients with Parkinsons disease receiving treatment with Baclofen and levodopa and carbidopa, there have been several reports of mental confusion, hallucinations, headaches, nausea and agitation.
  • The concurrent use of MAO inhibitors and Baclofen may result in increased CNS depressant effects. Caution is advised and the dosage of one or both agents should be adjusted accordingly.
  • Caution should be exercised when administering Baclofen and magnesium sulphate or other neuromuscular blocking agents since a synergistic effect may theoretically occur.
Pregnancy & lactationView
Pregnancy category B3. Safe use of Baclofen during pregnancy has not been established. Baclofen crosses the placental barrier. Baclofen should only be administered to pregnant women when in the judgement of the physician concludes that the potential benefits outweigh the possible hazards. Baclofen is excreted in breast milk however evidence to date suggests that the quantities are so small that no undesirable effects on the infant would be expected.
Overdose effectsView
Gastric lavage is important in case of severe overdose.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flexivan

Aceclofenac
Tablet 100 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

DosageView

Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.

Side effectsView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

ContraindicationsView

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

PrecautionsView

Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
  • Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
  • Diuretics: may interact the activity of diuretics.
  • Anticoagulants: may enhance the activity of anticoagulant.
  • Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView

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

Flexivan ER

Aceclofenac
Tablet (Extended Release) 200 mg Allopathic Drugs for Osteoarthritis

Indications

Spondylitis

Indication detailsView
Aceclofenac is indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis, ankylosing spondylitis, toothache, trauma and lumbago.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

DosageView

Extended release tablet: The recommended dose in adults is one 200 mg Aceclofenac tablet daily or as prescribed by the physician.
Film coated tablet: The recommended dose in adults is 100 mg, twice daily.

Side effectsView

Aceclofenac is a non-steroidal drug with anti-inflammatory and analgesic properties. It is a potent inhibitor of the enzyme cyclooxygenase, which is involved in the production of prostaglandin. After oral administration, it is rapidly and completely absorbed an unchanged drug.

ContraindicationsView

Aceclofenac is contraindicated in patients with known hypersensitivity to it or in whom aspirin or NSAIDs precipitate attacks of asthma.

PrecautionsView

Caution should be exercised to patients with active or suspected peptic ulcer or gastro-intestinal bleeding moderate to severe hepatic impairment and cardiac or renal impairment. Caution should also be exercised in patients suffering from dizziness or urticaria.

InteractionsView
No significant drug interactions has not been observed but close monitoring of patients is required when it is used with:
  • Lithium and Digoxin: may increase plasma concentration of lithium and digoxin.
  • Diuretics: may interact the activity of diuretics.
  • Anticoagulants: may enhance the activity of anticoagulant.
  • Methotrexate: may increase the plasma level of methotrexate.
Pregnancy & lactationView

The use of Aceclofenac should be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the fetus.

Pediatric usageView
There are no clinical data on the use of Aceclofenac in children.
StorageView

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

Flexor

Cyclobenzaprine Hydrochloride
Tablet 10 mg Allopathic Locally acting Skeletal Muscle Relaxants

Indications

Muscle spasm

Indication detailsView
Cyclobenzaprine is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Therapeutic classView
Locally acting Skeletal Muscle Relaxants
PharmacologyView
Cyclobenzaprine, a centrally-acting skeletal muscle relaxant, is structurally related to tricyclic antidepressants, thus they share similar properties. It acts on the brain stem, decreasing tonic-somatic motor activities influencing both the α and δ motor systems. It is used as an adjunct in the symptomatic treatment of painful muscle spasms associated with musculoskeletal conditions.
DosageView
Adult: 5 mg tid, may increase to 10 mg tid if needed. Treatment should not last more than 2-3 wk. Max: 60 mg.

Elderly: Initiate with 5 mg with less frequent dosing.

Pediatric: Safety and effectiveness of Cyclobenzaprine Hydrochloride in pediatric patients below 15 years of age have not been established.
Side effectsView
The adverse reactions reported most frequently with Cyclobenzaprine Hydrochloride are drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions is lower in the surveillance program than in the controlled clinical studies.
ContraindicationsView
Recent MI, arrhythmias, severe liver disease.
PrecautionsView
Because of its atropine-like action, Cyclobenzaprine Hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
InteractionsView
Plasma concentration may be increased with the use of cimetidine, diltiazem, disulfiram, methylphenidate, ritonavir, and verapamil. Side-effects are increased by adrenaline, amiodarone, general anesthetics, SSRIs, antihistamines, antimuscarinics, antipsychotics, anxiolytics and hypnotics, clozapine, disopyramide, diuretics, flecainide, MAOIs, moclobemide, moxifloxacin, nefopam, nicorandil, noradrenaline, phenothiazine, pimozide, procainamide, propafenone, quinidine, selegiline, sibutramine, sotalol, terfenadine, thioridazine, and tramadol. Effects of adrenergic neurone blockers, clonidine, barbiturates, nitrates, and primidone are reduced while effects of baclofen, opioid analgesics, and thyroid hormones are enhanced with concomitant use of cyclobenzaprine. Carbamazepine and rifampicin may increase metabolism of cyclobenzaprine. Effects may be antagonized by oestrogens. Avoid use with brimonidine, entacapone, artemether with lumefantrine, or sibutramine. CNS effects may be enhanced by other CNS depressants.
Pregnancy & lactationView
Pregnancy category B. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Cyclobenzaprine Hydrochloride is administered to a nursing mother
Pediatric usageView
Dose in hepatic impairment: Cyclobenzaprine should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. The use of Cyclobenzaprine in subjects with moderate to severe impairment is not recommended.
Overdose effectsView
Although rare, deaths may occur from over dosage with Cyclobenzaprine Hydrochloride. Signs and symptoms of toxicity may develop rapidly after Cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible.

Flexor

Cyclobenzaprine Hydrochloride
Tablet 5 mg Allopathic Locally acting Skeletal Muscle Relaxants

Indications

Muscle spasm

Indication detailsView
Cyclobenzaprine is indicated as an adjunct to rest and physical therapy for relief of muscle spasm associated with acute, painful musculoskeletal conditions. Improvement is manifested by relief of muscle spasm and its associated signs and symptoms, namely, pain, tenderness, limitation of motion, and restriction in activities of daily living.
Therapeutic classView
Locally acting Skeletal Muscle Relaxants
PharmacologyView
Cyclobenzaprine, a centrally-acting skeletal muscle relaxant, is structurally related to tricyclic antidepressants, thus they share similar properties. It acts on the brain stem, decreasing tonic-somatic motor activities influencing both the α and δ motor systems. It is used as an adjunct in the symptomatic treatment of painful muscle spasms associated with musculoskeletal conditions.
DosageView
Adult: 5 mg tid, may increase to 10 mg tid if needed. Treatment should not last more than 2-3 wk. Max: 60 mg.

Elderly: Initiate with 5 mg with less frequent dosing.

Pediatric: Safety and effectiveness of Cyclobenzaprine Hydrochloride in pediatric patients below 15 years of age have not been established.
Side effectsView
The adverse reactions reported most frequently with Cyclobenzaprine Hydrochloride are drowsiness, dry mouth and dizziness. The incidence of these common adverse reactions is lower in the surveillance program than in the controlled clinical studies.
ContraindicationsView
Recent MI, arrhythmias, severe liver disease.
PrecautionsView
Because of its atropine-like action, Cyclobenzaprine Hydrochloride should be used with caution in patients with a history of urinary retention, angle-closure glaucoma, increased intraocular pressure, and in patients taking anticholinergic medication.
InteractionsView
Plasma concentration may be increased with the use of cimetidine, diltiazem, disulfiram, methylphenidate, ritonavir, and verapamil. Side-effects are increased by adrenaline, amiodarone, general anesthetics, SSRIs, antihistamines, antimuscarinics, antipsychotics, anxiolytics and hypnotics, clozapine, disopyramide, diuretics, flecainide, MAOIs, moclobemide, moxifloxacin, nefopam, nicorandil, noradrenaline, phenothiazine, pimozide, procainamide, propafenone, quinidine, selegiline, sibutramine, sotalol, terfenadine, thioridazine, and tramadol. Effects of adrenergic neurone blockers, clonidine, barbiturates, nitrates, and primidone are reduced while effects of baclofen, opioid analgesics, and thyroid hormones are enhanced with concomitant use of cyclobenzaprine. Carbamazepine and rifampicin may increase metabolism of cyclobenzaprine. Effects may be antagonized by oestrogens. Avoid use with brimonidine, entacapone, artemether with lumefantrine, or sibutramine. CNS effects may be enhanced by other CNS depressants.
Pregnancy & lactationView
Pregnancy category B. This drug should be used during pregnancy only if clearly needed. Caution should be exercised when Cyclobenzaprine Hydrochloride is administered to a nursing mother
Pediatric usageView
Dose in hepatic impairment: Cyclobenzaprine should be used with caution in subjects with mild hepatic impairment starting with the 5 mg dose and titrating slowly upward. The use of Cyclobenzaprine in subjects with moderate to severe impairment is not recommended.
Overdose effectsView
Although rare, deaths may occur from over dosage with Cyclobenzaprine Hydrochloride. Signs and symptoms of toxicity may develop rapidly after Cyclobenzaprine overdose; therefore, hospital monitoring is required as soon as possible.

Fliban

Flibanserin
Tablet 100 mg Allopathic Serotonin-norepinephrine reuptake inhibitor (SNRI)
Indication detailsView
Flibanserin is indicated for the treatment of premenopausal women with acquired, generalized hypoactive sexual desire disorder (HSDD), as characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to:
  • A co-existing medical or psychiatric condition,
  • Problems within the relationship, or
  • The effects of a medication or other drug substance.
Acquired HSDD refers to HSDD that develops in a patient who previously had no problems with sexual desire. Generalized HSDD refers to HSDD that occurs regardless of the type of stimulation, situation or partner.
Therapeutic classView
Serotonin-norepinephrine reuptake inhibitor (SNRI)
PharmacologyView
Flibansetrin has high affinity for serotonin receptors in the brain: it acts as an agonist on 5-HT1A and an antagonist on 5-HT2A. In vivo, flibanserin binds equally to 5-HT1A and 5-HT2A receptors. However, under higher levels of brain 5-HT (i.e., under stress), flibanserin may occupy 5-HT2A receptors in higher proportion than 5-HT(1A) receptors. It may also moderately antagonize D4 (dopamine) receptors and 5-HT2B and 5-HTB2C. Its action on neurotransmitter receptors may contribute to reduction in serotonin levels and increase in dopamine and norepinephrine levels, all of which may play part in reward processing.
DosageView
The recommended dosage of Flibanserin is 100 mg administered orally once per day at bedtime. Flibanserin is dosed at bedtime because administration during waking hours increases the risks of hypotension, syncope, accidental injury, and central nervous system (CNS) depression (such as somnolence and sedation). If a dose of Flibanserin is missed at bedtime, instruct the patient to take the next dose at bedtime on the next day. Instruct the patient to not double the next dose.

Pediatric Use: Flibanserin is not indicated for use in pediatric patients.

Geriatric Use: Flibanserin is not indicated for use in geriatric patients. Safety and effectiveness have not been established in geriatric patients.
Side effectsView
Most common adverse reactions are Dizziness, Somnolence, Nausea, Fatigue, Insomnia, Dry mouth.
ContraindicationsView
Flibanserin is contraindicated: with use of alcohol, with concomitant use with moderate or strong CYP3A4 inhibitors, in patients with hepatic impairment.
PrecautionsView
Hypotension and Syncope with Flibanserin Alone: Patients with pre-syncope should immediately lie supine and promptly seek medical help if symptoms do not resolve.

Central Nervous System (CNS) Depression (e.g., Somnolence, Sedation): Can occur with Flibanserin alone. Exacerbated by other CNS depressants, and in settings where flibanserin concentrations are increased. Patients should avoid activities requiring full alertness (e.g., operating machinery or driving) until at least 6 hours after each dose and until they know how Flibanserin affects them.
InteractionsView
  • Oral Contraceptives and Other Weak CYP3A4 Inhibitors: Increases flibanserin exposures and incidence of adverse reactions.
  • Strong CYP2C19 Inhibitors: Increases flibanserin exposure which may increase risk of hypotension, syncope, and CNS depression.
  • CYP3A4 Inducers: Use of flibanserin not recommended; flibanserin concentrations substantially reduced.
  • Digoxin: Increases digoxin concentrations, which may lead to digoxin toxicity. Increase monitoring of digoxin concentrations.
Pregnancy & lactationView
There are no studies of Flibanserin in pregnant women to inform whether there is a drug-associated risk in humans. Flibanserin is excreted in rat milk. It is unknown whether flibanserin is present in human milk, whether Flibanserin has effects on the breastfed infant, or whether Flibanserin affects milk production. Because of the potential for serious adverse reactions including sedation in a breastfed infant, breastfeeding is not recommended during treatment with Flibanserin.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.

Flindof

Doxophylline
Tablet 200 mg Allopathic Bronchodilator

Indications

Severe bronchospasm

Indication detailsView
Doxophylline is used to treat in following indications:
  • Bronchial asthma
  • Bronchospasm
  • Chronic obstructive pulmonary disease (COPD)
  • Pulmonary disease with spastic bronchial component.
Therapeutic classView
Bronchodilator, Methyl xanthine derivatives
PharmacologyView
Doxophylline is a novel bronchodilator. It structurally differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phosphodiesterase 4 thereby relaxes bronchial smooth muscle. However, differently from Theophylline, Doxophylline appears to have decreased affinities toward adenosine A1 and A2 receptors, which may account for the better safety profile of the drug. Doxophylline is reported to inhibit platelet activating factor (PAF) and generation of leukotriene production.
DosageView
Elderly: 200 mg tablet two or three times daily.

Adults: 400 mg tablet two or three times daily or as prescribed by the physician.

Children:
  • >12 years of age: 10 ml syrup or 200 mg tablet two or three times daily.
  • 6-12 years of age: 6-9 mg/kg body weight two times daily, i.e. if body weight is 10 kg, 3 ml (60 mg) two times daily or as prescribed by the physician.
If required daily dose of Doxophylline is 400 mg then Doxophylline SR tablet to be taken once daily or as prescribed by the physician
Side effectsView
Doxophylline rarely causes serious side effects, however possible side effects are similar for taking excess amount of caffeine. These include: nausea, vomiting, headache, upset stomach and heartburn.
ContraindicationsView
Doxophylline is contraindicated in acute myocardial infarction. It is also contraindicated in patients with hypotension, in lactating women & patients who have shown hypersensitivity to its components.
PrecautionsView
The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, in patients with congestive heart failure and in those patients taking certain other drugs like erythromycin, troleandomycin, lincomycin, allopurinol, cimetidine, propanolol and anti-flu vaccine. In these cases, a lower dose of Doxophylline may be needed. Phenytoin, other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half-life. In these cases higher doses of Doxophylline may be needed.
InteractionsView
Doxophylline should not be administered together with other xanthine derivatives. Toxic synergism with ephedrine has been documented for xanthines. Like other xanthines, concomitant therapy with troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, ranitidine, propranolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels. No evidence of a relationship between Doxophylline serum concentrations and toxic events have been reported.
Pregnancy & lactationView
Animal reproduction studies indicate that, Doxophylline does not cause fetal harm when administered to pregnant animals or can not affect reproduction capacity. However, since there is limited experience in human during pregnancy, xanthines should be given to pregnant women only if clearly needed. Doxophylline is contraindicated in nursing mothers.
Overdose effectsView
In case of overdose severe cardiac arrhythmias and tonic-clonic seizure may occur. These effects may represent the first signs of intoxication. The appearance of side effects may require discontinuation of the treatment which, if necessary, at the physician’s discretion, may be resumed at lower doses after all signs and symptoms of toxicity have subsided.

As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children. Doxophylline should be used only on prescription of specialist physician.

Flindof

Doxophylline
Tablet 400 mg Allopathic Bronchodilator

Indications

Severe bronchospasm

Indication detailsView
Doxophylline is used to treat in following indications:
  • Bronchial asthma
  • Bronchospasm
  • Chronic obstructive pulmonary disease (COPD)
  • Pulmonary disease with spastic bronchial component.
Therapeutic classView
Bronchodilator, Methyl xanthine derivatives
PharmacologyView
Doxophylline is a novel bronchodilator. It structurally differs from Theophylline due to the presence of a dioxolane group in position 7. Doxophylline selectively inhibits phosphodiesterase 4 thereby relaxes bronchial smooth muscle. However, differently from Theophylline, Doxophylline appears to have decreased affinities toward adenosine A1 and A2 receptors, which may account for the better safety profile of the drug. Doxophylline is reported to inhibit platelet activating factor (PAF) and generation of leukotriene production.
DosageView
Elderly: 200 mg tablet two or three times daily.

Adults: 400 mg tablet two or three times daily or as prescribed by the physician.

Children:
  • >12 years of age: 10 ml syrup or 200 mg tablet two or three times daily.
  • 6-12 years of age: 6-9 mg/kg body weight two times daily, i.e. if body weight is 10 kg, 3 ml (60 mg) two times daily or as prescribed by the physician.
If required daily dose of Doxophylline is 400 mg then Doxophylline SR tablet to be taken once daily or as prescribed by the physician
Side effectsView
Doxophylline rarely causes serious side effects, however possible side effects are similar for taking excess amount of caffeine. These include: nausea, vomiting, headache, upset stomach and heartburn.
ContraindicationsView
Doxophylline is contraindicated in acute myocardial infarction. It is also contraindicated in patients with hypotension, in lactating women & patients who have shown hypersensitivity to its components.
PrecautionsView
The half-life of xanthine derivatives is influenced by a number of known variables. It may be prolonged in patients with liver disease, in patients with congestive heart failure and in those patients taking certain other drugs like erythromycin, troleandomycin, lincomycin, allopurinol, cimetidine, propanolol and anti-flu vaccine. In these cases, a lower dose of Doxophylline may be needed. Phenytoin, other anticonvulsants and smoking may cause an increase in clearance with a shorter mean half-life. In these cases higher doses of Doxophylline may be needed.
InteractionsView
Doxophylline should not be administered together with other xanthine derivatives. Toxic synergism with ephedrine has been documented for xanthines. Like other xanthines, concomitant therapy with troleandomycin, lincomycin, clindamycin, allopurinol, cimetidine, ranitidine, propranolol and anti-flu vaccine may decrease the hepatic clearance of xanthines causing an increase in blood levels. No evidence of a relationship between Doxophylline serum concentrations and toxic events have been reported.
Pregnancy & lactationView
Animal reproduction studies indicate that, Doxophylline does not cause fetal harm when administered to pregnant animals or can not affect reproduction capacity. However, since there is limited experience in human during pregnancy, xanthines should be given to pregnant women only if clearly needed. Doxophylline is contraindicated in nursing mothers.
Overdose effectsView
In case of overdose severe cardiac arrhythmias and tonic-clonic seizure may occur. These effects may represent the first signs of intoxication. The appearance of side effects may require discontinuation of the treatment which, if necessary, at the physician’s discretion, may be resumed at lower doses after all signs and symptoms of toxicity have subsided.

As there is no specific antidote, in case of overdose a symptomatic treatment of cardiovascular collapse should be instituted.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children. Doxophylline should be used only on prescription of specialist physician.

Flintex

Ambroxol Hydrochloride
Syrup 15 mg/5 ml Allopathic Cough expectorants & mucolytics

Indications

Sore throat

Indication detailsView
This is indicated in-
  • Productive cough
  • Acute and chronic inflammatory disorders of upper and lower respiratory tracts associated with viscid mucus including acute and chronic bronchitis
  • Inflammatory disease of rhinopharyngeal tract (laryngitis, pharyngitis, sinusitis and rhinitis) associated with viscid mucus
  • Asthmatic bronchitis bronchial asthma with thick expectoration
  • Bronchiectasis
  • Chronic pneumonia etc.
Therapeutic classView
Cough expectorants & mucolytics
PharmacologyView
Ambroxol is the active metabolite of bromhexine and it has been proven that this metabolite possesses a greater bronchosecretolytic effect than bromhexine. It improves sputum rheology by hydrating mechanism leading to liquefaction of mucus in the lumen of respiratory tract, thus facilitating expectoration of mucus and reducing dyspnea. It stimulates production of phospholipids of surfactant by alveolar cells, thus contributing to the lowering of superficial tension in the alveoli. It also reduces bronchial hyperactivity. Ambroxol has anti inflammatory properties owing to the inhibitory effect on the production of cellular cytokines and arachidonic acid metabolites. In patients with COPD it traditionally improves airway patency.
DosageView
Average daily dose (preferably after meal):

Pediatric Drops:
  • 0-6 months: 0.5 ml 2 times a day
  • 6-12 months: 1 ml 2 times a day
  • 1-2 years: 1.25 ml 2 times a day
Syrup:
  • 2-5 years: 2.5 ml (1/2 teaspoonful) 2-3 times a day
  • 5-10 years: 5 ml (1 teaspoonful) 2-3 times a day
  • 10 years and adults: 10 ml (2 teaspoonful) 3 times a day.
Sustained release capsule: Adult and children over 12 years old: 1 capsule once daily.
Side effectsView
Gastrointestinal side effects like epigastric pain, stomach overfill feeling may occur occasionally. Rarely allergic responses such as eruption, urticaria or angioneurotic edema have been reported.
ContraindicationsView
Contraindicated in known hypersensitivity to Ambroxol or Bromhexine.
PrecautionsView
Ambroxol should be given cautiously to patients with gastric and duodenal ulceration or convulsive disorders. Patients with hepatic and renal insufficiency should take it with caution.
InteractionsView
Ambroxol should not be taken simultaneously with antitussives (e.g.Codeine) because phlegm, which has been liquefied by Ambroxol might not be expectorated.
Pregnancy & lactationView
Teratogenic and fetal toxicity studies have shown no harmful effect of Ambroxol. However, it is advised not to use it in pregnancy, especially during the1st trimester. Safety during lactation has not been established yet.
StorageView
Protect from direct light exposure, Store in a dry place at a temperature not exceeding 30°C, Keep out of the reach of children.

Flixocort

Fluticasone Propionate (Inhaler)
Inhaler 125 mcg/metered dose Allopathic Fluocinolone & Combined Preparations

Indications

Asthma

Indication detailsView
Fluticasone Propionate HFA is an inhaled corticosteroid (ICS) indicated for: Maintenance treatment of asthma as prophylactic therapy in patients aged 4 years and older.
Therapeutic classView
Fluocinolone & Combined Preparations, Respiratory corticosteroids
PharmacologyView
Fluticasone propionate is a synthetic trifluorinated corticosteroid with anti-inflammatory activity.  Fluticasone propionate has been shown in vitro to exhibit a binding affinity for the human glucocorticoid receptor that is 18 times that of dexamethasone, almost twice that of beclomethasone-17-monopropionate (BMP), the active metabolite of beclomethasone dipropionate, and over 3 times that of budesonide. Data from the McKenzie vasoconstrictor assay in man are consistent with these results. The clinical significance of these findings is unknown.

Inflammation is an important component in the pathogenesis of asthma. Corticosteroids have been shown to have a wide range of actions on multiple cell types (e.g., mast cells, eosinophils, neutrophils, macrophages, lymphocytes) and mediators (e.g., histamine, eicosanoids, leukotrienes, cytokines) involved in inflammation. These anti-inflammatory actions of corticosteroids contribute to their efficacy in asthma.

Though effective for the treatment of asthma, corticosteroids do not affect asthma symptoms immediately. Individual patients will experience a variable time to onset and degree of symptom relief. Maximum benefit may not be achieved for 1 to 2 weeks or longer after starting treatment. When corticosteroids are discontinued, asthma stability may persist for several days or longer.

Trials in subjects with asthma have shown a favorable ratio between topical anti-inflammatory activity and systemic corticosteroid effects with recommended doses of orally inhaled fluticasone propionate. This is explained by a combination of a relatively high local anti-inflammatory effect, negligible oral systemic bioavailability (<1%), and the minimal pharmacological activity of the only metabolite detected in man.
DosageView
Adult and adolescent patients aged 12 Years and older: The starting dosage is based on previous asthma therapy and asthma severity, including consideration of patients’ current control of asthma symptoms and risk of future exacerbation. The recommended starting dosage for patients aged 12 years and older who are not on an inhaled corticosteroid (ICS) is 88 mcg twice daily, approximately 12 hours apart. For other patients, and for patients who do not respond adequately to the starting dosage after 2 weeks of therapy, higher dosages may provide additional asthma control. The maximum recommended dosage for patients aged 12 years and older is 880 mcg twice daily.

Pediatric patients aged 4 to 11 years: The recommended dosage for patients aged 4 to 11 years is 88 mcg twice daily, approximately 12 hours apart.
AdministrationView
Using an Inhaler seems simple, but most patients do not know how to use it in the right way. If the Inhaler is used in the wrong way, less medicine can reach the lungs. Correct and regular use of the Inhaler will prevent or lessen the severity of asthma attacks.

Following simple steps can help to use Inhaler effectively (According to "National Asthma Guidelines for Medical Practitioners" published by Asthma Association):
  1. Take off the cap.
  2. Shake the inhaler (at least six times) vigorously before each use.
  3. If the inhaler is new or if it has not been used for a week or more, shake it well and release one puff into the air to make sure that it works.
  4. Breathe out as full as comfortably possible & hold the inhaler upright.
  5. Place the actuator into mouth between the teeth and close lips around the mouthpiece.
  6. While breathing deeply and slowly through the mouth, press down firmly add fully on the canister to release medicine.
  7. Remove the inhaler from mouth. Continue holding breath for at least for 10 seconds or as long as it is comfortable.
  8. If doctor has prescribed more than one inhalation per treatment, wait 1 minute between puffs (inhalations). Shake the inhaler well and repeat steps 4 to 7.
  9. After use, replace the cap on the mouthpiece. After each treatment, rinse mouth with water.
  10. Check your technique in front of a mirror from time to time, if you see a white mist during the inhalation, you may not have closed your lips properly around mouthpiece, or you may not be breathing in as you press the can. This indicates failure of technique. If this happens, repeat the procedure from step 4 carefully.
Instructions for Cleaning Inhaler: Clean your Inhaler at least once a week. Remove canister and rinse the plastic actuator and cap in warm water but do not put the metal canister into water. Dry the actuator and cap thoroughly and gently replace the metal canister into the actuator with a twisting motion. Put the cap on the mouthpiece.
Side effectsView
Most common adverse reactions (incidence >3%) are upper respiratory tract infection or inflammation, throat irritation, sinusitis, dysphonia, candidiasis, cough, bronchitis, and headache.
ContraindicationsView
The use of Fluticasone Propionate Inhaler is contraindicated in the following conditions: Primary treatment of status asthmaticus or other acute episodes of asthma where intensive measures are required. Hypersensitivity to any of the ingredients.
PrecautionsView
  • Candida albicans infection of the mouth and pharynx may occur. Monitor patients periodically. Advise the patient to rinse his/her mouth with water without swallowing after inhalation to help reduce the risk.
  • Potential worsening of infections (e.g., existing tuberculosis; fungal, bacterial, viral, or parasitic infections; ocular herpes simplex). Use with caution in patients with these infections. More serious or even fatal course of chickenpox or measles can occur in susceptible patients.
  • Risk of impaired adrenal function when transferring from systemic corticosteroids. Taper patients slowly from systemic corticosteroids if transferring to Fluticasone propionate HFA.
  • Hypercorticism and adrenal suppression may occur with very high dosages or at the regular dosage in susceptible individuals. If such changes occur, discontinue Fluticasone propionate HFA slowly.
  • Assess for decrease in bone mineral density initially and periodically thereafter.
  • Monitor growth of pediatric patients.
  • Glaucoma and cataracts may occur with long-term use of ICS. Consider referral to an ophthalmologist in patients who develop ocular symptoms or use Fluticasone propionate HFA long term.
InteractionsView
Inhibitors of Cytochrome P450 3A4: Fluticasone propionate is a substrate of CYP3A4. The use of strong CYP3A4 inhibitors (e.g., ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir, ketoconazole, telithromycin) with Fluticasone Propionate HFA is not recommended because increased systemic corticosteroid adverse effects may occur.

Ritonavir: A drug interaction trial with fluticasone propionate aqueous nasal spray in healthy subjects has shown that ritonavir (a strong CYP3A4 inhibitor) can significantly increase plasma fluticasone propionate exposure, resulting in significantly reduced serum cortisol concentrations. During postmarketing use, there have been reports of clinically significant drug interactions in patients receiving fluticasone propionate and ritonavir, resulting in systemic corticosteroid effects including Cushing’s syndrome and adrenal suppression.

Ketoconazole: Coadministration of orally inhaled fluticasone propionate (1,000 mcg) and ketoconazole (200 mg once daily) resulted in a 1.9-fold increase in plasma fluticasone propionate exposure and a 45% decrease in plasma cortisol area under the curve (AUC), but had no effect on urinary excretion of cortisol.
Pregnancy & lactationView
There are insufficient data on the use of Fluticasone propionate HFA in pregnant women. There are clinical considerations with the use of Fluticasone propionate HFA in pregnant women. There are no available data on the presence of fluticasone propionate in human milk, the effects on the breastfed child, or the effects on milk production. Other corticosteroids have been detected in human milk.
Pediatric usageView
Pediatric Use: The safety and effectiveness of Fluticasone Propionate Inhaler in children aged 4 years and older have been established
Overdose effectsView
Chronic overdosage may result in signs/symptoms of hypercorticism. Inhalation by healthy volunteers of a single dose of 1,760 or 3,520 mcg of fluticasone propionate CFC inhalation aerosol was well tolerated. Fluticasone propionate given by inhalation aerosol at dosages of 1,320 mcg twice daily for 7 to 15 days to healthy human volunteers was also well tolerated. Repeat oral doses up to 80 mg daily for 10 days in healthy volunteers and repeat oral doses up to 20 mg daily for 42 days in subjects were well tolerated. Adverse reactions were of mild or moderate severity, and incidences were similar in active and placebo treatment groups.
StorageView
Store at room temperature between 20°C and 25°C. Keep away from light & moisture. Keep out of the reach of children.