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Mifenac
Diclofenac Sodium + Misoprostol
Mifenac
Diclofenac Sodium + Misoprostol
Indications
Rheumatoid arthritis
Indication detailsView
This combination is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
It is a combination product containing Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties and Misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E 1 analog. The mechanism of action of Diclofenac Sodium, like other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. NSAIDs inhibit prostaglandin synthesis. A deficiency of prostaglandins within the gastric and duodenal may lead to diminish bicarbonate and mucosal secretion and may contribute to mucosal damage caused by NSAIDs. Misoprostol can increase bicarbonate and mucous production & prevents gastric and duodenal ulcers.
DosageView
Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
Side effectsView
The most common reported side effects are abdominal pain, diarrhea and other GI symptoms. Diarrhea and abdominal pain developed early in the course of therapy and were usually self-limited (resolved after 2 to 7 days). Rare instances of profound diarrhea leading to severe dehydration have been reported in patients receiving Misoprostol.
ContraindicationsView
This is contraindicated in patients with hypersensitivity to Diclofenac, Misoprostol or to other prostaglandins. This should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
PrecautionsView
Patients with an underlying condition such as inflammatory bowel disease or those in whom dehydration should be monitored carefully if Diclofenac Sodium plus Misoprostol is prescribed.
InteractionsView
Aspirin: Concomitant administration with aspirin is not recommended because Diclofenac Sodium is displaced from its binding sites by aspirin, resulting in lower plasma concentrations, peak plasma levels and AUC values.
Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium. Antihypertensives: NSAIDs can inhibit the activity of antihypertensives, including ACE inhibitors.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious bleeding greater than users of either drug alone.
Oral hypoglycaemics: Diclofenac Sodium does not alter glucose metabolism in healthy people nor it alters the effects of oral hypoglycaemics. Diclofenac Sodium may alter diabetic patient’s response to insulin or oral hypoglycaemics.
Antacids: Antacids reduce the bioavailability of Misoprostol. Antacids may also delay absorption of Diclofenac Sodium.
Diuretics: The Diclofenac Sodium component like other NSAIDs, can inhibit the activity of diuretics. Concomitant therapy with potassium-sparing diuretics may be associated with increased serum potassium levels.
Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium. Antihypertensives: NSAIDs can inhibit the activity of antihypertensives, including ACE inhibitors.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious bleeding greater than users of either drug alone.
Oral hypoglycaemics: Diclofenac Sodium does not alter glucose metabolism in healthy people nor it alters the effects of oral hypoglycaemics. Diclofenac Sodium may alter diabetic patient’s response to insulin or oral hypoglycaemics.
Antacids: Antacids reduce the bioavailability of Misoprostol. Antacids may also delay absorption of Diclofenac Sodium.
Diuretics: The Diclofenac Sodium component like other NSAIDs, can inhibit the activity of diuretics. Concomitant therapy with potassium-sparing diuretics may be associated with increased serum potassium levels.
Pregnancy & lactationView
Because of the abortifacient property of the Misoprostol component, this is contraindicated in women who are pregnant. Diclofenac Sodium has been found in the milk of nursing mothers. Diclofenac Sodium plus Misoprostol is not recommended for use by nursing mothers.
Pediatric usageView
Paediatric use: Safety and effectiveness of Diclofenac Sodium and Misoprostol combination in paediatric patients have not been established.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly person cannot be ruled out. As with any NSAID, the elderly are likely to tolerate adverse events less well than younger patients.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly person cannot be ruled out. As with any NSAID, the elderly are likely to tolerate adverse events less well than younger patients.
Overdose effectsView
Misoprostol: Convulsions, sedation, tremor, dyspnoea, diarrhoea, abdominal pain, fever, palpitations, hypotension, bradycardia. Management: Supportive treatment.
Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely
Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely
StorageView
Store in a cool and dry place below 25º C. Protect from light.
Mifenac
Diclofenac Sodium + Misoprostol
Mifenac
Diclofenac Sodium + Misoprostol
Indications
Rheumatoid arthritis
Indication detailsView
This combination is indicated for treatment of the signs and symptoms of osteoarthritis or rheumatoid arthritis in patients at high risk of developing NSAID-induced gastric and duodenal ulcers and their complications.
Therapeutic classView
Drugs for Osteoarthritis, Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs)
PharmacologyView
It is a combination product containing Diclofenac Sodium, a nonsteroidal anti-inflammatory drug (NSAID) with analgesic properties and Misoprostol, a gastrointestinal (GI) mucosal protective prostaglandin E 1 analog. The mechanism of action of Diclofenac Sodium, like other NSAIDs, is not completely understood but may be related to prostaglandin synthetase inhibition. NSAIDs inhibit prostaglandin synthesis. A deficiency of prostaglandins within the gastric and duodenal may lead to diminish bicarbonate and mucosal secretion and may contribute to mucosal damage caused by NSAIDs. Misoprostol can increase bicarbonate and mucous production & prevents gastric and duodenal ulcers.
DosageView
Osteoarthritis: The recommended dosage for maximal GI mucosal protection is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
Rheumatoid arthritis: The recommended dosage is Diclofenac Sodium 50 mg & Misoprostol 200 µg tid or qid. For patients who experience intolerance, Diclofenac Sodium 75 mg & Misoprostol 200 µg bid or Diclofenac Sodium 50 mg & Misoprostol 200 µg bid can be used.
Side effectsView
The most common reported side effects are abdominal pain, diarrhea and other GI symptoms. Diarrhea and abdominal pain developed early in the course of therapy and were usually self-limited (resolved after 2 to 7 days). Rare instances of profound diarrhea leading to severe dehydration have been reported in patients receiving Misoprostol.
ContraindicationsView
This is contraindicated in patients with hypersensitivity to Diclofenac, Misoprostol or to other prostaglandins. This should not be given to patients who have experienced asthma, urticaria or other allergic-type reactions after taking aspirin or other NSAIDs.
PrecautionsView
Patients with an underlying condition such as inflammatory bowel disease or those in whom dehydration should be monitored carefully if Diclofenac Sodium plus Misoprostol is prescribed.
InteractionsView
Aspirin: Concomitant administration with aspirin is not recommended because Diclofenac Sodium is displaced from its binding sites by aspirin, resulting in lower plasma concentrations, peak plasma levels and AUC values.
Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium. Antihypertensives: NSAIDs can inhibit the activity of antihypertensives, including ACE inhibitors.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious bleeding greater than users of either drug alone.
Oral hypoglycaemics: Diclofenac Sodium does not alter glucose metabolism in healthy people nor it alters the effects of oral hypoglycaemics. Diclofenac Sodium may alter diabetic patient’s response to insulin or oral hypoglycaemics.
Antacids: Antacids reduce the bioavailability of Misoprostol. Antacids may also delay absorption of Diclofenac Sodium.
Diuretics: The Diclofenac Sodium component like other NSAIDs, can inhibit the activity of diuretics. Concomitant therapy with potassium-sparing diuretics may be associated with increased serum potassium levels.
Digoxin: Elevated digoxin levels have been reported in patients receiving digoxin and Diclofenac Sodium. Antihypertensives: NSAIDs can inhibit the activity of antihypertensives, including ACE inhibitors.
Warfarin: The effects of warfarin and NSAIDs on GI bleeding are synergistic, such that users of both drugs together have a risk of serious bleeding greater than users of either drug alone.
Oral hypoglycaemics: Diclofenac Sodium does not alter glucose metabolism in healthy people nor it alters the effects of oral hypoglycaemics. Diclofenac Sodium may alter diabetic patient’s response to insulin or oral hypoglycaemics.
Antacids: Antacids reduce the bioavailability of Misoprostol. Antacids may also delay absorption of Diclofenac Sodium.
Diuretics: The Diclofenac Sodium component like other NSAIDs, can inhibit the activity of diuretics. Concomitant therapy with potassium-sparing diuretics may be associated with increased serum potassium levels.
Pregnancy & lactationView
Because of the abortifacient property of the Misoprostol component, this is contraindicated in women who are pregnant. Diclofenac Sodium has been found in the milk of nursing mothers. Diclofenac Sodium plus Misoprostol is not recommended for use by nursing mothers.
Pediatric usageView
Paediatric use: Safety and effectiveness of Diclofenac Sodium and Misoprostol combination in paediatric patients have not been established.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly person cannot be ruled out. As with any NSAID, the elderly are likely to tolerate adverse events less well than younger patients.
Geriatric use: No overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some elderly person cannot be ruled out. As with any NSAID, the elderly are likely to tolerate adverse events less well than younger patients.
Overdose effectsView
Misoprostol: Convulsions, sedation, tremor, dyspnoea, diarrhoea, abdominal pain, fever, palpitations, hypotension, bradycardia. Management: Supportive treatment.
Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely
Diclofenac: Lethargy, drowsiness, nausea, vomiting, epigastric pain, GI bleeding. HTN, acute renal failure, resp depression, anaphylactoid reactions and coma may occur rarely
StorageView
Store in a cool and dry place below 25º C. Protect from light.
Mifeston
Mifepristone
Mifeston
Mifepristone
Indications
Uterine fibroids
Indication detailsView
Mifepristone is indicated:
- As a medical alternative to surgical termination of intra-uterine pregnancy
- Softening and dilatation of the cervix uteri prior to surgical pregnancy termination
- Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons
- Labour induction for the expulsion of a dead fetus (fetal death in utero).
Therapeutic classView
Drugs acting on the Uterus
PharmacologyView
Mifepristone is a synthetic steroid which blocks the effects of progesterone by competitively binding to the intracellular progesterone receptor. It sensitises the myometrium to the contraction-inducing action of prostaglandin. At higher doses, it blocks the effect of cortisol at the glucocorticoid receptor while increasing circulating cortisol concentrations.
DosageView
As a medical alternative to surgical termination of intra-uterine pregnancy in early pregnancy: 600 mg Mifepristone in a single oral dose followed 36-48 hrs later, by the administration of a prostaglandin analogue Misoprostol 400 mcg orally (up to 49 days) or Gemeprost 1 mg vaginally (up to 63 days).
Softening and dilatation of the cervix uteri prior to surgical pregnancy termination: 200 mg Mifepristone, followed 36-48 hrs later (but not beyond) by a surgical termination of pregnancy.
Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (to reduce the doses of prostaglandin): 600 mg of Mifepristone taken in a single oral dose, 36-48 hrs prior to scheduled prostaglandin administration which will be repeated as often as indicated.
Labour induction for expulsion of a dead fetus (fetal death in utero): 600 mg of Mifepristone in a single oral daily dose for 2 consecutive days. Mifepristone alone leads to expulsion in about 60%. Labour should be induced by the usual methods if it has not started within 72 hrs following the first administration of Mifepristone.
Softening and dilatation of the cervix uteri prior to surgical pregnancy termination: 200 mg Mifepristone, followed 36-48 hrs later (but not beyond) by a surgical termination of pregnancy.
Preparation for the action of prostaglandin analogues in the termination of pregnancy for medical reasons (to reduce the doses of prostaglandin): 600 mg of Mifepristone taken in a single oral dose, 36-48 hrs prior to scheduled prostaglandin administration which will be repeated as often as indicated.
Labour induction for expulsion of a dead fetus (fetal death in utero): 600 mg of Mifepristone in a single oral daily dose for 2 consecutive days. Mifepristone alone leads to expulsion in about 60%. Labour should be induced by the usual methods if it has not started within 72 hrs following the first administration of Mifepristone.
AdministrationView
There are no precautions for timing in relation to food.
Side effectsView
It is very common for women to experience uterine contractions or cramping (10-45%) in the hours following prostaglandin intake. Bleeding increases with gestational age. Heavy bleeding occurs in about 5% of cases and from 0-1.4% may require haemostatic curettage. Uterine rupture, hypotension, skin rashes, urticaria, hot flashes and dizziness have been uncommonly reported.
ContraindicationsView
Mifepristone must not be administered if there is doubt as to the existence or age of the pregnancy or if an extra-uterine pregnancy is suspected. An ultrasound scan and/or measurement of Beta-hCG must be performed before administration. For first trimester abortions, Mifepristone is contraindicated if the pregnancy is beyond 49 days of amenorrhoea when used with Misoprostol, or beyond 63 days of amenorrhoea when used with Gemeprost. Mifepristone should never be prescribed in patients with chronic adrenal failure, known allergy to Mifepristone or to any component of the product, severe asthma uncontrolled by corticosteroid therapy, porphyrias and renal failure, liver failure or malnutrition, or during breast feeding. Mifepristone is a lipophilic compound and may theoretically be excreted in the mother\'s breast milk, however no data is available.
PrecautionsView
Mifepristone is available only in single dose packaging. Administration must be under the supervision of a qualified physician. There are no data on the safety and efficacy of Mifepristone in women with chronic medical conditions such as cardiovascular, hypertensive, hepatic, respiratory or renal disease; insulin-dependent diabetes mellitus; severe anemia or heavy smoking. Women who are more than 35 years of age and who also smoke 10 or more cigarettes per day should be treated with caution because such patients were generally excluded from clinical trials of Mifepristone. Although there is no clinical evidence, the effectiveness of Mifepristone may be lower if Misoprostol is administered more than two days after Mifepristone administration.
InteractionsView
ketoconazole, itraconazole, erythromycin and grapefruit juice may inhibit its metabolism (increasing serum levels of mifepristone). Furthermore, rifampicin, dexamethasone, St John's Wort and certain anticonvulsants (phenytoin, phenobarbital, carbamazepine) may induce mifepristone metabolism (lowering serum levels of Mifepristone). Based on invitro inhibition information, co-administration of mifepristone may lead to an increase in serum levels of drugs that are CYP3A4 substrates.
Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of Mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical termination of pregnancy.
Limited evidence suggests that co-administration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of Mifepristone or the prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical termination of pregnancy.
Pregnancy & lactationView
Pregnancy: Mifepristone is indicated for use in the termination of pregnancy (through 49 days’ pregnancy) and has no other approved indication for use during pregnancy.
Lactation: It is not known whether Mifepristone is excreted in human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their health care provider to decide if they should discard their breast milk for a few days following administration of the medications.
Lactation: It is not known whether Mifepristone is excreted in human milk. Many hormones with a similar chemical structure, however, are excreted in breast milk. Since the effects of Mifepristone on infants are unknown, breast-feeding women should consult with their health care provider to decide if they should discard their breast milk for a few days following administration of the medications.
Pediatric usageView
Use in children: Safety and effectiveness in pediatric patients have not been established.
Overdose effectsView
Single doses of Mifepristone up to 2 gm caused no unwanted reaction. In the event of massive ingestion, signs of adrenal failure might occur. Acute intoxication may require admission to hospital and if relevant treatment with dexamethasone.
StorageView
Store at 25° C.
Miganil
Flunarizine
Miganil
Flunarizine
Indications
Vertigo
Indication detailsView
Flunarizine is indicated for
- Prophylaxis of classic (with aura) or common (without aura) migraine
- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
- Peripheral Vascular Disease (PVD)
- Motion sickness
- Refractory epilepsy resistant to conventional antiepileptic therapy.
Therapeutic classView
Miscellaneous prophylactic migraine preparations
PharmacologyView
Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
DosageView
Migraine Prophylaxis:
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
Side effectsView
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
ContraindicationsView
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
PrecautionsView
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
Pregnancy & lactationView
Safety in pregnancy and lactation has not been established.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Miganil
Flunarizine
Miganil
Flunarizine
Indications
Vertigo
Indication detailsView
Flunarizine is indicated for
- Prophylaxis of classic (with aura) or common (without aura) migraine
- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
- Peripheral Vascular Disease (PVD)
- Motion sickness
- Refractory epilepsy resistant to conventional antiepileptic therapy.
Therapeutic classView
Miscellaneous prophylactic migraine preparations
PharmacologyView
Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
DosageView
Migraine Prophylaxis:
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
Side effectsView
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
ContraindicationsView
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
PrecautionsView
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
Pregnancy & lactationView
Safety in pregnancy and lactation has not been established.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Migesic
Tolfenamic acid
Migesic
Tolfenamic acid
Indications
Pain
Indication detailsView
Tolfenamic acid is used specifically for relieving the pain of migraine headache and also recommended for use as an analgesic in post-operative pain and fever.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine
PharmacologyView
Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) belongs to the fenamate group and is a potent inhibitor of cyclooxygenase enzyme, thus it inhibits the synthesis of important inflammatory mediators such as thromboxane (TX) B2 and prostaglandin (PG) E2. Prostaglandins are responsible for causing swelling pain and inflammation associated with these conditions. It acts not only by inhibiting prostaglandin synthesis, but it also has direct antagonistic action on its receptors.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
DosageView
Adult:
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
- Acute migraine attacks: 200 mg when symptoms appear may be repeated once after 1-2 hour.
- Mild to moderate pain: 100-200 mg tid
- Renal impairment: Dose adjustments may be needed.
- Severe renal impairment: Avoid.
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
Side effectsView
Dysuria especially in males, diarrhoea, nausea epigastric pain, vomiting, dyspepsia, erythema, headache, tremor, euphoria, fatigue, pulmonary infiltration & haematuria. Potentially fatal: Blood dyscrasias and hepatitis.
ContraindicationsView
Active peptic ulcer or bleeding in the gut. Severe heart, kidney or liver failure.
PrecautionsView
Precaution should be needed for patients with asthma bronchospasm, bleeding disorders, cardiovascular diseases, peptic ulceration, hypertension, liver infection, cardiac or renal function impairment and elderly. Increase water intake or dose reduction to reduce dysuria.
InteractionsView
The rate of absorption of Tolfenamic acid increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolfenamic acid. It decreases antihypertensive response to loop diuretics, B-blockers and ACE Inhibitors. Co-administration increases plasma concentration of Lithium Methotrexate and cardiac glycosides. It also increases the risk of nephrotoxicity with ACE inhibitors, Ciclosporin, Tacrolimus or diuretics
Pregnancy & lactationView
This medicine is not recommended for using during pregnancy unless considered essential by doctor Not to be given during the third trimester of pregnancy. NSAID's can appear in breast milk in very low concentrations NSAID's should, if possible, be avoided when breastfeeding.
Overdose effectsView
Symptoms include headache, nausea, vomiting, epigastric pain. gastrointestinal bleeding, diarrhoea excitation, coma, drowsiness dizziness, tinnitus, fainting and convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.
StorageView
Store in a cool and dry place, away from light Keep out of the reach of children.
Migofen
Pizotifen
Migofen
Pizotifen
Indications
Migraine
Indication detailsView
Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.
Therapeutic classView
Anti-histamine Preparations, Other drugs for migraine
PharmacologyView
Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.
DosageView
Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Side effectsView
The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.
ContraindicationsView
Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.
PrecautionsView
Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.
InteractionsView
The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.
Pregnancy & lactationView
Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Migofen
Pizotifen
Migofen
Pizotifen
Indications
Migraine
Indication detailsView
Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.
Therapeutic classView
Anti-histamine Preparations, Other drugs for migraine
PharmacologyView
Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.
DosageView
Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Side effectsView
The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.
ContraindicationsView
Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.
PrecautionsView
Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.
InteractionsView
The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.
Pregnancy & lactationView
Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Migon
Flunarizine
Migon
Flunarizine
Indications
Vertigo
Indication detailsView
Flunarizine is indicated for
- Prophylaxis of classic (with aura) or common (without aura) migraine
- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
- Peripheral Vascular Disease (PVD)
- Motion sickness
- Refractory epilepsy resistant to conventional antiepileptic therapy.
Therapeutic classView
Miscellaneous prophylactic migraine preparations
PharmacologyView
Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
DosageView
Migraine Prophylaxis:
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
Side effectsView
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
ContraindicationsView
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
PrecautionsView
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
Pregnancy & lactationView
Safety in pregnancy and lactation has not been established.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Migon
Flunarizine
Migon
Flunarizine
Indications
Vertigo
Indication detailsView
Flunarizine is indicated for
- Prophylaxis of classic (with aura) or common (without aura) migraine
- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
- Peripheral Vascular Disease (PVD)
- Motion sickness
- Refractory epilepsy resistant to conventional antiepileptic therapy.
Therapeutic classView
Miscellaneous prophylactic migraine preparations
PharmacologyView
Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
DosageView
Migraine Prophylaxis:
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
Side effectsView
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
ContraindicationsView
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
PrecautionsView
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
Pregnancy & lactationView
Safety in pregnancy and lactation has not been established.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Migranex
Pizotifen
Migranex
Pizotifen
Indications
Migraine
Indication detailsView
Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.
Therapeutic classView
Anti-histamine Preparations, Other drugs for migraine
PharmacologyView
Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.
DosageView
Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Side effectsView
The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.
ContraindicationsView
Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.
PrecautionsView
Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.
InteractionsView
The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.
Pregnancy & lactationView
Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Migranex
Pizotifen
Migranex
Pizotifen
Indications
Migraine
Indication detailsView
Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.
Therapeutic classView
Anti-histamine Preparations, Other drugs for migraine
PharmacologyView
Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.
DosageView
Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Side effectsView
The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.
ContraindicationsView
Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.
PrecautionsView
Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.
InteractionsView
The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.
Pregnancy & lactationView
Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Migranil
Pizotifen
Migranil
Pizotifen
Indications
Migraine
Indication detailsView
Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.
Therapeutic classView
Anti-histamine Preparations, Other drugs for migraine
PharmacologyView
Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.
DosageView
Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Side effectsView
The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.
ContraindicationsView
Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.
PrecautionsView
Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.
InteractionsView
The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.
Pregnancy & lactationView
Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Migranil
Pizotifen
Migranil
Pizotifen
Indications
Migraine
Indication detailsView
Pizotifen is indicated as prophylactic treatment of vascular headache of migraine type such as classical migraine, common migraine and cluster headache. It is not effective in relieving migraine attacks once in progress.
Therapeutic classView
Anti-histamine Preparations, Other drugs for migraine
PharmacologyView
Pizotifen works by inhibiting the peripheral actions of serotonin and histamine in increasing the membrane permeability of cranial vessels and transudation of plasmakinin, while altering pain thresholds in migraines. By blocking 5-HT receptors, pizotifen attenuates the signalling of serotonin in causing cranial vasoconstriction, as well as serotonin-enhanced platelet function and aggregation. There is evidence that it also inhibits the peripheral actions of bradykinin. Pizotifen may inhibit serotonin reuptake by blood platelets, which affects the tonicity and decreases passive distension of extracranial arteries. The effects of pizotifen leading to appetite stimulation may be due to the drug acting at the metabolic level rather than a direct stimulation of the appetite centre.
DosageView
Adults: Usually 1.5 mg daily. This may be taken as a single dose at night or in three divided doses. Dosage should be adjusted to the individual patient requirements up to a maximum of 4.5 mg daily. Up to 3 mg may be given as a single dose.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Children (aged over 2 years): Up to 1.5 mg daily, usually as a divided dose, although up to 1 mg has been given as a single dose at night.
Side effectsView
The most common side effects are appetite stimulating effect, increase in body weight and drowsiness.
ContraindicationsView
Pizotifen is contraindicated in patients with known hypersensitivity to any of its ingredients.
PrecautionsView
Urinary retention, renal impairment should be taken in consideration. Drowsiness may affect the performance driving vehicles & operation of machineries. Pizotifen enhances the action of alcohol.
InteractionsView
The central effects of sedatives, hypnotics, antihistamines (including certain common cold preparations) and alcohol may be enhanced by Pizotifen. Pizotifen antagonizes the hypotensive effect of adrenergic neurone blockers.
Pregnancy & lactationView
Information of using Pizotifen in pregnancy is limited, although no ill effects have been reported. The drug should therefore only be given during pregnancy if the potential benefit to mother justifies the potential risk to the fetus. The safety of Pizotifen during lactation has not been established, so mothers should avoid taking it when breast feeding.
StorageView
Keep in a dry place away from light and heat. Keep out of the reach of children.
Migratol
Tolfenamic acid
Migratol
Tolfenamic acid
Indications
Pain
Indication detailsView
Tolfenamic acid is used specifically for relieving the pain of migraine headache and also recommended for use as an analgesic in post-operative pain and fever.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine
PharmacologyView
Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) belongs to the fenamate group and is a potent inhibitor of cyclooxygenase enzyme, thus it inhibits the synthesis of important inflammatory mediators such as thromboxane (TX) B2 and prostaglandin (PG) E2. Prostaglandins are responsible for causing swelling pain and inflammation associated with these conditions. It acts not only by inhibiting prostaglandin synthesis, but it also has direct antagonistic action on its receptors.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
DosageView
Adult:
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
- Acute migraine attacks: 200 mg when symptoms appear may be repeated once after 1-2 hour.
- Mild to moderate pain: 100-200 mg tid
- Renal impairment: Dose adjustments may be needed.
- Severe renal impairment: Avoid.
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
Side effectsView
Dysuria especially in males, diarrhoea, nausea epigastric pain, vomiting, dyspepsia, erythema, headache, tremor, euphoria, fatigue, pulmonary infiltration & haematuria. Potentially fatal: Blood dyscrasias and hepatitis.
ContraindicationsView
Active peptic ulcer or bleeding in the gut. Severe heart, kidney or liver failure.
PrecautionsView
Precaution should be needed for patients with asthma bronchospasm, bleeding disorders, cardiovascular diseases, peptic ulceration, hypertension, liver infection, cardiac or renal function impairment and elderly. Increase water intake or dose reduction to reduce dysuria.
InteractionsView
The rate of absorption of Tolfenamic acid increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolfenamic acid. It decreases antihypertensive response to loop diuretics, B-blockers and ACE Inhibitors. Co-administration increases plasma concentration of Lithium Methotrexate and cardiac glycosides. It also increases the risk of nephrotoxicity with ACE inhibitors, Ciclosporin, Tacrolimus or diuretics
Pregnancy & lactationView
This medicine is not recommended for using during pregnancy unless considered essential by doctor Not to be given during the third trimester of pregnancy. NSAID's can appear in breast milk in very low concentrations NSAID's should, if possible, be avoided when breastfeeding.
Overdose effectsView
Symptoms include headache, nausea, vomiting, epigastric pain. gastrointestinal bleeding, diarrhoea excitation, coma, drowsiness dizziness, tinnitus, fainting and convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.
StorageView
Store in a cool and dry place, away from light Keep out of the reach of children.
Migrex
Tolfenamic acid
Migrex
Tolfenamic acid
Indications
Pain
Indication detailsView
Tolfenamic acid is used specifically for relieving the pain of migraine headache and also recommended for use as an analgesic in post-operative pain and fever.
Therapeutic classView
Drugs used for Rheumatoid Arthritis, Non-steroidal Anti-inflammatory Drugs (NSAIDs), Other drugs for migraine
PharmacologyView
Tolfenamic acid (N-(2-methyl-3-chlorophenyl) anthranilic acid) belongs to the fenamate group and is a potent inhibitor of cyclooxygenase enzyme, thus it inhibits the synthesis of important inflammatory mediators such as thromboxane (TX) B2 and prostaglandin (PG) E2. Prostaglandins are responsible for causing swelling pain and inflammation associated with these conditions. It acts not only by inhibiting prostaglandin synthesis, but it also has direct antagonistic action on its receptors.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
Pharmacokinetic properties: Absorption Readily absorbed from GI tract. Peak plasma concentration: 60-90 min. Bioavailability 85%. Distribution: Protein-binding: 99% Plasma half-life 2 hours. Metabolism: Metabolised in the liver. Tolfenamic acid undergoes enterohepatic circulation. Excretion: Excreted in urine (90%) and faces.
DosageView
Adult:
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
- Acute migraine attacks: 200 mg when symptoms appear may be repeated once after 1-2 hour.
- Mild to moderate pain: 100-200 mg tid
- Renal impairment: Dose adjustments may be needed.
- Severe renal impairment: Avoid.
Tolfenamic acid should be taken with food. Take water during or immediately after meals.
Side effectsView
Dysuria especially in males, diarrhoea, nausea epigastric pain, vomiting, dyspepsia, erythema, headache, tremor, euphoria, fatigue, pulmonary infiltration & haematuria. Potentially fatal: Blood dyscrasias and hepatitis.
ContraindicationsView
Active peptic ulcer or bleeding in the gut. Severe heart, kidney or liver failure.
PrecautionsView
Precaution should be needed for patients with asthma bronchospasm, bleeding disorders, cardiovascular diseases, peptic ulceration, hypertension, liver infection, cardiac or renal function impairment and elderly. Increase water intake or dose reduction to reduce dysuria.
InteractionsView
The rate of absorption of Tolfenamic acid increases with Metoclopramide and Magnesium hydroxide but decreases with Aluminium hydroxide. Risk of bleeding with anticoagulants and other NSAIDS increases when use with Tolfenamic acid. It decreases antihypertensive response to loop diuretics, B-blockers and ACE Inhibitors. Co-administration increases plasma concentration of Lithium Methotrexate and cardiac glycosides. It also increases the risk of nephrotoxicity with ACE inhibitors, Ciclosporin, Tacrolimus or diuretics
Pregnancy & lactationView
This medicine is not recommended for using during pregnancy unless considered essential by doctor Not to be given during the third trimester of pregnancy. NSAID's can appear in breast milk in very low concentrations NSAID's should, if possible, be avoided when breastfeeding.
Overdose effectsView
Symptoms include headache, nausea, vomiting, epigastric pain. gastrointestinal bleeding, diarrhoea excitation, coma, drowsiness dizziness, tinnitus, fainting and convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible. Patients should be treated symptomatically as required.
StorageView
Store in a cool and dry place, away from light Keep out of the reach of children.
Migrin
Ergotamine Tartrate + Caffeine
Migrin
Ergotamine Tartrate + Caffeine
Indications
Acute migraine attacks
Indication detailsView
Ergotamine Tartrate and caffeine are indicated as therapy to abort or prevent vascular headache; e.g., migraine, migraine variants or so-called “histaminic cephalalgia.”
Therapeutic classView
Ergot Alkaloids
PharmacologyView
Ergotamine is an α-adrenergic blocker with a direct stimulating effect on the smooth muscle of peripheral and cranial blood vessels, it also depresses central vasomotor centers.
Caffeine is also a cranial vasoconstrictor.
Caffeine is also a cranial vasoconstrictor.
DosageView
Usual Adult Dose for Cluster Headache:
Oral, Sublingual: 2 mg ergotamine in fixed combination with caffeine given as quickly as possible after the first symptom of headache. Additional 1 mg doses can be given every 30 minutes until the headache has been aborted or until a total dose of 6 mg has been reached or 10 mg/week.Rectal: 2 mg ergotamine in fixed combination with caffeine given as quickly as possible after the first symptom of headache. An additional 2 mg dose can be given 1 hour later if the first dose fails to abort the headache. The total dose should not exceed 4 mg/attack or 10 mg/week.
Usual Adult Dose for Migraine:
Oral, Sublingual: 2 mg ergotamine in fixed combination with caffeine given as quickly as possible after the first symptom of headache. Additional 1 mg doses can be given every 30 minutes until the headache has been aborted or until a total dose of 6 mg has been reached or 10 mg/week.Rectal: 2 mg ergotamine in fixed combination with caffeine given as quickly as possible after the first symptom of headache. An additional 2 mg dose can be given 1 hour later if the first dose fails to abort the headache. The total dose should not exceed 4 mg/attack or 10 mg/week.
Side effectsView
Increased BP, hypotension, rapid and weak pulse, palpitations, arrhythmias, precordial pain, coronary infarction, fibrotic thickening of the heart valves. Cerebral ischaemia and thrombosis, blurred vision, sleep disturbances, urinary retention, muscle cramps and joint pains.
GI symptoms such as nausea, vomiting, constipation, abdominal pain. Dysaesthesia, paraesthesia, formication, tremor, convulsions, headache, extrapyramidal effects. Anxiety, depression, confusion, hallucinations, psychomotor impairment.
GI symptoms such as nausea, vomiting, constipation, abdominal pain. Dysaesthesia, paraesthesia, formication, tremor, convulsions, headache, extrapyramidal effects. Anxiety, depression, confusion, hallucinations, psychomotor impairment.
ContraindicationsView
Not to be used with potent inhibitors of CYP3A4 and protease inhibitors. Hyperthyroidism, renal or hepatic impairment. Pre existing vascular disease including coronary disease, obliterative vascular disease, angina, claudication, peripheral ischaemia, Raynaud's syndrome and hypertension. Not to be used when there is sepsis. Pregnancy and lactation.
PrecautionsView
Not to be taken regularly or used for migraine prophylaxis. Increased risk of arterial constriction and other symptoms of ergotism. Discontinue treatment when symptoms of arterial occlusion occur e.g. numbness and tingling of the extremities. Caution when used in patients with infective hepatitis, cardiac disease or anaemia. GI tract obstructive disease, glaucoma, prostatic hypertrophy or urinary retention may be worsened by cyclizine. May increase risk of retroperitoneal and/or pleuropulmonary fibrosis. Not recommended for use with other vasoconstrictors. Elderly.
Pregnancy & lactationView
Pregnancy: Category X. This medicine should not be used during pregnancy as it may be harmful to the unborn baby.
Lactation: Significant amounts of this medicine may pass into breast milk. It should not be used by breastfeeding mothers as it may be harmful to the nursing infant.
Lactation: Significant amounts of this medicine may pass into breast milk. It should not be used by breastfeeding mothers as it may be harmful to the nursing infant.
Pediatric usageView
Pediatric Use: Safety and effectiveness in pediatric patients have not been established.
Renal Dose Adjustments: Contraindicated in patients with renal dysfunction
Liver Dose Adjustments: Contraindicated in patients with liver dysfunction
Renal Dose Adjustments: Contraindicated in patients with renal dysfunction
Liver Dose Adjustments: Contraindicated in patients with liver dysfunction
Overdose effectsView
Acute overdosage:
- Symptoms: Nausea, vomiting, diarrhoea, extreme thirst, coldness, weakness, tingling and itching of the skin, rapid and weak pulse, hypotension, shock, confusion, convulsions and unconsciousness. BP may be difficult to measure; may result in fatalities. Further symptoms of peripheral vasoconstriction or CV disturbances may occur but be delayed.
- Treatment includes using activated charcoal to reduce absorption. General supportive measures should be instituted. IV vasodilators such as sodium nitroprusside infusion may be required to relieve vasospasm. Peritoneal dialysis and forced diuresis may be used to remove ergotamine from the body.
- Symptoms: Peripheral ischaemia of the extremities, especially the feet and legs. Gangrene may develop in the toes and fingers. Anginal pain, tachycardia or bradycardia and BP fluctuations may occur. Excessive use may lead to pleural and peritoneal fibrosis. Rebound headache may occur and is a major withdrawal symptom following the development of ergotamine dependence.
- Treatment: IV vasodilators e.g. nitroprusside and nitroglycerin may be used to re-establish normal blood flow. Captopril may be used to reverse the effects of chronic overdosage with ergotamine.
StorageView
Store below 25°C.
Migrium
Flunarizine
Migrium
Flunarizine
Indications
Vertigo
Indication detailsView
Flunarizine is indicated for
- Prophylaxis of classic (with aura) or common (without aura) migraine
- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
- Peripheral Vascular Disease (PVD)
- Motion sickness
- Refractory epilepsy resistant to conventional antiepileptic therapy.
Therapeutic classView
Miscellaneous prophylactic migraine preparations
PharmacologyView
Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
DosageView
Migraine Prophylaxis:
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
Side effectsView
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
ContraindicationsView
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
PrecautionsView
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
Pregnancy & lactationView
Safety in pregnancy and lactation has not been established.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Migrium
Flunarizine
Migrium
Flunarizine
Indications
Vertigo
Indication detailsView
Flunarizine is indicated for
- Prophylaxis of classic (with aura) or common (without aura) migraine
- Symptomatic treatment of vestibular vertigo (due to a diagnosed functional disorder of the vestibular system).
- Peripheral Vascular Disease (PVD)
- Motion sickness
- Refractory epilepsy resistant to conventional antiepileptic therapy.
Therapeutic classView
Miscellaneous prophylactic migraine preparations
PharmacologyView
Flunarizine is the difluorinated derivative of cinnarizine. It is a selective calcium channel antagonist. By reducing excessive transmembrane influx of calcium Flunarizine prevents cellular calcium overload. It does not interfere with normal cellular calcium homeostasis. Flunarizine also has some antihistaminic and sedative properties. It binds at an affinity of 99% to plasma protein.
DosageView
Migraine Prophylaxis:
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
- Starting Dose: 10 mg at night in patients less than 65 years of age and 5 mg daily in patients older than 65 years. If, during this treatment depressive, extrapyramidal or other unacceptable symptoms occur, administration should be discontinued. If, after 2 months of this initial treatment, no significant improvement is observed, the patient should be considered a non-responder and administration should be discontinued.
- Maintenance Treatment: If a patient is responding satisfactorily and if a maintenance treatment is needed, the dose should be decreased to 5 days treatment at the same daily dose with two successive medicine free days every week. Even if the prophylactic maintenance treatment is successful and well tolerated, it should be interrupted after 6 months and it should be re-initiated only if the patient relapses.
Vertigo & motion sickness: 10-20 mg daily for adults and 5 mg daily for children (> 40 kg).
Epileptic seizure: 15-20 mg daily in adults and 5 to 10 mg daily for children as an add-on therapy
Side effectsView
Drowsiness and/or fatigue, as well as weight gain and/or increased appetite may occur. The following adverse experiences have been reported during chronic treatment with Flunarizine: depression, of which female patients with a history of depressive illness may be particularly at risk; extrapyramidal symptoms (such as bradykinesia, rigidity, akathisia, orofacial dyskinesia, tremor), of which elderly patients seem particularly at risk. Infrequently reported adverse reaction are: heartburn; nausea; gastralgia; insomnia; anxiety; galactorrhoea; dry mouth; muscle ache; skin rash.
ContraindicationsView
Hypersensitivity to Flunarizine. Flunarizine is contra-indicated in patients with a history of depressive illness, or with pre-existing symptoms of Parkinson's disease or other extrapyramidal disorders.
PrecautionsView
Flunarizine may lead to drowsiness which is aggravated by the simultaneous intake of alcohol or other central nervous system depressants. Patients should be cautioned against driving motor vehicles or performing other potentially hazardous tasks where a loss of mental alertness may lead to accidents. Flunarizine is not suited for aborting a migraine attack. The possible occurrence of an attack is therefore no reason to increase the dose of Flunarizine. This treatment may give rise to extrapyramidal and depressive symptoms and reveal Parkinsonism, especially in predisposed patients such as the elderly. Flunarizine should therefore be used with caution in such patients.
InteractionsView
Galactorrhoea has been reported in few women on oral contraceptives within the first two months of Flunarizine treatment. Hepatic enzyme inducers such as Carbamazepine and Phenytoin may interact with flunarizine by increasing its metabolism. So an increase in dosage of flunarizine may be required.
Pregnancy & lactationView
Safety in pregnancy and lactation has not been established.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.
Mikacin
Amikacin
Mikacin
Amikacin
Indications
Urinary tract infection
Indication detailsView
Amikacin is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria. Amikacin is effective in bacterial septicemia (including neonatal sepsis); in serious infections of the respiratory tract, bones and joints, central nervous system (including meningitis) and skin and soft tissue; intra-abdominal infections (including peritonitis); and in burns and postoperative infections (including postvascular surgery). Clinical studies have shown Amikacin also to be effective in serious complicated and recurrent urinary tract infections due to those organisms.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
Amikacin was effective in infections caused by gentamicin and/or tobramycin-resistant strains of Gram-negative organisms, particularly Proteus rettgeri, Providencia stuartii, Serratia marcescens, and Pseudomonas aeruginosa.
Amikacin has also been shown to be effective in staphylococci infections and may be considered as initial therapy under certain conditions in the treatment of known or suspected staphylococcal disease such as, severe infections where the causative organism may be either a Gram-negative bacterium or a staphylococcus.
Therapeutic classView
Aminoglycosides
PharmacologyView
Amikacin Sulfate is a semi-synthetic aminoglycoside antibiotic. Amikacin is active in vitro against pseudomonas species, Escherichia coli, Proteus species, Providencia species, Klebsiella-Enterobacter species, Acinetobacter species, and Citrobacter freundii. When strains of the above organisms are found to be resistant to other aminoglycosides, including Gentamicin, TobrAmykin and KanAmykin, many are susceptible to Amikacin. Amikacin sulfate is active in vitro against penicillinase and nonpenicillinase-producing Staphylococcus species including methicillin-resistant strains.
DosageView
Adults and children: 15 mg/kg/day in two equally-divided doses (equivalent to 500 mg bid in adults). Use of the 100 mg is recommended for children for the accurate measurement of the appropriate dose.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
Neonates and premature children: An initial loading dose of 10 mg/kg followed by 15 mg/kg/day in two equally divided doses.
Elderly: Amikacin is excreted by the renal route. Renal function should be assessed whenever possible and dosage adjusted as described under impaired renal function.
Life-threatening infections and/or those caused by Pseudomonas: The adult dose may be increased to 500 mg every eight hours but should neither exceed 1.5g/day nor be administered for a period longer than 10 days. A maximum total adult dose of 15g should not be exceeded.
Urinary tract infections (other than pseudomonal infections): 7.5mg/kg/day in two equally divided doses (equivalent to 250 mg b.i.d. in adults).
Impaired renal function: In patients with impaired renal function, the daily dose should be reduced and/or the intervals between doses increased to avoid accumulation of the drug.
AdministrationView
Intramuscular or intravenous administration: For most infections the intramuscular route is preferred, but in life threatening infections, or in patients in whom intramuscular injection route is not feasible the intravenous route may be used.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
Intraperitoneal use: Amikacin may be used as an irrigant after recovery from anesthesia in concentration of 0.25%.
Side effectsView
The adverse effects have been reported with the use of Amikacin are tinnitus, vertigo, partial reversible or irreversible deafness, skin rash, drug fever, headache, paraesthesia, nausea and vomiting.
ContraindicationsView
Amikacin Injection is contraindicated in patients with a known history of hypersensitivity to Amikacin, any constituents of the injection.
PrecautionsView
Since Amikacin is present in high concentrations in the renal excretory system, patients should be well hydrated to minimize chemical irritation of the renal tubules. If azotemia increases, treatment should be stopped. Monitoring of renal function during treatment with aminoglycosides is particularly important.
InteractionsView
Concurrent administration of Amikacin with myorelaxants leads to potentiation of their effects and there is a possibility of cessation of the breathing. The combination with other Aminoglycoside antibiotics should be avoided because of the augmentation of their ototoxic and nephrotoxic effects. Concurrent administration of Amikacin with fast acting diuretics increases the risk of ototoxicity in patients with renal failure. Combination with Cephalosporins or Polymixins increases the risk of nephrotoxicity.
Pregnancy & lactationView
Amikacin rapidly crosses the placenta into the foetal circulation and amniotic fluid and there is a potential risk of ototoxicity in the foetus. There is no information available regarding the safety of this drug during breastfeeding.
Pediatric usageView
Pediatric Use: Safety and effectiveness of Amikacin for injection in children or adolescents under 16 years have not been established
Overdose effectsView
In the event of overdose or toxic reaction, peritoneal dialysis or haemodialysis will aid in the removal of Amikacin from the blood.
StorageView
Keep below 30°C temperature, away from light & moisture. Keep out of the reach of children.